[Senate Hearing 117-479]
[From the U.S. Government Publishing Office]
S. Hrg. 117-479
COVID-19--2021
=======================================================================
HEARING
before the
COMMITTEE ON
HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
and the
COMMITTEE ON RULES AND ADMINISTRATION
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
----------
PREPAREDNESS FOR COVID-19: THE INITIAL PANDEMIC RESPONSE AND LESSONS
LEARNED, APRIL 14, 2021 AND
COVID-19 PART II: EVALUATING THE MEDICAL SUPPLY CHAIN AND PANDEMIC
RESPONSE GAPS, MAY 19, 2021
----------
Available via the World Wide Web: http://www.govinfo.gov
Printed for the use of the
Committee on Homeland Security and Governmental Affairs
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
S. Hrg. 117-479
COVID-19--2021
=======================================================================
HEARING
before the
COMMITTEE ON
HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
and the
COMMITTEE ON RULES AND ADMINISTRATION
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
__________
PREPAREDNESS FOR COVID-19: THE INITIAL PANDEMIC RESPONSE AND LESSONS
LEARNED, APRIL 14, 2021 AND
COVID-19 PART II: EVALUATING THE MEDICAL SUPPLY CHAIN AND PANDEMIC
RESPONSE GAPS, MAY 19, 2021
__________
Available via the World Wide Web: http://www.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
45-981 PDF WASHINGTON : 2022
COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
GARY C. PETERS, Michigan, Chairman
THOMAS R. CARPER, Delaware ROB PORTMAN, Ohio
MAGGIE HASSAN, New Hampshire RON JOHNSON, Wisconsin
KYRSTEN SINEMA, Arizona RAND PAUL, Kentucky
JACKY ROSEN, Nevada JAMES LANKFORD, Oklahoma
ALEX PADILLA, California MITT ROMNEY, Utah
JON OSSOFF, Georgia RICK SCOTT, Florida
JOSH HAWLEY, Missouri
David M. Weinberg, Staff Director
Zachary I. Schram, Chief Counsel
Christopher J. Mulkins, Director of Homeland Security
Alan S. Kahn, Chief Investigative Counsel
Yelena Tsilker, Professional Staf
Megan L. Petry, Investigative Counsel
Pamela Thiessen, Minority Staff Director
Andrew Dockham, Minority Chief Counsel and Deputy Staff Director
Loren Terry, Minority Investigative Counsel
William H.,W. McKenna, Minority Chief Investigator
Laura W. Kilbride, Chief Clerk
Thomas J. Spino, Hearing Clerk
C O N T E N T S
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Opening statements:
Page
Senator Peters................................................1, 87
Senator Portman...............................................3, 89
Senator Hassan............................................. 19, 103
Senator Hawley..............................................21, 108
Senator Rosen...............................................24, 111
Senator Johnson.............................................26, 106
Senator Ossoff..............................................29, 113
Senator Padilla.............................................. 33
Prepared statements:
Senator Peters..............................................37, 119
Senator Portman.............................................40, 121
Wednesday, April 14, 2021
WITNESSES
Hon. Nicole Lurie, M.D., Former Assistant Secretary for
Preparedness and Response, U.S. Department of Health and Human
Services....................................................... 6
Julie L. Gerberding, M.D., Former Director of the Centers for
Disease Control and Prevention, U.S. Department of Health and
Human Services................................................. 8
Hon. Joseph L. Nimmich, Former Deputy Administrator, Federal
Emergency Management, U.S. Department of Homeland Security..... 11
Elizabeth A. Zimmermnan, Former Associate Administrator, Office
of Response and Recovery, Federal Emergency Management, U.S.
Department of Homeland Security................................ 13
Alphabetical List of Witnesses
Gerberding, Julie L. M.D.:
Testimony.................................................... 8
Prepared statement........................................... 54
Lurie, Hon., Nicole, M.D.:
Testimony.................................................... 6
Prepared statement........................................... 43
Nimmich, Hon. Joseph L.:
Testimony.................................................... 11
Prepared statement........................................... 60
Zimmerman, Elizabeth A.:
Testimony.................................................... 13
Prepared statement........................................... 65
APPENDIX
Response to post-hearing questions submitted for the Record
Ms. Lurie.................................................... 74
Ms. Gerberding............................................... 77
Mr. Nimmich.................................................. 84
Ms. Zimmerman................................................ 85
Wednesday, May 19, 2021
WITNESSES
Shereef Elnahal, M.D., President and Chief Executive Officer,
University Hospital, Newark, New Jersey........................ 91
Robert Handfield, Ph.D., Professor, Poole College of Management,
North Carolina State University................................ 93
Stephen Schondelmeyer, Pharm.D., Ph.D., Professor, College of
Pharmacy, Co-Principal Investigator, Resilient Drug Supply
Project, University of Minnesota............................... 95
Kimberly Glas, President and Chief Executive Officer, National
Council of Textile Organizations............................... 97
Alphabetical List of Witnesses
Elnahal, Shereef, M.D.:
Testimony.................................................... 91
Prepared statement........................................... 123
Glas, Kimberly:
Testimony.................................................... 97
Prepared statement........................................... 217
Handfield, Robert Ph.D.:
Testimony.................................................... 93
Prepared statement........................................... 130
Schondelmeyer, Stephen Pharm.D., Ph.D.:
Testimony.................................................... 95
Prepared statement........................................... 152
APPENDIX
Statements submitted for the Record:
American Hospital Association................................ 231
Ravi M. Anupindi, Ph.D....................................... 235
American Society of Health-System Pharmacists................ 243
BioOhio...................................................... 245
MN Deptartment of Administration............................. 247
Henry Ford Health System..................................... 249
Health Industry Distributors Association..................... 252
Michigan Health and Hospital Association..................... 265
Munson Healthcare............................................ 268
Jared Polis.................................................. 269
Premier Healthcare........................................... 270
Robert J Wiehe UC Health..................................... 278
Sparrow Health............................................... 282
Trinity Health............................................... 284
United States Pharmacopeia................................... 286
Response to post-hearing questions submitted for the Record
Mr. Elnahal.................................................. 292
Mr. Handfield................................................ 300
Mr. Schondelmeyer............................................ 323
Ms. Glas..................................................... 372
PREPAREDNESS FOR COVID-19: THE INITIAL
PANDEMIC RESPONSE AND LESSONS LEARNED
----------
WEDNESDAY, APRIL 14, 2021
U.S. Senate,
Committee on Homeland Security
and Governmental Affairs,
and the Committee on Rules and Administration,
Washington, DC.
The Committee met, pursuant to other business, at 10 a.m.,
via Webex, Hon. Gary C. Peters, Chairman of the Committee,
presiding.
Present: Senators Peters, Carper, Hassan, Sinema, Rosen,
Padilla, Ossoff, Portman, Johnson, Paul, Lankford, Romney,
Scott, and Hawley.
OPENING STATEMENT OF CHAIRMAN PETERS\1\
Chairman Peters. This Committee will come to order.
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Peters appear in the Appendix
on page 37.
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First, I want to thank each of our witnesses for joining
today's discussion, which will be the first in a series of
hearings focusing on the Federal Government's preparation for,
and response to, the coronavirus (COVID) pandemic.
We have to examine and confront our failures, identify and
build on what went right, and propose reforms to ensure our
Nation can combat this pandemic and be better prepared to
prevent and respond to future pandemics, which we know will
occur at some point, and other public health threats.
I appreciate Ranking Member Portman for joining me to
conduct this bipartisan oversight of the Federal pandemic
preparedness and response efforts. This approach is another
clear example of how this Committee is stronger when we work
together.
And no challenge requires a bipartisan approach more than
tackling this once-in-a-lifetime pandemic. Since the first
cases were diagnosed in the United States, more than 562,000
Americans have now lost their lives.
While Congress has provided critical relief over the course
of this pandemic, millions of Americans lost their jobs,
families continue struggling to make ends meet, and countless
small businesses are being forced to close their doors
permanently.
More than 4 million Americans are getting immunized every
day and the number of deaths from coronavirus are declining, so
there indeed is a light at the end of the tunnel.
But we are not out of the darkness yet, and I am concerned
that cases continue to rise, particularly in my home State of
Michigan right now.
Vaccines are certainly an important step to prevent the
spread of COVID-19, but we still need to practice social
distancing, wear masks, and follow the advice of public health
experts to get the resurgence of this virus under control,
especially as variants continue to spread all across the
country.
Tragically, it did not have to be this way. The lives lost,
the permanent changes to people's personal health, the economic
devastation, and the long months of personal sacrifice and
suffering were not inevitable.
Adherence to years of pandemic planning by prior
administrations, decisive action, and clear leadership from the
Trump administration could have helped mitigate this pandemic.
In fact, since the first whole-of-government pandemic
response plan was published in 2005, the United States has had
ample opportunity to prepare for this type of public health
crisis.
Professionals across our government spent years working to
improve our pandemic preparedness, from a pandemic response
playbook drafted by the National Security Council (NSC) in
2016, to a 2019 Department of Health and Human Services (HHS)
series of exercises called ``Crimson Contagion'' that simulated
a highly contagious airborne influenza pandemic.
In 2019, I conducted an investigation and released a report
that identified the serious national security risks posed by
our overreliance on foreign manufacturers for critical drugs
and medical supplies.
My report found the United States was unprepared to deliver
vaccinations on the scale needed during a pandemic and made
critical recommendations that could help onshore manufacturing
for essential supplies.
Unfortunately, despite preemptive actions and warnings, the
previous administration failed to take necessary steps that
would have limited the impact of this coronavirus pandemic.
Instead of acting swiftly and decisively, the previous
administration chose to sideline our Nation's foremost medical
experts and failed to implement a comprehensive national
strategy that left individual States to combat the virus all on
their own.
In fact, we know President Trump was aware the virus was
both deadly and contagious as early as February 2020. However,
he continued to tell the American people it would
``miraculously disappear'' and initially even compared its
effects to the common flu, when scientific evidence clearly
showed that coronavirus was much more lethal.
At a time when the administration could have provided clear
and consistent communication, supported scientific guidance on
needed public health measures, and ramped up production of
personal protective equipment (PPE) and other critical medical
supplies through emergency contracts and fully invoking the
Defense Production Act (DPA), among other critical actions, the
previous administration sought to rather downplay the virus'
severity to the public.
On top of those failures, there have been numerous reports
of widespread political interference in Federal agencies'
COVID-19 response, including reports that Health and Human
Services political appointees reviewed and may have altered or
delayed weekly scientific reports issued by the Centers for
Disease Control and Prevention (CDC) about the pandemic.
The Trump administration's inaction and efforts to minimize
the threat posed by COVID-19 contributed to the carnage our
communities have seen over the past year.
Despite representing only four percent of the world's
population, by January 2021, the United States accounted for
nearly a quarter of the global COVID-19 cases.
There is no question that the Federal Government must learn
from these missteps and urgently work to strengthen our
pandemic response, to ensure that we can both combat the
ongoing pandemic, and prevent the next crisis, whatever it may
be, from reaching the magnitude we have seen with this one.
Today we will hear from former officials from key agencies
in the Federal Government, all of whom are widely credited
experts in their respective public health and emergency
preparedness fields.
I look forward to a very frank and open discussion and
clear and candid recommendations about what we must do to
prevent past mistakes from moving forward. It is our duty to
ensure that our Nation is better able to meet whatever the next
crisis may be.
With that, I turn it over to Ranking Member Portman.
OPENING STATEMENT OF SENATOR PORTMAN\1\
Senator Portman. Thank you, Mr. Chairman. I appreciate the
fact that our oversight so far--and we have sent a lot of
letters and done a lot of interviews--that that oversight has
been not just bipartisan but nonpartisan, and that we have been
able to set aside politics and focus on the facts and past
events, but also on the road ahead of us and how we can learn
from what happened during this unprecedented, tragic
coronavirus situation.
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\1\ The prepared statement of Senator Portman appears in the
Appendix on page 40.
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First, though, I want to take a moment to acknowledge the
extraordinary loss that our Nation has experienced. As of this
morning, 559,741 Americans have died because of COVID-19. And
like just about all Americans, I have lost friends, I have also
lost former staff members, and we all join with the families in
grieving those we have lost during this pandemic.
I also want to express my gratitude for the work and the
sacrifice of those who have been on the front lines,
particularly those health care professionals who have been out
there on the front lines for all of us, 1,541 of whom died
fighting this pandemic.
COVID-19 has been catastrophic; there is no mistake about
that. It also presented an unprecedented challenge to, in many
ways, an unprepared U.S. public health system. Why were we
unprepared? That is one of the questions we will get into
today.
Unlike emergencies more localized in nature, a pandemic is
not a singular event. COVID-19 has stretched across our entire
country, in fact, the entire globe, with no regard for borders
or beliefs. The scope is unprecedented. It has stressed our
supply and health care systems--including our critical front-
line personnel as we said--and it has stressed it often to a
breaking point. We have seen the economic damage. Millions have
lost their jobs as a result of pandemic restrictions.
We are here today to understand some important issues: the
United States' preparedness and initial efforts leading into
the COVID-19 pandemic; the initial Federal response; and to
identify recommendations to improve Federal preparedness for
future pandemics and other public health threats.
We owe it to those Americans who did die as a result of
COVID-19, to their families and countless others who are
struggling to make ends meet, to make this a serious,
nonpartisan oversight effort. Looking at the steps the Federal
Government took in the initial days of the pandemic, we have to
learn from the experience for the future.
To that end, I think there are three issues that are
important to address. First, CDC surveillance systems and the
lack of testing limited our early response. We know that China
irresponsibly downplayed the initial severity of COVID-19. In
my view, there is no question about that. That presents
questions about our ability to work with global partners,
particularly China, to identify and combat pandemics in their
nascent stages.
But how did we do in the United States at recognizing and
communicating COVID-19 cases, symptoms, and deaths, once the
pandemic reached our shores? The CDC can only communicate and
address the issues it knows about and understands. In many
instances, what we found out is that COVID-19 cases manifested
in patient symptoms and were ultimately the cause of death, but
that information was slow to reach the CDC. Why was that?
Instead of seeing real-time data, the CDC was only seeing
fragmented, historical data. Adding to surveillance challenges,
diagnostic testing was slow to develop and then slow to scale
up to the level required by the pandemic. Why was that? It is
critical that we enable State and local public health officials
to communicate effectively and directly to the CDC. We also
must have the capability to scale up testing when needed. We
know those things. We have to talk about how we can do that
better. In a future pandemic, this could mean the difference
between quick, life-saving decisions, or confusion, and the
needless loss of life.
Second, who was in charge? Where was the accountability?
This is something I look forward to asking some of our
distinguished panel about today because they have a lot of
experience in how these things are managed. The reoccurring
narrative in interviews with former government officials, like
the ones we have today, and public health professionals is
that, in the initial stages of the pandemic, leadership roles
were not well defined, and they still are not well defined, in
my view, in some respects. This resulted in confusion at the
Federal, State, and the local level and likely slowed our
initial response considerably.
But we knew this was going to be an issue. In 2019, HHS ran
an influenza pandemic tabletop exercise called ``Crimson
Contagion.'' That exercise identified the lack of defined
leadership as a major challenge. The exercise found that
insufficient and conflicting statutory authorities defining
leadership roles hampered the Federal Government's ability to
effectively respond to a pandemic. Confusion about leadership
was also an issue identified following the 2009-10 H1N1
pandemic. This should be a cautionary tale for us as we
continue our review. It is not enough to identify issues; we
have to be forward-thinking and actually implement solutions to
the issues we discover.
Third, this unprecedented pandemic crippled the U.S.
medical supply chain in the initial weeks of the pandemic. Why
was that? It was due, in large part, to a longstanding
overreliance on China for pharmaceuticals and other medical
supplies, including PPE. Reports indicate that China, as early
as December 2019, increased imports and decreased exports of
medical supplies as their own needs increased, dramatically
shrinking U.S. purchasing ability. Compounding this issue was
the lack of an organic medical supply stockpile here in our
country.
The Strategic National Stockpile (SNS), which we will talk
a lot about today--the largest Federal repository of
pharmaceuticals and critical medical supplies, available for
rapid delivery to support the response to a public health
emergency--was not adequate when those State and local supplies
are depleted. It was, frankly, understocked. We need to talk
about why and, again, how to prepare for the future. The SNS
was never replenished, despite urgent requests, after the 2009
H1N1 pandemic, and, further, it was never meant for a
nationwide response. This, too, was an issue we knew about.
Past pandemic exercises and lessons learned from prior
pandemics--such as H1N1--told us that the supply chain
resiliency was an issue.
Now, let us consider this: A critical supply chain with a
single point of failure. A Strategic National Stockpile that
was never meant for a national response. I understand the
supply chain has mostly recovered, and the stockpile is
restocking, but we cannot allow these issues to impede a future
pandemic response.
The tragic loss of life, the devastating impacts on the
economy and American workers, and also the destabilizing effect
on global stability and security has taken a toll on all of us
and all nations. Given the extent of existing issues within the
public health system I just discussed, it is little surprise
that the initial pandemic response was chaotic and unorganized.
Again, Mr. Chairman, I appreciate the nonpartisan nature of
this review so far, and I stress the importance of identifying
a bipartisan way forward. We have to figure out how to come
together, learn from these lessons, and be better prepared next
time. I thank our witnesses for being here today. I look
forward to hearing from them, and I look forward to hearing
their thoughts on the way forward.
Thank you.
Chairman Peters. Thank you, Ranking Member Portman, for
your opening comments, and I, too, look forward to working
closely with you and every Member of this Committee to find
answers to the questions that we have and then put forward
meaningful solutions and action plans. I look forward to that
work.
It is the practice of the Homeland Security and
Governmental Affairs Committee (HSGAC) to swear in witnesses,
so if each of you who will be testifying--I know you are on
video, but if you would not mind standing and raising your
right hand, we would appreciate it at this time. 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? If you would respond ``I do,'' please.
Dr. Lurie. I do.
Dr. Gerberding. I do.
Mr. Nimmich. I do.
Ms. Zimmerman. I do.
Chairman Peters. Thank you so much. You may be seated.
Our first witness today is Dr. Nicole Lurie, former
Assistant Secretary for Preparedness and Response (ASPR) at the
U.S. Department of Health and Human Services from 2009 until
2017. Dr. Lurie is currently the strategic advisor to the Chief
Executive Officer (CEO) and response lead at the Coalition for
Epidemic Preparedness Innovations, and during her 8-year term
as Assistant Secretary for Preparedness and Response, she led
the HHS response to a number of public health emergencies from
infectious disease to natural and manmade disasters, and is
responsible for many innovations in emergency preparedness and
response.
Dr. Lurie, welcome to the Committee, and you are now
recognized for your five-minute opening statement.
TESTIMONY OF THE HONORABLE NICOLE LURIE, M.D.,\1\ FORMER
ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE (2009-17),
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Lurie. Thank you, and good morning, Chairman Peters,
Ranking Member Portman, and others. As you heard, I am Dr.
Nicole Lurie. Let me just stress that today I represent only
myself.
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\1\ The prepared statement of Dr. Lurie appears in the Appendix on
page 43.
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The role of government is to protect its people from harms
and to build resilience to those that cannot be prevented, and
that means preparing for the worst and scaling back when it is
appropriate to do so. As we know, the U.S. Government has been
preparing for a pandemic for decades, and as a country, we have
developed, exercised, and refined plans, created robust
authorities that have enabled nimble response systems and
infrastructure, and as we know, these have been put to the text
during many events which were successfully managed within
existing authorities.
After the West Africa Ebola epidemic, the pandemic office
at NSC was reconstituted and developed a comprehensive
playbook. Countermeasure development was guided through a
formal coordination process known as the Public Health
Emergency Medical Countermeasure Enterprise (PHEMCE), and that
process was significantly degraded. But even these actions
cannot fully explain the failure to act when we were first
alerted to a potential pandemic, and I want to peg that at the
end of December 2019.
We lost a month of valuable time between then and when a
public health emergency was declared. In part, I believe that a
climate of fear and retribution had developed over the years
leading up to the pandemic, and that this inhibited seasoned
career employees in key agencies from stepping up and speaking
out.
You have asked whether or not the authorities for a
successful response were sufficient, and I believe the answer
is generally yes. But all the authorities in the world cannot
make up for the failure of leadership and its devastating
outcomes.
Here are 10 things I think should have happened early on.
As soon as hearing about the outbreak in China, the
administration should have played out the likely scenarios,
making a plan for each.
Communicating from the top in a clear, forthright, and
consistent way about the severity of the threat and what to do
about it.
Developing and executing a real-time research agenda.
Strengthening surveillance and testing. The failure of test
development at CDC and the inability of State and local health
departments to deal with testing and tracing is well-known, but
the authorities to develop and scale testing were not
leveraged, and public health and health care data remained
largely unlinked, with signals of the staggering racial and
ethnic inequalities going unaddressed for way too long.
Examining what was in the SNS. It was always clear there
was not enough PPE, but emergency contracts to ramp up
production in early January and to gain visibility into the
supply chain should have been executed.
Recognizing and addressing the other health-related supply
chain vulnerabilities predicted from the get-go.
Putting the health care system on alert so it could prepare
the staff, supplies, policies, and for community-wide
coordination.
Starting countermeasure development early, as soon as the
threat was detected, to include diagnostics, therapeutics, and
vaccines. The National Institute of Allergy and Infectious
Disease (NIAID) jumpstarted work on an mRNA vaccine, but
Biomedical Advanced Research and Development Authority (BARDA)
was hamstrung in taking early action. While Operation Warp
Speed (OWS) came together and did a phenomenal job with vaccine
development, it could not make up for lost time, especially
with regard to diagnostics and therapeutics.
As a point of reference, Coalition for Epidemic
Preparedness Innovations (CEPI), where I work, was worried
enough about an impending pandemic that its staff activated
vaccine developers in early January, even before the sequence
was posted. It could always take an off ramp, but not make up
for lost time.
Coordinating across all levels of government and providing
guidance for health care settings so people were not left to
fend for themselves and compete with one another.
And mobilizing private sector partners.
I appreciate the opportunity to look forward, and here are
a few things that I think we need to do.
First, I think we need to make it safer for career
employees to do their jobs, including maintaining the integrity
of our science agencies.
Second, reconceptualize the organization and role for
public health. America needs a modern public health system, not
just at CDC but across the country.
Third, maintain a standing emerging infectious disease fund
at BARDA.
Four, reexamine the SNS, what it is for, ensure it can be
activated for surge production on demand, and has
responsibility for monitoring and addressing critical supply
chains going forward.
Five, strengthen and clarify selected authorities at the
Food and Drug Administration (FDA).
I will say, six, protect against cyber threats to our
research, our manufacturing, our supply chains, and our public.
It is important to remember that preparedness requires
continuous, proactive financial investment. It is all too easy
to lose sight of the fact that preparedness is forever. We
cannot afford to let our guard down. Almost 600,000 dead and
still counting. We cannot make up for lost time or lost lives,
but we can act on the hard lessons learned. Preparedness and
response have always been bipartisan or nonpartisan, and I
appreciate the spirit in which this hearing is being held.
Thank you.
Chairman Peters. Thank you, Dr. Lurie, for your opening
comments.
Our second witness is Dr. Julie Gerberding, a former
Director of the Centers for Disease Control and Prevention at
HHS from 2002 to 2009. Dr. Gerberding is currently the
executive vice president and chief patient officer at Merck &
Company. She also co-chairs the Center for Strategic and
International Studies (CSIS) Commission on Strengthening
America's Health Security. While at CDC, Dr. Gerberding led the
agency through more than 40 emergency responses to public
health crises. She has been recognized for her leadership in
responses to anthrax, bioterrorism, and the September 11, 2001,
attacks.
Welcome, Dr. Gerberding, and you may proceed now with your
five-minute opening statement.
TESTIMONY OF JULIE L. GERBERDING, M.D.,\1\ FORMER DIRECTOR
(2002-09), CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Gerberding. Thank you so much. Chairman Peters, Ranking
Member Portman, and all the Members of the Committee, it is an
opportunity to appear today and do whatever I can do to
contribute to improving upon the lessons that we have learned.
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\1\ The prepared statement of Dr. Gerberding appears in the
Appendix on page 54.
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Unfortunately, we cannot expect this pandemic to be an
isolated event, and what we can do now will help improve our
overall preparedness and response for this crisis, but also for
whatever is in store for us in the future.
We are in the middle of a war right now, and it is too soon
to declare victory, but I am sure we will eventually prevail.
We are dealing with on one side the virus, which continues to
spread and cause severe disease in new populations and
certainly new countries and new regions. We are dealing with
variants, 15 so far that are of some degree of concern, and one
of which, the B117 variant, which is now the dominant
transmitted virus in the United States. But we are also dealing
with vulnerability, a population of people that is increasingly
vulnerable not just to the impacts of this virus but also the
disruption in our social system, our care system, and the
experiences that they have with the difficulties in sustaining
care and treatment for their other underlying medical
conditions.
On the good side, we have the vaccines, which I think have
exceeded everyone's expectations. We have a lot more to learn
about them, the safety, the long-term durability of their
protection, and I will not be surprised if down the road we
will need a 2.0 or a 3.0 vaccine armamentarium. But at the very
least, this is an incredibly powerful tool, and we need to make
sure that we can deploy it to all the people who need
vaccination.
We also have vigilance, and I know this is a controversial
topic, but we have seen around the world that vigilance really
can contain this pandemic without vaccine. We need to ask our
citizens to continue to contribute that part of the equation
until such time that we really do have vaccine-induced
immunoprotection.
In my written testimony, I try to summarize the critical
requirements for success, the lessons that we have learned so
far, and some of the action items that I think we could be
taking right now that would strengthen our position. I will not
review all of those, of course, but I do think that, in
addition to the sort of interim lessons learned analysis, we
need to strongly encourage a commission, a review of all of the
complexities that this pandemic has created for us, something
along the lines of the 9/11 Commission that Dr. Phil Zelikow
chaired in the past. Some of us are actually involved in
supporting the planning for such a commission. I think down the
road that is going to really be helpful not just to this
Committee but to our Nation as we harden our biosecurity front
lines and really get serious about what we need to do to
protect America. So let me just talk about four critical areas
that I see as the most important right now.
First and foremost is still case detection, and while we
have made incredible progress with the support of the private
sector and getting all kinds of tests available, we are still
missing cases, and that becomes extremely important in the
construct of vaccine breakthroughs or recurrent infections in
people who have been infected more than once, as we need to
understand how the variants are playing into that and what
really is the long-term outlook for protection. So we must
continue that ability to test and look for the genomic
variability.
In order to do that, we need to think about how to support
the front line of that effort, and that takes more than
emergency funding. We really have to transition to sustainable
funding models that allow our public health system to invest
and develop the workforce necessary to provide these services,
but also a more proactive stance going forward, and that
includes funding our immunization infrastructure, the data
system modernization that you have already referred to, and the
ability to use more modern techniques and tools in the digital
space to improve the speed and accuracy of this overall case
detection phenomenon.
We must also improve our care to sick people. I think we
have made progress there, but we are not deploying the
guidance, and the front-line workers are not necessarily using
the tools that we have made available. As I said, we still need
to slow transmission in communities, and we have new tools
there, too. Merck, for example, is hoping that we will be able
to assess one of our antiviral medicines as a post-exposure
prophylaxis tool, and there are others that might add to our
ability to keep people out of the hospital and slow down
transmission in our communities.
The last piece of this, of course, is countermeasure
development. I have already said the biggest lesson learned is
how important our biopharmaceutical and related ecosystem has
been, surprising everyone with the speed, the collaboration,
and the overall volume of countermeasures that have been coming
forward. But we need to focus on the deployment of those
countermeasures not just in the United States but globally,
because, there is no wall tall enough to keep this virus out;
and if it is being spread anywhere in the world, it presents a
threat to us.
We also need to think ahead, and I hate to be a harbinger
of negative information, but I think we are learning our lesson
at a much faster pace now about how frequently these emergences
will occur. So we have to change our doctrine of response to
being much more involved in predicting where spillovers will
occur, preempting those spillovers, and expanding, at least an
order of magnitude, our armamentarium of countermeasures
through mechanisms like CEPI, National Institute of Health
(NIH), and most certainly the private sector, which I believe
we have learned is absolutely critical to both the development
as well as the manufacturing of these countermeasures in real
time going forward.
I will stop there and just thank you again for including me
in this hearing.
[Pause.]
Senator Portman. Mr. Chair, I think you are on mute.
Chairman Peters. Oh, sorry about that. Thank you, Dr.
Gerberding. You missed my ``thank you.'' Now that I am off
mute, thank you for your testimony and for being here today.
Our third witness is Mr. Joseph Nimmich, former Deputy
Administrator of the Federal Emergency Management Agency (FEMA)
at the U.S. Department of Homeland Security (DHS) from 2014 to
2017. Mr. Nimmich is currently a partner at Potomac Ridge
Consulting. He served in the United States Coast Guard (USCG)
for over 33 years and retired in 2010 as a Rear Admiral. Mr.
Nimmich has four decades of experience in disaster management
and response and recovery operations.
Mr. Nimmich, it is great to have you here today to testify.
You may proceed with your five-minute opening statement.
TESTIMONY OF THE HONORABLE JOSEPH NIMMICH,\1\ FORMER DEPUTY
ADMINISTRATOR (2014-17), FEDERAL EMERGENCY MANAGEMENT AGENCY,
U.S. DEPARTMENT OF HOMELAND SECURITY
Mr. Nimmich. Good morning, Chairman Peters, Ranking Member
Portman, and members of the Committee. Thank you for this
opportunity to appear before you. I am proud to have served as
the Deputy Administrator at FEMA and in the U.S. Coast Guard. I
hope my experiences provide insights useful to your program of
learning lessons from the COVID-19 response and the future
preparedness of our Nation.
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\1\ The prepared statement of Mr. Nimmich appears in the Appendix
on page 60.
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The work of the Commission on the National Response
Enterprise convened by Business Executives for National
Security (BENS) has strongly influenced my thinking about the
pandemic response. I was honored to serve as a Commissioner in
this effort, along with a very august team of leaders from
business, civil society, and government at all levels,
including Senator Hassan and Senator Cassidy.
The whole-of-society approach to this challenge made the
work of the Commission second to none, in my opinion, and
resulted in 11 actionable recommendations for redesigning our
response capabilities that I offer to the Committee to look at
closely.
I want to start with some good news. The Commission found
that the components of our integrated national response
capability are largely in place, but COVID-19 response exposed
critical execution challenges, particularly when a crisis
impacts numerous States simultaneously.
I would like to focus on two of the areas of weakness
identified today--that is, the exercising of our response plans
and the surging of the human capital, the ability to respond to
the crisis.
For exercising, the lack of planning really causes a
performance shortfall. It is usually the fact that a plan is
never as good as when it is first created. Time passes. New
crises deflect decisionmakers' attention. People in positions
change dissipating the trust between stakeholders, and the plan
loses its effectiveness.
The U.S. had multiple plans for the response, and,
Chairman, you have already indicated the exercise in 2019
called ``Crimson Contagion.'' It encountered and predicted
virtually every problem experienced less than several months
later during the COVID-19 response. Why were we not more ready?
The BENS Commission identified weaknesses in the national
exercise program and contributed the performance challenges we
saw in responding, including the low frequency of national-
level exercises, the limited participant knowledge of our
plans, the National Response Framework (NRF), and the crisis-
specific action plans, the lack of clear understanding of
authorities that are dictated in multiple authorizations and
Homeland Security Presidential Directives (HSPDs), and the
delegation of the responsibility for participating in those
exercises from the decisionmakers to their subordinates. Only
frequent and continual exercising keeps plans alive, enabling
updating and improvements. When we think of Crimson Contagion,
there was no time to be able to improve the response from the
time the exercise occurred because it occurred so late in the
process.
Elevating the priority placed on exercising drives more
effective coordination of the plans, and it allows the entire
emergency response enterprise to be aware of the plans.
When we talk about surge, right now 80 percent of FEMA's
workforce is deployed in support of national COVID-19
vaccination efforts as well as existing disasters. The problem
is that these FEMA employees have day jobs. They run the
National Flood Insurance Program (NFIP). They oversee the
billions of dollars in grant programs. They hire the FEMA
workforce. They provide the information technology (IT) that
FEMA relies on. Continual deployment caused by escalating
frequency and significance of disaster declarations has put
unsustainable pressure on the FEMA personnel and the agency
itself.
I am passionate about one of the Commission's
recommendations to alleviate the pressure: the creation of a
true civilian expertise reserve (CER) program for disasters.
Modeled after the National Guard, these CERs could activate for
service in both State and Federal crises and would provide
emergency managers with a highly trained rapid response force
of professionals, just as the National Guard does today. They
would possess the skills and experience contemporary
emergencies require: data analytics, cybersecurity, information
technology, along with what we would expect, medical,
engineering, and construction capabilities. They would have the
same protections provided by USARA as the National Guard does.
The Guard's command and control structure could present a
model for the CER management with State-based operations, a
leadership hierarchy in each State, and a national leadership
based in Washington, DC, to assume command of these forces when
Federalized. As envisioned, the Civilian Expertise Reserve
workforce gives the Nation a trained workforce to address
disasters large and smile, while delivering the essential
capacity only when it is needed.
In closing, FEMA now has activated for nearly 400 days.
That is five times more than the 70-day record of 2017. The
dedication of every one of our Nation's first responders and
FEMA employees is incomparable. They answer the call every
single time America needs them. Congress needs to understand
the pressures on FEMA, provide the necessary authorities and
adequate resources for the agency's success. The Nation
deserves it.
Thank you again for your time today, and I will be happy to
answer any of the Committee's questions.
Chairman Peters. Thank you, Mr. Nimmich. We appreciate you
being here today and for your testimony.
Our final witness today is Ms. Elizabeth Zimmerman, former
Associate Administrator for the Office of Response and Recovery
(ORR) within FEMA from 2014 to 2017. Ms. Zimmerman is an
internationally recognized emergency manager with over 35 years
of experience, and during her tenure at FEMA, Ms. Zimmerman
held dual titles of Associate Administrator and Director of
Disaster Operations where she directed and coordinated programs
and day-to-day operations within FEMA's Response, Recovery,
Logistics, and Field Operations Directorates, including during
major disaster and emergency activations.
Welcome, Ms. Zimmerman. Good to have you here with us. You
may proceed with your 5-minute opening Statement.
TESTIMONY OF ELIZABETH A. ZIMMERMAN,\1\ FORMER ASSOCIATE
ADMINISTRATOR (2014-17), OFFICE OF RESPONSE AND RECOVERY OF THE
FEDERAL EMERGENCY MANAGEMENT AGENCY, U.S. DEPARTMENT OF
HOMELAND SECURITY
Ms. Zimmerman. Great. Good morning, Chairman Peters,
Ranking Member Portman, and Members of the Committee. I thank
you for the opportunity to speak with you today regarding the
preparedness for COVID-19.
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\1\ The prepared statement of Ms. Zimmerman appears in the Appendix
on page 65.
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The COVID-19 pandemic is a maximum of maximum event that
has stressed and challenged the United States' health, social,
and economic systems. This was a national emergency, not just a
public health emergency, and for the first time in our Nation's
history, all 50 States, the District of Columbia, and the U.S.
territories were under a State of emergency due to the
consequences of COVID-19 being so severe, and they overwhelmed
the State, local, tribal, and territorial (SLTT) governments.
COVID-19 differs from other State and regional emergencies
in that every level of government was responding and focused on
saving the lives of their residents, while attempting to
prevent the collapse of their economy and medical systems. All
levels of government and the private sector were competing for
the same scarce resources such as medical personnel, PPE, and
ventilators, while simultaneously attempting to prepare for the
unknowns of the COVID-19 global pandemic.
Several issues arose in the early days of COVID-19 that in
hindsight could have been handled more effectively and
efficiently. Our Nation's emergency response and public health
systems must learn from our recent experiences and mistakes by
taking action now to update the plans, procedures, and better
define the authorities to be ready for the next pandemic or any
national emergency.
In my written Statement, I outline six areas that I believe
require further exploration for lessons learned, including the
issues and recommendations for these changes. The six areas
included the plans, lead Federal agency, data management models
and forecasting, commodities and logistics, the funding, and,
last, the workforce. I am going to highlight a few of the
issues and recommendations now.
The plans: The National Response Framework is the
overarching foundational framework for how we as a country
respond to and coordinate disasters. The NRF is used by all
levels of government to develop their plans. At the onset of
the pandemic, the NRF, the incident command and coordination
system were not acknowledged as being used. COVID-19 was being
managed by siloed health system operations, not coordinated
across the whole of government or with the private sector. In
mid-March 2020, when FEMA was named as the lead Federal agency
and brought the response under the NRF and organized the
National Response Coordination Center (NRCC), which is a system
that everyone is trained, exercised, and accustomed to use.
Recommendations going forward is that the NRF should be
used for all events and incidents as the foundation for
response operations in the U.S. Any agency can lead the
coordination under the NRF.
The second issue was designating a lead Federal agency.
Many times during national crises, FEMA becomes the Federal
Government's 911. COVID-19 was not the first time FEMA has been
called upon to organize and/or lead events on behalf of another
Federal agency that is outside of FEMA's Stafford Act
authority. H1N1, Ebola, Zika, Flint water crisis, the surge and
sheltering of unaccompanied minor children all fall within HHS'
mission and responsibility.
FEMA was also involved in the U.S. Environmental Protection
Agency (EPA) and U.S. Coast Guard's Deepwater Horizon response,
the Department of Agriculture's (USDA) avian flu response, and
the U.S. Department of Housing and Urban Development (HUD's)
long-term recovery and housing missions. While FEMA
successfully took on these responses, if FEMA is going to be
the 911 for the Federal Government, they must be given
authority, staffing, and resources to ensure successful
outcomes.
Which leads to my third and final issue and recommendation
that I will mention this morning. Typically, this time of year
FEMA's workforce has down time amid responding to tornados,
severe storms, and river flooding; however, this is not so in
2021. They have been working nonstop for over 15 months, with a
record number of staff deployed, second only to the 2017
hurricane season, and they are expected to top that number of
deployed staff by early May. They are stretched very thin, and
we know hurricane season is right around the corner.
The recommendation is that if FEMA is going to be the go-to
agency, their Reservist Program needs to be increased and
professionalized, similar to the military reserve corps, as Joe
Nimmich also mentioned earlier, where individuals can take a
leave of absence from their jobs to serve their country and
have the guarantee of returning to their job.
I thank you for the opportunity to participate in today's
hearing. As a lifetime emergency manager, it is important for
us as a Nation to make sure we include the whole community--
government and nongovernment, private sector--in preparing for,
mitigating against, responding to, and recovering from
disasters. We need to be prepared now for the next pandemic. As
COVID-19 demonstrated, it is not if but when it will happen. I
look forward to our discussion this morning, and I thank you
for this opportunity.
[The prepared Statement of Ms. Zimmerman follows:]
Chairman Peters. Thank you, Ms. Zimmerman, for your
testimony. You are absolutely right. The men and women of FEMA
do not have any down time, and they certainly --we all
appreciate their work. They are outstanding professionals, and
we appreciate all that they do each and every day.
Last month, former White House coronavirus response
coordinator Dr. Deborah Birx said, and I am going to quote Dr.
Birx here: ``There were about 100,000 deaths that came from the
original surge. All of the rest of them, in my mind, could have
been mitigated or decreased substantially.''
That is certainly a pretty damning assessment in the wake
of over half a million deaths in the United States and
increasing cases in Michigan right now and in States across the
country.
So my first question for you, Dr. Lurie--I am not going to
ask you to put any kind of number on it, but, generally, would
you agree with Dr. Birx's assessment?
Dr. Lurie. Oh, absolutely I would agree, and I think there
have been a number of, you know, modeling exercises that have
suggested that 40-plus percent of the deaths were avoidable. I
want to remind us that it is not only the deaths, but it is
people who have suffered long-term health consequences from
COVID; it is people who have suffered long-term mental health
consequences from COVID; it is their families, and obviously
the consequences of social and economic disruption.
I would also just say, going forward, there is still a lot
of opportunity to avoid deaths, not only with vaccination but,
as you and Dr. Gerberding point out, by taking seriously now
the surge we are seeing in cases and having people take the
appropriate public health measures. We are still all in this.
Chairman Peters. Absolutely, we definitely are.
Dr. Gerberding, would you agree with Dr. Lurie and Dr.
Birx, again, without giving any numbers but the general
assessment of their Statements?
Dr. Gerberding. Of course, I do not have the actual data or
the modeling raw material, but I think it is common sense that
if we had been able to identify cases and isolate them and
their contacts sooner, we would have seen a much slower startup
to this problem, and we would have bought a lot more time than
we were left to deal with once we recognized how widespread it
had already become. So that clearly is a major issue. The
reasons for it are complex. I have tried to understand them
from the outside looking in, but I think, as I mentioned in my
written testimony, there are some things we can do now to
harden ourselves against a future that brings that particular
problem to bear, again, on the inability to respond initially.
I will also say that this is a shared responsibility. CDC
certainly made its share of missteps at the beginning. We also
needed some regulatory support for expanding access to tests
when they became available, and then a faster mechanism to
bring the private sector that can really scale testing into the
situation. So the solution is broad but, nevertheless, it was a
very early and unfortunate problem.
Chairman Peters. No question about that, and I want to
focus now with you, Dr. Gerberding, on the three week period in
late February to early March 2020, at the very beginning of
what we saw with this pandemic. The number of COVID-19 cases in
the U.S. increased by more than 1,000-fold, according to the
CDC--a critical period, clearly, at the beginning of this
pandemic.
My question to you is: In your view, what factors led to
that rapid rise in COVID-19 cases? And you have alluded to many
of the different types of stuff, but if you could just focus in
on that initial stage, which was just so critical, what steps
could the Federal Government have taken to mitigate that spread
right at the very outset during that three week period, late
February to early March?
Dr. Gerberding. Yes, I think it is tough. What we now know
in retrospect is this is one of the most transmissible viruses
we have ever had to deal with from a respiratory perspective.
The fact that we had ongoing coronavirus transmission but
essentially no flu transmission tells you what the differential
is in terms of their probability of spread. So it was a really
tough challenge, and it was made a lot tougher by not being
able to get in there early and really not just look at people
with a travel history or those that we suspected were at high
risk, but to understand very early in the course of things that
asymptomatic transmission was happening at a rate, again,
somewhat unprecedented in disease transmission. And we also, I
think, really would have been much more assertive about doing
sampling studies, population-level sampling studies where we
really look for the hot spots based on what we know about
previous settings where viruses are easily transmitted by the
respiratory route, and accelerated the science of the
transmission coefficient so that we would be able to better
predict where to go to look for cases even when testing was not
widely available.
So in a sense, this was a failure of imagination, a failure
to appreciate that this was not going to be like severe acute
respiratory syndrome (SARS) or Middle East respiratory syndrome
(MERS) where the efficiency of transmission from person to
person was low. This was a disease that spread like wildfire,
and we responded as if it were sort of business as usual.
Chairman Peters. Dr. Lurie, I want to ask you a question
related to those very initial stages as well where we saw this
acceleration of the spread of the virus. In your testimony, you
identify multiple missteps in that initial response, and you
specifically highlight--and I want to quote what you
specifically highlight. You say,``. . . all the authorities in
the world cannot make up for the failure of leadership.''
My question to you is: What avoidable harm, in your view,
flowed most directly from this failure of leadership as the
initial pandemic response unfolded in January, February, and
March of last year?
Dr. Lurie. I think the avoidable harm started with the
ability of the virus to spread like wildfire because we did not
acknowledge that it was going on and we did not take the steps
to contain it, either the public health kinds of measures that
Dr. Gerberding talked about, the steps to ramp up things like
the production of masks and PPE to protect health care workers
and to protect the supply chain and others, and everything that
has unfolded from there.
If you think that the first 100,000 cases were maybe
unavoidable, or less, certainly we could have changed the
trajectory of this and saved countless lives.
So the failure to take all of the early actions, those that
I mentioned and more, were really all avoidable and would have
been much more avoidable had there been open and public
acknowledgment of these risks. Even if we did not know how bad
it was, it was our responsibility to prepare for the worst and
to alert the public.
The other really avoidable harm has been the politicization
of this, and so the public has gotten really confused about who
to believe, what to believe, and obviously, people are still at
odds with each other over a lot of aspects of this.
Chairman Peters. All right. Thank you.
Ranking Member Portman, you are recognized for your
questions.
Senator Portman. Great. Thank you, Mr. Chairman. And thanks
to all the witnesses.
I want to start with the surveillance issue. We talked a
lot this morning already about CDC, but what happened? Why
didn't CDC have the ability through the surveillance systems
that we had in place to be able to detect this sooner? It seems
to me they were relying on incomplete and outdated public
health information, among other things, as I said in my
opening. Some of you have talked today about the need for
digital monitoring and that there were early warning signals
that were not picked up.
Dr. Gerberding, you focused on that. What sort of
surveillance indicators was the CDC relying on at the outset of
the pandemic to inform the public health response?
Dr. Gerberding. I think first and foremost was to take a
look at what was going on globally. We had some information
about the extent of spread in the Wuhan Province. We had
examples of pretty well documented spread from travelers into
work settings in other parts of the world. I think the clues
were there that this was a very transmissible infection, unlike
SARS was in 2003. So that was the first thing, is to lean into
the threat that exists.
The second thing is testing and, you know, I think it was
unlikely, even under the most rehearsed scenario, that we would
have been able to immediately deploy a test for a brand-new
pathogen to 300 million people on short order. But we certainly
could have utilized the tests that were available elsewhere in
the world that had proven to be useful, and we could have
worked much faster to bring the scale of testing up to speed
with better cooperation and earlier engagement of the academic
sector as well as the private sector. So the first thing that
needs to happen is case detection and then the isolation of the
cases, the quarantine of their contacts.
Now, that is a problem in the United States because finding
contacts is basically shoe leather right now. It means you have
to go out and more or less door-to-door to track down the
people who might have been exposed. And our workforce is way
too thin to have been able to accomplish that once we had so
many cases. It became almost impossible.
I think a third piece of this is to use our epidemiologic
common sense and recognize that with a respiratory pathogen
there are going to be certain congregate settings--confinement,
high degrees of contact--where there is likely to be
transmission, and to get into those settings first, do the
testing and the epidemiologic assessment so we are ahead of the
curve rather than waiting until cases were hospitalized and
then find the hot spots in retrospect. So a lot of things are a
combination of testing, workforce scarcity, and I think, again,
just the inability up front to imagine how bad it was going to
be.
Senator Portman. I would like to dig a little deeper on the
testing with you and Dr. Lurie and anybody else who wants to
jump in. But backing up on surveillance for a moment, because
it is not just about testing, as you indicate it is also about
the World Health Organization (WHO) telling us what was going
on, which they did not, China being more transparent, we know
that. But what type of fixes do you think we need to make
beyond additional funding, which I appreciate, and I appreciate
the fact that you said the personnel are needed. You mentioned,
for instance, using technology better in your testimony and
digitizing some of this. Just quickly, if you could, what could
we do under a surveillance system, in addition to testing, to
make it more effective?
Dr. Gerberding. One really important point that I think is
implied in your question is that this is a global challenge,
and if we had really actualized the promise of the global
health security agenda, we would have had much better insight
into where this disease started and how fast it was spreading
internationally. We do need to come back to that global network
of surveillance, not just a U.S. network. In the United States,
I agree with you on the digital tools and the application of
our technology in new and exciting ways, but at the end of the
day, it boils down to case detection as the first step.
Senator Portman. Yes, let us talk about testing for a
second. Again, anybody is free to jump in here. I tell you, my
frustration on testing was that CDC--and some of you have been
involved in CDC over the years, and, there is plenty of blame
to go around here. But CDC had lousy tests. In Ohio, we were
given a bunch of CDC tests, and that was the only place to get
tests, as we understood it. They did not work. There were
defects in them. It prevented our labs from being able to
validate the tests, rendering them basically useless.
I do not know if you know this, but in Ohio, the result of
this was that some of the private sector jumped in, and
particularly the Cleveland Clinic developed its own test, and I
will give you some dates here. We got our botched tests from
CDC on February 7th. We did not get a working test from CDC
until March 5th, so virtually a month went by. And talk about a
waste and an opportunity to save lives. And the Cleveland
Clinic developed their own test and put it online on March
13th. That test I took, by the way, early on. But why were we
so reliant on CDC? Shouldn't we have been encouraging the
private sector to be involved all along? Again, Dr. Lurie, if
you could jump in here, how did the legal and regulatory
landscape at the time help or hinder institutions like the
clinic, to use them as an example, but there were groups all
over the country doing this, developing their own tests? Could
you respond to that, Dr. Lurie?
Dr. Lurie. Yes, sure. What I would say is, when it was
clear very early on that we were going to need an awful lot of
tests, and tests were developed around the world. As Dr.
Gerberding said, some of them worked quite well, and we could
have used them. When CDC was struggling with its tests, or even
before, BARDA should have exercised its authorities and gotten
in early on to stimulate the development of diagnostic tests
across the private sector and in the academic sector so that
you would have had a variety of tests earlier.
No one--there was no entity that took responsibility for
pulling samples together to validate diagnostic tests, and so
all the test developers really struggled. And so FDA gave an
awful lot of them a pass and said, well, you are not going to
need an Emergency Use Authorization (EUA); we are going to go
ahead and assume a number of things. Then it turned out that we
had diagnostic tests that did not perform well at all and had
to come back off the market.
So the failure to get in early, ask the private sector to
develop tests, agree to work with them, provide the sept that
they would need for validation, and then be able to scale I
think were really significant failures stemming from the
failure to want to recognize that this was happening.
Senator Portman. Thank you. We have to learn from that,
clearly, and, it amazes me that we were so ill prepared in
terms of our diagnostics.
My time is coming to an end. Admiral Nimmich, I had planned
to ask you some questions about the BENS Commission. I
appreciate the work on that. Senator Hassan was involved, who
is on the panel today, and Senator Cassidy. But we really have
appreciated that, and we are using some of your work. I guess
the planning and the exercises, were not adequate in this case,
and one question I want to leave with you as I end my time is:
Is FEMA the right organization to head up something like this?
There is a difference of opinion as to whether it should have
been HHS or FEMA. And was FEMA the right entity? I will sort of
leave that question out there hoping that somebody else follows
up on it who has more time available.
Thank you, Mr. Chairman.
Chairman Peters. Thank you, Ranking Member Portman.
Senator Hassan, you are recognized for your questions.
OPENING STATEMENT OF SENATOR HASSAN
Senator Hassan. Thank you, Chairman Peters. And to Ranking
Member Portman, thank you as well for the nonpartisan approach
that you have taken to convening this hearing.
To our witnesses, thank you for being here today, but also
thank you for your service.
I do want to start with a question to Mr. Nimmich, and I
will ask you the question, and then if you want to fold into
your answer a little bit about your thoughts to Senator
Portman's question, that is fine, too.
It was really a pleasure, Mr. Nimmich, working with you on
the BENS Commission on the National Response Enterprise. In
your testimony, you discussed one of the topics addressed by
the Commission, which is the importance of exercising emergency
plans. A report from the 2019 Crimson Contagion exercise found
that, with regard to the crisis in that exercise, there was
``confusion between HHS, FEMA, and the Department of Homeland
Security on which Federal agency would take lead in the
crisis.'' Unfortunately, we witnessed this very same confusion
between the role of HHS and FEMA during the COVID-19 pandemic,
and this confusion certainly contributed to an overall lack of
coordinated national response.
First, Mr. Nimmich, do you support updating the Stafford
Act to clarify FEMA's response role to include pandemics?
Mr. Nimmich. I think the two questions are highly related,
and the question really comes, support and supporting. I use an
awful lot of Department of Defense (DOD) concepts because
response to whether it is a Department of Defense issue or a
domestic issue, responding is pretty standard. I do not think
it is--it is a requirement that we identify early on who is the
lead agency and who is supporting them. You can add into the
Stafford Act for pandemic, for cybersecurity, cyber events, and
that would allow FEMA to be funded to do the work that is
necessary. But it does not have to put FEMA in the leadership
role. FEMA coordinates, and they take the rest of the whole of
government and bring it to the event.
I do think that FEMA has a role to play in a pandemic. It
has a role to play in almost any type of a national crisis. But
it does not necessarily have to be in the lead, but it has to
be defined early. The pandemic playbook that the NSC had in
their hands had triggers of when certain things should happen,
and those triggers rely on the data, whether it comes from CDC
or someone else. You have to validate those. You have to
exercise that and make sure each administration is comfortable
that the data they are receiving, when the trigger is set, that
they know who they are going to put in charge.
Senator Hassan. Thank you. I want to follow up on that a
little bit just in terms of the exercise issue as well, because
regarding the 2019 exercise that identified this potential
problem, how do we ensure that the Federal Government is
actually implementing improvements on what is learned from
these emergency exercises?
Mr. Nimmich. I think that is a great question, and the
challenge always is where do the resources and the policy
changes being made in order to address the problems you found
in the exercise. All too often we say that was a great
exercise; we planned for what we can do and not necessarily
what will be done. I ran the Spill of National Significance
(SONS) exercise in January and February 2010. We did a great
job. We identified certain problems. But we planned on what we
could do, a ship running aground with 600 million gallons of
oil. We learned in April of that year that you can have an
uncontained spill, with the new Horizon. I do believe it is
planning for, as Dr. Lurie said, sometimes the unimaginable and
then exercising those plans.
Senator Hassan. And then making sure there is communication
about what you learned.
Mr. Nimmich. That is right, the policy and the funding.
Senator Hassan. Thank you.
To Dr. Gerberding, as former CDC Director, you understand
the importance of communicating effectively with the American
public. As you know, there was some who are concerned that
vaccine hesitancy may begin to impact our vaccine
administration efforts in the coming weeks. What steps can we
take now to improve public confidence in existing COVID-19
vaccines so that we can vaccinate at a rate that mitigates the
threat of emerging variants? How do we communicate the
importance of vaccination as critical steps toward reaching
herd immunity?
Dr. Gerberding. Thank you so much for bringing this up,
because as I am sure you know, at baseline we deal with a
severe crisis in vaccine confidence in the United States and
elsewhere, so this pandemic has brought that to the forefront
in every way.
The good news is the efforts so far, which particularly
emphasized reaching into the communities and constituencies
that have the greatest degree of concern and bringing not just
scientific information facts and figures, but the messages and
the engagement of people they trust. Sometimes at the community
level that is a pastor or a barber, or it may be the front-line
primary care provider. But we have to build out a network of
people who have the facts, but also have the trust of the
community.
In many communities the government is not the most trusted
part of the equation, nor are the manufacturers of vaccines.
This is a matter of all of us affecting--in my company, at
Merck, we are working hard to build confidence among our own
employees. We are working with the World Economic Forum (WEF)
to help employers understand how they can inform their
employees and help them make the right choice about
vaccination. I think it is an uphill battle, and we are pleased
with the support and the supplement to help the CDC lead that
communication effort. At the same time, we have a long way to
go before we really achieve herd immunity on the basis of
vaccination because of the reluctance of so many people.
Whenever there is a safety concern, people really struggle to
put the very high risk of COVID into the context of low but
real potential risk from immunization. It seems like the risk
of the vaccine looms so large in your mind, and yet the risk of
COVID is deadly to far too many people, and we have to help
folks recognize that this is a really important tool,
especially if we use it right now.
I would love to talk with you offline more about this
because I think there is much more we can and should do.
Senator Hassan. I thank you because you really answered my
next question, too, about how do we get to communities where
the skepticism is the greatest and that have traditionally and
historically faced the biggest challenges in access, too. I
will look forward to that. I thank you so much, too, for
pointing out not only the risk of death from COVID but also the
long-term risks for long-haul COVID patients compared with the
low risks of vaccine.
Thank you, Mr. Chairman, and, last, I will just say to Mr.
Nimmich, you can expect a follow-up question from us on how do
we make sure that we have the kind of surge capacity we need as
we move forward with FEMA having more and more responsibility
as that kind of lead emergency agency.
Thanks again for the hearing.
Chairman Peters. Thank you, Senator Hassan.
Senator Hawley, you are recognized for your questions.
OPENING STATEMENT OF SENATOR HAWLEY
Senator Hawley. Thank you, Mr. Chairman. Thanks to the
witnesses for being here.
Ms. Zimmerman, I would like to start with you, if we could,
and discuss the supply chain issue. I noticed in your written
testimony your recommendations about logistics and just-in-time
manufacturing, saying that they do not really work in your
experience and observation when we are in the midst of a global
event like the one we have just gone through. I certainly agree
with that, and I am wondering if you can just elaborate about
your experiences at FEMA. What demonstrated to you that the
just-in-time model is insufficient for a major crisis like the
one that we have just gone through?
Ms. Zimmerman. Right. Thank you, Senator. The just-in-time,
when we are working especially in the medical supply chain,
medical supply to hospitals, what we have noticed is that they
do not have supply on hand for much more than a few days. They
require the just-in-time to replenish. They have their
contracts so that they can get the supplies they need for their
day-to-day operations come in, and they do not have to also
have a huge warehouse to store them in. They rely on the
private sector for doing that.
So being able to get those commodities when you need them
in the extreme amounts that we did during COVID in early days
before manufacturing can get pulled up, it made it very
critical, and that is when we saw that, there were not supplies
within the United States. We needed to go elsewhere. We needed
to go to other countries and when it was set up to bring in the
commodities from other places.
So the just-in-time can work fine in smaller events, just
like the FEMA distribution centers that they have across the
country, that stockpile of the water and the blankets and the
things that we need to protect lives and get things stabilized
during normal natural disasters that FEMA works in. But when it
really comes to a global event like this, just-in-time does not
work when we do not have manufacturing ready to go to bring in
those commodities in the numbers that were needed.
Senator Hawley. I have been an advocate of reshoring our
critical supply chains and introduced legislation to do that,
and I think it is absolutely something that we have to pursue
and make a top priority. But you and I both know that that
process of onshoring will take time. It is vital we do it, but
that is a medium-to long-term project that we need to start
now. In the short term, do you have any recommendations about
how we can reduce our reliance on the just-in-time model and
improve our resiliency in the midst of a major crisis? What can
we do immediately that will have short-term implications or
effects?
Ms. Zimmerman. I think immediately we need to look at what
supplies are on hand. We look at the Strategic National
Stockpile when it comes to COVID or any other pandemic and
medical issue, looking at those types of things. We try to plan
for those maximum of maximum events so that we have things when
they use the Defense Production Act to change over
manufacturing from cars to ventilators and that. How do we
really do that? But what are those key critical things that we
need? I think after the last year, we saw the PPE and the
supplies that were needed by the medical first responders. We
need to make sure that we have a way of getting those within
those country and how we stand up those abilities immediately
when we see something happening.
I think this is an opportunity right now. We are still in
the midst of the COVID-19, and where are we now with getting
commodities in and how we have resourced and been able to get
things even for the American people, the masks that people are
wearing, the other supplies and things that we need, so looking
at where we are today, and we need to accept where we are
today, but what are those other things that we might need going
forward? We need to be prepared to supply those.
Senator Hawley. Very good. Thank you.
Mr. Nimmich, let me just give you a chance to weigh in here
given your experience at FEMA. Do you have a view on the supply
chain question, whether that is stockpiling, as Ms. Zimmerman
just said, stockpiling commodities or ramping up production on
a temporary basis or something different?
Mr. Nimmich. Not dramatically different, Senator, but you
could tell from my body language, yes, I have some pretty
strong opinions on the ability to move from just-in-time, and
the National Stockpile is a good thing, but it is not the only
thing we can do. While we are bringing ashore the capacity and
being able to understand the Defense Production Act and how we
would utilize that in a future capability, we can incentivize
hospitals and local medical capability to go over their
efficient level, to be able to bring in and actually rotate the
stock of medical equipment so that if it is in the National
Stockpile, it does not go stale on the shelf and then have to
be replaced at a larger cost.
I think we could look at ways of incentivizing hospitals
and medical facilities to keep 110 percent of what their daily
requirements are, and that 10 percent, if we incentivize it,
the Federal Government or the States could reallocate to other
areas. You have now distributed your stockpile across the
Nation, and it is closer to where you are going to need it
whenever you need it.
Senator Hawley. That is good. That is very interesting. Let
me ask you about the Supply Chain Stabilization Task Force led
jointly by DOD and FEMA, which the last administration helped
set up--or did set up to help coordinate and maximize the
procurement of things like PPE. How well do you think that
worked? What should we learn from that experience?
Mr. Nimmich. Like any task force, it took time to establish
itself understand each other's roles. When you again look at
the Department of Defense, they understand the National defense
industrial base. They know where the capabilities are. We do
not try to create a comparable industrial base that we
understand and we maintain, and it goes to your bringing back
to shore the infrastructure to be able to do this.
I think the task force performed admirably once it had been
established and they understood each other's roles, but you
have to have, like DOD does, the infrastructure in place to
understand how you are going to do this before an event.
Creating it during the event reduces that time to perform.
Senator Hawley. Very good.
Dr. Lurie. Let me just try to jump in here for a minute, if
I could, with one additional suggestion, and we experienced
both shortages in H1N1 and Ebola and found that in different
places in the private sector and in government there were
actually large supplies that were double and triple ordered,
but the government did not necessarily have the mechanism to go
to all the manufacturers and distributors and ask where it was
in the system. So clarifying authorities for it to be able to
do that in an emergency, you can see where it is and
redistribute it quickly, I think would be very helpful.
Senator Hawley. That is helpful. Thank you.
I see my time has expired. I will have a few more
questions, Dr. Gerberding, for you and, Dr. Lurie, for you as
well for the record.\1\
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\1\ The questions of Senator Hawley appears in the Appendix on page
83.
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Senator Hawley. Thank you, Mr. Chairman.
Chairman Peters. Thank you, Senator Hawley.
Senator Rosen, you are recognized for your questions.
OPENING STATEMENT OF SENATOR ROSEN
Senator Rosen. Thank you, Chair Peters and Ranking Member
Portman. This is a really important hearing, and I appreciate
all the witnesses for everything you have done and for being
here today.
I want to talk a little bit about data tracking and early
pandemic response. As we know, the pandemic dominated American
life last year and, of course, into this year. Our focus has
rightly remained on tackling the immediate challenges before
us. We have to work to save lives and livelihoods.
However, I do think there were missed opportunities to get
a better picture of the pandemic, which is critical to
understanding how to protect people dealing with the long-term
effects of COVID, making sure we are not leaving anybody
behind.
So moving forward, I believe we need to be sure we have a
comprehensive understanding of priorities while still doing
research efficiently so that data collection does not delay us
getting help to those who need it, it is not so cumbersome,
because a novel virus like COVID-19, it is critical we have a
full understanding of the impacts. Only through data collection
is it going to tell you that.
Last year, I introduced the bipartisan Ensuring
Understanding of COVID-19 to Protect Public Health Act. I want
to make sure we get started on those comprehensive long-term
studies with regular reporting right away so that researchers
and clinicians can have the latest information. Some of the
studies have started, but, of course, there are significant
gaps. I hope all my colleagues will join me.
But, Dr. Gerberding, can you please discuss some of the
remaining gaps in research we have, especially now that we are
seeing the long haulers, people who are in it for the long
term, they seem fine and things are popping back up? How does
the virus seem to be impacting patients differently, especially
so we need to do research on this?
Dr. Gerberding. We have a lot to learn, to start with the
medical dimensions of the infection. You are absolutely right.
We do not really understand the actual pathogenesis or the
mechanism by which this virus causes such a myriad
constellation of diseases, everything from no symptoms all the
way to devastating multi-organ system failure. Some of that is
perhaps related to viral load; some of it is genetic. But there
is much to be learned there, just at a very basic medical
level.
But, in addition, the syndrome of the post-infectious phase
of COVID, which is increasingly recognized as the broad
constellation of findings with a pretty durable impact on
people, not just their physical health but their mental health
and their ability to function, we have to understand this post-
infectious phase of illness. But I think there are also many
things that we need to learn about the basic epidemiology, and,
again, that is where data systems can be our best friend
because we may be able to probe things from existing data or
more rapidly get our hands on data that are evolving through
our health systems and our public health systems to be able to
draw connections and see patterns that we cannot currently
recognize without the use of artificial intelligence (AI) or
machine learning-type tools.
The list of what we need to know is long. I think right now
everyone is kind of focused on the most critical things in the
context of care of patients and vaccination, but we are going
to be with this coronavirus for a long time.
Senator Rosen. I agree with you. The list is long, so we
need a vast amount of information, but we need it quickly. I
have heard from some caregivers up and down my State,
especially in smaller, more rural areas. They are hesitating on
some things because they do not know if they have the capacity
to comply with the various reporting systems.
How do you think we need to simplify the process so that
everybody getting vaccinations and treatments in our community
health centers, in our smaller hospitals, that we have the
interoperability and the ease of reporting so we can get vast
amount of data to us quickly? Dr. Lurie and Ms. Zimmerman,
maybe you might respond to the collecting of data and the
interoperability to give the doctors the tools they need going
forward, give us all of us really.
Dr. Lurie. Sure. I would say a couple of things. First of
all, it got going late, but there are now mechanisms through
something called ``Project Echo'' to pull doctors together
every week for sort of peer-to-peer learning about best
practices and how to treat one another. I would encourage all
kinds of health care providers to take advantage of that.
But make no mistake. Our data systems are really siloed.
You are right; they are not interoperable. In fact, there are
vast amounts of data out there that go unanalyzed because we do
not have the tools to do it and we do not have the workforce to
do it.
Going forward, I think we could ask ourselves very fairly
now, what needs to be done by humans? Or could you have sort of
early aberrant signals picked up now by machine learning, by
artificial intelligence, and others, so we could put the highly
trained human capacity where it needs to go and not miss
signals and be able to aggregate data much more quickly? On the
data end, we have made such great progress from the perspective
of integrating it or health care and public health data
together into the way we understand the disease and the way we
make decisions. We have a really long way to go and a huge
opportunity there to do better.
Senator Rosen. Thank you.
Ms. Zimmerman, what do you think we might be able to do to
help improve this interoperability between, I guess, I want to
say ``partners,'' whether they are health care, FEMA, community
partners, mobile clinics, you name it, hospitals, all of our
system? Do you have suggestions for us?
Ms. Zimmerman. Yes, thank you, Senator, exactly, because
when you start chasing the data--and in the beginning of COVID-
19 everybody was chasing all sorts of data. There was no set
parameters of what was needed to make decisions. In the
beginning you are making it with limited data, and that is what
emergency managers do. They go forth and push.
But I think we have a great opportunity right now to look
at what data provided us the best information in order to make
those decisions. What are those immediate decisions you need to
make at the onset of a pandemic or any type of major medical
thing that is impacting the Nation? I think it is looking at
what were the things that gave us the outcomes. To me, you need
to look at the outcomes and what is the data needed to get that
and to be able to put the smart people in the room to determine
what is needed in that regard I think is very key right now,
because, otherwise, with all of the technology and everything
that is out there, we go chasing a lot of data points that do
not give us an outcome that matters, and we need to look at
what are those outcomes that are going to matter to shortening
the time period for all of this that we have been through.
Senator Rosen. Thank you. As a former analyst, I could not
agree more that the data tells a story if you figure out how
you need to listen to it, and we really need to understand the
lessons we have learned that we can use, not just for going
forward in this pandemic, but God forbid we have another or the
next public health emergency. So this should be able to guide
us.
Thank you. I will submit the rest of the questions for the
record.
Senator Rosen. Thank you.
Chairman Peters. Thank you, Senator Rosen.
Senator Johnson, you are recognized for your questions.
OPENING STATEMENT OF SENATOR JOHNSON
Senator Johnson. Thank you, Mr. Chairman.
Dr. Gerberding, first of all, welcome back to the
Committee. I remember you testifying before our Committee on
February 12th on many of these same issues. I am sure we talked
about testing. I want to talk a little bit about that. But I
know it was in that hearing that I found out, because FDA
Commissioner Gottlieb also testified, about our lack of active
pharmaceutical ingredient (API).
As I further investigated that, I found out there is
something even before API, which is what they call
``intermediate.'' It is an odd name because it is really the
precursor chemicals. It sounds like most of those precursor
chemicals, because it is a dirty manufacturing process, occurs
in China. Is that accurate?
Dr. Gerberding. I think it depends on what product you are
talking about, but the global supply chain that is the raw
materials, the intermediates, and the API, certainly includes
China, India, and many other locations around the world.
Senator Johnson. But if we really want security in terms of
our pharmaceutical industry, we really need to get not only API
back in the United States, but we are going to have to do that,
the intermediate, the precursor chemicals as well, and we are
going to have to figure out how to do that environmentally
safely. Correct?
Dr. Gerberding. I think the safety and the fidelity and the
consistency of the supply are really critical issues. All of us
in the context of COVID have been examining our supply chains,
not just for vaccines and the most critical countermeasures,
but for our entire supply chain, many companies have a system
of having kind of a bubble, sort of what we were talking about
with the Strategic National Stockpile, so that we have a
contingency planning around those intermediates. But our
vulnerabilities are clear now, and we are going to need to do
more to make sure we can sustain the most critical essential
medicines and vaccines in times of international stress.
Senator Johnson. Let us talk about testing. February 4th,
we were still pretty early into this pandemic. I think
everybody recognized we would like to get tests so that we can
identify cases so we can quarantine people. It took many weeks,
a number of stumbles. I guess maybe it is my manufacturing
background where I am a little more sympathetic that these
things just are not that easy. It takes time to ramp up
manufacturing. You need basic supplies. We found out--just
glass vials, we needed the reagents, we needed the chemicals,
that type of thing.
So the question I have is: Assuming we could have
immediately get a test that worked, and even that, I mean, it
is nice to be a Monday morning quarterback, but we did not even
have the pathogen, we did not even have the virus. I do not
know how much better we could have done, maybe a few weeks. But
what do we need to put in place today, what supplies do we need
to keep in the National Stockpile or through a private sector
distribution system where we maybe pay people to carry excess
inventories? Do we need glass vials? Do we need certain
chemicals? What do we need so we can prepare and be testing
earlier next time?
Again, I am not sure we could have done that much better.
Maybe by a few weeks. I think the horse was out of the barn at
that point in time. I think we maybe overstate the case in
terms of how the pandemic played out. But what do we need in
terms of testing supplies?
Dr. Gerberding. First of all, this is a perfect storm, much
asymptomatic disease, so who do you test? You cannot test 300
million people all at once, so that really challenged everyone,
even, as you said, with the perfect test available to us.
Second, scaling a test quickly depends not only on the
ability to make the test kits and deploy them; it also depends
on having the samples of known cases so that you can determine
if the test is actually reliable or not. And that was a gap
that I think Dr. Lurie has already mentioned.
The third thing I would say about testing per se is that I
worked at the CDC for a long time, and I have watched them
before and after, and CDC is actually extremely good at making
tests for new pathogens. So this problem in this situation was
tragic, but an isolated situation, and I know there are going
to need to be specific remediation steps. But going beyond
that, I think to solve this problem in the future, we have to
plan ahead for how we bring in the private sector right at the
beginning and have the consortium of people available to work
collaboratively.
I do not think the testing issue is so much a supply issue
per se as it was simply the ability to validate and prove the
reliability. Of course, we have had a lot of bad tests come
out, and we have had some counterfeit tests come out. That is a
whole other set of issues that we kind of had to contend with.
Senator Johnson. Again, it is fine to be a Monday morning
quarterback, but I think we need to be a little careful. Back
in 2009, with H1N1, CDC in the end estimated somewhere between
43 and 89 million people got infected with H1N1. Right now we
are about 31 million. To a certain extent, we have flattened
the curve by what we have done. I think we need to actually
take a look at the numbers. I have been tracking the numbers
very carefully. Deaths per million, Italy, about 2,700; U.K.,
about 1,870--these are as of April 1st. The United States, we
are at a little under 1,700. Everybody criticized Sweden for--
not everybody. I did not--for a different approach, isolate the
sick, quarantine the sick, protect the vulnerable, and then
have the rest of us go about our lives as carefully as
possible. They are below us at about a little over 1,500. But,
I want to see if anybody can explain why is India at 120 deaths
per million when all these U.S. and European countries are well
over 1,500 deaths per million? What is the difference?
Dr. Gerberding. Many differences, but one of them is that
testing is even less available in India. The infrastructure of
public health there is even more impaired, many billions of
people that are not necessarily accounted for are included in
those numerators and denominators, and India----
Senator Johnson. So you question the numbers on that one?
Dr. Gerberding. I am sorry?
Senator Johnson. You are questioning the numbers they are
reporting.
Dr. Gerberding. I think----
Senator Johnson. I have no idea.
Dr. Gerberding [continuing]. But India also right now is
the leading edge of surge on a global basis, so they are coming
into----
Senator Johnson. A stark difference, 120 deaths per million
versus--I will try to get an explanation on that.
The final question I have is: I think we have to factor in
the human toll, the cost, the economic devastation of these
shutdowns, and really ask ourselves what was worse. We had Dr.
Bhattacharya testify before our Committee talking about a WHO
study that said there were 130 million people at risk of
starvation. I think we have to within our pandemic planning,
next time we jump to shutting down our economy, I think we have
to also understand the human toll of these shutdowns. Would you
agree or disagree with that?
Dr. Gerberding. I think when you are looking at now 563,000
deaths in America, it is hard to feel good about that----
Senator Johnson. I am not saying we should.
Dr. Gerberding [continuing]. Under these circumstances, so,
we need to understand the full ripple effects. But, clearly,
the social distancing and the isolation, the devastating
economic circumstances have their own toll. There is no doubt
about it. One of the most important dimensions of that is that
people are not getting their ordinary care. We are not
vaccinating our kids, we are not taking care of our diabetes,
we are not screening for cancers. These are things whose toll
with accumulate over a much longer period of time.
So, yes, this is a very wicked problem we are trying to
solve here. The most important thing is to contain the virus as
quickly as we can.
Senator Johnson. OK. Thank you, Mr. Chairman.
Chairman Peters. Thank you, Senator Johnson.
Senator Ossoff, you are recognized for your questions.
OPENING STATEMENT OF SENATOR OSSOFF
Senator Ossoff. Thank you, Mr. Chairman. Thank you to our
distinguished panelists.
Dr. Gerberding, I want to thank you as well for your
service and leadership of the Centers for Disease Control and
Prevention, which, of course, as you well know, are located in
my home State of Georgia. We have such an outstanding team of
public health professionals, medical doctors, and civil
servants who lead our Nation's epidemiological efforts and
disease control efforts.
Dr. Gerberding, based on your experience and your
assessment of what has gone wrong and what has gone right over
the last year and a half, I would like to ask you to take this
opportunity to make recommendations to this Committee and to
the Congress with respect to how we can empower and resource
the CDC to augment its capacity, empower its nonpartisan public
health professionals, and make more robust our national
capacity to adapt and respond to a pandemic.
Dr. Gerberding. Thank you, and I will follow up with you
because we are exploring this issue with the CSIS Commission on
Global Health Security as well. But there are some big buckets
here.
First is structural. I think we have seen that it is very
possible for the CDC science to not have the role it needs to
have in planning and responding to a serious health threat, and
that just cannot happen again. Scientists need to be able to
bring the science to the policymakers unfettered.
Secondly, there are structural issues related to the way
the CDC is funded. The budget is inconsistent from year to
year. The crisis-to-complacency cycle--``boom or bust'' some
people call it--results in unstable funding. It is very
difficult for State and locals to hire the people they need. It
is very difficult for the CDC to sustain progressive
preparedness over time.
Then I think the third issue really is certain parts of the
CDC science need to be modernized. We are kind of in a stable
level of support, but science is bursting ahead, and we need to
bring the more modern tools, the data sciences, the data
information modernization. There are a whole number of areas of
scientific inquiry relevant to public health. We need the same
kind of funding support that we give to NIH and biomedical
research, but that is, a long-term investment, and we are
really going to need congressional support for that. So thank
you for the question.
Senator Ossoff. Thank you, Dr. Gerberding. Let us talk a
little bit about effective public health communication and how
we can improve public health experts' capacity to deliver
evidence-based information to the public, to families, to
organizations, when you have an emerging situation such as we
did where there is uncertainty and fear, particularly in the
early months of this pandemic, and where you have political
actors with no relevant public health expertise, such as in
this case the President of the United States speculating about
the efficacy of bleach treatments in response to COVID-19 from
the White House Press Briefing Room. How can we enhance the
capacity of public health experts and medical doctors who are
qualified to assess the available data and make evidence-based
recommendations to the public, acknowledging that there will
always be uncertainty, particularly when we are facing a new
pathogen whose means of transmission and lethality and
mechanism of action is not yet fully established? How can we
enhance our ability to deliver evidence-based information from
public health experts to the public in an emergency such as
this one?
Dr. Gerberding. There is no question to that
misinformation, in many cases disinformation is easy to
propagate now, and it has tremendous impact on people through
the expansion in the social networks that perpetuate it. This
has to happen at every level. Trust is the foundational
dimension of this.
When people see scientists arguing with each other about
data, that in and of itself creates mistrust. In the context of
the rapid learning curve we are in, sometimes that is
inevitable. But I think the CDC Director today, Dr. Wollensky,
is doing a fantastic job of persistently saying the same thing,
standing strong, speaking regularly and often, doing the best
she can to translate evolving information to the public. But
that has to be cascaded throughout our whole system.
We learned during some of the outbreaks that I managed that
the most trusted person for most people is not their Federal
official or their politician or even someone who is
pontificating on boxes on the network news. It is their local
doctor. And so bringing the clinician community into the
knowledge base to share that evidence and giving them the tools
and the training they need to help translate it is also
critically important.
I think we have seen that done well in other countries like
New Zealand, but we need to go back to basics and restart our
process of getting the whole ecosystem of trusted health
officials to sing from the same sheet of music and translate
that information into messages that matter to people.
Senator Ossoff. Thank you so much, Doctor. Thank you all
for your testimony today, for your service, and for the
expertise and experience you have shared with us.
Mr. Chairman, I yield.
Chairman Peters. Thank you, Senator Ossoff.
We may have another Senator or two. We are about ready to
start votes, and, folks, we have multiple committees so we may
have another Senator or two arrive. In the meantime, I am going
to take the liberty as Chair to ask another couple questions
while we wait.
My first question, I am going to put it out to the panel to
give me a sense. One thing that is clear as we have gone
through this critically difficult time is that there are many
conflicting authorities, and we have talked about that
throughout this hearing. So although it is clear there are
conflicting authorities, there is no clear path as to who
should actually be in charge. You think about the multiple laws
right now that we have on the books that determine disaster and
public health emergency response authorities. We have the
Public Health Services Act, the Stafford Act, the National
Emergencies Act, various Homeland Security Presidential
Directives, Presidential policy directives, and that list,
unfortunately, can just go on.
I will ask this to you first, Dr. Lurie, but I would
certainly love to have the input of all of you. Dr. Lurie, I
ask it first because you already testified about the need for a
clear Federal agency to lead in pandemic response. Yet from
this initial COVID-19 response, there was continued confusion.
There were changes in authorities as we went along.
So it is a very direct question. Who at the Federal level
should have led the response, in your mind, for this public
health crisis? I would love to hear from the other panelists as
well.
Dr. Lurie. Sure. I think the White House should have
designated a lead at NSC supported by FEMA to lead this and
pull together a whole-of-government response as they have for
so many other crises. As Mr. Nimmich testified and Ms.
Zimmerman testified, FEMA can help coordinate and support. At
the beginning you do not even know how bad it is going to be,
and it evolves over time. And so it may be that the lead in
coordination needs to evolve over time. But there is no reason
not to mobilize a whole-of-government response, and there are
many mechanisms to do that. You just have to choose one.
Chairman Peters. Great. Anyone else? Just jump in, please.
Dr. Gerberding. I will say I think the whole-of-government
is the concept, although it is more than government, as we have
seen; the private sector is critically important, and the whole
health system matters in a situation like this. But the concept
of planning for the whole-of-government, the strategic
framework for the operation being something that really has to
be done by the administration because all the Cabinets are
involved, and then executing the components of that plan in the
agency that is best suited to carry out the specific tasks or
objectives at hand. It is kind of plan horizontally, execute
vertically, and then maintain that coordinating function.
From an operational and logistical perspective, I think the
FEMA conversation can also come into play here, especially when
there are issues about deployment of material goods or getting
things moved around from one place to another. So there are
many different dimensions of the operation, but the strategic
framework, the intent of the response really needs to be
centralized, in my opinion, in the White House.
Chairman Peters. Right.
Mr. Nimmich. Chairman, I have to respond that the National
Response Framework gives you the ability to do this, and as Dr.
Lurie will attest, FEMA supported HHS in Flint, Michigan; we
supported HHS in the Ebola outbreak; we supported HHS in the
Zika outbreak. The ability to use the infrastructure and the
response, training, and professionalism inside FEMA--it does
not have to be in charge, but you have to make that clear. I do
think there was a stumble when we said HHS was not in charge
and now FEMA is in charge. It should have been HHS is in charge
and FEMA is the supporting entity that is implementing HHS'
knowledge base of the pandemic.
Dr. Lurie. I would agree.
Chairman Peters. Ms. Zimmerman.
Ms. Zimmerman. Yes, and I agree with what Mr. Nimmich has
just said. This is something FEMA does. They do it for all
disasters all the time. The system that is in place within the
NRF and within the National Response Coordination Center, all
the Federal agencies, voluntary agencies, even the private
sector is very familiar with how that works. And to be able to
employ that very quickly during disasters is key. It does not
matter how big or small. It is practiced all the time. State
level, States have set up their emergency operation centers
much the same way. So it is really something that gives people
that opportunity to jump right into events, and I think doing
that but I think being led by the agency that has the known
mission set such as any pandemic, with HHS being the lead for
that, and then how, in this event they established the Unified
Coordination Group (UCG), which was the first time ever at a
national--at the Federal level, to establish that I think was
key. I think just to keep that in the forefront is very
important going forward.
Mr. Nimmich. Mr. Chairman, if I could have another
opportunity?
Chairman Peters. Yes.
Mr. Nimmich. I do think that the challenge is deciding if
you are going to activate the National Response Coordination
Center at FEMA. I think that there should be a much more robust
interface of all the departments, particularly ASPR and FEMA,
on a day-to-day basis. It should not be when we make a decision
that we have crossed the threshold that we now activate the
NRCC. There needs to be--each of the emergency support
functions needs a day-to-day connectivity in the environment we
are in because things happen so quickly.
Chairman Peters. Very good. Mr. Nimmich, I am going to ask
you a question. In your testimony you discuss the need to
create additional surge capacity for supplies in an emergency,
and you recommended this responsibility be given to a new FEMA
surge center. So my question to you is: What additional
authorities and funding, if any, do you believe that this
center would need if we were to set it up?
Mr. Nimmich. I think, Chairman, this goes back to the
ability to access all those silos of data Dr. Lurie talked
about, and it is not just in the medical side, but it is in the
supply side and the demand side of these. We often protect our
data or do not want to trust our data, so that surge center
would create an environment where we can have data that is
protected, not utilized in a way that the provider of that data
would not want it. So the public sector can bring in and tell
me there is excess capacity of PPE at this location and know
that that is being trusted and will only be used when there is
a need nationally, or we can inform another State or another
county that that capacity exists somewhere and they can access
it.
But that does not exist. It will require additional
authorities to allow FEMA to integrate that data. It can be
done with medical data, as well as Dr. Lurie pointed out, and
it will require improvement in technology. The technology
exists today. Whether it is in how we protect our information
but also access our information, we have the technology now to
be able to access all of that. The artificial intelligence will
start us to be able to be smarter of where we put our human
capability. But it is really a center where you can bring that
data in on a day-to-day basis and add to it. I was not
monitoring how much of the precursor elements were needed for
our pharmaceuticals. Now I want to access that information and
understand where those precursor chemicals come in.
Chairman Peters. Great. Thank you.
Senator Padilla, you are recognized for your questions.
OPENING STATEMENT OF SENATOR PADILLA
Senator Padilla. Thank you, Mr. Chair. Thank you to all the
witnesses for your participation and your testimony today.
As several of our colleagues have raised throughout the
course of the last year, I want to ask questions specifically
concerning the aspects of COVID-19 and its disproportionate
impact on communities of color and lower-income communities.
And just using my own home State as an example, in California
the death rate for Latinos is 22 percent higher than the
statewide average. The case rate for Pacific Islanders is 32
percent higher than the statewide average. The case rate for
communities with median incomes below $40,000 a year is 37
percent higher than the statewide average.
COVID-19 has clearly exposed large underlying racial and
socioeconomic disparities in our health care system, in our
pandemic response plans, particularly at earlier stages, and
the disproportionate risk for essential worker populations.
So a question for Ms. Lurie and Mr. Nimmich. How can we
ensure that our pandemic response plans and our disaster
response plans more broadly take into account these underlying
issues of inequity?
Dr. Lurie. It is such a terrific and important question
that needs to be considered really comprehensively. We talked a
lot earlier about planning, and certainly racial and ethnic
minorities and low-income communities and others need to be
involved in the planning process from the get-go. They need to
be understood. Every single time we think about doing
surveillance, that we think about doing data collection, that
we think about getting a complete picture of what the situation
is, we need those sort of data elements about race, ethnicity,
income, social vulnerability index of where someone lives.
Frankly, that has to be a reflex part of every single bit of
analysis so that we can identify as quickly as possible the
populations that are the most adversely affected and address
them as quickly as possible.
But, also operationally, you have to have representatives
of all of those communities with you at the table and part of
the operational plan to get going. In a nutshell, it is just
end to end looking at everything you do through this lens of
equity.
Mr. Nimmich. Senator, it is one of the toughest questions
that we have to deal with, and it is a challenge. It is a
community--the underserved and economically disadvantaged tend
to have less trust in the Federal Government, tend to have less
trust in what is being said. We need to encourage them to
participate in the planning and the understanding. But we need
to reach out to those community leaders that are able to
explain.
I can tell you from a FEMA perspective the ability for that
community to request the assistance that they deserve is often
limited. They do not even understand that there are
opportunities there for them to take advantage of.
Finally, when they do take advantage, they are often put in
difficult situations, multiple different questions, multiple
different programs. I am registered for a State program, a
Federal program, and it becomes overwhelming for them to be
able to participate and provide the details that we as a
government require before we are willing to give out aid.
Senator Padilla. Thank you. What leads to that question is
a recognition of what the data is telling us. So my next
question for a couple of you is not just underscoring the value
of data but fundamental science. Many of you have mentioned in
your testimony science is the foundation of our response
measures to disasters. Science and research guide the public
health recommendations and directives, including during COVID,
social distancing, masks, face coverings, vaccine stations and
distribution plans, et cetera. So without basic research done
through NIH-funded institutes, our responses and vaccines could
have taken much longer to develop and complete.
Ms. Lurie and Ms. Gerberding, could you both comment on how
we can more effectively use research from the COVID-19 response
to improve our responses to future disasters and pandemics and
what kind of data might have been more helpful earlier in the
pandemic as, again, a case study to inform future emergencies?
Dr. Lurie. Sure. One of the first things I would note is
that in prior crises we have pulled together early and often
with the help of the National Academies, developed a research
agenda that prioritizes the most important questions to ask and
answer as a country so that we can get on top of that quickly.
Unfortunately, that really did not happen.
A second thing I would want to note is that science
includes social science, includes anthropology and sociology,
and, here I think we missed for a long time, as Mr. Nimmich was
pointing out, the way different population groups were being
impacted by this. I think social science brought to bear early
on would be critically important.
Then, third, as I said, always look at the population
subgroups that you think are going to be the most vulnerable,
and sometimes you are surprised about who they are, but to be
able to have that ability to do that. We have to be able to
continue to fund science, and we have to be able, as I
testified, to protect the integrity of our science agencies, to
do science and to speak the truth about results. I think that
last part, while we have not dwelt on it, deserves a lot of
consideration.
Senator Padilla. Thank you.
Dr. Gerberding. Yes, I will add to what Dr. Lurie said
because I agree with her entire statement and especially the
component of the National Academy of Medicine contribution to
setting the research agenda, is that we need practical science
as well, just nuts and bolts, like: Do masks work? It took us a
long time to really establish that this was an aerosol virus,
and that is something that, had we set about finding that
information early in the course of the situation, we might have
been able to have better guidance up front about the importance
of masks and what kinds of masks and how well they work, et
cetera. There is a whole set of practical questions that come
up in any outbreak, but were certainly critically important in
this one, especially with the large degree of high-titer
asymptomatic infections.
I think a second aspect of this really relates to how we
can build the science of the new tools that we need, as
mentioned earlier, the data tools, the artificial intelligence
machine learning that can take advantage of the information
that we do have and create knowledge out of it.
The third thing I would say, for a long time there has been
a paucity of investment in what I would consider to be public
health research. Not all of the research done at the NIH is
germane to some of these practical translational problems that
I am talking about, and CDC does really need a bigger research
budget so they can get the best and the brightest people in our
academic environment, our medical schools, our schools of
public health, our social science schools, to get on to some of
these issues and really build out the science base. It will
serve us well in the short run in this context, but it is
something that we need foundationally going into whatever the
next new emerging infection is.
Senator Padilla. Thank you both.
Thank you, Mr. Chair.
Chairman Peters. Thank you, Senator Padilla.
We are going to be wrapping up this hearing. This has been
fascinating. But I do have one last question for Dr. Lurie, and
then we will wrap this up.
Dr. Lurie, in your testimony you discuss the need to gain
additional visibility into the medical supply chain, and you
noted in that testimony that during the H1N1 and Ebola
epidemics, HHS put together a system to gain visibility into
the supply chain, which is critical. As part of our Federal
preparedness, as we are looking forward, should the U.S.
Government establish as part of its infrastructure a permanent
system to track medical supply chain? And as you are thinking
that through and with an answer, what limitations currently
restrict ASPR's visibility into the supply chain that we need
to be aware of?
Dr. Lurie. Terrific question, and I think obviously, as we
have talked about at this hearing, we have talked about
precursor material; we have talked about API; we have talked
about all kinds of supplies. And, yes, we absolutely do need to
have visibility into all of the critical elements of the
medical and health care supply chain. This goes from essential
medications all the way, as I think in my written testimony I
talked about the pipette tips and the little laboratory wells
that are important for running the diagnostic tests.
The Strategic National Stockpile has traditionally only had
visibility on what is there, and yet we know that there is a
lot more in the supply chain. We know we have critical drug
shortages every year, and we do not do a good job monitoring
those either. So, yes, I think either a system that Mr. Nimmich
outlined or the Strategic National Stockpile needs to build the
capability to have that visibility and monitor critical health
and medical supplies.
When we did it in H1N1 and Ebola, we did it using the
threat of the Defense Production Act to ask manufacturers and
suppliers to share the information, and we are able to keep it
confidential so we did not disrupt their businesses. But this
is an area where I do think new authorities and funding will be
really important to set up this system so that you know what
you need and can track that day to day and that you have
enhanced ability to track and, if needed, voluntarily or
compulsorily redistribute in an emergency situation. It is
going to be a big lift and a big build, but the whole private
sector of our economy does this very successfully every day,
day in and day out. And there is a lot of expertise and tools
to use out there to build such a system. It is critical.
Chairman Peters. I agree with you, and it is clear from
your statement that you do believe there are additional
authorities that are necessary, so legislative action will be
necessary?
Dr. Lurie. Yes.
Chairman Peters. Very good. We will look forward to talking
further with you on that. We are in the process of drafting
some of that, so we will look forward to working with the
details.
Again, I want to thank each of our witnesses today. This
was just a great hearing. We have an awful lot of information.
Clearly, there is a whole lot more information to gather in the
months ahead as we continue to look at what happened and think
through how we can do it better.
As I mentioned at the beginning of the hearing, we always
want to celebrate our successes. We should do that. But we also
need to find out where the failures were and make sure that we
are plugging those gaps, and that is the intent of what we want
to do in this hearing.
With that, the hearing record will remain open for 15 days
until April 29th at 5 p.m. for the submission of statements and
questions for the record. This hearing is now adjourned.
[Whereupon, at 11:58 a.m., the Committee was adjourned.]
A P P E N D I X
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[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
COVID-19 PART II:
EVALUATING THE MEDICAL SUPPLY CHAIN AND PANDEMIC RESPONSE GAPS
----------
WEDNESDAY, MAY 19, 2021
U.S. Senate,
Committee on Homeland Security and Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 2:30 p.m., via
Webex and in room SD-342, Dirksen Senate Office Building, Hon.
Gary C. Peters, Chairman of the Committee, presiding.
Present: Senators Peters, Hassan, Sinema, Rosen, Ossoff,
Portman, Johnson, Lankford, Scott, and Hawley.
OPENING STATEMENT OF CHAIRMAN PETERS\1\
Chairman Peters. The Committee will come to order.
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Peters appear in the Appendix
on page 119.
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Today's hearing, the second in a series examining the
Federal Government's response to the coronavirus disease
(COVID) pandemic, will focus on vulnerabilities in our medical
supply chain that were fully exposed last year, as the United
States struggled to secure desperately needed supplies to
combat the spread of COVID-19.
Despite years of warnings about the dangers of our Nation's
overreliance on foreign sources and manufacturers for critical
medical supplies, our Nation was still unprepared to acquire
the masks, the gloves, the gowns, and ventilators necessary to
treat the significant number of COVID patients, stop the spread
of the virus, and save lives.
While the Federal Government had plans in place and
authorities available to help address these longstanding supply
chain challenges, the Trump administration failed to use them
at the onset of the pandemic to coordinate an effective,
unified Federal response.
To date, this tragic and historic public health crisis has
taken the lives of more than 586,000 Americans, left untold
economic destruction in its wake, and resulted in long-term
health consequences for thousands of Americans.
Thanks to the ingenuity of American scientists and the
Biden administration's actions to ensure rapid distribution of
vaccines, there is light at the end of the tunnel.
However, as we learned in our first oversight hearing, the
loss of life, the damage to the health and livelihoods of
countless Americans, and the suffering caused by this pandemic
were not inevitable.
Swift, decisive action, and a comprehensive national
strategy from the previous administration could have reduced
the devastation this pandemic wrought on our communities.
The Federal Government should have taken early action to
ramp up production of personal protective equipment (PPE) and
other critical medical supplies by issuing emergency contracts
or fully invoking the Defense Production Act (DPA).
Instead, the Trump administration left individual States to
secure supplies and combat the virus on their own. Instead of a
coordinated Federal effort to secure and direct supplies where
they were needed the most, the Trump administration's inaction
forced States, and even individual hospitals, to bid against
each other for limited protective gear.
This forced our front-line health care workers to resort to
wearing trash bags, snorkel masks, and other ineffective
alternatives when they could not get appropriate medical
supplies.
Access to sufficient PPE, like N95 respirators, face masks,
gloves, and gowns, could have helped save lives, including the
nearly 4,000 health care workers who gave their lives on the
front lines to fight this pandemic.
Even though we had limited information about how this virus
spread when cases first started spiking in the United States,
the warning signs about our supply chain were already there.
As early as July 2019, the Federal Emergency Management
Agency (FEMA) outlined that a ``worst-case'' pandemic scenario,
like COVID-19, would result in a shortage of medical supplies,
beds, and health care workers as hospitals became overwhelmed.
In December 2019, I released a report warning of the
serious national security risks posed by our overreliance on
foreign nations for critical drugs.
Last Congress, I pressed for legislation to help increase
domestic production for critical drugs and medical supplies to
address these threats, and I am going to continue working with
my colleagues to find common-sense solutions to ensure that our
Nation is better prepared in the event of a future crisis.
I want to thank our witnesses for joining us today, and I
look forward to hearing their perspectives on the challenges
our country faced, the impact these shortages have had on
health care workers and the public, and how we can strengthen
our medical supply chain to prevent a similar disaster in the
future.
We have received significant interest in this hearing, and
I now ask unanimous consent (UC) that all statements submitted
to the Committee, including those from the American Hospital
Association (AHA), Michigan Hospital Association, Henry Ford
Health System, Munson Health Care, Sparrow Health System,
Trinity Health, and Premier, be entered into the record.\1\
Without objection, the Statements will be entered into the
record.
---------------------------------------------------------------------------
\1\ The statements submitted for the Record appears in the Appendix
on page 231.
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I understand my Ranking Member is being delayed on the
floor. He will be here shortly. He can present his opening
remarks at that time, so we will move forward with the witness
testimony at this point.
It is the practice of the Homeland Security and
Governmental Affairs Committee (HSGAC) to swear in witnesses,
so if you will stand and raise your right hand, and the witness
online, if you could at least raise your hand, if not stand,
that would be great. 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?
Dr. Elnahal. I do.
Mr. Handfield. I do.
Mr. Schondelmeyer. I do.
Ms. Glas. I do.
Chairman Peters. You may be seated.
Our first witness today is Dr. Shereef Elnahal, the
president and chief executive officer (CEO) of University
Hospital in Newark, New Jersey.
I will give a more complete opening to you before your
testimony, but I am pleased that we have been joined by the
Ranking Member, who scurried from his duties on the floor of
the Senate to be here. Thank you very much, Ranking Member, and
you may proceed with your opening comments.
OPENING STATEMENT OF SENATOR PORTMAN\1\
Senator Portman. Thank you, Mr. Chairman, I look forward to
hearing from the witnesses today.
---------------------------------------------------------------------------
\1\ The prepared statement of Senator Portman appears in the
Appendix on page 121.
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Last month we did hold an oversight hearing on this general
topic to help us understand some of the early failures that
reduced the effectiveness to the pandemic response, and this is
a continuation of that. I was pleased that at the last hearing,
we tried to keep politics out of it and focus on solutions.
Today's hearing is going to focus on a really important
aspect of the pandemic response, which was the supply chain
vulnerability that we all experienced and continue to
experience, and to help this Committee, in my view, to develop
legislation to help solve these problems for the future. I
think we owe it to those who lost their lives during this
pandemic and all the disruption it has caused to get this
right.
We studied this issue because it became apparent that by
the time the virus reached our shores, there was little we
could do to prevent the shortages of critical supplies. The
spike in demand for medical supplies was too high, the
production of those supplies too far away, and too centralized
in places hit hard by the virus. At the same time, the
Strategic National Stockpile (SNS) was underprepared. The roots
of these issues extend far past December 31, 2019, when a
cluster of cases was first reported in Wuhan, China.
So what does this mean? Preparation for the pandemic should
have begun years in advance, obviously. The constraints
experienced by Federal, State, and local agencies, as well as
hospitals, responders, and front-line workers, is the result of
a supply chain and preparedness culture that seems to have
suffered a failure of imagination regarding those worst-case
scenarios.
While many factors contributed to our poor state of medical
supply preparedness--which we will discuss here today--the
State of the Strategic National Stockpile is chief among them,
and that is our responsibility here in the Federal Government.
The stockpile's mandate has been to respond to discrete
emergencies, not a simultaneous 50-State pandemic. For more
than a decade, the stockpile focused on local chemical,
biological, radiological, and nuclear (CBRN) threats often at
the expense of pandemic preparedness. It did respond more
effectively to the H1N1 pandemic with millions of PPE items and
antivirals, but those were confined outbreaks, and the
stockpile was never replenished after that episode. In the
intervening years, of course, the stockpile's mission has
continued, but it has been less of a pandemic response and the
question is, Why?
Compounding these preparation failures by the stockpile,
the past two decades have seen a consistent offshoring of
medical supply manufacturing. We all know about that; we will
hear about that more today, particularly the United States
relying on China for 75 percent of sanitary and hospital bed
articles and 50 percent of our PPE, including N95 masks.
Today I look forward to hearing from our witnesses on three
broad questions.
First, what steps should the United States take to reduce
overreliance on foreign countries for critical medical
supplies? We need to understand how to diversify supply chains
away from China, reshoring manufacturing to the United States,
and incentivizing production in the Western Hemisphere.
Second, how do we foster a strong ``Industrial Commons''
for medical supplies here in the United States? It is a key
part of our competitiveness going forward, I think. It is where
you have a manufacturer, you have suppliers, inventors, skilled
workers, and distributors, all networked and integrated
together. It is not just about assembling gowns or
pharmaceuticals, but about building out a supply chain that
brings together the producers of the components of those items
with the innovators also. These networks offer efficiencies,
make it more difficult to offshore in the future, and increase
innovation.
Third, as we develop this effort for medical supplies, how
do we ensure that we have the right supplies, in the right
quantities, and effective distributions for the future crisis?
I also am concerned about the inadequacies of the SNS, as we
talked about--the stockpile. Going forward, we need to properly
define the role of that stockpile and be sure that it has the
resources and capabilities we need to succeed.
Thanks again to our witnesses for testifying today, I look
forward to hearing your thoughts on the path forward and, of
course, look forward to continuing our approach to this, which
I hope can remain nonpartisan and focused on actually how do
you come up with solutions so that we can be more prepared in
the future.
Thank you, Mr. Chairman.
Chairman Peters. Thank you, Ranking Member Portman.
Our first witness today is Dr. Shereef Elnahal, the
president and chief executive officer of the University
Hospital in Newark, New Jersey. Dr. Elnahal is a physician who
previously served in health care leadership roles in the public
and private sectors, including as the 21st commissioner of the
New Jersey Department of Health.
Welcome, Doctor. You are recognized for your 5-minute
opening comments.
TESTIMONY OF SHEREEF ELNAHAL, M.D.,\1\ PRESIDENT AND CHIEF
EXECUTIVE OFFICER, UNIVERSITY HOSPITAL, NEWARK, NEW JERSEY
Dr. Elnahal. Thank you, Chairman Peters, Ranking Member
Portman, Members of the Committee on Homeland Security and
Governmental Affairs, and my fellow panelists.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Elnahal appears in the Appendix
on page 217.
---------------------------------------------------------------------------
My name is Dr. Shereef Elnahal. I am president and CEO of
University Hospital in Newark, New Jersey.
I thank the Committee for the opportunity to offer insights
into my institution's experiences during COVID-19. I will also
say that the Pharmaceutical Accountability, Responsibility, and
Transparency (PART) Act and Help Onshore Manufacturing
Efficiencies for Drugs and Devices (HOME) Acts would have
helped my hospital better meet the care needs of our community
during a difficult time, and I thank the Committee for a
bipartisan effort to take action on this issue.
University Hospital is New Jersey's only State hospital and
one of only 962 State and local government-run community
hospitals in the United States. We are the Level 1 trauma
center for the densely populated northern New Jersey region. We
are an academic medical center and the principal teaching
hospital for all Newark-based medical education, including
Rutgers New Jersey Medical School--a robust, preeminent
training ground for the next generation of health care heroes.
Last year, we had more than 83,000 emergency room visits,
admitted some 15,000 patients, and had 200,000 outpatient
visits. As one of New Jersey's safety net hospitals, we serve
as a critical health care provider for a large population of
low-income and Black and brown residents.
COVID-19 brought us circumstances that we had never seen
before in health care--and things we hopefully will never see
again.
As the number of COVID cases in our emergency rooms and
intensive care units (ICU) multiplied, we found ourselves at
risk of running out of supplies that we had never seen depleted
before. This includes protective equipment for our staff and
ventilators for patients who needed it.
These vital supply shortages affected the entire health
care system, not just us, but the things that we needed the
most were the exact same resources that every hospital needed.
And so all hospitals were working their contacts in the global
supply chain at the same time. Suppliers, therefore, serviced
the highest and largest bidders, and safety net hospitals and
stand-alone hospitals like ours were frequently the last to be
called back.
Key medications, especially those which are used to sedate
patients on ventilators were also dangerously low. Failing to
sedate someone on a ventilator is agonizing for the patient. As
professionals dedicated to healing, this was an outcome that we
refused to accept, and so we worked around the clock on these
issues to help patients survive COVID.
No patient, thankfully, went without such medications, but
we were days away from this out in the most critical of times.
In many cases, we needed to find suppliers with whom we had no
track record and who we had no history of serving the U.S.
medical community. At the same time, we were keenly aware that
fraud was happening at many angles across the country.
Occasionally, we needed to return or discard deliveries when
items purchased were discovered to be ineffective.
For decades, this country has struggled to appropriately
focus on the Strategic National Stockpile which must also be an
important focus. I should also mention that the Coronavirus
Aid, Relief, and Economic Security (CARES) Act did save our
hospital, and I thank the Committee and every Member of
Congress who helped enact that. Without the funds that kept our
hospital afloat during the worst of this, we could not only not
afford the supply chain materials we needed, but also we could
not keep our doors open by August 2020. And so hospitals simply
cannot fail during a pandemic, and the quick action of the
Federal Government helped tremendously.
Aside from Federal assistance, New Jersey's State
government--including strong support from Governor Phil
Murphy--helped University Hospital get our fair share of the
national stockpile. Our important work did not stop with
patient care. In fact, we were one of the few sites nationwide
that conducted the Moderna vaccine trial in a majority-minority
community. We were the first hospital to administer a vaccine
in New Jersey outside of a clinical trial, and we continue to
provide all three approved vaccines to our community.
We did many virtual town halls to reassure our community
that they can trust the vaccine, helping to quell the justified
mistrust in the health care establishment dating back to
slavery and the horrors of the Tuskegee experiment, but also
acknowledging the implicit bias that people of color continue
to experience to this day. More and more people in the
community we serve accepted the vaccine over time, and now the
challenge is access. We have re-routed our vaccination strategy
in recent days to be where people are with mobile vaccination
efforts in collaboration with our city, county, and State
governments, and we hope that more organizations will join us
in this line of effort. Without efforts to shore up the vaccine
components and the supply chain, none of this would be
possible.
Today we are in the final miles of the pandemic, but our
public health crisis is not completely over. The reality is I
am still not convinced that we are prepared for the next
pandemic--whether from a vaccine-resistant variant of COVID-19
or a different pathogen altogether. While we are better off now
as a result of many of the initiatives from the Biden
administration on supply chain resiliency, there is still much
work to do.
Still, there remains the matter of financial solvency for
institutions like University Hospital. We need meaningful,
value-based payment reform sooner rather than later.
When the pandemic struck, there was never a higher demand
for health care in American hospitals, and yet the financial
risk for hospitals and health systems was never higher. This
fundamental disconnect between payment and value has existed
for decades and forced hospitals with thin margins to use just-
in-time inventory practices for these very critical items that
we were short on.
Thank you for the opportunity to provide our perspective,
and I look forward to your questions.
Chairman Peters. Thank you, Dr. Elnahal. We appreciate your
opening comments.
Our second witness is Dr. Robert Handfield, professor of
supply chain management in the Poole College of Management at
North Carolina State University, and the executive director of
the Supply Chain Resource Cooperative. In March 2020, Dr.
Handfield began consulting various national supply chain task
forces responding to COVID-19, including the Department of
Defense's Joint Acquisition Task Force. Dr. Handfield has also
served as a supply chain consultant to Fortune 100 companies in
health care, pharmaceutical, and industrial manufacturing.
Dr. Handfield, welcome to the Committee. You may proceed
with your 5-minute opening statement.
TESTIMONY OF ROBERT B. HANDFIELD, PH.D.,\1\ PROFESSOR, POOLE
COLLEGE OF MANAGEMENT, NORTH CAROLINA STATE UNIVERSITY
Mr. Handfield. Thank you, Senator Peters, and thank you to
the Committee. Good afternoon. My name is Rob Handfield, and I
currently serve as a professor at NC State. I have studied
supply chains for more than 30 years. I have published about
them in a number of journals, and I have been a consultant, as
you say, to many companies in health care, but also in
government, including the Veterans Affairs' (VA), the General
Services Administration (GSA), and the Department of Defense
(DOD). I am familiar with government acquisition.
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\1\ The prepared statement of Mr. Handfield appears in the Appendix
on page 130.
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As a pro bono consultant with the DOD Joint Acquisition
Task Force (JATF), I provided advice, market intelligence, and
analysis for the supply of PPE, ventilators, and
pharmaceuticals. I also interviewed chief procurement officers
(CPO) in every State in the country to understand their
challenges in obtaining PPE. Our team presented our
recommendations for the SNS 2.0 to the Principal Deputy
Assistant Secretary of Defense for Logistics at Office of the
Secretary of Defense (OSD) in May 2020.
In my testimony today, I will describe the State of the
Strategic National Stockpile prior to COVID and the events that
occurred early in 2020, as well as some of the suggested
reforms that I believe are necessary for future public health
emergencies.
I would first like to state that my testimony is in no way
intended to be acrimonious when it comes to the hardworking men
and women who worked in the SNS during COVID. My critiques here
are limited to the design of the SNS and government agencies as
opposed to a direct criticism of the people working in it.
Prior to COVID, the SNS was somewhat of a ``secret''
organization. They did not publicize what they did. They were
largely founded as a response to bioterrorism, and they were
never intended to be able to respond to pandemics such as
COVID. Most of the people who worked there worked as inventory
analysts, not supply chain experts. The decisions as to what
inventory to stockpile for potential threats was determined by
scientists within the Department of Health and Human Services
(HHS) who often have a clinical view of public health risks,
but do not often understand how supply chains get these
materials to hospitals.
So there are a number of problems which I observed during
the first half of 2020 in my work, and I have summarized some
recommendations for each of these.
First of all, a lack of supply market intelligence and
expired inventory left the government ill prepared for the
pandemic. The SNS was running blind in managing the supply
chain. The response was too little too late.
For the SNS to be better prepared, a multi-agency inventory
portfolio based on in-depth supply market analysis is needed.
This requires a supply management team that tracks the
condition of critical supply markets for medical supplies, the
supply risks within those markets, and acquisition strategies
to manage those risks.
Second, a lack of material visibility technology across the
SNS, FEMA, and State procurement offices led to a poor
estimation of demand forecasts and the inability to detect
shortages in health care networks. You cannot manage what you
cannot see. The SNS needs an inventory visibility system tied
to a control tower that tracks what is happening in real time.
During the COVID response, no one knew where products were
coming from, where they were being sent, and who was receiving
them. Material can be tracked through bar codes across a
trusted network of hospitals, distributors, and manufacturers.
This is not expensive technology and is relatively easy to
deploy.
Third, the U.S. health care system relies on suppliers that
are primarily overseas and leaves us at the mercy of export
policies and priorities of other nations, which led to
shortages. So this is a problem which we cannot fix easily
overnight. It requires a more nuanced set of policies.
Reshoring all health care products is not practical or cost-
efficient, and it is not clear who invest in this.
While I agree that critical pharmaceutical products can be
manufactured efficiently in the United States, we need more of
a customized strategy for different categories of health care
products, which I have outlined in my written testimony.
Fourth, disparate communication, lack of governance, or
decision rights and ownership of issues among public agencies
resulted in poor decisionmaking during pandemic. We observed a
systemic failure at response across multiple agencies and
firms. What we need is a playbook for how supply chain experts
will work alongside public health experts in a disciplined
manner using a structured response.
Fifth, States were competing with one another for material.
This is because there is no existing policy on how to
distribute material in an emergency. We need an equitable and
fair means of deploying material in the stockpile that is based
on need and avoids random allocations. Today no such policy
exists.
Finally, contracting with distributors to hold inventory
warehouses and holding them accountable for distribution in an
emergency was clearly not a reasonable solution. We need
alternative contracting approaches for the SNS 2.0, contractual
incentives with vetted suppliers and government agencies like
the VA that can create an effective way to turn around
inventory without it becoming expired.
To conclude, the idea behind the SNS is not so much to
focus on resiliency but immunity to shocks that might occur.
American exceptionalism became American hubris, and a system
failure to respond was the result of poor events planning on
the part of multiple agencies. The model I proposed is a
significant departure from previous versions of this agency,
but what we need is a bold and innovative strategy for
supporting our national response to public health emergencies.
I have outlined a set of solutions and would be willing to
support these efforts in any way moving forward.
Thank you very much.
Chairman Peters. Thank you, Dr. Handfield, for your
testimony.
Our third witness, Dr. Stephen Schondelmeyer, is a
professor of pharmaceutical economics in the College of
Pharmacy and co-principal investigator of the Resilient Drug
Supply Project at the University of Minnesota. Dr.
Schondelmeyer also has more than 45 years of research and
experience studying the pharmaceutical marketplace.
Welcome, Doctor. You may proceed with your five-minute
opening remarks.
TESTIMONY OF STEPHEN W. SCHONDELMEYER, PHARM.D., PH.D.,\1\
PROFESSOR, COLLEGE OF PHARMACY, CO-PRINCIPAL INVESTIGATOR,
RESILIENT DRUG SUPPLY PROJECT, UNIVERSITY OF MINNESOTA
Mr. Schondelmeyer. Great. Thank you, Chairman Peters,
Ranking Member Portman, and Members of the Committee, for this
opportunity to provide input on the resilience of the U.S. drug
supply.
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\1\ The prepared statement of Mr. Schondelmeyer appears in the
Appendix on page 152.
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First, I would ask, What was the state of the U.S. drug
supply prior to the pandemic? Let me remind us that virtually
everyone needs prescription drugs at some point in their life.
Americans have come to count on critical and essential
medicines for serious and life-threatening diseases such as
diabetes, epilepsy, or cancer, and we expect that these
essential medications will be available at a nearby community
pharmacy or the local hospital when they are needed.
Even before the pandemic, though, drug shortages were a
serious problem and recurring problem with a web of factors in
an opaque drug production and supply system.
We have tracked and reported on drug shortages for more
than two decades, and these reports show that we have had more
than 170 drugs in shortage at every point in time since 2014 or
before. That is 170 drugs in shortage at every point in time.
This current and ongoing rate of drug shortages in the
United States is unacceptable, yet for some reason, the market
has failed to support the sustainable presence and availability
of these drugs in the market.
What was the impact of the pandemic on the drug supply
chain? The medical and drug supply chains have not escaped the
monumental impact, and they experienced a triple threat during
the first year of the pandemic with extreme increases in
demand, unexpected disruptions leading to decreased supply, and
exposure of systemic vulnerabilities.
COVID dramatically impacted the demand side for drugs in
the United States and worldwide, with the most severe shortages
for critical drugs such as propofol, midazolam, azithromycin,
and other drugs. In fact, 40 critical COVID-19 drugs that were
identified by the Resilient Drug Supply Project had 70 percent,
or 28 out of 40, that were in short supply as recently as
January 2021. That is, 70 percent of the critical drugs are
still in short supply.
The rate of drug shortages is simply unacceptable, whether
in times of pandemic or not. COVID-19 jolted the global
pharmaceutical market at all levels and at many production
points. The supply side disruptions from factory closures,
shipping delays or shutdowns, and trade limitations or export
bans and barriers.
Vulnerabilities of the U.S. drug supply chain have become
more noticeable during the pandemic, including, but not limited
to, heavy dependence upon foreign sources of drug production;
old factories, equipment, and outdated manufacturing processes;
below-margin prices for older, well-established generics due to
overcompetition; lack of upstream visibility by purchasers,
policymakers, and key stakeholders; and lack of a nationally
coordinated policy approach to the pharmaceutical market. I
would remind you the pharmaceutical market represents four
percent of the U.S. economy, yet we do not have a policy
approach as to how to manage and move that market forward.
In October 2018, the University of Minnesota initiated its
Resilient Drug Supply Project. First, we examined the drug
supply chain based upon country of origin for active
pharmaceutical ingredients (API) and for finished drug
products. When we looked at the top brand, generic, and
critical access drugs, we found that nearly all drug products
have the name of a U.S.-based company on the label or a U.S.
subsidiary of a foreign company. From the downstream
perspective, nearly drug products in the U.S. market appear to
be U.S. products. But when we looked at the opaque upstream
supply chain, we found that as much as 80 percent of the
finished drug products were made outside of the United States,
and as much as 90 percent of the active pharmaceutical
ingredients were foreign-made. Most of the brand products were
made in Europe. Most of the generic products were made in
India, with up to 70 percent of their key starting materials
being provided by China. Most of the critical access drugs were
made in either China or India, and about 20 percent had totally
undisclosed sources in the market.
While production of pharmaceuticals in foreign countries is
not necessarily a bad thing, the current level of dependence on
foreign sources in the U.S. supply is concerning. There is a
long-term vulnerability of U.S. dependence on foreign sources
for these critical medications. It places undue opportunities
for political and economic leverage in the hands of other
countries over the United States. We could find ourselves held
hostage by other countries that dominate the production of
certain categories.
I have listed in my report four or five actions. One is we
should have a defined process and infrastructure for analyzing,
predicting, managing, and preventing shortages of critical
medications.
Second, we should have an ongoing, in-depth map of the U.S.
drug supply.
Third, we should authorize and fund a national entity that
builds this map and analyzes the drug supply to coordinate the
development of national policy.
Finally, the U.S. needs to establish an ongoing research
program on the resilience of the U.S. drug supply, including a
sentinel system and a predict-and-prevent process rather than
waiting for fail-and-fix.
Thank you.
Chairman Peters. Thank you, Dr. Schondelmeyer, for your
opening statement.
Our final witness today is Ms. Kimberly Glas, president and
chief executive officer of the National Council of Textile
Organizations (NCTO). Ms. Glas also serves as the appointed
Commissioner to the U.S.-China Economic Security Review
Commission. Ms. Glas also previously served as the Deputy
Assistant Secretary for Textiles, Consumer Goods, and Materials
at the U.S. Department of Commerce and spent a decade on
Capitol Hill working on manufacturing, trade, and economic
policy issues.
Ms. Glas, welcome to the Committee. You may proceed with
your five-minute opening statement.
TESTIMONY OF KIMBERLY GLAS,\1\ PRESIDENT AND CHIEF EXECUTIVE
OFFICER, NATIONAL COUNCIL OF TEXTILE ORGANIZATIONS
Ms. Glas. Thank you so much for the opportunity to testify
before you today. As you noted, I am the president and CEO of
the National Council of Textile Organizations, and I represent
the domestic textile industry, which employs approximately
530,000 workers.
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\1\ The prepared statement of Ms. Glas appears in the Appendix on
page 217.
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Last spring, when the PPE crisis was on the national news
nightly, showing workers wearing garbage bags as gowns and
reusing N95 masks, it was profound imagery. Our strong
overreliance on Chinese raw material components and finished
PPE production chains exposed a profound fragility in our
supply chains and exposed a significant national security
threat.
Years of offshoring this industry had severe ramifications
that played out on the national stage for all of us to see. As
the supply chains broken down and export controls from China
and elsewhere were placed on certain items, it left us
vulnerable in ways that we could have never imagined and I hope
we will never forget.
To frame it in a military context, it was like being on the
front lines and learning your supply chain had been cutoff. The
U.S. textile industry stepped in to fill an enormous void,
reconstructing supply chains literally overnight, producing
over 1 billion critical PPE items such as face masks, isolation
gowns, and testing kit swabs for front-line health care
workers. They welcome the calls from the highest levels of our
government and across the Nation and felt an enormous
responsibility and pride to retool their production lines.
As one of my members put it: ``The supply chains broke
down. I understood this is our calling. This is why we exist,
and this is why we must make these products in the United
States of America.''
I come before you today with an urgent plea. We must get
critical policies over the finish line immediately, or the very
supply chains that were retooled and reconstructed will remain
fragile and largely offshore. Several companies who retooled
their production and have significant PPE capacity are now
staring down bankruptcy. China has exponentially expanded its
global dominance, and key segments of PPE production are going
offshore once again.
I want to commend the Committee for your unanimous support
last week in advancing the Portman-Peters Make PPE in America
Act. This is critical legislation to address two significant
issues: long-term Federal Government contracts and domestic
Federal procurement of 100 percent made in America PPE. I have
outlined several key policy recommendations in my testimony and
will briefly touch on some here. This is how Congress could
help moving forward.
We need to create strong domestic procurement rules for
Federal PPE purchases and other essential products
substantially similar to the Berry amendment and the Kissell
amendment, which require 100 percent U.S. content from fiber
production forward. The Berry amendment is an essential
Department of Defense policy to ensure we have vertically
integrated supply chains for our warfighters so we are not held
hostage on overseas supply chains to protect our men and women
in the military. We need similar rules to strengthen the supply
chain for our health care workers for PPE.
We also need to expand the Berry amendment rules for other
essential products and purchasing by the Federal Government to
include Department of Homeland Security, Department of Justice
(DOJ), and beyond. A strong industrial base for the textile
industry means a strong industrial base for the PPE industry.
We must important forward-looking policies to shore up the
Strategic National Stockpile and issue long-term contracts to
incentivize investment in the domestic production of PPE
manufacturing.
We must create Federal incentives for private sector
hospitals and large provider networks to purchase domestically
produced PPE. These are the predominant critical purchasers of
PPE in non-pandemic times.
We must centralize U.S. Government contracting processes
and standardize vetting procedures.
We need to continue to deploy the Defense Production Act to
shore up the textile industrial base from raw materials to end
products for all essential items, including PPE, and work
closely with the U.S. industry on advancing those key
investments.
We have to ensure we have strong trade policies that
address dumping of imports and counterfeit illegal products and
addressing the substandard products that we are importing to
our shores.
We must support tariffs on PPE imports to help bolster U.S.
businesses and workers as well as our FTA partners, and we also
must expedite and prioritize regulatory approvals for U.S. PPE
manufacturers to strengthen this U.S. industry. With the right
policy framework, the domestic PPE supply chains built
overnight can endure and grow, creating a level of self-
sufficiency domestically that we have learned the hard way is
essential to our national health and economic security. Our
industry stands ready to help this Committee, Congress, and the
Nation's public health.
Thank you for the opportunity to testify today.
Chairman Peters. Thank you, Ms. Glas, for your testimony.
As the COVID-19 pandemic spread in April and May of last
year, we know the first responders and health care workers were
facing really dire shortages of critical drugs and personal
protective equipment, and as Ms. Glas talked about, doctors and
other health professionals were sometimes forced to reuse
masks, were wearing ponchos, using trash bags. Those images
were pretty startling for us to see. Hospitals across my State
as well as around the country were scrambling to find critical
drugs, including those needed to assist patients on ventilators
in particular.
Dr. Elnahal, this question is for you. You were on the
front lines there. You saw it firsthand. I think it is
important for the Committee's record for you to talk a little
bit about the impact of the lack of available drugs and PPE on
your hospital and hospitals like you. Please go a little bit
more in-depth as to the dire circumstances you found yourself
in so we know what we are dealing with here.
Dr. Elnahal. Thank you, Chairman, for the opportunity to
provide that perspective. So imagine having the sickest
patients that folks have ever had to treat come in at first
and, fives, tens, and then 20 to 30 admissions a night into my
hospital, having to retrofit parts of my hospital that do not
normally care for such patients because we simply did not have
the room, including expanding into our mother-baby unit,
pediatrics unit, and asking those staff, who really never care
for adults in respiratory distress, to do so not only in a
manageable number, but sometimes nine, ten patients at a time.
Then to add to that the lack of availability of PPE or
medications that will keep someone asleep while they have a
breathing tube down their throat, this was just a tremendous
amount of stress that piled on what otherwise would have been
already a very difficult situation.
And so not only were our leadership hand in hand with our
front-line heroes, carrying boxes of PPE, isolation gowns, and
everything in between to units themselves, we were on the phone
ourselves with suppliers basically begging them to pay
attention to our needs at a time when you had Goliath systems
doing the same and sometimes cooperating with each other to
make sure that they combine their purchasing power to acquire
that PPE.
We depended asymmetrically on the Strategic National
Stockpile materials, which makes that area of policy especially
germane to safety net hospitals like ours which serve the most
vulnerable; but also we really had to contend with the shortage
of many critical medications and increases in prices on
medications that were specifically helpful for COVID-19. To
have all those stresses on your as a clinician but then on top
of that not feeling like you have what you need to adequately
treat your patient and also broker conversations with family
members and patients who are dying, sometimes our health care
heroes were the only folks by the side of our patients as they
were deteriorating and doing FaceTime and virtual conversations
with family and loved ones. Just a tremendous amount of stress
that just hopefully drives home the importance of this issue.
Chairman Peters. Thank you for that, Doctor, and certainly
your testimony clearly confirms what we all know. The men and
women on the front lines are truly heroes, ones that we owe an
incredible debt of gratitude as they put their own lives and
families' lives in danger to help those who are suffering. So
our thanks from the entire Committee, and thanks to all the men
and women who are heroes in our country.
Dr. Handfield, you had contact with administration
officials responsible for providing medical supplies, and when
it was clear that the Federal Government was not prepared to
address drug and PPE shortages, what actions should have been
taken to adequately support State and local hospitals? If we
had a do-over, what should we be doing?
Mr. Handfield. Thank you for the opportunity to address
that, Senator Peters, and, by the way, I was on the faculty at
Michigan State for 10 years, so go, Spartans.
So, early on the SNS did have early indicators of a
pandemic. On January 29th, they issued an analysis logistics
summary, a new reporting mechanism that was piloting for the
first time, and that early warning on January 29th asked for a
response from key distributors who also were on allocation with
China. So by February 3rd, all the distributors were being
slammed with requests for PPE, and, I think a lot of the people
in the SNS did not understand how that supply chain was
designed and how much of it was located overseas.
What should have happened is--I think this is where we need
to have acquisition supply management professionals--to have
those early warning indicators and also to be able to work with
other agencies on predicting what potential problems might be
on the horizon. I should note in 2017 there was something
called the PHEMCE, Public Health Emergency Medical Counter
Measures Enterprise (PHEMCE), and they issued a strategic plan
which outlined the key areas for inventory investment for the
SNS. Number one on that list was $5.7 billion for pandemic
influenza, as well as development of vaccines with Biomedical
Advanced Research and Development Authority (BARDA).
So this was an excellent plan to be better prepared.
Unfortunately, this excellent plan was allowed to languish in
2018 and was never restarted. This was tragic, because I
believe that if we had executed on this plan, we would have
been in a much better place if it had been carried out.
For instance, the supply of N95 masks in the SNS inventory
was acquired during the 2009 severe acute respiratory syndrome
(SARS) epidemic. Those masks were acquired with one-time
supplemental influenza funding, therefore, were never
replenished; and when COVID hit, most of them were expired and
useless.
In addition, $2.3 billion had been allocated on anthrax
vaccines that were never shown to be effective for a threat
that was never validated, which dated back to 2004. So wasting
budgets on things like anthrax vaccines instead of real
credible threats like pandemics is facilitated by having better
market intelligence, better advance planning, and allocation of
inventory to a portfolio that is based on risks in conjunction
with public health experts that we can find across multiple
agencies.
Thank you.
Chairman Peters. Thank you.
Ranking Member Portman, you are recognized for your
questions.
Senator Portman. Thanks, Mr. Chairman. I appreciate all the
experts who are here today.
Let me just start with something simple. We know from data
that we have been able to uncover that 70 percent of the
medical protective gear that we needed in the United States was
based on China, and in February 2020, China nationalized
medical supply production and imposed export controls, of
course, on many of those critical supplies because they wanted
them for their own citizens.
So the first question is just for all four of you, a quick
yes or no. Do you think we were too dependent on China? Yes or
no.
Ms. Glas. Yes.
Mr. Schondelmeyer. Yes.
Dr. Elnahal. Yes.
Mr. Handfield. Yes.
Senator Portman. OK. That is a good start. It was 70
percent, but also it was not a reliable supply, obviously,
given the fact they put the export controls in place, making it
even worse, despite a lot of competition from around the world.
So that dependence impeded our COVID-19 response, right? No
question about it. And the question is, what do we do about it?
One of the things that we have talked about today and we
are trying to figure out is how to make more PPE here, but use
market forces to do it, so make it make sense. We have
manufacturers here in this country who are willing to make
stuff, but they need to know that they have a market. If they
do not, they cannot make the significant investments, millions
of dollars, to be able to convert their plants. This has
particularly been tough on the textile industry, and, Ms. Glas,
I want to thank you for being here, but also for your hard work
in support of this Make PPE in America Act, which you mentioned
we introduced and was passed in the Committee just last week.
In 1991, 56 percent of all clothes purchased in the United
States were made in the United States. By 2012, it was 2.6
percent. So we have a big reduction in our textile
manufacturing here. Has the general trend toward offshoring of
apparel and textile products that we have seen over the last
generation contributed to the specific lack of manufacturing of
PPE during the pandemic?
Ms. Glas. Undoubtedly, Senator Portman, absolutely 100
percent.
Senator Portman. This goal, as you know, of the Make PPE in
America Act is to require agencies to actually issue longer-
term contracts. Why are long-term contracts an effective way to
use those market forces to incentivize production here in the
United States?
Ms. Glas. Because, Senator, it provides a critical demand
signal for our industry that there will be a purchaser and that
they can invest in the new equipment necessary. We have Ohio
manufacturers like Standard Textile who have looked at trying
to invest more here in the United States, but they will not
without a strong demand signal. A strong demand signal are
long-term contracts. Other countries like Canada are issuing
long-term contracts to their manufacturers to bolster
production. Some of their contracts are as big and as large as
10 years because they know these are essential production
changes.
Senator Portman. As you know, I have had a great
frustration with our Department of Defense in this area, in
particular their refusal to issue those long-term contracts,
which I never understood. At the height of the pandemic, they
still were not willing to do it. But can you talk a little
about the Department of Defense role here and what they could
do better?
Ms. Glas. So throughout the pandemic, there were several
different purchasers across the Federal Government, including
FEMA, Department of Defense, HHS, and a lot of these contracts
were structured for 90 days, 120 days. While our industry
responded overwhelmingly to those solicitations, that is not
enough production time to invest in new equipment here in the
United States and make a long-term commitment that you are
going to make something here. We found so many fits and starts
with the Department of Defense purchasing, not just in terms of
the contract period but the vetting process associated with
this and the kinds of products that there were conflicting
demand signals that went to our industry.
In fact, I am just going to leave you this one anecdote.
Our industry ran for a very short-term contract--I think it was
120 days--millions of yards of fabric for reusable gowns, that
are sitting in warehouses that was never used because the
government decided at the last minute that they wanted to
purchase disposable gowns. That was because there was a lack of
coordination across the government. DOD was purchasing for HHS,
and the specifications and requirements were not----
Senator Portman. Those are all things that can be fixed,
and as you know, I am also not sure that disposable gowns make
sense. I mean, why not have a gown that is reusable? It is so
much a better deal for taxpayers, particularly that they tend
to be better gowns and safer in terms of the use by hospitals
in particular.
With regard to drugs, I just learned from you, Dr.
Schondelmeyer, that 80 percent of finished drugs are made
elsewhere; 90 percent of the components you said are made
elsewhere, which was actually a higher figure than I had
thought. I understand that labor costs are cheaper in places
like China, and that China also intervenes in its economy in a
non-market way to help their businesses. Are these the primary
reasons that China is so dominant in the manufacturing of
active pharmaceutical ingredients, APIs?
Mr. Schondelmeyer. Sir, I think those are among the primary
reasons, but it is a large and multiple factorial. I think
China as a government has set the intention in certain
therapeutic categories to become the dominant producer and
influence those markets in ways that affect trade policy, in
ways that allow them to dominate economically.
I would point out that just during this pandemic, of the
active pharmaceutical ingredients made in China that are
shipped to India to make products for the U.S. market, we have
seen price increases of 100 percent, 200 percent, or more.
China threatened to limit shipment of some products to India
and the U.S. market. Although they have not acted on the
threat, India itself did limit some exports of certain drugs
for a period of time to the United States. So there are a
number of factors, and those certainly are part of the process.
Senator Portman. Any reason the United States cannot figure
out a way to produce API here?
Mr. Schondelmeyer. We can. We have some. Actually, there is
a new wave of what we call ``green'' manufacturing, people that
use more efficient processes, cleaner processes that actually
can reduce the cost compared to what it is costing in China
given the old technology and the old processes. We could turn
this around, but we have to have a concerted, developed
national policy within the United States. To my knowledge,
there is no agency that sets broad, industry-wide policy for
the pharmaceutical market. The Food and Drug Administration
(FDA) approves drugs' safety and effectiveness, but they have
no authority to look at economic and market-based factors. In
fact, they are told not to.
Senator Portman. That should be a priority, I would think,
to learn from this. I have a lot of questions on the Strategic
National Stockpile, and we do not have time to get all the
answers. I do not want to go over my time because we have a lot
of colleagues who want to talk. But, Dr. Elnahal and Dr.
Handfield, if you could supply us with some more information on
what the Strategic National Stockpile ought to be--clearly the
50-State pandemic was not something they prepared for, right?
You have made that clear today. So that should be one criteria,
to be prepared for this possibility. But we are going to submit
some additional questions to the record for you all, and I
would appreciate your getting back to us so that we can, again,
try to put together some legislation that actually helps to
move us forward and be better prepared next time.
Thank you, Mr. Chairman.
Chairman Peters. Thank you, Senator Portman.
Senator Hassan, you are recognized for your questions.
OPENING STATEMENT OF SENATOR HASSAN
Senator Hassan. Thank you, Chair Peters and Ranking Member
Portman. To all of our witnesses, thank you for being here
today.
Dr. Handfield, I am going to start with a question to you,
and I am going to follow up a little bit on what Senator
Portman was just talking about. At the beginning of this public
health emergency, it became quite apparent that the Strategic
National Stockpile, a key resource for responding to biological
threats, did not have the necessary equipment or distribution
capacities to adequately respond to the scale of this disaster.
Despite the important role that the stockpile had played in
responding to, for instance, the H1N1 virus, key supplies such
as N95 respirators, surgical masks, and gowns were not
replenished ahead of the COVID-19 pandemic.
Dr. Handfield, moving forward, how can we ensure that the
stockpile has an adequate and up-to-date supply of unexpired
personal protective equipment at all times so that it can
adequately respond to public health emergencies across the
country?
Mr. Handfield. I think, one of the challenges with managing
a stockpile of inventory is just that, it is sitting there and
it is getting old. So in order to maintain an inventory of
material that is up to date, that is current, that is fresh, if
you will, you need to turn that inventory.
In my written testimony and in several other papers we have
written, what we are recommending is that there be what is
called a ``living stockpile.'' What I mean by that is that the
inventory for the stockpile can be kept in different places
throughout the government. We have VA hospitals around the
country. We have DOD depots. But what is also needed is what I
would call an ``inventory visibility system,'' which would be
able to keep track of where all this inventory is.
As I indicated, this is not expensive technology. It
requires just bar codes, a large data lake, and we can monitor
when these things are going to be expiring, and as they expire
or are getting close to their expiration date, they can be used
by VA hospitals, they can be used by regular hospitals, they
can be used by distributors. They can be replenished on a real-
time basis.
So this requires some investment in visibility systems to
track what is going on. It would also require a workforce
within the SNS that is much more focused on what I would call a
supply and acquisition mentality that is monitoring what I
would call the ``market intelligence,'' that is creating the
intelligence of what is going on in that market and keeping
apprised of that and continually updating their acquisition
strategies.
Senator Hassan. Thank you.
I also want to follow up a little bit on comments and
questions that you have heard from both the Chair and the
Ranking Member here. To both Dr. Handfield and Dr.
Schondelmeyer, in the early stages of the COVID-19 pandemic,
many patients struggled to access essential medications as we
saw disruptions in supply chains that interrupted the
manufacturing and shipment of some drugs and active
pharmaceutical ingredients. One way to avoid this problem in
the future is to add resiliency and redundancy to our medical
supply chains by expanding domestic manufacturing of essential
medications.
Drs. Handfield and Schondelmeyer, how can the Federal
Government incentivize domestic production of essential
medications--you began to get at this in your answer to Senator
Portman--particularly generic drugs that are widely relied upon
by seniors and individuals with chronic conditions? We will
start with Dr. Handfield and then go to Dr. Schondelmeyer.
Mr. Handfield. So that is an excellent question, and as you
point out, a lot of the active pharmaceutical ingredients for
generic drugs are produced in India and a lot of those raw
materials are produced in China. The reason they are produced
there is obviously low cost, and generics are inherently
reimbursed by insurance companies, by CMS, and others, and
there is a minimum cost that they will be reimbursed for.
Clearly, somebody has to pay, and if we do bring some of those
manufacturing sites back to the United States, we are going to
have to take a look at what the reimbursements are going to be
on some of those drugs.
It is great to have generics, but, if we are saving 5 cents
or 10 cents on a prescription and we are forgoing the
resiliency of our supply chain, we really have to question
that. I think there will need to be multiple agencies involved
in reviewing this recommendation. I do think it is very
possible to bring it back here.
Senator Hassan. OK. Thank you.
Dr. Schondelmeyer.
Mr. Schondelmeyer. Yes, I do think there are things we can
do to encourage particularly generic production in the United
States. The U.S. Government has already acted to engage a
company called Phlow Pharmaceuticals to make active
pharmaceutical ingredients in the United States using new
techniques and processes that, as I said earlier, are less
wasteful and lower cost. They have engaged with a company
called Civica, which is a nonprofit generic company whose goal
is to make drugs that are in short supply or overpriced in the
marketplace and available to all players.
But I would point out we need more than just one example of
each of those. We need to encourage other Phlow companies to
develop and other either nonprofit or companies dedicated to
low-cost generics in the marketplace at a profitable level. I
think we can learn from the lessons of the textile industry and
things they have done over time to encourage textile producers
in the United States. But one thing I would point out is, in
general, the pharmaceutical industry cannot turn around and
beef up or start new production quite as fast as they can in
the textile industry. They may be able to do it in two or three
weeks. In pharmaceuticals, it may take months to years to have
substantial increased new production facilities.
Senator Hassan. Thank you. I appreciate that.
Another question for you, Dr. Schondelmeyer. Over the past
year, we have seen the results of billions of dollars in
taxpayer investment into the development of life-saving COVID-
19 vaccines and therapeutics. While not all companies that
produce these technologies accepted funds specifically for
development of these projects, they all significantly benefited
from government-funded research that informed their approach as
well as in some cases the guaranteed sale of their product.
So how can we ensure that the pricing of COVID-19 vaccines
and therapeutics reflects the significant taxpayer investment
after the end of the public health emergency?
Mr. Schondelmeyer. I think we need to apply basic
principles we do for all things that are purchased by the
government. We need to assure accessibility to those who need
it. We need to assure affordability, that we can afford it
either on the Federal fisc or as individuals or as part of the
health system. We need to assure accountability. Are the costs
they are telling us that they have really bona fide costs, or
are they simply lining the pockets of the top executives or
shareholders beyond what is needed to induce production in the
market? So affordability, accessibility, and accountability all
need to be accounted for.
Senator Hassan. Thank you very much, and thank you, Mr.
Chair and Ranking Member. I have additional questions I will
submit for the record.
Chairman Peters. Thank you, Senator Hassan.
Senator Johnson, you are recognized for your questions.
OPENING STATEMENT OF SENATOR JOHNSON
Senator Johnson. Thank you, Mr. Chairman.
Let me start out by pointing out the 800-pound gorilla in
the room here. I come from a very competitive manufacturing
background, and I can pretty well guarantee if there is demand
for a product, it will be supplied as long as there is a price
that is high enough to justify the investment and the
manufacture of it. Unfortunately, in medicine, with CMS, with
Medicare, with Medicaid, with so much government intervention
in that marketplace, the Medicaid formularies--which I have
tried to understand, and they are impossible to understand--
that is the reason, I would argue, we have shortages.
So from my standpoint in trying to solve this problem, we
need to as much as possible rely on the pricing mechanism and
the pricing signals of the private sector. Obviously, during
COVID, we had a breakdown of government. It started with not
replenishing our national stockpile after 2009. I am not really
looking to government to solve this problem very effectively,
but we need government help in terms of working with the
private sector.
The private sector obviously was not prepared for this
because everything is on just-in-time, so we are going to have
to be incentivized in certain areas to carry inventory.
Mr. Handfield, real quick, rather than have government
agencies stockpile amounts and then have to come up with a
whole new inventory system, computer system to keep track of
expiration dates, why not spend money and contract with the
private distribution system to boost their levels of inventory
to the level we need for the national stockpile and
automatically be integrated into their current systems?
Wouldn't that make a whole lot more sense than trying to set up
a whole new system?
Mr. Handfield. To answer your question, Senator Johnson,
that is definitely something that we can do, and drugs are
primarily distributed by distributors, like the McKessons, the
Cardinals of the world. I think alternative contracting
approaches can be done to do that. I think, again, I would go
back to my earlier point of visibility. We also need to ensure
that they are actually holding that inventory----
Senator Johnson. Again, the private sector can do that, and
I would much rather rely on the private sector providing that
information than government agencies, which are rather opaque.
Dr. Schondelmeyer, I want to really talk about the supply
chain on pharmaceuticals. We held a roundtable here in February
right when COVID hit, and we had Dr. Scott Gottlieb here, and I
think that was where my eyes were really opened in terms of our
vulnerability as it relates to our pharmaceutical supply.
Everybody at that point was talking about the API. As I dug
into this more, it really first starts with what they call
``intermediate,'' which is kind of an odd name because it is
really precursor chemicals that primarily come from China.
There are environmental issues with that, correct, in terms
of--when is the last time we build a refinery, a chemical
refinery here in the United States?
Mr. Schondelmeyer. There are some; they can be dealt with.
But they are easier to deal with in China where they have
higher levels of pollution.
Senator Johnson. Right, so, again, that is a constraint. We
are going to have to overcome that if we want to bring--again,
make sure that I have the supply chain right. First comes the
intermediate, which is really the precursor basic chemicals,
the refinery process, have environmental issues. It goes from
those basic chemicals then into the active pharmaceutical
ingredients, primarily India. India is a big part. We have to
bring both of those back to a certain extent, correct?
Mr. Schondelmeyer. Either back to the United States or find
diverse sources that are outside of China and India.
Senator Johnson. That is the other point I wanted to make
in terms of looking to the supply chain. I do not think it
makes sense to do 100 percent buy America. I think the more
suppliers we have globally, it actually increases security as
long as we are not totally dependent on any one country or any
group of countries, and we obviously have some manufacturing
capability here. I think the balance is how do you get the
percent should we manufacture here in America in terms of
getting that accomplished. I think it is pretty simple in terms
of drugs. You just have the FDA say if you want to supply a
drug, an FDA-approved drug in America, it has to be
manufactured here in America to this extent, recognizing,
though, that that is going to increase costs, and I get back to
the 800-pound gorilla in the room here, is we limit the
reimbursement to private sector companies, which is why we have
170 drugs that are in shortage perennially. Isn't that
basically correct? Because if people could make money off these
drugs, we would not have a supply shortage.
Mr. Schondelmeyer. In part, yes, but in part, no.
Senator Johnson. Tell me where I am wrong.
Mr. Schondelmeyer. I believe in the market, sir, very much
and in westernized economic systems. But when it comes to drugs
and when a drug is needed in the marketplace and is not
available, the system will respond in the long run. Most
economists will tell you that in the long run the system will
clear out that process. But for the patient who needs that drug
today or in the next few hours or they will die, they will die
in the short run, and the market will not solve that problem.
Senator Johnson. If you have a steady demand for drugs, the
market, I think, will respond. I know you were talking about 70
percent of the COVID-related drugs were in short supply. That
makes sense. Nobody was prepared for this, and you could not
really expect them to be prepared. But how many other drugs
outside COVID really have big supply and demand spikes as
opposed to like heparin or things that just--you basically know
what the demand is going to be year in and year out. You can
plan on that.
Mr. Schondelmeyer. Even year in and year out, there are
wide fluctuations in certain drugs. There can be variations. It
is not all totally predictable, and that is partly why we got
caught with short supplies and our just-in-time inventories
that we had not planned for the amount of variation, even for
our flu season, let alone a pandemic event.
Senator Johnson. OK. Again, I really do believe
government's intervention in the marketplace, the payment, the
limitations on pricing, really distorts the marketplace. I am
not denying there are not other issues, but I think we really
do need to go to the root cause of why we had, 170 drugs in
perennial shortage. I think a big part of that is there is just
simply not the profit motive for companies to maintain them.
But I think I am pretty much out of time. Thank you, Mr.
Chairman.
Chairman Peters. Thank you, Senator Johnson.
Senator Hawley, you are recognized for your questions.
OPENING STATEMENT OF SENATOR HAWLEY
Senator Hawley. Thank you very much, Mr. Chairman, and
thanks to all the witnesses for being here.
Ms. Glas, if I could just start with you, you noted in your
testimony--and this caught my eye--that U.S. textile
manufacturers compete in one of the most unbalanced economic
playing fields of any industrial sector. Can you give us a
sense why that is the case? What role specifically has trade
policy played in this?
Ms. Glas. Thank you, Senator, for that question. Since the
mid-1990s, we have seen a significant offshoring of this
industry. There are a variety of reasons for that. The World
Trade Organization (WTO) had quota phase-outs for textile and
apparel products, the accession of the Chinese to the WTO,
permanent normal trade relations with Vietnam, and the
insatiable appetite for the lowest-cost producer, right? This
played out on a national stage when COVID hit. How many U.S.
textile manufacturers did I represent making PPE? Probably two
or three. What happened during the pandemic? About 140
companies of mine retooled their production chains to help
fight the crisis. Now a lot of those companies simply have no
orders. They are starting to see Chinese imports come in for
these products, obviously exponentially. Obviously, we are
thrilled about the vaccine being deployed; however, we are
starting to see products come in that are below cost, the
dumping of products coming into the U.S. market, and we have a
U.S. industry who has invested, who want to make these products
here, but with no demand signal, no long-term demand signal by
the Federal Government. We have not solved the equation of how
to get hospitals and nursing homes to purchase products that
are made here in the United States. A lot of them have relied
on foreign supply chains and distributor networks, and we need
to change that equation if we want to make sure we onshore this
long term.
Senator Hawley. Some of the hardship of this industry, you
put at least some of it, maybe a lot of it, down to WTO-related
policies, agreements, changes that happened in the 1990s and
the first decade of this century following China's admission to
the WTO and its permanent most-favored-nation status, permanent
trade status. Is that right? Have I got that correct?
Ms. Glas. Yes.
Senator Hawley. Remind me of the employment impact again.
What was the immediate employment impact of these----
Ms. Glas. Over time.
Senator Hawley. Yes, I should not say ``immediate,'' I
suppose.
Ms. Glas. The industry used to employ, I would say, 3
million workers in the 1990s, and now we are about 600,000
workers.
Senator Hawley. Wow, 3 million to 600,000, that is an
incredible impact. Tell us why you think the deck is still
stacked against domestic textile producers. You were started to
allude to this with the folks who retooled to produce PPE. Now
they do not have orders because they are seeing the imports
from abroad that are much cheaper. But give us a sense of why
you think the deck is stacked against domestic producers.
Ms. Glas. Because we are not playing on the same level
playing field, and, ironically, through this crisis, there was
a New York Times report this summer that 50 factories sprung up
in Xinjiang, and a number of those factories were making PPE
for our domestic marketplace. It is hard to compete globally
with a subsidized industry all over the world, including China.
So we have domestic manufacturers who can be globally
competitive. We just need to send them a strong demand signal,
and we need to get policies over the finish line here in
Congress to make sure that, yes, we can be more globally
competitive, but people are not going to invest. But I am going
to tell you the price points for some of the products,
importation of some of the key products are below market value.
Senator Hawley. And so people realize, when you refer to
Xinjiang, we are referring to the province where the Uyghurs,
among others, are imprisoned. And so there is a possibility
that this is exploited labor.
Ms. Glas. Exploited forced labor.
Senator Hawley. Yes, it is hard for free labor to compete
with exploited forced labor. Is that fair to say?
Ms. Glas. That is correct.
Senator Hawley. Give us a sense of what you think some of
the ways are that we can address these imbalances in our trade
policy when it comes to PPE and textiles.
Ms. Glas. I think we have to have a whole-of-government
approach to trade enforcement. First off, we need PPE tariffs,
and we also need to take a look at punitive tariffs associated
with PPE now that we are through the crisis of the pandemic.
The other thing is we need to enforce our trade laws on
environmental and labor standards and on forced labor. Customs
came out with the withhold release order (WRO) to say that, we
should not be importing products from Xinjiang or certain
factories or cotton products. We need to hold them to their
word, and we need to ensure that we are stopping importation of
products that are suspected to be used with forced labor, and
that requires Congress also providing a signal to the
administration that, this needs to be enforced with the full
throat of the U.S. Government.
Senator Hawley. Absolutely. Just to stay on China for a
second, why do you think that China is well placed to expand
its global dominance in this industry? Is it due to the
exploited labor? Is that the biggest single factor?
Ms. Glas. That, and the subsidization within this industry.
You will see over a period of time the Chinese have invested
significantly in raw material production, man-made fiber
production in the country. Man-made fiber is the essential raw
material that is used in PPE. So during the tight time in the
crisis, we could not just get N95 masks. There were export
controls on this. There were export controls on the raw
materials, so we could not even get those out of the--they have
continued to invest in this production chain, and it has been
at our peril. We saw this play out on the national stage. In
fact, I just pulled up the numbers. Since the beginning of the
pandemic, Chinese imports into the United States have grown 756
percent. Two-thirds of our imports for PPE are continuing to
come from China. While we have bolstered domestic production, I
am going to tell you a lot of my members who retooled simply
have no orders. So there is a sense of urgency to get something
over the finish line here.
Senator Hawley. Thank you very much for that.
Just in my few remaining moments here, Dr. Handfield, could
I ask you about your testimony? You write that in the 1970s
companies producing medical supplies began to move their
manufacturing abroad, and I wonder, in your assessment, what
caused the shift? Is it related to the trade policies that Ms.
Glas was just testifying about?
Mr. Handfield. A lot of the offshoring of medical supplies
to China occurred because of cost pressure, and at the time,
hospitals and health care in general were under a lot of
pressure to continually reduce costs. The channels through
which they purchased PPE are health care distributors and what
they also call ``group purchasing organizations.'' Their basic
mode of operating is, well, if you buy in huge quantities, we
will give you a big discount. So that incented them to go to
the lowest cost.
What it has also done, however, as you pointed out, we have
really hollowed out our ability to be self-sufficient when it
comes to medical supplies. I think there are a lot of reasons
why we can develop those products domestically, and another
reason for it is we can produce it just in time. ``Just in
time'' means you produce close to your customer, and so you do
not have to carry as much inventory. It does not have to sit on
a ship. It does not have to sit in a port. There are a lot of
benefits to doing it domestically.
Senator Hawley. Very good. Thank you for that testimony.
Thanks to all the witnesses.
Thank you, Mr. Chairman.
Chairman Peters. Thank you, Senator Hawley.
Senator Rosen, you are recognized for your questions.
OPENING STATEMENT OF SENATOR ROSEN
Senator Rosen. Thank you, Chair Peters, Ranking Member
Portman. Really, thank you for holding this hearing. It is
extremely timely and important, the pandemic, of course,
highlighting so many vulnerabilities in our global supply
chain. This is the time to learn and make improvement.
But I would like to talk a little bit about the nonprofit
drug and device manufacturing, because before the pandemic
there had been growing concern about, of course, both high drug
costs and shortages of critical drugs and, of course, medical
devices, the clear warnings about capacity in the event of a
pandemic, and then COVID-19 hit. We saw health providers, first
responders, most everyone has been testifying to the scrambling
for gloves, masks, other kinds of PPE. What we have to do, of
course, as everyone has been testifying, is strengthen our
global supply chains and our domestic capacity moving forward.
One of the things I think we can do is to boost the
nonprofit drug and device manufacturing sector in America. I am
working on some legislation that would lower prescription drug
costs, reduce drug shortages, boost domestic production, and
create American jobs by providing Federal support for the
nonprofit drug and medical device organizations.
Dr. Elnahal, as the leader of a major hospital, I have kind
of a multi-part question here. What impacts do unpredictable
drugs, medical devices, supply shortages, due to, of course,
disruption in the supply chain, have on your ability to treat
patients, No. 1? What is the impact when there is only one
source, No. 2? How do you think the increased availability of a
low-cost-option critical medications produced in the United
States, how would that improve patient outcomes in your
hospital?
Dr. Elnahal. Thank you, Senator, for the question. The
first thing I will say is the obvious point, that it impacts
patient care. So when you are days away from running out of a
medication that allows you to ventilate a patient or to
adequately treat them for a disease. You are forced to consider
alternatives that may be inferior, or you may not be able to
deliver care at all, and so this has real human costs and
consequences, as my co-panelists have mentioned.
But, also, it is not just potentially running out of a
medication. It is resorting to plans of care and treatment that
are simply not optimal. From a medical, legal, and ethical
standpoint, that is just unacceptable. I think we have a
responsibility as a country to ensure that hospitals like mine
can acquire and purchase what is needed to adequately deliver
patient care, especially something as basic as intensive care
that you provide to somebody who just simply cannot breathe.
Secondarily, as you mentioned, the costs can be
prohibitive, and we have seen just serially increasing costs as
a hospital and so many critical medications that we just cannot
do without. When you have to do these on a sole-source basis,
of course, the prices tend to be higher in contrast with the
value necessarily received from them. The availability of
generics and the availability of alternatives that are proven
through medical evidence to be just as effective is really
important, especially for the health care safety net in this
country. The fact is we are a public hospital, but the vast
majority of our revenue is earned, despite the aid that we do
receive from the States and Medicare and Medicaid
Disproportionate Share Hospital (DSH). All of that really
matters for us to be able to shore up our supplies and make
sure we do not see a repeat of what happened last year.
Senator Rosen. Hopefully my legislation and the nonprofit
sector can help you there. But I would like to talk to another
thing that really impacts our supply chain disruption, and that
is, of course, cyber attacks. Last week, the Colonial Pipeline,
of course, that is not health care, but it does affect lives
and livelihoods if our fire departments or first responders,
ambulances do not have gas, there could be electrical outages,
any of those things. Cyber attacks against hospitals, local
governments, businesses, other organizations, of course, are
happening every day. They pose significant threats. And
considering the challenges in our medical supply chain, any
disruption could be deadly.
Dr. Schondelmeyer, through your work with the Resilient
Drug Supply Project, as you map out supply chains, how do you
account for expected and unexpected disruptions? You know,
expected, you might have a hurricane or tornado. Unexpected, of
course, are the cyber attacks that might paralyze one of your
systems. How could we better support you in those efforts?
Mr. Schondelmeyer. We are still in the process of
identifying the threats that could affect the drug supply
system, but certainly cyber attacks are on our list of things
that could happen. There we really need to work with the
private market. The suppliers, the wholesalers, the group
purchasing organizations, and others have fairly efficient and
sophisticated information technology (IT) systems and cyber
operations, but we need to work with them to make sure that
they are secure and that we do not have an attack on the drug
supply systems, supply chains, like we saw with the oil
industry recently. That could be devastating to the country. If
we cannot get the needed drugs out to the hospitals or to the
community pharmacies, patients with diabetes and with heart
attacks and with other critical conditions are literally going
to die or suffer severe consequences from the absence of those
drugs. Things that we once thought unthinkable are not anymore.
Senator Rosen. Would you think it would be helpful to
designate some of our drug manufacturers, some things in these
global supply chains and maybe inpatient care settings as
critical infrastructure? Because not just livelihoods but lives
are on the line if there is disruption or attack.
Mr. Schondelmeyer. Yes, Senator, I certainly think that
would be helpful, and we need to keep in mind that the critical
infrastructure--they certainly are the large tertiary care
hospitals, and they are critical. But there are also critical
rural hospitals that are the only place for health care within,
tens to hundreds of miles for some patients. We need to keep in
mind health care institutions of all types and sizes, not just
a certain type of health care institution, as being critical.
Senator Rosen. I agree with you there. In rural Nevada, we
have hundreds of miles sometimes to drive. Of course, those
qualified Federal health centers, all of those community-based
care, are particularly important.
I appreciate you all for being here. I see that my time is
about to expire. Thank you, Mr. Chairman.
Chairman Peters. Thank you, Senator Rosen.
Senator Ossoff, you are recognized for your questions.
OPENING STATEMENT OF SENATOR OSSOFF
Senator Ossoff. Thank you, Mr. Chairman.
Ms. Glas, thank you for your testimony today. Thank you to
the entire panel. You noted in your testimony and have noted
throughout this hearing that, particularly in the early months
of the COVID-19 pandemic, severe PPE shortages impaired the
medical response and also put front-line health care workers at
unnecessary risk of infection. In the early days of the
pandemic, health care workers were forced to use ad hoc,
homemade solutions to protect themselves--trash bags, rain
ponchos
The experience of Phoebe Putney Memorial Hospital in
Albany, Georgia, is emblematic of how poorly prepared we were
and what a failure to manage the medical supply chain and
manage a surge in demand we saw in the execution of the Federal
Government's response. As these PPE shortages swept across the
country in the early months of the pandemic, nurses and doctors
at Phoebe Putney Memorial Hospital in Albany were literally
sewing their own face masks and producing their own protective
equipment. I will never forget the images of nurses assembled
in a room sewing homemade PPE so that they and their colleagues
could continue to treat patients as we saw a huge surge in
infections and a huge taxing demand on respiratory critical
care and intensive care services at Phoebe Putney in Albany.
My question for you, Ms. Glas is: Have we taken the
necessary steps since those early months of this crisis to
ensure that our nurses and doctors and front-line medical
providers such as those at Phoebe Putney in Albany are never
again forced to sew their own face masks or don trash bags or
ponchos to protect themselves in the midst of a deadly pandemic
while they do their jobs treating patients and saving lives?
Ms. Glas. Senator, thank you for that question, and that
description of that hospital is a description of so many
hospitals and institutions across our country. I had family
members calling me who were desperately seeking PPE, and they
were using substandard--whatever they could find to try to
protect themselves.
I think this is a complicated question, Senator. Has our
industry been able to retool and invest in some of this
critical PPE? Absolutely. But where we are today and where we
were in the spring of last year are two different scenarios.
But what I am concerned about, Senator, is a few months from
now those supply chains that we just constructed to help ensure
that those hospitals did not have to sew their own masks will
go offshore again. We are starting to see that. In addition,
prior to COVID-19, there was one testing swab producer in the
United States, and that producer has been invested in
significantly by the U.S. Government. But there is no dramatic
second producer here in the United States. When we are looking
at Defense Production Act funding, we have a manufacturer in
Ohio who can make testing kit swabs, but they are not sure if
they are going to be in the business long term without the
Defense Production Act.
We are going to need to diversify supply chains moving
forward. We need to show a demand signal to the industry. There
needs to be incentives for hospitals like the one that you have
that want to purchase USA-made product that is going to cost a
little bit more, and there are a lot of Georgia textile
manufacturers that want to respond to your local hospital
systems and make these products long term.
Senator Ossoff. Thank you very much for that answer, Ms.
Glas.
A question for you, please, Dr. Elnahal. As you consider
potential future public health crises, whether a pandemic or
otherwise, what are key medical products, types of medical
equipment, for which there was perhaps not an extraordinary
surge in demand during this COVID-19 pandemic, but for which
there might be in other plausible public health crises so that
we can begin now to prepare ensuring that the supply chains for
other critical medical supplies that will be in high demand in
a future crisis are robust and able to withstand a sudden surge
in demand if and when such a crisis arises?
Dr. Elnahal. Thank you for the question, Senator. The first
thing I will mention is that respiratory viruses and
respiratory diseases are not the only things that can cause
epidemics and pandemics. You have, for example, Ebola, which
keeps resurfacing in Africa. Newark Airport, for which we cover
emergency medical services (EMS) in New Jersey, was the site of
one patient who was suspected for Ebola, which caused a
national incident where essentially a nurse was forced into
quarantine. And so something that we focus on is the
possibility of Ebola coming, but also other pathogens that can
cause gastrointestinal diseases and other types of disease. For
each of those disease categories, you are going to have your
characteristic needs. But I can tell you that personal
protective equipment for every type of pathogen will be
important.
The types of equipment will be different, depending on the
specific disease. So, for example, pathogens that tend to cause
diarrhea and are transmitted through the fecal-oral route, you
really need to make sure that both disposable and reusable
gowns are replenished and available. Isolation gowns for
respiratory diseases and, contact-based diseases were an issue
in this pandemic, but there are also different types of
equipment specific to that.
I think the idea is to take a look at the possibility of
epidemics and pandemics in multiple different disease
categories and go down the list of everything that is needed.
But we really should not be having shortages for commonly used
medications of any type, and Dr. Schondelmeyer talked about
that really eloquently, to reduce that volatility through
effective policies, making sure that the stockpile is there and
exists. There were no real medication stockpiles we saw for
some of the sedating medications for folks on ventilators. All
of that will be important in addition to policies that shore up
manufacturing.
Senator Ossoff. Thank you, Dr. Elnahal, Dr. Schondelmeyer,
and Dr. Handfield, my time is running out. What I would like to
request of each witness is that you please submit for the
record an itemized list of the medical equipment products,\1\
the precursors for production of key medical supplies and
products, the pharmaceutical products that may swiftly be in
high demand and of which we may have shortages across a range
of plausible public health crises that you might anticipate so
that this Committee can refer to such lists as we consider
other supply chains that may require reinforcement.
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\1\ The information requested by Senator Ossoff appears in the
Appendix on page 296.
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Thank you so much, and I yield.
Chairman Peters. Thank you, Senator Ossoff.
Last Congress, I introduced two bills. One was called the
``HOME Act,'' the other was the ``PART Act.'' They were based
on the findings of our 2019 investigative report that I
mentioned in my opening comments where we saw the
vulnerabilities that existed because of offshore production of
critical supplies and drugs.
One thing that became quite apparent in the investigation
is we do not have a good handle on exactly what is made in the
United States, what is made overseas, what are the supplies,
what are the manufacturing capabilities. Dr. Schondelmeyer, the
PART Act is the act that deals with that. It would basically
expand manufacturer reporting requirements to include increased
demand, export restrictions, quarterly reporting on the amount
of drugs and active ingredients that are here, what is
overseas. It is difficult to put forward policies if you do not
have a real clear picture of what is out there. Do you see a
need for this type of legislation to increase supply chain
visibility as we work on this problem?
Mr. Schondelmeyer. Absolutely. I think we know so little
about our drug supply system, and many of the prescription
drugs sold in the U.S. market, as I said, have on the label the
name of a U.S. company or a U.S. subsidiary of a foreign
company. But that almost always says ``manufactured for'' or
``distributed by'' or ``marketed by.'' Less often does it say
``made by'' or ``origin'' or ``product of,'' which tells you
the country where it was really made.
We have a health care system and a pharmaceutical system
that masks the origin and provides kind of a stealth, and we do
not know where they come from. In testimony last fall, I
remember the FDA admitted that they do not know and they do not
have authority to collect volume and market production levels.
I think your act specifies that, spells it out, and would give
us some of the information we need to have this ongoing supply
map so we know what we are doing when we need to find drugs in
the marketplace.
I really watched the National Football League (NFL) draft,
and it is amazing how much those NFL teams know about the
football players they can select. We know so much less about
the drugs that we rely on every day that it is dangerous.
Chairman Peters. Yes, absolutely. Visibility and
understanding the scope of the problem is the first step in
order to try to solve this. That is the intent of that
legislation, and we are going to be working on reintroducing it
and certainly would welcome all the panelists' input into that
legislation.
The other act is the HOME Act, which then builds--after we
have that understanding of potential supply shortages that
could exist and where the manufacturing, once we understand
those dynamics, we have to bring it onshore, and onshore will
take a variety of strategies. The HOME Act talks about
authorizing HHS to actually make investments in domestic
advanced manufacturing of critical drugs and supplies through
loans, perhaps forgivable grants, but also focused in a very
strategic way as to those that we need to make those
investments, and that requires obviously visibility as to what
is out there, where it is manufactured, and the demand side as
to what we need and make sure that we have to have that in our
country, but understanding that we may have to take a proactive
approach of investment in those industries.
Dr. Handfield, with that brief introduction, in your view,
would something like that help us deal with some of the
critical shortcomings in our current supply chains? Is that
something that we should be exploring further?
[Pause.]
Mr. Handfield. Yes, I am sorry. That was directed to me. I
apologize. I really do believe that that approach would--as I
said before, using alternative contracting approaches would
make a lot of sense. First of all, I think you could target
those drugs that are immediately in short supply which we know
could be manufactured here. I have had some discussions with
FDA, and I believe that there is greater discretion on their
part of working with manufacturers to ensure that they meet the
Good Manufacturing Practices (GMP) requirements to be able to
do those quickly.
There are other parts of the supply chain that may take
longer to move domestically. There may be complications in
terms of regulatory issues. But we want to be able to identify
those areas that are really critical bottlenecks in the supply
chain, if you will, and it is those bottlenecks that are
sometimes two or three tiers down the supply chain that are
going to be the restrictive component that will halt and create
those shortages.
I think it makes sense to start with the Prevent Auto
Recycling Thefts (PART) Act, and manufacturers are going to be
reluctant, to be able to share that information. I would
venture to say that some of them may not even know what that
information is or who is in their supply chain. And then the
second part of that would be to say, well, what parts of that
do we want to bring back to the United States? I think there
are really, the right incentives, the right contractual
incentives that can lead them to do that would make a lot of
sense, and I would be happy to work further with you on
determining what kinds of drugs would best fit those types of
criteria.
Chairman Peters. Thank you, Dr. Handfield, for that offer,
and it certainly is interesting, the testimony that even the
manufacturers' companies are not sure what is in that supply
chain as well. So having greater visibility is going to be
important for us to deal with this issue.
I want to thank all of our witnesses for engaging in this
important discussion as part of this Committee's bipartisan
oversight of the Federal coronavirus pandemic response. I think
there is no question certainly from the testimony we heard here
today that our longstanding overreliance on foreign sources for
critical medical products, coupled with the Trump
administration's failure to take early action, led to mass
shortages of needed PPE and critical drugs throughout the
United States. As today's hearing demonstrated, the shortages
we experienced and continue to experience, as we have heard,
were and are foreseeable. Unfortunately, instead of acting
quickly and understanding the severity of the virus, the past
administration failed to effectively coordinate a unified
response and procure the medical supplies that we needed.
As our Committee continues its investigation into the
Federal response and identifies needed reforms, we look forward
to building on the testimony that we have received here today.
As we have seen from the dearth and destruction wrought by this
virus, the cost of inaction is simply far too great to bear.
So, with that, the hearing record will remain open for 15
days, until May 28th at 5 p.m., for the submission of
statements and questions for the record. With that, this
hearing is now adjourned.
[Whereupon, at 4:03 p.m., the Committee was adjourned.]
A P P E N D I X
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