[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
                           

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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:]
    
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    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:]
    
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    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:]
    
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    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:]
    
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    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.]
    [Material submitted for inclusion in the record follows:]
    
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