[Senate Hearing 116-557]
[From the U.S. Government Publishing Office]
S. Hrg. 116-557
COVID 19
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON
HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
----------
ROUNDTABLE: ARE WE PREPARED? PROTECTING THE U.S. FROM GLOBAL PANDEMICS,
FEBRUARY 12, 2020
THE FEDERAL INTERAGENCY RESPONSE TO THE CORONAVIRUS AND PREPARING FOR
FUTURE GLOBAL PANDEMICS, MARCH 5, 2020
REMOTE ROUNDTABLE COVID-19: HOW NEW INFORMATION SHOULD DRIVE POLICY,
MAY 6, 2020
EVALUATING THE FEDERAL GOVERNMENT'S PROCUREMENT AND DISTRIBUTION
STRATEGIES IN RESPONSE TO THE COVID-19
PANDEMIC, JUNE 9, 2020
THE ROLE OF THE STRATEGIC NATIONAL STOCKPILE IN PANDEMIC RESPONSE, JUNE
24, 2020
CBP OVERSIGHT: EXAMINING THE EVOLVING CHALLENGES FACING THE AGENCY,
JUNE 25, 2020
OVERSIGHT OF COVID-19 FINANCIAL RELIEF PACKAGES,
JULY 28, 2020
EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A
COVID-19 SOLUTION, NOVEMBER 19, 2020
EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A COVID-19 SOLUTION,
PART II, DECEMBER 8, 2020
----------
Available via the World Wide Web: http://govinfo.gov
Printed for the use of the
Committee on Homeland Security and Governmental Affairs
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
COVID-19--VOLUME 1
S. Hrg. 116-557
COVID 19
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON
HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
__________
ROUNDTABLE: ARE WE PREPARED? PROTECTING THE U.S. FROM GLOBAL PANDEMICS,
FEBRUARY 12, 2020
THE FEDERAL INTERAGENCY RESPONSE TO THE CORONAVIRUS AND PREPARING FOR
FUTURE GLOBAL PANDEMICS, MARCH 5, 2020
REMOTE ROUNDTABLE COVID-19: HOW NEW INFORMATION SHOULD DRIVE POLICY,
MAY 6, 2020
EVALUATING THE FEDERAL GOVERNMENT'S PROCUREMENT AND DISTRIBUTION
STRATEGIES IN RESPONSE TO THE COVID-19
PANDEMIC, JUNE 9, 2020
THE ROLE OF THE STRATEGIC NATIONAL STOCKPILE IN PANDEMIC RESPONSE, JUNE
24, 2020
CBP OVERSIGHT: EXAMINING THE EVOLVING CHALLENGES FACING THE AGENCY,
JUNE 25, 2020
OVERSIGHT OF COVID-19 FINANCIAL RELIEF PACKAGES,
JULY 28, 2020
EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A COVID-19 SOLUTION,
NOVEMBER 19, 2020
EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A COVID-19 SOLUTION,
PART II, DECEMBER 8, 2020
__________
Available via the World Wide Web: http://govinfo.gov
Printed for the use of the
Committee on Homeland Security and Governmental Affairs
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
__________
U.S. GOVERNMENT PUBLISHING OFFICE
40-549 PDF WASHINGTON : 2022
-----------------------------------------------------------------------------------
COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
RON JOHNSON, Wisconsin, Chairman
ROB PORTMAN, Ohio GARY C. PETERS, Michigan
RAND PAUL, Kentucky THOMAS R. CARPER, Delaware
JAMES LANKFORD, Oklahoma MAGGIE HASSAN, New Hampshire
MITT ROMNEY, Utah KAMALA D. HARRIS, California
RICK SCOTT, Florida KYRSTEN SINEMA, Arizona
MICHAEL B. ENZI, Wyoming JACKY ROSEN, Nevada
JOSH HAWLEY, Missouri
Gabrielle D'Adamo Singer, Staff Director
Joshua McLeod, Senior Professional Staff Member
Charles Carroll, Professional Staff Member
Barrett F. Percival, Professional Staff Member
Charles Carroll, Professional Staff Member
Caroline K. Bender, Research Assistant
Jessica J. McTigue, State Department Detailee
David M. Weinberg, Minority Staff Director
Zachary I. Schram, Minority Chief Counsel
Alexa E. Noruk, Minority Director of Homeland Security
Megan L. Petry, Minority Investigative Counsel
Christopher J. Mulkins, Minority Senior Professional Staff Member
Samuel Rodarte, Jr., Minority Professional Staff Member
Laura W. Kilbride, Chief Clerk
Thomas J. Spino, Hearing Clerk
C O N T E N T S
------
Opening statements:
Page
Senator Johnson
Senator Peters
Senator Hassan
Senator Carper
Senator Scott
Senator Harris
Senator Rosen
Senator Hawley
Senator Sinema
Senator Romney
Senator Lankford
Senator Portman
Senator Enzi................................................. 1174
Senator Paul................................................. 1976
Prepared statements:
Senator Johnson
Senator Peters
Senator Hassan............................................... 2008
Wednesday, February 12, 2020
WITNESSES
Hon. Scott Gottlieb, MD, Former Commissioner (2017-2019), of the
Food and Drug Administration, U.S. Department of Health and
Human Services................................................. 3
Julie L. Gerberding, MD, Former Director (2002-2009) of the
Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services...................................... 5
Luciana Borio, MD, Former Director for Medical and Biodefense
Preparedness (2017-2019) at the National Security Council...... 7
Nikki Clowers, Managing Director, Health Care Team, U.S.
Government Accountability Office............................... 9
Asha M. George, DrPH, Executive Director, Bipartisan Commission
on Biodefense.................................................. 10
Alphabetical List of Witnesses
Borio, Luciana MD:
Testimony.................................................... 7
Prepared statement........................................... 48
Clowers, Nikki:
Testimony.................................................... 9
George, Asha M. DrPH:
Testimony.................................................... 10
Prepared statement........................................... 52
Gerberding, Julie L. MD:
Testimony.................................................... 5
Gottlieb, Hon. Scott MD:
Testimony.................................................... 3
Prepared statement........................................... 42
APPENDIX
Chart submitted by Julie Gerberding.............................. 57
CSIS Report...................................................... 58
Bipartisan Commission on Biodefense Reports...................... 129
Thursday, March 5, 2020
WITNESSES
Hon. Ken Cuccinelli II, Senior Official Performing the Duties of
the Deputy Secretary, U.S. Department of Homeland Security..... 323
Hon. Robert Kadlec, M.D., Assistant Secretary for Preparedness
and Response, U.S. Department of Health and Human Services..... 325
Alphabetical List of Witnesses
Cuccinelli, Hon. Ken II:
Testimony.................................................... 323
Prepared statement........................................... 364
Kadlec, Hon. Robert M.D.:
Testimony.................................................... 325
Prepared statement........................................... 370
APPENDIX
HLC statement for the record..................................... 395
Wednesday, May 6, 2020
WITNESSES
Pierre Kory, MD, MPA, Critical Care Service Chief, Associate
Professor of Medicine, University of Wisconsin School of
Medicine and Public Health..................................... 402
David L. Katz, MD, MPH, President, True Health Initiative........ 407
Tom Inglesby, MD, Director, Center for Health Security, Johns
Hopkins Bloomberg School of Public Health...................... 411
Avik Roy, President, Foundation for Research on Equal Opportunity 412
John P.A. Ioannidis, MD, C.F. Rehnborg Professor in Disease
Prevention School of Medicine, Stanford University............. 414
Scott W. Atlas, MD, David and Joan Traitel Senior Fellow, Hoover
Institution, Stanford University............................... 417
Alphabetical List of Witnesses
Atlas, Scott W.:
Testimony.................................................... 417
Prepared statement........................................... 479
Inglesby, Tom MD:
Testimony.................................................... 411
Prepared statement........................................... 466
Ioannidis, John P.A.:
Testimony.................................................... 414
Prepared statement........................................... 476
Katz, David L.:
Testimony.................................................... 407
Prepared statement........................................... 458
Kory, Pierre:
Testimony.................................................... 402
Prepared statement........................................... 453
Roy, Avik:
Testimony.................................................... 412
Prepared statement........................................... 471
APPENDIX
Causes of Death chart............................................ 483
Influenza in U.S. chart.......................................... 484
States Compared Chart............................................ 485
Countries compared chart......................................... 486
COVID Age Risk Calculator........................................ 487
LinkedIn Article................................................. 488
MedRxiv Article.................................................. 492
Roger Stein statement............................................ 494
Medium Article................................................... 558
WSJ Article...................................................... 587
Tuesday, June 9, 2020
WITNESSES
Admiral Brett P. Giroir, M.D., Assistant Secretary for Health,
U.S. Department of Health and Human Services................... 595
Hon. Peter T. Gaynor, Administrator, Federal Emergency Management
Agency, U.S. Department of Homeland Security................... 597
Rear Admiral John Polowczyk, Vice Director for Logistics, Joint
Chiefs of Staff, U.S. Department of Defense.................... 599
Alphabetical List of Witnesses
Gaynor, Hon. Peter T.:
Testimony.................................................... 597
Joint prepared statement..................................... 645
Giroir, Admiral Brett P.:
Testimony.................................................... 595
Prepared statement........................................... 634
Polowczyk, Rear Admiral John:
Testimony.................................................... 599
Joint prepared statement..................................... 645
APPENDIX
Harris Letters................................................... 661
FEMA Hurricane Plan.............................................. 678
Responses to post-hearing questions for the Record:
Admiral Giroir............................................... 737
Mr. Gaynor and Rear Admiral Polowczyk........................ 751
Wednesday, June 24, 2020
WITNESSES
Julie Gerberding, M.D., Former Director, Centers for Disease
Control and Prevention, U.S. Department of Health and Human
Services....................................................... 786
Daniel M. Gerstein, Ph.D., Senior Policy Researcher, RAND
Corporation.................................................... 788
Andrew Phelps, Director, Oregon Office of Emergency Management,
on behalf of the National Emergency Management Association..... 790
Gregory Burel, Former Director, Strategic National Stockpile,
U.S. Department of Health and Human Services................... 792
Alphabetical List of Witnesses
Burel, Gregory:
Testimony.................................................... 792
Prepared statement........................................... 849
Gerberding, Julie, M.D.:
Testimony.................................................... 786
Prepared statement........................................... 820
Gerstein, Daniel M., Ph.D.:
Testimony.................................................... 788
Prepared statement........................................... 824
Phelps, Andrew:
Testimony.................................................... 790
Prepared statement........................................... 842
APPENDIX
Portman Letter to DOD............................................ 856
CSIS Report...................................................... 58
Responses to post-hearing questions for the Record:
Ms. Gerberding............................................... 859
Mr. Gerstein................................................. 870
Mr. Phelps................................................... 877
Mr. Burel.................................................... 884
Thursday, June 25, 2020
WITNESSES
Mark A. Morgan, Chief Operating Officer and Senior Official
Performing the Duties of the Commissioner, U.S. Customs and
Border Protection, U.S. Department of Homeland Security
Testimony.................................................... 896
Prepared statement........................................... 928
APPENDIX
SW Border Apprehensions Chart.................................... 940
Southwest Border Apprehensions/Asylum Claims Chart............... 941
SW Border Apprehensions Chart.................................... 942
Statements submitted by Senator Harris........................... 943
Statements submitted for the Record:
Church World Service......................................... 953
Human Rights First........................................... 954
Kids In Need of Defense...................................... 960
United States Conference of Catholic Bishops................. 963
Responses to post-hearing questions for the Record:
Mr. Morgan................................................... 971
Tuesday, July 28, 2020
WITNESSES
Maya MacGuineas, President, Committee for a Responsible Federal
Budget......................................................... 1035
Veronique de Rugy, Ph.D., Senior Research Fellow, Mercatus
Center, George Mason University................................ 1037
Danielle Brian, Executive Director, Project on Government
Oversight...................................................... 1038
Hon. Neil Barofsky, Partner, Jenner & Block, LLP, and Former
Special Inspector General (2008-11) Troubled Asset Relief
Program........................................................ 1040
Hon. Phil Gramm, Former U.S. Senator from the State of Texas, and
Visiting Scholar, American Enterprise Institute................ 1042
Alphabetical List of Witnesses
Barofsky, Hon. Neil:
Testimony.................................................... 1040
Prepared statement........................................... 1105
Brian, Danielle:
Testimony.................................................... 1038
Prepared statement........................................... 1088
de Rugy, Veronique, Ph.D.:
Testimony.................................................... 1037
Prepared statement........................................... 1083
Gramm, Hon. Phil:
Testimony.................................................... 1042
Prepared statement........................................... 1127
MacGuineas, Maya:
Testimony.................................................... 1035
Prepared statement........................................... 1073
APPENDIX
Danielle Brian attachment to testimony........................... 1130
Responses to post-hearing questions for the Record:
Mr. Barofsky................................................. 1137
Thursday, November 19, 2020
WITNESSES
Peter A. McCullough, M.D., M.P.H., Vice Chief of Internal
Medicine, Baylor University Medical Center..................... 1152
Harvey A. Risch, M.D., Ph.D., Professor of Epidemiology, Yale
School of Public Health........................................ 1154
George Fareed, M.D., Medical Director and Family Medicine
Specialist, Pioneers Medical Center............................ 1157
Ashish K. Jha, M.D., M.P.H., Dean, School of Public Health, Brown
University..................................................... 1159
Alphabetical List of Witnesses
Fareed, George M.D.:
Testimony.................................................... 1157
Prepared statement........................................... 1201
Jha, Ashish K., M.D., M.P.H.:
Testimony.................................................... 1159
Prepared statement........................................... 1203
McCullough, Peter A., M.D., M.P.H.:
Testimony.................................................... 1152
Prepared statement........................................... 1195
Risch, Harvey A., M.D., Ph.D.:
Testimony.................................................... 1154
Prepared statement........................................... 1197
APPENDIX
Hatfill statement................................................ 1226
Zelenko statement................................................ 1259
COVID studies.................................................... 1269
McCullough attachments........................................... 1580
Risch attachment................................................. 1599
Fareed's attachments............................................. 1900
Responses to post-hearing questions for the Record:
Dr. McCullough............................................... 1901
Dr. Risch.................................................... 1944
Dr. Fareed................................................... 1946
Dr. Jha...................................................... 1948
Tuesday, December 8, 2020
WITNESSES
Ramin Oskoui, M.D., Vice President of Medical Staff, Sibley
Memorial Hospital, and Chief Executive Officer, Foxhall
Cardiology..................................................... 1962
Jean-Jacques Rajter, M.D., Pulmonologist, Broward Health Medical
Center......................................................... 1964
Pierre Kory, M.D., Associate Professor of Medicine, St. Lukes
Aurora Medical Center.......................................... 1966
Armand Balboni, M.D., Ph.D., Chief Executive Officer, Appili
Therapeutics, Inc.............................................. 1969
Jane M. Orient, M.D., Executive Director, Association of American
Physicians and Surgeons........................................ 1971
Jayanta Bhattacharya, M.D., Ph.D., Professor of Medicine,
Stanford Institute for Economic Policy Research................ 1974
Alphabetical List of Witnesses
Balboni, Armand, M.D., Ph.D.:
Testimony.................................................... 1969
Prepared statement........................................... 2039
Bhattacharya, Jayanta, M.D., Ph.D.:
Testimony.................................................... 1974
Prepared statement........................................... 2043
Kory, Pierre, M.D.:
Testimony.................................................... 1966
Prepared statement........................................... 2023
Orient, Jane M., M.D.:
Testimony.................................................... 1971
Prepared statement........................................... 2041
Oskoui, Ramin, M.D.:
Testimony.................................................... 1962
Prepared statement........................................... 2009
Rajter, Jean-Jacques M.D.:
Testimony.................................................... 1964
Prepared statement........................................... 2017
APPENDIX
Four Pillars of Pandemic chart................................... 2047
Three stages of COVID chart...................................... 2048
Statements submitted by Senator Peters........................... 2049
Kory attachments................................................. 2089
Oskoui attachments............................................... 2136
Rajter attachment................................................ 2160
ROUNDTABLE: ARE WE PREPARED?
PROTECTING THE U.S. FROM GLOBAL PANDEMICS
----------
WEDNESDAY, FEBRUARY 12, 2020
U.S. Senate,
Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 9:34 a.m., in
room SD-G50, Dirksen Senate Office Building, Hon. Ron Johnson,
Chairman of the Committee, presiding.
Present: Senators Johnson, Lankford, Scott, Hawley, Peters,
Carper, Hassan, Harris, Sinema, and Rosen.
OPENING STATEMENT OF CHAIRMAN JOHNSON
Chairman Johnson. Good morning. I want to welcome all of
our witnesses, thank you for your time and your testimony and
the answers you will be providing to our questions. I want to
thank everybody else for coming as well.
This obviously is an important topic. I will say up front,
I am disappointed that we do not have a representative from the
Department of Homeland Security (DHS) or the Department of
Health and Human Services Centers for Disease Control (HHS CDC)
here. I spoke with those folks. I thought I had them convinced
to come, but apparently, they are doing an all-Senate briefing
at 11:30. I understand the demand on their time in terms of
briefing Senators, but I think it is extremely important the
public understands these things as well.
I have all kinds of questions, and what I told the
witnesses here is we are not going to confine your opening
statements to 2 minutes or 5 minutes. I want you to provide the
public information.
The main reason I called this roundtable is just to put
things in perspective. The Federal Government plays a role
here. We do not want the Federal Government to underreact, but
we also do not want the Federal Government to overreact. I
think the probability that they are going to get it just right
is zero, but I think it is important that we discuss what are
the considerations in the actions that we do take, what actions
would be effective, what actions will largely be ineffective.
I know a number of you have already published articles, and
you have had that kind of discussion. That is kind of what I
want to get on the table. I want this roundtable to layout the
information that the public needs to begin considering,
realizing there are no set answers yet. We just do not know all
kinds of things, but there is plenty that we do know. So let us
acknowledge the fact that there is a lot of unknowns in this
process yet, but information in the public realm is better than
not having the information out there.
I think we are seeing the difference right now between our
democratic open-press system versus China where I think because
of that closed system, it is probably getting closer to out of
control there, where we have the real possibility by providing
the public the information they need to have, providing health
professionals. People are aware. They can take, hopefully,
precautionary measures inside hospitals where you have severe
cases. We can limit the spread of this as best as possible.
I have a prepared statement. I will just enter it into the
record.\1\
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Johnson appear in the
Appendix on page 41.
---------------------------------------------------------------------------
Chairman Johnson. I will turn it over to Senator Peters.
OPENING STATEMENT OF SENATOR PETERS
Senator Peters. Thank you, Mr. Chairman. I will be brief
too.
Thank you to all of our witnesses for being here, and I
will just share my disappointment as well with you, Mr.
Chairman, that we do not have CDC and Homeland Security, but
hopefully, we will be able to have a hearing coming up that
will bring them in because I agree getting this information out
in the public is really important. When folks do not know
something, you can have a lot of misinformation getting around
there and kind of gin up fears. We do not want to do that. We
want to treat this with the seriousness that it deserves but
make sure there is full transparency as to what is happening
and how we are dealing with it.
I think this an important issue for us to address because
this is not going to be the last time. Wherever you have a
disease spreading fairly quickly--pandemics are part of human
history. They have been throughout human history. They are
going to continue. There are some that may argue that they
become more complicated as time goes on and as we become more
of an interconnected world as well. So I think we have to be
thinking about this in the long term, making sure our resources
are there.
I certainly was disappointed in the President's budget that
shows a pretty substantial cut to programs related to pandemics
at a time when we may be on the verge of a pandemic. It shows
that that is shortsighted, and we have to be thinking about
this from a homeland security issue as well.
We are the Homeland Security Committee. This is about
protecting the homeland. I am going to be asking questions
related to our capacity to produce vaccines, for example, if
and when a vaccine is developed, what sort of capacity is here
in the United States, and if we are relying on China to produce
vaccines for us here in the United States, I suspect they will
use those vaccines for their own people first before they come
to the United States. That would be a very rational and
reasonable expectation.
We have to make sure that we have the resources in our
country to protect ourselves, not only from naturally occurring
pandemics, but actually, Dr. Gerberding, we have talked about
it from the weaponization as well in a different committee that
I am on, Emerging Threats and Capabilities. There is also the
potential for bioweapons to be used, and we need to be prepared
on all fronts.
I look forward to the conversation and look forward to
moving forward on this important issue.
Chairman Johnson. Thank you, Senator Peters.
Why do not we start with Dr. Gottlieb, and then we will
kind of alternate back and forth.
TESTIMONY OF HON. SCOTT GOTTLIEB, MD, FORMER COMMISSIONER
(2017-2019) OF THE FOOD AND DRUG ADMINISTRATION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Gottlieb. I do not think these are working right now,
but thanks, Mr. Chairman, Mr. Ranking Member. I think they are
working now. I appreciate the opportunity to be here today
before you, and thank you for submitting my full statement to
the record.\1\
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Gottlieb appears in the Appendix
on page 42.
---------------------------------------------------------------------------
This is a deeply concerning event, this novel coronavirus
disease 2019 (COVID-19). We do not understand its true severity
at this point. We do not understand the transmissibility. I
think we are going to learn a lot more information in the
coming weeks as we start to see outbreaks emerge in other
regions of the world that are going to provide better
information than we have been able to get out of China.
But the fear right now is that this could occupy that
middle ground between contagion and virulence, where it is
contagious enough to spread very efficiently around the world
but still virulent enough to cause a lot of death and suffering
when it is distributed across a very large population.
I think one of the very instructive things right now that
we should keep a very close eye on is the situation in
Singapore, which is growing more and more concerning by the
day.
I would remind folks it is quite warm in Singapore right
now, about 90 degrees at a high during the day, lows in the
70s. While we would hope that this summer would be a backstop
against propagation of coronaviruses--and it typically is--it
might not be in this case where you have a very novel virus
that is going to transfer more easily because people do not
have any cross-immunity.
Of the 50 cases that have been identified in Singapore--and
they have an excellent system for doing tracking and tracing in
these kinds of situations--eight are currently in the intensive
care unit (ICU), and so that is at least some indication of the
potential severity of this.
I want to focus my brief remarks up front today on some of
the supply chain issues that this situation exposes and draw
from some of the work that I did previously at the Food and
Drug Administration (FDA) as well as what we seem to be
learning in the setting of this current out break.
Wuhan, in particular, in the Hubei Province was a center
for production of pharmaceutical ingredients but not
pharmaceutical ingredients that we typically think of when we
think of the active pharmaceutical ingredients (APIs) that go
into manufacturing drugs and into what we call the ``fill-
finishing process,'' actually taking the raw ingredient of the
drug product itself and putting it in the tablet or capsule.
Typically, a lot of the APIs manufactured, some of it in
China--a lot of it is manufactured in India, some of it in
Europe and the United States. The fill-finishing work, actually
taking that active pharmaceutical ingredient and turning it
into a capsule or a tablet, that is often done in the United
States or in countries like Ireland.
What goes on in China, the kind of production that they
have, is actually making the starting materials for the active
pharmaceutical ingredient. So the first chemicals that go into
the API is oftentimes what is made in China, and in many cases,
China is the sole source for that material.
A lot of the materials that were manufactured in Wuhan
actually got shipped to India where the Indian generic
companies did the manufacturing of the active pharmaceutical
ingredient, and what we are finding now is that in many cases,
China was the only supplier of these raw ingredients. So what
we have identified through this episode is a critical choke
point in the supply chain for pharmaceuticals and some critical
pharmaceuticals, a lot of anti-infectives that are
manufactured, generic anti-infectives that are manufactured in
India. The starting ingredients that go into those, those
intermediate products of the anti-infectives, are actually
manufactured in China.
So it calls into question whether or not we have the right
policies, I believe, in terms of how we look at potential
disruptions in the supply chain, because our orientation
historically has been focused on the finished product.
We have required manufacturers historically to report to
the FDA when there are shortages or near shortages of finished
product.
We have some insight into the manufacturer of API, but on
the whole, we are not typically looking all the way down
through the supply chain or requiring manufacturers to do that
and report on what these critical choke points can be.
So it begs the question whether or not we should reconsider
those policies, and it is not just in the setting of pandemics
where this can become a risk. It could be political upheaval.
It could be political strife. It could be situation, to your
point, Mr. Chairman, where countries try to nationalize
supplies, where there is a critical supply and they hold on to
enough supply to satisfy their local needs in the setting of a
public health crisis before they ship outside their borders.
Just in closing, some things I think we can consider going
forward to try to address these kinds of contingencies and
these kinds of risk to the supply chain that I believe this
episode is exposing in real time, we could, first of all, work
closely in the near term with manufacturers to try to get an
alternative supply for these chemicals into the market.
There is idle manufacturing capacity in India. These
facilities can be converted fairly quickly. The starting
ingredients for pharmaceutical production does not need to be
done under what we call good manufacturing practices. You do
not have to apply all the stringent oversight that you would to
a finished drug product because the regulation on the finished
drug product is what covers the drug ingredients. So the drug
ingredients do not need to meet those standards as long as the
finished drug product does, and that is a long way of saying we
probably could do this quickly if we wanted to convert
facilities and we had a real focus on where those choke points
and trying to mitigate them.
I think longer term, we should think about when we ask
manufacturers to focus on shortages of final products also
require them to report on the intermediate steps and
intermediate ingredients that could also come into shortage
that could create an adverse public health outcome.
We can require companies to identify alternative supply for
some of these products. We did that after September 11, 2001
(9/11), which Dr. Gerberding probably remembers well, where we
required manufacturers of critical products like insulin to
identify how they would come up with alternative supply of that
product should their core facility go down because of either an
intentional or an unintentional act.
We could do the same thing with some of these critical
facilities that supply raw ingredients for these drug products,
where it is, in many cases, sole source.
We also, finally in closing, just need to focus on getting
more manufacturing back into the United States, and this is
where this Committee has been very helpful. When I was at the
agency making investments in continuous manufacturing and other
kinds of high-tech, low-labor footprints for manufacturing
pharmaceutical ingredients and pharmaceutical products, that
are the kinds of facilities that if you are a manufacturer, you
would want to locate as close as possible to your site of sale.
So a continuous manufacturing platform really lends itself to
being domesticated here in the United States as opposed to
doing it in another part of the world.
So these are just some ideas, some of which I worked on
when I was at the agency, some of which I thought about since
leaving, but I would be delighted for the opportunity to work
with the Committee on these and other ideas on how we can
mitigate some of the risks that have been identified in this
current episode. Thanks.
Chairman Johnson. Thank you, Dr. Gottlieb, and I should
have pointed out that you are the former Commissioner of the
Food and Drug Administration.
Why do not we move next to Dr. Julie Gerberding. Dr.
Gerberding was former Director of the Centers for Disease
Control during the Bush Administration from 2002 to 2009.
Doctor.
TESTIMONY OF JULIE L. GERBERDING, MD, FORMER DIRECTOR (2002-
2009) OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Gerberding. Thank you. It is an honor and an important
opportunity to provide context and information. I really
appreciate the ability to have this conversation.
I am really here wearing three hats. One is as the Chief
Patient Officer at Merck. Like many multinational companies, we
have lots of people working in China right now, and of course,
we are concerned about our own employees. But as Dr. Gottlieb
has said, we are also worried about maintaining the supply of
medicines and vaccines to the people in China who need them but
also sustaining the supply chain across the board.
I am also wearing my hat as the co-chair of the Center for
Strategic and International Studies (CSIS) Commission on Global
Health Security, which recently published this report, which
includes recommendations to Congress about what we could do to
end this cycle of complacency in crisis that we continuously
circulate through as these infectious diseases emerge. This is
a commission that includes bipartisan members of both the House
of Represenatatives and Senate. So we have a very involved
Congress in this issue.
Finally, I am wearing my hat as the former CDC Director who
had the privilege of serving our country during the severe
acute respiratory syndrome (SARS) outbreak. I have had some
firsthand experience with the first coronavirus that emerged
but also lived through West Nile, monkeypox, avian influenza,
and a number of other infectious disease outbreaks, and worked
very hard across the entire government to try to improve our
preparedness for an influenza pandemic with lots of exercises
and advanced capability development. I am sober to be watching
this situation unfold today, and it is a little bit of a deja
vu all over again.
I thought I would just comment on kind of the big picture
of how we generally approach global outbreaks like this. The
first step is the detection, and in this case, I think we are
fortunate that the outbreak was observed and reported and
information was shared very early in the process, compared to
the situation with SARS where several months went before we
were aware of what was going on. So that is a positive
improvement.
The second step is to contain the virus at its source, and
I do not think there has been, probably in human history, a
more dramatic effort to try to contain a virus than what is
going on right now in China. The number of people who are on
lockdown, the scope and magnitude of the population involvement
in the quarantine and social distancing procedures is, in my
view, completely unprecedented, and the question to us is, Will
it work? Can you really keep this virus under control?
We obviously know there is spillover into several of the
provinces in China and several countries around the world. We
have also documented hotspots of sustained transmission. We
still have a lot to learn, and certainly, the experience on the
cruise ship in Japan is telling us how transmissible this can
be among people who are in a confined area. So we are very
concerned about the prospects for long-term containment.
If we cannot contain it, I think we need to be prepared for
what are we going to do to try to slow down the spread. Slowing
down spread is important because, if we have a lot of cases all
at once, we simply do not have the surge capacity to manage
that in our health care environment or in any of the related
services that would be necessary.
Slowing down means working hard to identify the people who
are infected and isolating them in a place where they cannot
infect other people and having available gloves and masks and
the isolation materials, which is also part of this supply
chain that we have some significant vulnerabilities in.
But slowing down also can involve social distancing, and by
that, I mean instructing people to avoid large crowds, early
school closures, so that child are not transmitting in the
opportunities of person-to-person and droplet transmission that
occur among young kids in school and a variety of other
measures that were employed in the 1918 pandemic, for example.
These measures along are not likely to prevent community
spread, but when taken as a cluster of interventions, we like
to use the Swiss cheese analogy. If you hold up a piece of
Swiss cheese, there are a lot of holes in it, but if you stack
them on stop of one another, you can end up with a pretty
effective barrier. I think that is the process of slowing down
until such time as we have a vaccine or countermeasures that
can be helpful in that.
I think where we are in the United States today is we are
observing a clustered outbreak of a significant scale in Asia,
we do not have that situation in the United States today. So we
are very alert. I do not think we are alarmed at this point,
but we need to be leaning in to what will the next step be if
we cannot contain it. I think that is why this conversation
that we are having today is so prescient because we will need
congressional support and investment to make that a feasible
opportunity.
So I think I will just stop there, and we can come back to
some specifics about transmission, which we have provided to
you in kind of this summary comparison of various viruses.
Chairman Johnson. Thank you, Doctor.
I think we will go next to Dr. Luciana Borio. Dr. Borio is
former National Security Council Director for Medical and
Biodefense Preparedness and Acting Chief Scientist for the U.S.
Food and Drug Administration. Dr. Borio.
TESTIMONY OF LUCIANA BORIO, MD,\1\ FORMER DIRECTOR FOR MEDICAL
AND BIODEFENSE PREPAREDNESS (2017-2019) AT THE NATIONAL
SECURITY COUNCIL
Dr. Borio. Good morning, Chairman Johnson and Ranking
Member Peters and Members of the Committee.
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\1\ The prepared statement of Dr. Borio appears in the Appendix on
page 48.
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Dr. Borio. OK. This one is working better. Thank you.
I am Dr. Borio, as you mentioned. I work for In-Q-Tel,
which is a non-for-profit strategic investment firm that
tailors innovative technology solutions to support the mission
of the U.S. national security community, but previously, I
served in U.S. Government positions and have been involved in
response to many public health emergencies. So thank you for
the opportunity to be here with you today.
You have heard about the numbers of the trajectory of this
epidemic, but we all know that the numbers both inside and
outside of China are likely much larger. There are some places
where we now have significant transportation hubs to China that
have not reported any cases yet, either because they do not
have adequate surveillance systems or do not have access to
diagnostic tests or are not looking.
Even though there is a lot we do not know about this virus
yet, as Drs. Gottlieb and Gerberding mentioned, the futures are
very concerning for a pandemic and global spread. Even though
we have seen most of this impact today in China, in Wuhan, and
the citizens are suffering a tremendous amount, its impact will
be felt globally.
I want to stress that even though we do not know how lethal
this virus is, it is pretty clear that it is sufficiently
lethal to stress severely the health care systems because of
the lack of surge capacity that we have today to take care of
large influx of patients with acute and serious respiratory
diseases.
I would like to speak a little bit about some progress we
have made since 2001 because it has been very significant
progress. We are much better prepared today than we were back
in 2001, and I want to acknowledge the work of Congress to help
us prepare because a lot of that progress would not have been
possible without the laws that were passed over the years to
provide the Executive Branch with very many vital authorities
to perform its duties, whether it has been establishment of the
BioShield fund or the establishment of a bar that would support
the private sector in technological countermeasures, Emergency
Use Authorization authorities for the FDA. There are many
others that proved vital for our current State of preparedness.
Over the years, it is very clear too that the Federal
response enterprise that comprises many agencies, but including
the CDC, the National Institute of Health (NIH), and the FDA,
are stronger than ever. The coordination and communication and
collaboration and resource sharing, the ability to get things
done is stronger than ever.
On an optimistic note, I think it is fair to say that the
science is advanced to appoint where we now can actually aim
for development, evaluation, and deployment of countermeasures
in time to maybe impact the course trajectory of a novel
outbreak.
In the past, the efforts were designed to protect from
subsequent outbreaks, but now the goal really is to impact the
current one. You have heard how the NIH is moving very quickly
to develop a vaccine. The CDC moved very quickly to develop
diagnostic tests. So there has been progress.
Now, I would like to say that we have fallen short in some
very key areas, and they cannot be overlooked going forward.
One has been the lack of prioritization for diagnosis tests,
and they are one of the most critical components of outbreak
management and control. They are necessary for even clinical
trials for vaccines. So we cannot afford to de-prioritize these
vital tools for outbreak preparedness response surveillance.
As Dr. Gerberding said, the health care system is not ready
for care of sick patients. So we have neglected our health care
system preparedness. Much needs to be done in the public health
arena, but more progress has been done at the State and local
level of public health than we have achieved in the health care
sector.
I love medical countermeasures. I love therapeutics and
specific therapeutics, but we have to remember that they are an
incremental benefit to delivery of supportive medical care.
Without that foundation, those countermeasures are not going to
be useful. We need to be able to, first and foremost, take care
of patients.
Last, as Dr. Gottlieb spoke about, we have not sufficiently
protected our supply chain of essential medicines and medical
equipment, and that needs to change going forward.
I do think that we have made some progress, but we need to
brace ourselves from some difficult weeks to months to come. I
believe that we are going to see a lot more cases in the United
States in the near future.
I would like to acknowledge the work of the Committee to
calling for the establishment of the National Biodefense
Strategy in 2017 and the National Defense Authorization Act
(NDAA), at your suggestion. It has been proven very important
to help coordinate the Federal Government's response.
I do not want to leave this opportunity without recognizing
the staff at the CDC, my former colleagues at the FDA, at DHS,
at U.S. Customs and Border Protection (CBP), and other Federal
agencies who I know are working around the clock to protect
Americans from harm and from this epidemic.
Thank you.
Chairman Johnson. Thank you, Doctor.
Let us switch over to the Government Accountability Office
(GAO) now. We have Nikki Clowers, who is the Managing Director
for GAO's Health Care Team. Ms. Clowers.
TESTIMONY OF NIKKI CLOWERS, MANAGING DIRECTOR, HEALTH CARE
TEAM, U.S. GOVERNMENT ACCOUNTABILITY OFFICE
Ms. Clowers. Thank you, Chairman Johnson, Ranking Member
Peters, and Members of the Committee. I thank you for having me
here today to talk about GAO's infectious disease preparedness
work.
Today I want to share four key lessons from our past work
on outbreaks as we consider the Nation's current preparedness
for and response to the 2019 coronavirus.
First, planning and coordination is critical. Although HHS
is the lead Federal agency for public health and medical
preparedness, multiple other Federal agencies, such as the
Department of Defense (DOD) and DHS, play an important role,
with State and local agencies on the front line; and of course,
in today's global environment with mobile populations,
coordination between countries is a must. Effective
preparedness and response requires advanced planning, such as
joint exercises among these entities.
Second and related to planning and coordination, entities
must understand theirs and other's roles and responsibilities.
Who is responsible for communicating with the public? What is
the contingency plan if a key entity's ability to respond is
limited? How can an entity fulfill its obligation despite these
limitations? Answers to these and many other questions must be
known and understood by all to ensure effective preparedness
and response, and I would note that these are related to the
issues that have been brought up by other witnesses about the
supply chain, our reliance on drug and supplies from other
countries. We have talked a lot about drugs so far, but it is
also the supplies, personal protective equipment. What happens
if those are limited, and where do we get those supplies from?
Third, clear and consistent communication is essential.
With the number of entities involved in preparedness and
response, it is important that the government speak with one
voice to avoid confusion and frustration. The lack of clear and
consistent communication can also create expectation gaps, like
we saw when the amount of vaccine available for the
hemagglutinin one neuraminidases one (H1N1) influenza in 2009
did not meet the public's expectation.
Finally, responding to the coronavirus cannot distract us
from continuing to prepare for tomorrow's threat. We need to
prepare for and response to the coronavirus, but we also must
continue to prepare for other public health threats, including
efforts to develop needed medical countermeasures. Developing
these countermeasures requires sustained attention to overcome
inherent challenges, such as the high failure rate for the
development of most drugs, vaccines, and diagnostic devices.
Mr. Chairman and Ranking Member, this concludes my prepared
statement. I look forward to today's discussion.
Chairman Johnson. Thank you, Ms. Clowers.
Last but not least, we have Dr. Asha George. Dr. George is
Executive Director of the Bipartisan Commission on Biodefense,
formerly known as the Blue Ribbon Panel. Dr. George.
TESTIMONY OF ASHA M. GEORGE, DrPH,\1\ EXECUTIVE DIRECTOR,
BIPARTISAN COMMISSION ON BIODEFENSE
Dr. George. Mr. Chairman, thank you very much for the
opportunity to come here today, Ranking Member Peters, and the
rest of the Committee.
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\1\ The prepared statement of Dr. George appear in the Appendix on
page 52.
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The Bipartisan Commission on Biodefense has appeared before
this Committee before, and I think it is an important point to
make because it is obvious that biodefense is a Homeland
Security issue. It is not just something that is relegated to
the health care and public health arenas.
As we approach this novel coronavirus virus situation now,
I think I will leave the health care and medical commentary to
my colleagues and just focus a little bit right now on what is
happening with Homeland Security.
I think it is important to note that the Coronavirus Task
Force does, in fact, have Homeland Security on it, somebody
from the Department of Homeland Security, but you will note
that the Homeland Security advisor is not a member of that task
force.
Now, the White House can do and arrange however the White
House wants to, but what that means is that that person from
the Department of Homeland Security is the representative for
Homeland Security interests and needs to address that at a
level that would not be the same as what would happen if the
Homeland Security advisor was involved.
Additionally, Homeland, as you have seen thus far, has had
some important roles to play. U.S. Customs and Border
Protection and the Transportation Security Administration (TSA)
have been critical in working with CDC in terms of trying to
screen people and shuttle airplanes in particular directions,
but other parts of the Department have been involved as well.
U.S. Citizenship and Immigration Services (USCIS), for example,
has been very clear about the offices that they have in China
and the need to close those down, but they understand that
illness can have an impact not just there where people are
trying to immigrate perhaps here to the United States, but also
vice versa with people being sick there and trying to move
around the world.
In addition, the U.S. Coast Guard (USCG) has issued a
Maritime Safety Information Bulletin, and I think these issues
or these activities on the part of the Coast Guard, CBP, U.S.
Immigration and Customs Enforcement (ICE), and so forth, these
are activities that are not necessarily new activities. Many of
them have long, hundreds of years of responsibilities for
public health that have to do with customs, that have to do
with protecting our ports of entry (POE), and they are simply
executing those right now, as they should.
Other parts of the Department, such as the Federal
Emergency Management Agency (FEMA) and the Cybersecurity and
Infrastructure Security Agency (CISA), they too have some
responsibilities. I would hope that right now they are doing
what Nikki suggested. They should be leaning forward right now.
We do not necessarily need to have all of the States
declaring emergencies and applying for emergency assistance
under the Stafford Act, but FEMA does have guidance that would
enable that if that was necessary. They should be making sure
everybody understands that at the State and local level, and
they should be trying to figure out how that might work when
HHS is already providing some assistance to begin with.
As far as infrastructure protection is concerned, we have
to be worried about the worst-case scenario. It is important
for Homeland to study what is happening in China, use that as a
scenario for the worst-case scenario here in the United States,
and then understand what impact that has on infrastructure in
particular. It has got to be more than just a workforce
management issue.
The Office of Infrastructure Protection has studied this
and addressed it in the past with pandemic influenza, and I
surely hope that they are dusting off some of those plans and
thoughts and looking to apply them here again.
Other than that, I think that I would just end with a
suggestion to the Committee. There are expectations in
legislation that still, abound, back from the Homeland Security
Act of 2002 and coming forward, in which this Committee and
others directed the Department of Homeland Security to take
upon themselves some responsibilities for health-related public
health issues.
With the reorganization to create the Office of Countering
Weapons of Mass Destruction (CWMD), there is a little confusion
there now with the Chief Medical Officer and the Officer in the
Management Directorate, but things like the National
Biosurveillance Integration System still in the CWMD office, it
is a little confusing. It is a little unclear, even within the
Department, who should be doing what and how.
I believe that the Committee should take a look at that,
but in particular, in the context of what is going on with
novel coronavirus, it is something that probably needs to be
fixed sooner than later, especially if we are going to assume
now that the Nation is going to have to deal with biological
events sooner than later, something for you to think about.
Chairman Johnson. Thank you, Doctor.
I definitely remember the Blue Ribbon Study Panel
testifying before our Committee. Actually, Senator Carper and I
met with the Vice President because your number one
recommendation is we need to put somebody in charge of these
things. That is a prevalent problem across a host of issues and
problem areas of who is going to be in charge. We have not
worked that out. I think that remains, from my standpoint, a
top priority.
Dr. Gerberding, I think you supplied this sheet to us. We
have an acronym now. It is COVID-19.
Dr. Gerberding. Exactly.
Chairman Johnson. But as I am looking at period of
infectivity versus seasonal flu 1918, SARS, Middle East
Respiratory Syndrome (MERS), I think what is, from my
standpoint not being a doctor, most disconcerting about COVID-
19 is now we are hearing it is about a 24-day contagious
period, incubation period, when people are just asymptomatic.
Does that tell us something about this virus?
Also, let us get it on the table. There are all kinds of
news stories going about in Wuhan they had certain facilities
there. Something escaped from a lab. Can you just kind of
discuss what we know? If there are issues you can lay to rest,
let us lay those things to rest today.
Dr. Gerberding. Thank you.
One point I would like to make is that although this seems
like it has been in the news for quite a while, these are
actually early days in terms of studying the outbreak.
One of the things that disease detectives are doing right
now is literally going door to door, finding a case,
understanding where that person was exposed, how many people
were they in contact, and what are the actual transmission
frequencies. So it takes time to do that kind of shoe-leather
epidemiology that has to be done.
It does not surprise me that we have some uncertainty
around these numbers, and we will continue to do that.
Different people are observing different populations. What we
see on the cruise ship is going to be different than what we
might see in a crowded hospital situation with someone who is
profoundly ill and not properly isolated. So a lot of
information is emerging. It makes it really hard to make
predictions or to make any firm statements about what we can
expect here.
But I am concerned about this virus for three reasons.
First of all, we do not know if the tip of the iceberg is
really the most severely ill patients who get admitted to the
hospital, but that the majority of the iceberg is transmission
that is going around people with mild illness or even
asymptomatic illness. That is profoundly important, obviously,
but at this moment in time, we do not really know what
proportion of the total universe of coronavirus infection is
among those most sick people. So we could be having much more
transmission, but those people are not being tested.
On the other hand, this does appear to be a very virulent
virus with a fatality rate that is significantly higher than
what we see with seasonal influenza, as I pointed out on this
chart.\1\ So given that situation, I think we have to be
concerned that even if most people are not very ill, there is
going to be a significant impact on the overall population, and
it does appear that vulnerable older people and perhaps young
children are certainly not immune to this and most of the
severe diseases among populations of people who have underlying
disease.
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\1\ The chart referenced by Dr. Gerberding appears in the Appendix
on page 57.
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Chairman Johnson. That is true, just seasonable flu as
well. So that is on the spectrum of how virulent this really is
and how deadly, correct?
Dr. Gerberding. That is exactly right.
Chairman Johnson. I am reading all kinds of things. One of
the reports I read was that they attempted to develop a vaccine
for SARS, and they were not successful; is that true? Did we
ever develop a successful vaccine for SARs?
Dr. Gerberding. This is an important perspective for the
Committee, I believe, and that is that when we have an outbreak
like SARS, there is a great deal of investment in doing
something quickly like developing a vaccine or a medicine.
But SARS was contained pretty quickly. 8,000 cases is a
pretty small outbreak on the global scale, and the money went
away. So the investment in bringing those vaccines all the way
to the finish line was not made. So the work was promising but
incomplete, and certainly, we do not have a SARS vaccine in the
freezer today. But I think we all recognize that----
Chairman Johnson. Is it because we stopped working on it,
or is it because there is just something inherent in that virus
that makes it very difficult to produce a vaccine?
Dr. Gerberding. I think it is because the work was not
completed.
Chairman Johnson. OK. Good. That makes me feel better as
opposed to something inherent.
Dr. Gottlieb, do you have an explanation of why these
precursors are only made in China? From my standpoint, again, a
former manufacturer, where there is a very labor-intensive
product, I can understand that. I would not think producing
precursors for drugs would be very labor-intensive as a result
of a fit for a low cost-labor country like China. Why do not we
maintain that here?
Dr. Gottlieb. A lot of the API and the chemical precursors
are manufactured outside the United States because the two
biggest components in terms of the cost of production are the
labor inputs, No. 1, and the second biggest component is the
energy inputs to producing API.
But it does beg the question with low-cost energy available
in the United States. You might be better off putting one of
these facilities next to a shale plant in Texas.
I think that there is an opportunity to try to re-
domesticate more of this manufacturing here in the United
States as the labor inputs start to diminish with different
kinds of manufacturing approaches, and that is why Congress
appropriated significant resources to the Food and Drug
Administration the last couple of years to try to invest in
converting more of the industry to continuous manufacturing
platforms on a premise that those are high-tech, low-labor,
high-energy input platforms are the kind of thing you might
want to locate in downtown Boston as opposed to Mumbai, India.
So, with that kind of a platform, I think we could see more
manufacturing come back to the United States.
Chairman Johnson. As a manufacturer myself supplying to the
medical field, our International Organization Standardization
(ISO) certification is always what is your backup. What happens
if something happens to your plant? Where can we get the
supplies? It is actually quite shocking to me that we have
allowed this to occur just within our manufacturing base and
ISO certification, much less would a potential solution to this
be with an FDA approval on a drug so that people prove that
there are multiple suppliers for the precursors?
Dr. Gottlieb. We do that right now for certain products. So
if you have a critical product where we could not sustain, from
a public health standpoint, a supply disruption, the agency
requires risk mitigation plans so that manufacturers have to
identify what the alternative supply would be and try to
maintain some supply. There are companies that literally have
redundant facilities mothballed, able to be stood up to supply
certain critical products. Nitric oxide gas is an example.
So you could expand those risk management plans to
encompass more components of the supply chain and
identification of these critical chokepoints. The manufacturers
might not have full insight into it as well. They might not
know that there is a sole-source supplier, but they could
ferret out that information. The agency working with them can
identify more of these chokepoints.
Chairman Johnson. I know part of the whole anti-vaccine
movement, I think they had an effect in terms of how many
vaccine manufacturers are in the United States, just the whole
litigious society we have. Is that also a factor here, or is
that not a factor?
Dr. Gottlieb. We made a concerted effort from a public
health and national security standpoint to try to create
domestic manufacturing capacity for vaccines and create some
redundant capacity in the United States, including our National
Strategic Chicken Stockpile for the production of influenza
vaccine. So we have tried to convert more of that industry to
sell base manufacturing platforms and actually invested in
building up some of those platforms here in the United States,
and Dr. Gerberding was instrumental in some of those efforts.
It has fallen off the radar in recent years. I think there
has not been as much emphasis in trying to get those kinds of
facilities into the United States.
I will just close by saying this is really critical because
in the setting of a pandemic flu where a lot of these vaccines
are manufactured ex-United States, the rational behavior of
another country is going to be to make sure that they can
supply their local population before they fulfill contracts to
the United States.
Chairman Johnson. This ought to be a huge wake-up call for
our country in terms of having those manufacturing capabilities
here in America. So I hope we heed it. Senator Peters.
Senator Peters. Thank you, Mr. Chairman.
We, the minority side, did a report on drug shortages that
came out just at the end of last year, and in hospitals that we
have talked to, it was interesting. One hospital, when we were
talking about the report in Michigan, would say every week,
they have to get together and determine which drugs will be in
shortage this week that they will not be able to get in an
American hospital, top-flight American hospital.
If they have those shortages and folks need the medicines,
then they will go to a more expensive medicine that is not
available in a low-cost generic, for example, and yet a
questionable increase of clinical benefit but costs a whole lot
more money. There is a significant problem, particularly with
some of the drugs, as you mentioned, Dr. Gottlieb, dealing with
anti-infection, things that are mass-produced and generic.
Looked at it from a supply chain, your point too, Mr.
Chairman, is that what we have in this country is that we have
manufacturing capability for the very high-priced drugs on
patents that are obviously making a lot of money for the drug
company, so that is manufactured here, but then as they go off
into the generic world, then it gets really competitive. It
gets more and more competitive, and then that all gets
offshored. We have very low-cost drugs that do not make a whole
lot of money for anybody, and those are the ones that tend to
be in a shortage situation.
It is almost like a barbell. We have very high-priced drugs
and we have extremely low-priced drugs and nothing in the
middle, and a lot of those low-priced drugs are related to the
80 percent of the precursors that underlie so much of the
necessary medicines but may not be very expensive because they
are not the ones on patent right now.
So how do we deal with that? To Dr. Gottlieb, some of this
deals with the government actually getting information. I think
you mentioned this in your opening as to the supply of these
drugs, the sources. We just do not have a good handle on that.
I think there is a dearth of information that we are getting as
to where these shortages could occur and where those
chokepoints are. Is that accurate, and do you have some ideas
on how we could fix that?
Dr. Gottlieb. I think that is right, Senator. I think
getting better information about where some of these critical
junctures are is important, but it is only going to be
sufficient if we can try to couple with some incentives to get
manufacturing back into these spaces and get redundant
manufacturing because we are not going to be able to mandate a
solution here.
The problem, I always said that there is a lot of drugs
that cost too much, and I think we would agree on that. There
are some drugs that cost too little, and with a lot of these
sterile, parenteral, meaning injectable generic drugs--and that
is really the category that goes in and out of shortages, these
sterile injectable drugs.
We have driven down reimbursement to levels where they sit.
The reimbursement levels sit at slightly above cost of goods.
That is OK if you are developing a small molecule-pill drug,
where the manufacturing complexity is relatively
straightforward, but when you are dealing with a complex drug
like a sterile injectable drug, where you want there to be
constant investments in upgrading manufacturing, making sure
the products are subject to stringent Good Manufacturing
Practices (GMP) requirements, and you are allowing a margin
that is slightly above cost of goods, it is hard to get the
kinds of investments in manufacturing that you need.
So what you have seen in these industries is you have seen
consolidation because the reimbursement is small. So the way
you make up for the margin is you produce at very big scale. So
you have a handful of consolidated manufacturers that have been
underinvesting in their manufacturing over time. So when
something goes wrong and a facility shuts down, you can create
a shortage from a single facility shutdown.
I think we need to think about how to identify these
chokepoints, how to identify where things can go awry, and then
thinking about how to change reimbursement schemes to drive
incentives back into these markets to make it profitable to
develop these drugs.
We are getting a lot of these drugs at very low prices.
That is very good for consumers until there is a shortage.
Senator Peters. Right.
It is not just the drugs. It is also medical supplies. I
think, Ms. Clowers, you mentioned that as well, the broad suite
of products that you need like masks and gloves that are
necessary.
In fact, I understand the third largest import from China
to the United States are medical supplies and drug-related
issues.
Given what is happening in China, there is going to be a
pretty big disruption, potentially, in that supply chain, as
that is where we get most of these supplies. So we could see
shortages in things like masks and gloves.
Do any of the panelists want to comment on concerns that we
may have related to what is happening in China for the supply
chain?
Dr. Gottlieb. I will just broaden that out quickly, and Dr.
Gerberding could speak to this too, because we have stockpiled
a lot of personal protective equipment in the Strategic
Stockpile for precisely these kinds of challenges.
I think where we are likely to see some potential
challenges going forward, if the supply does not get online in
China, is that a lot of components of complex medical devices
are also manufactured in China. So the implantable
defibrillator might not be made in China, but key components
are sole-sourced in China.
When you look at a lot of the manufacturers, they have
anywhere from a 1- tomonth inventory on hand,
including the drug manufacturers. I think if this extends--we
are now a month into this a little bit longer where
manufacturing has been shut down. If this extends in China
another month or two, I think we are going to start to see some
shortages of critical components, not just the personal
protective equipment, but also sophisticated electronics that
go into medical devices.
Ms. Clowers. I was also going to mention the stockpile, and
that is one of the issues where Congress can play a role was as
continuing oversight in terms of the agency's management of the
stockpile before outbreaks occur during the sort of normal
times, if you will, in terms of are we stockpiling the right
type of equipment.
I would also want to add on to the complexity job that FDA
has in overseeing the manufacturing throughout the world. The
inspection regime was really set up as a domestic inspection
process. Over the last 20 years, as manufacturing of drugs and
devices have moved offshore, it stretched their capabilities.
Right now, I think it is estimated there is about 400 drug
manufacturers in China. So you can see where this could have
the tentacles of this type of outbreak, not only the equipment
that you need to handle the current outbreak, the medicines for
other types of chronic diseases or just your generic drugs that
you take, what type of impacts when workers stop going to the
factories to work. How will that impact the delivery of those
drugs?
Dr. Gerberding. I was just going to add that the shortage
that concerns me the most is the antibiotic issue, both just in
terms of supplying the drugs that we might need, but also
because when people have a coronavirus infection, are in the
hospital, they are very prone to develop additional drug-
resistant bacterial infections on top of it. We do not have the
right antibiotics to treat those infections because we have a
different kind of market failure there, an inability to pay for
those drugs and incentivize manufacturers to create them.
Merck is one of the few companies that has an antibiotic
pipeline, and we really struggle to maintain a prudent
resistance model. We have watched lots of small companies go
out of business just in the last year because they cannot get
the reimbursement for the innovation.
In this context, that is a really important part of the
coronavirus response because often with influenza that is what
people die of, the bacterial infections that complicate the
underlying disease.
Senator Peters. I appreciate that. Thank you.
I just want a quick follow-up. I am out of time, so be
quick, Ms. Clowers. You mentioned the foreign inspections and
the foreign manufacturing. The FDA has approximately 188
inspectors. Only 12 are dedicated to foreign inspections is my
understanding, and with our dependence on drugs, that seems to
be a pretty low level.
Ms. Clowers. I think that is in reference to the foreign
cadre. There is also domestic inspectors that can play a role
in the inspection process, but in general, the number of
inspectors have declined. As a result, we have seen the ability
of FDA to maintain a number of inspections globally decrease in
recent years, and we have ongoing work looking at those issues
in terms of FDA's capacity as well as the other challenges that
they face conducting inspections overseas, whether it is the
need of translators when they go onsite, to being able to find
the firms.
We have seen instances where they go out to inspect, and
they show up to a facility. The facility does not exist.
We also have situations in most foreign inspections--it is
preannounced. So the firm gets about 3 months' notice or more
that FDA is coming to visit, and so you can imagine what type
of, maybe, cleanup goes on during those 3 months. That is
different from domestic inspections where FDA could show up
unannounced that day for an inspection.
Senator Peters. Thank you. Appreciate it.
Dr. Gottlieb. May I comment briefly?
Chairman Johnson. Yes, go ahead.
Dr. Gottlieb. The challenge, the witness is right that a
lot of foreign inspections are conducted by domestic inspectors
who will rotate into foreign inspection roles or inspect
foreign facilities.
It was a challenge to recruit and retain people
specifically into this foreign inspection post, and so that is
something that we need to address. Filling those jobs was
difficult.
We are also facing a situation now where the inspectors
largely have been pulled out of China, and so we need to think
about from a risk management standpoint how do we now ensure
the safety of American consumers from products that are coming
in from China if inspectors are not on the ground.
So it might require us to rethink import sampling and rely
on that more, even though it is imperfect relative to
inspections, or changing the risk management plan that the
agency adopts in terms of how it targets its oversight and
focus more resources on products coming from China, given the
fact that inspections are now being pulled out of that market.
Senator Peters. Thank you.
Chairman Johnson. I think this would be a good time for me
to repeat my plea to my colleagues. We ought to take the
Hippocratic Oath. First, do no harm. Again, I pointed out the
statistic, but as best as I can determine, out of a $3.7
trillion spend on health care, it is about $500 billion on
drugs. Even at a 20 percent after-tax rate of return, which is
massive, that is only $100 billion out of 3.7. So on a
bipartisan basis, we beat up on the drug companies, and no
doubt, there are some abuses and they need to be addressed.
Let us put it in perspective and understand the situation
like this. We need pharmaceutical companies to be successful.
We need to encourage manufacturing here in the United States. I
mean, things like heparin are in shortage. It is ridiculous.
Because we have driven any profit motivation, we have made it
very risky to manufacture because the risks are high of
litigation. So we need to really recognize the root cause of
this.
But I will get off my soapbox and go to Senator Hassan. She
can get on hers.
OPENING STATEMENT OF SENATOR HASSAN
Senator Hassan. I am trying to think of which soapbox to
get on, but thank you, Mr. Chair and ranking Member, for
convening us all. Thank you to all the witnesses for sharing
your expertise and your time with us today.
Dr. Gerberding, I wanted to start with a question to you
and, first of all, just thank you for many years of service to
our country.
Reflecting on your experience leading a number of public
health agencies, I would like to hear how you think we are
doing this time with respect to the coronavirus. Do you believe
that the Centers for Disease Control and Prevention have
sufficient staff and adequate, flexible staffing policies to
manage a public health emergency of this scale or larger?
Dr. Gerberding. Thank you for that question. I am watching
from afar. I am not in the CDC Operations Center----
Senator Hassan. Right.
Dr. Gerberding [continuing]. I do not have insight into
what is going on, on a day-to-day basis, but I have to say it
makes me really proud of the CDC to see what they have been
able to do so far.
I think their communication is regularized. They are
getting information out. They are working very closely with the
State and local health departments by building out that whole
front line.
So in terms of performance in this context, I think they
have a lot to be proud of.
In the broader view, I do feel like the CDC has suffered
from what I refer to as the ``herky-jerky funding.''
Senator Hassan. Yes.
Dr. Gerberding. A problem occurs. A budget emerges on an
emergency supplemental basis. When that emergency is gone, then
that money is repurposed. That is not the way to maintain a
continuous process of improvement in our overall preparedness,
and it is not just about the CDC. That spills over into every
State and city.
Senator Hassan. Yes.
Dr. Gerberding. I urge very close examination of the
sustainability of the effort, moving away from reactionary
funding to something that creates a more solid and allows this
kind of preparedness to continuously evolve over time.
Senator Hassan. Yes. It is a good reminder that you need to
invest in the things that you hope you never need.
Dr. Gerberding. Exactly.
Senator Hassan. But you need to be ready for them, and that
is something that I think we struggle with.
I wanted to follow up on that. As I understand it, the
United States was somewhat slow to confirm potential cases of
the coronavirus largely due to logistical challenges dealing
with sample testing. What we were told in a couple of briefings
we have had now is, specifically, the delay results from
hospitals and doctors' offices having to ship--and State health
departments having to ship patient samples to the CDC to be
tested instead of being able to send them to local public
health labs.
So now that the CDC has developed a portable diagnostic
test, are there public-private partnerships that we could
leverage in order to scale up the production and distribution
of those tests, if necessary, so CDC can direct its focus to
ongoing response efforts as the situation evolves?
Dr. Gerberding and then, Dr. Gottlieb, if you would like to
follow on.
Dr. Gerberding. So when there is a new infection of any
sort, it does take a little bit of time to develop a test and
perfect it, and then you have to prove its sensitivity and
specificity in its actual performance before it can be
released.
FDA has created provisions so that unlicensed tests can be
made available to public health labs, but there are a number of
quality steps that have to go on. So it does not happen as fast
as I think people would have liked.
I too saw some of the reports of 36 hours to rule in or
rule out infection. So it is a problem.
I think the private-public partnerships ultimately do
occur.
Senator Hassan. Yes.
Dr. Gerberding. That is the natural history of how these
tests evolve, but in the early days, I think the most important
thing is to just get the reagents made and get them out to the
public health lab network where people are familiar with using
the Polymerase Chain Reaction (PCR) tests, et cetera, and just
deal with the crisis and then move into a more stable
manufacturing platform.
Senator Hassan. OK. Dr. Gottlieb.
Dr. Gottlieb. So CDC made in very efficient time--and it is
a real testament to the efforts of the CDC and FDA--200 test
kits available to the Laboratory Response Network. Each test
kit can test between 700 and 800 samples. If you assume that on
a typical patient, you are going to be sending off multiple
samples, you can still test for upwards of maybe 50,000
patients with the tests that have been made available.
Those are just now being put in place. There was a press
release yesterday from the Public Health Department in Illinois
that they just stood up that test, and so we are just beginning
to get testing capacity in place.
I think two things need to happen. One, we need to broaden
the criteria of who gets tested. Right now, the criteria
requires that you are either a recent traveler from China or
have been in touch with someone who has traveled to China or
been in touch with someone who has been diagnosed with a
disease. We really should be trying to test anyone who presents
with an atypical severe pneumonia that tests negative for the
flu, negative for the multiplex test that currently tests for
different viral forms of pneumonia. We should be looking for
coronavirus. We should be trying to find it in the community.
That is how we are going to spot small outbreaks and prevent
them from becoming larger outbreaks.
The other thing that we need to try to develop in efficient
fashion is a point-in-care diagnostic, like we have for the
flu, something that does not require a reference lab but can
either be done in Quest Lab or some other kind of reference lab
or perhaps can be done as a screening tool more at the point of
care.
So you think of a company called Cefheid. It has a platform
called GeneXpert that they use to test for all kinds of things,
including it was, I think, adapted for Ebola as well.
One of these sort of point-of-care platforms to get these
tests into the hands of physicians is to broaden screen. That
is how we are going to identify an outbreak in this country
quickly.
Senator Hassan. OK. Thank you.
Dr. Gottlieb, I wanted to follow up with you too on asking
you to elaborate a bit on the role that the FDA plays during a
public health emergency. Can you describe the FDA's process for
allowing the use of unapproved medical devices and treatments
during emergencies, known as the Emergency Use Authorization
(EUA), and why is it important in a public health emergency?
Dr. Gottlieb. I am going to ask my former FDA colleague,
Dr. Borio, to comment on this as well.
Senator Hassan. Sure.
Dr. Gottlieb. She headed up this program at FDA for the
agency.
The agency has now issued an EUA, for the diagnostic tests.
That is how they were able to get it out. So it allows the
agency to bypass some of the traditional steps that would have
to be done that would extend the development timeline.
The flip side of that, though, is that at least with the
diagnostics, there might have been companies capable of
promulgating these tests as laboratory-developed tests inside
their own reference laboratories because the technology for
doing this is not that complex.
But now that the EUA has been issued, companies are unable
to promulgate laboratory-developed tests. Now they
affirmatively need to come into the agency to ask for
permission to put those tests into the market.
Dr. Borio. Thank you, Dr. Gottlieb.
I will say that the agency, when I was there--and my
understanding, it is still the case--they are very proactive in
a public health emergency with reviewing things in real time as
data are received, and they are very proactive in communicating
to developers what is it that is expected. It really is a very
streamlined validation process because there is an urgency of
getting tests out there.
It is, however, important to have a certain comfort with
the validation before these tests are being used because we do
not want to be in a situation like we are seeing in China, for
example, where there is a little bit of a concern about whether
the results are actually accurate.
So even though these tests are very routine and routinely
used everywhere, they still require some training and some
validation.
Last, I will just say that I cannot stress enough the
importance of moving forward having a point-of-care diagnostic
test. We should not be relying on a send-out test in a public
health emergency. It is not the way--anything that changes the
way physicians or clinicians are practicing with their patients
makes the response less efficient, and the technology exists
today. But these tests have had a very hard time in coming into
the market because of the more systemic issues that we
discussed earlier.
Senator Hassan. All right. Thank you very much.
Thank you, Mr. Chair.
Chairman Johnson. So just for my colleagues here, there
will be some votes being called. They are stacked. By the way,
we are under discussion about sitting at our desks on these
stacked votes to make it more efficient. Hopefully, we can get
that accomplished.
I am going to stay here. Apparently, my vote is not going
to be necessary. So I am going to keep the hearing going. All I
am going to ask of my colleagues, if you are going to go and if
you are going to come back, let me know, and we will try and
keep it going for you. But if you are going to leave for good,
let us know that as well. Senator Carper.
OPENING STATEMENT OF SENATOR CARPER
Senator Carper. Thanks, Mr. Chairman.
I want to thank all of you, not just for coming here, not
just for your testimony, not just for responding to us, but
some of you, we know pretty well, and it is good to see you.
For those who are here for their first time, welcome. Thank you
for what you do with our lives, and thank you for what you do
when you try to preserve a life here in this country and maybe
around the world.
My colleagues heard me tell this story before, but when I
was a brand-new Governor-elect, I remember meeting with a bunch
of people who were giving me advice before I raised my right
hand and took that oath of office. One very wise, old Methodist
minister from southern Delaware once said to me these words. He
said, ``Tom, just remember the main thing is to keep the main
thing, the main thing.'' I said, ``Would you say that again?''
He said, ``The main thing is to keep the main thing, the main
thing.''
We are covering a lot here. We are an oversight committee.
We have oversight of the whole Federal Government. There is a
lot in our bailiwick, but try to help us narrow down our
responsibilities here on the oversight committee, the Homeland
Security Committee, what we should be focusing on as we go into
this.
Nikki, would you just lead us off? Because we work a lot
with GAO, as you know, and we are grateful for what your agency
does.
Ms. Clowers. Thank you, Senator.
Senator Carper. Just be succinct.
Ms. Clowers. Yes, sir.
To pick up the focus on the main thing, one of the things I
would stress is that we do not lose sight of tomorrow.
Responding to the coronavirus today is very important, but
there is other public health threats. We cannot get in a cycle
which we sometimes find ourselves in as chasing Disease X, what
is going on this month, and we lose sight of the routine
preparedness that needs to occur, the funding of the routine
preparedness, what you would consider routine. When we lose
sight of that, then we get in this sort of never-ending cycle
of chasing.
Senator Carper. OK.
Ms. Clowers. The other thing I would mention, as we have
already discussed, is the reliance on manufacturing overseas,
and so I will not go into depth on that.
The other thing I would stress is just the important role
that you play as a committee in providing oversight to the
agencies, both before, during, and after an outbreak. The
before, making sure that they are preparing, that they have the
plans in place, that they know the roles and responsibilities.
After, are they conducting after-action reports? We found that
often after an outbreak occurs, it does down, people want to
walk away. After-action reports are not completed. If they are,
they are delayed or they do not include all of the
participants, and we are missing an opportunity to learn.
Then the last thing I would say is just what we have been
talking about as well. There is a Federal role to play in terms
of creating a market for countermeasure development. What kind
of incentives can we put in place to draw manufacturers to
develop needed countermeasures?
Senator Carper. Thank you. Thanks so much.
Dr. Gerberding. Very succinct, please, the main thing.
Dr. Gerberding. Right now in the United States, I think the
main thing is to exercise how we will sustain essential
services if we begin to see sustained transmission in our
communities, essential services meaning health care, of course,
but also all of the other Homeland Security services necessary
to keep our society operational, our supply chains running, and
civility among our citizens.
We have seen in previous outbreaks, for example with SARs,
what happens in a community when those services are disrupted,
and now is the time to exercise and make sure that we have a
plan in place to do that, if this does become worse.
Senator Carper. Thank you.
Dr. Gottlieb, good to see you. Thank you. The main thing,
please, just succinctly.
Dr. Gerberding. Modeling has shown that the time from first
introduction in China, which was probably in November, to
epidemic spread was about 10 weeks, if you think that cases
were introduced into the United States undetected late December
or early January, which is probably the case. Statistically, it
is quite probable. We are going to start to see those outbreaks
emerge sometime in the next 2 to 4 weeks.
I think that we should be leaning in very aggressively to
try to broaden diagnostic screening right now, particularly in
communities where there was a lot of immigration, where these
outbreaks could emerge, to identify them early enough that they
will be small enough that we can intervene to prevent more
epidemic spread in this country.
Senator Carper. Thanks so much.
Dr. Borio, same question. What is the main thing?
Dr. Borio. I think we need to assume that we are going to
see a lot more cases here, and I really worry about the health
care system preparedness and ability to take care of patients,
and I think we cannot afford to lose a minute in getting this
health care system as ready as we can before the influx of
patients arrive.
Senator Carper. All right. Thanks. Dr. George.
Dr. George. Senator, I think that the Committee should be
looking at what all of the Departments are doing right now to
address coronavirus, not just for employee safety, but in terms
of all of their responsibilities.
All of the Cabinet Departments and many independent
agencies have responsibilities for biodefense, and those should
carry forward now. We should not be waiting around. They should
not be waiting around until things get much worse to lean
forward, dust off their plans, and do what they need to, even
if it means that they have to stand back down because things
did not get as bad as they could.
Senator Carper. OK. Thanks.
Who is the lead agency responsible for coordinating the
development of a vaccine in a pandemic? I do not care who takes
that one. Who is the lead agency responsible for coordinating
the development of a vaccine in a pandemic? Who would like to
take that? Just very briefly.
Dr. Gerberding. NIH.
Senator Carper. OK. That was pretty brief. Can you be more
brief? [Laughter.]
What lessons did U.S. agencies and our foreign counterparts
learn from formulating vaccines and treatments for SARS, for
Ebola, and other global health threats?
Dr. Gerberding. I can take the question from the
perspective of Ebola because I work for the company that has
the licensed Ebola vaccine that is currently being used in the
Democratic Republic of the Congo (DRC).
I think the biggest lesson overall was the incredible
number of partnerships that have to emerge rapidly and
effectively to bring a product rapidly through clinical testing
for safety. All of the kinds of permits that have to happen to
move it cross-borders, et cetera, amazing requirement for all
kinds of agencies of government and civil society, and that is
just getting it into the clinical development.
Once we want to get it into the country to actually use it,
it brings up a whole other round, including the importance of
the front-line health workers.
Senator Carper. Last, one quick one. Can the reported 12-
to -month timeline for developing vaccines and treatments be
shortened safely and effectively? That could be either a yes or
no, and if it is a yes, then how? Just very briefly.
Dr. Gottlieb. You are the expert.
Dr. Gerberding. I think the Ebola virus vaccine development
proved that work that started in Canada right after the turn of
the century, 13 years before Ebola emerged, really was required
to get us to the point where from that point forward, we could
sprint.
Now we have a new entity called the Coalition for Epidemic
Preparedness (CEP) Innovation, which is a private-public
partnership funded by countries, by Gates, by Wellcome, by
others, civil societies, that is investing building products
and vaccines through phase IIB so that they are in the freezer
when one of these frightening pathogens does emerge. That will
speed up our ability to act quickly.
Dr. Gottlieb. I will just add briefly, doing a clinical
development, clinical trial in a setting of an outbreak of a
deadly pathogen is exceedingly difficult, and that is something
that we could be planning for right now. How are we going to
construct clinical trials of products that we want to test?
They are standing up a randomized trial of an antiviral
drug in China right now that was stood up very quickly. The
question is, Are we going to be able to gather information from
that that could inform a regulatory decision here in the United
States if we ultimately want to license that product for this
disease?
So thinking through how to stand up that infrastructure and
get that in place in a setting of a public health crisis can
greatly hasten the development timeline, and that is what we
were able to do with the Ebola vaccine, where we were able to
stand up a randomized trial in Western Africa to turn over the
data caught on that product very quickly.
Senator Carper. Thanks to all of you. Thank you so much.
Chairman Johnson. Senator Scott.
OPENING STATEMENT OF SENATOR SCOTT
Senator Scott. First of all, thanks to each of you for what
you have done in your prior jobs and what you are doing now.
There have been reports that the coronavirus may live up to
9 days on a surface. I have the call in to the CDC to get their
feedback, but do you have any views on that and whether that is
possible?
Dr. Gerberding. That is relevant in case contaminated
objects prove to be a source of transmission, which would be
highly unlikely and not an epidemiologic factor in most cases
of respiratory virus transmission.
You have to distinguish between finding the virus, meaning
maybe there is deoxyribonucleic acid (DNA) there, dead or
alive, versus the virus is alive and present in sufficient
quantities to be infectious. Those are two very different
things. I personally am not focused on environmental
contamination as a source of this. I think it is much more
likely to be droplet and potentially aerosols, and that is kind
of what we are seeing on the ship in the Japanese harbor.
Senator Scott. Anybody else? Anybody else have a different
view?
Dr. Gottlieb. The data with coronavirus shows typically
that it is probably a couple hours where you can get
transmission from what we call ``fomites,'' which is a
contaminated surface, touching it and then touching your face.
There have been some studies that have looked at transfer
of the virus under really ideal circumstances that are unlikely
to exist in nature that shows that it could be several days.
I think for most purposes, we should assume that the virus
has the capacity to live on a surface for a couple of hours. So
you could get transfer from what we call a ``fomite.''
That is why I think one of the roots of transmission that
we should be very concerned about is touching. It is not
necessarily wearing face masks that is going to provide the
best protection for individuals. It is going to be washing your
hands and using an alcohol sanitizer appropriately.
Senator Scott. So we import quite a few things from China:
ag products, food products, processed food, seafood, grains,
even live animals. Do you think we are doing all the right
things with regard to reviewing what comes in and deciding what
should not be
coming in until we get more information about how this
coronavirus--the transmission of it?
Dr. Gottlieb. I think from a regulatory standpoint,
Senator, that my focus would not necessarily be on the virus
cross-contaminating inanimate object and coming in. So a ship
package, I would have a very low level of concern around that
as a route of transmission.
I think the bigger concern right now with respect to the
imports coming in from China is just the lack of oversight of
manufacturing. We pulled out our own inspectors from the
country. You have to believe that their regulatory apparatus is
stretched right now and not providing the same level of
oversight, and I think it does behoove us to think of how we
are going to backstop that with other kinds of approaches like
greater import sampling. It is not an perfect substitute for
having inspectors on the ground, but it is a substitute. We
need to think about how we adapt the regulatory process and
take a different risk-based approach to looking at some of
these products that are still coming in that consumers here in
the United States still need.
Senator Scott. Those inspectors, what agencies have
inspectors over there?
Dr. Gottlieb. I know FDA does. I am sure other agencies as
well have inspectors in China but not necessarily looking over
FDA-regulated products.
As best I know, based on the public reporting, the U.S. FDA
inspectors were recalled from the country based on the new
travel guides from the State Department, and so we do not have
them on the ground.
Senator Scott. Taiwan is not allowed, I guess, to be a
member of the World Health Organization (WHO). By Communist
China not allowing Taiwan to be a member, how has that impacted
their ability to defend themselves against coronavirus, which
they are a lot closer to it than we are?
Dr. Gottlieb. Taiwan has not been part of the working
groups of the WHO. It has been a question for our Ambassador,
Andrew Bremberg, over there, but I think it is highly
unfortunate that China has continued to try to assert their
political prerogatives in a setting of this crisis in terms of
how they treated Taiwan.
So a lot of people have asked me why do not we receive
reporting from Taiwan. It is because the Chinese are baking the
Taiwanese numbers into their own estimates because they do not
see it as an independent nation. So that has certainly been
unfortunate. We can add to a long list of things I think the
Chinese government has done here that has made our response
more difficult, probably the most significant of which was not
admitting that there was human-to-human transmission until
January 20 on the same day that they disclosed that they had 14
health care workers that were infected.
Senator Scott. How comfortable are you with the numbers
that are coming out of China? You read reports that they are
significantly underreporting the number of cases, and there is
a lot of anecdotes that the number of deaths are way, way, way
higher. Do you have any feel for that?
Dr. Gottlieb. I will turn to Dr. Gerberding as well.
I do not trust the reporting in China, and I also believe
that the China numbers reflect the most severe cases. So we are
getting a skewed view of the case fatality rate and how severe
this is.
I suspect that if you were able to bake in all the mild to
moderate cases or asymptomatic cases, the case fatality rate
would go down. It could still be quite high. I mean, even a
case fatality rate of .2 or .5 could be catastrophic if this is
highly contagious and spreads around the world.
But I almost believe that the issues of the reporting from
China are not as relevant right now to how we perceive this
epidemic and potential pandemic because we now have experience
in Singapore, Japan, Hong Kong that is going to tell us a lot
more about how this virus is going to spread around the world.
We now know this is epidemic in China, and whether it
continues to grow or does not, that is not going to affect as
much whether or not this becomes pandemic as what is happening
in those other nations right now where the cases have already
been exported.
I will say, though, if China does take the brakes off of
some of the measures that they have taken--and they seem to be
making some noises about that because they are worried about
the economic impact--that could hasten the rate at which more
cases get exported out of China.
Senator Scott. Thank you.
Chairman Johnson. Senator Harris.
OPENING STATEMENT OF SENATOR HARRIS
Senator Harris. Thank you, Mr. Chairman.
I want to thank the panel for being here. Your experience
in past public health emergencies and crises is exceptional and
I think important to understanding how we should respond to the
coronavirus virus.
However, the American people also, Mr. Chairman, need to
hear from the officials who are currently responsible for
addressing this, and we need a public hearing with current
government officials as soon as possible. It is critical to my
State of California.
I have spoken with some of the current officials and asked
them why they are not here today, and they did not have a good
response for why they are not. In fact, they went on to say,
``Well, we have to take time to prepare talking points.'' The
American people deserve them to be here this morning.
That being said, Dr. Gerberding, thank you for your
service. The coronavirus outbreak demonstrates, obviously, how
important it is that we respond and be prepared to respond to a
public health threat. Yet just this week, President Trump
released the Fiscal Year (FY) 2021 budget that cuts funding for
the CDC and NIH, which you have mentioned would be the first
responder or most responsible for dealing with a pandemic, and
so these are obviously critical agencies that must response and
need to respond to the coronavirus.
So this is one in a long line of attacks on our country's
public health system that we have seen over the past 3 years
from trying to repeal the Affordable Care Act (ACA), to
restricting the way science can inform government decisions, to
slashing our investments in global health.
So my question to you, as a former CDC Director and
especially during the SARS epidemic, you must recognize,
obviously, the importance of a strong public health system to
guard against infectious disease threats. As Congress considers
the next fiscal cycle, what public health programs would you
prioritize to ensure that our country is prepared to address an
outbreak, this outbreak, and any future outbreaks?
Dr. Gerberding. Thank you for your question. It is a
question that has been asked for many years, and it is
frustrating to have to answer it for many years.
I will put on my hat as the chair of the Center for
Strategic and International Studies commission because that is
basically the question we asked as well: Where should
investments be made to improve our global health security? I
can share this with you. Other Members of Congress have
participated in its development.
But specifically with respect to the CDC, I think the whole
system of public health has been left behind as more and more
of our health resources have gone into care delivery, and we
have underinvested in prevention and preemptive care, including
the preparedness, to mention of that.
I also think that it is a small world, and we need to have
a cadre of people who are trained to be deployed to places like
the DRC when there is an outbreak there so that we can lend our
expertise and our competency in safe ways to be helpful at
containment when the problem is somewhere else.
The third issue really relates to what Dr. Gottlieb was
discussing, and that has to do with our laboratory network.
Across the public health system, we depend on the Laboratory
Response Network in situations like this, and they have made
dramatic steps over the past 10 years or so. But there is much
more to be done there, and we have to keep up with the state of
the science.
I totally agree with point-of-care diagnostics for
emergencies. We have a lot of work to do to really buildup the
public health system, and the great thing about it, it is not
just sitting there idly waiting for an outbreak. We can use it
for ordinary care as well. So it has a dual purpose, and I
think those are investments that make sense.
Senator Harris. So to your point that you have made these
recommendations before, to what do you attribute the lack of
progress?
Dr. Gerberding. I think we have a general mindset that
undervalues health promotion and prevention, and I include
preparedness in that dimension. When something happens, as a
Nation, we are very competent at making an emergency investment
and stepping up in the crisis to get miraculous things
accomplished, but we do not sustain it. It is complacency
crisis.
Senator Harris. But what you are describing goes to the
very core of the point of the public health model, which tells
us prevention----
Dr. Gerberding. Promotion, preparedness.
Senator Harris. It is the smartest and cheapest way.
Dr. Gerberding. Absolutely.
Senator Harris. Then if the sniffles take on, early
intervention, but if we are dealing with it in the emergency
room, it is too late, and it is too expensive.
So this is not a new concept, and I am just at a loss to
understand why we have not made progress, then.
Dr. Gerberding. I would love to follow up with you in a
deeper conversation than that because it is a complicated
cultural issue in our country, but I think it also has to do
with just generally the tendency to have wishful thinking that
a bad thing is not going to happen.
Individuals do that when they smoke cigarettes or do things
that they know are bad for their health, but I think as a
society, we have a similar challenge.
Senator Harris. Can you talk with me, based on your
experience and your thoughts about how we can better, what is
the system in place? Because I am having a difficult time
getting it, even when I have talked to current government
officials, about the system for Federal funding and how it is
distributed to State and local governments who in the current
crisis, the coronavirus, and in past circumstances, it is not
happening as it should. There seems to be a distribution of
responsibility but not a distribution of resources to the State
and local governments.
Dr. Gerberding. I do not have any insight into how that is
happening with the coronavirus situation. So I cannot respond
in a contemporaneous way.
Generally, the funding mechanism waits for emergency
supplemental to come, and then it is distributed according to
population and other parameters across the public health
system.
I do not think that is the optimal solution. I think we
need to have these systems and the support in place.
A major vulnerability, in my opinion, it gets back to what
we were discussing earlier, and that is that our health system
has so little surge capacity in it. Hospitals are not going to
build that without investment. We have to support hospital
surge capability.
Senator Harris. Because in my State, for example, there are
large counties like Los Angeles and smaller counties like San
Benito that just simply do not have the resources that are
necessary to address the issue, and they are sitting there
waiting for reimbursement, with no clear indication of when
they are going to get it and what will be reimbursed. Their
work includes a number of things, but all of the work is being
done by local officials, not Federal officials.
Dr. Gerberding. At the end of the day, it is the front
line. I am a licensed physician in your State and work at San
Francisco General Hospital. So I am well aware of what you are
talking about.
Senator Harris. Thank you for your work.
Ms. Clowers. Senator, may I add something about on the
funding?
Senator Harris. Please.
Ms. Clowers. There are three core programs that fund State
and local activities, two of which are CDC. One is
Administration for Strategic Preparedness and Response (ASPR).
We have looked at the funding over time. From about 2003 to
2017, each year that those programs in total, starting in 2003,
awarded about $1.4 billion. It has decreased to about $1
billion now. So what we have heard from State and local
officials, they really do then rely on the supplemental funding
that is provided, and about that timeframe, it has been $2.9
billion for Zika, Ebola, and other types of diseases.
The concerns with the supplemental funding, while it does
enable the surge capacity that is needed, often the timing is
off, and so it is too late.
Senator Harris. Right
Ms. Clowers. The other mechanism that has been used is
reprogramming, which we have heard the Secretary recently
announce. Again, that gets the money out quick as needed, but
again, what we have heard from State and local officials is
that that is essentially robbing Peter to pay Paul. It takes
money away from the routine preparedness, and then it delays
and disrupts the preparations at that level.
Senator Harris. Thank you.
Thank you, Mr. Chairman.
Chairman Johnson. Senator Rosen.
OPENING STATEMENT OF SENATOR ROSEN
Senator Rosen. Thank you, Mr. Chairman, and thank you for
being here today for the work that you have done.
I want to agree with you and Senator Harris that we need
the current administration here, not just to address today's
issue on coronavirus, but our future preparedness and our
readiness. It is very important.
We talk a lot about our large population centers when we
have a potential pandemic like this one, but our community
hospitals and clinics, just like you alluded to, they are on
the front lines, particularly those in our underserved urban
areas and our remote and rural areas.
Nevada, we have 300,000, about 10 percent of our
population, living in frontier and remote rural areas, and so
we need guidance, and we need staff that is well trained to
have the right equipment ahead of time.
So for Dr. Gerberding and Dr. Borio, what Federal
investments--where can we target these most effectively to
ensure our local rural providers have what they need to
respond, not just to a large-scale epidemic, but to mass
casualty, a natural disaster? Those also have an impact on
public health and the system to respond.
Dr. Gerberding. As we said a minute ago, the front line is
local. I do not think it is realistic for every health facility
and every provider to be fully up to speed on every emerging
infection that could occur. So we have to think about a hub-
and-spoke model.
What is most important for every provider is to have the
ability to be quickly updated if there is something new and
emerging so that a training system is in place, the information
system can quickly get information out to people, and they know
what to do when the first patient appears in the emergency room
with a suspicious diagnosis or something that is suspicious for
an emerging infectious disease threat, and then that we have
the capacity to get advice and refer or transport the person to
a facility that has the more advanced infection control and
care, just like we do for other complex medical problems.
But the problem is reaching the front line in a reliable
and systematic way, and that requires a system of ongoing
education and training that is incomplete, as you have pointed
out.
I will let you talk a little bit about the medicine.
Dr. Borio. I will just add that I agree that with the
tiered approach, because that is probably most of complex
medical delivery occurs, anyway, right? So not every hospital
can do the most complex procedures.
But the funding has been approximately, ball park, $250
million a year, and it is being filtered through State public
health systems. This funding is very necessary for planning
purposes, but it is just not sufficient to really achieve
preparedness. We need to find a way to go from planning to
actual preparedness.
It is going to require more expectations, I think, on part
of the Federal Government coupled with resources to fulfill
those expectations, but we cannot stress enough how important
that preparedness at the hospital level is.
Senator Rosen. Do you think that we can potentiate using
the telemedicine capabilities between our urban hospitals that
are very well equipped to our rural providers that are out
there? How do you think that we could best put some funding
into that mechanism to be sure that out in smaller communities
we have some of those issues taken care of?
Dr. Borio. It is clear that today's system does not
leverage the most innovative technology that exists in the
marketplace, and telemedicine is--it is hard to imagine that we
are going to achieve the level of preparedness that we need to
in the absence of exploring more of those technologies that
include telemedicine and telehealth.
We see some progress in that regard, some increase in
uptake in the medical care system, but a lot more could be done
to leverage those technologies for preparedness.
Senator Rosen. So I think that needs to be part of the
funding stream perhaps as well?
Dr. Borio. Absolutely.
Senator Rosen. Thank you. I yield back.
Dr. Gerberding. Could I just add one thing? Because when we
are having this conversation about how do we build a cascade of
preparedness, I want to go back in time to the efforts that
were made when I was still at the CDC. Secretary Mike Levitt at
the Department took on the issue of pandemic preparedness,
heart and soul.
We went to every Cabinet Secretary in government and sat
with the book about the 1918 pandemic, outlined sections of it
that were relevant, and had conversations about what their
Cabinet could be responsible for and contribute.
Secretary Levitt also took those of us in the Department
who were involved to every State in the Nation and met with the
Governor, the head of education, faith-based, you name it. The
community of experts assembled in every State and then had an
exercise about what they would need to do in their State, and
in many States, that exercise cascaded down into cities.
So it brought attention to exactly what you are talking
about. It is local, and if we do not build that preparedness
into the system, we have kind of lost the game.
Senator Rosen. We need to bring FEMA into some of these
conversations too as we talk about whether it is a mass
casualty, a natural disaster, a hurricane, an earthquake,
something else that can happen that could leave some of our
communities unprepared in the same way as for this. So maybe
FEMA needs to come into this conversation training as well.
Ms. Clowers. Absolutely. It will require all agencies at
Federal, State, and local, as well as the private sector, and
that was one of the reasons why we called for a National
Biodefense Strategy, which was issued in 2018, and for the
first time does lay out a process for enterprise-wide strategy
that looks at all the threats in an integrated way, because we
cannot have the fragmentation both of understanding, trying to
collect information, and integrating information, prioritizing
risk. That must be done in a strategic fashion.
Senator Rosen. Thank you.
Chairman Johnson. Senator Hawley.
OPENING STATEMENT OF SENATOR HAWLEY
Senator Hawley. Thank you, Mr. Chairman.
Thanks to all of you for being here.
I think a version of this question may have been asked, but
I would like to hear the answer with my own two ears. Ms.
Clowers, I will direct it to you, but anybody is welcome to
answer.
When it comes to the number of cases that China is
reporting, what is our assessment of the accuracy of these
reports, both in terms of infections and deaths, and how do we
rate these statistics in terms of trustworthiness?
Ms. Clowers. I would agree with the other witnesses in
terms of we should look at those numbers with some questions in
terms of reliability of both the number of deaths as well as
the reproductive index.
Senator Hawley. Go ahead, Doctor.
Dr. Gerberding. I would say one could worry about
obfuscation of information, but I think more to the point, it
is who is being tested. If the asymptomatic or mildly ill
people are not coming forward or not being tested, then we are
obviously missing the rest of the iceberg.
Dr. Gottlieb. Yes. I think that is a critical point that we
are probably overestimating the case fatality rate right now
because we are only testing more significant illness, and it is
probably the case that a lot of people who have mild to
moderate illness just are not even presenting to the system
anymore, now that they have locked down the entire Hubei
Province.
The issue right now, the questions that we need to grapple
with right now are it is clear this is epidemic throughout
China. Is it becoming epidemic in other parts of China? So the
reporting in the other provinces is important, what is
happening in Beijing.
But even more important than that, it is going to be what
is happening in Singapore, Japan, Hong Kong. Why do not we have
any cases in Malaysia? There has to be imported cases into
Malaysia. They are just not finding them. What is happening in
Western Africa? There has to be imported cases in to Africa,
given all the connections. What is happening here?
There is probably spread that we are just not detecting
yet, and I think that the situation in China, we are going to
quickly have learned as much as we are going to learn from
China, and we are going to start to focus our attention on
these other regions what is becoming epidemic or at least there
is sustained community transmission and where then reporting is
a lot better, including Singapore, which has done exquisite
reporting on their cases.
Senator Hawley. What do we know about the rate of reported
infections in terms of the curve, the derivative curve, if you
like? Is it still bending up at a pretty fast pace?
Dr. Gerberding. Right now, a true epi-curve, exactly what
you are asking for, has not really been created.
What we do see are the number of reported cases, but we do
not see the curve in terms of when they started. So that is the
frustration that I have. I cannot be an epidemiologist without
an epidemic curve, but I think just kind of crudely looking at
the numbers as they have climbed up day to day, we are still on
the upslope of the curve for sure.
Senator Hawley. Go ahead, Dr. Borio.
Dr. Borio. They may not have enough diagnostic test kids to
test everybody who may need to be tested. So we may see a
certain number reporting because that is all they could test
for that day.
Dr. Gottlieb. Yes. The reports out of the Hubei Province a
number of days ago was that they had the capacity to test 6,000
samples a day. So if you figure that there is at least a couple
of samples per patient, their testing capacity was limited
somewhere around 3,000, which is why we got a week worth of
reporting of 3,000 new cases, probably. I think that had
something to do with it.
Senator Hawley. Yes. Go ahead, Dr. George.
Dr. George. I would also add that we have a resource
problem now too. In China and possibly elsewhere, if you have a
limited number of diagnostic tests, you are not necessarily
going to use those to test the people that have already passed
away.
So our understanding of the entire outbreak out in China is
limited by the resources that they have as well. It is not just
a lack of desire on the part of the Chinese government to
report.
Senator Hawley. Thank you. That is very helpful.
Just on the resources point and turning our focus here
domestically to the United States, what measures are we taking,
whether it is masks, whether it is kits, whether it is other
supplies that we are going to need, if we were to see a
significant uptick in cases here? What measures are we taking
to make sure that we are fully and amply prepared?
Dr. Gerberding. I think it is important to remember that we
have a Strategic National Stockpile, which is an enormous
reservoir of medical equipment, supplies, medicines, vaccines,
et cetera, strategically situated around our country. So that
is our first line of defense that would have to come into play
if we were experiencing a major surge in requirements.
The stockpile is not limitless, and as we have already
heard, the supply chains who are replenishing it will be very
marginal at best. So I do not think it is a solution, but it
will definitely help us buy some time.
Senator Hawley. Does anyone else have anything to add to
that?
[No response.]
Can I just pursue with you, then, a worst-case scenario?
Dr. George, maybe I will direct this to you in the first
instance, but anybody is welcome to answer.
Based on what we are seeing in the region, in the Pacific
region--Japan, South Korea, and all of East Asia--at the end of
the day, what are the worst-case scenarios that we face here
domestically in the Continental United States based on what we
know now?
Dr. George. I think we have to look and see what is
happening in these other countries and assume the same thing is
going to happen here, especially when we do not understand
exactly how the disease is behaving and all of its
characteristics. It is something that we can do here.
I think we have to learn some lessons from some previous
outbreaks as well. During H1N1, the government had assumed that
pandemic influenza would start somewhere else, and in fact,
there is debate as to whether it started in the United States
or in Mexico or both sort of at the same time. So we need to
learn from those.
But I think it is also important for us to be looking at
the new cases and the clusters that we are seeing throughout
the world in places where we would not necessarily expect to
see them. There is a cluster in France now, for example, and I
think that should inform what we are doing here and what we are
planning for.
I do not think we should be planning for the onesie-twosie
cases that we have been seeing thus far in the United States. I
think we have to plan for something larger.
Senator Hawley. When you say larger, you mean what
potentially?
Dr. George. I think that we have to plan for the
possibility that we have thousands of cases.
In the schools of public health, they often train us to
look at the data that you have been provided, and assume that
you do not have all the data. Even here in the United States,
you do not have a comprehensive set of data and then multiply.
So we are often taught to multiply by seven or eight times what
you have been told. For every one case you see, there are seven
or eight out there that you do not.
So that means, actually, we would be looking at hundreds of
thousands of cases. I think that is the scale at which we
should be planning.
Dr. Gottlieb. The strategy seems to be try the slow
introduction of the virus as much as possible to push off the
time at which we are going to start to see outbreaks in this
country, hope that the summer provides some kind of backstop,
because you typically do not see coronavirus transferring as
efficiently in the summer, although that does not seem to be
the case here--it is 90 degrees in Singapore right now--and
hopefully buy yourself enough time to get to a vaccine or some
kind of therapeutic.
So that is not an unreasonable strategy right now, given
what we do not know and what we do not have, but it does
behoove us to think about how are we going to try to develop a
technology that could be a backstop here if this does become
endemic, meaning this becomes part of the normal mix of viruses
that propagate, or we start to see very large outbreaks in the
United States that we do not have sufficient capacity to
contain and control.
Senator Hawley. Last question, Mr. Chairman.
Surely, this has been asked, but again, I will ask it, just
since you raised it, Dr. Gottlieb. Where are we in terms of a
therapeutic or an antiviral for this strain?
Dr. Gottlieb. I will just comment briefly, and Dr.
Gerberding has far more insight into this. There is one drug,
remdesivir, that has been in the media that is manufactured by
a company called Gilead that is currently in investigator-led
studies in China.
There are two studies ongoing, one in mild and moderate
patients, about 300 mild to moderate patients, and another
study in about 450 severe patients.
If you believe that part of what is killing people with
coronavirus might be an inflammatory response to the virus
itself, there is a question of whether or not simply
intervening at the point when someone becomes very ill to block
further viral replication is going to be beneficial at that
point. It might actually do more harm by killing a lot of virus
that then causes, then sort of potentiates the inflammatory
response.
So there is a lot we do not know, and I do not think that
we can just sort of hang our hat on the idea that we are going
to have an effective antiviral here. It might be difficult.
Dr. Gerberding. I would just add that this week, the WHO
hosted a meeting of all of the parties who are involved in
drugs or vaccine development for this entity and looked at what
can be done to accelerate and support.
There are mechanisms to get that ball started in January,
very fast in January, Coalition for Epidemic Preparedness
Innovations (CEPI), which is this private-public partnership
that funds early stage development work for pathogens that
could cause pandemics. They funded three companies just within
weeks of recognizing that this problem was emerging. So the
work is getting off to a good start.
NIH is obviously priming the pump here, but the reality is
it takes time. It is 2020. The work on the Ebola vaccine for
the emergency response in Africa took a couple of years to
really wrap up and get submitted to Federal agencies for
approval, even though there is an ongoing outbreak there. We
did not get our final U.S. license until December 2019.
So we have to be realistic about the timeline, even when
pressured with emergency situations.
Senator Hawley. Thank you very much.
Thank you, Mr. Chairman.
Chairman Johnson. Before I turn it over to Senator Peters,
I think this might be a good time to try and put these things
into perspective with facts because this is what I am trying to
sort out.
You started out, Dr. Gottlieb, talking about contagion
versus virulence. In 2003, SARS had a little over 8,000 cases
worldwide, 8 in the United States, had about a 10 percent death
rate. In 2009, we had H1N1. Again, in the public perception,
everybody is scared. You have SARS. You have H1N1. You had 200
million cases worldwide, 60.8 million in the United States, and
a lot of people died, 150- to 500,000 people. But that is kind
of true of seasonal flu as well, right? Then you had MERS in
2012, 2,500 cases worldwide, 2 in the United States, with a
death rate of 34 percent. Ebola, a virus different than kind of
flu.
Now you have coronavirus. It is looking to me a little bit
more like H1N1, maybe more contagious, maybe not as virulent.
Can you just kind of put it into--I know we do not know much
about this, but where does this all fit in, in terms of
seasonal flu? Was H1N1 that much different than a normal
seasonal flu, just a different variety that sounded scary?
Dr. Gottlieb. H1N1 was a novel influenza that people did
not have cross-immunity to. So it was highly contagious because
of that.
I think it is hard to make an estimate on where coronavirus
is going to sit in that continuum.
I think the concern that you are hearing from us and public
health officials is that this could sort of occupy that sweet
spot between being contagious enough that it transfer very
efficiently but still virulent enough that when distributed
over a very large population, it causes a lot of death and
disease.
To put it in perspective, influenza has what we call an
``R-naught,'' meaning how many new cases are infected for every
case that you have of about 1.5, I believe, 1.3, 1.5. It is
1.28.
It looks like based on the modeling that has been done, the
R-naught here is going to be somewhere between 2 and 3. So this
is much more infectious. The case fatality rate----
Chairman Johnson. That grows geometrically too, right?
Dr. Gottlieb. Yes.
The case fatality rate in normal influenza is .1 or less. A
severe strain might be .1. Sometimes it is a little less than
that.
The case fatality rate here right now, the estimates are it
is about 2 percent. That is probably based on underreporting of
the mild to moderate cases. So that is probably going to come
down, but it might still be .2 or .5 percent. Now, that does
not sound like a lot, but that is devastating. If you have
something that has an R-naught of 2 to 3 and a case fatality
rate of .2, that could be quite devastating.
I will say that I think we are going to know much more in
the next 2 weeks as we examine what is happening in Singapore
and what is happening on a very unfortunate cruise ship,
because we are going to get a better estimate of how many
people with disease actually progressed to severe disease.
So far in Singapore, with 50 cases identified--and I
believe that they are doing a good job of identifying their
cases--eight are in the ICU. That is deeply concerning to me.
Chairman Johnson. Talk a little bit more about Singapore.
Again, you have the flu season. It gets cold. People are
confined versus in the summer months. Talk a little bit about
why you are simply concerned about Singapore.
Dr. Gottlieb. Because, first of all, it is warm right now.
So you should not see efficient transfer.
Second of all, Singapore has about 3.4 million travelers
from China a year. We have about 3 million. So on a statistical
basis, there is no reason to believe that if Singapore got
implants of this virus, we did not. You would expect them to be
identified earlier in Singapore, a very dense island nation,
city-State. You would expect those viruses to be identified
sooner there than it would be in a big country like ours. But
it does suggest, at least to me, that we probably have some
community spread right now that we just have not identified yet
and will identify it in time, hopefully in time to intervene to
prevent further propagation and make sure that we contain the
small outbreaks.
Chairman Johnson. One of the questions I did not get
adequately answered from my standpoint when I was talking to--
and by the way, in defense of the current administration, they
are not ignoring us. There has been a lot of interaction.
Another briefing here starts in about 5 minutes, where DHS and
CDC will be there.
But in my discussions, I did not get a real clear answer. I
think I finally did, but I am still--who is following up?
Let me start it this why because I might have been you, Dr.
Gerberding. I think it was in your testimony. You talked about
the fact that you really did not think these travel
restrictions are really going to be particularly effective. It
sounds good. It seems like the responsible thing to do, but in
the end--or did I read that from somebody else? Somebody in an
article or in testimony really kind of toned out----
Dr. George. Senator Lieberman said it, actually, that
perhaps at first, there is something to be said for travel
restrictions. But beyond a certain point, especially with all
the travel that has occurred, the 5 million people we believe
left Wuhan before any travel restrictions were imposed, et
cetera, travel restrictions are not going to remain the sole
way to try and control all this.
Chairman Johnson. OK. So do people agree with that or
disagree with that? Does somebody want to answer?
Dr. Gerberding. If you start with the concept of
containment very early on, yes, it makes sense to do everything
possible to contain a new pathogen in an area.
Once you start seeing sustained community transmission
elsewhere, the horse is out of the barn, and that strategy is
no longer likely to have an impact.
Chairman Johnson. One of the questions I had is--so we have
identified these--for example, we have a case in Madison. We
know the flight. So I was asking, ``Are we contacting everybody
on that flight? Are we contacting passengers three rows to end,
and who is doing that?'' because I know CDC does not have the
personnel. CBP does, and this is where we are talking about the
whole of government. Who is going to actually follow up?
Dr. Gerberding. So this goes back to the question earlier
about the public health system. When there is a situation like
that, a travel exposure, potentially, it is the local and State
public health department that identify the case and begin the
process of working with the airline to contact passengers. This
is a routine that our Division of Quarantine at CDC does
routinely coordinate, but the shoe-leather aspect of it is at
the State level. That is why we need to support them.
Dr. Gottlieb. I would also add, Senator, our system is
excellent. CDC does an excellent job of, once we identify a
case, doing that track and trace and that containment in the
quarantine where necessary.
I think what we should be worried about is not the cases
that we know about. It is the cases we do not know about, and
there are certainly cases we do not know about.
Chairman Johnson. Explain yourself a little bit more. That
statement confused a little bit.
Dr. Gottlieb. We should not assume that the 13 cases that
we have identified--and I think 10 of them were travel related,
people who came directly from China and imported the virus into
the United States--that we just managed to find all 10 people
coming in from China who happen to have coronavirus, especially
since we know that there is mild to moderate people or maybe
even asymptomatic, but certainly people with mild to moderate
disease who can transmit the disease.
We have to believe that over the course of the month or 6
weeks that this was epidemic in China, people came over from
China, and we just did not identify them. Some of the modeling
out of the United Kingdom (UK) suggests that we are capturing
about 25 percent of the cases at best. So for every case we
identify, there are three or four that we did not identify. At
least some of those cases probably are propagating virus at a
local level, but not enough cases have accumulated yet to be
identifiable.
Chairman Johnson. Again, I do not want to downplay this at
all, but I also do not want to overhype it.
I remember when we had the Ebola outbreak, and people were
projecting a million cases of Ebola. In the end, we are so
fortunate. It was confined to a couple tens of thousands.
When will we know that we are out of the woods on this? Are
we talking in 6 to 10 weeks, we ought to pretty well know
whether we have something that is out of control?
Dr. Gerberding. I would say yes. It is unfolding as we
speak. We will be able to understand if there are more serious
cases because of the numbers that Dr. Gottlieb has pointed out.
As you said, the exponential spread, if we are seeing a
transmission that is not detected because most cases are mild
and not being tested, we will know it soon because we will
begin to see more cases. They will not be directly linked to
travel to China. They will be in people who were exposed to
someone who has traveled to the endemic area.
Chairman Johnson. Seasonal flu kind of starts petering out
when?
Dr. Gerberding. It is very variable. Early spring,
generally speaking. It is still actively being transmitted now.
So we are not out of the woods on that one yet either.
Chairman Johnson. But our concern is coronavirus may not
decline as other normal seasonal flus in terms of what we are
looking at Singapore.
Dr. Gottlieb. If you look at the medical literature, you
would expect the coronavirus not to transfer in the warm
months, and I think people are hoping that we can prevent
enough transmission that you get into the summer and that is a
backstop, and then maybe we are dealing with this again in the
fall. But by then, hopefully, we have a better strategy and
maybe even a candidate vaccine.
But the situation in Singapore is concerning because it is
warm there right now, and it seems to be transferring. We do
not know the full scope of it, but they do seem to have some
level of community spread right now.
Chairman Johnson. We have reason to believe that we should
be able to develop an effective vaccine so that in a year from
now, we should be protected by this?
Dr. Gottlieb. I will also add, it is 60 degrees in Wuhan
right now.
Dr. Gerberding. Another aspect of the seasonality is that
the coronavirus--is that human beings are used to dealing with
the four sort of cold-like viruses are upper-airway viruses.
This is a lower airway disease, and so I do not know that I
would want to predict any seasonal impact on its transmission
pattern.
If you go back to 1918, we think of influenza as being a
winter disease, but that was not the case with the 1918
pandemic, so lots of uncertainty, and we just need to be
careful not to jump to any conclusion too early.
Chairman Johnson. Again, I really appreciate the time you
spent answering all of our questions here. There are a lot of
questions, obviously, that remain, and we will continue to
press.
I will again say I am disappointed that we did not have DHS
and CDC or HHS here. I am going to leave now and go to the
briefing where they will be present. The public has a right to
know these things. So, again, information to me is going to be
helpful here.
With that, I will say that the record will remain open for
15 days until February 27th at 5 p.m. for the submission of
statements and questions for the record. This roundtable is
adjourned.
[Whereupon, at 11:36 a.m., the Committee was adjourned.]
A P P E N D I X
----------
[[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
THE FEDERAL INTERAGENCY RESPONSE TO
THE CORONAVIRUS AND PREPARING FOR FUTURE GLOBAL PANDEMICS
----------
THURSDAY, MARCH 5, 2020
U.S. Senate,
Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 9:32 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Ron Johnson,
Chairman of the Committee, presiding.
Present: Senators Johnson, Romney, Scott, Hawley, Peters,
Carper, Hassan, Harris, Sinema, and Rosen.
OPENING STATEMENT OF CHAIRMAN JOHNSON
Chairman Johnson. Good morning. This hearing will come to
order.
I want to thank the witnesses first and foremost for your
efforts as they are related to the current--I guess we have to
call it a ``pandemic'' at this point in time, right?--with
coronavirus disease 2019 (COVID-19). I do think it is important
we put everything in perspective, and I would ask my Committee
Members to include my written statement in the record.\1\
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Johnson appear in the
Appendix on page 361.
---------------------------------------------------------------------------
I think we oftentimes fail to recognize and put this in
proper perspective, so let me just rattle off a couple figures
here.
Ebola, total cases worldwide ended up being less than
29,000. I remember in the midst of that crisis we were talking
about this thing spreading and it could be a million people,
which obviously would have been a huge problem because Ebola
had a mortality rate of 40 percent. But in the end, because of
really effective action on the part of the World Health
Organization (WHO) and the Obama Administration, we surged
resources in there, and we prevented that from spreading. So
less than 29,000 people actually contracted that; about 11,000
people died.
Now, we have had other outbreaks of Ebola, but we are
getting better at it. We have developed, I think, some
relatively effective vaccines that certainly helped protect our
health workers, and we will talk a little bit about that. Mr.
Cuccinelli in our Senate briefings pointed out that that is a
finite resource.
The next deadliest virus that we have been dealing with is
the 2012 Middle East Respiratory Syndrome (MERS) outbreak.
Total cases were less than 2,500; 815 people died, so that was
a mortality rate of 34 percent.
In 2003, we dealt with Severe Acute Respiratory Syndrome
(SARS); 8,000 people affected, 774 people died, a mortality
rate of 9.6 percent.
The average flu, the seasonal flu--and these numbers are a
wide dispersion of what happens--9 million to 45 million people
a year catch it; 140,000 to 810,000 people are hospitalized
with it. Obviously, anybody with underlying health conditions
and the elderly are most affected by it, and we will lose--
there will be 12 to 60 some thousand fatalities per year with
just seasonal flu.
Another virus that certainly reached pandemic levels that
sure sounded scary was the H1N1 virus. The actual stats on
that, about 60 million Americans caught H1N1. Worldwide, I
think it was over 200 million. Worldwide, 150,000 to 575,000
people died from H1N1 globally. But the fatality rates were not
that high. I mean, thousands died in the United States, but we
have dealt with these things in the past.
So the current stats, as far as I have them, that we know
about, 81,000 individuals have contracted and tested positive
for
COVID-19, close to 3,000 deaths. The latest mortality rate is
about 3.4 percent, which is serious. The normal flu mortality
is about 0.1 percent. So this is definitely more virulent, a
higher mortality rate, but I would caution everybody in terms
of that mortality rate. This is just deaths from people that we
have tested, and we do not have the types of test kits or the
numbers yet. We are developing them rapidly, thanks to, I
think, reducing government regulatory burdens in terms of the
testing. Again, we will talk a little bit about that. We
definitely do want to clarify that situation. But my guess is
the mortality rate, when all is said and done, once we actually
do have a sense of how many people actually contract this,
where they either do not display symptoms or they are very
mild, particularly in younger people, I think that mortality
rate, I would think, would probably come down. But, again,
nobody knows. There is an awful lot about this disease that
nobody knows.
So what I am hoping we can accomplish in today's hearing is
talk about this administration's response--which, by the way, I
think has been almost immediate. From what I have seen, my
interaction, the accessibility of whether it is Acting
Secretary Chad Wolf, Mr. Cuccinelli, members of the Centers for
Disease Control (CDC), the National Institute of Health (NIH),
I have had access to them. Now, I have not abused that access
because I really want you working to mitigate this problem. But
they have been very accessible. I do not know how many
briefings I have already attended. I appreciate we have two
individuals here. You may say, well, why don't we have
everybody representing every agency? I want them to work. They
have a job to do. I know there have been a lot of hearings, so
you have been very accessible. I think you have taken a whole-
of-government approach.
As I have said repeatedly, I certainly do not see the
administration underresponding. In fact, you have taken
unprecedented steps: travel bans, quarantines, I think--is this
correct?--for the first time in 50 years?
Mr. Cuccinelli. Over.
Chairman Johnson. Unprecedented steps. So we have not
underreacted, but I think this administration is fully aware
and cognizant of the costs of overreacting. So the basic fact
of the matter is the chances of the administration getting it
just right, reacting perfectly, is zero. It will not happen.
But, again, from my own knowledge, my own interaction, what we
have seen in terms of the interaction with the Senate and the
House, this is an all-government approach; this is all hands on
deck. This is not being ignored. You can just see, the $8
billion response as opposed to the $2.5 billion funding
request. Funds are not going to be an issue. Congress will make
sure that the administration has the funds.
In terms of priority of action, it is important that we are
able to test so we know the extent of what the outbreak is. I
really want to talk about the regulatory issues, just the basic
science issues. I was talking to Dr. Kadlec in the front room.
There is a reason they call it ``medical practice.'' This does
not just happen overnight. This is a whole new virus. It just
became known to mankind, what, 3 months ago, Mr. Cuccinelli,
you were saying?
Mr. Cuccinelli. Less, less.
Chairman Johnson. So it takes time to develop the tests to
make sure that the tests do not produce false positives. Then
you have to manufacture them.
So I am heartened by what I am basically hearing. I will
not tell the figures now. I want to hear about those, and we
want to delve into those, so we know what we are really talking
about in terms of what testing kits are available, how they are
going to be distributed throughout the Nation, kind of what the
priority is for that distribution, so we really do get a sense
by being able to test as many individuals as doctors want to
test, because right now it has been limited. There are a
limited number of tests, so there is pretty high criteria to
test any patient.
I want to talk about current travel restrictions.
Obviously, this is the Homeland Security Committee. We want to
talk about Customs and Border Protection (CBPs) role, the
Transportation Security Administration (TSAs) role, how you are
cooperating with CDC, what the screening measures are, what
data we are collecting. Mr. Cuccinelli, we talked about that,
and you reacted to our conversations reflecting more data so we
can trace travelers that may have come in contact with people
that are infected. So we want to talk about all those issues as
it relates to the Department of Homeland Security (DHS).
Again, testing is a top priority, but then we also want to
talk about the current issues with the supply chain, but also
in the future. Once we have this all stabilized and we know
where we are at--and hopefully this will prove to be somewhat
seasonal, although there are indications it may not be. Once we
have taken care of this and vaccines are developed and are
accessible to the public, which will be quite some time in the
future, we really do need to take a look at the Strategic
National Stockpile (SNS). We need to take a look at the supply
chains. We need to really ask ourselves in a manufacturing
process that is not labor intensive, why are so many of these
precursor chemicals for drugs produced in India, which is now,
according to news reports, blocking export of some of these
chemicals as well.
I see no reason for manufactured drugs approved by the Food
and Drug Administration (FDA) for the United States use that
those things should be manufactured overseas. I just do not. We
have to learn from these types of situations and put in place
either regulations or laws so that we are better prepared for
the next pandemic, because there will be a next pandemic. I
have just rattled off the ones we have already had to deal
with.
So, again, I really want to thank the witnesses. I am
hoping this is a really good discussion. I hope it is a
clarifying discussion. This is about transparency, recognizing
that you do not have all the answers because there are just
things right now that are unknowable. But thank you again for
your work in this. Thanks for appearing before our Committee.
With that, I will turn it over to our Ranking Member,
Senator Peters.
OPENING STATEMENT OF SENATOR PETERS\1\
Senator Peters. Thank you, Mr. Chairman. Thank you to our
witnesses for being here today.
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Peters appear in the Appendix
on page 363.
---------------------------------------------------------------------------
The top priority of this Committee and of your agencies, is
quite simple: keep Americans safe. To be clear, this
coronavirus outbreak in the United States is not currently
widespread, but, nevertheless, it does pose a significant
threat to our public health and our homeland security, and we
have to take it seriously.
I am grateful for the efforts of your agencies and public
health officials across the country to limit the spread of this
contagious virus.
While we have seen growing numbers of cases in the United
States, we have thankfully not yet seen widespread outbreak yet
in this country.
It is the job of this administration to work with Congress
and our State and local governments to do everything we can to
limit the spread of this virus. It is clear to me that we
should also prepare for a worst case scenario and widespread
infections.
Assessing clear information about coronavirus has been a
significant challenge for the public to date. The American
people have a lot of questions. They want accurate, reliable
information about the virus's spread and what the government is
actually doing to protect their health and safety.
As we have learned from past epidemics and pandemics,
outbreaks like this require an aggressive, coordinated, and
comprehensive response as well as timely and trusted, useful
guidance from public health officials as well as security
officials.
In the coming weeks and months, your agencies will play a
critical role in containing the outbreak, educating Americans
about this virus, and protecting public health.
Whether your response is timely and effective will truly be
a matter of life and death. With that in mind, I appreciate you
joining us today. My constituents in Michigan and the American
people want clear answers to some of the most pressing
questions that they have right now.
I look forward to hearing about what steps your departments
are taking to ensure that we have the right plans and that you
have adequate resources to actually execute those plans in
order to stop the spread of this highly contagious disease.
Thank you again for taking time to be with us today.
Chairman Johnson. Thank you, Senator Peters.
It is the tradition of this Committee to swear in
witnesses, so if you will both stand and raise your right hand.
Do you swear that the testimony you will give before this
Committee will be the truth, the whole truth, and nothing but
the truth, so help you, God?
Mr. Cuccinelli. I do.
Dr. Kadlec. I do.
Chairman Johnson. Please be seated.
Our first witness is Ken Cuccinelli. Mr. Cuccinelli is the
senior official performing the duties of the Deputy Secretary
at the U.S. Department of Homeland Security. Mr. Cuccinelli
most recently served as the Acting Director of U.S. Citizenship
and Immigration Services (USCIS). He previously served as the
Attorney General (AG) for the Commonwealth of Virginia. Mr.
Cuccinelli.
TESTIMONY OF THE HONORABLE KEN CUCCINELLI II,\1\ SENIOR
OFFICIAL PERFORMING THE DUTIES OF THE DEPUTY SECRETARY, U.S.
DEPARTMENT OF HOMELAND SECURITY
Mr. Cuccinelli. Chairman Johnson, Ranking Member Peters,
and distinguished Members of the Committee, it is my honor to
appear before you today to testify about the work of DHS and
what we are doing to respond to the outbreak of Coronavirus
Disease 19.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Cuccinelli appear in the Appendix
on page 364.
---------------------------------------------------------------------------
Let me first say I am very proud of the work that the men
and women of DHS and our partners at the Department of Health
and Human Services (HHS) and across the government are doing to
contain the spread of the disease, slow the spread of the
disease, and to prepare for a domestic response. The
Department's top priority is the safety and security of the
American people, and we are committed to an aggressive,
proactive, and preemptive whole-of-government response in
fulfilling that mission. As required by Congress, in 2018
President Trump signed the first ever ``National Biodefense
Strategy'' to build upon our ability to rapidly respond to and
limit the impacts of bioincidents like the one we are facing
now. We are seeing that strategy pay dividends as we implement
a whole-of-government response to this disease.
DHS is taking action at airports of entry to support HHS in
slowing the spread of the novel coronavirus. DHS is working to
decrease the workload of public health officials, expedite the
processing of U.S. citizens returning from China, and, above
all, ensure that resources are focused on the health and safety
of the American people.
DHS, including Customs and Border Protection and the
Transportation Security Administration, continues to work very
closely with our partners at CDC to route all admissible
persons who have been in Mainland China and Iran in the
previous 14 days to one of 11 designated airports of entry
where the Federal Government has focused public health
resources.
Any admissible person who has been in Hubei Province,
China, in the previous 14 days is subject to up to 14 days of
mandatory quarantine where CDC has made arrangements with State
and local authorities to ensure they are provided proper
medical care and health screening. Any admissible person who
has been in the rest of Mainland China or Iran within the
previous 14 days undergoes proactive entry health screening at
one of the airports and, if they are asymptomatic, up to 14
days of self-monitoring to ensure they have not contracted the
virus and do not pose a health threat.
DHS continues to facilitate enhanced health screening of
travelers entering the United States who have recently been in
China or Iran. Travelers identified by CBP officers during
their primary inspection are then referred to Countering
Weapons of Mass Destruction (CWMD) medical screeners. We have
500 of them, over 500 contracted, and about 95 on duty at any
given time. For those that through medical screening are
identified as particularly at risk, they are then referred to
CDC personnel who are onsite and have made arrangements with
local health authorities. This has involved over 53,000 air
travelers to date.
We realize these actions could prolong travel times for
some individuals; however, public health and security experts
do agree these measures are necessary to contain the spread of
the virus and protect the American people.
To minimize disruptions, CBP and the air carriers are
working to identify qualifying passengers before their
scheduled flights.
DHS CWMD is currently supporting the enhanced screening
efforts through agreements with State, local, or private sector
Emergency Medical Services (EMS), public health, and first
responder personnel. That is where those 500 contractors come
from.
CWMD established this capability in response to the Ebola
virus threat that was emerging last summer, and these actions
ensured a trained, vetted, and badged workforce was ready to
rapidly deploy to support CDC with airport screening
operations. DHS was able to adapt this capability to quickly
address the COVID-19 threat.
CWMD is also providing direct support to CDC's effort to
collect passenger information at all 11 airports, allowing CDC
to provide direct information to public health officials to
facilitate contact tracing efforts. CWMD's efforts have
significantly increased the accuracy of the data collected.
CBP and the U.S. Coast Guard (USCG) continue their work to
recognize, detect, and assist individuals arriving through our
land ports and waterways who may be carrying the virus, all in
coordination with CDC. The Coast Guard continues to review all
Advance Notices of Arrival (ANOA). This is a notice they get 96
hours before any ship comes to an American port. It gives a
full accounting of the medical status of everyone on the ship.
The Captain of the Port will communicate any concerns stemming
from sick or deceased crew or passengers to their Coast Guard
chain of command and the cognizant CDC quarantine station, who
will coordinate with local health authorities.
To ensure continued facilitation of international trade,
non-passenger commercial vessels that have been in China or
Iran or embarked crew members who have been in China or Iran
within the previous 14 days, with no sick crew members, may be
permitted to enter U.S. waters and offload their cargo, reload,
and depart the port.
My time is up. I will go ahead and stop with the opening
statement that we submitted covering a lot of this territory,
and I am happy to answer your questions.
Chairman Johnson. Thank you, Mr. Cuccinelli.
Our next witness is Dr. Robert Kadlec. Dr. Kadlec is the
Assistant Secretary for Preparedness and Response (ASPR) for
the U.S. Department of Health and Human Services. Prior to
joining the Department in 2017, he served as Staff Director for
the U.S. Senate Select Committee on Intelligence and as Special
Assistant to President George W. Bush for Biodefense Policy.
Dr. Kadlec served in the U.S. Air Force (USAF) for over 20
years and was named U.S. Air Force Flight Surgeon in the year
1986.
In a more expanded biography--I want to read a little bit
more--Dr. Kadlec was instrumental in drafting the Pandemic and
All-Hazard Preparedness Bill which was signed into law to
improve the Nation's public health and medical preparedness and
response capabilities for emergencies, whether deliberate,
accidental, or natural. He served in the White House from 2002
to 2005 as the Director for Biodefense on the Homeland Security
Council, where he was responsible for conducting the biodefense
end-to-end assessment, which culminated in drafting the
National Biodefense Policy for the 21st Century. He served as
the Special Adviser for Counterproliferation Policy at the
Office of the Secretary of Defense, where he assisted
Department of Defense (DOD) efforts to counter chemical,
biological, radiological, and nuclear (CBRN) threats in the
wake of 9/11 and contributed to the Federal Bureau of
Investigation (FBI) investigation of the anthrax letter
attacks.
I felt it was important to point out just really how
extensive your experience is in this and, as a result, what an
appropriate witness you are for this particular hearing. Dr.
Kadlec.
TESTIMONY OF THE HONORABLE ROBERT KADLEC, M.D.,\1\ ASSISTANT
SECRETARY FOR PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Dr. Kadlec. Thank you, Mr. Chairman. I appreciate it very
much. That is a very nice way of saying I am one-trick pony.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Kadlec appear in the Appendix on
page 370.
---------------------------------------------------------------------------
Chairman Johnson, Ranking Member Peters, and distinguished
Members of this Committee, thank you for the opportunity to
testify before you today on how HHS is supporting the whole of
HHS and U.S. Government response to the 2019 coronavirus
outbreak.
This morning, I just want to take a few minutes to discuss
how we are addressing this issue from a point of strategic
anticipation. Working with my colleagues at CDC, FDA, the
Centers for Medicare and Medicaid Services (CMS), and NIH
across the U.S. Government supporting State and local
authorities, we are working hard to contain and mitigate this
virus outbreak to save lives and protect Americans.
ASPR has a four-pronged approach to manage and support
domestic response. This includes medical countermeasure
development, supporting the health care system, incident
management, and direct support to State and local entities.
In the area of medical countermeasure development, we are
rapidly establishing an Interdepartmental Medical
Countermeasure Task Force that includes partners across HHS,
Department of Defense, and other Federal agencies and the
private sector to identify therapeutics, diagnostics, and
vaccines that could be rapidly brought through the pipeline to
address the coronavirus threat. Specifically, we are looking at
point-of-care diagnostics to aid public health in rapid
detection and guide treatment. We are also identifying
potential therapeutics to aid and support the treatment of
infected persons. Last, we are also working very closely with
NIH concerning multiple potential vaccine candidates. Combined,
all of our efforts are pushing platforms and candidates forward
as fast as possible to aid the overall response.
Turning to how do we support the public health system
through ASPR's Hospital Preparedness Program and in
coordination with CDC's Public Health Emergency Preparedness
Program (PHEP), we have improved coordination and collaboration
between hospitals in the public health sector and other
entities like Emergency Medical Services. We have also
leveraged the National Ebola Treatment Network, which was an
idea that was created by Congress and established as a response
to the 2014 Ebola outbreak, to support the treatment of
repatriated persons. As the health care system prepares for
possible spread of the coronavirus, this network has and will
continue to link technical experts with quarantine and
isolation experience to aid transport and treatment efforts at
the State and local level.
Shifting to our overall response structure, since
repatriation efforts began, we have been working with the
Federal Emergency Management Agency (FEMA), to put in place an
active incident management network that is based on the
National Response Framework (NRF). This is the first time we
have formally implemented this structure. Though we had
practiced activating this such structure during previous
exercises, we are doing it for real now, and it means that we
can leverage the capacities of FEMA and all the emergency
support functions that may be necessary to deploy responders to
assist States and local authorities in responding to the
coronavirus outbreak if and when asked.
I want to end with just a few brief updates how we are
providing direct support to State and local entities.
First, I mentioned our repatriation efforts early in my
statement where we successfully brought back approximately
1,100 Americans from Wuhan and from the Diamond Princess cruise
ship under very difficult circumstances. Currently there are no
additional planned repatriation efforts at this time, but
should the need be raised, we are standing ready to support the
State Department or any other authority. We have shifted our
efforts now to provide direct support and aid to States. In the
State of Washington, we have used the Strategic National
Stockpile to deploy personal protective equipment (PPE) to
protect health care workers, and a second shipment is arriving
today to augment what we have already sent earlier this week.
We are also planning to send 28 of our Commission Corps Public
Health Service officers and our National Disaster Medical
System (NDMS) team members to support them as well.
We are concerned about health care entities like long-term
and elder-care facilities where we know the most vulnerable
populations reside and are working proactively with CMS and
with CDC to provide information on best practices and, when
possible, help them shield our elder populations from the
impact of the coronavirus.
With that, I would be happy to yield the rest of my time
and be happy to answer any questions you may have. Thank you,
sir.
Chairman Johnson. Thank you, Dr. Kadlec.
I do want to ask some questions. Normally I yield and ask
later, but I just want to get some clarity on a few things
because I know this has been confusing. Let us talk about the
test kits.
My understanding is that 2,500 test kits will be
distributed they say the end of this week, which is like
tomorrow. Each test kit can perform 500 tests. So if you do the
numbers on that, that is 1.25 million individual tests. Senator
Hassan was remarking yesterday that each patient really, to be
sure, should be tested twice, so that is about 600,000
Americans.
Is that an accurate assessment? Or where are we at in terms
of----
Dr. Kadlec. Yes, sir.
Chairman Johnson [continuing]. Tests, because this is--so
who is manufacturing this? Is it a private sector manufacturer?
Dr. Kadlec. Sir, CDC started initially manufacturing some
of these test kits, and within a week or 10 days of when the
sequence of the virus was posted by the Chinese, began to work
on a polymerase chain reaction test, which is really a genetic
test, to look for the presence of ribonucleic acid (RNA) from
this virus. They were able to basically do a proof of concept
and develop a prototype and then began to produce that there at
CDC and then have shifted it to a commercial manufacturer
called Integrated DNA Technologies (IDT). They are the
individuals that basically are making the 2,500 test kits,
which include 500 tests per kit, to your point of 1.2 million
tests.
Chairman Johnson. Those will be going out to how many
different centers?
Dr. Kadlec. They will be going out to 190 places around the
country, but, quite frankly, the CDC has already distributed
75,000 tests already, of their tests, if you will. The intent
of the Secretary and the Vice President is really to maximize
the number of tests that can be performed.
Now, to just kind of put some reasonable expectations
behind this, these are test kits that are going to be sent out
to labs around the country. They are going to have to basically
validate these labs for their test procedures and train their
personnel. So they will not become immediately available, but
they will become increasingly available over the next week or
two to basically test Americans, which is another part of this
critical function, which is there have been several things to
do to basically enhance our testing posture. One is make more
test kits, distribute them, train the people who need to do
that, but also ensure that they are validated. But there have
also been things that have been done to increase the use of
these tests by indicating that people who fit the case
definition for possible coronavirus can be relaxed so we can
test more people, and that has significantly enhanced the
ability of doctors and first-line primary care physicians and
nurses to judge when their patients should get tested if they
suspect coronavirus.
So there are a lot of things that are in play here,
regulatory, definitional, as well as manufacturing and
distribution.
Chairman Johnson. So, obviously, I think there is
oftentimes unrealistic expectations. It is a new virus. We just
found out about this literally 3 months ago. It takes time to
first develop the test. It takes time to validate it in the
CDC, because you do not want false positives.
Dr. Kadlec. With the FDA.
Chairman Johnson. Then it takes time to manufacture the
first test kits. Then it takes time in the labs to validate the
labs so the personnel--they need to be trained. But you are
thinking within a couple of weeks there will be a capability
for testing, about 1.25 million tests, and then my guess is
that manufacturing can ramp up pretty quick.
Dr. Kadlec. Yes, sir. In fact, I think there is the
expectation for this particular company to expand their
manufacturing, and there is also a parallel effort that is
being done by the Biomedical
Advanced Research and Development Authority (BARDA) to
basically engage commercial laboratory testers--the Quests, the
LabCorps--to basically introduce the test in their systems so
that would proliferate it across the domain.
I think the thing is where there has been maybe a lack of
test kits, there will be plenty of opportunity for testing. I
think the key thing and what we are focusing on is being able
to do point-of-care diagnostics to support physicians on the
front line in their offices and to basically test people in
their offices to decide whether or not someone has coronavirus.
What will happen at this point is it is going to be hospital-
based, public health laboratory-based, and then commercial
laboratory-based, and we are trying to push it out as far and
as far as we can. It will take us some time, but we are on the
way.
Chairman Johnson. Again, as a former manufacturer, I
realize this takes time. You wish it would not, but it does
take a little bit of time. I think this has actually been
proceeding pretty rapidly. But everybody recognizes how
incredibly important this is because we really cannot get a
game plan until we really know the extent of the problem.
Let us just quickly talk about the vaccine time because,
again, I want to have people's expectations be reasonable. It
sounds like we are developing a vaccine at pretty much a rapid
pace. So it will go into Phase 1, which is just the safety,
make sure the vaccine is safe, when, approximately?
Dr. Kadlec. So I think Dr. Fauci is the best in the world
in this, and he basically believes it can be done in a couple
of months. Even then after that is done, there will be a period
of time to evaluate the safety data and then enter into the
next phase.
Chairman Johnson. OK. So, again, let us talk about the
approximate period of time. Nobody is going to hold you to
this, but I want to create the expectation. So a couple months
to develop one. Then we are going to have to validate the
safety.
Dr. Kadlec. Right, a Phase 1 study.
Chairman Johnson. Validate that. That will take?
Dr. Kadlec. Another couple months.
Chairman Johnson. OK. So now we are at 4 or 5 months out.
Dr. Kadlec. Then Phase 2.
Chairman Johnson. Then is it effective?
Dr. Kadlec. That is the Phase 2 study that will actually
look at that.
Chairman Johnson. That will take how many months?
Dr. Kadlec. Another 6 months.
Chairman Johnson. A year before we really have a vaccine
that we think is safe and that will be effective. Then you have
to manufacture it, right?
Dr. Kadlec. I think the reasonable expectation is between a
year and 18 months, honestly. I think Dr. Fauci has said up to
a year and a half, again, to moderate expectation.
Chairman Johnson. So let us say everything goes swimmingly
well, and after a year we actually have a vaccine that we know
is safe and effective. But you are not going to be able to mass
produce that yet. But will you be able to produce enough to
provide to our first-line responders, to doctors, to nurses? I
would think that would be--you would prioritize who is going to
have access to this before the general population.
Dr. Kadlec. Yes, sir. That is an area that, quite frankly,
is I think recognized in the supplemental, the generous funding
that you all provided. Our domestic manufacturing for a vaccine
for this particular virus is limited. Typically--and, again, a
lot of our plans are based on pandemic influenza where we could
use eggs and much of our capacity, domestic capacity, is egg-
based production. For these newer technologies like synthetic
RNA or recombinant genetic vaccines or cell culture vaccines,
we have a limited capacity. So we will be somewhat constrained
to get a vaccine for everyone, but to your point, it would be
prioritized to those who would need it most, health care
workers and----
Chairman Johnson. So we already know this vaccine will use
one of those more sophisticated techniques as well as the egg-
based?
Dr. Kadlec. Yes, sir.
Chairman Johnson. So if you are talking about 18 months
before you are really starting to manufacture it for the
general population, we will miss next year's flu season, and
you are really not going to have a vaccine available until
really the 2022 flu season. Correct? Is that the right year?
Dr. Kadlec. So that is conceivable, and, again, that is why
we are putting a lot of emphasis on diagnostics and
therapeutics to basically look at it. I did not mention it in
my opening statement, but screening existing FDA-approved drugs
and they have activity to basically do that, and the
supplemental has helped us basically actualize that. We are
looking at thousands of compounds that may be available that we
could be using that could be--as well as the candidates that
Dr. Fauci has talked about, Rendesivir and some other drugs, an
anti-human immunodeficiency virus (HIV) drug. But, quite
frankly, right now the only thing we really have is really kind
of 18th century public health as well as things like N95
respirators.
Chairman Johnson. OK. So, again, the vaccine is in the
future as a solution, so now you really, again, turn to how do
you mitigate this, and that will be how do you screen, how do
you get your arms around exactly where this is, quarantines--
and we will talk further about other contemplated actions
should this thing really spread and become a far more
significant outbreak.
My time is up. Senator Peters.
Senator Peters. Thank you, Mr. Chairman.
This information is very important that you are providing,
and as I mentioned in my opening comments, it is just so
important for us to get this information out to the American
people and in a trusted source.
One thing I have called for and handed information to the
Vice President yesterday is that, as I have looked and our
folks have looked to find out where information is for the
public through the Federal Government, there is good
information. CDC has some information. But there is additional
information that DHS needs to have. There is no one coordinated
place where people can go to find out exactly what the
government is doing with all of the agencies, a whole-of-
government kind of approach coming forward. So, my suggestion
is we have a dot-gov website. Dot-gov is trusted by everybody,
that really talks about not just what the CDC puts out but what
travel restrictions are, what the Homeland Security Department
is doing, all of this where people can go to, because right now
people are just actively searching--and I get this back home
all the time. They are actively searching for information.
There are all sorts of websites that are not accurate. There
are folks that are trying to peddle products and create fear in
order to make money. There is a lot of stuff happening right
now. We have to tamp that down. To me, to have one coordinated
site makes sense.
Does that make sense to both of you gentlemen, that we have
a place where all the agencies, and it is trusted, a dot-gov
site? Mr. Cuccinelli.
Mr. Cuccinelli. It does. Obviously at DHS we have used our
websites for each agency and at the departmental level to
describe what we are doing. But this is, as Dr. Kadlec
described it, a whole-of-government approach. It is a
complicated interaction at the government level.
I would also note--and we will talk more about it, I am
sure--the preponderant role that local and State officials play
in this response and then coordinating between different levels
of government as well. So, yes, and I saw your letter, Senator,
was glad to see it, and I believe that it makes an awful lot of
sense, particularly in a circumstance like this where, while
Dr. Kadlec, for instance, has the lead Federal agency, there is
an awful lot of us working on this subject, which is why the
President convened the task force and so forth. So it is
definitely something--we heard you loud and clear in your
letter and we are taking it back to the task force to talk
about it.
Senator Peters. I appreciate that, and I would just say we
just saw another incident. I am looking at the CDC website,
putting out facts about the disease. I know last night the
President was being interviewed, and some of the comments that
he made have caused some confusion. So I want to take an
opportunity at this hearing. It says here: ``If you are sick,
to keep from spreading respiratory illness, you should stay at
home when sick.'' Is that accurate, you should stay at home
when sick? I know there is some confusion now.
Dr. Kadlec. Yes, sir.
Senator Peters. Which is why it is important that we have
one trusted source.
Dr. Kadlec. Yes, sir, I think that is part of the best
thing is self-isolation if you have a respiratory illness and
you are not sure what it is, if it is flu, good reason to stay
home. It is coronavirus, better reason to stay home. But it is
a good practice.
Senator Peters. Right. Thank you.
Mr. Cuccinelli, there are some reports that some foreign
nationals that have traveled to China in the past 14 days are
actually coming into Canada, which does not have those same
restrictions, and they are crossing the land port of entry
(POEs) from our Northern Border--obviously, Michigan has a very
active Northern Border, but all across the Northern Border. Are
you aware of these reports? Is CBP conducting any screening of
the Northern Border to try to intercept folks who may be using
Canada as a port of entry and then using a land port to come to
the United States?
Mr. Cuccinelli. Yes, Senator. To broaden the context even
further, it has not been uncommon for Chinese nationals to fly
to Tijuana, Vancouver, or Montreal--that is not the limit, but
by way of example--and then cross into the United States. The
three largest land ports of entry for Chinese nationals are
Blaine, Washington, Buffalo, New York, and San Ysidro in
California. As you know, of course, with Detroit, they are not
the only ones.
Senator Peters. Right.
Mr. Cuccinelli. At those three ports, the numbers are
sufficiently high that we staged, in cooperation with HHS,
medical personnel there much like we have at the airport. It
was not widely advertised, necessarily.
I would note that the 212(f) Proclamation applies at land
as well as airports, and we have excluded over 300 foreign
nationals. Some people may find it ironic, but the largest
excluded group are Canadians, and it is Canadians who had
traveled to China in the previous 2 weeks. The next largest
group were Chinese nationals, and then it dropped substantially
from there. I want to say 90 Chinese nationals.
So the challenge you pose is real. We have been very aware
of it and confront it head on and turning those folks back,
frankly.
Senator Peters. So do you screen passengers in vehicles?
Because it is a different screening process, clearly, when you
are coming across the land border. It is easier in an airport
as you are walking by CBP folks. How do you deal with
passengers who are in the vehicle and have an opportunity to
really screen them?
Mr. Cuccinelli. So the first screen and the most important
screen that CBP is best at is a travel screening. So, for
instance, I described turnaways, people who are not allowed in
the United States because of their travel history. So CBP does
have some access to this at the border, depending on how the
individual or family perhaps in front of them came to be there.
If they came through air travel recently, that is a fairly
straightforward determination. But they are also doing
interviews, essentially, of people at the ports of entry in
addition.
So if you think of the airport arena, the CBP folks do a
travel interview: Where have you been? Who did you encounter?
et cetera. Then the next layer, you get more of a medical
interview. But that first one, it is the location where they
have been that is the first and biggest flag. Predating this
virus situation, CBP has always had direct access to CDC when
people present in front of them with the appearance of illness.
Now, of course, the danger here is you can be asymptomatic
with this particular virus, but that process has been
vigorously engaged in on both borders, north and south.
Senator Peters. You are talking about airports. It is even
more complicated when someone is coming across----
Mr. Cuccinelli. Yes.
Senator Peters. Address that. You are coming across in a
vehicle. Two of the three busiest border crossings in North
America are in Michigan. Lots of vehicle traffic. How are you
doing that?
Mr. Cuccinelli. So the main screen that is our first filter
and our biggest filter is the travel screen. We are using the
data systems we have available to our officers and that
interview which, while they were always doing it, there is
obviously a heightened focus on China, on Iran, but also Korea,
Italy, Japan, et cetera. There is not a proclamation barring
those, but if you get a ``yes'' answer to those areas of the
world, you are still going to pay closer attention. These are
not medically trained individuals, but if there is anything
they suspect, then those individuals will be pulled to
secondary screening, contact will be made with CDC, and it
essentially becomes a consultation at that point with genuinely
medically trained folks but who are not physically present.
Senator Peters. Right. Thank you so much.
Mr. Cuccinelli. Yes, sir.
Chairman Johnson. The bottom line is it is a far from
foolproof system. Again, that is just the nature of the beast.
Mr. Cuccinelli. If I could, that is a really important
point, Mr. Chairman. This has never been from day one intended
to be a hermetically sealed process. We are trying to reduce
and delay the biggest peak in the virus wave hit on the United
States of America. All of these steps reduce and delay; they do
not stop the virus. We have never suggested we were capable of
doing that, and viruses do not care about boundaries, right? So
it is an obvious point for us to try to provide extra safety to
the American people, but it is by no means foolproof.
Chairman Johnson. Again, my comment is not a criticism. It
is just trying to create realistic expectations, OK? Because if
it was hermetically sealed, we would not have trade at the
border. It would just be--again, overreacting here would be
unbelievably costly.
Senator Peters. Right, and I am just saying the ability of
that is just to slow it down, to buy time, to have more testing
kits out there.
Chairman Johnson. To mitigate it.
Senator Peters. To be able to mitigate it. You are buying
us time at the border, so thank you for doing that.
Chairman Johnson. Which, again, is what Dr. Fauci said in a
private briefing. The travel ban definitely delayed this,
definitely helped mitigate this, reduce the----
Mr. Cuccinelli. It was contrary to the models. It was not
necessarily predicted to work that way. Our analysis of the
task force, we came to a different conclusion, and now we can
Monday morning quarterback ourselves. That has clearly been
effective. It does not mean perfectly, as you point out, Mr.
Chairman, but it bought us time.
Chairman Johnson. Senator Carper.
OPENING STATEMENT OF SENATOR CARPER
Senator Carper. Thanks, Mr. Chairman. Welcome. Thank you
for joining us today and for your testimony and for your work.
Dr. Kadlec, given the potential for fairly rapid spread of
this virus, we cannot afford for our patients to delay
screening because of concerns of affordability with respect to
insurance deductibles and co-pays. Recently the news media has
documented one short-term health insurance plan in Florida, I
believe, billing a patient more than $3,000 for his coronavirus
screening and flu test. Three thousand dollars.
What are you and your staff doing to ensure that
coronavirus screenings and treatment are low cost and
affordable? Have you asked health insurers and employers to
lower or remove financial barriers to coronavirus screenings?
Dr. Kadlec. Sir, that was appreciated, and that is why Dr.
Seema Verma, who is a head of CMS, is now part of the task
force, to really focus in on that part of the problem. One is
about the accessibility of health care for people who may have
the coronavirus and how that is being covered, as well as the
affordability issue. She has been engaging with insurance
companies, and it is not surprising that someone may be taking
advantage of this. But she is not someone to be fooled with,
and I clearly have confidence that she is going to engage on
this fully. But we can certainly have her available for a
briefing for members, if that would be helpful, to talk more
about what CMS is doing to address that concern, accessibility
and affordability.
Senator Carper. I think that would be well received. Thank
you.
There is a Bipartisan Commission on Biodefense. I think,
Dr. Kadlec, you might have been the founding Staff Director of
that Commission.
Dr. Kadlec. Yes, sir.
Senator Carper. I think it is co-chaired now by Tom Ridge,
former Governor, former Secretary, and Joe Lieberman, who was
once the Chairman of this Committee, as you may recall.
Dr. Kadlec. Yes, sir.
Senator Carper. In 2015, that group issued a report. I
think that report included 33 recommendations to improve our
Nation's preparedness for intentional or naturally occurring
biologic threats. I am pleased to know that the President has
filled one of those recommendations, and that is centralizing
response efforts at the highest level of government, in this
case with the Vice President. Many of the recommendations,
however, remain unfulfilled.
As the founding Staff Director of that Commission, could
you just speak for a minute or so about the recommendations
that still remain to be completed and what stands in our way
for completing them?
Dr. Kadlec. Thank you, sir. I think just broadly there was
a second one that was completed. That was the National
Biodefense Strategy, which was really the foundational document
or effort to really understand what as a whole of government we
need to do. There was a lot of great work that Congress did
with the administration back in 2005 and 2006, and, quite
frankly, that is unfinished business. I think that was the
intent of that study panel, to basically evaluate what needs to
be done.
So broad strokes in the health care system. We have a
health care system that is about 95 percent privatized, that is
running on very limited margins in terms of profitability,
limited surge, and that surge capacity or lack of surge
capacity is going to be tested to the limit here. So that is
one area in terms of health or hospital health care system
preparedness' major vulnerability.
The other one critical infrastructure is the public health
infrastructure, which is really about the people at the State
and local level, and there are serious issues there in terms of
the numbers of people who are willing to get involved in that
business. I call it the ``Rodney Dangerfield of medicine.''
They get no respect, because when they do everything right,
nothing happens. It is a circumstance, I think, there that
really does require a little more nuanced effort to promote and
incentivize that.
The third is a different kind of infrastructure, and that
is what I would say is the infrastructure for medical
countermeasure development. We talked a little bit about the
domestic production of vaccines, and that is a good thing,
because if we can expand that, that is not only making sure we
have the right vaccines but we have great jobs for Americans in
many parts of the country and really enhance innovation in
health care. That is the fourth element where we are doing some
of that to address maybe some issues that would be related to
supply chain that have to be addressed, things like active
pharmaceutical ingredients (API), the precursors for that, and
where that is manufactured. Much of it is overseas and a great
vulnerability as we all learned through this experience.
So there are four quick things in broad strokes that I
would suggest that that study panel has done to raise our
awareness and focus our efforts to do that.
Senator Carper. You may have answered this, but I am not
sure. Just take another minute and talk to us about steps,
additional steps that the administration is taking to fill
other recommendations. You mentioned four that have been
fulfilled. The other 30-some that maybe have not been.
Dr. Kadlec. Yes, sir, and I will put it in broad strokes,
because we have talked about the Biodefense Strategy. The one
thing was the Executive Order (EO) on pandemic influenza which
really talks about, relevant to this issue, quite frankly, how
do we basically manage a potential pandemic of flu. Again, a
lot of that is really about speed, speed of action, which I
think is a fundamental issue in this event. The virus is moving
faster than sometimes we can even think and act.
Then the second thing is really about domestic capacities
and supplies, things like the Strategic National Stockpile that
have to be maintained over time. I will just point out that one
of the findings out of the Biodefense Strategy was we invest
about $8 billion in this kind of activity each year. It sounds
like a lot of money, but when you consider that an aircraft
carrier costs $17 billion and we have 12 of them as a country,
that gives you some kind of scale of what we invest in one arm
of our national defense that we probably want to invest in our
national health security.
Senator Carper. All right. Thank you.
As you know, pharmaceutical companies that exist, maybe
that were founded and operate exclusively in this country,
oftentimes partner with pharmaceutical companies in other parts
of the world in order to try to solve Alzheimer's disease,
Parkinson's disease, and Multiple Sclerosis (MS). What kind of
collaborations are being encouraged, should be encouraged with
respect to shortening the development time for the vaccines to
address this virus?
Dr. Kadlec. Senator, some examples. Coalition for Epidemic
Preparedness Innovations (CEPI) is a group that is kind of an
international consortium that involves the Wellcome Trust, the
Gates Foundation, the U.S. Government is involved, several
European governments are involved, to focus on major disease
areas. Coronavirus is one of them, quite frankly, as well as
Marburg virus, a hemorrhagic fever. I think those kinds of
initiatives are valuable because they can, if you will,
consolidate small resources and give bigger opportunities, and,
again, tap into the wealth of innovative thinking around the
world to address some of these hardest problems, and also
understand that in many of these cases, the underdeveloped
world is probably the greatest at risk, and so to make it
affordable and more accessible. So those kinds of models are
very helpful.
The Global Health Security Agenda is another thing that was
created in the Obama Administration, perpetuated in the Trump
administration, to address how we can build capacity in
countries so they can be better positioned to help themselves.
That was the success of the western Congo outbreak of Ebola
where small amounts of money helped build the infrastructure,
as well as the availability of an effective vaccine. Obviously,
eastern Democratic Republic of the Congo (DRC) is a different
story, but those are some examples I would use, sir.
Senator Carper. Great. Thank you so much.
Chairman Johnson. Senator Hassan.
OPENING STATEMENT OF SENATOR HASSAN
Senator Hassan. thank you, Mr. Chair, and thanks to both of
our witnesses not only for your presence here this morning, but
to you and your teams, thank you for your service and theirs,
and please take our thanks back to everybody on the front
lines.
Dr. Kadlec, I wanted to just start with following up on
Senator Johnson's line of questioning about what we can be
communicating to our constituents about the timing of increased
testing availability. You went through--we have tests at public
health labs. Now we are surging up on the commercial side. We
have talked about a million-plus test capacity. But part of the
process here is going to be once the commercial labs get these
testing kits, they have to validate them, right? So how long
does the validation process take? I am just trying to get to a
timeline----
Dr. Kadlec. Sure.
Senator Hassan [continuing]. So people understand when this
surge will really be making a difference in their experience.
Dr. Kadlec. I think the key thing is, based on what is the
availability of these tests now in terms of delivery, they are
being delivered now.
Senator Hassan. Right.
Dr. Kadlec. In the public health labs, they will be
increasingly--by the end of next week, you will probably see
very high capacity and capability, so about a week. Then you
can imagine that the commercial laboratories will be lagging
about a week behind them.
Senator Hassan. Then how long does the validation process
take?
Dr. Kadlec. It takes a couple of days to do that.
Senator Hassan. For each kit?
Dr. Kadlec. No, it is the machine and basically validating
the test itself on the machine.
Senator Hassan. OK.
Dr. Kadlec. The people who have to basically work the
machines and the test kits.
Senator Hassan. I think it would be very helpful--and I
want to move on to some other questions. I do not want to
belabor this. But if the administration would put down a
timeline so that people could see in writing on a website when
to--you do not have to promise an exact date, but when it would
be reasonable to expect commercial labs to be able to perform
this test if your doctor suggests you get it, I think that
would be very helpful.
I wanted to move on to another issue. As you know, Dr.
Kadlec, the National Disaster Medical System and other programs
play a critical role in ensuring that uninsured and
underinsured patients can receive care during emergencies by
helping reimburse hospitals. I know that you mentioned earlier
in the week that this issue was under discussion within the
administration. Can you provide an update on those
conversations and, more broadly, what the administration is
doing to help ensure that underinsured and uninsured patients
can receive the emergency care that they need?
Dr. Kadlec. Ma'am, I am probably not the best one to answer
that. I think Dr. Verma may be.
Senator Hassan. OK.
Dr. Kadlec. But I do know that in the supplemental there is
money to basically support that; that would basically expand
it. I think it is about $1 billion, so you were very generous
in that allocation. I think that will be money that will be
used for that purpose, to basically ensure that we can take
care of everyone, literally everyone who is afflicted with
this.
Senator Hassan. All right. I will follow up with Dr. Verma
to be sure, but it is going to be an important issue, and if we
need more resources to make sure that people are not only
getting the care they need, but, getting the test they need so
that they will not be infecting other people.
Earlier this week, Dr. Kadlec, I met with New Hampshire's
public health officials. They have in-State stockpiles of
protective equipment such as masks, but they recognize that
their stockpiles may be quickly used up, and we have already
had at least one confirmed case in New Hampshire. Public health
officials in my State have attempted to order more supplies,
but they were told such supplies are on backorder until May.
Based on your testimony earlier this week, I am concerned
that the National Strategic Stockpile will not be sufficient to
meet the demand. What is the timeline for getting the equipment
in the field? How will you advise people to protect themselves
in the interim?
Dr. Kadlec. Ma'am, we have taken a multi-pronged strategy
to basically address what I think is your point, which is
unless you have it on hand immediately, you are going to face
some challenges. One is that we have a stockpile, a limited
stockpile right now of masks--when I say ``masks,'' surgical
masks--N95 respirators, and we are in the midst of procuring
more immediately, meaning tens of millions, and then have
introduced or released as of yesterday a request for proposals
for 500 million N95 respirators to basically be provided over
the next 6 to 12 months.
Senator Hassan. OK.
Dr. Kadlec. So the intent is that that will ramp up.
Senator Hassan. The supplemental provides funding for
that----
Dr. Kadlec. Yes, ma'am.
Senator Hassan [continuing]. So that the manufacturers know
they will get paid. OK. So do you have a plan in place to
ensure that firefighters, public health officials, and other
first responders are appropriately prioritized for receiving
the equipment?
Dr. Kadlec. We met with the manufacturers yesterday, and I
think that is one of the conversations we are having. They are
making allocations on their own, but--and then realize that in
the course of, let us say, just these N95 masks, in a given
year, only 10 percent is used by the health care professionals
and lump in the first responders. And so much of it is used by
construction, mining, and manufacturers. The FDA has given an
emergency use authorization (EUA) to allow non-medical masks to
be used by a broader population, first responders included, and
we are going to try to work to see if we can get an allocation
to make sure that those first responders are covered.
Senator Hassan. OK. So that is helpful to know. In addition
to States needing these supplies, it is going to be important
to provide training to any responders or providers who will be
tasked with assisting or treating coronavirus patients. What
efforts are underway at the Federal level to ensure that
responders and providers can access training on the use of
personal protective equipment?
Dr. Kadlec. Thank you, ma'am. One of the critical things--
and, again, a product of Congress' work has been the National
Ebola Treatment Network that was created post the 2014 Ebola
event.
Senator Hassan. Right.
Dr. Kadlec. With that, there was more generous monies then
than now to basically address not only ten regional centers,
three national centers of excellence, but we have also, like in
the north New England area, started a regional Disaster Health
Response Network with Mass. General Hospital that is working
with your catchment area to basically train and prepare people.
So that will be one mechanism. We can get training out and
specific information on how to manage these coronavirus
experts, and, actually, we used some of the people from Mass.
General in the repatriation of the people from Diamond
Princess.
Senator Hassan. OK. I think it is going to be important,
something that I asked Acting Secretary Wolf about yesterday,
too, because in the proposed DHS budget there are actually cuts
to programs that train first responders in this kind of work.
So I want to make sure we are focused on that.
I am just about out of time, so I thank you both, and I
thank you, Mr. Chair.
Chairman Johnson. Senator Rosen.
OPENING STATEMENT OF SENATOR ROSEN
Senator Rosen. Thank you, Mr. Chairman. Thank you for being
here. I know you have been in a lot of hearings. We appreciate
your around-the-clock work.
As no surprise to anyone, the virus is moving fast. Nevada
has just reported its first case of the virus today. I have
been in close contact with our State officials, our Governor's
office, and I want to emphasize, really stress the importance,
just like the other Senators have here, how important it is to
keep those clear lines of communication open with really good
data that they can respond; they are our boots on the ground.
But what I would like to address is Federal assistance for
the impacted individuals. If larger quarantine measures are
needed and medically justified, what plans are in place to
provide relief to those Americans who may miss work due to
government-impose quarantine but not necessarily to their
illness? Many folks live paycheck to paycheck. The loss of a
few days' work is a major hardship, let alone staying home for
a few weeks. This could lead to people losing their homes, not
being able to afford food or other essentials.
If we have disaster-like situations on the ground, what can
FEMA do to help alleviate this in the short term? What do you
need from us to help with that?
Mr. Cuccinelli. FEMA has been in place with ASPR at HHS for
almost a month now and assisting them, bringing the expertise
FEMA brings to disaster response to this effort, still with
ASPR as the lead Federal agency, of course. People naturally
look to Stafford Act, and this is a disaster of sorts, but the
response mechanisms are not the same. It is not currently
anticipated that you would see a Stafford Act declaration. The
intensity of the problem will be different in Nevada than it
will be in Virginia, for instance. There is the base fund where
Governors can make requests when elements of their systems are
overwhelmed for funding. There is a $5 million cap that is
waivable for that, and this is not the Disaster Relief Fund
(DRF), the $34 billion disaster--this is a base fund that has
about $640 million or so in it.
Senator Rosen. Would they be able to use this? We know that
around the country some places are reporting school closures.
We could anticipate maybe closures of senior centers. So we
have many kids across this country, many in my State, kids on
free or reduced lunch, free breakfast. We have senior centers
where those seniors reliant on those meals every day. How do we
ramp up and give the ability, if there is a school closure, a
senior center closure, to use Meals on Wheels or give brown
bags to these kids and their families? Can you speak to that?
Mr. Cuccinelli. Yes, but it is a belief. I believe
Secretary Azar has some authority to expand aid, welfare
programs, under these circumstances. But FEMA nor DHS do not
have dollars available that would legally fit the description
of the relief you are describing, Senator. So that is something
that I believe is being covered and addressed in the
supplemental, and that is the appropriate vehicle.
I would just note more generally that Dr. Kadlec referred
to the planning efforts that have gone before this all arose,
and we operate off the Pandemic Crisis Action Plan (PANCAP) 18
plan, and in that plan it was envisioned that the financial
vehicle to deal with an outbreak of this nature was via a
supplemental. So we are sticking with that plan, and as was
said 6 weeks ago, if we need dollars, we will come to the
Congress. We are here now, of course, and that discussion is
going on. It is including the kind of things you are
describing?
Senator Rosen. So our Governors would be able to request
this and funnel it to communities that need it, is what you are
saying?
Mr. Cuccinelli. No. I think you are mixing two things. If
the supplemental includes monies to address the types of
shortcomings, financial shortcomings you are describing, then
the answer would be yes.
Senator Rosen. OK.
Mr. Cuccinelli. There is nothing currently legally in place
that FEMA has available that would fulfill the needs you are
describing. I want to make sure that----
Senator Rosen. So we may have to look to that in the future
and see what we----
Mr. Cuccinelli. Yes, ma'am.
Senator Rosen [continuing]. Have to do to take care of
those vulnerable populations.
The next thing I would like to ask you is about immigrants
that are seeking care. Nevada's diversity is its strength, with
about one in five Nevadans born outside the United States, many
more living in households with immigrants, some of whom are
undocumented. As we work to contain the coronavirus, we have to
ensure that there is timely access to medical care for everyone
who needs it, regardless of their status. This is a public
health and safety issue. Anything less puts all of our
communities at risk.
So, Mr. Cuccinelli, no one should be afraid to seek care as
the coronavirus spreads, placing our communities at risk. Will
the Department refrain from apprehending individuals based
solely on their immigration status while they are in the
process of seeking care?
Mr. Cuccinelli. So much like the CDC-CBP relationship
preexists this virus, it is something that has stood before,
U.S. Immigration and Customs Enforcement (ICE) also has an
already-in-place policy, their sensitive locations policy. They
do not do enforcement in health care facilities absent single
case exigent circumstances. So there is no reason anyone should
expect that law enforcement take place----
Senator Rosen. But would they refrain from potential
intimidation factors such as placing vans outside of community
centers or health centers where people may go to seek these
tests?
Mr. Cuccinelli. That would be consistent with the policy,
Senator.
Senator Rosen. Thank you. I yield back.
Chairman Johnson. Mr. Cuccinelli, very quickly, because we
discussed this. Senator Portman brought this up yesterday. He
had a chance to look at the supplemental. Zero dollars for DHS.
We talked a little bit about this in the cloakroom. Can you
describe what the thinking of Congress is on that and how DHS
is going to get the funding to do the things you need to do in
this situation?
Mr. Cuccinelli. So the easiest starting point on that is
what is already going on. So FEMA is in the office every day
with Dr. Kadlec assisting HHS. That is financed by HHS. So
there are interagency agreements in place, so dollars that flow
to HHS to address the virus challenge, as the source of the
lead Federal agency, do flow to DHS when we are providing those
sorts of supportive efforts from any of our agencies or
components, the most obvious one day to day being FEMA at the
moment.
Chairman Johnson. So there is a mechanism in place between
agencies, so you are not concerned when you look at that
supplemental, well, where is our support, where are our
resources? You are going to get those through HHS and, again,
the administration requested $2.5 billion. We are going to give
them $8 billion. Resourcing should not be a problem.
Mr. Cuccinelli. That is exactly how this will work going
forward, as it has, as I noted, for the last month or so.
Chairman Johnson. OK. Senator Hawley.
OPENING STATEMENT OF SENATOR HAWLEY
Senator Hawley. Thank you, Mr. Chairman. Thanks to both of
you for being here. Thanks for the excellent work that you are
doing to address this outbreak. I have to say it is very
concerning. I am concerned about the spread of the virus
nationwide. I am also concerned about what this has exposed.
One of the things is I think the fragility, the vulnerability
of our medical supply chains. You referenced this a moment ago,
Dr. Kadlec, the fact that for medical devices too many of our
drugs or pharmaceuticals themselves are manufactured in whole
or in part in other places, China in particular. Now we have
already seen early reports about potential drug shortages
because of Chinese factory closures. This is something that we
have to scramble to address now to make sure that, as this
outbreak continues, we are not caught with severe medical
shortages in key drugs, antibiotics, antivirals, but also going
forward that we take necessary action.
So, Dr. Kadlec, let me just start with you on this. Can you
describe the actions that ASPR and the task force are taking or
have taken to ensure that our health care providers have
uninterrupted access to personal protective equipment like
masks and gloves?
Dr. Kadlec. Sir, I think the key thing is we have been
working with the manufacturers, the key manufacturers, all the
manufacturers in the United States, with the distributors.
Again, it is kind of a delicate balance to ensure that what is
made available is available into the stockpile, and not only
our stockpile but to distributors so they can provide for
private health care workers as well as institutions. Many
States do have a limited supply, a limited stockpile, and our
intent is to basically provide--support the States by providing
them materials as we did in the State of Washington, to
basically supplement what they already have on hand, what is
available commercially, to ensure that they do not run out in
an emergency of this nature.
Senator Hawley. In your written testimony, you wrote about
the Strategic National Stockpile and that it is working hand in
hand with commercial supply chain partners to monitor
shortages. Can you just elaborate on that?
Dr. Kadlec. Sir, basically, again, if not daily, weekly
conversations with the major suppliers of, let us say,
overgarments, Dupont; respirators, 3M, Honeywell, all the
others; to basically understand what their allocations are to
the private sector and what are the needs for the Federal
Government as well. There are many departments and agencies
that have needs as well, and we are monitoring that so that we
can moderate what is perceived needs versus actual needs to
ensure that we have enough in the pipeline for the private
sector to meet their first-line needs.
Senator Hawley. It is my understanding that the FDA is
currently working with manufacturers to monitor potential
shortfalls for drugs and devices. To what extent are
manufacturers complying, to your knowledge, with requests from
the FDA in this regard?
Dr. Kadlec. Sir, the FDA does this through a confidential
kind of business arrangement with them, so I do not have
visibility entirely, as appropriate in this case, to know
exactly what the particulars are. But Dr. Hahn would be an
excellent source to come in and brief you all on what they are
doing.
At this point, however, there is only one drug, prescribed
drug that has really been identified as being potentially in a
shortfall. There are alternative products available in the U.S.
market that could be substituted. So the impact of that
limitation does not seem to be great. But he is kind of
monitoring that like a hawk with his team to ensure that they
cannot only identify near-term but longer-term risks to our
medical pipeline.
Senator Hawley. My own view is that we need to give the FDA
more authority to look under the hood, find out exactly where
our drugs and medical devices come from, what the supply chain
vulnerabilities may be, and then give them the authority to
backfill by speeding up approval of alternative devices or
drugs manufactured in other areas. I have introduced
legislation to do just that.
Mr. Cuccinelli, let me turn to you. Do we need to be
considering expanded travel restrictions as the virus spreads?
How do you evaluate that?
Mr. Cuccinelli. The short answer is yes, but it is yes
because we have literally been considering them on a daily
basis. The driving factors would include--and they vary how
they weigh in each country--first, the transparency of the
Nation under consideration. You compare, say, China's
transparency to Korea. It is a rather dramatic difference. The
ability of their own health care system to respond to the
outbreak in their country; and the capacity remaining after
they do so.
So, for instance--I will give you an example--the State
Department's warnings early on about China were not just
because of the outbreak. They were also directed to keeping all
of our U.S. employees safe, because if you got in a car
accident, completely unrelated to the coronavirus, in Hubei
Province, there was not a doctor to take care of you. So their
systems in parts of their country were and are overwhelmed, so
that is another consideration.
Now, China, on the other hand, would be a very different
consideration than, say, their neighbor Mongolia, which, you
compare the health care systems, Mongolia closed their border
very fast, and part of the rationale was that they do not have
the ability to respond. We are talking in this Committee about
our strengths and weaknesses and what we could better in the
future, but they have no ability. So those sorts of factors
weigh in on those other countries.
Senator Hawley. You are reevaluating, your testimony is
that you are reevaluating this on a daily basis.
Mr. Cuccinelli. Daily basis.
Senator Hawley. Is that an interagency process?
Mr. Cuccinelli. It is an interagency process, and we are
using two scales to warn Americans: both the State Department's
Travel Advisory Scale, which is a 1 to 4, and the CDC Health
Scale, which is alert to 3. Their numbers naturally are off by
one as we go up and down, so 4 and 3 are the tops,
respectively. But we have found, as Steve Biegun, the Deputy
Secretary who sits on the task force, would tell you, I am
sure, they I do not think have ever seen such responsiveness to
their travel advisories. We have never seen such consumption by
the American public, much like CDC, I believe, had 500,000
downloads of their business advice, their business guidance in
the last 24 to 48 hours. So that is all having a real
meaningful effect without government mandates.
Of course, there is a 212 Proclamation with China. The TSA
issued security directives yesterday, effective yesterday, with
respect to Korea and Italy, but really a very minimal legal
impact, more advice and weight of the value and credibility of
the government advice.
Senator Hawley. Very good. Dr. Kadlec, let me just come
back to you before my time completely expires. I am sure that
you are aware of news reports I have seen of the other
countries like South Korea, for instance, is performing over
10,000 diagnostic tests per day. They have even set up drive-
through clinics in South Korea where citizens can go and be
tested.
Why are we not at scale and able to do something like that?
While we are on this topic, can you explain the precise reason
for the defective kits that we saw earlier?
Dr. Kadlec. Sir, I cannot provide the exact reason for the
defective kits. We probably need to have CDC come and brief you
on that. But in terms of the scaling, earlier conversations by
the Chairman were that we are scaling up now by
commercialization of not only test kits that could be used in
public health laboratories, but really engaging the private
sector, the commercial labs that can do large-volume testing.
That is going to be kind of rolling off the line here in the
next week or two that would significantly expand the
opportunity to not only do testing in public health labs,
hospitals, and clinics, and even doctors' offices that use
these commercial laboratories. That will rapidly be turned
around.
Again, we may not get to drive-through swabbing, if you
want to call it that, but also I just want to comment on that
point alone. You have to do it with some precision how you take
those naso-oral pharyngeal swabs. The risk is you can swab
somebody if you are not careful and get a false negative. It
does take a little bit of training, so I would not think that
Jack in the Box will be swabbing here in the United States any
time soon.
Chairman Johnson. Senator Scott.
OPENING STATEMENT OF SENATOR SCOTT
Senator Scott. Dr. Kadlec, we have a lot of information at
NIH and CDC. I have not seen anything where everyone is talking
about the risk for pregnant women. Is there increased risk? Are
there any precautions they have to take?
Dr. Kadlec. Sir, little data on that. Honestly, at this
point in time I think there needs to be a better understanding
of that. That is a particularly vulnerable population for a
variety of reasons, two lives, as well as the different
physiological effects of pregnancy on women and the baby. And
so that is an issue.
The earliest report has been a coronavirus report or a case
in a newborn in China, but that is the only thing. That is an
anecdotal case, but certainly that is a major issue and
concern.
Senator Scott. So nothing has come out of South Korea or
Japan or----
Dr. Kadlec. Nothing as of yet, sir. We are getting high-
level statistical data, but not case reports that are vital for
this purpose.
Senator Scott. OK. Thank you.
Secretary Cuccinelli, I am from Florida. We have 150
million-plus passengers through our airports. Then we have all
the millions and millions of people who go through our cruise
ships. What advice are you giving to both our airports and our
seaports to deal with? We have so many people coming from now
all over the world that we know these countries have
coronavirus. What advice are you giving them? What precautions
are you putting in place?
Mr. Cuccinelli. So a few things. First of all, the Coast
Guard, TSA in particular, have very regular communication with
the cruise lines and the airlines. In fact, I have been doing
that as well. You will have noticed that for the first time
ever--we were talking about travel advisories with Senator
Hawley--we issued a travel advisory, the Department of State
specifically, related to cruise ships--not a country, not a
location, but to cruise ships, because they have proven to be
such a risky venture from a health standpoint. That was unique.
It was effective in terms of the responses. That is not
economically good for the cruise ship industry, but we have
also see--I mean, the Diamond Princess was a viral disaster,
and avoiding a repeat of that series of mistakes that really
are going to take a long time to even understand completely has
driven a lot of that response.
On the airline front, we are seeing point-to-point declines
in traffic. I have data on some of that if you would like.
Needless to say, China's flights have gone through the floor,
and Korea has declined maybe by half, Japan by about 25
percent, just by way of example. There are good reasons for
that.
The cruise ships themselves, in my discussions with some of
the representatives, are themselves trying to avoid bringing on
passengers from these hot zones and to avoid a repeat of the
result of essentially quarantining a ship. As it works in the
ports--and you do have many of those in Florida--the Captain of
the Port, the Coast Guard person in command of that port, is in
absolute control of that port. We hold ships offshore when
needed, and we have done that throughout this entire time. That
has primarily been associated with cargo shipping because we
have tried very hard, to some of the discussion about supply
chain, to keep the cargo flowing--not for dollar reasons but
because of the interconnected nature of our supply chains. We
have taken special steps, for instance, keeping ship crews on
ships, allowing offloading and reloading of ships and they
leave without the usual coming ashore.
In a passenger context, that is much more difficult, and we
continue to contend with these. You are sitting next to Senator
Harris. We are dealing with one coming in San Francisco, and
literally as we speak that is being dealt with directly. The
Captain of the Port will work directly with the regional CDC
head to address these on a case-by-case basis in terms of how
to deal with passengers. As you might imagine, of course,
having been Governor of Florida, you can appreciate if we were
to try to use the health care facilities in one port to deal
with an entire cruise ship, we would immediately swamp the
health care system locally. That is our counterbalancing
challenge that we rely on CDC to make those State-local
arrangements, though they are conversations that the Coast
Guard has all the time.
So we really are handling them one at a time, but it is
with an eye to not bringing ashore virus spread. That is the
priority, and it is part of why we have warned Americans not to
go on them in the first place.
Senator Scott. Particularly airports, we all have lots of
international flights. We have a lot in Florida. So what is it
going to take for you to do the same thing you did restricting
travel out of China? What do we have to have?
Mr. Cuccinelli. Of course, that step was taken in literally
the world's epicenter there in Hubei Province, still the
largest number of cases in the world. We do not see anything
like that developing to that scale, though Korea and Italy are
kicking case numbers up very fast. It is important to remember
when you take a snapshot of today's cases, that is a week, 2-
week, 3-week lagging indicator of what was already there. We
are operating on dealing with this virus that has not been
known to exist in humans for 3 months yet, lots of areas we
lack knowledge. We are trying to err on the side of
conservativeness. If you are in the cruise business or airline
business, that is hurting you right now, and that is going to
keep hurting you for a little while. We do not know how long.
But, obviously, our challenge is to try to keep Americans safe.
Senator Scott. I do not trust any of the information coming
out of China. I do not believe they are a transparent country.
It is Communist China run by the Communist Party. So do you
have any inclination to open up travel from China any time
soon?
Mr. Cuccinelli. That is not on the discussion table. We are
not even talking about it right now.
Senator Scott. OK. I think it would clearly be important
for my State, but on the cruise industry, do you think you are
going to get to the point where you are going to say you are
going to start testing everybody that is going to come off?
Mr. Cuccinelli. Again, that would be a case-by-case. We
will not be able to for a few weeks at least. However, we are
right now literally as we speak flying test kits out to a
cruise ship off San Francisco--off California, I should say; it
is moving up to San Francisco--with Coast Guard helos and
Parajumpers (PJs) basically dropping onto the ship and bringing
kits. We are going to test, if not everybody, a very large
number of individuals relative to the ship. That we have full
information, when the Captain of that Port in San Francisco is
talking to their local CDC authority--and they have already
been working as an action group with the cruise line
themselves, so this is not popping on us. We have been working
it for days.
Senator Scott. All right. Thank you. Thanks to both of you.
Chairman Johnson. Thank you, Senator Scott.
Just real quick, on the cruise industry, I would think in
terms of availability of testing kits, because it is such a
unique situation, that would be one of the priorities in terms
of getting test kits so that is a capability. Senator Harris.
OPENING STATEMENT OF SENATOR HARRIS
Senator Harris. Thank you, Mr. Chairman.
As you know, my State is home to 40 million people, and we
have the largest number of cases, 62. Yesterday our Governor
declared a State of emergency for the entire State. The
coronavirus I think presents an interesting convergence between
public health concerns and pay equity concern. Specifically,
two-thirds of low-income workers in the United States do not
have paid sick leave, and as we know, we have been encouraging
people who are sick to stay at home. Often people who are in
that pay category also are in the service industry. They work
in restaurants; they work in hotels; they work in child care.
They have contact with a lot of people. For them to stay at
home in the interest of public safety means they may not be
able to put food on their table.
So my question is: Understanding this is a very real issue.
What is the administration planning to do to encourage
employers to provide paid sick leave for sick employees so that
they will stay at home and not have to face that awful decision
about whether they stay at home in the interest of public
safety or do not put food on the table of their family?
Mr. Cuccinelli. So I will speak first to the communications
we have had with people across the private sector. In addition
to our accelerated communications with local and State-level
officials, we have also been talking to non-health care private
enterprises and encouraging them in this direction as well,
recognizing the burden that asking employees to stay home
imposes both on the business and on the employee. You
identified, Senator, certain businesses where it is important
for everyone else, not just co-workers, for that person to stay
home.
Senator Harris. Right.
Mr. Cuccinelli. If you are serving food and the customers
in that restaurant----
Senator Harris. Like a fast-food restaurant.
Mr. Cuccinelli. Yes. They do not want you to come to work,
right.
Senator Harris. So what can we do to support you talking
with the private sector about providing paid family leave
during this concern?
Mr. Cuccinelli. So Cybersecurity and Infrastructure
Security Agency (CISA) has already standing sector consortiums
that they are talking to, and this is one of the subjects that
they have talked to them about, about supporting employees who
are asked to stay home.
Obviously, we are also asking businesses in those lines of
work where it is possible to make the telework arrangements so
people can keep working and they can keep getting paid. You do
not function as well, but they can still earn money for their
families.
Senator Harris. But my concern is that for the majority of
low-income workers who do not have paid sick leave, they are in
the service industry, so teleworking is not an option for them.
So perhaps we can follow up to determine how we can support
what sounds like is your effort to figure out ways that we can
make sure that these employees do not have to make a decision
between paying their rent or contributing to what we know is in
the interest of public health.
Mr. Cuccinelli. There actually is more money available, and
I would defer to Dr. Kadlec because that is out of HHS.
Dr. Kadlec. Just one other area, ma'am, on the White House
task force, Secretary Mnuchin, Mr. Kudlow, and the National
Economic Council are involved in this, and they are looking at
ways--and the conversations I have heard have been about small
businesses and, again, a very critical part of supporting
individuals and how they can do that. So I am sure they will
welcome the opportunity to work with Congress to figure out
ways to basically support individuals who are facing this
problem, who are challenged.
Senator Harris. Thank you. Federal employees. So we have
many Federal employees who, again, their job does not allow
them to telecommute, TSA, for example, postal workers. What is
the administration's plan for those workers in terms of what--
also, soon-to-be enumerators for the 2020 census, which, of
course, starts April 1. What is the administration's plan for
dealing with those Federal workers who do not have the ability
to telework and do their job?
Mr. Cuccinelli. So one of the sub-groups in the task force
is dealing with the Federal workforce, and, of course, to use
the Department of Homeland Security as an example, we have a
building in Washington State where we, unfortunately, have had
an employee test positive. That is an office building setting.
That is one setting that DHS operates. It is a lot different
than a Border Patrol station or a TSA desk where a bunch of
people are going by you in close proximity each day.
For those folks, people like the TSA example you used,
Senator--and it would apply to CBP and others--we have made PPE
available to them. The medical guidance on how to use it, it
does require appropriate training to use correctly in a way
that is advantageous to the wearer. I have been out to Dulles
Airport myself when China flights were coming, and I observed
the difference in the employees, for instance, the CBP's Office
of Field Operations (OFO) employees, who, when I arrived at the
airport with no flights, had their uniform on and otherwise
looked like you and me. When the China flights were arriving,
gloves and masks were on.
Senator Harris. That is great.
Mr. Cuccinelli. That is available to all of our employees,
and that is true for the front-line folks across the Federal
Government. But that is being closely studied, and we are doing
things like pulling down unnecessary travel, other things where
we do not create risks for either our employees or the general
public.
Senator Harris. Thank you. In follow-up to Senator Rosen's
question about immigrants and undocumented immigrants, the
reality is that we have many undocumented immigrants who are in
America's workforce. We also recently had an announcement from
ICE that they were going to increase enforcement. So it is a
legitimate and real concern that undocumented immigrants in
particular and their family members are in fear of and
certainly discouraged from going to public health facilities to
receive treatment if they are sick.
I heard what you said about the policy. Would you be
willing, Mr. Cuccinelli, to issue a public statement that
during the crisis that we are now facing around the
coronavirus, there will not be ICE enforcement at these public
health facilities, be they hospitals, medical clinics, or
things of that nature?
Mr. Cuccinelli. We actually issued a statement yesterday in
response to similar inquiries. Obviously, our statement was
based off the existing policy, but we did restate that publicly
just yesterday.
Senator Harris. OK. That is great. Then for both witnesses,
there has been a lot of discrimination against Asian Americans
and Asian immigrants, and public health experts agree that the
coronavirus does not focus on or target any group by race or
ethnicity, yet we are seeing many reports and hearing many
reports of intimidation, of profiling, and threats in
particular to our Asian American community and friends.
So what is the administration prepared to do in terms of
committing to actively dispelling misinformation about this
issue? Because it is very real, and we already have enough fear
about the public health crisis, but to compound that, that our
friends and relatives and neighbors would have fear about being
profiled is something very real.
Mr. Cuccinelli. Obviously, we are trying to convey calmly
lots of different information about a virus about which much is
unknown, and we have woven into remarks really at every level
of government the very same concern you have just voiced,
because periodically--and we typically do it, candidly, when we
have instances brought to our attention, so that in our--
``our'' now is the Department of Homeland Security, and the
same would apply in other places--in our soon thereafter public
statements is when we try to knock that back. That is when we
talk about that. We want to be very clear, as you said and I
will say it clearly, the task force, there is without question
no difference that this virus shows whether you are black,
white, Asian, Hispanic, anything else. The dangers are to the
same people regardless of race, ethnicity, et cetera, and our
responses should be irregardless of people's skin color or
ethnicity. Obviously, that is how the Federal Government and
how we are responding to it. At the same time--I used the
Northern Border with the China 212(f) Proclamation. More
Canadians have been barred from the United States on the
Northern Border than Chinese, 113 to 90, because of that
proclamation, and it is because it was travel-based. It was not
that you are Chinese. It is that you have been in the hot zone
in the targeted time period of 14 days. We will continue to
operate that way and continue to make efforts to knock down
story lines or narratives that say anything different from
that.
Senator Harris. Thank you.
Chairman Johnson. Senator Sinema.
OPENING STATEMENT OF SENATOR SINEMA
Senator Sinema. Thank you, Chairman Johnson, and thank you
to Ranking Member Peters and our witnesses for participating in
today's important hearing.
I represent Arizona, a State with confirmed coronavirus
cases, and I would like to acknowledge the Arizona Department
of Health Services, the Arizona State Lab, the Maricopa County
Department of Public Health, and Arizona State University for
their swift actions to care for those individuals and to
mitigate potential exposure to those in the community. We need
to see that same level of cooperation and coordination on the
Federal level. I have constituents who were quarantined at
Lackland Air Force Base who received little to no information
about when they would be able to go home after another
individual who had been released later tested positive for the
coronavirus.
While many of them are now on their way home to their loved
ones, some are still in quarantine, and this lack of
communication is simply unacceptable. Our constituents deserve
straight answers from the Federal Government on both quarantine
guidelines and efforts to develop a coronavirus vaccine and
treatments. These answers must be driven by evidence-based
public health expertise.
My first question is actually directed to both of you.
Innovative companies, both large and small, are working to
develop vaccines, therapeutics, better diagnostics, and are
lending their expertise from previous pandemics. Moderna,
Johnson & Johnson, GlaxoSmithKline (GSK), Takeda, Sanofi,
Merck, Gilead, Regeneron, Roche, and others are included in
this all-hands-on-deck effort. Newer innovators like Arizona's
own Phoenix Biometrics have also submitted information to the
CDC to evaluate their biosensor technology to detect airborne
viruses.
But once a vaccine is approved, what will the
prioritization strategy be for its deployment, specifically
targeting vulnerable populations such as seniors and those with
underlying health conditions? Also, what about front-line
workers at our Border Patrol stations, our ports of entry, or
health care workers, and our servicemembers who are stationed
abroad in hard-hit countries?
Dr. Kadlec. Ma'am, I will take the first shot at this, and,
quite frankly, we have actively been reaching out to innovative
companies, and at BARDA and ASPR, we actually have met with
over 1,500, engaged 1,500 commercial entities and universities
and the like. So we would be delighted to receive a white paper
or any suggestions from your folks on this, and I will be very
happy to provide that information as well.
I think the key thing here is we are looking across the
domain. BARDA yesterday put out--and my Director of BARDA is
behind me, if I am right; still behind me. Basically, they put
out a broad area announcement to basically look for innovative
ideas across the spectrum of medical countermeasures. So,
again, there is a way to both physically and, if you will,
electronically engage in that area.
Subject to the issue of the vaccine, clearly that is not an
imminent possibility. From earlier conversations, it is 12
months to more like 18 months when we would have something, and
the scale of that availability will be dependent on the kind of
vaccine that will be developed. Right now there are primarily
three candidates that are being considered: Moderna is one,
Johnson & Johnson is another, and then there is Sanofi as well
as the third. So much of what will be available will be
determined on the prioritization you identify. Clearly, there
is a national security component of this, what would we need to
protect our forces. There is also the criticality of how do we
protect the people on front lines like health care workers.
Then as you highlighted, the vulnerable populations, which are
significant in our country, but still--and so that all has to
be factored into that. Again, those are, I think, answers yet
to be determined based on, like you said, the best evidence and
scientific answers that we can come up with in the time that we
have.
Senator Sinema. OK.
Mr. Cuccinelli. With respect to the prioritization, you can
expect to see, when we reach that point, what I would call a
``traditional prioritization,'' and you mentioned it yourself,
Senator. High-risk categories, the mortality rate if you are
over 60 and have a secondary condition is much higher than if
you are under 50. And so limited supply will be funneled to the
priority categories as typically happens already.
We are also going to have to work through exactly the kind
of challenges you describe, the force protection as well as
front-line law enforcement and first responders, the people who
come face to face--and health care workers. I am sure you are
familiar with the sort of--the first doctor in China to really
speak publicly about this has now passed away. He was an
otherwise healthy 34-year-old. But health care workers are a
limited resource in the sense that nothing any of us are going
to do here will make more health care workers to fight this
battle. So they get priority to care for them because we need
them to care for everyone else. And that priority will go
forward, and it will be similar for first responders. So you
can fully expect to see that play out, and in your State, as a
border State, that will include Border Patrol agents and so
forth who man those posts and deal with people who do not come
in with documentation, who do not come in with medical
histories.
Senator Sinema. Right.
Mr. Cuccinelli. And we have to be very cautious in those
circumstances. And, frankly, one or two people in a facility
like that can wipe that facility out for utility purposes.
Senator Sinema. All right. Thank you.
Mr. Cuccinelli. Yes, ma'am.
Senator Sinema. My second question is for Dr. Kadlec. The
FDA recently announced it will allow more types of respirators
to be used by health care personnel as part of the coronavirus
response to address shortage concerns. This week, Senator Deb
Fischer and I introduced the Health Care Workforce Protection
Act. It addresses manufacturer liability concerns by amending
the Public Readiness and Emergency Preparedness (PREP) Act to
include respirators that are certified by the National
Institute for Occupational Safety and Health.
Could you talk a little bit about some of the coordination
efforts that your office is leading to ensure adequate supplies
of protective equipment, including efforts to incentivize
manufacturers to increase production?
Dr. Kadlec. Thank you, ma'am, for that question. That is a
critical issue that has to be addressed. I happened to be on
the Health, Education, Labor and Pensions (HELP) Committee at
the time when the PREP Act was originally considered and
enacted, so I have firsthand experience. And one thing that we
did not consider at that time, quite frankly, is the situation
we have here right now, which is then we thought a pandemic of
influenza would be the principal threat we would have to
confront. And with that we focused a lot on the idea of medical
countermeasures that would be necessary to protect our front-
line health care workers and vulnerable populations--vaccines,
therapeutics like antivirals, and diagnostics and the like.
And, again, and with that, the PREP Act was focused on those
particular things and did not include respirators.
So that was 15 years ago, a little bit of oversight, but
has significantly implications today. I want to thank you for
introducing that bill with Senator Fischer and acknowledge that
in the House there is a companion bill with Representatives
Bacon and Tonko, and I would hope that Congress would make
action on it. We did try to make an effort to have it included
in the supplemental language but were unable to. But this is
vital, I think, for the producers of these products who, as you
pointed out, the Food and Drug Administration gave an Emergency
Use Authorization which allows non-medical N95 respirators to
be used by the health care industry. That is vital to do that.
We have a requirement that for health care workers,
depending on how severe this outbreak is, for a billion to a
couple of billion N95 respirators, and there is no physical way
that we can produce those respirators, particularly the medical
ones, which are important particularly in the use in the
operating room, intensive care units, that are splash
resistant. But we can use other ones that are used by industry
which are not splash resistant that could be used in other
health care settings that would incredibly expand our ability
to protect front-line health care workers, because right now
the only thing we have is that personal protective equipment to
protect our front-line health care workers and first
responders, so thank you.
Senator Sinema. Thank you.
Thank you, Mr. Chairman.
Chairman Johnson. Thank you, Senator Sinema.
Senator Hassan has a couple extra questions.
Senator Hassan. I appreciate this very much, Mr. Chair, and
I appreciate our witnesses' stamina because I know you started
at 8 o'clock this morning with an all-Senators briefing.
Look, I just wanted to circle back, Mr. Cuccinelli, to
something you had talked about on the cruise ship issue. We
learned some lessons from the Diamond Princess, right? The
first positive test I think was February 1 on that ship. It
took several days, at least, before a quarantine was
implemented. At the end of the day, there were 3,700 people on
board; 700 tested positive, 6 deaths. And so we determined, I
thought, that it was not a good idea, if there is a positive
result on a cruise ship, to keep everybody on that cruise ship
together.
Now, apparently, from news reports and a little bit of what
you said in response to Senator Scott, we are hearing that
there is a cruise ship off California, which, to Senator
Harris' point, has 40 million people, lots of military bases,
lots of hospitals, lots of health care and public health
facilities, and yet we do not seem to have a protocol to get
those folks off the ship into quarantine in a way that would
minimize the spread of infection.
So I am just curious and concerned that, given the example
of the Diamond Princess and what we thought we learned, we do
not seem to have a protocol in place right now that is clear.
Mr. Cuccinelli. So, first of all, let us be clear about
what we learned. That was a bad quarantine. That was not a
successful quarantine situation, and not just because the virus
spread. That was a secondary effect of a bad quarantine. So the
lessons we learned there were negative lessons. I am sure that
does not surprise you.
Senator Hassan. No, but that is my point. And it is
sounding from news reports that what happened on the Diamond
Princess is being repeated on this ship off the coast of
California.
Mr. Cuccinelli. So the initial assessment with the Diamond
Princess before the spread accelerated was that the safest
thing for all the passengers was to hunker down.
Senator Hassan. Right.
Mr. Cuccinelli. It was to isolate in place. And because the
quarantine was not maintained effectively, that did not hold.
Had it been done well, it would have been the right course. And
so we do not want to obviously use one bad example to set the
rule for everything else, and that is why we have flown test
kits out to the ship. Literally as we are speaking, that is
going out, so that we have greater clarity on exactly what we
are contending with. And we will do, as we did--you may
remember the cruise ship that went out of Bayonne, New Jersey.
It seems like a long time ago now. But when that one came back,
we basically investigated the circumstances on the ship and
designed an offload strategy for that ship under those
circumstances, and this was the Captain of the Port working
very smoothly with the regional head for CDC there, and then
last, but not least, brought those who were suspected of
infection off the ship separately to prearrange the local
health care facilities.
Now, we could do that because it was four people. If you
start putting zeros on that number with a heavy suspicion they
are positive, you can overwhelm local health care capacity.
Senator Hassan. Understood, and I do not want to belabor
the point except to say this: It is not as if we have to take
all of the people who have tested positive on a cruise ship off
and send them to one local health care facility. We are the
United States. We have lots of them. Some States are being hit
a lot more than others. And I just think it is important that
we have protocols in place. I understand the importance of
factual, case-based determinations.
Mr. Cuccinelli. Sure.
Senator Hassan. But it seems like there is some confusion
going on here. So that is just an observation. I appreciate the
response. But we have the whole country available to us, and we
do not have to worry about overwhelming a single point.
Mr. Cuccinelli. If I just could, we do not. There is a
misconception about the capacity we could put together for
quarantining, and, frankly, Dr. Kadlec is better positioned
than I, but this is an important misconception that I think
would be helpful for this Committee----
Senator Hassan. Why do we not address that, Dr. Kadlec?
Because if we do not have the capacity, knowing now for at
least a couple of months that a highly contagious virus, not as
lethal as some but a highly contagious virus, was heading our
way in all likelihood, what is our quarantine capacity then and
what do we need to do to increase it? I know that in my State
we have the capacity on a State level to quarantine when we
need to. So why don't you address that?
Dr. Kadlec. Ma'am, we do not have the quarantine or
isolation capabilities or even the treatment capabilities to
kind of manage these things. Even though we have made
investments for Ebola, for example, it has been really on the
single-digit kind of events. And, fortunately, we had that
capacity, as modest as that is, where we had only a couple
dozen of isolation beds that we could use for an Ebola-like
disease that we could use here, and we maxed out that capacity,
particularly at the University of Nebraska, where they have 12
beds and they expanded it to 16 beds for us to basically help
take care of the most seriously at-risk personnel from the
Diamond Princess.
So I think there is another area for, I think, Congress to
consider. How do we do this in the future given the nature of
what we experienced? And to the Chairman's point, this is not
the last one. There will be another one behind it as----
Senator Hassan. How do we ramp up now if we need to is the
other thing, because, again----
Dr. Kadlec. Yes, ma'am.
Senator Hassan. We are Americans. We know how to do things.
And we do hard things, and we can ramp up capacity. We have a
lot of resources, and we have a lot of smart and able people,
and we are good people who want to take care of each other. So
let us figure this out.
One other question, just to follow up on something Senator
Harris was touching on. As we know, a lot of people who should
stay home if they get sick, to Senator Harris' point, cannot
stay home and still feed their families and pay the rent. So I
wanted, Dr. Kadlec, just to follow up with you on a question I
posed earlier this week in one of our briefings. Sometimes the
Federal Government invokes authorities to help those in need
during a natural disaster by, for instance, providing
Supplemental Nutrition Assistance Program (SNAP) benefits and
Temporary Assistance for Needy Families (TANF) to go beyond
those typically eligible. Since we know many of our citizens
cannot afford to miss a day of work and they face very real
financial burdens, have you considered providing similar
support during a public health emergency?
Dr. Kadlec. Ma'am, HHS, and Secretary Azar, is exploring
all these options honestly to ensure those who need care or
assistance can receive it. And assuming funding, potentially
through a supplemental, HHS does have authorities to not only
reimburse hospitals but potentially do these other things. So I
think----
Senator Hassan. So when are we going to have a
determination then about whether you are going to do it?
Because, again, we have a virus spreading in our country. If
people know that they could get SNAP benefits or TANF if they
need to stay home, they are more likely right now to self-
quarantine when we need them to. So when is the answer going to
come?
Dr. Kadlec. Ma'am, I will have to get you a firm answer on
that. I will take the question back.
Senator Hassan. It is a question that has been asked
already this week. It is a question that needs an answer. They
sent you here to us today, so I would appreciate it as quickly
as possible, please.
Dr. Kadlec. Yes, ma'am.
Senator Hassan. Thank you.
Dr. Kadlec. Thank you.
Chairman Johnson. Before I turn it over to Senator Peters,
I want to go back to the definition of ``quarantine capacity.''
My guess is we are talking about something pretty strictly
defined in terms of its capabilities, medical facility, for
very sick people, that type of thing. If we have to, again, if
this thing becomes more and more significant, there are things
we can do. It may not be a perfectly defined quarantine
facility, but you can still do things. Can you just define--
when you are saying we have limited capacity, I am not denying
that. But in what way is it limited?
Dr. Kadlec. Sir, for institutional quarantine we have
limited capacities, and, in fact, DOD was vital, instrumental
to basically accommodate individuals and disrupt some of their
activities, training and otherwise, to----
Chairman Johnson. Again, do you know what ``institutional
quarantine''--what does that mean?
Dr. Kadlec. It is basically having dorm rooms or places
where you can put people. Probably the best place you can
quarantine people is in their homes. And in the cases of Wuhan
and the Diamond Princess, that was not necessarily feasible
when you are basically trying to move a large group of people
who are representative across the Nation and realize they are
at risk and potentially could be at risk to society, you have
to put them in one place at one time and monitor them over
time. I think if you talk about a distributed approach, the
best place to do it--and, again, CDC has been working with
State and local authorities to do this--is for people who are
particularly being identified in travel screenings at airports
is try to get them to maybe their home of record and have them
self-quarantine or isolate so that they can be in familiar
settings and not put a burden on everyone else.
Chairman Johnson. And, again, this discussion, all is
dependent on this thing ramping up to a certain level of
significance where we would start doing these things. One of
the issues of home quarantine is: Will people actually do it? I
just read a case of some kid who went out to a party, should
have been self-quarantined and here he is out someplace where a
lot of people are coming in contact with him.
Mr. Cuccinelli, do you have----
Mr. Cuccinelli. Yes, so in the Ebola experience, what
experts told us is they use this tactic, smaller numbers but it
was over 98 percent effective. I just want to give you a sense
of scale. I am sorry the Senator left, but, if you just look at
the number of people who have been referred by the medical
screeners at the 11 funneling airports, and that is it, for
home quarantining, that is over 32,000 people in only 11
communities. They are all big cities, but they are not
unlimited in their health care capacity. And the logistics of
just getting that person safely--and that means the people
getting them to the next point must remain safe--from Point A
to Point B are very substantial. You just look at the
repatriation flights. They were enormously expensive, they were
enormous logistical undertakings, and just moving a single
person from Point A to Point B becomes a real challenge. And
you get local authorities who say, ``No, do not move them
through here'' because of the fear factor.
Chairman Johnson. And that is just the beginning of this
event. So that would contemplate, if you are really--the only
solution might be self-quarantining. I guess there would have
to be some kind of penalties at least threatened. Is that
something you already have the authority to do? Is that
something that Congress would have to pass?
Mr. Cuccinelli. It is really----
Chairman Johnson. Again, this is assuming something becomes
far more significant. We are not suggesting it now.
Mr. Cuccinelli. Yes, but you noted earlier, Mr. Chairman,
that we used Federal quarantine here on a scale not used in
over 50 years. The last time was smallpox in 1969. Remember
smallpox? It has been that long. The real authority and day-to-
day expectation is that local and State authorities are going
to make these sorts of decisions because they have the most
knowledge about their communities.
Now, I will say the legal authorities vary rather
dramatically from State to State and with home-rule States
locality to locality. But that is where we expect those to take
place, and I will give
you an example that one of your colleagues has talked to me
about--it is at an airport--and wonders about the economic
exceptions, cargo pilots and so forth going into town. Their
equivalent of Secretary Alex Azar, the State equivalent--I
talked to their Attorney General--has the legal authority to
keep them in the plane and to force that company effectively to
use two crews, fly in, turn it around, fly out, like we are
doing with the Coast Guard with ships frequently. And that is a
State authority, and they have the sensitivity to make that
decision in the case of their community, because it also has
economic impacts, it has all these other impacts that we would
rather not impose at the Federal level, being Federalist
respecters, on local authorities, but we obviously want them to
be engaged. We want them to make those well-informed decisions.
We stand with them shoulder to shoulder in walking through
those. That is why I was talking to an Attorney General. That
is why we were talking to their health commissioner.
Chairman Johnson. So the Federal Government's role will be
robust in this, but so will the State and local governments'
role. And we will certainly be providing resources. We will be
advising; we will be providing information, accumulating all
that information. But in some of these cases, this will really
be dependent on local and State authorities to--OK. That is
helpful. Senator Peters.
Senator Peters. A question regarding the air travel and
tracking folks that are traveling. This is both to Mr.
Cuccinelli and Dr. Kadlec. Airlines indicate that they do not
have all the requisite information that the CDC needs to help
trace the spread of viruses. I think it is primarily because
passengers only provide a phone number or email when they
purchase airline tickets, so it is difficult to track if
someone was on that plane and who they were sitting next to and
where they have gone.
My question to both of you: Are you aware of the holes in
the data between what is provided by travelers when they
purchase tickets and what the CBP and airlines provide to the
CDC? And should we be looking at that?
Mr. Cuccinelli. So, yes, and I think we both have elements
to speak to on this. There has been a 15-year battle going on
with the CDC and the airlines, with CDC trying to get a
regulation in place to get what they would say are the five key
pieces of data they need to effectively do contact tracing if
the need arises. And the airlines have successfully fought it
off for 15 years.
The task force dealt with an interim final rule that CDC,
in fact, has issued directing the airlines to provide these
pieces of information. There is now a logistical gap between
right here as we sit here together and when they can have the
systems in place to actually do this, because it has to happen
at the point of ticket purchase. And, of course, many people
have already bought tickets already.
I would also note that airlines are not the only ones that
sell us our tickets. We will go to Orbitz or Travelocity and so
forth, and they provide even less information to the airline
than you or I would provide them if we went to their website or
called their sales folks.
So it is very widely varying, and when this broke out, CBP
went through their databases, pulled manifest information going
back 2 weeks from the then previously existing Wuhan flights.
So we are talking about 7,000 passengers over the course of 2
weeks, roughly. And it took CDC time to process through using
that information to try to contact those individuals, and what
they found is they could only actually ultimately reach about
25 percent of them. And when I say ``they,'' their partners in
this were the local and State public health officials. We
mentioned already how important they are. This is one of the
roles they play, is the investigation.
So what has happened is we evolved, and Senator Johnson and
I were talking. In the midst of the changes we were making,
only as a practical matter not as a legal matter, where we used
that secondary screening, we brought on more contractors and
got CDC to give us, meaning the DHS personnel there, their
computers, and we started just manually entering this
information one person at a time, straight into their system.
Now, since that time, they have been able to contact well
over 95 percent of the people they have been trying to contact.
And, again, ``they'' in this situation is heavily weighted to
local and State public health authorities. That is who gets
this information. CDC works with them, but they are the ones
really pulling the oars on this work. So that has changed
dramatically, and you can expect, Senator, that when the
Instrument Flight Rules (IFR) is functionally in place, not
merely legally in place, but the airlines are collecting and
delivering this information immediately, we should maintain
that level of performance, above 95 percent contact rates.
Chairman Johnson. Let me quickly interject because this is
from my standpoint one of the prime examples of how responsive
the administration has been here. In some of our briefings, I
was not getting satisfactory answers out of the CDC. Remember
the all-Senator briefing. We talked about that. I am talking to
Ken and really in a very rapid period of time--again, you are
already on the case--you changed that procedure so you could
capture that information. So, again, that is what I am saying.
From my own personal experience, this administration has been
on top of these issues, grappling with gaps, and then trying to
correct them as rapidly as they can correct these issues.
So, anyway, Senator Peters.
Senator Peters. As we are talking about the cooperation
between industry and government and sharing that information,
it is also critical that we are doing that in the supply chain
as we have talked about here in the hearing throughout the day,
that we have to have data as to where things are in the chain.
Dr. Kadlec, information sharing is important, and my
question is: Are you receiving the information that you need
from interagency counterparts, such as data from manufacturers
collected by the FDA to adequately assess supply chain security
and where those vulnerabilities are? And if not, what more
should we be doing?
Dr. Kadlec. Sir, the way we have organized this--and,
again, since FDA has authorities to have that kind of
commercial proprietary information, I look to Dr. Hahn to
basically provide me his kind of analysis of what is necessary
and not getting into the details. So he is part of our team.
FDA is embedded in what we are doing. They have the insight
authorities to do that kind of work, and we look to them to
provide the guidance as well as awareness as to anything that
may be awry or at risk.
Senator Peters. So my understanding is the pandemic
influenza plan did not formally address drug delivery devices,
such as needles and syringes, which would be important for
vaccines, mass vaccines, for example. What steps is HHS taking
to ensure that these types of supplies are available to respond
to this outbreak?
Dr. Kadlec. Sir, there are a couple of ways. Obviously, you
can do it the old-fashioned way and buy it. However, a lot of
that material is kind of just-in-time, so the ability to
provide, for example, for a pandemic influenza, you may need
600 million or more, more like 800 million needles and syringes
to do that. Now, that is a lot of needles and syringes, right?
Mr. Cuccinelli. Right.
Dr. Kadlec. And so whether or not that can be stockpiled,
we have been looking to innovate around that. We have worked
with a very innovative company called ``Abboject'' that is
looking to be able to just-in-time mass manufacture a very
simplified one-dose, non-reusable needle and syringe. It is
quite elegant in its design, and it would be something that
could be used not only here domestically during a pandemic, but
it could be used around the world, particularly in developing
countries.
So what we are looking at is a joint public-private
partnership to address that, and with the benefit of the
supplemental monies, we intend to actually kind of work to
build some capacity to do that using that kind of innovative
approach, as well as other innovative approaches like
transdermal application or administration of vaccines.
Dr. Bright, who leads BARDA here, has been very successful
in their endeavors. There are 53--is that right, 53? Fifty-
four. As I was here testifying, we have probably got 54, so my
apologies. But the point is really trying to look at innovation
to basically help solve some of these very difficult supply
chain issues. We do not just have to do it the old way. We can
find new ways to do it just as effectively and likely more
cheaper as well.
Senator Peters. Great. Thank you. A final question, Mr.
Cuccinelli. Is the Department now considering issuing an
emergency declaration under the Stafford Act given what
happened, or do we have to wait to see what happens as it
develops--maybe you could walk me through that a little bit--to
issue an emergency declaration under the Stafford Act that
would allow the government to deploy disaster medical teams,
incident management teams, mobile hospitals, or transportation
support? We have done that in a variety of times in the past
with West Nile virus and Ebola, et cetera. Walk me through
that, your thinking about that.
Mr. Cuccinelli. So the answer to the first part of the
question is no, but that does not foreclose the use, for
instance, of the Incident Management Assistance Teams (IMAT).
So just to give you an idea of some of the work we have been
doing, with the time we bought with the strategies we have been
using, you are familiar with our IMAT teams at FEMA, Senator,
and they are sizable numbers of people. We have reshuffled them
down to four-and five-person teams who we provided some
additional training to deal with a virus situation versus, say,
a hurricane, a tornado in Tennessee that we are dealing with
right now. And the reason we did that is because the impact of
a virus, unlike a weather event, can be everywhere at once in a
worst-case scenario, we created enough stand-alone teams that
we could help all 50 States in smaller degree with the kind of
support that FEMA brings in terms of experience and so forth.
So, again, not sitting idly, those are the kinds of changes we
have been making to our structure so we are responsive to what
is out there today.
But the Stafford Act does not envision a circumstance like
this. I mentioned earlier the availability of the base fund,
not the Disaster Relief Fund that really I think you have to go
back to the 1990s, and I think it was West Nile. It was New
York and New Jersey, if memory serves, that made requests of
the base fund to get ahead of, alleviate--the easier example is
a forest fire. Hey, if you help us now, we can keep this thing
from getting bigger. Same idea. But it has a $5 million cap. It
is a waivable cap. And it is designed to avoid rolling damage
to a system. In this circumstance, you are probably looking at
when a community or a State has its health care system
threatened to be overwhelmed because they are getting hit
harder than other parts of the country.
So there is some money available for that purpose. I would
say the Stafford Act is not really designed for this, and not
surprising to you, we have analyzed it for these purposes sort
of backwards and forwards. So you are seeing--even those IMAT
teams would typically be deployed alongside HHS here and in
support of them, and HHS would reimburse us--that is how the
budget piece would work--for their deployment, just as they are
for the FEMA team that is supporting them at the State
Operations Center (SOC) right now.
Senator Peters. Great. Thank you.
Chairman Johnson. Thank you, Senator Peters.
Just real quick, I really need to close this out here
pretty quick, but, Dr. Kadlec, who is in control of the
Strategic Stockpile?
Dr. Kadlec. Sir, I have operational control, and the
Secretary is really the overall--I will not say incident
manager, but he is the person in charge at HHS to basically
manage this event.
Chairman Johnson. So how many items are inventoried in the
stockpile?
Dr. Kadlec. Sir, it is about an $8 billion enterprise
with----
Chairman Johnson. 8 or 80?
Dr. Kadlec. $8 billion.
Chairman Johnson. An $8 billion enterprise. How many items?
How many SKUs?
Dr. Kadlec. Hundreds of vaccines, therapeutics, all kinds
of supplies, masks.
Chairman Johnson. So who and how are the inventory levels
set?
Dr. Kadlec. Sir, we have requirements that are set that are
based on a requirements process. Some of it has been fixated on
the basis of what can we buy or can we afford to buy as much as
what we may need, particularly----
Chairman Johnson. So how close are we to actually having
the required levels in inventory now?
Dr. Kadlec. Sir, I would have to give you a detailed kind
of answer back on that----
Chairman Johnson. OK. Again, that is----
Dr. Kadlec [continuing]. But I think the thing is--it is
something--we have a multi-year budget that looks at what we
would need to do it, so I think you can look back over the last
5 years as what should be those levels of funding that reflect
many of those requirements.
Chairman Johnson. So, again, the point was not to get the
answer to my question, but to just raise the issue. From my
standpoint, in terms of the supply chain and what we need in
the stockpile, we have the short-term situation about what we
need now and how are we going to procure it, so that if this
thing continues to get worse and worse, we have the supplies.
And recognize, again, not to create unrealistic expectations,
it takes time to manufacture things. And if it is not in the
stockpile right now, those are going to be some issues. But,
again, I really appreciate your pointing out that our first
Strategic Stockpile is the number of doctors and nurses and
health care professionals, and that is a finite amount, and so
we need to protect them first.
But then long term, I told Senator Hawley on his way out,
we do need to take a look at how we fill that stockpile, based
on our experience of how this all ends up, what inventory
levels should be there, what things should be inventoried, how
much money should we spend. Again, I think somebody pointed out
the aircraft carrier. This is $8 billion versus $17 billion.
Hopefully we learn from this, and I certainly want to use this
Committee--and I would imagine you are the person to deal
with--in terms of what we need to pass legislatively to make
sure that we are better prepared next time. So learn the
lessons from this episode and be better prepared.
I will also say to me it is ridiculous--I am a
manufacturer. OK? I am all for global supply chains. But when
we have an FDA approving drugs for use in America, the fact
that we have really put ourselves in a position where--I think
it is about 70-some percent of the API comes from India,
correct?
Dr. Kadlec. Yes, sir. A lot of it comes from overseas.
Chairman Johnson. A lot of stuff comes from China. But, a
lot of--that is not a labor-intensive manufacturing process, I
would not believe. So there is no reason, I do not believe,
that the FDA--OK, if it is an approved drug here, it needs to
be manufactured here. We do need to take a look at these things
and be smart about this. The way you do it in industry, we need
to do the same thing from the standpoint of government as well.
So I really want to work with you. When the dust settles on
this, when we get by this event, we have to prepare better, and
I think that is going to require legislation and appropriation,
but it is going to require thoughtful analysis.
So to close this out, I want to thank all the Committee
Members that are not here, but hopefully they will hear it, for
their respectful questions, for their attendance. And I want to
thank you. I hope the press, I hope the American people are
listening to the thoughtful responses. It would give them a
fair amount of confidence. This is uncertain. We do not know
where this is going to go. But from my standpoint, having dealt
directly with members of the administration and people
throughout these agencies, first of all, thank the men and
women of your agencies, but this is being carefully considered.
We are thoughtfully working our way through this process in a
very uncertain situation.
So, again, thank you, thank the men and women in your
agencies. Again, I really do appreciate the Members of this
Committee being very respectful and thoughtful in their
questions as well.
The hearing record will remain open for 15 days until March
20th at 5 p.m. for the submission of statements and questions
for the record. This hearing is adjourned.
[Whereupon, at 11:38 a.m., the Committee was adjourned.]
A P P E N D I X
----------
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
ROUNDTABLE COVID-19: HOW NEW INFORMATION SHOULD DRIVE POLICY
----------
WEDNESDAY, MAY 6, 2020
U.S. Senate,
Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 2:19 p.m., via
video conference, Hon. Ron Johnson, Chairman of the Committee,
presiding.
Present: Senators Johnson, Portman, Lankford, Romney,
Scott, Hawley, Peters, Carper, Hassan, Harris, Sinema, and
Rosen.
OPENING STATEMENT OF CHAIRMAN JOHNSON
Chairman Johnson. Hello, everybody. I want to welcome
everybody to this roundtable, the first one we have ever done
that is completely on the internet via video. We tested out
this capability yesterday. It looks pretty slick, but I would
anticipate a few hitches. But, everybody, I think we can handle
this if we just kind of follow the rules, and so let me quickly
go over some of the rules here.
First of all, if you will take a look at the circles on the
bottom of your screen there, if you have a mouse and you get
your little arrow up and going, there are two icons. On the far
left, there is a microphone and a video. If you are in
attendance as a member or a witness, keep your video unmuted. I
just muted mine, just unmuted it there, so you can see how that
works.
Do not touch your audio. Everybody is muted until it is
your turn to speak, and we are doing that not to be cruel but
just because it makes an awful lot of sense in terms of being
able to not have a bunch of chaos during this roundtable.
Again, because that is a disruption, sensitive, multiple
microphones, do not touch that mute button.
If you would like to speak at another time, there is on the
attendee list at the very bottom, if you take a look, it is
very small. There is a little hand. There are three little
squares and a little hand. If you click on that--I am clicking
on mine right now--that will signal either the witnesses or me
that you want to make a point.
Certainly, I do not have a problem with the witnesses doing
it. I am hoping Members do it sparingly. Again, this is not
going to be like a normal hearing. So it is not quite the same
kind of free flow that we normally have.
What I would urge all the Members, direct your questions at
a particular witness because it is going to be pretty hard to
have this wide open. So if you have a particular question, ask
it to a particular witness or possibly witnesses, but be very
specific.
And we are going to be very mindful of the time. I want
both Senators and the witnesses to be watching that 7-minute
clock run down. A favorite technique of Senators is to ask
about a question that requires about a 5-minute answer right
after the 6:59 mark. I do not want to really allow that. We can
take those types of questions under advisement for questions
for the record.
So, with that, Dan, if you can quickly put it up, I have
just got four little charts. It should really surprise nobody,
but I just want to start out with some basic information
because what this hearing really is, from my standpoint, all
about is as we develop data.
Let us face it. When we found out about coronavirus disease
(COVID), a brand-new virus, nobody had ever heard about it,
pretty darn scary. You see folks in China in moon suits, and so
it is that fear of the unknown that is driving so much of
policy right now. I have not been critical of really any
policymaker who has had to make very tough decisions with very
limited information.
But as we were gathering that data now--and that is what
this hearing is all about--we should take that new information,
that new data into account in terms of how do we modify our
policy as well as what I have been advising for quite some
time. We have to look at the totality of the harm being done,
not only just the tragedy from the standpoint of lives lost and
lives destroyed, but also the economic destruction, the human
toll that that is taking as well.
So I have just got four quick slides, just some basic
information to try and keep everything in perspective. The
first one is the one on the screen, ``Causes of Death,
2018.''\1\ You will notice 2.8 million Americans died that
year. That is pretty typical. It is almost 8,000 people per
day. I think the largest number of per-day deaths per COVID is
slightly over 2,000. So you can understand how significant an
issue, the significant tragedy that COVID really is.
---------------------------------------------------------------------------
\1\ The Causes of Death chart appears in the Appendix on page 483.
---------------------------------------------------------------------------
Next slide. This is just the 9-year history off the Centers
for Disease Control (CDC) website of seasonal flu.\2\ I think
it is important to point out the magnitude of that problem. I
think the figure is only 40 percent of Americans get vaccinated
for this. The vaccine is not 100 percent effective, and you can
see how many Americans die on an annual basis over the last 9
years. In total, 337,000 Americans have lost their lives due to
seasonal flu over the last 9 years. That is an average of a
symptomatic-case fatality rate of 0.13 percent.
---------------------------------------------------------------------------
\2\ The Influenza in U.S. chart appears in the Appendix on page
484.
---------------------------------------------------------------------------
You can see in the past years. The lowest level is about
0.1 percent. A really bad flu season is almost 0.18 percent. I
think those numbers are important to keep in mind as we take a
look and we eventually find out not only the case infection
rate is with COVID, but what is the actual infection fatality
rate, which as the denominator grows and that infection
fatality rate decreases, hopefully some of the fear will be
reduced. Again, I am not saying the fear is not irrational. It
absolutely is legitimate, but in order to really regain our
economy and open it back up, we do need people looking at this
from a proper perspective and hopefully with effective therapy
and cure.
We are going to have Dr. Kory on to talk about some pretty
hopeful signs in terms of therapies in the hospital. Hopefully,
we can also bring down that fear level so people can go back to
a more normal type of life. You can see 337,000 deaths over the
last 9 years just due to seasonal flu.
Next. These are up-to-date figures as of this morning. Here
is a State and Territory comparison.\1\ Unfortunately, for New
York, it leads the pack in terms of number of cases, in terms
of number of deaths, in terms of percent of the population that
are known cases, 1.7 percent, percent of deaths of the
population, 0.13 percent. The lowest percent of population in
terms of cases is Hawaii and Montana at about 0.043 compared to
New York which is 1.7. In terms of percent deaths, there are a
lot of States, fortunately, that are only 0.001.
---------------------------------------------------------------------------
\1\ The States compared chart appears in the Appendix on page 485.
---------------------------------------------------------------------------
On average, America is about 0.36 of the population is
reported as a case, and 0.02 of the population has actually
died from COVID.
The final chart. These are country comparisons.\2\ I have
12 countries on here that I have been tracking pretty much on a
daily basis. I am going to throw Russia and China out in terms
of actual comparisons because I am, quite honestly, not sure
how accurate their reporting is.
---------------------------------------------------------------------------
\2\ The Countries compared chart appears in the Appendix on page
486.
---------------------------------------------------------------------------
Let us face it. Everybody is going to have different
standards on how they report these cases and how they collect
information, but I think it is important to point out when you
take a look at cases as a percentage of population, the United
States ranks No. 3 in terms of worst, in terms of highest
percentage of the population that has been infected, but we
rate seventh when it comes to percentage of population of the
deaths at 0.02.
I want to point out Sweden because Sweden definitely took a
different approach to responding to COVID. They basically took
the approach of we will quarantine the sick, we will protect
the vulnerable, and the rest of us will basically go about our
lives, obviously following the guidelines of social distancing,
sanitizing, personal hygiene, that type of thing.
Again, these numbers, we do not know where they will
eventually turn out, but Sweden in the scheme of things is not
going that badly. In terms of percentage of their population
that have a confirmed case, they rate eighth at 0.26. In terms
of the percent of the population that have died, they rate
sixth on this list of these 12 countries at 0.03.
So, again, that is just some basic information. I have
tried to get that to all the witnesses and Senators to, again,
put all this in perspective.
With that, I will turn it over to Senator Peters, my
Ranking Member, for his opening comments.
OPENING STATEMENT OF SENATOR PETERS\1\
Senator Peters. Thank you, Mr. Chairman.
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Peters appear in the Appendix
on page 451.
---------------------------------------------------------------------------
The coronavirus pandemic has certainly profoundly altered
our world. It is putting millions of people out of work,
threatening the future of small businesses, exposing serious
inequities in our health care system, and it is taking the
lives, to date, of more than 71,000 Americans.
Like so many of us, I am ready to start getting America
back to work, but we need a clear plan, backed by science and
by data, that will give us a roadmap to safely reopening our
economy in stages.
While cases in some parts of the country appear to be
plateauing, we know that there are other communities that are
experiencing rising numbers right now.
We currently do not have enough tests to fully understand
how many people have contracted or succumbed to the virus.
We are still struggling to get enough masks, gloves, and
other personal protective equipment (PPE) to our frontline
workers, and we do not yet have the supplies needed to prevent
a resurgence of this virus.
We need a robust contact-tracing plan to identify possible
exposure to coronavirus and prevent further spread that could
result in another wave of cases, hospitalizations, and
unfortunately, tragic deaths.
We need to protect and grow the capacity of our hospitals
to deal with these localized outbreaks, and we need to take
back production of life-saving drugs and medical supplies. We
need to take back that production from China.
We need to develop and deploy a vaccine to inoculate
Americans who have not contracted the virus, and we need clear
data and metrics that are backed by science to tell us what is
working and what is not. And we need to push these best
practices to help our small businesses out so that they can
keep their employees safe and their customer's confidence.
This critical information and the lessons we have learned
will help create a plan for how we can safely reopen.
Without this data-driven plan, we risk undermining the
progress that we have made and a repeat the unbearable loss of
human life and economic shock that we are experiencing.
Despite all this hardship, I am encouraged every day by the
workers and the entrepreneurs in my home State of Michigan that
are finding ways to keep their workplaces safe and, as we
speak, are retooling their businesses to meet the needs of
frontline responders.
I have talked to many of them over the last few months, and
they all are saying they need clear guidance by reliable data
to back up their actions.
We also must remain focused on the unequal impact of this
virus and how it inflicts and impacts communities of color. In
Michigan, black residents make up 13 percent of the population
but represent 40 percent of the deaths from COVID-19. This
disparity is rooted in systemic inequity, and we must change
our plans in response to the data and protect these
communities, not simply accept the inequity of the inevitable.
These decisions are a matter of life and death, and we
cannot accept tens of thousands more coronavirus deaths as
unavoidable, just as we cannot accept that reopening our
economy while minimizing risks is not possible.
We must have a clear plan that provides people with
guidelines that are backed by science to help us reopen.
I look forward to today's discussion and to continuing to
work with my colleagues to ensure that we are taking the
appropriate steps necessary to allow us to safely reopen our
economy while protecting our most precious resource, the
American people.
Thank you, Mr. Chairman.
Chairman Johnson. Thanks, Senator Peters.
I would really like to thank all of our witnesses for the
time you have taken out of your day just to participate in this
but also the time you have spent, first of all, speaking to
these issues. I think all but one of you, I have seen on some
television (TV) show in the last couple weeks, but you have put
your lives and you have done a lot of work to try and educate
the public. And I truly appreciate that.
Our first witness will be Dr. Pierre Kory. I just spoke
with him last week. He is affiliated with the University of
Wisconsin, Madison, but he is a New Yorker, and he is currently
on the frontlines in New York. And the reason I wanted to put
him first is to give us a little bit of hope.
What he is talking about in terms of effective therapy once
individuals have been hospitalized, I think, is very
encouraging, and I wanted to give him enough time to kind of
speak to that before we kind of open up into sort of the main
purpose of what this hearing was all about, which is really
taking a look at the data and taking a look at the policy
choice and decisions that we have made and that we need to make
based on what that information and what that data tells us and
instructs us.
Again, our next witness is Dr. Pierre Kory. He is the Chief
of Critical Care Service, the Medical Director of the Trauma
and Life Support Center, and Associate Professor of Medicine at
the University of Wisconsin School of Medicine and Public
Health. He is board-certified in critical medicine, pulmonary
diseases, and internal medicine. He previously served as
Director of the Advanced Courses sponsored by the American
College of Chest Physicians. Dr. Kory received a Doctor of
Medicine (MD) at the St. George's University School of
Medicine. Dr. Kory.
TESTIMONY OF PIERRE KORY, MD, MPA,\1\ CRITICAL CARE SERVICE
CHIEF, ASSOCIATE PROFESSOR OF MEDICINE, UNIVERSITY OF WISCONSIN
SCHOOL OF MEDICINE AND PUBLIC HEALTH
Dr. Kory. All right. Thank you. I believe I am unmuted. So
thanks for the invitation. I really appreciate the opportunity
to talk about COVID.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Kory appears in the Appendix on
page 453.
---------------------------------------------------------------------------
I do want to start out by saying that I am speaking today
as part of a group. I have bonded with five colleagues of some
of the most well-known and highly published and most impactful
critical care experts in the world, and I do want to make sure
that I mention them.
One is my colleague, Dr. Paul Marik. He is from the Eastern
Virginia Medical School, very well known in our specialty; also
Dr. Umberto Meduri, who is from the University of Tennessee in
Memphis; and then also Dr. Joe Varon in Houston and then Dr.
Jose Iglesias from Hackensack.
Now, the five of us, we came together early on in COVID,
and we have been trying to figure out this disease. I got to
tell you, we came up with a protocol, and I want to talk about
that protocol but with some other issues that I think the
health care system needs to be aware of.
First of all, let me just tell you about some of the
results of our protocol. Members of our group have now treated
in excess of 100 hospitalized patients with our treatment
protocol, and we are going to report that nearly all survived.
The two that died were in their 80s and had advanced chronic
medical conditions. None of the patients had long stays in the
ventilators. None are ventilator-dependent, and most of them
had short hospital stays and were discharged in general good
health.
I am going to say that is good news. Many people are going
to be skeptical and ask about that, but let me talk a little
bit more about why we are seeing that.
The first thing is I just want to say how troubled we were.
I appreciate your comments, Senator Johnson, about how we are
all doing the best we can with the data we have, and so it is
hard to point fingers. But I have to say that we are dismayed
by the lack of proposal for an effective treatment protocol.
There are three critical things that we have seen over the
last month that we really want to talk about. So No. 1--and,
again, I do not want to diminish the value and the expertise of
our national health care societies and international health
care societies like the World Health Organization (WHO) and the
CDC; however, I think those are bodies that are built for
peacetime and not for war. And we are at war right now with
this virus.
One of the main issues that we have seen is that they
initially came out--all of the national health care societies
came out with recommendations that focus on supportive care
only, which is generally you give Tylenol for a fever. You
treat symptoms. You might give a little hydration nutrition,
and you give oxygen and ventilators for support when they
cannot breathe. That is reasonable for a viral syndrome, but
this thing is different, No. 1.
No. 2, that strategy is failing. I do not think I need to
spend a lot of time showing how badly that is failing. The
mortality and morbidity rates of this disease are
unprecedented. I have been doing critical care for a decade and
a half. I do not see mortality rates associated with any severe
illness that I see in this one.
Supportive care is not working. We are just trying to put a
call out to the world to rethink this supportive care-only
strategy. So that is one major concern we have had.
The second is we want to call attention to the world to
what we think is a tragic error in analysis of medical data,
and that is the fact that all societies from the beginning of
COVID have advised against the use of corticosteroids in COVID-
19. We think that is a fatal and tragic flaw.
And I will tell you why. One of the members of my group,
Dr. Umberto Meduri, who is probably the world expert on
corticosteroid therapy and critical illness, 3 weeks ago, he
published a paper along with five other internationally known
experts. They published a paper in Critical Care Explorations,
which essentially reviewed the role and impact of
corticosteroid therapy in all the prior pandemics, including
the coronavirus pandemics of severe acute respiratory syndrome
(SARS), Middle East respiratory syndrome (MERS), and H1N1.
Contrary to the conclusion of the reviews done by all those
national societies, they showed that in the two largest and
most carefully executed studies of all of the impacts of
corticosteroids that corticosteroids are actually lifesaving in
these severe viral syndromes. They showed drastic reductions in
mortality in anyone who had anything beyond mild disease. You
should not use it early as an outpatient, but once you hit the
hospital, it is lifesaving, and just this week, we are starting
to get even more really impressive data showing the importance
of corticosteroid therapy in these syndromes.
So, for instances, just this week, Sorin Draghici--he is
the Chief Executive Officer (CEO) of Advaita Bioinformatics.
And this is fascinating stuff, and this is about as cutting-
edge and futuristic medicine that you can imagine. They have
the sophisticated artificial intelligent platform called
iPathwayGuide. What they did is they cultured human cells, and
they infected them with coronavirus. They were able to analyze
the genes that were activated by the coronavirus. They were
able to do this with multiple viruses, and what they saw is
that in the coronavirus cell types, the types of genes that
were activated, they were able to match that against medicines
that suppress that activation of those genes. And the one drug
that they found that perfectly met the ability to counteract
that gene activation was methylprednisolone, which is a
corticosteroid.
At the same time that they did that, Dr. Mayer Ramesh, at
the Henry Ford Hospital--he is a transmit infectious disease
expert and immunologist. He implemented a methylprednisolone
protocol. Their study just came out this week, and what they
showed--and I even talked to him in a personal communication--
is once they started using methylprednisolone, their needs for
ventilators went down. Their mortality went down. They are
reporting this in a study that is right now in just
prepublication, but in over 200 patients, they saw dramatic
effects.
He said the entire environment changed. There were less
codes, less need for ventilators. Their ventilators peaked and
decreased. They came out of a mass casualty environment to a
much more controlled condition.
Then right now we are also getting word that there is a
paper under review from our colleagues in Spain, critical care
experts, all of them, who are now reporting that when they used
methylprednisolone therapy earlier and longer than in the Henry
Ford study, they are showing absolutely dramatic reductions in
mortality.
So those mortality rates that you are seeing, we think that
there is a really strong answer to that, and we need to change
our treatment strategy, which was one where we did not use
corticosteroids, which we think are critical and we want to use
them.
Again, the standards of medical evidence have changed a
little bit in this crisis, and so I am going to use some
Facebook posts. But these were posts that were posted
anonymously by doctors who are in the middle of this surge, and
this is what one of them posted 2 weeks ago. This is a hospital
that is in Southeast Michigan, and he wrote, ``We floundered
for 2 weeks, lots of codes, intubations, and death, maybe 15
discharges. We started steroids and discharged 250 patients,
less intubations, less codes, and the ones that ended up on a
ventilator not as serious. If they have chest x-ray or
computerized axial tomography (CAT) scan changes, start
steroids. If they are hypoxic, start steroids. If they are
ambulatory and hypoxic, start steroids. This completely changed
our trajectory.
Steroids are a game changer. This critical efficacy is
being noticed more and more around the world. We are seeing it
pop up in new protocols and guidelines.
Another post from a doctor in New Orleans who also got
inundated in the surge. They found and he writes, ``I am here
in New Orleans. Since we started using steroids, we were able
to free ventilators and get elderly patients out of the
hospital without needing a ventilator. Patients that were
obviously crashing quickly who we had to have end-of-life talks
with were able to walk out of the hospital. At no point did any
of our patients worsen because of steroids. These patients shed
viruses 4 weeks later with or without steroids. The virus does
not kill anybody; it is the inflammation that does.''
So those two things that I just reviewed which is, one, the
fact that the supportive care only is failing; two, the lack of
steroids may be a critical absence in the treatment strategy of
these patients.
And then No. 3, the other thing that we have seen all
around the world in many institutions and medical journals and
editorials is this constant cry for randomized control trials
or prospective trials.
Listen, we in our group, we all know the critical need for
data and trials, but we think there is an overemphasis. And we
are forgetting some of the ethics of doing research in a
pandemic when patients are dying and they are very sick, and I
want to remind us of a few ethical principles that the world
has agreed on.
So, No. 1, the Declaration of Geneva of the World Medical
Association (WMA), binds the physician with the words ``The
health of my patient will be my first consideration.''
No. 2, the International Code of Medical Ethics declares
that ``A physician shall act in the patient's best interest in
providing medical care.''
And then most importantly, this is where everyone is
getting confused is that this idea that what we are doing is
unproven or experimental therapies. I want to call particular
attention to Article 37 of the World Medical Association
Declaration of Helsinki, for approved in 1964 and most recently
approved in 2013. In that Article 37, which is titled
``Unproven Interventions in Clinical Practice,'' it reads--and
I paraphrase--In the treatment of an individual patient, where
proven interventions do not exist, a physician may use an
unproven intervention if in the physician's judgment it offers
hope of saving life, reestablishing health, or alleviating
suffering.
Having said that, let me just talk about what our group
did, and I am sorry if I am going a little bit overtime. But
this is what we did. So myself, Dr. Marik, Dr. Meduri, Dr.
Iglesias, and Dr. Varon, we got together early on, and all we
did is talk COVID 24 hours a day. We exchanged emails and
papers and clinical discussions.
Probably, my biggest contribution to the group is I am a
New Yorker. I have trained with, I have been trained by, and I
have trained almost every person in every intensive care unit
(ICU) in New York City, and from the beginning, while I was in
Madison preparing for the surge, I got to talk to them each and
every day. The accumulating clinical experiences, the
impressions, the responses of different treatment strategies,
we all got to observe, and we convened a group. And we came up
with a treatment protocol. It is based on decades of our
experience of taking care of patients, our research, as well as
hundreds of publications.
What we noticed was three things that I think people are
not recognizing is that the way that this virus is killing
people and causing all these organ failures is there are three
major pathologic processes that were seen, which is this stage
of extreme hyper and dysregulated inflammation. Some people are
calling it a cytokine storm. That is No. 1. No. 2, we are
seeing hypercoagulability with frequent and excessive clotting;
and No. 3, we are seeing this outside hypoxemia, which
approaches to treating that have sort of been evolving. But I
think we failed in the beginning.
So based on those three processes and based on our
knowledge of therapies and therapeutics, we came up with what
we call Methylprednisolone Ascorbic acid Thiamine Heparin
(MATH+) protocol. It is on our website. It so
covid19criticalcare.com, but I am going to go through it really
quickly.
No. 1, the three critical medicines is methylprednisolone--
I just gave you some of the evidence and some of the rationale
why that is critical. We know it worked in SARS, MERS, and
H1N1. The fact that we are not using it here, I think, is
causing some of this needless death. So methylprednisolone, No.
1, it is a powerful anti-inflammatory drug that we use to
suppress the immune system and prevent organ damage. This
condition on COVID-19, which is the cytokine storm, a
corticosteroid is the standard recommended treatment accepted
around the world for cytokine storm.
Ascorbic acid, although known as vitamin C, everyone
dismisses that as a vitamin. Those of us who use it and know
its physiology and its potency, it is not only a vitamin. It
acts as a stress hormone in fighting off infections. It is
critical. It has synergistic capabilities along with steroids,
and so we strongly promote that. It prevents the development of
leaky blood vessels within the lung, and it avoid the
development of lung failure. It should always be used when
paired with corticosteroids.
Heparin is another one. It is a blood thinner. We are
seeing excessive blood clotting. Almost all centers and
institutions around that have promoted the use of some amount
of blood thinners. Some have been more cautious than others.
Some are more aggressive than others, but we all recognize the
critical need.
Then the last thing is what a lot of us got wrong. I am
going to say at the University of Wisconsin, we did not. I am
going to toot my own horn here, but we avoided the early
intubation. Early intubation with these patients is harming
them. The machine makes the disease worse, and so we should try
to avoid intubating until last resort. And as we do that, we
are seeing that we are able to alter the trajectory of these
patients away from the ventilators, and we are seeing lives
saved.
So I am just going to summarize by saying our treatment is
not unique. We are starting to see it pop up in centers and
protocols and countries around the world. The most recent
Italian guidelines were extremely aggressive. They are
mandating an overall focus on treating inflammation with
tocilizumab and mandatory steroid use early on in the disease.
They are saying to do it as soon as someone's oxygen level
drops.
And this is what I want to say. This is the last tragedy,
and I know that probably what I have said is a little bit
heated. I am emotional, but this is absolutely a calamity that
is going on in medicine. I have been in New York City for 2
weeks trying to treat these patients with COVID. Either I have
been inundated with patients who are chronically on the vent
and who are dying of end-stage fibrotic lung disease, or I am
seeing patients who are crashing into my ICU. But as opposed to
a month ago where they were coming in with these mild
abnormalities on chest x-ray and maybe mild abnormalities in
their oxygen intake, now we are seeing floridly abnormal x-rays
with very advanced disease. I am throwing the book at them, and
it is not working.
I have to emphasize that the timing of initiation of this
therapy is critical. The world needs to know this.
What happened here in New York is that initial surge caused
so many terrible reports of patients being unattended to,
running out of resources, not enough physicians and nurses, and
now the population is scared. They are not coming to the
hospital early enough, and now when they are coming, they are
so far advanced that the medicines do not work as well, and so
we need to get the word out that things are better on the
ground. We are definitely much more stable in the hospitals. We
are much more resources. We are regrouped. We are ready to take
care of patients, but the patients have to come. If they wait
at home with these symptoms, we are not going to be able to
save them.
So I just want to finish by saying, finally, our group and
what we have tried to do is put effective, sound, physiologic,
and evidence-based protocol, and we have been trying to
disseminate it. We have sent it. It has gone to the White House
three times now.
A month ago, it was given to a member of, I think,
Kushner's team and brought to the White House. They apparently
liked it; however, they got pushback from the National
Institute of Health (NIH) and the CDC, who I think were
cautious on the steroids.
Then 2 weeks ago, Dr. Marik was interviewed by former
Speaker Newt Gingrich, who also brought it to the White House.
We still have not heard.
Then this week, our protocol and our group's efforts were
published in the American Spectator, and the editor of the
American Spectator also brought it to the White House. We still
have not heard anything.
We do think that we need to develop a national effective
treatment strategy, and with that, I think I am just going to
end there and just say we are experts in our field. This is
what we do. We know how to take care of patients. Let us take
care of these patients. We know that these medicines are sound.
We know the safety profile. Everything in our protocol is safe,
Food Drug Administration (FDA)-approved, has been used for
decades. Yes, it is off label, but we do off-label stuff every
day.
With that, I probably took too much time. I am done. Thank
you.
Chairman Johnson. First of all, thank you, Dr. Kory, for
just being a doctor, for your passion. I can tell you, now your
protocol has been sent to the White House four times. I sent it
to Mark Meadows today with a text that I pray somebody in the
White House will pay attention to this and give it very serious
attention. So, again, thank you for that. Again, thank you.
Our next witness is going to be Dr. David Katz. Dr. Katz is
the president of the nonprofit True Health Initiative; CEO of
Diet ID, Inc.; and a board-certified specialist with 30 years
of experience in preventive medicine and public health, having
trained and later taught at Yale University School of Medicine.
Dr. Katz is the founding director of the Yale University's
Yale-Griffin Prevention Research Center, received an MD from
the Albert Einstein College of Medicine and Master's in Public
Health from the Yale University School of Public Health. Dr.
Katz.
TESTIMONY OF DAVID L. KATZ, MD, MPH,\1\ PRESIDENT, TRUE HEALTH
INITIATIVE
Dr. Katz. Senators, I greatly appreciate the privilege of
addressing you, the opportunity to share my perspective. I
deeply regret doing so without recourse to a professional
haircut. If someone had told me I was going to be addressing a
committee of the U.S. Senate and doing so sporting my hairdo
from 1978, I am not sure which of those two things I would have
found harder to believe, but here we are.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Katz appear in the Appendix on
page 458.
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I would like to make five quick points about COVID, and I
will quickly note that I am addressing this primarily as
someone schooled in epidemiology, public health, scrutinizing
the global data and the data here in the United States. But I
did volunteer in New York, did several shifts in an emergency
department in the Bronx. This was part of the Montefiore
system, and, Dr. Kory, you will be pleased to hear everything
you just mentioned was standard procedure when I was there 2
weeks ago. It had not been the week before. Steroids were being
used routinely. Apixaban was being used routinely, and on it
goes.
So the word is getting out. Whether or not the White House
got the memo, others have.
The first point, this is different diseases in different
populations. We heard about the population landing in the
hospital, needing intensive care, but the global data clearly
show that elderly people and people with a significant burden
of prior chronic illness are at high risk of severe COVID
infection, life-threatening infection.
But the global data showed at the very beginning and appear
to show to this day that 98 to 99 percent of all cases are
mild. Younger people, certainly people under 50, maybe under
60, people free of major chronic disease like heart disease,
diabetes, this tends to be a relatively mild infection and may
often be asymptomatic.
Mr. Chairman, you showed us the data out of New York and
talked about the fatality rate there, but a seroprevalence
study in New York showed that maybe 20 percent of the
population of New York City and perhaps the whole State has
already had this infection. That would be 4 million people, and
when the denominator swells to that degree, the percent of
severe cases drops precipitously.
It is actually quite interesting that 20 percent is the
same number we got from the Diamond Princess cruise ship. Maybe
a significant portion of the population is just natively
resistant to this bug, but it is different diseases in
different populations. There is a high-risk group--elderly,
chronically ill. There is a low-risk group--younger, generally
healthy.
Second point, from the start, it has been clear there were
two ways for COVID-19 to hurt people, damage health, and ruin
lives. One was by infecting them, but the other basically was
the unintended consequences of our interdiction efforts. If we
were protecting people who did not need to be protected from
this virus because it was not acutely dangerous to them, then
causing them to lose their livelihood, putting them in a
position of food insecurity and potential poverty was more
likely to hurt them than the virus.
I think a humanist, a public health person needs to look at
that and say both ways that the situation can hurt people are
bad, and that leads to my third point.
We really need to have one national policy objective, and
it has nothing to do with trading lives against dollars. That
objective is total harm minimization. We acknowledge that
people can be hurt by losing their jobs, and that hurt
reverberates through public health and something we call social
determinants of health. Food insecurity hurts people.
Desperation hurts people--depression, addiction. We have seen
spikes in everything from gun sales to domestic violence to
suicides since the advent of this pandemic, and those are real
families. Those are real people. All of that warrants our
attention too.
By the way, it is not clear how much of the toll of COVID
in New York, in the United States, we mitigated with our
interdiction efforts, because we may have closed the barn door
after all the horses were out. It seems clear now that COVID
was circulating in the United States before we knew about it.
We have evidence to suggest from seroprevalence studies that
millions and millions of people in New York and around the
Nation have already been infected. So a lot of what we are
saying may be what we would have seen even with significantly
less draconian interdiction efforts.
The other thing we want to do, of course, is restore key
elements of our society because those are crucial to services,
good, and supply chains, and ultimately become limiting in
terms of people's health.
We also need to worry about people staying away from the
hospital who have other important conditions because of the
fear of going where COVID is that Dr. Kory described so
beautifully.
And then one other critical issue that I think is often
overlooked and that is we do need an all clear. Frankly, I
think about people like my parents who are 80 years old. My
mother worries that she could get COVID and die because she is
in the high-risk group at that age. She also worries, though,
if we are on an indefinite timeline waiting for a vaccine, that
she could die of something else before she ever again gets to
hug her grandchildren. So I do think important segments of the
population are waiting on a plan back, and the most likely
proximal route to an all clear is herd immunity. And that does
not mean putting people in harm's way; it means risk
stratifying the population. So we are able to say who can
encounter this infection safely because they are overwhelmingly
likely to have a mild bout of it, get over it, make antibodies,
and it is fairly clear from the global data, we do make
antibodies. We do become immune. There was some communication
on that topic that I think was a bit misleading.
Point No. 4 is we need data to inform a risk-stratified
approach back to life as we knew it before, protect the
vulnerable, but allow many of us who are not prone to severe
infection back. And in order to inform a risk-stratified
approach, two things. First, we do not need millions of tests.
We need a representative random sample. That could be 20,000
people, 30,000 people, or 50,000 people. We could make it a
fairly big and robust number, but as long as it traverses
urban, suburban, rural, all the different ZIP codes, all the
different age groups, all the different health status, it would
be enough to extrapolate to the population of 330 million of us
and tell us what we need to know, who is at risk, who is likely
to be hospitalized, who might need the ICU, who is at risk of
death, and for whom is the risk of COVID infection commensurate
with many other risks associated just with living routinely,
and I think that is a critical element.
Frankly, this is something CDC does routinely, and it is
the work of several days, at most a week, and it does not
require millions of test kits.
Then, finally, in speaking with colleagues, some of whom
are joining as witnesses today, others like Dr. Mike Osterholm
at the University of Minnesota, arguably the Nation's greatest
pandemic response expert, we do need a bracing does of
humility.
Previous pandemics have fooled us. When we thought we were
most of the way through the woods, we would get a second wave.
We do need supplies of PPE. We do need to know we will have
hospital beds if this come back in the fall. We need to know
that the ventilators are available. So we have been forewarned
we need to be forearmed, and it is possible that there will be
additional waves.
I am hopeful there will not be. I am hopeful this has
actually already been quite widespread in our Nation. Many
people have had this that did not even know. Many people may be
natively resistant, and maybe we are well on our way to herd
immunity.
Sweden is an encouraging example, but I think we could do
even better than Sweden by more carefully protecting the high-
risk groups and using American data to inform that effort.
Then, finally, there has never been a better time for a Get
Healthy America campaign. The things that place people at risk
for severe COVID infection are things that were taking years
from lives and life from years before: heart disease, diabetes,
hypotension, obesity. These are all fixable, and they are
fixable with lifestyle. We can use risk calculators to identify
someone's individual risk. We can take advantage of the
fixation on this condition and the acuity of concern to
suddenly get people to care about those long-term risk issues,
which have been a threat to people's lives, a threat to
people's livelihoods, a drain on the economy, all the bad stuff
associated with COVID. That was going on before, but I would
encourage you to think about basically making lemonade from the
lemons here.
We do not just have COVID to deal with. We were especially
vulnerable to a higher percentage of severe cases because the
health of the Nation was in peril before from chronic disease,
and if we address that effectively now, we will both lower
people's acute risk for COVID and create a gift that keeps on
giving, a healthier America.
Thank you.
Chairman Johnson. Thank you, Dr. Katz.
Our next witness is Dr. Tom Inglesby. Dr. Inglesby is the
Director of the Center for Health Security at the Bloomberg
School of Public Health within Johns Hopkins University. Dr.
Inglesby is also a professor in the Department of Environmental
Health and Engineering at the Johns Hopkins Bloomberg School of
Public Health. Prior to that, he was chair of the Board of the
Scientific Counselors, Office of Public Health Preparedness and
Response, U.S. Centers for Disease Control and Prevention from
2010 to 2019. Dr. Inglesby received an MD from Columbia
University College of Physicians and Surgeons. Dr. Inglesby.
TESTIMONY OF TOM INGLESBY, MD,\1\ DIRECTOR, CENTER FOR HEALTH
SECURITY, JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH
Dr. Inglesby. Good day. COVID-19 has done great damage to
our country, first in terms of people sickened and lives lost
and second in terms of the terrible economic consequences and
job loss. As a sign of the speed of its spread, as of 2 months
ago on March 6, there were 200 people diagnosed with COVID-19
in the United States. As of yesterday, 1.19 million Americans
have been diagnosed with COVID, and more than 71,000 people
have died. In the absence of social distancing, this epidemic
doubles in size approximately every week. That is the data that
we have up until social distancing began.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Inglesby appear in the Appendix
on page 466.
---------------------------------------------------------------------------
In the last month, more than 200,000 new American COVID
cases have been diagnosed every week. We have a national
plateau of about 25,000 to 30,000 new cases daily. We had more
than 2,000 deaths yesterday from this virus, and a great
majority of U.S. deaths have occurred in the last 30 days.
Yesterday 33 U.S. States reported more than 150 new cases
of COVID in their States. Seventeen States have daily case
counts that are still on the rise. On the other hand, 10 States
do have a 2-week decline in numbers, which is encouraging, and
States that have 2-week declines and meet other conditions for
a safe reopening could be the least risky places for initiating
reopening process. States reopening without safe conditions
could be at risk for a rapid acceleration of cases.
Our team worked with colleagues at the American Enterprise
Institute to publish a report recommending four conditions that
should be in place before a State eases social distancing.
The first is sustained reduction in cases for at least 14
days. The second is capacity for hospitals to give all patients
with COVID the full standard of care. The third is the capacity
to test all people with COVID-19 symptoms, whether they are
mild, moderate, or severe; and the fourth is capacity to
conduct active monitoring and quarantine of cases and their
contacts. These conditions are largely consistent with the
criteria and core State preparedness capabilities in the White
House guidance report called ``Opening Up America Again.''
Thirty-eight percent of adults in the United States, or
92.6 million people, are at higher risk of serious COVID
infection, given their age of 65 or older or underlying health
conditions.
Some have called for focusing social distancing and
mitigation efforts only on this high-risk group, but there are
no feasible approaches to separate off this one-third of
American adults. Most estimates of the infected mortality rate
by epidemiologist and public health organizations are that this
virus causes something on the order of 0.5 to 1 percent
infected mortality rate. If this virus transmitted widely
without social distancing and high numbers of people got sick
with COVID in the same period in a given city or State, there
would be the potential of overwhelming health care facilities,
outstripping available ventilators, and/or the people needed to
run them.
We came very close to this scenario in New York City last
month. If that did happen and there were not enough ventilators
to go around for the people with COVID, the infected fatality
rate, which I just noted, could go up substantially, as it
appeared to do both in Wuhan and in Lombardy, Italy. It is very
important to look at the experience of Wuhan and Lombardy and
New York City in dealing with COVID. In each of them, this
virus was rapidly able to go from being nearly invisible to
causing a complete health crisis in a period of weeks. That
pattern is absolutely nothing like influenza or any disease we
have dealt with in modern times.
In the time ahead, we have to find a way to cope with the
severe potential public health toll and the severe economic
toll of this virus in the United States. Some States are in a
safer position than others to cautiously start to move ahead on
easing social distancing. Any State that does should recognize
that COVID could rebound, rebound sharply, in the time that
follows easing social distancing, and those States should track
hospitalization rates, ICU bed rates, ventilator rates, and
deaths very carefully and be prepared to change course if
numbers substantially worsen.
Leaders in those State should communicate clearly to the
public that individual physical distancing measures, distancing
between people, mask use in public, avoiding gatherings will
all remain critically important throughout this entire period
until we have a vaccine.
Even the epidemic from rebounding and causing new waves
will take collective great action on the part of the American
public.
Thank you.
Chairman Johnson. Thank you, Dr. Inglesby.
Our next witness is Avik Roy. Mr. Roy is the President of
Foundation for Research on Equal Opportunity, a think tank
focused on expanding economic opportunity for those who least
have it. From 2011 to 2016, Mr. Roy was a Senior Fellow at the
Manhattan Institute for Policy Research. Prior to that, Mr. Roy
was a financial analyst and portfolio manager at several
investment firms. Mr. Roy writes for Forbes and has advised
numerous candidates for public office on health care policy.
Mr. Roy was educated at the Massachusetts Institute of
Technology and Yale University School of Medicine. Mr. Roy.
TESTIMONY OF AVIK ROY,\1\ PRESIDENT, FOUNDATION FOR RESEARCH ON
EQUAL OPPORTUNITY
Mr. Roy. Chairman Johnson, Senator Peters, and members of
the Homeland Security and Government Affairs Committee, thanks
for inviting me to speak with you today.
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\1\ The prepared statement of Mr. Roy appears in the Appendix on
page 471.
---------------------------------------------------------------------------
As Chairman Johnson mentioned, I am Avik Roy. I am the
President of the Foundation for Research on Equal Opportunity
(FREOPP), a nonpartisan, nonprofit think tank focused on
expanding economic opportunities to those who least have it.
All research conducted by FREOPP considers the impact of public
policies and proposed reforms on those with incomes or wealth
below the U.S. median.
It is for this reason that I am gravely concerned about the
profound economic destruction that the COVID-19 lockdowns have
caused.
You know that 30 million Americans have lost their jobs,
and that the Congressional Budget Office (CBO) estimates that
second quarter gross domestic product (GDP) will be 40 percent
lower than it was at this time last year. Jobs for hourly wage
earners, the most vulnerable workers in our economy, are down
60 percent relative to pre-pandemic levels. These are
hairdressers and line cooks. They work at doctors' offices and
on assembly lines. They are, in President Clinton's words,
``those who work hard and play by the rules,''
The good news is that the lockdowns have done what they
were supposed to do, ensure that our hospitals and our ICUs
were not overwhelmed, Italy style, with severely ill COVID-19
patients. The bad news is that the shapers of conventional
wisdom now claim that we must continue lockdowns for as long as
we cannot test the entire population for COVID-19 and have an
effective treatment and develop herd immunity and produce a
vaccine. All of this, we are assured, can take place in the
next 12 to 18 months.
But what if it takes us 12 to 18 years to develop a
vaccine? We have never developed a coronavirus vaccine before.
The best scientists in the world have been trying to develop a
vaccine for human immunodeficiency virus (HIV) for nearly 40
years, and we still do not have one. Effective non-vaccine
treatments may arrive sooner, but when? And is it realistic to
stick 6-inch swabs up the nostrils of millions of Americans
every day until that happens?
The question of when is of urgent importance. Every week
matters. The average small business holds less than 4 weeks of
cash in reserve. For urban small businesses, it is more like 2
weeks. Some have been able to take advantage of the Paycheck
Protection Program, but as you know, it is actually medium-
sized businesses, not small businesses, that have been
organized enough and savvy enough to maximize that opportunity.
Shapers of the conventional wisdom argue that these
devastating economic costs are necessary and acceptable because
we must do everything possible to protect people from COVID-19.
Let me explain why this thinking is flawed. First, the
costs of the lockdown are not merely financial. The closure of
schools has only widened educational disparities between the
haves and have-nots. There is considerable evidence that high
unemployment rates are associated with higher mortality,
including deaths of despair. And there is a cost in lives and
health among those who have been unable to seek non-COVID-
related health care, including unmanaged chronic disease,
missed cancer diagnoses, untreated heart attacks, and
unavailable organ transplants.
Second, one-site-fits-all lockdowns are not based on actual
evidence or science regarding COVID-19 but are instead based on
fear and on off-the-shelf playbooks designed for influenza, a
meaningfully different disease.
The risk of death due to COVID-19, as we have discussed, is
very low for those under the age of 55, and yet our
restrictions on economic activity apply equally to people of
all ages.
Roughly half the deaths from COVID-19 have taken place in
the tri-State area around New York City, and yet we are
treating Oklahoma, Utah, and Wyoming no different than
Manhattan.
According to an analysis by my FREOPP colleague, Gregg
Girvan, that we will be publishing this week, nearly half of
all U.S. deaths due to COVID-19 are taking place in nursing
homes, and yet we are not incorporating that fact into our
assessment of the risks outside of nursing homes.
Similarly, the risk of outdoor transmission appears to be
much lower than for indoor transmission, and yet many States
are applying equally onerous restrictions to indoor and outdoor
activity.
Third, we have forgotten how we deal with risk in other
aspects of our society. 100,000 Americans die of hospital-
acquired infections each year, and yet we do not shut down the
hospital industry. 37,000 Americans die each year in traffic
fatalities, and yet we do not shut down the roads.
Indeed, traffic fatalities is a good mental framework for
thinking about how to live with COVID-19. Instead of abolishing
cars, we enforce traffic laws and speed limits and prohibit
drunk driving. We set a minimum standard for car safety. But,
most of all, we expect individual drivers to be responsible for
their own conduct and the conduct of passengers.
Something similar can work for COVID-19. Businesses can
deep-clean their surfaces and provide hand sanitizer and masks
to their workers and customers. People can wash their hands
regularly and minimize close contact with strangers. This is,
in fact, what East Asian countries did after the----
[Pause.]
Chairman Johnson. We have lost him. We seemed to have lost
Mr. Roy.
We will come back to Mr. Roy to have him finish up his
testimony. I guess in the meantime, we will move on to our
fifth witness, Dr. John Ioannidis.
Dr. Ioannidis is a professor of Disease Prevention at the
Stanford School of Medicine. He is the Director of the Stanford
Prevention Research Center and a Co-Director of the Meta-
Research Innovation Center at Stanford (METRICS). Prior to
joining Stanford, Mr. Ioannidis chaired the Department of
Hygiene and Epidemiology at the University of--I cannot
pronounce that one--Ioannina Medical School and was an adjunct
professor at several other schools of medicine. Dr. Ioannidis
received his MD from the University of Athens School of
Medicine and trained in internal medicine and infectious
disease at Harvard Medical School and Tufts University School
of Medicine.
Sorry for all the mispronunciations, but Dr. Ioannidis.
TESTIMONY OF JOHN P.A. IOANNIDIS, MD,\1\ C.F. REHNBORG
PROFESSOR IN DISEASE PREVENTION SCHOOL OF MEDICINE, STANFORD
UNIVERSITY
Dr. Ioannidis. Thank you for the kind invitation and the
honor to join this hearing and to share some thoughts with our
Senators.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Ioannidis appear in the Appendix
on page 476.
---------------------------------------------------------------------------
COVID-19 represents a major crisis with major loss of life.
There is no doubt about that. We should use the best science in
a data-driven, evidence-based approach to minimize human loss
from this pandemic. We need to consider both the benefits and
harms of each of our policy interventions and to adjust our
interventions according to continuous feedback with reliable
data.
Shelter-in-place and lockdown orders were justified
initially when announcements declared a new contagious virus
with 3.4 percent fatality rate and no asymptomatic infections.
Prospects of 60 million deaths worldwide led to comparisons
against 1918 influenza. However, currently we know that
asymptomatic or mildly symptomatic infections that people are
not even aware of and do nothing about are very common. The
number of people infected are actually far, far more than those
documented to date with polymerise chain reaction (PCR)
testing.
Infection fatality rate is accordingly much lower than the
crude fatality rates derived from dividing the number of deaths
by the number of documented cases. The exact infection fatality
rate will vary from one place to another, depending on whether
hospitals have crashed or elderly care nursing homes have been
widely contaminated or not, but in places that do not see these
disasters, it is very comparable to seasonal influenza.
While this is a very contagious virus and many people can
be infected, to date person-years of life lost from COVID-19
worldwide is probably in the range of a hundred- to a
thousandfold less than the person-years of life lost from
influenza in 1918. At a global level, the number of person-
years lost this year from COVID-19 is comparable or less than
that of seasonal influenza around the world.
Of course, a second wave cannot yet be excluded, and we
need to be very cautious about that. Its occurrence and
potential magnitude can only be speculated with mathematical
models, but unfortunately, models have not been successful so
far in making COVID-19 predictions. Therefore, we need to
proceed with caution in lifting lockdown and monitor the impact
of any changes in policy measures with real data as opposed to
just using models.
The fatality rate from COVID-19 is highly dependent on age,
and it is modulated by the presence of comorbidities. For
children and young adults, it appears that infection fatality
rate is lower than seasonal influenza, and for middle-age
adults, it is about the same. Infection fatality rate can
increase sharply, however, when nursing homes are massively
infected and when unprepared hospitals are running close to
full capacity even on a regular season are overwhelmed and the
infection spreads to hospitalized patients or what we call
nosocomial infections. This explains the paradox why COVID-19
is typically a very mild benign infection, but at the same
time, it also has the potential to become devastating in
specific settings.
While lockdowns were justified initially, their
perpetuation may risk many lives. Unemployment may create more
marginalized citizens without health insurance. Mental health
can be affected with increases in depression, suicides,
domestic violence, and child abuse. Gun sales have increased
drastically. Starvation is becoming a global threat. Moreover,
deaths from common chronic diseases and treatable conditions
such as heart attacks may increase as patients avoid hospitals
from fear, as interaction with their caregivers is disrupted
and hospitals become financially devastated.
Excess deaths accruing during COVID-19 weeks may reflect
both COVID-19 itself but also deaths from health care
disruption. COVID-19 overwhelmed a few dozen hospitals, while
COVID-19 measures may jeopardize services and multiple health
outcomes in thousands of hospitals.
Moving forward, we need to defend hospitals and nursing
homes with strict infection control and hygienic measures. We
need to have universal and periodic testing of all personnel.
We need to have quarantine for infected and exposed personnel.
Conversely, we should reassure most citizens, those of younger
ages and, of course, all of those without serious preexisting
conditions, but also many that just have hypertension or some
mild condition that they are at extremely low risk.
Reopening efforts require great caution with continuous
feedback to identify and limit any potential surge of
hospitalizations and deaths upon reopening. Reopening should be
gradual, with continuous feedback on epidemic activity. This
includes data on seroprevalence, which means the proportion of
people already infected, and incidence of new infections. These
data should be balanced against bed capacity reserves. It is
unrealistic to expect that new PCR-detected cases to disappear
before reopening. PCR remains positive for a while in many
patients who are no longer infectious.
Moreover, with increased testing and with a large pool of
previously undetected infections, numbers of PCR-positive
samples may seem to remain quite high, even though the epidemic
wave has largely passed.
It is also unrealistic to expect COVID-19 deaths to stop
accruing before reopening. Deaths may happen 3 weeks after
infection, and modern medical technology can maintain some
people on mechanical support even for months.
Finally, it is unrealistic to expect that complete contact
tracing will need to be feasible before reopening. In most
locations, the number of people infected is already too large,
and their casual contacts may include a large portion, if not
the large majority of the entire population, thus, making
complete contact tracing infeasible. Complete contact tracing
can be more feasible when the epidemic activity has ceased, for
example, in the future when trying to catch early and
extinguish potentially new waves.
The pace of the reopening may differ across locations,
depending on their evolving levels of infection, hospital
capacity, and population vulnerability structure. While
treatment advances and vaccine efforts may be successful
eventually, lockdown measures cannot be prolonged until we find
treatments and vaccines that save many lives, since such
breakthroughs may take a long time or may even never happen.
For example, remdesivir has shown promising results in
shortening disease duration, but no conclusive evidence yet for
saving lives.
Thank you for listening.
Chairman Johnson. Thank you, Dr. Ioannidis.
Before we go back to Mr. Roy, we will have our last
witness, Dr. Scott Atlas, testify.
Dr. Atlas is the David and Joan Traitel Senior Fellow at
the Hoover Institution at Stanford University and a member of
the Hoover Institution's Working Group on Health Care Policy.
Prior to joining the Hoover Institution, Dr. Atlas was
Professor and Chief of Neuroradiology at Stanford University
Medical Center for 14 years. He received an MD from the
University of Chicago's School of Medicine. Dr. Atlas.
TESTIMONY OF SCOTT W. ATLAS,\1\ DAVID AND JOAN TRAITEL SENIOR
FELLOW, HOOVER INSTITUTION, STANFORD UNIVERSITY
Dr. Atlas. OK. Thank you. Thank you, Mr. Chairman, and
thank you for inviting me to speak here today.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Atlas appears in the Appendix on
page 479.
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As we all know, the consequences of the COVID-19 pandemic,
of course, have been enormous. That said, the direct daily toll
from the infection has markedly declined, including in the
epicenter of New York. The curves have been flattened. The
stated goal of the isolation has been accomplished for both
hospitalizations per day and deaths per day, the two curves
that needed to be flattened.
We now, though, have an even greater urgency specifically
due to the extension of the severe single-minded policies
already implemented. Treating COVID-19 at all costs is severely
restricting other medical care and instilling fear in the
public, creating a massive health disaster in addition to the
severe economic harms that could generate a world poverty
crisis with incalculable consequences.
Half of neurosurgery patients still today refuse to come in
for treatment of the disease that if left untreated risk brain
hemorrhage, paralysis, and death, even when their doctors
directly reassure them because of the fear. Transplants from
living donors are down 85 percent from last year. In the United
States alone, 150,000 new cancer cases arise every single
month. These patients are not being seen. Biopsies of unknown,
undiscovered possible cancers number thousands per week. They
are not being done. That does not include the latest reports of
skipping two-thirds to three-fourths of cancer screening tests,
most childhood vaccinations, and treatments for emergency new
strokes and known cancer chemotherapy.
One more thing we absolutely know is that this total
isolation policy prevents broad population immunity. We know
from decades of medical science that the population develops
immunity while acquiring antibodies. Indeed, that is the main
purpose of widespread immunization, to assist with herd
immunity.
In the COVID epicenter of New York, undoubtedly muted by
the extreme policies, we still see that more than 24 percent of
those tested have antibodies, and a similar finding was
reported in Boston. That fact has been incorrectly portrayed to
the public as an urgent problem requiring mass isolation, but
on the contrary, infected people are the immediately available
vehicle for establishing widespread immunity among low-risk
groups. While we do not know with certainty that antibodies
stop infection, it is expected based upon decades of virology
science, including with other coronavirus respiratory viruses.
That is exactly why scientists are hopeful about using COVID-19
antibodies to treat the sickest patients. That is the basis for
the drive to generate a vaccine.
Reassuring the public about reentry is critical, and it
requires repeating the facts, what we know about the threat and
who it targets. By now, as Dr. Ioannidis implied, multiple
studies from all over the world suggest that the overall
fatality rate is far lower than early estimates, and those were
the estimates that motivated the extreme isolation.
We also now know who to protect because this disease by the
data is not equally dangerous across the population. For
example, in Detroit's Oakland County, 75 percent of deaths were
those over 70, 91 percent over 60, similar findings of New
York. Again, healthier younger people have virtually no risk of
death and almost no risk of serious disease and, similarly,
highly unlikely to be hospitalized.
Here, specific science-based logical steps strategically
and safety restore the pathway to normal life.
First, we must finally focus on protecting the known most
vulnerable. That specifically is nursing home patients. Given
that older people with underlying conditions were always the
obvious setups for serious complications from respiratory
diseases like this, it is difficult to even excuse policies
that allowed almost 30 percent of U.S. deaths to die in nursing
homes, more than half in some States, particularly when they
already live under controlled access. This is an urgent need
and probably too late to help for most people, but targeted
strict regulation of all who enter, including mandatory testing
for these people must be done. We must continue to educate and
inform the public about what they have already learned
regarding at-risk age groups and how to deal with them.
In addition to the standards of hygiene and appropriate
social distancing that we already know, that has to be
reinforced, and we know that people can do it. That is what is
being done.
Second, those with mild symptoms of the illness should
strictly self-isolate for 2 weeks. It is absolutely not urgent
to test them. We assume they have the infection at this point.
That includes confinement at home, having the highest concerns
for sanitization, wearing masks when others in their homes
enter their room.
Third, K through 12 schools should be opened. If under 18
and in good health, you have virtually no risk of serious
illness. Exceptions exist, as they do with every single
clinically encountered infection, but that does not outweigh
and cannot outweigh the overwhelming evidence to the contrary.
Again, standards for consciously protecting elderly and other
at-risk family members and friends, including the teachers in
high-risk groups, should still be employed.
Fourth, most businesses can be opened, including
restaurants and offices, but of course, we require new
standards for hygiene and sanitization, with more stringent
regulations than we have had. It is reasonable to post warnings
for customers who are older or in other ways at risk, and
indeed, we already see businesses and workplaces setting up
such environments because they already understand the obvious
need to allay fears of workers and customers in order to regain
function. However, it is not logical that younger age groups
must somehow be isolated or maintain a 6-foot spacing from each
other. If infection in low-risk groups is still prevalent,
which it is, socializing represents the opportunity for
developing the widespread immunity eradicating the threat to
the vulnerable.
Fifth, public transportation, which is the lifeblood of
much of the workforce, should resume. In addition to the
standards of cleanliness and hygiene that passengers would
welcome, of course, regional authorities could require things
like barrier masks for passengers. Given the state of our
fearful public, it is highly likely that most people will
choose to wear them. Similarly, air travel hygiene has already
been improved, and further changes are likely, regardless of
any requirement, because travelers will simply not have the
confidence to fly.
Sixth, parks and beaches should be open. There is no
scientific reason to insist that people remain indoors. Given
now that we know who to protect and how to protect them, even
inside our homes, outdoor activities can resume with smart,
considered limits on large-group gatherings.
Finally, prioritized testing is important, but it is
important in three specific groups: nursing home workers,
health care workers and first responders, and patients in
hospitals with respiratory symptoms or fever. Widespread
testing for the entire population is not a predicate for
reopening as above with these guidelines, and contact tracing,
although an important part of the overall preparation for
potential future outbreaks, is not critical right now and is
not as valuable after a disease is already widespread,
infecting tens of millions of people.
In summary, targeted protection for the known vulnerable,
standards and commonsense recommendations for individuals and
businesses and prioritized testing are the basis of an urgently
needed, strategic reentry plan that would save lives, prevent
overcrowding of hospitals, and limit what are the enormous
harms compounded by continued total isolation.
Smart, safe reentry cannot be delayed by fear or
hypothetical projections. We have direct data on risk, and we
have now experience with managing it. The goal of the strict
isolation has been accomplished. We need to stop
underemphasizing the actual empirical data and established
medical science while instead somehow doubling down on
hypothetical models. Science and logic must prevail over fear
and worst-case scenarios.
Thank you.
Chairman Johnson. Thank you, Dr. Atlas.
Mr. Roy, you are back. I think we heard most of your
testimony. Do you want to finish off, though? Do you know where
you blinked out?
Mr. Roy. I am happy to finish up.
Chairman Johnson. OK. Go ahead, Mr. Roy.
Mr. Roy. Thank you.
So I was mentioning that something similar can work for
COVID-19 in terms of the analogy I made to traffic fatalities
and responsibility for the roads. businesses can clean their
surfaces and provide hand sanitizer and masks for their workers
and customers. People can wash their hands regularly and
minimize close contact with strangers. This is, in fact, what
East Asian countries did during the original SARS outbreak in
2003, and it enabled them to gradually return to normal life,
despite the absence of a vaccine or effective treatments.
We discuss this and many more opportunities for strategies
for reopening in our coherent, bipartisan, evidence-based plan
for reopening the economy called ``A New Strategy for Bringing
People Back to Work During COVID-19,'' coauthored by Lanhee
Chen of the Hoover Institution; Bob Kocher of Stanford
University; and Bob Wachter, Chair of the Department of
Medicine at the University of California, San Francisco. The
report is available at our website freopp.org.
I look forward to discussing these ideas during today's
conversation. Thank you very much, and again, apologies for the
interruption.
Chairman Johnson. Not a problem. Thank you, Mr. Roy.
Just out of respect for everybody's time, I will hold off
on my questioning until the very end. I will just warn
everybody--not warn, but give you a heads-up in terms of
witnesses. I think during my questioning, I will ask each of
you, if you have something, if you disagree with another panel
member--I do not want to get heated arguments, but I do want
this to be a discussion and challenge other people's
assumptions or conclusions as well. So that will be kind of
what I will go after at the very end.
Otherwise, we will go down in order of basically seniority.
I will again remind the Members. I will let you during your 7
minutes pretty well control the little hand thing. If you see
one of the witnesses that you did not call on that puts up his
hand and actually wants to speak to your question, I will let
you determine whether or not you want to call on that
individual or just move on to your next question.
So if you do, as a witness, get your little hand up there
and it does not get called on, I do not want you to be
offended. People may not be noticing it, or they may want to
direct their question to another witness.
With that, Senator Peters.
Senator Peters. All right. Thank you. Thank you, Mr.
Chairman, and thank you to all of our witnesses. A fascinating
testimony and certainly, really a range of ideas for us to be
thinking about.
My first question is to Dr. Inglesby. I have been speaking
to a lot of our businesses all across Michigan over these last
few weeks, and certainly, everyone is anxious to try to find
whatever that new normal is and to try to open up their
businesses. A number of the very large businesses in Michigan
have developed very detailed plans. Our auto industry, for
example, has put together elaborate plans to keep their workers
safe as they open up production in the future, to keep them
safe, spacing folks out, making sure certain exist and egresses
are used and traffic flows, temperature testing, et cetera. All
these basic guidelines are being put in place, and some of the
major auto suppliers will be able to do that as well.
However, I am concerned that many small businesses simply
do not have the resources on their own to put together that
kind of plan for their business and will have to figure out how
do they operate to keep their employees safe and, equally as
important, make sure customers feel comfortable coming into
those places that are open.
So my question to you is, What more could the Federal
Government do to help those small businesses really understand
what they need to do in order to keep their employees and their
customers safe? How should we be thinking about it?
Dr. Inglesby. Senator Peters, I have heard from big
businesses and small businesses that what business really wants
is some kind of very clear and detailed guidance from the
Federal Government to help them set their own standards.
They worry about their own employees not feeling confident
in coming back to the workplace. They worry about customers not
feeling confident that businesses have necessarily taken all
the right steps.
So for them, at least what I have heard, is that they
really would like detailed guidance from CDC or Occupational
Safety and Health Administration (OSHA) that would help them
measure themselves. They are not necessarily asking for new
regulations, but they are asking for a lot of clarity about
what a safe environment looks like in different kinds of work,
both retail, construction, office space, a variety of different
settings, really tailored to those industries.
So for the industries you are talking about in Michigan,
both in the automotive industries but also in agriculture, the
more detailed guidance that employers can get, that workers can
see, I think the better.
I think the other thing, for places that are large indoor
facilities, they definitely are going to need access to the
right kind of protective equipment. Now we have seen countless
meatpacking facilities get very large outbreaks. We have seen
outbreaks in prisons. We have seen outbreaks in nursing homes,
in cruise ships. Indoor congregate settings are really among
the highest-risk places.
We do think, fortunately, that smaller businesses are
probably at lower risk. There is less people coming in and out
of those organizations. They are less dense, but certainly, I
think many of them would like to get either from a State agency
or even probably for many who work in multiple States, they
would like some kind of Federal clarity about what they should
be doing.
Senator Peters. Thank you, Dr. Inglesby.
I want to actually pick up on a point you mentioned about
having personal protection equipment and how important that is
going to be outside of just medical settings, where clearly
that is where their priority is.
But if we look at what has transpired over these last few
weeks, it has been a real challenge to get the masks, the
respirators, the gloves just to our critical frontline folks,
our doctors and nurses and med technicians. But as we start
looking at opening up the economy, the demand for PPE is going
to go up dramatically.
So my question to you is, Do you believe that the current
supply chain is prepared to meet these needs right now in your
assessment? I know Johns Hopkins has done some assessment of
that.
Dr. Inglesby. It is difficult to know because there are not
any clear metrics that I think are being put out by the Federal
Government or State governments on this. I think if you speak
to hospitals, it is a patchwork. Some hospitals feel like they
have been able to get the PPE that they need. Other hospitals
clearly do not feel that way, and we have not been able to
really extend PPE supplies to industry in the way that industry
seems to be seeking. And I think it is quite important.
My colleague at our center calculated that over a 100-day
period in COVID, so a 3-month period, the country would need an
additional 3.3 billion gloves, 57 million N95 masks above
normal usage, and 179 million surgical masks for use around the
country in health care facilities. This is exclusive of the
need for business or for the need to use those masks in other
settings.
So I think that is a very high demand. I do not know
whether we have met it. There is no real way to measure that,
and that was for the first 3 months of this illness. So as
COVID goes on, we will need to reassess, see where we are in
the outbreak, see how it has responded to the coming changes in
our social distancing policy, and then make decisions about
that.
Senator Peters. Those are big numbers, and when you
multiply it by all of the businesses that are going to need it,
they are astronomical numbers in terms of what we are going to
need.
Given our supply chain that we have now is primarily
overseas, most of all this equipment is produced in China and
other places. Give me your sense of how important it is for us
to be thinking about bringing back production from China or
actually taking it back. A lot of it has gone over there, but
take it back and how we really need to source this type of
manufacturing capability in the United States, not only to deal
with this pandemic, but future pandemics.
Dr. Inglesby. Yes. I completely agree with that. I think,
unfortunately, both for PPE but also for antibiotics, a
majority of what we get is from overseas, and that has been
done for kind of commodity, again, the cheapest pricing over
the years, but at this point, I think given the experience we
have lived through, it have been searing and terrible. I think
we should be very dedicated in bringing back those kinds of
industries that we will need in future emergencies, and that
does not mean we need to bring back the production of every
medicine in America, but bring back the medicines that we
believe we will need in the first months of a crisis, the PPE
that we will need in the first months of a crisis, that we
cannot afford to have cutoff from overseas productions. I think
that should be a strategic goal of ours coming out of this
pandemic.
Senator Peters. Great. Thank you. Thank you for those
answers.
Thank you, Mr. Chairman.
Chairman Johnson. Thanks, Senator Peters.
I want to apologize to everybody for how we started late,
and I realize some of you are going to have to go. We will not
be offended if you have to go to other things. It is perfectly
understandable.
What I will do is I will alternate between parties now
based on seniority of who is actually in the WebEx seminar
right now. I do not see Portman, Paul, or Lankford. So I think
I will go next to Senator Romney. I see you are on, if you are
ready, Mitt.
OPENING STATEMENT OF SENATOR ROMNEY
Senator Romney. Yes. Thank you. I am.
I have just a couple of comments first. I appreciate the
work that each of these individuals has provided and their
testimony today.
A couple of comments first. Mr. Roy's comment that
comparing, if you will, the number of deaths with 1918 as well
as from the standard flu, I would note that, yes, they are much
lower numbers than one might associate with this pandemic, but
the President just last night said that without the actions he
had taken to close down the economy, we would have had 2
million dead. So I think we have to recognize that while the
numbers we are looking at are consistent with the normal
influenza year, at least so far, we have taken pretty dramatic
action, and that is, perhaps, one of the reasons why they are
not as high as they could have been.
Dr. Atlas also indicated that the COVID infection rate has
declined, that the curve is now aiming downward. I think that
is true if you include the tri-State area or, frankly, just New
York, but if you look at the national figures, excluding New
York, why, the numbers continue to go up. I think we have 19
States that are actually seeing the number of infections and
the number of deaths going up.
But my question that I am going to pose to Dr. Ioannidis or
anyone else who would like to comment on it is this. I feel, as
you do, that, gosh, this is very much like a standard flu.
Maybe we have overestimated the mortality rate associated with
this, and it is very dangerous for people who are older or who
have underlying conditions. I look at the data that came from
Massachusetts and from New York and from the prison study in
the South as well, and it all suggests that there are a lot of
asymptomatic people, and that perhaps this does not have the
mortality rate that we feared.
On the other hand, I look at the data that comes from the
meatpacking facilities, the number of people who died that just
work in the meat processing area, likewise grocery store
stocking clerks, a normal flu, you do not have dozens of people
die that are stocking clerks. You do not have dozens of people
die that work in meatpacking processes. What accounts for that
phenomenon that you are seeing a lot more deaths than you would
normally see were this just like a standard flu for people,
under 50 years of age?
Dr. Ioannidis. I think that the reason for that paradox,
which is indeed very prominent, is that there is a very steep
gradient of risk. Influenza has less steep of a gradient of
risk across age, even though it also has an age gradient, and
also a less gradient of risk across people who are at high risk
in facilities like those that you mentioned, even more so in
nursing homes or in hospitals that you may get hospitalized,
people getting infected with nosocomial infections.
In contrast to influenza, we do not have a vaccine. So
staff in nursing homes, for example, typically have very high
rates of vaccination, same thing for personnel in hospitals, in
acute care hospitals. So it is really different when it hits
these locations where you have a lot of vulnerable individuals
clustered together, and you do not have the same background of
vaccine protection that we have for influenza.
However, this being said, we have the means to protect
these specific locations that can be the places where disaster
can happen, and the vast majority of the population that are at
risk would be the same or even less compared to influenza.
Influenza, for example, kills thousands of kids around the
world every year. This does not happen with COVID-19. It gives
lots of very young, completely healthy people--this does not
happen with COVID-19.
We need to be smart. We need to avoid the disasters. We
need to protect very carefully all the settings where we can
get a disaster and at the same time mobilize something like 85,
90 percent, perhaps more of the population who would be at
minimal risk or very low risk.
Senator Romney. Yes. I do understand that, although people
who are working in food processing and working in grocery
stores are not a population that we would think we need special
care for. I mean, I understand certainly nursing homes and the
like, yes, we really need to make a very special effort there.
But these are normal Americans that are seeing a very high
level of mortality, which is inconsistent with the idea that
this is just sort of the normal flu-type mortality.
Another question that I had for you, Dr. Ioannidis, is
this. I really wonder how many people are asymptomatic. There
are some studies. The prison study in the South, for instance,
in five States in the South, I think it was, suggested that
like 93 percent of the people that tested positive for COVID-19
had no symptoms, and if that were the case, you would say,
well, there is no way to stop this from spreading rampantly
through a society. You could not possibly get people who were
asymptomatic to know that they need to isolate.
But on the other hand, you have a place like South Korea,
which has pretty well snuffed out the extent of the disease,
and there are other places, Australia, New Zealand, and so
forth. So if there were massive numbers of asymptomatic people,
how would they have been able to snuff out the number of severe
cases that we are seeing in the rest of the world?
It is hard for me to square some of the data. That is the
challenge I have. I look at some data that says all sorts of
asymptomatic people, and then I look at the others, and I say
that is impossible. Where do you come down on that? What do you
think the proportion of our population is that is really
asymptomatic and is still spreading the disease?
Dr. Ioannidis. I think that all the studies point to the
fact that asymptomatic infections or mildly symptomatic
infections that do not reach the level of attention that people
would want to be tested are the vast majority.
If you retrospectively ask people, of course, if you ask
them, ``Do you have any cough or any symptoms in the last few
months?'' probably most of us will say, ``Oh, yes, I can
remember something.'' Maybe--who knows?--2 weeks go or 4 weeks
ago or 2 months ago. But the vast majority of infections are
not at a level that would draw attention, either asymptomatic
or very mildly symptomatic.
What happened in South Korea and also in Taiwan is that
they were very aggressive in testing very early on and in
tracing contacts of people who were infected. Taiwan is a
country that has practically one large international airport.
They were very aggressive to just test everyone who would be
suspicious and then quarantine and then test all the contacts
and again quarantine, and this worked. It worked very nicely,
and if we have a new wave or, let us say, a new pandemic, this
is a way to go, especially if you get it very early on. You
have that intense testing and tracking.
Senator Romney. Thank you.
Dr. Ioannidis. It is not going to work in a situation where
you have 30 percent of New York already infected at the moment
or 5 percent in other States or 10 percent or 12 or who knows.
It is very difficult to contract trace when you have a sizable
portion of the population already infected. They have been
exposing almost everyone else to the infection.
Senator Romney. Thank you.
Dr. Ioannidis. South Korea had more cases, but actually,
they had a very big outbreak in a religious sect.
Senator Romney. Right.
Dr. Ioannidis. So they knew how to limit and how to contain
the boundaries of their testing, and they also were very
aggressive in asking people to come in and get tested right
away.
Senator Romney. Thank you.
Chairman Johnson. Thanks, Senator Romney.
Again, I want to just draw everybody's attention to the 7-
minute limit. I am mindful that three of the witnesses put up
their hand, but that is up to the Senators to call on those
individual witnesses if they choose to.
Our next Senator up to the plate is Senator Carper.
OPENING STATEMENT OF SENATOR CARPER
Senator Carper. Thank you. I used to have the privilege of
chairing this committee, and I am now the senior Democrat on
the Environment and Public Works (EPW) Committee, which
reported out unanimously today major legislation on
infrastructure. Sometimes people think we cannot find anything
to agree on, but every now and then, we do. What do they say
about a blind squirrel that can easily find an acorn? We are
going to look for some acorns right here with all of you.
I am going to ask Dr. Inglesby, if you will. Dr. Inglesby,
I am going to ask you to just go back and think about what each
of our other witnesses have said. We will start with Dr. Atlas.
Let us pick something that Dr. Atlas said that you agree with.
It does not have to be profound. If we were actually doing a
real hearing, what I would do would be to ask you, go down line
and ask each of you to say what are all the points where you
agree. I do not know that works today, but I will just pick on
you, Dr. Inglesby.
Dr. Ioannidis. Sure.
Senator Carper. Just something that Scott Atlas from
Stanford--our son went to graduate school there. Nice to see
you.
But something he said that you think, yes, absolutely.
Dr. Inglesby. I agree with Dr. Atlas about the critical
importance of doing better with nursing homes and how it has
been, I would say, so far a collective failure across the
country to be able to prevent so much sickness and death in
nursing homes. I think that is very important.
Senator Carper. All right. Thank you.
So I am going back to Dr. Katz. Can you recall something
that Dr. Katz might have said that you said I agree with that?
Dr. Inglesby. Yes. Let us see. I think Dr. Katz is right
that many people are deferring hospital care, and that is
creating its own secondary large problem. And we need to
communicate better with people that they should be coming to
the hospital and getting their regular medical care.
Senator Carper. All right. Thank you.
And, Dr. Ioannidis, has anyone ever mispronounced your
name?
Dr. Ioannidis. I think that there is 80 variances, and all
of them are equally fine.
Senator Carper. All right. Dr. Inglesby, how about
something that Dr. Ioannidis said that maybe----
Dr. Inglesby. I think Dr. Ioannidis said something along
the lines of how important it will be to measure very carefully
as we begin the next phase and to be very carefully monitoring
how our social distancing changes are affecting the disease
rate. I think he said that.
Senator Carper. All right. And how about something that Dr.
Roy said? I can see the faces of all these people as you
mention----
Dr. Inglesby. Yes. And I am trying to remember. I think Dr.
Roy----
Senator Carper. They can always say, ``I never said that.''
Dr. Inglesby. Dr. Roy talked about the profound economic
hardship that this disease is causing across the country, and I
absolutely agree with all that he said about the hardship that
Americans are going through, the job loss, the importance of
considering strategies now that we can to reverse that.
Senator Carper. All right. Dr. Kory. Dr. Kory did not have
much time to talk to today, but do you think anything he said
in his remarks that----
Dr. Inglesby. Oh, I am sorry. I think----
Senator Carper. Conflated? You conflated?
Dr. Inglesby. I think I mixed up two of the speakers.
I think the speaker who was speaking--Dr. Roy was speaking
about--I think Dr. Kory was speaking about medical
interventions, and I thought his discussion about how the
conditions in New York City and the urgency with which we
needed to deal with the onslaught or the incoming numbers of
patients who need critical care, I thought that was very
important.
Senator Carper. All right. And now back to Dr. Roy.
Dr. Inglesby. I think that was what I said before about the
economic losses and the hardships. I agree completely with his
assessment of the economic implications of what is happening.
Senator Carper. We do not have many doctors who have served
here in the U.S. Senate. We just lost a former Ranking Member,
Ranking Member Tom Coburn, who died last month, very sadly. He
was a great member.
But if you were serving on this Committee, let me just go
through the list. I will start with Dr. Roy. If you were
serving here with us in the U.S. Senate, what would be the one
thing that you would focus on in getting out of this and
getting back on the right track? Very brief from Dr. Roy,
please.
Mr. Roy. A great question, Senator. In the plan, I would
say the things that we would highlight are--particularly for
what Congress can do is give safe harbor to businesses that can
reopen, but the one thing I would just amplify what has been
said before about guidance from OSHA and CDC, it is also
important to give liability protection to businesses that
reopen but also give aid to workers who do not feel confident
to go back to work, some sort of paid sick leave or some
analogy to that, so that businesses can get back to work and
workers can feel confident and have relief if they do not.
Similarly, aid to schools----
Senator Carper. Hold it right there.
Mr. Roy. Yes.
Senator Carper. I see Senator Harris has joined us. I think
she has asked me if I would yield my last minute. Do I have
30--I have 90 seconds. If you have time, will she be
recognized, Mr. Chairman? Otherwise, I will yield what is left
of my time.
Chairman Johnson. That is fine. If you want to give her 90
seconds, go ahead. Senator Harris.
OPENING STATEMENT OF SENATOR HARRIS
Senator Harris. Can you hear and see me?
Senator Carper. We can hear you now.
Chairman Johnson. We can hear you now. Yes, go ahead.
Senator Harris. OK. Hopefully, you can also see me. Can you
see me?
Senator Carper. No.
Chairman Johnson. There you go.
Senator Carper. Yes.
Chairman Johnson. We got all of you.
Senator Harris. OK, great.
Thank you, Senator Carper.
It is very brief and very to the point. Chairman, it has
been 2 months since our Committee last met to remotely discuss
COVID-19, and at the time that we last met, the number of
coronavirus cases were about 200, and now they are 1.2 million.
The death count in the country has gone from low double digits
to over 70,000, and of course, these are our neighbors and our
friends and family members. And then let us not talk about the
global crisis around the world that is now affecting 186
countries.
I said at our roundtable in February--and I will repeat
it--that we must hear from the officials who are currently
responsible in the administration, who are currently
responsible for addressing this pandemic.
Our Congress has passed four consecutive relief bills
totaling at least $3 trillion, and there have been a multitude
of problems with the way that that money has been disbursed, be
it PPEs to frontline workers, be it small businesses and
minority-owned businesses who are not going to gain the relief
of the Paycheck Protection Program, be it the fact that we do
not have enough testing to reasonably reopen our country.
It is in our job as our Committee--given that the Federal
Emergency Management Agency (FEMA) is responsible for
organizing and coordinating all of the Federal agencies, and of
course, our Committee has the responsibility for oversight of
FEMA--that we bring current administration officials in to
discuss with us what their plan is for the administration of
taxpayer dollars. And at the Health Committee, they are having
Dr. Fauci come. They are having the point person at the top
level of the administration. We should do no less. We should
not have low-level officials. We should have those folks who
have the responsibility and the authority for the
administration of the American taxpayer dollars to come in and
be accountable to our Committee and our responsibility of
oversight.
So that is my request of you, which is that immediately we
bring those to administration officials in to be accountable to
the American people, to get the American people through this
pandemic and through this crisis in the most efficient and
productive way possible.
Chairman Johnson. Thank you, Senator Harris. We will
absolutely be doing oversight.
I have certainly been participating in multiple hour-long
conference calls with officials across the administration. I
know Senator Hassan has been on a lot of those calls. I think
those things are pretty wide open to Members. The
administration certainly has been briefing us. We will do the
oversight. Those folks are working like 24/7. So I want them to
concentrate on the job before they start testifying before
Congress. They are briefing us quite regularly.
What we will do now is we will move on to----
Senator Harris. That logic would suggest that we do not
have them come in before there is a vaccine, which, of course,
is unacceptable.
Chairman Johnson. I do not----
Senator Harris. It is our responsibility to engage in
oversight, Mr. Chairman, and I have registered my request of
you and what I believe to be the mission and the responsibility
of our Committee.
I appreciate you giving me this time. Thank you.
Chairman Johnson. OK. I understand.
Senator Lankford is now online. So, Senator Lankford.
OPENING STATEMENT OF SENATOR LANKFORD
Senator Lankford. Jumped in between you there.
It is good to get a chance to be able to hear all of the
testimony. I appreciate all the folks that are here. Let me
bounce a couple of questions.
Dr. Kory, I want to go back to some of the statements you
made at the very beginning. Thanks for your description of what
you have already done and the process you have gone through and
the different ways that the disease itself is presenting, and
it has changed pretty dramatically, the shortness of breath and
everyone talking about this being a lung issue. It is now being
blood, heart, and all the different aspects that are coming up
now.
You made a comment about intubation of patients. I want to
be able to follow up on that a little bit. Are you suggesting
that we are using too many ventilators, that we are using the
wrong process, that we are using intubation too often? What has
changed in what you have seen in the process of taking care of
patients?
Dr. Kory. Terrific. That is a terrific question. OK. So let
me tell you what I have understood, and again, I do not want to
claim to be the world expert, but I will tell you I have been
talking every day for 6 weeks to people all around the world
and mostly in New York.
Here is the issue. It is that when this disease first
presented, all the doctors were quite intimidated because there
was so many reports of like this acute respiratory failure
where patients could not breathe on their own. So a lot of
systems and a lot of institutions, they decided to adopt these
early intubation protocols. Whereas, traditionally, when we see
someone who is having difficulty breathing or in respiratory
distress, it is a challenge.
I am a pulmonologist and a critical care doctor. I have
never in my career been able to decide when to intubate
someone. It is a chronic challenge because you do not want to
intubate too early and you do not want to intubate too late,
because if you intubate too late, sometimes at least a cardiac
arrest and it leads to very poor outcomes of the patients. If
you intubate too early, you might put someone on a mechanical
ventilator in which the harms of mechanical ventilation will be
profound. Whereas, you could have avoided that if you did not
intubate. So I just want to say that is the core challenge of
my specialty.
When COVID came along, it was just weird, the reports
coming out of China and Italy about how noninvasive ventilation
and other respiratory support structures were failing. Many
people in this country, around the country, said, ``You know
what? The best thing is to intubate them early. They are going
to fail. Let us intubate them early and protect them,'' and
that is what happened a month and a month and a half ago.
I fought against that. I thought it was going to be harmful
to intubate the patients too early, although the severity and
the acuity of this disease and how rapidly it progresses, we
really did not know. But I was on the phone every day talking
to patients, talking to my colleagues around the country,
asking them what they were seeing.
So all I am going to do--and I am going to finish with this
is that most centers around the country, I believe, adopted
early intubation protocols in which they put patients on
ventilators probably and they thought safely before they needed
to, but that led to untold harms.
Now what I am seeing in New York City is unbelievable. I am
seeing in my hospital here that I am working at is we have a
tolerance to avoid intubation to the extremes. These patients
are being supported with oxygen support, noninvasive
ventilation, and we are avoiding intubation because the
outcomes after you put them on an invasive mechanical
ventilator are really dismal. So we are trying to avoid that at
all costs.
So it is really a moving target, and we are evolving in how
we approach this. But it is a challenge. I do not know that we
are getting it right, but all I can tell you is I think we got
it wrong in the beginning. But we are doing much better now.
Senator Lankford. OK. That is extremely helpful. I really
do appreciate the insight on that because you got a chance to
be able to see, obviously, a lot of patients and a path that
you are seeing for care, and I am grateful for folks that early
on trying to be able to work through to be able to solve this,
because you are going to be able to share a lot of wisdom and
insight to a lot of other folks.
Let me shift to something that Dr. Katz had mentioned
before. Dr. Katz, you had mentioned something about unique
moments to deal with the health of Americans. If you could
drill down on that. Obviously, there is a lot of conversation
about diabetes and being oversight and be able to have greater
heart strength through exercise and such. Is that what you are
talking about as a part of being preventative on this disease?
Are you suggesting that what you are seeing on COVID-19, you
are less likely to be able to face the severity of the symptoms
of COVID-19 if you are doing exercise, if you are taking
vitamins, if you are eating healthier, if you get your weight
down? Is that what you are suggesting?
Dr. Katz. All of the above, Senator, and thank you.
Actually, I think this relates back to a question Senator
Romney raised a little bit ago: Why were we seeing higher rates
of severe disease among people working in a meatpacking plant?
Senator Lankford. Right.
Dr. Katz. There really is a perfect storm of confluence
where the portion of the population most harmed by
unemployment, because they were living hand to mouth, and
struggling most, perhaps, to access the medical system and most
burdened with those chronic diseases that sadly are all hyper
endemic in the United States vis-a-vis type 2 diabetes, heart
disease, all occur in the same population.
So I think among the strategies we have to adopt--and there
really is an opportunity here at the Federal level to provide
leadership--I think we have been relatively, if I may say it,
contemptuous of chronic disease simply because it is chronic.
The human nervous system is sort of hardwired to perceive
threats that come at us fast. The fighter flight response,
right? It is something that is coming at you in seconds,
minutes, hours, maybe days, activates your adrenal gland and
get your attention. COVID has it. Everybody is fixated on this.
But a large segment--I actually shared via the chat
function of a paper that colleagues and I just pre-published
today looking at the prevalence in the United States of these
chronic disease liabilities that increase the acute risk for
severe COVID infection. So that is exactly what I am saying.
These things are hyper endemic, but the good news is dietary
practices can modify immune function, improve immune balance in
a matter of hours, significantly in a matter of just days, and
profoundly in weeks. Control of type 2 diabetes could be
improved significantly with lifestyle intervention over a very
short period of time. Blood pressure can be lowered.
Inflammatory states can be mitigated.
So the very same things we maybe should have been thinking
about before to make America healthier now really becomes a
matter of acute defense against COVID.
I think we can also use--in addition to representative
random sampling to get a good understanding of the national
data, we actually can use risk calculators\1\ to determine what
is the risk of severe infection, hospitalization, ICU need, or
even at the individual level, and then offer up resources to
individuals by various means, some via the internet, but all
the resources that are collected, disposal, to empower people
while they are sheltering in place as we transition to the next
phase of policy, actually acutely lower their risk.
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\1\ COVID Age Risk Calculator appears in the Appendix on page 487.
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A sizable portion of our population could shift from the
higher-risk group because of their current state with regard to
chronic disease and weight and inflammation and migrate down to
a lower-risk group by using lifestyle as medicine. I do not
think there has ever been a better opportunity, and frankly, we
think about the health of the population, both acutely and
chronically. This is clearly a homeland security issue. So this
is a great place to take up that mantle.
Senator Lankford. Thank you.
Mr. Chairman, thank you for the time, and thanks for
pulling the hearing together.
Chairman Johnson. Thanks, Senator Lankford. Senator Hassan.
OPENING STATEMENT OF SENATOR HASSAN
Senator Hassan. Thank you very much, Mr. Chairman and
Ranking Member Peters, for having this hearing, and it is good
to hear agreement about the importance of population health to
our homeland security because that is one of the reasons that
so many of us want to make sure that every American has access
to good health care, all up and down the spectrum.
I also wanted to thank all of the witnesses for your
participation today and just comment on the fact that what I
would like to focus on is not a binary choice between opening
our economy and having more people get COVID-19, some of whom
will terribly and tragically die from it, or stay in a lockdown
forever. I think there is another path, and it is the path that
public health experts have been talking to us about, which is
how do we implement public health tools, use the right kind of
public health tools to reopen safely, protecting life as well
as livelihood.
Dr. Inglesby, I would like to start with a question to you,
please. First of all, thank you for your work during this
pandemic to help provide medical and scientific expertise about
what we need to be doing to keep Americans safe and our country
strong.
There has already been some mention in our discussion today
and in some of the testimony about the need for more daily
testing, but I want to return to that topic because I think it
has to be a focal point of any conversation about reopening the
economy.
As you know, there are a variety of reports from public
health experts projecting how many tests per day will be
required nationwide as a part of a safe reopening strategy.
The Center for Ethics at Harvard recently put out a blue
ribbon report stating that as a Nation, we may need 5- to 20
million tests per day. Other estimates have been even higher.
So, Dr. Inglesby, while I realize that modeling can vary
and is dependent on a variety of factors, based on your
research, have you determined how many tests we need to perform
on a daily basis in order to fully reopen the economy
nationwide, and are we at that level currently?
Dr. Inglesby. So right now, we are testing somewhere on the
order of 250,000 people a day, give or take, and we have been
focusing primarily on people who have severe illness, people
who are hospitalized, people who are in nursing homes, and then
to some extent, the outbreaks that we have talked about,
meatpacking, et cetera.
We know they were missing a large number of people with
that strategy because we have not had testing to be able to
reach out to them. So people who have mild to moderate illness,
they could be COVID. We are not easily able to test them. They
either cannot get a test, or they cannot get it quickly. So our
estimate at our center is given the number of people that we
believe have been infected in the country that have not been
counted, we believe we need to scale up testing by an order of
five times or so daily. So that would be about a million tests
a day to get the full complement of everyone who has COVID
symptoms on a daily basis in the country.
That might go down if the epidemic gets better, but for
now, given the numbers that we have, we think that would be an
approximate number.
I was just going to say the one thing it does not include,
which the Harvard Center also tried to get to and others, is
the second category of organizations that want testing, which
is business in America and institutions, universities. They
want to include testing as part of their reopening strategy.
They want to incorporate screening. They want to incorporate
sentinel testing. So if you include that, that is another
additional set of testing which there is no real estimate yet
that has been created by big business in America, but I think
that would add millions of tests a day if we actually are able
to do that.
Senator Hassan. Do you have an idea of when we could
reasonably expect to get to the point where we are doing the
level of daily testing that you are talking about? Let us start
with the million that would be testing people with symptoms or
on the front lines and the most ill. What will it take to get
there?
Dr. Inglesby. I talked to a representative from the
diagnostic industry earlier this week, and their sense is that
they are getting close to that number in terms of being able to
manufacture that number of tests, a million tests a day. But,
clearly, that number is not actually happening, and part of the
reason for that is maldistribution in the country. Part of that
is lack of reagents. They might have a test kit, but they do
not have the right reagent. They may not have swabs. We may
have actual kits for that many people presently, but we do not
have the full package or the operational planning to be able to
deliver those tests to where they need to get.
Senator Hassan. What could we do as Congress to help us get
there?
Dr. Inglesby. I think continued monitoring of industry and
a commitment to the industry that this market is secure, that
if they make tests for COVID-19, they will be purchased by the
U.S. Government for this process. This is probably something
that they are aware, but I do not think they have a sense of
what market size the U.S. Government wants or U.S. industry
wants. So there is some uncertainty. Should they make capital
investments? Should they shut down other lines in favor of this
one? Are they going to be crowded by other diagnostic
developers? I think it is a complicated calculus for them, and
the more that the U.S. Congress and the administration can say
we intend to purchase these, we intend this market to be
secure, it will grow over time because we need it for business,
university, institutional purposes, as well as public health. I
think that could help.
Senator Hassan. OK. Thank you.
I have one other question for you, Doctor, and it follows
up really on the line of questioning that Senator Peters had.
In recent weeks, even with social distancing measures in
place, we have seen outbreaks of the disease at businesses and
at gatherings across the country. For example, 81 employees
tested positive at a Walmart in Massachusetts last week. It is
unknown how long the virus was spreading within that store or
how many people those employees had contacts with.
In order to reopen in a way that keeps employees,
customers, and families safe, we need to be able to contain
these types of outbreaks before they become widespread, and
that requires support beyond diagnostic testing for people with
symptoms.
We talked with Senator Peters some about the things
businesses can do to open up safely, the kind of guidelines
they need, but could you focus a little bit on the importance
of robust contact tracing to contain community spread and
immunity or vaccine registries that could be used to protect
high-risk individuals?
Dr. Inglesby. So all countries in the world that have done
well against COVID-19 so far have had very strong public health
capacity and the ability to do contact tracing and to isolate
cases and then quarantine contacts and track them over 2 weeks.
We saw that in places around Asia. We have seen it in New
Zealand, Iceland, countries in Europe, and places that are
succeeding have very strong contact tracing programs.
And we are beginning to move in that direction. States have
announced programs to hire many contact tracers. Congress has
done a number of things moving in that direction. The reason
why that is so important is because that is the way to cutoff
the chains of transmission. That is the way to get people
isolated so they are no longer infecting others, and that gets
people out of commission a bit at home, and it begins to drive
down the numbers of infection. We have seen this in many and
great detail in places around the world.
So we need to build that. It is not complicated to do it,
but it takes some time. It takes resources for States to hire
people. It does not need to be a commitment for 10 years, but
it needs to be a commitment for the course of this pandemic.
Senator Hassan. Thank you. I think it also would be very
important in terms of giving the public confidence that when
they do go out and they do engage in commerce or any other
activity of their daily lives that the likelihood of them being
in a safe place is much greater, and I think that goes to the
concerns that the public understandably has about this disease.
Thank you, Doctor, for your work and your testimony.
Dr. Inglesby. Agree. Thank you.
Senator Hassan. Thank you, Mr. Chair, for this hearing.
Chairman Johnson. Thanks, Senator Hassan.
We do not have a Republican teed up. What I would like to
do is I see three witnesses with their hands kind of up, if
they want to say something. So I will give them each a shot. I
would appreciate succinctness before we go to Senator Rosen.
We will start with Dr. Atlas. Then we will go to Mr. Roy
and then to Dr. Katz. Dr. Atlas.
Dr. Atlas. Great. Thank you for allowing that.
Just a couple of points of clarification, and these are
things that keep being repeated, but they are just
misconceptions.
Senator Romney said that the curves are not coming down
because the number of cases are actually going up in certain
States. That is really not a curve to really watch at this
point. We know that the more testing we do, the more cases we
have. That is not a relevant curve. That was never a direct
goal of the policy. The only curves that count are the number
of hospitalizations per day and the number of deaths per day,
not the number of cases.
Second point that again really needs to be clarified, there
is somehow a false narrative that is being perpetrated that the
people who do not want to total lockdown are saying there
should be wide-open economic--and the isolation. That is
actually not true. No one here is saying that. I do not know
anyone who believes that. Everything is about targeted,
protecting the at-risk people and allowing people to get out
who are not in those groups, particularly so that we can
increase herd immunity.
And then one more point, if I can, about testing. The role
of testing is important, but it is very different at various
time points in a pandemic. The role of testing in the beginning
for South Korea and the urgent needs were very different than
it is right now, especially for contact tracing. We have tens
of millions of people who have had the infection here. Contact
tracing, that seems sort of absurd to me unless it is for
preparation of the next pandemic.
And then the final point, we keep discarding the massive
harms. We are killing people with total isolation and lockdown.
I do not know how many times this has to be said, but hundreds
of thousands of people have serious diseases that are not being
treated and not just that the economics alone is causing a
massive catastrophe that is, in terms of health and poverty,
throughout the world, because many economies are linked, in
fact, the whole world for those in the United States and the
western world.
Thank you.
Chairman Johnson. Thank you, Dr. Atlas.
By the way, is it Mr. Roy or Doctor? I do not want to----
Mr. Roy. Mr. Roy is fine. That is fine. Thank you very
much, Senator.
Chairman Johnson. How about Avik?
Mr. Roy. Yeah, that works.
Chairman Johnson. Mr. Roy, go ahead.
Mr. Roy. So, similarly, I want to clarify a couple things.
First, quickly, Senator Romney, I think, misunderstood my
comments of comparing to other types of fatalities. I was not
comparing to the flu. COVID-19 is clearly more serious than the
flu, especially for people over 65 and those with
cardiovascular chronic disease.
My point was to analogize to traffic fatalities and
hospital-acquired infections to say we do not shut down
hospitals because 100,000 people die of hospital-acquired
infections. We try to manage and mitigate and reduce those
deaths. Similarly, with traffic fatalities, we have a whole
regulatory system in place and impress upon people they need to
be responsible. Those kinds of tools can be relevant here, just
as they were in the East Asian countries that recovered from
SARS in 2003.
I want to make one other comment about the testing
discussion we were just having.
It is very important. I think a lot of people are under a
false impression about just if we have X number of tests, then
everything is going to be fine. We have to remember that
antibody-based testing or serology testing does not generally
measure an active infection. The antibodies only generate in a
patient 3 weeks or 4 weeks after they have been infected.
So for testing the population to see if they have been
infected or they have a current infection, it is not going to
work, and the deoxyribonucleic acid (DNA) or viral ribonucleic
acid (RNA)-based testing, Reverse Transciption Polymerase Chain
Reaction (RT-PCR) tests, those are much more invasive at the
moment, much more cumbersome, and very difficult to scale up.
So when we talk about the number of testing, I think it is
unrealistic to expect massive population-wide testing, and
people who are interested in more details about that, we can
either get into it in this hearing, or you can review the
freopp.org paper I mentioned earlier, where we delve into this
topic at length.
Chairman Johnson. Thank you, Mr. Roy. Dr. Katz.
Dr. Katz. Thank you, Senator.
I also wanted to comment on testing, which I have seen up
close and personal in the emergency department, and it is
cumbersome. One of the issues we have to overcome is the
unreliability of a lot of the tests we are using. There still
is a high false-negative rate.
But it does seem to me we are setting up a Catch-22 if any
semblance of return to normalcy is predicated on a number of
tests we know we cannot do and will not be able to do for the
foreseeable future.
I think we need to ask ourselves what do we need the data
for. We want to know what percent of the population is likely
to get this infection. Is it everybody who is exposed, or is it
one in five? So far, it really looks to be one in five on Navy
ships, on cruise ships, and contained populations.
Of the group that gets this, how many develop symptoms? Of
those, how many need to be hospitalized? Of those, how many are
likely to need the ICU? Of those, how many are at risk of
dying? On the basis of what antecedent risk factors? How does
that shift with the presence or absence of hypertension,
coronary disease, type 2 diabetes, body mass index (BMI), and
those factors?
When we think about the utility of data, we really are not
bogged down with testing millions of people. We need a
representative random sample large enough to give us that
actionable information. That is much more doable. We have the
resources to do it now. It is proximal. It is the work of
several days, and if the goal of getting data is not just to
say look how much data we have, but look what we now understand
to inform policy, representative random sampling will do.
The other thing I wanted to say is that there is an
alternative to contact tracing, and that is to say we identify
people at higher risk, and we carefully protect them from
exposure to the virus. People at low risk, we actually expect
the virus to circulate. So contact tracing in that group almost
defeats the purpose of saying low-risk people, if we are ever
going to get our lives back and not be on the indefinite
timeline of maybe there will be a highly effective vaccine mass
produced, we actually need the virus to circulate among people
who can safely get it, get over it, make antibodies, which
historically, before the advent of highly effective vaccines,
it was how pandemics ended. Immunity developed.
But what we can do now artfully is say there are people who
cannot safely get through this infection, we will protect them.
There are people who can. They can go back to the world. I
think contact tracing at scale in that group is not likely to
be helpful, and I think we should do better than contact
tracing for the high-risk people over 70, people over 80,
people with a large burden of chronic disease. We need to
double down on protecting them so they are not exposed, until
we can document with ongoing at least random sampling, that
viral transmission is near zero, and a high level of protective
immunity has been achieved, and then basically everybody's
grandparents can hug their grandchildren safely again.
Chairman Johnson. OK. Thank you, Dr. Katz.
I feel bad because I lost Senator Rosen. I know Senator
Sinema is available. So, Senator Sinema, why do not you go, and
then I see Dr. Inglesby as well as Dr. Kory have some points to
make. But let us go to Senator Sinema first.
OPENING STATEMENT OF SENATOR SINEMA
Senator Sinema. Thank you so much, Senator Johnson. Can you
all hear me fine?
Chairman Johnson. We can.
Senator Sinema. Great. So thank you, Chairman Johnson and
to Ranking Member Peters, for holding today's roundtable and
for everyone's flexibility during this time of coronavirus.
We have made some hard-fought progress in my home State of
Arizona in flattening the curve by adhering to social
distancing and other guidance from the CDC. It has not been
easy, of course, and everyone has made sacrifices. I do not
want those actions to be in vain by reopening too quickly and
triggering a second surge of cases that will further harm our
hospitals and our economy.
As you all may know, Arizona ranks dead last in the Nation
in terms of coronavirus tests administered per capital. This is
from the latest data from the Kaiser Family Foundation that
ranked all 50 States and Washington, DC. They found Arizona was
51st in the Nation. So the data clearly shows that Arizona has
work to do before it is safe to get back to normal, and public
messages need to reflect that.
Ensuring Arizonans have the information they need to safe
is my highest priority, but too many Americans are still
confused about what is best practices to keep themselves and
their families safe.
We have already lost too many lives, and I have serious
concerns based on consistent data and analysis from the CDC's
infectious disease experts that opening too quickly or
softening social distancing without a better understanding of
the prevalence of the virus will lead to spikes in infections
and deaths.
We want the economy to open as quickly and safely as
possible, but in my regular calls with mayors, county
officials, health care providers, and small business owners, I
hear directly from Arizonans who want to reopen and get back to
normal. But they want to do it safe, and they want to do it
smart. Moving too quickly or taking on too much risk could lead
to a resurgence of the virus, a greater loss of life, and
longer-lasting economic harm.
So I have heard from business leaders that continually
reopening and closing the economy could be an economic disaster
for them. So we have a long way to go to get through this
crisis, and I know that if we are safe and smart, we can bounce
back from this.
So I hope that this Committee will also consider a future
hearing when it is safe to do so with relevant members of the
White House Coronavirus Task Force to provide oversight over
our Federal response as well.
So, with that, I have a couple of questions for Dr.
Inglesby. The administration has included contact tracing as
one of the critical components involved in safely and slowly
reopening localities following the guidance of infectious
disease experts. How can States determine if their contact
tracking model is robust enough to move forward with what is
commonly known as Phase two, when a community is shifting away
from slowing the spread and into opening and public places
reopening?
Dr. Inglesby. So one measure is just the measure of contact
tracers per population, and I think, in general, at this point,
it seems like with early stage, the numbers of contact tracers
per 10,000 people is somewhere in the order of one, two, or
three contact tracers per 10,000 people. That seems to be a
growing consensus around that. We do not have evidence around
that, but it seems consistent with other efforts in other parts
of the world which have been successful around contact tracing.
The second thing is for a State to be able to say can our
State actually trace--can we isolate the people that are
getting sick on a given day, and can we trace those contacts,
in many States in the country, there are numbers that are low
enough for--starting today if a contact tracing effort began,
they would be able to isolate those cases and trace their
contacts and put them in quarantine.
So while we have to acknowledge the stuff that has gone on
before, those people are out there in the community, starting
now we could begin to trace and isolate those contacts.
But there are some States in the country where the numbers
are so high, and the number of contact tracers is so low that
there would be no chance of trying to be able to identify and
trace contacts and get them in quarantine. So, partly, it is a
function of the size of the State and the number of cases that
they have. If they have many cases on a given day, then they
are going to have more challenges. If they have few cases, then
their contact tracing force on hand may be able to cope with
that as they hire others.
Senator Sinema. So a follow-up question on contact tracing,
as you know, in Arizona, the hardest-hit community we have is
the Navajo Nation where technology and access to technology and
broadband can be very difficult to rely on. So apps or phone
calls may not work effectively in those communities. What
should contact tracers do, and how can they do it effectively
to help reduce the spread and hopefully contain before a second
wave comes for the Navajo Nation?
Dr. Inglesby. Yes. I think that is particularly important
because my understanding is that in the town of Gallup, outside
Navajo Nation, it is a new hotspot. It shows that hotspots can
arise in places that are not kind of traditional major urban
centers. It sounds like a really serious situation.
I have also heard that Navajo Nation is having a lot of
difficulty getting diagnostic tests and has really appealed to
the administration to get more testing. So I hope that can
happen soon.
I think for places without access to high technology, human
capital really is the most important thing in contact tracing,
people who can call people up, understand who their contacts
were, call them back the next day, make sure things are going
well, make sure they have not developed symptoms, make sure
they understand what is going on.
So even before we had any technology, contact tracing has
been part of public health for a long time. It has not been
needed on this scale ever in this country, but I think if we
get the right people in place and do kind of relatively just-
in-time training for those people, that can make an enormous
difference. And then it can be supplemented by technology.
Senator Sinema. Oh, I appreciate that.
A follow-up question for you. You are trained as an
infectious disease physician, and you are still seeing patients
at a clinic. So my question for you is, How does your training
in your practice impact how you approach the testing, modeling,
and development of strategies for reopening?
Again, I am concerned because Arizona is 51st in the Nation
in terms of testing per capita. How do you see your approach as
different from that of an economist or other medical
professionals?
Dr. Inglesby. It is hard for me to speak about the
perspectives of others, but I will tell you from our
perspective in our center and what I do, there has been a lot
of development of diagnostic strategy within the hospital
system. Hospitals very much need to know and want to know the
status of a person that is coming in the front door. They want
to know the status of all the people that are being treated as
outpatients.
We need to know if someone in our clinic has a fever. It is
not enough for us to know right now that they have a fever. We
need to know whether they have COVID. We need to know what the
threshold is for them coming into the hospital. People with
COVID can deteriorate quickly. So we need to know how they are
doing at home. We check in with them over time. So our hospital
system has developed kind of a sophisticated layered way of
making sure that its patients when they get sick are able to
get tested, and that is really important for everyone who has
COVID symptoms.
Senator Sinema. Thank you.
Thank you, Mr. Chairman.
Chairman Johnson. Thanks, Senator Sinema.
I am looking at our participant sheet here, and it looks
like it is just me and our witnesses. I want to thank, first of
all, all the witnesses for hanging in there. I really
appreciate it. This is, I am sure, longer than we all thought
this was going to go.
I am going to have three questions. One is going to be
directed to Dr. Kory. Two, I am going to ask all of you to get
rid of your little hand signals there because I am going to ask
you to put up your hand if you think you can really excellently
answer the two questions, and then I am going to give all of
you, in reverse order of original testimony, a chance to either
refute something or just whatever is on your mind in terms of
the last thing you want to say.
Let me start with Dr. Kory. I have been advocating quite
some time publicly to really allow doctors to be doctors, to
allow them to practice medicine, to explore different theories
of the case, different therapies, and certainly, what you are
doing into--once patients have been hospitalized.
Certainly, I have been trying to find, whether it is
hydroxychloroquine--I noticed in your testimony, you are
talking about potential benefits of that, once we have the
studies on it. But that looks like it is only effective maybe
in the first 5 days of symptoms, probably even before a test
comes back.
You are talking about a therapy that once people are ill,
to present themselves to a hospital. That is the problem.
Can you just kind of speak to the different stages of this
disease, the different types of techniques, what will work
early, what will not work very late? Just quickly address that.
Dr. Kory. Absolutely. I am really glad you brought this
point. I have listened through the whole discussion. I
understand this multifaceted parts of this disease in this
epidemic, and I appreciate my colleagues. I am not in my league
when we are talking about testing and opening the economy and
social distancing. That is not what I do.
I know how to treat severe illness. Let us talk about that.
So what we understand about this disease, this is what we
experts--is that there are two phases. One is the viral
replicative phase, which is really in the outpatient. Those are
those first symptoms of sore throat when the virus invades the
soft tissues of the head and neck, where you get maybe some
fevers. You do not feel well, and most of those patients
actually do OK. If somehow this virus triggers this
hyperinflammatory response when you go into organ failure or
multi-organ failure, that is when you come to the hospital, and
that is where I am an expert.
What we know about antiviral therapies and vaccines is that
they are most effective early on in the disease. So things like
hydroxychloroquine, which is purportedly an antiviral
medication, should be given in the outpatient setting, in the
early days of symptoms. It is not a hospital drug. I have seen
too many patients dying on hydroxychloroquine in the hospital.
The idea that you should wait until they come and they fall so
ill in the hospital, to me as a physician, does not make any
sense.
Remdesivir is the same thing. Why would you give it if the
patients are already in the hospital who are in severe stages
of disease? We have to understand this as two stages.
So the early part, where you talk about vaccines,
hydroxychloroquine or remdesivir, that should be focused in the
outpatient setting. Come to me. I am a hospital doctor. Once
you come to me, it is the hyperinflammatory phase.
We are talking about cytokine storm, multi-organ
dysfunction, and that is why I try to talk about the fact that
we really need powerful anti-inflammatory and anti-coagulant
drugs, and if we employ them early and systematically, I really
believe we are going to change the trajectory of the massive
morbidity and mortality that we are seeing.
I understand all the public health experts, and I
understand the impacts on the economy and how to manage all
that. That is way out of my lane.
When you come to me in the hospital, I want to try to keep
you alive. I want to prevent death, and I want to prevent the
massive uptake of ventilator and ICU resources. I know I can do
that, but you need to come to me. And I need to be able to use
these medicines early and powerfully. I do what I do. I mean, I
live in ICUs, and I want to take care of critically ill
patients.
Chairman Johnson. We will come back to you.
So two, hopefully, quick questions, and again, get rid of
your little hand because I want the person who really thinks
they can answer this.
New York City. What was so unique about New York City? Why
did it explode so much?
I saw Mr. Roy raise his hand right off the bat there. Mr.
Roy?
Mr. Roy. Yes. Senator, we, of course, do not know for sure,
but we have evidence about two things. One, a group of
economists at Massachusetts Institute of Technology (MIT)
traced subway stations in New York City to certain ZIP codes
where there were outbreaks, and they found a high correlation.
So there appears to be a lot of correlation between the use of
the New York City subway system to outbreaks of COVID-19.
The other piece that is really important in New York State,
which affects New York City as well, of course, is New York
State and New Jersey both had policies of requiring that
nursing homes accept patients who were discharged from the
hospital with COVID-19, even if they still might have an active
infection, and that may have contributed to the outbreak of
COVID-19 in nursing homes in those States.
Chairman Johnson. OK. So I will take that as the answer.
Again, if you want to refute that, the very last stage of
questions.
The last one is the stated policy of all these economic
shutdowns and safer-at-home policies, that type of thing, was
to flatten the curve so we do not overwhelm our health care
system, but in flattening the curve, is there any guarantee
that it will actually reduce the ultimate number of infections
or ultimate number of deaths, barring a cure?
Anybody want to really take that one?
Dr. Katz. Yes. Senator, I am happy to address that.
I think in our discussion, I mentioned that I have been
privileged to work with a number of experts in mathematical
modeling, and in particular, I can cite a paper by Maria
Chikina at the University of Pittsburgh and Wes Pegden at
Carnegie Mellon. They work collaboratively and published a pop
culture piece calling for honesty in pandemic modeling.
The problem with an interdiction strategy that starts and
ends with flattening the curve is you can never stop. Everybody
has been kept away from the virus. Everybody has been
sheltering in place. Nobody has immunity.
So if there is any level of viral circulation, asymptomatic
carriers, for example, everyone remains vulnerable. The minute
you release those clamps, you get the spike you thought you had
prevented. You just make it happen on a different day.
So flattening the curve makes good sense while you devise a
strategy for the next phase, and again, I think most of us
collectively are arguing for that transition to a phase where
we risk stratify, get better data, identify who is at risk,
protect them, but allow for viral circulation in the portion of
the population at very low risk of needing a hospital bed or
getting very sick.
But if all you do is flatten the curve, you can never stop.
You can never stop until for some reason that you do not
necessarily understand, seasonality, the virus goes away, maybe
to come back, or you not only have a highly effective vaccine,
but mass produce it and give it to everybody, or you have to
allow the virus to circulate, and those who can safely get
through it develop their immunity. But that is the problem with
flattening the curve.
Absolutely a critical tactic to avoid overwhelming a
medical system at a given placed in a given time, but it really
can only be phase one of a multiphase plan.
Chairman Johnson. OK. I am glad to see Senator Rosen came
back. I will switch it over to you, Senator Rosen, and then
when we close out the hearing, anybody wants to stick around, I
will go in reverse order. You can make your closing comment.
Senator Rosen.
OPENING STATEMENT OF SENATOR ROSEN
Senator Rosen. Thank you for having this hearing.
I want to thank the witnesses for being here today.
I do want to mention before my questions that Senator Rubio
and I have requested a longitudinal study on COVID from NIH and
CDC, a 10-year study to be reported initially every 3 months, 6
months going forward. I do believe that that will help us. That
data will point us in some direction as to what policies work
and where we might need to fund or put our efforts going
forward. Data is very important, and I hope to be doing some
more studies. I think the data matters and can really, like I
said, point us in the right way to a policy and legislation.
But today I want to talk about worker safety. Dr. Inglesby,
I want to ask you a question in your capacity as someone on a
recovery team. You are charged with helping the Governor reopen
the economy of a State. A big part of reopening, of course, is
the workers returning to their physical workspaces.
So, in Nevada, we are known, of course, for a hospitality
industry, from Lake Tahoe to Lake Mead, Reno, Las Vegas,
hotels, gaming, entertainment, outdoor tourism, everything in
between. Our hospitality workers cannot do their jobs remotely.
They are all so eager to go back to work, and some are
concerned that they might put their families at risk if they do
return.
So what can you recommend to the hospitality industry,
which is a huge portion of Nevada's base, as they reopen slowly
in the coming months? What are our best practices for hotel
rooms? And we want to protect our workers and our tourists that
come. So how do we balance that, customer safety and employee
safety? Because we want everyone to come back and enjoy Las
Vegas and Reno, their conventions and vacations.
Dr. Inglesby. Yes. I think the tourism industry is probably
one of the most challenging industries to consider as we think
about reopening, given the density of many of the activities
and the closeness of people interacting.
My understanding is that the travel industry is really also
seeking lots of guidance from the Federal Government about what
would be the most safe practices. I think those practices will
include things like trying to increase spacing in places where
people are gathering, which will be difficult, especially in
many of the settings that you just mentioned.
They will talk about hotel rooms and things like that.
Terminal cleaning of hotel rooms, that is much more intense
than you might have considered before, giving employees
personal protective equipment where relevant. It is one thing
to consider the customer that is coming into a facility, but I
think the experience of the workers there, where they are
actually on the receiving end of lots of interaction, I think
they have special concerns about not getting infected on their
jobs.
And then information to employees in languages that they
speak in so they understand the low bar, where they have a
range of symptoms that could be COVID and getting very early
medical intervention and the possibility of including testing
in some of this, the regime, or the workplace, either return to
work or regular testing on the job to make sure, to give people
confidence in those workforces, that there are not people who
are sick at work.
I think I hear many employers asking about the possibility
of testing in those settings, so that combination of things.
And then I think that it will be useful for that industry
to have guidance from the Federal Government that they can lean
against and say to both their customers and to their own
employees, ``We have done what the government believes is the
most safe as we have reopened.''
Senator Rosen. Thank you. That was actually my next
question. What role does the Federal Government--because we
have so many of our companies, they want a clear standard for
everyone to kind of follow as best they can, at least a broad
standard. So I think that is our role, and it is really
important that we have that, basic standards to meet.
We have also been focused, of course, in Nevada, not just
our tourism and the Las Vegas Strip and Reno, but we have a
booming outdoor tourism, if you have been to our mountains and
Lake Tahoe and Lake Mead, skiing, hiking, and biking. But
indoors is one thing for our hotels and conventions, but what
do we do about our outdoor tourism or even our restaurants,
things that can move outdoors with natural ventilation and no
enclosed spaces? What kind of protections or guidance do you
think we need there? Of course, it is going to be a little bit
different. I want to be able to speak to our businesses that
are in that outdoor recreation space as well. What can you tell
me that you think we need to do there, kind of direction?
Dr. Inglesby. I think what we know so far from studies,
especially studies from China but other places as well, is that
outdoor infections are much less common than indoor infections
with COVID. So outdoor spaces will be safer and will have less
risk than----
Senator Rosen. You mean just the mask----
Dr. Inglesby. Yes, when people are in close proximity, then
masking is important, but then keeping people's space, if
possible, when they are outside together, unless they are with
people that they live with, that would be a safe practice that
people could probably do in many of the outdoor environments
that you are talking about.
Senator Rosen. Thank you.
I think I have one more question for you on therapeutics
and testing. Would you discuss in just the short time we have
left what markers we need to reach regarding effective COVID--
effective therapeutics that are widely available to treat the
more serious cases before we are ready to fully lift those
stay-at-home orders?
A lot of the people that I talk to, whether they are
business owners, friends, family members, members of my church,
community, they do not feel safe to go back out because they
are worried that there is not any treatment for them. They are
not thinking even about a vaccine, that if I go, there is no
treatment to make me better. So can you talk a little more
broadly about the markers we might need to reach on that, on
therapeutics before people can feel safe?
Dr. Inglesby. Yes. Unfortunately, I think it is going to be
difficult to get to those markers sometimes soon.
I think there are a number of therapies that are in
development, and they should be studied. I think there are very
sophisticated trials going on around the country and people
working on those issues with NIH and independently, but I do
not see--even remdesivir, which did have a promising result, it
is not going to make them sick. It is going to make them get
out of the intensive care unit perhaps a bit more quickly, but
we do not have a medicine that is close on the horizon that is
kind of a cure-all.
So I think for people who are at high-risk----
Senator Rosen. Right.
Dr. Inglesby [continuing]. Older people, people with
underlying conditions, at this point, if there is community
spread in their community--and many places in the country,
there are and do continue to be number of cases in those States
or those communities--then I think there is a level of risk to
being out and interacting.
There are places in the country where the numbers have come
down very low, and that would be different in those places, but
I think for people in communities where there is community
spread, I do not think we are going to have a therapeutic
solution anytime soon.
I hope we do, and there are things that are being studied,
but I do not think that should be probably a marker for
reopening broadly, because I do not know that we are going to
get there.
Senator Rosen. Thank you. I appreciate your time.
Chairman Johnson. Thank you, Senator Rosen. Sorry we missed
you your first time around.
Here will be the final round. We will go in reverse order.
I would ask you to keep your comment relatively succinct, if
you can do it in a minute. I will interrupt you probably around
the 2-minute mark, but try and be respectful for the other
witnesses' time.
Again, I just want to thank all of you. You have hung in
there. You have been incredibly patient. I have warned you all,
this would be frustrating, but again, this was, I think,
incredibly valuable testimony from everybody.
So we will start with Dr. Atlas.
Dr. Atlas. Yes. Thank you for allowing me to participate.
I just want to make sure everybody understands we are not
at the same place we were when this all started. We have
learned a tremendous amount. We have a tremendous amount of
evidence. We do not need at this point to start doubling down
on hypothetical models because we have empirical data. We have
decades of established medical knowledge, and now we use logic
applying the data. We know who to protect. We know who is not
at risk for hospitalization and who is, and we need to make
those protections very strong while making sure we are not
interfering with the actual pathway to establishing population
immunity and safety. And that is the idea of allowing low-risk
groups to set up these immune-based population immunity result
of so-called ``herd immunity.''
There are artificial barriers being set up that are
obstacles for allowing ending the massive destruction from
total isolation. We really need to be very cognizant of that. A
strategy of stopping COVID-19 infection is not an appropriate
strategy.
Chairman Johnson. Thank you, Dr. Atlas. Dr. Ioannidis.
Dr. Ioannidis. To be at this hearing, I really feel that I
learned a lot hearing my colleagues and also getting some
excellent questions from Senators.
We need to realize, as Dr. Atlas said, that this is a
crisis that we have almost gone through at least for this
season, and even though we lost many lives, we have every
reason to be optimistic.
We know very well who are the people and what are the
settings that we need to protect. We can reassure the vast
majority of the American population that their risk is
extremely low in the range of other activities that they do
routinely every day, like driving a car. They do not even give
it a thought, a second thought, of whether they should do it or
not.
At the same time, we know where are the devastating
settings. We know that nursing homes, we know that hospitals
with nosocomial infection, we know that particular occupations
are susceptible to outbreaks, and we know how to protect them.
We know how to focus our efforts in securing a safe environment
in these places and not allowing major outbreaks to happen.
I am pretty optimistic that we need to move forward with
relieving shelter-in-place orders and lockdowns, because
currently, the risk-benefit balance is clearly against our
continuation, even if we get a resurgence of a second wave, by
lifting some of the measures.
We need to try with science, with continuous feedback of
information on incidence and prevalence and bed capacity, but
hopefully, we will do very well. And if one of our steps is not
the one that we should take, we can always backtrack and
correct it.
Chairman Johnson. Thank you, Dr. Ioannidis. Mr. Roy.
Mr. Roy. Thank you, Mr. Chairman, again for having us all
here.
I want to emphasize that the detailed version of our plan
is at freopp.org. I am more than happy to brief any Members of
this Committee or staff on some of the recommendations we have
for Congress on how to reopen the economy.
A question that came up at an earlier part of the hearing
was why is it that New Zealand and South Korea and some of
these other countries have done well. I want to emphasize this.
They have very disparate or heterogeneous reactions from a
policy standpoint, very different health care system. The
common element in all those Pacific Rim countries is they dealt
with SARS-CoV-1 in 2003, and that meant the populations as well
as the policymakers knew how to react to this serious threat in
a way that those of us in the West did not. And I think that
made the biggest difference in their ability to get out in
front of SARS-CoV-2 and COVID-19 in a way that I think a lot of
us have not appreciated.
And that leads to this point about the second wave. There
is a lot of talk about a second wave. We should remember that
there was no second wave with SARS-CoV-1. SARS-CoV-1 happened,
and then it flamed out. Those economies re-bounced or bounced
back in about 6 months. People still remained scared and alert
and wore masks to work when they had got sick, but life
eventually did return to normal without massive testing
regimes, without a cure or a vaccine.
I will mention Sweden very quickly. Sweden is a model that
I think we should look at more closely. The one thing that we
can improve on relative to Sweden, though, is they did not do a
good job of protecting their nursing homes. A lot of their
deaths proportionately have happened in nursing homes. We can
do a lot to restrict visitations and make sure that staff stay
local within a particular nursing home. Do not go to multiple
nursing homes and spread disease that way.
Finally, I want to mention the fiscal crisis. We have not
talked about the fiscal crisis at all that has come out of the
economic crisis. We have spent about $4 trillion and increased
the debt. As you all know, that is a huge long-term national
security problem along with everything else that a fiscal
crisis can be. That is what increases the urgency of getting
the economy back in place because the more we accelerate our
fiscal crisis, the more long-term problems we have across all
the things that Congress has to think about.
Thank you again very much.
Chairman Johnson. Thank you, Mr. Roy. Dr. Inglesby.
Dr. Inglesby. Yes. First of all, thank you so much for
having me today. I have really appreciated this discussion.
A couple of points. The first is that there has been some
discussion about how this disease might be already widely
prevalent in the United States. I do not agree with that. I do
not think we have evidence for that yet. It may prove to be the
case, but at this point, I think the evidence is more
consistent with single-digit prevalence in the United States.
And that relates to the second point, which is it seems
like some of the other witnesses are encouraging us to move
toward a herd immunity strategy, and I just want to lodge my
disagreement with that strategy. I think it is pretty clear
that we need to get up to 60 to 70 percent or more of the
population to begin to develop herd immunity. That is a long
way from where we are now, which may be as low as 3 or 4
percent in much of the country.
We have had 70,000 deaths from this disease with
seroprevalence, which I believe is low. We will find out when
studies get better. So I do not agree with that, and I think
that would be dangerous.
I think it is also dangerous to say that young people are
at zero risk with this disease. It is true they are at much
lower risk, but we are seeing young people get strokes in New
York City. We do see some young people that are quite ill from
this. I am not saying it is a grave threat as compared to other
threats, but it is also not correct to say that there is zero
risk to young people.
Then the other thing people have been talking about is
whether there will be a new wave or not. We are already still
in the middle of a rise in cases in this country, and I do not
think it will be the fall before we have further undulations of
cases across the country. I think we are at risk of having
small waves throughout the summer. I do not see any evidence
yet that there will be major seasonal change. I hope there is,
but we have not had strong evidence of that. So I think we
should be prepared for recurrence of cases in the summertime,
right now, as people begin to do social distancing changes.
I am in favor of easing social distancing carefully in
places which are ready for that, but in general, I do not think
there will be a normal economy when people feel and see that
cases are rising around them until they feel like there is
control of this epidemic. And I think the way to get control is
through diagnostics, hospital capacity, and contact tracing.
Chairman Johnson. Thank you, Dr. Inglesby. Thank you. Dr.
Katz.
Dr. Katz. Senator, thank you so much for including me. I
have appreciated listening to the questions, listening to my
colleagues.
I think there is a lot of agreement. In particular, I think
we would all agree we do want to minimize the total harms of
this, even if there are some disagreements so far based on the
best ways of doing that.
We have also posted a lot of materials online at my
nonprofit, truehealthinitiative.org. We have risk models. We
have arguments there for this total harm and immunization
approach, and I think it allows for a range of opinions about
what is the best way to get there.
I largely agree with my colleagues that we have the needed
information to risk stratify the population, but I would argue
it is crude risk stratification at this point. We know elderly
people with chronic disease are at high risk. We know young
healthy people are at lower risk.
But is a 40-year-old with mild obesity or mild hypertension
at higher or lower risk than a 50-year-old without those
conditions? There are a lot of combinations where I think we
really do need representative random sampling.
So a particular plea to you in your capacity as Chair of
this Committee that the Federal Government implement a policy
of representative random sampling. We do not need millions of
tests. Let us do 50,000 tests, but let us make sure we do them
in a population that represents all of the United States.
Second thing is we do need a health promotion campaign
because we cannot modify age, we cannot modify sex, but we can
modify many of the chronic disease risk factors and many of the
lifestyle practices that are influencing the acute risk for
COVID. So these chronic liabilities that really were a huge
drag on health and vitality and, for that matter, the economy
in America there were all along are now an acute threat as
well.
And I think part of the return-to-normalcy policy ought to
be we are going to help everybody get healthier, so you
actually come out of this stronger. There is an acute benefit.
There is a lasting benefit.
So those two requests really for the Federal Government,
representative random sampling so we are flying through a less
dense fog and a nationally coordinated focus on helping to
alleviate the burden of chronic disease that is now an acute
liability too.
Chairman Johnson. Thank you, Dr. Katz.
Before we go to our final witness, I just want to point
out, I was the guy that Championed Public Law 115-176, Trickett
Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina
Right To Try Act of 2017. I am a big believer in letting
doctors be doctors to practice medicine. There is nothing that
is universal, and certainly, in this case, one of the reasons I
have been pushing that so hard is an effective therapy, an
effective cure will break the back of this disease almost
overnight. It will end the economic crisis.
So that is why I really did invite Dr. Kory because I was
very encouraged by the work he and his colleagues were doing
once people became hospitalized, but again, I really want to
make sure that we are also pushing the envelope, allowing
doctors to prescribe off label. Let us not restrict their use.
It is what we have done with hydroxychloroquine. Again, I do
not know it is going to, for sure, work. There is an awful lot
of anecdotal evidence.
But, again, I really want to make sure that we continue to
support doctors like Dr. Kory and others that are, again,
practicing medicine, exploring different theories of this case.
The sooner we can end up with the effective therapy or a cure,
again, we break the back of this disease, this crisis, this
horror almost overnight.
So, again, I will turn it over to you, Dr. Kory. Give us a
little bit more hope, and keep practicing medicine.
Dr. Kory. Yes. No. Thank you, Senator Johnson, and you and
I have an affinity on this. I totally agree the gloves need to
come off.
This disease is wicked. I get confused when people are
comparing this to the flu. I have been a doctor in an ICU for
15 years. There is nothing like this disease. Let us stop
comparing it to other ones.
I have patients filling ICUs with fibrotic lung disease who
I cannot ventilate without deep sedation and paralytics because
their lungs are destroyed. This is not what the influenza does.
This is a completely different disease in the sense that its
acuity, its severity, and its rapidity is unlike any other that
I have seen.
It does not mean I cannot handle it. I know I can treat
this, but you have to let me do it. We have to get it earlier.
My problem is that everybody looks at the ICU doctors to
solve this. It is not the ICU doctors. We just need to move
more powerful therapies a little farther out. We need to get it
in the emergency department (ED) and the hospital wards.
I promise you, we can avert this tragedy of fibrotic lung
disease and ventilators. I know we can do it. We need to have a
much more robust treatment strategy.
The other issue, I have to say I totally agree with Dr.
Inglesby. Again, I do not want to be outside of my lane, but
the prevalence in this her immunity stuff, I do not know about
that. That is not what I am an expert at. I get the whole thing
about balancing between saving lives and continuing life, which
is an economic activity and financial activity and all of that.
I do not really know the answer to that.
But I really do believe that if we can find effective
solutions to prevent the deadliness of this disease, it would
mitigate and it would help everything else, and that is what I
am just trying to promote. I think we can do this. We have
effective therapies. I am getting increasing reports of really
good responses to treatments.
And like you said, Senator, we just need to be able to
treat these things. Everybody has to stop thinking that we need
to do everything in randomized control trials and this is
experimental and dangerous. We know what we do. I do not know.
If we come up with an effective medical therapy, this would
mitigate a lot of the harms of everything that you guys are
talking about, which is opening or closing or not--which I just
got to say I am a doctor. I work in a hospital, and I really
believe that the world needs to think about and the health
societies need to think about what they are proposing for
treatment. I really think we got this wrong.
We have to be stronger, hit harder, faster, and earlier,
and we will do better. This will change the economy. That is
all I am saying as a doctor.
Chairman Johnson. Listen, I appreciate that. I am so afraid
that we are letting the bureaucracy--and, again, these are good
people that are trying to do the right thing. They want to have
safe drugs, but----
Dr. Kory. I agree.
Chairman Johnson [continuing]. We have safe drugs. Let
doctors practice medicine and use off label, explore different
theories of the case, develop that therapy, and to me, that is
the solution.
Dr. Kory. I agree.
Chairman Johnson. It will be available, hopefully, far
sooner than a vaccine, which may never come, which has also
been brought up in testimony.
So, again, I want to thank all of you for your patience,
for your testimony, for what you are doing, for being a doctor,
for saving lives. God bless all of you.
The record will remain open for 15 days until May 21 at 5
p.m. for the submission of statements and questions for the
record.
This roundtable is adjourned. God bless all of you. Take
care.
[Whereupon, at 4:59 p.m., the Committee was adjourned.]
A P P E N D I X
----------
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
EVALUATING THE FEDERAL GOVERNMENT'S
PROCUREMENT AND DISTRIBUTION
STRATEGIES IN RESPONSE TO THE COVID-19 PANDEMIC
----------
TUESDAY, JUNE 9, 2020
U.S. Senate,
Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 10 a.m., in room
SD-562, Dirksen Senate Office Building, Hon. Ron Johnson,
Chairman of the Committee, presiding.
Present: Senators Johnson, Portman, Lankford, Romney,
Scott, Hawley, Peters, Carper, Hassan, Harris, Sinema, and
Rosen.
OPENING STATEMENT OF CHAIRMAN JOHNSON
Chairman Johnson. Good morning. This hearing will come to
order.
I want to thank our witnesses, Admiral Brett Giroir,
Administrator Peter Gaynor, and Rear Admiral John Polowczyk,
first of all, for your service to this Nation. Also, I think on
behalf of the Committee, if you can thank the men and women
that have worked with you in this, what I think is a pretty
tremendous effort, trying to deal with an overwhelming
situation. I think as a Nation we all need to be very grateful
for all your efforts. I realize you probably have not had too
many days off much less hours off, pretty much dealing with
this 24/7, and I really truly do appreciate that.
I want to ask for consent to have my written statement
entered in the record,\1\ and I just want to go through just a
couple facts, a little timeline here, just to kind of lay out
really how extraordinary and overwhelming this effort has been.
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Johnson appears in the
Appendix on page 631.
---------------------------------------------------------------------------
But back on January 21st, not that long ago, we had the
first case reported of coronavirus disease 2019 (COVID-19).
Eight days later, on January 29th, the administration
established the Coronavirus Task Force. At that point in time,
we only had five cases, zero deaths. From my standpoint, I am
thinking that is pretty forward-looking.
Two days later, President Trump announced travel
restrictions on China. That was not a very popular decision,
but as Dr. Fauci said, that probably saved many lives and
certainly bought us time to be able to flatten the curve to
hopefully save additional lives.
Ten days later, on February 10th, the Federal Emergency
Management Agency (FEMA) began assisting the Department of
Health and Human Services (HHS). At that point in time, there
were 12 cases, still zero deaths. Again, I would think that is
pretty forward-looking. February 10th, FEMA is already
recognizing this is going to be a real problem here and
providing the types of expertise and capability that really
only FEMA has in support of HHS' efforts.
About a month later, on March 13th, President Trump
declared a national emergency, and basically FEMA was put in
charge of the effort. By that time, we had over 2,000 cases
and, unfortunately, 47 deaths.
Six days later, on March 19th, Vice President Pence
designated FEMA to lead the Federal response to this. At that
point we had about 12,000 cases, a couple hundred deaths.
Eleven days later, on March 30th, FEMA announced the Supply
Chain Stabilization Task Force. By that time it started
exploding. We had 160,000 cases and 3,000 deaths.
I point that out because it is awful easy to sit up here at
the dais and Monday morning quarterback. The easiest thing in
the world is to be a Monday morning quarterback or armchair
quarterback. But when I look through the testimony and I see
what has been accomplished, in light of how overwhelming the
situation was, how many unknowns there were, how this was a
brand-new virus--it was never on Earth; no human had ever
experienced it. We had no tests for it; we had to develop all
these things from scratch. Again, I just have to say, Well
done, you guys did an extraordinary job. Not perfect. We passed
$2.9 trillion of financial aid. Far from perfect. Had to be
done. We did the best we could do. But I think you guys have
really done a tremendous job. As of June 2nd, FEMA has spent
$6.3 billion on COVID-19 from the Disaster Relief Fund (DRF).
I was talking to Administrator Gaynor earlier. Probably
close to 100,000 employees, and that includes about 40-some
thousand National Guard troops, 100,000 people involved in this
effort. I had a tough time managing a couple hundred people in
my manufacturing plant much less 100,000. So, again, this was a
task force, an effort assembled in a very short period of time
and really performing pretty well.
We can talk about this later in terms of the data, the
charts, but I do appreciate some of the charts you have
supplied the Committee. I think you really need to, as much as
possible, make that information public. I realize a lot of this
is preliminary and you hate publishing data that was not quite
right. I get that. I know I have to be able to restrain, but
when I look at the five types of personal protective equipment
(PPE) that is really vital--N95 masks, gowns, surgical masks,
gloves, and face shields--you look at that and it is anywhere
from 1.6 to 3.2 times the normal demand as a result of this,
because, supply and demand in a normal economy is pretty evenly
matched. All of a sudden we had a requirement for double to
triple that amount overnight. Coming from a manufacturing base,
I realize that that is not very easy. I think what we have been
able to do, recognizing that so much of this equipment is
sourced overseas, and those countries are grappling with this
as well, and there is a global demand for these supplies. What
you were able to do in terms of, for example, sterilizing N95
masks, the airlift operation, really some pretty innovative
rapid response, pretty extraordinary effort. I just take my hat
off to you. I am not going to Monday morning quarterback.
But I will just conclude by kind of asking the questions
that I think need to be asked. As we will see in Administrator
Gaynor's testimony, he will talk about, as in any Federal
disaster, the proper course of action is local effort first,
supported by the State, finally supported by the Federal
Government. This was so overwhelming. The Federal Government
had to take in many respects a real lead, and I think they
have. But I think the questions we need to be asking,
particularly in this hearing, which is about the National
Stockpile. We will also be holding hearings on our supply chain
vulnerabilities, whether it comes to medical devices, medical
equipment, PPE, and certainly pharmaceuticals. That is a big
subject but an incredibly important subject. This one I think
is really going to be more targeted on your response, what we
need to be doing to respond to potentially a fall surge or a
future pandemic when it comes to the National Stockpile,
because let us face it, we were not ready. We just were not
ready. Again, blame us all. As a government, as a Nation, we
were not ready for this. We need to learn the lessons we need
to be ready in the future.
So the questions we have to ask: What should the items in
the National Stockpile, what should those be? Who should hold
them? Should it be at the local level? Should it be at the
State level? Should it be the Federal? Should this be going
through normal general commercial distributors supported by
Federal or State or local funding?
So what should those inventory levels be of those items?
Who should hold them? How do we take care of the inventory
turns? You cannot just buy a billion N95 masks, walk away for
10 years, and expect that those things are not going to
degrade. So we have to have some process of keeping a
stockpile. Maybe we use private sector warehouses, and we just
say, in the regional warehouses we maintain an inventory that
you continue to turn. So if your standard inventory is a
million masks, maybe we support financially a 2 million
inventory level. Those are the types of things. And then, of
course, it always gets down to who should pay.
But as is always the case when I discuss FEMA, I will
continue to emphasize it starts at the local level. When the
locals cannot handle it, the State steps in. When the State is
overwhelmed, the Federal Government has to be ready to assist
and support, and I do believe in this case you truly were.
So, again, I thank you and the men and women that serve in
your agencies.
With that, I will turn it over to Senator Peters.
OPENING STATEMENT OF SENATOR PETERS\1\
Senator Peters. Thank you, Mr. Chairman, and thank you to
our witnesses for being here today and for your service to our
country in this urgent time of need.
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Peters appears in the
Appendix on page 632.
---------------------------------------------------------------------------
In our lifetimes, we have encountered few, if any,
challenges of the size and scope of the coronavirus pandemic.
Addressing this pandemic is clearly a monumental task, and the
Federal Government's failure to adequately prepare and quickly
respond to this crisis has led to costly and tragic missteps.
We have now lost more than 110,000 Americans to this
pandemic--loved ones whose lives will never be replaced. As
families across the country grieve these unimaginable losses,
we must make every effort to examine how we reached this
heartbreaking point and ensure that we are better prepared to
protect Americans from the challenges of the future, including
a potential second wave.
My home State of Michigan has been hit especially hard
among our State's minority communities, in particular, in
cities like Detroit. This pandemic has highlighted longstanding
disparities and health inequities facing minority communities.
And when disasters strike, minority communities often suffer
some of the most severe impacts but are among the last to
receive assistance.
This crisis has served as a chilling reminder that we must
do more to protect our most vulnerable and underserved
communities going forward.
A rigorous examination of the Federal Government's response
will help ensure that successes can be replicated and any
shortcomings can be addressed. These efforts are critical to
containing this deadly virus and to continuing the safe
reopening of our economy.
In Michigan and across the country, Americans are eager to
get back to work. But many industries are still struggling to
access the personal protective equipment that they need to
reopen safely. Americans need these items so that they have the
confidence that they are safe when visiting a restaurant or a
store.
I warned in a 2019 report that we faced a grave national
security risk because of our overreliance on foreign
manufacturers for medical supplies, including those
manufactured in China. The pandemic only intensified those
vulnerabilities.
I have heard from manufacturers in Michigan who want to do
their part to help produce these critical supplies. Yet the
White House was reluctant to fully use its authorities to
mobilize private industry. There is no doubt in my mind that
this hesitation slowed our response efforts, damaged our
economy, and cost American lives.
I greatly appreciate the hard work so far to obtain and
distribute supplies to those in great need.
But as our economy continues to reopen, we must redouble
our efforts to secure the resources to keep workers and
customers safe.
Effectively addressing this pandemic will also require
widespread testing. But months into the most severe public
health crisis of our lifetimes, we still have more questions
than answers about our national testing capability.
Every State in the country has encountered challenges
securing the resources to test people. Even now, my home State
of Michigan only has the resources to conduct 15,000 tests per
day.
Without sufficient testing, we cannot fully understand the
extent of the catastrophe or take the necessary precautions to
protect our communities. Moving forward, we must adopt and
implement a clear, effective, and comprehensive national
testing strategy.
These are just a few of the issues that I hope to discuss
with you today. The loss and the heartbreak that we have
experienced in this crisis are simply immeasurable, and we must
do everything in our power to prevent a return to our most
difficult days. The hearing is long overdue, but I am eager to
work with you on this vital mission.
Thank you, Mr. Chairman.
Chairman Johnson. Thank you, Senator Peters.
It is the tradition of this Committee to swear in
witnesses, so if you will all stand and raise your right hand.
Do you swear that the testimony you will give before this
Committee will be the truth, the whole truth, and nothing but
the truth, so help you, God?
Admiral Giroir. I do.
Mr. Gaynor. I do.
Admiral Polowczyk. I do.
Chairman Johnson. Please be seated.
Our first witness is Admiral Brett Giroir. Admiral Giroir
currently serves as the Assistant Secretary for Health at the
Department of Health and Human Services. In his capacity as
Assistant Secretary, he is the principal medical and science
adviser to the HHS Secretary. Admiral Giroir has served as a
member of the Unified Coordination Group (UCG) and was
designated as the Federal Coordinator for COVID-19 testing.
Prior to joining HHS, he served as Chief Executive Officer
(CEO) of ViraCyte, LLC, and executive vice president and CEO of
Texas A&M's Health Science Center. Admiral Giroir.
TESTIMONY OF THE HONORABLE ADMIRAL BRETT P. GIROIR, M.D.,\1\
ASSISTANT SECRETARY FOR HEALTH, U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Admiral Giroir. Thank you, Chairman Johnson, Ranking Member
Peters, and distinguished Members of the Committee. I am
honored to be here to update you on our Nation's progress
regarding COVID-19 testing and to provide details about the
close coordination between HHS and FEMA during the pandemic
response.
---------------------------------------------------------------------------
\1\ The prepared statement of Admiral Giroir appears in the
Appendix on page 634.
---------------------------------------------------------------------------
On March 12th, Secretary Azar requested that I lead COVID-
19 testing efforts within HHS, including oversight and
coordination of the Food and Drug Administration (FDA) and the
Centers for Disease Control and Prevention (CDC) with regard to
testing. Since then, the Nation has performed more than 20
million COVID-19 tests, now on pace to perform at least 3
million per week. The Nation's capability will continue to
increase so that we will have the capacity to perform 40 to 50
million tests per month by September.
To meet the complex public health challenges, we
implemented a phased approach that enabled the Nation to meet
the specific testing needs at each stage of the pandemic,
especially now during reopening, when the need for testing is
the greatest.
In early March, HHS and FEMA developed and implemented 41
community-based drive-through testing sites in locations
prioritized by the CDC in collaboration with State and local
partners. These sites have tested over 245,000 high-risk
individuals and served as prototypes that have been duplicated
multifold.
Next, building on these prototypes, we leveraged trusted
pharmacies to further implement community-based testing. This
Federal program is now providing testing at 437 locations in 49
States, and 70 percent of these locations are in communities
with moderate to high social vulnerability by the CDC's Social
Vulnerability Index. This program has tested over 516,000
individuals.
To further expand safe access to COVID-19 testing, we
authorized all licensed pharmacists to order and administer
COVID-19 testing under the Public Readiness and Emergency
Preparedness (PREP) Act. Over 90 percent of Americans live
within 5 miles of a pharmacy.
To meet the truly unprecedented demands, as the Chairman
pointed out, for testing supplies, reagents, and laboratory
platforms, we secured the global supply chain through a
military airbridge. We worked directly with manufacturers to
increase domestic production. We collaborated with the private
sector and the FDA to validate multiple technologies that
expanded existing testing capacity while minimizing the need
for PPE. The government secured and prioritized scarce point-
of-care testing assets to supply State public health
laboratories, the Indian Health Service, and other critical
needs. Finally, we used Title III of the Defense Production Act
(DPA) to further invest in domestic manufacturing.
These and many other efforts culminated in the current
partnerships to support State reopenings and to provide early
warning of any new outbreaks. Together we are working with
States, territories, and tribal communities to support their
testing plans and goals that are evidence-based and adaptable.
Before this experience, I only knew of FEMA as the agency
that quite literally rescued my family's future after
hurricanes and flooding in Louisiana. Now I have even more
respect for the agency, and especially for the people who make
it great.
HHS has integrated seamlessly into the FEMA process,
working closely with all of our Federal, State, and local
partners truly on a daily basis. The National Response
Coordination Center (NRCC) has provided invaluable and
unparalleled infrastructure, communications, process
methodology, and personnel upon which to build an integrated
and effective pandemic response, the scale of which has been
unequaled in modern history.
I am a member of the Unified Coordinating Group, led by
Administrator Gaynor. The UCG meets daily to provide strategic
direction, leadership, and collaborative decisionmaking and
ensures that all levels of government work together in response
to COVID-19. My primary role on the UCG is to advise on and
operationalize the full spectrum of public health and science
issues and to help prioritize deployment of the U.S. Public
Health Service Commissioned Corps, the uniform service that I
lead.
And in this regard, I will close by recognizing and
expressing my heartfelt gratitude to my fellow officers in the
Commissioned Corps; 4,329 men and women have deployed to
directly support this response, including to the Diamond
Princess cruise ship in Japan, to our military bases
repatriating Americans, to our community-based testing sites in
international airports, to FEMA and our task forces, to nursing
facilities, and to field hospitals in hard-hit communities
across our Nation. I thank each and every one of these officers
and their families and on their behalf thank all of you in
Congress for supporting our training needs and the
establishment of a ready reserve to supplement our ranks during
inevitable future national emergencies.
Thank you for the opportunity to provide these remarks.
Chairman Johnson. Thank you, Admiral.
Our next witness is Pete Gaynor. Mr. Gaynor currently
serves as the Administrator of FEMA. In his capacity as
Administrator, he is the principal adviser to the President,
Homeland Security Council, and the Secretary of Homeland
Security for all matters related to emergency management. He
has over a decade of experience at the local, State, and
Federal levels in emergency management. Prior to his experience
as an emergency manager, he served for 26 years in the United
States Marine Corps (USMC). Mr. Gaynor.
TESTIMONY OF THE HONORABLE PETER T. GAYNOR,\1\ ADMINISTRATOR,
FEDERAL EMERGENCY MANAGEMENT AGENCY, U.S. DEPARTMENT OF
HOMELAND SECURITY
Mr. Gaynor. Good morning, Chairman Johnson, Ranking Member
Peters, and distinguished Members of the Committee. My name is
Pete Gaynor. I am the FEMA Administrator. Thank you for this
opportunity to discuss the actions taken by FEMA to protect the
lives of and lessen the impact on the American people during
this pandemic.
---------------------------------------------------------------------------
\1\ The joint prepared statement of Mr. Gaynor appears in the
Appendix on page 645.
---------------------------------------------------------------------------
On behalf of the men and women of FEMA, I would like to
begin today by acknowledging and offering my condolences to the
loved ones of the exactly 110,949 Americans who have lost their
lives to COVID-19. One life lost is one life too many, and our
hearts go out to all those who have been affected by the
pandemic.
This has been a trying time for our country, and FEMA has
been working around the clock to help our Nation respond to
this historic and unprecedented global pandemic. As the FEMA
Administrator, it has been an honor to work alongside the
dedicated men and women of FEMA. Today I want to acknowledge
that workforce and our many partners for their commitment to
the Nation during this response. This response continues to be
one that is locally executed, State managed, and federally
supported.
When President Trump made the unprecedented decision to
declare a nationwide emergency on March 13th, the entire team
has worked tirelessly to make a positive impact, many risking
their own health and safety to do so. For the first time in
American history, we have a major disaster declaration in every
State, territory, the District of Columbia, and one tribe
concurrently. Today FEMA is responding to 104 active disasters.
The magnitude of this pandemic has required us to reexamine
our past practices, to keep the risk to our staff as low as
possible, while refusing to fail in meeting our mission. COVID-
19 has been a global crisis with most countries competing for
the exact same medical supplies.
Every government across the Nation has been competing for
the same resources, such as PPE. To complicate matters further,
most PPE is made in Asia, where the virus significantly slowed
manufacturing and where U.S. law and authorities only matter so
much.
During national disasters FEMA typically manages abundant
resources for disasters that are limited in geographic scope
and impact. In responding to COVID-19, FEMA has had a much
different and difficult task of managing the lack of critical
medical supplies and equipment. Rather than managing resources,
we are managing shortages.
We have worked tirelessly to find medical supplies and
equipment across the globe and rapidly move them to America. We
quickly prioritized resources to ensure that locations with the
highest risk of COVID-19 cases and deaths would not be in
danger of running out of supplies and lifesaving equipment.
Using the HHS Strategic National Stockpile (SNS) early on, it
quickly became clear the scope and scale of this pandemic went
far beyond what the stockpile was designed for. It could not be
relied upon as the single solution for pandemic supplies in the
United States.
To address these widespread shortages, the Supply Chain
Stabilization Task Force was swiftly created by FEMA and its
Federal partners, and in less than 10 days, we established an
airbridge to expedite critical supplies already purchased and
owned by some of the Nation's largest medical distributors,
with the goal of providing temporary relief through stabilizing
supply chains. This airbridge cut international shipments from
37 days on a ship to just 1 day by air. Since March 29th, we
have completed over 200 flights carrying lifesaving supplies to
the American public.
In addition to expediting supplies into the United States,
the Federal response focused on stabilizing the lives of
Americans in many impactful ways. I would like to provide you
with a few facts that illustrate FEMA's commitment and speed of
delivery to the COVID-19 mission.
Since March 13th, we have provided $6.8 billion in
obligations to States for COVID-19-related activities, with the
first $1 billion obligated in just 11 days; $27 million in
commodities, including emergency food; $17 million in crisis
counseling; over $1 billion each to the States of New York and
California; $1.4 billion in support of the National Guard and
Title 32; the deployment of 5,600 Department of Defense (DOD)
Title 10 medical professionals, afloat and ashore, providing
critical medical support to numerous hospitals under stress;
and supporting the Testing Blueprint, the procurement, and
delivery of 13 million swabs and 9 million units of media in
just 1 month; the procurement of 16,000 new ventilators with a
goal of 110,000 ventilators; through mission assignments to the
U.S. Army Corps of Engineers (USACE), built 38 alternative care
facilities and deployed 41 Federal medical stations; and,
finally, conducted nearly 500 informational engagements with
Congress, Governors, mayors, and tribal leaders.
While we continue to respond to COVID-19, we recognize the
risk for future outbreaks exist, and we want to ensure we are
all using available resources to address these critical
shortfalls. To do so, we are utilizing the Defense Production
Act to increase the amount of medical equipment manufactured
domestically to ensure our Nation's future preparedness is not
overly reliant on foreign producers. This transition will allow
FEMA to pivot toward focus on hurricane season and other
natural disasters. As part of this pivot, FEMA recently
released planning guides for the 2020 hurricane season to help
local officials best prepare for disasters within the context
of a pandemic.
The Nation continues to count on FEMA to accomplish our
mission, and we will do so in accordance with our core values
of compassion, fairness, integrity, and respect. This historic
response and our preparations for the future will continue to
require a whole-of-America effort, and FEMA looks forward to
coordinating closely with Congress as we work together to
protect the lives of the American people.
I would like to thank the Committee for providing FEMA with
the resources to meet these complex mission requirements, and I
look forward to any questions you may have. Thank you.
Chairman Johnson. Thank you, Administrator Gaynor.
Our final witness is Rear Admiral John Polowczyk. Rear
Admiral Polowczyk currently serves as the Vice Director for
Logistics for the Joint Chiefs of Staff. In this role he
oversees a portfolio of work focused on core logistics
capabilities such as supply, distribution, and health services
support. He has served in the United States Navy for more than
30 years, largely focusing on managing logistics. Since March,
Rear Admiral Polowczyk has led the Federal Government's Supply
Chain Stabilization Task Force. Rear Admiral.
TESTIMONY OF REAR ADMIRAL JOHN POLOWCZYK,\1\ VICE DIRECTOR FOR
LOGISTICS, JOINT CHIEFS OF STAFF, U.S. DEPARTMENT OF DEFENSE
Admiral Polowczyk. Good morning, Chairman Johnson, Ranking
Member Peters, and distinguished members of the Committee. I am
Rear Admiral John Polowczyk----
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\1\ The joint prepared statement of Admiral Polowczyk appear in the
Appendix on page 645.
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Good morning, Chairman Johnson, Ranking Member Peters, and
distinguished Members of the Committee. I am Rear Admiral John
Polowczyk, Vice Director for Logistics, Joint Staff. Thank you
for the opportunity to discuss the Federal response to the
COVID pandemic and strategies for future planning.
Let me start by offering my condolences to the families and
friends who have lost loved ones to this pandemic.
On a personal note, let me share that this pandemic hits
close to home, as it did for many Americans. I have two family
members working on the health care front lines. My sister is a
nurse in Westchester, and my niece is a nurse on Long Island.
Through daily communications I am very cognizant of the needs
of health care workers and if they are being met.
On March 19th, I was asked to support the management of
critical medical supplies needed to combat the pandemic,
specifically ventilators, personal protective equipment, and
equipment for testing. It was clear the global demand for
critical medical supplies could not be met domestically as
U.S.-based manufacturing was limited. Upon arrival, I quickly
realized the Strategic National Stockpile could not address the
Nation's requirement as the bulk of the stockpile was already
being allocated. On March 20th we established the Supply Chain
Stabilization Task Force to address the widespread shortfalls
amidst the global competition for lifesaving equipment.
The task force consists of over a dozen departments and
agencies across the U.S. Government and liaisons from the
private sector. I also want to add that the support extended
globally, with the Department of State helping track down
viable manufacturers around the world. Our goal since the
beginning has been to provide medical supplies to where it is
needed when it is needed.
A strategy had to be developed and quickly executed to
deliver the lifesaving supplies to COVID outbreaks popping up
around the country. We made a decision to leverage the
strengths of both government and private sector for a whole-of-
America approach. To execute this strategy, we developed four
lines of effort.
The acceleration and preservation lines of effort were
designed for outcomes measured in hours and days while the
allocation and expansion lines of effort focused on a longer
time horizon. With the shortages in PPE, acceleration of the
commercial market was required because we could not wait for
shipments of critical resources. Normal distribution methods
using maritime shipping could not meet the speed needed to
immediately get critical supplies to the point of care.
Project Airbridge is a major focus of this effort and
expedited the movement of critical supplies from the global
market to locations across the United States. On March 29th the
first flight landed in New York with gloves, masks, and
respirators. By April 30th, the 100th flight, Airbridge had
delivered nearly 800,000 N95 respirators, 825 million gloves,
75 million surgical masks, over 11 million surgical gowns, more
than 2 million thermometers, 650,000 face shields. Using the
airbridge, we cut the amount of time it takes to transport
supplies from Asia to the United States from months to days.
The supplies I just listed would still have been at sea on
April 30th and not available to our health care workers if
normal shipping methods were used. At its core, the airbridge
is a public-private partnership with six major medical
distributors. The Federal Government covers the cost to fly
supplies purchased by the private sector into the United States
from overseas factories. As part of the agreement, 50 percent
of the distributors' supplies in each plane are directed to
points of care in geographic areas needed using CDC data along
with inputs from Dr. Birx. Based on CDC data, prioritization
was given to hospitals, health care facilities, nursing homes
around the country to COVID hot spots such as New York, New
Jersey, Chicago, and Detroit.
Beyond the airbridge, our acceleration efforts continue to
source supplies with flights carrying over 55 million FEMA-
procured masks and 2 million gowns into the United States.
Working with CDC, we provided preservation guidance on how to
extend the life of PPE and introduced options like
decontamination systems that allow for multiple use of N95
masks.
You cannot run a supply chain if you cannot visualize it.
Using data-driven decisions for allocation ensures the right
quantities of critical medical supplies get to the right place
at the right time. In an unprecedented fashion, we consolidated
business system data from the six major medical distributors
into the cloud of FEMA, creating a data lake of information.
For the first time, using a supply chain tool from DOD, we were
able to see the health care supply chain from supplier to point
of care, all done within a matter of 2 weeks. We could now see
inventory held by competing companies for distribution in the
United States and how the supply chain was filling those
orders. We combined this supply chain data with CDC
information, ensuring the commercial markets moved resources to
the hot spots.
Looking at the longer time horizon, expansion is needed to
align U.S. manufacturing with current COVID and future demands.
Prior to COVID, the medical community procured the majority of
supplies from cheap overseas markets. We need to change that.
American business leaders continue to respond. For example,
with no financial incentive from the government, Walmart teamed
with the medical supply chain and produced over 200 million
hospital isolation gowns. Using the Defense Production Act, we
are creating investment across manufacturers in the United
States to make domestic production equal to the surge in COVID
demand. We used DPA to raise the U.S. production of N95 masks
and bring in 50 million N95s from 3M's overseas production.
Another example is rated contracts for ventilator production
under the DPA, including contracts for thousands of ventilators
delivered to the stockpile.
Looking ahead, we are preparing America to be fully
prepared for any future outbreaks, beginning with increasing
our reserves, expanding our domestic capacity. We now have more
ventilators in the Strategic National Stockpile than before the
pandemic thanks to U.S. production. Pre-COVID, the stockpile
had less than 18 million N95 masks. We are growing that to 300
million. The SNS had no ventilator drugs. We will now have at
least five drugs in stock with 3 months' worth of supply. There
were no swabs. The stockpile will now include swabs for
testing.
This updated version of the stockpile will regularly
refresh stocks, capitalize on our work to understand the whole
supply chain for linkage with the private sector. A larger
National Stockpile combined with more U.S. production will
enable a continued Federal response.
Thank you for the opportunity to testify today. I look
forward to answering any questions that you may have.
Chairman Johnson. Thank you, Rear Admiral.
I will defer my questioning to the end. The order of
questioning will be Senators Peters, Lankford, Carper, Hassan,
Rosen, Portman, Scott, and Romney. Senator Peters.
Senator Peters. Thank you, Mr. Chairman.
Admiral Giroir, the first question is for you. The
coronavirus pandemic, as we all know, has disproportionately
impacted the African American community, yet reports suggest
that diagnostic testing for coronavirus is disproportionately
located in areas with higher incomes and lower minority
populations. So could you walk me through the steps that the
Department has taken to evaluate access to coronavirus testing
for minority communities, including at the individual and even
neighborhood level for these communities, if we could get a
better understanding as to how you approach it?
Admiral Giroir. Yes, thank you, Senator. In my job before
COVID, this was a major part of my job as Assistant Secretary
for Health working on health disparities, so it is a topic that
I feel fairly familiar with.
The first thing we did--and I mentioned this in my
remarks--is the federally sponsored pharmacy sites. There are
437 of those. We made sure--this was by contract--that the
majority of which are located in sites of high social
vulnerability. Seventy percent of those 437 are there. The
Social Vulnerability Index takes into account race and
ethnicity, income, languages, disability, and other areas. So
it is the way that we can target those resources.
Second, the federally qualified health centers--we now call
them ``community health centers''--they take care of 30 million
primarily of the poor and under-or uninsured in our Nation.
Ninety-two percent of them are offering COVID testing right
now, so almost all of them, and they are located in the
neighborhoods of need.
Last week, we released guidance--and this was a flaw in the
system. There was no requirement for reporting of race,
ethnicity, age, sex, even zip code or location, with lab
reports. It was very difficult to understand what the data
were, and we still do not have a good understanding of that.
This was an authority that the Coronavirus Aid, Relief, and
Economic Security (CARES) Act gave to the Secretary, and we
enabled that last week. My office, the Office of Minority
Health, has a funding announcement that is available right now
to create an entire national infrastructure to focus on
minority issues, primarily linkages to testing as well as
linkages to services following that testing. I think you said
in your remarks and something that we are focusing on more and
more is health disparities have plagued this country for
decades. The underserved minorities sometimes it really is
true, your zip code matters more than your genetic code. And
this was really not something new, but it was a magnification
of the health disparities we see. I do not want to take up your
time, sir, but we just saw what had occurred for decades just
magnified because of this pandemic.
Senator Peters. There is no question about that, and we
have to lean in very heavily to deal with those, and that will
be at a future time we can talk about that.
Just kind of the follow-up question. You talked about how
these resources are in these different areas, and yet you also
said we did not really have data until just recently. So how
can you make that statement without data? How are you about
to----
Admiral Giroir. So what we do know is the Social
Vulnerability Index is a published index to understand what
communities are really vulnerable. So we placed our testing
centers in those communities. What I do not have is the
national data to say how many African Americans have been
tested, how many Hispanics have been tested, because that is
not a requirement, and the Federal Government does not get
that. We have mandated that as part of the guideline from the
Secretary last week, but we have very limited data. We just
have very limited data to understand the percentage of those
tested. We know how many are hospitalized, who suffers the
consequences, but testing, we are flying blind until this comes
in, sir.
Senator Peters. Right. And you agree that this data is
essential, we have to have it?
Admiral Giroir. It is absolutely essential. We cannot
develop a national strategy to reach the underserved to know
how well we are doing until we have the data that shows us if
we are reaching them or not. So, yes, we are very anxious for
that data, and I wish I could present that. But it was an
authority that just gave to us in CARES, and it is a guideline
now that people will have to report.
Senator Peters. What steps are you taking to collaborate
with other partners such as FEMA and the Housing and Urban
Development (HUD) and others in these efforts?
Admiral Giroir. So these are my brothers here. I mean,
literally, since things moved to FEMA, we are informally
probably meeting five times a day, but there is a formal
meeting every single day where every task force reports to the
Unified Coordinating Group. We hear from every region, so we
really hear it where the boots on the ground are, because you
cannot know everything in Washington, but we hear directly from
HHS, the FEMA Regional Administrators, and then almost every
day we have a Uniform Coordinating Group that really provides
direction and decisionmaking. And then Admiral Polowczyk and I
are not officially on the White House task force, but we are
regular invitees. So, again, we are there along with the
Administrator, who is. So every day we have multiple hours of
contact with each other. It has been one of the great, I think,
teams that have sort of self-assembled during this given FEMA's
structure really allowed us to do that.
Senator Peters. Administrator Gaynor, a just response
requires leadership, as you know very well, at the highest
level of the agency and a dedicated office to develop a
proactive plan that can assist that leadership. And we have to
ensure that aid and assistance is always delivered equitably.
I introduced the Achieving Racial Equity in Disaster
Response, Recovery, and Resilience Act of 2020 which will
basically establish an office of equal rights and community
inclusion at FEMA that would refocus the agency's efforts on
those communities that have been left behind, and as we
mentioned, the disparities with communities of color in
particular.
So my question for you, Administrator Gaynor, would you
commit to working with me to move this legislation and bring
greater focus within FEMA to communities that are particularly
vulnerable?
Mr. Gaynor. Yes, sir. And just for the record, FEMA already
has an Office of Equal Rights and Civil Rights, and so we would
be happy to work with you about what we have been doing, some
of our successes, and I would be happy to offer technical
assistance to you and your staff on that legislation.
Senator Peters. I appreciate it, and I know you have that
office, and we appreciate the work that that office does. But I
think what we have seen transpire in the last few months, we
should probably redouble our efforts and focus more on that.
That is certainly the spirit behind the legislation, that we
bring even greater focus. For example, the lack of data, those
are things that we should have been doing from day one, and we
need to have lessons learned from the past as we move forward
to make sure that we have more equitable responses in the
future. So that is the spirit of the legislation.
Mr. Gaynor. Yes, sir. If I could share just one thing to
just tell you how early we were concerned about equal rights
and civil rights. Early on in the process, in May, my Office of
Equal Rights put out a bulletin to all FEMA employees working
on COVID-19. I sent 25 civil rights advisers out to my ten
regions across the country. They adjudicated 211 civil rights
items before they became official. So we have been out there on
the front line adjudicating civil rights, making sure that we
stand up for what is right, what we believe in. And so, again,
I would love to work with you and your staff on moving that
forward to even a greater effort.
Senator Peters. I appreciate it. Thank you. Thank you,
Admiral, as well for your comments. Appreciate it.
Chairman Johnson. Thank you, Senator Peters.
Senator Lankford, by the way, I think I mentioned this to
you. When I got home last night, my wife has C-SPAN on, and she
said, ``You have to watch what Senator Lankford had to say.'' I
thought you did an extraordinary job, so I would recommend
everybody go and get a clip of Senator Lankford talking about
disparity. As Senator Carper always says, we do not have a
perfect union. We are trying to form a more perfect union. But,
excellent remarks. Senator Lankford.
OPENING STATEMENT OF SENATOR LANKFORD
Senator Lankford. Thanks, Chairman.
Gentlemen, thanks for your service, what you are doing. You
do a lot of work behind the scenes that Americans do not have
the opportunity to be able to say thank you, so from the people
of Oklahoma, let me pass on my thanks because you have done
quite a bit to be able to serve the folks in my State and
across the country.
Let us talk a little bit about the National Stockpile,
though. There was a lot of early engagement on expired N95
masks and expired prescriptions and such in the National
Stockpile. Help me understand how we got to that point that
things were expired, and how does it get better to be able to
deal with the rotation so that we do not have expired materials
in the future?
Admiral Polowczyk. Yes, Senator. I am going to refrain from
talking previous to March 19th, so I cannot speak to those
practices. But I will talk to you about what we are doing going
forward. The National Stockpile should not be thought about as
I buy it, I put it on a shelf, and I am done.
Working with the colleagues at Health and Human Services, I
am trying to develop a National Stockpile next that uses
practices that DOD has done, has used. DOD has a Warstopper
Program where we buy inventory, we put it on the shelf with our
commercial partners, and as the commercial partners make
issues, they replenish and they manage shelf life for us. That
is just one example. And so we are looking to change from a
stagnant mentality of buy it, put it on the shelf, and then
have to figure out how to rotate stock. It is not just N95
masks. Even simple things like needles and syringes that are
sterilized and wrapped, they all have a shelf life based on the
sterilization.
So there is work to do there going forward, and it is going
to change, and it is going to take a little bit of----
Senator Lankford. Do you need legislation to do that at
this point or do you have the authorities you need to be able
to do it right now?
Admiral Polowczyk. I believe Health and Human Services has
the authorities, but it may take a difference in understanding
of funding resources for them, and I will not be able to speak
specifically for Health and Human Services. But I think they
are going to need an annual appropriation that pays for
different inventory management practices than they have had.
You cannot just put it on the shelf and then walk away from it.
Senator Lankford. Right. We will look forward to getting a
chance to be able to walk through that because obviously, if we
buy a product and it sits on a shelf for a period of time and
then it starts to get near expiration, it would be much better
to be able to sell that and to be able to get it off or to be
able to rotate it out and be able to keep that moving. Again,
you were talking about the DOD process and what they are doing
and storing it with commercial entities as well.
Are we at a point right now that if we had a vaccine, let
us say in November, that we would have enough syringes and
distribution to be able to get it out?
Admiral Polowczyk. Sir, to answer that specifically, we are
on glide path to have approximately 400 million needles and
syringes by, I will say, December. I do not have the numbers
right in front of me, but it is at least 400 million as we get
into the winter, and 700-some-odd million as we get into next
year.
Senator Lankford. OK. Mr. Gaynor, let me ask you about
this. FEMA is all about mitigation, storm mitigation, trying to
prepare ahead of time and to be able to get communities
prepared ahead of time. Have you started a list right now with
what we can do to be able to help hospitals, States, local
entities, for how they can prepare for the pandemic? Because it
was not just the Federal Government that was caught flat-footed
on this. A lot of hospitals and local entities had a 2-or 3-day
supply of PPE knowing they could just reorder if they needed
more. But no one could just reorder at that point, so everyone
across the country was caught flat-footed in this.
Have you all started a process already to brainstorm what
we can do to be able to help prepare local entities in
mitigation efforts?
Mr. Gaynor. Yes, sir. It is a great question, and I am
going to start with the way this whole system works, and when
it works the best, everyone is involved, so locally executed,
State managed, federally supported, to include our citizens
across the country.
We are probably going to have to readjust some grants. We
put out about $2.4 billion in preparedness grants. Over the
past couple of years, we have focused on cyber and terrorism
and things like that. So maybe it is time to refocus what
really is important or what we have learned from the past 90 to
120 days, what we have learned from that and how we are going
to correct it so we do not fall into the same trap ahead. So,
again, everyone needs to embrace preparedness from the local,
State, and Federal level, to include hospitals and everyone
else.
I think we need to embrace preservation of PPE. There were
moments over the past 90 days where it was dim when it came to
having enough PPE. So we need to think about how we use PPE in
a new way. So I think, we are all very--we like cheap 70-cent
masks from China, disposable, throw it away after one time, and
it keeps everybody happy. Maybe that is not the way we need to
go forward. Again, the majority of PPE is not manufactured in
the United States. I know we have a great effort to bring that
back home, but we really need to change the culture about what
really is important and make sure everyone is invested in all
these things.
So, again, everyone needs to--if you are in the hospital,
maybe you need to think about how you are going to manage your
PPE and how you are going to manage surge and how you are going
to make sure that it stays fresh over time. I think everyone
owns a piece of this puzzle, not just the Federal Government.
Senator Lankford. That is great. Let me make a couple of
comments, if I can, on this as well. I will do a quick question
on it. One, we have to relook again--and it is something this
Committee can continue to work on, and thank you, Mr. Chairman,
for this Committee's work in this area--is dealing with
domestic manufacturing. All of the things that we had to get
with an airbridge to be able to ship over in a moment of a
pandemic, I would suggest every one of those supplies we should
reexamine what is our domestic manufacturing for those supplies
that we were in such a desperate moment that we had to be able
to move those things via an airbridge from Asia. Why are we not
producing those domestically? And what can we do to create more
domestic supply on those so that we can ramp up working nights
and weekends rather than ramping up and to be able to move them
over from Asia and a point where we are exposed on this?
I do want to ask one more question, though, on Veterans
Affairs (VA), the current VA process for testing in particular.
HHS makes the decision on what the need is across the VA. It
gets to FEMA. FEMA then gets those supplies onto national VA
and it gets down to hospitals. My numbers, if they are correct
on it, about 300 testing units are getting to hospitals or most
entities across the country, somewhere on average of that a
month. The hospitals in my State are looking for about 700
tests a week to be able to test more people coming in and to be
able to help evaluate that.
How do we bump up the numbers that are available to VA as
we have a complicated process where HHS decides that FEMA
distributes, it gets down to VA, then distributes down to the
individual hospitals and clinics?
Admiral Giroir. Sir, thank you for that question, and it is
good to shed some light on that. Dr. Stone, who is the chief
executive of the Veterans Health Administration (VHA), and I
talk regularly. The VA makes a request, and we fulfill it. That
is just that clear. If they need 100,000 swabs, we give them
100,000 swabs. We have had to tide them over with Abbott ID NOW
rapid testing machines, the Cepheid cartridges in order to
buildup their--so, quite simply, for the VA and for the DOD, if
they have asked for anything, we have supplied it to them.
Now, how the VA distributes that within their system is
kind of behind the curtain to me, but we supply nationally to
take care of our veterans because a lot of them were in the
vulnerable age groups, as you know. They are co-morbid and they
are elderly, and I will look specifically into Oklahoma. But at
that level, the VA gets what they need.
Senator Lankford. Good.
Mr. Gaynor. Sir, just in addition to that, the VA has a
dedicated liaison officer at FEMA full-time, and so if there is
a requirement, a request, a problem, we hear that directly, all
three of us, and take immediate action. So they are on the
inside of this process, and, again, we take immediate action on
anything that we see.
Senator Lankford. That is great. We will try to follow up
from there. Thank you.
Chairman Johnson. So let me answer the first part of your
question. As a former manufacturer, in order to guarantee
manufacturing in the United States, we have to guarantee orders
at a reasonable price that guarantees a reasonable rate of
return. It is that simple--not how exactly we do it, but that
is what we have to do. And that will be a decision I think the
Congress will have to make.
Senator Hassan. Just hold because we cannot hear you yet.
There you go.
OPENING STATEMENT OF SENATOR HASSAN
Senator Hassan. Folks, can you hear me?
Chairman Johnson. Yes, we can hear you now.
Senator Hassan. OK. So I just wanted to add my thanks not
only to the witnesses, but to all the men and women who work in
the field for your agencies during this extraordinary time. We
do know that this has been an unprecedented amount of work, and
we are very grateful.
Having said that, I just want to add a caution because
while the time for an after-action report on what was done well
and what was not is for after the pandemic, I think there is
general agreement that we needed to establish our goals earlier
and that we still have some ways to go in terms of being
transparent about what our goals for things like PPE and
testing are.
There is a difference between saying we have worked really
hard and done all these things and knowing that we have
actually met our need. There is a difference between saying let
us see what we can do and here is what we need to do. And so
that is what my questions are really focused on.
I will start with Administrator Gaynor, and, again, I want
to thank you and everybody at FEMA for all the hard work you
have been putting in. But I have had a consistent frustration,
and we have shared it with you, and I know it is shared by the
Chairman and other Members of this Committee, about the
administration's inability or refusal to publicly lay out clear
numerical projections and goals for its COVID-19 response.
I have been asking for months now for the administration's
estimates of how many N95 masks and pieces of other personal
protective equipment our country needs. It took over a month of
pressure from this Committee to even get verbal answers to
these questions, and it was not until late last Friday night
that I got anything in writing. And even now that I have this
document, which you all produced to my staff Friday night, the
administration still says, ``We cannot make it public.''
There are real questions about this document, but I do not
see the utility of asking about it if the public does not have
access to it at the same time so they can follow our
discussion. The American people deserve answers to these basic
questions: how much personal protective equipment we need and
what our plan is to get there.
So, Administrator Gaynor, why is the administration
refusing to make this document public? Public scrutiny is
critical to evaluate these projections, how they were
developed, whether they account for real needs in nursing
homes, hospitals, schools, and business. Why can't I share this
document with my constituents?
Mr. Gaynor. Yes, ma'am, thanks for the question. So I do
not know of any prohibition about sharing the slides, so if you
have an interest in sharing those slides publicly, go ahead and
do so. We provided those slides to you and the Committee for
your use, and if that includes sharing those with U.S.
constituents, I do not see a prohibition against it.
When it comes to understanding PPE--and I will defer to the
Admiral here in a minute, but when it comes to understanding
PPE scarcity, a demand for things that some sectors have never
had a use for before, it has taken some time for us to
understand that. And so, early on we want to understand what
usage was against what pre-COVID numbers look like. Now that we
are moving into opening government, what do those numbers look
like? Elective surgeries, dentists, all these things are new
and additive to the problem.
So as we go, we learn more. We will update those slides.
They will be more comprehensive.
Senator Hassan. Director Gaynor, I thank you. But I will
just say--and I have limited time--your staff explicitly told
our staff that we could not share these documents publicly. So
I am glad for your commitment today, but I just want to be
clear on the record that we were told we could not share these
documents.
Mr. Gaynor. Yes, ma'am, and I apologize for that.
Senator Hassan. Thank you.
I would like to move on to a question to Admiral Polowczyk,
please, and I will just say again it would be better to
forecast what you think the needs are as you have discussions
with different sectors so that we can then develop a plan to
meet the need.
Admiral Polowczyk, related to my question to the
Administrator is the fact that critical facilities still face
severe shortages. Federal data released last week showed that
nursing homes around the country still do not have the personal
protective equipment that they need to keep people safe. More
than 500 nursing homes in our country lack any N95 masks, and
more than 250 do not even have surgical masks.
Admiral, I appreciate that this is a challenging situation,
but those numbers are completely unacceptable. About 40 percent
of all U.S. COVID-19 deaths are residents or workers at nursing
homes or other long-term facilities. And in New Hampshire, over
80 percent of deaths are in long-term-care settings. The
Federal Government has to do more.
What are you doing to remedy the lack of personal
protective equipment available to nursing homes and other long-
term-care facilities across the country?
Admiral Polowczyk. Thank you. That is a great question, and
I appreciate your passion for the vulnerable. So we are doing
several things. One, in our prioritization scheme, the first
priority is public hospitals, then the VA, private hospitals,
and then nursing homes. So nursing homes are one of our top
priorities as we work to get items where it is needed and when
it is needed.
Second, we have instituted a project to bring personal
protective equipment to every single registered nursing home in
America--that is 15,408 nursing homes--delivered directly to
their front doors. That is millions of surgical masks,
millions----
Senator Hassan. And when is that going to happen?
Admiral Polowczyk. We started that project, building the
volume of supplies necessary, in April. We started deliveries
in May, and that will run through weekly--they will be getting
deliveries of several weeks' worth of PPE as we go through
August and into September, and we are----
Senator Hassan. So, Admiral, what--and I realize that I am
over time, but, Admiral, what I am looking for is a plan that
tells every nursing home in America when they are getting the
equipment they need----
Admiral Polowczyk. Yes, ma'am, so we give every Governor
every Monday, when the Vice President has the Governors call, I
give them a State breakout with every single nursing home in
their State and the address, including the amount of supplies
and when the item is being shipped and if it has been
delivered. So we have a great communication with----
Senator Hassan. As you know, we still do not have this
equipment in many nursing homes.
Admiral Polowczyk. So, ma'am, one of the things that the
Healthcare Ready network is now producing is an input of
nursing home information, and they are working with
Administrator Seema Verma, and I see regularly inputs from
nursing homes where less than 2 percent of nursing homes that
are reporting say that they do not have a week's worth of
personal protective equipment. I would really love to sit with
your staff to go through that information and understand what
you are saying that there are hundreds of nursing homes that do
not have----
Senator Hassan. Well, it is----
Admiral Polowczyk [continuing]. Data being collected, and I
am being--from the Healthcare Ready network is showing a very
small amount. And once we see those numbers, we go work with
each one of those nursing homes to make sure that they have
PPE.
Senator Hassan. I would appreciate following up with you on
that. Mr. Chair, if there is a second round of questions, I
would appreciate being able to ask them. Thank you.
Chairman Johnson. OK. Senator Rosen.
OPENING STATEMENT OF SENATOR ROSEN
Senator Rosen. Thank you, Chairman Johnson, thank you,
Ranking Member Peters. I want to thank all of our witnesses
today for your service and your hard work.
I would like to address natural disasters and the pandemic
because in Nevada we are about to enter wildfire season. In the
past month, we have unfortunately experienced multiple
earthquakes, including a 6.5 magnitude event that shook our
entire State. Flooding and other disasters are also possible
throughout the year. So I would like to hear more about what
FEMA and HHS are doing to prepare for responding to the COVID-
19 pandemic while we are also responding dynamically to these
natural disasters. It is absolutely critical that we have a
detailed concurrent plan, our planning going on right now, as
we see the pandemic hitting, of course, across the country. We
have to be nimble in order to respond, and, FEMA, for you to
address a multiple-disasters situation simultaneously.
So, for Administrator Gaynor and Admiral Giroir, how are
FEMA and HHS preparing for testing for COVID, treatment for
COVID, and vaccine delivery if power is impacted by a natural
disaster? Are there additional mobile generators for
refrigeration systems? Are these being acquired? What type of
equipment might you need in a remote scenario? We have very
rural, remote areas that get the wildfires, have the
earthquakes. What supply chains could be disrupted? What do you
need from Congress to start doing this? Or have you started
doing it? We will start with Administrator Gaynor, please.
Mr. Gaynor. Yes, ma'am, thank you for the question. So if I
can just zoom out a little bit and focus on some of the wider
efforts that we have done at FEMA and across the country--and,
again, with my many partners here, Admiral Giroir, DOD, and
many others that are not here, early on, probably before the
President declared a nationwide emergency in March, we knew
that hurricane season was coming, and we wanted to make sure
that we were prepared for hurricane season with the overlay of
responding to COVID-19. And so along that way, my team and my
partners collected best practices, lessons learned, the best
resources for COVID-19, and we built in 27 days--I am not sure
if you can see it, but I brought a prop with me here--the
COVID-19 Pandemic Operational Guidance for the 2020 Hurricane
Season.\1\ Although it says ``hurricane season,'' you could
scratch that out and put in ``wildfire'' or ``earthquake'' or
``flooding,'' because all the lessons learned in here apply to
all hazards.
---------------------------------------------------------------------------
\1\ FEMA Hurricane Plan appears in the Appendix on page 678.
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Senator Rosen. Let me ask you this question, and I am going
to take a look at that after this. But is there strong support
in there for our State and local agencies, our first
responders? Is that in your document as well?
Mr. Gaynor. Yes, ma'am. Back to a line in my opening
statement, ``locally executed, State managed, and federally
supported,'' and I will just give you an example about some of
the challenges that we will face this year. It does not matter
if it is hurricane or wildfire or an earthquake. It is about
sheltering. In it, we want to make sure that we stimulate
conversation at the State, local, tribal, and territorial level
(SLTT), emergency managers, State health officials, to ask
those questions. What does evacuation look like in your
community under COVID-19? Do you have enough space? Do you have
enough hygiene equipment? Can you screen people? If you have
somebody that is positive, what do you do with that? Are you
going to do testing?
So lots of prompting questions to have every emergency
manager in the Nation go look at their plans and make sure that
they are up to date for whatever hazard they may face and
COVID-19. I have held conversations with every State emergency
manager in the country on this. We have an exercise kits that
we encourage all levels of government to use to exercise those
plans with COVID-19. So pretty comprehensive. I will make sure
that you and your staff have a copy, and I would be happy to
answer any questions after that. When it comes to testing, I
will turn it over to Admiral Giroir about what testing may look
like in the future.
Admiral Giroir. Yes, thank you, Senator, and thank you,
Administrator. On the testing side--and I am so appreciative
you brought this out--it is the reason why we are working
directly with each State individually to make custom evidence-
based plans for those States. My multidisciplinary team has met
with the multidisciplinary teams from every State now three
times to establish the initial State goals, and we did this in
late April. So for Nevada, your team's goal was 120,000 tests.
We concurred, 120,000 tests were very good for your State. We
provided all the supplies that are needed to do those 120,000
tests. Not only was it numerical, but there are specific
issues. Like your State is number 8 in relying on the public
health laboratory, so you are very highly reliant on the public
health laboratory, and that being the case, we supply more
supplies to your public health laboratory than other States
that are not so reliant on it. We also focus on any indigenous
populations through the Indian Health Service.
So it really is a custom plan for your State, and, by the
way, in May your State did really good, just about met your
State goals, certainly within a stone's throw of it. So we look
forward to that. And now we are reviewing every single State
plan as required by the Paycheck Protection Program (PPP)
legislation along with the $10.25 billion. We have a specific
State plan that we are reviewing now for May and June, and then
on June 15th, it will be the plan for the rest of the year.
Again, this is a cooperative agreement between the CDC and
the States, meaning we are working together. It is not the
State's responsibility; it is not a Federal responsibility. It
is us to work together to make sure that that State plan is
appropriate and can be executed.
Senator Rosen. Admiral, I want to just follow up on
something Senator Lankford asked about syringes and things that
we are preparing for, for a vaccine. What about our vaccine
vial supplies? Do we have enough borosilicate that is the
special glass that we need for those vials to contain the
vaccine? If we do not have enough, are there alternative
material that we can consider using as we ramp up not just
syringes but the vials that are needed as well?
Admiral Polowczyk. Ma'am, great question. So there is a
little bit of a dividing line between my efforts and then
Operation Warp Speed. I am working closely with them, but they
have a plan for vials and syringes. There is also a secondary
plan of a new technology, a blister-pack blown product where it
will be pre-filled, and you will get the dosage in a blister
pack, be able to open it, and inject it and squeeze it so it is
one. We are actually using some investment money, the Defense
Production Act, on that item.
But Operation Warp Speed has all the details there, but
because it has something to do with the supply chain, prior to
the stand-up of Operation Warp Speed, I dived into needles and
syringes just because I thought that was what is next. But I
will have to work with Operation Warp Speed to get you a
specific answer on the vials, ma'am.
Senator Rosen. Thank you. I appreciate it.
Chairman Johnson. Senator Portman.
OPENING STATEMENT OF SENATOR PORTMAN
Senator Portman. Can you hear me?
Chairman Johnson. Yes, we can hear you now. OK. Great. We
will reset you for 7 minutes.
Senator Portman. I am almost out of my time. I apologize.
First, I want to thank you----
Chairman Johnson. You are going to have to talk a lot
louder, though.
Senator Portman. Admiral Polowczyk, I want to thank you for
your hard work on how to improve our supply chains in
particular. I have had this conversation in person [inaudible]
times. I know you are a sincere champion of American reshoring
[inaudible] like China and----
Chairman Johnson. Rob, you have to put that microphone
really close to your mouth. It is kind of fading in and out,
and we can barely hear you.
Senator Portman. OK. I do not think the microphone is
working. Can you hear me?
Chairman Johnson. Yes, we hear real good right now.
Senator Portman. OK. You just testified, Admiral Polowczyk,
that we are ramping up domestic production to meet the COVID
challenge. We are preparing America by increasing U.S.
production. As you know, and, again, I know you are sincere
about that, but this Joint Acquisition Task Force that is
vetting contracts, because it has shifted now over to Defense
Logistics Agency (DLA), they are vetting contracts to supply
PPE over the next 90 days. And as Chairman Johnson said
earlier, you have to have that demand signal. You have to have
that long-term contract to make the investment to actually
bring this PPE production back to America. And I just have not
seen an indication that this Joint Acquisition Task Force and
DLA are issuing these needed long-term contracts for PPE. These
companies need the certainty to be able to make the investment.
It is a huge investment. It is the right thing to do. And my
question to you I guess would be about that. There is an Ohio
company I have talked to you about that has an exciting plan to
actually bring textile production back to America. They are
already [inaudible] sheets and towels already, seeing Mitt
Romney is listening to us, they provided them to the Marriott
Corporation, which then [inaudible] that can do this. They have
U.S. sheets and towels and other linens. So they cannot do it
unless they would like to make reusable gowns here in America,
but they cannot do it unless they have these long-term
contracts.
So I want to know, one, what your view is on that. On the
record, do you agree that it is in the national interest to
make [inaudible] in the United States?
Admiral Polowczyk. Sir, I had a little bit of a hard time
hearing your question, but I get the genesis is a little bit
about our plan to bring manufacturing back and the
requirement----
Senator Portman. Do you support bringing it back? Do you
support reshoring----
Admiral Polowczyk. Yes, sir, right. I do not think we could
be ready for any future pandemic, and so a little bit longer
lens than just, say, for a second wave in the fall. I talked
about a vignette from--unfortunately, I bring a lot of DOD with
me, right? So, you cannot be resilient and ready if you are not
managing your supply chains and managing the production of
required resilient items. So let me give you an example.
While the Navy has full magazines of Tomahawk cruise
missiles, we still buy Tomahawk cruise missiles every year and
keep them on low-rate production. And that is so we can surge.
That same mentality I believe has to happen in the health care
area. We are working to aggregate demand, so the slides that
the Committee got about demand, we are working to aggregate
that long-term demand and bring that to industry to say, hey,
look, this is the repeatable, long-term demand for health care
items, not just personal protective equipment but----
Senator Portman. Admiral, let me ask you a follow-up on
that. Do you agree that in order to do that we need to have, in
addition to the short-term contracts for immediate need--I get
that--but do we need to have these long-term contracts to
provide that demand signal for these U.S. manufacturers so that
they do bring production back to these shores?
Admiral Polowczyk. Right. So I am busily in the process of
aggregating demand across DOD, the National Stockpile, VA, and
then in consultation with each State through their Regional
Administrators, to understand what the States would desire to
stockpile, kind of the three levels of inventory there, and
bringing that national demand forward.
I would also say that there will be work that the
administration must do on the right backstopping to make sure
that the items do not go back overseas. But there is a need for
having long-term demand with stable funding.
Senator Portman. Great. Thank you. Could you tell us when
DOD is going to issue long-term contracts to companies who are
looking to bring PPE back to our shores?
Admiral Polowczyk. Sir, we are continuing to do that right
now. We have asked the Defense Logistics Agency essentially for
a first wave of items. I think that was 450 million. That ought
to be followed up by several billion, and then as you bring
forward DOD's requirement, the VA's requirement, and the
States' requirements, that number will be quite large, and we
will be sharing that with industry as we go. And we continue to
work the back stream, the raw materials pieces of these supply
chains. So we have pending Defense Production Act investments
to bring millions, additional millions of square feet of
meltblown, the non-woven fabric to make either gowns or
surgical masks here in America with American-made product.
Senator Portman. Thank you, Admiral. I agree with you we
need to have these long-term contracts to provide that demand,
and I hope that you will get DLA to do that quickly.
Admiral Giroir, thank you for all of your help with Ohio. I
have had the opportunity to work with you on a number of
projects. Right now we need more testing in Ohio. We are the
43rd in the country in testing per capita even though we are
the seventh most populous State. We have a real issue with
testing. We need the help. We have the Thermo Fisher test, as
you know. They are heavily reliant on people, on staffing. They
do not have enough lab technicians necessary to be actually
running these tests, and we have been trying to work with you
all to get other tests into Ohio, particularly tests that
require less of that staffing. My understanding is that you
have been willing to work with Ohio on that, but we are still
not there.
My question for you is: What can we do to get more testing
into Ohio? The Hologic test in particular is one that you have
access to that we need in Ohio. Seventy percent of our State's
deaths looks like occurred in nursing homes. There are only a
quarter of those deaths nationally, and that is an example
where we just need more testing so that in congregate settings
like that, we can be sure that the virus is not spreading,
because we do not have insights into what is happening without
testing.
Can you give us a sense of where we are in terms of getting
those tests to Ohio?
Admiral Giroir. Yes, thank you, Senator, and I really
appreciated our calls that we have had multiple times during
the pandemic. In addition to working with your State in the
plan that we outlined, we probably a week ago had a special
session with all of your leadership in Ohio because the
Governor was concerned about the relatively lower performance
of Ohio compared to other States.
The good news is that has changed pretty dramatically over
the past couple of weeks, so when we met with your teams, your
State health official, your State person who ran the
laboratories, a whole multidisciplinary team, it looked like
things were really on track, and I do think they are. You did
very well with your May goals, really within a stone's throw of
achieving exactly your May goals for testing. So that is
excellent.
In terms of specific machines, I just wanted to clarify
this, that like everything else, there is not enough of any
single material to go around and, therefore, it really requires
a couple different approaches. For things like swabs and media,
the market was so fragmented with multiple small producers that
literally the Federal Government buys the supplies, and we are
committed to doing that through December at a rate of about 20
million of each--tubes, media, and swabs--and distributing
those to the States, at least through December and maybe
further.
For other markets that are more mature, what we are doing
is matching the supplies that are in the market to the States.
In other words, we are helping match what the capabilities are
to what the States have. And that is where we are going to be
for the next few months, and we will do well. We did almost 12
million tests in May, which is just an enormous milestone and
very close to the State's full goals.
In terms of the specific questions you asked about Hologic,
I do want to be clear that not everybody is going to be able to
get the specific newest technology that they want the moment
they want it. We are going to have to deal with the existing
technologies. I call them the ``Ford trucks.'' I have a Ford
truck. I love my Ford Truck. It gets me places. But it is not,
a sports car, right? So the sports cars in the laboratory
environment like the Hologic Panther, they are new items. They
are being ordered, and we tracked down--and Ohio is actually
getting, I think, two or three of their machines within the
next couple of weeks.
So that is kind of where we are. Ohio is doing much better,
really moved up the charts in the last couple of weeks, and
your team seems to be satisfied, and we will continue to work
with them individually at any time. They are a really
professional, highly skilled, and collegial team, and we really
enjoyed working with them.
Senator Portman. Thank you, Admiral. My time has expired,
but we appreciate your service and the service of all of the
folks who work with you.
Chairman Johnson. Senator Romney.
OPENING STATEMENT OF SENATOR ROMNEY
Senator Romney. Thank you, Mr. Chairman. Can you hear me
OK?
Chairman Johnson. Loud and clear. Yes, thanks.
Senator Romney. Good. Thank you. Thank you, gentlemen, for
your participation on this panel today. Thank you, Mr. Chairman
and Ranking Member for calling this panel.
Some have hypothesized that Asia was able to respond more
quickly than the Western nations in part because they had the
experience with Severe Acute Respiratory Syndrome (SARS). They
learned from that experience, the old, COVID-19, fool us once,
shame on you; but fool us twice, shame on us. And so I do want
to look back at some of the things that we did not do terribly
well and try and understand why.
I know, Rear Admiral Polowczyk, you indicated you did not
want to talk about things that happened before, I think, March
19th. But given where you are, you probably have some
perspective on that. We did not have a very substantial
stockpile then, as you pointed out. We now have what sounds
like an ample and going stockpile that is going to be well
rotated, it sounds ideal. But why were we so, if you will,
short prepared with regards to our stockpile? Was it the
bureaucracy? Was it the administration's--I am not look for any
particular names. I am looking for where the problem was. Was
it Congress? Did we not provide sufficient funds to actually--
purchase the stockpile? Where was the problem? And how do we
avoid that in the future?
Admiral Polowczyk. Sir, again, I have a pretty good working
knowledge of the National Stockpile. I will tell you that the
Health and Human Services team brought that up from the Centers
for Disease Control in Atlanta to the Assistant Secretary for
Preparedness about a year-plus ago, and so, again, I was moved
from the Joint Staff as the Vice Director for Logistics in mid-
March and had not worked with the Health and Human Services
staff.
The National Stockpile has more in it than just pandemic-
related supplies. It also has a chem/bio focus, so it----
Senator Romney. Admiral, I have such a short period of
time. If you do not have a good understanding of where the
problem was with regards to medical supplies, that is fine. But
is that something you want to address or should I move on?
Admiral Polowczyk. No, sir. Again, I am not a Health and
Human Services employee. I was pulled to go forward and
stabilize the supply chain, and so I have not spent a
significant amount of time worrying about why they did or did
not do things in the past. So I would ask that maybe----
Senator Romney. That is fine. I think it would be helpful
if there is some effort to understand. That is so we can avoid
that in the future and be better prepared if needed.
Admiral Giroir, you spoke just momentarily ago about the
fact that you are coordinating the swabs and I think the
medium, which makes sense to me. When something is in short
supply, there needs to be coordination of how that gets
distributed throughout our country. But I think there is the
perception that at the very beginnings of this crisis that the
Federal Government said to the States, OK, Governors, you have
to get your own stuff. I am not sure which things were included
in that, but I did talk to more than one Governor who said that
they were scrambling on their own to try and find protective
equipment or try and find testing equipment, and they were
competing with each other and in many cases asking for more
than they actually needed because they knew they had to do that
in order to get what they might need.
As we look forward, can you help us put together a model
for what should be originated at the Federal level and what
should be originated at the State level? And I do not know
whether--I am sure it was not perfect in the past, but with the
experience that we have had now, I think it would be very
helpful if you in your role could say, hey, look, these things
need to be done federally, these things have to be done at the
State level. Is that appropriate?
Admiral Giroir. Yes, sir, and thank you for the question. I
think you are exactly on target. I will just make a comment
that during the early parts of this, from mid-March to mid-
April, we had absolute shortages. There was no question we had
shortages of everything, and we were in a posture of getting
requests through the FEMA system that is part of the
organization that they brought in trying to adjudicate those
requests as much as possible because we could not get
prospective like we are now in terms of testing. So it was
really down to how many new cases there were, what the
hospitals were in allocating those limited supplies.
Moving forward, from mid-April through now, we have been
able to be more prospective to provide States what they have
asked for up front, but you are exactly right that an overall
strategy and framework of how we work together, particularly in
diagnostics moving forward, is exactly what we need.
I think we have a working framework. It was built while we
were flying the airplane. But I think now is a good time to
look back and make sure that is precisely right and what we
need.
Senator Romney. Thank you, Admiral.
I am going to open this to all three of you, and I guess no
one is going to want to respond to it, but I will ask it
nonetheless. Do any of you see any gaps, any things we are
missing? We are asking questions based on our perceptions, but
you are right there. Are there some things we should be focused
on to prepare for the next pandemic that we are really not
thinking about? Or, for that matter, are there things we should
be thinking about with regards to the distribution of vaccines
through our country that we are not thinking about? Is
everything ready for the next time this happens? Or could you
direct us to places where we should be making a better effort?
Admiral Giroir. I will just make a quick comment, and we
are obviously working on this because when we see a gap, we try
to fill it. I think there is a lot of work on what we are doing
right now, and there is a lot of futuristic work through the
Rapid Acceleration of Diagnostics (RADx) Program. And these are
really fantastic things, but I think we have to work on
magnifying networking, improving process flow of what we have
right now, because we can get a lot more juice out of the
squeeze we are doing right now, and I really want to focus on
that, things like: Can we really pull samples so that we can
use one test to test ten people? I think we need to be working
with a lot more private partners, universities, Historically
black colleges and universities (HBCUs), other groups, in order
to make sure that we are reaching the populations we need to
reach and we are addressing all the concerns that they have.
So it is not that this is not being done, but I think we
have a lot of do it now and the futuristic things, but there is
a lot in the middle that we really need to focus on, because
that is where really the advantages are going to be reaped for
September and October.
Senator Romney. Thank you, Admiral. I see my time is up.
Mr. Chairman, thank you.
Chairman Johnson. Thank you, Senator Romney. Senator
Harris.
OPENING STATEMENT OF SENATOR HARRIS
Senator Harris. Thank you, Mr. Chairman. It is obviously
impossible to conduct oversight when FEMA has not provided
timely responses to critical questions on everything from
disaster preparedness to addressing racial disparities. So I
would first like to ask unanimous consent (UC) to enter into
the record the four oversight letters\1\ that I have sent to
FEMA during this pandemic for which I have not received a
response.
---------------------------------------------------------------------------
\1\ The letters referenced by Senator Harris appears in the
Appendix on page 661.
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Chairman Johnson. Without objection.
Senator Harris. Thank you.
This is directed to the full panel. In the midst of this
deadly epidemic, the President has stated that help from the
Federal Government was a ``two-way street,'' indicating that
States would only get assistance if their elected officials
were ``nice'' to him. There have been multiple reports that
while FEMA and other administration officials sought to
prioritize resources to States and localities most in need, the
President sought to prioritize his personal allies instead.
Mr. Gaynor, Mr. Polowczyk, and Mr. Giroir--is that the
correct--yes, thank you----
Admiral Polowczyk. No. It is Admiral Polowczyk, not
``Mister.''
Senator Harris. Thank you for that, Admiral. During the
Federal response to COVID-19, has the President, Admiral, or
any of the other panelists, or anyone at the White House
directed, suggested, or implied that you direct or redirect
resources to certain States or localities for political
reasons? Admiral, why don't you start?
Admiral Polowczyk. Yes, ma'am. Thank you. I have received
no direction from anybody over at the White House to tell me
where to send anything. We have a prioritization cell at FEMA
that takes CDC inputs and inputs from Dr. Birx to provide COVID
communities most in need, and so anything that was distributed
or sent was based on those priorities.
Senator Harris. And reports also suggest--this is a follow-
up to you--that the White House has intervened in the Federal
contracting process, which is designed, of course, to be devoid
of political interference. Has the President or anyone at the
White House ever directed, suggested, or implied that you
should award or deny contracts to specific entities? And that
is just a yes or no, please.
Admiral Polowczyk. I am not involved in the contracting
process, so I have no knowledge of that. The FEMA organization
has its own contracting staff, and they do not work for me, and
I have no involvement in contracting.
Senator Harris. Thank you. Mr. Gaynor.
Mr. Gaynor. What question do you want me to start on,
ma'am?
Senator Harris. The first one, please, which is during the
Federal response to COVID-19, has the President or anyone at
the White House directed, suggested, or implied that you direct
or redirect resources to certain States or localities for
political reasons?
Mr. Gaynor. Absolutely not.
Senator Harris. And has anyone at the White House or the
President ever directed or suggested or implied that you should
award or deny contracts?
Mr. Gaynor. Ma'am, when it comes to contracting, there is--
between a potential lead that comes from multiple different
places, so from Governors to Senators, from Congressmen, those
leads are generated, and they go into a validation system
inside FEMA. Between that lead and a contract, that chasm is as
wide as the Grand Canyon. Those things do not touch. I have the
highest confidence in my contracting team, acquisition and
procurement, that every contract was executed according to all
the Federal regulations, without influence from anyone in
government, no matter where they sit.
Senator Harris. Thank you. And, Admiral Giroir?
Admiral Giroir. Thank you, ma'am. The answer to the first
question is, no, ma'am, I have not been directed to put any
resources anywhere. It has always gone through the
prioritization cell or other HHS mechanisms. And for the
second, I have no knowledge of that. Again, I am not a
contracting officer either, so I am not involved in the
contracting process. But I do not have any knowledge of that.
Senator Harris. OK. Thank you. And the Federal Government
has a very bleak history, frankly, of failing to provide
adequate resources like food, housing, financial support, and
others to specific communities that have experienced a
disaster, and I am referencing the administration's response to
Hurricane Harvey in Texas and Hurricane Maria in Puerto Rico.
On April 24th, I led a letter with Ranking Member Peters
demanding answers to how the administration is addressing
racial disparities. I believe this has come up earlier in this
hearing. I finally received a response yesterday evening.
Unfortunately, it was inadequate, frankly, and referred to data
that HHS and CDC are collecting. But in a House hearing last
week, CDC Director Redfield acknowledged that HHS has not
fulfilled its responsibility to collect racial data. As it
relates to nongovernmental data, the ones that we have do not
indicate the mortality rate for--or they actually do indicate
that the mortality rate for black Americans is nearly 2\1/2\
times higher than for white Americans, and other minority
populations, particularly Native and indigenous communities,
are also disproportionately impacted.
So I asked this question of Admiral Giroir. I know HHS is
using a Social Vulnerability Index, so I thank you for that.
Mr. Gaynor, what specific action are you taking?
Mr. Gaynor. Yes, ma'am, if I can just address the letters.
So FEMA and my great partners are still responding to COVID-19
across the Nation, so that is an ongoing response. I have
received in excess of 300 letters from Congress. These are
numbers that we have not seen before, and we try to get to each
and every one of them as fast as we can. I think FEMA has a
great relationship with Congress about how fast we speed
responses to the Congress. So we will get to every one of
those, and so I apologize for the delay, but my effort and my
focus has really been on response.
To offset that, to include myself personally and my staff,
over 500 engagements with Congress, Governors, mayors on COVID-
19, providing all the up-to-date data we can get, including----
Senator Harris. I appreciate that. I only have a few
minutes left. But I would appreciate your attention to getting
a response for us as soon as possible. I thank you for that.
Mr. Gaynor. I will try to do that, ma'am.
Senator Harris. And my last question is: I had previously
asked about how FEMA plans to address the wildfire season, and
I have asked this a number of times to a number of different
people at FEMA, and we have still not received what is the
disaster preparedness response plan for wildfires, which
disproportionately impact my State, in the midst of the
pandemic. Can you tell me when we are going to get that?
Mr. Gaynor. Yes, ma'am. You actually have it. Again, I want
to step back. This whole system works locally executed, State
managed, federally supported. I was a local emergency manager.
I have a responsibility to my mayor, to my top manager, to my
tribal chief, to----
Senator Harris. I appreciate the chain of command, but,
sir, this is my question: We actually have a hurricane plan.
Mr. Gaynor. Yes, ma'am.
Senator Harris. Is that what you are referring to? Because
that is very different by nature than wildfire.
Mr. Gaynor. Although it does say ``hurricane'' on the
cover, in the first paragraph of the opening statement, it says
that the lessons learned in this can be applied to any
disaster.
Senator Harris. Let me point out a distinction between
hurricanes and fires and wildfires, and you can point my
direction to where in that pamphlet this might be addressed.
Hurricanes, we get forecasts. Thankfully, we have come to a
point where we have science and technology (S&T) that gives us
warning time. That is not the case with wildfires. So where in
your report is that fact addressed? Because I have spent time
with the families, the firefighters, in the midst of embers
burning during the devastation of the wildfires, and there was
no warning for the families that live in those communities,
much less for the firefighters and the first responders.
So can you tell me in your report where the nature of that
is addressed, including the fact that wildfires spread quickly?
They are not regional. They will spread quickly. And where is
that fact distinguished between wildfires and hurricanes?
Mr. Gaynor. Yes, ma'am. So it is true that there is a
difference in forecasting for hurricanes and wildfires, and so
you do not need to forecast to do actually planning. And so
what this encourages, every emergency manager across the
country, from the lowest level to the highest level, take their
existing plans. So if you have a fire evacuation planning in--
--
Senator Harris. Is there a reason you do not have a plan
for fires, for wildfires, and you only have a plan for
hurricanes? Because it is not addressed specifically in your
report.
Mr. Gaynor. Again, ma'am, the lessons in this guide can be
applied to any disaster. We are an all-hazards agency, so
specifically for this season, the hurricane season, it is named
the ``Hurricane Plan.''\1\ You can apply all the lessons
learned and best practices and resources to local/State
planning and disaster that----
---------------------------------------------------------------------------
\1\ The FEMA Hurricane Plan appears in the Appendix on page 678.
---------------------------------------------------------------------------
Senator Harris. I am sorry, sir. The firefighters in my
State would disagree with what you are saying in terms of
applying the same principles and standards in response to a
hurricane as to a wildfire.
Thank you, Mr. Chairman.
Chairman Johnson. Senator Carper.
OPENING STATEMENT OF SENATOR CARPER
Senator Carper. Gentlemen, nice to see you all again. Thank
you for your extraordinary service, and thank you for your
leadership during one of the most challenging chapters in the
history of this country, at least in the years that I have
spent on this Earth.
My colleagues would tell you--you do not know me well, but
my colleagues would tell you I am a glass-half-full guy. I take
to my heart the words in the Bible, ``In all things give
thanks.'' Sometimes that is hard to do. In the words of Albert
Einstein, ``In adversity lies opportunity.'' And sometimes that
is hard to realize, but this is adversity. God knows this is
adversity, and there has to be some opportunity here as well.
I served in uniform--never made it to Admiral. I made it as
far as captain. And I was, along with John--with the death of
John McCain, I am one of the last Vietnam veterans serving in
the U.S. Senate. I like to run down to the Lincoln Memorial. I
usually go home at night, but I love to run from here down to
the Lincoln Memorial. In fact, I always run by the Vietnam
Veterans Memorial as well. And there are 58,000 names carved
into that stone, and I think about them every time I run by
them. That is 58,000 names.
We learned this week--I would say this to Administrator
Gaynor: We learned this week, Pete, that the number of deaths
is not 110,000 in this country. It is 117,000. I just learned
that this morning. That is twice as many people who died from
this virus has died in the entire Vietnam War from beginning to
end. And that war was predicated on an untruth, and we paid a
severe price for that.
We are in a different kind of war today, and we are in a
war that you are trying to help us turn the corner on and turn
the tide. I just want to say that the work that you have
described, the efforts that you have described from men and
women in uniform, folks who are medical professionals, folks
who are in the private sector, who fly airplanes and move goods
from all across the world, heroic efforts. Heroic efforts.
We have somebody who is really close to our family who is
an anesthesiologist, and she is very special to us. She
graduated from her anesthesiology training, 4 years as an
about-to-be anesthesiologist, and finished last week. For
months, she has worked in a hospital intubating people so that
they could be placed into a coma and be placed on a ventilator
and hopefully survive. Most did not. And she is a hero is
well--a heroine as well. There are all kinds of people,
hundreds, thousands, tens of thousands across the country. And
I am inspired by them, and I am inspired by the efforts that
you described here today.
But what I am not inspired by are these numbers. In a world
where we in the United States have less than 5 percent of the
world's population, we have recorded more than 25 percent of
the world's deaths from COVID-19.
I have a friend who, when you ask him how he is doing, he
always says, ``Compared to what?'' And I am just going to say I
just want to compare the United States to what, and we are
117,000 and counting. New Zealand, 22; Singapore, 25; Taiwan,
7; Australia, 102; Canada, 7,800; South Korea, 274; Germany,
8,800; Japan, 916. China, and I do not know that I believe
these numbers, but with 1.4 billion people they are reporting
less than 10,000 deaths. Even if you doubled that, it is still
only 20,000.
And the thing that I have a hard time getting my head
around and understanding is how, by comparison, our deaths, how
have they reached these kind of staggering numbers by
comparison to these other nations I just mentioned. I am not a
real partisan guy, but I am just going to share with you what
may sound partisan, but it is the truth. I want to use these
words from our President. February 28, 2020, this is what he
said. He said, ``It is going to disappear. One day, it is like
a miracle, it will disappear.'' That was February 28, 2020.
March 6th, the President's words: ``Anybody that wants a
tests can get a test. That is what the bottom line is.''
Really? March 6th.
Here is March 10th, the same President, he said, ``This was
unexpected, and we are prepared, and we are doing a great job
with it.'' And he added, ``And it will go away. Just stay calm.
It will go away.''
March 24th: ``We have never closed down the country for the
flu, so you can say to yourself, `What is this all about?'"
And May 20th: ``When you say that we lead in cases, that is
because we have more testing than anybody else. I do not look
at that as a bad thing. I look at it as a badge of honor.''
That just flies in the face of the truth.
You have been asked and handed an incredibly difficult
challenge. And if truth be known, it is because we were really
late out of the starting gate, realizing what we faced, and
addressing it right up front.
A fellow who used to be the head of General Motors used to
say, ``Leadership is staying out of step when everyone else is
marching to the wrong tune.'' The people that you have to lead
have had to march a lot faster because of the lack of
leadership that we had in February and March and into April.
So I just want to thank you for the Herculean effort to try
to get us out of this crisis finally. And we are not there yet.
But because of your efforts, we will be there someday.
A question: When I was a Member of the House of
Representatives, I co-authored the reauthorization of the
Defense Production Act, one of the things I was proud of. I
have followed with interest the role that this administration
has played with respect to using the Defense Production Act.
But what is the role of this White House--this would be for
you, Admiral and Administrator Gaynor. What is the role of the
White House, if any, in steering Defense Production Act policy
in response to COVID? And, specifically, what is the role of
the President's Trade Adviser, Peter Navarro, in approving
Defense Production Act requests or shaping DPA policy? And I
would ask that of Admiral Polowczyk and Administrator Gaynor,
please. Thank you. In that order.
Admiral Polowczyk. Administrator, I will go first.
So any use of the Defense Production Act, no matter where
it may came from, so let me describe a little bit to you. As I
do my work, we have figured out that, N95 masks were in
incredibly short supply, a line on Asia. The first action that
I put over to the Joint Acquisition Task Force was increase
U.S. production of N95 masks. That work came back from the
acquisition professionals at DOD, came back in through the
Federal Emergency Management Agency, whose staff brought it to
the Unified Command Group (UCG), where Administrator Gaynor,
Dr. Kadlec and Admiral Giroir lead that, approved that item,
and then sent it to the White House, the NSC, to work through
the staffing at the White House. And then it was again briefed
to the White House Task Force for approval.
I would imagine that Mr. Navarro is in that management
process, but I have no firsthand knowledge of a Mr. Navarro
approval of something. It was all approved at the White House
Task Force. Mr. Gaynor.
Senator Carper. Just a brief response, if you would,
please.
Mr. Gaynor. Yes, sir. I wholly agree with the Admiral's
recital of how that process works. That is exactly how it
works. There is a function for that. We have used DPA, FEMA and
my other partners, 15 times, Title I, Title III, Title VII, all
those uses follow that process. And it is pretty
straightforward from my point of view.
Senator Carper. All right. Thanks very much.
Thank you, Mr. Chairman.
Chairman Johnson. Senator Hawley.
OPENING STATEMENT OF SENATOR HAWLEY
Senator Hawley. Thank you, Mr. Chairman.
Mr. Gaynor, let me start with you, if I could. I have
appreciated your help in getting Missouri, my home State, the
PPE and other resources that we need. I have written to you a
number of times. You have been responsive, and your agency, so
thank you for that. I want to ask you a question along these
lines. We just spoke to my Governor today, and the Governor
tells me that the State really wants to continue to buildup
their supply of PPE because of the second-line personnel, and
there we are thinking particularly of law enforcement, first
responders, clinics, others who are having trouble getting PPE.
The State wants to be able to resource them. Of course, they do
not have the ability, these particular personnel do not have
the ability to order directly themselves. They have to get
resourced by the States, and the State really feels they need
to continue to build their supply of PPE.
Would you be willing to work with me on that to make sure
that Missouri gets fully resourced and that these responders,
again, law enforcement, clinics, first responders, are able to
get what they need?
Mr. Gaynor. Yes, sir, and I just think for context--and I
think this is some of the dynamics we are trying to understand.
There are hospitals and nursing homes that had a pre-COVID use
for PPE, medical grade PPE. Now that COVID is with us, there
are other critical infrastructure factors that had no pre-COVID
use for PPE, especially medical grade. So trying to understand
exactly what some of these individuals or companies or private
sector are looking for, we would want to understand that. So I
would love to have a conversation about what exactly is the
delta. Is it medical grade PPE for medical purposes? Or is it
cloth facial masks? Because you need less than 6 feet to
actually get back to work in some business.
I think between the Admiral and I, we can help solve that
problem, identify the need, and then obviously identify a
source.
Senator Hawley. Great. Good. I think that making sure that
our law enforcement and first responders get appropriately
resourced is a priority that I would hope would be a high
priority, and I hope that you would be able to work with me on
that. So I will hold you to that.
Admiral Polowczyk, let me turn to you. Let us talk a little
bit about supply chain questions, which you were just
referencing in your answer to Senator Carper. I have been
following the work that you have done to expedite imports of
PPE. Project Airbridge, for instance, I applaud your work on
this. And my own view is that we are going to need to reshore
these critical supply chains for essential medical products as
soon as possible to make sure that we do not find ourselves in
a situation like the one we have confronted here in the last
several months.
But let me just ask you, in your assessment, Admiral, how
severely have export controls by other nations impeded the flow
of PPE or impeded our ability to acquire PPE?
Admiral Polowczyk. Senator, that is a great question. There
are a bunch of unsung heroes--the cargo pilots, the Federal
Express (FEDEX), the United Parcel Service (UPS), the National
Air Cargo. I could go on and on about those folks. China
changed the rules multiple times, subjected our pilots to all
sorts of tests, all sorts of other behavior, spraying them with
disinfectant. So it is not just export controls which China has
changed, as well as other nations have changed, that slowed
down or tried to interrupt.
In my opening remarks, I mentioned how fully involved the
Department of State was. I had great access to senior leaders
within the Department of State to bring up all of these issues
to them, and they continued to work great efforts to loosen
controls. Every time China changed a process, the Department of
State was able to work with the ministerials there, along with
asking countries like Malaysia to put workers back in glove
factories. So unsung heroes, the Department of State, you may
not be thinking about all of the partnerships. This was a great
partnership between FEMA, the Department of State, and others.
Senator Hawley. You mentioned China. Let me just ask you,
lots of Chinese companies have no experience in producing
medical equipment but retooled their factories to produce PPE
during this crisis. Can you give us a sense of the quality of
those Chinese products?
Admiral Polowczyk. Right. So one of the things we did,
realizing that everybody said that they had or they could
produce--I was very skeptical of those things. So very early
on, I realized there was really nothing to buy that the health
care supply chain already was not working to bring to the
points of care needed.
So, again, we used the Department of State. They deployed
members in country to go actually visit vendors, go look at
warehouses. And then FEMA let a contract with Underwriters
Laboratories to actually go do inspection for us so we would
not bring inferior product back to the United States.
Senator Hawley. Very good. Broadly speaking, Admiral, how
would you assess the State of our domestic productive capacity
when it comes to PPE, the sorts of devices we have been talking
about?
Admiral Polowczyk. So currently it is starting to ramp up.
Let me just give you a slight metric. We essentially make zero
nitrile gloves in the United States, and so we are working with
one or two companies--the Joint Acquisition Task Force has
identified several manufacturers that could ramp up to make
nitrile gloves, and so that will be a forthcoming DPA action.
N95 masks, we already had some U.S. production going into
the middle of March. We used the Defense Production Act to ramp
that up from 30, 40 million masks a month to 180 million masks
a month, which I think will be sufficient.
Then there are other items such as ventilator drugs, which
are going to be significantly more difficult because the
advance pharmaceuticals come from multiple places across the
globe. And so we are working a process to onshore those along
with things like penicillin. My comment to you would be that is
going to be a little bit more of a rheostat than a light switch
because it is going to take a little bit more investment and
process to go work, where it is going from very little to a lot
more.
Senator Hawley. Give us a sense of what you think the delta
is right now between our needs and our domestic productive
capacity, if you had to spit ball one.
Admiral Polowczyk. N95 masks, I think we are ramping up to
meeting our needs. Something like disposable gowns, we are in
that process to start making more non-woven fabric, and so that
one we have turned to our textile industry to make textile
gowns, non-disposable gowns, and so that is 50 percent there,
but on a ramp to be there by the fall.
Senator Hawley. Very good. Thank you, Mr. Chairman.
Chairman Johnson. Thank you, Senator Hawley.
I have a 12:15 commitment, so I want to wrap this up before
then. I have just got a couple quick questions.
Admiral Giroir, can you explain why is so important to have
a less than 10 percent positivity rate in terms of testing and
what is our current metric on that?
Admiral Giroir. Yes, thank you, Senator. This gets to the
question of how many tests are enough, and the number of tests
that are needed in New Jersey and New York and Massachusetts
and the Detroit area are going to be different than what is
needed in Montana, Wyoming, and other areas just because of the
overall disease.
One reasonable metric that everybody can sort of get their
hands on is what we call the ``percent positivity of tests.''
That means if you do 100 tests, how many of those 100 are
positive? It is generally accepted that we should shoot for a
rate of under 10 percent. So for 10 percent, that means you are
testing ten people for everyone one positive. You can sort of
understand if 80 percent of the people you test are positive,
you do not have enough tests out there. So that is a general
metric. It is one that the World Health Organization (WHO) says
is an objective. It is generally accepted by most
epidemiologists. It is not a magic number. It is not written on
stone tablets.
Nationally right now we are at 5.8 percent positivity,
which means, by that metric we are in a pretty good range. I
follow this every morning per State. Right now there is only
one State and the District of Columbia that is outside of that
10-percent range, and they are right on the margin. Again, we
are not going to stop there, but that is a metric that we can
look at to give us an idea about how we are doing. You see when
there is an outbreak in a certain State, like in a meat-
processing facility or something, that percent positive goes
up, and we need to ramp up our testing more.
Chairman Johnson. One thing that really drove a lot of this
policy was the scary numbers coming out of China, for example,
about 3.4 percent case fatality rate. I have been monitoring
the Oxford Center for Evidence-based Medicine. Their current
estimate is somewhere between 0.1 and 0.41 infection fatality
rate. The 9-year average for seasonal flu is 0.13 percent; a
bad year--2010, 2011--it was, I think, 0.18.
Currently, do we have an estimate in terms of what we think
the infection fatality rate is going to be globally on COVID-
19?
Admiral Giroir. So several months ago, I came into the
Senate and House--it was a joint session--and we made the
estimate back then that the infection fatality rate was going
to be about 0.1 to 0.5 percent. There was a lot of yelling and
screaming that we were underestimating it, but it is going to
be in the 0.1, 0.2 percent range. Again, whatever the rate is,
117,000 is----
Chairman Johnson. There is no doubt about it.
Admiral Giroir. But it is going to be in that rate, and it
is going to vary from country to country. I expect our
infection fatality rate to be lower than many countries. It is
going to be higher than some. But it will be in that range. I
think in the spirit of this hearing, this could be considered
one of the best of the worst cases because we could have had a
virus where that fatality rate was much higher. So as godawful
as this has been and how much suffering this has brought, I do
consider us in one of the best of the worst cases, and we need
to prepare for a lot worse.
Chairman Johnson. So we have talked about not having enough
PPE for long-term-care facilities. New York, they forced long-
term-care facilities to keep COVID patients--Florida said no
hospitals, you keep them. Because there is a higher fatality
rate, obviously, if you are particularly 75 and over, why
wasn't there a game plan? Or should we have a game plan moving
forward to transfer those that test positive for COVID out of
elderly care and into some kind of segregated hospitalization
system? Where, by the way, the PPE could be utilized far more
efficiently and effectively than in a long-term-care facility.
Admiral Giroir. So thank you for that. As was pointed out
earlier, 40 or 45 percent of all our deaths occur in elderly,
primarily in long-term-care facilities. In an ideal world--and
we do not live in an ideal world. In the theoretical world, you
could put an elderly person back into a long-term-care facility
and do the appropriate isolation. That is very difficult to do
given the amount and range of employees and all the
interactions.
So Centers for Medicare and Medicaid Services (CMS) have
put out some very specific guidelines about how we need to
test, how we need to test weekly for workers in long-term-care
facilities. And the CDC continues and will have more guidelines
soon about how we really need to cohort. But I think in general
it is a very dangerous practice to put actively positive
patients back into an environment that you cannot contain it,
particularly those of the highest vulnerability.
Chairman Johnson. It seems like we really ought to be
moving them out of there into a different type of facility.
Admiral Giroir. Into a different type of facility or into a
long-term-care facility where everybody is positive so that
they are cohorted. But, cohorting by room or even by hallway is
just a very difficult thing to do. It is something that
hospitals can do, but the 15,000 long-term-care facilities
often with workers who have minimal training and low wages is
just very difficult to make that happen. So I think you really
need to apply the extra precautions that you are suggesting and
that we are recommending.
Chairman Johnson. I see that Senator Sinema just joined us,
so, Senator Sinema, are you ready?
OPENING STATEMENT OF SENATOR SINEMA
Senator Sinema. Thank you.
I want to first start by thanking the Chairman and our
witnesses for holding today's hearing. Arizona has been
significantly impacted by the coronavirus. Over the weekend, we
crossed the 1,000-death threshold, and the Navajo Nation
continues to experience unrivaled per capita infection rates.
Last week, the University of California, Los Angeles (UCLA)
American Indian Study Center made the illustrative point that
if tribal nations were counted as States, the five States with
the highest infection rates in the country would all be tribal
nations. So our tribes are hurting badly, and they need our
help.
My first question is for FEMA Administrator Gaynor. Unlike
State and local governments, tribes do not have a tax base to
generate revenue. Funding for essential tribal programs comes
from the Federal Government or tribally owned enterprises. As a
result of the COVID-19 pandemic, tribes are not generating
revenue, which is leading to the closure of vital services. As
a result, many tribal governments do not have the funding
necessary to pay for emergency protective measures ahead of
reimbursement.
Yesterday I and many of my colleagues sent a letter to FEMA
requesting advance payments, possibly similar to Section 428
public assistance alternative procedures. Can you work with me
to find an alternative pathway for tribal governments on this
issue?
Mr. Gaynor. Yes, ma'am. I cannot say I have seen the
letter, but I would be happy to work with you and your staff on
a way forward. And just again, for context, specifically with
the Navajo Nation, a significant amount of effort from all our
partners to include Health and Human Services, Indian Health
Service, the States of Arizona, New Mexico, and Utah, all in
support of the Nation. We have provided nearly $5 million of
direct Federal support to the Navajo Nation, and, again, the
Indian Health Service has provided an allocation of about $80
million, again, all to help the Nation deal with COVID-19.
So, again, I would be happy to work with you and your staff
on a way forward.
Senator Sinema. Thank you. I have a follow-up question for
you. Many tribal governments contending with the coronavirus
outbreak have not previously worked directly with FEMA. Tribes
that elect to seek direct assistance from FEMA must overcome a
number of administrative hurdles. These requirements include
completing a FEMA Tribal Agreement providing proof of an active
emergency response plan and completing a public assistance
administrative plan before they can apply for reimbursement.
Streamlining this administratively burdensome process would
allow tribal governments expedited access to the funding
necessary to save lives and protect their public safety.
How can FEMA streamline this process for the duration of
the pandemic?
Mr. Gaynor. Yes, ma'am, again, through our Regional
Administrators across the country, there is a special
relationship with the federally recognized tribes and the
Federal Government. They can work through their State if they
decide to do that, or they can come directly to us, and we will
do either way. Again, we will provide technical assistance to
any tribe who needs help, and, again, I do that through my ten
regions. Again, if there is a specific tribe you are talking
about that needs that technical assistance or more, we would be
happy to provide that to them.
Senator Sinema. Thank you. We are going to follow up with
you because we do have some tribes that do need this direct
technical assistance, so I appreciate that.
My third question: The Arizona Department of Emergency and
Military Affairs has expressed concerns with FEMA's guidance
that says that the agency will be the arbiter of duplication
decisions between FEMA Category B and other Federal funding
available to the State. And yet there has been little guidance
to address the many areas where overlap in eligibility may
exist. Could you explain how this process works in practice?
And then my second question would be: When can we expect to
see complete written eligibility guidance to address those
areas of potential overlap?
Mr. Gaynor. Yes, ma'am. So no matter COVID-19 or any other
natural disaster, we are always worried about--especially if we
are competing with another Federal agency that may have
jurisdictional like authority, we always want to make sure that
we do not do a callback because we have duplicated benefits.
COVID-19 has been a little more challenging mainly because of
all the different kinds of COVID-19 supplemental money--CARES
Act money. And so we want to work thoughtfully through that to
make sure that the appropriate agency owns that problem and
those that are trying to use that money derive the greatest
benefit from that money, in some cases under the Stafford Act
it is a 75-25 cost share. Maybe if you used another agency,
like HHS, maybe it is 100 percent.
So we are working through all those variables, and, again,
we would be happy to work with you and your staff about trying
to untangle that so any jurisdiction can maximize the Federal
benefit when it comes to whether it is Stafford Act or CARES
Act.
Senator Sinema. Thank you.
Thank you, Mr. Chairman. I yield back.
Chairman Johnson. Thank you, Senator Sinema.
I have just one final question, probably for either the
Rear Admiral or the Administrator. We talked a little bit about
this earlier, but, again, there is going to be a fair amount of
complexity of really honing in on how to handle the Strategic
National Stockpile moving forward. The question I have is: Who
is going to be making those decisions? And when will those
decisions be made?
Admiral Polowczyk. Senator, I will start. Those decisions
on the National Stockpile will work its way through the Unified
Coordination Group up to the White House Task Force. What I
mean by that is levels of inventory--I have personally briefed
the Vice President on where I think the high end is. We are
working with Health and Human Services to bring to bear the
resources Congress provided in the CARES Act to go do that. The
administration, the President has already agreed with, more on
the shelf, more items, like swabs were not there, the inventory
practices of using the commercial marketplace potentially to
rotate inventory. So I would say, sir, that the decisions have
already been made, but as we get down to the actual resources
being applied, the numbers, I hold that up through Health and
Human Services, the UCG, to the White House Task Force.
Chairman Johnson. Administrator Gaynor.
Mr. Gaynor. Yes, sir. There are plenty of lessons learned
over the past 90 days when it comes to PPE and the National
Stockpile. I know that the Admiral is on the next-generation
SNS Task Force. We will take all those lessons learned, and we
will make the best decisions to make sure that we are ready in
the short term, over the summer and into the fall, if there is
a second wave. And then, obviously, for the longer term, I
think that is probably the greater challenge: How do we sustain
all these great lessons learned over the long haul not to get
put back in the position that we see ourselves in today?
So this is an ongoing working effort, and we will continue,
again, to be part of that process. And we would love to have
input from Congress on that on how to make it better, how to
fund it, and, again, we would be happy to work with you and
your staff on all those things.
Chairman Johnson. You will need not only input, but you
will need consultation from Congress. This is going to be a
long-term process. One of the things I have found a little
frustrating, we set up about ten members of our staff on really
oversight of COVID-19, National Stockpile, the supply chain
vulnerability. For example, this Committee does not even get
information on the National Stockpile. That goes to the United
States Senate Committee on Health, Education, Labor and
Pensions (HELP) Committee. Perfectly appropriate for that, but,
really, this is a long-term process. We all need to take
responsibility for this, which means we all need to be on a
long-term basis involved in the process. So it has to be that
collaborative effort. It cannot just be one administration, one
time, or it sits on the shelf and it gets forgotten. This
really ought to be an annual hearing out of this Committee to
take a look at that, where we sit and what we anticipate in the
future.
Again, I really do want to thank----
Admiral Polowczyk. Can I add something? I do not mean to
interrupt you.
Chairman Johnson. Sure.
Admiral Polowczyk. I bring analogies of how we treat
readiness in the Department of Defense, and the readiness of
whether it be the stockpile, the health care supply chain, or
the readiness of health care in the Nation, I think this has
shown that there is a potentially different way that we should
be thinking about it. I echo your concerns that it should not
be a one-and-done. I did not fully understand your question, I
think, when you asked me. I do think there is a ton of
collaboration that needs to happen to help change mind-sets of,
hey, I just put some stuff on the shelf and I am good to go.
How resilient are we? I think in things of great power
competition, and I think you could see where great power
competition may have led us in other areas of resiliency. And
so I do think that there is--and I am just suggesting that
maybe there is, like you said, an annual hearing on the
readiness of those things that we desire to be resilient. I
think you are on the right track, sir.
Chairman Johnson. I appreciate that.
Admiral Giroir. I absolutely agree with that, and, just as
the pediatrician in me, the pediatric Intensive Care Unit (ICU)
doctor, it is not just being resilient for the event that we
are facing but what have we had to give up in the normal health
care system in order to achieve that. Childhood immunization
rates have plummeted during the COVID pandemic. Our screening
for colon cancer, breast cancer, cancer across the--has gone
down. We have had many more cardiovascular attacks in the home
and sudden deaths. So in terms of resiliency, I would even
broaden the view even more, that it is not just about what we
are attacking at that point, but what we have had to give up,
and how do we have a total system resiliency, how do we meet
that.
Chairman Johnson. I have always chafed when I hear people
talk about we are going to cancel elective procedures, because
one person's elective procedure is somebody else's lifesaving
treatment or lifesaving diagnostic test, and we cannot forget
that. The whole goal of the shutdown was to flatten the curve
so we would not overwhelm our health care system. Fortunately,
we did not overwhelm our health care system. What we did is we
underwhelmed it in so many cases and, it has resulted in
layoffs. There is a lot to be learned. There are a lot of tough
decisions being made with imperfect information. I do not want
to be critical of those, but we have to look back. We have to
analyze what we did, what we did not do right, what we did do
right, but we really need to be better prepared in the future.
I want to thank all three of you. I truly want to thank the
men and women that work with you. I think it has been an
extraordinary effort. Right, it has not been perfect. How could
it possibly be? But what is always so true in America, when we
face these crises, we really do see just the absolute best come
out of our country, the doctors and nurses, the grocery store
clerks. I mean, throughout our country people have stepped up
to the plate to keep this country as together as possible
during a crisis. Quite honestly, it does inspire me. So, again,
thank you all for your service.
The hearing record will remain open for 15 days, until June
24th at 5 p.m., for the submission of statements and questions
for the record.
This hearing is adjourned.
[Whereupon, at 12:13 p.m., the Committee was adjourned.]
A P P E N D I X
----------
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
THE ROLE OF THE STRATEGIC
NATIONAL STOCKPILE IN PANDEMIC RESPONSE
----------
WEDNESDAY, JUNE 24, 2020
U.S. Senate,
Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Committee met by videoconference, pursuant to notice,
at 10:01 a.m., Hon. Ron Johnson, Chairman of the Committee,
presiding.
Present: Senators Johnson, Portman, Lankford, Romney,
Scott, Hawley, Peters, Carper, Hassan, Sinema, and Rosen.
OPENING STATEMENT OF CHAIRMAN JOHNSON
Chairman Johnson. Good morning. This hearing will come to
order.
I want to welcome and thank all the witnesses for their
participation and for their thoughtful testimony. I will ask
unanimous consent (UC) to enter their full testimony into the
record as well as Dr. Gerberding has requested that ``Ending
the Cycle of Crisis and Complacency,'' their report,\2\ be
added into the Congressional Record, as well as my opening
statement.\1\
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Johnson appears in the
Appendix on page 817.
\2\ The report appears in the Appendix on page 58.
---------------------------------------------------------------------------
Again, I want to thank everybody for participating.
Coronavirus disease 2019 (COVID-19) continues to inflict a
terrible human and economic toll on the United States. In just
over 5 months, the United States has experienced over 120,000
deaths and over 2 million total infections, and tens of
millions have lost their jobs. As Congress reviews our response
to COVID-19, it is important to take the lessons we have
learned during this crisis to better prepare for a pandemic or
other biological event of this scale in the future.
The focus of today's hearing is the Strategic National
Stockpile (SNS). First established with a $51 million
appropriation in 1998 as the National Pharmaceutical Stockpile,
the SNS was codified in 2002 and obtained its current name with
an expanded mission in 2003. Over the years, management
responsibility for the SNS has changed between different
agencies within the Department of Health and Human Services
(HHS) and the Department of Homeland Security (DHS).
In developing a plan for this Committee's oversight of the
Federal Government's response to the Coronavirus, the role of
the Strategic National Stockpile was an obvious area of
interest, as is the vulnerability of our supply chain, and they
are very interrelated. I had assumed that staff would be able
to quickly obtain the list of items that should be held,
together with the required and actual inventory levels of each
item. Once again, I learned that it is dangerous to assume. We
quickly found out that those lists do not exist or certainly
are not made available to Congress or the public.
As we will hear in testimony, it is not from a lack of
dedicated individuals working within the agencies or with the
Strategic National Stockpile. Instead, it seems to be a more
pervasive problem of a lack of clarity and understanding of
exactly what the SNS' role is and what it should be. As
indicated above, to the extent there has been a congressional
or executive branch articulated mission statement, it has
evolved over time, and outside the managing department or
agency, it has not been generally understood.
We are paying the price for this lack of articulation and
clarity during the current pandemic. The frustration expressed
by State, local, tribal, and territorial (SLTT) governments and
their elected representatives is largely caused by the reality
that demand for so many of the needed products and supplies has
dramatically exceeded supply--both in the form of available
inventory and production capacity.
As a manufacturer in the private sector, whenever I was
faced with a problem, I always asked what opportunity presented
itself in finding a solution. The same dynamic can apply here.
As the men and women who are working tirelessly to address the
current demand develop data and models, that information needs
to be captured and put immediately to use updating and
redesigning the structure and management of the Strategic
National Stockpile.
Again, I would like to thank our witnesses today for their
testimony, their past efforts, and any future help they can
provide to improve our Nation's response to future pandemics.
With that, I will turn it over to Senator Peters.
OPENING STATEMENT OF SENATOR PETERS\1\
Senator Peters. Thank you, Mr. Chairman, and thank you to
our witnesses for being here today.
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Peters appear in the Appendix
on page 818.
---------------------------------------------------------------------------
Over the past several months, the United States has faced
an almost unprecedented challenge, fighting a deadly virus that
has infected millions and taken the lives of more than 120,000
Americans.
A pandemic can overwhelm even the most prepared
communities, and that is why we have the Strategic National
Stockpile, the Nation's largest store of lifesaving
pharmaceuticals and medical supplies, to ensure the Federal
Government has the resources to help States protect the health
and safety of Americans during a public health emergency.
But the scale of the Coronavirus pandemic depleted our
national stockpile in just a matter of weeks, leaving State and
local governments scrambling to acquire the masks, the gloves,
and other supplies that were so desperately needed in order to
keep people safe.
Many communities facing the highest rates of infection
struggled to obtain the supplies that they needed, including my
home State of Michigan.
Instead of providing a coordinated, national approach to
effectively using the Strategic National Stockpile and other
tools to acquire and distribute supplies nationwide, the
President told States that they were on their own. That move
forced States to compete against each other and the Federal
Government for lifesaving medical supplies that were already in
shortage all across the world.
Since this crisis began, Congress has passed several
supplemental emergency appropriations bills to rebuild the
stockpile. While this funding will help provide some stability,
there is no question that our Nation would have been better
positioned to tackle the pandemic if Congress and both the
current and prior administrations had invested more in the
stockpile before this crisis struck.
It is abundantly clear that the Federal Government was not
fully prepared to address a crisis on the scale of the
Coronavirus pandemic. And the result is the tragic loss of
120,000 of our fellow Americans and millions of families who
have suffered the consequences.
Ensuring the preparedness of the Strategic National
Stockpile is an issue of national security and should be
treated as such. We cannot allow a disaster of this magnitude
to catch our government off guard again. We must provide steady
funding to all our pandemic response efforts and also ensure
that the Strategic National Stockpile is well maintained and
prepared to address a broad range of possible threats.
We must improve the communication between States and the
Federal Government regarding available resources and strengthen
the Federal Government's role in managing supplies during this
and future crises.
Finally, we must also take steps to address our
overreliance on foreign manufacturers of critical drugs and
medical supplies.
This is a serious national security vulnerability, and the
pandemic has only further highlighted just how significant this
risk is to the health and safety of the American people.
So today's discussion will help us identify and prioritize
critical decisions and investments to ensure we can continue to
combat the Coronavirus as well as emergencies in the future. I
look forward to hearing from all of our witnesses and look
forward to working alongside each and every one of you to deal
with this very daunting challenge.
Thank you, Mr. Chairman.
Chairman Johnson. Thank you, Senator Peters.
It is the tradition of this Committee to swear in
witnesses. You do not need to stand, but if you will raise your
right hand. Do you solemnly swear that the testimony you will
give before this Committee will be the truth, the whole truth,
and nothing but the truth, so help you, God?
Dr. Gerberding. I do.
Mr. Gerstein. I do.
Mr. Phelps. I do.
Mr. Burel. I do.
Chairman Johnson. Thank you.
Our first witness is Dr. Julie Gerberding. Dr. Gerberding
is the former Director of the Centers for Disease Control and
Prevention (CDC) and the former Administrator of the Agency for
Toxic Substances and Disease Registry. Dr. Gerberding is now
the executive vice president for strategic communications,
global public policy, and population health and the chief
patient officer at Merck. She also co-chairs the Center for
Strategic and International Studies (CSIS) Commission on
Strengthening America's Health Security. Dr. Gerberding.
TESTIMONY OF JULIE GERBERDING, M.D.,\1\ FORMER DIRECTOR (2002-
09), CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Gerberding. Chairman Johnson, Ranking Member Peters, as
well as the distinguished Members of the Committee, I am really
honored to have a chance to talk with you today about the
Strategic National Stockpile because I know what an incredibly
important asset it is and I know how disappointed some people
have been in certain aspects of its deployment and performance
this year.
---------------------------------------------------------------------------
\1\ The prepared statement of Ms. Gerberding appears in the
Appendix on page 820.
---------------------------------------------------------------------------
I am going to testify in front of you from four
perspectives: first and foremost is my background as an
infectious doctor who was hospital epidemiologist at San
Francisco General and responsible for occupational safety of
health workers in the early acquired immunodeficiency syndrome
(AIDS) era and an expert in personal protective equipment (PPE)
and how to really keep health workers safe.
As you mentioned, I also co-chair, with former Senator
Kelly Ayotte, the CSIS Commission on Strengthening America's
Health Security, and thank you for accepting that into the
record.\2\
---------------------------------------------------------------------------
\2\ The CSIS Report appears in the Appendix on page 58.
---------------------------------------------------------------------------
I also am the chief patient officer and an Executive Vice
President (EVP) at Merck, where we have engaged from a
manufacturing perspective with various interactions with the
U.S. Government in our efforts to bring an Ebola vaccine
through the licensure process for the emergencies in the
Democratic Republic of the Congo (DRC) and West Africa, but
also other products that are germane to our overall health
security.
And then, finally, I will say that I was the CDC Director
during not the very beginning of the stockpile but in its
infancy, and I watched it evolve over time. I visited several
of the sites where the stockpile is hidden in plain sight and
participated in observing some of the exercises of deployment
and so forth. I have a pretty deep knowledge of what is in
there and how it has evolved over time and what we may need to
be doing going forward.
I do believe this is a strategic national asset. We are
somewhat unique in the world in having such an asset at our
disposal, and obviously it is an enormous investment and one
that we need to make the best of.
It is incredibly innovative, and I would say overall
through its entire history it has been reasonably well managed
from a budgetary and fiscal responsibility perspective, and it
has been innovative in its approaches to preparing for many
challenges.
But in spite of that overarching point of view, I recognize
that there are important areas where the stockpile needs
clarification and improvement, and I will just mention a few.
I think the most important thing is the clarification and
consistency of the strategic intent of the stockpile. It has
gone from being something that was oriented toward
bioterrorism, then to all hazards, chemical, biological,
radiological, and nuclear (CBRN) preparation, then influenza
pandemic. There have been debates and inconsistencies in
whether or not it was conceived as something that would be
deployed locally, not preparing for a national crisis of a pan-
American scale, if you will, to where we are now today where we
needed it to be able to meet the needs of our health system
across the entire country.
It is also not clear whether it is an asset that should
operate as a stand-alone entity and be prepared to provide for
all the needs or whether or not it is there to augment what
States and health care settings are already doing and have
hardened into their own planning. So that inconsistency has led
to somewhat of a ping-pong approach to what should be in it and
how to make decisions about procurement.
I think there is another opportunity for improvement in
terms of the accountable leadership of the stockpile. As you
know, it has moved back and forth from the CDC to DHS to CDC to
HHS, and Federal Emergency Management Agency (FEMA) has been
involved in the logistics of the current deployment. So there
has not been consistent and accountable leadership for really
making sure that, No. 1, there is clarity of strategic intent;
but, No. 2, that the stockpile consistently delivers in support
of that intent and that there is accountability and measurement
of the success.
I think a third area for improvement is the budget process.
It is impossible for Congress or anyone else to be able to
budget to the stockpile if there is not clarity about what it
is supposed to accomplish at what scale. What has happened all
too often is that the tail wags the dog, so we may have ideas
about what the stockpile should be capable of supporting, but
the budget is the thing that determines what actually gets
procured. The current budget going into this event was not
adequate to provide for the kind of PPE that we needed for a
pan-American infectious disease pandemic. In part, that is
because there was not consistency in exactly what the
requirements were for the stockpile and whether it was
supplemental to the States or whether it was intended to be
able to supply the full force.
I think last there is a real opportunity to improve the
engagement with the private sector. As you have said, our
supply chains are very problematic, and the people who know the
most about that and have the most to contribute are people in
the private sector who I believe would be only too willing to
engage to think through how can we improve resilience, agility,
and surge capacity in support of this strategic national
defense.
The last point I would make is one that has not come up
through the CSIS process, but I think as the commission moves
forward, we would be very willing to take it on, and that is
that the stockpile is not a warehouse full of stuff. The
stockpile is a capability, and it needs to be thought of not
just in terms of what do we buy but how do we learn how to
deploy and utilize those resources at the State, local,
territorial, and tribal level, in collaboration with the health
system and the public health end users. And that means a strong
exercise curriculum, continued deployment and utilization
capability enhancement, and a cycle of planning and improvement
that is inclusive of the front-line personnel.
I will stop there and, again, just thank you for the
opportunity to testify. I am looking forward to the comments of
my esteemed colleagues. Thank you.
Chairman Johnson. Thank you, Dr. Gerberding.
Our next witness is Dr. Daniel M. Gerstein. Dr. Gerstein is
a senior policy researcher at the research and development
(RAND) Corporation. Prior to his work with RAND, Dr. Gerstein
served as the Acting Under Secretary and Deputy Under Secretary
at the Department of Homeland Security's Science and Technology
Directorate. Before his time with DHS, Dr. Gerstein served in
the U.S. Army, both in active duty and as the Principal
Director for Countering Weapons of Mass Destruction (CWMD) in
the Office of the Secretary of Defense. Dr. Gerstein.
TESTIMONY OF DANIEL M. GERSTEIN, PH.D.,\1\ SENIOR POLICY
RESEARCHER, RAND CORPORATION
Mr. Gerstein. Good morning, Chairman Johnson, Ranking
Member Peters, and distinguished Members of the Committee. I
thank you for the opportunity to appear today and discuss the
future of the pandemic preparedness and response and the
Strategic National Stockpile.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Gerstein appears in the Appendix
on page 824.
---------------------------------------------------------------------------
While I will focus a majority of my remarks on looking
forward, I do want to briefly assess the U.S. response to date.
In short, COVID-19 has exposed serious weaknesses in our
national preparedness and response systems. The United States
relies on a just-in-time medical delivery system that lacks
resilience in terms of crisis. We are also witnessing an
inability to scale at that national level to meet the demands
of a public health emergency.
Overall, the Federal response has been slow and
inconsistent, confusing at times, and has deservedly become a
target of criticism. We have seen shortfalls in areas from the
basic science to our emergency management governance and
doctrine through strategic communications with the American
people.
One particular concern is the Strategic National Stockpile.
Several key SNS issues have been evident, including unrealistic
expectations for the SNS, the historical underfunding of the
stockpile, lack of timely decisions regarding energizing supply
chains, and the Federal Government's altering of the mission of
the SNS during this national emergency.
Looking to the future, a bipartisan commission should be
established to review the Nation's performance during this
pandemic. Basic assumptions regarding emergency management and
disaster preparedness and response, including the role of
government at all levels, should be on the table. One outcome
should be agreement that public health must be elevated to and
receive prioritization and funding as a national security
issue, just as the Department of Defense (DOD) and intelligence
community (IC).
Specifically, I offer five recommendations for improving
our Nation's preparedness and response capabilities.
First, reexamine the SNS concept. Congress should ask for a
complete accounting of the SNS performance during this
pandemic. The mission of the SNS should also be reconsidered. A
new mission statement, codified in law and not subject to the
whims of any administration, should be developed to signal the
capacities and limits of the stockpile. The Federal Government
owes this to the State and local authorities. The agreed
stockpile concept must be stress tested and optimized through
training and exercises to ensure it meets the preparedness and
response goals that have been set.
Second, develop a strategic national supply chain approach.
Rather than consider the SNS as a discrete element, it needs to
be thought of as part of a broader national supply chain that
combines stockpiling and direct contracting with manufacturers,
warm production lines for some key commodities, procuring large
quantities at the national level to take advantage of economies
of scale, and shortening supply chains. The goal should be to
determine the most effective and efficient methods for ensuring
critical needs will be met for the envisioned SNS scenarios.
This would require mapping out critical equipment and supplies
to allow for a determination of their anticipated availability
over time.
Third, increase public health funding. Years of
underfunding of State, local, tribal, and territorial public
health programs should be reversed. These shortages affect
preparedness and response for a wide variety of naturally
occurring public health events, accidents and natural
disasters, and deliberate attacks. During the COVID response
these shortfalls have negatively affected staff support to
government leaders at all levels, biosurveillance activities,
contact tracing, stockpile shortages at the beginning of the
pandemic, and broader supply chain issues. Public health
shortages have also adversely affected the CDC and National
Institutes of Health (NIH).
Fourth, develop the vaccine distribution system now. An
important part of the supply chain for this current pandemic
will entail the distribution of a vaccine when it becomes
available. While a vaccine may be ready by early 2021, much
remains to be done to ensure timely distribution. Planning
should be ongoing now for administering a vaccine here in the
United States and globally. Only after a large portion of the
world's population is immunized will COVID-19 be controlled.
Fifth, reestablish U.S. leadership in global public health.
U.S. leadership is needed now more than ever. International
collaboration will be vital for understanding the spread of the
disease and developing medical countermeasures. We should also
seek to repair our relationship with the World Health
Organization (WHO) while working to make the organization more
accountable. We need the WHO to serve as a conduit for
information and to coordinate with other nations as the COVID-
19 disease spreads to other parts of the world and for future
health crises.
In conclusion, some have called the novel Coronavirus a
``black swan event,'' an event that is unforeseen. I reject
this characterization. We have had ample evidence of the
potential for a global pandemic. However, competing priorities,
inadequate funding, and a lack of national focus led us to
ignore this potentially existential threat until it was too
late. Unfortunately, we will see more pandemic events in the
future given human activities that disrupt environmental
habitats, promote the mixing of species, and allow humans and
pathogens to crisscross the world along global supply chains.
Efforts should be made now to ready ourselves for such a future
event.
Thank you for inviting me to speak today, and I look
forward to your questions.
Chairman Johnson. Thank you, Dr. Gerstein.
Our next witness is Andrew Phelps. Mr. Phelps is the
director of Oregon's Office of Emergency Management. Previously
Mr. Phelps managed the New Mexico Department of Homeland
Security and Emergency Management's Local Preparedness Program.
He also served as the planning section chief for New Mexico's
Emergency Operations Center. He appears before our Committee
today on behalf of the National Emergency Management
Association (NEMA). Mr. Phelps.
TESTIMONY OF ANDREW PHELPS,\1\ DIRECTOR, OREGON OFFICE OF
EMERGENCY MANAGEMENT, ON BEHALF OF THE NATIONAL EMERGENCY
MANAGEMENT ASSOCIATION
Mr. Phelps. Thank you, Chairman Johnson, Ranking Member
Peters, and distinguished Members of the Committee for inviting
me today.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Phelps appear in the Appendix on
page 842.
---------------------------------------------------------------------------
I am proud to present testimony representing the National
Emergency Management Association. On behalf of my colleagues,
we thank you for holding this discussion on the Strategic
National Stockpile during the ongoing response to the COVID-19
pandemic.
The 122,000 COVID-19-related deaths in the United States,
190 of them Oregonians, each life lost has a profound impact on
responders, State and national leaders, and me personally.
Preventing loss of life is why we do what we do. Our heartfelt
condolences go out to those currently diagnosed, recovering
from, or bereaving the loss of a loved one during this
pandemic.
Governor Brown took bold action early, likely saving
hundreds if not thousands of lives. Comparatively speaking,
Oregon has fared well to this point in the fight against COVID-
19. We have utilized our entire emergency management system,
including [inaudible] logistics, to support the important work
of our public health partners and the Oregon health authority.
We continue to adapt our structure to compensate for
insufficient Federal resources and continuing guidance. For
instance, there was initial confusion as to whether Coronavirus
Aid, Relief, and Economic Security (CARES) Act funding would
enhance or replace programs typically available through Federal
disaster assistance. We expect bold action from the Federal
Government. When it became apparent that the SNS PPE allocation
would be a fraction of what was planned for and what was
[inaudible], we began preparing PPE on our own. To date, Oregon
has received only 15 percent of the surgical masks and 5
percent of the gowns we were expecting.
While the major disaster declaration was certainly
appreciated, Oregon has yet to receive a response for a
requested investment of 75 percent Federal cost share submitted
nearly 3 months ago. At least 44 other States are also awaiting
a response. This lack of commitment added to an already
uncertain financial [inaudible] as we manage this national
crisis. We also await confirmation and guidance regarding
reduced Coronavirus Relief Fund (CRF) dollars [inaudible]
public assistance grants [inaudible] some of the critical
response possible. This lack of guidance and unwillingness to
commit to a cost-share adjustment leaves States in limbo,
nervous about improper spending of CRF dollars, and slows our
recovery efforts. Our experience in Oregon is shared by many of
my colleagues across the country. It has led to six initial
recommendations for improving the capacity of the SNS to
support State and local pandemic response.
We need to understand inventory and demand. As keepers of
the SNS, the Federal Government [inaudible] programs. States
can integrate these shortfalls into planning assumptions and
preparedness action. State and local pandemic emergency plans
rely on SNS support in times of crisis. States need to know
what they can or cannot expect from the SNS. We have to
strengthen this [inaudible]. Rather than only maintaining a
large stockpile [inaudible] our Federal partners [inaudible] to
support States' critical needs of supply chain metrics
[inaudible] manufacturers [inaudible]. Throughout the response,
nearly every State [inaudible] external reliance on critical
supply national security put States in an unfamiliar role
[inaudible] some States [inaudible]. The average delivery time
for gowns to one State was 46 days. Supplies are [inaudible]
sometimes faulty supplies like [inaudible] masks, counterfeit
respirators, [inaudible] or boxes that were fractions of what
we paid them.
We must empower States and resource [inaudible]. To relieve
some demand on the SNS, States should be encouraged to
establish stockpiles. At a minimum, this should be done
regionally, and when possible, shared between State Emergency
Management Assistance Compact (EMAC). Some States receive
[inaudible] some equivalent, more equivalent [inaudible] than
they receive from the SNS.
Other recommendations included in my written testimony
focus on [inaudible] and enhanced tracking [inaudible].
As a Nation, we remain in active response mode to COVID-19,
[inaudible] uncertainty. Overall, any failure in the system
does not rest solely with the SNS. Challenges with authorities,
communication, and a lack of investment in the emergency
management system at all levels have left us unprepared. The
supply chain for PPE lacks transparency and relies too heavily
on foreign entities. We have seen a lack of expectation
management for what the SNS can and cannot do for officials
managing a complex, statewide, national event. Addressing these
interrelated issues allows for a more sustainable and flexible
response system through which States can utilize the SNS to
respond to any disaster with greater efficiency, confidence,
and most importantly, public trust.
Thank you for the opportunity to testify today, and I look
forward to any questions you may have.
Chairman Johnson. Thank you, Mr. Phelps. I was able to hear
you, but your audio is not coming in real strong. Your video
looks good, so maybe you want to see if maybe you have a
different microphone when you start answering some questions.
Our next witness is Greg Burel. Mr. Burel is the former
Director of the Strategic National Stockpile, a position he
held for 12 years. Prior to that, Mr. Burel served as FEMA's
Director of Administration and Resource Planning and Senior
Disaster Logistics Official. Mr. Burel is the president and
principal consultant for Hamilton Grace LLC. Mr. Burel.
TESTIMONY OF GREGORY BUREL,\1\ FORMER DIRECTOR (2007-20),
STRATEGIC NATIONAL STOCKPILE, U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mr. Burel. Chairman Johnson, Ranking Member Peters and
Members of the Committee, thank you for the opportunity to
testify on the Role of the Strategic National Stockpile in
Pandemic Response. I am honored to continue to support the
mission of this critical organization by testifying today. I
had the privilege of serving as Director for almost 13 years. I
am a Fellow of the National Academy of Public Administration
and, as Chairman Johnson noted, president of Hamilton Grace
LLC.
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\1\ The prepared statement of Mr. Burel appears in the Appendix on
page 849.
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For more than 20 years, the SNS has protected national
health security as the Nation's repository of medical
countermeasures, both drugs and devices. SNS is a highly
specialized and capable organization, but its utility for
certain responses, such as those for a nationwide pandemic
event, are constrained primarily by a lack of funding.
When SNS was established as the National Pharmaceutical
Stockpile, the design was to develop inventory to respond to
chemical, biological, radiological, and nuclear threats. By
December 2019, the inventory was valued at around $8 billion.
Over time, SNS' highly specialized exceptional medical
logistics capabilities became apparent across government. As a
result, SNS expanded to an all-hazards mission. But instead of
``mission creep,'' SNS actually experienced ``mission gallop.''
Such a leap in expectation cannot occur, however, without
commensurate increases in funding. Appropriations simply have
not kept pace with the growing burden to expand inventory and
capability to meet all-hazards mission expectations.
The statutes require a threat-based annual review that
drives decisions to define the desired available content of the
SNS. The review is conducted under the auspices of the Public
Health Emergency Management Countermeasures Enterprise
(PHEMCE). PHEMCE is comprised of those best experts across
government in disease threats and other specialized medical and
scientific areas. They recommend the content to be held in the
SNS. The top level PHEMCE committee is actually led by the HHS
Assistant Secretary for Preparedness and Response (ASPR), and
it includes the Director of CDC, the Director of National
Institute of Allergy and Infectious Disease (NIAID), and other
highly senior officials across government. This group makes the
final decisions for the SNS contents based on the
recommendations of the other experts.
But because appropriations are limited, it is necessary to
balance a risk-based need across threats to purchase the best
mix of products when we try to buy down that risk. It is also
notable that statute requires SNS prioritize products that are
simply unavailable in the commercial market. Many things
procured by the SNS are purchased and held nowhere else. These,
for example, include the only Food and Drug Administration
(FDA)-licensed botulinum antitoxin, which saved lives and
reduced illness during the 2015 outbreak in Ohio. Simply put,
without SNS procurements, these products would not be developed
or manufactured, and there is insufficient demand for these
product outside the Federal Government for them to allow
continued development and manufacture.
Any lack of national public health preparedness does not
sit solely or predominantly with SNS or any other individual
entity, but is instead the result of insufficient investment in
public health at all levels of government. Limitations on
manufacturing compound these problems, and the Nation also must
rely on a very lean medical supply chain, which, while
optimized for the best value, is less than optimal for crisis
response.
In the early 2000s, Congress authorized supplemental funds
to prepare for pandemic influenza. Much of the products
developed in that process were used to respond to the 2009 H1N1
pandemic flu, and additional funds were never reauthorized to
replace that material.
State, local, tribal, and territorial public health are
another key piece of the public health preparedness puzzle, and
they have a vital role to play. These levels of government are
responsible for planning and response in their unique
jurisdictions so that Federal assets can be called upon and
used correctly when other options have run out. Prior to the
2009 H1N1 response, many States had their own stocks, and these
were ultimately disposed of later due to declining funds. State
and local public health must be funded.
Public health overall must be consistently and robustly
funded. We have a long history of heavily investing in public
health when it is clear there is a problem. The further we move
from those significant adverse events, the public memory fades
and funds often decrease along with that. Our way forward must
include more consistent mandatory funding for public health and
include a greater emphasis on public-private partnerships. The
Nation is better prepared with government and private sector
working together for preparedness.
I would welcome the opportunity to work with my fellow
panelists, the Congress, and all other stakeholders to improve
the SNS and our public health preparedness.
Thank you again for the opportunity and the invitation to
participate today.
Chairman Johnson. Thank you, Mr. Burel.
I do not think there is any doubt that we are going to have
to provide more funding for the Strategic National Stockpile.
But I think the first step--and I think it is an incredibly
important first step--is it needs a mission statement designed
and codified and articulated clearly.
The only one we can find right now is on the HHS website.
It is not a codified statement, but let me read the current
mission statement for the SNS:
``The Strategic National Stockpile's role is to supplement
State and local supplies during public health emergencies. Many
States have products stockpiled as well.'' I am not sure that
is really true. ``The supplies, medicines, and devices for
lifesaving here contained in the stockpile can be used as a
short-term stop-gap buffer when the immediate supply of
adequate amounts of these materials may not be immediately
available.''
I think we just described what the problems have been. The
Strategic National Stockpile implies we have this massive
amount of well-thought-out supplies and we have them adequately
stocked to handle a pandemic. There is nothing in the mission
statement that even talks about the level of supplies we would
need for a massive pandemic like we are going through right
now.
So if that is the role we expect the Strategic National
Stockpile to play, we need to articulate that. We need to
codify that. So from my standpoint, the first step is, as
Congress, we have to codify and articulate the mission
statement that we intend. We need to assign the proper roles
between local, State, and the Federal Government. And then the
next step is going to be, really lay out that list.
I want to start with Mr. Burel. Was there a different
mission statement when you were head of the national stockpile?
Has this been modified? Has this been reduced?
Mr. Burel. Senator Johnson, thank you for the question. I
think that you have described the situation we find ourselves
in extremely well. Originally, we were working toward building
stocks, as Dr. Gerberding even noted, to respond to biological
terrorism, chemical, radiological, nuclear events. What we have
seen over the years is more and more emphasis has been placed
in the Strategic National Stockpile to be prepared for all
hazards.
Unfortunately, funding has not followed to be prepared for
every hazard, particularly a nationwide pandemic. What we have
been able to do is concentrate on that primary mission that we
have held from the beginning, and that is establishing stocks
of CBRN materials that really do not exist anywhere else. We
have developed capabilities to be able to respond to those
types of events. They have been used well also to respond to
natural events. We have responded, I think successfully, to the
H1N1 pandemic, and it really comes back to an issue of: What is
the emphasis that the Congress chooses to give the SNS? How can
it be funded to meet all of the many requirements that it is
called upon to meet?
Chairman Johnson. Again, I want to talk about at what
level. I mean, to be the sole supplier? To stockpile or having
manufacturing capability to provide every N95 mask? I mean, is
there no responsibility for the State and local governments to
stockpile? Again, I think there is such a lack of clarity of
what that mission statement is. You can say, we were going to
stockpile these kind of supplies. OK. At what level?
I know in my briefing I saw that with Ebola we have
stockpiled 50 Ebola kits. Fifty. Now, fortunately, we did not
need all those 50, but we might have needed thousands of tens
of thousands. Or, in the case of this pandemic, we literally
need hundreds of millions if not billions of some of these
supplies.
So I will ask you, Dr. Gerberding, do you agree that just
first it has to be to define the mission of what the SNS is
going to be about? We can talk about what inventory items, but
unless we really know what its mission is, what its role is,
and what State and local government roles are, we are still
completely blind and will come up short.
I cannot hear you, Dr. Gerberding.
Dr. Gerberding. Thank you. That is exactly what I hoped to
try to emphasize in my written testimony and my oral comments.
If we do not have a consistent and clear strategic intent that
the whole-of-government agrees with--and when I say ``whole-of-
government,'' I mean State and local, territorial and tribal,
not just Federal--we are just bouncing around from the last
crisis to the next crisis and not really consistently building
that level of preparedness.
That is why one of the main recommendations from the CSIS
report is that we establish permanent leadership of our health
security at the level of the National Security Council who has
accountability for articulating, among other things, the
strategic intent of the Strategic National Stockpile to support
the level of health security our Nation intends to achieve.
Chairman Johnson. In a number of different situations,
whether it is cyber, whether it is biodefense, and now here, it
seems like the recommendations of these commissions have been
consistently somebody has to be in charge. While I do not
disagree with that, I do not necessarily think it is going to
be that person that should lay out this mission statement. I
really do believe this falls to Congress working with the
administration, possibly working with that individual to codify
what this statement is so that everybody knows what the role
is, what the level of the role is.
Dr. Gerberding. I agree with you, Senator. I believe that
the national strategy for health security is a responsibility
of the National Security Council, but Congress is the bill
payer, and obviously, in order to build the stockpile that we
need, Congress needs to direct the strategic intent, in support
of the national security agenda but, nevertheless, it would be
a great help to have that clarity and consistency from
Congress.
Chairman Johnson. Mr. Gerstein, real quick, again, I really
appreciated your testimony. You laid things out quite nicely.
Once we have established that mission statement, we are going
to have to then identify the items; we are going to have to
figure out certainly what the inventory levels and the
manufacturing capability needs to be. I think you hit it in
your testimony. I do not think this should be filling a bunch
of distinct warehouses. This needs to be looking at the entire
supply chain and figuring out exactly how this flows through
that. At what level do we have excess inventories? And how do
you keep rotating stock? I mean, this is actually a pretty
complex logistics problem here. Would you agree with that?
Mr. Gerstein. Absolutely, Senator. I think you have hit it
right on the head. We look at the SNS, and we are having a
discussion about the SNS, and we are very focused on this
particular program and set of facilities. But I think it goes
broader than that. It is actually understanding where supplies
come from and making strategic decisions about how to satisfy
the requirements we anticipate.
There is not enough money, unless we completely redid lots
of different programs, in order to outfit for every envisioned
scenario. But what we can do is understand where supplies and
equipment, reagents and such, will come from and be able to map
those in and determine what are those choke points that we need
to resource or have manufacturing here in the United States,
what are those that we can outsource. We need to understand the
timelines in which we can satisfy those.
So I would like to see it as part of a broader discussion.
The SNS definition is absolutely essential starting out, but
then we also need to on all sides of that talk about things
like stockpiling and direct contracting and warm production
lines and procuring large quantities. We need to have an
agreement with the States and the locals in terms of what are
they going to do and what are the Federal responsibilities. It
is very important so that the expectations on all sides by all
stakeholders, including industry, who is an absolutely
essential stakeholder, needs to be able to come to the table
and talk about how they would assist in this process.
Chairman Johnson. I am out of time, but let me make my
final point. I think we absolutely have to change the name of
the Strategic National Stockpile. I think it is misleading.
That will be one of the components of what we need to do here.
We will have to stockpile some things. This is more a
coordinating role, very similar to FEMA, where we really rely
on local governments to do what they can do first; when they
cannot handle it, the States step in; when they cannot handle
it, the national government steps in. So there are certain
things that only the Federal Government can do, but it is a far
more coordinating role.
So I guess for my colleagues, as we look at potentially
legislative fixes for this, I would first suggest we need that
mission statement, and we need a new name; because, otherwise,
we will continue to mislead people and have them believe that
literally there is all this PPE just sitting in a stockpile and
why don't we have our fair share. Why can you not supply us
everything we need? Again, the frustration--and it is a
legitimate frustration, but it is because we simply do not have
the supplies to meet the enormous demand in this type of
situation.
With that, I will turn it over to Senator Peters.
Senator Peters. Thank you, Mr. Chairman, and thank you to
each of our witnesses for your very comprehensive opening
statements, and I appreciate your testimony here today.
I want to spend a little time focusing on the supply chain,
which has come up repeatedly in testimony as well as in some of
the answers to the questions from the Chairman. So my first
question is to Mr. Burel. Certainly this pandemic has exposed
our country's reliance on foreign countries to provide critical
medical supplies to us, particularly China, which manufactures
critical drugs and medical supplies. In fact, last year I
released a report from this Committee identifying
vulnerabilities and called for action to address what is
fundamentally in my mind a national security threat given our
reliance on these foreign entities.
So my question to you, Mr. Burel, is: As the former
Director of the SNS for 13 years, what is your opinion on our
reliance on foreign suppliers for critical drugs and medical
supplies? And what steps specifically would you believe that we
should be taking in order to address this threat?
Mr. Burel. Senator, I am as concerned as anyone else about
our overreliance on foreign-produced products. I think that
this is a significant issue that we face in this particular
event, but in all events as well. If something disrupts that
supply chain outside the United States and we cannot do
anything about it domestically, we have a significantly worse
issue than we would otherwise.
Some of the things that I think we can do is encourage
manufacturing to come back into the United States. I think that
we also have a responsibility to expand those public-private
partnerships so that we can understand what it is going to take
to get the private sector to come back and do more
manufacturing and how they can create more robust capabilities
themselves, whether it be more manufacturing, additional
security stocks of finished products, additional security
stocks, for example, in the drug world of active pharmaceutical
ingredients.
So I believe that we must encourage continued relations
with the private sector in a strong, comprehensive, cooperative
way so that we can together find the best way forward not just
for these events but for all health care needs in the United
States. We see drug shortages routinely, and many are impacted
by the situation you describe.
Senator Peters. Thank you.
Dr. Gerstein, the same question to you. Do you have any
recommendations on how the Federal Government can work more
effectively with the private sector to address this national
security threat?
Mr. Gerstein. I do. I think that we have to make known what
the requirements are going to be that the Federal Government in
coordination with the State, local, tribal, and territorial
governments sees as what will be required for a pandemic or for
any sort of event that we intend to have the SNS or whatever
follows it, because whatever we intend to have is the set of
scenarios. But I guess, it all comes down to really mapping
this out very methodically and understanding the types of
scenarios that we intend to be prepared for and building
resilience and flexibility into the system.
This virus has been very different than, say, what we faced
in the H1N1 in 2009 or during Ebola, and if history is any
indication, we need to design it with a great deal of
flexibility. So I would say that we should rely on U.S.
innovation. We should get with stakeholder communities,
including the private sector, and we need to figure out what
their capacities are. In some cases we do need to have warm
lines available that can be turned on very rapidly.
We know if it is going to be a global pandemic, we are
going to face the exact same set of circumstances with a global
competition which is unhelpful, but it is a matter of what is
going to go on for other nations to try to get supplies that
they might need. So we need to be prepared and build in
resilience.
And make no mistake, though, Senator. It will cost money to
prepare for this, but we have done this in other areas where we
have prioritization, and we should do it for global public
health or for U.S. public health as well.
Senator Peters. Very good. The point about how we have to
have more information I think is significant, and my
understanding is that ASPR does not have the information that
it needs to inform planning for the Strategic National
Stockpile or to sufficiently protect critical infrastructure
such as essential manufacturing plants that we may have here in
this country. For example, ASPR should know the location of
where those manufacturing plants are for some of the active
ingredients, the Active Pharmaceutical Ingredients (APIs), and
other critical drugs.
I have actually introduced legislation called the
Pharmaceutical Accountability, Responsibility, and Transparency
(PART) Act which would address this by--it actually requires
the FDA to share certain manufacturing data with ASPR and the
DOD to help serve the drug supplies. So maybe your comments on
what would be additional information required by this PART Act,
how would that help us prepare for future pandemics, natural
disasters as well, national security threats?
Mr. Burel, I am going to ask you to comment as well, but,
first, your comments. You have been certainly focused on the
lack of information. I would love to have your thoughts, Dr.
Gerstein.
Mr. Gerstein. Yes, I think you have hit it right on the
head, Senator. We need to understand in the same way that other
corporations who are providing supply chain support--I will not
name them, but I think we all know who many of them are. They
know who their suppliers are. They know what happens and, what
their lead times are and what happens if their supply chain is
disrupted. So they have developed a business model that makes
sure that they do not ever run out of those items within the
supply chain. And we need to do the same thing. We need
information.
One of the problems that occurred, interestingly, when you
had the transition from CDC to ASPR and then during this
immediate pandemic to FEMA providing some sort of support, an
interesting outcome was that it was not clear that FEMA knew
where all the stockages were. So they did not have the initial
understanding of what was remaining in the stockpile. FEMA is
good with management and logistics, but they do it for the
sorts of supplies they typically rely on for natural disasters
and such. This is a very specialized set of requirements that
is inherent in the SNS, and so not having that information is a
little bit like trying to make allocations with blinders on.
Senator Peters. Thank you. I am out of time now. Mr. Burel,
we will get back to you to get some information from you. I
would like to get your viewpoints as well. But thank you for
your testimony.
Thank you, Mr. Chairman.
Chairman Johnson. Senator Portman.
OPENING STATEMENT OF SENATOR PORTMAN
Senator Portman. Thank you, Mr. Chairman.
First, I want to thank you all for having the hearing and
to our witnesses, and this is a critical issue not just with
regard to the pandemic but going forward. We need to change our
approach. I agree with the Chairman that there needs to be a
mission that is clearly defined. I also agree and was struck by
Dr. Gerberding's comments about the lack of consistent
accountable leadership. I have experienced some of that in
dealing with the issues of PPE. But when you go from CDC to
ASPR to DHS to FEMA to Defense Logistics Agency (DLA), there is
a lack of consistent leadership and certain accountability. I
know there are some interagency groups. As an example, Mr.
Burel talked about the deal with the contents of the Strategic
National Stockpile. But the problem is there does not seem to
be consistent and accountable and performance measures are not
in place to be able to keep people accountable. So a mission is
a good idea, but leadership to me is critical.
I wondered, Dr. Gerberding, since you raised that issue, if
you could comment on what that leadership ought to be, and
perhaps, Mr. Burel, you could comment on that as well.
Dr. Gerberding, are you there?
Dr. Gerberding. Yes, I am on. Can you unmute me, please?
Can you hear me now?
Senator Portman. We can hear you.
Dr. Gerberding. OK.
Senator Portman. Tell us what your solution is in terms of
leadership and accountability.
Dr. Gerberding. I wish it was that easy, sir. As I tried to
express, people think of the stockpile as a warehouse of stuff
we buy and store, but it really is a capability. And there are
different aspects of capability, and they may not all need to
be under the same roof.
For example, ASPR probably is the right place to do the
contracting and procurement for novel countermeasures that need
that NIH-Biomedical Advanced Research and Development Authority
(BARDA) close interface for decisionmaking, prioritization,
procurement, and management of those contracts and processes.
But the stockpile utilization and planning is a very
operationally driven effort, and to me that is why you have
operating agencies like the CDC that is intimately connected
with the users of the stockpile and is in a great position to
be able to understand what are we aiming for, where are the
gaps, and how do we plan, exercise, deploy, and improve our
ability to be sure that the stockpile does meet the local
requirements?
So in my world, I think the accountability for the
operation of development, management, exercise, and deployment
of the stockpile is best suited for an operating agency like
the CDC, but the aspects of the contracting and procurement of
these new and novel countermeasures and other things that may
be on the innovation forefront, that is the kind of thing that
ASPR and BARDA are really designed to do well. It is not a one-
size-fits-all solution, but I think you can hold the
accountability to the leaders who are responsible for their
specific performance measures and requirements. And that has
never really happened.
Senator Portman. I am going to ask you to think about that
a little bit because it seems to me you said leaders, plural.
If no one is in charge, then it is very difficult to hold one
entity accountable. So I would challenge you on that, and I
think CDC, if you say that is the operational entity, it
certainly did not work this time. So I would challenge you to
just give us some more clear guidance as to how do you get
exactly what you identified, because it is absolutely right
that you need consistent, accountable leadership----
Dr. Gerberding. Senator, could I just very quickly come
back to that is why we need the national strategy, and I do
agree one person needs to have the accountability. My own view
is that person should be the Director of the CDC because that
has been my experience and my framework for that. But that does
not mean that other agencies do not have specific
responsibilities, and I think it is that sort of having an
accountable leader, plan horizontally, and make sure you
execute vertically with the appropriate measures of success.
Senator Portman. That is helpful. I will say I am also
intrigued by what I have heard today about our lack of
understanding of the needs for a pandemic like this, but also
the reality with regard to CBRN, everything else out there that
the stockpile was supposed to be for initially, including a
nuclear attack, let us say, CDC may not be the right entity for
that. It is the Center for Disease Control, not for a
biological or nuclear attack, which would be more of a war
footing.
So, anyway, I think we need to do some thinking about that,
and we need to figure out what is the right leadership model to
go along with the appropriate strategy.
With regard to this issue of PPE and the stockpile, my
great frustration is that we do not seem to be doing the
obvious things to be able to reshore our PPE, and I would ask
the question, I guess, of the entire panel here and see who
would like to answer it. But do you agree, one, that we need a
reliable source of PPE in the stockpile? Therefore, do you
agree with me that we ought to be reshoring PPE--not all of it,
depending on, again, what we find is the real mission of the
Strategic National Stockpile, but some of it, enough of it to
be able to be reliable. By the way, with something like a
global pandemic, you cannot rely on global sources that you
might otherwise, because they need the PPE also. We certainly
learned that in the last few months.
I have a real frustration with the Executive Branch not
providing long-term contracts, because for domestic reshoring
you have to have the market signal that you are going to have a
customer, and that customer is going to be the U.S. Government
in terms of the stockpile at the national level. It may be the
States; it may be even some private sector entities that are
given responsibility here. But we do not have that now. DLA is
only issuing contracts for 90 days right now.
So my question is: Do you agree that we need to give
industry this clear signal to build up our capacity? And do you
think that it is necessary to have a reliable surge capacity?
You are on the video, so what do you think?
Dr. Gerberding. I will start just by saying that we have to
understand from the standpoint of PPE that we are supply
constrained. It does not really matter whether it is in the
stockpile or whether it is in the health care system or the
State. We have a supply constraint there, and that is the first
and foremost thing we need to concentrate on remediating. And,
yes, I agree that the more we can build out our national
capacity in that regard, the more secure we will be in the
context of a global pandemic.
The other point about long-term contracting I could not
agree with more. As the company that just got an Ebola vaccine
licensed and are under contract to fulfill a certain number of
doses for our stockpile, what happens when that ends? We have
built a factory to make this vaccine, and we are going to be
sitting with idle capacity because there really is no future
there.
Senator Portman. You will not have the investment, and I
hope to hear from the other panelists as well, but I know my
time is up. Let me just say that today I am sending a letter to
DLA along with three other Republicans and three Democrats
asking for them to change their policy with regard to the 90-
day versus a long-term contract so that U.S. companies can make
that investment with certainty to be able to bring PPE back to
our shores.
Thank you, Mr. Chairman.
Chairman Johnson. Is Senator Carper ready?
Senator Portman. Mr. Chairman, by the way, could I ask
unanimous consent to have that letter be made part of the
record?\1\
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\1\ The letter referenced by Senator Portman appears in the
Appendix on page 856.
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Chairman Johnson. Absolutely. Without objection.
Senator Portman. Thank you.
Chairman Johnson. Senator Carper, are you available?
OPENING STATEMENT OF SENATOR CARPER
Senator Carper. I am here.
Chairman Johnson. OK. Go ahead.
Senator Carper. Good morning, everyone. Our thanks to our
witnesses. I do not know who lined up these witnesses, but this
reminds me of the New York Yankees back in the 1930s. This is
like the Killers' Row. What talent. Nice work.
In reading through the testimony, rereading it during this
hearing, I have been looking at, Mr. Gerstein, what you said
about recommendations. You made five recommendations, and I am
just going to repeat them. What I am going to do is ask the
other three witnesses if they agree with you on any of these
five recommendations. All right? That is going to be my
question.
The first recommendation that you make is to reexamine the
Strategic National Stockpile concept, and let me just say for
those of you who agree with that, raise your hand. If you agree
with that recommendation, reexamine the SNS concept, raise your
hand. OK. Some of you are raising two hands.
All right. The second recommendation you make is develop a
strategic national supply chain approach. Develop a strategic
national supply chain approach. If any of you agree with that,
would you also raise your hand, please? OK. Thank you.
The third is to increase public health funding. Increase
public health funding. If you agree, please raise your hand.
All right.
Mr. Gerstein, you are not agreeing with your own
recommendation. [Laughter.]
All right. The fourth one is to develop the vaccine
distribution system now. Develop the vaccine distribution
system now. We got some two hands on those. All right. Good.
And, finally, to reestablish U.S. leadership in global
public health. If you agreed with that? Yes, oh, good. All
right. Mr. Gerstein, you have a lot of support there from your
colleagues.
Mr. Gerstein. That is always good to hear, Senator.
Senator Carper. I wish I did that well among my colleagues.
You enjoy that position.
I have a couple other questions. This next question is for
all of our witnesses, and let me just take a moment to discuss
the importance of oversight. Our Committee is an oversight
Committee. That is what we do. That is what they pay us the big
bucks for. I often like to point to the Government
Accountability Office (GAO's) High-Risk List as our to-do list
for our Committee here in this Congress. GAO provides this
Committee every 2 years specifically with routine information
on government programs that help us do a better job in
conducting oversight. Actually, they give us the High-Risk List
every 2 years.
The Strategic National Stockpile has been managed and
overseen by several different agencies over the years, and it
appears that effective management would require agencies
partnering with each other and with Congress to ensure that the
stockpile has the resources and management needed to respond to
a national emergency.
A question again for all the witnesses. What additional
actions should Congress and the administration consider taking
to ensure that effective oversight of the stockpile is being
conducted on a regular basis? Anybody want to take a shot at
that? Let us start with Dr. Gerberding.
Dr. Gerberding. Thank you, and I do not have a short answer
today, but as I do co-chair the CSIS commission, I would say
that I, with former Senator Ayotte, oversee a panel of some
incredible experts but also some bipartisan Members of Congress
on both the Senate and the House side--Senators Young and
Murray and Representatives Eshoo, Cole, Bera--and I forgot my
fourth member. I apologize. But the point is that we are well
positioned to be able to perhaps provide some advice on that
issue and would be interested in doing that.
Senator Carper. Tell Kelly her old colleagues send their
best, OK?
Dr. Gerberding. Thank you.
Senator Carper. Same question. What additional action
should Congress and the administration consider taking to
ensure that effective oversight of the stockpile is being
conducted on a regular basis? Mr. Burel, would you like to take
that?
Mr. Burel. There are several different things that can be
done. I am a Fellow of the National Academy of Public
Administration (NAPA) has done a good job in the past making
recommendations to Congress about how to manage government
programs, how to think about government programs. NAPA might be
an excellent source to try to get involved in thinking in these
things.
I think one of the things that I would suggest is the good
thing about the oversight particularly would make people more
aware of what the SNS does, what the SNS needs, and how to move
forward. So I think to help suggest a comprehensive oversight
structure beyond what exists today, I, as Dr. Gerberding
suggested, would love to come back to you with additional
thoughts on that.
Senator Carper. That would be great. I am going to ask our
other two witnesses to answer that question for the record.
I have a different question relating to GAO that I would
like to ask of Mr. Gerstein and Mr. Phelps. That question is:
Should an independent organization such as GAO be tasked with
regularly reviewing the stockpile and reporting on its ability
to respond to a national emergency? Do you think that is a good
idea?
Mr. Gerstein. Senator, this is Dan Gerstein. If I
understood--you broke up a little bit there, but I think you
were asking about should an organization such as GAO do
periodic reviews. And in answer to that, I would say, having
been subjected to many reviews during my fairly lengthy service
in government, I would say absolutely. The reviews will be
important, especially given that we are talking now about
redefining what the SNS is, thinking about turning it into an
element within a national supply chain for public health
equipment and supplies, and all of that is really something
that is going to require somebody to take a look at it.
An issue that you also brought up had to do with--and I
will use the military term, and that is ``command and
control.'' I think it is going to be very important to
understand--and the GAO is well suited to look at this and to
determine, if things are moving in the right direction with
respect to who is going to be in charge, who is going to have
oversight and the authorities to be able to manage this
process.
Senator Carper. Thank you.
Same question, then I am done. Mr. Phelps, should an
independent organization such as GAO be tasked with regularly
reviewing the stockpile and reporting on its ability to respond
to a national emergency? Just very briefly, please.
Mr. Phelps. Thank you, Senator. Absolutely. I think it
would help with identifying performance metrics, evaluating the
efficacy of the existing performance metrics and hopefully help
with expectation management. If we at the State level and the
local level have a better idea of what we can expect
[inaudible] our procurement, our ability to stockpile much more
effectively.
Senator Carper. Mr. Chairman, I do not come up with many
good ideas, but I think that might be a good idea and something
we could do every couple of years, a request to make, and I am
sure they would be interested in doing that. Thank you,
everybody.
Chairman Johnson. OK. I appreciate that, Senator Carper.
Just so everybody is aware, it will next be Senator Scott,
then Rosen, Lankford, Hawley, Romney, and Hassan. So, Senator
Scott?
OPENING STATEMENT OF SENATOR SCOTT
Senator Scott. Sure. First of all, thank you, Chairman, for
organizing this, and I agree with you. I think it starts with
coming up with exactly what our mission is, and if you have the
right mission and you have the right funding, then you can
probably get a good result.
I finished 8 years as Governor of Florida, we went through
quite a few hurricanes, and we did not just sit down and wait
for the Federal Government to show up. We created our own
stockpiles for food and water, tarps, and things like that just
to make sure that we were prepared, because we did not--you
cannot expect that somebody else is going to always be able to
take care of you.
I think we have a lot of people all across the country who
are trying to figure out how to put ourselves in a better
position for the next pandemic while they are also trying to
figure out how to make sure we have all the right protective
gear just with this pandemic. I know as I talk to some of my
friends in the health care community, they are still struggling
with getting the right protective gear, and part of it, it is
all being controlled by FEMA, which might make a lot of sense,
but we have to change how we do this.
I think all of us have learned that we cannot trust China.
It is Communist China. We know now that they are our adversary,
and I am very concerned that we do anything in the future that
continues to rely on Communist China for any part of our
protective gear or pharmaceuticals or anything, because we know
they are not a reliable partner.
I think we have to figure out how to produce American goods
and also have American companies ready to ramp up at the time
that we have the next pandemic.
So I propose today--I have a bill called the ``American-
Made Protection for Healthcare Workers and First Responders
Act,'' and basically what it requires is, whether it is through
stockpile or whether it is through companies getting ready in
America, but we buildup American capacity to take care of our
first responders and deal with the next pandemic.
I just want to get your feedback on how important do you
think it is to reduce our reliance on Communist China and how
important it is to help make sure, whether it is through
stockpile or whether it is through having American companies
ready to ramp up, that we have American-made products ready for
the next pandemic.
Mr. Burel. Senator Scott, I appreciate your question. I
think it is vitally important to our preparedness overall that
we ensure as many of the products we need for essential health
care be made in the United States so that we can control the
supply chain better, so that we understand how to protect it
better. We have done some work with the Health Industry
Distributors Association to map locations of manufacturers, but
we cannot reach back to active pharmaceutical ingredient
manufacturers, for example, or some constituent components of
devices because they are outside the United States.
I think that we need to have as much capability in the
United States to do that as we possibly can. But we have to
work with the private sector to understand what it is going to
take to really bring that back to the United States, what they
need, whether it is the longer-term contracts that have been
mentioned before, which I also support, or anything else that
we need to do to help encourage them to do that work with the
Federal Government and for the public. I know they want to do
that.
I would say to your comment about FEMA doing buying, I
think FEMA can be a great partner for the SNS and anyone else,
but as has been said previously, some of these are very unique
items, and to try to buy the right things that are licensed and
appropriate for use, I think HHS and SNS are best qualified to
help direct that, and particularly to direct how we work with
bringing manufacturing of those critical items back to the
United States.
Thank you, sir.
Senator Scott. Thanks.
Mr. Gerstein and Ms. Gerberding, what do you think about
stopping our reliance on Communist China and our inability to
rely on them in the future and the importance of making sure it
is American-made products?
Mr. Gerstein. Senator, I will start off. I certainly agree
that we need to take a look at the supply chain and understand
those critical elements, if you will, that are on the critical
path to be able to have the capability that we need for a
future pandemic. I would try to inject a dose of reality on a
couple things. The way our supply chains have stood up with
respect to things like active pharmaceutical ingredients, some
of the PPE, these have been made through economic decisions
that essentially have been turned over to industry, that is,
those that are providing the health care. And so if those kinds
of commitments are to be made, it is going to be more than
just, putting out a pronouncement. It also has to do with
looking at subsidizing the medical delivery industry to be able
to incentivize them to want to be a provider, to bring the
manufacturing back.
We should also recognize there are probably some elements
that we are not all that keen to bring back if it can be done
more cheaply and they are not on the critical path. So we need
to figure out the critical path issues.
The other thing I would say is that, we do need to think
about the international role in global public health, or in our
national public health, said another way. So while there are
frustrations with some of the ways in which China has gone
about with transparency and such, we definitely need to
continue to rely on a global system, and that was why I
recommended in the fifth recommendation about trying to repair
our relationships on the global public health stage.
Senator Scott. Ms. Gerberding.
Dr. Gerberding. From the CSIS Commission perspective, I
think we are trying to frame our health security in the same
mental model that we use for other elements of our national
security. And in that sense, I think we might want to have this
same outlook on how we manage our critical pathway supply chain
that we would if we were thinking about how we outfit our
Department of Defense and our foot soldiers. If in that domain
we would not want to be dependent on an international supply
chain, I do not think we should be dependent on an
international supply chain when it comes to protecting the
health of Americans.
Senator Scott. That is a good way of thinking about it
because, you are right, it is no different than buying supplies
for our military and trying to keep our public safe. It is the
same issue, and we should be thinking about it the exact same
way.
Mr. Phelps, did you want to add anything?
Mr. Phelps. Yes, let me add that I think that our reliance
on the foreign supply chain caused a couple of different
problems for us at the State and local level. We saw FEMA do
something pretty innovative, bringing [inaudible] much less
visibility on where PPE was going. In many cases [inaudible]
hospitals or to counties, and that caused problems for us.
The other big problem, I think, is the quality of the
actual equipment. It was very frustrating for us here in Oregon
[inaudible] based on emergency use authorization, thousands of
KN95 masks that we were told we could go ahead and purchase,
only to be told at a later date those were no longer suitable
for [inaudible]. The quality control is as big of an issue if
not bigger than [inaudible] relying on [inaudible].
Senator Scott. Thank you.
Thank you, Mr. Chairman.
Chairman Johnson. Thank you, Senator Scott. Senator Rosen.
OPENING STATEMENT OF SENATOR ROSEN
Senator Rosen. Thank you, Mr. Chairman and Ranking Member,
for bringing this important hearing here today. I want to thank
all of our witnesses for their lifetime of hard work in this
area, preparing and planning for emergencies, pandemics,
disasters. It is hard work, it is good work, and we appreciate
you there.
First, we were talking about the supply chain and Federal
response. According to Johns Hopkins, the United States has now
over 121,000 deaths from COVID-19. A recent data analysis shows
that 70 to 99 percent of the deaths from the virus so far could
have been prevented. However, there is still time to make a
difference based on how we proceed.
As Dr. Fauci has recently said, we are still in the first
wave, so with this in mind, we must continue to respond to this
pandemic with urgency. Our response must be timely, targeted,
and thoughtful because different parts of the country are
experiencing the pandemic at different rates with varied
timing. We can and we must protect lives and livelihoods, and
we have to do better than we have done before.
It does require a strong national strategy and a process
for delivering key supplies to all of our communities, and we
should be constantly correcting our actions to be sure that we
improve our response.
So I know we need to improve transparency in the supply
chain. Of course, we are all going to recommend that. I believe
we should have used greater use of the Defense Production Act
(DPA) in our national response. But to Mr. Burel and Mr.
Phelps, I want to talk about our rural areas. They have seen
fewer cases of COVID-19 compared to urban areas, but they have
felt a real impact of this pandemic. They have a huge scarcity
of supplies. Access to care has been a challenge, especially
for the more remote areas in my State of Nevada.
So what specific recommendations do you have on how we
might improve responses for our rural areas' critical testing
supplies, PPE? What changes might you recommend in the future?
I guess, Mr. Burel, you can go first, then Mr. Phelps.
Mr. Burel. Thank you, Senator. We have long recognized that
there is a vast difference among the States and the localities
in what their capabilities are to respond, how they are
positioned in terms of whether it be material assets or
personnel assets to respond, both from a regular emergency
management perspective or from a health care need. So I think
that we need to continue to create better relationships,
stronger ties with State and local government so that we
understand better what some of those unique needs of those
rural localities, for example, are.
So just as we might consider a dense urban populated area
and how we need to respond to that differently, we need to
think about the same thing for a rural area. I think that for
the States to be able to establish stockpiles that are
independent of the Federal Government, as many of them had some
years ago to try to help supply those rural areas directly as
we bring in more product, they have a better understanding. We
recognize the States and the locals have a better understanding
of what they need for support than the Federal Government does.
If we position them to be better able to support themselves, I
think that the response would be stronger in the rural areas.
Senator Rosen. Thank you. I actually am going to--Senator
Hassan has another call that she needs to be on, so I am going
to yield the balance of my time to Senator Hassan, if everyone
does not mind. Thank you.
OPENING STATEMENT OF SENATOR HASSAN
Senator Hassan. Thank you so much. Thank you, Senator
Rosen, so much for your graciousness and the Chair for
accommodating my schedule, and to all of the panelists, thank
you so much for your work in this area.
I wanted to ask a question first of Dr. Gerstein.
Obviously, we have to improve the procurement and distribution
of Strategic National Stockpile supplies during a pandemic. My
State of New Hampshire, like so many others, struggled to get
the basics. And when they did get supplies from the national
stockpile, many items were unusable or they were expired. It is
not enough to say that we have a stockpile. Our stockpile has
to be sufficient, and it has to be up to date.
What best practices do you recommend that the Assistant
Secretary for Preparedness and Response implement to ensure
that the Strategic National Stockpile supplies are adequate but
also that they are rotated and distributed before they expire?
Mr. Gerstein. Thanks for that question. Obviously, the
rotation of stocks is a big deal. It is a very expensive
process. The Federal Government is spending about $570 million
a year to maintain the stockpile, which includes the rotation;
it includes, moving things through and restocking where
necessary.
I would also say that improving the stockpile is also going
to come down to things like Dr. Gerberding talked about, and
that is that last mile. It is about training the State and
local. It is not that they just have a different focus at the
State, local, tribal, territorial level. And, one of the things
the Federal Government can do is to assist with the training on
some of these very complex medical countermeasures, things like
nerve agent antidotes and you heard about the serum for
botulinum neurotoxin. These kinds of training capacities need
to be pushed from the Federal level down into the State, local,
tribal, territorial.
One of the calls we had is we need--once we get it in
position, once we get the stockpile the way we want, we need to
exercise and stress test it hard to make sure it is doing what
we think, and that all partners, all stakeholders can actually
be confident with what has been developed. That is where I
would be interested in seeing it go.
Senator Hassan. Thank you for that answer.
One other question to Mr. Burel. The Strategic National
Stockpile consists of a variety of items, some shelf-stable,
some needing refrigeration, and most requiring regular rotation
before they expire, as we just discussed. Does the SNS maintain
a national database of every item in the stockpile, including
condition, date of purchase, and expiration date?
Mr. Burel. Senator, we do maintain that information in a
national database that we rely on for the kind of product
rotation we do. We also invest in assuring that we can extend
life spans where it is chemically and scientifically proven
that we can do that for particular drugs as long as possible to
protect the Nation's investment.
The other thing that would help us is if we had the ability
to, let us use the term, ``sell off'' stock as it nears its
expiry and realize the income from selling off that stock so
that we could invest it in new stock. Right now we do not have
that option.
Senator Hassan. Thank you for that answer. It kind of begs
the question about why the administration has failed to provide
a clear picture of disbursement and replenishment rates over
the past 3 months. But I will take that up with them. I thank
you for your service.
Thank you, Mr. Chair.
Chairman Johnson. Senator Lankford. Then it will be Hawley
and Romney.
OPENING STATEMENT OF SENATOR LANKFORD
Senator Lankford. Thank you, Chairman.
Let me pick up on what Senator Hassan was just talking
about on expiration, because that is an issue that needs to be
resolved long term.
Mr. Burel, you just mentioned before about the authority to
be able to sell off. There are really two philosophies here. As
you have talked about frequently, this is not a big warehouse
that would just store things. At this point it is not that kind
of structure. Selling off things is one way to do this.
Managing the stockpile in another location, that is, with the
producers, that they actually manage it at spots, and they do a
regular rotation to be able to move out is another way to do
it. Are you trying to determine what is the right way to be
able to do this, have it, own it, and then be able to ship it
out once it gets close to expiration so they can sell it before
it is lost, be replenished, or to be able to maintain it in
other locations and there is a normal turn there?
Mr. Burel. Senator, we already engage in what you describe.
We call it ``vendor-managed inventory.'' The problem is much of
the material that we hold we hold in so great a quantity that
the market cannot absorb the rotation of that material on a
regular basis. We have to hold those large quantities to
protect the United States, and as we discuss a pandemic, it
seems like we need even larger quantities of some things.
I think that there is a lot of logic in using vendor-
managed inventory where it makes economic sense, and we have
actually done a lot of work in the Strategic National Stockpile
when I was there to do economic analysis of where that vendor-
managed inventory works well and saves the government money
versus the government owning it itself and then trying to
dispose of it in some other way.
Senator Lankford. So you are saying you need legislation
for those resources that we own that we could sell before
expiration?
Mr. Burel. We need legislation that would allow us to sell
off product before it expires, but also to realize the income
and have it not go back to the general fund so that we can use
that to buy replacement for that product or to buy the next
generation of product in that line or to buy whatever else the
stockpile needs that day.
Senator Lankford. All right. I think it is a reasonable
request, and I think it is something our Committee should be
able to work on as a result of this hearing. Do you have text
that you are proposing on that, or it is just an idea that you
propose?
Mr. Burel. Thank you, sir. I have proposed text previously,
and I will send that to you under separate cover.
Senator Lankford. Great. Thank you. We appreciate that very
much.
How do we avoid the pendulum swing that is always
inevitable, that the Strategic National Stockpile is not just
about a virus pandemic naturally occurring? Obviously, there
are a lot of other issues, chemical attacks and other things
that we focus in on. The natural pendulum swing here is, hey,
we were not ready for this, and so let us do whatever we can
and take our eye off the ball in other areas. What are we doing
to be able to turn and say let us be strategic in all areas,
not just overcompensate for one?
Mr. Burel. Sir, I think that again is an excellent
question. We get concerned about that, and we have always been
concerned about not having enough money to cover the entire
waterfront of known threats, including pandemics.
I would suggest that we consider making the Strategic
National Stockpile or the successor organization whatever we
think we need to do here, mandatorily funded at a minimum level
to be able to manage and rotate current requirements at the
time that that mandatory appropriation is set. I think that we
can continue to grow the stockpile beyond that. I think there
are a number of things that could contribute to that, whether
it is additional supplemental appropriations as new
requirements are identified that cannot be covered in a
mandatory appropriation, whether it may be, for example,
setting up a capability for the stockpile to receive donations
from philanthropic organizations, to reinvest the sales
authority I spoke to before, and so on.
Senator Lankford. We talked before about supply chain, and
that is a very significant issue for all of us in this. I have
seen some for our military, for instance, where it is not just
the manufacturer of the parts of the plane, whatever it may be,
the product. It is the products that go into that product
obviously getting in the supply chain. And you asked the
question, who actually manufactures, the manufacturers, and
start working your way back to be able to identify it. I would
hope that there is a process in place already like that that
you all are working through. It is not just who is the
contractor, who is the subcontractor, and who is the
subcontractor to the sub.
We talked before about precursor chemicals for
pharmaceuticals. That is the most obvious issue at this point,
because obviously we are very dependent on Communist China for
a lot of the precursor chemicals. It may be the pharmaceuticals
from there, but the chemicals that go into the pharmaceuticals
are from there. It may not be the product, but the rare earth
mineral that goes into that product is 60 to 90 percent from
Communist China, so all of those areas.
How in-depth are you going as you are actually pursuing the
supply chain?
Mr. Burel. Senator, this is something that we have
struggled with over years, but we are trying to make inroads in
this area in just the last several years, in fact. Much of that
supply chain beyond that precedes that finished product is
extremely opaque to the Federal Government and to the Strategic
National Stockpile in particular. We understand that many
private firms want to closely hold the information about their
ultimate supply chain all the way back to the earliest item in
that constituent product, but we have to understand better what
that comes from, because only then would we be able to say to
you we are particularly concerned about this product because
the only active pharmaceutical ingredient availability comes
from China or some other location, and we are concerned that we
may not be able to get it.
We would need your help to allow the Strategic National
Stockpile to reach into FDA for data that they hold and to
possibly even ask for additional data around things like what
is the API source of all these critical products, but with the
authority to insist that we get that data. I know that that is
concerning to the private sector.
Senator Lankford. So do you believe you or the organization
should house them should track that? Or should there be someone
else that actually manages that supply chain and delivers it to
you?
Mr. Burel. I think the SNS could do that work, but it is
going to have to be expanded to do that kind of work. One of
the reasons I think it is well placed under the Assistant
Secretary for Preparedness and Response is it can work across
that organization with BARDA who knows about the products they
are buying, maybe in more depth than we do commercially
available products, and with the critical infrastructure
protection group that already exists in the ASPR, maybe
combining that in some way with the SNS to figure out how best
to understand that supply chain, all the way back to the
earliest precursor product or finished good.
Senator Lankford. I would hope that we could do that, and
let us start to work on authorities to be able to break down
barriers, trying to get access to that information. I
appreciate how many times you have all talked about local
entities have to be prepared. We found for the PPE that a lot
of hospitals and clinics and such had only days' supplies
there. They also were not prepared for this, and there was a
wide assumption that they would be able to get PPE when they
needed it. That proved not to be true. So we are grateful for
what you are doing and also helping local entities be better
prepared for the next time as well.
Thank you.
Chairman Johnson. Senator Hawley.
OPENING STATEMENT OF SENATOR HAWLEY
Senator Hawley. Thank you, Mr. Chairman. And thanks to all
of the witnesses for being here.
Mr. Burel, can I start with you? I want to ask, if I could,
a couple of questions about stockpile levels and replenishment
after the H1N1 pandemic in the late 2000s. You wrote about this
in your testimony about some of the factors that affected
replenishment following the 2009 outbreak.
I have seen reports that the H1N1 pandemic drew down 100
million masks, including N95 respirators, from the stockpile.
Is that right? Do I have those figures right?
Mr. Burel. Senator, I no longer have access to that exact
data, but I believe that your numbers are approximately
correct.
Senator Hawley. It is also my understanding that a
federally sponsored H1N1 task force recommended replenishing
those masks in that supply. Is that your understanding?
Mr. Burel. Yes, sir.
Senator Hawley. Do you have any idea why those task force
recommendations were not acted upon?
Mr. Burel. It is a matter of available appropriations to
make those purchases. All of the purchases made for H1N1 were
made with supplemental funding authority that we were provided
to prepare for a pandemic. That funding, after we used those
products, was never reauthorized. We never received funding to
do that again, so we closely guarded what we had available in
the event that it needed to be used again. We need more funds
to be able to address the CBRN threats as well as emerging
infectious disease threats.
Senator Hawley. Let me ask you more about the funding. Back
in 2012, I believe it was, the HHS Secretary at the time,
Kathleen Sebelius, was asked to explain the rationale for why
the administration, President Obama's administration, was
proposing cutting $48 million out of the stockpile funding.
This was at a House Appropriations Committee hearing, and she
responded that resources ought to be focused on replacing
expiring countermeasures such as anthrax treatments, which I
think we would probably all agree are very vital. I am just
wondering if you think enough attention was being paid to
restocking PPE at that time. And did you ever get the sense
that when it came to the stockpile, in the balance of things
PPE was really being prioritized?
Mr. Burel. Sir, what we tried to do is prioritize the best
that we can do across threat levels based on available funds.
We looked to the PHEMCE that I mentioned earlier to help us
make those priorities. A reality is many of the drugs we need
for those CBRN events would never be produced and would stop
being available if we did not invest in those. Unfortunately,
when we do that, that leaves limited funds available for many
of these expected to be commercially available items like PPE.
So to your question, I think that we have to prioritize
both in some way, but the problem is the funds do not support
being able to do that. If we give up buying CBRN drugs, they
will not be made. But we also see we need more of the
commercially available products.
Senator Hawley. In your view, what should have been done
differently following the H1N1 pandemic to adequately restock
the stockpile, particularly when it comes to these vital PPE
that we have been in such short supply of?
Mr. Burel. Sir, I believe that we should have had available
funding so that we could buy what we used and replace that, and
maybe that is something we need to think about legislatively
such that every time product is deployed from the SNS, there
would be an automatic fund for replenishing that.
I also think that we never achieve the full amount of
product to be prepared for a complex pandemic such as we face
with COVID to build the stock to the place it should have been
for pandemic influenza even. So there were additional funds
needed then.
Senator Hawley. Very good. Thank you for that. I think
clearly as we look back, I mean, there is a lot we can learn
from this recent experience. But as we look back about choices
that were made in the past, we arrived at the present crisis
clearly at a deficit. I think we have got to take steps to make
sure that that does not happen again, particularly with
something as basic as PPE, which was not adequately provided
for in the stockpile, and that is a big problem.
Dr. Gerberding, let me switch to you, if I could. I would
like to discuss a little bit more the dual role that SNS
currently plays in our crisis response. I know the Chairman and
some of my colleagues have raised issues about the stockpile's
mission, and you have been discussing that. But let us talk
about it just a little bit more. You write in your testimony
that we need an effective balance in the stockpile's dual
mission, and you have discussed that that covers both public
health threats and biological, chemical, radiological, and
nuclear threats. Can you just elaborate a little bit more on
what you think that effective balance is and given the resource
constraints that Mr. Burel and I were just discussing?
Dr. Gerberding. Thank you, Senator. I used the expression
``the tail wagging the dog,'' and I just think when you listen
to Greg's testimony, he is basically saying the same thing. We
have a finite budget, and so we build the stockpile to utilize
the budget, but we do not necessarily build the stockpile to
address the threats that, implicit or explicit, are on the
table in part of the planning scenario. So, the history of the
stockpile has flexed between one point of view and another, but
I think always in the background the intent was to be assured
that the stockpile was able to handle the all-hazards or CBRN
threats. As Greg said, that is an area where, if we did not
invest Federal dollars in those countermeasures, we would not
have those countermeasures. And we are not done yet.
Ideally, in my point of view, the thinking about those
bioterrorism--or, excuse me, terrorism threats, the all-hazard
threats, we need to be thinking not what is the countermeasure
for this but, really, what can we do to take this threat off
the table. And that mentality is not afforded by the current
budget approach that we have to the Strategic National
Stockpile.
But we have revealed how vulnerable we are to those kinds
of threats. I do not think the terror threat is any less today
than it was in 2001 when we were dealing with anthrax.
Senator Hawley. In your experience, Doctor, when you think
about the role that SNS plays, public health, bioterrorism, has
one of those typically been given priority over the other in
your observation?
Dr. Gerberding. Independent of the Strategic National
Stockpile alone, I think broadly speaking we fight the last
war. So we have an anthrax attack, so we make sure that will
not happen again. Then we have a severe acute respiratory
syndrome (SARS), so then we go to SARS. And we are constantly
responding appropriately to what we needed to learn from the
last problem we had, but we do not consistently forge ahead in
the prospective sense to assure that we are broadening our
preparedness, not just adjusting to what we missed last time.
Senator Hawley. What do you think of the idea of creating a
separate stockpile just for the procuring and deployment of PPE
in a disease outbreak?
Dr. Gerberding. I do not think that would really help
things because what PPE and disease outbreak materials are
necessary would largely depend on the nature of the specifics
of the biological threat, so it is really hard to draw a
dividing line. And the capabilities and the planning and
exercising for that are going to apply to a much broader set of
issues. So I think by segmenting that out, you would create a
redundancy, and to some extent there is an overlap between the
PPE you need for COVID and the PPE you need for an anthrax
attack. So it is hard to separate them.
Senator Hawley. But given the fact that PPE was not
prioritized after the last major pandemic and we entered this
crisis at a very significant deficit, which it took us quite
some time to recover from, and given your testimony and Mr.
Burel's about the often lack of available funds to do
everything that you would like to do, wouldn't creating a
separate authorization and funding stream be something that is
useful?
Dr. Gerberding. It is always worth looking into. I do want
to emphasize, however, that the PPE bottleneck is a supply
constraint, and in order to improve the availability of those
materials, we really have to create the capacity in the market
for us to tolerate an inventory. And right now those products
are commoditized, and they are purchased really just in time in
most health care settings. They do not keep a large inventory
because they count on the availability of the turnover. So when
suddenly there is a surge in demand, there is no pipeline of
product to flow into it. So the stockpile really has to create
the bubble in the system.
That will not be efficient, as Greg has pointed out,
because those materials will be at risk for expiry. But if we
are trying to build a stockpile for efficiency, we have already
lost the battle.
Senator Hawley. Very good. I see my time has expired. We
will follow up with some additional questions for you in
written form.
Thank you very much, Mr. Chairman.
Chairman Johnson. Senator Sinema.
OPENING STATEMENT OF SENATOR SINEMA
Senator Sinema. Thank you, Chairman Johnson, and thank you,
Ranking Member Peters, for this important discussion. I want to
thank our witnesses for joining us today to discuss the
Strategic National Stockpile and its role as part of the
Coronavirus response.
As you all are aware, Arizona is a growing hot spot. The
number of confirmed cases, positive test rates, and
hospitalizations have increased dramatically since the end of
the State's stay-at-home orders in the middle of May. We have
lacked sufficient supplies of personal protective equipment,
which has stunted our testing capacity since the pandemic first
started and, of course, significantly contributed to our
State's current dangerous situation.
Arizona still ranks in the bottom quartile of States for
testing numbers, according to data from Johns Hopkins
University. That leads me to my first question for Dr. Burel
and Mr. Phelps. When we realized that State and local supplies
of personal protective equipment and allocations from the
stockpile would be grossly inadequate for Arizona's coronavirus
response, I moved to help our local manufacturers switch their
production lines to making PPE. I was inspired by the dozens of
local businesses and manufacturers in Arizona that shifted or
retooled their production and manufacturing capabilities and
began producing face shields, masks, gowns, hand sanitizer, and
other needed PPE. These are companies like AmSafe in Phoenix,
WL Gore in Flagstaff, TYR Tactical in Peoria, ClickTech in
Scottsdale.
Our breweries and distilleries began producing hand
sanitizer and donating them to food banks, first responders,
and local businesses. Arizona State University and
entrepreneurs like the Van Hook Dental Studio in Tempe have
used their 3D printers to help produce the nasal swabs and the
face shields needed to stand up community testing sites.
So my question is: How do we make it easier for the
stockpile as well as State, local, and tribal governments to
partner with these types of domestic suppliers who step up
during a crisis but do not normally produce these items in the
regular course of business?
Mr. Burel. Thank you for your question. I was the recipient
of several questions from small business that wanted to try to
help, and many of those wanted to try to do it in more of a
philanthropic way than anything else. They knew that they had
capabilities to make something else, and they wanted to be able
to donate those for us where they were best needed.
So one of the things that we need to do is we need to
continue the ongoing outreach from the Strategic National
Stockpile to private sector partners. Maybe we need to think
about how to widen that audience from that health care
marketplace that we normally talk to, that we have talked to
very frequently, to other businesses.
Another thing that would be helpful is I have been able to
watch over the years the CDC Foundation support the CDC in its
mission. So to provide for the Strategic National Stockpile to
have an outlet, a capability to work with a foundation
dedicated to the Strategic National Stockpile, to help look for
those philanthropic new capabilities and so on, and bring those
to bear through the stockpile or directly to States and locals
when they need them I think would be useful as well.
Mr. Phelps. Senator, from my perspective here in Oregon, we
were overwhelmed in a positive way with the outpouring of
support and innovation from our private sector partners. We
saw, as you saw in Arizona, a lot of distilleries producing
hand sanitizer. We saw our athletic manufacturing companies
producing face masks. A lot of this equipment was not meant
necessarily for medical use but for individual citizens to use
as face coverings and some of those individual protective
measures.
I think we can empower and make it a little bit easier for
these private sector partners to integrate into the system. We
stood up a website very early on that allowed manufacturers to
indicate to us what they could offer, and we would do outreach
to those manufacturers to plug them into our system and
incorporate them into our distribution effort.
Ultimately, though, in a State like Oregon with over 4
million people, it was a drop in the bucket, quite frankly, and
we really rely on those mass producers of quality medical grade
equipment to protect our first responders. But I will say that
the private sector and the resources they brought to bear
certainly had an impact on limiting the spread, the community
spread here in the State of Oregon.
The other issue with a lot of these requests to assist, it
forced a lot of time in tracking down whether or not it was a
viable resource. Everyone seemed to have a cousin who knew
someone who could produce or procure N95 masks, and that was an
inordinate amount of time to track those down, vet those
requests, and make sure that we were getting the resources that
would ultimately help protect our medical front-line workers.
Senator Sinema. Thank you.
I am going to move on to my next question for Dr.
Gerberding and Dr. Burel. The initial allocation from the
Strategic National Stockpile was based on population size, and
there were additional supplies of personal protective equipment
and ventilators going to States with the highest level of need.
That hurt us in Arizona because our lack of testing made our
caseload appear artificially low at the beginning of the
coronavirus.
What recommendations do you have on how the stockpile and
other Federal resources can establish a better allocation
process that is more fair and equitable and takes into account
testing and consistencies, which, of course, are likely to be
present in any pandemic-type situation?
Dr. Gerberding. Thank you. I will just start. I think there
is a situational dependence here because, obviously, in this
case the pandemic did not roll out simultaneously around the
United States and was initially at least concentrated in
certain places that had higher needs and whose health systems
were very overwhelmed. But I do think that is an opportunity
where advance planning and exercising could be extremely
informative.
I looked at Arizona. I know something about the population
demographics in your State, and you and I have talked about
that. So, it would not surprise me at all that there would be a
fairly high need for personal protective equipment in Arizona,
and I think that is something that in the process of planning
ahead for this kind of situation, that need could have been
better recognized and would have been a factor that could have
been better considered in the allocation process.
Mr. Burel. I agree with Dr. Gerberding. It is very
situationally dependent. One of the things that we had at the
Strategic National Stockpile when I initially became Director
was a strong tie to public health emergency preparedness at the
State level and, to a certain extent, even at the local level.
Unfortunately, the decision was made that that would better
reside in another part of CDC's organization. At that time the
SNS lost its direct tie to the States and to the localities. I
think that we need to reestablish those. At the time that we
did that work, we used a tool called the ``Technical Assistance
Review'' to really understand what the demographics were, what
they would really need, and how we could better do allocation
in the event of this type of a concern.
Senator Sinema. Thank you.
Mr. Chairman, I see my time has expired. Thank you.
Chairman Johnson. Thank you, Senator Sinema.
Again, I just want to thank all of our witnesses. I think
this has been, first of all, an incredibly important hearing,
but also a very informative one. I cannot thank you enough. I
really want to work with a number of you moving forward on this
incredibly complex issue. I think we need to emphasize how
complex this problem truly is, which is why I emphasized from
the very beginning we need to articulate exactly what the
national stockpile needs to accomplish, what those capabilities
are, what the responsibilities are between local, State, and
the Federal Government. So it starts there, and then you
start--once we have that established, then you start really
dealing with the complexity.
So, again, thank you for your participation, and I look
forward to working with you in the future on this, as well as
my colleagues not only on this Committee but also within the
Senate.
The record will remain open for 15 days until July 9 at 5
p.m. for the submission of statements and questions for the
record. This hearing is adjourned.
[Whereupon, at 11:49 a.m., the Committee was adjourned.]
A P P E N D I X
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[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
CBP OVERSIGHT: EXAMINING THE
EVOLVING CHALLENGES FACING THE AGENCY
----------
THURSDAY, JUNE 25, 2020
U.S. Senate,
Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 9:31 a.m., in
room SD-562, Dirksen Senate Office Building, Hon. Ron Johnson,
Chairman of the Committee, presiding.
Present: Senators Johnson, Portman, Lankford, Romney,
Scott, Hawley, Peters, Carper, Hassan, Harris, and Rosen.
OPENING STATEMENT OF CHAIRMAN JOHNSON
Chairman Johnson. Good morning. The hearing will come to
order.
I am looking at the title of this hearing: U.S. Customs and
Border Protection ``(CBP) Oversight: Examining the Evolving
Challenges Facing the Agency.'' I was talking to Mr. Morgan
earlier. I am wondering, if he could have foretold the future
before he took this position, whether he would have done so. I
mean, it has just been--challenges, yes; crisis after crisis
after crisis. So I first want to thank the witness, thank you,
Mr. Morgan, for your perseverance, for your service to this
Nation, both past, present, and in the future, too. Things are
not getting a whole lot better anytime soon, I fear.
I would ask consent that my written opening statement be
entered into the record.\1\
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Johnson appear in the
Appendix on page 925.
---------------------------------------------------------------------------
It is a hearing on the border. We have not had one for
quite a few months, so I obviously need to use a chart, and
that is really what I want to talk about in my opening
comments.
We have held I think close to 40 hearings on some aspect of
the issues on the border, and with our horribly broken
immigration system, we began keeping this chart\2\ particularly
on unaccompanied children, but then as the whole issue with
people coming across and exploiting our asylum laws, coming in
as families, the problem just exploded in late 2018 and into
2019. And the main reason I want to show this chart, you can
see the gold-colored bars are single adults, down slightly, but
that has been pretty persistent, pretty stable for the 8 years
that this chart represents.
---------------------------------------------------------------------------
\2\ The chart referenced by Senator Johnson appears in the Appendix
on page 940.
---------------------------------------------------------------------------
What you do see, though, in red is unaccompanied children,
blue are the family units, and, again, you can see the
explosion of the family units drawn by the incentives of our
broken immigration system where they really crescendoed in May
2019.
I am not going to put the chart\1\ up, but you all have a
little spread sheet here where we have been keeping track of
monthly averages. In May 2019, we were averaging 4,651
individuals either crossing illegally between the ports of
entry (POE) or showing up at the ports claiming asylum. That is
4,651 people per day. The most recent month where we have
consolidated figures, that number is down to about 745 people
per day, and when it comes to an approximate number of
children, it is down to about 50 a day, 49 a day.
---------------------------------------------------------------------------
\1\ The chart referenced by Senator Johnson appears in the Appendix
on page 941.
---------------------------------------------------------------------------
So we have made a huge level of progress, and I did want to
point out particularly with this chart, it is not just because
of coronavirus disease 2019 (COVID-19). I think that has
definitely reduced the numbers, but we had made dramatic
reductions prior to that because of some of the programs that
Customs and Border Protection has implemented. I know some of
them not everybody agrees with, but from my standpoint, it is
extremely important that we enforce our laws. And I know that
is certainly what Mr. Morgan agrees with as well.
Again, I think this has been some tremendous progress. In
my own mind, I am thinking, What would it have been like if
COVID hit when we were at May 2019 numbers, close to 4,651
people per day showing up at the border, with CBP personnel
having to deal with that? It would have been completely
overwhelming. It was overwhelming back then, but, throw COVID
on top of that, so, again, congratulations, very good work at
bringing the numbers down before this crisis hit. We obviously
extend our condolences to the family members of the Customs and
Border Protection Officers (CBPO) who lost their life because
they contracted COVID and others that have contracted it as
well.
So you are still dealing with enormous challenges. I am
certainly looking forward to hear your testimony in terms of
how you have handled it, how you are trying to deal with it
today, and, again, thank you for your service.
With that, I will turn it over to Senator Peters.
OPENING STATEMENT OF SENATOR PETERS
Senator Peters. Thank you, Mr. Chairman, and thank you,
Acting Commissioner Morgan. Thank you for being here today. It
is always good to see you.
Mr. Chairman, before I make my statement, I have three
statements--one from Human Rights First, one from Kids in Need
of Defense (KIND), and a testimony from the U.S. Conference of
Catholic Bishops (USCCB)--that I would like to enter into the
record by unanimous consent.\2\
---------------------------------------------------------------------------
\2\ The statements referenced by Senator Peters appear in the
Appendix on page 953.
---------------------------------------------------------------------------
Chairman Johnson. Without objection.
Senator Peters. Thank you, Mr. Chairman.
Customs and Border Protection certainly has played a vital
role on the frontlines of our Nation's efforts to limit the
spread of COVID-19 and, as always, to keep Americans safe.
Even in the face of this deadly virus that has infected
millions around the globe and killed more than 120,000
Americans, the men and women of the CBP continue to do their
essential jobs and protect our national security in very
difficult situations.
However, CBP's service has not been without sacrifice, and
I want to acknowledge the losses that your agency has suffered
during this pandemic.
The lives of officers is a terrible price to pay, and I
think I speak for all Members of this Committee when I express
my grief and condolences to the families and to everyone at
CBP.
In order to prevent more tragedy at the agency, we must
ensure that frontline agents and Customs and Border Protection
Officers have access to the personal protective equipment (PPE)
necessary to defend themselves against COVID-19. We count on
these officers to keep us safe. But they cannot do so
effectively if they themselves are left unprotected.
Even in normal times, the agency plays an important role in
border States like my home State of Michigan. And as we are all
aware, these are far from normal times.
In the face of the Coronavirus, CBP has been tasked with
limiting unnecessary travel between Canada and the United
States, while continuing to support trade and essential
services, including the vital medical professionals who cross
the border to support Detroit's efforts to combat COVID-19.
As the Nation looks to reopen, cross-border communities in
States like Michigan will rely on clear and well-communicated
information about plans for loosening restrictions at the
border. We must avoid confusion and uncertainties that occurred
as these restrictions were announced and were implemented.
As we continue reopening, more trade and travelers will be
returning to our Nation's ports of entry, especially at
airports and land crossings. We must be diligent in applying
the lessons learned over the past few months to ensure that CBP
is ready to safely meet these very changing circumstances.
As we continue to move forward, we must strive to both
implement strong safety and security measures and uphold our
Nation's long-held values for the families and children who
continue to seek asylum at our Southern Border.
CBP's priorities are often difficult to balance but the
agency cannot simply abandon one part of their mission because
things get tough. Congress and the Administration must work
together to support effective trade, travel, migration, and
security operations, particularly in this time of a pandemic.
So, again, Mr. Morgan, thank you for taking the time to be
here with us here today. I look forward to your testimony and
hearing what we can do to assist you in facing these extensive
challenges.
Thank you.
Chairman Johnson. Thank you, Senator Peters.
It is the tradition of this Committee to swear in
witnesses, so if you will please stand and raise your right
hand. Do you swear that the testimony you will give before this
Committee will be the truth, the whole truth, and nothing but
the truth, so help you, God?
Mr. Morgan. I do.
Chairman Johnson. Please be seated.
Mark Morgan is the Chief Operating Officer (COO) and Senior
Official Performing the Duties of the Commissioner at U.S.
Customs and Border Protection. He began serving his country as
a U.S. Marine and his community in local law enforcement. After
completing a 20-year career in the Federal Bureau of
Investigation (FBI), Mr. Morgan started at the Department of
Homeland Security (DHS) as the Acting Assistant Commissioner
for Internal Affairs before being appointed by President Obama
as Chief of the U.S. Border Patrol. He served as Chief until
January 2017. He later returned to DHS as the Acting Director
of Immigration and Customs and Enforcement (ICE) in May 2019
and has been leading U.S. Customs and Border Protection since
July 2019. Mr. Morgan.
TESTIMONY OF MARK A. MORGAN,\1\ CHIEF OPERATING OFFICER AND
SENIOR OFFICIAL PERFORMING THE DUTIES OF THE COMMISSIONER, U.S.
CUSTOMS AND BORDER PROTECTION, U.S. DEPARTMENT OF HOMELAND
SECURITY
Mr. Morgan. Chairman Johnson, Ranking Member Peters, and
Members of the Committee, thank you for giving me the
opportunity to appear before you today to discuss the many
challenges facing the United States Customs and Border
Protection. Of course, topping the list of those challenges is
the global COVID-19 pandemic. Infectious diseases, as we know,
they do not know borders, and it serves as another example of
why border security is so important.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Morgan appears in the Appendix on
page 928.
---------------------------------------------------------------------------
Today and every day, individuals arriving at our border,
with or without COVID symptoms, pose potential public health
risks to the American people, our frontline personnel, our
health care workers, and our community.
As we have discussed before, CBP encounters travelers and
illegal aliens from more than 130 countries in a given year,
most of which are also currently facing significant COVID-19
outbreaks. Thankfully, several early Presidential proclamations
temporarily suspended the entry of travelers from certain
countries. And as was mentioned, CBP, along with other United
States Government (USG) personnel, were on the front lines
enforcing those critical and essential containment and
mitigation strategies. These actions no doubt saved American
lives early on, and I am proud of the CBP workforce for their
efforts.
Moreover, CDC issued a public health order on March 20 of
this year, finding that the introduction of persons who would
likely be held in congregate settings in ports of entry and
Border Patrol stations increases the risk to public health. The
Centers for Disease Control and Prevention (CDC) order has been
a critically important tool in the fight against this public
health crisis. It allows CBP to prevent the introduction and
further spread of this virus in an effort to protect the
American people, our workforce, and the immigrants themselves.
Let us be clear. This order is not about immigration
enforcement. It is about taking immediate and decisive actions
to address the public health threat that still continues today.
Early on after that order, we saw those trying to illegally
enter our country drop by more than 50 percent from our pre-
COVID numbers. And rather than introducing the illegal aliens
into our facilities, increasing the exposure risk to our
workforce and our country, CBP, because of this order, is
returning approximately 95 percent of those we encounter
expeditiously to their country of last transit.
And as the Chairman said, can you imagine what we would be
going through right now if we were going through this pandemic
this same time last year when our Southwest Border facilities
were overwhelmed and overcrowded with families and children? At
one point we had more than 20,000 individuals in our custody.
Introducing a single COVID migrant into these conditions would
have been catastrophic, and I hope we are united that we must
work together to prevent those conditions from ever happening
again.
Now we are averaging about 150 to 200 people in our custody
at any given time, and we have seen a 70-percent reduction in
unaccompanied minors. As the Chairman said, it is important to
note that CBP and DHS as a whole were already better positioned
to deal with this global pandemic because of the success of the
administration's network of immigration policies and
initiatives that had been in place 10 months prior to COVID.
These initiatives, as well as our partnership with the
Government of Mexico and Central American countries had already
reduced the flow of illegal migration by 76 percent from the
height in May 2019. Our custody numbers went from 20,000 to
just over 3,400, and the driving force behind the crisis--
families from the Northern Triangle countries--have been
reduced by 94 percent. And we had all but ended catch-and-
release.
Even as CBP shifted our resources to mitigate the spread of
this deadly virus, we maintained and continued our efforts
against a vast, complex, and challenging array of threats. This
year, fiscal year (FY) to date, we have seized over 500,000
pounds of drugs, an increase from this same time last year.
Although the cartels had to adjust their tactics because of
COVID, they are alive and well, and they adjusted quickly.
In fact, just after the first few months of this year, we
saw a little bit of a downward departure at the beginning, but
then soon after that, last May, they began to skyrocket back
up. We saw a significant increase this past May.
Methamphetamine seizures alone jumped 66 percent. This is why
border security is national security. This is why border
matters and, importantly, why the wall matters as well.
Last, while many in our country are self-quarantining or
working from home, the majority of the CBP workforce does not
have that option. They get up every day, they say good-bye to
their loved ones, and they go to work protecting this Nation.
They are our frontline defenders, as we have just said already.
They are good, decent, honorable people who heroically carry
out CBP's broad mission day after day, despite the risk to
their own health and safety. I personally want to thank you,
Chairman, Ranking Member Peters, for your acknowledgment of the
seven CBP personnel that we have lost this year. That is
personal, and I sincerely appreciate you knowing that,
understanding that, and acknowledging that. That means a lot
that we can be united in acknowledging their sacrifices and the
dedication to this country and the citizens they protect. I
personally thank you for that, and I am looking forward today
to answering your questions.
Chairman Johnson. Thank you, Mr. Morgan.
Without a doubt, the men and women of CBP, from my
standpoint they are heroes. We are witnessing now an assault
against law enforcement. I do not know how that could even
possibly be a solution. And the same thing is true in terms of
enforcing and securing our borders as well. Again, think of the
situation we would have been in.
My first question really has to do with moving forward,
anticipating what we are going to be dealing with, let us say,
August, September, or October of this year. This is far
different from the position we were in in May 2019 when
America's unemployment rate was at record lows across all
demographic lines. And, of course, those opportunities that
only America is really known for was a huge draw combined with
our broken system that could be exploited. Now we are going to
have, I would anticipate, unemployment levels in excess of 10
percent. We are going to have Americans out of work. But we are
also going to have economic hardship in countries south of our
border as well.
How are you going to cope with that? Just talk a little bit
about what your plans are and what you think the challenge is
going to be.
Mr. Morgan. Yes, sir. So, first of all, I think you are
spot-on. And so right now, what we are going through right now
with the CDC order, as I mentioned, really is from a public
health perspective. But at some point, we are going to get on
the other side of COVID, and my concern--I share your concern--
is that what we are seeing right now is that while our economy
has started going, it is by far worse in Mexico, Northern
Triangle countries, really in the Western Hemisphere. So what I
am concerned about is we are going to see the same pull factors
that we have historically, but it is going to be magnified,
because what we like to say with the accelerant of COVID it is
that we are going to see these countries--their economic
conditions are going to be far worse than ours. And we
anticipate that we are going to see an increase, another surge
of migration due to the economic conditions and the economic
pull factor coming forward. It is a significant concern for us.
Chairman Johnson. For years, I have been saying, as we
faced this crisis at our border, that the first goal is to
reduce the flow of people coming in, exploiting our system,
breaking our laws. Describe some of those programs. And, again,
I realize not everybody agrees with them, but I think it is
hard to disagree with the results. We have reduced the flow.
Talk about those programs, what was most effective, and will
they remain effective?
Mr. Morgan. Yes, sir.
Chairman Johnson. And are they going to be challenged?
Mr. Morgan. Yes, sir. I will take the latter first. So,
yes, they are challenged. They have always been challenged, and
I am assuming they are going to continue to be challenged. But
as you said, although we may philosophically disagree, as the
Acting Commissioner of CBP, from our perspective, they have
been effective with the goal of reducing the flow of illegal
immigration. So you are spot-on. We have a multitude of
programs that we are working with the Northern Triangle
countries. I think most people are familiar with the Asylum
Cooperative Agreement (ACA), and that is where those that
transit through a country and come to our border, for example,
we send them to Guatemala where they can go through the asylum
process there in Guatemala. It has been effective.
Another program I know everyone here is familiar with is
the Migrant Protection Protocol (MPP). That has been an
unbelievably effective program, probably the most successful
program that we have. Within a few months of its application,
we started seeing a significant decrease in those that were
trying to illegally enter the country because of that.
There are a couple other programs, Prompt Asylum Claim
Review (PACR) and Humanitarian Asylum Review Process (HARP),
and, sir, I think you know them well because they really
mirrored what you started, Operation Safe Return, I believe
last year, and I know there are other Members of this Committee
that kind of joined you, how we can still give them the due
process according to our laws that they deserve with respect to
the law, how can we do that more effectively, more efficiently.
Basically in a nutshell, that means we are just bringing the
whole-of-government approach to the border, and we are doing it
more efficiently. And we have done that. Again, conceptually,
the same as Operation Safe Return, that has been effective as
well.
So as we are seeing, as we are anticipating the increase of
the flow coming because the economic conditions driving the
pull factors that they always have, these programs are going to
be absolutely essential to continue to stem the flow.
Chairman Johnson. Do you have any doubt, had you not
initiated those programs, implemented them, carried them out,
that we would not be at those excess of 4,000 people per day?
Mr. Morgan. There is no doubt in my mind, without those
programs we would still be in the middle of a crisis, seeing
thousands of folks illegally entering every day.
Chairman Johnson. I know something else that is not 100
percent agreed on or appreciated is the border fencing. I know
you were just down with the President earlier this week talking
about how many miles we have implemented. Can you talk a little
bit about what we have done in terms of new fencing, what you
anticipate will be completed by the end of the year, and your
evaluation of the effectiveness of that fencing now that it is
in place?
Mr. Morgan. Yes, sir. So, first of all--and I think this is
something that I try to get every time. This is not the
President's wall. This is the wall system for the United States
Customs and Border Protection, for the American people. This is
something that, when this Administration came into being, they
asked: What do you need? They actually asked the men and women
on the front lines. They asked the leadership of Border Patrol,
What do you need? And they said: We need a border wall system.
And I say ``system'' on purpose, sir, because that is very
important. So far, 220 miles of wall system has been built, and
people ask me, well, how many new miles have been built? I say
220 miles of new wall system, because it is not just a bunch of
metal going into the ground. It has integrated lighting,
technology, access roads. This new wall system, every mile that
is built is a new mile of capability that did not exist before.
So it is a new mile of wall when it goes in the ground. So far,
220 miles, and as we have anticipated, we planned, we believe
that in this year we are going to have completed 450 miles of
the wall system.
And here is the fact: Again, this is not a political
statement. This is a factually based statement that I can open
the checkbook and show everybody, everywhere that a wall system
has been built as part of a multi-layer strategy,
infrastructure technology and personnel, all the stats you can
imagine go in the right direction. Less people enter in that
area. Less drugs come across that area. Less criminals come
across that area. Less gang members come across that area. That
is just a fact, and we can prove it, and it is effective. It is
an effective impedance and denial tool, and everybody Border
Patrol agent on the lines will tell you that.
Chairman Johnson. Thank you, Mr. Morgan. Senator Peters.
Senator Peters. Thank you, Mr. Chairman, Commissioner
Morgan.
The border restrictions at land ports of entry have been,
as you know, extended three times and are going to remain in
place until at least July 21. These restrictions, while very
important--and I understand the importance of them--also have
real-world impacts on States like Michigan. For example,
hospitals in the Detroit area rely on Canadian doctors and
especially nurses; a very large number of nurses cross the
border daily to work in those hospitals in Detroit.
So my question to you, sir, is: What factors is CBP
considering when determining the need for additional
extensions? Are there any particular metrics or criteria that
need to be met before reopening?
Mr. Morgan. So, first of all, I completely agree with what
you just said, and we are seeing the same thing on the northern
border and the southwest border as well. And it even goes
beyond, you know, those heroes in the medical profession that
actually come to the United States to provide some vital
service. But it is also economies on both sides. Obviously, I
do not need to tell you, you are very well aware that there are
economies on the Mexican side as well as the United States side
that thrive and are dependent on each other, especially in the
border cities. That is important.
And so we have been involved in those discussions. They
have sought our input with respect to each time that they have
made the decision to first implement the travel restrictions
and to implement them, additionally to renew them. We are an
integral part of that. I can tell you personally I have had
conversations, for example, on the Southwest Border from Baja
to Brownsville of leaders all across the board, not just law
enforcement but local leadership as well, to really listen to
them and understand, get a better understanding of exactly what
they are experiencing. And so I think when we look at this, it
cannot be done just from a public health perspective. It has to
be a balance of the public health risks and the economy.
I feel very confident, at least the elements that I have
been involved with in CBP, that we are trying to do just that.
Senator Peters. So when can we expect details from CBP
about what the reopening of the border is going to look like
and specifically get a better sense of how you engage in with
our partners like the Canada Border Services Agency? There was
some confusion between the United States and Canada, as you are
well aware. I want to make sure that we have proper guidance so
we do not have that kind of confusion as you are starting to
reopen. Tell me a little bit about your work with the Canadian
Government.
Mr. Morgan. So, again, I completely agree. Early on there
were some fits and starts, but we had and did and continue to
work with our counterparts there to make sure that we are
addressing those issues, to make sure that we are implementing
these restrictions better. But equally as important, as we
start to open back up--now, obviously, as CBP we do not make
that decision when the travel restrictions will be lifted or
modified. But we are already working both on the Northern
Border and Southern Border with our partners what that will
look like, how that will look like.
We anticipate, for example, on the land border that when
the travel restrictions are lifted, we are going to see--we
anticipate it is going to get back to normal pretty quick.
Right now, if you look at the pedestrian vehicle traffic, those
are down 50 and 60 percent, respectively. We think when we lift
those restrictions in the land environment, those numbers are
going to get back to normal pretty quick, unlike the air
environment. So it is definitely an issue. We are working with
them, I would say almost on a daily basis with our partners.
Senator Peters. Good. We certainly saw some confusion at
the beginning stages of the crisis at airports, including
Detroit, with travel restrictions, lack of screening protocols,
and some of those shortfalls created some dangerous situations
with folks waiting in very long lines to get through the
process and often not having any kind of protection that they
were wearing. And now, months later, if we are looking at
infection totals around the globe, they are actually very high
and continue to be high. Yet we are also seeing travel now
starting to pick up at the same time.
So my question to you is: What lessons did CBP learn from
securing our border in the early days of COVID-19? And what
practices would you plan to resume in the event of a continued
resurgence abroad, particularly folks coming from China?
Mr. Morgan. I will give you an example: contact tracing. I
think that is one of those areas where we had some challenges
when we implemented that at the start and we learned. There is
another example in Chicago, same thing, where lines were
lengthy. We are trying to look at our system. We have Advance
Passenger Information System (APIS) and a couple other systems
that we use, that we were able to collect the data that CDC
needs, but it is cumbersome, it is manually, and it is not
efficient.
And so early on that is where you saw we were trying to
collect this information that CDC needs for the very important
contact tracing. So what we are doing is we are working with
CDC, we are working with the Department of Health and Human
Services (HHS), we are working with industry stakeholders, for
example, in the air environment, I personally have been on a
couple of calls. We have had those discussions of what can we
do to get better to collect that information. And so that is
what we are trying to work toward in the future, and when I saw
pretty quickly, probably by September, we need to have an
interim solution. But what we have done since then, though,
immediately, kind of the 3-meter target, if you will, is we
changed how we have done that now, so now that contact
information, we kind of do what we call ``pre-primary,'' really
right after they get off the plane, they de-board from the
plane, and we have our DHS contract personnel there collecting
that information, doing the medical screening, and asking the
questions that they should while CBP personnel are there. That
has absolutely helped tremendously. But we still need to get
better on that, and that is why we are still working for a
better solution.
Senator Peters. Good. Reports indicate that, like the U.S.
Citizenship and Immigration Services (USCIS), CBP is going to
face some funding shortfalls as a result of COVID-19-related
decrease in the user fees that folks pay. I have worked on a
number of provisions to support the hiring and adequate
staffing within CBP and worked with you to make that happen,
which I appreciate. But I am concerned about the impact that
the shortfall will have on the workforce as well as security at
the ports of entry.
My first question: Will you have to furlough officers based
on some of the reports that we are seeing?
Mr. Morgan. Right now, seeing what I see, no. I am not
anticipating that right now. But, sir, you are absolutely
right. It is an issue. Right now, I think you probably know
better than most, about 40 percent of the workforce are funded
through user fees, and most of those are through international
travel. We are seeing a significant reduction. We are looking
at a $600 to $700 million shortfall in user fees. So it is
definitely a challenge. We are working with DHS, we will work
with the Office of Management and Budget (OMB), we will work
with the appropriators to try to find a solution.
Senator Peters. Do you expect that you are going to be
requesting some supplemental funding to get through this?
Mr. Morgan. I do not want to get too far ahead of that, but
I think we are going to need some help from Congress. What that
help is going to look like I think we are still trying to work
through, but we will definitely need some assistance.
Senator Peters. Thank you.
Mr. Morgan. Thank you, sir.
Chairman Johnson. Senator Lankford.
OPENING STATEMENT OF SENATOR LANKFORD
Senator Lankford. Mr. Chairman, thank you. Mark, thanks so
much for----
Chairman Johnson. We cannot hear you.
Senator Lankford. I am not on mute, so----
Chairman Johnson. Still cannot hear you, James.
Senator Carper. You look great.
Chairman Johnson. Yes, we can see you just fine.
Senator Lankford. I am not on mute, so it is on your end.
Chairman Johnson. If you do not mind, let us go to Senator
Carper, and then we will come back to you once we get your
audio fixed. Sorry about that. Senator Carper.
OPENING STATEMENT OF SENATOR CARPER
Senator Carper. Mr. Morgan, welcome. Thank you for joining
us today. And I want to join my colleagues in expressing our
appreciation and our affection for the men and women that you
serve with and lead.
It is true that travel bans, when used effectively and
imposed in a timely manner, can help delay the arrival of a
highly contagious virus to our shores. But we were reminded
just earlier this week by Dr. Julie Gerberding, former CDC
Director who appeared before our Committee yesterday, she said
back in February at a roundtable, a Homeland Security and
Governmental Affairs Committee (HSGAC) roundtable, and I will
quote her: ``Once you see sustained community transmission, the
horse is out of the barn.'' And Ron Klain, who was the Ebola
czar back a couple of years ago, and quite a successful effort,
as you will recall, he said in February about the President's
order blocking travel from China, he said, ``We do not have a
travel ban.'' He said, ``We have a travel Band-Aid right now.''
First, before it was imposed, 300,000 people came here from
China in the previous month, so the horse is out of the barn.
This week, seven States reported their highest-ever
hospitalizations from COVID. Three months and 121,000 deaths
later, unfortunately, we are still not prepared.
I have a friend, and if you ask him how he is doing, he
always says, ``Compared to what?'' I just want to review with
you and share with you some numbers that I shared with my
colleagues a couple of weeks ago. ``Compared to what?'' Let us
compare population and deaths in Taiwan to what we face. Taiwan
has about 25 million people. So far they have suffered seven
deaths. Twenty-five million people, seven deaths. South Korea
has over 50 million people. They have suffered 274 deaths.
Singapore, about 6 million people, 25 deaths. New Zealand, 22
deaths; Australia, 102 deaths; Japan with 126 million people,
916 deaths; China, with 1.4 billion people, they are reporting
about 4,600 deaths. Let us say they are not telling the truth.
Let us say it is twice that much. That is still under 10,000.
Germany, 83 million people, 9,000 deaths; Canada, our neighbor
to the north, 38 million people, 7,800 deaths. Mexico, our
neighbors to the south, 128 million people, 14,000 deaths; and
the United States with 328 million people, now we are up to
121,000 deaths.
Back in February, February 28, the President said of the
virus, he said, ``It is going to disappear. One day it is like
a miracle. It will just disappear.''
March 6, he said, ``Anybody that wants a test can get a
test. That is what the bottom line is.
March 10, 2020, he said, ``This was unexpected, and we are
prepared and we are doing a great job with it. And it will go
away. Just stay calm. It will go away.''
March 24, he said, ``We have never closed down the country
for the flu, so you say to yourself, `What is this flu all
about?' "
May 20, 2020, on the United States having the most cases in
the world at 1.5 million to that date, despite testing
shortages, he said, ``When you say that we lead in cases, that
is because we have more testing than anybody else. We do not
look at that as a bad thing. That is a badge of honor.''
``A badge of honor'' to have 121,000 people die from this
pandemic.
I want to ask you a couple questions, if I may,
Commissioner, and one of those--let me just ask you to just
react to what I just shared. Just react to what I just shared.
Mr. Morgan. Sir, I think I guess my initial thought is I am
not a medical professional, and as Acting Commissioner of CBP,
when we were called upon to implement and provide our guidance
and our knowledge with respect to what would be the most
appropriate way to implement travel restrictions, both in the
air environment, sea environment, and land environment, that is
what we did. And I think that the men and women of the CBP have
done an incredible job doing that.
There are areas where individual agencies like the CDC are
needing a certain type of information, and CBP has done just
yeoman's work to try to improve those processes to get the work
they need to be able to safeguard this country. And what I can
say is from a public health perspective, in our role as CBP, I
think we have done an incredible job. I think the efforts that
we have taken both in the air, sea, and land environment have
saved countless. I could not even guess how many thousands of
American lives have been saved because----
Senator Carper. I am going to reclaim my time. Can you
imagine, had you not done a great job, how much worse it would
be? The numbers that I just shared with you, we have less than
5 percent of the world's population; we have over 25 percent of
the world's deaths. Can you imagine how much worse it would
have been if CBP had not been doing a sterling job?
Let me ask another question, if I can. Last summer, as you
will recall, in response to the growing humanitarian crisis at
the Southern Border, Congress passed and the President signed
into law a supplemental appropriations bill of about $4.5
billion. Of that funding, $1.1 billion went to CBP. The funds
were to be used to ease severe overcrowding at CBP stations and
at ICE detention facilities, lack of adequate health care
facilities and personnel, and a lack of administrative capacity
to support CBP agents and officers. Congress provided the
funding with strict instructions on how it should be used and
how it should not be used. This month, the Government
Accountability Office (GAO) reported that CBP has misspent a
portion of these funds, violating the statutory provisions that
governed their use. Among the items purchased with taxpayer
funding to ensure the safety of migrants in CBP custody were
such items as dirt bikes, motorcycle, all-terrain vehicles
(ATVs), and surveillance equipment.
GAO has recommended that CBP either adjust its expenditures
to account for these deficiencies or that it report a violation
of the Anti-Deficiency Act as required by law. I would just ask
for--I do not have any more time left, but just a yes or no
answer: Do you commit to following GAO's recommendations?
Mr. Morgan. Absolutely. Yes, sir.
Senator Carper. Thank you very much.
Chairman Johnson. That is one way to----
Senator Carper. Live and in person.
Chairman Johnson. That is one way to solve technological
problems. Senator Lankford.
Senator Lankford. Yes, physical presence does make a
difference. Apparently they could hear me online, but it does
make it harder for you to answer the questions, Mark, so you
could not actually hear. Mark, thanks for your work and for
your service. Please pass on our condolences to the families of
the seven that we have lost from CBP and a lot of folks that
live every day with the threats that are coming at them, as
every person coming across the border they do not get the
privilege of being socially distanced from and they are not
wearing masks when they come across. It is a very different
environment for them. So for those folks, please tell them
thank you for the work that they continue to do.
I want to back up on a series of questions dealing with
seizures. I know CBP has been very engaged in seizing fake
testing kits and fake medications, fake masks, N95 masks. What
is the status on that and what are you seeing?
Mr. Morgan. Absolutely, sir. Unfortunately, every time that
there is a crisis, from a law enforcement perspective the first
thing we get together collectively is we set up a task force
because we know that criminals are going to take advantage of
it, and COVID-19 has been no exception, and that is right. So
we have really gotten together as USG, we have gotten together
with a host of investigative agencies to really focus on this,
and hundreds of thousands of fake masks have been recovered,
countless COVID tests have been recovered that really could
have done serious harm to the American consumer had it gotten
into their hands, and this is something that as we are trying
to implement the travel restrictions and stop COVID from coming
into our country, we have still been equally as committed to
this.
Senator Lankford. I appreciate that very much. You also
made a comment earlier that the number of individuals illegally
crossing the border has decreased and the apprehensions,
obviously, have been along those same lines as well. The amount
of drugs coming into the country has increased per pound. Are
you seeing changes in amounts? Are you seeing more
methamphetamine, more fentanyl, more cocaine? Are there trends
that you are seeing in that as well, not only total amounts but
are you seeing--what I am looking for is types of drugs as
well.
Mr. Morgan. Absolutely. So the four hard narcotics that I
call--they are increasing, especially from this time last year.
I think I said in my opening that methamphetamine, for example,
just last month increased 66 percent. I will get the numbers if
I am off a little bit--but from this time last year, it is up
20, 30 percent from this time last year. What we are seeing,
the cartels do what they do best. They change their tactics and
techniques quicker than anything that I have ever seen in the
history of law enforcement. And so when COVID hit, it impacted
them.
I will give you a quick example. The number of vehicles
coming across have dropped by 65 percent, and so their normal
mode was smaller loads and vehicles and just try to get them
through the masses, and it was fairly effective. And now since
the number of vehicles coming through has drastically reduced,
that is not working anymore. So now they are going to the cargo
environment because cargo has continued to flow the entire
time, and so now they are taking a little bit of risk, and they
are actually putting larger loads in the cargo to get it
through. So they are shifty.
But now we are seeing them take greater risk. They are
using pedestrians more, body carries, and we have seen them
continue to shift, and they are effective.
Senator Lankford. We know the cartels make a significant
amount of money in transporting families and children across
the border. That has been a significant amount as well as
single adults, as the cartels' major income source, along with
drugs, is to be able to move people. Obviously, with the
significant drop of people, is it your assumption that we are
seeing the increase in drugs because they want to be able to
keep their same income source? Or why do you think we are
seeing the increase in drugs at this point?
Mr. Morgan. Absolutely, sir. I think you are spot-on. I
think that is part of it. I mean, that is what they do, right?
They will go to anything to them for a profit, and if something
is being hit and taking profit away, they are just going to
shift to another entity to make profit. As I said, from this
time last year, overall pre-COVID, 76-percent reduction. Since
COVID, we have had an overall 84-percent reduction in the total
flow from this time last May. So you can imagine that has taken
billions of dollars out of their pocket. So they are absolutely
shifting. That is why I think we are going to continue to see
an increase of drugs coming into this country. I think that is
why we have seen an increase of the hard narcotics increase
across the board. They are changing their tactics. They are
going by sea more. They are doing what we call ``mixed loads''
now, both drugs and smuggling humans as well. And so they are
really branching out. We are seeing them use air more, tunnels
more. They are expanding as much as they can.
Senator Lankford. OK. Title 42 authorities dealing with a
health emergency and communicable disease overseas an from
people transiting into the country at this point, there is a
significant amount of authorities that are there. Walk me
through how those are actually applied, those Title 42
authorities, and what you think the difference is in the
enforcement and the number of people trying to cross, because,
obviously, there are still a lot of people that want to be able
to come to the United States. What difference do you think
those Title 42 authorities make and what are they?
Mr. Morgan. So it has been significant. I think, if I can,
if I back up fairly quickly to put it in context, prior to
COVID and prior to Title 42, because of administration
admission policies, we had already made a significant decrease
in the flow--again, 76 percent. We went from 20,000 in custody
to 3,400 in custody prior to COVID.
OK, now COVID, Title 42. What we saw initially, March 21,
within the first probably 2, 3 weeks, we saw a 50-percent
decline in those trying to attempt to illegally enter. That was
significant. I mean, it really shows that the individuals
listened to the medical experts, they are self-quarantining,
they are not taking a risk from a public health perspective,
and it was working.
What we have seen now, though, is we are seeing the numbers
start to increase a little bit, especially Mexican nationals.
So now we have seen that shift in demographics 100 percent.
About 75, 80 percent now are Mexican nationals, and that is a
shift from what it was last year.
Senator Lankford. Do you think the count of Mexican
nationals is increasing or the percentage is increasing?
Mr. Morgan. The percentage is increasing.
Senator Lankford. But you think the count is close, folks
that are other than Mexican has declined that much?
Mr. Morgan. That is correct. If you look at this time last
year, I think it was around 17,500. This past month it was
almost that, but the percentage increased. But what we are
concerned about, though, is that, again, as we get on the other
side of COVID, Mexico's economy, really the Western
Hemisphere's economy is really bad, we think that that is going
to create an additional pull factor because of the economic
conditions.
Senator Lankford. The last number that I saw was this
fiscal year, which would be October 1 of last year until the
end of May this year, about 276,000 people that had been
apprehended that were inadmissible. Those were either at ports
of entry or between ports of entry along the Southwest Border.
Does that number seem about right?
Mr. Morgan. Yes, it does.
Senator Lankford. So around a quarter million at this point
that we have picked up during that time period. That is a
significant decrease from what we have seen in the past, but
that is a very large number.
I also thought it was interesting as well, I went back to
look at the number of people that were given naturalization
last year, to be able to just look at the last year that we
have a full year of naturalization: 833,000 people legally went
through the process and were naturalized. That is an 11-year
high.
So one of the things I just want to be able to mention to
you is this administration has continued to be able to
accelerate into legal immigration and naturalization with an
11-year high for the number of people that legally went through
the process to be naturalized, but have also been very focused
on declining illegal admissions into the country. So just,
again, tell your folks thank you for the work that you continue
to be able to do to enforce the law and continue to be able to
protect your people.
Thank you.
Mr. Morgan. Yes, sir, and if I can, thank you for that. I
thanked the Chairman and Ranking Member earlier, too. I will
take that back, and I can tell you the men and women out there,
when they hear that from their elected leaders, it means
something. So I will take that back, sir. Thank you.
Chairman Johnson. Thank you, Senator Lankford.
We will try Senator Scott. Try to talk and see if we can
hear you.
OPENING STATEMENT OF SENATOR SCOTT
Senator Scott. Hi, can you hear me?
Chairman Johnson. Yes, I think we can. Turn it up.
Senator Scott. So we would like to thank you, Chairman
Johnson, for the hearing. I want to thank Mr. Morgan and
everybody at Customs and Border Protection for what you are
doing.
Earlier this year, I had the opportunity to visit----
Chairman Johnson. We can barely hear you. We are trying to
boost the volume. Do you have volume control on yours?
Mr. Morgan. I cannot hear at all.
Senator Scott. Is this better? Can you hear me now?
Chairman Johnson. A little bit better, yes.
Senator Scott. OK. So do you want me to go ahead and go? Or
do you want to go to somebody else first?
Chairman Johnson. Actually, we can hear you pretty good.
Just get as close to your--there you go?
Mr. Morgan. Where is the speakers at, sir? I am still
having a hard time hearing.
Senator Scott. All right. So, Mr. Morgan, can you hear me?
Chairman Johnson. Mark, can you hear?
Mr. Morgan. It is tough, sir.
Chairman Johnson. OK. It is not going to be good if the
witness cannot hear you, so I think we are just going to have
to say if you want to come in and ask questions, you are going
to have to come down to the hearing room--or come up to the
hearing room.
Senator Scott. OK. All right. Let me try it one more time.
Can you hear me now?
Chairman Johnson. Mark, you have to answer that.
Mr. Morgan. I can but it is not great. We can try it.
Chairman Johnson. OK. Give it a shot.
Senator Scott. OK. First off, I just want to thank you for
what everybody does at the international mail facilities around
the country. I had the opportunity to visit the one down in
Miami, and one of the concerns I have, which I think a lot of
us have, is the amount of counterfeit goods that are coming in
from Communist China, and I want to compliment you for what you
are doing all the time. If you could talk about what Customs
and Border Protection is trying to do to stop the amount of
counterfeit goods that are coming in from Communist China, I
would appreciate it.
Mr. Morgan. Yes, sir. So I did hear that, and this is
something that you are absolutely spot-on. This is a
significant issue. The counterfeit goods that are coming in, a
considerable amount from China, absolutely cross the spectrum.
If it is made, it is being counterfeited. And many of these
items go directly to impact the public health of the consumers
here in this country. So we are continuing to work with all of
the appropriate partners in USG to come up with not only new
policies to address to better position us, but also new
techniques and new processes which will increase our ability to
actually identify, detect, seize, and stop those counterfeit
goods from coming into this country.
Senator Scott. Do you have the resources to be able to do
it?
Mr. Morgan. So that is always the question, and it depends
on what the scale is. If you look at the amount of volume,
especially on the ecommerce, especially on the de minimis,
which I know you are familiar with, the numbers are
astronomical that come in. And so that is a challenge. So we
are doing some operations, Operation Mega Flex, for example,
where we are surging resources. We are working with the United
States Postal Service (USPS) as well where we are surging
resources to increase our capacity to seize, interdict, and
stop those counterfeit goods. But to say that we have both the
technology and the boots on the ground, if you will, to be able
to adequately look at everything coming across right now, the
answer is no.
Senator Scott. The trade deal that we signed with Communist
China, did it do anything to require them to try to crack down
on either the counterfeit or the substandard products that they
ship over to the United States?
Mr. Morgan. Yes. In fact, I have had several conversations
with Peter Navarro, and we are working together, and that is
exactly something that they are trying to drive. That is really
a driving factor outside of CBP, but we are fully supportive of
that because that is important. If there is not some sort of
accountability, then we are not going to see a significant
shift. And the last strategic plan that we put out last year
had provisions in there where we will as the USG be able to
hold China more accountable with respect to counterfeit goods.
Senator Scott. Are they complying? Are they actually trying
to be helpful at all? I mean, my concern is that China never
complies with anything. They will say they will do something,
and then, of course, they never do it. They have never complied
with any agreement they have ever signed that I have found.
Mr. Morgan. I think what I am probably comfortable saying
is those dialogues and negotiations are continuing, and we will
continue to look at the data and make an assessment.
Senator Scott. OK. Are there things that Customs and Border
Protection is doing now to deal with our airports and how we
can make them safer as a result of the COVID or the risk of
things coming--I guess it is primarily goods, but coming from
outside this country, including Communist China?
Mr. Morgan. Yes, sir, and that may be when it comes to a
global pandemic, we are mainly going to implement what the
medical experts decide. In this case, CDC, our medical
professionals within DHS, as well as the medical professionals
we have with the CBP, they are engaged. They have been early
on, often, all day, every day, it seems like. They are talking
to each other, and they are trying to come up with new
solutions on how we can make that environment safer for
passengers that are coming in.
I think a key important element to that is also the
stakeholders, the airlines. So we are working with the
airlines. In fact, last week, I participated personally in a
couple of trade conversations when we talked to the airlines
and we specifically had conversations about this. How can we do
that? Because part of this is, balancing that public health
risk, but also increasing consumer awareness and their
comfortableness with flying again. That is critical. So we have
to balance that, both of those needs.
Senator Scott. It is pretty important to the Florida
economy to be able to get individuals comfortable flying again.
There are things that, of course, government can do, but a lot
of it has to be done at the airline level to get people
comfortable.
I just want to finish by thanking you for what you do. I
want to thank everybody at Customs and Border Protection for
what they do every day to try to keep Americans safe and try to
make sure American products that come in here are not,
counterfeit, they are not things that are bad for us. So if you
will thank everybody on behalf of me from the State of Florida,
I am very appreciable of what you all do.
Mr. Morgan. Yes, sir, I absolutely will. Thank you.
Chairman Johnson. Senator Rosen.
OPENING STATEMENT OF SENATOR ROSEN
Senator Rosen. Thank you, Senator Johnson, Ranking Member
Peters, for having this important oversight hearing today. And,
of course, Acting Commissioner Morgan, I appreciate you being
here in person with us today as well.
I want to talk a little bit about the entry restrictions
for children. On March 21, 2020, CDC and DHS suspended
admission of certain immigrants regardless of their country of
origin, purportedly due to the health concerns of COVID-19.
Reports indicate that under new policy DHS has deported nearly
3,000 unaccompanied children arriving at the U.S. border
instead of transferring them to the Office of Refugee
Resettlement (ORR) custody, as required by Federal anti-
trafficking law. The Trafficking Victims Protection
Reauthorization Act (TVPRA), as it is a lot easier to say that,
the removal really places these children at risk of human
trafficking, persecution, and other grave harm.
So is CBP transferring unaccompanied children arriving at
the U.S. Southern Border to ORR custody and screening them as
required by law?
Mr. Morgan. So the answer is yes and no. So Title 42--and I
think this is important. Again, I am being obvious here, but as
we are in the midst of this public health pandemic, this global
pandemic, the priority must be to contain and mitigate the
spread of this virus and to keep it from further being
introduced into the United States.
But, ma'am, I can assure you that CBP, through implementing
the CDC order, it is consistent with law, policy, including our
non-refoulement obligations.
Senator Rosen. Can you tell me how many, do you know how
many unaccompanied children you have removed since March 21?
Mr. Morgan. Yes, I have those numbers----
Senator Rosen. And then while you are looking for those, do
you have the number of how many were not screened for
trafficking or protection concerns? Because that is what we are
concerned about.
Mr. Morgan. Yes, ma'am. So I have this down. I will make
sure I follow up with my staff to make sure the numbers are
right, but approximately under Title 42, the CDC order, about
2,000 were processed under Title 42, and just shy of 300 were
processed under Title 8, and they would go to the normal
procedure through----
Senator Rosen. So only 300 were screened out of the 2,000?
Mr. Morgan. No, ma'am. No, ma'am. So they are all screened,
and----
Senator Rosen. A hundred percent of these kinds were
screened for trafficking and protection concerns?
Mr. Morgan. Yes, ma'am. So that does not change. So we are
still--if we see anybody, any signs that someone is trafficked,
then they are going to fall out of Title 42, and they are going
to be then treated under----
Senator Rosen. Regardless of seeing signs, the regulation
is that all unaccompanied minors are screened. You are
screening all unaccompanied minors. Is that what I am
understanding?
Mr. Morgan. Yes, ma'am. We are complying with our non-
refoulement requirements under the law. Yes, ma'am.
Senator Rosen. OK. Thank you. I want to move on a little
bit now to a little bit of transparency and oversight, this is
a Committee hearing on oversight, and so Nevada, of course, we
are home to thousands of immigrant families. They make up part
of the diverse fabric of our State and of our country. And too
often, unfortunately, I hear concerns from our State's
immigrant community and advocates about DHS oversight when it
comes to investigating abuse by ICE and CBP personnel,
including sometimes racist remarks made by Border Patrol agents
at the Southern Border.
So can you please give us a little insight into what
accountability measures are in place for CBP agents and their
officers who engage in verbal abuse or other forms of
misconduct directed at immigrants?
Mr. Morgan. It is handled like any allegation of
misconduct, ma'am. So we have a robust Internal Affairs Office
of Professional Responsibility. It used to be called ``Internal
Affairs.''
Senator Rosen. Could you describe the grievance process
then? The immigrant has to make the claim? Another officer
makes the claim? Can you speak to that a little bit, please?
Mr. Morgan. It depends on the circumstances, but if an
individual, if an immigrant feels that they have been
mistreated in any form or fashion, yes, it----
Senator Rosen. So what is their process? If I am an
immigrant, I am in custody at the border. I have been a victim
of some form of abuse or comment. How do I go about talking
about that?
Mr. Morgan. There is a variety of options for them, ma'am.
Senator Rosen. Just give me one example.
Mr. Morgan. I can give you one. They can report it to a
supervisory CBPO or a Border Patrol agent.
Senator Rosen. And then where does it--like where is the
oversight in there that they have some way to get their claim
heard?
Mr. Morgan. Right. So then the process is that claim--like
for this example, if it is reported to a supervisory Border
Patrol agent or CBPO, then that allegation will immediately go
to our joint intake center and our Office of Professional
Responsibility.
Senator Rosen. And have you conducted an independent review
of this process?
Mr. Morgan. Yes. Yes, we actually have a cadre of hundreds
of special agents that this is what they do. Their full-time
job is to investigate allegations of misconduct.
Senator Rosen. And so have you produced reports of this
independent review? Is there something that we can look at and
see?
Mr. Morgan. Yes, ma'am. Every year--in fact, the 2018
report just recently came out.
Senator Rosen. It is 2020, so can we see that? Can you
please direct that to us so we can see how the grievance
process----
Mr. Morgan. Yes, ma'am. We can work with your staff to get
you whatever current information we have. Absolutely.
Senator Rosen. Thank you. I appreciate that.
I guess I have about a minute left, and so how about if we
talk a little bit about the remain in Mexico program, the
Migrant Protection Protocols (MPP). Two months ago, DHS and
Office of Immigration Review announced they are going to be
rescheduling all those MPP hearings due to COVID-19, so people
in Mexico awaiting their court dates are forced to travel to
their destination port only to find that their date--they have
traveled unnecessarily, only to find that their date has been
changed to receive notice that they have a new hearing date.
And so I think this is a shortsighted policy, and how do we be
sure that people are not traveling just to find out that they
cannot get there?
So can you tell me how many immigrants waiting in Mexico
for their scheduled court date were required to make the
journey back just to receive notice of the postponed court
dates?
Mr. Morgan. So I am not aware of that, ma'am. My
understanding was we communicated that out for those
circumstances where they had to come. We can take a look at
that and we can get----
Senator Rosen. I would like to see some numbers on that, if
I could.
Mr. Morgan. We can get better at that, but I can assure you
the decision behind continuing to postpone this I fully
support. As Mexico cases continue to rise, deaths continue to
rise really in the Western Hemisphere--Brazil now has become
the epicenter, Latin America really has become higher than the
European countries as far as the number of cases. So it is
still a real threat----
Senator Rosen. So if you are going to change the court date
and you are going to require someone to come in person to
receive that tear notice or however that notice is, can you
modify that policy to let them know so they do not have to make
this trip unnecessarily just to find out that they cannot be--
--
Mr. Morgan. My understanding is that was not happening, but
if that was, yes, ma'am, we can get better at that.
Senator Rosen. I appreciate that. I look forward to hearing
those numbers. Thank you.
Mr. Morgan. Yes, ma'am.
Chairman Johnson. So I do not see Senator Hawley. I do not
think he is coming in. So we will go next to Senator Romney.
Then it would be Senator Hassan, then Senator Portman. Senator
Romney.
OPENING STATEMENT OF SENATOR ROMNEY
Senator Romney. Yes, can you hear me?
Chairman Johnson. We actually can, yes.
Senator Romney. Good. Thank you.
Chairman Johnson. Talk as loud as you can, though.
Senator Romney. OK. I have a big voice. I will do my very
best.
First, I want to express appreciation to your entire team
for the work that you do helping keep our country safe from
products that are coming in that are adulterated that could
cause harm to our citizens, products that are also coming in
that are not adulterated but are themselves going to cause harm
to our citizens, and I am talking about, of course, drugs and
other illegal substances, and also protecting our workforce
from those who would come in and take jobs that they are not
qualified or authorized to take.
One of the things I learned on my trip to the border in San
Diego, as I met with Border Patrol agents and, in fact, with
the head of the Border Patrol agent union, he said to me
something interesting. He said, ``One of the problems we have
is that the magnet is so strong, people are going to find a way
to get here, whether we like it or not.'' And I said, ``What
magnet are you talking about?'' And he said, ``The magnet I am
talking about is the job magnet,'' which is if people can earn
$10 an hour on one side of the border and $1 an hour on the
other side of the border, they are going to try and move from
one to the other. They are going to come to America for the
opportunity for a better-paying job and also for a better
future for their kids. And his point was that, yes, it is
important to have a wall built, to make it more difficult for
people to cross into our country illegally, but that if we
really want to stop the amount of illegal immigration that
comes in and takes American jobs, we are going to have to have
an effective way to prevent people from getting American jobs
if they are here illegally.
And that is why, of course, the Nation has our E-Verify
system, and yet this is not mandatory. Businesses of all kinds
are not required and not using the system to determine if
someone is here legally or illegally.
I guess the question is: What is your perspective and the
perspective of the people you work with on what we need to do
not just to build a wall, which is important and I support, but
also to change the conditions in our country so that we reduce
the incentive for people to come here illegally?
Mr. Morgan. Yes, sir. So you are spot-on. The job magnet
statement I completely agree with. That is what we see. That is
absolutely without a doubt. The overwhelming majority of the
pull factor is that they are coming here for economic reasons.
That is a fact. That is not hyperbole. It is a fact. So you are
absolutely right. So we have to do things collectively as USG,
as a Congress, to pass meaningful legislation to address those
incentives, job factors. We need to continue to make sure and
hold employers accountable that continue to hire people that
are in this country illegally. If we do not do that, they are
going to continue to come. No matter how bad our economy is in
this country, it is worse elsewhere, and that is what we are
seeing right now with COVID. If not, they would not keep
coming. It is just, a little bit of common sense.
So you are absolutely right on that, and there are more
incentives, though, than just the jobs. I mean incentives that
once they get here, they know that they are going to be able to
stay here and remain. We have so many loopholes in our system,
and that is why, with all due respect, I have been saying for a
long time we still need Congress to step up to pass meaningful
legislation to address this crisis, to actually address the
incentives. So I agree with you.
I will say, though, that the wall is still a very important
thing because it helps us with drugs and criminals and a lot of
other bad stuff coming in as well. We need to do it all,
including the wall.
Senator Romney. Thank you. I do agree. I am one of those
that is pushing for mandatory E-Verify and penalizing
companies, penalizing employers that do not use E-Verify,
penalizing them just like we do if they do not pay their taxes,
they get in trouble. I would have the same kind of penalties
associated with not using E-Verify and hiring people that are
here illegally. I welcome, as Senator Lankford indicated, legal
immigration, and the fact that that has been enhanced is good
news. But illegal immigration is not fair to the millions of
people who would like to come here ultimately and want to do so
legally.
Of course, the other issue relates to drugs coming into our
country, and I do not know that you have any recommendations in
that regard. Of course, as long as there is demand, as long as
there are people here willing to spend a lot of money to buy
drugs, the drugs are going to find a way to get into this
country, either through the mail system or through tunnels that
people dig, or in the ocean or in aircraft. I mean, they will
find a way.
Do you or do your colleagues have any thoughts about what
we could do to reduce the demand pull, the magnet, if you will,
that has been a scourge for so long in our country, a health
scourge, but also a real challenge, I am sure, for you and your
agents as you seek to try and close off as many avenues as
possible?
Mr. Morgan. Sir, again, I think you are spot-on. I say
often we are not going to seize our way out of this drug
problem. That is not going to happen. This really does take a
whole-of-government approach to this as well, and so as we are
looking at the criminal element, as we are targeting the
Transnational Criminal Organizations (TCOs), we also have to
address that very real demand side in this country. If we are
going to solve the problem, it has to be simultaneously
attacking that.
But you are right. We are seeing drugs coming in the mail
environment. We are seeing them come in through the air
environment, through the sea environment, the land environment.
You name it, they are using every technique that they can. But
Attorney General (AG) Barr is spearheading a USG collective
approach of how we can get better to target the cartels, target
the smuggling organizations. CBP is an integral part of that.
And we are making some headway. We are continuing to improve
our strategies so that positions ourselves to more effectively
go after these cartels and hopefully try to disrupt them as
much as we can.
Senator Romney. Thank you, Director. I appreciate your
responses to these questions and very much appreciate the work
that you and your team are carrying out on behalf of our
country.
Thank you, Mr. Chairman.
Chairman Johnson. Thank you, Senator Romney. Senator
Hassan.
OPENING STATEMENT OF SENATOR HASSAN
Senator Hassan. Thank you, Mr. Chairman and Ranking Member,
for holding this hearing, and thank you, Mr. Morgan, for coming
before the Committee. I just want to add my thanks to those you
have already heard for the men and women of CBP for all the
hard work they do, and I join my colleagues in mourning the
loss of the officers that we have lost.
I want to follow up a little bit on questions that Senator
Lankford and now Senator Romney had asked you about the drugs
that are trafficking across our border, but I want to focus on
fentanyl. As you know, my State and many States continue to
grapple with the effects of opioid abuse stemming from the
trafficking of drugs like fentanyl. Our latest numbers in New
Hampshire, unfortunately, indicate that overdose deaths are
keeping pace with recent years in the midst of this pandemic,
if not being slightly higher.
Can you please provide me with an update on fentanyl and
other drug seizures at the Southern Border and all other points
of entry during the pandemic?
Mr. Morgan. So for the most part, it has not slowed down.
We saw, early on this year, at the height of COVID, we saw
drugs across dip down a little bit, but I would say in the last
30 days, in May, they went back up to include meth and fentanyl
both. In fact, Border Patrol seizures in between the ports of
entry of meth have gone up. So it is still there, and it is
still coming, and it is still a problem.
Senator Hassan. And are they still using the same essential
strategies on fentanyl?
Mr. Morgan. Yes.
Senator Hassan. OK. Can you also please update us on
efforts to combat illegal trafficking of fentanyl through the
U.S. mail system from countries like China? Have we seen any
changes in patterns since the start of the pandemic?
Mr. Morgan. We have. Actually, I would go forward before
the pandemic.
Senator Hassan. OK.
Mr. Morgan. So that is really where we made our strides. So
we worked with China. We got them to schedule certain drugs so
they are made illegal in China.
Senator Hassan. Right.
Mr. Morgan. So China was working with us, but that was
dramatic. In the mail environment, we saw drugs coming in from
China specifically go down dramatically, and this has really
been, pre-COVID.
Senator Hassan. OK.
Mr. Morgan. We are working with the United States Postal
Inspection Service. We are doing operations; I mentioned Mega
Flex. We are specifically targeting the mail environment, and
we have seen that go down. But the cartels, what do they do?
They just have the precursor chemicals sent right to Mexico.
They have their own chemists.
Senator Hassan. Right.
Mr. Morgan. They are developing them themselves now.
Senator Hassan. That is right. OK. Thank you for that
update.
I also want to follow up a little bit on something that
Senator Carper mentioned. A Government Accountability Office
review of emergency border security aid expenditures
appropriated by Congress revealed that CBP spent funds reserved
for migrant care and aid on CBP border equipment, like
motorcycles, all-terrain vehicles, and boats. After the release
of this audit, your agency has conceded that the GAO report is
accurate and that CBP was at fault for spending these funds
incorrectly. I really appreciate that forthrightness and
admission, but I would like to know specifically how much was
misspent on equipment. Can you give us those numbers, please?
Mr. Morgan. So what it came to is that 95 percent of the $1
billion emergency supplement, there were no errors, and what
they found was there was a chunk of $112 million that there
were some issues. Sixty million of that is what is really in
question. And so some of that, about half of that we believe
were due to some technical errors. I am not an accountant, but
basically we put it in the wrong line, and so it was a
technical error. Thirty million is really what is left that we
think is in question. It still requires some further analysis
and kind of a legal opinion with respect to that, and we will
work with the GAO on that. Again, glad they did the audit.
The last thing I would say is we believe that there was no
violation of the Anti-Deficiency Act, meaning we believe all
the charges appear to be valid CBP operating expenses. We just
may have put them in the wrong bucket.
Senator Hassan. So what you are telling me is it may have
been as much as $30 million of aid that Congress appropriated
for emergency purposes which was intended to address an
overwhelming crisis from last summer. I know that--I
appreciate, again, that you guys are being forthright, but it
is important that you are fixing this after the GAO audit. But
why isn't CBP doing a real-time audit of these numbers in order
to ensure that misspent emergency aid can be refocused in an
equally timely manner?
Mr. Morgan. So two things, ma'am. If I misspoke, I
apologize. I am not saying that we actually agree that the
money was misspent. Again, that $30 million is what we believe
is what requires further analysis. And so what we think, it was
technical errors, which we need to correct, and we need to get
better and make sure that does not happen. But we do not
believe that there was any violation, again, of the Anti-
Deficiency Act going forward.
Senator Hassan. As I read the summary of the GAO report, I
might differ with that because I think expenditures on certain
kinds of vehicles are not connected to the kind of emergency
care that Congress intended that funding to be spent on, and I
would look forward to following up with you all on that.
Mr. Morgan. Yes, ma'am, absolutely.
Senator Hassan. One last question. Last fall, I traveled to
Afghanistan in part to assess U.S. efforts to battle opium
production by Afghan poppy farmers and the Taliban.
Unfortunately, it appears that opium farming remains
widespread, and we have made far less progress than I would
have liked and I am sure all of us would have liked on this
effort.
We also learned that the opium farmed in Afghanistan
generally supplies Europe and Canada and rarely makes its way
to the United States. However, my State shares a border with
Canada, as do many of my fellow Committee Members' States. If
U.S. forces withdraw completely from Afghanistan without
addressing opium production, how do you think this will affect
our ability to stop opioid trafficking efforts into the United
States?
Mr. Morgan. Ma'am, I am really not positioned to be able to
definitively address that, but obviously, as you stated, that
is a problem. That is a problem that has to be addressed, and
that is why we need to and I know we are attacking this as a
USG problem. And we are not just attacking this and waiting for
this stuff to come to our borders. We are trying to get out
there and stop it from coming to our borders.
Senator Hassan. I thank you for that. One of my concerns is
that as we continue to attempt to slow drug trafficking from
our Southern Border, if our Northern Border is considerably
more porous and we know that opium from Afghanistan goes to
Canada, that gives traffickers a whole other strategy to
pursue.
Mr. Morgan. Yes, ma'am.
Senator Hassan. So, again, I would look forward to
continuing this conversation with a whole-of-government
approach. Thank you.
Mr. Morgan. And you well know most of the drugs coming in
come from outside our borders.
Senator Hassan. Thank you very much.
Thank you, Mr. Chair.
Chairman Johnson. Senator Portman, we will see if we can
hear you.
OPENING STATEMENT OF SENATOR PORTMAN
Senator Portman. How is that, Mr. Chairman?
Chairman Johnson. Actually, very good. Great. Thank you.
Senator Portman. Thank you for holding the hearing. And,
Mark, thank you for being here.
I, first of all, want to say that I think during the COVID-
19 period, your people have not gotten the credit they deserve
to be able to keep our transportation system working well.
Having traveled a lot on airplanes in the last couple months, I
can say that people are back. The airports are not entirely
full again, but planes, instead of being 10 percent and instead
of being 25 percent, are now 80 percent full that I have been
on, and the people you have who are putting their own health at
risk every day are to be commended, and I thank you for that.
Please, pass along our gratitude for all of those individuals
for helping to protect all Americans as we try to get this
economy back going again in the midst of continued concerns
about COVID.
One question I have for you, I have talked to your people;
I have talked to them about the importance of the masks and the
hand sanitizer and the gloves and so on. What has the incidence
of COVID been among your people that you can attribute to
infections that are resulting from interaction with passengers?
Have you had an issue there?
Mr. Morgan. So that is a hard one to quantify, but overall
I would say, yes, clearly. And if you look at, as well, the
epicenter for us as CBP, it has kind of mirrored what has
happened in the United States. So our first largest degree of
COVID-related outbreak for our personnel happened in New York a
few weeks ago. And now as expected, as we are starting to get
additional outbreaks in Texas and Arizona and California, the
trend of CBP personnel is following that.
What is hard to determine sometimes is whether they have
that from community spread outside of work or they got that
while at work. But, again, I know I am saying the obvious here,
as you said, they are out there every day, especially right now
on the Southwest Border. They happen to--not everybody has
given up down there. A lot of these folks are running from
them, and they are having to go down and get up close and have
close contact, ``high-risk contact,'' we could call it, so
definitely exposed. We have had several hundred that have
tested positive.
Senator Portman. Thanks for helping to keep Americans safe
and also to keep your people safe.
On the kids, I think about 22,000 UACs, kids, have come in.
And as you know, we have done a lot of work on this issue in
the Permanent Subcommittee on Investigations (PSI) and some of
the four interagency communication between HHS, DHS--my sense
is some of that is better. I want to hear from you on that. But
my general point would be I am pleased to hear that you
continue to do the screenings on trafficking. None of us want
to see these kids trafficked. And it is in the COVID era a
different situation. I know you have to return some people
because of the fear of COVID being spread. But I want you to
know I appreciate your personal commitment to continuing this
screening for trafficking.
Mr. Morgan. Sir, if I could real quick, if we go back to
May of--this time last year, we were averaging about 370
children a day. Now it is 31. That is just tremendous. And so
those children that under Title 42 we do return, we are
intensely working with the government that we are returning
them to, to make sure that they are returned in a safe, humane,
compassionate manner, and then make sure that those countries
that we are returning them to are working to return them with
their families.
I mean, this process actually is--that is what we are
trying to do. We are actually trying to reunite the children
with their families back in their home country.
Senator Portman. And that is exactly what we should be
doing. As you know, I got involved with this egg farm issue in
Marion, Ohio, my home State, where you had kids actually
returned to the traffickers by HHS. And my sense is that the
reforms have been put in place to help on that.
With regard to Customs and Border Protection and the
fentanyl issue, you did not mention the Synthetics Trafficking
and Overdose Prevention Act of 2018 (STOP Act) earlier, and
this Committee, as you know, passed the STOP Act and got it
through Congress, and what it did was it required the Postal
Service for the first time to require this advance electronic
data so that your people can identify the packages coming from
China and elsewhere that might have fentanyl in them. And we
required 100 percent from China, by the way, for good reason.
Can you give us a report on that? My sense is we are not
quite at 100 percent. We were at 86 percent as of last year.
And my sense is that this has been very successful. Already the
Federal Express (FedEx) and the DHSs, the other private
carriers, had to provide this data. You all were in their
distribution centers. You were finding the contraband. Now you
are doing it with the post office. As a result, the traffickers
have shifted their means of entry into the United States, and
more of it is coming across the border now instead of through
the mail.
But could you give us a sense of how you have been working
with the Postal Service in particular and whether you think
that is working well, whether the STOP Act needs to be
improved, or whether you think it is actually effective at
stopping this fentanyl that was coming almost entirely through
the mail at one point and then primarily through the mail?
Mr. Morgan. So I do not know--I will have to get back to
you, sir, on the exact stats, the percentage we are at right
now, but we can get back to you on that.
But the work of CBP and the Postal Service, it is a great
relationship. It is a great partnership. We have been working
together for a very long time. I think I mentioned a couple
times the Operation Mega Flex that we have done, and because of
that work, we actually went out to the corporate world, and we
put a statement out there saying, hey, we need some folks to
come up with innovative ideas on how we can get better at
detecting drugs in the mail environment. And that is being
worked on right now.
So we are continuing to do things to improve our ability to
do that, but you are spot-on. Like I said earlier, we attack
that together kind of a USG perspective, and we saw a dramatic
increase, especially coming from China. But as you said,
unfortunately, they are just shipping it now directly to
Mexico, and it is coming across the land border.
Senator Portman. Yes. By the way, the best thing we can do
to help you is stuff like the STOP Act, which required the post
office to do what they refused to do. The International
Narcotics Trafficking Emergency Response by Detecting Incoming
Contraband with Technology Act (INTERDICT) Act also provided
funding for some of this technology to be able to help you do
your job. So let us know where we can be helpful. I think the
place we can be most helpful right now, frankly, is on the
prevention, treatment, and recovery side, to try to reduce that
demand that drives so much of this with these huge profits that
you talked about earlier. And we were making great progress
there with regard to opioids. As you know, in the 3 years
before COVID hit, we finally had reductions for the first time
ever in any way you measure it, including the number of
overdoses and overdose deaths. Now I think we are back up
again, unfortunately. At least in my home State of Ohio, we are
seeing more overdose deaths in some cities than we had last
year or the year before, getting back to our high level of
2017. So we have to do a better job to help you to reduce that
demand because, otherwise, you have an impossible job, very
much the same as we were talking about the importance of the E-
Verify system and immigration, that magnet of jobs, whether it
is the magnet of the demand for drugs here or the magnet for
jobs.
On E-Verify, quickly, our big issue has been the
identifier. So the E-Verify system, in my view, ought to be
mandatory. I think Senator Romney spoke well about that
previously, but the issue is these employers who say, yes, I
accepted the ID, which was the Social Security card and
driver's license that were issued in my State, and it seemed
valid. But they are fraudulent, and it has been difficult for
us to figure out a way without a national identifier to be able
to assure that the person is, in fact, someone who should be in
this country and is here legally.
What are your thoughts about fraudulent documents and
identifiers and how we can address that issue which is really
the bottleneck in having an effective E-Verify system?
Mr. Morgan. What I would say, as you know, it is a little--
E-Verify is outside of CBP. It really is in ICE's purview, so I
want to be cautious and not speak on behalf of Director Albence
for ICE. But it is a challenge.
Senator Portman. I understand that, but it affects your
guys and women as they are trying to do their job, unless we
can deal with the demand, again, and this magnet. So, if you
could weigh in a little bit this morning--and my time has
expired, but also just stay engaged in this issue because your
telling them, ``This helps us to be able to do our job,'' I
think may be effective in getting us to a better system.
Mr. Morgan. Yes, sir, and we have those discussions all the
time. So even though it is outside my purview, trust me, I am
on board. Again, we have to get better at holding those
companies that are intentionally hiring illegal workers, we
have to hold them accountable. But it is a complicated, tough
matter to investigate.
Senator Portman. Yes. I will say there is some new
technology, facial recognition technology that people are
talking about, because, again, you cannot rely on these
documents, many of which are fraudulent. You can buy a Social
Security card apparently for $25 on the street that is
fraudulent but effective sometimes for those purposes.
So thank you again. Thank your people. Tell them that we
appreciate what they are doing every day.
Mr. Morgan. Thank you. I will.
Chairman Johnson. Senator Harris.
OPENING STATEMENT OF SENATOR HARRIS
Senator Harris. Thank you, Mr. Chairman.
Commissioner Morgan, for the past several weeks, as you
know, people from all walks of life have been demonstrating in
all the 50 States, and they are protesting the unlawful killing
of, in particular, black men and women by police.
According to a government document obtained by Yahoo News,
at least 400 CBP personnel have been deployed to some of these
marches. I sent you a letter on June 5, and it was joined by my
colleagues, asking you a number of questions that included what
identification and equipment your personnel are carrying, what
forms of force are they authorized to use, and what
surveillance are you conducting during these deployments. I
have not received a response. Can you give me today a date that
I can expect to get that response?
Mr. Morgan. I will get with the staff, ma'am, and we will
get that to you as fast as we can.
Senator Harris. By the end of next week, please.
Mr. Morgan. We will do our best to do that, yes, ma'am.
Senator Harris. OK. Thank you. And given your mission to
focus on our borders, why are you deploying your folks to these
protests?
Mr. Morgan. Because we were asked.
Senator Harris. By whom?
Mr. Morgan. By a few different individuals, and it is not
just that we deployed resources to the National Capital Region.
We also deployed resources all over this country.
Senator Harris. I am glad you brought that up. Which States
did you deploy them to?
Mr. Morgan. I have that information. I can provide it to
you. I think it was 11 or 12 States that we deployed, and we
got those requests from a variety of individuals. We got some
of those requests from other Federal agencies, but we also
received those requests directly from State and local police
departments that specifically requested a certain type of
assistance.
Senator Harris. Great, so I look forward to the follow-up,
and if you could include, just as you have mentioned, not only
where you have deployed but also the requester.
Mr. Morgan. Yes, ma'am. We have all that information.
Senator Harris. Thank you. I appreciate that.
As you know, U.S. Customs and Border Protection is the
largest Federal law enforcement agency in the country and has,
unfortunately, a documented history of abuse and misconduct
allegations. And there is a 2014 analysis that I am familiar
with by the American Immigration Council of 809 complaints of
abuses by Border Patrol agencies from 2009 through 2012, which
found that in 97 percent of the cases in which an outcome was
reported, no action was taken against the officer. The
complaints included hitting someone's head against a rock,
stomping on someone's back, touching women inappropriately, and
kicking a pregnant woman, causing her to miscarry.
In a 2017 report, on 2,178 complaints from 2012 to 2015,
the percentage of cases with reported outcomes where no action
was taken against the officer was 96 percent. So, obviously,
the people in the streets are marching because of their concern
about those cases where law enforcement has abused its power
and exercised excessive force.
How are you dealing with these cases in your agency?
Because, obviously, these numbers are troubling when in the
high 90-percent-range there is no action taken on these
complaints. Do you believe that that number reflects the actual
behaviors that have been reported? And are you confident that
you have conducted the investigations accurately and
adequately?
Mr. Morgan. So I am not sure what you are implying by that
totally, but to answer that question, yes, I have confidence in
the system. I think we have a robust process, and when there
is----
Senator Harris. So let me just, so I can clarify----
Mr. Morgan [continuing]. An allegation of misconduct, that
it is fully investigated.
Senator Harris. So I will clarify. So where there were 809
complaints, there was no action taken in 97 percent of the
cases. So you are confident that only 3 percent of those cases
were actionable?
Mr. Morgan. I am confident, ma'am, that we--like you said,
we are the largest law enforcement organization, 61,000. Now, a
single allegation of misconduct is important, but if you look
at that number and put it in perspective, that number is
actually very low for a workforce of 61,000. And what I will
say is that I am confident in the system. Is it a perfect
system? I would never say that. But I am confident in the
system that we have a cadre of individuals within our own
agency as well as outside agencies. These allegations of
misconduct are routinely reviewed from the local district
attorney's office, as you well know, to the Department of
Justice Civil Rights Division as well as our own internal
mechanism as well.
Senator Harris. What is your internal----
Mr. Morgan. So I am confident in that system.
Senator Harris. What is your internal mechanism? Is there a
division within your agency?
Mr. Morgan. Yes, ma'am.
Senator Harris. What is the name of that division?
Mr. Morgan. Office of Professional Responsibility. Back
then it would have been called ``Internal Affairs.'' So we have
hundreds and hundreds of special agents that are dedicated,
their whole job 24/7 is to do nothing but investigate
allegations of misconduct.
Senator Harris. And do you report these investigations and
outcomes in a public report?
Mr. Morgan. We put out a report every year, yes, ma'am.
Senator Harris. And that report, what is the name of that
report?
Mr. Morgan. I do not know the title of the report off the
top of my head.
Senator Harris. So you produced one last year as well?
Mr. Morgan. The last one that I have seen is 2018, and they
are working on 2019s.
Senator Harris. OK. When do you expect that to be complete?
Mr. Morgan. I do not have that information, but I could get
that to you.
Senator Harris. OK.
How are you ensuring then that your personnel who are now
being deployed to these demonstrations are complying with your
rules and your ethical rules as well?
Mr. Morgan. So, one, they are trained, so they fully
understand what their use-of-force guidelines are. We have an
appropriate leadership and supervision that is there also. And
then like we always do when there is a special deployment, we
have briefings, and the totality of the circumstances are
explained to them, what their mission is, and what the
expectations are.
Senator Harris. And so do you have in written documents an
outline of what are your stages of discipline for specific
types of behavior of your agents when they break the rules or
break the law?
Mr. Morgan. Absolutely. It is well documented and pretty
extensive.
Senator Harris. Can you provide our Committee with that,
please.
Mr. Morgan. Of course. Yes, ma'am.
Senator Harris. Thank you.
Since March 20 of this year, there was a policy that your
agency has implemented that turns away people who come to our
border without fully letting them make their case for why they
are in danger in their home countries and deserve refuge in the
United States. By many accounts, this policy denies these folks
due process and access to our asylum protections.
Since implementation of this policy, I understand you have
turned away 43,000 people, and reportedly at least 2,175 of
them are unaccompanied children.
Mr. Morgan. Ma'am, what policy are you referring to?
Senator Harris. The policy that you initiated on March 20,
2020.
Mr. Morgan. CDC order.
Senator Harris. Yes?
Mr. Morgan. Right, so that was actually not a DHS or CBP
policy. That was actually a CDC directive and order under Title
42----
Senator Harris. Which you implemented.
Mr. Morgan. Yes, directed us to implement----
Senator Harris. Right, that is what I said.
Mr. Morgan [continuing]. For the public health of the
country, yes, ma'am.
Senator Harris. Right, you implemented it.
Mr. Morgan. Yes, ma'am.
Senator Harris. OK. So public health experts have said that
this policy ``fails to protect public health'' and ``disregards
alternative measures that can protect public health while
preserving access to asylum and other protection.''
Mr. Chairman, I am going to ask unanimous consent (UC) to
submit a package of letters from these organizations into the
record.\1\
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\1\ The letters referenced by Senator Harris appear in the Appendix
on page 943.
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Chairman Johnson. Without objection.
Senator Harris. Thank you.
So, Commissioner Morgan, I understand today you testified
that you have expelled about 2,000 unaccompanied children. Is
that right?
Mr. Morgan. We have removed approximately 2,000 children
under the CDC Title 42 order to ensure the public health and
reduce the introduction of COVID-19 into this country, yes.
Senator Harris. And have any of those children suffered
violence, trafficking, assault, or any other harm after you
turned them away?
Mr. Morgan. We work extensively with the government of the
countries that they are being returned to, to make sure that
they are returned in a safe, humane, compassionate way, and
that they are actually reunited with their parents in their
home country.
Senator Harris. Have you received any reports of any of
those children that you have turned away having been----
Mr. Morgan. No, I have not seen----
Senator Harris [continuing]. Exposed to any type of abuse
or harm?
Mr. Morgan. I have not seen any report.
Senator Harris. Have you been told of any reports of that?
Mr. Morgan. I have not been told of any specific child that
under the CDC order that we returned to their country of
origin, that was a victim of abuse.
Senator Harris. And my last question on this point: How
many of those children have been reunified with their family?
Mr. Morgan. We would have to work with the government that
we returned them to to get that information. The governments
would have that information. We do not track that information.
Senator Harris. Is there a reason you do not track that
information if you are concerned about their safety after you
turn them away?
Mr. Morgan. Because we rely on the country of origin for
them to reunite them with their family.
Senator Harris. I would ask that you consider putting in
place a policy where you do track whether those children are
actually reunified with their families once you turn them away.
Mr. Morgan. We can look at that, ma'am. Yes, ma'am.
Senator Harris. Thank you. I appreciate it.
Thank you, Mr. Chairman.
Chairman Johnson. Thank you, Senator Harris.
Mr. Morgan, again, thank you. Thank the men and women that
work in your agency. They are putting their lives on the line.
Again, tragically we lost seven due to COVID, but we have also
had over the years, tragically, other CBP officers that have
lost their lives in the line of duty. So law enforcement is
hard. I think you saw pretty unanimously of this Committee, we
truly appreciate the level of service and sacrifice, so please
pass that along to them as well. So thank you for your
testimony. Thank you for your time.
The hearing record will remain open for 15 days until July
10 at 5 p.m. for the submission of statements and questions for
the record.
This hearing is adjourned.
[Whereupon, at 11:04 a.m., the Committee was adjourned.]
A P P E N D I X
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