[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]




 
    THE STATE OF U.S. PUBLIC HEALTH BIOPREPAREDNESS: RESPONDING TO 
    BIOLOGICAL ATTACKS, PANDEMICS, AND EMERGING INFECTIOUS DISEASE 
                               OUTBREAKS

=======================================================================

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FIFTEENTH CONGRESS

                             SECOND SESSION

                               __________

                         FRIDAY, JUNE 15, 2018

                               __________

                           Serial No. 115-140


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov
                        
                        
                               _________ 
                                  
                  U.S. GOVERNMENT PUBLISHING OFFICE
 35-127                     WASHINGTON : 2019                        
 
                        
                        
                    COMMITTEE ON ENERGY AND COMMERCE

                          GREG WALDEN, Oregon
                                 Chairman
JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
FRED UPTON, Michigan                 BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
MICHAEL C. BURGESS, Texas            ELIOT L. ENGEL, New York
MARSHA BLACKBURN, Tennessee          GENE GREEN, Texas
STEVE SCALISE, Louisiana             DIANA DeGETTE, Colorado
ROBERT E. LATTA, Ohio                MICHAEL F. DOYLE, Pennsylvania
CATHY McMORRIS RODGERS, Washington   JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi            G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
BRETT GUTHRIE, Kentucky              KATHY CASTOR, Florida
PETE OLSON, Texas                    JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia     JERRY McNERNEY, California
ADAM KINZINGER, Illinois             PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia         BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida            PAUL TONKO, New York
BILL JOHNSON, Ohio                   YVETTE D. CLARKE, New York
BILLY LONG, Missouri                 DAVID LOEBSACK, Iowa
LARRY BUCSHON, Indiana               KURT SCHRADER, Oregon
BILL FLORES, Texas                   JOSEPH P. KENNEDY, III, 
SUSAN W. BROOKS, Indiana                 Massachusetts
MARKWAYNE MULLIN, Oklahoma           TONY CARDENAS, California
RICHARD HUDSON, North Carolina       RAUL RUIZ, California
CHRIS COLLINS, New York              SCOTT H. PETERS, California
KEVIN CRAMER, North Dakota           DEBBIE DINGELL, Michigan
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
JEFF DUNCAN, South Carolina

              Subcommittee on Oversight and Investigations

                       GREGG HARPER, Mississippi
                                 Chairman
H. MORGAN GRIFFITH, Virginia         DIANA DeGETTE, Colorado
  Vice Chairman                        Ranking Member
JOE BARTON, Texas                    JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas            KATHY CASTOR, Florida
SUSAN W. BROOKS, Indiana             PAUL TONKO, New York
CHRIS COLLINS, New York              YVETTE D. CLARKE, New York
TIM WALBERG, Michigan                RAUL RUIZ, California
MIMI WALTERS, California             SCOTT H. PETERS, California
RYAN A. COSTELLO, Pennsylvania       FRANK PALLONE, Jr., New Jersey (ex 
EARL L. ``BUDDY'' CARTER, Georgia        officio)
GREG WALDEN, Oregon (ex officio)
  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Gregg Harper, a Representative in Congress from the State of 
  Mississippi, opening statement.................................     1
    Prepared statement...........................................     3
Hon. Diana DeGette, a Representative in Congress from the state 
  of Colorado, opening statement.................................     4
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     5
    Prepared statement...........................................     7
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     9

                               Witnesses

Rick A. Bright, Ph.D., Director, Biomedical Advanced Research and 
  Development Authority, Deputy Assistant Secretary, Office of 
  the Assistant Secretary for Preparedness and Response, U.S. 
  Department of Health and Human Services........................    11
    Prepared statement...........................................    14
    Answers to submitted questions...............................   102
Anne Schuchat, M.D. (RADM, USPHS), Principal Deputy Director, 
  Centers for Disease Control and Prevention, U.S. Department of 
  Health and Human Services......................................    24
    Prepared statement...........................................    26
    Answers to submitted questions \1\...........................   112
Anthony Fauci, M.D., Director, National Institute of Allergy and 
  Infectious Diseases, National Institutes of Health.............    36
    Prepared statement...........................................    38
    Answers to submitted questions...............................   115
Denise Hinton (RADM, USPHS), Chief Scientist, U.S. Food and Drug 
  Administration.................................................    43
    Prepared statement...........................................    45
    Answers to submitted questions \2\...........................   124

                           Submitted Material

Subcommittee memorandum..........................................    80
Report of the Independent Panel on the U.S. Department of Health 
  and Human Services (HHS) Ebola Response \3\
Strategic National Stockpile Estimated Spending Graph............    95
Statement of the Blue Ribbon Study Panel on Biodefense...........    96

----------
\1\ The committee did not receive a response to Ms. Schuchat's 
  submitted questions for the record by the time of printing.
\2\ The committee did not receive a response to Ms. Hinton's 
  submitted questions for the record by the time of printing.
\3\ The information can be found at: https://docs.house.gov/
  meetings/IF/IF02/20180615/108422/HHRG-115-IF02-20180615-
  SD003.pdf.


    THE STATE OF U.S. PUBLIC HEALTH BIOPREPAREDNESS: RESPONDING TO 
    BIOLOGICAL ATTACKS, PANDEMICS, AND EMERGING INFECTIOUS DISEASE 
                               OUTBREAKS

                              ----------                              


                         FRIDAY, JUNE 15, 2018

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:01 a.m., in 
room 2123, Rayburn House Office Building, Hon. Gregg Harper 
(chairman of the subcommittee) presiding.
    Present: Representatives Harper, Griffith, Burgess, Brooks, 
Collins, Walberg, Walters, Costello, Carter, Walden (ex 
officio), Degette, Schakowsky, Castor, Ruiz, and Pallone (ex 
officio).
    Also Present: Representative Eshoo.
    Staff Present: Jennifer Barblan, Chief Counsel, Oversight 
and Investigations; Adam Fromm, Director of Outreach and 
Coalitions; Ali Fulling, Legislative Clerk, Oversight and 
Investigations, Digital Commerce and Consumer Protection; 
Christopher Santini, Counsel, Oversight and Investigations; 
Jennifer Sherman, Press Secretary; Alan Slobodin, Chief 
Investigative Counsel, Oversight and Investigations; Austin 
Stonebraker, Press Assistant; Christina Calce, Minority 
Counsel; Jeff Carroll, Minority Staff Director; Chris Knauer, 
Minority Oversight Staff Director; Miles Lichtman, Minority 
Policy Analyst; C.J. Young, Minority Press Secretary; and Perry 
Lusk, Minority GAO Detailee.

  OPENING STATEMENT OF HON. GREGG HARPER, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF MISSISSIPPI

    Mr. Harper. Good morning. Today, the subcommittee continues 
its longstanding oversight of the U.S. public health system's 
preparedness to respond to biological threats and emerging 
infectious diseases that endanger the public health. The 
purpose of today's hearing is to hear from top public health 
experts on the good work being done at their agencies to 
protect the public and to explore where improvements need to be 
made.
    The biological threats facing the United States in today's 
global society are varied, ever-evolving and, in some cases, 
intensifying. The CDC just reported that the seasonal influenza 
claimed the lives of 172 children during the most recent flu 
season, making it the deadliest seasonal flu season for 
children on record.
    In recent years, the U.S. has also seen an increase in the 
number of antibiotic-resistant bacteria. Around the world, 
viruses are emerging, adapting and, in some cases, reemerging. 
Currently, there is an Ebola outbreak in West Africa and a 
Nipah virus outbreak in India that has killed at least 17.
    In recent years, we have also seen humans in China contract 
the H7N9 strain of influenza which has been confined to birds. 
The H7N9 influenza strain is rated by the CDC's influenza risk 
assessment tool as posing the greatest risk to cause a public 
pandemic.
    The 2013 ricin mailings addressed to President Obama and 
Senator Roger Wicker that originated in my home State of 
Mississippi, as well as the 2001 anthrax mailings and foreign 
terrorist threats, is a reminder of the risk of intentional 
biological attacks.
    Today's hearing is especially timely, given that the 
committee is considering bipartisan legislation sponsored by 
Mrs. Brooks and Ms. Eshoo to reauthorize the Pandemic and All 
Hazards Preparedness Act, PAHPA, which is set to expire at the 
end of September. Passage of PAHPA's reauthorization would not 
only provide critical certainty for public health agencies and 
industry partners, it would also bring about some much needed 
reforms. One such reform proposed in the legislation is 
transferring control of the Strategic National Stockpile from 
the CDC to HHS' Office of the Assistant Secretary for 
Preparedness and Response, to improve management of the 
stockpile.
    A year ago, HHS' Office of Inspector General reported 
systemic issues with security and inventory management of the 
stockpile, risking CDC's ability to deploy the stockpile during 
a public health emergency. These issues need to be addressed, 
as does improving the training of State and local stakeholders 
on deployment of medical countermeasures.
    Administrative reforms are also of interest. For example, 
are there ways to improve the timeliness of the decisionmaking 
process on threat assessments and appropriate countermeasures? 
Effective threat detection has been a subject of committee 
oversight. In 2016, the committee questioned the CDC about the 
effectiveness of its Laboratory Response Network, or LRN, which 
is responsible for developing assays for public health labs to 
test for the presence of Federal select agents.
    In a May 2017 letter to the committee, the CDC reported 
that the LRN had only developed three assays approved by the 
FDA to detect specific Federal select agents. While the LRN has 
also had those cleared by the FDA under emergency use 
authorization, after nearly 20 years of this program, with 
about $135 million in funding over the last decade, could the 
LRN have cleared a significantly higher number of assays 
through the most rigorous FDA 510(k) process?
    Finally, maintaining public confidence in critical Federal 
biopreparedness research is essential. In response to safety 
lapses in 2014 and to an expert panel's recommendations, the 
CDC and FDA each formed new offices in 2015 to centralize and 
elevate oversight of laboratory safety, with the directors of 
those offices reporting directly to the agency head.
    These changes sent a strong message that lab safety was a 
top priority, backed by the clout of direct backing from the 
agency head. Unfortunately, both agencies seem to be 
backtracking from this good direction.
    In the FDA's case, less than a year after this 
administration approved the direct report organization--or 
reorganization, the sudden change is curious and would seem to 
be a step in the wrong direction. So we need to hear more 
details about the basis for this new direction.
    I would like to thank the distinguished members of our 
panel for being here today and for your service to our country.
    I now recognize the ranking member of the subcommittee from 
Colorado, Ms. DeGette, for 5 minutes.
    [The prepared statement of Mr. Harper follows:]

                Prepared statement of Hon. Gregg Harper

    Good morning, today the Subcommittee continues its long-
standing oversight of the U.S. public health system's 
preparedness to respond to biological threats and emerging 
infectious diseases that endanger the public health. The 
purpose of today's hearing is to hear from top public health 
experts on the good work being done at their agencies to 
protect the public, and to explore where improvements in 
biopreparedness may still be needed.
    The biological threats facing the United States in today's 
global society are varied, ever-evolving, and in some cases, 
intensifying. The CDC just reported that the seasonal influenza 
claimed the lives of 172 children during the most recent flu 
season, making it the deadliest seasonal flu season for 
children on record. In recent years the U.S. has also seen an 
increase in the number of antibiotic resistant bacteria.
    Around the world, viruses are emerging, adapting, and in 
some cases, re-emerging. Currently, there is an Ebola outbreak 
in West Africa and a Nipah virus outbreak in India, that has 
killed at least 17 people.
    In recent years, we have also seen humans in China contract 
the H7N9 strain of influenza, which had been confined to birds. 
The H7N9 influenza strain is rated by the CDC's Influenza Risk 
Assessment Tool as posing the greatest risk to cause a possible 
pandemic.
    The 2013 ricin mailings addressed to President Obama and 
Senator Roger Wicker that originated in my home state of 
Mississippi, as well as the 2001 anthrax mailings and foreign 
terrorist threats, is a reminder of the risk of intentional 
biological attacks.
    Today's hearing is especially timely given that the 
Committee is considering bipartisan legislation, sponsored by 
Ms. Brooks and Ms. Eshoo, to reauthorize the Pandemic and All-
Hazards Preparedness Act (PAHPA), which is set to expire at the 
end of September. Passage of PAHPA's reauthorization would not 
only provide critical certainty for public health agencies and 
industry partners, it would also bring about some much-needed 
reforms.
    One such reform, proposed in the legislation, is 
transferring control of the Strategic National Stockpile from 
the CDC to HHS' Office of the Assistant Secretary for 
Preparedness and Response to improve management of the 
Stockpile. A year ago, HHS's Office of Inspector General 
reported systemic issues with security and inventory management 
of the Stockpile, risking CDC's ability to deploy the stockpile 
during a public health emergency. These issues need to be 
addressed, as does improving the training of state and local 
stakeholders on deployment of medical countermeasures.
    Administrative reforms are also of interest. For example, 
are there ways to improve the timeliness of the decision-making 
process on threat assessments and appropriate countermeasures?
    Effective threat detection has been a subject of Committee 
oversight. In 2016, the Committee questioned the CDC about the 
effectiveness of its Laboratory Response Network (LRN), or LRN, 
which is responsible for developing assays for public health 
labs to test for the presence of federal select agents. In a 
May 2017 letter to the Committee, the CDC reported that the LRN 
had only developed three assays approved by FDA to detect 
specific federal select agents. While the LRN has also had 
assays cleared by the FDA under Emergency Use Authorization, 
after nearly 20 years of this program with about $135 million 
in funding over the last decade, could the LRN have cleared a 
significantly higher number of assays through the more rigorous 
FDA 510(k) process?
    Finally, maintaining public confidence in critical federal 
biopreparedness research is essential. In response to safety 
lapses in 2014 and to an expert panel's recommendations, the 
CDC and FDA each formed new offices in 2015 to centralize and 
elevate oversight of laboratory safety, with the directors of 
those offices reporting directly to the agency head. These 
changes sent a strong message that lab safety was a top 
priority backed by the clout of direct backing from the agency 
head. Unfortunately, both agencies seem to be backtracking from 
this good direction, in the FDA's case less than a year after 
this Administration approved the direct-report reorganization. 
The sudden change is curious, and would seem to be a step in 
the wrong direction. We need to hear more details about the 
basis for this new direction.
    I would like to thank the distinguished members of our 
panel for being here today and for your service to our country. 
I now recognize the Ranking Member of the Subcommittee from 
Colorado, Ms. DeGette, for 5 minutes.

 OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Ms. DeGette. Thank you, Mr. Chairman.
    I know we agree that preparing this country for a 
bioincident is of critical importance. The threat, as you said, 
is real and it's growing.
    In April, the CDC reported that in 2017, Colorado saw 25 
cases of an antibiotic-resistant bacteria known descriptively 
as the nightmare bacteria, because 50 percent of those infected 
by it die. Thankfully, those cases were isolated, but the same 
CDC study noted that it's possible for these germs to ``spread 
like wildfire.'' If that happens, we need to know that we're 
able to respond.
    We've looked at this issue in this subcommittee many times 
over the years, as our panel well knows. It's a regular 
appearance, and I want to thank you for coming again. And again 
and again, we've found that the Federal Government has to 
scramble to address biosafety incidents.
    Those of us who were here during the fall of 2001 vividly 
recall the chaos that a few small envelopes of anthrax caused 
on Capitol Hill. Offices were closed. Buildings were fumigated. 
Some congressional business was suspended, and thousands of 
staffers and other personnel lined up for days to get tested 
for exposure. Far worse, some of the workers in our Postal 
Service were infected and died.
    In 2009, we again had to scramble to produce sufficient 
doses of the H1N1 swine flu vaccine to protect against this new 
strain of the disease.
    In 2014, hospitals and healthcare providers were not 
adequately prepared to deal with the arrival of Ebola patients 
in America. In one case, a hospital in Dallas failed to 
diagnose Ebola in a patient who had traveled to West Africa and 
discharged him. The virus was later transmitted from that 
patient to two healthcare workers. In the days and weeks that 
followed, important questions were raised about how this event 
was handled and were we adequately prepared for the larger 
event.
    And then, of course, in 2015, the Zika outbreak underscored 
the need for the U.S. Government to focus on disease 
preparedness every day. And I know our panel here today does 
just that.
    I'd like to know today, though, what lessons we've learned 
from these incidents, and I want to know how the agencies are 
using what we've learned to better prepare for the next crisis, 
because there will be one.
    For example, do we have adequate medical countermeasures in 
place to respond quickly when an outbreak occurs or a toxin is 
released? Do we have the capacity to quickly deliver these 
countermeasures to the doctors and nurses who will actually use 
them? And do the healthcare workers understand how to deploy 
the countermeasures?
    Similarly, research into emerging pathogens and existing 
pathogens that have mutated is key to helping us quickly 
respond to new and expanding outbreaks. How is this research 
informing our surveillance and detection methodologies? Are we 
prioritizing research into threats of greatest concern? And are 
we dedicating adequate resources to the threats?
    I also want to hear more about how all of our agencies--
CDC, ASPR, NIAID and FDA--coordinate their research, 
surveillance, and response efforts. Because while each one of 
these agencies today has a specific valuable role to play in 
ensuring preparedness, nobody can operate effectively alone.
    In fact, one major finding of the Blue Ribbon Panel's 2015 
report on biodefense preparedness was these agencies must 
ensure they're equipped to work together to respond to 
pandemics. The Blue Ribbon report also found that the Federal 
Government must dramatically increase the support provided to 
local jurisdictions to help them build and sustain their 
biodefense capabilities.
    Local providers like hospitals and healthcare workers will 
be on the front lines in a public health emergency. I want to 
ensure that we're adequately supporting these providers, as 
well as State and local Health Departments, so they are 
equipped to detect incidents when they happen and respond 
appropriately.
    Mr. Chairman, I'm really hoping we'll hear today that we've 
made tangible, measurable progress in this area, but, again, I 
urge us to revisit the work of the Blue Ribbon Panel and some 
of its findings to determine what more we need to do to better 
prepare the Nation for the threats that we will be discussing 
today.
    I just can't thank our panel today enough for the tireless 
work that they put in to keeping America safe. We always have a 
great opportunity to hear from you, and we know that you're 
working hard. We think by having you come up here and take the 
time, it really helps us represent our constituents, and it 
helps all of us be better prepared for the next emergency that 
faces us.
    Thank you, and I yield back.
    Mr. Harper. The gentlewoman yields back.
    The chair now recognizes the chairman of the full 
committee, the gentleman from Oregon, Mr. Walden, for 5 
minutes.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Thank you very much, Mr. Chairman. To all our 
committee members, thanks for your work on this. And to our 
panelists, thank you, not only for your guidance on this issue, 
but also what we tap into you for along the way. And so we 
appreciate your professionalism and your assistance in our 
policy debates.
    The topic of biopreparedness really hits home for me. I 
think I was the first Member of Congress to be diagnosed with 
H1N1 years ago. Not a distinction I was glad to get, but one 
apparently I had. But more than that, 30 years ago, a religious 
group called the Rajneeshees moved to Oregon. You may have seen 
the documentary on Netflix called Wild Country. And if you read 
Judith Miller's book Germs, you'll find it was the largest 
bioterror attack in the Nation's history, but it took the 
Federal Government a year, I think she wrote, to admit that 
that's really what it was. They grew their own salmonella and 
then sprinkled it over salad bars in Dalles, Oregon, and 
sickened 751 people, many of whom I know.
    Deliberate biological attacks are just one risk. With more 
global travel, there's, of course, increased risk of spread of 
infectious diseases. As we've seen with influenza, our vaccines 
must be constantly updated to keep up with the latest strains. 
Meanwhile, other pathogens can develop antibiotic resistance, 
and our ability to quickly recognize evolving diseases and 
respond to new outbreaks is reliant on the testing and 
treatment and capabilities in the men and women who do the work 
that you all oversee.
    Lack of preparation is not an option. A mock pandemic 
exercise hosted last month by Johns Hopkins Center for Health 
Security with a group of current and former government 
officials, including our own colleague Susan Brooks, I'm told 
was quite eye-opening. The exercise resulted in a failure to 
develop a vaccine within 20 months, and that led in this 
exercise to 150 million deaths globally. So obviously, we've 
got to do more to be prepared for these types of outbreaks.
    So that's where the reauthorization of the Pandemic and All 
Hazards Preparedness Act comes in. PAHPA originally was adopted 
in 2006. It's set to expire at the end of September. We intend 
to move forward with legislation prior to that.
    Our Health Subcommittee met just last week to consider a 
bipartisan discussion draft to reauthorize this law and 
continues to fine-tune it. It's critically important Congress 
reauthorizes this law in time and to make sure that all levels 
of government are well-equipped to handle, not just current and 
emerging biothreats, but also chemical attacks, radiological 
emergencies, cybersecurity incidents, and mass casualty events.
    Through letters, hearings, and investigations, the 
Committee has raised numerous issues regarding biological 
threats to the U.S. and our nation's ability to respond to 
infectious disease outbreaks. For example, the Committee has 
examined concerns about the CDC's management and the security 
of the Strategic National Stockpile and the capabilities of CDC 
Laboratory Response Network. The Trump administration is set to 
transfer management of the stockpile from the CDC to the 
Assistant Secretary for Preparedness and Response, known as 
ASPR. And we look forward to hearing more details about how 
this transfer will work.
    Another area of interest to the Committee is the 
improvement of our biosurveillance capabilities. Innovation in 
this field could bolster our public health response in the 
event of an attack or epidemic. So I'll be interested in 
learning more about that as well.
    One thing we do know, the Federal Government needs to act 
faster to identify and determine material threats. The 
Department of Homeland Security in March 2018 made a material 
threat determination for pharmaceutical-based agents such as 
Fentanyl. It took 2 years for the DHS to make this designation, 
yet carfentanil, a highly potent form of Fentanyl, was used in 
a terrorist attack more than 15 years ago. So it's only after 
that designation is made that the Public Health Emergency 
Medical Countermeasures Enterprise can approve countermeasure 
development and acquisition. If we knew about it 15 years ago 
and it took 2 years to get that designation, we can do better.
    Maintaining public support for critical biopreparedness 
research relies on Federal scientists and researchers working 
with these diseases and dangerous pathogens in a safe and 
secure manner. Following several safety lapses at CDC and FDA 
labs in 2014, both FDA and CDC created new offices to oversee 
and prioritize lab safety. These are positive steps. The recent 
proposals at these agencies to lower the status of their lab 
safety offices raises concerns with this committee.
    So I thank you for being here today.
    And I'd like to yield the balance of my time to Dr. Burgess 
and hopefully to Mrs. Brooks.
    [The prepared statement of Chairman Walden follows:]

                 Prepared statement of Hon. Greg Walden

    Mr. Chairman, thank you for holding this hearing. The topic 
ofbiopreparedness hits home for me. Some of you may recall that 
in 2009 I was diagnosed with H1N1--the swine flu. It was 
reported at the time that I was the first Member of Congress to 
contract swine flu--a distinction I'm not particularly proud 
of. But that's not all. The first and single largest 
bioterrorism attack in the U.S. occurred in my district. More 
than 30 years ago, a group of Rajneeshee cult members used 
salmonella to contaminate at least 10 restaurant salad bars in 
The Dalles, Oregon, causing at least 751 people to get ill.
    Deliberate biological attacks are just one risk. With more 
global travel, there is increased risk of the spread of 
infectious diseases.
    As we've seen with influenza, our vaccines must be 
constantly updated to keep up with the latest strain mutations. 
Meanwhile other pathogens can develop antibiotic resistance. 
Our ability to quickly recognize evolving diseases and respond 
to new outbreaks is reliant on our testing and treatment 
capabilities.
    Lack of preparation is not an option. A mock pandemic 
exercise hosted last month by Johns Hopkins Center for Health 
Security with a group of current and former government 
officials, including our colleague Susan Brooks, was eye 
opening. This exercise resulted in a failure to develop a 
vaccine within 20 months and led to 150 million deaths 
globally. We must do more. We must be prepared for potential 
outbreaks.
    That's where the reauthorization of the Pandemic and All-
Hazards Preparedness Act (PAHPA) comes in. PAHPA, originally 
adopted in 2006, is set to expire at the end of September. Our 
Health Subcommittee met just last week to consider a bipartisan 
discussion draft to reauthorize this law and continues to fine 
tune it. It is critically important Congress reauthorizes this 
law to ensure that all levels of government are well-equipped 
to handle not just current and emerging biothreats, but also 
chemical attacks, radiological emergencies, cybersecurity 
incidents, and mass casualty events.
    Through letters, hearings and investigations, the committee 
has raised numerous issues regarding biological threats to the 
U.S. and our nation's ability to respond to infectious disease 
outbreaks. For example, the committee has examined concerns 
about the CDC's management and security of the Strategic 
National Stockpile, and the capabilities of the CDC Laboratory 
Response Network. The Trump Administration is set to transfer 
management of the stockpile from the CDC to the Assistant 
Secretary for Preparedness and Response (ASPR), and we look 
forward to hearing more details about how this transfer will 
work.
    Another area of interest to the committee is the 
improvement of our biosurveillance capabilities. Innovation in 
this field could bolster our public health response in the 
event of an attack or epidemic. I will be interested to learn 
whether more intensive research could help expedite addressing 
the technical challenges.
    One thing we do know: The Federal Government needs to act 
faster to identify and determine material threats. The 
Department of Homeland Security (DHS) in March 2018 made a 
material threat determination for pharmaceutical-based agents 
such as fentanyl. It took 2 years for DHS to make this 
designation. Yet carfentanil, a highly potent form of fentanyl, 
was used in a terrorist attack more than 15 years ago. It's 
only after that designation is made that the Public Health 
Emergency Medical Countermeasures Enterprise can approve 
countermeasure development and acquisition. We must move 
faster.
    Maintaining public support for critical biopreparedness 
research relies on federal scientists and researchers working 
with these diseases and dangerous pathogens in a safe and 
secure manner. Following several safety lapses at CDC and FDA 
labs in 2014, both CDC and FDA created new offices to oversee 
and prioritize lab safety. These were positive steps, but 
recent proposals at these agencies to lower the status of their 
lab safety offices raise concerns.
    I'd like to thank our witnesses for being here with us 
today. We value the feedback and insight you provide and look 
forward to today's discussion.

    Mr. Burgess. Thank you, Mr. Chairman.
    And this issue is one that is important and timely for this 
subcommittee. And last week, the Health Subcommittee had a 
hearing on the discussion draft of the Pandemic and All Hazards 
Preparedness Act authored by Representatives Brooks and Eshoo. 
At that hearing, we heard from witnesses with firsthand 
experience in combating these biological threats to our nation 
and received input on the draft legislation.
    Certainly, our witness panel today is well-known to us and 
they are all experts. I look forward to hearing from our 
witnesses.
    And I thank you, Mr. Chairman, and I will yield to Mrs. 
Brooks.
    Mr. Harper. Maybe with unanimous consent, due to your 
leadership role in this, 30 seconds.
    Mrs. Brooks. Thank you, Mr. Chairman.
    And thank you to our witnesses for your work on this public 
health and national security issue.
    Last February, our subcommittee here held a hearing 
examining how we best combat biological threats. And I'm 
pleased we're once again examining the state of our 
preparedness as we prepare to reauthorize PAHPA.
    As everyone here knows, it is not a question of if we face 
a threat; it's a question of again, once again, when we face a 
threat. And we've been reminded by the stories that we've heard 
here today that these types of incidents have already happened 
in our country over the last decade and a half.
    Created in 1999, the National Stockpile is the repository 
of vaccines, antibiotics, and supplies used in the event of an 
attack or an outbreak. But HHS OIG, in June of 2017, issued a 
report identifying serious systemic issues within the CDC's 
management of the stockpile.
    I look forward to hearing from our witnesses today how we 
are going to ensure that our stockpile is properly managed and 
that we can be prepared as a country for whatever threat we are 
and may face.
    I yield back.
    Mr. Harper. The chair now recognizes the ranking member of 
the full committee, the gentleman from New Jersey, Mr. Pallone, 
for 5 minutes.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. Thank you, Mr. Chairman.
    Ensuring that our nation is equipped to respond to 
pandemics, natural disasters, and the accidental or intentional 
release of toxins is a key part of protecting public health. 
Past work by this committee has suggested that our nation has 
not always been as prepared as we need to be, so I'm glad that 
we're having this hearing today, and I hope to hear that we 
have made tangible progress towards increasing our Nation's 
preparedness.
    In 2015, the Blue Ribbon Panel on Biodefense conducted a 
comprehensive review of the Federal Government's 
biopreparedness efforts. The panel found that, ``The Nation is 
dangerously vulnerable to a biological event.'' It produced an 
extensive report recommending 30 action items for our public 
health infrastructure to address.
    While the Blue Ribbon Panel was the most recent high-level 
commission to examine our nation's biopreparedness, it was not 
the first. In fact, for many years, experts have warned that 
our ability to respond to biologic and other emerging threats 
must be improved.
    These recommendations remain important today, because the 
emerging health threats this country faces continue to grow. 
Just this week, officials announced that a child in Idaho had 
contracted bubonic plague. Last year, an outbreak of this 
plague killed 200 people in Madagascar.
    In March, we heard at a hearing that the threat of pandemic 
flu is among the greatest concerns in the public health world. 
And antibiotic resistance also poses a major threat to public 
health, killing 23,000 Americans every year and making everyday 
procedures like surgery and chemotherapy increasingly risky. In 
May, a study showed that warming temperatures were associated 
with higher levels of antibiotic resistance in common strains 
of bacteria.
    Extreme weather events can also lead to serious public 
health emergencies. The hurricanes in Puerto Rico, the Virgin 
Islands, Texas, and Florida last year were a stark reminder of 
this fact. We must be prepared to address threats from all 
these sources.
    The Blue Ribbon Panel produced many recommendations for 
improving our biopreparedness, and I hope our witnesses will 
show that we have made real progress. For example, I hope to 
hear that the agencies have established a plan for who will 
take the lead in response to a public health threat and how the 
efforts will be coordinated.
    Along these same lines, I hope we will learn how CDC, NIH, 
ASPR, and FDA are working together to identify the greatest 
threats and to prioritize the research, surveillance, and 
response capabilities needed to target these threats.
    We must also focus on how these agencies collaborate with 
State and local health departments as well as healthcare 
providers, such as hospitals. These entities are likely to be 
the first to see patients impacted by an infectious disease 
outbreak or other incident. In most cases, they'll be the ones 
to dispense countermeasures and to treat those impacted.
    In 2014, for example, we witnessed the negative 
consequences that ensued when our healthcare infrastructure was 
unprepared to diagnose and treat patients with Ebola. A 
hospital failed to detect the disease in the patient in Dallas, 
and that patient later transmitted Ebola to two healthcare 
workers. This incident led to a serious question about whether 
we would be able to handle a larger scale event or incident. 
And we must make sure everyone on the ground has all the 
resources they need to respond effectively in such a crisis.
    We also want to hear more about how we are conducting 
surveillance so that when an outbreak happens or a toxin is 
released, we know as soon as possible. While we cannot 
anticipate every possible new or mutated pathogen, if we can 
quickly detect when such a pathogen has emerged, we can respond 
much more effectively.
    And along these same lines, I understand the CDC is 
gathering a substantial amount of data from laboratories, 
public health departments, and clinicians across the country 
every day. So we must ensure that this agency has the resources 
it needs to effectively use and analyze this data as it comes 
in.
    And finally, I want to hear more about what we're doing to 
prioritize development of medical countermeasures to help us 
respond to a biosafety incident. Countermeasures include 
preventative measures like vaccines as well as therapeutics 
like antibiotics and antivirals.
    BARDA, I understand that you work closely with the private 
sector to develop many of these products, and I hope that we 
will hear today about how these partnerships have produced 
useful, safe, and effective products that truly address the 
challenges we face.
    So, Mr. Chairman, I'd like to thank our panel once again 
for being here. Preparing for these threats is certainly not 
easy, but I'm confident that you're up for the task as long as 
we do our part and provide you with all the resources that you 
need.
    I yield back, Mr. Chairman.
    Mr. Harper. The gentleman yields back.
    I ask unanimous consent that the members' written opening 
statements be made part of the record. Without objection, they 
will be so entered into the record.
    And additionally, I ask unanimous consent that Energy and 
Commerce members not on the Subcommittee on Oversight and 
Investigations be permitted to participate in today's hearing. 
Without objection, so ordered.
    I would now like to introduce our witnesses for today's 
hearing. First, we have Dr. Rick Bright, Director of Biomedical 
Advanced Research and Development Authority and Deputy 
Assistant Secretary at the Office of the Assistant Secretary 
for Preparedness and Response. Next is Dr. Anne Schuchat, 
Principal Deputy Director at the Centers for Disease Control 
and Prevention. Then we have Dr. Anthony Fauci, Director of the 
National Institute of Allergy and Infectious Diseases at the 
National Institutes of Health. Finally, we have Rear Admiral 
Denise Hinton, Chief Scientist at the U.S. Food and Drug 
Administration.
    We welcome all of you.
    And you are each aware that the Committee is holding an 
investigative hearing and when doing so has had the practice of 
taking testimony under oath. Do you have any objection to 
testifying under oath?
    Let the record reflect that all of the witnesses have 
reflected that they do not.
    The chair then advises you that under the rules of the 
House and the rules of the committee, you're entitled to be 
accompanied by counsel. Do you desire to be accompanied by 
counsel during your testimony today?
    Let the record reflect that each of the witnesses reflected 
that they do not.
    In that case, if you would please rise and raise your right 
hand, I will swear you in.
    [Witnesses sworn.]
    Mr. Harper. You are now under oath and subject to the 
penalties set forth in title 18, section 1001 of the United 
States Code. You may now give a 5-minute summary of your 
written statement.
    And I will begin with you, Dr. Bright. Welcome back.

   TESTIMONY OF RICK A. BRIGHT, PH.D., DIRECTOR, BIOMEDICAL 
 ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, DEPUTY ASSISTANT 
 SECRETARY, OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS 
  AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; 
 ANNE SCHUCHAT, M.D. (RADM, USPHS), PRINCIPAL DEPUTY DIRECTOR, 
CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF 
   HEALTH AND HUMAN SERVICES; ANTHONY FAUCI, M.D., DIRECTOR, 
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL 
 INSTITUTES OF HEALTH; AND DENISE HINTON (RADM, USPHS), CHIEF 
          SCIENTIST, U.S. FOOD AND DRUG ADMINISTRATION

               TESTIMONY OF RICK A BRIGHT, PH.D.

    Mr. Bright. Thank you.
    Chairman Harper, Ranking Member DeGette, and distinguished 
members of the subcommittee, it's a pleasure to speak today on 
behalf of our Assistant Secretary for Preparedness Response to 
discuss the state of the Nation's health security preparedness.
    I'm Dr. Rick Bright, the Director of the Biomedical 
Advanced Research and Development Authority, BARDA, and the 
Deputy Assistant Secretary for Preparedness and Response.
    ASPR's mission is to save lives and protect Americans from 
21st century health security threats. BARDA is a component of 
ASPR created to ensure that we have products to protect people 
from numerous dire threats that we face as a nation. ASPR's 
staff is dedicated to preparing for and responding to these 
threats.
    We are currently coordinating HHS' response to the Ebola 
outbreak in the DRC and monitoring H7N9 influenza in China. In 
communities affected by last year's hurricanes, we're there for 
the long haul, helping local health officials manage recovery 
and build resilience.
    ASPR coordinates across the Federal Government to support 
State and local partners in emergencies. We enhance medical 
search capacity through our National Disaster Medical System 
and Hospital Preparedness Program, and we oversee the 
development and procurement of medical countermeasures. We've 
made great progress in public health preparedness response 
since Congress established ASPR and BARDA in 2006.
    BARDA was created to bridge government and industry to 
accelerate the development of life-saving medical 
countermeasures that would not otherwise be available. We use 
flexible authorities, multiyear advanced funding, public-
private partnerships, and deep technical expertise to push 
vaccines, drugs, and diagnostics towards FDA approval. In our 
12 years, BARDA has formed over 200 public-private partnerships 
with industry to accomplish our mission.
    I want to pause for one second to acknowledge the hard work 
of our partners who, together with the U.S. Government, work 
very hard to create a more secure nation with not only products 
but capabilities to respond when needed. These partnerships 
have led to 35 FDA approvals of products that form a protective 
shield for our nation against a range of the most serious CBRN 
and pandemic and emerging infectious disease threats.
    Through Project BioShield, BARDA has supported 27 vaccines, 
drugs, and devices to address national security threats, 
including smallpox, anthrax, botulinum, rad/nuc and chemical 
exposure. Fourteen of these are now in the Strategic National 
Stockpile for use in an emergency, and seven have now achieved 
FDA approval. These outcomes are the spirit of PAHPA: 
leadership, coordination, partnerships, and capabilities, 
working together to protect our nation.
    While this effort has created life-saving products to be 
procured by the SNS, it has also created challenges to acquire 
and sustain sufficient quantities to address the requirements 
needed for each threat. Critically, each product also 
represents a company with a response capability that must be 
sustained to ensure we have these products available when 
they're needed. Project BioShield and the SNS together 
represent a marketplace for these products that would otherwise 
never exist and the products would quickly vanish without it.
    PAHPA, ASPR, BARDA, and BioShield have all played valuable 
roles in enhancing our preparedness. However, the threats 
continue to evolve, and technology to modify and create new 
deadly threats have become simpler. We must modernize our 
capabilities, emphasizing an end-to-end approach, ranging from 
early detection through the last mile of administering vaccines 
and treatments to patients.
    With new technologies and innovation, the time is here to 
apply transformative approaches to these daunting health 
security problems. Last week, we announced a new initiative 
called DRIVe, a nationwide business-friendly approach to 
identify, capture, and accelerate life-saving innovation. Using 
authorities you enacted in the 21st Century Cures Act, DRIVe 
brings together innovators, government, and now the investment 
community to create solutions for today's threats.
    As you consider reauthorization of PAHPA, important changes 
to BARDA's authorities would sustain and enhance our 
capabilities. First, advanced appropriations for Project 
BioShield will attract more partners to support our mission. 
Without this consistent and guaranteed market, the companies 
are reluctant to work with us. Second, an authorization of 
appropriation for BARDA's pandemic influenza program will 
sustain our domestic flu vaccine production capabilities, 
modernize our vaccine technologies, and bring new treatments 
and faster diagnostics into the homes across America.
    I look forward to working with members of this panel, this 
subcommittee, your congressional colleagues, and I'm grateful 
for the opportunity to present to you today and look forward to 
your questions.
    [The prepared statement of Mr. Bright follows:]
    
    
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    Mr. Harper. Thank you, Dr. Bright.
    The chair will now recognize Dr. Anne Schuchat for 5 
minutes. Welcome.

                TESTIMONY OF ANNE SCHUCHAT, M.D.

    Dr. Schuchat. Thank you.
    Chairman Harper, Ranking Member DeGette, and members of the 
subcommittee, thank you so much for the opportunity to testify 
before you today to describe CDC's role in preparing, 
detecting, and responding to biological attacks, pandemics, and 
emerging infectious disease outbreaks.
    Today I'll highlight CDC's role in protecting the Nation 
against health threats. I'll describe our role in three areas: 
preparedness, detection, and response.
    The three themes I'd like you to take away are, first, the 
work CDC does every day in public health lays the foundation 
for responding to emergencies. Second, the CDC's world-class 
scientific and medical expertise ensures we're ready to respond 
to any threat. And third, our longstanding connection to State 
and local health departments ensures that public health systems 
function effectively, both day-to-day and during emergency 
response.
    Let me first address how we prepare for emergencies. CDC 
works every day with State and local health departments. In 
fact, we have 590 staff assigned to State and local health 
departments. We fund the Public Health Emergency Preparedness 
Cooperative Agreement Program and the Cities Readiness 
Initiative.
    Public Health Emergency Preparedness grants go to every 
State, eight territories, and four cities. These funds support 
staff, enable exercises to test and validate capabilities, and 
pay for laboratory and communications equipment.
    The Cities Readiness Initiative funds this nation's 72 
largest cities, to develop and test plans to receive and 
dispense medical countermeasures from the Strategic National 
Stockpile.
    CDC expertise helps assure protection of vulnerable 
populations against diverse threats. For example, CDC worked 
with the American Academy of Pediatrics, the FDA, and other 
stakeholders to address gaps in existing countermeasures for 
anthrax in children, taking advantage of the agency's 
scientific and clinical expertise and longstanding 
relationships with AAP.
    Turning now to detecting threats. The CDC's lab and 
surveillance systems are able to detect and identify agents 
causing illness, ranging from infectious agents to chemical or 
radiation exposures. Every year, labs from all over the world 
send specimens to CDC, because they know we'll be able to 
identify pathogens that other laboratories cannot.
    Rapid identification of disease permits intervention before 
a health threat becomes a crisis. CDC's Laboratory Response 
Network maintains an integrated, scaleable, and flexible system 
of 125 Federal, State, and local laboratories. The development 
of this laboratory network established in 1999 has provided a 
larger capacity to test and report more quickly than was 
previously possible. For example, during the Zika virus 
outbreak response, CDC and our Laboratory Response laboratories 
processed over 207,000 specimens just for Zika.
    Now I'll turn to response. When there's a crisis, CDC 
responds. We're able to rapidly deploy scientific and medical 
experts anywhere in the world. By the end of the 21-month Ebola 
response, 3,700 CDC staff had shifted from their day-to-day 
duties to assist with the response. 1,500 of our staff deployed 
to West Africa, making over 2,000 trips. Today, we're 
responding to a much smaller Ebola outbreak in the Democratic 
Republic of Congo.
    During health emergencies, CDC communicates. For example, 
during the 2009 H1N1 response, CDC held 39 full press 
conferences and 21 telebriefings. During the Zika response, CDC 
published 51 morbidity and mortality weekly report articles to 
make sure the public health and healthcare professionals had 
the latest and best information.
    Being able to prepare, detect, and respond to public health 
threats is a top priority for us at CDC. Our preparedness and 
response capabilities are built on broad and deep scientific, 
medical, and program expertise. Our longstanding partnerships 
with State and local public health authorities ensures an 
integrated approach wherever that approach is needed, resulting 
in better responses and better public health outcomes, which 
translate to better protection of the people we serve.
    Thank you, and I'll be happy to answer questions.
    [The prepared statement of Dr. Schuchat follows:]
    
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    Mr. Harper. Thank you, Dr. Schuchat.
    The chair will now recognize Dr. Fauci for 5 minutes for 
your opening statement.

                TESTIMONY OF ANTHONY FAUCI, M.D.

    Dr. Fauci. Thank you very much, Mr. Chairman.
    Chairman Harper, Ranking Minority DeGette, members of the 
committee, thank you very much for giving me the opportunity 
today to present to you the role of the National Institute of 
Allergy and Infectious Diseases in addressing biodefense and 
emerging infectious diseases.
    Our role in this really dates back many years, but was 
really solidified following the attacks of 9/11 with the 
anthrax attacks, which prompted us, together with our 
colleagues at HHS, to develop a strategic plan and a research 
agenda. For our role in that, as you know, the NIH for years, 
with regard to any emerging infectious disease, is involved in 
having a number of approaches, stemming from basic and clinical 
research, research resources for both industry and academic 
communities, with the ultimate goal of developing vaccines, 
therapeutics, and diagnostics.
    We have been in a very strong partnership with BARDA in 
developing the concepts for interventions, which were then 
handed over to them for advanced development.
    This slide just shows a representative example of some key 
achievements directed specifically at the category A agents 
that were in our strategic plan. Very briefly, for example, a 
better smallpox vaccine, next-generation vaccines for anthrax, 
antitoxins for botulism, antibiotics for plague, and, 
interestingly, the development of an Ebola vaccine, which long 
antedated the outbreak that we experienced in West Africa in 
2014.
    Having said that, it is important to point out, as we have 
in the past and as shown in this interesting article from 
Newsday of 2001, the worst bioterrorist may actually be nature 
itself.
    It is interesting to point out, Mr. Chairman, that I have 
been testifying before this committee for the last 33 years. 
The first time I did, I drew a map, and it's shown here. And 
the reason I drew the map is I wanted to point out that there 
would be emerging and reemerging infectious diseases. And the 
first time I testified before this committee, I put HIV on the 
map as shown there.
    Today, the map is the same structurally, but this is what 
it looks like. And these are the emerging and reemerging 
infectious diseases. Many of them, many of them are curiosities 
and are not really of great public health impact, but others 
are really important and we've experienced them recently, such 
as Ebola, Zika, and the threat of a pandemic influenza.
    Now, let's take one of these, Ebola. You mentioned in your 
opening statement, as others have, about the West Africa 
outbreak and the recent outbreak in the Democratic Republic of 
the Congo. It's important that the CDC, the NIH, and other 
agencies of the Public Health Service responded very rapidly 
there.
    One thing that was proven that's important is that you can 
do good research in the context of an outbreak. And we 
developed, with others, a vaccine, which is called the VSV 
vaccine, which was first tried in a Phase I trial right in 
Bethesda at the NIH Clinical Center, and then went over to 
Africa in a Phase II trial. This is the vaccine that was used 
in the ring vaccination program that was actually involved in 
the West Africa outbreak.
    If you then fast forward a couple of years to where we are 
today, with the outbreak in the Democratic Republic of the 
Congo, we have actually learned a lot and are applying what we 
learned to that. Let me give you an example. The experimental 
vaccine that was used in the ring vaccination program has now 
been deployed to the Democratic Republic of Congo, and even as 
we speak today, it is being used in a ring vaccination with 50 
rings and 150 vaccinations per ring.
    Interestingly, and as I mentioned before we came, that in 
1995, there was an outbreak in Kikwit in the Democratic 
Republic of the Congo. To just show you the connection between 
clinical care and research, we brought one of the survivors of 
Kikwit to Bethesda, took their B cells, cloned it, made a 
monoclonal antibody. And now the Democratic Republic of the 
Congo has asked us to ship that to them for their discretion 
use as a countermeasure in the epidemic. So it came full circle 
that our collaboration with them came back with something that 
perhaps could help them.
    I want to close in the last couple of seconds with 
influenza. I wrote this article just a few months ago, talking 
about the need for a universal flu vaccine. And, in fact, we 
have developed a strategic plan and a research agenda because 
of the threat, not only of getting a better seasonal flu 
vaccine, but also a threat of a pandemic. And we could only do 
that with a vaccine that essentially is able to protect us 
against all subtypes of influenza.
    And I'll close on this last slide--this is not working very 
well, sorry--which is an article that I actually wrote 17 years 
ago, but it's very relevant today. And what it says is that 
emerging infections are a perpetual challenge. We've always had 
them, we have them now, and we always will have them. So if 
they are a perpetual challenge and a perpetual risk, we must 
meet them with perpetual readiness and, hopefully, we'll be 
able to do that.
    Thank you.
    [The prepared statement of Dr. Fauci follows:]
    
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    Mr. Harper. Thank you very much.
    We now have the privilege of hearing from Rear Admiral 
Denise Hinton.
    Admiral Hinton, you are recognized for 5 minutes.

            TESTIMONY OF REAR ADMIRAL DENISE HINTON

    Admiral Hinton. Thank you.
    Chairman Harper, Ranking Member DeGette, and members of the 
committee, thank you for the opportunity to appear today to 
discuss the state of biopreparedness.
    Medical and public health preparedness and response is 
critically important to the health and security of our nation. 
And I am pleased to be here today to discuss how FDA is working 
towards the shared goal of making sure that we have the medical 
products necessary to protect our nation from a range of public 
health threats, whether naturally occurring, accidental, or 
deliberate.
    The outbreak of Ebola virus disease in the Democratic 
Republic of the Congo serves as a reminder that biological 
threats can and often do emerge with little to no warning and 
can rapidly become global challenges. I can assure you that FDA 
is dedicated to helping end this outbreak as quickly as 
possible, as we are actively engaged in supporting 
international response efforts.
    FDA plays a critical role in facilitating preparedness for 
and response to biological threats. Our role focuses largely on 
facilitating the development and availability of medical 
countermeasures, or MCMs, such as vaccines, therapeutics, and 
diagnostic tests to protect against and respond to these 
threats.
    Toward that end, we work closely with our HHS partners 
testifying here with me today as well as other U.S. Government 
partners, product developers, and nongovernmental organizations 
to facilitate the development and availability of MCMs. FDA 
also works closely with the Department of Defense to facilitate 
the development and availability of MCMs to support the needs 
of our nation's military personnel.
    Prior to joining FDA and the U.S. Public Health Service 
Commissioned Corps, I proudly served as an officer in the 
United States Air Force. So these efforts are near and dear to 
me, and we are fully committed to closely working with our 
colleagues at the DOD to support the unique needs of the U.S. 
military personnel.
    At FDA, we have made it a priority to utilize our 
authorities to proactively work with our private sector and 
government partners to help facilitate the translation of 
discoveries in science and technology into safe and effective 
MCMs as part of advancing public health and strengthening our 
national security.
    We share Congress' goal of having safe and effective MCMs 
available in the event that they are needed, and we have made 
significant progress toward this important goal. For example, 
since 2012, FDA has approved, licensed, or cleared more than 
120 MCMs, including supplemental changes to already approved 
products and modifications to diagnostic devices for a diverse 
array of threats, including anthrax, botulinum toxin, plague, 
smallpox, and pandemic influenza.
    We have also issued more than 60 emergency use 
authorizations since 2005 to enable access to products to 
respond to threats, including for Zika virus, Ebola virus, H7N9 
influenza virus, and the Middle East Respiratory Syndrome 
Coronavirus.
    While the close collaboration and coordination among the 
agencies represented here today has achieved many successes in 
the development of MCMs, I would emphasize that developing MCMs 
is highly complex and there remain regulatory science gaps that 
can challenge development programs, such as a lack of models 
and biomarkers to enable the extrapolation of data generated in 
animal models to humans. Without such tools, it is difficult to 
generate the data necessary to support regulatory 
decisionmaking.
    Addressing these regulatory science gaps remains a high 
priority for the FDA, and we have established a broad and 
robust portfolio of cutting-edge research under our MCMs 
Initiative regulatory science program to develop these tools 
and to promote innovation in the development of MCMs.
    FDA is acutely aware that biothreats can emerge from an 
accidental release or exposure to threat agents during the 
course of conducting research. As such, we are working to 
ensure that our laboratories and workplaces are operated in a 
safe and secure manner to protect employees, the surrounding 
communities, and the environment. As the FDA's chief scientist, 
I can assure you that the laboratory safety is a high priority 
for me and the agency.
    FDA remains deeply committed to working closely with its 
partners and fully using the authorities Congress provides to 
help facilitate and accelerate the development and availability 
of safe and effective medical countermeasures. While we have 
made significant progress, we know that more work remains to be 
done. We look forward to partnering with Congress and 
stakeholders as we work together to further enhance 
biopreparedness.
    Thank you for inviting me to testify today. I look forward 
to answering any questions you may have.
    [The prepared statement of Admiral Hinton follows:]
    
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    Mr. Harper. Thank you very much.
    I ask unanimous consent that the contents of the document 
binder be introduced into the record and to authorize staff to 
make any appropriate redactions. Without objection, the 
documents will be entered into the record with any redactions 
that staff determines are appropriate.
    It is now time for members to have the opportunity to ask 
you questions, and I will recognize myself for 5 minutes.
    Let me begin by saying that in my 10 years of service in 
Congress, I don't know if I've ever been at a committee hearing 
with a better lineup of witnesses. And so thank you all for 
being here. We look forward to your responses today.
    And this is a question that will go rather quickly for all 
of you. And for each witness, which biological threat is of 
greatest concern to you and why? Let's start with Dr. Bright 
and then go down.
    Mr. Bright. That's a difficult question. As Dr. Fauci has 
laid out, there are so many threats. They're constantly 
emerging. And I wish I could take some of them off the table, 
but they keep coming at us. And even more concerning is 
technology advancing so much that they can change the 
biological threats that we know today into something different 
that we may not be prepared for.
    I think our greatest threat for any of those is our 
response capabilities and being able to respond to anything 
that comes our way.
    Mr. Harper. Dr. Schuchat, is there one biological threat 
that is at the top of your list? I know they're all important, 
but is there one that gives you the greatest concern?
    Dr. Schuchat. I think influenza needs to be at the top of 
my list. It can affect everyone rapidly and is constantly 
changing. And with pandemics, all of the population of the 
world can be susceptible. So the threat of a pandemic has to be 
at the top of the list, because it can all happen fast.
    Mr. Harper. Dr. Fauci.
    Dr. Fauci. My number one and maybe number two and number 
three is influenza also. I agree, for the reasons that Dr. 
Schuchat has mentioned.
    When you have a respiratory virus that can be spread by 
droplets and aerosol, and then you have the situation if 
there's a degree of morbidity associated with that, you can 
have a catastrophe. We've experienced in real world those types 
of things. The one that we always talk about is the 1918 
pandemic which killed between 50 and 100 million people.
    It is likely that it would be an influenza, but if not 
influenza, an influenza-like respiratory virus. We had a scare 
with SARS. Fortunately, public health measures were able to 
contain it, but influenza first or something like influenza is 
the one that keeps me up at night.
    Mr. Harper. Admiral Hinton.
    Admiral Hinton. Thank you for the question. I would say the 
threat that would keep me up at night would be the unknown. If 
we don't know what that threat may be, we have to be able to 
anticipate. So with the emerging spectrum of diseases, it would 
be the unknown that would keep me up at night.
    Mr. Harper. Thank you.
    For each witness, what area of biopreparedness is of the 
highest priority and why? Dr. Bright.
    Mr. Bright. The area of biopreparedness of the highest 
priority would be the ability to rapidly detect something that 
has entered our community or has been used as a weapon. The 
sooner we detect something, the sooner we can turn on the 
machinery and call in the capabilities to begin making vaccines 
and drugs.
    Mr. Harper. Dr. Schuchat.
    Dr. Schuchat. I would say our global health security would 
be at the top of my list, because, as you know, a threat 
anywhere is a threat everywhere. And I think our greatest 
vulnerabilities are in the weakest countries of the world.
    We saw in Ebola how rapidly West African countries were 
overwhelmed, and that was an issue for us as well. So I think 
being able to strengthen the ability of every country to be 
able to prevent, detect, and respond to threats is where I'd 
place my focus.
    Mr. Harper. Dr. Fauci.
    Dr. Fauci. I would agree with those two. But let me add an 
additional one that may not necessarily be my first, is in our 
ability to respond, for example, with a vaccine, the modern day 
21st century technologies of platform technology, where you 
don't have to wait 6 to 7 months to get a vaccine, where you 
can really get it out there within a period of a couple of 
months, which is doable if we put our mind and our resources to 
it.
    Mr. Harper. Thank you.
    Admiral Hinton.
    Admiral Hinton. Our continued efforts in the Ebola, and 
then making sure that we contain it within the specific regions 
and not letting it cross the borders.
    Mr. Harper. Thank you.
    Dr. Bright, if I could ask you, obviously, the need to 
rapidly respond to a biological threat is essential. Does the 
public health system have the capability to deliver and 
administer medical countermeasures rapidly and effectively in a 
timely manner as you sit there today?
    Mr. Bright. As we sit here today, we are much better and 
can respond much more quickly than we were in the past 10 
years. We've built a national response capability and an 
international capability incorporating new sciences and 
technologies. There is a lot of room for improvement. It still 
takes too long to respond to respond adequately to protect 
everyone in our nation.
    Mr. Harper. Thank you very much.
    I will now recognize the ranking member, Ms. DeGette, for 5 
minutes for her questions.
    Ms. DeGette. Thank you very much.
    Well, building on the question by the chairman just now, 
Dr. Bright, what changes do we need to make to make the system 
for developing countermeasures work more effectively and 
efficiently? ASPR has been a good start, but, you know, where 
do we need to go?
    Mr. Bright. Well, given the 12 years' experience with ASPR 
and the enterprise, working across government and working with 
our public-private partnerships, we've learned a lot in the 
past 12 years. Not everything is working as effectively or 
efficiently----
    Ms. DeGette. So what do we need to do?
    Mr. Bright. We need to improve our communications and our 
transparency and how we bridge our different agencies and 
bridge government with industry. We need to ensure there's 
consistency in funding and availability so the partners that we 
work with can better align their business models with our 
government models as well. And we need to improve the 
efficiency at which we communicate and respond to proposals and 
other contractual mechanisms that we use to work with our 
industry partners.
    Ms. DeGette. Are efforts underway being made to do all of 
those things?
    Mr. Bright. Yes, efforts are underway.
    Ms. DeGette. And is there something Congress can do to help 
you?
    Mr. Bright. Congress has been very generous with the 
authorities to date. There are things that we can do to improve 
our language in our other transactional authorities to be able 
to work more fluidly and flexibly with our industry partners, 
and we would be happy to submit language to assist in that.
    Ms. DeGette. We would be delighted to have that language. 
That would really help.
    Dr. Fauci, none of these hearings can go without me asking 
you about what's going on with pandemic flu. And you had said 
that we are getting closer to being able to develop a universal 
vaccine. And you've said that before, because you've been 
trying to do it for a long time.
    What does your timeframe look like now and what are the 
barriers?
    Dr. Fauci. Congresswoman DeGette, the timeframe really 
varies about the level that you're talking about. There's not 
going to be one home run universal flu vaccine. There will be 
various iterations.
    So I would say the timeframe. And I know every time when 
asked about a timeframe, people back off, and I don't want to 
get in court to be able to say something that's not going to be 
able to deliver. But since we spoke last, we have put into a 
Phase 2 trial a universal flu vaccine with a company called 
BiondVax, which is a multiple peptide prime followed by a 
killed vaccine boost.
    Being in a Phase 2 trial means that you're another step 
closer to getting a product that you'll be able to use.
    Ms. DeGette. Right.
    Dr. Fauci. So I would think that if you----
    Ms. DeGette. How long is this trial going on for?
    Dr. Fauci. The trial will probably take--it's a Phase 2 
trial, so that probably is going to take at least a year to 
determine if this induces the kind of response that you would 
predict would have some broad protection.
    The first iteration of a universal flu vaccine is not going 
to be against all flu, absolutely. What we're hoping for is 
that the first iteration will cover, for example, all of a 
particular type, like all of the H3N2s. If we get that 
successful, then maybe all of the H1N1s.
    There are two major groups of influenzas. The ultimate 
perfect one would be one that covers all of them. I think 
that's years and years and years away, but the first iteration 
may be 5 or so years away.
    Ms. DeGette. And I'll ask you the same question I asked Dr. 
Bright. What can Congress do to help you?
    Dr. Fauci. I think Congress has been extraordinary in their 
positive effect on us in helping us. For example, in the 2018 
omnibus, we were given an additional $40 million to develop a 
universal flu vaccine, and we're getting additional money in 
the proposal of the House for our 2019 budget. So you've been 
very supportive and we really appreciate it.
    Ms. DeGette. We think it's a high priority. I think I can 
speak for everybody in this room.
    One more question. You're developing lots of different 
vaccines: smallpox, flu, anthrax, Ebola. How do you prioritize 
your efforts to target the pathogens and toxins that provide 
the greatest risk?
    Dr. Fauci. That's a very good question. We do two things, 
Congressman. We target specific pathogens based on the threat. 
If you're talking about a bioterror threat, it's the 
intelligence that we get. And if you're talking about the 
possibility of an emerging infection, it's very difficult to 
guess what's going to come out.
    Ms. DeGette. Right.
    Dr. Fauci. So we know, and it was mentioned in one of the 
opening statements, that H7N9, for example, if you look at the 
CDC chart, it's way up there as a threat. So we clearly made an 
investment of a considerable amount of money to develop a 
vaccine for that.
    But as I mentioned in answer to one of the other questions, 
it's to develop platform technologies that's applicable to any 
disease, as opposed to picking out all the diseases and 
preemptively making a vaccine. In other words, making a kind of 
a vaccine that you could easily apply to whatever is the 
outbreak.
    Ms. DeGette. Thank you. Thank you, Mr. Chairman.
    Mr. Harper. The gentlewoman yields back.
    The chair will now recognize Dr. Burgess for 5 minutes.
    Mr. Burgess. Thank you, Mr. Chairman, and thanks to our 
panel for being here today.
    Dr. Fauci, I wasn't going to do it, but you brought it up. 
And you said sometimes you'll give a timeframe, and then if it 
doesn't work out, then people will point that out to you. A 
couple of years ago, I think you gave us an 18-month figure on 
a Zika virus vaccine. How close are we today?
    Dr. Fauci. Thank you for that question. So when you're 
proving that a vaccine works or not, in the classical way, you 
have to get what's called an efficacy signal. There has to be 
infections in the community to get an efficacy signal.
    Right now, thankfully for the countries involved, the Zika 
infections have plummeted almost to very, very few. However, 
the Phase IIb trial that I spoke to you about some months ago 
is still ongoing, and it's accruing volunteers in the study. So 
there's an interesting possibility here.
    Let's say there are not enough Zika cases to be able to get 
an efficacy signal. We have been in discussions, with a lot of 
help from the FDA, about the possibility that if we get a 
considerable amount, and I say thousands of volunteers with 
safety data, immunogenicity data, namely inducing the kind of 
response that you would predict would be protective, and you 
bridge it to the animal studies, there's a possibility that 
they would at least consider that there would be an accelerated 
approval. You never can guarantee anything, but that's at least 
on the table.
    So my short answer to your question, Congressman Burgess, 
is that we are on the road to getting a Zika vaccine, and I 
feel pretty confident about that.
    Mr. Burgess. And from the FDA's perspective, that expedited 
approval that was talked about, is that something we can look 
for?
    Dr. Fauci. Well, I'll let the FDA speak for themselves, but 
you never want to anticipate what they're going to do. You can 
just give them the data and the information that they ask for, 
but----
    Mr. Burgess. I may submit that in writing, because I do 
want to ask you about another--on the golly gee whiz slide that 
you put up with all of the things that can happen to us, 
enterovirus D68 was included on that list.
    Dr. Fauci. Yes.
    Mr. Burgess. And CDC has put out a paper on acute flaccid 
myelitis and the incidence of that. And I recognize that it's 
low, but it does seem to peak every other August. So as we are 
coming up on one of those every other Augusts, do we know any 
more about this illness and why it has had the effect that it 
has?
    Dr. Schuchat. Yes. The outbreak of severe respiratory 
disease in children from the enterovirus D68 a few years ago 
was of concern. It was contemporary with the outbreak of acute 
flaccid myelitis. Very difficult to confirm that one caused the 
other, but there's a good probability that they did.
    The family of enteroviruses are known to be able to cause 
neuropathic problems. And when you have a very common set of 
infections, it could be that that was a real rare end of the 
spectrum among the common ones.
    So I think we do need to be ready for that. Unfortunately, 
there are so many different enteroviruses that it's very 
difficult to pick one that you would necessarily focus on for 
countermeasure development. There's some work on antivirals 
that might be promising as having a broader protection, but 
that's the state of it right now.
    Mr. Burgess. As you'll recall, fairly frightening when that 
did occur, the concern we heard from parents.
    Dr. Schuchat. Exactly. It was happening the same time as 
Ebola in Africa. When the President visited CDC, he was briefed 
on Ebola and on enterovirus D68.
    Mr. Burgess. Admiral Hinton, let me ask you. When Ebola was 
really a much more significant problem, September of 2014, the 
monoclonal antibody ZMapp was in trials, and then FDA put a 
clinical hold on it. My understanding at the time, there was a 
Herxheimer-type reaction that was fairly severe and so we 
stopped looking at it.
    Is there a way--when we've got a problem of that order of 
magnitude going on, I guess I want some reassurance that the 
regulatory side is not going to interfere with the delivery of 
what may be a very potent tool, because several people have 
mentioned ZMapp. I mean, it's now a recognized tool in the 
toolbox. Is that correct?
    Admiral Hinton. That's correct. And Dr. Fauci can please 
feel free to add in, but that is correct. And the FDA is not 
there to be a roadblock; it's to ensure that the drugs are safe 
and efficacious. So the reasons behind that may not be privy to 
us, but we do make sure that we have safe and effective 
available drugs on the market to treat these and in emergency 
situations as well.
    Dr. Fauci.
    Dr. Fauci. So ZMapp was part of a randomized controlled 
trial that was run by the NIH. It was published in The New 
England Journal of Medicine. The results, because of the 
diminution of cases at the time, were very strongly suggestive 
of efficacy, but not enough to be statistically significant. So 
the trial is technically still on. And right now, in DRC, they 
could use ZMapp either on a trial or, if they want, as 
compassionate use. But it is available.
    Mr. Burgess. It is available. Thank you all very much. 
Thanks for your testimony this morning.
    Mr. Harper. The gentleman yields back, who also serves as 
the chair of our Health Subcommittee.
    Mr. Burgess. Mr. Chairman, I'm also going to ask unanimous 
consent to place into the record the report of the Independent 
Panel of the United States Department of Health and Human 
Services to the Ebola response from 2015.
    Mr. Harper. Without objection, so entered.
    [The information has been retained in committee files and 
can be found at https://docs.house.gov/meetings/IF/IF02/
20180615/108422/HHRG-115-IF02-20180615-SD003.pdf.]
    Mr. Harper. The chair now recognizes the gentlewoman from 
Illinois, Ms. Schakowsky, for 5 minutes.
    Ms. Schakowsky. Thank you, Mr. Chairman. I want to agree 
with you, Mr. Chairman, that this is an extraordinary panel.
    Dr. Fauci, 33 years before this committee, that's a long 
time, and we appreciate you every time we see you.
    I also want Dr.--I looked this up. Dr. Schuchat, it looks 
like you're about 28 years. Is it more than that? How many?
    Dr. Schuchat. It's 30 in July.
    Ms. Schakowsky. OK, 30 in July. And such experience in all 
of you. It's just really remarkable. I thank all of you for 
being here today.
    I'm particularly concerned about the improper and overuse 
of antibiotics that's driving the growth of antibiotic 
resistance around the world. I noticed, Dr. Fauci, in your new 
map with all the lines, right at the top was antibiotic 
resistance on the left there.
    I feel an obligation to raise this issue too for my sister 
and colleague, the late Louise Slaughter, who was always 
raising this issue. In the United States, somewhere between 20 
and 50 percent of all antibiotic prescriptions in hospitals are 
either unnecessary or inappropriate. Evidence suggests that 
antibiotic stewardship programs in hospitals can improve 
prescribing practices and help reduce the occurrence of 
antibiotic resistance.
    So I'm interested in hearing more from our witnesses on 
this program. Whoever wants to go first. Dr. Schuchat.
    Dr. Schuchat. Yes. The problem with antimicrobial 
resistance is a transformational challenge for us because it 
obviously threatens modern medicine. CDC has been investing in 
efforts to improve stewardship of antibiotics, and at this 
point, by our latest data, two out of three hospitals had an 
antibiotic stewardship program, which is a big increase from 
before. But we think that there's much more to be done.
    In addition, we have 850 hospitals around the country are 
reporting on their antibiotic use data to the National 
Healthcare Safety Network. So we're tracking data.
    What we find in the healthcare system is when you track 
antibiotic use and feed back to clinicians how they're doing, 
they can improve. A lot of clinicians are test takers, and we 
like to do really well on those tests. And so learning that 
we're not doing as well as our peers in terms of the 
appropriateness of our prescribing can help improve that.
    We're also tracking resistance. And we've really invested, 
thanks to the congressional support, we've been able to invest 
in much better timely, accurate, quality antimicrobial 
resistance detection around the Nation. It's where we got those 
nightmare bacteria reports that we came out with recently.
    So I would say that behavior change in clinicians is 
difficult, but we're making progress. And a stewardship program 
in every hospital is a good start, but it takes more than the 
hospital to make that happen. We need the whole plans, the 
outpatient prescribers as well, to be part of the system.
    Ms. Schakowsky. But you're saying that we do have a 
tracking system now for clinicians, for hospitals?
    Dr. Schuchat. Right. In our National Healthcare Safety 
Network, I'm told that 850 hospitals are already reporting to 
us on their antibiotic use. It includes 80 VA hospitals and 30 
military hospitals. And they're having that be part of their--
it's voluntary, but it's part of their ability to monitor 
what's going on in their own institution and then look across 
institutions.
    Ms. Schakowsky. What percentage of hospitals does that 
represent, do you know?
    Dr. Schuchat. I don't actually have that information, but 
we could get that for you.
    Ms. Schakowsky. OK. Has the CDC identified any obstacles to 
successfully implementing stewardship programs? If so, how are 
you addressing those?
    Dr. Schuchat. I would say that incorporating the outpatient 
facilities in the stewardship is important. We also found that 
rural areas, critical areas, we're challenged in being able to 
do all the things that we recommend in terms of antibiotic 
stewardship.
    Our program convened a batch of the rural or critical area 
hospital stewardship leads, who had figured out ways to make a 
difference, and we're working with them to share their best 
practices more broadly. So I would say that large hospitals are 
really on the case now, and helping the smaller facilities get 
up to speed is important.
    Ms. Schakowsky. Thank you. In the remaining seconds, does 
anybody else----
    Dr. Fauci. Yes. How we address antibiotic resistance is 
really governmentwide, and it's a program called CARB, 
Combating Antibiotic-Resistant Bacteria, that was established 
years ago, a few years ago, that involves what Dr. Schuchat had 
mentioned regarding the CDC. It involves the FDA research 
component from the NIH to develop new drugs to understand the 
mechanisms of resistance to harness the immune system, but also 
an organization called CARB-X, which BARDA has a major role in.
    So maybe, Rick, you want to just mention that briefly.
    Mr. Bright. Very briefly. So since 2010, BARDA has invested 
over a billion dollars in addressing the development of new 
antibiotics to address antimicrobial resistance. We have, just 
in the last year, had the first antibiotic drug licensed in our 
program. We have several more in Phase 2 and Phase 3.
    We also realized that the early stage pipeline was not 
sufficient to have a stream of new candidates going into 
advanced stage development. So we did launch a public-private 
partnership called CARB-X, in collaboration with NIAID, also 
sponsored by Wellcome Trust, now Bill and Melinda Gates 
Foundation in the U.K. Government. So we have now funded 34 
different novel technologies to address new mechanisms of 
action for new antibiotics and vaccines.
    Ms. Schakowsky. Thank you. My time is up, but I hope that 
in addition to development, that we're looking at prevention 
here as well.
    Thank you for your courtesy, Mr. Chairman. Thank you.
    Mr. Harper. Thank you. The gentlewoman yields back.
    The chair will now recognize the chair of the House Ethics 
Committee and a valuable member of this subcommittee, the 
gentlewoman from Indiana, Mrs. Brooks, for 5 minutes.
    Mrs. Brooks. Thank you, Mr. Chairman.
    Dr. Schuchat, and if, Rear Admiral Hinton, if you could 
pass that binder, please, over to Dr. Schuchat. The last page 
of that binder has a chart that I would like to enter into the 
record and ask unanimous consent to enter into the record. It's 
PHEMCE's budget report for fiscal year 2016-2020.
    Mr. Harper. Without objection.
    [The information appears at the conclusion of the hearing.]
    Mrs. Brooks. A large percentage of the CDC's Strategic 
National Stockpile budget appears to not go to procuring and 
updating medical countermeasures for the stockpile, but 
instead, goes to a category entitled nonprocurement costs. And 
in an effort to inform the discussion today, committee staff 
did ask CDC to provide a breakdown for what is in this 
nonprocurement, but we never got it.
    Can you please share with us very briefly, and you might 
need to supplement with written response, what makes up the 
nonprocurement spending for the Strategic National Stockpile?
    Dr. Schuchat. Thanks so much for your question. As you 
know, the Strategic National Stockpile has an inventory of 
about $7 billion. So the annual appropriation is just a piece 
of that. Most of the dollars that are in the nonprocurement go 
for sustaining and operating. So that would be the rental 
space, the security for the warehouses, the staff that work, 
the salaries for the staff, as well as the clinical expertise 
that's helping with the guidance on how to use the product.
    Mrs. Brooks. Thank you. Could we get a written breakdown of 
what that is?
    Dr. Schuchat. Absolutely.
    Mrs. Brooks. Because we could not tell what that was.
    Dr. Schuchat. That should be on its way to you.
    Mrs. Brooks. Thank you very much.
    Dr. Bright, last year, HHS OIG issued a report after 
conducting five site audits at the various Strategic National 
Stockpile locations over a 2-year period, and they talked about 
systemic issues, putting that $7 billion that was just 
mentioned into great concern.
    So, Dr. Bright, what actions does ASPR plan to take in the 
transfer that is anticipated October 1 to ensure the Strategic 
National Stockpile assets will be available in case of public 
health emergencies?
    Mr. Bright. As you probably know, we have several working 
groups working very closely between CDC and ASPR to evaluate 
various components of the stockpile transfer. So we are still--
--
    Mrs. Brooks. Can I interrupt one second? We just heard, in 
her opening testimony, Dr. Schuchat talk about all the many 
things CDC does relative to public health and these 
emergencies. And so are you going through all of those things 
to make sure there is coordination? And is that what the 
working groups are actually doing, figuring out what part CDC 
is going to maintain and what part ASPR will have? Is that what 
the working groups are doing?
    Mr. Bright. Absolutely. There's five different working 
groups. They're meeting weekly actually, and some of them have 
daily communications, to understand the various components, 
understanding how we maintain and sustain the best science and 
expertise that's currently in the SNS, understanding how we're 
building and augmenting the relationship with States and locals 
to ensure that that is also maintained for a robust SNS 
enterprise. We're also looking at the contracting and the 
financing. We're looking at the nonprocurement cost as well.
    We assure you that we are doing everything we can to make 
sure that those nonprocurement costs are supporting the SNS and 
its mission.
    Mrs. Brooks. I have a question with respect to--I 
understand there have been instances where BARDA--and you 
mentioned it--had to use Project BioShield funds to procure 
FDA-approved clinical countermeasures or medical 
countermeasures, because, for whatever reason, CDC declined to 
procure those countermeasures for the stockpile.
    How does that uncertainty affect BARDA's ability to partner 
with industry, and is that being addressed in your working 
groups?
    Mr. Bright. That uncertainty is critical. As you know, it's 
very difficult to make these countermeasures. It's very 
lengthy, very risky, and the companies put aside other very 
profitable and successful endeavors to work with us in these 
areas. That marketplace assurance is absolutely essential to 
them working with us.
    So we realize that, as we've been more successful with our 
partners and making additional countermeasures, it has created 
an additional burden on the SNS. We are working with the SNS at 
the CDC and our internal staff now to make sure that we are 
able to address those lapses or those gaps in communication or 
transparency to make sure that we have a successful----
    Mrs. Brooks. Thank you. I'd also like to enter into the 
record a letter from the Blue Ribbon Study Panel on Biodefense 
that was sent to Dr. Kadlec with a very detailed seven 
recommendations to improve our biodefense posture.
    Mr. Harper. Without objection.
    [The information appears at the conclusion of the hearing.]
    Mrs. Brooks. And among those was the need to improve the 
coordination with State and local partners and to address 
problems that have existed in the past.
    Can you tell us how ASPR plans to engage with State and 
local partners once it assumes control of the stockpile, which 
is of great concern to State and local partners?
    Mr. Bright. I agree that it is an essential part of an 
effective enterprise, the end-to-end approach, from early 
detection down to distribution. The State and local and tribal 
and territorial partners are the front line. They are the ones 
who are distributing and administering the vaccines and 
treatments. So we are dedicated to working with them, making 
sure they have a voice in the structure, in our system, to 
understand how they need those medical countermeasures and how 
they need them to be delivered most effectively.
    It doesn't do us any good to make new drugs and vaccines if 
they're not suitable for our frontline workers at the State and 
local and tribal and territories to deliver and administer 
those.
    Mrs. Brooks. And so they know how to deliver and 
administer.
    Mr. Bright. Absolutely.
    Mrs. Brooks. Thank you. With that, I yield back. Thank you 
for your time.
    Mr. Harper. The gentlewoman yields back.
    The chair will now recognize the gentlewoman from Florida, 
Ms. Castor, for 5 minutes.
    Ms. Castor. Thank you, Mr. Chairman.
    Good morning. Last year, Florida recorded 262 known cases 
of Zika. They were overwhelmingly travel-related cases, but of 
those known cases, 136 were pregnant women, and three babies 
were born in Florida with congenital Zika syndrome. Thankfully, 
those statistics are down substantially from 2015 and 2016, but 
the threat to young women of childbearing years and families 
remains very serious.
    A study was just published where researchers from the CDC 
and the Annenberg Public Policy Center determined that most 
people have let their guard down now, that they're not taking 
the precautions that they should when it comes to Zika.
    So, Dr. Schuchat, now that you have the results of that 
study and the threat of congenital Zika syndrome remains very 
serious, what do you plan to do to help keep families informed 
and make sure they're taking all precautions?
    Dr. Schuchat. Thank you. Zika was such a devastating new 
problem to have. For a mosquito bite to be able to cause birth 
defects, not something that was on any of our radars, really.
    I think you know that, in May, we issued one of our monthly 
high-visibility reports of vital signs on mosquito and tick-
borne diseases, which have really been increasing, trying to 
get that word out in advance of the mosquito season so people 
would take these threats seriously.
    We have another report that's focused on Zika that will be 
coming out in about 2 months, really highlighting what have we 
learned from the, unfortunately, thousands of pregnancies that 
were complicated by Zika in folks who reside in the 50 States, 
to show what the followups have been and what has happened to 
the babies as they develop.
    We need to make mosquito protection much easier for 
individuals and we need to have better tools for countering 
mosquitoes, in terms of environmentally safe and acceptable 
tools for them. We have been appreciative of the investments in 
strengthening our vector control so that there's better 
surveillance for vector-borne disease, and also better 
understanding of resistance patterns so we have the right 
products that can be used.
    Ms. Castor. And there must be more we can do to communicate 
to young women and young men, especially now that--I mean, it 
was very strange that Zika became transferable via sex as well. 
So----
    Dr. Schuchat. Yes. The signs are still up in the airports, 
but people turn them off. So I think continuing to raise 
concerns is a challenge when people become complacent. So it's 
sort of our perpetual challenge in prevention.
    Ms. Castor. Thank you.
    Responding to public health emergencies requires us to have 
a good understanding of what is happening on the ground in real 
time. And doctors and nurses and others who work directly with 
patients are likely to be the first to interact with 
individuals affected in a public health emergency.
    How does CDC gather data from these clinicians to detect 
emerging illnesses and other threats?
    Dr. Schuchat. We have a variety of surveillance systems to 
try to identify both the known threats and then the unknown or 
the new unusual clusters. Most important is for there to be a 
close connection between the clinical community, the doctors 
and nurses on the front line, and their local and State public 
health authorities.
    The first cases of West Nile virus disease in New York City 
were detected, there were some animal losses, but it was that 
link between clinicians and the local health department. So 
part of our day-to-day everyday public health system is vital 
for the unknown emerging----
    Ms. Castor. And CDC has a Laboratory Response Network that 
plays a vital role in biopreparedness by ensuring that we are 
able to quickly diagnose public health threats using rapid 
testing methods known as assays, but I understand that right 
now, there are no assay kits or rapid tests available for many 
dangerous pathogens and toxins.
    What is going on here, and what are the barriers to 
developing assays targeting a wide variety of pathogens and 
toxins?
    Dr. Schuchat. Yes. What I would say is that the Laboratory 
Response Network, or LRN, is a group of 125 hospitals around 
the--or laboratories around the country that are within a 2-
hour drive of 85 percent of all of the population. They are 
equipped to use validated, standardized assays to detect a 
variety of conditions.
    The CDC has the ability to detect and confirm a longer list 
of the select agents and dangerous pathogens, and we prioritize 
which of the detection methods or assays need to be deployed 
close to where people live, which ones can be deployed and 
maintained centrally, because it's quite expensive to have the 
standards high enough to be able to reproduce the results in 
all of the 125 hospitals.
    So while there's 45 select agents, we have assays for 
nearly all of them. Many of those are managed at the CDC or at 
Regional Centers of Excellence, while the 125 laboratories can 
test for the things that we think are the most likely, 
including things like MERS, where we rolled out an emergency 
use authorization for a new diagnostic test for that, Ebola, et 
cetera, the H1N1 initially. So we try to deploy distally the 
assays for the threats that are the most important to have 
local ability to detect rapidly.
    Mr. Bright. If I can add just a second on that too. That is 
another area of innovation that BARDA has been focusing on with 
our industry partners is to drive diagnostics, not only out of 
centralized labs to augment that centralized laboratory 
network, but put the diagnostics in the hands of the physicians 
in the physician's office at point-of-care testing. And even go 
further now, to drive diagnostics into the home, so people will 
know earlier when they've been infected with something so they 
can take responsible action to either get treated sooner when 
drugs are more effective and also to take activities to reduce 
the further spread or transmission of that virus. This area is 
ripe for innovation to augment our national laboratory support 
system.
    Ms. Castor. Thank you very much.
    Mr. Harper. The gentlewoman yields back.
    The chair now recognizes the gentleman from New York, Mr. 
Collins, for 5 minutes.
    Mr. Collins. Thank you, Mr. Chairman.
    I want to thank our witnesses and follow up a little bit 
more on the Laboratory Response Network, Dr. Schuchat. I 
understand that's been around about 9 years or thereabouts, 
since I think 1999?
    Dr. Schuchat. Yes, since 1999.
    Mr. Collins. Actually, I've lost 10 years. Twenty years. I 
deliberately lost those 10 years, by the way.
    So I know you mentioned 125 labs here in the country, but 
this is, from what I understand also, there's international 
labs. We all know the key to a lot of this is early detection, 
whether it was Ebola or some other things, SARS, which 
initially people thought they had the flu, even anthrax. But 
early detection's the key to jumping on top of this, which 
means the laboratories that are located outside the country. 
And I know this is a collaborative effort.
    Are you, let's use the word ``comfortable,'' and how is 
that collaboration between the United States and other 
countries around the world--as you mentioned, in many cases, 
these could be in Africa and other places--for the ability to 
identify these select agents?
    Dr. Schuchat. The Laboratory Response Network is in other 
countries as well, but I would say there's other means, other 
laboratories that we collaborate with around the world to help 
have that rapid detection and response. And actually, that's 
really what the global health security agenda is about, making 
sure that there are abilities to find, stop, and prevent 
epidemics wherever they occur, natural or not.
    And the international collaboration, I think, is 
strengthened by the daily links we have in partnership on other 
threats. As you heard, we're working on Ebola in DRC right now. 
The Nipah virus detection in India was based on training that 
CDC had given to the laboratory in India years before so that 
India could recognize that pathogen themselves without having 
to take the time to ship the specimens out of the country.
    Mr. Collins. So, following up on that, what I would call 
proficiency testing that we do for all of our labs, whether 
it's on influenza or HIV or any of the STDs, I'm assuming 
there's also a proficiency testing program related to our LRNs, 
which is always maybe a little more complicated because the 45 
select agents are not nearly as prevalent as influenza. But can 
you speak to the proficiency program, how often these 
laboratories are tested, their workers, how their grades are, 
so that, in fact, we're comfortable that, if there is an 
outbreak, they're properly identifying it?
    Dr. Schuchat. Yes. The proficiency testing and assuring the 
quality of the laboratory test is vital. That's one of the 
reasons that we don't have assays for every one of the select 
agents in each of the LRN labs, because we want to certify that 
lab for that test and make sure that they maintain their 
reagents adequately and that everyone who's working on that 
test is doing it the right way. So we really try to prioritize 
which assays will be run regularly in every lab, because we do 
have to make sure that year in and year out, they're getting 
the accurate results. Otherwise, it makes no sense to run the 
test.
    Mr. Collins. Is that done yearly, more than yearly? How 
often is that done? And does the CDC conduct the proficiency 
tests themselves or do you use outside agencies like CAP or 
someone like that?
    Dr. Schuchat. Let me get the details on that for the 
committee in followup, because I don't have all of them myself.
    Mr. Collins. OK. Thank you. I think that's an important 
piece.
    In the remaining time, Admiral Hinton, egg-based versus 
cell-based vaccines, could you comment? YIs the FDA looking 
at--as we're moving forward certainly through our influenza 
season, are you making progress on the cell-based? Are you 
seeing positive potential there?
    Admiral Hinton. Absolutely. And we actually have both. We 
have the egg-based versus the cell-based vaccines available, 
and continue to do evaluation and work in that area. But both 
are available, both are promising.
    Mr. Collins. Because, there's always been some folks--if 
anyone else would like to comment on potential problems with 
the egg-based. Are we seeing positive steps in the other or----
    Admiral Hinton. We are seeing positive steps in the other 
direction. And then as far as the egg-based, I know we run into 
issues with people having allergens and the like to them and 
not being able to have them. So having different options there 
to be able to provide and treat people with is promising and is 
available.
    Mr. Harper. Dr. Fauci.
    Dr. Fauci. There are other problems with egg-based, which 
is the reason why we're really trying to get away from egg-
based and get more towards more advanced platform technologies.
    One of the accidental mismatches that we had in 2016-2017, 
particularly in Australia, was that the virus was chosen for 
the vaccine, was put into eggs, and as it mutated in the eggs 
as it was growing, it mutated so that the virus that came out 
of the eggs was not the virus that you put into the egg. So we 
had an accidental mismatch.
    That doesn't happen all the time by any means, but the idea 
of having to grow a virus in a 6-month process is something 
that we really need to, as I often say, graduate into the 21st 
century and do it a little bit better with more advanced 
technologies.
    Mr. Collins. Thank you for that.
    Mr. Chair, I yield back.
    Mr. Harper. The chair is going to allow Dr. Bright to 
finish his response that he wanted to make here quickly.
    Mr. Bright. Thank you very much. I'd like to add just a 
little bit more to that as well. It's very important to 
understand the need for diversified vaccine production systems 
for influenza. Influenza's a tricky virus. Eggs have been a 
reliable vaccine substrate for a number of years. We are 
working to find ways to not only diversify and augment our 
cell-based and recombinant-based influenza vaccines, but also 
to improve egg-based vaccines. It's important not to completely 
discard a reliable technology without having a modernized 
technology to replace that. So we are working with each of the 
manufacturers now to identify ways to make our flu vaccines 
more effective now while we wait for that universal flu vaccine 
candidate in the future.
    Mr. Harper. The chair will now recognize the gentleman from 
California, Mr. Ruiz, for 5 minutes.
    Mr. Ruiz. Thank you, Mr. Chairman.
    Emerging infectious diseases are a major threat to the 
health of American citizens and to people around the world. 
This includes both new diseases that emerge in populations, as 
well as previously known diseases that re-emerge. In just the 
past 2 months, for example, we have seen outbreaks of Ebola in 
the Congo and Nipah in Northern India.
    Dr. Schuchat, what steps are we taking to monitor emerging 
and re-emerging infectious diseases in the developing world, 
and how are we partnering with international players on this?
    Dr. Schuchat. Yes. CDC works closely with dozens of 
ministries of health around the world, as well as with 
international partners like the World Health Organization and 
the World Food Organization to--or the World Animal Health 
Organization to be able to find, stop, and prevent epidemics.
    Mr. Ruiz. Give me an example of how you do that in a very 
underdeveloped, poor infrastructure nation.
    Dr. Schuchat. Right. As you know, in Liberia, they suffered 
from a devastating outbreak of Ebola in 2014. We have a country 
office in Liberia that's working closely with them focused on 
four key areas: strengthening laboratory systems, strengthening 
surveillance, strengthening emergency operation centers and 
rapid response, and workforce development through the disease 
detective program that we call the field epidemiology training 
program.
    That means they can shorten the time to recognition of 
Ebola or something else and respond capably.
    Mr. Ruiz. Thank you.
    And in 2014, 2016, the Ebola epidemic killed more than 
11,000 people in West Africa, and we know in October 2014, a 
physician who traveled from West Africa to Dallas in Texas died 
of Ebola; two others that contracted the Ebola virus survived.
    What did we learn from that experience? And what are the 
changes that you've made because of that?
    Dr. Schuchat. There are three key lessons learned. One was 
that we need every country to have the ability to find, stop, 
and prevent epidemics, and that's what we call this Global 
Health Security Agenda.
    A second thing was that we need the world organizations, 
the global organizations, to be able to surge rapidly when a 
country's capacity is overwhelmed. And that has actually 
happened effectively in the Democratic Republic of Congo with 
this Ebola outbreak recently.
    And the third thing that we've learned is that infection 
control is essential; that an issue that is one illness or a 
couple illnesses can amplify into a very large-scale problem 
when we don't have adequate infection control. That's important 
in the United States for antimicrobial resistance, it's 
important in developing countries for TB, and it's very 
important for Ebola in SARS.
    Mr. Ruiz. This patient and these two other healthcare 
workers who contracted Ebola, obviously, were in emergency 
departments, went to emergency departments, were treated in 
emergency departments. The first line of defense against any 
emerging infection or outbreak in the United States is going to 
be the emergency departments and also the first responders.
    So what are you doing in terms of the CDC to coordinate to 
make sure that they are well-equipped? And then I'm going to 
ask Dr. Bright that same question.
    Dr. Schuchat. Yes. We have a family of efforts to educate 
and keep up-to-date clinicians that include tens of thousands 
of clinicians regularly getting updates from us, whether it's 
through phone calls----
    Mr. Ruiz. It's hard for very busy clinicians who work in 
emergency departments, seeing 20 patients at once to----
    Dr. Schuchat. Right. And that's----
    Mr. Ruiz. How do you integrate that into their daily 
practice?
    Dr. Schuchat. Yes. The system changes are really important. 
When I saw a doctor at Emory last week, before I could even 
talk to anyone, I was asked, Have you traveled out of the 
country the last 3 weeks? It's actually on their phone line 
before you make an appointment.
    So institutions instituting systemwide checks can help make 
sure that you don't have problems with human error.
    Mr. Ruiz. Dr. Bright?
    Mr. Bright. Also, I'd like to highlight that ASPR has spent 
a lot of time with our hospital protection program and our 
healthcare coalitions to establish now even a national Ebola 
training center and education center, so we can train the 
hospital and first responders.
    We now have 178 Ebola assessment hospitals. We have 69 
State or jurisdictions designated Ebola treatment centers. We 
have 10 regional Ebola and other special pathogen treatment----
    Mr. Ruiz. Well, I'm an emergency physician. I have to take 
exams like crazy just to keep my board certifications and my 
licensing. So I think integrating it as part of their 
continuing medical education and training would be very 
essential.
    Now, the President's budget--or the administration wants to 
move the strategic National Stockpile under the ASPR. I'd like 
to ask Dr. Schuchat what are your competitive advantages and 
why should I think about even considering keeping it at the 
CDC?
    Dr. Schuchat. What I could say is that there's already been 
an administrative decision to move the stockpile, and so 
currently, CDC is working diligently very closely with ASPR to 
make that transfer as seamless as possible and to mitigate any 
negative consequences that may have been unintended but that 
may occur.
    I think the critical areas that we are going to focus on 
are to make sure that State and local support is seamless, and 
that we work with State and local health departments every day 
on a variety of things and know them and know where our gaps 
are and where we need to make progress. We need to make sure 
that that close relationship continues in a way that doesn't 
jeopardize the American public.
    Second area is the deep scientific expertise that we have 
across the agency that has contributed to maintenance of the 
SNS so that when we need clinical guidance for children for 
anthrax countermeasures, we can get that best advice 
incorporated. We need to make sure that that continues, but we 
are well on the way to executing that seamless transition.
    Mr. Harper. The gentleman yields back.
    The chair will now recognize the vice chair of the 
subcommittee, the gentleman from Virginia, Mr. Griffith, for 5 
minutes.
    Mr. Griffith. Thank you, Mr. Chairman.
    After a series of safety lapses in 2014 involving the 
mishandling of anthrax and smallpox, in response to 
recommendations from a lab safety expert panel, both the FDA 
and CDC formed new offices to provide centralized oversight of 
laboratory safety and science.
    Rear Admiral Hinton, I have several questions for you 
regarding the FDA's Office of Laboratory Science and Safety.
    First, how many labs does the FDA have, or oversee?
    Admiral Hinton. The FDA has 56 lab facilities.
    Mr. Griffith. And do you oversee more than that?
    Admiral Hinton. No.
    Mr. Griffith. And are you counting everything in a single 
building, or is that all your labs combined?
    Admiral Hinton. Those are the facilities. Within those 
facilities, there might be a total of 2,800 rooms, with those 
rooms being described as a space, an office, a closet.
    Mr. Griffith. Yes, ma'am.
    How many safety inspections of these labs were conducted by 
the OLSS over the past year?
    Admiral Hinton. No inspections have been conducted by OLSS 
in the past year. However, their labs have been inspected by 
other entities.
    Mr. Griffith. OK. Have there been any laboratory-acquired 
infections at FDA labs during the past year?
    Admiral Hinton. There have been two noted infections within 
the last year. The staff that had acquired those infections 
have been observed and the case is closed.
    Mr. Griffith. All right. And can you get us the reports on 
those two incidences, please?
    Admiral Hinton. I'll work with my staff to get that to you.
    Mr. Griffith. Thank you very much.
    Likewise, have there been any potential exposures to threat 
agents at FDA labs during the past year?
    Admiral Hinton. Not to my knowledge. No.
    Mr. Griffith. All right. At tab 5 in the document binder is 
a September 2016 letter to the FDA sent the committee 
indicating its intention to hire 13 permanent full-time 
employees in the Office of Laboratory Science and Safety, OLSS.
    The FDA told the committee this week that OLSS is staffed 
by only three permanent full-time employees, and three 
detailees.
    Why doesn't the OLSS have the 13 permanent employees that 
were promised in a September letter of 2016?
    Admiral Hinton. Sir, we have put forth the proposal, and as 
soon as we have the dedicated budget for OLSS, we expect for 
their current staff to double.
    They actually have three permanent staff and three detailed 
working on this space.
    Mr. Griffith. That still only puts you at six as opposed to 
the 13 that was indicated in 2016.
    Admiral Hinton. I agree. And we note that, and then with 
the approval of the upcoming budget, we will be able to double 
that and they will have the 13 staff.
    Mr. Griffith. The FDA, in the September 2016 letter, 
committed to this committee, and in July of 2017, published a 
notice in the Federal Register evaluating the OLSS so the 
office would directly to the FDA commissioner instead of the 
chief scientist.
    Earlier this week, the FDA told committee staff that the 
FDA has decided to reorganize again, and that under the new 
proposal, OLSS will no longer be a direct report to the 
commissioner and will report to the chief scientist again, just 
as they did when we had the lapses back in 2014 and contrary to 
the expert panel's recommendations.
    I just would like to know, first, is the chief scientist 
reporting to you now?
    Admiral Hinton. I am the chief scientist. But the Director 
of OLSS----
    Mr. Griffith. Is OLSS reporting to you?
    Admiral Hinton. Yes, sir.
    Mr. Griffith. And then you report on up the line?
    Admiral Hinton. Yes. I do.
    Mr. Griffith. So why did FDA reverse course in less than a 
year and decide to have the OLSS revert back to reporting to 
the chief scientist?
    Admiral Hinton. Well, sir, since that was announced, we 
have had the chance over the past year to observe and to see 
where it might be best fit for the alignment within the office.
    Within the office of the chief scientist, which reports 
into the office of the commissioner and to the commissioner, we 
work on cross cutting cross-scientific issues to include those 
within laboratory science space.
    So we thought that the OLSS would be best aligned there 
under my direct supervision on their day-to-day activities. The 
commissioner will be fully apprised of those activities.
    Mr. Griffith. Well, and I certainly mean no disrespect to 
you, but that was the same setup we had when there were 
problems being reported and we had the expert panel come in and 
give us recommendations, which FDA agreed to, and now you all 
are backtracking.
    I understand some different personnel, but it seems to me 
we're just creating the same problem we had before.
    I see my time is up, and I have to yield back. Thank you, 
Mr. Chairman.
    Mr. Harper. The gentleman yields back.
    The chair will now recognize the gentlewoman from 
California, Ms. Walters, for 5 minutes.
    Ms. Walters. Thank you, Mr. Chairman.
    Dr. Bright and Dr. Schuchat, either through stockpile 
procurement or through other means, how do your agencies ensure 
we have sufficient diagnostic test capacity to identify cases 
of pandemic influenza or other infectious diseases?
    Mr. Bright. In terms of development, so we have worked with 
a number of different manufacturers through the last 10 years 
to develop diagnostics for influenza, not only laboratory-based 
diagnostics, but to standardize and update the point-of-care 
diagnostics for influenza to make sure those are available and 
in the marketplace for use for pandemic and seasonal influenza 
detection.
    Dr. Schuchat. Yes. And I would say that CDC both develops 
assays and helps with validation.
    You know, a number of years ago, there were quite a few 
point-of-care tests for influenza detection, and some of them 
didn't perform as well in the field as we had hoped. So we did 
quite an effort of validation comparison, shared the data with 
FDA, and new labeling and improvements in the tests followed 
from that.
    So we will develop tests against pandemic or avian flu and 
other high-threat concerns, develop them through to emergency 
use authorization when appropriate, 501(k) when possible.
    The 501(k) final process is very labor intensive, very 
expensive, and there's a limited number of our tests that we 
are able to put through to that level. But we do work closely 
with FDA and BARDA on a number of the priority ones.
    Ms. Walters. Thank you.
    Dr. Fauci, you mentioned work by the National Institute of 
Allergy and Infection Diseases to support research involving 
diagnostic testing.
    From a Homeland Security and public health perspective, 
multiplex point-of-care technologies are beneficial because 
they can be used to simultaneously test for multiple infectious 
disease pathogens with a single blood or urine sample.
    Can you tell us about the research NIAID is doing with 
respect to multiplex point-of-care technologies and how these 
technologies enhance our ability to detect material threats and 
infectious diseases?
    Dr. Fauci. Thank you very much for that question.
    Yes. We are very heavily involved in that, both with our 
grantees to get concept to develop into something that's 
translatable, as well as contract.
    There's multiplex, as you mentioned in your statement, is a 
very important tool of the future now for detecting outbreaks. 
For example, we have multiplex assays involving a whole series 
of particular types of viruses. For example, the flaviviruses, 
which are many of them that we have, particularly in the 
Western Hemisphere, that we are involved right now in research 
for the development of a multiplex that would essentially cover 
all of the associated flaviviruses, and we're doing that with a 
number of other viruses.
    So there's really a very important, I believe, and 
aggressive ongoing research program at the NIH, mostly through 
our grantees and contractors.
    Ms. Walters. OK.
    Mr. Bright. If I can jump in, the challenge with the beauty 
of multiplex assays is that they can do a lot. And the 
challenge with them is they're very large instruments generally 
in centralized laboratories in a hospital or a public health 
laboratory.
    The innovation that we're driving today with companies that 
move multiplex assays to point of care into a physician's 
office, and even to work with those multiplex technologies to 
push some of those now out into the home, one of our greatest 
challenges with our diagnostics for any disease is how long it 
takes for a patient to get to that system and into the system 
so they can get a sample drawn and can get a result.
    Too much time elapses in that. So we're trying to also use 
this new technology for multiplex point of care to multiplex 
point of need into the home to get people earlier notification 
to empower patients to get treated sooner.
    Ms. Walters. OK. Thank you.
    Rear Admiral Hinton, how many multiplex point-of-care 
diagnostic tests has the FDA approved for use?
    Admiral Hinton. Thank you for your question, ma'am.
    Work in this area is progressing well at FDA. We've cleared 
more than 25 multiplex tests that could be suitable for point-
of-care tests.
    Ms. Walters. OK. And how many others are currently under 
assessment by the FDA?
    Admiral Hinton. I'll have to get back to you. I don't have 
the exact number.
    Ms. Walters. OK. Can you describe the range of capabilities 
that these tests have? You know, how many diseases can one 
multiplex point-of-care diagnostic test detect?
    Admiral Hinton. It can detect many. We can do up to 20--and 
more than--at one time, which is incredibly important, 
especially at the point of care so that we can help to easily 
detect in order to find the best treatment.
    Ms. Walters. OK. Thank you, and I yield back the balance of 
my time.

    Mr. Harper. The gentlewoman yields back.
    The chair will now recognize the gentleman from Georgia, 
Mr. Carter, for 5 minutes.
    Mr. Carter. Thank you, Mr. Chairman.
    And, Mr. Chairman, I want to echo your comments earlier 
about what an outstanding panel this is. Thank you all for the 
very important work that you do. It is extremely important to 
our country, and we appreciate it very much.
    Dr. Bright, I want to start with you. Being, of course, 
from Georgia, I am somewhat concerned, even still, about the 
move of the strategic National Stockpile and the management of 
that from the CDC to ASPR, and I just want to be assured again 
from you. I've met Dr. Redfield, and I think he's doing a great 
job. Dr. Schuchat and I have worked together, and I just can't 
say enough good things about the CDC and the outstanding work 
that they do for our country.
    And I just want to make sure that they're still going to 
have the opportunity to stay involved and to be involved in the 
medical counter-measurement development and everything else 
that goes along with the SNS.
    Mr. Bright. Sir, you have my complete assurance. I echo 
your comments about the CDC and the great work they are doing. 
Many people don't know I got my first start in science at the 
CDC as an ORISE fellow coming from Emory University in Georgia.
    I understand and appreciate the great scientific leadership 
of the CDC and their relationship with state and local and the 
value of that.
    We plan to always include that in our assessment and our 
programs for the new strategic National Stockpile management.
    Mr. Carter. We talked on it earlier. One of my colleagues 
had mentioned about the concern particularly that the transfer 
is not disruptive for the state and local agencies.
    What would you suggest that we do to make that as least 
disruptive as we can?
    Mr. Bright. Well, the most important thing is to recognize 
the value of their voice in the entire process, not just in the 
transition of the management of the SNS, but an entire end-to-
end process of our efficient response to any emergency or 
public health emergency threat.
    So we already have an intentional working group focusing on 
the state and local and tribal and territory partners and their 
specific needs and their specific interests to make sure those 
are encapsulated in our management of the SNS.
    Mr. Carter. Great.
    Dr. Schuchat, would you care to comment on that as well? 
How can well assure that this is not disruptive to our local 
and state communities?
    Dr. Schuchat. I think that change is, by necessity, 
disruptive, and I think our job is to mitigate that disruption 
so that people aren't harmed. So I think it's on our radar. 
We're working really closely together. The Association of State 
and Territorial Health Officers Board was just at CDC yesterday 
talking to us about how we can make sure this all goes as well 
as possible.
    Mr. Carter. And let me ask you--I run the risk of being a 
little self-serving here--but wouldn't it make sense to look at 
perhaps just having ASPR colocate down to Atlanta with the CDC? 
I recognize you're part of HHS, but we have to get out of the 
mindset that not everybody's got to be in Washington, D.C. We 
have a big country out here. Dr. Bright, I'm looking at you.
    Mr. Bright. We have a big and beautiful country, sir, and I 
agree with you, and there is no intent to move the strategic 
National Stockpile from Atlanta to Washington, D.C. There might 
be one or two individuals who are located in our ASPR office to 
ensure we have smooth and efficient ongoing communication with 
the expert staff that is in Atlanta, Georgia.
    Mr. Carter. OK. Well, that might be a good compromise, and 
we appreciate that very much.
    The Ebola crisis that we had, obviously we learned a lot of 
lessons there, but I was so proud of the public/private 
partnership between Emory University and the CDC, and all four 
patients recovered.
    And I just wanted to know, will you be using that model in 
the future for other pandemics and other risks that we might 
run into? Because we're very proud of the work that was done at 
Emory University, and I think it's a great example of what we 
can do in the future.
    Dr. Schuchat?
    Dr. Schuchat. I would say that CDC benefits tremendously 
from being located right next to Emory, and there's a really 
close working relationship. We were fortunate that they such a 
terrific job in the Ebola--in the care of the patients there.
    There's ongoing collaboration and communication and 
support.
    I think ASPR may have a more direct role in the hospitals 
and the care of such patients, and Dr. Bright might want to 
comment.
    Mr. Bright. I also want to make sure that we capitalize and 
not lose that expert and lessons learned from Emory University.
    As you may know, we stood up a National Ebola Training and 
Education Center. It's based in Nebraska as collaboration with 
Emory University, University of Nebraska, and Bellevue. It is 
an example of one the finest educational centers on Ebola and 
other epidemic treatments in the world now.
    Mr. Carter. OK. Again, I want to thank all of you for the 
work that you do. Extremely important, and especially shout out 
to CDC and the work that they do.
    Thank you, and I yield back, Mr. Chairman.
    Mr. Harper. The gentleman yields back.
    The chair will now recognize the gentlewoman from 
California, Ms. Eshoo, for 5 minutes.
    Ms. Eshoo. Thank you, Mr. Chairman, for extending the 
legislative courtesy to me, since I'm not a member of this 
subcommittee, but I have a great interest in the subject 
matter, since we're looking to reauthorize PAHPA and all of the 
listening to what's taken place in this hearing and the superb 
testimony from each one of you. We've made great progress since 
the legislation was first written in 2006.
    So I'm pleased, but in America, we're never satisfied with 
exactly where we are. We always want to improve. And so there's 
been an important pathway of improvement, and I thank each one 
of you.
    I'm very proud of the two women that are here. Rear Admiral 
Hinton, it's really a source of pride to me to hear you respond 
to the tough questions that have come your way. To Dr. 
Schuchat, it's always a pleasure to hear you. Dr. Bright, the 
partnership with BARDA has been a very important one, and I 
think that you're taking it to new places.
    And to Dr. Fauci, I don't have any questions to ask you. I 
wish I could canonize you. You are such a gift to our country. 
You could be in the private sector probably making millions of 
dollars. You've devoted your entire life to the people of our 
country, and you make the National Institutes of--the NIH 
really stand for the National Institutes of Hope. You're a 
leader in that, and I just revere your record, your leadership, 
and what you've done and what you continue to do.
    To Dr. Bright, how has restoring BARDA as a contracting 
authority led to increases in the efficiency and the certainty 
that surrounds the medical countermeasures at research and 
development? That's my first question.
    And my second one is, does your agency interpret your 
existing authority to allow the stockpile to invest in 
countermeasures other than those explicitly mentioned in the 
current statute?
    Maybe start with the second question.
    Mr. Bright. Thank you very much.
    Ms. Eshoo. Do you need any additional authorities?
    Mr. Bright. To be more effective, I believe we need to 
modify some of the authorities that we have to allow us to work 
more flexibly with our industry.
    Ms. Eshoo. So you don't need additional authorities?
    Mr. Bright. We don't need additional authorities. I believe 
we need to modify the authorities that we have.
    Ms. Eshoo. What does that mean, modify the authorities?
    Mr. Bright. Our other transactional authority, for example, 
does have limitations on how we can interface with our industry 
partners and how they might qualify for that type of 
partnership. So we have a draft of suggested language that 
might allow us that greater flexibility to do so.
    Ms. Eshoo. And have you gotten that to us?
    Mr. Bright. If it hasn't been sent to you yet, we will make 
sure that it is quickly.
    Ms. Eshoo. Do BARDA's existing additional authorities 
promote work on the, and it's been brought up, not only at this 
subcommittee, but at others, of the antimicrobial resistance 
and the antibiotic development, or does your agency need 
additional authorities to engage in that work?
    Mr. Bright. We've been working with the authorities we have 
since 2010 to address antimicrobial resistance.
    One area of authority that is lacking, we believe, would be 
beneficial would be a specific authority for the appropriations 
for pandemic influenza, because there's a lot of critical work 
that needs to happen in pandemic----
    Ms. Eshoo. Have you gotten that to us?
    Mr. Bright. I do not have that authority yet.
    Ms. Eshoo. Are you going to make that request of us?
    Mr. Bright. I believe that request has been submitted. I 
hope so.
    Ms. Eshoo. There was some mention earlier about how 
important the advanced--I think you might have raised it in 
your opening statement, on advanced appropriations. I believe 
that, because the Senate has different rules on this, that we 
will meet the standard that needs to be met. That's probably 
the tidiest way for me to say it.
    But it is critical, because if you don't have the advanced 
appropriations at BARDA, then our partners in the private 
sector are not going to be able to continue the important work 
that they're doing.
    Mr. Bright. That's absolutely correct. They are business 
partners working in long-term cycles and forward-looking 
cycles, and the consistency and assurance of that advanced 
appropriations allows them to have that assurance that we will 
still be there doing our part so they can plan appropriately as 
well.
    Ms. Eshoo. Thank you very much to each one of you for what 
you're doing for our country. You're all heroes of mine.
    Thank you, Mr. Chairman. Yield back.
    Mr. Harper. The gentlewoman yields back.
    The chair will now recognize Ranking Member DeGette for 
concluding remarks.
    Ms. DeGette. Thank you very much, Mr. Chairman, for the 
moment of personal privilege.
    I wanted to bring up another issue that I think is a real 
crisis right now in this country.
    I know we have a lot of HHS agency representatives here, 
and, of course, ASPR is under the purview of HHS.
    Yesterday, our ranking member, Frank Pallone, wrote a 
letter to Secretary Azar about the HHS Office of Refugee 
Resettlement. And these kids who are being taken from their 
parents at the border, and then being put under the auspices of 
this agency, we have real concerns about what's happening to 
these children. And we have real concerns about their long-term 
prospects, being taken from their parents.
    And, Mr. Chairman, I just wanted to bring this up, because 
you're going to be getting a request from the minority to have 
a hearing about this, and we would hope that you would 
seriously consider this, because we are quite concerned about 
the human aspects of this situation.
    Thank you, and I yield back.
    Mr. Harper. The gentlewoman yields back.
    The chair will recognize Dr. Burgess for a concluding 
remark.
    Mr. Burgess. Well, Mr. Chairman, thank you for the 
recognition.
    I would just point out that this committee, and this 
subcommittee in particular, has a significant history of 
oversight on the ORR. I do feel obligated to point out this is 
not the agency that makes the decision about whether or not a 
family unit is kept together, but they are obligated to take 
care of--whether a child arrives unaccompanied or is separated 
from their family at the DHS facility. But that is the 
responsibility of, in fact, the Health Subcommittee, and we do 
take that responsibility very seriously.
    In fact, it was our work in July of 2014 that allowed them 
to acquire an actual physician to be in those facilities to 
assess those children as they were brought in.
    And it was our committee that raised the question shouldn't 
we at least have some way of contacting the children after they 
have been placed with a family, at least on a voluntary basis.
    So it was our committee that did that work, and that work 
will continue. I've been in contact with both Secretary Azar 
and with the gentleman that runs ORR, and I expect to have 
robust discussions with them going forward, and I yield back.
    Ms. DeGette. If the gentleman will yield, thank you very 
much, and I look forward to working with you on this, because 
it's really a critical issue, and I'm on that subcommittee, 
too. Thank you.
    Mr. Harper. I want to thank each of you for being here. 
Great insights and expertise, and I thank you for participating 
in today's hearing.
    I remind Members that they have 10 business days to submit 
questions for the record, and I ask that the witnesses agree to 
respond promptly to any such questions.
    With that, the subcommittee's adjourned.
    [Whereupon, at 10:58 a.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
    
    
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