[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
EXAMINING H.R. 3299, STRENGTHENING PUBLIC HEALTH EMERGENCY RESPONSE ACT
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
MAY 19, 2016
__________
Serial No. 114-147
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
21-335 PDF WASHINGTON : 2017
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Chairman Emeritus Ranking Member
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
JOSEPH R. PITTS, Pennsylvania ELIOT L. ENGEL, New York
GREG WALDEN, Oregon GENE GREEN, Texas
TIM MURPHY, Pennsylvania DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee MICHAEL F. DOYLE, Pennsylvania
Vice Chairman JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington KATHY CASTOR, Florida
GREGG HARPER, Mississippi JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey JERRY McNERNEY, California
BRETT GUTHRIE, Kentucky PETER WELCH, Vermont
PETE OLSON, Texas BEN RAY LUJAN, New Mexico
DAVID B. McKINLEY, West Virginia PAUL TONKO, New York
MIKE POMPEO, Kansas JOHN A. YARMUTH, Kentucky
ADAM KINZINGER, Illinois YVETTE D. CLARKE, New York
H. MORGAN GRIFFITH, Virginia DAVID LOEBSACK, Iowa
GUS M. BILIRAKIS, Florida KURT SCHRADER, Oregon
BILL JOHNSON, Ohio JOSEPH P. KENNEDY, III,
BILLY LONG, Missouri Massachusetts
RENEE L. ELLMERS, North Carolina TONY CARDENAS, California7
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota
Subcommittee on Health
JOSEPH R. PITTS, Pennsylvania
Chairman
BRETT GUTHRIE, Kentucky GENE GREEN, Texas
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey DORIS O. MATSUI, California
H. MORGAN GRIFFITH, Virginia BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida KURT SCHRADER, Oregon
BILLY LONG, Missouri JOSEPH P. KENNEDY, III,
RENEE L. ELLMERS, North Carolina Massachusetts
LARRY BUCSHON, Indiana TONY CARDENAS, California
SUSAN W. BROOKS, Indiana FRANK PALLONE, Jr., New Jersey (ex
CHRIS COLLINS, New York officio)
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)
(ii)
C O N T E N T S
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Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 3
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 4
Hon. Susan W. Brooks, a Representative in Congress from the State
of Indiana, opening statement.................................. 5
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 7
Prepared statement........................................... 9
Witnesses
Richard J. Hatchett, M.D., Acting Deputy Assistant Secretary,
Office of the Assistant Secretary for Preparedness and
Response, Acting Director, Biomedical Advanced Research and
Development Authority, Department of Health and Human Services. 11
Prepared statement........................................... 13
Answers to submitted questions \1\........................... 104
Michael Mair, Director of Strategic Operations, Office of
Counterterrorism and Emerging Threats, Food and Drug
Administration................................................. 28
Prepared statement........................................... 30
Colonel Russell E. Coleman, Ph.D., Joint Project Manager for
Medical Countermeasures Systems, Joint Program Executive Office
for Chemical and Biological Defense, Department of the Army,
Department of Defense.......................................... 39
Prepared statement........................................... 41
Submitted Material
H. R. 3299, the Strengthening Public Health Emergency Response
Act of 2015, submitted by Mr. Pitts............................ 56
Letter of May 17, 2016, from Nancy Goodman, Executive Director,
Kids v Cancer, to Mr. Upton and Mr. Pallone, submitted by Mr.
Pallone........................................................ 63
Letter of May 17, 2016, from David Ridley, Ph.D., Faculty
Director, Health Sector Management, Duke University, to Mr.
Pallone and Mr. Green, submitted by Mr. Pallone................ 65
Statement of Richard Hamburg, Interim President and CEO, Trust
for America's Health, May 19, 2016, submitted by Mr. Pallone... 67
Letter of February 11, 2016, from Joseph I. Lieberman and Thomas
J. Ridge, Co-Chairs, Blue Ribbon Study Panel on Biodefense, to
Mrs. Brooks and Ms. Eshoo, submitted by Mr. Pitts.............. 70
Letter of May 19, 2016, from the American Thoracic Society, et
al., to Mr. Pitts and Mr Green, submitted by Mr. Green......... 71
Letter of April 1, 2016, from Douglas W. Bryce, Joint Program
Executive Officer for Chemical and Biological Defense, to Mrs.
Brooks, submitted by Mrs. Brooks............................... 75
Letter of July 29, 2015, from Elisabeth Posillico and Paul
Chaplin, Co-Chairs, Alliance for Biosecurity, to Mrs. Brooks
and Ms. Eshoo, submitted by Mrs. Brooks........................ 76
----------
\1\ Dr. Hatchett did not answer submitted questions for the record by
the time of printing.
Letter of September 16, 2015, from Todd Gillenwater, Executive
Vice President, Advocacy & External Relations, California Life
Sciences Association, to Mrs. Brooks and Ms. Eshoo, submitted
by Mrs. Brooks................................................. 78
Letter of September 14, 2015, from James C. Greenwood, President
and CEO, Biotechnology Industry Organization, to Mrs. Brooks
and Ms. Eshoo, submitted by Mrs. Brooks........................ 79
Letter of October 14, 2015, from Bertrand C. Liang, et al., to
Mrs. Brooks and Ms. Eshoo, submitted by Mrs. Brooks............ 80
Article of June 2009, ``Drug and Vaccine Development for
Infectious Diseases: The Value of Priority Review Vouchers,''
by J. Matheny, et al., Clinical Pharmacology & Therapeutics,
submitted by Mrs. Brooks....................................... 82
Article of 2007, ``Incentives for Biodefense Countermeasure
Development,'' by Jason Matheny, et al., Biosecurity and
Bioterrorism: Biodefense Strategy, Practice, and Science,
submitted by Mrs. Brooks....................................... 84
Article of May 2016, ``The Commercial Market for Priority Review
Vouchers,'' by David B. Ridley and Stephane A. Regnier, Health
Affairs, submitted by Mr. Green................................ 95
EXAMINING H.R. 3299, STRENGTHENING PUBLIC HEALTH EMERGENCY RESPONSE ACT
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THURSDAY, MAY 19, 2016
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. Joseph R. Pitts
(chairman of the subcommittee) presiding.
Members resent: Representatives Pitts, Guthrie, Shimkus,
Murphy, Burgess, Lance, Bilirakis, Ellmers, Brooks, Collins,
Green, Engel, Capps, Schakowsky, Butterfield, and Pallone (ex
officio).
Also present: Representative Eshoo.
Staff present: Rebecca Card, Assistant Press Secretary;
Carly McWilliams, Professional Staff Member, Health; Graham
Pittman, Legislative Clerk; Chris Sarley, Policy Coordinator,
Environment and Economy; Heidi Stirrup, Policy Coordinator,
Health; John Stone, Counsel, Health; Sophie Trainor, Policy
Advisor, Health; Waverly Gordon, Democratic Professional Staff
Member; Tiffany Guarascio, Democratic Deputy Staff Director and
Chief Health Advisor; Samantha Satchell, Democratic Policy
Analyst; Andrew Souvall, Democratic Director of Communications,
Outreach, and Member Services; and Kimberlee Trzeciak,
Democratic Health Policy Advisor.
Mr. Pitts. Ladies and gentlemen, if our guests will take
their seats, the subcommittee will come to order. The Chair
will recognize himself for an opening statement.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Today's hearing will take a closer look at bipartisan
legislation introduced by our Energy and Commerce Committee
colleagues Representative Brooks and Eshoo, H.R. 3299.
This bipartisan bill builds upon our previous work to
modernize our biodefense systems, ensuring that we are well
equipped to handle current and emerging biothreats.
The biothreat is not new. Pandemics have occurred
throughout history. There have been four flu pandemics in the
United States since 1918, each with different characteristics
such as the H1N1 flu most recently in 2010. Even more worrisome
is the threat of biological weapons or infectious diseases
employed as weapons of terror, such as the use of salmonella in
Oregon in 1984 by the Rajneeshee cult or the anthrax scare in
2001.
Science has made significant advances in genomics and
genetics and biotechnology that hold tremendous promise for
those affected by illness and disease. However, that same
technology could theoretically be used to biologically engineer
superbugs that are more virulent, more lethal, more difficult
to treat than their naturally occurring counterparts.
Imagine a weaponized and bioengineered version of the Ebola
virus or polio or smallpox, and the devastating effect that
would have on an American city.
Since the terror attacks on September 11, 2001, Congress
took steps to build our Nation's health infrastructure and
foster a development of medical countermeasures, MCM, in the
event of a future chemical, biological, radioactive, or
nuclear, CBRN, attack.
In 2004, Congress enacted the Project BioShield Act, and
later, in 2006, enacted the Pandemic and All Hazards
Preparedness Act, PAHPA, which was authorized through 2011. In
addition to establishing a strategic plan to direct research,
development, procurement of MCMs, PAHPA also established the
Biodefense Advanced Research and Development Authority, BARDA,
within the Department of Health and Human Services.
BARDA was charged with coordinating and accelerating the
development of MCMs. BARDA was created from the understanding
that most MCMs needed by the Nation did not yet exist, and
their development is a risky, expensive, and lengthy process.
There is little to no demand in the private market for vaccines
and therapeutics that protect against bioterror agents.
BARDA bridges the funding gap between early stage research
and the ultimate procurement of products for the National
Stockpile under Project BioShield. By partnering with private
industry, using money from the Biodefense Advanced Research and
Development Fund, BARDA, can reduce the development risk
entailed in MCM research, thereby helping to mitigate the
disincentives associated with countermeasure development and
ultimately improving our national readiness with regard to a
CBRN attack.
The bill before us today reforms our Nation's medical
countermeasure acquisition process, incentivizes research to
combat the next generation of deadly diseases, and increases
accountability of preparedness spending. Such improvements will
go a long way toward helping our preparedness for future public
health emergencies, such as Ebola, by creating new incentives
for developing necessary medicines and vaccines and
streamlining the contracting process for medical
countermeasures.
Incentives are necessary to attract private investment in
product development, and so too must the contracting processes
be efficient. We must get this right. The stakes are too high,
the cost of failure too dire. And I look forward to our
discussion today about how to best protect our country from
biological threats.
[H.R. 3299 appears at the conclusion of the hearing.]
[The prepared statement of Mr. Pitts follows:]
Prepared statement of Hon. Joseph R. Pitts
Today's hearing will take a closer look at bipartisan
legislation introduced by our Energy and Commerce Committee
colleagues, Reps. Brooks and Eshoo, H.R. 3299. This bipartisan
bill builds upon our previous work to modernize our biodefense
systems, ensuring that we are well-equipped to handle current
and emerging biothreats.
The biothreat is not new. Pandemics have occurred
throughout history. There have been four flu pandemics in the
United States since 1918, each with different characteristics,
such as the H1N1 Flu most recently in 2010. Even more worrisome
is the threat of biological weapons or infectious diseases
employed as weapons of terror, such as the use of salmonella in
Oregon in 1984 by the Rajneeshee cult or the anthrax scare in
2001.
Science has made significant advancements in genomics,
genetics, and biotechnology that hold tremendous promise for
those afflicted by illness and disease. However, that same
technology could theoretically be used to biologically engineer
``superbugs'' that are more virulent, more lethal and more
difficult to treat than their naturally occurring counterparts.
Imagine a weaponized and bioengineered version of the Ebola
virus, or polio, or smallpox and the devastating effect that
would have on an American city.
Since the terror attacks on September 11, 2001, Congress
took steps to build our Nation's health infrastructure and
foster development of medical countermeasures (MCM) in the
event of a future chemical, biological, radioactive, or nuclear
(CBRN) attack.
In 2004, Congress enacted the Project Bioshield Act and
later in 2006, enacted the Pandemic and All-Hazards
Preparedness Act (PAHPA) which was authorized through 2011. In
addition to establishing a strategic plan to direct research,
development and procurement of MCMs, PAHPA also established the
Biodefense Advanced Research and Development Authority (BARDA)
within the Department of Health and Human Services. BARDA was
charged with coordinating and accelerating the development of
MCMs.
BARDA was created from the understanding that most MCMs
needed by the Nation did not yet exist and their development is
a risky, expensive and lengthy process. There is little to no
demand in the private market for vaccines and therapeutics that
protect against bioterror agents.
BARDA bridges the funding gap between early-stage research
and the ultimate procurement of products for the national
stockpile under Project BioShield. By partnering with private
industry using money from the Advanced Research and Development
Fund, BARDA can reduce the development risk entailed in MCM
research, thereby helping to mitigate the disincentives
associated with countermeasure development, and ultimately
improving our national readiness with regard to a CBRN attack.
The bill before us today reforms our Nation's medical
countermeasure acquisition process, incentivizes research to
combat the next generation of deadly diseases, and increases
accountability of preparedness spending.
Such improvements will go a long way toward helping our
preparedness for future public health emergencies, such as
Ebola, by creating new incentives for developing necessary
medicines and vaccines and streamlining the contracting process
for medical countermeasures. Incentives are necessary to
attract private investment in product development. And so too
must the contracting processes be efficient.
We must get this right. The stakes are too high and the
cost of failure too dire. I look forward to our discussion
today about how best to protect our country from biological
threats.
Mr. Pitts. Mrs. Brooks, do you seek time?
Mrs. Brooks. Yes, Mr. Chairman.
Mr. Pitts. The Chair will recognize Mrs. Brooks for her
time.
Mrs. Brooks. Thank you, Mr. Chairman.
I want to thank you and the leadership of the Energy and
Commerce Committee so much for holding this important hearing
today on our bill. Congresswoman Eshoo and I and our staffs
have worked very hard over the course of this Congress to craft
this piece of legislation that now enjoys significant support
from both sides of the aisle. And I commend the chairman for
understanding the urgency of this matter.
Last Congress, I served as chairman of the Homeland
Security Committee's Subcommittee on Emergency Preparedness and
Response, where I was amazed to learn of truly what I thought
was the dire straits our biodefense capabilities are in as a
result of more than a decade of neglect. I wish I could sit
here today and tell you that I think things have improved
dramatically over the last couple of years. And I appreciate
from your written testimony that some of you believe they have.
Mr. Pitts. If you will suspend, I will recognize you for
the chairman when he comes in. You will have more time.
Mrs. Brooks. Oh, I am sorry.
Mr. Pitts. The Chair now will recognize the ranking member
of the subcommittee, 5 minutes for an opening statement.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman, and to our witnesses
for joining us this morning.
The Federal Government has undertaken many initiatives,
especially since the anthrax attacks of 2001, to fortify our
biodefense capabilities to address the threat of a biological
outbreak or attack. With stockpiling medical countermeasures,
MCMs, to build public health capacity, we are better prepared
today than we were a decade ago.
But the fact is we still are dramatically underprepared to
respond to biological event of disaster proportions. The
current Zika virus epidemic underscores our need for a robust
pipeline of vaccines and treatments effective against current
and emerging threats. Over the last decade, the amount of
cooperation between Government and the private sector has
improved and our level of preparedness has increased, but we
must do more in order to meet the new challenges we face.
Currently, the Federal Government's biodefense initiatives
span across a number of agencies and vary in scope and
approach. Department of Homeland Security, Department of Health
and Human Services, and Department of Defense each play a role.
For example, HHS operates the Biomedical Research and
Development Authority, or BARDA, which was created to advance
capability to develop, manufacture, and distribute medical
countermeasures, like vaccines, during public health
emergencies. BARDA is housed within the Assistant Secretary for
Preparedness, or ASPR, the agency responsible for leading
prevention, preparations, and response to the adverse health
effects of public health emergency disasters.
H.R. 3299, Strengthening the Public Health Emergency
Response Act, offers a range of ideas to move our biodefense
and medical countermeasures development and procurement
capacities forward. I want to thank the bill's sponsors for
their leadership. Medical countermeasures are essential to our
Nation's health and security. There is a clear and vital role
for the Federal Government to play in order to contribute to a
greater public health security and ensure preparedness against
biological threats.
We need meaningful countermeasures, research incentives,
transparency, and predictability, and flexible contracting
mechanism in order to shore up our ability to respond to
biological threats and infectious disease outbreaks. Without
strong commitment from the Federal Government, public-private
partnerships, predictable processes and incentives, this market
arguably could not exist.
The Government is the only market for most of the medical
countermeasures. Unlike other drugs and vaccines, these
products are not sold or distributed within the healthcare
system. To incentivize companies to develop and produce these
critical products, Congress created the Project BioShield
Special Reserve Fund in 2004. The Special Reserve Fund was a
market for medical countermeasures and was originally funded
through the advanced appropriations at $5.6 billion over 10
years to procure successful product candidates.
The availability and certainty this 10-year fund offered
had a positive impact on the Government's ability to attract
innovative companies into this space. Twelve MCMs against
several national security threats were delivered to the
National Stockpile under this program. Unfortunately, in fiscal
year 2014, we shifted to annual appropriations for the Special
Reserve Fund, which created an uncertainty where there was once
confidence that there would be a markup for urgently needed new
vaccines and treatments.
The market guarantee for successful MCM candidates is much
weaker, and funding has dropped significantly. While Congress
has many levers and options to incentivize development, many of
these simply nibble around the edges and fall short of making
up with the lack of long-term sustained funding. This Congress,
I cofounded the Public Health Caucus to evaluate the
conversation around public health and emergency preparedness.
We need to break the cycle of lurching from crisis to
crisis, outbreak to outbreak, and invest in public health
infrastructure and medical product development that protects us
against current future threats. H.R. 3299 puts forth a range of
reforms to improve MCM development and procurement response to
emerging infectious diseases and hospital preparedness.
While I have some concerns about the aspect of the
legislation, I believe we can find common ground and strike the
right balance to protect the health and welfare of our Nation.
And I want to thank the stakeholders for their willingness to
work with us and look forward to learning more about their
proposals in today's hearing.
And I want to thank, again, our panel and the chairman for
calling this. I think sometimes we are not topical, but with
Zika and 2 years ago Ebola and no telling what is coming next,
this is a very important hearing.
And, Mr. Chairman, I will yield back my time.
Mr. Pitts. The Chair thanks the gentleman.
I now recognize the gentlelady, Mrs. Brooks, for 5 minutes
for opening statement.
OPENING STATEMENT OF HON. SUSAN W. BROOKS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF INDIANA
Mrs. Brooks. Thank you, Mr. Chairman.
I want to thank you so very much and the leadership of
Energy and Commerce for holding this hearing today.
This legislation now enjoys significant bipartisan support
from both sides of the aisle, including 21 members of Energy
and Commerce, and I commend the chairman for understanding the
urgency of this matter.
Imagine for a second if the weapons used in San Bernardino,
Paris, or Brussels were not guns and bombs, but instead
aerosolized smallpox. And this isn't farfetched. In fact, I
learned last week at a simulation at the McCain Institute in
Washington that this easily weaponized, highly contagious
disease could result in the death of upwards of 1 million
people if dispersed in Madison Square Garden alone.
That number is not just for New York City. But in reality,
those expose individuals would have returned home infecting
every person with whom they came into contact along the way.
And for a disease with a 30-percent kill rate, responsible for
the deaths of 300 million people in the 20th century alone, the
fallout would be global and catastrophic.
So I have been working with my good friend from California,
Congresswoman Eshoo, one of the original architects of Project
BioShield, to develop a set of policy changes that could make a
difference in the next outbreak or, God forbid, a terrorist
attack. H.R. 3299 was developed in collaboration with leading
experts in biodefense, academia, first responders, and the
private sector.
Among other things, this bill would reform contracting
procedures at BARDA to ensure faster development of critical
medical countermeasures and create a limited priority review
voucher for diseases on DHS' material threat list. Returning
this negotiating authority to BARDA will alleviate the
bureaucratic red tape, make an immediate impact on the
development of vaccines and treatments, and the new PRV program
will spur development in an effective vaccine to stockpile
against threats like Ebola, anthrax, or smallpox, which often
take more than a decade and cost hundreds of millions of
dollars.
So when you think about how we can improve our system, we
could have possibly saved lives if we had an Ebola vaccine--
thousands of lives--had it been deployed to West Africa. Or the
Zika vaccine could have possibly already last spring have been
in process and saved pregnant women in Brazil. The impact can
be immeasurable if we make improvements and acknowledge that
the system can be improved.
And so these are commonsense reforms. But they are not just
coming from Congress. This Blue Ribbon Study Panel, the
National Blueprint for Biodefense, listed 33 recommendations to
improve our biodefense. It was authored by experts, some of
whom have testified before our committee. It includes leaders
such as former Senators Tom Daschle and Joe Lieberman; former
Governor Ridge; Donna Shalala, the former HHS Secretary under
President Clinton.
Now, a similar version of our bill has been authored by
Senators Burr and Casey, and it has already passed out of the
Senate Health Committee by a wide bipartisan margin.
Preparedness is not a partisan issue. It has never been, and it
shouldn't be treated as such again. And so I assure my
colleagues that any concerns we might have with this
legislation can be addressed in a bipartisan manner because it
is our duty to really support and protect the American people.
I think that is Federal Government's top priority and must be
our first priority.
I look forward to hearing from our witnesses, working with
my colleagues to pass H.R. 3299.
And at this point, I would yield the remainder of my time
to Dr. Burgess.
Mr. Burgess. I thank you for yielding.
I thank the chairman for holding this hearing.
And recognizing the topic of this hearing is strengthening
public health response, I hope we will spend some time visiting
the recent past and expanding upon whether or not we have
learned any lessons from what has happened to us in the past
few years.
Almost in a twist of cruel irony, President Obama went to
the CDC in Georgia and gave a talk that Ebola has not come--
this was in September of 2014. He made the statement that Ebola
has not come to this country, but if it does, we will be ready.
Well, less than 2 weeks later, Ebola did come to our country.
It came at the back door of a hospital in the middle of the
night, wasn't recognized, the patient was sent home, eventually
came back, eventually died, infected two other people in the
hospital. So the second part of his statement was not
operative. We were not ready.
And then I saw, with this problem literally in my backyard
for the section several months, just how that not being ready,
how that was manifest. We didn't have the type of direction for
people. And the first responders in our emergency rooms, they
didn't have the type of protective equipment. What was posted
on the CDC Web site was woefully inadequate, as we
unfortunately learned later, when two nurses were infected at
the hospital.
When people were looking for the type of protective
clothing that they would need, if someone showed up in the
middle of the night of their emergency room, how can they get
an additional moon suit or two? Do they call a hospital across
town? Are they going to be willing to give up their moon suit
because they could have a patient coming in within the hour
with the same set of symptoms?
I hope we have explored these situations. I hope we have
learned from them. One of, I think, the biggest weaknesses from
2 years ago was the lack of a single repository, a single place
that a hospital administrator or manager or doctor could call
to be able to access the equipment from the National Stockpile.
So, Mr. Chairman, thank you for calling the hearing. I look
forward to the testimony of our witnesses, and I think this is
a timely topic. I yield back.
Mr. Pitts. The Chair thanks the gentleman.
I now recognize the ranking member of the full committee,
Mr. Pallone, 5 minutes for an opening statement.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Mr. Chairman.
Since the attacks of September 11, Congress has worked in a
bipartisan manner to increase our efforts to combat and respond
to biological threats. However, experts have repeatedly warned
that our ability to respond to biological threats must be
improved.
Earlier this year, the Subcommittee on Oversight and
Investigations heard from another member of the Blue Ribbon
Panel on Biodefense and other experts about the U.S.'
biodefense preparedness. According to this report, the Unites
States, quote, ``does not afford the biological threat the same
level of attention as it does other threats,'' unquote. The
report notes that we lack a centralized leader for biodefense,
a comprehensive national strategic plan, and a dedicated budget
for biodefense. And this review also offered 33 recommendations
about how Congress and the administration can improve our
preparedness.
H.R. 3299, the Strengthening Public Health Emergency
Response Act, includes a number of provisions that would make
progress in improving our readiness. While I support the intent
of this legislation, I do have some concerns that I am
interested in discussing with our panel today.
One area is related to the hospital preparedness program.
This legislation would limit the amount of funding that the
Assistant Secretary for Preparedness and Response can use to
operate this program to 3 percent of the program's total
funding. And I am concerned that this limitation, while well-
intended, could limit the ability of ASPR to effectively
oversee and evaluate the hospital preparedness program. And
this limitation also would eliminate funding for other efforts
that support our healthcare preparedness, response, and
recovery ecosystem. So this is one thing we need to look at.
I am also concerned about the delegation of contract
authority to the Biomedical Advanced Research and Development
Authority, or BARDA. Like other HHS divisions, ASPR operates
the contracting office for all divisions and programs under its
authority. This structure ensures that Federal investments are
made through a fair and open process that is free of any
conflicts. Removing ASPR oversight could lead to some influence
on the contracting process by the BARDA Director, another
program officer and outside source.
Then, finally, I want to express some concern about further
expanding the Tropical Disease Priority Review Voucher Program.
This program, created in 2007, was intended to incentivize
research and development of drugs to treat tropical diseases
that disproportionately affect poor and marginalized
populations. Once a qualifying drug is approved, the sponsor
receives a priority review voucher that entitles the sponsor to
a second 6-month review of any other human drug application,
and the sponsor is also able to sell this voucher.
Recently, a priority review voucher sold for $350 million.
Since creation of the Tropical Disease PRV Program, three PRVs
have been awarded, and there has been a significant interest
from industry and others in expanding the program as a way to
encourage development of medical countermeasures.
While I believe we should explore additional ways to
incentivize medical countermeasure development, I do not
believe expanding the Tropical Disease PRV Program is
necessarily the answer. Not only could expansion decrease the
value of a PRV and the incentive to develop drugs under such
programs, but it also increases the burden on FDA to expedite
review of additional applications that may not otherwise
qualify for expedited review.
I am concerned that expansion would only exacerbate known
flaws in the current program. For example, current law requires
FDA to award vouchers to sponsors even if a drug was previously
approved in other countries. Additionally, there is no
requirement that a sponsor market a product approved under the
program; therefore, there is no guarantee that these drugs are
actually helping.
So I look forward to hearing from our Government witnesses
on these issues. And as the committee moves forward, I hope
there will be an opportunity for members to hear from
additional stakeholders.
I would like to yield the minute I have left to Mr.
Butterfield. Oh, he left, OK.
Then I yield back.
[The prepared statement of Mr. Pallone follows:]
Prepared statement of Hon. Frank Pallone, Jr.
Thank you, Mr. Chairman. Since the attacks of September
11th, Congress has worked in a bipartisan manner to increase
our efforts to combat and respond to biological threats.
However, experts have repeatedly warned that our ability to
respond to biological threats must be improved.
Earlier this year, the Subcommittee on Oversight and
Investigations heard from members of the Blue Ribbon Panel on
Biodefense and other experts about the U.S.'s biodefense
preparedness. According to this report, the United States
``does not afford the biological threat the same level of
attention as it does other threats.'' The report notes that we
lack a centralized leader for biodefense, a comprehensive
national strategic plan, and a dedicated budget for biodefense.
This comprehensive review also offered 33 recommendations about
how Congress and the administration can improve our
preparedness.
H.R. 3299, the Strengthening Public Health Emergency
Response Act, includes a number of provisions that would make
progress in improving our readiness.
While I support the intent of this legislation, I do have
some concerns that I am interested in discussing with our panel
of witnesses today. One such area is related to the Hospital
Preparedness Program. This legislation would limit the amount
of funding that the Assistant Secretary for Preparedness and
Response can use to operate this program to three percent of
the program's total funding. I am concerned that this
limitation, while well-intended, would limit the ability of
ASPR to effectively oversee and evaluate the Hospital
Preparedness Program. This limitation also would eliminate
funding for other efforts that support our health care
preparedness, response, and recovery ecosystem. This change may
harm rather than strengthen our health system preparedness.
I am also concerned about the delegation of contract
authority to the BiomedicalAdvanced Research and Development
Authority or BARDA. Like other HHS divisions,ASPR operates the
contracting office for all divisions and programs under
itsauthority. This structure ensures that Federal investments
are made through a fair andopen process that is free of any
conflicts. Removing ASPR oversight could lead toundue influence
on the contracting process by the BARDA Director, another
programofficer, or an outside source.
Finally, I want to express serious concerns about further
expanding the tropical diseasepriority review voucher program.
This program, created in 2007, was intended toincentivize
research and development of drugs to treat tropical diseases
thatdisproportionately affect poor and marginalized
populations. Once a qualifying drug isapproved, the sponsor
receives a priority review voucher that entitles the sponsor to
asecond six-month review of any other human drug application.
The sponsor is also ableto sell this voucher. Recently, a
priority review voucher sold for $350 million. Sincecreation of
the tropical disease PRV program, three PRVs have been awarded.
There has been significant interest from industry and
others in expanding this programas a way to encourage
development of medical countermeasures. While I believe
weshould explore additional ways to incentivize medical
countermeasure development, Ido not believe expanding the
tropical disease PRV program is the answer. Not only could
expansion decrease the value of a PRV and the incentive to
develop drugs undersuch programs, but it also increases the
burden on FDA to expedite review of additionalapplications that
may not otherwise qualify for expedited review. This undermines
theagency's public health mission.
I'm concerned that expansion would only exacerbate known
flaws in the currentprogram. For example, current law requires
FDA to award vouchers to sponsors even ifa drug was previously
approved in other countries. Additionally, there is no
requirementthat a sponsor market a product approved under the
program. Therefore, there is noguarantee that these drugs are
actually helping the people Congress intended to help.
I look forward to hearing from our Government witnesses on
these issues. And, as the committee moves forward with this
legislation, I hope there will be an opportunity forMembers to
hear from additional stakeholders about these concerns and how
they can best be addressed.
Thank you.
Mr. Pitts. The Chair thanks the gentleman.
Mr. Pallone. Mr. Chairman, could I ask, I had three letters
I would like to, unanimous consent, to enter into the record,
one from Kids v Cancer, regarding added medical countermeasures
to the Tropical Disease PRV Program; a letter from David
Ridley, the architect of the Tropical Disease PRV Program and
his Health Affairs article regarding the impact of expanding
the program; and a third from Trust for America's Health.
Mr. Pitts. And I would like to add to that one letter from
the Blue Ribbon Study Panel on Defense.
So, without objection, these are put into the record.
[The letters appear at the conclusion of the hearing.]
Mr. Pitts. As usual, all members' opening statements will
be made a part of the record. And we will now introduce the
panel. We have one panel today, and I will introduce them in
the order of their presentation.
First, we have Dr. Richard Hatchett, Acting Director,
Biomedical Advanced Research and Development Authority, BARDA,
and Acting Deputy Assistant Secretary in the Office of the
Assistant Secretary for Preparedness and Response, ASPR, U.S.
Department of Health and Human Services. Secondly, we have Mr.
Michael Mair, Director of Strategic Operations, Office of
Counterterrorism and Emerging Threats in the Food and Drug
Administration; finally, Colonel Russ Coleman, Ph.D., Joint
Project Manager, Medical Countermeasures Systems, Department of
Defense.
Thank you for coming today. Your written testimony will be
made part of the record. You will each have 5 minutes to
summarize your written testimony.
So, Dr. Hatchett, you are recognized for 5 minutes for your
summary.
STATEMENTS OF RICHARD J. HATCHETT, M.D., ACTING DEPUTY
ASSISTANT SECRETARY, OFFICE OF THE ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, ACTING DIRECTOR, BIOMEDICAL ADVANCED
RESEARCH AND DEVELOPMENT AUTHORITY, DEPARTMENT OF HEALTH AND
HUMAN SERVICES; MICHAEL MAIR, DIRECTOR OF STRATEGIC OPERATIONS,
OFFICE OF COUNTERTERRORISM AND EMERGING THREATS, FOOD AND DRUG
ADMINISTRATION; AND COLONEL RUSSELL E. COLEMAN, PH.D., JOINT
PROJECT MANAGER FOR MEDICAL COUNTERMEASURES SYSTEMS, JOINT
PROGRAM EXECUTIVE OFFICE FOR CHEMICAL AND BIOLOGICAL DEFENSE,
DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE
STATEMENT OF RICHARD J. HATCHETT
Dr. Hatchett. Chairman Pitts, Ranking Member Green, Mrs.
Brooks, Ms. Eshoo, distinguished members of the House Energy
and Commerce Committee, thank you for the opportunity to
testify today regarding biosecurity issues and H.R. 3299, the
Strengthening Public Health Emergency Response Act.
I am Dr. Richard Hatchett, the Acting Director of BARDA,
and I will focus on steps taken by ASPR to strengthen our
Nation's health security and the contributions of my own office
toward that end.
We have made substantial progress in the past 10 years to
advance the state of our national biodefense. Thanks to the
support of this committee and others in Congress, we have
established ASPR and BARDA and made critical investments in
biodefense and our healthcare system. However, as highlighted
by recent challenges, such as Ebola and Zika, there remain gaps
in our preparedness.
Where the civilian public health and medical response to
such events is concerned, the ASPR is charged by statute to
play a strong leadership role. The ASPR serves as a principal
adviser to the Secretary of HHS on all matters related to
Federal medical preparedness and response for public health
emergencies.
The ASPR is the author and custodian of the National Health
Security Strategy, which focuses on protecting public health
during an emergency. The ASPR chairs the Public Health
Emergency Medical Countermeasures Enterprise, or PHEMCE, which
coordinates medical countermeasure development efforts across
the interagency. And the ASPR oversees the Hospital
Preparedness Program, or HPP, which enhances medical
preparedness and resiliency at the community level through its
support of healthcare coalitions, which incentivize diverse and
often competitive healthcare organizations to work together.
The health of communities is deeply intertwined with the
abilities of its institutions to provide care to all
populations. And investments in HPP are critical to limiting
the cascade of negative health effects caused by disasters. The
PHEMCE promotes the development and acquisition of medical
countermeasures for chemical, biological, radiological, and
nuclear threats, pandemic influenza, and emerging infectious
diseases. And it has achieved a record of success that is now
being studied as a model for global preparedness.
The strong and direct incentives we have put in place to
support the development of medical countermeasures work. The
PHEMCE has achieved technical success. BARDA has achieved
technical success. Twenty three products that BARDA has
supported have received FDA approval, licensure, or clearance.
And the pace of success is accelerating. Fourteen of these
approvals have occurred since 2011, and five have occurred in
the last 14 months.
Seventeen products, ranging from anthrax antitoxins to an
array of products for the management of thermal burns, have
been procured for the Strategic National Stockpile under
Project BioShield, with another seven anticipated between now
and the end of fiscal year 2018. Over the last decade, we have
honed a model of public-private partnership that works. It
depends on combining push-and-pull incentives in the form of
nondiluted funding and guaranteed market commitments with
access to subject-matter expertise and product development
services. We thank you for your continued support and sustained
commitment to these programs.
To support BARDA's activities, ASPR has established a
separate Office of Acquisitions, Management, Contracts, and
Grants, or AMCG. AMCG is an award-winning and innovative
contracting office that has led the Department in meeting
contracting timelines, and its independent line of reporting
mitigates potential conflicts of interest and ensures the
highest standards of program integrity.
AMCG can work fast. While the departmental benchmark for
contract actions is 180 days, 70 percent of our Ebola contract
actions were awarded within 60 days. And the median time for
recent Project BioShield and other major acquisition awards was
90 days from the publication of the RFP. And AMCG is fair. Last
year, over 95 percent of ASPR's contract actions were competed,
ensuring a level playing field for businesses capable of
meeting HHS requirements. Fifty-one percent of eligible
contract dollars were awarded to small businesses.
These investments in preparedness have already paid
dividends. Because of the workforce in capabilities ASPR has
developed over the last 9 years, we and our Nation's
communities are much better prepared to respond quickly to
disasters and emerging threats.
Thank you again for the invitation to speak with you, and I
look forward to addressing your questions.
[The prepared statement of Dr. Hatchett follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The Chair thanks the gentleman.
I will recognize Mr. Mair, 5 minutes for your summary.
STATEMENT OF MICHAEL MAIR
Mr. Mair. Good morning, Chairman Pitts, Ranking Member
Green, and members of the subcommittee. Thank you for the
opportunity to discuss FDA's perspective on H.R. 3299, the
Strengthening Public Health Emergency Response Act, which
contains provisions intended to help improve preparedness for a
response to chemical, biological, radiological, and nuclear, or
CBRN, threats.
FDA plays a critical role in protecting the United States
from deliberate CBRN threats and naturally incurring infectious
diseases, such as Zika virus and pandemic influenza. FDA is
responsible for ensuring that medical countermeasures,
including drugs, vaccines, and diagnostic tests, to counter
these threats are safe and effective.
We work closely with our interagency partners, including
our partners seated here with me today, as well as with product
developers to facilitate to the development and availability of
medical countermeasures. This collaboration has been extremely
successful. For example, since 2000, FDA has approved 89
medical countermeasures for CBRN threats and pandemic
influenza, as well as 17 supplemental changes to already
approved applications and 71 modifications to diagnostic
devices. This success is in part due to the continuing support
provided by Congress in establishing the programs and
authorities necessary as well as providing the funding needed
to create and sustain a robust Medical Countermeasures
Enterprise.
As you know, H.R. 3299 contains a provision intended to
help incentivize medical countermeasure development by enabling
product developers to receive a priority review voucher, or
PRV, under FDA's Tropical Disease PRV Program provided certain
criteria are met. The PRV may be used by the product developer
who receives it or sold to another product developer who may
then use it to obtain priority review for a product application
that otherwise would not receive priority review.
When a marketing application receives a priority review
designation, FDA's goal is to take action on that application
within 6 months, as compared to 10 months under standard
review. Thus, the PRV enables the product developer to
potentially bring a product to market sooner than it would
under standard review time, which is valuable to product
developers.
While FDA fully supports the intent in H.R. 3299 to further
incentivize the medical countermeasure development, we do not
believe that adding CBRN threats to the Tropical Disease PRV
Program is likely to achieve that goal. Only three PRVs have
been awarded to date under the Tropical Disease PRV Program
since its inception in 2007, and these were for products that
had been in development prior to the creation of the PRV
program. Thus, it remains unclear at this time how effective
this program is in spurring product development, particularly
for new product development.
And even if PRV has ultimately proved successful in
incentivizing product development, expanding the Tropical
Disease PRV Program to CBRN threats has the potential to
increase the number of PRVs that are issued over time, which
could negatively affect the sales value of PRVs and thus the
ability of the PRV program to do what it is intended to do:
incentivize product development.
As Dr. Hatchett noted, the U.S. Government already provides
significant incentives to help facilitate medical
countermeasure development, including funding for research and
development, clinical trial costs, and procurement contracts,
and extensive technical assistance throughout the development
process. These incentives have been highly successful in
facilitating the development of medical countermeasures
required for emergency preparedness and response. Therefore, it
is unclear that extending PRVs to CBRN threats is sufficient or
even necessary to incentivize additional medical countermeasure
development.
FDA is also very concerned that adding CBRN threats to the
Tropical Disease PRV Program will have a negative impact on
FDA's ability to support product development. PRVs are redeemed
for products that would not otherwise qualify for priority
review, such as drugs to treat conditions for which safe and
effective therapies often already exist: for example, elevated
cholesterol or diabetes.
The clinical trials for these applications are typically
more numerous, involving thousands more patients, and more
complex than for the types of products that would normally
qualify for priority review. Reviewing such applications within
the target 6-month priority review timeframe is very
challenging and requires many more person-hours and a larger
review team. Thus, managers and reviewers must refocus time and
resources away from other important public health work.
If there are more PRVs being issued and redeemed as a
result of the proposed expansion of the Tropical Disease PRV
Program, FDA will have fewer resources available to review
other marketing applications, including for serious diseases
for which no available therapies exist.
These resource constraints will also undermine FDA's
ability to conduct its portfolio of public health work from
providing advice and guidance in the early stages to help
facilitate product development, including for medical
countermeasures, as well as to monitoring safety and approval.
Given the uncertainty related to the utility of extending PRVs
to CBRN threats and the potential negative unintended
consequences associated with doing so, FDA believes Congress
should approach the expansion of the PRV program to CBRN
threats with caution.
We suggest that it would be advantageous to conduct a full
assessment of U.S. Government medical countermeasure programs
to determine if additional incentives are needed, and if so,
bring together key experts and stakeholders to explore the most
appropriate incentives to add.
Thank you, and I will be happy to answer any questions you
may have.
[The prepared statement of Mr. Mair follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The Chair thanks the gentleman.
I recognize Colonel Coleman, 5 minutes for your summary.
STATEMENT OF RUSSELL E. COLEMAN
Colonel Coleman. Good morning. Chairman Pitts, Ranking
Member Green, and distinguished members of the subcommittee,
thank you for the opportunity to testify on Department of
Defense efforts to partner with industry on the development of
medical countermeasures that threaten our deployed military
forces. I am talking about chemical, biological, radiological,
and nuclear agents, CBRN.
As the DOD Joint Project Manager for Medical
Countermeasures Systems, my mission is the advanced
development, procurement, and sustainment of FDA-approved
diagnostics, vaccines, and therapeutics needed to protect the
warfighters from these deadly hazards.
I am one of five Joint Project Managers within the DOD's
Joint Program Executive Office for Chemical and Biological
Defense, which is the material developer for the Department of
Defense Chemical and Biological Defense Program, providing
full-spectrum capabilities against CBRN attacks. Today,
available economic and regulatory incentives have not succeeded
in encouraging the industry to partner with the Department of
Defense on the development of medical countermeasures against
CBRN hazards.
In general, medical countermeasures against these threats
for the military would be used in rare emergency situations.
And the military market is small. We are talking, you know, a
couple hundred thousand forces, not tens of millions or
hundreds of millions. This market is small so that it is
unlikely to yield an acceptable return on investment for our
industry partners. And industry performers, in my talks with
them, have indicated that return on investment is their top
priority, and there is simply little or no benefit in targeting
these low-likelihood, high-impact threats.
I personally believe that incentives are needed to inspire
additional innovation in this market. There are a variety of
potential incentives that could be used to encourage this
investment, and the Department of Defense recognizes that the
development of incentives will require a careful assessment of
the risks and benefits that extend well beyond just the
Department of Defense.
Please recognize that we are not idle in the face of the
challenges we have. My organization is taking steps to increase
the Department of Defense's ability to more rapidly develop and
field medical countermeasures for the Joint Forces.
We have recently announced the award of an other
transaction authority consortium specific for the development
of medical countermeasures in order to make it easier for
nontraditional defense contractors, such as pharmaceutical
industry, to partner with the Department of Defense. The OTA is
a special contracting vehicle that has flexibility that is
appealing to the pharmaceutical companies.
Additionally, my office is standing up the DOD Medical
Countermeasures, Advanced Development, and Manufacturing
Capability, a dedicated and enduring capability to conduct
advanced development and manufacturing of products for the
warfighter. This facility will make it easier and more likely
that small biopharmaceutical companies, with which the DOD
already engages but who lack the necessary experience with the
FDA and with manufacture and production, to actually succeed at
filling our DOD role.
The bottom line is that the DOD is determined to field and
fully fulfill those validated warfighter requirements that will
provide those urgently required capabilities against CBRN
threats. I applaud the conversation now ongoing as to which
incentives can best meet those requirements and generate
innovation in this area.
Thank you again for the opportunity to provide my
perspective. I look forward to continued congressional efforts
to achieve results for the warfighter and the taxpayer.
[The prepared statement of Colonel Coleman follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The Chair thanks the gentleman.
We are voting on the floor. We still have time to begin
questioning, so I will begin the questioning. I recognize
myself 5 minutes for that purpose.
Colonel Coleman, the Department of Homeland Security has
identified 13 material threats to U.S. national security. Would
a PRV for threats on the material threat list help develop new
MCMs for DOD? And why is it so important that we make sure
these products are developed?
Colonel Coleman. Thank you, sir. There is a Department of
Homeland Security threat list, the material threat list, and a
DOD threat list. They have many commonalities. So I believe
that the availability of PRVs for agents on that material
threat list would be of value to the Department of Defense.
As to the second part of your question, why is this
necessary for the Department of Defense? We face a myriad of
threats on the battlefield. Our environment is fundamentally
different from that face defending the homeland. We deploy our
military forces to remote areas of the world where we have an
austere environment, limited resources, difficult situations.
And so the situation for the military is not the same as for
the homeland.
There are a myriad of threats that we face, and we don't
have capabilities against many of them. We recognize the need,
and we have ongoing problems and programs. The best example I
can highlight is Ebola virus in the recent outbreak that is so
fresh in our minds. I deployed to Zaire in 1995 as part of a
small team dealing with an Ebola outbreak. At that time, I was
given a thermometer. This was the medical countermeasure
available. Take your temperature, and we will throw you in the
isolation ward.
Flash forward 20 years, and while the Government has been
actively involved in developing countermeasures for Ebola
virus, what did we have? We did not have FDA-approved products.
Yes, we had experimental compounds that all of us worked to
make available to help save lives, but we had not been able to
get them over the finish line. From my personal perspective,
again, for the military, it is the lack of industry interest
just because of the lack of return on investment.
We wish that, for our military needs, we would have a large
enough guarantee that we would buy enough product to make it
worthwhile. That is just not the case for the military. So
alternative incentives, in my mind, could replace the return on
investment. Now, I have to caveat, these are my personal
perspectives and not a Department of Defense position. There is
no real position from the Department of Defense on the value of
priority review programs, but there is great interest in better
understanding the incentives that could be made available.
Thank you, sir.
Mr. Pitts. Thank you.
Mr. Mair, you said, in 2009, in an article that you
authored, quote: ``Priority review vouchers are an innovative,
high-impact, low-cost mechanism for encouraging the development
of new medicines and vaccines for infectious diseases,'' end
quote.
In your testimony, you say that concern that extending the
Tropical Disease PRV Program to CBRN threats may not
effectively incentivize medical countermeasure development.
Have you changed your position? Explain, you know, the change
there.
Mr. Mair. Thank you. So back when I wrote about the value--
potential value of PRVs for CBRN threats, I initially got--it
was initially not even a program that was anything but an idea
back in 2007 when I initially published on that. And at that
time, PRVs were only an idea, and then since that time,
Congress created the Tropical Disease PRV Program, and then we
also have now a pediatric rare disease PRV program.
So both of those programs now exist, and they have a lot of
products that you could get through under that. So my concern
at this point is twofold: One is that to continue to increase
the program will reduce the value of the vouchers. And so it is
unclear that to keep growing the program is going to undermine
the program. And so there is that problem and also the issue of
the effect on FDA's ability to conduct its work. At the time, I
didn't appreciate that because I was not in Government. And it
sounded at the time like it was reasonable that FDA could
charge an extra user fee and they would be able to bring on
extra staff to do the extra work associated with those PRV
reviews. But it turns out that it doesn't work that way because
we can't just staff up quickly because those fees are one time
and unpredictable.
And so the effect on FDA's ability to do its other work is
sort of balanced against the value of the PRV. And also, at
this time, it is not even clear that these PRVs are really
valuable to the developers who might get them, especially if we
continue to grow the program and they become less valuable.
Mr. Pitts. Thank you.
I have a question for you, Dr. Hatchett, but my time is
expired for now, so I will recognize the ranking member.
Mr. Green, 5 minutes for questions.
Mr. Green. Thank you, Mr. Chairman.
Dr. Hatchett, thank you for joining us today. I think it is
important to understand each element of H.R. 3299. I would like
to focus on the provision which would give BARDA its
contracting authority. When BARDA was created in 2006, Congress
gave the agency sole authority to negotiate and execute medical
countermeasure contracts to ensure that it would react quickly
to the development of vaccines and appropriate solutions.
My understanding is that the contracting was moved from
BARDA to AMCG in 2009 in order to streamline ASPR's internal
process. However, I heard from stakeholders that this
transition has several unintended consequences which serve to
slow down the procurement process for medical countermeasures.
For example, companies often respond to BARDA requests to
submit proposals with a 24 to 48-hour turnaround only to have
these proposals language in the AMCG's review process for
multiple weeks or months.
Countermeasure and development is critical to our national
security and requires a more urgent and efficient contracting
process than traditional grants at HHS. Though I am sure AMCG
is well intended, they do not appear best suited to deal with
the complexities of vaccine or medical countermeasures
development the way BARDA does.
Dr. Hatchett, I know you have only been on a job for a
couple of months, but do you believe that we could achieve more
efficiencies in the contracting process? If so, what
recommendations would you have for this committee?
Dr. Hatchett. Thank you, Mr. Green. Thank you for the
question.
Let me address the major part of the question first, which
is whether I think that we should move the contracting activity
within ASPR back into BARDA. And I actually do not think that
we should do that. There were good reasons of policy, as
opposed to just streamlining ASPR's contracting activity, that
underlay the decision to move that contracting activity out of
BARDA and to have it provide a separate line of reporting
directly to the Assistant Secretary for Preparedness and
Response.
Having the independent contracting authority provides
checks and balances, obviously. It helps ASPR conduct its
business with autonomy, without either the perception or
potentially the reality of undue influence by the BARDA
Director. And it allows the Assistant Secretary, which is a
Senate-approved Presidential appointment, to provide direct
oversight of the contracting activity within ASPR.
Mr. Green. I have got some other questions. And I
understand the separation of powers and the checkpoints, but I
also know that, if it is an emergency, you know, for the
companies to submit the contract within 48 hours, why would it
take months to do it if we actually had an emergency that we
needed? And a good example is Zika, which we are experiencing
right now.
Dr. Hatchett. So Zika is a good example. Thank you for that
question. When it is an emergency, our AMCG, our contracting
office can act very, very rapidly. In fact, during the Zika
crisis, there was an incident that was potentially going to
turn into a medical crisis where FDA issued guidance about the
collection of blood in areas where ongoing Zika transmission
was occurring, and it was going to require blood collection in
areas with active Zika transmission to be stopped.
We learned about the impact that this was going to have on
Puerto Rico, which could potentially produce a medical crisis
there, on February 24, and within 6 business days, our
contracting office had issued contracts to support the
emergency delivery of blood to Puerto Rico. And 1 day after the
contract was issued, blood supplies began to be moved to Puerto
Rico. That was in Zika.
During----
Mr. Green. And I appreciate that, you know, but, again, we
all have to be on our toes. Two years ago, it was Ebola, and
now it is Zika. And, you know, where I come from in Texas, we
have a lot of other challenges that--but I appreciate it.
What other serious infectious disease threats is ASPR and
BARDA monitoring and is concerned about the potential impact on
public health? And what sustained approaches and questions and
steps can be taken to prepare for emerging threats before they
reach the level of being immediate and urgent public health
concerns?
Dr. Hatchett. So we are constantly scanning to act
proactively if we detect emerging threats. We are, for example,
paying very close attention to the yellow fever outbreak in
Angola at present and monitoring the manufacturing capacity in
status of yellow fever vaccine stockpiles. We certainly are
continuing to monitor Ebola. We are working very closely with
the international community. There is an ongoing effort right
now to prioritize known emerging pathogens in terms of the
potential threat they face.
Mr. Green. OK. Mr. Chairman, thank you. I would like to ask
unanimous consent to place in the record a letter from the
Doctors Without Borders.
Mr. Pitts. Without objection, so ordered.
[The letter appears at the conclusion of the hearing.]
Mr. Pitts. We are voting on the floor. We still have a
couple of minutes left to vote. There are 11 votes, so we are
going to stand in recess until the conclusion of those votes.
It should be around 11:30.
So, without objection, the committee stands in recess.
[Recess.]
Mr. Pitts. All right. Thank you for your patience. The time
of recess having expired, we will reconvene the hearing.
And the Chair now recognizes the gentlelady from Indiana,
Mrs. Brooks, for 5 minutes of questions.
Mrs. Brooks. Thank you, Mr. Chairman.
And I would ask unanimous consent to provide to the record
five letters of support for a bill, H.R. 3299: one from Douglas
Bryce, Joint Program Executive Officer for Chemical and
Biological Defense from the Department of the Army; one from
the Alliance for Biosecurity; one from the California Life
Sciences Association; one from the Biotechnology Innovation
Organization; and one that is categorized from a number of
venture capital firms.
Mr. Pitts. Without objection, so ordered.
[The letters appear at the conclusion of the hearing.]
Mrs. Brooks. Thank you.
Dr. Hatchett, I realize that you have only taken over very
recently as the BARDA Director, as recently as last month, but
I am curious, and I would like to share with you some
statements that your predecessor, Dr. Robin Robinson, told this
committee under oath last year in November of 2015.
He was asked the question if he believed that additional
incentives were needed to get the private sector involved in
the medical countermeasures development, and he answered yes.
He also, when asked if he believed that creation of a
priority review voucher limited to the material threats
identified by DHS would be a useful incentive for the private
sector, he answered yes to that as well.
And when asked if he believed Congress gave BARDA the
unique contracting authority based on its unique national
security mission, he answered originally yes.
When asked if it would be helpful to further expedite the
medical countermeasures contracting process, he answered yes.
And, finally, he asked if it would be helpful, most
directly, for BARDA to have direct control over its advance
development and procurement contracts as it has in the past.
And he indicated, whatever would be helpful, whatever we could
do, yes.
And so could you please explain the agency's and the leader
of the agency's dramatic shift in thinking? And I appreciate
your praise of, you know, ASPR's contracting authority and so
forth, but how is it that the leader of BARDA previously has a
180-degree different view than you do?
Dr. Hatchett. Thank you for giving me the opportunity to
address that. Would you like me to address the question about
incentives in the priority review voucher first, or would you
like me to tackle the contracting?
Mrs. Brooks. Whichever you prefer.
Dr. Hatchett. OK. Let me start with the incentives
question.
We are very concerned about ensuring that we have
appropriate incentives in place to support medical
countermeasure development. As you and the members of the
committee know, most of the medical countermeasures do not have
viable commercial markets that can justify their existence. And
in the absence of an appropriate set of incentives--and I do
think it is important that we have a set of incentives--that
development just will not take place. And it has taken us over
a decade to get a set of incentives in place that have begun to
show results, as I mentioned in my original testimony.
I believe, with respect to the priority review vouchers,
that--I certainly also hear from our partners in industry about
their interest in seeing the priority review voucher being
extended into this space. My perception is that the reason they
are interested in seeing a priority review voucher extended
into this space--a priority review voucher is what we call a
pull incentive. It is a prize for delivering, you know, the
goods. It is not to help them perform research, but it is
something that we give them when they succeed. We----
Mrs. Brooks. But just, if I could clarify----
Dr. Hatchett. Yes, ma'am.
Mrs. Brooks [continuing]. This involves no taxpayer
dollars. Is that correct?
Dr. Hatchett. The priority review voucher does have costs.
They are distributed differently. It is not a direct taxpayer-
dollar-funded incentive.
But it is a pull incentive, because if a company can
receive a priority review voucher, then they have this prize
which they can trade on the open market, and it provides
potentially a great deal of value to the company.
My perception is that the companies that have expressed
support for this are expressing support for a new pull
incentive because of their concern about our collective
commitment to the biodefense enterprise. Without a sustained,
substantial commitment to supporting medical countermeasure
development, they, I believe, view the addition of a new
incentive as potentially valuable.
I believe that the incentives that we have in place, if
they are sustained and fully supported, are demonstrating that
they can work. And that is why I differ with my predecessor
about the value of a priority review voucher. I understand the
interest in the priority review voucher. I am not denying that
it serves as a pull incentive. But I believe there are more
direct and less deleterious ways that we can achieve success.
Mrs. Brooks. But would you agree with me, though, it is
certainly not just the private-sector companies who engage in
this space. It also was endorsed in a significant way by the
National Blueprint for Biodefense by the blue-ribbon panel. And
so a number of experts for a long period of time believed that
this would be the way forward. In fact, it is a number of their
recommendations.
Dr. Hatchett. We are very interested in looking at all
potential incentives that can be brought to the table.
And the one other thing that I would say is that, in the
various spaces that we work in, for CBRN threats, for pan flu,
for antimicrobial resistance, and now for emerging diseases,
the market failures for each of those areas differ, and I
believe that they will require potentially different sets of
incentives to achieve success against each of those threats.
Mrs. Brooks. Thank you.
Mr. Chairman, I failed to also ask if we could submit for
the record--I know that you, I believe, in your questioning,
mentioned prior articles written by Dr. Mair. And I have two
articles with respect to the priority review vouchers and the
value that I would like to submit for the record written, in
part, by Dr. Mair.
Mr. Pitts. Without objection, so ordered.
[The articles appear at the conclusion of the hearing.]
Mrs. Brooks. Thank you. My time has expired. I yield back.
Mr. Pitts. The Chair thanks the gentlelady.
I now recognize the vice chairman of the subcommittee, Mr.
Guthrie, for 5 minutes.
Mr. Guthrie. Thank you.
Thank you all for being here and your patience. We
appreciate it.
Mr. Mair, I know that you have claimed that when a priority
review voucher is redeemed, FDA has a harder time reviewing
other priority review applications on time. However, in its
most recent PDUFA performance report to Congress, the FDA
stated that it met review goals for 100 percent of the 29
priority review applications it received. And it appears, from
FDA's own data, the use of priority review vouchers has not had
any impact on review times for other priority applications.
If the FDA doesn't support the priority review voucher
incentive, then what other kind of incentives could be
appropriate for developing countermeasures? I know you are not
going to endorse any or ask for any, but what are other
incentives that we could look at?
Mr. Mair. Thank you for the question.
So, with respect to the effect, I think--with respect to
the effect of the vouchers, potential effect on our ability to
do other reviews, I think our concern we are raising here is
expanding the program. Well, there will be more vouchers out
there that will eventually come in. And so this has the
potential to affect our ability to do more of our other work
down the road, especially if we continue to expand the program.
So while, you know, one or two might by doable, if we end
up getting, you know, 5, 10, 15 vouchers out there, it, you
know, has the potential to grow to a point where it is----
Mr. Guthrie. Are there other incentives that might be
workable if we need priorities to move forward?
Mr. Mair. You know, it is a difficult question and
something we should look at, but there are--you know, it is a
question of, you know, the incentives we currently have, can we
treat them, can we hone them in some way, can we improve what
is currently available, or can we add new incentives to the
mix, and what is most valuable, and what can get us there in
the best possible way with the most value to the taxpayer in
terms of getting us there most efficiently. So it----
Mr. Guthrie. OK. Thanks. I am going to try to get through a
couple more questions. I appreciate that. Thanks a lot. I
wasn't cutting you off to be rude, just to get to a couple more
questions in my 5 minutes.
Colonel Coleman, do you believe the Department of Defense
has the requisite number of medical countermeasures developed,
licensed, and available to protect our warfighters from
biological agents? And, in your opinion, should Congress be
doing more to encourage the development of medical
countermeasures against these threats, like creating priority
review vouchers for the medical countermeasures?
Colonel Coleman. Yes, sir. Thank you for that question.
So I can unequivocally say that we don't have the full
array of medical countermeasures needed to combat weapons of
mass destruction. Ergo, we have a robust program with funds
provided by Congress for this express purpose. So, clearly, the
needs continue, and we are a long way from where we ultimately
need to be.
In terms of any Department of Defense position, there is no
position, as I stated earlier--I mean, there is a clear belief
that we need an array of incentives. Personal opinion, which I
think you asked, regarding priority review vouchers, I believe
they could potentially be of great value.
I will refer back to the Ebola virus outbreak. Post-
outbreak, I have engaged with conversations with many of the
pharmaceutical companies that chose to engage at the time of
the outbreak, and their interest is waning. And some of the
companies have indicated that, when they choose to stay in, it
is really for the priority review voucher, which was added to
that neglected tropical disease threat list. So I am getting
the feedback from commercial enterprises that they see the
value to this.
Mr. Guthrie. OK. Thank you.
And, Dr. Hatchett, some claim that it is important that
BARDA does not have contracting authority because of potential
conflicts of interest or undue influence of the BARDA Director.
Why was your contracting authority taken away? And did the
BARDA office lack program integrity?
Dr. Hatchett. Thank you for asking about the contracting
authority again because I didn't get to answer Mrs. Brooks'
question----
Mr. Guthrie. OK.
Dr. Hatchett [continuing]. And would like to address her
question as well.
The contracting authority was removed from BARDA, I
believe, in 2009, which was prior to--I joined BARDA in 2011.
Mr. Guthrie. Yes. There was no implication on you in there.
Dr. Hatchett. Yes. And I believe the concern was
legitimately that contracting is such an important activity, it
manages the taxpayers' dollar, that it was extremely important
that it be independent and that it represent the business
function of Government independently in terms of negotiations
with companies.
Our contracting office is right down the hall from my
office. The head of our contracting authority, retired
Brigadier General Jeff Scarborough, is--you know, his office is
less than 100 yards from mine. We talk every single day. Our
staff interact with the contracting officer staff every single
day. So, you know, there are no barriers to our working
together. We work together on all contracting actions.
And in point of fact, to answer Ms. Brooks' question about
why I have a different opinion than my predecessor, I have
looked at the data. I have looked at the data as to the
timelines for individual contracting actions as well as
aggregate timelines. And it is quite impressive that we are
well below Federal and departmental benchmarks in terms of our
performance. There are outliers, some that are large outliers
that result in, you know, the average times being actually
being lower than the median times. That happens.
But, overall, I think our contracting office is providing a
service to the American citizen by ensuring the integrity of
our procurement process. And I am very comfortable with the
system as it currently exists. I just have a different opinion
than my predecessor.
Mr. Guthrie. Thank you, Mr. Chairman. My time has expired,
so I yield back.
Mr. Pitts. The Chair thanks the gentleman.
Without objection, we have a member of the Energy and
Commerce Committee, not a member of the subcommittee, here, one
of prime sponsors of legislation. I would like to yield to Ms.
Eshoo 5 minutes for questioning.
Ms. Eshoo. Thank you very much, Mr. Chairman, for your
legislative courtesy.
And I would like to thank the witnesses for their testimony
today.
I am very proud of the legislation that former Congressman
Mike Rogers and myself shaped and shepherded to create the law
that led to BARDA. We are both members of the Energy and
Commerce Committee, but, very importantly, both members of the
House Intelligence Committee. And we viewed this issue in many
ways as the tip of the spear, that our national security is a
portfolio that contains many items that must be addressed.
And so it is a pleasure to work with Congresswoman Brooks
to update BARDA, but the principles, the underlying principles
still remain, and that is that we be effective, that we be
limber, that we be timely, that we be able to identify, that we
be able to attract those who are actually going to produce the
stockpiles for our country so that we are indeed prepared.
And I hear some back and forth here, the innards and some
of the weeds and the whatever. I think we have to raise our
vision and keep in front of us exactly what I just said.
So, Mr. Mair, the FDA claims that allowing biodefense
medical countermeasures to qualify for a priority review
voucher would dramatically increase the number of PRVs awarded.
Now, DHS has identified only 13 material threats to U.S.
national security, and since the creation of BARDA in 2006, 12
years ago, there have been 3 medical countermeasures.
Now, it has been stated before, it is worth stating again,
that this program is privately funded. There are no taxpayer
dollars in it.
How many medical countermeasures are you aware of in the
pipeline that would qualify for a PRV under this bill?
Mr. Mair. Thank you for the question. I might defer that to
Richard to speak to----
Ms. Eshoo. Yes, let's go quickly, because I only have 5
minutes.
Mr. Mair. Sorry--to Richard, what is in the BARDA pipeline.
Ms. Eshoo. How many countermeasures are you aware of in the
pipeline that would qualify?
Dr. Hatchett. Ma'am, I don't have a specific number
available to me. I would be happy to provide that information--
--
Ms. Eshoo. That would be great.
Dr. Hatchett [continuing]. To you and will do so.
Ms. Eshoo. And would you please provide the committee with
a list of those medical countermeasures, the candidates that
you believe would qualify? All right?
Dr. Hatchett. Uh-huh.
Ms. Eshoo. Dr. Hatchett, how long does your average vaccine
procurement take from solicitation to award?
Dr. Hatchett. The most recent numbers that I have looked at
are actually aggregate numbers of major acquisition programs.
And so those include Project Bioshield procurement actions, the
most recent four procurement actions, as well as three
additional major acquisition----
Ms. Eshoo. Yes, I just want to know how long does your
average vaccine procurement take from solicitation to award.
Dr. Hatchett. Sure.
Ms. Eshoo. Because timeliness is of the essence in all of
this. If we can't be timely--identify, target, be timely, bring
it up, have these measures in place, then this is just a piece
of paper with good ideas on it.
Dr. Hatchett. So the four actions that I have data for
immediately available, three of them took 90 days from
solicitation to award.
Ms. Eshoo. I am asking about vaccine procurement.
Dr. Hatchett. OK. I will have to get back to you with
definitive data.
Ms. Eshoo. OK. I would appreciate that.
Dr. Hatchett. OK.
Ms. Eshoo. I really don't get your reason, your thinking,
and what you have testified today, Dr. Hatchett, about
contracting authority under BARDA. It is the way the
legislation was written originally. The Commission--I mean, if
there was ever a bipartisan commission of some of the most
highlyregarded individuals in public service--they don't agree
with you.
How did you arrive at your thinking? I mean, does it make
it faster? More effective? What is it that you don't like about
it?
Dr. Hatchett. First, in terms of how the Department of
Health and Human Services handles contracting throughout the
operating divisions----
Ms. Eshoo. No, I am asking you. I am asking you.
Dr. Hatchett. So I am trying to address your question,
ma'am.
The contracting activity at NIH, at FDA, at CDC report
directly to the director of those agencies and provide services
to the components of those agencies. The contracting activity
within ASPR reports directly to the ASPR and provides----
Ms. Eshoo. I think you are talking about an organization
chart. I want to know, in terms of our national security and
the import of what this law is about, why do you take the
position that you do?
Dr. Hatchett. I take the position that I do because I
understand the complaints that have been articulated by our
private-sector partners, and they have gone on to propose a
solution, which is to move the contracting authority back into
BARDA.
Their complaints relate to concerns about the length of
time it takes, about their interactions with the contracting
authority. I believe there are other ways to address the
complaints that they have articulated that preserve the
integrity of our procurement process in a way that would be
more effective than moving the contracting authority back into
BARDA.
Ms. Eshoo. Thank you.
Thank you, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentlelady.
Dr. Hatchett, I didn't get to ask my question of you, so I
would like to do that and let the ranking member or anyone else
ask a followup if they would like.
I would like to read from a letter sent to Congress by a
group of venture capital investors who have experience with
MCMs. And they say, quote, ``We have watched the biodefense
enterprise struggle to attract and sustain investment and
participation from companies and financial partners. The lack
of sustainable and predictable incentives for companies who
have promising technologies for biodefense applications is the
primary driver of this struggle. Quite simply, the decision to
invest in the biodefense sector is infinitely more risky than
any other portion of the biotech sector,'' end quote.
So, Dr. Hatchett, I would like--and I will enter into the
record this letter, without objection.
Mr. Green. No objection.
Mr. Pitts. With no objection, so ordered.
[The letter appears at the conclusion of the hearing.]
Mr. Pitts. Multiple developers have indicated that
investors actually devalue the biodefense work they do with the
U.S. Government because it is so risky and unpredictable. So my
question is, if this is the case, why would anyone oppose this
limited incentive for MCMs? What are your thoughts on this
issue?
Dr. Hatchett. Well, thank you, Mr. Chairman, for the
question.
I think you are actually making the same point that I was
making earlier, which is that, in the absence of predictable
and sustained incentives, it does become an extremely risky
business to be in because of the absence of the commercial
markets for the products at the end of the day.
I believe if the administration, whatever that flavor is,
and Congress agree to provide the sustained incentives and
strong support, that we have demonstrated that the system can
work technically. We can bring countermeasures forward; we can
address the technical challenges.
In terms of it being a risky and unpredictable business to
be in, in 2010 we undertook an interagency review of the entire
medical countermeasures enterprise specifically to address
areas of risk that the Government had some control over that
could reduce that risk and make the Government better partners
with our private-sector partners.
And I think the results of the last 6 years since that
review was performed have demonstrated an acceleration in the
delivery of countermeasures. And so many of the steps that we
have undertaken have addressed the different risks--the
financial risk, the technical risk, the regulatory risk, the
risk of working with Government as a partner because of the way
the political winds blow.
We are extremely mindful of the risks that our partners
face. We are working to address those risks, reduce those
risks. And we certainly thank you for the support that you have
provided so far. We ask for continued strong support for this
effort because, without that support, the enterprise is
jeopardized.
Mr. Pitts. Thank you.
The Ebola and Zika outbreaks have been lessons in the
seriousness of the challenges we face in this space, and H.R.
3299 was written to increase the efficiency of this program
administratively and incentivize the product development. And I
think you agree every minute is critical. It is important that
we continue to work in a bipartisan manner to improve our
emergency preparedness, incentivize medical countermeasures
development.
I will yield to the ranking member for any closing
questions or thoughts.
Mr. Green. Thank you, Mr. Chairman.
I would like to ask unanimous consent to place an article
from Health Affairs----
Mr. Pitts. Without objection----
Mr. Green [continuing]. Into the record.
Mr. Pitts [continuing]. So ordered.
Mr. Green. Thank you.
[The article appears at the conclusion of the hearing.]
Mr. Pitts. All right. We will have followup questions. We
have been interrupted. We apologize for that. Thank you for
your patience. But members do have followup questions, and
other members have written questions. We will submit those to
you in writing and ask that you would please respond.
And I would remind members that they have 10 business days
to submit questions for the record. Members should submit their
questions by the close of business on Thursday, June the 2nd.
Very, very important issue, very important hearing. Thank
you. We look forward to continuing to work with you on this
issue.
Without objection, the hearing is adjourned.
[Whereupon, at 12:31 p.m., the subcommittee was adjourned.]
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