[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
EXAMINING THE REAUTHORIZATION OF THE
PANDEMIC AND ALL-HAZARDS PREPAREDNESS ACT
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTEENTH CONGRESS
SECOND SESSION
__________
JUNE 6, 2018
__________
Serial No. 115-136
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
_________
U.S. GOVERNMENT PUBLISHING OFFICE
34-016 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 Health
MICHAEL C. BURGESS, Texas
Chairman
BRETT GUTHRIE, Kentucky GENE GREEN, Texas
Vice Chairman Ranking Member
JOE BARTON, Texas ELIOT L. ENGEL, New York
FRED UPTON, Michigan JANICE D. SCHAKOWSKY, Illinois
JOHN SHIMKUS, Illinois G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee DORIS O. MATSUI, California
ROBERT E. LATTA, Ohio KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia KURT SCHRADER, Oregon
GUS M. BILIRAKIS, Florida JOSEPH P. KENNEDY, III,
BILLY LONG, Missouri Massachusetts
LARRY BUCSHON, Indiana TONY CARDENAS, California
SUSAN W. BROOKS, Indiana ANNA G. ESHOO, California
MARKWAYNE MULLIN, Oklahoma DIANA DeGETTE, Colorado
RICHARD HUDSON, North Carolina FRANK PALLONE, Jr., New Jersey (ex
CHRIS COLLINS, New York officio)
EARL L. ``BUDDY'' CARTER, Georgia
GREG WALDEN, Oregon (ex officio)
C O N T E N T S
----------
Page
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 1
Prepared statement........................................... 3
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 4
Prepared statement........................................... 5
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 7
Prepared statement........................................... 8
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 9
Prepared statement........................................... 11
Witnesses
Robert Kadlec, Assistant Secretary for Preparedness And Response,
U.S. Department of Health and Human Services................... 13
Prepared statement........................................... 15
Answers to submitted questions............................... 169
Stephen Redd, Director, Centers for Disease Control and
Prevention..................................................... 27
Prepared statement........................................... 29
Answers to submitted questions............................... 193
Anna Abram, Deputy Commissioner for Policy, Planning,
Legislation, and Analysis, U.S. Food and Drug Administration... 39
Prepared statement........................................... 42
Answers to submitted questions............................... 208
Umair Shah, Executive Director, Harris County Public Health...... 84
Prepared statement........................................... 87
Answers to submitted questions............................... 217
Dr. Michelle Berrey, President and CEO, Chimerix, Inc............ 96
Prepared statement........................................... 98
Answers to submitted questions............................... 228
Erik Decker, Chief Security and Privacy Officer, University of
Chicago Medicine............................................... 107
Prepared statement........................................... 109
Answers to submitted questions............................... 232
Submitted Material
Burgess documents
Shattuck Lecture, given by Bill Gates, New England Journal of
Medicine, May 31, 2018..................................... 129
Statement of the American Academy of Pediatrics.............. 133
Statement of the American Hospital Association............... 135
Statement of the American Society for Microbiology........... 140
Statement of America's Essential Hospitals................... 143
Statement of the Global Health Technologies Coalition........ 145
Statement of the Healthcare Leadership Council............... 148
Statement of the Infectious Disease Society of America....... 152
Statement of the International Safety Equipment Association.. 160
Statement of the Trust for America's Health.................. 165
EXAMINING THE REAUTHORIZATION OF THE PANDEMIC AND ALL-HAZARDS
PREPAREDNESS ACT
----------
WEDNESDAY, JUNE 6, 2018
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:00 a.m., in
room 2123 Rayburn House Office Building, Hon. Michael Burgess
(chairman of the subcommittee) presiding.
Members present: Representatives Burgess, Guthrie, Barton,
Shimkus, Blackburn, Latta, Lance, Griffith, Long, Brooks,
Mullin, Hudson, Collins, Carter, Walden (ex officio), Green,
Engel, Schakowsky, Matsui, Castor, Eshoo, DeGette, and Pallone
(ex officio).
Staff present: Karen Christian, General Counsel; Paul
Eddatel, Chief Counsel, Health; Margaret Tucker Fogarty, Staff
Assistant; Ali Fulling, Legislative Clerk, Oversight &
Investigations, Digital Commerce and Consumer Protection; Ed
Kim, Policy Coordinator, Health; Ryan Long, Deputy Staff
Director; Kristen Shatynski, Professional Staff Member, Health;
Alan Slobodin, Chief Investigative Counsel, Oversight &
Investigations; Danielle Steele, Counsel, Health; John Stone,
Senior Counsel, Health; Austin Stonebraker, Press Assistant;
Josh Trent, Deputy Chief Health Counsel, Health; Hamlin Wade,
Special Advisor, External Affairs; Jessica Wilkerson,
Professional Staff, Oversight & Investigations; Jeff Carroll,
Minority Staff Director; Tiffany Guarascio, Minority Deputy
Staff Director and Chief Health Advisor; Samantha Satchell,
Minority Policy Analyst; Andrew Souvall, Minority Director of
Communications, Outreach and Member Services; Kimberlee
Trzeciak, Minority Senior Health Policy Advisor; and C.J.
Young, Minority Press Secretary.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Let me just ask all of our guests to please
take their seats. The Subcommittee on Health will now come to
order. The chair recognizes himself for 5 minutes for an
opening statement.
But first, as auspicious as we gather today it is a day
that is so steeped in history. Last night was the California
primary election. We all remember 50 years ago after the
California elections when the country lost Senator Robert
Kennedy.
This is also the 74th anniversary of the landing in
Normandy and D-Day. This is the 100-year anniversary of the
battle of Belleau Woods when the Marines basically initiated
World War I for the United States of America, and it is 100
years since the Spanish Flu ravaged not just our country but
the world.
So it's appropriate that we convene today to authorize the
Pandemic All-Hazardous Preparedness Act. Again, a century ago,
our country was in the worst pandemic in its history, claiming
the lives of almost 700,000 Americans and killing more than 50
million people worldwide. We have elicited testimony and we
will discuss this critical legislation. It is paramount that we
remember the significance of this centennial anniversary.
Sporadic flu activity had been spreading through the United
States, Europe, and Asia. In the months following, the country
and our soldiers faced an illness that we were not prepared to
handle. In that October over a hundred years ago, more than
100,000 Americans died as a result of the Spanish flu.
It goes without saying that we have indeed come a long way.
A century later we were substantially more prepared. As we
consider this legislation, we must remember that there is more
to be done to support America's public health security.
The creation of the Assistant Secretary of Preparedness and
Response under the original legislation in 2006 has helped us
to make monumental strides in preparedness, coordination, and
response. Close collaboration and efforts between the Centers
for Disease Control, the Food and Drug Administration, our
local, state, and tribal and territorial health partners has
been vital in making progress in this regard.
Much like politics, public health is local and it is
executed on the ground by our hospitals, by our health
departments, and our emergency responders who are our front
lines addressing infectious diseases, disasters, and threats.
I do want to thank my fellow Texan on our second panel, Dr.
Umair Shah, for being here today and to share his testimony and
for his leadership in protecting the health of Harris County,
Texas. Recently, Dr. Shah and his team responded on the front
lines for Hurricane Harvey, which caused such catastrophic
damage in the Houston metropolitan area and did require a large
coordinated response from all of the organizations that we have
before us today.
You'll hear more about critical issues that must be
addressed to continue and strengthen the nation's preparedness
and response capabilities.
We will talk about proposals to strengthen the Strategic
National Stockpile, our cache of life-saving medications and
supplies for public health emergencies. We also must address
the policies that affect our regional disaster response system.
It is essential the program continues to integrate and
coordinate at the local level. Additionally, we must provide
assurances to protect those who respond to our health
emergencies.
We will also discuss sustaining the robust and reliable
security capabilities such as disease surveillance,
containment, risk, and countermeasure distribution. We must
evaluate the domestic biologic surveillance systems such as
BioWatch, taking a closer look at what can be done to bring
these programs up to date so that they are operating with the
most efficient technologies and capabilities. I believe we must
look for innovative ways to continue to advance medical
countermeasures, ensuring that Americans can access medications
that will provide critical protection in the future. As we
consider the problem of antimicrobial resistance in this
country, we must address new methods to curb this growing
problem.
Frontline facilities and responders in Dallas, Texas
experienced this firsthand in 2014 when a patient presented
with Ebola in a DFW emergency department. We must remember that
infectious diseases are a mere plane ride away and we must
continue to ensure that we are prepared and ready to respond.
This Pandemic All-Hazards Preparedness Reauthorization is
critical in protecting the lives of all Americans and providing
the necessary tools and infrastructure to ensure that they are
in place when disaster strikes. I want to thank both
Representative Susan Brooks and Anna Eshoo for working on this
draft legislation which is being considered today.
Lastly, I want to thank all of our witnesses for testifying
before us this morning. I do look forward to a productive
discussion on a broad array of issues that will be the focus of
this authorization.
And will yield the balance of my time to the gentlelady
from Tennessee, who I believe is celebrating a birthday on this
day rich in history.
[The prepared statement of Mr. Burgess follows:]
Prepared statement of Hon. Michael C. Burgess
Today, we convene to consider legislation to reauthorize
the Pandemic and All-Hazards Preparedness Act (PAHPA). One
century ago our country was in the midst of the worst pandemic
in its history, claiming the lives of almost 700,000 Americans
and killing more than 50 million people worldwide. As we listen
to testimony and discuss this critical legislation, it is
paramount that we remember the significance of the centennial
anniversary of the 1918 influenza pandemic. On this very day,
in 1918, the first large-scale battle of World War I had begun,
and hundreds of thousands of soldiers traveled across the
Atlantic to be deployed for war. At the same time, sporadic flu
activity was spreading throughout the United States, Europe,
and Asia. In the months following, the country and our soldiers
faced an illness that we were not prepared to handle. In that
October alone, more than 100,000 Americans died as a result of
the Spanish flu.
It goes without saying that we have come a long way. A
century later, we are substantially more prepared. As we
consider this legislation, we must remember that there is more
to be done to bolster America's public health security.
The creation of the Assistant Secretary of Preparedness and
Response under the original legislation in 2006 has helped us
to make monumental strides in preparedness, coordination, and
response. Close collaboration and efforts between the Centers
for Disease Control and Prevention, Food and Drug
Administration, and our state, local, tribal, and territorial
public health partners has been vital in making this progress.
Much like politics, much of public health is local and
executed on the ground by our hospitals, health departments,
and emergency responders who are our front lines addressing
infectious diseases, disasters, and threats.
I want to thank my fellow Texan, Dr. Umair Shah, for being
here today to share his testimony and for his leadership
protecting the health of Harris County. Recently, Dr. Shah and
his team responded on the front lines of Hurricane Harvey,
which caused catastrophic damages in the Houston metropolitan
area and required a large coordinated response from all of the
organizations before you today.
We will hear more about the critical issues that must be
addressed to continue to strengthen the nation's preparedness
and response capabilities.
We will talk about proposals to strengthen the Strategic
National Stockpile, our cache of life-saving medications and
supplies for public health emergencies. We also must address
the policies that affect our Regional Disaster Response System.
It is essential that the program continues to integrate and
coordinate at the local level. Additionally, we must provide
assurances to protect those who respond to health emergencies.
We also will discuss sustaining robust and reliable
security capabilities such as disease surveillance,
containment, risk, and countermeasure distribution. We must
evaluate the domestic biological surveillance systems such as
BioWatch. We must also take a closer look at what can be done
to bring these programs up to date, so that they are operating
with the most efficient capabilities and technologies. Finally,
we must look for innovative ways to continue to advance medical
countermeasures, ensuring that Americans can access the
medications that will provide critical protection in the
future. As we consider the problem antimicrobial resistance in
this country, we must discuss new methods to curb this growing
problem.
Frontline facilities and responders in Dallas experienced
this firsthand in 2014 when a patient presented with Ebola in a
DFW emergency department. We must remember that infectious
diseases are a mere plane ride away, and we must continue to
ensure we are prepared and ready to respond.
This Pandemic All-Hazards Preparedness Reauthorization is
critical in protecting the lives of all Americans, and
providing the necessary tools and infrastructure are in place
when disaster strikes. I want to thank both Representatives
Susan Brooks and Anna Eshoo for their work on the draft
legislation being considered today.
Lastly, I thank all of our witnesses for testifying before
us this morning. I look forward to a productive discussion on
the broad array of issues that will be the focus of this
reauthorization.
Mrs. Blackburn. I am indeed celebrating a birthday and I
thank you for yielding.
Thank you all for being with us to discuss this. We have
focused on how the response ought to be to address our national
disasters and our natural disasters, and this has been a
process.
We have worked with our friends in the Senate, our friends
here. As you know, this is something we have done in a
bipartisan manner so we thank you for your time, and I yield
back to the gentleman.
Mr. Burgess. Chair thanks the gentlelady. The gentlelady
yields back.
The chair recognizes the gentleman from Texas, the ranking
member of the subcommittee, Mr. Green, 5 minutes for an opening
statement, please.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman, and again I'd like to
welcome the panels--both the first panel and I particularly
want to thank Umair Shah, the executive director of Harris
County Public Health, for joining us this morning on the second
panel. They help keep my constituents healthy.
Events in recent years including natural disasters, cyber
terrorism, influenza epidemic has posed a threat to our public
health systems and our national security. PAHPA provides a
framework that allows us to address in a coordinated way
various threats both natural and manmade. As a founding member
of the Congressional Public Health Caucus and a long-time
advocate for public health, I hope our committee will look at
the very real threat that antimicrobial resistance poses.
Antibiotics and antimicrobial agents have been used for the
last 70 years to treat patients who have infectious diseases.
These drugs greatly reduce illnesses and death from infectious
diseases. However, these drugs are being used so widely and for
so long that the infectious organisms that the antibiotics are
designed to kill have adapted to them and make the drugs less
effective. Each year in our country at least 2 million people
become infected with bacteria that are resistant to antibiotics
and at least 23,000 people die annually as a result of these
infections.
In the past years, the Generating Antibiotic Incentives
Act--GAIN--and the Antibiotic Development of Advanced Patient
treatment--ADAPT--have sought to address both the economic
hurdles and the regulatory barriers to the development of new
antibiotics. Through the reauthorization of PAHPA we need to
ensure that the proper incentives are in place that will lead
to investment in the development of new antibiotics and
antimicrobial agents.
I believe the creation of a market entry reward program
that incentivize the manufacturers to develop novel antibiotics
would provide the best bang for our buck in this space.
I'd like to work with my colleagues and I have over the
years with Congressman Phil Gingrey recently on our committee
and also currently with Congressman Shimkus. It's such a
critical issue.
In addition to addressing antimicrobial resistance, we also
need to further consider the proposal to move the Strategic
National Stockpile--SNS--from CDC to the office of Assistant
Secretary for Preparedness and Response.
My home state and our district was heavily impacted by
Hurricane Harvey last year in response to the flooding. The SNS
was deployed to Houston and provided needed material to help
local and state health departments respond to the overwhelming
needs of the community.
SNS had been deployed countless times since its inception.
It was placed in CDC over the years. CDC has worked closely
with state and local health departments to respond to public
health emergencies.
Before our committee codifies any change in the SNS, we
must learn whether it's the best policy to advance human
health. Additionally, as we have discussed the move of the
stockpile from CDC to ASPR we have to ensure that the systems
and networks which have been in place are not disrupted in
order that the stockpile may be deployed successfully when
needed.
Mr. Chairman, I yield the remainder of my time to my
colleague from California and co-sponsor of the bill,
Congresswoman Eshoo.
[The prepared statement of Mr. Green follows:]
Prepared statement of Hon. Gene Green
Thank you, Mr. Chairman, for holding today's hearing on the
reauthorization of the Pandemic and All-Hazards Preparedness
Act (PAHPA). I also thank our witnesses, particularly Umair
Shah, Executive Director of Harris County Public Health, for
joining us this morning.
Events in recent years, including natural disasters,
cyberterrorism and the influenza epidemic have posed a threat
to our public health systems and our national security. PAHPA
provides a framework that allows us to address in a coordinated
way various threats both natural and man-made.
As a founding member of the Congressional Public Health
Caucus and longtime advocate for public health, I hope our
committee will look at the very real threat that antimicrobial
resistance poses.
Antibiotics and antimicrobial agents have been used for the
last 70 years to treat patients who have infectious diseases.
These drugs have greatly reduced illness and death from
infectious diseases. However, these drugs have been used so
widely and for so long that the infectious organisms the
antibiotics are designed to kill have adapted to them, making
the drugs less effective.
Each year in our country, at least 2 million people become
infected with bacteria that are resistant to antibiotics and at
least 23,000 people die annually as a direct result of these
infections.
In past years, the Generating Antibiotic Incentives Now
(GAIN) and the Antibiotic Development to Advance Patient
Treatment Act (ADAPT) have sought to address both the economic
hurdles and the regulatory barriers to the development of new
antibiotics.
Through the reauthorization of PAHPA, we need to ensure
that the proper incentives are in place that will lead to
investment in the development of new antibiotics and
antimicrobial agents.
I believe the creation of a market entry reward program
that incentivizes manufacturers to develop novel antibiotics
would provide the best bang-for-your-buck in this space. I
would like to work with my colleagues on this critical issue.
In addition to addressing antimicrobial resistance, we also
need to further consider the proposal to move the Strategic
National Stockpile (SNS) from the CDC to the Office of the
Assistant Secretary for Preparedness and Response. My home
state and my district were heavily impacted by Hurricane Harvey
last year. In response to the flooding, the SNS was deployed to
Houston to provide needed materiel to help local and state
health departments respond to the overwhelming needs of the
community.
The SNS been deployed countless times. Since its inception,
it was placed in the CDC. Over the years, the CDC has worked
closely with state and local health departments, to respond to
public health emergencies.
Before our committee codifies any changes to the SNS, we
must learn whether this is the best policy and will advance
human health. Additionally, as we discuss the move of the
stockpile from the CDC to the ASPR, we have to ensure that the
systems and networks which have been put in place are not
disrupted in order that the stockpile may be deployed
successfully when needed.
Thank you, Mr. Chairman. I yield the remainder of my time
to my colleague, Congresswoman Eshoo of California.
Ms. Eshoo. I thank the gentleman for yielding, and welcome
to the witnesses. And Mr. Chairman, thank you for your opening
remarks, especially about the 50th anniversary of Senator
Robert Kennedy.
In 2001, our nation endured the attacks of September 11th
and the anthrax attacks shortly after that. It was one of the
most grueling times, I think, in the modern history of our
country.
Congress realized that our country was not prepared to
coordinate responses to mass casualty events or chemical
attacks. I authored legislation with then Representative
Richard Burr, who was a member of the Committee, that
established the Office of the Assistant Secretary for
Preparedness and Response--we refer to it as ASPR--to be
responsible for coordinating federal responses and the
Biomedical Advanced Research and Development Authority we call
BARDA to be responsible for developing the needed medical
countermeasures for chemical, biologic, radiological, and
nuclear threats. That important bipartisan legislation, the
Pandemic All-Hazards Preparedness Act, or PAHPA, was signed
into law in 2006.
The threats we faced in 2001 have not gone away. They have
evolved and new threats have emerged and that's why it's
important that this committee work to reauthorize PAHPA in a
timely manner before it expires at the end of this fiscal year.
We need to give the agency the tools that they need and the
resources they need to respond to the threats that confront us.
This is the discussion today and I think all members need
to keep that in mind because stakeholders and others have not
seen their suggestions come into a draft yet.
So I think all members need to keep that in mind and I'd
like to compliment Congresswoman Brooks. I couldn't have a
better partner in this.
So thank you, Mr. Chairman. I yield back.
Mr. Burgess. The chair thanks the gentlelady. The
gentlelady yields back.
The chair recognizes the gentleman from Oregon, the
chairman of the full committee, Mr. Walden, 5 minutes for an
opening statement, please.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. Well, thank you, Mr. Chairman. Thanks for your
leadership on this issue and that of Ms. Eshoo and Mrs. Brooks
as well. I know we will be hearing from both of them even more
during this process.
I appreciate their work together on this. They've been the
team leaders for this for our committee.
Since the terrorist attacks of September 11th, 2001, our
country has taken important steps to fortify our health
preparedness and response infrastructure. The Federal
Government has recognized that we must foster development of
important medical countermeasures in the event of a potential
chemical, biological, radioactive, or nuclear attack.
Preparing for and responding to these kinds of incidents
and mass casualty events requires the collaboration of all
levels of government with hospitals, biotech firms, community
leaders, members, and other partners both public and private
all across the country.
Recent diverse threats illustrate the importance of our
country having an effective and an efficient emergency
preparedness system in place. In the last few years alone, we
have seen the arrival of the Zika virus, last year's
devastating hurricane season, the WannaCry malware outbreak,
and looking ahead, I can think about other prospects including
the projected devastating earthquake of Cascade event that they
predict could hit the Oregon coast as it did hundreds and
hundreds of years ago.
In 2004, Congress authorized Project BioShield. I was here
when that happened, and later in 2006 enacted the Pandemic and
All-Hazards Preparedness Act. In addition to establishing a
strategic plan to direct research, development, and procurement
of medical countermeasures, PAHPA also created the Assistant
Secretary for Preparedness and Response--ASPR--and the
Biodefense Advanced Research and Development Authority--BARDA--
within the Department of Health and Human Services.
So today's hearing really will take a closer look at this
bipartisan discussion draft led by our colleagues, Susan Brooks
and Anna Eshoo. Thank you both for your leadership on this
bill.
This bipartisan bill builds upon our previous work to
modernize our health preparedness and response systems,
ensuring that we are well equipped across all levels and
government agencies to handle current emergency--emergent bio
threats, chemical attacks, radiological emergencies,
cybersecurity instances, and mass casualty events.
This is an important conversation. It's an important issue.
We will move forward. We will move forward expeditiously.
We realize there is a deadline ahead for reauthorization
and so we look forward to getting your feedback as we put this
legislation into final form and move it through this committee.
With that, I'd yield the balance of my time to the
gentlelady from Indiana, Mrs. Brooks.
[The prepared statement of Mr. Walden follows:]
Prepared statement of Hon. Greg Walden
Since the terrorist attacks on September 11, 2001, the
Nation has taken important steps to fortify our health
preparedness and response infrastructure. The federal
government has recognized that we must foster development of
important medical countermeasures in the event of a potential
chemical, biological, radioactive, or nuclear attack.
Preparing for and responding to these kinds of incidents
and mass casualty events requires the collaboration of all
levels of government with hospitals, biotech firms, community
members, and other partners--both public and private--across
the country.
Recent, diverse threats illustrate the importance of our
country having an effective and efficient emergency
preparedness system in place. In the last few years alone, we
saw the arrival of the Zika virus, last year's devastating
hurricane season, and the WannaCry malware outbreak. Looking
ahead, I think about the prospect of a devastating earthquake
``Cascadia'' predicted to hit my home state of Oregon.
In 2004, Congress authorized Project Bioshield, and later
in 2006, enacted the Pandemic and All-Hazards Preparedness Act
(PAHPA). In addition to establishing a strategic plan to direct
research, development and procurement of medical
countermeasures, PAHPA also created the Assistant Secretary for
Preparedness and Response (ASPR) and the Biodefense Advanced
Research and Development Authority (BARDA) within the
Department of Health and Human Services.
Today's hearing will take a closer look at a bipartisan
discussion draft lead by our Energy and Commerce Committee
colleagues, Reps. Susan Brooks (R-IN) and Anna Eshoo (D-CA).
Thank you both for your leadership on this critical bill.
This bipartisan bill builds upon our previous work to
modernize our health preparedness and response systems,
ensuring that we are well-equipped across all levels and
government agencies to handle current and emerging biothreats,
chemical attacks, radiological emergencies, cybersecurity
incidents, and mass casualty events.
It's an important conversation, and I look forward to
continuing our work today. Lastly, I'd like to thank our
witnesses for being with us today. We look forward to gaining
your feedback. This is a critical reauthorization that can have
a tremendous impact on our country, and it's imperative we get
it right.
Mrs. Brooks. Thank you, Mr. Chairman, and thank you for
holding this hearing today to examine the issues surrounding
the reauthorization of PAHPA.
I am proud to be working on this important bill with my
good friend, Representative Eshoo, who was one of the authors
of the first PAHPA bill in 2006, as well as the lead author of
the last reauthorization in 2013.
As everyone here knows, this is not a question of if we
will face a threat. It is more of a question of when we will
face the threat. The threat of chemical, biological,
radiological, or nuclear incidents continues to grow. Every day
our adversaries are looking for more effective and faster ways
to produce a threat. We have already faced threats from
naturally occurring outbreaks such as Ebola and Zika as well as
from hurricanes. In addition, cyber-attacks like the WannaCry
incident illustrate the vulnerability of our public health
system. Reauthorizing PAHPA is an important public health and
national security issue and I look forward to working with all
members of the committee on this bipartisan effort.
The discussion draft bill that we have written creates a
PAHPA--a Public Health Emergency Response Fund for the HHS
secretary to use as a funding bridge when we face an outbreak
like Ebola so that immediate funding is available so that we
can supplement them with an emergency appropriation bill. The
bill strengthens the hospital preparedness program to improve
surge capacity by allowing grantees to use federal funding for
health care surge capacity response activities in addition to
the preparedness activities. It establishes a pandemic
influenza program as well as an emerging infectious disease
program at BARDA. Our bill includes and this draft includes
requests from CDC, ASPR, HHS, and FDA, and we look forward to
working with everyone to improve the bill and ensure that it's
ready for introduction later this month.
Thank the PAHPA, already we have seen 14 products placed in
the Strategic National Stockpile to be used in an emergency.
Our bill increases funding for the Strategic National Stockpile
to $610 million per year in order to keep the authorized level
consistent with what we have currently appropriated.
In addition, the bill codifies moving the SNS from the CDC
to ASPR but, really, it's more an appropriate realignment of
the responsibilities and it's a move that the administration is
already making. And so it seems as members of Congress it's
important that we provide that oversight and the guardrails for
any move or any changes.
PAHPA reauthorization is a unique opportunity to examine
our response to all threats and ensure we look forward to the
future, that we have the procedures, the resources, and the
support in place to protect ourselves and our citizens, and I
look forward to hearing from our witnesses this morning.
I yield back.
Mr. Burgess. And the chair thanks the gentlelady. The
gentlelady yields back.
The chair now would like to recognize the ranking member of
the full committee, Mr. Pallone of New Jersey, 5 minutes for an
opening statement, please.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Mr. Chairman.
Today, we will examine the reauthorization of a critical
law known as the Pandemic All-Hazards Preparedness
Reauthorization Act, or PAHPA. It's designed to prepare for and
respond to health security events and emergencies that
unfortunately are all too common, and these include
bioterrorism acts, the spread of emerging infectious diseases,
and natural disasters.
In order to effectively prepare for and respond to these
types of events, we must have extensive coordination between
Federal, State, local, and tribal governments and the private
sector organizations, and the critical programs included in
this law help to accomplish that goal.
That's why I am disappointed that on a bill of such
magnitude my staff and our witnesses including the
administration did not receive the draft legislation until late
last week. This has been a very broken legislative process to
date, and now the administration is limited in the feedback it
can provide on the specific provisions of the bill. And I hope,
moving forward, we will work together to ensure that these
policies are fully understood.
Federal funding and support for local, State, and tribal
public health activities is critical to saving lives. This
existing public health infrastructure is how we respond to all
types of hazards. Unfortunately, our public health capacity and
infrastructure is not as strong as it could be. Public dollars
have been depleted and the workforce has shrunk. Public funding
is also not stable or reliable from year to year, making
planning across all levels of government difficult.
I am worried that there is a lack of public health funding
at a time when communities are facing increased need. For
example, climate change is creating conditions for increased
extreme weather events. Last year, hurricanes in Texas,
Florida, Puerto Rico, and the U.S. Virgin Islands placed
significant stress on our public health system and we need to
increase public health funding including to programs authorized
by this bill to bolster both our ability to prepare for and
respond to these threats.
While I am generally supportive of the draft bill, I'd like
to outline some specific concerns and questions. First, the
public health emergency response fund is funded under transfer
authority, and this is short-sighted. We witnessed the downside
of this approach firsthand during the Zika outbreak when the
Republican Congress forced the administration to fund our
initial Zika efforts through transfers of existing
appropriations. As a result, a state like Michigan, which was
confronting its own public health emergency--the Flint water
crisis--had some of its public health funding sent to states at
high risk of local Zika transmission. Michigan lost funding
that it could have used to address its own crisis in Flint and
we shouldn't have to pick one crisis over another. New real
funding should be put in this fund.
Second, I have yet to hear a strong argument for moving the
Strategic National Stockpile--or SNS--from the Centers for
Disease Control and Prevention to the Assistant Secretary of
Preparedness and Response--or ASPR--in statute. The Secretary
of HHS has already started the process of moving the SNS under
existing law and I see no reason to codify this move before we
know the consequences. We must make certain that placing the
SNS in ASPR instead of CDC does not weaken our current
preparedness and response capabilities before making such a
move permanent. From what I can tell, we are trading some
debatable improvements and procurement efficiency on the front
end for the ability to more effectively reach communities and
individuals with the materials they need in case of a public
health emergency, and I would argue that ensuring that we can
reach people with potentially lifesaving drugs and medical
supplies in the event of a public health emergency must be our
top priority. CDC has the relationships and expertise that make
the most sense managing and operationalizing the stockpile as
well as the record of successful stewardship of the SNS.
And third, I have numerous questions regarding the intent
of the cybersecurity language in this draft. As many are aware,
the Oversight and Investigations Subcommittee has been working
on this issue and has discovered challenges regarding internal
and external cybersecurity preparedness within HHS. I agree we
need to do more to protect our health system from cyber-attacks
and the potential interruptions of care because of these
attacks. However, we need to make certain that placing
increased cybersecurity authorities within ASPR as part of
other emergency preparedness and response programs is the
optimal solution, and if it is, that we authorize the resources
to support any new authorities. Simply adding the word
cybersecurity to certain programs within the Public Health
Service Act and FDA's emergency use authorities will do little
to boost our preparedness and response for cybersecurity
threats unless it is done thoughtfully and with consideration
for the problems we are trying to solve.
So I look forward to learning what exactly the role of the
Assistant Secretary for preparedness and response would play
under this legislation in the event of a cybersecurity attack
on the health care system.
I believe we should evaluate this legislation, Mr.
Chairman, based on whether Americans in all corners of the
country will be safer or not, and I look forward to continuing
our work on this bill.
So thank you, Mr. Chairman.
[The prepared statement of Mr. Pallone follows:]
Prepared statement of Hon. Frank Pallone, Jr.
Today we will examine the reauthorization of a critical law
known as the Pandemic All- Hazards Preparedness Reauthorization
Act or PAHPA. It is designed to prepare for and respond to
health security events and emergencies that unfortunately are
all too common. These include bioterrorism acts, the spread of
emerging infectious diseases, and natural disasters.
In order to effectively prepare for and respond to these
types of events, we must have extensive coordination between
federal, state, local, tribal governments and private sector
organizations. The critical programs included in this law help
to accomplish that goal.
That is why I am disappointed that on a bill of such
magnitude my staff and our witnesses, including the
Administration, did not receive the draft legislation until
late last week. This has been a very broken legislative process
to date. And now the Administration is limited in the feedback
it can provide on the specific provisions of the bill. I hope
moving forward we will work together to ensure that these
policies are fully understood.
Federal funding and support for local, state, and tribal
public health activities is critical to saving lives. This
existing public health infrastructure is how we respond to all
types of hazards. Unfortunately, our public health capacity and
infrastructure is not as strong as it could be. Public dollars
have been depleted and the workforce has shrunk. Public funding
is also not stable or reliable from year to year, making
planning across all levels of government difficult.
I am worried that there is a lack of public health funding
at a time when communities are facing increased need. For
example, climate change is creating conditions for increased
extreme weather events. Last year, hurricanes in Texas,
Florida, Puerto Rico and the U.S. Virgin Islands placed
significant stress on our public health system. We need to
increase public health funding, including to programs
authorized by this bill, to bolster both our ability to prepare
for and respond to these threats.
While I am generally supportive of the draft bill - I'd
like to outline some specific concerns and questions. First,
the Public Health Emergency Response Fund is funded using
transfer authority. This is short sighted. We witnessed the
downside of this approach firsthand during the Zika outbreak
when the Republican Congress forced the Administration to fund
our initial Zika efforts through transfers of existing
appropriations. As a result, a state like Michigan, which was
confronting its own public health emergency, the Flint water
crisis, had some of its public health funding sent to states at
high risk of local Zika transmission.Michigan lost funding that
it could have used to address its own crisis in Flint. We
shouldn't have to pick one crisis over another. New, real
funding should be put in this fund.
Second, I have yet to hear a strong argument for moving the
Strategic National Stockpile (SNS) from the Centers for Disease
Control and Prevention (CDC) to the Assistant Secretary of
Preparedness and Response (ASPR) in statute. The Secretary of
HHS can and has already started the process of moving the SNS
under existing law, and I see no reason to codify this move
before we know the consequences. We must make certain that
placing the SNS in ASPR instead of CDC does not weaken our
current preparedness and response capabilities before making
such a move permanent. From what I can tell, we are trading
some debatable improvements in procurement efficiency on the
front end for the ability to more effectively reach communities
and individuals with the materials they need in case of a
public health emergency. I would argue that ensuring that we
can reach people with potentially life-saving drugs and medical
supplies in the event of a public health emergency must be our
top priority. CDC has the relationships and expertise that make
the most sense for managing and operationalizing the stockpile,
as well as a record of successful stewardship of the SNS.
Third, I have numerous questions regarding the intent of
the cybersecurity language in this draft. As many are aware,
the Oversight and Investigations Subcommittee has been working
on this issue, and has discovered challenges regarding internal
and external cybersecurity preparedness within HHS. I agree we
need to do more to protect our health system from cyberattacks
and the potential interruptions of care because of those
attacks. However, we need to make certain that placing
increased cybersecurity authorities within ASPR and as part of
other emergency preparedness and response programs is the
optimal solution. And if it is, that we authorize the resources
to support any new authorities. Simply adding the word
``cybersecurity'' to certain programs within the Public Health
Service Act and FDA's emergency use authorities will do little
to boost our preparedness and response for cybersecurity
threats unless it is done thoughtfully and with consideration
for the problem we are trying to solve. I look forward to
learning what exactly the role the Assistant Secretary for
Preparedness and Response would play, under this legislation,
in the event of a cybersecurity attack on the health care
system.
I believe we should evaluate this legislation based on
whether Americans in all corners of the country will be safer
or not. I look forward to continuing our work on this bill.
Thank you, I yield the remainder of my time.
Mr. Burgess. The Chair thanks the gentleman. The gentleman
yields back.
This concludes member opening statements and the Chair
would remind members that pursuant to committee rules all
members' opening statements will be made part of the record.
And we do want to thank our witnesses for being here this
morning and taking the time to testify before the subcommittee.
Each witness will have the opportunity to give an opening
statement followed by questions from members.
Our first panel this morning we will hear from Dr. Robert
Kadlec, Assistant Secretary for Preparedness and Response from
the United States Department of Health and Human Services. We
will also hear from Rear Admiral Stephen Redd, Director of the
Office of Public Health Preparedness and Response, Center for
Disease Control and Prevention, and Ms. Anna Abram, Deputy
Commissioner for Policy Planning, Legislation, and Analysis at
the United States Food and Drug Administration.
We appreciate each of you being here today and, Dr. Kadlec,
you're now recognized for 5 minutes to summarize your opening
statement, please.
STATEMENTS OF DR. ROBERT KADLEC, ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES; REAR ADMIRAL UPPER HALF STEPHEN REDD, DIRECTOR,
CENTERS FOR DISEASE CONTROL AND PREVENTION; ANNA ABRAM, DEPUTY
COMMISSIONER FOR POLICY, PLANNING, LEGISLATION, AND ANALYSIS,
U.S. FOOD AND DRUG ADMINISTRATION
STATEMENT OF ROBERT KADLEC
Dr. Kadlec. Thank you. Good morning, Chairman Burgess,
Ranking Member Green, and distinguished members of the
committee.
I am Dr. Bob Kadlec, the Assistant Secretary for
Preparedness and Response--ASPR. Thank you for this opportunity
to appear before you today as you consider the second
reauthorization of the Pandemic All-Hazards Preparedness Act.
This committee championed the drafting and passage of PAHPA
more than a decade ago and I want to acknowledge the original
vision and leadership of Representative Mike Rogers and Anna
Eshoo, now under the stewardship of Representative Brooks and
Representative Eshoo as well. Thank you again for your hard
efforts in this work.
One of our Constitution's sacred obligations to our
citizens is to provide for the common defense, to protect the
American people, our homeland, and our way of life. The ability
of our nation's public health and medical infrastructure to
quickly mobilize a coordinated national response to 21st
century threats like pandemics, deliberate attacks, and natural
disasters is a national security imperative and is at the heart
of my efforts at the ASPR.
When ASPR was originally established by PAHPA, the
objective was to answer a very simple question: who's in charge
of federal public health and medical preparedness and response
functions. The approach adopted was modeled on the Goldwater-
Nichols Act that created the unity of effort at the Department
of Defense. My goal is to ensure that we can mobilize the
capabilities of the federal government to support state, local,
tribal, and territorial health authorities to save lives and
protect Americans.
I have four key priorities: provide strong leadership;
develop a regional disaster health response system; advocate
for CDC sustainment of robust responsive public health security
capabilities; and advance an innovative medical countermeasure
enterprise. I will elaborate on two of these. The importance of
national health care readiness and medical surge capacity was
highlighted during the last hurricane season when ASPR led
Federal medical and public health response and recovery
activities under the national response framework. We worked
closely with FEMA and state and territorial health officials to
augment health care with HHS disaster medical assistant teams,
many of whom are your constituents who are health care
providers, and public health commission core officers as well
as physicians and health care providers from the VA, Department
of Homeland Security, and the Department of Defense.
As we speak, we are implementing many lessons learned from
the hurricanes and from the 2014 Ebola outbreak two work with
our colleagues across HHS and the Federal interagency to better
coordinate our national preparedness and response to the
current Ebola outbreak in the Democratic Republic of Congo as
well as actively monitoring the dynamic global national
security landscape as well as the weather landscape.
As we look forward, we are actively engaging our public and
private partners in health care delivery to understand how we
can most effectively improve their readiness for potential
catastrophic threats. I believe we need to modernize our
existing programs to build a tiered regional system utilizing
local health care coalitions and trauma center systems that
integrates all medical response capabilities, expands specialty
care expertise in trauma and other related disciplines such as
burn and radiation treatment, and incentivize the health care
system to integrate measures of preparedness into daily
standards of care. I call this the foundation of a regional
disaster health response system.
The second area to highlight is our medical countermeasure
enterprise. PAHPA established the Biomedical Advanced Research
and Development Authority, or BARDA, which is the component of
ASPR to bridge the so-called valley of death in the late stage
of development of vaccines, drugs, and diagnostics where many
products historically languished or failed. By using flexible
nimble authorities, multi-year advance funding, strong public-
private partnerships, and cutting-edge expertise, BARDA has
achieved a remarkable 35 FDA approvals.
Just yesterday, we announced an exciting new public-private
engagement model called DRIVe--the Division for Research,
Innovation, and Ventures--which is designed to accelerate
innovation, address some of the Nation's most pressing health
security challenges and potentially affect major health care
markets.
It is the brainchild of this committee in the 21st Century
Cures Act. At a time when synthetic biology and personalized
medicine are not just conceivable but attainable, the time is
right to apply an innovative approach to some of the most
daunting far-reaching health security problems such as sepsis
and early diagnosis of infectious disease.
We are opening our doors to more innovators and, most
importantly, investors to better leverage advances in science
and technology.
Thank you again for your bipartisan commitment to this
national security imperative. I am happy to answer any
questions you may have.
Thank you.
[The prepared statement of Dr. Kadlec follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. The chair thanks the gentleman.
The chair now recognizes Rear Admiral Redd. Dr. Redd,
you're recognized for 5 minutes, please.
STATEMENT OF STEPHEN REDD
Admiral Redd. Chairman Burgess, Ranking Member Green, and
members of the subcommittee, I am Rear Admiral Stephen Redd,
director of CDC's Office of Public Health Preparedness and
Response.
Thank you for the opportunity to testify before you today
to describe the role that CDC plays in public health
preparedness and response including those responsibilities
under the Pandemic and All-Hazards Preparedness Reauthorization
Act.
Today, I will highlight CDC's role in protecting the Nation
against health threats and I will describe that in three areas:
preparedness, protection, and response. Within that discussion,
there are three themes that I would like you to appreciate:
first, the work that CDC does every day in public health lays
the foundation for responding to emergencies; second, CDC's
world-class scientific and medical expertise ensures we are
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 responses.
Let me first address the issue of preparing 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.
Our 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. Cities
Readiness Initiative funds the Nation's 72 largest cities to
develop and test plans to receive and dispense medical
countermeasures from the Strategic National Stockpile.
Turning now to detecting threats, CDC's laboratories and
surveillance systems are able to detect and identify agents
causing illness, whether that cause is microbial or from
chemical or radiation exposure. Every year, laboratories from
all over the world send several hundred thousands of specimens
to CDC because they know that we will be able to identify
pathogens other laboratories cannot.
Rapid identification of disease permits intervention before
a health threat becomes a crisis. CDC's laboratory response
network maintains an integrated, scalable, and flexible system
of 153 Federal, State, and local laboratories. The development
of this network over the past 15 years has provided a larger
capacity to test and report more quickly than was possible
before. For example, during the Zika outbreak, CDC and other
laboratory response network laboratories processed over 207,000
specimens.
Now, turning to response, when there's a crisis, CDC
responds. We are able to deploy scientific and medical experts
anywhere in the world. For example, by the end of the 21-month
Ebola response, 3,700 CDC staff, more than a quarter of our
workforce, shifted from their day-to-day duties to assist in
the response. Fifteen hundred staff deployed to West Africa,
accounting for over 2,000 trips. Today, we are responding to
the much smaller outbreak in the Democratic Republic of Congo.
During health emergencies, CDC communicates. For example,
during the 2009 H1N1 response, CDC held 39 press conferences
and 21 telebriefings. During the Zika response, CDC published
51 morbidity and mortality weekly report articles ensuring that
the public and health professionals had the latest and best
information. Being able to prepare for, detect, and respond to
public health threats is a top priority for CDC. Our
preparedness and response capabilities are built on a broad and
deep scientific medical and program expertise. Our longstanding
partnerships with State, local, and public health authorities
assured an integrated approach wherever that approach is
needed, resulting in better responses and better public health
outcomes.
Thank you for the opportunity to testify here today. I look
forward to answering your questions.
[The prepared statement of Admiral Redd follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Dr. Redd.
Ms. Abram, you're recognized for 5 minutes, please.
STATEMENT OF ANNA ABRAM
Ms. Abram. Thank you.
Chairman Burgess, Ranking Member Green, and the other
members of the committee, thank you for the opportunity to
appear today and discuss reauthorization of the Pandemic and
All-Hazards Act, or PAHPA.
Medical and public health preparedness and response is of
critical importance to the health and security of our nation
and I am pleased to be here today to share how FDA is working
toward the shared goal of making sure we have the medical
products we need to protect Americans from a range of public
health threats, whether naturally occurring, like a pandemic,
or the result of a deliberate attack.
We are reminded of the urgency and need to remain ever
vigilant against identified and emerging public health threats
as we carefully monitor the current outbreak of Ebola virus
disease, this time in the Democratic Republic of Congo. I can
assure you that FDA is dedicated to helping end this outbreak
as quickly as possible and we are actively engaged with our
Federal colleagues testifying here with me today, as well as
with medical product developers, international organizations
including the World Health Organization, to support
international response efforts. This most recent Ebola outbreak
accentuates the continuing threat posed by emerging infectious
diseases, which can and often do emerge with little to no
warning and the need for us to continue to optimize our
preparedness and response capabilities.
PAHPA, which was passed in 2006 and reauthorized in 2013,
in addition to other key pieces of legislation that has served
to significantly strengthen our nation's preparedness and
response capabilities to respond to public health emergencies
involving chemical, biological, radiological and nuclear--or
CBRN--threats as well as emerging infectious disease threats
such as the Zika virus, Ebola virus, and pandemic influenza.
Prior to joining FDA, I worked for more than a decade on
health care policy with your colleagues in the United States
Senate, serving as a health policy director to U.S. Senator
Richard Burr from North Carolina on the Health, Education,
Labor, and Pensions Committee for many years. In that capacity,
I collaborated with colleagues serving in the United States
House of Representatives, including this committee, and it's
nice to see some of those colleagues here today. I was actively
involved in working on a range of health care issues and my
tenure was very much highlighted by my work on medical and
public health preparedness and response issues including the
bipartisan 2013 PAHPA Reauthorization ACT, or PAHPA, and more
recently the 21st Century Cures Act.
PAHPA recognized the key role FDA plays in emergency
preparedness and response and codified and built on FDA's
ongoing efforts to augment our review processes and advance
regulatory science to enable better response to public health
emergencies and emerging health threats. The provisions in
PAHPRA have been critical to FDA's efforts to drive innovation
in the medical countermeasure space and have provided FDA with
essential tools that continue to support our mission to protect
and promote public health.
At FDA we've made it a priority to utilize these
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
medical countermeasures as part of advancing public health and
strengthening our national security.
We share Congress' goal to have safe and effective medical
countermeasures available in the event they are needed and we
have made key progress towards this important goal. As of the
end of fiscal year 2017, FDA has approved, licensed, or cleared
121 medical countermeasures including supplementals to
approvals, licensures, and cleared medical products. We have
issued more than 60 emergency-use authorizations since 2005,
including about 40 since 2013, including for Ebola and Zika.
Medical countermeasures can face unique development challenges
that require medical product sponsors to rely on animal models
because even efficacy trials would not be ethical.
PAHPRA required FDA to issue final guidance regarding the
development of animal models to support the approval and
clearance of medical countermeasures. FDA finalized this
guidance in October 2015 and to date, 13 medical
countermeasures have been approved under the animal rule,
including the approval of a new indication for a medical
countermeasure to increase survival of adult and pediatric
patients acutely exposed to myeloid suppressive doses of
radiation as could occur after a radiological or a nuclear
event. This is the third FDA-approved medical countermeasure
that is indicated to increase survival in patients exposed to
myeloid suppressive doses of radiation.
Other approvals under the animal rule include inhalational
anthrax therapeutics of botulism antitoxin, antibiotics for the
treatment and prophylaxis of plague, prophylaxis against the
lethal effects of some nerve agent poisoning and treatment of
known or suspected cyanide poisoning.
We have been actively implementing the new authorities
within our medical countermeasures initiative, specific to our
engagements with the Department of Defense as well. In January
of 2018, the agency launched enhanced engagements with the
Department of Defense under a joint program to prioritize the
efficient development of safe and effective medical projects
intended for our U.S. military personnel.
We are fully committed to working with our colleagues at
the Department of Defense to support the needs of our U.S.
military personnel and look forward to continue to enhance
collaborations in these endeavors.
Finally, I am pleased to share that today we are releasing
our medical countermeasures initiative program update which
highlights the many notable achievements the agency has made to
advance the development and availability of safe and effective
medical countermeasures in fiscal year 2017. This report
provides an in-depth insight into the breadth of activities and
the progress FDA has contributed to our nation's medical
countermeasure assets.
FDA remains deeply committed to working closely with its
partners and fully using the authorities and resources Congress
provides us to advance this mission.
We look forward to partnering with this committee and the
Senate in the reauthorization of PAHPA. Thank you again for the
opportunity to testify today and I would be happy to answer any
questions.
[The prepared statement of Ms. Abram follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Well, I thank you for your testimony. I thank
all of our witnesses for their testimony. We will proceed to
the question and answer portion of the hearing.
Let me recognize myself for 5 minutes for questions and, as
always, I will run out of time before I finish questions. So we
will be submitting some for the record.
Ms. Abram, let me just ask you, several years ago in the
middle of a flu epidemic in Fort Worth, Texas, I came home one
Thursday night to the Channel 8 news and they said the FDA was
making available expired Tamiflu to the area hospitals.
So, as you can imagine, Dr. Hamburg and I had a call the
next morning, and she assured me that expired Tamiflu would in
fact be just as efficacious. But as far as the Strategic
National Stockpile goes, do you try to rotate stock in and out
so we don't end up with an expired national stockpile?
Ms. Abram. So FDA supports the Strategic National Stockpile
very much from a technical and regulatory perspective. Congress
has given us the authorities to help to extend the shelf life
of products.
So we will look at products to see if--even if they have a
certain expiration date that they've been assigned whether or
not it would be appropriate and they could still convey a
therapeutic benefit if they were used.
And I don't know if my colleague would like to add anything
further to that.
Admiral Redd. That's exactly right. The products are maybe
labeled expired but they're tested to assure that they haven't
expired.
Mr. Burgess. So, Dr. Kadlec, let me just ask you--of
course, we had Ebola in Dallas, Texas, a few years ago and
recognized the unified response was certainly necessary in that
public health emergency and all systems need to be able to
coordinate their efforts at the Federal, State, and local
level.
So can you perhaps enlighten us further how ASPR would
identify partners who would be involved in this collaboration
and enhance our medical surge capacity?
Dr. Kadlec. Yes, sir. In fact, during this Ebola outbreak
we've--the secretary asked me to basically lead the
coordination across the department. So we've been holding
regular conversations with HHS partners as well as other
Federal interagency partners to do two things.
One is establish whatever is needed to support the response
overseas, keep the disease over there rather than over here,
and the second one is making sure that our capabilities
domestically are prepared.
We do have the National Ebola Treatment Network that was
created with supplemental funding that runs out in fiscal year
2019 that created three national centers for the treatment of
Ebola patients as well as 10 regional centers in addition to
the NIH clinical facility here in Bethesda. So it was basically
assuring that the training, the equipping, and the requirements
were all up to date in terms of if their case should show up on
our soil how would we respond.
Second is mobilizing the assets that were funded largely by
BARDA, though NIH had some significant capabilities to include
diagnostics that were basically made available and donated by
the company to DRC as well as vaccines that BARDA supported
with Merck that was deployed and has immunized and the folks
down there, the responders, have immunized 1,100 folks so far
in vaccination.
So there have been a number of activities that we've
monitored, coordinated on, and just ensured that we had
everything ready to go should this outbreak take a different
turn than it has so far shown.
Mr. Burgess. What we discovered 2 \1/2\ years ago, whenever
the previous outbreak occurred, is a state like Texas, where
you have got some big distances between communities, hospitals
did form networks and were agreeable to helping each other at
the same time. If you had a car show up with a group of folks
where high index of suspicion for a problem, all of the assets
in a local area could be consumed very quickly.
Are you looking at how to deal with that?
Dr. Kadlec. Yes, sir. And beyond those 10 regional
treatment centers we've also had 60 designated state Ebola
treatment centers and 178 Ebola assessment hospitals. So we've
really focused on the concentration of those skills and
supplies necessary for those leading edge hospitals or clinics
to basically initially evaluate patients, safely do so for
themselves and for their patients and then make the referrals
up the chain to higher levels of care and treatment.
Mr. Burgess. Let me ask you this. You stressed strong
leadership several times in your testimony. I am grateful that
you are where you are. I want you to be there.
But just in general, as far as your position is concerned,
there are some jurisdictional issues. There are some
Interagency issues. There has been some discussion about
designating the office of the vice president as part of that
central command. What are your thoughts about that?
Dr. Kadlec. Sir, in an operational sense, I think the ASPR
performs a function as part of the national response plan. In
terms of orchestrating probably beyond the operational levels
of the strategic levels, particularly for resourcing, having a
friend or an ally at senior levels in the White House is a good
thing.
Having served as a special assistant to the President
during the Bush administration--the second tour--I can only say
that having support by the vice president or someone of stature
like his would be exceptional and very force multiplying in
terms of having the support to get the resources to support
what we need to do at the operational or at the tactical level.
Mr. Burgess. Thank you, and my time expired. I will
recognize the gentleman from Texas, Mr. Green, 5 minutes for
questions, please.
Mr. Green. Thank you, Mr. Chairman.
Dr. Kadlec, antibiotic resistance is a real and growing
problem. I think we all agree to that, that in occurring
pandemics, chemical, biological, radiological, and nuclear
attack medical counter measures need to be able to treat the
initial injury from these attacks.
But, as you know, these patients may be suffering from
burns and wounds, for example, that are susceptible to
secondary bacterial infections. Antibiotics are an integral
part of that with the growing threat of antibiotic resistance
in public health as well as preparedness and response efforts.
Can you tell us what role you see BARDA playing in shoring
up this pipeline of new antibiotics?
Dr. Kadlec. Well, thank you for the question, sir, and
BARDA has been very active in this area. They set up a program
called CARB-X which is an active program, which is interesting
because it really forms as a model for what we believe the
DRIVe program will look like.
It's the idea of creating public-private partnerships and
in this case CARB-X and BARDA has basically interactions with
28 different companies who make novel anti-bacterial drugs,
vaccines, or diagnostics, and as a result of that, there have
been identified eight new classes of antibiotics. So that's
important. But, significantly, for the taxpayer, $70 million of
Federal investment by CARB-X has resulted in about $485 million
in private equity following that investment.
So not only are we trying to create new avenues and
interest in this area which, quite frankly doesn't have a large
commercial market for the drug companies, but we've worked
effectively with the private sector to build, I think, the
requisite investment to identify promising candidates that we
can move through the developmental cycle and pathway to
ultimate licensure.
Mr. Green. There are not enough new antibiotics in the
pipeline. Almost 75 percent of those products in clinical
development are based on previously-approved classes of
antibiotics. Novel structures and approaches are needed to stay
ahead of the resistance--innovative preclinical antibiotic
approaches.
CARB-X is a global public-private partnership with BARDA
and NIAID and other global partners ensure that a robust
pipeline of preclinical innovation candidates that a product
protect human health from the most serious bacterial infection.
Can you describe how BARDA, CARB-X, and NIAID are working
to ensure that there are enough preclinical products moving on
to clinical trials?
Dr. Kadlec. Well, sir, they do so by a variety of methods.
Part of it is active--I want to say query which is part of it.
And again, I will just use the example that we hope to build on
is using innovation accelerators around the country to
basically identify promising candidates that could be
antibiotics or antimicrobials that would be part of this CARB-X
program or part of the larger innovation program.
So the thing is is that we work closely with NIAID on this.
We do work with the Wellcome Trust as other organizations as
well as with companies to basically identify these.
Obviously, it's going to take long-term constant vigilance
and, again creating new drugs is just part of the challenge, as
Dr. Burgess would identify. Part of it is basically monitoring
the environment and I think Dr. Redd can highlight on those
pieces as well as practices by physicians in prescribing
antibiotics. Dr. Redd.
Admiral Redd. Yes. First of all, I want to acknowledge the
significance of the problem, that if we run out of antibiotics,
not just treatment of infects but things like cancer therapy
and surgery are going to be much more difficult than they are
today.
In addition to developing new products, there are steps
that need to be undertaken and are being undertaken in the
public health domain. First is just preventing infections in
hospitals--that bacteria in hospitals is where real resistance
is bred.
Secondly is tracking and identifying infections when they
occur with resistant organisms so that intensive infection
control measures can be undertaken to prevent the spread of
those organisms to other individuals.
And then thirdly, improving the prescribing of
antimicrobial--that if these drugs can be limited to the people
who really need them, that will also slow the development of
resistance.
Mr. Green. Is there any overlap between the CDC's
investment in antibiotic resistance laboratory network and what
ASPR does?
Admiral Redd. There's not. We are funding laboratory
testing as part of the surveillance system to identify
resistant organisms so that those interventions can be
undertaken to prevent their spread.
Mr. Green. Well, and I want to thank the CDC because in
2005, after Hurricane Katrina in Louisiana, Houston, Texas got
about a quarter of a million people from south Louisiana, and
CDC was there bringing in the medications and also the public
health officers to help our local medical schools and our
hospital system.
So CDC is very valuable, and I yield back my time, Mr.
Chairman.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
The chair recognizes the gentlelady from Tennessee, Mrs.
Blackburn, 5 minutes for questions, please.
Mrs. Blackburn. Thank you, Mr. Chairman.
Ms. Abram, I want to come to you for just a minute and talk
a little bit about the stockpile and the definition that is
there. It is in statute, defined to include drugs, biological
products, or devices.
And until 2016, when we passed 21st Century Cures and
included in that the Software Act, which deals with medical
technology, medical software had been included in that
definition of medical devices. And what happened or what we did
in that was to remove some classifications of medical software
from FDA oversight, and I know that you're familiar with the
legislation and familiar that FDA is still in the process of
implementing that law and making those determinations which
products are going to go where. And we recently--I think it was
the end of December--received more guidance documents to that
fact.
So what I wanted to know from you is are there any types of
medical software or applications currently in the stockpile
that no longer fall under the device definition?
Ms. Abram. Thank you so much for the question. You alluded
to this and mentioned it in your remarks. Yes, we are actively
implementing a number of the provisions that were enacted as
part of Cures including delineating in a risk-based manner the
regulation of various devices and the software kind of
components that get into that.
Traditionally, much of what has been procured into the
stockpile has focused more on vaccines, therapeutics,
diagnostics, and some of the other materiel--for example, I
believe, like, personal protective equipment would be something
purchased there.
And I would like to acknowledge that one of the additions
to the draft that was released over the past week includes the
concept of cyber security, which is, of course, a very
important matter.
Mrs. Blackburn. OK. Let me ask you this. Would you
recommend that we amend the definition of security
countermeasures to include medical software in applications
when there is a clear need that some of these products may need
to be procured?
Ms. Abram. So the addition of the cybersecurity references
and the context of where that may interface here with the
software considerations and device considerations has raised
some novel questions and considerations.
And having just recently received the text we are having
our subject matter experts look at it quickly because we
understand this is an area of interest for the committee and we
want to make sure we are providing very thorough and thoughtful
input on these points because, as I mentioned, cybersecurity
is, obviously, a very serious concern and we want to be
responsive to it. We have looked at it in the context of
devices form a total produce life cycle approach. At the same
time, much of the framework that you're referencing has
traditionally been looked at in a CBRN context.
So this does raise some new questions for us. But we look
forward to working with the committee and providing technical
assistance.
Mrs. Blackburn. Well, I think that--and probably Ms. Eshoo
and Mrs. Brooks would agree with me--when you all conduct that
oversight and look at this and formulate an opinion, I think we
would like to have that----
Ms. Abram. Absolutely.
Mrs. Blackburn [continuing]. And include it in the
information from this hearing.
Ms. Abram. Absolutely. We'd be happy to follow up.
Mrs. Blackburn. OK. That would be great.
Kadlec, let me ask you a little bit about--we've had a bill
here, the Good Samaritan Act, and of course, there is part of
the language included in the Senate HELP's version of PAHPA,
and I have worked on this for several years and I am
appreciative that it is included. Part of that language is
included here.
But I am interested to hear your thoughts on how we can
truly harness the services of health care professionals who are
willing to volunteer their skills during emergencies.
And, after Katrina we saw the need to get people into the
area. After the Boston Marathon bombing, we saw the need to get
people in.
So I would love a quick response on that.
Dr. Kadlec. Well, thank you, ma'am, for the question. And,
clearly, there's a real significant role for volunteers in this
situation. I think the best case scenario is when they identify
before the crisis or the disaster happens and there are two
programs that allow that--Medical Reserve Corps and ESAR-VHP,
which is a volunteer program to allow people to enroll so they
can be identified.
I think the key thing is is, as many know, that sometimes
even though volunteers come forward, their ability to help is
going to be based on their knowledge and training. And so we
would prefer that those people would be identified before an
event and then we have confidence what to do and the right
things to do so they do not cause any further injury or harm.
We are very supportive of volunteers. They're a critical
part of the response as we've seen historically and we know in
the future they'll be there as we witnessed in the cases of
several events recently. So very supportive of this notion.
Mrs. Blackburn. I yield back.
Mr. Burgess. The gentlelady's time has expired.
The chair now needs to recognize the gentleman from New
York, Mr. Engel, 5 minutes for questions, please.
Mr. Engel. Thank you, Chairman Burgess and Ranking Member
Green, for holding this very important hearing.
I don't think we'll have properly considered pandemic
preparedness without discussing the threat of antimicrobial
resistance, a serious international drug crisis wherein
diseases are able to resist the very drugs meant to destroy
them.
To underscore the seriousness of antimicrobial resistance,
I want to talk about tuberculosis, or TB, not only because
Ranking Member Green and I are two of the co-chairs of the
House TB Elimination Caucus, because TB and airborne infection
kills more people worldwide than any other infectious disease,
and drug resistant TB is the most common and deadly airborne
antimicrobial resistant disease.
Cases of anti-resistant TB cost much more to treat than
drug-sensitive TB in cases of multi-drug resistant TB, and
extensively drug-resistant TB unfortunately becoming much more
frequent. While we may typically think drug resistance is
caused by inappropriate treatment, most drug resistant TB cases
are now caused by transmission from person to person, making it
much easier for drug resistant TB to spread to new parts of the
world.
History has shown us that we cannot stop infectious threats
with isolationist policies. We need to invest in new tools to
keep Americans safe and the growing threat of antimicrobial
resistance and the very real possibility that one day,
unfortunately, there might be a drug-resistant outbreak in the
United States.
So Dr. Kadlec, let me ask you what more can BARDA do to
spur the development of novel antimicrobials and ensure that we
have the tools we need to address antimicrobial resistance and
improve health security in this country?
Dr. Kadlec. Thank you, sir, for the question and, again, I
would just, again, like to reemphasize the role that BARDA does
have in this area, working closely with NIAID and with foreign
activities Wellcome Trust to basically create CARB-X, which is
really the opportunity to pool resources to promote research
into a variety of different potential candidates.
I mentioned the possibility of eight new classes of
antibiotics. To this date, 30 potential high-quality
antibacterial products have been identified and are being
evaluated for this. So I think part of this is is realizing
that there is an ongoing activity that BARDA is working with
NIAID on. It's informed by CDC in terms of its role subject to
monitoring the environment and identifying those cases and
evaluating the sensitivities of those organisms, whether it be
TB or anything else, quite frankly, and the ability to evaluate
what we can do to promote renewed interest and research and
commitment not only by the government but also by the private
sector into these areas.
Mr. Engel. Thank you very much.
Let me also say, to truly protect Americans from health
threats I believe we, obviously, cannot limit our focus to
threats within the United States itself.
So Dr. Redd, you know from your years of service, including
during the 2009 H1N1 pandemic and the 2014 West Africa Ebola
outbreak, the disease that knows no borders, do you think it's
important for the U.S. to evaluate the global threats to health
security to ensure that we are prepared to face these threats?
Admiral Redd. Yes, sir. The work that has been done to
strengthen global health security since 2014 is very important
and needs to continue.
I think our work in the Democratic Republic of Congo is
emblematic of the kinds of threats that we need to be able to
detect and, working with host countries, contain at the source.
Mr. Engel. Thank you.
Ms. Abram, would you like to comment on any of the things
that I've mentioned?
Ms. Abram. I would just further add to some of the comments
that my colleagues have made is that FDA is also actively
involved in helping to foster and bring forward next-generation
of antibiotic products.
We've been implementing the GAIN Act provisions and we've
also been actively implementing the break points provisions
that were included as part of the Cures Act, which are very
helpful in helping to inform providers of proper utilization of
the antibiotics that are available to treat.
Mr. Engel. Thank you.
Thank you, Mr. Chairman. I yield back.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman.
The chair recognizes the gentleman from Illinois, Mr.
Shimkus, 5 minutes for your questions, please.
Mr. Shimkus. Thank you, Mr. Chairman. It's great to have
you all. Thanks for your work.
Anyone who's followed this committee knows that I've been
working on the antimicrobial resistance front for many, many
years. Good to see folks who have been in this battle.
You probably heard me say that we need to develop products
we hope we never has to use. The fact is we are in a race, you
all know, against antibiotic resistance by bacterial and fungal
pathogens and we are losing because these diseases are
developing resistance faster than our efforts can develop new
agents. And BARDA is very valuable to these efforts, but it's
clear that BARDA's work, even combined with commercial
potential, isn't enough.
FDA Janet Woodcock, CDC's Tom Frieden, and the National
Institute of Allergy and Infectious Diseases, and NIAID's
director, Tony Fauci, have joined every major country's
assessment, acknowledging that there is simply very little
incentive for biopharma companies to do the necessary R&D.
I want to first go to Dr. Kadlec but others can chime in if
they'd like. Can you comment on why antibiotics are a focal
point of BARDA's work?
Dr. Kadlec. For two reasons. As you defined, it is a public
health challenge but, quite frankly, it's inextricably linked
to the issues that relate to other threats that may happen--
emerging infectious disease as well as deliberate threats.
So it would be a circumstance that you could anticipate I
think as highlighted before either in cases of radiation
exposure where the immune system is depressed or burns where
the immune system is compromised. Infection becomes a
significant consideration as well as if you had the intentional
use of infectious diseases.
Mr. Shimkus. Would you agree that the situation is dire?
Dr. Kadlec. Sir, it's difficult and, depending on the agent
or organism you're talking about, it can be dire, and for the
individual who's afflicted by it, it is dire, quite honestly.
Mr. Shimkus. Can you commit or will you work with my office
and this committee on solutions that spur the proper level of
critically-needed antimicrobial development?
Dr. Kadlec. Yes, sir.
Mr. Shimkus. Mr. Green and I have been trying to deal with
this over the past couple years. He did touch on this issue and
you mentioned the ongoing activities.
But it's my understanding that these efforts may fall short
when it comes to incentivizing development. Anyone want to
comment on that observation? Admiral.
Admiral Redd. I think the point I was going to make is that
these products are used in a system and the detection and
infection control procedures and assessment of effectiveness
are all part of to ensure that these products are used to
obtain the greatest effect.
More products are, clearly, needed but we also need to do
better in who is prescribed antimicrobials, making sure that
there is as narrow a spectrum as is possible and, hopefully,
that race we can kind of slow down the spread and evolution of
resistance so that as new products develop they'll be effective
for longer periods of time.
Mr. Shimkus. Go ahead.
Ms. Abram. Yes, I was just going to add, there's another
facet to this that I think is important and you actually
touched upon this in the opening of your question, which is
around the development of products that you hope to never have
to use but you may need to use.
And so one of the aspects of actually being able to capture
some of this data and real-world experience with the
utilization of antibiotics and these other naturally occurring
circumstances helps to add to our data set for understanding
how these products might be used in the event of a bioterrorism
event.
Mr. Shimkus. And I've always been concerned. My observation
is that they're too small. I always talk about raising capital,
assuming risk and a return. Now you want to raise capital,
assume risk, hoping never to get a return.
And even though there's attempts being made to encourage
that we just--I still think it's too small, based upon the risk
out there.
So go ahead.
Dr. Kadlec. Sir, I think you're kind of highlighting the
issue of kind of two kind of categories of incentives. One is
the push--what can we do to help companies be successful in
their endeavor to bring new antibiotics or class of antibiotics
to the table, and then what's the pull--what's the incentive on
the other side that would kind of somehow offset the cost,
either opportunity or real, to execute that.
We are actively looking at that. I think in the past
Congress has responded in terms of the priority review
vouchers, obviously, the incentives in terms of investments
into this are.
But we are trying to evaluate what is the road to success
and what's a sustainable road to success, which is another
story here in terms of looking at incentives over time that
make sense as well as are affordable.
Mr. Shimkus. Excellent. Thank you very much.
Yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
The chair recognizes the gentlelady from Illinois, Ms.
Schakowsky, 5 minutes.
Ms. Schakowsky. Thank you, Mr. Chairman, and I want to
thank our panelists all for being here.
One absolutely essentially part of disaster preparedness is
having the workforce in place to respond to public health
emergencies and the workforce is, of course, the backbone of
disaster preparedness, in my view, and that's why I am proud
I've introduced H.R. 5998, which is the Securing Experts to
Control, Understand, and Respond to Emergencies--or the SECURE
Act--to support and build a robust disaster preparedness
workforce and the bill would actually simply reauthorize the
education loan repayment program for the Epidemic Intelligence
Service--EIS--at the Centers for Disease Control.
So I am hopeful that this program can be reauthorized and
make it a part of the underlying bill. EIS officers are health
professionals who serve on the front lines of public health
emergencies as boots on the ground, disaster detectives who
investigate outbreaks and assist during natural disasters. And
since its creation in 1951, the EIS program has trained more
than 3,600 officers and based in state and local public health
departments across the country. EIS officers are deployed more
than 200 times every year, responding to public health
emergencies at home and abroad.
So Dr. Redd, I wanted to ask you how important in our
ability to recruit this workforce is this program, the loan
repayment program?
Admiral Redd. So I agree with you that the Epidemic
Intelligence Service, or the EIS, is a major asset for CDC and
the country. It's a major vehicle to recruit health
professionals and, in particular, physicians to public service.
I was actually an EIS officer quite a few years ago. The
proportion of physicians that have been included has decreased
over the years and I think that probably--that is a part of
that.
I am not going to specifically address your bill but I can
say that for myself when I came to the EIS program I did have
student loans and it would have been an incentive to have some
method to have those loans repaid.
I think it is really critical that we continue and
strengthen the EIS program.
Ms. Schakowsky. So why don't you tell us all what EIS
officers--how they protect the public's health, what kind of
events do they respond to, and what role do they play in
responding to those events?
Admiral Redd. Sure. So Epidemic Intelligence Service
officers either have doctorate degrees in public health
sciences or in medicine, generally finish their training, come
to CDC for post-graduate training. So the EIS program is a 2-
year experiential training program.
Officers are assigned either within CDC or with state and
local health departments and the experience part is
investigating outbreaks. For example, I investigated a
Legionnaire's disease outbreak in California as part of my EIS
experience, working with state health departments and local
health departments to identify risk factors and implement
control measures.
It's a great lead-in to public service and to public
health----
Ms. Schakowsky. That's really what I wanted to get at.
After the EIS 2-year training period, 85 percent of EIS
graduates enter the public health workforce.
So I think what I am hearing you say and I would agree that
EIS acts as a pipeline for the next generation of health care
leaders and contributes to a strong workforce. Would you agree?
Admiral Redd. Absolutely. As a personal matter, I am pretty
sure I wouldn't be here today if I hadn't done the EIS program
a number of years ago.
Ms. Schakowsky. Well, thank you. I know you can't comment
on the legislation but I am going to really try and make sure
that this incentive to get more people into this program is
part of the legislation.
Thank you so much for your service.
Mr. Burgess. The gentlelady yields back. The chair thanks
the gentlelady.
The chair recognizes the gentleman from New Jersey, Mr.
Lance, for 5 minutes.
Mr. Lance. Thank you, Mr. Chairman.
Good morning to the distinguished panel. Dr. Kadlec,
scientists and drug companies are looking to discover and
develop approaches other than traditional antibiotics to combat
bacterial infections and these can range from using viruses to
attack the bacteria, creating vaccines to prevent hospital-
acquired infections, applying known successful interventions in
treating cancer by changing the way the human immune system
responds to infections.
Scientists harness cutting-edge science that will combat
bacteria in new ways and potentially reduce risk of resistance.
Would you please talk about BARDA's role in fostering the
discovery and development of non-traditional approaches?
Dr. Kadlec. Sir, BARDA is very interested in those kinds of
approaches and, quite frankly, I think it's part of the
innovation side that was required through 21st Century Cures
Act is now building a program to actually look for those kind
of innovative ideas.
To your point about viruses to beat bacteria, that's phage
technology, which BARDA is actively investigating and actually
looking at different programs that exist that could be relevant
in terms of addressing--again, a novel way of addressing
antimicrobial resistance.
Every bacteria has a counter virus that effectively can
either disarm it, kill it, or potentially change its antibiotic
resistance patterns. And so those are things that are actively
being investigated right now. It is, I think, one of the areas
that probably deserves more consideration. We welcome the
opportunity through the 21st Century Cures Act to open these
new doors to innovative approaches and to maybe non-traditional
approaches and we look forward to Congress' continued support
to do more of that, going forward.
Mr. Lance. Thank you very much, Doctor.
To the panel in general, the Presidential Advisory Council
on combatting antibiotic-resistant bacteria was created under
an executive order in 2014 and has twice been continued, most
recently in 2017.
The Advisory Council is set to expire on September 20th,
2019, unless there is another continuation by executive order.
Considering the danger posed by antibiotic-resistant bacterial
infections, the fact that this remains quite high, is there any
reason why the Advisory Council should not be extended to
continue its mission to produce reports and recommendations
that influence Federal combating antibiotic-resistant bacteria
activities both here and abroad?
Admiral Redd. Well, I think this problem is going to be
with us for the foreseeable future. So I think that, regardless
of the exact structure used to organize our response to that,
this will be a problem that we'll be facing for years and years
to come.
Mr. Lance. So that means, I assume, that looking in the
future we probably should extend this beyond the current
deadline?
Admiral Redd. I think that's a decision that won't be mine
to make. I think we'll have to look at what progress we've made
and how that panel had encouraged that progress.
Mr. Lance. Thank you.
Would anyone else on the panel like to comment?
Yes. Go ahead.
Ms. Abram. I was just going to add, there's,
understandably, a considerable amount of interest in the
antimicrobial-resistant issues and one point I haven't made, be
remiss if I didn't, is also the importance of regulatory
certainty when it comes to bringing forward the next generation
of antibiotics products and they, like other medical
countermeasures, can face unique development challenges.
And so one thing that FDA has also been very focused on is
putting out product-specific guidance. For example, we've
issued guidance on the clinical trial design for specific
diseases including prophylaxis of inhalational anthrax.
And so we are trying to do our part, what we can to help
make the pathway as clear as possible, recognizing that there
are some inherent challenges that have been discussed at length
at the hearing.
Mr. Lance. Thank you very much, and please keep up the good
work--a very distinguished panel.
I yield back 37 seconds, Mr. Chairman.
Mr. Burgess. The chair is overjoyed and thanks the
gentleman for yielding back.
The chair now recognizes the ranking member of the full
committee, Mr. Pallone, 5 minutes for questions, please.
Mr. Pallone. Thank you, Mr. Chairman. I am trying to get in
some questions about the Strategic National Stockpile and also
the priority review vouchers. So try to be quick in answering
the questions.
Dr. Redd, I am interested in learning more about CDC's past
work in leading the Strategic National Stockpile. Can you
describe the range and type of deployments as well as the types
of products CDC has delivered through the SNS program?
Admiral Redd. Thank you for that question.
There have been in the neighborhood of a hundred
deployments since the formation of the Strategic National
Stockpile. Many of these are very small deployments, for
example, for treatment of adverse reaction to smallpox
vaccine--vaccinia immune globulin--also for containing or for
treating people who've been involved in a botulism outbreak
with the antitoxin.
The largest deployment of the stockpile was during the H1N1
pandemic. A quarter of the stockpile of antiviral drugs--about
12 million treatment courses--were distributed to states. Also,
personal protective equipment was distributed.
Another product that is frequently distributed--it's called
Federal medical stations. These are basically hospitals but
without the building. They've been deployed for the hurricanes.
About every other year there's a significant deployment of
Federal medical stations.
Mr. Pallone. OK. How does CDC help ensure that State and
local health departments are ready for the last-mile deployment
of the SNS in which items are dispensed to the public in the
event of a public health emergency?
Admiral Redd. Well, the state and locals have a very
important responsibility to assure that products are dispensed
quickly and in accordance with guidelines.
So we've been working through really two different parts of
our state and local program. The Cities Readiness Initiate
funds states to develop those systems.
We also have an assessment process called the medical
countermeasure operational readiness review where we have
worked with each of the grantees and, in fact, the grantees
have worked with their subgrantees and local departments--
around 500 assessments of state and local capability. The
things that we found in that are that there are some areas
where we need to improve.
The capability to dispense from a manpower standpoint, the
staffing and then also staffing for security areas that are not
universally but pretty general challenges that state and local
health departments face.
Mr. Pallone. All right. Thanks.
I understand that some of these training activities are
funded through the SNS program appropriations. So, Dr. Kadlec,
will SNS funding continue to be used to pay for these important
training activities?
Dr. Kadlec. Yes, sir. I think the key thing is
understanding in this transition of oversight that nothing, and
nobody's moving, if you want to call it that, and we are
leveraging all the resources and expertise that CDC has offered
in the past.
And, again, to highlight one thing that Dr. Redd talked
about is in a recent preparedness summit that was held in
Atlanta, we did an informal survey of state and local
authorities about what kind of help they need. And so what we
found out is true to his characterization they need more people
to help deploy and dispense these kinds of things, particularly
if they were interested in the opportunity for residential
delivery or potentially capitalizing on retail distributors
that could be used to distribute some of these products in the
event of an emergency and that's maybe the one, if you will,
new area that we are hoping to work with CDC, going forward, is
using our state representatives from ASPR to basically work
together to help more on the sense of what can we do nationally
to help state and local authorities do that. Part of it may be
mobilizing the Federal workforce, which has been considered
before. Part of it may be looking at alternative means to help
with residential delivery. People have suggested even Amazon.
And then the third area is really about what can we do with
retail outlets that could basically facilitate for this. And so
in the end, I think what we hope to build is a stronger
partnership with our state and local authorities, realizing if
they're not successful, no one is successful, and that is our
intent is to basically build on the past success of the
programs and basically further extend them to support state and
local authorities.
Mr. Pallone. All right. Thank you. I wanted to ask about
priority review voucher but I think I've run out of time. So I
will have to get back to you on that. Thank you.
Mr. Burgess. Gentleman yields back. The chair thanks the
gentleman.
The chair recognizes the gentleman from Ohio, Mr. Latta, 5
minutes for your questions, please.
Will the gentleman suspend? I didn't realize Mr. Barton had
come on the end of the dais. The gentleman----
Mr. Barton. I will only take 2 or 3 minutes.
Mr. Burgess. The gentleman is recognized for 5 minutes.
Mr. Barton. Normally, I would yield to Mr. Latta but I've
got to leave and go to another meeting. So I am just going to
be real quick.
First, thank our panel, especially Dr. Kadlec. It says that
you used to work for Senator Burr and Senator Kennedy. The
senator doesn't talk about it but he used to be a congressman
on this committee and he and I worked on what's now Medicare
Part D, the prescription drug benefit, way back when and, of
course, Senator Kennedy helped me tremendously on what was the
reauthorization of the National Institute of Health.
Senator Kennedy has passed away but Senator Burr is still
over there and they're both good men.
So you were trained right, or maybe you trained them right.
I don't know.
Dr. Kadlec. Well, sir, Anna Abram was also trained by him
so you got a pair of us here, bookends.
Mr. Barton. Oh, well, that's good. Well, apparently, the
big controversy in the pending reauthorization is the transfer
of the stockpile from CDC to APR whatever.
I am going to start with you, Admiral. You're the one who
controls it now. Why should we keep it with you?
Admiral Redd. Well, we are implementing the transfer and so
that is a process that's underway. We've worked--been working
closely with ASPR. We've actually formed a number of committees
to make sure that the transition doesn't result in any
degradation----
Mr. Barton. So you don't oppose the transfer?
Admiral Redd. Well, I will say that we are working to make
sure that when we make the transfer it doesn't result in any
loss of capability.
Mr. Barton. It's obvious your Navy training is kicking in.
You have been giving a directive and I thought I would get a
little different answer.
Well, I will go to you, Dr.----
Admiral Redd. Let me mention a couple of areas that we are
working closely with--that in these five committees the two
areas that I think are really essential to sustain are the
linkage with subject matter expertise at CDC in the stockpile
and in the decision making process, and the other was the
question earlier about the state and local capabilities in our
work to strengthen or assure that the state health departments
are able to dispense.
That's something that we are working very closely on, I
would say, on a more than weekly basis.
Mr. Barton. OK. Well, that's a great answer.
Dr. Kadlec, why should we transfer it to your agency?
Dr. Kadlec. Well, sir, we are all in the business about
preparedness and response. I think the secretary, when he made
his decisions, thought about three things in particular--
integrating with the other operational assets that exist within
the national medical system.
There's another logistics system within HHS that supports
disaster response. The second thing is is how do we streamline
the medical countermeasure enterprise to make sure what we have
in it can be sustained and replenished over time efficiently as
well.
And then the last thing is, is to this point is how can we
better support state and local authorities in the last mile.
Mr. Barton. It sounds like your two groups are working well
together. Would you both agree with that?
Dr. Kadlec. Yes, sir.
Mr. Barton. OK. And Ms. Abram, since you don't have a dog
in this hunt, does the FDA have a position on where it should
go and if so, what is it?
Ms. Abram. The FDA stands ready to support the Strategic
National Stockpile wherever it ends up being housed.
Mr. Barton. It's a very politically correct answer.
With that, Mr. Chairman. I yield back.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman.
The chair recognizes the gentlelady from California, Ms.
Matsui, 5 minutes for questions, please.
Ms. Matsui. Thank you, Mr. Chairman. I want to thank the
witnesses for being with us today.
Some of the scariest potential attacks that the world is
vulnerable to today are now posed by chemical and biological
weapons as well as cyber-attacks. We made so much progress with
the innovation of new drugs and treatments as well as
technology. But those new advancements come with new
vulnerabilities.
We also continue to see damage from ever-increasing natural
disasters. We want our health system to be prepared to respond
to hurricanes, fires, and earthquakes as well as things like
Ebola and anthrax.
PAHPA is critical to our success in both responding to
public health emergencies including minimizing harm of any
attacks and this field is constantly changing. So we need to
keep up. I am pleased that we are working on the
reauthorization in a bipartisan manner on this committee. I
look forward to working with my colleagues, Representatives
Eshoo and Brooks, to advance their legislation.
One of the main issues that we are discussing today is the
Strategic National Stockpile supplies that can be deployed in
case of a variety of types of emergencies under discussions
which you have all been talking about with your last--in the
last witness here is the--whether it's appropriate and
necessary to transfer some SNS functions from CDC to assistant
secretary.
I am interested in hearing more of your thoughts on this.
But I want to ask a specific question related to safety of
products stored in a stockpile.
I understand that vaccines and other injectable drugs can
be contaminated by glass because the glass containers may
break, crack, delaminate, or contain glass particles.
In some cases, glass failure is a result of recalls because
they pose a potential threat to patient safety. Dr. Redd, do
you have any concerns about the impact of glass failures on the
safety, security, or sterility of counter measures in the
stockpile?
Admiral Redd. So I think the issue of assuring the safety
of the material that is stored in the stockpile is a very
important issue. The products are stored at undisclosed
locations.
There is a standard monitoring of those materials. As Ms.
Abram noted earlier, there's a process for products for which
the shelf life extension program is appropriate to test them
and make sure that they retain their capability. For products
that need to be stored at certain temperatures there is quite a
system----
Ms. Matsui. Right. How about glass in particular? Dr.
Kadlec or Ms. Abram, would you like to comment on the issue of
glass contamination?
Ms. Abram. Yes. I would be happy to take that one and thank
you for the question.
The agency, FDA, did put out information specific to some
of the analysis we have been looking at in recent years. You're
touching upon the phenomenon that can occur with glass vials.
Glass affords many advantages as a packaging. However, there
can be this phenomenon where you have these thin flexible
fragments that break off.
Ms. Matsui. Right.
Ms. Abram [continuing]. And that's something that we've
been studying to look at.
We issued an advisory in 2011 and went back and did some
pretty extensive surveillance of products on market that had
these type of vials, going back to fiscal year 2008 through
fiscal year 2017.
We've actually seen a decrease in the number of recalls
associated with particulates and so we recently shared. Based
on that analysis, we didn't see a new or emerging safety signal
or trend. We chose not to update the analysis at that time.
There's been particular interest around new glass design
and how that compares to the more traditional borosilicate
glass vials, and in that regard our studies demonstrated that
the novel glass vials exhibited improved performance in terms
of withstanding mechanical stress and scratching relative to
type one borosilicate glass vials in the study.
But we also looked at this from the standpoint of chemical
durability because, under certain stress conditions such as a
more basic environment, the novel glass vials exhibited an
improvement over one of the borosilicate glass vials. But there
was no definitive difference in performance relative to the
other borosilicate vials.
Ms. Matsui. So are you continuing to follow up on this to
ensure that, you look at the glass, ensure----
Ms. Abram. Yes.
Ms. Matsui. OK.
Ms. Abram. Absolutely.
Ms. Matsui. OK. Thank you, and I am running out of time
already. I have further questions and I will submit them.
Thank you. I yield back.
Mr. Burgess. The gentlelady yields back. The chair thanks
the gentlelady.
The chair now recognizes the gentleman from Ohio 5 minutes
for questions, please.
Mr. Latta. I thank the chairman very much and I also want
to thank our witnesses for being with us today on this very
important topic.
And Dr. Kadlec, if I could pose my questions to you right
off the bat. First of all, I want to thank you very much for
your service to our country in the Air Force for your 20 years
of service.
And as we talk about cybersecurity, I think it's really
important because this committee has been involved in very--not
only involved but concerned about what's going on out there,
and I've served on a cybersecurity task force in the past and
in the hearings that we've had so it's a huge issue.
I represent a very unique district--that I have more
community hospitals than anybody else in the state of Ohio, and
when I am out one of the things I hear from my community
hospitals is on the cybersecurity and cybersecurity threats
that they're under.
In the last Congress, Mr. Welch from this committee--from
Vermont--and I did the Internet of Things Working Group and we
heard from folks, especially when we are dealing with
telehealth and when you look at electronic medical records and
the Internet of Things what's happening on the great things
there. But then again, on the cyber side it's always a concern.
So the question I have is as I've seen in your testimony
that the healthcare sector very nearly suffered a severe cyber-
attack last year due because of WannaCry. In fact, while the
United States was spared the worst of the damage, the U.K. had
34 percent of its hospitals affected and there are numerous
other examples of recent and growing cybersecurity threats to
the healthcare sector.
All that being said, I notice that cybersecurity isn't
listed in one of your key priorities. Does this mean that
cybersecurity isn't a key priority at ASPR and, if not, is
there a part of HHS that does consider healthcare cybersecurity
be a priority?
Dr. Kadlec. Thank you for your question, sir, and I just
want to reiterate the importance of this issue as it relates to
our health care systems because they can range from hospitals
to actually individual devices that may be at risk and I think
it's important to note that in the Department of HHS that the
deputy secretary basically manages the overall cybersecurity of
the department.
And so from that standpoint, each operation and staff
division has its own cybersecurity piece of this but it's
managed and if you will--overseen at that level to ensure that
there is uniformity of policy as well as oversight and
capabilities.
Mr. Latta. Well, let me follow up then because you say the
Deputy Secretary is there, because in their report to this
committee last spring the previous HHS secretary had designated
your office as the health care sector specific agency to lead
the health care cybersecurity.
Did you agree with that designation?
Dr. Kadlec. Sir, I don't disagree with it. I think one of
the things that happened as a result of the WannaCry event is
that because the potential impacts are much greater than just
simply ASPR that they can affect CMS, FDA, CDC, all of OpDivs
and StaffDivs that I think it was the decision at that point in
time.
But to be fair to your question, sir, I will be very happy
to provide an answer for the record, if you'd like.
Mr. Latta. OK. Let me just follow up, though.
So, with the deputy secretary then because are you saying
then that you think that that--the specific and the proper
position would be having that cybersecurity control for the
HHS, then?
Dr. Kadlec. Sir, I think the fact is is that the only
person higher than the deputy secretary is the secretary to
manage the issue and I think the issue here is is that the
deputy secretary I think performs a vital function to ensure
that it remains on the forefront of everyone's consideration
for the different staff and operational divisions of HHS.
Mr. Latta. Well, if you could follow up again on that with
me I would greatly appreciate it.
Dr. Kadlec. I would be happy to, sir.
Mr. Latta. And we look forward to that.
Mr. Chairman, I am going to yield back the balance of my
time.
Mr. Guthrie [presiding]. The gentleman yields back his
time.
The chair recognizes the gentlelady from California, Ms.
Eshoo, 5 minutes for questions.
Ms. Eshoo. Thank you, Mr. Chairman, and thank you to the
witnesses for your testimony.
Just a couple of comments before I get to my questions. I
wish Dr. Bright were here today, who heads up BARDA. He
couldn't. I think there was a conflict relative to his
schedule. But I want the members to have a deep appreciation of
what BARDA has accomplished--35 approved measures in 10 years.
I don't know of a pharmaceutical company that has produced 10
major drugs in a decade. And so that really is an outstanding
record. Many members have raised the issue of the whole issue
of antimicrobial infections. Now, God forbid there's an anthrax
attack and we have something for that but you're in the
hospital and you contract a terrible infection and I think that
we are all worried about that. I don't know of conversation
with friends of mine where someone doesn't mention someone
having been in the hospital and contracted an infection.
So I want members to know that Dr. Bright is all over this.
He truly is, even in the meeting that Congresswoman Brooks and
I had just recently over at BARDA.
Admiral, you described in detail how the CDC is responding
today, and I know that we just heard Congressman Barton raise
the issue of CDC, the stockpile. I think it's important for all
members to know that the stockpile isn't moving anywhere. It's
going to remain with the CDC.
There is an administrative change here. With the shift
from--what's in the legislation from CDC to ASPR, what actually
changes for you? Do you have to get permission from ASPR to do
something? Is it that you and ASPR are going to coordinate? In
a very clear way, can you just set down in a sentence or two
what is going to change?
Admiral Redd. So thanks for that question, and you're
correct. The people----
Ms. Eshoo. Well, I know that. But just tell us what it is.
Admiral Redd. Sure.
[Laughter.]
Ms. Eshoo. You don't have to thank me.
Admiral Redd. The stockpile provides funding within CDC and
that's one of the things that we are talking about with ASPR is
what things in that mission----
Ms. Eshoo. So it's not decided yet, you're saying?
Admiral Redd. Well, some areas are, some aren't. But we are
still working on the details.
Ms. Eshoo. Well, that's interesting. All right. Thank you.
To Dr. Kadlec, always good to see you. In your opening
statement, you used the term in terms of responsibilities, one
of them territorial responsibility. It's very important.
The official government death count for Hurricane Maria,
relative to Puerto Rico, was 64. Now the New England Journal of
Medicine last week, one of the most prestigious publications in
our country, they concluded that the death toll was 70 times
higher than the official estimate.
What is ASPR doing in Puerto Rico? I think that even in the
meeting that we had we came over to the agency, you sensed my
lack of confidence in what ASPR is doing.
Dr. Kadlec. Yes, ma'am.
Let me first just comment on the New England Journal
article because I think it's important to realize----
Ms. Eshoo. Well, do you accept that?
Dr. Kadlec. I accept it that it's an estimate. I accept it
that----
Ms. Eshoo. Look, there are two and there's a chasm between
the two. So tell the committee what you're doing on the----
Dr. Kadlec. Sure, ma'am.
On the issue of the mortality rates, I've been working
this----
Ms. Eshoo. Tell us what you're doing in Puerto Rico right
now. Who's on the ground, what's being used, are people being
inoculated?
Dr. Kadlec. I just wanted to differentiate between
mortality for sure. We have 40 personnel down in Puerto Rico
right now working with the Puerto Rican Department of Health
looking how to basically make their system more resilient and
that goes to the issue of not only the hospitals, which are
both private and public, as well as federally qualified
health----
Ms. Eshoo. So you're having discussions with their public
health people. Do you have people that are administering
anything to the Puerto Rican people?
Dr. Kadlec. Based on the requests from the Puerto Rican
Department of Health, no, ma'am, at this point in time. We
basically extended our emergency prescription assistance
program that was basically providing 30 days of prescriptions
free to people.
We've left 13 DMAT caches there, which is a host of medical
supplies that we----
Ms. Eshoo. Well, my time is--my time has run out. But I
really would like a full report from you on it.
Dr. Kadlec. Sure. Be happy to. We can do that, ma'am.
Ms. Eshoo. Yes.
Dr. Kadlec. I would just add we are also maintaining or
taking care of about a hundred or so people who were evacuated
from the Virgin Islands and Puerto Rico who are dialysis
dependent until they can go home and receive their care at
home. But we'll be happy to provide a more fulsome picture for
you and for the record.
Ms. Eshoo. Thank you. Yield back.
Mr. Burgess [presiding]. The gentlelady's time has expired.
The chair is pleased to recognize the gentleman from
Virginia, Mr. Griffith, 5 minutes for your questions, please.
Mr. Griffith. Thank you very much.
Let's continue with Puerto Rico for a minute, and I
appreciate what you all are doing down there. But Admiral Redd,
were any of the stockpiles that we've talked about today used
in Puerto Rico?
Dr. Kadlec. Yes, sir. We deployed both our DMAT, or
disaster medical assistant team caches, actually 13 of them, as
well as field medical stations, which are these kind of like
hospitals in a box kind of thing.
Mr. Griffith. Right. So here's my question. Back to you,
Ms. Abram.
When we start talking about the vials and the delamination
and whether or not there's a better product, you indicated that
the new novel product does better under stress but it was one
product was better than the other in chemical situations or
more normal situations it was pretty much the same.
My question is, though, isn't the stockpile for emergency
situations and wouldn't the stress be greater if you're sending
something in either before or immediately after a hurricane or
other natural disaster and so wouldn't we want to have the
better product in those situations?
Ms. Abram. We want to make sure that we have high quality
safe and effective medical countermeasures in the event they
need to be used and there's a number of steps that go into
making sure that the products that we have are what we are
expecting them to do in terms of safety efficacy and being
effective.
Mr. Griffith. And my concern is just this.
Ms. Abram. Yes.
Mr. Griffith. If they're just sitting on the shelf and we
go in one day into the back storage room and say we need these,
I get it. The current glass works.
But if there's a risk of delamination, which we've seen in
the past, and there's a product that takes care of that, at
least with the stockpile wouldn't we be better off using the
glass that's less likely to have glass fragments floating
around in what we are trying to then use in an emergency
situation? Because when people are trying to get something in
there in a hurry, whether before or after the storm, they're
not necessarily handling it with kid gloves. Wouldn't you agree
they're not handling it with kid gloves under those
circumstances?
Ms. Abram. The handling is a matter of importance to the
product, depending upon if it's something that has to be
temperature controlled. That's one of the issues that is at
play with the Ebola response efforts right now.
So depending upon the countermeasure, depending upon how
it's going to be used, it could bring unique handling and care
instructions.
Mr. Griffith. I appreciate that. Thank you.
I do want to ask about and I've heard a lot and I am
stepping a little bit outside of my comfort zone. I've heard a
lot about the antimicrobials and the antibiotics and the
concerns there. I am just wondering is BARDA looking at some
interesting and new novel approaches?
I recently toured a facility in my district--a very small
start-up group, Techulon, and they have a platform technology
for gene targeting. So I asked my team to find out what that is
and here's what I got back, so I don't get it wrong.
It is an anti-sense approach. It knocks down gene
expressions. That kills the pathogen--basically, disrupts gene
functions, which means there's no way for the pathogen to adapt
because basically you're going in and knocking out part of
their genes and they die. Are we looking at some of that kind
of new novel approach?
Dr. Kadlec. Sir, I would like to hear more about it, quite
frankly. I haven't heard of that particular approach but I
would be welcome to the idea that we would hear about it and
understanding how we could learn more and potentially see it in
the future of our efforts.
Mr. Griffith. But it's fair to say for both you and the
rear admiral that there's a lot of interesting things going on
out there and it's hard to keep track of it. I will make sure
you get some of the info on this.
Dr. Kadlec. Sir, and again, compliments to the committee
with the creation of the Medical Countermeasure Innovation
Partnership because that's one of the things we hope to do with
this program called DRIVe is to basically set up the
opportunity for great ideas to come in.
We've identified so far as of yesterday eight accelerators
in your different states around the country to basically be
these receptive points for these great ideas so that we can
make sure to sweep them up and don't miss them.
Mr. Griffith. Thank you. I appreciate that.
I would be remiss--and I appreciate the chairman bringing
this up in his opening remarks--if I didn't mention the
historic nature of today's date.
Being the representative on this committee from Virginia,
we have a national D-Day memorial in Bedford because, per
capita, they lost more boys on D-Day than any other part of the
country, and I had the opportunity to meet the sister of one of
the boys who was part of the D-Day boys of Bedford and knew Bob
Slaughter, who pushed for the memorial and had the great thrill
about 12 years ago before he passed away to introduce my
daughter to him in a local cafeteria.
He was just there, as humble as he could be, but these were
true heroes and they really did save the possibility of a
vibrant world with democratic principles in place and it all
came down to that one morning on this day 74 years ago.
So I yield back.
Mr. Burgess. Gentleman yields back. The chair thanks the
gentleman.
The chair recognizes the gentlelady from Colorado, Ms.
DeGette, 5 minutes for questions, please.
Ms. DeGette. Thank you, Mr, Chairman.
I want to thank Representatives Eshoo and Brooks for their
leadership on this important draft that we are discussing
today. Medical countermeasures are really an important element
of preparing for pandemics.
Several of our witnesses have mentioned the 21st Century
Cures Act, which Fred Upton and I authored but which everybody
on this committee had input into, and Representatives Eshoo and
Brooks were really instrumental in helping us put some of the
medical countermeasures into that bill. They included
encouragement of complex, adaptive, and other novel trial and
medical advice designs, fostering potential use of real-world
evidence for the development of drugs, and harmonizing FDA
human subject protections with the common rule, otherwise known
as the Federal policy for protection of human subjects.
And in addition, Cures includes provisions that would waive
certain paperwork requirements during a public health emergency
along with streamlining BARDA procurement process and allowing
BARDA to enter into agreements with independent non-profit
entities to support medical countermeasure development.
Now, Commissioner Abram, you spoke a little bit earlier
about the recent Ebola outbreak in the Democratic Republic of
the Congo. I am wondering if you can talk for a minute about
exactly how the lessons learned in the 2014 Ebola outbreak are
being used to help contain the recent outbreak.
Ms. Abram. Absolutely, and I will likely ask my colleague
from CDC to join as well.
Ms. DeGette. Great.
Ms. Abram. We've been very much supporting the efforts and
helping to facilitate the export of vaccine that's being used
overseas as part of the outbreak control measures.
We've also continued to engage with our international
collaborators and conversations with developers around
diagnostics and therapeutics. And so I think one of the
continual lessons learned and actually that PAHPRA was very
effective in doing is helping to make some accommodations and
adjustments in our authorities so that we can be even better
prepared in prepositioning which helps us then when we do have
these emergent situations to be even more timely in the
response effort.
Ms. DeGette. That's good to hear. Yes?
Admiral Redd. So I think one of the lessons of 2014 is that
when an outbreak like what is happening in the Democratic
Republic of Congo occurs you really have to pursue it until
there are no more cases.
Ms. DeGette. That's right.
Admiral Redd. There was an opportunity to do that in West
Africa in the spring and that opportunity was lost, resulting
in the outbreak over the summer and fall.
In the Democratic Republic of Congo, CDC has had a long-
standing presence. There are actually 33 staff there----
Ms. DeGette. Excuse me. I don't have a lot of time and so
my question really was what, from the 2014 outbreak, helped us
now. If you can address that.
Admiral Redd. Sure. I think there is a much more intense
focus on contact tracing, making sure that our partnership with
WHO and the country ministry of health is solid and that things
are slipping through the cracks.
So there's much more intense follow-up, identification of
cases. Laboratory testing is in place now. We are working on
measures of exit screening with the ministry. So all the things
that we should have done in 2014 are happening now.
Ms. DeGette. Mr. Kadlec, do you want to add on?
Dr. Kadlec. Yes, ma'am. May I just insert that we have two
candidate vaccines, one that's actually being used for ring
vaccination.
We have a point of care diagnostic that has been deployed,
donated by the companies, as well as those vaccines, as well as
three different monoclonal antibody therapies that could be
used. The one from NIH is actually deployed down there right
now.
Ms. DeGette. Right. OK. Thank you.
While I've got you on the hot seat, you indicate that
increasing BARDA's authorization levels would increase BARDA to
implement new innovation authorities that the 21st Century
Cures Act provided.
Can you talk about those new authorities and how additional
funding would actually help increase the goals of BARDA?
Dr. Kadlec. Yes, ma'am. We announced yesterday, with the
creation of DRIVe--the Division for Research, Innovation, and
Ventures--with the intent that right now $25 million will be
spent on two areas, which will be one is on the treatment of
sepsis.
Sepsis basically afflicts 1.5 million Americans a year,
kills 250,000, costs the health care system $24 billion, and so
we think that's an area ripe for an opportunity to find things
that could either prevent or mitigate that.
The second area is actually identifying or finding
diagnostics that would identify people who have been exposed
who are not yet sick so that you can institute treatment or
therapies to actually prevent them becoming ill or potentially
dying.
Ms. DeGette. Thank you.
Thank you very much, Mr. Chairman.
Mr. Burgess. Gentlelady yields back. The chair thanks the
gentlelady.
The chair recognizes the gentlelady from Indiana, Mrs.
Brooks, 5 minutes for your questions, please.
Mrs. Brooks. Thank you, Mr. Chairman, and thank you all so
very much for your testimony and for your important work.
I think there continues to be a little bit of confusion
that has come up with the various members regarding what I
think the word that might be causing confusion is the word
moving the Strategic National Stockpile, which is in our draft
text of the bill from CDC to ASPR.
But as I understand it, discussions and things are still
taking place relative to what the roles will be and I think we
all have the same goal and that is to ensure that all medical
countermeasures get to our citizens in the appropriate time and
as fast and as efficient as possible.
And so for our sake, maybe starting with Dr. Kadlec and
then going to Admiral Redd, if we could please talk about where
that stands right now and are there tools or resources you need
to effectively carry out the execution of the Strategic
National Stockpile for our citizens who expect it to work.
Dr. Kadlec and then Admiral Redd.
Dr. Kadlec. Yes, ma'am. Thank you, ma'am. I need----
Mrs. Brooks. We just need to clarify and make sure we
understand.
Dr. Kadlec. Sure. Sure. As Dr. Redd identified earlier,
there are a number of working groups. I think the key thing is
some of them dealt with contracts and particularly how would
the contracts that have been previously administered by CDC be
administered by ASPR.
And so part of that is kind of--I think the word is
novate--contracts to ASPR so that in terms of replenishing the
stockpile in the future so you'd have single oversight of how
you would basically develop, procure, and resupply this, the
Strategic National Stockpile.
There are issues around personnel, how many people would
be, basically, transferred to the ASPR and would be the
responsibility of ASPR to basically pay for or provide services
to. And then, lastly, one of the areas that's still under
negotiation is what percentage, if any, of those people who are
working with the state and locals would be transferred to ASPR
as well.
And so that is an area that is further under discussion.
The intent is to meet with senior CDC officials later this
month to basically hopefully finalize that.
But as to this date, there has been no requirement for any
legislative language--the facility to transfer is within the
secretary's purview and authorities to do so.
Mrs. Brooks. And I think that's what the greatest concern
is is that local and state authorities--and one of our next
witnesses in the next panel expresses that as well and so we
need to make sure that that relationship with whomever is
responsible.
And I think what I am hearing you say, though, and I would
like, Admiral Redd, you to talk about what you believe the role
is and is going to be because we want to make sure that there
is no problem working with state and local officials that
actually do the work on the ground.
Admiral Redd. Yes, ma'am. I think actually Dr. Kadlec
summarized the current situation quite well. The areas that I
think are critical to just make sure we've got good clarity on
are the role that subject matter experts at CDC will have both
whether or not they're funded by the stockpile now or not--that
that linkage with the stockpile and with planning, for example,
in clinical guidance, how the product should be used, under
what circumstances to control or to respond to emerging events,
that we've got that part nailed down and then similarly work
that we have been doing partly funded by the stockpile, partly
by the state and local program that we've got very good
agreement on the work that we are going to continue in that
domain to make sure that state and locals are able to dispense
products.
I think the overall medical countermeasure structure is now
more completely under the ASPR but that state and local role--
we think we have a role to support both state and locals and
the mission of the ASPR.
Mrs. Brooks. And would you agree with that, Dr. Kadlec?
Dr. Kadlec. Yes, ma'am, and we also have a role at the
state and local level and we look to figure out how we can best
integrate that to provide the best support in state and locals.
Mrs. Brooks. Well, and I think integration is the key here
and it is trying to ensure that everyone is clear as to what
CDC's role is with state and local partnership and what ASPR's
role is. But it sounds as if the contracting piece and the
management of the product, so to speak, and mostly the
vaccines, the diagnostic testing, is what would move to ASPR
but yet both agencies will be or both parts of--will be working
with state and local health officials. Is that correct? Fair to
say?
Dr. Kadlec. I think that's the overall intent.
Mrs. Brooks. And very briefly, Ms. Abram, a very quick
question relative to diagnostic tests and so forth, and can you
speak to the role of diagnostic tests including point of care
tests and influence in infectious disease detection and
management and how FDA ensures that we have what we need for
diagnostic testing because it's not just about vaccines. It's
also about the diagnostic.
Ms. Abram. Right. When we think about medical
countermeasures it runs the full gamut of medical products from
vaccines, therapeutics, and, of course, diagnostics, and rapid
point of care of diagnostics is something that also colleagues
at BARDA and ASPR are working on.
It's absolutely critical and it's not just critical in the
context of emergency response as a public health emergency.
It's critical as part of good routine care. The sooner you can
pinpoint what a patient is dealing with the faster you can
provide optimal care.
Mrs. Brooks. Thank you. My time is up. I yield back.
Mr. Burgess. The gentlelady yields back. The chair thanks
the gentlelady.
The chair recognizes the gentlelady from Florida 5 minutes
for questions, please.
Ms. Castor. Thank you, and thank you to the witnesses for
everything you do to strengthen America's public health
infrastructure, especially when we are talking about medical
emergencies and preparedness and response.
And I want to thank the authors for their bipartisan work
on PAHPA. I am very pleased that we are going to codify what
CDC is doing relating to the children's preparedness unit into
this bill because when we are talking about public health
emergencies, children have very special needs and we have to
ensure that they're not overlooked, and for many years CDC has
had a group of experts working through their children's
preparedness unit.
Just think about the Zika emergency. Child development was
the issue. Think about Flint and the water crisis--lead in the
water. That had a direct impact on babies and children. So it's
very important that we do.
So, Dr. Redd, does this codification language--does it do
what we need to do? Is there anything that's left out here?
Admiral Redd. I think we recognize the importance of
children in emergencies and we'll work on that. Whether or
not----
Ms. Castor. Yes. So this is actually Senate language that
we need to bring into this version because this version just
has kind of the national advisory committee.
Admiral Redd. Well, I think that both in preparing for and
then responding to almost any emergency, children are going to
be an important part of that and there are particular
considerations that need to be taken into account.
And as you noted, we have, within CDC, a children's
preparedness unit. That unit mobilizes when we have a response.
For example, in the Ebola response there was work on reopening
schools that unit played an important--in West Africa--that
that unit played an important role in.
Ms. Castor. So I hope the authors can look at what the
Senate language is and make sure that we are carrying over this
very important initiative where they bring in the
pediatricians, the psychologists, everyone, at the table to
make sure that it's properly recognized, funded, and
structured.
Dr. Redd, the draft legislation also would allow the
secretary to transfer 1 percent of any appropriation to the
public health emergency response fund. The emergency response
fund would supplement the response of local and state
authorities during any number of public health emergencies.
Previously, this has been an issue and it's been a problem
because transfers during emergency situations resulted in
automatic cuts elsewhere in funding in critical areas for state
and local governments. They were kind of left in the lurch--
created a lot of uncertainty for communities back home.
For example, during the height of the Zika crisis in 2016
funds were pulled from emergency preparedness and public health
grants across the country, despite the fact that those
communities needed to prepare, they needed to respond, and they
were hamstrung at that time.
Probably the most troubling example--and I am glad Mrs.
Dingell is here because she worked so hard on this--was the
fact that during that Zika crisis we had a terrible crisis in
Flint, Michigan, and when they had to go take funds to address
Zika, they swept some of the grants back in Flint and in
Michigan that they needed for their public health emergency.
In a Washington Post article, the president of the
Association of State and Territorial Health Officials said it
is short-sighted to fund the Zika response by weakening all
states' ability to respond to future public health crises.
So based on your experience with the Zika response, could
you describe how state and local public health departments were
impacted when the funds were taken and drained from the public
health emergency prepared cooperative agreement?
Admiral Redd. Yes, ma'am.
Ms. Castor. Go into a little detail for us on that.
Admiral Redd. So, first of all, this is a real problem. In
the H1N1 response there was a 54-day interval between the
request for funding and the appropriation. For Ebola there was
a 4-month interval and for Zika 190 days. So this is a
significant problem that is inhibiting the best response.
I am not going to speak directly to the bill but I will say
that during the Zika response the PHEP award overall was cut by
about 8 percent and we heard from states that that was causing
problems with staffing. There was sort of a payback about 6
months later but there was a period of uncertainty and I think
that uncertainty really is not helpful to the preparedness
interval.
Ms. Castor. And I think congressional members have a lot of
responsibility for those. When you get into government
shutdowns and you can't work together when we are talking about
emergency situations in Flint, Michigan, or Zika or flu we
simply cannot be caught up in these partisan fights. There has
to be a pot of money where we can adequately respond to public
health emergencies without getting into the partisan food
fights, not in times of emergency.
So I would hope that the authors would work on that with
all of us as we move forward. Thank you, and I yield back.
Mr. Burgess. The gentlelady's time has expired.
The chair recognizes the gentleman from North Carolina, Mr.
Hudson, 5 minutes for questions, please.
Mr. Hudson. Thank you, Mr. Chairman, and thank you to each
member of the panel for what you do on behalf of our country.
Thank you for being here with us today.
Every time there is a disaster or an infectious disease
outbreak I hear from my constituents back home. Hurricane
Matthew, Zika, and Ebola outbreaks are all recent events that
have quickened the pulses of my constituents. Understandably,
they're concerned and want to know what we are doing to ensure
their communities have the resources they need and these
outbreaks are contained.
One thing I've heard from physicians, emergency medical
responders, and hospitals is that there are continuing drug
shortages, particularly essential emergency medications. These
providers are concerned that they're not prepared to respond to
a massive public health emergency.
Dr. Kadlec, you mentioned in your testimony that the
strength of our nation's public health and medical
infrastructure and the capabilities necessary to respond to
emergencies and disasters are foundational to the quality of
life of our citizens and I completely agree with you. But I
believe these drug shortages hamstring our ability to properly
respond. So I want to see how we can work tighter to best fix
these problems.
So, Dr. Kadlec and Ms. Abram, can you share your thoughts
from both the FDA and ASPR's perspective on assuring the
availability of emergency medications in a public health
emergency and are there options Congress should be considering
as part of PAHPA and beyond?
Ms. Abram. I will go ahead and jump in and take it first
and then turn it over to my colleague. Drug shortages is a
serious concern.
It's a serious concern not just in routine everyday
clinical care but also in the context of what a particularly
lifesaving product--the shortage of a lifesaving product at a
time of a public health emergency might mean. We've got medical
countermeasures and we've also got other products that would
certainly go toward patients and be part of care, perhaps
supportive care.
And we've also recognized that even though we have a very
dedicated team that is focused on this at the agency among our
CDER colleagues, we continue to see some challenges persist.
The agency is doing everything that we can to mitigate and
prevent. Particularly, we've been very forthcoming about some
of our work in the IV saline solution shortages and our work to
work with developers.
We encourage manufacturers to try to build in capacity.
It's not something that we can require. But we do encourage
that they try to do that to help to mitigate.
We've also worked in a discreet manner to help to import
product to supplement where there have been shortages. But it's
a continual challenge and it's something we continue to look at
and would welcome the opportunity to have dialogue with the
committee around what other solutions might be brought to bear
as part of this.
Mr. Hudson. Thank you.
Dr. Kadlec. Sir, for the purposes of time, I would probably
want to get back to you on the record on this. But I just want
to highlight as--I think it was alluded to by Ms. Abram and
that is the subject to the events in Puerto Rico and how that
impacted on several critical supplies of critical medicines--
not only saline solution but also pediatric oncology drugs and
the like. And we have an interest in that in terms of how do
you basically make sure that that critical infrastructure is
more resilient. I will just highlight that there is some
interesting legislation in the House subject to the Disaster
Recovery Reform Act of 2017. I think it's being considered with
the FAA Act as well, and that is subject to how we can use some
of our disaster relief funding in advance of an event to
basically make things more resilient.
I think there's a couple of pieces here as to how can you
make your production supply chain more resilient before a
disaster and then what to do with the events, as Ms. Abram had
mentioned about what can we do to make sure that there is an
uninterrupted supply of these critical supplies.
But we'll be happy to get back to you with further details.
Mr. Hudson. Great. Well, I appreciate that and appreciate
the commitment to work with us on it.
Just changing topics, Dr. Kadlec, I have become aware of
the time-intensive process involved in producing a vaccine
through egg-based production. Oftentimes, this manufacturing
can take up to 6 months, which is a lifetime in the ever-
changing world of infectious disease. I've recently become
aware of the new flexible platform techniques--technologies
that have the potential to reduce production time for vaccines
from months to weeks.
I understand BARDA's primary mission is to support products
that are being tested in clinical trials of which I know of one
product in phase three. But there are also products in
preclinical testing. I understand ASPR and BARDA are examining
these innovative platform technologies. But I want to get some
clarification from you.
How would these rapid response platform technologies
benefit BARDA and its mission and can BARDA play a more
proactive role in fostering the plug-and-play platforms that
are beyond basic research but not yet at the clinical trial
stage?
Dr. Kadlec. Sir, I think just two things to echo what your
comments are, our dependence on egg production, which provides
more than 70 percent of our vaccine for flu, and eggs are not
very flexible and they're not very fast. The only other vaccine
you can produce from an egg is yellow fever. So the idea of
having flexible and fast capabilities which are platform
technologies is either cell or recombinant production that is
going to be critical, going forward.
So we see that as an essence and there's also been the
situation we experienced this past seasonal flu season where
some of the vaccine strains drifted a little bit from egg
production and so that's another liability.
So there's several reasons why we are relooking at what we
are doing. But we really owe you and this committee probably a
detailed brief on not only the situation we experienced in the
past but what may be a strategy to address how to avoid those
limitations and get us the most flexibility and speed in the
future. I will turn to Anna.
Ms. Abram. Yes. I was just going to quickly add we'd be
happy to follow up with some of the work that we've been doing
to advance continuing manufacturing and innovations. We think
that this could be responsive in terms of helping to foster a
more nimble flexible responsive framework.
Mr. Hudson. I agree. Thank you, Chair.
Mr. Burgess. And the gentleman's time has expired.
The chair recognizes the gentleman from Kentucky, Mr.
Guthrie, 5 minutes for questions.
Mr. Guthrie. Thank you, Mr. Chairman. I thank the panel for
being here today.
And so this kind of follows on what he's saying about new
platforms. There's a company in my district, Kentucky
BioProcessing, in Owensboro that actually uses a plant-based
platform to more efficiently produce recombinant protein
products.
In fact, applying their platform technology they rapidly
developed an experimental antibody and used it to successfully
treat an American doctor who contracted Ebola while treating
patients in Africa.
I understand a major goal of BARDA is to identify new
approaches and capabilities that allow for better preparedness
and response to multiple public threats by serving as platform
technologies.
So, Dr. Kadlec, how can BARDA interact with and support
companies which have developed such technologies but do not
have a specific medical countermeasure in clinical development?
Dr. Kadlec. Well, I think that's an issue that we probably
need to follow up with on the notion of this flexible and agile
kind of production capacity and how do we basically nurture
that and promote that in a way that to this date hasn't been
fully actualized.
So I think it's an area that I think we'd be very welcome
to work with you and our colleagues at FDA who are also
evaluating these kinds of innovative ideas and how do we do
that.
We think that the DRIVe program that was--we just announced
yesterday could be one of those venues to basically evaluate
that as well as promote those kinds of concepts.
Mr. Guthrie. Thank you. I would encourage BARDA to use its
current authorities to support preclinical platform
technologies--planned technology which has demonstrated its
ability to deliver BARDA's needs in one-third of the time of
traditional platforms.
So that follows up what he just said so I appreciate that.
Matter of fact, the plant they used for Ebola was tobacco. So
it's nice that we have a use for one of our plants that's
positive in that direction. So we appreciate that very much.
And also, Dr. Kadlec, kind of switching gears a little bit,
could you speak to how the discussion draft can further empower
ASPR to be the vital coordinating agency for both planning and
responding to a biological threat?
Dr. Kadlec. Well, sir, I think just reauthorizing the
language that already exists is critical. I think there's some
areas in there in terms of effectively improving our ability to
respond in terms of direct hiring for national disaster medical
personnel will be very important. That was one of the critical
shortfalls during the last hurricane season. We only had less
than half of the number of intermittent Federal employees who
basically service our disaster medical assistant teams.
We also believe that what you have in your discussion draft
is so important in terms of providing, if you will, life
benefits to those people who would lose their lives in an event
of a response to make sure that they get the equal
consideration as to public safety officers.
So there are several areas. There's also mention about in
your draft about the PHEMCE, or the Public Health Emergency
Medical Countermeasure Enterprise. We think the idea of
basically having that role to ensure that, as Dr. Redd said,
that we use the expertise within the department and CDC, FDA,
NIH to basically ensure that whatever we are trying to develop
and produce is not only useable but safe and efficacious to use
in our population, both children and adults and elderly.
So those are all positive things that I think just off--in
the little time that I have. I would be happy to follow up on
the record if you'd like.
Mr. Guthrie. Thank you very much. We appreciate that and
look forward to, hopefully, a briefing as you talked about and
schedule that sometime in the future.
That concludes my questions and I yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
The chair recognizes the gentleman from Missouri, Mr. Long,
5 minutes for questions, please.
Mr. Long. Thank you, Mr. Chairman, and Dr. Kadlec, as you
may be aware, I've introduced legislation along with Ms. Matsui
to allow the HHS secretary to reorganize HHS cybersecurity
offices as the secretary thinks best.
One of the motivations for this legislation is the
recognition that many organizations including HHS are using the
cybersecurity organizational strategies that were originally
designed in the early 2000s and my not be suited for modern-day
threats.
I think you would agree with me--I will ask you if you do--
that the nature and severity of cybersecurity threats to
healthcare have significantly changed over the last 20 years. I
don't think your mic is on.
Dr. Kadlec. Yes, sir. They have.
Mr. Long. Do you think the evolution of cybersecurity
threats may require organizations like HHS to evolve their
cybersecurity strategies including the way they organize their
cybersecurity offices and officials to manage?
Dr. Kadlec. Sir, I believe giving the secretary that
flexibility and the authority would be appropriate.
Mr. Long. And how has HHS addressed its cybersecurity
strategies to confront the changing cyber threats and what more
needs to be done, in your recommendations?
Dr. Kadlec. Sir, thank you for that question. As I outlined
earlier, the center of gravity for the department is in the
deputy secretary's office at the present time.
I think we probably owe you a full and fulsome response to
that question. If you don't mind I will take it for the record
and provide you a complete outline of what is ongoing and
anticipated for the department in these areas that could help
guide your future actions.
Mr. Long. OK. Thank you.
And Mr. Chairman, I yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back and the chair is aware that Dr. Kadlec has another
engagement at HHS. But we'll now recognize the gentlelady from
Michigan, who's not on the subcommittee, 5 minutes for
questions, please.
Mrs. Dingell. I will be brief. Thank you, Mr. Chairman and
Mr. Green, for holding this hearing.
I do have a concern, like everybody else has. We've asked a
lot of questions but not gotten as much into the long-term care
and hospital preparation when we have these hurricane
emergencies.
So, Dr. Kadlec, I am going to go right to you and ask you.
You have said that a regional disaster health response system
would incentivize the health care system to integrate measures
of preparedness into daily standards of care.
Would this include an important sector of the health care
system, the long-term care facilities, which in these most
recent hurricanes have really suffered some tragedies?
Dr. Kadlec. Yes, ma'am, and I just want to annotate two
things really quickly. In Puerto Rico, we evaluated in an acute
situation about 1,900 adult senior living facilities of varying
different types in terms of their resilience and their
functioning during that terrible period of time there, and
certainly we know the events in Florida and I just acknowledge
that Florida has established new guidelines for its hospitals
and skilled nursing facilities. So I think we have to have
greater sensitivity to these areas as they take care of some of
the most vulnerable populations in our society.
Mrs. Dingell. Thank you.
In an effort to improve our understanding involved with
threats hospitals and long-term care facilities face I have a
bipartisan bill that directs HHS to engage with the National
Academy of Medicine to conduct a comprehensive study into the
assessment of future threats impacting emergency preparedness
policies and procedures across the health care system.
In your opinion, would a study of this kind be helpful as
you establish a regional disaster health response system?
Dr. Kadlec. I am always having very bright and experienced
people consider these efforts and to do a deep study would
always be beneficial and, obviously, the National Academy of
Sciences is the place to do it.
Mrs. Dingell. Thank you.
So we talked briefly a minute ago about the tragedies in
Florida where one home lost 12 residents who eventually died.
Following the disaster of this kind, how do we best ensure that
long-term care facilities that lose power are prioritized as
hospitals are and back up and running fast? Because that was
part of the problem.
Dr. Kadlec. Part of the practical situation is is that in
terms of our approach to these events, a pre-event to identify
those facilities--I don't know if you're familiar with the
Empower program that we have in the department, but I think
it's the idea of identifying those places where people of
particular vulnerability are housed and how quickly you can
make sure that they have the capacity and capabilities and are
identified early so that you can connect with them and that was
an issue that, quite frankly, in Puerto Rico we did on foot,
place by place, because the nature of their facilities was very
different than what you'd find in places like Florida.
Mrs. Dingell. We do need to worry about it.
My colleagues, Debbie Wasserman Shultz, Ms. Eshoo, and I
have a bill that would, among other things, require states to
prioritize nursing homes in the same manner as hospitals are
prioritized in all-hazards public health emergency preparedness
and response plans and would include in those plans information
on how utilities plan to ensure that nursing homes return to
operating as soon as practical following a disaster.
I would urge all of my colleagues to support that. We are
down to 1 minute so, Deputy Commissioner Abram, some have
advocated that as a part of the reauthorization of PAHPA that
we should make the MCM PRV program permanent.
Can you comment on FDA's viewpoint regarding whether or not
this program should be permanent at this time?
Ms. Abram. We think it's premature to determine how
effective the program has been. I think Congress had good
foresight when enacting the MCM PRV program and reauthorizing
the pediatric PRV program to charge GAO with looking at this.
One of the dynamics with the priority review voucher
programs--and we now have three programs: one for neglected
tropical diseases, one focused on peds, one focused on security
medical countermeasures, which I would point out are those
which are linked to material threat determinations.
So these are pretty serious--is the more vouchers you have,
it diminishes then the incentive and the value of the voucher.
And so I think Congress had good foresight to consider that
this would need to be looked at as how many vouchers are out
there--is the program having the intended effect.
There has always, throughout the journey of these issues,
been a consistent threshold question, which is have we
optimized the incentives for bringing forward the medical
countermeasures we need to protect the American people and I
think if you look at the bipartisan history of these issues
from BioShield to the creation of BARDA to the innovation
collaboration that Dr. Kadlec has talked about today to the MCM
PRV, this continues to be a threshold question.
Mrs. Dingell. Thank you.
Mr. Burgess. The gentlelady's time has expired.
Dr. Kadlec, we know you're needing to depart and I think
all the members now asked questions. I do want to just note for
the record that you were part of a bipartisan Energy and
Commerce delegation to the island of Puerto Rico last--late
last year and were very much a part of our work in assessing
the damage there.
Also, you mentioned in your prepared testimony about the
BioWatch program and I will note that the Shattuck Lecture that
was published in this week's New England Journal of Medicine
given by Bill Gates, the subject innovation for pandemics also
talks about an early detection system. I will probably be
submitting a question for the record for you on that because I
believe that should be part of our work here.
Dr. Kadlec. Thank you, sir. I look forward to it.
Mr. Burgess. Mr. Green, any parting comments?
Mr. Green. No.
Mr. Burgess. Bye. All right. We will excuse this panel and
Dr. Kadlec, again, thank you for your forbearance and we
appreciate all of you being here today.
And we will transition immediately to our second panel.
[Pause.]
I will ask all of our participants to take their seats and
the subcommittee will continue. We are pleased to have our
second panel here today.
Just as a housekeeping detail there is likely to be a
series of votes on the floor. If that does occur we will recess
briefly to attend to those votes and then immediately resume
activities here.
But I do want to thank our second panel of witnesses for
being here today. You each have a chance to give an opening
statement followed by questions from members.
We are pleased today to welcome Dr. Umair Shah, Executive
Director of Harris County Public Health; Dr. Michelle Berrey,
President and CEO, Chimerix, Incorporated; and Mr. Erik Decker,
Chief Security and Privacy Officer, University of Chicago
School of Medicine.
We appreciate each of you being here today and we
appreciate you sticking with us through the first panel.
Dr. Shah, you are now recognized 5 minutes for an opening
statement.
STATEMENTS OF DR. UMAIR SHAH, EXECUTIVE DIRECTOR, HARRIS COUNTY
PUBLIC HEALTH; DR. MICHELLE BERREY, PRESIDENT AND CEO,
CHIMERIX, INC.; ERIK DECKER, CHIEF SECURITY AND PRIVACY
OFFICER, UNIVERSITY OF CHICAGO MEDICINE
STATEMENT OF UMAIR SHAH
Dr. Shah. Thank you, Chairman Burgess and Ranking Member
Green. A pleasure to see you, Representative Barton. As fellow
Texans, it's always great to have a conversation with you as
well.
To members of the House Energy and Commerce Health
Subcommittee, thank you for inviting me to testify this morning
on this very important topic.
My name is Dr. Umair Shah. I am the Executive Director of
Harris County Public Health, the county health department in
Houston, Texas, the third largest county in the U.S. with 4.7
million people.
I am also the local health authority of Harris County,
Texas. I am also here as the President of NACCHO, the National
Association of County and City Health Officials, representing
the Nation's nearly 3,000 local health departments.
I refer you to my full written testimony today. In the
interest of time, I will touch on three main points. One, that
public health truly matters, especially at the local level and
in emergencies. The PAHPA reauthorization, number two, is
extremely important to support our work. Number three, CDC and
ASPR must appropriately be funded and getting dollars to local
communities.
So public health is vital to the health of our communities.
This is especially true in emergencies. Public health does all
the behind-the-scenes work and is truly boots on the ground,
performing disease surveillance, ensuring the safety of our
environment, spraying for mosquitoes, providing immunizations,
picking up dangerous animals, supporting chronic disease and
mental health efforts. These are just some of what public
health departments do to keep our communities healthy,
protected, and safe.
I can tell you firsthand how important these roles are
because I am from an impacted community. Dating back to
Tropical Storm Allison in 2001, the Nation's first BioWatch had
Hurricanes Katrina, Rita, and Ike, H1N1 pandemic, Ebola, and
Zika and, most recently, 300-plus year floods in 3 years
including Hurricane Harvey with its 1 trillion gallons of water
that were dumped on Harris County.
Emergencies abound. But our story is one of a community of
resilience, one that has invested in our health and response
systems and understands the importance of working together to
prepare, respond, and recover and that's what Texans do.
Truly, our strong response to Harvey was built on the
responses to Tropical Storm Allison on forward. Indeed, you can
learn from previous emergencies and investments can and do pay
off. Harvey was just one storm, though.
In the last year, our nation has seen severe weather
events, ice storms, floods, hurricanes, wildfires, acts of
violence, a severe flu season. This doesn't even include the
issue of opioids or global health challenges that impact
domestic health. Truly, two things are certain. Emergencies can
and will be lurking around the next corner and public health
agencies will be there to respond in kind. But we cannot do our
job without the adequate resourcing and support that both
public health emergency preparedness and the hospital
preparedness program funding streams--PHEP and HPP--provide.
That's why, number two, the PAHPA reauthorization bill is
so critically important for our work. Let me now speak briefly
to some of the proposed provisions.
First, we strongly support the reauthorization of the PHEP
and HPP programs through 2023. These are complementary programs
that work hand in hand to enable health departments and health
care systems alike to prepare and respond to emergencies.
Secondly, the Medical Reserve Corps program strengthens our
ability to respond by deploying an army of volunteers. We urge
you to maintain the authorization level under the current law.
Thirdly, with respect to the public health emergency fund,
we are concerned about the 1 percent transfer authority to
infuse the fund when a public health emergency is declared. The
transfer authority would take vital dollars away from other
public health programs in the midst of a funding cycle and we
recognize that multiple emergencies can be happening at one
time.
Finally, the SNS plays a critical role in preparedness
regardless of its structure or location. With the proposed
authority from CDC to ASPR legislative language must assure
maintenance of appropriate coordination and support of state
and local health departments. Public health response
capabilities cannot get lost in the sea of other health care
system capability needs.
Number three, we feel strongly that CDC and ASPR are
agencies that are critical to support what we do on the ground.
They provide not just funding and resources, technical
expertise, and advice, but they often are the response agencies
that deploy at a moment's notice when necessary. We must ensure
that the authorization levels of both agencies are maintained.
Truly, as we do our work in public health we remain hidden
from the public's eye. We have a visibility crisis in public
health and it impacts our ability to be appropriately
resourced.
I think of public health as the offensive line of a
football team. Of course, it is Texas so I must say football.
Whether it is Tom Brady or Aaron Rodgers, everyone knows the
quarterback but very few know members of the offensive line,
yet they are critical to the success of that line. Just like
the behind-the-scenes offensive line absolutely critical to the
wellbeing of our communities.
Since we don't invest appropriately in public health
capacity, we find ourselves reactively scrambling to act when
the next emergency is upon us. Decreased investment in public
health leaves us more vulnerable and forces us to rob Peter to
pay Paul by taking from elsewhere, and funding fluctuations
also take a toll. If funding for public health is cut by 10
percent, for example, the expectations of our communities do
not decrease by 10 percent in kind. We must have adequate
resources to do our job appropriately.
Let me close by saying I am honored to represent the strong
dedicated public health workforce that give it their all as
first responders in emergencies just like fire, EMS, law
enforcement, et cetera, even when themselves personally
impacted.
This proposed bill helps support our work. More is needed,
of course, especially to support the values of innovation,
engagement, equity of collaborative multi-disciplinary linking
of one health, global domestic health, and all-hazards
preparedness with ongoing public health capacity building,
ensuring funds get equitably to jurisdictions based on both
need and risk. This reauthorization is an important step in
that direction.
Thank you, and I look forward to taking your questions.
[The prepared statement of Dr. Shah follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Dr. Shah.
Dr. Berrey, you're recognized for 5 minutes, please.
STATEMENT OF MICHELLE BERREY
Dr. Berrey. Good morning. My name is Michelle Berrey. I
would like to thank Chairman Burgess and Ranking Member Green,
other members of the committee, for the opportunity to speak to
you today.
I am here in support of reauthorization of PAHPA and to
highlight the important components of successful public-private
relationships to develop medical countermeasures from the
perspective of a small biotechnology company.
I am a board-certified infectious disease and public health
physician. I spent the last 20 years developing new drugs for
viral diseases. I currently serve as CEO of Chimerix, a small
publicly-traded biotech of 85 employees in Durham, North
Carolina. We are one of many companies currently collaborating
with BARDA in development of medical countermeasures against
CBRN threats.
We are here today as members of the Alliance for
Biosecurity as a strong supporter of reauthorization of PAHPA.
Our lead candidate, brincidofovir, or brinci for short, is an
anti-viral with activity against a broad range of viruses. It
is in late stage development for treatment of small pox. Brinci
is one of a handful of dual-use agents, meaning it is in
development both as a medical countermeasure for protection of
the public health and to address some of the most common
viruses in patients with urgent needs for new treatments. For
brinci, this is for children undergoing bone marrow
transplants. It was Federal funding that allowed us to
jumpstart our smallpox program and to progress to full
development and our currently collaboration with BARDA.
When smallpox was eradicated in the 1970s, routine
vaccinations ceased. Without broad immunity, weaponized
smallpox could be devastating to the global population and thus
it became an appealing potential biological weapon. It is a
highly infectious easily transmitted airborne virus with at
least a 30 percent mortality date. As the first lien of defence
for smallpox exposure, vaccines are stockpiled by BARDA for
every American including the one in five Americans who would
require a next-generation or attenuated vaccine.
So why did the Institute of Medicine also recommend that
the U.S. stockpile two different smallpox antivirals with
different mechanisms of action? The reason that antivirals are
critical is for three separate populations: one, those who
remain ineligible for vaccine; two, patients with severe side
effects from the vaccine; and three, those with symptomatic
smallpox.
Like the flu, once symptoms begin it is too late for a
vaccine. Specifically for brinci, we have completed over a
dozen efficacy studies for the treatment of smallpox under the
FDA's animal rule. In our largest rabbit pox study, we
demonstrated 100 percent survival in animals that we began
dosing at the time we confirmed infection. Our studies have
also shown that brinci may also reduce transmission of smallpox
by accelerating clearance of virus. This point could be
critical in stopping an outbreak.
Chimerix has worked closely with our colleagues at the
Division of Antivirals at the FDA to progress this challenging
program. Just this morning, we received orphan drug designation
from the FDA, which provides a waiver for FDUFA fees and will
thus provide further savings for BARDA. Developing
countermeasures as dual-use compounds allows us to stretch
precious federal resources and to ensure sustainability of the
enterprise.
We've also seen that brinci's development for the treatment
of life-threatening antivirus infections has provided
innovations for drug formulations that are paid for fully by
private sector dollars and this has reaped additional benefits
for compounds that are included in the medical countermeasures
and the stockpile.
The passage of Project BioShield and PAHPA created a market
for medical countermeasures where one did not previously exist.
Knowing that there is a fund dedicated to support stockpiling
provides for our common defense. This is critical. We are
developing a solution for a problem that we all hope never
presents itself.
But not being prepared for a smallpox event is not an
option. We commend the Committee for the bipartisan
collaboration on PAHPA reauthorization and in particular for
the 10-year advance appropriation for the Project BioShield
special reserve fund.
Companies like Chimerix rely on the existence of a
government market for medical countermeasures in order to
sustain the long-term investment in research and development
for these critical.
I will be happy to welcome any your questions.
[The prepared statement of Dr. Berrey follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Dr. Berrey.
Mr. Decker, you're recognized for 5 minutes, please.
STATEMENT OF ERIK DECKER
Mr. Decker. Thank you, Chairman Burgess, Ranking Member
Green, and members of the subcommittee. It's an honor to
testify concerning the reauthorization of PAHPA.
I am the Chief Security and Privacy Officer for the
University of Chicago Medicine. I also serve as the Chairman of
the Advisory Board for the Associations of Executives and
Health Care Information Security, otherwise known as AHIS.
AHIS is an association that represents more than 850 senior
security leaders within health care. Lastly, I serve as the
Industry Lead and Co-chair of a public private partnership task
group sponsored by the Department of Health and Human Services
for establishing cybersecurity best practices within the health
care sector. This group is the result of a legislative
imperative of the Cybersecurity Act of 2015, Section 405(d) and
authorized under the National Infrastructure Protection Plan.
We are organized under the joint cybersecurity working
group within the Healthcare Sector Coordinating Council and the
Government Coordinating Council. We support the reauthorization
of PAHPA. Specifically, we support the inclusion of
cybersecurity as an identified hazard and the need to designate
a sector-specific agency such as ASPR to interface with the
health care industry.
Over the last decade, the health care sector has witnessed
the evolution of cyber-attacks against our health systems.
Today's cyber-attacks have become more numerous and
sophisticated from the establishment of underground markets for
the exchange of stolen sensitive information to the creation of
a ``hacking as a service industry.'' In the hyper-connected
world of health care, the digital footprint has exploded,
creating more points of entry than ever for attacks to be
successful.
As was evidenced by the WannaCry ransomware attack that was
launched in May of 2017, we must recognize that cyber-attacks
are a real and present danger. What the recent WannaCry
incident has signaled to the industry that attacks are no
longer localized to one particular health system or another but
can impact us locally, regionally, and nationally.
We need a system of prevention and response that is similar
to the disease prevention and infection control practices
within the health care industry. This system should encourage
and incentivize the adoption of standard cyber hygiene
practices, as our clinicians do with washing their hands, and
that is capable of coordinating large-scale emergency response
to cyber threats as HHS has done with the Ebola and Zika
outbreaks.
We feel that this is the perfect moment to introduce the
inclusion of cybersecurity to PAHPA and strengthen the
partnership with the Federal Government. Specifically, we feel
that ASPR, in combination with the right cybersecurity
expertise, capabilities, and funding will serve as an impartial
partner to help bolster the industry's cyber capabilities.
I would like to offer a few methods that ASPR could deploy
to achieve these outcomes. Number one, encourage the adoption
of a cybersecurity framework and a soon to be released top ten
cybersecurity best practices within health care.
Number two, bolster the importance of cybersecurity
technical--of sharing technical cybersecurity threat
intelligence information through the use of a national
healthcare ISAC, otherwise called NHISAC. Ensure that this
information is protected from regulators.
Number three, offer enforcement relief for organizations
that demonstrate the adoption of the cyber framework--the
aforementioned best practices and participation within NHISAC.
And number four, establish a national response program in
partnership with NHISAC and potentially DHS that is capable of
facilitating a response to the national threat.
I sincerely thank the committee for allowing me to speak on
this important topic and I look forward to answering your
questions.
[The prepared statement of Mr. Decker follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. And I thank all of our witnesses for their
testimony. We will proceed into the question and answer portion
of the hearing. I will recognize myself 5 minutes for
questions.
And Dr. Shah, again, thank you. Before I go to you, Dr.
Shah, I wanted to introduce the Shattuck Lecture that was
printed in the New England Journal of Medicine given by Bill
Gates, specifically the comments about the early detection
system and BioWatch.
So I will be asking unanimous consent to make that as part
of the record. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
So now, Dr. Shah, again, I appreciate you being here today.
Appreciate all the work that you have done for the county of
Harris where I lived for a while while I was in medical school.
So I am very familiar with the issues that you elucidated in
your testimony.
We talked a little bit about BioWatch. I think Dr. Kadlec
mentioned that in his testimony. So do you see a need to update
the technology currently used in the BioWatch program and is
the guidance provided by Health and Human Services and
Department of Homeland Security appropriate for our local
responses?
Dr. Shah. Thank you, Mr. Chairman.
So let me answer that with going back a little bit in the
history. So as the first BioWatch hit that we had in Houston in
our community and then over the years having multiple BioWatch
actionable results at the bars. What we've seen over the years
is that there has been a shift in the way BioWatch was actually
looked at.
Initially, it was you have a hit, it is an act of intent
and you have to launch an all public health response to it.
That has now shifted, fortunately, in a way that it is a
laboratory confirmation--a sensor positive that doesn't
necessarily mean that it's a public health positive, and this
is the difference between the science of public health and the
art of public health where we have to put all the other
epidemiologic data, all the other environmental health data,
all of the other factors in so we can make a determination
whether this is truly a terrorist attack or a terrorist threat,
and that, I think, is the way to go. But what that really
implies is that we have to make sure that the technology is as
strong as it can be, it's as certain as possible to give us the
right result.
And so we, certainly at the local level and even really
thinking about this more from a physician standpoint, we really
want to make sure that if you ask for a test that you know what
you're going to do with the result and that's the first adage
in medicine and that's what applies here is that we want to
make sure that the technology is certain, gives us the right
results, and then we can use all of the other information that
we have at our disposal to make a determination. So we support
better technology. We also support better guidance because
continuation of changing shifting guidance over the years means
that we have to relook at what kind of guidance has been given
to local health departments and state health departments so we
could relook at this program and make sure that it really meets
the needs of today and not just yesterday.
Mr. Burgess. So if I could ask, what is the state of the
art? The level of precision that is now technically available
is--obviously, you can work with that at the local level?
Dr. Shah. Yes, we can. There are some challenges with the
proposed some technologies that were there.
The initial technology would allow for more information
about what the results were and how there was some move toward
saying it was, more or less, for all intents and purposes, a
positive or a negative and not giving you all the factors that
were in play.
And, fortunately, DHS has moved away from that. But that
was a challenge and so we are really recognizing that it's
really important to work with Federal, state, and local
partners in a transparent way so that we can actually
understand the science because we too can interpret information
and we are partners as part of that system.
Mr. Burgess. Thank you for that answer.
Dr. Berrey, I referenced I went to medical school in
Houston. It was a number of years ago. The New England Journal
of Medicine back in 1974 or 1975 or 1976 talked about the fact
that smallpox was going to be eradicated from the face of the
earth. As I sat in my study cubicle that day in the mid-1970s I
thought it was until I arrived here a number of years later as
a member of Congress and found out that it wasn't.
But I just want to mention that as a thanks to you and your
company for working on those agents. Right after 9/11 when
people were concerned about biologic agents there was really an
open question as to whether or not we were prepared because of
the nonvaccination of the population and the lack of a
substantial stockpile to deal with what could have been a
significant attack.
So you're welcome to respond to that but I just wanted to
thank you for the work that your company has done.
Dr. Berrey. Thank you, Chairman Burgess, and we appreciate
the opportunity to speak here today. We do believe the
eradication of naturally-occurring smallpox remains probably
the greatest contribution of medicine to humankind on the
planet.
It is unfortunate that the technologies available to would-
be attackers have kept a step ahead and we are hoping that we
are keeping in lockstep with them.
I really commend BARDA for their foresight in moving
forward not just with vaccination and being at the ready but
their close work with CDC to be prepared to implement ring
vaccination, to be able to control another outbreak that could
begin from either naturally occurring or more likely from an
attack of smallpox.
Some of the more recent information available about the
likelihood of being able to implement synthetic smallpox is
something we've had a lot of discussions about with our
colleagues at BARDA and really hope to, by having multiple
therapeutics available within the stockpile, to be prepared in
the event to face whatever form that that smallpox could take.
Mr. Burgess. Thank you for that.
My time has expired. I will recognize the gentleman from
Texas, Mr. Green, 5 minutes for questions, please.
Mr. Green. Thank you, Mr. Chairman, and again, Dr. Shah,
and our whole panel, thank you for being here.
I know in the Houston areas that I represent we have a
coordinated effort. Both our county judge, Ed Emmett in the
city of Houston and Harris County and some of the responses
that we've had necessitate the deployment of the national
strategic stockpile.
In your statement, you made reference, Dr. Shah, to the
fact that the response to Hurricane Harvey was more than an
acute response but was instead the result of years of planning
and coordination.
With the likely transfer of SNS from CDC to ASPR, do you
foresee any possible disruptions to the planning, coordination,
and development of the SNS in future events, given that
frequency, intensity of weather-related events will only
increase?
Dr. Shah. First of all, Congressman Green, thank you so
much for your service and for the continued partnership that
you have given to our health department and our community in
general.
What I would say is that Hurricane Harvey was the
culmination and the continuation of a lot of the lessons that
we have learned over the decade plus since Tropical Storm
Allison. And, fortunately, we have learned those lessons and
there has been an incredible amount of investment in both
public health and health care. With respect to the SNS, as you
heard from the earlier panel, there certainly are challenges as
we think about a transfer and there's some uncertainty at least
at the local level of what exactly this means when they say
it's being moved from the CDC to ASPR.
The biggest concern that I would put out there is the fact
that we know that ASPR is responsible for hospital readiness
and health care readiness, and we also know that oftentimes
public health gets drowned out by the hospitals and healthcare
system. And so one of the biggest challenges we would have as
moving SNS over to ASPR is to ensure that it does not get lost
in all the public health activities that we at the local level
and the state level, that we require from an SNS as well--from
our Federal partners. And so ensuring that the legislation has
that built in is absolutely critical. The other aspect of this
is the federal medical station that was deployed during SNS for
Hurricane Harvey response was very much about really having a
field hospital that we were able to rely on.
Unfortunately, Florida and Hurricane Irma happened right
afterwards and it started to move. And so one of our big
challenges is to ensure that when we have multiple emergencies
happening how do we really try to figure out what those Federal
assets are and how we can use them locally as well as across
the system. I think that's another challenge.
Mr. Green. Well, I appreciate it, because I know the
response with Hurricane Harvey and Katrina--when the CDC came
in we were treating a lot of our visitors, who are now Texans,
from Louisiana. CDC can bring other resources, including the
public health service, and I just didn't want to disrupt some
of the good things we had.
If you have any suggestions on how we may make sure that
that process will not lose the success we have now, I would be
glad to see what we can do when we are marking up the bill,
because that's my concern--the change from CDC to ASPR, which
is a great agency, but I don't want to lose that effort.
Dr. Shah, one of the other concerns I have is we spent some
today discussing the importance of well-funded public health
infrastructure for preparedness and response.
A related discussion in the provision of the bill would
allow the secretary to transfer 1 percent of any appropriation
to the public health emergency response fund. The intent of the
fund is to provide a source of extra funding for responding to
public emergencies like Katrina or Harvey.
However, in your written testimony, you indicated that you
had significant concerns about the transfer authority.
Specifically, you mentioned that the authority will take away
vital dollars from other public health programs.
And my question is from the perspective of the local public
health officials on the ground can you describe the challenges
that would occur from allowing the secretary to transfer 1
percent of HHS funding to the public health emergency response
in case of a public health emergency declaration?
Dr. Shah. Thank you again for that question.
What I would say is that we recognize the importance of
having a fund because in the midst of an emergency you have to
have that funding ready right then. You cannot waits months or
some period of time to get those dollars back into the system.
The challenge that we have is that while we were looking at
what happened during Zika, we started to go back and pull
dollars from Ebola. But Ebola was still a threat while we were
also trying to find the dollars over to Zika.
And at our own health department, for example, we had hired
a physician for chronic disease prevention for diabetes and
high blood pressure and immediately because we did not have
those funds we had to move that physician over to be part of
the response system for Zika.
And so I think it's a real challenge that we have to
remember that there are multiple challenges and issues the
public health departments at the local level are facing all the
time. What we don't want to have happen is in mid-cycle dollars
are shifted from one place to another and you now start to lose
infrastructure in that existing area that is equally important.
And we also have to remember that multiple emergencies can
happen at the same time. So yes, those are our concerns,
Congressman, that we are interested in discussing.
Mr. Green. Thank you. I know I am out of time but that's
another issue we'll look at because I still have my
constituents waiting for FEMA assistance 10 months now since
Harvey and I would not like to have our public health have to
wait that long because then we could end up with epidemics.
Thank you, Mr. Chairman.
Dr. Shah. When you wait for dollars that can cost lives,
and so that's very important. Thank you.
Mr. Burgess. The chair thanks the gentleman.
The chair recognizes the gentlelady from Indiana 5 minutes
for questions, please.
Mrs. Brooks. Thank you, Mr. Chairman.
Dr. Berrey, in 2004 Congress passed the Project BioShield
Act, which created the special reserve fund of $5.6 billion
made available over a 10-year period to help create stability
and ease concerns from companies about the likelihood of--help
them decide about whether or not to get into the market for
medical countermeasures. That has traditionally been
unprofitable, and once this initial funding expired, Congress
reverted to appropriating for the program on an annual basis,
which I understand has created less long-term certainty.
Do you agree that recommitting to a multi-year funding
approach for medical countermeasures development and
procurement would help strengthen our nation against biological
threats and could you please talk about whether or not it's
incentives or how can we better prioritize our existing funding
for medical countermeasures?
Dr. Berrey. Absolutely. Thank you, Congresswoman Brooks,
and I want to thank both you and Congresswoman Eshoo for
sponsoring this bill.
I will say without question that having Federal moneys
available for support of these long-term research and
development projects is absolutely critical. We know that the
private sector does not establish the same value--does not
support those programs, especially these longer-term programs,
and thus it is critical that we have federal moneys available.
We've seen the impact in other small and large companies
that are committed to this space. But without a multi-year
authorization have seen the dollar value and the size of those
procurement contracts decrease because BARDA does not have that
capability of having the security of a longer-term multi-year
commitment there. Having that dedicated fund is absolutely
critical. We believe in dual use and both the economic and the
medical benefits that dual-use compounds can bring.
We've seen benefits to our medical countermeasure program
that have been exclusively paid for through our private sector
dollars. One specific example is optimization of our pediatric
suspension. We now have a suspension that has no need for
refrigeration, which is ideal for the SNS, and because we are
treating children through our clinical program for adenovirus,
we have real-world data that can support the dosing information
specific for pediatric use in the event of a smallpox outbreak.
I believe that both the long-term funding and continued
support through PAHPA reauthorization are critical for that
but, secondly, I wanted to make the point that I do believe
dual-use compounds, even though they do bring additional
challenges, have additional economic benefits.
Mrs. Brooks. Thank you.
Mr. Decker, the Blue Ribbon Study Panel on Biodefense
called for the development and implementation of a government-
wide security strategy for stored pathogen data that
incorporates deterrent and enforcement measures, oversight, and
inspection.
Would you be willing or interested in contributing to such
a process and do you believe a strategy like this would improve
the security of sensitive public health information?
Mr. Decker. Well, certainly, I think that focusing any
amount of preparation and effort on securing sensitive
information is going to be important.
I am not familiar with that particular provision so I am
happy to take that back and provide an answer to you, if you'd
like.
Mrs. Brooks. Are you familiar with the Blue Ribbon Study
Panel on Biodefense and recommendations they made?
Mr. Decker. No, I am not.
Mrs. Brooks. OK. Well, we would welcome the opportunity to
work with you on that and to get your further thoughts on what
they recommended.
And finally, Dr. Shah, if we could just go in a little bit
with respect--can you help us understand the role that CDC--
we've certainly had quite a debate and discussion this morning
about CDC's role and what would you say?
Are there any additional tools CDC needs that--or resources
that they need that we ought to be providing as we explore what
their role is, going forward, relative to ASPR's?
Dr. Shah. Yes, that's a tough one. Thank you for that
question.
That's a tough one only because there are a number of needs
that public health in general has at the Federal, state, and
local level. And so I could reall have a nice----
Mrs. Brooks. That's a huge lecture. I understand that.
Dr. Shah. Yes. Yes. Exactly. Exactly.
That said, I do think that outside of supply chain
logistics and those kinds of things that, obviously, and ASPR
would be very good at doing, there would be an opportunity
really to be looking at the real consultation and the technical
assistance----
Mrs. Brooks. Right.
Dr. Shah [continuing]. And the support that's given to
local and state health departments. Really, that's what CDC is
really, really good at--technical assistance and really being
able to pick up a phone and call and/or even deploy in if you
need help and assistance and want to make sure that that
consultation piece is available.
But also the real piece about the support that is given to
local health departments as they're doing their work. If this
shifts over to ASPR and that piece is not so strong then at the
end of the day the last mile is really the most important piece
about SNS is how do you get medications into the mouths of
people and you want to make sure that local health departments
have the support to be able to get that done well and that,
obviously, would mean that we would continue to have that
support from whomever is going to be providing it.
So those guardrails really need to be in place.
Mrs. Brooks. Thank you. I agree. I yield back.
Mr. Guthrie [presiding]. The gentlelady yields back and I
will recognize myself for 5 minutes to ask questions, and thank
you all for being here today.
And Dr. Shah, this is for you. During an Ebola outbreak in
West Africa--the Ebola outbreak in 2014, much was made about
the lack of standards and guidelines for the use of personal
protective equipment in hospitals that were treating infected
patients.
What are your thoughts on establishing reasonable personal
protective equipment guidelines and requirements for emergency
medical service personnel in advance of a biological event
based on existing research and lessons learned?
Dr. Shah. Thank you for that question.
I would say, first of all, there are a few things about
Ebola. I think Ebola and Zika and H1N1, the pandemic, teach us
that global health is very much connected with domestic health
and we have to keep that in mind.
So, really, the way to be able to interrupt the
transmission or get to zero risk for the American people is to
be able to interrupt transmission in global communities, for
example, in West Africa in 2014 or in the case of Zika in Latin
American and Caribbean countries.
That also, obviously, is a concern now with the Democratic
Republic of Congo with DRC because the concern now is does this
get into an urban environment that potentially you could get
spread and get on a plane and you can now get to North America
and here we are, we are back and playing for years later a very
similar situation.
So we work very closely with our environmental health
folks. The environmental health field is amazing when it comes
to really helping us as well as the occupational health field
when it comes to those personal protective equipment and those
environment changes that need to be made and we really believe
with a disease like Ebola, because it's so meticulous that you
have to use personal protective equipment every single time, we
have to recognize the absolute importance of ensuring that we
are working with our private sector that are designing these
suits, designing those gloves, designing those masks, designing
all those materials but we also train local practitioners so
they know what they're doing, how they're doing it, how they're
putting it on, how they're using it so they are meticulous.
One example I will give you is from Hurricane Harvey. We
have J.R. Atkins, who was an EMS responder, who volunteered. He
was meticulous about using personal protective equipment except
one time where he was bitten by a mosquito--it was a spider,
most likely, and he wound up having necrotizing fasciitis, a
flesh-eating bacteria, and we wound up going to the operating
room three to five times.
So we have to be meticulous when it comes to infectious
disease control and we certainly support that.
Mr. Guthrie. OK. Thank you very much.
And this for you but anybody on the panel that would like
to address it--the public health emergency preparedness
cooperative agreement is an annual source of direct funding for
state and local public health systems.
Can you speak about the importance of these agreements in
terms of capability to address biological threats and how do
state, local, and territorial public officials leverage the
Federal support and how does it help prepare the country for
the next outbreak?
Dr. Shah. Thank you again for that question.
What I would say is that we recognize that there is a lot
of capacity already at the local and state level. There is a
lot that's already being done with the resources that we have
in state and local communities.
But it would be important to say that public health
emergency preparedness funding--that 55 percent of local health
departments are actually relying on those dollars for their
preparedness work. It is so critical to many of our local
health departments, especially the smaller local health
departments, the more frontier local health departments. We
have to make sure that those dollars are available and that
they can support and really augment what's already happening at
the local level.
The other piece around the biologics is that we want to
make sure that there is improved recognition of quicker digital
systems and recognition of surveillance systems that really
allow us to do disease pattern recognition.
The final point that I would make in the interest of time
is the fact that we have to really be thinking about where the
risk is, where the threats are, and really ensuring that those
dollars are going not just to certain areas of a community but
all of a community to make sure that those dollars are really
reaching those local health agencies that are boots on the
ground to ensure that they can do the work that they're doing.
Mr. Guthrie. Thank you.
Anybody comment? I know that's more his area but anybody
want to comment on that as well?
Dr. Berrey. The only additional point that I would make is
as we look back on smallpox and as Chairman Burgess noted
earlier that we haven't seen smallpox since the 1970s. So when
you think about the physicians that are currently staffing
emergency rooms, it's very unlikely that any of the physicians
who are currently serving in those first response settings have
actually seen smallpox.
So a big component not just in diagnosis is first to think
about this could be a bioweapon, could be a chemical weapon,
reflect recently on coverage of the nurses who was treating the
Russian spy and his daughter who entered into the emergency
room considered it was mostly likely an opioid overdose, and
only an hour later as the police officer was brought in with
similar symptoms did they realize that this was not in fact an
opioid overdose.
So we really have to go back to thinking about those
zebras. When you hear hoof beats, don't always think of zebras,
but today might be the day for us to begin remembering those
zebras. We can be educating our physicians to think about early
diagnosis and give them the tools to make sure that diagnosis
can occur rapidly.
Mr. Guthrie. Thank you. My time is expired.
I will recognize the gentleman from Missouri, Mr. Long, for
5 minutes for questions.
Mr. Long. Thank you, Mr. Chairman.
Mr. Decker, did you participate in the industry calls that
HHS led during the WannaCry cyber-attack?
Mr. Decker. Yes, I did.
Mr. Long. Did you find them valuable?
Mr. Decker. Yes, I did. What was valuable was getting the
information out to all the health systems so that we could
understand what was happening--if we were being impacted.
Having a sort of a pulse on what was going on in Europe and the
U.K. at the time and if that was coming over across the pond
was important.
There was some confusion on some of the calls--some
information that came out of those calls that was technical in
nature and it was not necessarily related to the actual
technical nature of the attack that was occurring. But the
coordinated and facilitation effort of what those calls were
doing was highly useful.
Mr. Long. So I am assuming that you did find it valuable to
interact with HHS in real time?
Mr. Decker. Absolutely.
Mr. Long. Do you think that if another WannaCry attack took
place today HHS would be able to serve a similar kind of
function?
Mr. Decker. I think they would stand up a similar type of
activity--an incident response function like that. I think it
would be beneficial for the preparedness of that response to be
a little more coordinated.
The means by which HHS is facilitating the process versus
the means by which information sharing and analysis centers
facilitate technical and distribute technical information down
to the health systems, I think there's some better coordination
that could occur there as well as some further monitoring of
the other critical infrastructures that's occurring.
But, ultimately, you know, having HHS serve as the focal
point and facilitation point and the coordination point for a
national response so that we can have an open line of
communication with them in case we need help is, I think,
incredibly important.
Mr. Long. If another cybersecurity incident like WannaCry
were to take place, would you want to contact HHS for guidance
and additional information?
Mr. Decker. Personally, yes. I think there's also a bit of
hesitancy from some of our constituents on HHS being a
regulator as well as an office that provides support and
resources.
I think there's a hesitancy for some to not open up the
lines of communication. So I think that further bolstering the
knowledge of who that sector-specific agency is, what the
protection is----
Mr. Long. Knowledge of what? I am sorry.
Mr. Decker. Of who the sector-specific agency is and how we
can communicate with them under protection is something that
would help with disseminating that information.
Mr. Long. If it did happen again, who would you want to
contact at HHS and how do you know that that would be the right
person to contact?
Mr. Decker. Yes. So contacting ASPR would be on the list as
well--now, ASPR would probably be the main focus point, or the
MCIC within the Department of Health and Human--or DHS.
Mr. Long. You mentioned some people might have concerns
about sharing information with HHS since HHS is your
regulator----
Mr. Decker. Yes.
Mr. Long [continuing]. In addition to your sector-specific
agency. You said other people had that concern. Do you share
that concern?
Mr. Decker. Do I share that concern?
I think there is a clear line between which operating
division is responsible for interfacing with industry and which
is responsible for regulating the industry.
But I don't think that is common knowledge throughout all
the healthcare industry. I think people see HHS as the
regulator. They don't understand the intricacies inside of HHS.
So though I understand the difference between what ASPR is,
what OCR, what ONC, CMS, et cetera, are, I think it's not
common knowledge.
Mr. Long. What steps could HHS take to address some of the
concerns that you detail?
Mr. Decker. A lot of focused education and awareness I
think would be important. Designating a very specific agency
that's going to be responsible for coordinating with the
industry is, I think, very important.
Being able to facilitate the various guidance between OCR,
FDA, ONC, CMS, et cetera, because all of those operating
divisions produce guidance for cybersecurity for the health
care industry.
But it's potentially in conflicting matters and so
deconflicting the guidance that comes out and being able to
really lower the barrier of entry to the cyber space I think is
going to be important, especially for the smaller practice
organizations like small practices, one- or two-physician
practices, critical access hospitals, community hospitals where
they're resource strapped and every dollar that they have, if
they spend it on cyber or if they spend it on public health, or
they spend it on something is something they have to consider.
Mr. Long. With all the players involved in the soup it
sounds like acronymology to me.
Mr. Decker. It is a little bit.
[Laughter.]
Mr. Long. Thank you, Mr. Chairman. I yield back.
Mr. Burgess [presiding]. The chair thanks the gentleman.
The gentleman yields back. We are just about to have votes on
the floor so it looks like there are no further members wishing
to ask questions.
So I want to thank our witnesses for being here with us
today. Pursuant to committee rules, I will remind members they
have 10 business days to submit additional questions for the
record. I am going to ask witnesses to submit their response
within 10 business days upon receipt of those questions.
I would also like to submit documents from the following,
for the record: American Academy of Pediatrics, the American
Hospital Association, the American Society for Microbiology,
America's Essential Hospitals, Global Health Technologies
Coalition, Healthcare Leadership Council, Infectious Disease
Society of America, International Safety Equipment Association,
and the Trust for America's Health statement.
Again, members have 10 business days to submit additional
questions. I ask the witnesses to submit their responses within
10 business days of the receipt of those questions.
Without objection, the subcommittee is adjourned.
[Whereupon, at 1:13 p.m., the committee was adjourned.]
[Material submitted for inclusion in the record follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]