[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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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.]
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