[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
OUTBREAKS, ATTACKS, AND ACCIDENTS: COMBATING BIOLOGICAL THREATS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
FEBRUARY 12, 2016
__________
Serial No. 114-117
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
__________
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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, California
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
7_____
Subcommittee on Oversight and Investigations
TIM MURPHY, Pennsylvania
Chairman
DAVID B. McKINLEY, West Virginia DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
LARRY BUCSHON, Indiana JOHN A. YARMUTH, Kentucky
BILL FLORES, Texas YVETTE D. CLARKE, New York
SUSAN W. BROOKS, Indiana JOSEPH P. KENNEDY, III,
MARKWAYNE MULLIN, Oklahoma Massachusetts
RICHARD HUDSON, North Carolina GENE GREEN, Texas
CHRIS COLLINS, New York PETER WELCH, Vermont
KEVIN CRAMER, North Dakota FRANK PALLONE, Jr., New Jersey (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
(ii)
C O N T E N T S
----------
Page
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 3
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 5
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, prepared statement........................ 6
Witnesses
Donna E. Shalala, Panel Member, Blue Ribbon Study Panel on
Biodefense..................................................... 8
Prepared statement........................................... 11
Answers to submitted questions............................... 102
James C. Greenwood, Panel Member, Blue Ribbon Study Panel on
Biodefense..................................................... 21
Prepared statement........................................... 24
Answers to submitted questions............................... 104
Tara O'Toole, M.D., Executive Vice President, In-Q-Tel........... 32
Prepared statement........................................... 34
Answers to submitted questions............................... 112
Gerald W. Parker, Jr., D.V.M., Associate Vice President, Public
Health Preparedness and Response, Texas A&M Health Science
Center......................................................... 43
Prepared statement........................................... 45
Answers to submitted questions............................... 115
Submitted Material
Subcommittee memorandum.......................................... 76
OUTBREAKS, ATTACKS, AND ACCIDENTS: COMBATING BIOLOGICAL THREATS
----------
FRIDAY, FEBRUARY 12, 2016
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 9:00 a.m., in
room 2123, Rayburn House Office Building, Hon. Tim Murphy
(chairman of the subcommittee) presiding.
Members present: Representatives Murphy, Burgess,
Blackburn, Griffith, Bucshon, Flores, Brooks, Mullin, Collins,
Cramer, Upton (ex officio), DeGette, Castor, Tonko, Kennedy,
Green, and Welch.
Also present: Representative Bilirakis.
Staff present: Leighton Brown, Deputy Press Secretary;
Rebecca Card, Assistant Press Secretary; Karen Christian,
General Counsel; Brittany Havens, Oversight Associate; Charles
Ingebretson, Chief Counsel, Oversight and Investigations;
Graham Pittman, Legislative Clerk; Chris Santini, Policy
Coordinator, Oversight and Investigations; Alan Slobodin,
Deputy Chief Counsel, Oversight; Dylan Vorbach, Legislative
Clerk; Ryan Gottschall, Democratic GAO Detailee; Christopher
Knauer, Democratic Oversight Staff Director; Una Lee,
Democratic Chief Oversight Counsel; and Elizabeth Letter,
Democratic Professional Staff Member.
Mr. Murphy. Good morning. We will begin this hearing, to a
large extent. We're going to be having votes in a couple hours,
so we'll want to make sure we move quickly through this.
Before I start, I want to acknowledge that our good friend
and ranking member of the committee, Frank Pallone, is not with
us today because his father died. We keep his family in our
prayers. And although I did not personally know Frank Pallone,
Sr., I know he raised a good son. And so we thank him for that.
And we'll continue on from there.
Next, I'm joined today also with my colleague, who is
wearing Denver Broncos orange. And congratulations for a Super
Bowl. They must be a good team because they beat the Steelers.
Now, on with our hearing.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Good morning. We're reminded on a nearly basis that there
are those who are seeking to do us harm through a variety of
means, including biological attacks. The threats from attack
and disease outbreaks are growing and ever changing, and we are
ill prepared to detect and respond to these threats as rapidly
needed.
Put simply, we have been caught flatfooted too many times
in the past. We face a deadly enemy we cannot see. Our methods
to find it are woefully inadequate. And we may not even know
it's there until it's too late, and this is frightening. The
Federal Government's ambivalence towards biological threats
must end.
Today the biological threats confronting the U.S. generally
fall into three distinct categories: one, a naturally
occurring; two, accidental incidents; and, three, intentional
acts which are often associated with acts of terrorism. We must
be ready to guard against and respond to each of these threats
appropriately.
Now, it's easier for nation-states and terrorists to obtain
the resources necessary to produce biological weapons than ever
before, and given the ease with which one can obtain and
transport these resources, it is difficult for the intelligence
community to collect, analyze, and produce intelligence about
biological threats. The threat of a biological attack is not as
remote as one would hope.
Now, at the same time, pandemic and other highly pathogenic
disease are occurring with greater frequency and spreading more
quickly throughout the world. As human populations put
increasing pressure on remote areas and with ease of global
travel, we will see more and more infectious diseases emerge.
Since 2002, the world has seen outbreaks of SARS, Chikungunya,
cholera, influenza, measles, Ebola, MERS, and now Zika.
The U.S. response to Ebola was a humbling reminder of the
adage that everyone has a plan until they are punched in the
face. We were not prepared for Ebola, and actions were
described with confidence one day and determined to be
ineffective the next. This is what shakes the public's
confidence, and instead of ensuring that the U.S. had strong
central leadership, the administration's answer was to appoint
an Ebola czar who served for 3 months.
Sadly, the ad hoc approach continues. A Zika outbreak now
threatens the continental U.S. What the world initially thought
was a mild illness could in fact have far greater consequences
if the virus also brings increases in microencephaly, Guillain-
Barre syndrome, eye disorders, and potential for later
developmental problems in children.
While the administration has submitted a $1.8 billion
emergency request to combat Zika, its latest budget request
continues to leave funding gaps of more than $1.8 billion in
Project BioShield's Special Reserve Fund and pandemic flu
countermeasures.
Over the last 3 years, this committee has examined the
impacts of and our preparedness for natural and accidental
biological incidents. We've held hearings on our flawed
response to the Ebola crisis, the need for better preparedness
for pandemic and seasonal influenzas, the unsafe practices by
the Department of Defense and the Centers for Disease Control
on the handling of live anthrax, and the Department of Homeland
Security's broken BioWatch system. In the coming weeks we will
examine the Federal response to the Zika virus.
Each of these topics has a common denominator: the Federal
Government was not adequately prepared. For years, we have
lunged from crises to crises, reacting to what just occurred,
instead of planning for the next outbreak or attack. The
subcommittee's oversight work has made a difference in each
area, but I am very concerned that the Federal Government lacks
an overall plan for biodefense. Instead of being reactionary,
we must be proactive, with a new approach.
Last fall, the Blue Ribbon Study Panel on Biodefense
published its ``National Blueprint for Biodefense.'' The Panel
examined the current state of biodefense in the United States,
examining issues related to prevention, deterrence,
preparedness, detection, and response, to name a few. This is
not a book that should sit dusty on a shelf but one that people
should read. And I am pleased that two distinguished commission
members, Secretary Donna Shalala and former chairman of this
subcommittee, Congressman Jim Greenwood, are here today to
speak about the important work of this Panel. We thank you.
The Panel's findings that we are, quote, ``dangerously
vulnerable,'' unquote, to a biological event because we lack
leadership and an overall strategy are frightening. The Panel
made 33 recommendations, many which fall within the
jurisdiction of the Energy and Commerce Committee and impact
work that this subcommittee has done and will continue to do.
The need for improved leadership echoes throughout the
Panel's report and is unfortunately a theme we have heard far
too often about the Federal Government. Without leadership,
there is no coordination of biodefense research, preparedness,
and other issues, and without leadership, there is no strategy.
The Panel also makes a number of specific recommendations.
We must improve our biosurveillance and biodetection
capabilities. We need to detect pathogens in the air in hours
and eventually minutes, not days. Agencies already collecting
surveillance data should share it, not squirrel it away. We
need a platform that allows for rapid diagnostic testing and
vaccine development that can be applied not only to the
diseases and pathogens we currently know about, but also to the
ones we have not yet discovered.
The Energy and Commerce Committee, and this subcommittee in
particular, must take the lead in understanding and improving
our biodefense capabilities.
I thank our witnesses for being with us today. We look
forward to hearing your testimony.
[The prepared statement of Mr. Murphy follows:]
Prepared statement of Hon. Tim Murphy
We are reminded, on nearly a daily basis, that there are
those who seek to do us harm through a variety of means,
including biological attacks. The threats from attack and
disease outbreaks are growing and ever changing, and we are ill
prepared to detect and respond to these threats as rapidly as
needed. Put simply, we have been caught flat-footed too many
times in the past. The Federal Government's ambivalence towards
biological threats must end.
Today, the biological threats confronting the U.S.
generally fall within three distinct categories: 1, naturally
occurring; 2, accidental incidents; and 3, intentional acts,
which are often associated with acts of terrorism. We must be
ready to guard against and respond to each of these threats.
It is easier for nation-states and terrorists to obtain the
resources necessary to produce biological weapons than ever
before. And, given the ease with which one can obtain these
resources, it is difficult for the intelligence community to
collect, analyze, and produce intelligence about biological
threats. The threat of a biological attack is not as remote as
one would hope.
At the same time, pandemic and other highly pathogenic
diseases are occurring with greater frequency and spreading
more quickly throughout the world. As human populations put
increasing pressure on remote areas and with ease of global
travel, we will see more and more infectious diseases emerge.
Since 2002, the world has seen outbreaks of SARS, Chikungunya,
cholera, influenza, measles, Ebola, MERS, and now Zika.
The U.S. response to Ebola was a humbling reminder of the
adage that everyone has a plan until they are punched in the
face. We were not prepared for Ebola. Actions that were
described with great confidence one day were likely determined
to be ineffective the next. This is what shakes the public's
confidence. Instead of ensuring that the U.S. had strong,
central leadership, the administration's answer was to appoint
an Ebola czar who served for three months.
Sadly, the ad hoc approach continues. A Zika outbreak
threatens the continental U.S. What the world initially thought
was a mild illness could, in fact, have far greater
consequences if the virus also brings increases in
microcephaly, Guillain-Barre (gee-YAN-buh-RAY) Syndrome, eye
disorders, and potential for later developmental problems in
children. While the administration has submitted a $1.8 billion
emergency request to combat Zika, its latest budget request
continues to leave funding gaps of more than $1.8 billion in
Project Bioshield's Special Reserve Fund and pandemic flu
countermeasures.
Over the last 3 years, this subcommittee has examined the
impacts of and our preparedness for natural and accidental
biological incidents. We have held hearings on our flawed
response to the Ebola crisis, the need for better preparedness
for pandemic and seasonal influenzas, the unsafe practices by
the Department of Defense and the Centers for Disease Control
on the handling of live anthrax, and the Department of Homeland
Security's broken BioWatch system. In the coming weeks we will
examine the Federal response to the Zika virus.
Each of these topics has a common denominator-the Federal
Government was not adequately prepared. For years, we have
lunged from crisis to crisis, reacting to what just occurred
instead of planning for the next outbreak or attack. The
subcommittee's oversight work has made a difference in each
area, but I am very concerned that the Federal Government lacks
an overall plan for biodefense. The time for a new approach is
long past due. Instead of being reactionary, we must be
proactive.
Last fall, the Blue Ribbon Study Panel on Biodefense
published its ``National Blueprint for Biodefense.'' The Panel
examined the current state of biodefense in the United States,
examining issues related to prevention, deterrence,
preparedness, detection, and response, to name a few. I am
pleased that two very distinguished commission members,
Secretary Donna Shalala and the former chairman of this
subcommittee, Congressman Jim Greenwood, are here today to
speak about the important work of the Panel.
The Panel's findings--that we are ``dangerously
vulnerable'' to a biological event because we lack leadership
and an overall strategy--are frightening. The Panel made 33
recommendations, many of which fall within the jurisdiction of
the Energy and Commerce Committee and impact work that this
subcommittee has done and will continue to do.
The need for improved leadership echoes throughout the
Panel's report, and is unfortunately a theme we hear far too
often about the Federal Government. Without leadership there is
no coordination of biodefense research, preparedness, and other
issues. Without leadership there is no strategy.
The Panel also makes a number of specific recommendations.
We must improve our biosurveillance and biodetection
capabilities. We need to detect pathogens in the air in hours
and eventually minutes--not days. Agencies already collecting
surveillance data should share it, not squirrel it away. We
need a platform that allows for rapid diagnostic testing and
vaccine development that can be applied not only to the
diseases and pathogens we currently know about, but also to the
ones we have not yet discovered.
The Energy and Commerce Committee, and this subcommittee in
particular, must take the lead in understanding and improving
our biodefense capabilities.
Mr. Murphy. And I now recognize the ranking member of the
subcommittee, Ms. DeGette, for 5 minutes.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you so much, Mr. Chairman. I too want to
welcome our witnesses, in particular former Congressman
Greenwood, who sat right there in the chair you're sitting in
for many years and who sat next to me while we had a lot of the
hearings on these issues that you mentioned in your opening
statement today. And I know he's just as frustrated as you and
I are about the fact that we still continue to lurch from
crisis to crisis in this country without any kind of unified or
comprehensive response to some of these issues.
When I was listening to your opening statement, Mr.
Chairman, I thought to myself, ``Who says bipartisanship is
dead?'' because my opening statement mirrors your opening
statement to the point of talking about some of the very same
examples that you discussed. So I won't read the whole opening
statement, because I do not subscribe to the adage that
everything's been said but it hasn't been said by everybody. So
I'll put it into the record. I just want to highlight a couple
of the issues.
We've got the Zika virus going on, as you mentioned, right
now, and we're scrambling once again after the fact to deploy
the appropriate resources to protect our citizens as this
spreads. Last year, it was the Ebola outbreak. We did finally
organize to respond to that, and we're still trying to put the
systems in place to make sure that Ebola doesn't spring up
again.
This ``National Blueprint for Biodefense'' made a number of
important findings on how to respond to these natural-occurring
threats, but also how to respond to deliberate attack. As you
mentioned, Mr. Chairman, the Panel made three dozen
recommendations to better posture our Government to respond to
these emerging biothreats.
Now, for those of us who were here during the fall of 2001,
we remember vividly those little few envelopes of anthrax that
arrived on Capitol Hill and the chaos that it caused within the
Congress. Offices were closed. Buildings were fumigated. Some
congressional business was suspended. Thousands of staffers and
Members of Congress lined up to get tested for exposure. And
even worse, of course, some of the workers in the postal
centers died.
Now, this was a relatively small attack. So imagine what
would happen if we had a large attack in a major metropolitan
area or someplace else. That's why we have to be organized to
deal with these things, and that's what brings us back to the
findings of this Panel.
There are a number of really important recommendations, and
I recommend to every member of this Panel and every member of
the audience that you read the actual blueprint, because it is
sobering. But I think that the top observation that's made in
this blueprint is that the Nation is underprepared for a
bioattack because we still lack centralized biodefense
leadership. The Panel recommends appointment of a single
national leader under which preparedness for and response to
biological threats could be consolidated.
The Panel recommends this authority be institutionalized in
the Office of the Vice President of the United States. And what
the Panel says is that this will, quote, ``ensure that
biodefense will be addressed by every administration at the
highest levels with adequate access to the President.'' I think
this is a very unique recommendation and one that we should
explore.
And I just want to say one more thing, Mr. Chairman. One of
the grand traditions of the Oversight and Investigation
Subcommittee is to shine light on issues like this and to
actually move the dialogue forward. So I was really gratified
to hear you saying in your opening statement that you don't
just intend to have this hearing today and let this go.
I think if we really have a series of hearings diving
deeply into the recommendations of the committee and take their
recommendation that we have some of these hearings, we actually
can make a long-term difference in how this Nation is prepared.
And that may be the very best legacy that not only this Blue
Ribbon committee, but also this subcommittee of Energy and
Commerce can leave.
With that, I'll put my full statement in the record, but
I'd also like to ask unanimous consent to put Ranking Member
Pallone's full statement in the record due to his inability to
be here with his father's death.
Thank you very much, and I yield back.
Mr. Murphy. All right. Yes. And I'll just ask unanimous
consent that any other members' written opening statements be
introduced into the record. And without objection, they will be
entered.
[The prepared statement of Mr. Pallone follows:]
Prepared statement of Hon. Frank Pallone, Jr.
Thank you for holding this hearing. Combating biological
threats is a critical issue that has not been given adequate
attention, but I'm hopeful today's hearing can be another
important step towards increasing our Nation's preparedness.
The Blue Ribbon Panel on Biodefense has conducted a
comprehensive review of the Federal Government's efforts to
address the biological threat and identified what remains to be
done. Before us today are two distinguished Panel members who
are no strangers to this committee: Secretary Shalala, who led
the Department of Health and Human Services for 8 years, and
Congressman Jim Greenwood, the former chairman of this
subcommittee. In addition, I'd like to welcome two individuals
who offered their expertise to the Panel: Dr. Tara O'Toole, who
served as Undersecretary for Science and Technology at the
Department of Homeland Security, and Dr. Gerald Parker, who has
provided leadership on these issues at the Departments of
Health and Human Services, Homeland Security, and Defense.
Thank you to all of our witnesses for being here and for
sharing your expertise.
This is not the first high-level commission to examine our
Nation's biodefense preparedness. Experts have repeatedly
warned that our ability to respond to biological threats must
be improved. However, previous commissions did not produce
changes that sufficiently prepared this Nation for the threats
that will be discussed today.
That brings us to the Blue Ribbon Study Panel and our
hearing today. The Blue Ribbon Panel, following extensive
study, has suggested a series of oversight hearings addressing
fourteen key areas, many of which fall under this committee's
jurisdiction.
We need to ensure that this Panel's work does not become
yet another undertaking by experts whose recommendations go
unanswered. Congressional oversight is key to ensuring that
Federal departments and agencies are meeting their mandates and
doing so in an effective and efficient way. And therefore, I
urge the committee to follow through on the Panel's
recommendations by holding not just this session, but a series
of hearings to assess the Nation's ability to prepare for and
respond to biological threats.
I would like to thank our panelists once again for coming
and sharing their expertise. I look forward to hearing from
each of you about what our Nation can do to improve our
biodefense network.
Mr. Murphy. And I believe, Mr. Chairman, you don't have an
opening statement. And, again, given the rush, we want to make
sure we hear everything and every member gets a chance to ask
questions before votes. We'll just move forward.
So I will introduce the witnesses on the panel for today's
hearing. The first witness on today's panel is the Honorable
Donna Shalala--welcome here, it is an honor to have you here--
former Secretary of Health and Human Services, and here today
as a member of the Blue Ribbon Study Panel on Biodefense. Over
the course of her career, Secretary Shalala has demonstrated a
strong commitment to public service, from the Peace Corps to
the Department of Housing and Urban Development. She is a
recipient of the Medal of Freedom and currently serves as
president and CEO of the Clinton Foundation.
We appreciate your time here today.
Next, my friend and colleague from Pennsylvania, the
Honorable Jim Greenwood, former Congressman from the Eighth
Direct of Pennsylvania, chairman of the subcommittee from 2001
to 2004. Mr. Greenwood is also a member of the Blue Ribbon
Study Panel on Biodefense and has served since 2005 as
president and CEO of the Biotechnology Innovation Organization.
In this capacity he has worked with Bio's 1,200 member
organizations to aid in the development of biotech solutions to
major challenges in agriculture and health care.
And we also look forward to hearing your insights.
Next, Dr. Tara O'Toole, who serves as a senior fellow and
executive vice president at In-Q-Tel, a nonprofit strategic
investment firm that works to facilitate connection and
cooperation between venture-backed technology startups with the
U.S. intelligence community. Dr. O'Toole formerly served as
Under Secretary of Science and Technology at the Department of
Homeland Security and Assistant Secretary for Environmental
Health and Safety at the Department of Energy.
I'm looking forward to hearing your expertise today during
the hearing, and thank you also for being here.
And now I'll yield to Mr. Flores, who will introduce our
next witness from Texas.
Mr. Flores. Thank you, Mr. Chairman. Also, I thank you for
holding this hearing today and for the courtesy of allowing me
to introduce one of my classmates and a fellow Texas Aggie and
a renowned expert on public health. Dr. Jerry Parker serves as
the vice president for public health preparedness and response
at the Texas A&M Health Science Center. At Texas A&M he
oversees the largest Federal public-private partnership with
the Health and Human Services' Biomedical Advanced Research and
Development Authority, commonly referred to as BARDA, for
vaccine development and manufacture.
Prior to his current role at A&M, Dr. Parker had a
distinguished career in public and military service, including
serving as a Deputy Assistant Secretary of Defense for Chemical
and Biological Defense, and in that position he was responsible
for the military's readiness on many of the issues that are
before us today. Dr. Parker also served as a Principal Deputy
Assistant Secretary in the Office of the Assistant Secretary
for Preparedness and Response at HHS and in a similar role at
the Department of Homeland Security.
Again, Mr. Chairman, thank you for allowing me the time to
introduce Dr. Parker. His senior leadership positions at the
Texas A&M Health Science Center, the Department of Defense,
HHS, and DHS are critical to the topic before this committee.
And thank you, Dr. Parker, for being with us today.
I yield back.
Mr. Murphy. The gentleman yields back. And if there's no
more comments, we'll proceed here.
So you're all aware that this committee is holding an
investigative hearing and when doing so has had the practice of
taking testimony under oath.
Do any of our witnesses have any objections to giving
testimony under oath?
Seeing no objections, the Chair then advises you that under
the rules of the House and the rules of the committee, you are
entitled to be advised by counsel.
Do any of you desire to be advised by counsel during
testimony today?
And all the witnesses say no.
In that case, if you would all please rise and raise your
right hand, I'll swear you in.
[Witnesses sworn.]
Mr. Murphy. Thank you. All the witnesses said, ``I do.''
You are now under oath and subject to the penalties set
forth in Title 18, Section 1001 of the United States Code. We
will now entertain each of you with a 5-minute summary of your
opening statement. We will begin with Ms. Shalala. You're
recognized for 5 minutes. Just turn the microphone on and pull
it close to you.
STATEMENTS OF DONNA E. SHALALA, PANEL MEMBER, BLUE RIBBON STUDY
PANEL ON BIODEFENSE; JAMES C. GREENWOOD, PANEL MEMBER, BLUE
RIBBON STUDY PANEL ON BIODEFENSE; TARA O'TOOLE, M.D., EXECUTIVE
VICE PRESIDENT, IN-Q-TEL; AND GERALD W. PARKER, JR., D.V.M.,
ASSOCIATE VICE PRESIDENT, PUBLIC HEALTH PREPAREDNESS AND
RESPONSE, TEXAS A&M HEALTH SCIENCE CENTER
STATEMENT OF DONNA E. SHALALA
Ms. Shalala. Good afternoon, Mr. Chairman, Congresswoman
DeGette, and members of the subcommittee. I've submitted a
lengthy testimony for the record. Thank you for inviting us
here to present our views and recommendations of the bipartisan
Blue Ribbon Study Panel on Biodefense. I'm pleased to be
joining former Representative Jim Greenwood. We're here on
behalf of our co-chairs, former Senator Joe Lieberman and
Governor Tom Ridge, and the other members of our Panel, former
Senate Majority Leader Tom Daschle and former Homeland Security
Advisor Ken Wainstein. It's also good to see Dr. Jerry Parker,
who is one of our ex officios, as well as Dr. Tara O'Toole, who
constantly advises all of us on this important subject.
We are deeply concerned about the biological threat,
whether intentionally induced, naturally occurring, or
accidentally released. And I want to emphasize those three
issues, because this is not a report just on intentionally
induced biological threat. It also covers the naturally
occurring ones or the accidentally released.
I want to take a moment to address the threat now, but let
me recommend that you get a classified briefing at your
earliest opportunity. Make no mistake, we've been told that our
enemies are seriously considering the use of biological
weapons. During the invasion of Afghanistan, the United States
uncovered evidence that Al Qaeda was trying to develop
biological weapons. More recently, ISIL has gained control of
enough land, physical infrastructure, scientific expertise, and
professional military personnel to potentially create and
deploy biological weapons, and they have expressed their intent
to use them.
Additionally, the verification protocols associated with
the Biological Weapons and Toxin Convention are weak and do not
do what the world needs them to do, differentiate between
legitimate and malicious activities.
We're equally concerned about the threat of naturally
occurring diseases with catastrophic pandemic potential. It's
often very difficult for our scientists to guess the correct
combination of viruses that will even make up the strain of
influenza that will circulate the following year. Nevertheless,
diseases do not have to kill millions to produce impact. There
are a number of diseases that have affected my own State of
Florida and New York and Puerto Rico and the U.S. Virgin
Islands and American Samoa over the last 2 years.
Now Zika virus is on the move as well, in some cases
resulting in microencephaly in newborns who contract it from
their mother. The first case of local transmission has occurred
in the United States, in Dallas, which of course was the first
city with an Ebola case. This transmission did not occur from
mosquitoes. It was sexually transmitted. Imagine the
devastating societal consequences if we cannot stop the spread
of this disease.
Accidental releases also contribute to biological risk. I'm
sure that you're aware of the recent laboratory biosecurity and
biosafety mishaps at a number of our high-level laboratories.
The organisms in which these laboratories work are too serious,
too infectious, and too deadly for us to react indignantly,
only to forget after a few months and move on to the next
challenge.
Our change must be institutionalized and sustained, and
that is our fundamental message today. Our attention span tends
to increase and decrease cyclically as different events occur
and their impacts fade over time. Since I was Secretary of
Health and Human Services, I have seen three administrations
increase and decrease their emphasis on biological threats,
usually in response to and after recovering from incidents such
as the anthrax events of 2001, SARS, H1N1, MERS, and Ebola, and
now we're all gearing up again for the Zika virus.
We need a leader at the highest level of Government to take
responsibility and develop a comprehensive strategy and a
unified budget and lead the whole of the Government, along with
nongovernmental partners, to improve our national biodefense
and to do so attentively and consistently. We recommend that
that person be the Vice President of the United States, one of
the few who can get the Government agencies and the
nongovernmental partners to work together.
We are not necessarily talking about new programs or
funding. Instead, we believe we can build on existing programs
and infrastructure. And let me give you a few examples.
We ought to be able to take an environmental biodetection
system that was originally designed for the battlefield, for
example, evaluate it, and if it seems useful, then modify it to
fulfill our needs domestically. We should see how we could
build on our preexisting pervasive and familiar system of
community pharmacies to get pharmaceuticals to localities in
the midst of a biological incident and maybe create smaller
caches in advance. We cannot depend solely on a federally
driven public-point-of-dispensing model. Or take our hospitals,
which meet accreditation criteria associated with funding
provided by the Centers for Medicare and Medicaid Services. We
can use that to address various specialties, like trauma, for
example.
Doing the same for biodefense would cultivate better
hospital preparedness for major infectious disease events. In
doing so, we could create a stratified hospital system in
advance of a biological event, knowing exactly which facilities
are best positioned to handle cases.
The funding that we could get through----
Mr. Murphy. Ms. Shalala----
Ms. Shalala [continuing]. Is far greater than what is
currently available through the Hospital Preparedness Program.
While we support this grant program, it is simply never going
to be resourced enough to meet the need.
Mr. Murphy. Could you just give a wrap-up because you're
over a couple minutes. I just want to make sure we have time
for everybody.
Ms. Shalala. I'm closing.
Mr. Murphy. OK.
Ms. Shalala. In closing, I just want to note that Congress
plays a critical role in providing necessary oversight and
legislation. We need all of you to consider these
recommendations and, hopefully, to move forward. And now, after
you've heard from Jim Greenwood, we'd be happy to answer any
questions you have.
[The prepared testimony of Ms. Shalala follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you very much.
Mr. Greenwood, you're recognized for 5 minutes.
STATEMENT OF JAMES C. GREENWOOD
Mr. Greenwood. Thank you, Mr. Chairman. I'm tempted to ask
unanimous consent to insert your opening statement and the
opening statement of Ranking Member DeGette as a preface to our
report, because it's gratifying to see how aligned you already
are with our recommendations.
So thank you for inviting me to discuss preparedness for
biological threats on behalf of the bipartisan Blue Ribbon
Study Panel on Defense. As the former chair of this
subcommittee, I am especially honored to be testifying here
today.
The hearing is quite timely, not because a catastrophic
biological event has recently occurred, but because one has not
occurred on U.S. soil. Whether it's the reintroduction of
smallpox by a terrorist, a dirty bomb in an urban center, or
another pandemic influenza outbreak, as the Panel notes in our
report, we are underprepared to respond to these threats, and
we must take immediate steps to be better prepared.
It has been a great privilege to serve on the study panel
with my esteemed colleagues. Our report starts from the premise
that the biological threat is real and it is growing. While we
are better prepared today than we were a decade ago due to
Federal and private sector investments, the fact is we are
still dramatically underprepared. Our report outlines 33
recommendations. And as Secretary Shalala stated, we as a Panel
all strongly support the first recommendation calling for a
centralization of leadership over biodefense in the Office of
the Vice President.
I would like to further focus on the recommendations
related to strengthening the public-private partnership, as
industry plays a key role in protecting our Nation. Consider a
company with a novel technology applicable to the biothreats of
emerging diseases identified by HHS. This company wants to
partner with the Government. But there are so many unique
market challenges. Unlike products with a viable commercial
market, the market for most medical countermeasures, or MCMs,
is defined and supported solely by the Federal Government,
making it a major source of research funding and the primary
purchaser of vaccines, therapies, and diagnostics against these
unique threats.
Many companies begin research at their own risk, conducting
R&D even before receiving Federal Government funds. Over the
last few years, Government funding for MCM R&D has been
decreasing, just as the number of threats have been increasing.
The investor community views these products as risky and a
distraction from similar products that have a clear commercial
value, making it difficult to raise the necessary R&D funds for
MCMs in the private capital markets. The regulatory pathway is
not always clear.
Lastly, industry has seen a precipitous drop in the level
of funds for the purchase of the final MCMs. For many companies
the biggest risk is that they will invest significant internal
funds and time developing a product only to find there is no
clear procurement strategy from the U.S. Government due to
sudden shifts in priorities or dearth of funds.
Given all this, we strongly support the need for a
comprehensive multiyear strategic plan and unified budget that
clearly outlines the priorities for R&D and procurement of
medical countermeasures and pandemic influenza products. Such a
strategic document would provide much needed transparency on
governmental priorities and projected requirements, thus
helping companies determine what products to pursue in this
partnership.
The MCM enterprise must be fully funded. The Project
BioShield Special Reserve Fund, the SRF, was created to provide
companies with a guaranteed market for MCMs by establishing a
10-year advanced appropriation of $5.6 billion. The SRF has
indeed proved successful in attracting companies to invest in
MCM R&D. Twelve MCMs were procured during a 10-year period, and
there are over 200 MCMs in the pipeline.
But the progress made due to Congress' initial $5.6 billion
investment is now in jeopardy. The SRF was reauthorized at $2.8
billion for fiscal year 2014 through 2018, but rather than a
set-aside sum of money, the program has been funded through
annual appropriations and much lower than the authorized
amount. Unless funding increases, we are risking a $600 million
to a $1 billion shortfall. Such a sustained deficit endangers
the progress we have made and puts the 200 product candidates
in the pipeline at risk.
Similarly, pandemic influenza has been woefully underfunded
the last few years. Pandemic influenza is a known threat that
is very challenging given its versatile and persistent nature.
It is imperative that our pandemic preparedness include
advanced development of vaccines, antivirals, and diagnostics,
rapid response capability building, and the replenishment of
vaccine and antiviral stockpiles. Our plan calls for Congress
to provide a legislative authorization to define and guide
pandemic influenza programs in order to ensure that they
receive the funding needed.
Novel incentives could demonstrate the Government's
commitment to MCM development. One of the most important
incentives in the report is the priority review voucher, the
PRV program, for pathogens designated as material threats. The
PRV is a proven and valuable incentive that has helped to spur
investment in other complex and neglected areas of R&D, such as
neglected tropical diseases. An extension of the PRV program to
include material threats is viewed by many as a way to offset
the dramatic decline in procurement funding for MCMs. Adding
MCM targets to the PRV program may help convince investors that
the Government is committed to this endeavor and provide
increased certainty that MCMs have value.
Improvement must be made in the contracting process as
well. In addition to robust sustained funding, the public-
private partnership must be strengthened through improvements
to the contracting process within BARDA to make it more
efficient and predictable. Streamlining is key to ensuring that
there are not excessive delays in the implementation of vital
research.
I therefore call on Congress to swiftly pass H.R. 3299, the
Strengthening Public Health Emergency Response Act of 2015.
This bill focuses on many of the issues I've raised today and
represents a strong initial step toward implementing the
recommendations of the Panel.
This subcommittee plays an integral role through your
oversight of Federal biodefense programs. I commend the
committee's recent attention to pandemic influenza preparedness
and the letters the committee sent to the administration about
flu vaccine supply and development and strategic plans. I hope
that the Energy and Commerce Committee and this subcommittee
continue to exam the issues of biopreparedness further.
The threats facing our Nation are real and many. Having
products to support our national preparedness relies on the
work of a few dozen biopharmaceutical companies. The only way
these companies can continue vital R&D and capacity building is
if the U.S. Government demonstrates a strong commitment to them
by providing clear priorities, sustained funding, and real
incentives. If we invest well now in the broader set of known
threats, we will be better prepared to pivot and respond when
faced with an unknown threat.
Thank you again for the opportunity to testify on the work
of the Blue Ribbon Study commission. I commend the subcommittee
for examining the state of our national preparedness for
biological threats, and I look forward to your questions.
[The prepared testimony of Mr. Greenwood follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Chairman Greenwood.
And now, Dr. O'Toole, you're recognized for 5 minutes.
STATEMENT OF TARA O'TOOLE
Dr. O'Toole. Thank you, Mr. Chairman. I am very happy to be
here today to discuss this topic, which has been a
preoccupation of mine for most of my professional career. I
want to thank you for your kind introduction and emphasize the
views I express are my own, not those of In-Q-Tel.
I want to start by congratulating the Blue Ribbon Study
Panel on their excellent report, which I hope will be highly
influential. I especially endorse and share the Panel's sense
of urgency about repairing the country's vulnerability to
highly consequential bioevents.
Today, I want to briefly address three issues. First, I
want to emphasize the nature and the significance of biological
weapons threats and explain why it is a first-tier national
security problem.
Secondly, I want to describe why naturally occurring
epidemics almost certainly will increase in frequency and
impact in the coming years. Natural epidemics, it is important
to understand, are different from deliberate bioattacks. The
latter would be faster, fiercer, and it may be that many
victims are beyond rescue. But if we cannot handle natural
outbreaks more effectively and efficiently, we have no defense
against biological weapons.
Thirdly, there is a major revolution in our understanding
of how the biological world works and our ability to manipulate
it. The advances in bioscience and biotechnologies should be
part of the foundation of U.S. biodefense against both natural
and deliberate epidemics. These advances are going to be
extremely beneficial to humankind across many different fields
that go beyond biomedicine. But it also means that we now have
created a world in which there is wide access to advanced
biological knowledge and the materials needed to build and
disseminate biological weapons.
As the Defense Science Board said in 2001, an age ago in
terms of scientific advances, there are no technical barriers
to nonstate actors, including terrorist groups and lone wolves,
carrying out devastating bioattacks that could kill millions
and cost billions. But these advances in science and in
biotechnology also, for the first time, give us powerful tools
that could allow us to prevent and to rapidly detect and quench
epidemics, whatever their cause. And I'm going to give you some
examples of critical technologies which might help realize the
Panel's assertion that innovation is a key ingredient and that
dramatic improvements in biodefense are within reach.
First of all, the potential destructive power of biological
weapons is akin to that of nuclear weapons. In 1993, the
Congressional Office of Technology Assessment estimated that a
kilogram of aerosolized anthrax dropped on Washington, DC, in
ideal weather conditions would result in 1 to 3 million deaths.
That's about the same toll as a 1-megaton hydrogen bomb.
These statements are not based on speculation, but on
decades of development and field testing by the U.S. military
during the Offensive Biological Weapons program of the United
States, which was ended by President Nixon in 1969. We also
know that the USSR had a massive secret offensive BW program
created after they signed the Biological Weapons Convention in
1972. These were both ambitious, and at least in the case of
the U.S., highly successful programs. During the cold war, the
U.S. field tested many different bioweapons in realistic
conditions, including releases from air, boats, ships, and
subways. Declassified U.S. documents from the '60s clearly
recognized the strategic power of bioweapons. We do not now
know the fate of the Soviet effort.
In the half-century since the U.S. ended its Offensive BW
program, there has been a revolution in bioscience. Advances in
many fields, including pharmacology and aerosol biological, and
our ability to read, write, and edit DNA, the code of life,
have resulted in tremendous beneficial achievements. But these
advances have also meant the global spread of bioknowledge and
access to sophisticated biotechnologies. The materials and
know-how needed to build a bioweapon have many legitimate uses.
These are dual-use technologies, and as the chairman said, this
makes the task of collecting intelligence about covert
bioweapons programs exceedingly difficult.
We are going to see an increase in the tempo of naturally
occurring epidemics, which we can talk about in the discussion.
I want to end by saying that there are two critical
technologies that have not gotten sufficient attention in our
biodefense program. The first is rapid diagnostics, upon which
we've spent very little money and for which there is a very big
market problem that makes it difficult for private companies to
pursue diagnostics. And the second is vaccines.
I see that I am out of time, Mr. Chairman, so I will await
your questions. Thank you.
[The prepared testimony of Dr. O'Toole follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you.
Now we recognize Dr. Parker for 5 minutes.
STATEMENT OF GERALD W. PARKER, JR.
Dr. Parker. Thank you. Good morning, Chairman Murphy and
Ranking Member DeGette. And thank you for the invitation to
appear before you today. It is an honor to be here with
Secretary Shalala and Congressman Greenwood, who are
representing the Blue Ribbon Panel, and Under Secretary
O'Toole, who is one of our Nation's highest regarded biodefense
leaders.
I put an exclamation point on the bioterror threat. For my
part, I've been involved in biodefense since 1982 to the
present, from the cold war to the rise of violent extremism,
and the rapidly growing risk of naturally occurring
transboundary emerging infectious diseases. I have been at the
eye of the storm witnessing the evolving biological threat over
my career.
Today, I am more concerned than ever about the risk of
biological threats, including biological warfare, bioterrorism,
and emerging infectious diseases. Biological threats are
serious, whether naturally occurring, from an attack, or
accidental release. The American public is starting to realize
the threat of emerging infectious diseases following Ebola and
now presumably Zika. Although the threat of biological warfare,
and particularly biological terrorism, is very real too, it is
less well understood.
If there's any good news here, the number of countries
thought to be conducting some type of illicit biological
weapons activity, it has gone down from the end of the cold war
from about 12 to 5. But those countries include China, Iran,
Russia, Syria, and North Korea, and their operational scenarios
for use are no longer limited to military targets.
Today, the risk from a bioterror attack from nonstate
actors, violent extremist groups, or individuals on civilian
populations is a reality. Biological weapons are sometimes
called the poor man's atom bomb, a term first used during the
cold war because biological weapons, as we have heard, have the
potential to cause mass casualties on the scale of a nuclear
weapon. But even a simple bioterror attack, as we heard earlier
today, can have devastating consequences, such as occurred from
the anthrax letter attacks in 2001 that took 5 lives, sickened
17 more, and over 32,000 people took antibiotics because of
potential exposure, and it could have been much worse from that
simple attack.
Some question the seriousness of the risk today because
further bioattacks have not followed. And fortunately
additional attacks have not occurred, which I partially
attribute to successful counterterrorism strategies. Why
further attacks have not occurred given the relative ease of
mounting such an attack, coupled with our vulnerability, is up
for debate.
I do not want to overstate and particularly underestimate
the threat and risk of a biological attack, and I also cannot
predict the future. But we cannot ignore that extremists intend
to do us harm by any means, and they are not morally
constrained in the methods they use. The intent to acquire and
use weapons of mass destruction by the likes of Al Qaeda, ISIL,
and others is known. Intelligence gathering is extremely
difficult to detect a biological capability and imminent
threat, but we should not take the lack of intelligence as lack
of threat. The discovery of an ISIL computer containing plans
to develop plague as a bioweapon should give us pause. Just
this week the Director of National Intelligence confirmed
reports that the Islamic State used a chemical warfare agent in
Iraq and Syria.
The Islamic State is growing rapidly, has resources,
controls necessary infrastructure and safe havens, and is
recruiting scientists that could be capable of developing
chemical and biological weapons. It may also be only a matter
of time before a biologist becomes a self-inspired violent
extremist. We must assume the threat is real and serious.
In addition to bioterror attacks, naturally occurring
emerging infectious diseases continue to happen with greater
frequency. Pandemic potential influenza viruses, SARS, MERS-
CoV, West Nile Virus, Chikungunya, dengue, Ebola, and now Zika
are real experiences that tell us we may be on the verge of a
global pandemic any time. Our biological threat preparedness
response enterprise must also be ready any time.
Biological threats are not new, but we seem to pay
attention only when an outbreak occurs or an attack occurs and
ignore it between outbreaks. The time between outbreaks, or the
interepidemic period, though, is precisely when urgent actions
are needed to optimize resources to hone our preparedness and
response systems.
Before closing, I would also like to add that initiatives
in global health security and One Health are critical too, and
they enable work in the prevention side. I would like to thank
the members of the subcommittee again for this opportunity, and
I'm happy to answer any questions you may have. Thank you.
[The prepared testimony of Dr. Parker follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. I thank you, Dr. Parker, and all the panelists.
It's pretty sobering testimony we hear. So let me start off and
recognize myself for 5 minutes.
First, Dr. O'Toole, you refer to this as a first-tier
national security problem and that bioattacks are faster and
fiercer. So it seems like these natural outbreaks, they really
are test runs for prevention. How we handled Ebola, how we
handled SARS, how we will handle the Zika virus gives us an
opportunity to work on prevention, detection, and responding.
But I don't think we are at all where we need to be. So given
that, is there reason to be more concerned or less concerned
about the threats of bioterrorism?
Dr. O'Toole. Well, Mr. Chairman, I think you're right. I
think our response to naturally occurring epidemics should be
seen as test runs. Everyone here has lived through a lot of
natural epidemics at this point, and we have gotten better.
Again, I think for the first time we can actually
contemplate the strategy of creating a foundation such that we
could rapidly design and build, for example, a vaccine suitable
for a particular threat in a much shorter time than is now the
case. And I think we do have to prepare for a whole array of
threats which we're not going to be able to predict.
The other issue that Dr. Shalala mentioned is that a lot of
our response depends on the State and local public health
departments. They have lost almost 50,000 people since 2008.
And so one could argue that our capacity to respond to an
epidemic today has diminished compared to then, and that's a
problem.
Mr. Murphy. Thank you.
Secretary Shalala and Congressman Greenwood, would it be
fair to say that your bipartisan Panel's general concern is
that biological threats are increasing while important aspects
of U.S. biodefense preparedness are actually declining or
inadequate. Is that a proper conclusion? Ms. Shalala?
Ms. Shalala. Yes, I think that's fair. And to echo Dr.
O'Toole, our infrastructure for dealing with these has gotten
weaker, starting with the State and local response. One of the
things that we forgot in the Ebola discussion is the States are
our first line of defense. We've been putting resources and
building the public health infrastructure for years with
essentially block grants from the CDC.
Those have been weakened. And if you don't have a State and
local response--think about the outbreak of diseases caused by
food poisoning, for example. It's that infrastructure that is
the first line of defense for these biological issues that
we're talking about. If we don't have a strong State role, with
their laboratories, with their tracking systems, then it's very
difficult for us to pick up something that's going to recur,
that we know that's going the recur over a long period of time.
That's why we talk about the Vice President, because it's
very difficult for anyone else to pull in all the actors, the
private sector actors as well as the public sector agencies.
Mr. Murphy. Well, given these things, Chairman Greenwood,
so as we have increasing number of these naturally occurring
and accidentally occurring bioattacks, is our diminished
capacity just because we're strained or because we have
actually lost ground in dealing with these issues overall?
Mr. Greenwood. Well, I think your original question--is the
threat growing while the capacity to defend against it is
decreasing?--the answer to that question is absolutely yes. So
if you think about the bioterror threat and you think about
ISIS and you look at what they've been able to do with rifles
and assault weapons and so forth, it's clear and it's obvious
that their intention is to kill as many infidels and apostates
as they possible can. And you can do a heck of a lot better job
at that using chemical and biological weapons than you can with
convention armaments. They want to do that, and there is
evidence that's been cited I think already that they are trying
to figure out how to use bubonic plague. They are trying to
have a plan to poison the Turkish water system. So the
intention is clear.
While that's happening, the same technology, synthetic
biology, gene editing, that is enabling our companies to do
amazing things in terms of developing new drugs and new
products, is also making it easier to formulate these new
weapons.
And so the threat is growing. And to see that in the face
of all of that the Federal Government's commitment to funding
BARDA, to funding our abilities to develop these
countermeasures is diminishing is frightening.
I'm glad you're having this hearing now, because the
hearing you don't want to have is the one that happens after
tens of thousands of people have lost their lives and you're
sitting here asking yourselves and Government officials why we
weren't ready.
Mr. Murphy. Thank you. And that could happen at any time.
I see my time's up, and I'll recognize Ms. DeGette for 5
minutes.
Ms. DeGette. Thank you very much.
Mr. Greenwood, you're exactly right. This is what keeps me
up at night, is the responsibility that this subcommittee has
to actually move the ball forward, not just to have these
hearings every so often. And the chairman will tell you, every
year, like in about July, I start nagging to have a hearing on
pandemic flu before we're actually in the middle of the flu
season. But I think what the Blue Ribbon Panel is saying is we
need to go even further than that. We need to have a system in
place that's not based on response after the fact. Would that
be your assessment too?
Mr. Greenwood. Absolutely. And if I may, let me describe to
you what that system is.
The only thing that stands between these pandemic viruses
and intentional bioterror attacks, the only thing that stands
between those things and the safety of our people is, frankly,
a handful of private companies in this country who were willing
to take the risk of developing countermeasures. And as has been
said, this is unique. You don't sell those countermeasures at
Walmart.
Ms. DeGette. Right.
Mr. Greenwood. The only potential procurer of those is the
Federal Government. And those companies, like every little
biotech company, rely on investors. And those investors can put
their money into a conventional biotech company, they can put
it into an IT company, they can put it anywhere they want. They
are looking for return on investment.
Ms. DeGette. Right.
Mr. Greenwood. And if they see a system that's uncertain
due to lack of certainty that these products will be procured,
they're going to put their money elsewhere.
Ms. DeGette. And we've really seen this in the pandemic
influenza program and trying to prepare for that. And with
these cuts, so I'm wondering, maybe, Secretary Shalala, you can
talk about how the funding cuts have hampered a response to the
potential pandemic flu outbreaks.
Ms. Shalala. And I wouldn't underestimate, in addition to
the private sector, those very fragile biotech companies, the
importance of the National Institutes of Health and the
fundamental science that we're doing, because if you don't have
that, you wouldn't have the companies. So it's a combination of
things.
Ms. DeGette. Yes. The problem is you need to get the basic
research. And then you also need to have the robust pandemic
flu program so that you can support development of the vaccine
by the private company. So it really is a partnership.
Ms. Shalala. Exactly. And vaccines have not been a major
priority of the multinational pharmaceutical companies. They
don't make enough money from them.
Ms. DeGette. Right.
Ms. Shalala. They are marginal, particularly when the
Government is the only purchaser.
Ms. DeGette. Right.
Ms. Shalala. As was pointed out here, they don't have a lot
of confidence that we're going to give them the kind of margins
they can get from other kinds of investments. So this is a real
challenge.
Let me make one other point. Health as a national defense
issue is relatively new. Twenty years ago, no one was thinking
about a national security issue related to some aspect of
health. So think of this as the cutting edge of a dramatic new
conceptualization of our defense. We're actually talking about
the defense of a nation and about the health aspect of that.
Ms. DeGette. Right. Let me ask you, why is it that the
Panel recommends centralized leadership in the Vice President's
office to coordinate all of this?
Ms. Shalala. Well, since I sat in the major agency
responsible for many of these issues, and since we now have a
Homeland Security agency, the fact is that the responsibilities
for different aspects of this are spread across the Government.
And even the lead agency concept will not solve that or, in my
judgment, a czar sitting in the White House. The czars work
best when there's an emergency.
But if you really want to build up the infrastructure, you
have to have a powerful person. And you can't have that in a
Cabinet agency which is a peer of all the other Cabinet
agencies. So the Vice President is the only person that can cut
through that, talk to the private sector, and simultaneously
talk to State and local governments, and put all those pieces
together. He's also the only person that can demand a unified
budget out of the OMB and across the Government.
Ms. DeGette. And this was a bipartisan recommendation.
Ms. Shalala. It was as bipartisan recommendation. And I
have to tell you, I hesitated, as someone who sat in a
Government agency, a powerful Government agency, I hesitate to
transfer power to a Vice President or to the White House in
general. As you know, Cabinet agencies have a certain amount of
tension with White Houses. But at the end of the day, this is
one of the areas where you need a unified budget. The only
place we have a unified budget is actually in intelligence. So
this is a parallel to that, to pull all the pieces together,
and it's important enough to identify the Vice President. And
Vice Presidents always have some time to take on other
responsibilities.
Ms. DeGette. Thank you very much. Thanks.
Ms. Shalala. With all due respect to our very nice Vice
President.
Mr. Murphy. I'm sure he'll be pleased that you said he has
lots of time on his hands.
Ms. Shalala. We have discussed this with the current Vice
President. It's not he particularly that we identified, but the
office itself.
Mr. Murphy. We'll bring him in here and ask him about that.
I recognize Mr. Flores for 5 minutes.
Mr. Flores. Hard to follow that.
Dr. Parker, you emphasized in your testimony that we should
be urgently preparing for biological threats in the time
between outbreaks. And in 2006, as you know, Congress created
BARDA to do exactly this. But as you explained, we continue to
seem to go in crisis mode only when we have an outbreak. So
what else should the Government do in these interepidemic
periods?
Dr. Parker. Well, thank you, Congressman Flores. And
actually in answering your question, I'm going to come right
back to the centralized leadership and how important that is.
And I'll answer it actually with an example in my own
experience and my own career.
In that very same time in 2006, as the Pandemic and All-
Hazards Preparedness Act was passed, BARDA was created, we got
very concerned about pandemic influenza to the point that an
emergency supplemental was appropriated in that time, $7
billion. It was accompanied by a very strong White House-led
pandemic influenza strategy, coupled to a pandemic influenza
implementation plan.
This is the closest example I think that has happened to
date that kind of reflects the centralized leadership
biodefense strategy that we actually did for pandemic influenza
that accompanied an appropriation that really covered almost
all the department agencies, State, local, private sector, that
were involved in pandemic preparedness back at that time.
This implementation plan contained over 300 action items.
It identified lead department agencies and supporting
department agencies. It was very detailed. In fact, in my own
department at the time, HHS, there was a lot of complaints that
it was micromanaging and maybe superseding department
authorities. Maybe it was. But we got stuff done. It allowed us
to establish things that otherwise we would not have been able
to do.
And so I just offer that as an example of something that
we've already done. Let me also add that we were very
responsible for meeting our milestones and metrics that were
part of this implementation plan, both in the executive branch
and to Congress, because all congressional committees that had
the appropriate oversight for their department agencies were
regularly being updated. Hearings were happening on progress of
that plan.
So I just offer that up as an example of something in the
past that I think is in the spirit of what the Panel has
recommended that would drive us a long way forward to doing
what we need to do in that interepidemic period and before an
attack occurs.
Mr. Flores. Well, thank you. I think that's helpful.
Also I want to compliment you on the great work that you're
doing in the BARDA public-private partnership.
Dr. O'Toole, the World Health Organization recently
assessed that the potential impact of synthetic biology on
smallpox preparedness and control and the WHO scientific group
found that the risk of reemergence of smallpox has increased
due to the low cost and widespread availability of technology
and know-how on how to create the smallpox virus.
So the BRSP focused heavily on the threats that we face
today. Can you tell me what's possible given the rapid advances
in synthetic biology, and how have these advances in synthetic
biological escalated the threat?
Dr. O'Toole. Virtually anything is possible today
theoretically. Smallpox is an ancient huge virus. It would be
very difficult to create synthetically a functional smallpox
virus. There are many other choices available. We know, for
example, that the Soviets created a vaccine-resistant plague
strain.
New gene-editing techniques make that kind of creation of
resistant viruses quite straightforward, although nonresistant
pathogens can do a great deal of damage too. I'm not sure it
makes sense to go to the trouble of making a synthetic bug.
But what we are missing is the opportunities on the upside
that synthetic biological and other advances allow.
Mr. Flores. Right.
Dr. O'Toole. OK? I mean, we are in a revolutionary phase of
biological science, and virtually none of this is being
leveraged against our biodefense needs. We need a lot more than
improved contracting procedures in BARDA. We need a commitment
to revolutionize the way we make vaccines. Same thing with
diagnostics.
We can do this. We can shift the advantage to biodefense.
But we can't do this with incremental, you know, tweaks on the
programs we have now, in my opinion. We need a much deeper
investment in bioscience and biotech.
Mr. Flores. OK. Thank you. That's helpful.
I've exhausted my time. I yield back.
Mr. Murphy. Thank you.
I now recognize Mr. Tonko for 5 minutes.
Mr. Tonko. Thank you, Mr. Chairman.
Welcome to our witnesses.
Dr. O'Toole, in your testimony, you speak of the need to
take advantage of recent developments in bioscience to rapidly
develop tests and manufacture vaccines against emergent
infectious diseases. Can you speak to the role that the centers
for innovation in advanced development and technology play in
this process? And is this program indicative of the types of
public-private partnerships we should be pursuing in this
space?
Dr. O'Toole. I'm sorry, sir, I didn't hear. Centers for----
Mr. Tonko. Centers for innovation in advanced development
and technology.
Dr. O'Toole. Yes, they can play a very critical role. For
example, new diagnostics have a very difficult time getting
approval to be paid for. So that discourages innovative biotech
companies from making them. Imagine the difference it would
make if we had a rapid diagnostic test right now for Zika and
we could very clearly say, ``You're infected, what is the
outcome of your pregnancy?'' or, ``You're not infected.'' Same
thing for Ebola. Image if we were able to tell within minutes
if somebody was infected with Ebola, preferably before they're
symptomatic.
The technologies for a whole host of new diagnostics are
out there. The path to making money on them is very, very
troubled, both from a regulatory point of view--it is almost as
hard as it is to get a new drug through and the return on
investment is not nearly as great--and also from the payment
mechanism. So, yes, the centers have a tremendous role to play.
Mr. Tonko. Thank you.
And Secretary Shalala, how does the first recommendation
that you've shared with us today get off the ground? Should
there be a congressional mandate to have the executive branch
explore and implement if experts agree it's needed? What are
the next steps to take us forward?
Ms. Shalala. You know, I'm not sure what the answer to that
question is, whether Congress can designate the Vice President
of the United States. It's a different branch. You certainly
could make a recommendation in this area. And I think the fact
that this committee would make a recommendation as part of a
more integrated piece of authorizing legislation would have an
effect.
It is a new recommendation. If you look through all of the
other commission reports, this is the first time this has been
elevated to this level. So I think both a combination of the
visibility and some enthusiasm from Congress, from this
committee in particular, would convince the next President of
the United States to look at it very seriously.
And of course there are budget implications in that,
particularly tying it to an integrated budget approach, which I
think we all think is extremely important, and in which there
have been very few examples at a very high level. Probably
intelligence is the major one. The defense kinds of ones, you
know, the defense agency itself usually leads. So it would take
some identification by this committee, I think, that would make
a difference.
Mr. Greenwood. Congressman, can I give 15 seconds on that?
Mr. Tonko. Sure, sure.
Mr. Greenwood. I'm not a lawyer, let alone a constitutional
lawyer, but I think that the Congress can provide the
authorization to the Vice President, and then perhaps it's up
to the President and the Vice President to decide to utilize
that authorization. But I think that's probably the way it
would work.
Mr. Tonko. Thank you. Thank you to both of you.
And, Secretary Shalala, given the complications created by
transferring technology from an innovator company to the
centers for innovation and advanced development in technology,
do you believe it would be beneficial to establish a single
location wherein the complete process from innovation to
manufacture can take place quickly and nimbly in order to
rapidly respond to the various emerging threats?
Ms. Shalala. You know, periodically the leaders of
Government on both parties have looked at that process and seen
whether we can fast track it so that we can get products faster
to market. There are so many jurisdictional issues, if a
product has to go through the FDA process, for example, if it's
exempted from the FDA process.
So I think that that's an example where a Vice President
looking at the process and making recommendations about the
integration, because it's a piece of the larger strategy, where
that would make a difference. We certainly did that when we
looked at, during my time when we looked at fast tracking AIDS
drugs, for example, and we were able to take different elements
and put them together in a way that protected safety, but also
moved the needle very quickly in that area. But that's why,
because there are so many agencies of jurisdiction, you need
someone to think it through.
Mr. Tonko. Thank you to each of you.
And Mr. Chair, I yield back.
Mr. Murphy. Thank you.
I now recognize Mrs. Brooks for 5 minutes.
Mrs. Brooks. Thank you, Mr. Chairman.
And thank you to our esteemed panel for being here today.
I was a U.S. attorney in 2001 and was part of the response
in the anthrax attacks, and actually had an office where that
powder was sent to. You know, multiple Government offices were
receiving powder, which, you know, terrified that employee who
opened the mail not knowing if it was actually anthrax or if it
was just powder. And I have to tell you, I thought, and I was
in Federal service until 2007 and it felt like we were moving
forward, but I have to tell you, until this report came out,
and until we have seen kind of the lack of adequate response to
Ebola, quite frankly, I really do believe we have stepped back
and that we have just moved from crisis to crisis.
But I just encourage my colleagues, this is an outstanding
report with 33 recommendations. It is a roadmap. It is a
blueprint. And it is in part the basis upon which Congresswoman
Eshoo and I introduced 3299, the Strengthening Public Health
Emergency Response Act of 2015. And I want to talk about that
because I really appreciate all of these recommendations. I
encourage my colleagues throughout Congress to read this book,
because you as experts talked to experts around the country as
well. It's not just the people on the Panel. A lot of work went
into this. So I commend your work.
Mr. Greenwood, can you please share with us the merit that
you see in returning the contracting authority to BARDA, back
to BARDA, which is in my bill, and can you talk about the
importance of that and what has happened and why we're not able
to get, you know, vaccines and our medical countermeasures
through the pipeline as fast as we need them?
Mr. Greenwood. Well, thank you. Originally, the contracting
authority was with BARDA and it was changed. It was moved to,
I'm going to refer to my notes here, it was moved to the
office, an office called the Acquisitions Management, Contracts
and Grants Office. And the problem is that the technical
experts are not there, and they are, in fact, at BARDA. And, in
fact, because of certain regulations, there's a firewall
between the two, and sometimes they actually cannot speak to
one another.
Imagine how frustrating it is for a company trying to get a
contract and it's talking to folks who know a lot about
contracts but they don't know a lot about this issue, about
medical countermeasures. And so I think it makes all of the
sense in the world to eliminate that level of bureaucracy, put
the contracting back at BARDA where it belongs so that the
experts in the field can talk to the experts in the company
with whom they are attempting to create contracts.
Mrs. Brooks. Thank you.
And with respect to the companies trying to get vaccines
into our stockpiles, can you and Dr. Shalala please talk about
the fact that we don't have a sufficient coordinating mechanism
in our National Strategic Stockpile also identified? So we
don't even have, if I'm not mistaken, the right coordination
between CDC and BARDA to have the right vaccines in our
stockpile. Can you talk about that?
Ms. Shalala. Yes. And we made recommendations in that
regard, because the system is weak now and needs to be
strengthened. And thank you, Congresswoman, for your leadership
on this issue as well.
Mrs. Brooks. Thank you.
Mr. Greenwood, any comments with respect to the stockpile?
Mr. Greenwood. Well, I think it goes to the essential
point, which is that we are not organized as a Government to
effectively and quickly respond to either pandemics or
bioterror because the authorities are diffuse, they don't
always talk to one another. And that is exactly why a central
unified plan, a strategic plan, a central budget, and giving
the authority to the Vice President makes all the sense.
Mrs. Brooks. And I think citizens believe and know we have
these stockpiles, and believe that they are adequately filled
with the proper, right types of vaccines. Would anyone else
like to comment on our National strategic stockpile?
Dr. O'Toole.
Dr. O'Toole. I'm the chair of the National Academy
committee on the Strategic National Stockpile right now, and
they have made tremendous progress in the last 20 years. The
problem with the stockpile is that the new drugs that are going
into it are largely biologicals, and they are very expensive,
and they expire in 2 or 3 years. So there is a pipeline of new
countermeasures coming in that increases inexorably the cost of
the stockpile and everybody's budget is staying flat.
So the limitations on the countermeasures we have in the
stockpile, first of all, are budgetary limitations. I mean,
this is an expensive proposition. The stockpile already holds
about $7 billion worth of stuff. But we are talking about
having to cover multiple cities with these sometimes very
expensive drugs and vaccines. We need a cheaper way to do it.
Which is why I say you are never going to be able to create a
stockpile that has everything you want in it against every
contingency. We have to move to a strategy of being able to
quickly design and manufacture at scale what we need.
Mrs. Brooks. Thank you all for sounding the alarm. I
appreciate your leadership.
I yield back.
Mr. Murphy. Thank you.
I now recognize Mr. Mullin for 5 minutes.
Mr. Mullin. Thank you, Chairman.
And thank you for the witnesses being here.
I first want to thank Ms. Shalala--I hope I say that
right--and Mr. Greenwood for this report. I'll tell you, the
more that I learn about it, the more I wish I wouldn't read it.
I'm serious. It's very troubling when you understand the false
security that we have even from something as simple, yet
dangerous, as the flu to the most serious threats that we're
facing today.
And in a previous hearing, I was talking about our CDC's
National Stockpile, Strategic Stockpile that we have, and in
particular the weaknesses that we have there. And following
Mrs. Brooks here, I want to get a little bit more in depth
about what you see as maybe our biggest weakness, maybe the
biggest two weaknesses, some of the biggest threats we have
with the stockpile, some recommendations. Don't get into it too
deep. Just maybe one or two that we can start working on in the
committee here.
Ms. Shalala. Well, I actually think Dr. O'Toole is the
expert on the stockpile issue and that she has outlined what
the challenges are in the stockpile. It doesn't cover
everything. It's expensive to maintain because they have a
short shelf life. It was a good idea at the time, but
constantly having to renew it is our biggest challenge.
I think that most of us think that there are other issues
we can address, and certainly scientific issues that would give
us a longer life in some of these areas. And I think on the
production side, Tara, our ability to produce something faster
and not being totally dependent on the stockpile is probably
where your IOM commission is going.
Mr. Mullin. You know, yesterday I had a meeting with some
biodefense individuals and they were telling me that, you know,
there is technology that they're looking at that would extend
the shelf life through maybe a dry freeze. Is that correct? And
then also, they are retesting it too, and some of it that was
designed it'll go 2 or 3 years has lasted as long as 15 years.
So they're constantly retesting it.
But how do we dispense it? How do we get it out? Having it
in a stockpile is OK, but it doesn't do us any good if it's
housed one place and we can't get it to where it's needed.
Ms. Shalala. One of our recommendations was to use the
existing community pharmacies. The original idea was to use the
VA's because they are spread across the country and they do
keep a certain amount of supplies.
Mr. Mullin. We're having enough problems with the VA right
now.
Ms. Shalala. And they're well located, the VA hospital
system and warehouse system. The Government has also contracted
with, I think with FedEx, to move pallets around the country.
And the reason for that is because the military is not well
situated to do that kind of thing. So there has been extensive
discussions in the Government and a strategy for moving pallets
of drugs very quickly using--I think the contract was with the
FedEx system originally to move pallets around the country when
there are outbreaks.
Mr. Mullin. Ms. O'Toole.
Dr. O'Toole. The big problem with the stockpile is
traversing what's called the last mile. It's not about
delivering the stockpile to the State public health
departments. It's about getting it into the hands of people.
And as you can imagine, that dispensing function is very
complex.
Washington State is going through pharmacies. That won't
work in every State, particularly rural States, although most
Americans live within reach of a pharmacy. Advanced deployment
is also being used in those very few States that can move very,
very quickly to dispense, such as New York City.
One thing that would definitely help is more money for
State health departments and local health departments to do
drills on dispensing. These are invaluable, but they are very
time consuming and expensive, and they simply don't have the
money to do them. New York City does them, some of the big
municipalities do them. But making those a more viable way to
practice would, I think, make an appreciable difference.
Mr. Mullin. That's a great recommendation.
Mr. Parker--Dr. Parker.
Dr. Parker. Yes, I just wanted to come back. Everything
you're asking actually really comes back to centralized
leadership. We've been talking about lyophilization of vaccines
for 15 years or more, the last model of dispensing medical
countermeasures from our SNS. That is the hardest challenge.
In fact, there was an executive order in about 2009, 2010,
and I was just discussing this with one of my colleagues from
public health from Chicago yesterday. It seems that that work
has just disappeared. But with centralized leadership, focused
work on how to solve that last mile of actually dispensing the
medical countermeasures would go on, and we need that. Because
it's one thing to have a stockpile with Cipro and Tetracycline,
and it's one thing to be able to get it FedExed to get it to an
urban center. But actually getting it into people's hands is a
huge unsolved problem.
Mr. Mullin. Thank you. I'm out of time. I appreciate it.
Mr. Murphy. Thank you. I now recognize Ms. Castor for 5
minutes.
Ms. Castor. Well, good morning, and thank you to the Panel
your terrific work on this important subject.
And Ms. Shalala, the folks at the University of Miami were
so appreciative, and everyone across the country, for your
service. I know they miss you there. But it's great to see that
you continue on in your service.
I wanted to focus on hospital preparedness. During the
Ebola outbreak in Africa in 2014, we took a critical look at
hospital preparedness and its important role in our Nation's
response biological events. At that time, in response to that,
the President requested emergency supplemental funding for
Ebola. The Congress responded. Now, with Zika, we're having to
do that again. This doesn't seem to be the most efficient way
to prepare for emergencies.
I'd like to ask a few questions about this, about what we
can do to assist hospitals throughout the country in their
response. You know, we had some that were very well prepared,
like Emory University, what a terrific job they did because of
their association with the CDC. And NIH, of course, was at the
forefront in that Ebola response. But some did not do quite as
well. And there's no mystery that if that had been more
serious, that a lot of hospitals across the country would have
struggled.
So what lessons do you think we learned from this, from the
Ebola outbreak in Africa and the few cases that came to the
U.S.? I'd like to ask maybe Ms. O'Toole first.
Dr. O'Toole. Hospital preparedness is very important. I
think between 2002 and 2008 it did improve, for two reasons.
First of all, disaster response drills are required for
accreditation by JCAHO, by the hospital-accrediting facility.
Again, for hospitals doing those kinds of drills, it's
expensive and difficult.
There also was a CDC/HHS flow of money to hospitals to help
them with bioterrorism and pandemic flu preparedness. And what
happened with that money is the hospital started forming
coalitions. In my city, in 2001, Baltimore, the mayor for the
first time got all the CEOs of the hospitals together in one
room. This is a private sector competitive industry. They don't
necessarily cooperate, let alone collaborate.
And those CDC funds made a real difference. These regional
coalitions of hospitals were used to figuring out how they were
going to share resources, share information, et cetera, et
cetera. That funding has been cut in half since 2010. That
makes a big difference.
Ms. Castor. Secretary Shalala, the Panel's report mentions
that disease-specific preparedness funding is the most
inefficient and costly manner in which to fund preparedness.
What are the alternatives to disease-specific programs,
especially since many States have frayed their public health
infrastructure? How can we respond better and give the
hospitals in our local communities the tools they need?
Ms. Shalala. We have specific recommendations in this area,
including a steady stream of funding. We recommend that it be
done through the accreditation system and through CMS.
In addition to that, we have recommended a tiered system.
Every hospital in this country cannot be prepared for every
complex disease. So both the regional coordination, but more
importantly, identifying those hospitals that can have special
rooms set aside.
In Florida, for example, all of us looked at--particularly
at the great public hospital in Miami, whether we could build
separate rooms with separate access to handle Ebola patients,
and in fact went through an exercise to make that possible.
A great public hospital that sees all sorts of diseases
probably is the best place to do that, as well as academic
hospitals around the country. So creating a tiered system in
which we know where we would send patients--once they are
stabilized obviously--that would have the capacity and the
separation to be able to handle these diseases is certainly the
way to go.
We have some specific recommendations both on funding, on
the accreditation process, but in particular on creating a
tiered system in this country that would give us coverage
across the country as there are outbreaks.
Ms. Castor. I think that is a very important recommendation
and I would encourage the committee to act on it as soon as
possible. Thank you very much.
Mr. Murphy. Thank you.
I recognize Mr. Cramer for 5 minutes.
Mr. Cramer. Thank you, Mr. Chairman.
And thanks to the panelists.
I want to focus on this incentive issue, Congressman, that
you've raised.
And I will admit right up front that what I'm about to do
is very dangerous. I want to think out loud for a little bit.
And then I also admit that you're not going to adequately
inform and educate me in 5 minutes. So you're going to have to
come to my office and help me work through this idea, because
you've all done a great job, as has the Panel, the Blue Ribbon
Panel, in scaring me to death. So I'm adequately prepared to
understand the threat, and I think that's very important.
But in our political world, of course, when it comes to the
appropriations process, part of why I think you don't see
Congress acting or the Government acting proactively is because
we respond to the people we represent. And they will blame us
when we're not prepared and they'll blame us when we spent
money foolishly. And of course we're talking about finding a
way to invest in something that we hope is never needed. And so
that's our political dilemma.
I would, starting with you, Congresswoman Greenwood, and
others if you want to weigh in, maybe just to elaborate a
little on the SRF, the PRV, how we could help pharmaceuticals,
the private sector, feel comfortable with the investment and
the innovation. And we've talked a fair bit about it, but if
there's a way we could elaborate just a little bit more to help
me better understand how we're going to do this.
And I might also emphasize, is there a way to put a cost-
benefit analysis on this? For example, Ms. Castor was talking
about emergency responding. That's a cost. That's a cost that
could be avoided, perhaps, if we were better prepared. Right?
So has there been some work done in that arena that helps
me assure my constituents that we're not just appropriating,
but that we're efficiently and effectively governing?
Mr. Greenwood. Well, thank you for admitting that we
frightened you. And, obviously, our constituents, your
constituents are not clamoring for this, because it is a
sleeper.
No one is thinking that this is going to happen. And as I
said earlier, the hearing you don't want to have is the one
about why we were unprepared for the event that was so tragic.
So I think to some extent leadership involves informing
your constituents, and this hearing is an important part of
that, that this threat is real. I calculate when it comes to
bioterror that they have the--the terrorists have the motive.
They are trying to acquire the means. And despite our best
efforts to deflect that, over time the likelihood of that
happening is one over one, OK, it is going to happen.
Mr. Cramer. Uh-huh.
Mr. Greenwood. And we have to be--you have to believe that,
we have to believe that the threat is real.
So in terms of what works to be prepared, we talked about
the contracting reform, which is a minor thing but an important
thing, and Congresswoman Brooks is a leader on that. We've
talked about the need for there to be sufficient funding to
actually procure these MCMs when they're developed. The
Secretary was completely correct when she said not to
underestimate basic research at the NIH; that's critical.
But when it comes, just like in every other medicine that
we develop, when it comes to actually developing the product
and manufacturing the product, the private sector is the only
place where that is done. And to invest money in that--the
companies are willing to take the risk that maybe they will
fail at the science, but the investors are not willing to take
the risk that if they succeed the Federal Government is not
going to be prepared to reward them by procuring the product.
So that's critical. And you need enough money over time to
be certain, so there's a certainty that when you get to the end
of the road and you get your product approved, that Congress
hasn't moved the money around and it's no longer there.
Mr. Cramer. Secretary Shalala, you may want to weigh in on
this. But one of the things--I appreciate your national defense
analogy, because I was thinking a lot about, you know, we spend
billions of dollars on weapons we hope we never use, right? Now
they do have the benefit of being a deterrent, understandably.
But it isn't dissimilar. We have to constantly make this case.
So I thank you for that. And the centralized leadership as
well. I'm still struggling with the whole Vice President thing
myself. But the more you talk about it, the more sense it
makes. So I appreciate that.
Is there anything else anybody would add to what the
Congressman said about the investment piece?
Dr. Parker. Yes, I would like to add a little bit, and
perhaps maybe just pull on the contracting itself as well. As
we've heard, many of the companies in this space that are
really contributing to biodefense, and particularly those that
are bringing the more innovative solutions, are struggling
themselves.
And the typical FAR-based Government contracting is really
contrary to the biotechnology industry in and of itself.
And so I would think, you know, I have actually been
encouraged recently with some pronouncements by DOD to begin to
start using some authorities they already have, like other
transaction authorities.
So I think just also taking a look at what are other things
and just the basics of contracting that could make it more
readily accessible that the innovative biotechnology companies
would actually do business with us in the Government is
something to look at as well, sir.
Mr. Cramer. Thank you very much. And if we could solve the
DOD contracting in the context of this, that would be a bonus.
That would be a cost-benefit analysis. Thank you.
Mr. Murphy. Thank you.
I recognize now Mr. Green of Texas for 5 minutes.
Mr. Green. If we could solve the DOD contracting, we could
probably have them audited.
I want to welcome our panel here.
The Blue Ribbon Study Panel on Biodefense highlighted
vulnerabilities in our ability to combat emerging and
reemerging infectious diseases, particularly drug-resistant
infections, which could cause catastrophic loss of life and
have already started to make even minor infections fatal.
Without greater investment in antibiotics we face a future that
resembles the days before these miracle drugs were developed,
one in which people died of common infections, many medical
advancements we take for granted become impossible, including
surgery, chemotherapy, and organ transplantation.
The challenges presented by the rise of drug-resistant
bacteria for which we have no effective treatments are
representative of the challenge facing medical countermeasure
product development. The market forces simply do not work and
fail to foster the kind of pipeline we need.
In 2012, this committee passed and Congress passed the GAIN
Act, and again in this current session, in the 21st Century
Cures Act, we worked to remove the financial and regulatory
barriers to antibiotic drug development.
Secretary Shalala, can you elaborate on the study's
recommendation for incentivizing the development of medical
countermeasures for emerging infectious diseases with pandemic
potential? Specifically, please explain why there is such a
need for Government to play a leadership role in this space.
Ms. Shalala. Well, I think it's pretty straightforward that
the only purchaser will be the Government. There's not a
private sector market for these particular biologicals. And,
therefore, the Government both has to incentivize the companies
financially so that--and I think the other thing to
understand--Jim, could explain this better than I can--these
are relatively small companies, often with a small number of
products. We've known a lot about the biotech industry. They're
fragile. I like to use the word ``fragile'' when you talk about
them. So that unless they know that they're going to be
compensated and reimbursed for the cost of development, not
just the cost of production, but the cost of development,
unless there are financial incentives, I don't know how we're
going to move very quickly in this area.
We've had some experience. Congressman Waxman in the Orphan
Drug Act. We had a lot of diseases in which there were very
small markets, at least initially, and the Congress in its
wisdom passed legislation that encouraged companies to invest
in creating drugs and treatments for a very small part of the
population.
Our problem here is we start small, but we may need a
production line that's huge at the end of the day. I don't know
any other way to do it except with financial incentives. I just
don't know. I think everything that we've learned, it's not
just that I'm a capitalist, it's just that, from our point of
view at a public policy issue, when the market is going to be
the Government there is no other way to get a very small number
of industry people to invest unless they know there's going to
be a market at the end of the day.
Mr. Green. Jim. And, again, welcome back to your committee.
Mr. Greenwood. Thank you, Congressman. So nice to see you.
One of the proposals we have is the priority review
voucher, the PRV. And the beauty of it, I mean, if you look
at--Congress, in its wisdom, looked at neglected tropical
diseases, and we knew that there's no financial pull, that
these diseases that occur in places like Africa, the countries
are so poor that they really can't afford to buy the product.
So investors just aren't putting their money there.
When Congress created the priority review voucher, it works
beautifully, because what it does is it says to a company, if I
can get a drug approved, even if I don't make enough return on
my investment from the procurement of that product, another,
maybe a large biopharmaceutical company, will pay me. And these
things have gone, there are only two or three of them have been
sold, but they go--have gone for $200 million, $300 million,
$400 million.
It doesn't cost the taxpayers a penny. Pfizer or Merck or
Glaxo or somebody buys that, which just simply gives them a
foreshortened review period for some other product. And that
doesn't cost the taxpayers any money either. They pay their
PDUFA fee, they get their product approved. And sometimes they
don't get their product approved. But if they do it, it gets
approved a little faster. It gets on the market. And by the
way, then it goes off patent sooner anyway. So it still doesn't
have any cost to society.
Mr. Green. Mr. Chairman, I know I'm out of time, but we had
legislation that's in the Senate that would fast track, because
we recognize the Government is going to be the one that has to
do it, because free enterprise can't invest that money for
something. But there is legislation and hopefully the Senate
will deal with Cures and the complete package that our full
committee approved overwhelmingly.
Thank you, Mr. Chairman.
Mr. Greenwood. Thank you, Congressman.
Mr. Murphy. That would be nice.
I recognize the vice chair of the full committee--I'm
sorry, Doctor--well, Mrs. Blackburn.
Mrs. Blackburn. Yes, that woman from Tennessee.
I tell you what, Dr. Parker, I am so happy to see an Aggie
on the panel. I've got Aggies in my family, and they always
bring good, commonsense, seasoned wisdom to the table. So happy
to see you there, and of course Mr. Greenwood, and how much we
appreciate your insights on this and your dedication to the
biotechnologies and the work that you've done there.
Just a couple of things that I want to touch base on. In
talking with some of my research centers--and in Tennessee we
have such an aggressive biotechnology group. And when I was in
the State senate, I helped to formulate that group. And so
they've got a good underpinning. And it doesn't matter if it's
Vanderbilt or St. Jude's or whatever. They talk to me a good
bit about the right balance between Government and regulatory
oversight and then the ability to incent.
And, Mr. Greenwood, I'm so pleased that you just mentioned
the priority review voucher for the MCMs. I just think this is,
when you look at these medical countermeasures, that is just so
important that we have that. And it doesn't matter if it is a
material threat, if it is something like Zika, we have to have
a way to go about this.
But I want to come to something that Dr. O'Toole mentioned,
and then, Congressman Greenwood, if you will kind of answer to
that. Basically her point was you move products to a point of
scalability, and then if you need something, you're ready to
move with it and can push that scalability quickly.
So let's go back to that voucher, Mr. Greenwood, and if
you'll continue that conversation and kind of build that, the
importance of that, how you would address these for something
that is a material threat. Or like the Zika virus, which right
now there is not a vaccine and people are saying: What are you
going to do, why didn't you know this was a problem, the
Olympics are coming to Brazil, people have been vacationing for
months in the zone that is affected, et cetera.
So let's go back to the importance of having that priority
review process for this type of occurrence.
Mr. Greenwood. So there's great uncertainty for a company
to--we've seen our companies, and proudly, jumping into the
Zika issue and trying to do some research on it very quickly to
develop products. But I remember a member company of Bio that
was involved in trying to--it looked like it was close to
having something on Ebola. And they almost didn't want to talk
about it because their stock was fluctuating like this. All of
a sudden everybody would invest in that company and then
another company was doing something and people would pull out.
And it created unpredictability and volatility. And so it's an
example of how the norms of economics don't work in this field
at all.
So the priority review voucher takes away one of the
uncertainties. And that uncertainty is that it doesn't take
away the uncertainty of: Can we make this product, and will it
be safe, and will it be effective? That's always a risk. And I
will tell you that doing that is harder than putting a man on
the moon. Most companies fail and most projects fail. So it's
hugely risky to even bother trying. But if you do try and you
do succeed, the only reason your investors are giving you the
leeway to go and do that is because they think that somehow
they will get a return, a fair return on that investment.
One way to do that is to have enough money in the Reserve
Fund and have it there not just year by year, but have it there
multiple years so that companies can know and their investors
can know, if we succeed here, they will buy the product and we
will get our investment back.
But the priority review voucher is an entirely different
way to do that, and because they have become so valuable, it is
a huge driver, it is a huge incentive. Because if you can
succeed--let's say that right now we had a priority review
voucher for Zika, right, companies would know that if they
could succeed, not only would they have the great satisfaction
of being able to spare people from this disease and, God
forbid, more children born with microencephaly, but that they
would have this voucher they could then take to the marketplace
and sell it at a very nice return and use that money to invest
in the next countermeasure.
So I think it's a no-brainer to me. I know that there's
some political questions about it, but I don't think there
should be because it costs the taxpayers nothing, it costs
society nothing, and it provides nothing but benefit.
Thank you.
Mrs. Blackburn. Thank you.
I yield back.
Mr. Murphy. Thank you. The gentlelady yields back.
I now recognize Dr. Burgess of Texas for 5 minutes.
Mr. Burgess. Thank you, Mr. Chairman.
Thanks to our panelists for being here today. I apologize
for missing part of the hearing. We're having our budget
season. Mr. Greenwood, you'll remember what that is like. So
never a dull moment around here today.
Dr. O'Toole, I just want to ask you, because we've had
several hearings over the past several years. Just for context,
my congressional career goes from SARS now to Zika, long enough
for people back home to say ``term limits,'' but on the other
hand, there may be some value in seeing some of this stuff over
a continuum.
But you reference in your testimony about what are called
laboratory developed tests. And Zika really comes in focus
because, OK, you've got a polymerase chain reaction, but only a
few places can do it. It's pretty valuable, pretty accurate,
but it's hard to get. You got to go through a health department
to get it. There is an IGM antibody, but it will cross-react
with some other viruses, so you are not really sure if your
result is accurate.
But would you just speak to the regulatory hurdles that you
describe in your testimony and laboratory developed tests?
Because we in this committee have been studying that. There is
a movement, as you may be aware, to move the regulation of
laboratory developed tests from CLIA, the Clinical Lab
Improvement Amendment, which is basically administered through
the Centers for Medicare and Medicaid Services, over into the
Food and Drug Administration, and requires basically the
licensing of laboratory developed tests just as if they were a
new drug or device. And we know the problems with the timeline
of those things. So could you just speak to that briefly?
Dr. O'Toole. Yes. Thank you for the question, Congressman.
First of all, the reason FDA is so concerned about
diagnostics is that they can have life-or-death consequences.
And we might want to think about different standards for
diagnostics during public health emergencies.
Mr. Burgess. Yes, I'm going to interrupt you for a minute.
That is called clinical judgment, and you and I understand that
because we trained as physicians, and that has to be part of
the equation.
It took me 3 years to get from Dr. Shuren at the FDA a list
of the problems that he was worried about with the development
of laboratory developed tests. Where are the outliers? Where
are the problems? To his credit, the last time he was in here,
a few months ago, he did produce a list of 20 tests that he
said that these may be problematic. But there are 11,000
laboratory developed tests out there, and they are useful every
day of the week in a clinician's office. So I'm sorry, but
continue.
Dr. O'Toole. So let me narrow the problem down to tests
that we need for infectious disease, and particularly during
epidemics, OK? And we need a variety of different kinds of
tests. As you know, you want a very sensitive test when you
have a low prevalence, but you don't want that same test when
you're in the middle of an epidemic. So it gets tricky.
However, here's the problem. It's very difficult to
validate a new diagnostic against Ebola, or even Zika, if you
don't have curated samples of those diseases. In my view, the
Government--you can put this in DOD, you can put it in HHS, you
can put it in FDA--the Government should develop a curated bank
of diseases about which we are worried so that companies,
especially these small, agile, fragile companies, could come
and test their diagnostics against them so that they could much
more rapidly give FDA useful data on how well their test works.
That's one.
Secondly, I think just as FDA has emergency use rules for
medical countermeasures during public health emergencies, we
ought to think about emergency use rules for diagnostics, which
I think we can actually create rather rapidly and manufacture
quickly during public health----
Mr. Burgess. Yes, I will just tell you, last year or 18
months ago during the peak of the Ebola outbreak in September,
I went to a hearing at the Foreign Affairs Committee where we
heard that the FDA had actually put a clinical hold on, I
think, a drug called TKM-Ebola that was at that time in use in
treating patients with Ebola. I mean, I didn't want to hear
about clinical holds, I wanted to hear about clinical trials.
So it really did seem like they were an obstacle faced with
this worldwide scourge.
Dr. Shalala, I just need to ask you a quick question on
your--and I just appreciate your listing out the
recommendations of the Blue Ribbon Task Force. In my political
training, which, granted, was a street-level course, I was sort
of taught that you only do three things. If you produce a list
of 33 things, no one listens to you after the 3rd one.
But I did read through your list, and it is a good list,
it's an exhaustive. I hope it's not static. Because one of the
things that we've worked on, on the 21st Century Cures bill, is
the whole issue of interoperability of electronic health
records. And if we do not address that fact in this--in the
recommendations that you have, I think that's actually going to
stymie the ability for researchers and clinicians to
communicate rapidly, de-identify data, to be sure, respect
patient privacy rights. But at the same time, we need to have
that ability for rapid learning within the system, whatever
develops.
Ms. Shalala. Well, as you know, there has been a lot of
progress on electronic medical records in this country and
continues to be. And you're absolutely right, it's the
touchstone piece.
I should say that even though we have 33 recommendations,
we have actually staggered them, to identify those that we
think Congress should do immediately that have more of a
midterm value and a longer-term strategy. So we very carefully
laid out a strategy that would be workable for Congress.
Mr. Burgess. Thank you, Mr. Chairman.
Ms. Shalala. And the Federal agencies at the same time.
These are not just recommendations for Congress.
Mr. Burgess. Very good. I yield back.
Mr. Murphy. Thank you. The gentleman yields back.
I now recognize Mr. Bilirakis for 5 minutes.
Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate this
very much. Thank you for allowing me to sit in on this very
important hearing.
As the former chairman of the Emergency Preparedness,
Response, and Communications Subcommittee for Homeland
Security, I recognize a need for the country to be proactive,
not just reactive, to a host of biological threats, both
natural and manmade. I'm glad that I can continue to be
involved in the Energy and Commerce Committee. So I appreciate
being given the opportunity to sit in on this subcommittee.
Secretary Shalala, earlier you mentioned that the State and
local agencies are the first in line of defense against
outbreaks and attacks. You also said that much of their funding
through block grant programs has been weakened. What should we
do to enable State and local entities to be prepared to respond
to outbreaks or attacks? Is there enough of a focus on medical
surge capacity and mass prophylaxis capabilities? Do we need
flexibility in our grant programs?
Ms. Shalala. Well, we have flexible grant programs. I think
they are not well funded. That is our point, I think in the
report, is that the funding has either been level or gone down
over a number of years. The CDC's grant to the States is pretty
flexible. I mean, there's some exceptions in it. But the States
are really underfunded in terms of their infrastructure. As was
pointed out, we have lost 50,000 public health experts across
the country in the States because of----
Mr. Murphy. Could you turn your microphone on, please?
Ms. Shalala. Oh, I'm sorry.
We've lost 50,000 public health employees in our States and
local governments as well, and that has to be properly funded.
The tradition has been to have almost a block grant that goes
from CDC to the States. I believe in that tradition. I believe
in the relationship between the CDC and States and local
governments to build an infrastructure. Because the CDC is not
a line agency. When we're in an emergency we think they are.
But it's really the States and the local governments and their
public health departments that are responsible for both the
tracking, the identification for all of us in this country. And
we have to make sure that infrastructure--the States are under
great fiscal pressure in this country and we have to make sure
that infrastructure is beefed up, that stays in place.
Mr. Bilirakis. Thank you.
The next question is for the panel. You all mentioned the
lack of comprehensive biodefense strategy and the need for
centralized leadership. What, if any, protocol is in place now
to enable coordination between the agencies, such as DHS, CDC,
HHS, and various State agencies, when there is a disease
outbreak? And what capability gaps exist in coordinating
efforts between agencies? What makes coordination a challenge?
We can start with the Secretary.
Ms. Shalala. Well, I think earlier I talked about the fact
that there were multiple agencies that are involved when we
have an outbreak like this. And while HHS has very strong
responsibilities and has the scientific and public health
expertise, Homeland Security, the Defense Department, I mean,
there are all sorts of agencies across the board.
And we have made a very strong recommendation that the Vice
President be the ongoing coordinator in this country because
the lead agency concept no longer works when you have various
jurisdictions involved; and in particular, when you need to
work with the private sector, with State and local governments.
Unlike FEMA, which basically can order people around, it's very
difficult for one agency. And I say this reluctantly because,
as the former HHS Secretary, I wanted to own the world.
But when you don't have proper jurisdiction, when you don't
have the leverage, then you have to elevate it, elevate both
the responsibility. And we are much more sophisticated about
the role of the private sector, the development of diagnostics,
and that this has to all be part of our overall strategy in
this country.
Dr. Parker. Yes, I just want to add to that, and the need
to be able to elevate it. And that centralized leadership not
only is needed at the Federal level, and to try to close these
gaps between each individual department and agency because they
want to exercise their own authorities, but there are gaps
between them.
But this will transcend all the way down to the State,
local, private sector level. And it's only if you have
centralized leadership coming from the White House, however
that's done, it's going to help kind of break that and
transcend that leadership.
And as an example you mentioned surge medical at the local
level. It's not just a public health thing. In fact, it's going
to be more logistics. That's why emergency management and other
disciplines are going to be so necessary to effect, in your
example, surge medical dispensing of antibiotics. It's more
logistics. Public health doesn't do logistics.
So that's really why it's so important, this centralized
leadership concept is just so critical, everything comes back
to it, and it transcends the Federal, State, local, private
sector levels, to close these gaps that we have between the
multiple disciplines and agencies that have to contribute to
biodefense.
Thank you.
Mr. Bilirakis. Thank you.
I'll yield back. Thank you, Mr. Chairman.
Mr. Murphy. Thank you.
I now recognize Mr. Griffith of Virginia for 5 minutes.
Mr. Griffith. Thank you very much.
Thank you all for being here today.
Dr. O'Toole, during the Ebola outbreak there were
weaknesses identified in our system that we are now witnessing
again with Zika: surveillance, detection, diagnostics. Overall,
how would improved surveillance of animal disease outbreaks
strengthen our surveillance of human disease outbreaks and make
us better prepared for dealing with epidemics?
Dr. O'Toole. Well, the majority of emerging infectious
diseases come from animals. They're diseases that affect both
humans and animals. So we definitely need to do a better job
looking at those hotspots where we are likely to see spillover
from one species to humans.
Most of those hotspots are in tropical zones, in the
jungles of South America and Asia and Africa. Most of our
surveillance is in temperate zones, for starters. And we are
now beginning to have tools such as high-sequencing genomics,
high-speed genomics that could actually give us a much better
handle of what diseases might be able to spill over. So we
ought to think about funding field surveillance of these
hotspot ecosystems, for starters.
Secondly, we ought to fund much more rigorously the USDA's
existing program for looking at agricultural animals, because,
you know, modern methods of agriculture put sometimes tens of
thousands of animals together, creating our own industrial
hotspots for spillover, and we have seen that with flu and the
loss of turkeys and chickens in the past years.
Thirdly, for humans, we have to have a much more strategic
approach to surveillance. We've spent billions, literally
billions on surveillance in the past 15 years. Some things have
worked; some things haven't. We've done a terrible job at
lessons learned. And we ought to go back and figure out what
really has made a difference.
Part of that is, again, we sound like broken records,
funding State health departments, because that's where, you
know, the rubber meets the road. But we have to help State
health departments do a better job.
Diagnostics, again, critical, critical, critical, critical.
Clinical disease is very vague. If you don't have the
diagnostics to say this is Zika and this is dengue, you're
going to have a hard time figuring out what's going on at the
beginning and at the middle of an epidemic.
I would be very careful about investing large amounts of
money in particular surveillance programs unless you know
exactly what they're supposed to do, whether they work, and
who's going to use that information.
Mr. Griffith. Well, and my next question was going to be
that, you know, are we doing an adequate job of integrating
human, animal, and environment health. I think you already
answered that by saying no, we're not doing such a good job of
integrating those.
Secretary Shalala, how can we improve integrating those
three components to develop a more comprehensive strategy to
ensure that we are prepared for whatever's next?
Ms. Shalala. I think our major recommendation is that we
put this responsibility in the Office of the Vice President;
that we really need a national leader with the clout to
integrate all these pieces and to help us--actually to help us
think through a strategy, because the integration itself will
have to be done by agencies and by others. But the strategy,
having the metrics for it, keeping people accountable, we've
all recommended that we elevate that to the Office of the Vice
President.
Mr. Griffith. I appreciate that.
Dr. O'Toole, lots of concerns being raised about Zika and
our athletes competing this summer in the Olympics; not only
our athletes, but all the spectators who will go down, the
coaches, the family member, et cetera. Do you believe that we
will be ready? Obviously, the Brazilians are going to have to
do some things and this is an international effort. But do you
believe that we are going to be ready to be able to defend our
folks or have the biodefense efforts ready to defend our
athletes and spectators and coaches and family members who go
to the Olympics this year?
Dr. O'Toole. Well, I understand the deep concern that Zika
has raised. Whenever children are affected, you know, grownups
get deeply, deeply worried, and that's what's happening here.
I will say that there are dozens of very dangerous
mosquito, and even tick-borne diseases, that have been with us
for millennia. And you can to some extent protect yourself from
mosquito bites by using DEET and dressing well and sleeping in
places with screens and so forth. That's not a perfect
protection. It's not a zero risk.
We have to wait and see until we have more information
about what is really going on. We've known there has been more
or less an epidemic of dengue and Chikungunya. And dengue is a
serious disease in South America for a few years. That hasn't
stopped people from going down there.
I think we have to wait till there is more scientific data
about Zika. I know NIH is working on a vaccine. I wish we had
one. But I think if I were a young woman who was pregnant or
getting pregnant, I'd think twice about going to South America
right now. But I think for most people there are ways to at
least mitigate the risk.
Mr. Griffith. All right. Thank you.
I yield back.
Mr. Greenwood. Mr. Chairman, would you indulge me 30
seconds on the Zika question?
Mr. Murphy. Yes.
Mr. Greenwood. Thank you.
I just wanted to point out that, aside from medical
countermeasures on Zika, there's a whole field of looking at
how to bioengineer mosquitos, which we already know how to do,
so that they are actually--they're all males, they don't bite,
and they mate with the females, and the progeny don't survive.
And I think that's a fascinating new technology that may be
part of the solution to this problem.
Mr. Murphy. Thank you. Thank you. I know we have votes in a
few minutes.
But Mrs. Brooks, if you have one quick follow-up question.
Mrs. Brooks. One quick follow-up question--thank you, Mr.
Chairman--to Mr. Greenwood, with respect to the priority review
voucher program.
Can you share with us existing PRV programs for rare
pediatric disease or neglected tropical diseases increasing the
biotech investments in this area? Can you give us some examples
where you've seen that already happen?
Mr. Greenwood. I probably have that in my notes, and if I
had time, I'd be whispered to behind. But I'd just say----
Mrs. Brooks. And if you would like to submit it for the
record, that would be fine.
Mr. Greenwood. We'll submit that for the record.
[The information appears at the conclusion of the hearing.]
Mr. Greenwood. But suffice it to say that it is working. It
has created, both in the area of pediatrics and in the area of
neglected tropical diseases, it has generated a tremendous
amount of interest and investment. And it is working perfectly
well, just as a Congress intended, and I have no doubts that it
would well in this field as well.
Mrs. Brooks. And do you believe that if we added the DHS'
material threats to the FDA's PRV program, it would spur
additional development of the medical countermeasures?
Mr. Greenwood. I think that is precisely what needs to be
done, and I have no doubt whatsoever that it will be successful
in inspiring investment in this very dangerous field.
Mrs. Brooks. Thank you all.
I yield back.
Mr. Murphy. Dr. Burgess, do you need a quick follow-up
question?
Mr. Burgess. Yes.
And, Secretary Shalala, you've spoken about the Vice
President as sort of the overseer of all of this, and I
appreciate the fact that there are too many agencies and too
many people involved, and when too many people are in charge,
no one's in charge, and I get that.
Ms. Shalala. And too many committees of jurisdiction.
Mr. Burgess. And I don't quite share your enthusiasm for
putting this into the executive branch. Perhaps it should be a
Speaker's position. But, nevertheless, I will just tell you, I
was down at the border, that Low Rio Grande border last
weekend, and you realize you've got a CDC map that shows Mexico
and Central America being purple with Zika, and my State's the
other side of a relatively narrow river. It just seems to me we
don't pay enough attention to border control. I know you can't
stop mosquitos at the border, but really the issue is stopping
people who are infected or potentially infected.
And right now we are undergoing another surge of
unaccompanied minors and family units. And to the best of my
ability to detect, we're not looking, and that is a point of
great concern to me. So all of the other things we've talked
about are extremely important, but let us not forget border
control, because that's an issue as well.
Ms. Shalala. Well, I'll leave that to your comments. But I
would say that we also have to beef up global health, and that
is PAHO, the Pan American Health Organization, which is part of
the World Health Organization.
We can't stop mosquitos from coming across borders, whether
it's in people or they're just flying across. But it's not only
beefing up our own infrastructure. One of the things that we
learned with Ebola is that the World Health Organization
doesn't have the kind of authorities it needs. It doesn't have
the resources they need.
And so it's not just a State and local issue or a Federal
issue, it's also an international issue. And I think your point
about border security is also. But I would put it in the
context of international health security and looking at the
agencies that we have now, the international agencies that we
have now.
And we know that they're weak. We learned that during Ebola
and previously. And this committee also might have a hearing,
because there have been recent reports on the international
health organizations, to take a look at those relationships as
well.
Mr. Murphy. Thank you.
I know they're going to call votes at any moment here. I
just want to follow up with two quick questions. If you can't
answer this here, get back to us. I'd like an answer from each
of you.If you know of countries that have model programs to do
the very thing you're describing, we'd love to know about that.
Does anybody know any offhand, or would you like the get back
to us on that?
Mr. Greenwood. My only comment, Mr. Chairman, is that if we
don't have it, I'd be very surprised if anyone else in the
world----
Mr. Murphy. That's what I feared.
Ms. Shalala. To be fair, there are centralized health
systems in smaller places that may be more integrated, but I
think that we have different levels of Government, different
levels of responsibility. We can't use their models. We'll have
to put our own system together.
Mr. Murphy. Thank you.
Another question, just hope you can get information to us
for the record. Given the recent GAO report on the failings of
BioWatch programs, including the lack of valid performance
data, should we continue to fund it? Do you have an answer for
that, or do you want to get back to us?
Mr. Greenwood. I'm sorry. Would you repeat the question,
Mr. Chairman?
Mr. Murphy. Should the Federal Government continue to fund
the BioWatch program given the recent GAO report on its
failings and problems, including the lack of valid performance
data?
Mr. Greenwood. I think we probably will get back to you on
the record with that.
[The information appears at the conclusion of the hearing.]
Mr. Murphy. Ms. O'Toole, can you answer that?
Dr. O'Toole. I'm a longtime critic of BioWatch, but I think
you should continue to fund the current program for a defined
period of time until we have a strategy for what we're going to
go do next. I think the notion that BioWatch, or even the next-
gen BioWatch, a series of environmental sensors, can protect
the country is wrongheaded. The technology just isn't good
enough. Its cost-effectiveness ratio is just not advantageous.
We need a new generation of technology. It's not there yet.
Again, diagnostics would make a big difference. You do need
these sorts of sensors to protect high-risk targets and
national security events and so forth.
The problem with BioWatch right now is it is not
characterized, as GAO points out very graphically and I think
accurately. We don't know that it works. It's not clear that it
doesn't work. It has a very limited range of bugs that it looks
for. And to really cover an area of a city you would need a lot
of those machines. So it would be very expensive.
Mr. Murphy. Thank you.
Well, with that I want the committee--first of all, thank
you----
Ms. DeGette. Can I just say one thing?
Mr. Murphy. Oh, yes. Ms. DeGette.
Ms. DeGette. Thank you.
First of all, with all due respect to my friend from Texas,
I don't think that any kind of border control, even building a
wall, is going to stop these vector-borne diseases from coming
over. And I know that's not what you mean.
But what it does really highlight is how we are an
international community. It's not just the mosquitos coming. We
even had Ebola cases come here because of international travel.
And so that's why it's so unbelievably critical that we take
this report seriously and that we really work hard as a
committee.
And, Mr. Chairman, I just want to commend you again for
calling this hearing. I know you're planning to have a
classified briefing when we come back from the February recess,
and I think that's a good other step.
And then I would just finally offer my input and the input
of the minority staff and members to help come up with a robust
hearing schedule for the rest of the year. I think if there's
nothing else we do than spend our time on this report and the
recommendations, trying to get our arms around it and get that
sense of urgency to our respective leaderships, then it will
have been successful.
And I want to thank everybody again from the commission for
doing this deep dive because it really is important.
Mr. Murphy. And let me also announce on March 2 we will
have a hearing on the Zika virus where many of these issues
will come up, we'll take a deep dive in that, as well as what
my friend said about getting into a classified briefing on some
of biodefense issues, critically important, and should be a
wakeup call for America. But as you've said a couple times, Mr.
Greenwood, we may not do these things until after the fact, and
that would be a tragedy. So we'll get moving on that.
So in conclusion, again, I want to thank all the witnesses
and members for participating in today's hearing. I remind
members they have 10 business days to submit questions for the
record. I ask all the witnesses to agree to respond promptly to
the questions.
And with that, this committee hearing is adjourned.
[Whereupon, at 11:05 a.m., the subcommittee was adjourned.]
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