[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]


  U.S. PUBLIC HEALTH RESPONSE TO THE ZIKA VIRUS: CONTINUING CHALLENGES

=======================================================================

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FIFTEENTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 23, 2017

                               __________

                           Serial No. 115-34



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                    COMMITTEE ON ENERGY AND COMMERCE
                                      
                                       
                    
                          GREG WALDEN, Oregon
                                 Chairman

JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
FRED UPTON, Michigan                 BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
TIM MURPHY, Pennsylvania             ELIOT L. ENGEL, New York
MICHAEL C. BURGESS, Texas            GENE GREEN, Texas
MARSHA BLACKBURN, Tennessee          DIANA DeGETTE, Colorado
STEVE SCALISE, Louisiana             MICHAEL F. DOYLE, Pennsylvania
ROBERT E. LATTA, Ohio                JANICE D. SCHAKOWSKY, Illinois
CATHY McMORRIS RODGERS, Washington   G.K. BUTTERFIELD, North Carolina
GREGG HARPER, Mississippi            DORIS O. MATSUI, California
LEONARD LANCE, New Jersey            KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky              JOHN P. SARBANES, Maryland
PETE OLSON, Texas                    JERRY McNERNEY, California
DAVID B. McKINLEY, West Virginia     PETER WELCH, Vermont
ADAM KINZINGER, Illinois             BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
GUS M. BILIRAKIS, Florida            YVETTE D. CLARKE, New York
BILL JOHNSON, Ohio                   DAVID LOEBSACK, Iowa
BILLY LONG, Missouri                 KURT SCHRADER, Oregon
LARRY BUCSHON, Indiana               JOSEPH P. KENNEDY, III, 
BILL FLORES, Texas                   Massachusetts
SUSAN W. BROOKS, Indiana             TONY CARDENAS, California
MARKWAYNE MULLIN, Oklahoma           RAUL RUIZ, California
RICHARD HUDSON, North Carolina       SCOTT H. PETERS, California
CHRIS COLLINS, New York              DEBBIE DINGELL, Michigan
KEVIN CRAMER, North Dakota
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia

                                 7_____

              Subcommittee on Oversight and Investigations

                        TIM MURPHY, Pennsylvania
                                 Chairman
H. MORGAN GRIFFITH, Virginia         DIANA DeGETTE, Colorado
  Vice Chairman                        Ranking Member
JOE BARTON, Texas                    JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas            KATHY CASTOR, Florida
SUSAN W. BROOKS, Indiana             PAUL TONKO, New York
CHRIS COLLINS, New York              YVETTE D. CLARKE, New York
TIM WALBERG, Michigan                RAUL RUIZ, California
MIMI WALTERS, California             SCOTT H. PETERS, California
RYAN A. COSTELLO, Pennsylvania       FRANK PALLONE, Jr., New Jersey (ex 
EARL L. ``BUDDY'' CARTER, Georgia        officio)
GREG WALDEN, Oregon (ex officio)

                                  (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.................................     4
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     5
    Prepared statement...........................................     7
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     8
    Prepared statement...........................................     9

                               Witnesses

Timothy M. Persons, Ph.D., Chief Scientist, Government 
  Accountability Office..........................................    12
    Prepared statement...........................................    15
    Answers to submitted questions...............................   149
Lyle R. Peterson, M.D., Director, Division of Vector-Borne 
  Diseases, National Center for Emerging and Zoonotic Infectious 
  Diseases, Centers for Disease Control and Prevention...........    30
    Prepared statement...........................................    32
    Answers to submitted questions...............................   154
Luciana Borio, M.D., Acting Chief Scientist, Food and Drug 
  Administration.................................................    41
    Prepared statement...........................................    43
    Answers to submitted questions...............................   163
Anthony S. Fauci, M.D., Director, National Institute of Allergy 
  and Infectious Diseases, National Institutes of Health.........    54
    Prepared statement and slide presentation....................    56
    Answers to submitted questions...............................   167
Rick A. Bright, Ph.D., Director, Biomedical Advanced Research and 
  Development Authority, and Deputy Assistant Secretary, Office 
  of the Assistant Secretary for Preparedness and Response, 
  Department of Health and Human Services........................    77
    Prepared statement...........................................    79
    Answers to submitted questions...............................   172

                           Submitted Material

Subcommittee memorandum..........................................   121
Letter of February 15, 2017, from Ms. Schakowsky, et al., to 
  Robert M. Speer, Acting Secretary of the Army, submitted by Ms. 
  Schakowsky.....................................................   133
Letter of May 10. 2017, from John Bel Edwards, Governor, State of 
  Louisiana, to Robert M. Speer, Acting Secretary of the Army, 
  submitted by Ms. Schakowsky....................................   136
Letter of May 22, 2017, from Adam Gluck, Vice President and Head, 
  U.S. Government Relations, Sanofi, to Mr. Murphy and Ms. 
  DeGette, submitted by Ms. DeGette..............................   138
Article of May 2017, ``Emerging Infectious Diseases in 
  Pregnancy,'' by Richard H. Beigi, Obstetrics & Gynecology, Vol. 
  129, No. 5, submitted by Mr. Burgess...........................   140

 
  U.S. PUBLIC HEALTH RESPONSE TO THE ZIKA VIRUS: CONTINUING CHALLENGES

                              ----------                              


                         TUESDAY, MAY 23, 2017

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:04 a.m., in 
Room 2123, Rayburn House Office Building, Hon. Tim Murphy 
(chairman of the subcommittee) presiding.
    Members present: Representatives Murphy, Griffith, Burgess, 
Brooks, Collins, Barton, Walberg, Walters, Costello, Carter, 
Walden (ex officio), DeGette, Schakowsky, Castor, Tonko, 
Clarke, Ruiz, and Pallone (ex officio).
    Also present: Mr. Bilirakis.
    Staff present: Jennifer Barblan, Chief Counsel, Oversight 
and Investigations; Ray Baum, Staff Director; Elena Brennan, 
Legislative Clerk, Oversight and Investigations; Adam Fromm, 
Director of Outreach and Coalitions; Brittany Havens, 
Professional Staff Member, Oversight and Investigations; Katie 
McKeough, Press Assistant; David Schaub, Detailee, Oversight 
and Investigations; Jennifer Sherman, Press Secretary; Alan 
Slobodin, Chief Investigative Counsel, Oversight and 
Investigations; Sam Spector, Policy Coordinator, Oversight and 
Investigations; Evan Viau, Staff Assistant; Hamlin Wade, 
Special Advisor for External Affairs; Jeff Carroll, Minority 
Staff Director; Waverly Gordon, Minority Counsel, Health; Chris 
Knauer, Minority Oversight Staff Director; Miles Lichtman, 
Minority Policy Analyst; Kevin McAloon, Minority Professional 
Staff Member; Dino Papanastasiou, Minority GAO Detailee; Olivia 
Pham, Minority Health Fellow; and C.J. Young, Minority Press 
Secretary.

   OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Murphy. Good morning, and welcome to our Oversight and 
Investigations Subcommittee hearing on ``U.S. Public Health 
Response to the Zika Virus: Continuing Challenges.''
    Today, the subcommittee continues its examination of the 
Zika virus, and the subcommittee first examined the virus last 
year during the early stages of the outbreak across Central and 
South America.
    As this year's mosquito season is about to begin, the time 
has come to review what has been done and what we have learned 
since then and to examine the challenges that our Federal 
health agencies continue to face. To date, every State in the 
continental United States, minus Alaska, has reported cases of 
the Zika virus, and two States, Florida and Texas, have 
reported cases of locally acquired mosquito-borne transmission.
    As of March 2017, there were 84 countries, territories, or 
subnational areas with evidence of vector-borne Zika virus, and 
13 countries have reported evidence of person-to-person 
transmission of the virus.
    A recent report released by the Centers for Disease Control 
and Prevention, or the CDC, found that 1 in 10 women in the 
United States with a confirmed Zika virus infection during 
pregnancy had a baby with a virus-related birth defect.
    Emerging infectious diseases present unique challenges to 
public health systems here and around the world. When the 
committee held its hearing on Zika last March, much was unknown 
about the virus and its impact on public health. I want to 
commend our public health agencies for the work that they have 
all done. Diagnostic tools were quickly developed and approved 
under Emergency Use Authority, and more are in the pipeline 
now. Multiple vaccine candidates are in development, and much 
research into the virus and its effects have taken place. When 
instances of local transmission occurred in Florida and Texas, 
the CDC acted quickly in tandem with State and local partners 
to contain the spread.
    But despite these efforts, the unknowns of this disease 
still outnumber the knowns. We don't know the actual number of 
infections in the United States. We don't know the long-term 
impact of Zika infection during pregnancy on children born to 
infected mothers. We don't know about the long-term impacts of 
infection on men or on people who exhibit no symptoms of Zika. 
There are difficulties with the diagnostic tests we have in use 
today, and we don't have good information or modeling on how 
the virus will spread this year, let alone beyond that.
    The GAO is here today reporting on its evaluation of the 
U.S. public response to Zika, work commissioned by this 
committee. This is not the first time GAO has done such an 
analysis and response to emerging infectious diseases, and each 
time, GAO has found that HHS was reactive in its response to 
outbreak prevention, preparedness, detection, and response. 
Once again, GAO has shown that we are not fully prepared at the 
outset of the outbreak.
    The GAO evaluated the U.S. public health response to Zika 
in three key areas: one, case definition and an understanding 
of how the disease spreads into community and the factors that 
affect this distribution; two, the development and use of 
diagnostic tools; and, three, methods of mosquito control.
    The GAO findings are sobering. While there have been many 
advances, actions are needed to address major challenges. 
According to the GAO, the lack of standardized Zika case 
definition at the beginning of the outbreak complicated the 
collection of consistent and timely data. The diagnostic tests 
varied in their ability to detect the virus and provide 
accurate results. Manufacturers of diagnostic tests faced 
multiple challenges, including gaining access to FDA-authorized 
tests for comparison use, and the users of the tests could not 
even determine the most accurate diagnostic tests based on the 
information provided.
    And of great concern, the GAO report raises questions about 
CDC's and FDA's disclosure of test information and the 
treatment of CDC's own subject-matter expert, who was removed 
and then reinstated to his position after dissenting over 
concerns about the CDC Zika diagnostic tests provided to labs.
    With regard to State and local mosquito control efforts, 
CDC developed technical guidance and provided funding and 
technical assistance. GAO identified challenges here as well 
for Federal agencies, including the need to effectively 
communicate information about the geographical distribution of 
the mosquito that primarily transmits the Zika virus. Much of 
the money appropriated by Congress last year to respond to Zika 
went to States and localities in the form of grants, and 
effective communication is critical to ensure that our Federal 
tax dollars are spent wising.
    It is clear that we have much to discuss today. We will 
hear from a panel of distinguished Federal witnesses, including 
the Centers for Disease Control and Prevention, the National 
Institutes of Health, the Food and Drug Administration, the 
Biomedical Advanced Research and Development Authority, as well 
as the Government Accountability Office.
    I want to thank all of our witnesses for joining us this 
morning.
    [The prepared statement of Mr. Murphy follows:]

                 Prepared statement of Hon. Tim Murphy

    Today the subcommittee continues its examination of the 
U.S. public health response to the Zika virus. The subcommittee 
first examined the Zika virus last year during the early stages 
of the outbreak across Central and South America. As this 
year's mosquito season is about to begin, the time has come to 
review what has been done-and what we have learned-since then, 
and to examine the challenges that our Federal health agencies 
continue to face.
    To date, every State in the continental United States, 
minus Alaska, has reported cases of the Zika virus, and two 
States--Florida and Texas--have reported cases of locally 
acquired mosquito-borne transmission. As of March 2017, there 
were 84 countries, territories, or subnational areas with 
evidence of vector-borne Zika virus and 13 countries have 
reported evidence of person-to-person transmission of the 
virus. A recent report released by the Centers for Disease 
Control and Prevention (CDC) found that one in ten women in the 
United States with a confirmed Zika virus infection during a 
pregnancy had a baby with a virus-related birth defect.
    Emerging infectious diseases present unique challenges to 
public health systems here and around the world. When the 
committee held its hearing on Zika in March of last year, much 
was unknown about the virus and its impact on public health. I 
want to commend our public health agencies for the work they 
have done. Diagnostic tools were quickly developed and approved 
under Emergency Use Authority, and more are in the pipeline 
now. Multiple vaccine candidates are in development, and much 
research into the virus and its effects have taken place. When 
instances of local transmission occurred in Florida and Texas, 
the CDC acted quickly in tandem with State and local partners 
to contain the spread.
    But despite these efforts, the unknowns of this disease 
still outnumber the knowns. We don't know the actual number of 
infections in the United States. We don't know the long-term 
impact of Zika infection during pregnancy on children born to 
infected mothers. We don't know about the long-term impacts of 
infection on men, or on people who exhibit no symptoms of Zika. 
There are difficulties with the diagnostic tests we have in use 
today. And we don't have good information or modeling on how 
the virus will spread this year, let alone beyond that.
    The GAO is here today reporting on its evaluation of the 
U.S. public health response to Zika-work commissioned by this 
committee. This is not the first time GAO has done such an 
analysis in response to emerging infectious diseases. And each 
time, GAO has found that HHS was reactive in its response to 
outbreak prevention, preparedness, detection, and response. 
Once again, GAO has shown that we were not fully prepared at 
the outset of the outbreak.
    The GAO evaluated the U.S. public health response to Zika 
in three key areas: (1) case-definition and an understanding of 
how the disease spreads into community and the factors that 
affect this distribution; (2) the development and use of 
diagnostic tools; and (3) methods of mosquito control. The GAO 
findings are sobering: while there have been many advances, 
actions are needed to address major challenges.
    According to the GAO, the lack of a standardized Zika case 
definition at the beginning of the outbreak complicated the 
collection of consistent and timely data. The diagnostic tests 
varied in their ability to detect the virus and provide 
accurate test results. Manufacturers of diagnostic tests faced 
multiple challenges including gaining access to FDA-authorized 
tests for comparison use, and users of the tests could not even 
determine the most accurate diagnostic test based on the 
information provided.
    And, of great concern, the GAO report raises questions 
about CDC's and FDA's disclosure of test information and the 
treatment of CDC's own subject matter expert who was removed 
and then reinstated to his position after dissenting over 
concerns about the CDC Zika diagnostic test being provided to 
labs.
    With regard to State and local mosquito control efforts, 
CDC developed technical guidance and provided funding and 
technical assistance. GAO identified challenges here as well 
for Federal agencies, including the need to effectively 
communicate information about the geographical distribution of 
the mosquito that primarily transmits the Zika virus. Much of 
the money appropriated by Congress last year to respond to Zika 
went to States and localities in the form of grants, and 
effective communication is critical to ensure that our Federal 
tax dollars are spent wisely.
    It is clear that we have much to discuss today. We will 
hear from a panel of distinguished Federal witnesses, including 
the Centers of Disease Control and Prevention, the National 
Institutes of Health, the Food and Drug Administration, the 
Biomedical Advanced Research and Development Authority, as well 
as the Government Accountability Office.
    I would like to thank all of our witnesses for joining us 
this morning. I now recognize the ranking member of the 
subcommittee, Ms. DeGette, for a 5-minute opening statement.

    Mr. Murphy. I now recognize the ranking member of this 
subcommittee, Ms. DeGette, for a 5-minute opening statement.

 OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Ms. DeGette. Thank you very much, Mr. Chairman.
    This committee has been examining issues related to disease 
preparedness for more than a decade. We have looked recently at 
preparedness and response capabilities related to Ebola, 
seasonal flu, and pandemic flu, and, of course, now the Zika 
virus.
    As you mentioned, last year, the Zika epidemic spread 
across Brazil, Latin America, and into the U.S. There were more 
than 5,000 Zika cases in the U.S. and over 36,000 in the U.S. 
territories.
    Now, as we continue to face challenges with these epidemics 
and global pandemics, we can't be satisfied with simply 
reacting to each new emergency. Instead, we have to devote 
efforts and resources to ensuring that we're prepared before 
the next threat occurs. Oftentimes, we don't even know where 
those will come from.
    We need to do more at the Federal and State levels to 
combat emerging infectious diseases. As I pointed out over a 
year ago, the bipartisan Blue Ribbon Study Panel on Biodefense 
concluded that the U.S. is underprepared for bioincidents, 
whether they're deliberate attacks or naturally occurring 
events. This is still a problem, despite our assiduous 
attention to it. For example, just this month, members of this 
subcommittee released a comprehensive GAO report on avian flu. 
That audit uncovered shortcomings in our preparedness and 
raised key questions about our ability to rapidly respond to 
future outbreaks. GAO found that, while we can impose 
biosecurity measures after an emergency hits, our preparation 
is limited to voluntary actions, which are too often 
ineffective.
    Today, we're going to hear again from the GAO, but this 
time on how our disease-fighting agencies are addressing the 
ongoing Zika threat and the remaining challenges. So, even 
though we're working on getting there, we're still not where we 
need to be when it comes to disease preparedness and emerging 
infectious threats.
    I'm looking forward to hearing from all of the witnesses 
today about how we can improve processes in response to the 
GAO's recommendation.
    I want to talk about another area, which is funding, and I 
know with the release of the President's budget today, 
everybody is concerned about funding. I'm really concerned 
about whether agencies have adequate funding to prepare and 
respond to a potential outbreak. We're fortunate to have 
premier public health agencies overseeing these efforts, but if 
their hands are tied with funding, those agencies can't do 
their work.
    Last year, Congress made available $1.1 billion to fight 
Zika, but key agencies received far less money than they 
requested. In the end, agencies like the CDC had to reprogram 
funds to respond to this unfolding threat, diverting the 
funding from other top priorities.
    This year, as I said, President Trump has proposed slashing 
HHS' budget and making deep cuts to public health agencies like 
the CDC or the NIH. This is so counterproductive. Now is not 
the time to make draconian threats--cuts to the agencies 
charged with stopping Zika or any other health crisis. Although 
we don't know what funds the administration will need to 
address the Zika threat for 2017, I don't have any reason to 
believe that they're going to need less than last year.
    So I intend to ask the panelists whether they think that 
we're adequately resourced to go into the 2017 mosquito season. 
We don't want to find ourselves in the middle of this summer 
scrambling to cobble together another emergency supplemental.
    And, finally, I want to welcome Dr. Petersen from Fort 
Collins here today. Dr. Petersen is the Director of the 
Division of Vector-borne Diseases, and that agency is in Fort 
Collins, Colorado. I went up and visited the facilities, Mr. 
Chairman, last year, and thanks to the efforts of former 
Congressman Bob Schaffer and myself, we were able to get new 
state-of-the-art facilities up there a few years ago. They're 
doing remarkable research, and I just want to thank you for 
adding your intelligence and your perspective today. And I also 
want to welcome all of our witnesses, of course.
    And, with that, Mr. Chairman, I will yield back.
    Mr. Murphy. Thank you.
    The gentlelady yields back, and I will recognize the 
chairman of the full committee for a 5-minute opening 
statement.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. I thank the chairman.
    Thank you for holding this timely hearing on U.S. public 
health response to the Zika virus. I want thank all of our 
witnesses for being here today and for providing us with your 
testimony.
    For well over a year, our bipartisan committee staff have 
been working diligently to examine our public health 
preparedness for Zika and other emerging infectious diseases. 
This is our second hearing since the outbreak of this virus.
    First, I want to commend the agencies that are appearing 
before us today. Each agency has undertaken a huge effort to 
increase our knowledge of the virus, to develop diagnostic 
tests and vaccine candidates quickly, and to educate our 
communities about how to respond to this virus and the mosquito 
that carries it.
    I also want to commend the State and local entities that 
are working hard to treat those impacted by Zika and to reduce 
the population of Zika-carrying mosquitoes. While much progress 
has been made over the past year, the GAO released a report 
today showing our understanding and preparedness to combat this 
virus and other biological threats still face significant 
challenges. Particularly as we head into the summer months, we 
must do better.
    Though the FDA has authorized two different types of 
diagnostic tests under the Emergency Use Authorizations, 
there's still no commercially available diagnostic tests on the 
market for the detection of the Zika virus. Currently, there 
are no specific therapies or vaccines approved by the FDA to 
prevent or treat the virus. Perhaps most concerning is we still 
don't know the full spectrum of health consequences associated 
with mother-to-child transmission, nor do we know what the 
short-term and long-term outcomes are for those who contract 
the virus with or without clinical symptoms.
    We also continue to face significant issues in supporting 
mosquito control efforts and our ability to accurately model 
and predict the spread of viruses geographically. The number 
and implication of unknowns is frankly a bit alarming. It begs 
the question, how prepared are we for the next outbreak? Zika 
is not the only biological threat that we face today. As our 
society becomes increasingly global and world travel becomes 
easier, more efficient, and more frequent, the risk of 
spreading disease through human contact will increase rapidly.
    Sadly, emerging infectious diseases, including Zika, Ebola, 
yellow fever, dengue, pandemic influenza, and others, perhaps 
many more that have yet to even be discovered threaten our 
human and bioterrorism defenses every day. The slides made 
famous on national television by our witness, Dr. Anthony 
Fauci, dramatizes the change from 30 years ago with just HIV as 
a global example of emerging infectious disease to a recent 
slide showing more than 40 examples.
    Last year, the subcommittee held a hearing on the report of 
the Blue Ribbon Study Panel on Biodefense. It presented several 
concerns and expert recommendations to improve U.S. biodefense. 
The experts on the panel made it quite clear we need to stop 
thinking of disease preparedness and response as occasional 
episodic events, a reactive approach that's left us constantly 
lagging in our response efforts. Instead, we must shift our 
mindsets and strategies toward a broader, more comprehensive, 
and proactive approach, one that considers the larger context 
of our preparedness for future infectious diseases and 
outbreaks.
    Federal witnesses testifying before us this morning are 
uniquely positioned to help aid in our efforts, and I thank you 
all for appearing before the subcommittee.
    [The prepared statement of Mr. Walden follows:]

                 Prepared statement of Hon. Greg Walden

    Mr. Chairman, thank you for holding this very timely 
hearing on the U.S. public health response to the Zika virus.
    For well over a year our bipartisan committee staff has 
been working diligently to examine our public health 
preparedness for Zika and other emerging infectious diseases. 
This is our second hearing since the outbreak of the virus.
    First, I want to commend the agencies that are appearing 
before us today. Each agency has undertaken a huge effort to 
increase our knowledge of the virus, to develop diagnostic 
tests and vaccine candidates quickly, and to educate our 
communities about how to respond to this virus and the mosquito 
that carries it. I also want to commend the State and local 
entities that are working hard to treat those impacted by Zika, 
and to reduce the population of Zika-carrying mosquitoes.
    While much progress has been made over the past year, the 
GAO report released today shows our understanding and 
preparedness to combat this virus--and other biological 
threats--still faces significant challenges. Particularly as we 
head into the summer months, we must do better.
    Though the FDA has authorized two different types of 
diagnostic tests under Emergency Use Authorizations, there are 
still no commercially available diagnostic tests on the market 
for the detection of the Zika virus. Currently, there are no 
specific therapies or vaccines approved by the FDA to prevent 
or treat the virus.
    Perhaps most concerning is that we still don't know the 
full spectrum of health consequences associated with mother-to-
child transmission. Nor do we know what the short-term and 
long-term outcomes are for those who contract the virus, with 
or without clinical symptoms. We also continue to face 
significant issues in supporting mosquito control efforts and 
our ability to accurately model and predict the spread of 
viruses geographically.
    The number and implication of unknowns is alarming. It begs 
the question: How prepared are we for the next outbreak?
    Zika isn't the only biological threat that we face today. 
As our society becomes increasingly global and world travel 
becomes easier, more efficient, and more frequent, the risk of 
spreading disease through human contact will increase rapidly. 
Sadly, emerging infectious diseases including Zika, Ebola, 
yellow fever, Dengue, Chikungunya, pandemic influenza--and 
perhaps many more that have yet to be discovered--threaten our 
human and bioterrorism defenses every day. The slides made 
famous on national television by one of our witnesses, Dr. 
Anthony Fauci, dramatizes the change from 30 years ago with 
just HIV as the global example of emerging infectious disease 
to a recent slide showing more than 40 examples.
    Last year, this subcommittee held a hearing on the report 
of the Blue Ribbon Study Panel on Biodefense, which presented 
several concerns and expert recommendations to improve U.S. 
biodefense. The experts on the panel made it quite clear that 
we need to stop thinking of disease preparedness and response 
as occasional, episodic events--a reactive approach that has 
left us constantly lagging in our response efforts. Instead, we 
must shift our mindsets and strategies towards a broader, more 
comprehensive, and proactive approach--one that considers the 
larger context of our preparedness for future infectious 
diseases and outbreaks.
    The Federal witnesses testifying before us this morning are 
uniquely positioned to help aide us in these efforts, and I 
thank them for appearing before the subcommittee this morning.

    Mr. Walden. And I yield the balance of my time to the 
chairman of the Health Subcommittee, Dr. Burgess.
    Mr. Burgess. Thank you, Mr. Chairman. Thank you for 
yielding.
    So, to paraphrase the Rolling Stones, summer is here, and 
the time is right for fighting vectors in the street. I want to 
thank our panelists for being here today. Some new faces, and 
that will be good to get to know you a little bit better, and 
some people that we have talked with many times before.
    And, Dr. Fauci, just thinking back to the 108th Congress, 
we talked about SARS, we talked about avian flu, we talked 
about swine flu, we talked about Ebola, and we talked about 
Zika. And every one of those illnesses, of course, has a 
particular impact upon women and pregnancy, and that has 
certainly been--and I appreciate the focus that you have put on 
that during the times that we have had the privilege of having 
you before our subcommittee.
    So I want to welcome our witnesses. Look forward to what 
your testimony is going to be today.
    And, Mr. Chairman, I yield back.
    Mr. Murphy. With that then----
    Ms. DeGette. Will the gentleman yield? It is not the 
Rolling Stones. It is Bruce Springsteen.
    Mr. Murphy. The record will stand corrected.
    Mr. Burgess. No, no, no correction of the record. I will 
put my iTunes against yours.
    Mr. Murphy. Thank you. Well, we reached a new level for 
this hearing. The gentleman yields back.
    I recognize Mr. Pallone for 5 minutes.
    Mr. Pallone. I won't comment because I don't know.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Thank you, Mr. Chairman, and thank you to all our witnesses 
for joining us this morning to discuss the Federal Government's 
preparations for the 2017 Zika season. I look forward to 
hearing from our panelists today about how they believe the 
Zika virus will spread in 2017, what they anticipate the 
upcoming mosquito season will look like, what challenges 
remain, and what additional resources they need to do their 
job.
    In March of 2016, the committee held a hearing to examine 
the Federal Government's response to the spreading Zika threat. 
Since then, we have learned a great deal more about this virus. 
For example, scientific consensus now indicates that Zika 
infections in mothers during pregnancy can cause microcephaly 
in newborns, a severe birth defect of the brain.
    As we'll hear from GAO today, although CDC and FDA took 
steps to respond to the unique challenges posed by the Zika 
outbreak last year, there remains room for improvement. This is 
particularly true regarding our ability to predict the spread 
of Zika, to better coordinate and control mosquito populations 
at the local level, and to more rapidly develop diagnostic 
tests for detecting Zika infection.
    These steps to improve preparedness should also go hand-in-
hand with strengthening our healthcare programs. We must ensure 
that individuals affected by Zika, particularly pregnant women 
and children born with microcephaly, have access to ongoing 
screening and health services.
    An integral part of that effort is the Medicaid program. 
Medicaid provides contraceptive services that help prevent Zika 
infection and diagnostic services to detect infection. Medicaid 
is also a vital source of care for children born with special 
healthcare needs like microcephaly.
    Today, Medicaid covers one in three children in the United 
States. The President's budget is expected within the hour, and 
there are reports that he plans to propose slashing Medicaid by 
over $800 billion, and this would decimate the Medicaid program 
and endanger our ability to manage public health emergencies 
like Zika.
    I also remain concerned about the status of Medicaid 
funding in Puerto Rico. As everyone in this room understands, 
Zika has wreaked havoc upon Puerto Rico, yet as we head into 
the 2017 mosquito season, funding for Puerto Rico's Medicaid 
program through the Affordable Care Act is on track to be 
exhausted as early as this October. And despite the $295 
million allocated for Medicaid funding in Puerto Rico as part 
of the recent continuing resolution, up to 900,000 people 
remain at risk of losing their health coverage at the end of 
this year.
    So, in short, a strong public health infrastructure is also 
one of the best tools to fight epidemics, and Medicaid is an 
essential component in protecting us from threats such as Zika. 
Fighting Zika will not be easy, but the first step should be to 
maintain critical health services for those who may be affected 
and provide agencies with the resources they will need to 
respond to an outbreak.
    Now I'm concerned about recent reports that nearly 700 
positions at CDC are vacant because of the ongoing hiring 
freeze and that Federal support to States for Zika response may 
be discontinued. That's why Democratic members of this 
committee sent a letter to CDC last week asking whether the 
agency has sufficient funding to prepare and respond to Zika 
this year. It is critical that we give these agencies the tools 
they need to bolster our preparedness.
    So let me conclude by saying thank you to the agencies 
before us today who work on a daily basis to fight this 
disease. I don't think anybody else wants to--you would like 
to? I yield the balance of my time to the gentlewoman from 
Florida.
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Thank you, Mr. Chairman, and thank you to all our witnesses 
for joining us this morning to discuss the Federal Government's 
preparations for the 2017 Zika season.
    I look forward to hearing from our panelists today about 
how they believe the Zika virus will spread in 2017, what they 
anticipate the upcoming mosquito season will look like, what 
challenges remain, and what additional resources they need to 
do their job.
    In March of 2016, this committee held a hearing to examine 
the Federal Government's response to the spreading Zika threat. 
Since then, we have learned a great deal more about this virus. 
For example, scientific consensus now indicates that Zika 
infection in mothers during pregnancy can cause microcephaly in 
newborns, a severe birth defect of the brain.
    As we will hear from GAO today, although CDC and FDA took 
steps to respond to the unique challenges posed by the Zika 
outbreak last year, there remains room for improvement. This is 
particularly true regarding our ability to predict the spread 
of Zika, to better coordinate and control mosquito populations 
at the local level, and to more rapidly develop diagnostic 
tests for detecting Zika infection.
    These steps to improve preparedness should also go hand-in-
hand with strengthening our health care programs. We must 
ensure that individuals affected by Zika, particularly pregnant 
women and children born with microcephaly, have access to 
ongoing screening and health services.
    An integral part of that effort is the Medicaid program. 
Medicaid provides contraceptive services to help prevent Zika 
infection, and diagnostic services to detect infection. 
Medicaid is also a vital source of care for children born with 
special health care needs, like microcephaly. Today, Medicaid 
covers 1 in 3 children in the United States.
    The President's budget is expected within the hour, and 
there are reports that he plans to propose slashing Medicaid by 
over $800 billion. This would decimate the Medicaid program and 
endanger our ability to manage public health emergencies like 
Zika.
    I also remain concerned about the status of Medicaid 
funding in Puerto Rico. As everyone in this room understands, 
Zika has wreaked havoc upon Puerto Rico. Yet, as we head into 
the 2017 mosquito season, funding for Puerto Rico's Medicaid 
program through the Affordable Care Act is on track to be 
exhausted as early as this October.
    And despite the $295 million allocated for Medicaid funding 
in Puerto Rico as part of the recent Continuing Resolution, up 
to 900,000 people remain at risk of losing their health 
coverage at the end of this year.
    In short, a strong public health infrastructure is often 
one of the best tools to fight epidemics, and Medicaid is an 
essential component in protecting us from threats such as Zika. 
Fighting Zika will not be easy, but the first step should be to 
maintain critical health services for those who may be affected 
and provide agencies with the resources they will need to 
respond to an outbreak.
    I'm concerned about recent reports that nearly 700 
positions at CDC are vacant because of the ongoing hiring 
freeze, and that Federal support to States for Zika response 
may be discontinued. That is why Democratic members of this 
committee sent a letter to CDC last week asking whether the 
agency has sufficient funding to prepare and respond to Zika 
this year. It is critical that we give these agencies the tools 
they need to bolster our preparedness.
    Let me conclude by saying thank you to the agencies before 
us today who work on a daily basis to fight this disease.
    Thank you, and I yield back.

    Ms. Castor. Thank you, Mr. Pallone, for yielding the time.
    I'm very concerned for families all across American and 
particularly in the State of Florida and Puerto Rico because 
the birth defects related to the Zika virus are so severe and 
costly and because America's emergency public health response 
to Zika is at risk right now. After the Congress provided a 
billion dollars last year, we ramped up an emergency public 
health response that included our local communities, States, 
extensive surveillance, mosquito control, laboratories, 
development of vaccines, but as we stand now, there are too 
many unanswered questions about transmission of Zika and the 
medical consequences. Our families are at risk because of that.
    They're also at risk because we're facing a funding cliff 
for the Zika emergency response. What is the most important in 
a public health emergency response is you have consistency. And 
right now, all of the agencies in local communities and States 
are looking at this cliff that's going to come to the end over 
the next few weeks, definitely by September.
    I see great risk because of the hiring freeze that the 
Trump administration put into place that is now keeping public 
health professionals off the job at CDC and NIH and other 
important agencies. And then, with the budget that comes out 
today, we're going to have to deal with this overarching desire 
by the Trump administration to pull the rug out from under 
families because they're going to target cuts to medical 
research and the Centers for Disease Control all at the time 
where they say we're going to give big tax cuts to billionaires 
who will have all the resources in the world to deal with a 
Zika diagnosis in their family, but meanwhile, families across 
America will be left with very serious consequences.
    So this committee needs to develop a plan of action in the 
coming weeks, and hopefully the expert advice from this panel 
will help guide us there. Thank you very much.
    Mr. Murphy. The gentlelady's time is expired.
    At this point, I just want to say that I ask unanimous 
consent that the Members' written opening statements be 
introduced into the record and, without objection, the 
documents be entered into the record.
    I now would like to introduce our panel of Federal 
witnesses for today's hearing: Dr. Timothy Persons, Chief 
Scientist, U.S. Government Accountability Office; Dr. Lyle 
Petersen, Director, Division of Vector-Borne Diseases, National 
Center for Emerging and Zoonotic Infectious Diseases, Centers 
for Disease Control and Prevention; Dr. Luciana Borio, Acting 
Chief Scientist, U.S. Food and Drug Administration; Dr. Anthony 
Fauci, Director of the National Institute of Allergy and 
Infectious Diseases, National Institutes of Health; and Dr. 
Rick Bright, Director of Biomedical Advanced Research and 
Development Authority and Deputy Assistant Secretary for 
Preparedness and Response, U.S. Department of Health and Human 
Services. Thank you all for being here today and providing 
testimony.
    We look forward to a very productive discussion and how we 
can better prepare for and respond not only to Zika virus but 
to all the emerging infectious diseases and biological threats 
to our Nation.
    You are aware this committee is holding an investigative 
hearing and, when doing so, has a practice of taking testimony 
under oath. Do any of you have any objections to giving 
testimony under oath?
    Seeing none, 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?
    No one has indicated that. Then, in that case, will you 
please rise, raise your right hand, and I will swear you in.
    [Witnesses sworn.]
    Mr. Murphy. Thank you. You may all be seated.
    Seeing that all have answered in the affirmative, you are 
now under oath and subject to the penalties set forth in title 
18 under section 1001 of the United States Code. We'll ask you 
each to give a 5-minute summary of your written statement. 
Please pay attention to the light there.
    Dr. Persons, you are recognized first for 5 minutes.

   STATEMENTS OF TIMOTHY M. PERSONS, PH.D., CHIEF SCIENTIST, 
   GOVERNMENT ACCOUNTABILITY OFFICE; LYLE R. PETERSEN, M.D., 
 DIRECTOR, DIVISION OF VECTOR-BORNE DISEASES, NATIONAL CENTER 
  FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES, CENTERS FOR 
  DISEASE CONTROL AND PREVENTION; LUCIANA BORIO, M.D., ACTING 
   CHIEF SCIENTIST, FOOD AND DRUG ADMINISTRATION; ANTHONY S. 
   FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND 
INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH; AND RICK A. 
   BRIGHT, PH.D., DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND 
 DEVELOPMENT AUTHORITY, AND DEPUTY ASSISTANT SECRETARY, OFFICE 
   OF THE ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES

                STATEMENT OF TIMOTHY M. PERSONS

    Dr. Persons. Thank you, Mr. Chairman. Good morning and good 
morning, Ranking Member DeGette and members of the 
subcommittee. Thank you for the opportunity to discuss our work 
on the Federal response to Zika virus disease outbreaks with 
particular focus on epidemiology, diagnostic tests, and 
mosquito control. As this committee has pointed out even this 
morning, emerging infectious diseases, such as Zika virus 
disease, are an ongoing threat to the health and livelihoods of 
people and animals worldwide.
    Despite many advances in medical research and treatments 
during the past century, infectious diseases are still a 
leading cause of death. Over the past few decades, several 
emerging infectious diseases have similarly taken the global 
community by surprise, including H1N1 influenza, Ebola, and 
Zika, among others.
    In each case, the Department of Health and Human Services, 
though diligent in its work to address rapidly emerging 
threats, was nonetheless reactive in some respects, such as 
outbreak prevention, preparedness, detection, and response. 
Although HHS has key agencies working on various important 
aspects of this problem, currently no one person or agency is 
in charge of making sure the U.S. is ready for the next 
outbreak of an emerging infectious disease.
    The Zika virus attracted attention from health officials 
here and abroad after causal links were suspected between 
increases in reported cases of Zika virus infection and 
reported cases of microcephaly in newborns and other 
neurological disorders in Brazil in 2015.
    An effective response to an emerging infectious disease 
like Zika involves the establishment of a case definition, 
gaining an understanding of the disease's spread into the 
population, rapidly developing and deploying reliable 
diagnostic tools at the beginning of the outbreak, and, when 
the disease is vector-borne as Zika is, effective methods of 
mosquito control.
    While recent Zika virus disease outbreaks have yielded new 
insights, several key unknowns remain, including the total 
number of infections, various biological mechanisms and risk 
factors, and the full spectrum of short- and long-term outcomes 
of Zika virus infection, among others.
    We also identify two key challenges for Zika virus 
epidemiological research. One is the time and resources needed 
to better understand the short- and long-term effects of Zika 
virus disease, and the other is an insufficiency of data and a 
lack of computer models for predicting the spread of Zika 
virus. Moreover, at the beginning of the U.S. outbreak, there 
was no U.S. medical case definition, despite there being 
candidates from other affected countries.
    Even though the U.S. had known about and was conducting 
surveillance on Zika virus disease outbreaks, including those 
in U.S. territories, no accurate and reliable diagnostic tools 
had been authorized. The FDA had authorized over 15 diagnostic 
tests for the Zika virus under the Emergency Use Authorization 
process following the public health emergency declaration.
    Manufacturers of diagnostic tests face several challenges, 
including lack of knowledge of key scientific aspects of the 
virus, difficulty in accessing well-characterized clinical 
samples, getting access to EUA samples to use for comparison, 
gaining cooperation with international entities, and according 
to some, a lack of effective communication from the FDA.
    One major issue users face with these diagnostic tests is 
that it was not possible for them to easily compare the tests 
based on information on the product insert. Users of the tests 
also identified challenges that included, for example, 
complying with a test EUA label specifying certain equipment 
required to perform the test and determining the most accurate 
test, in part because of the challenges comparing performance 
characteristics reported in the EUA labels.
    Turning to mosquito-control efforts, the Federal Government 
has a limited and indirect role in supporting them since they 
were implemented at the State and local levels. CDC developed 
technical guidance and provided funding and technical 
assistance to support State and local mosquito-control 
activities but does not serve, nor does any other agency serve, 
as a central coordinator for mosquito control nationwide.
    We identify four challenges the Federal Government faced in 
supporting these mosquito-control efforts during the Zika virus 
outbreaks. One is the timing and availability of the funds, 
including the sustaining of expertise throughout the year. 
Second is the limited communication about the actual 
distribution of mosquitoes. Third is linking the effects of 
mosquito control to disease outcomes. And fourth is having 
limited information about mosquito-control entities themselves.
    In short, our report indicates that there's still work to 
be done to better coordinate and more effectively implement 
mosquito control nationwide. In conclusion, HHS has led the way 
in making progress in our understanding of the Zika virus 
disease, but several challenges remain. Although the EUA 
process is aimed at getting the diagnostic tests out quickly in 
emergency situations, it is equally important to clinical users 
that the authorized tests be compared to one another with 
respect to key performance characteristics. That will allow 
them to determine which is the most appropriate.
    We have identified several areas where improvements can be 
made and have made five recommendations. HHS agreed with four, 
partially concurred with the fifth, and provided clarifying 
information. In response to our recommendation to include 
information on CDC-developed tests distributed to public health 
laboratories, HHS agreed that it should share information on 
such tests that have received EUA. However, HHS did not agree 
with our recommendation that it should share information on 
CDC's lab-developed tests that have not received EUA because 
CDC is unable to provide detailed information on the 
characteristics of these unstandardized tests.
    Mr. Murphy. Dr. Persons, we are way over time. Do you have 
a final thought?
    Dr. Persons. Yes, sir. We maintain that sharing information 
about the lab-developed tests that are used for comparison is 
important because it could help other diagnostic test users 
about which tests to adopt or recommend.
    Chairman Murphy, Ranking Member DeGette, and members of the 
subcommittee, this concludes my prepared statement. Thank you 
for your sustained attention on this issue, and I would like to 
thank the GAO team who made this testimony possible. I'll be 
happy to answer your questions.
    [The prepared statement of Dr. Persons follows:]
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    Mr. Murphy. Thank you.
    Dr. Petersen, you're recognized for 5 minutes.

                 STATEMENT OF LYLE R. PETERSEN

    Dr. Petersen. Thank you, Chairman Murphy, Ranking Member 
DeGette, and members of the subcommittee, for the opportunity 
to discuss CDC's response to the Zika virus outbreak. I'm Dr. 
Lyle Petersen, Director of the Division of Vector-Borne 
Diseases in CDC's National Center for Emerging and Zoonotic 
Infectious Diseases. I also had the opportunity to serve as 
CDC's Zika response incident manager throughout most of 2016, 
and I would like to make three key points to start.
    First, it has been almost 17 months since CDC activated its 
emergency operation center for Zika, and it is clear that this 
outbreak has resulted in CDC's most complex emergency response 
to date.
    Second, we have accomplished a great deal very rapidly, in 
large part due to support in supplemental funding from 
Congress. However, we still have much to learn, and much 
remains to be done.
    Third, Zika remains a significant threat today, 
particularly to pregnant women and their infants. We need to 
remain ready for Zika and for mosquito-borne diseases in 
general as we expect more to emerge in the upcoming years.
    Looking at the response to date, we have learned a 
tremendous amount about a little known virus in a very short 
amount of time. First, we confirmed the link between Zika virus 
infection during pregnancy and severe birth defects, including 
microcephaly. Along with State and local territorial partners, 
we have begun to quantify the risk of birth defects, which we 
now know affects about 10 percent of fetuses exposed to Zika. 
We also discovered that Zika can be sexually transmitted, and 
we also have better information about the geographic range of 
mosquitoes that can spread Zika.
    The support efforts on the ground: CDC has provided $251 
million in Zika-specific funding to State, local, and 
territorial health departments, as well as ongoing CDC 
technical assistance.
    I want to briefly turn to one of the most challenging 
aspects of the response: diagnostic testing for Zika. Because 
Zika's impact on pregnancies can be devastating, CDC has 
recommended testing for all pregnant women who live in or have 
traveled to an area at risk for Zika. When the emergency 
response began in January 2016, women did not have access to 
even one Zika test authorized for clinical use. However, by 
March 2016, Emergency Use Authorizations were in place for two 
CDC-developed tests, allowing for distribution of these testing 
resources to State laboratories while also sharing information 
with manufacturers that were developing their own tests. CDC 
remains committed to improving Zika diagnostics, so that 
they're faster and more accurate, and will continue to share 
information with public health and commercial laboratories as 
it becomes available.
    So, as we approach summer, it is impossible to predict with 
certainty what we will see in the way of local transmission of 
Zika. However, we anticipate that the Zika virus will continue 
to circulate indefinitely in most regions in the Americas where 
it has been introduced. We will undoubtedly continue to see 
pregnant women test positive for Zika virus in both States and 
U.S. territories.
    We expect fewer Zika cases this year in some areas outside 
of the 50 States, such as Puerto Rico, simply because a 
significant proportion of the population was infected in 2016 
and is no longer susceptible to infection.
    Within the continental United States, local outbreaks 
remain possible, such as those seen in this past year in 
Florida and Texas. Any local outbreaks will, of course, be of 
deep concern, and we must be prepared for different scenarios, 
including more extensive transmission.
    Finally, we have learned to expect the unexpected when it 
comes to Zika. So it is critical to remain vigilant and sustain 
our response efforts.
    So, in closing, CDC, our sister agencies within HHS, and 
our partners have accomplished much, but we continue to face 
numerous challenges. One major challenge is to continue 
learning as much as we can about Zika. We know of the most 
devastating effect of microcephaly, but we need to follow the 
development of these babies to understand the full spectrum of 
long-term effects.
    Also, we can expect Zika to circulate for many years. So we 
must be prepared to scale up Zika prevention efforts at any 
time. Even after a Zika vaccine becomes available, other Zika 
prevention efforts, including surveillance and mosquito 
control, will be required.
    Lastly, the emergence of mosquito-borne diseases is 
accelerating. So we must address the threat of vector-borne 
diseases systematically and continually, rather than 
episodically and sporadically.
    Thank you again for the opportunity to appear before you 
today.
    [The prepared statement of Dr. Petersen follows:]
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    Mr. Murphy. Thank you, Dr. Petersen.
    Dr. Borio, you're recognized for 5 minutes.

                   STATEMENT OF LUCIANA BORIO

    Dr. Borio. Good morning, Chairman Murphy, Ranking Member 
DeGette, and members of the subcommittee. I greatly appreciate 
the opportunity to be here today and tell you about FDA's 
ongoing actions to respond to the Zika virus outbreak.
    FDA plays a central role in the Nation's response to public 
health emergencies. In addition to responding to Zika, our 
teams are fully engaged in responding to the H7N9 influenza 
virus that has emerged in China and the most recent outbreak of 
Ebola in the DRC.
    Since the 2009 influenza pandemic, multidisciplinary teams 
have worked collaboratively across the agency to respond to a 
number of public health crises. They bring vision, experience, 
and expertise to their work at hand, which, backed by FDA's 
flexible regulatory framework, allows for us to make important 
contributions to global health security. So today I'm here to 
assure you that FDA remains fully engaged with our partners to 
help minimize the impact of Zika virus.
    We are focused on four work streams: supporting the 
expedited development and availability of diagnostic tests, 
investigational vaccines, and therapies; working to advance 
innovative strategies for vector control; keeping the Nation's 
blood supply safe; and protecting the public from fraudulent 
products. And let me tell you more about some of these efforts.
    At the start of this outbreak, there were no clinical 
diagnostic tests for Zika available for use. We have worked 
urgently with our colleagues at the CDC to make Zika tests 
rapidly available. In February and March of 2016, FDA 
authorized the use of two CDC-developed tests under our 
Emergency Use Authorities. We also immediately began working 
interactively with interested commercial manufacturers. We 
granted an EUA for the first commercial test in April of 2016.
    FDA has taken several proactive steps to help advance the 
development and availability of Zika tests. We developed and 
made available to developers fillable forms that lay out the 
data requirements for an EUA. Our scientists generated 
reference materials to help developers assess the analytical 
performance of their molecular diagnostic tests. And our 
scientists in collaboration with both establishments are 
developing reference materials to help developers of 
serological tests.
    There's some very complex scientific challenges associated 
with developing Zika diagnostic tests, as you heard from Dr. 
Petersen. This is especially true for serological tests 
designed to detect the presence of antibodies to Zika due to 
issues of cross-reactivity with other flaviviruses like dengue 
and yellow fever. FDA continues to work interactively with 
dozens of developers as they try to overcome these challenges.
    FDA has held more than 15 face-to-face meetings, 150 
teleconferences, and more than 3,500 written exchanges with 
developers to help guide their programs. This highly 
interactive approach has been extremely successful. To date, we 
have authorized the use of 16 diagnostic tests for Zika. And 
even after an EUA is issued, FDA and developers continue to 
work interactively to optimize the authorized tests. We have 
issued 21 amendments to EUAs designed to improve product 
performance, and thanks to these efforts, a broad range of Zika 
tests with a broad range of performance are now available in 
laboratories throughout the U.S.
    As you heard from my colleague, Dr. Petersen, CDC projects 
that Zika will become established in the Americas, posing a 
continuing threat, especially to pregnant women. One of our 
highest priorities is to facilitate the development and 
availability of an effective vaccine. We are working closely 
with the NIH, BARDA, and the private sector on this, and 
there's reason for optimism, with several vaccine's candidates 
progressing at a rapidly expedited pace.
    In addition, FDA continues to work with blood collection 
establishments to protect the safety of the blood supply. In 
August of 2016, after careful consideration of the evolving 
scientific and epidemiological data, we issued guidance 
recommending that all States and U.S. territories screen blood 
with an investigational screening test.
    We are very appreciative of blood collection 
establishments' efforts to implement universal screening for 
Zika across the U.S. in a timely fashion. To date, the 
screening has been prevented nearly 400 infected donations from 
entering the blood supply.
    The FDA remains fully committed to sustaining our deep 
engagement and aggressive activities to support a robust 
response to Zika.
    In closing, I would like to recognize and thank the more 
than 500 staff members at the FDA who approached this work with 
incredible dedication, innovation, and expediency. Thank you, 
and I'm happy to answer your questions later.
    [The prepared statement of Dr. Borio follows:]
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    Mr. Murphy. Thank you, Dr. Borio.
    Dr. Fauci you're recognized for 5 minutes.

                 STATEMENT OF ANTHONY S. FAUCI

    Dr. Fauci. Mr. Chairman, Ranking Member DeGette, Vice 
Chairman Griffith, members of the committee, thank you for 
giving me the opportunity to present to you today in a few 
minutes the role of the NIH research endeavor in addressing the 
Zika outbreak. I have some visuals that I'll show if we can get 
them up.
    As you know, I have testified about Zika before this 
committee before, and what I outlined for you was that the 
NIH's responsibility ranges from the fundamental basic 
research, clinical research, expansion of research capacity 
with the ultimate goal in mind to develop the countermeasures 
that we have been discussing thus far in the form of 
diagnostics, therapeutics, and vaccines.
    With regard to diagnostics, the CDC, as you had mentioned 
and that Dr. Petersen responded, is primarily responsible for 
on-the-ground development rapidly of diagnostics that could 
address this outbreak. However, the NIH's role in that is to 
try and develop a pipeline of rapid, specific, low-cost 
diagnostic tools that are delineated on this slide.
    [Slide shown.]
    They're divided into a few subgroups. The first are 
molecular tests to detect the presence of the virus itself in a 
highly sensitive and specific manner. The second are 
serological tests, which are the most problematic, namely to 
detect the immune response of someone who has already been 
infected and to distinguish that immune response to infections 
to other flaviviruses, such as dengue. And, third, research 
resources, namely to make reagents and viral strains available 
to our collaborators throughout the world.
    [Slide shown.]
    In addition, we're responsible for clinical research. I 
will give you one example of that, and that has to do with the 
Zika in Infants and Pregnancy, or ZIP, study in which we are 
performing in collaboration with the Fiocruz Institute in 
Brazil.
    [Slide shown.]
    It is a prospective cohort study observational of 10,000 
pregnant women, following them for the incidence of Zika 
infection, following their pregnancies to determine the 
incidence of involvement of the fetus with congenital 
abnormalities, and then following birth to follow the infants 
for at least 1 year of age.
    [Slide shown.]
    However, probably the most important and impactful of what 
we do is the development of a vaccine.
    [Slide shown.]
    Now, this slide shows five candidate vaccines that are in 
various levels of development for Zika. The first one that is 
on the slide is the DNA vaccine. I want to caution the 
committee that just because something is temporally ahead of 
something else in development doesn't necessarily mean it is 
going to ultimately turn out to be the best vaccine. But we 
have been fortunate because we have been able to rapidly put 
several of these into trial, and I want to just mention one of 
these for the purposes of the discussion this morning. And that 
is the DNA vaccine.
    [Slide shown.]
    This is a vaccine that is a 21st century version of 
vaccinology; namely, we no longer isolate the virus, grow it 
and activate it or attenuate it, but we use molecular 
biological techniques.
    On this slide is shown how a DNA vaccine works. You get a 
circular piece of DNA, which is referred to as a plasmid. You 
insert a gene of a particular protein that you want to make an 
immune response to, and you then inject that into an 
individual, and then what happens is that, in response, a 
virus-like particle is formed, and the body makes a good immune 
response.
    [Slide shown.]
    On March 2nd of 2016, I testified before this committee 
that we were still in animal model, and I said that we would 
get into a human phase 1 trial very likely by the fall of 2016. 
And, in fact, we did in September and then again in December, 
showing that the vaccine was safe, and it induced the kind of 
response that you would at least predict would be protective.
    We also said we hoped to get into a phase 2 trial by the 
first quarter of 2017.
    [Slide shown.]
    And, in fact, at the end of March of this year, we actually 
initiated a phase 2 trial, first in Texas and Puerto Rico, and 
then, in the next few months, we're going to advance this into 
the countries shown by the red dots on the slide. We have a 
flexible capability so that, if there are outbreaks in one 
country more than the other, we'll be able to divert the 
resources to be able to get the vaccine deployed in an area 
where there is an outbreak.
    Now there's no guarantee that this is going to be effective 
or that there are going to be enough cases to at least prove 
that it is effective, but we are at least on time in our 
endeavor, and I would hope that, as we follow up on this in the 
coming year or so, we will be able to come back to this 
committee and say that we do, in fact, have a safe and 
effective vaccine.
    I'll stop there, Mr. Chairman, and be happy to answer 
questions later. Thank you.
    [The prepared statement and slide presentation of Dr. Fauci 
follow:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    Mr. Murphy. Thank you, Dr. Fauci.
    Dr. Bright, you're recognized for 5 minutes.

                  STATEMENT OF RICK A. BRIGHT

    Dr. Bright. Good morning, Chairman Murphy, Ranking Member 
DeGette, and distinguished members of the subcommittee. I'm Dr. 
Rick Bright, the Director of the Biomedical Advanced Research 
and Development Authority, otherwise known as BARDA. I'm also 
the Deputy Assistant Secretary for Preparedness and Response in 
the Office of the Assistant Secretary for Preparedness and 
Response, or the ASPR, within the U.S. Department of Health and 
Human Services.
    I appreciate the opportunity to speak with you today. This 
is the first opportunity I have had to testify since being 
named the BARDA Director last November.
    As a component of ASPR, BARDA was established to aid in 
securing our Nation from chemical, biological, radiological and 
nuclear threats as well as from pandemic influenza and other 
emerging infectious diseases.
    BARDA supports the transition of medical countermeasures, 
such as vaccines, drugs, and diagnostics, from research stages 
through advanced development toward consideration for approval 
by the FDA and often into the Strategic National Stockpile. Our 
mission is accomplished through the successful public-private 
partnerships with industry to share the risk, improve 
efficiency, and accelerate development, all while sustaining 
the marketplace for countermeasures that are vital for our 
national security.
    BARDA also collaborates and coordinates very closely with 
our Federal colleagues through the participation in the Public 
Health Emergency Medical Countermeasures Enterprise, which is 
chaired by the HHS ASPR. To support the overall HHS response to 
Zika, BARDA has established three goals to address medical 
countermeasure gaps: first, the prevention of Zika virus 
infection through the development of safe and effective 
vaccines; second, for the rapid detection of infection through 
the development of diagnostics; and, third, to ensure a safe 
blood supply by the development of screening tests for Zika and 
technologies that will inactivate pathogens in donated blood 
products.
    For diagnostics, our goal is to stimulate and accelerate 
the development of rapid and accurate serological tests. BARDA 
has partnered with five companies to support these tests. Some 
of these tests are laboratory based, and some of these tests 
are for point-of-care use.
    BARDA is also supporting the development of two tests that 
are now being used under an FDA investigational new drug 
protocol to screen Zika virus in donated blood. BARDA is also 
supporting the development of four Zika vaccine candidates. One 
candidate began as a collaboration between BARDA, the U.S. 
Department of Defense, and NIAID. And it is currently in 
multiple clinical trials. This candidate has now transitioned 
to an industry partner for further development.
    To introduce additional innovation into this outbreak, we 
are also supporting the development of a vaccine candidate that 
is based on a novel messenger RNA platform that is now in 
clinical trials. This is a new vaccine platform that has 
potential to develop and produce vaccines rapidly. This is 
essential for an effective response to emerging threats.
    Funding from Congress has been critical for our response to 
Zika. However, additional support will be needed to continue 
our progress. There is great value in keeping multiple 
candidates in the pipeline to increase the chance of success. 
Looking ahead, also having a Federal emergency response fund 
would contribute to a rapid medical countermeasure response for 
future public health threats.
    BARDA and ASPR are committed to using innovative 
technologies and innovative contractual tools to accomplish our 
mission. A nimble and flexible, yet consistent and transparent 
approach is critical to successful public-private partnerships, 
not only to address the early valley of death, but also to 
address challenges of market entry and sustainability that our 
industry partners face when products are approved. It is 
important to sustain capacity, capability, and partnerships 
with the private sector to be ready and able to respond when we 
confront threats to our national security and public health.
    Mr. Chairman, ASPR and BARDA are working with HHS 
colleagues, our interagency colleagues, and our private sector 
partners to prepare our Nation for range of national security 
and public health threats. Medical countermeasure development 
is a long, complicated, and a high-risk process. BARDA is 
greatly appreciative of the resources and authorities that 
Congress has provided to us to accomplish its mission. I look 
forward to working with members of this subcommittee and your 
congressional colleagues. I'm grateful for the opportunity to 
address you today, and I'm happy to take your questions.
    [The prepared statement of Dr. Bright follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Murphy. Thank you.
    That is quite a bit of knowledge here. So let me recognize 
myself for 5 minutes to start this process.
    Dr. Fauci, I guess you have been around since 1968, working 
through about eight Presidents here. So you may have learned a 
thing or two about this, but I just wonder, how did the pace of 
this progress on Zika vaccine compare with how quickly vaccines 
were developed for some of the other viruses?
    Dr. Fauci. Thank you for that question, Mr. Chairman. It 
actually is the fastest that we have done, because, if you look 
at the time from either the isolation of a pathogen or 
sequencing of it--so that you could do a molecular biological 
approach to the vaccine--Zika is the fastest we have done in 
history. It is about 3 months from the time that we actually 
had the sequence that we started putting it into an animal 
situation. So we really, from the standpoint of the development 
of a vaccine, which, as you know, with all the things that we 
have to go through with a vaccine, it takes some time to 
ultimately get the product, but to hit the ground running from 
the microbe to the actual vaccine in a preclinical is the 
quickest we have ever done.
    Mr. Murphy. You also said in your testimony you require 
more time because of the recent decline in Zika case trials 
across the Americas. What kind of statistical power do you need 
here to give you enough numbers on clinical trials? Are you 
advancing with enough cases here?
    Dr. Fauci. Yes. When you look at the activity that's going 
on right now, it would probably take a much longer period of 
time. It is a combination of the statistical power of the end 
with the amount of time that it would take to get it. So, if 
you have X number of cases a year, you may take 4 or 5 years to 
get it. If you get those amount of cases in a particular period 
of time, like a few months--for example, if there's an outbreak 
in Puerto Rico as we get into the summer of this coming year in 
Puerto Rico, we may get enough cases to be able to get an 
efficacy signal. If there's not, then we may need to wait a 
longer period of time.
    It is a combination of the more effective the vaccine is 
and the more number of cases, those both come together. If you 
have you a really effective vaccine and a modest number of 
cases, then you get your efficacy signal.
    Mr. Murphy. Would this likely then move toward approval for 
the Emergency Use Authorization of the FDA?
    Dr. Fauci. Well, that really depends, because if you get a 
good enough signal, you could get Expanded Access; you might 
not even need to use an Emergency Use Authorization. It really 
depends on the data and the robustness of the data.
    Mr. Murphy. Let me quickly ask another question here, 
because we focus a lot on neonatal and prenatal development, et 
cetera. Any news on studies on men and the impact of Zika virus 
on men?
    Dr. Fauci. Well, we're continuing to study. As you are I'm 
sure aware, there was a study that showed, in adult mice, that 
there's an effect on the testes with oligospermia and 
testicular atrophy.
    Right now, there's no indication that that's the case of an 
adult male human who gets infected, but we're doing prospective 
studies now in individuals, and that's related to determining 
the persistence of Zika in the semen. And you could do two 
studies. You could see if there's Zika in the semen, and you 
could also do sperm counts. So we'll be able to know if, in 
fact, infected individuals have a degree of oligospermia. But 
that's something that we're looking at in the future.
    Mr. Murphy. I appreciate that.
    Dr. Petersen, according to an internal CDC investigative 
report, the CDC Chief of Diagnostic and Reference Activity in 
the Arboviral Disease Branch, who had become a whistleblower 
about the CDC's promotion of the trioplex test for Zika, was 
moved from that position by DVBD leadership in May 2016. You're 
the Director of DVBD, and the branch is a part of your 
division. Why was the CDC expert whistleblower moved out of his 
position in the middle of the Zika emergency response, and why 
was he then reinstated as Chief in July of 2016?
    Dr. Petersen. Thank you for that question. I cannot speak 
to personnel issues, but I can present a little bit of 
background about the situation.
    There was some discussion among our scientists about the 
analytic sensitivity of the CDC trioplex test versus a 
laboratory-developed test known as the monoplex test, and at 
the time, the trioplex test had actually been EUA approved and 
was already being distributed to State public health 
laboratories and laboratories within the laboratory response 
network. So that test had been distributed already.
    An investigation was done into the whistleblower complaint 
by an independent panel with our Office of Laboratory Safety 
and Science. And that panel concluded that there was no 
wrongdoing on the part of CDC. Those results were reviewed by 
HHS and the Office of General Counsel, which came to the same 
conclusion.
    In the end, we had to make a very rapid decision because 
there were many women wanting test results. We decided to stay 
with the trioplex. In the end, it turned out that the trioplex, 
when tested with a larger panel of samples, was actually an 
extremely good test, in fact, one of the best out there.
    Mr. Murphy. Thank you. I'm out of time.
    Ms. DeGette, you're recognized for 5 minutes.
    Ms. DeGette. Thank you, Mr. Chairman.
    As I said in my opening remarks, I'm really interested both 
in our position going into the 2017 mosquito and travel season, 
but also our preparedness in the future.
    Dr. Persons, in your audit, you found that agencies like 
the CDC and FDA face a number of challenges when it came to 
addressing the Zika threat. One of the challenges is that the 
Federal Government had insufficient modeling capability for 
predicting the spread of the Zika virus. Is that correct?
    Dr. Persons. Yes.
    Ms. DeGette. And you also found that the CDC and its public 
health partner agencies faced challenges in establishing and 
implementing Zika surveillance systems. Is that correct?
    Dr. Persons. Yes.
    Ms. DeGette. And, also, Dr. Persons, your audit found that 
authorized diagnostic tests used for the Zika virus outbreak in 
the U.S. varied in both their performance and operational 
characteristics. Is that right?
    Dr. Persons. Yes.
    Ms. DeGette. Now, we're facing an increased array of 
pandemic threats: Ebola, avian flu, dengue, and now Zika. 
Although Zika is a unique virus, those challenges that we faced 
last year suggest the need for better preparedness overall. I'm 
concerned that what these things I just talked about have grave 
implications for our overall preparedness posture.
    I'm wondering if you can comment briefly about what the 
broader implications of the challenges on Zika are as they 
relate to the overall preparedness and where we need to still 
look at having preparedness for other infectious diseases that 
might come along.
    Dr. Persons. Yes, thanks, Ms. DeGette, for the question. As 
I think our study showed, Zika is a key issue at this point and 
another case, but it is still one of a type. So it is a 
pattern, as you all had pointed out. I think what is necessary 
is a more proactive framework for emerging infectious diseases 
that will include perhaps the idea of perhaps establishing a 
case definition earlier on, as soon as you can maybe iterate on 
that, rather than waiting until things happen here in the U.S. 
and that has to develop and we have sort of a U.S. stamp on 
that.
    Another thing is just getting data and information as 
quickly as possible about the accuracy and the limitations of 
reliable diagnostic tests. It also will be important to have 
evidence for diagnostic users or practitioners to have that, 
practitioners would be including scientists as well as 
clinicians, and certainly, whenever there's a mosquito- or 
vector-borne disease like this one, I think we're going to need 
to have more proactive standing infrastructure in terms of 
dealing with mosquito control.
    Ms. DeGette. Dr. Petersen, does your agency feel like those 
are good recommendations and we can use those in the future?
    Dr. Petersen. Those were very good recommendations. We 
certainly need a more proactive approach to dealing with 
mosquito-borne diseases, and the one thing we have learned, 
with the onset of, incursion of West Nile, then chikungunya, 
now Zika virus, is that these pathogens are coming to our 
shores at a more rapid rate than ever before, and we feel that 
we need to respond and prepare for the unexpected. Nobody would 
have predicted that Zika virus would be sexually transmitted. 
Nobody would have predicted any of the factors with that virus.
    Ms. DeGette. Right. Thank you. You know, last year, 
Congresswoman DeLauro proposed the creation of an emergency 
fund that would allocate $5 billion in funds for public health 
response efforts in advance of disease outbreaks simply because 
these things are also unpredictable, which would help us from 
having to scramble at the last minute to find this money.
    Dr. Fauci, what do you think about the idea of an emergency 
fund of this nature?
    Dr. Fauci. I think it's a good idea, and I've actually 
suggested it myself, as has Tom Frieden, when he was the 
Director of the CDC. And the reason that we did that is the 
experience that you alluded to in some of the comments from the 
committee and that the President had asked for a certain amount 
of money in February of 2016, 1.9 billion. And it wasn't until 
the end of September----
    Ms. DeGette. Right.
    Dr. Fauci [continuing]. That we got it. And that was really 
tough.
    Ms. DeGette. Because the season was almost over by then.
    Dr. Fauci. Yes. And we had to move money from other areas 
to be able to start our activities. And we moved them from 
Ebola. We moved them from other things.
    Ms. DeGette. I remember. I was in those meetings.
    Let me just ask you one more question, Dr. Fauci. What does 
Congress need to do to better help your agency and the other 
agencies on this panel better prepare for the next infectious 
disease epidemic?
    Dr. Fauci. Well, I think, as this committee has done in the 
past--and we are very grateful for that--is that continuing 
support, of the consistency of our support, because this is a 
marathon. If you have a sprint for every single outbreak, 
that's not good. This whole thing is a marathon, and we have to 
be prepared in a consistent way over the years with consistent 
support.
    Ms. DeGette. Over time.
    Dr. Bright, you're nodding yes.
    Dr. Bright. I absolutely agree. I think it's important 
that--we've appreciated all the support from Congress, but I 
think it's important to keep it constant, keep it consistent, 
keep the process transparent so we can bring innovation to the 
table to be able to be more proactive for these threats and not 
less reactive.
    Ms. DeGette. Thank you.
    Thank you, Mr. Chairman.
    Mr. Murphy. Thank you.
    We will recognize Mr. Walden, chairman of the committee, 
for 5 minutes.
    Mr. Walden. Thank you, Mr. Chairman.
    I want to commend our public health agencies for their 
extensive and very valuable work that you've accomplished 
during the response to Zika last year. In particular, the pace 
of Zika virus vaccine research and development has been really 
impressive, and we've talked about this before, and I 
congratulate you on that.
    Dr. Fauci, when do you think a Zika vaccine will be 
available for patients? What's your current view of that?
    Dr. Fauci. Thank you for the question, Mr. Walden. But I 
have to be honest with you: I can't predict that. And the 
reason you can't predict it, it's going to be based on two 
factors: one, how inherently good the vaccine is, and how long 
it takes us to prove how good it is.
    So you might have a very good vaccine, and, because of good 
public health measures or just luck, we don't have a lot of 
cases of Zika--it may take years before you finally prove 
statistically that it's good enough for the FDA to approve it. 
On the other hand, if you have a vaccine that's moderately 
effective but not really good effective, it still may take 
longer.
    So the best-case scenario from the standpoint of a vaccine, 
but not from the standpoint of the unfortunate people who 
suffer from the disease, is that if you have an outbreak over, 
let's say, the next season, and you have your vaccine 
implemented and deployed in place, you may be able to get an 
efficacy signal sometime, for example, in the beginning or mid 
of 2018.
    And then how good that signal is, the FDA will, in an 
unbiased way, evaluate that and make a decision. That's the 
best possible scenario.
    Mr. Walden. All right. So we're a ways off.
    Dr. Fauci. Right.
    Mr. Walden. Dr. Bright, I understand there are many 
candidates for diagnostic tests and vaccines in development 
today, far more than when we first learned about Zika last 
year. How do public-private partnerships expedite the 
development of medical countermeasures?
    Dr. Bright. Thank you for your question. It's very 
important to understand and recognize the contribution of the 
private sector, especially in responding to a public health 
emergency. Many of these companies are already focused on other 
more lucrative products and candidates in development.
    And to be able to bring the public and private sectors 
together for these emergency responses allows us to share the 
risk of development of these candidates, allows us to share the 
cost of development of these candidates, and it reduces and 
mitigates some of the pitfalls that we will face in a 
traditional, less supportive approach to developing medical 
countermeasures. So the public-private partnership is a 
critical component of success.
    Mr. Walden. All right.
    Dr. Petersen, your written statement noted that, and I 
quote, ``Alarmingly, the emergence of mosquito-borne diseases 
appears to be accelerating,'' close quote. Why does the CDC 
believe that the pace of emerging infectious diseases is 
accelerating? What's behind that?
    Dr. Petersen. I think there's several causes. One of the 
major causes is world population growth. We have the growth of 
mega cities in places where these viruses normally circulate in 
the tropical world. Combined with increases in travel and trade 
brings these viruses very rapidly to every corner of the Earth 
in a very short period of time.
    There's other factors that may be involved, such as climate 
change and other factors. And it's kind of a mixture of factors 
that's all promoting the emergence of these diseases.
    Mr. Walden. And in your written statement, you also mention 
that we need to address the threat of vector-borne diseases 
systematically rather than episodically. How would the CDC 
suggest that we address the threat systematically?
    Dr. Petersen. Well, I think we need to do two things. One 
is we need to increase our efforts towards innovation and 
discovery. We need better mosquito control methods, for 
example. We need better surveillance, et cetera, which will 
help us with the incursion of any kind of a pathogen, vector-
borne pathogen that's coming in.
    The other aspect is, is that we need to develop a more 
national and sustained approach towards vector control and 
laboratory testing; in other words, a more comprehensive 
approach towards--a programmatic approach towards dealing with 
these vector-borne diseases. Improving laboratory diagnostics, 
improving mosquito control, improving surveillance, for 
example. And this will require a sustained effort to rebuild 
the infrastructure that has been lost in the previous years.
    Mr. Walden. All right. My time has expired. Thank you all 
for your testimony and your good counsel.
    And I yield back.
    Mr. Murphy. The gentleman yields back.
    I recognize Mr. Pallone for 5 minutes.
    Mr. Pallone. Thank you, Mr. Chairman.
    It's clear to me that the ongoing Zika outbreak poses a 
serious threat to the health and well-being of the American 
public; in particular, pregnant women and infants are 
especially vulnerable. In the coming months, it will be crucial 
that pregnant women infected with Zika, as well as infants born 
with microcephaly, have access to necessary care and services.
    So I wanted to ask a couple questions, first with Dr. 
Petersen. Can you speak to the role that contraceptives and 
preventive care services play in our efforts to combat the Zika 
threat?
    Dr. Petersen. First, I think it's important to keep in mind 
that about half of the pregnancies in the United States are 
unplanned, and about two-thirds of the pregnancies in Puerto 
Rico are unplanned.
    Contraceptives and access for women to long-acting 
reversible contraceptives is one way that women can delay 
pregnancy, if they wish to. And so some women may choose to 
delay pregnancy, but it's not the Federal Government's role in 
advising women to delay pregnancy. But our goal is really to 
provide women with the most accurate information possible so 
they and their physicians can make the determination about 
pregnancy.
    Mr. Pallone. Let me ask Dr. Fauci, can you describe what 
kind of treatment and longer-term care will be necessary for 
infants born with microcephaly?
    Dr. Fauci. Well, in the tragic situations with babies who 
are born with microcephaly, the long-term care is both 
difficult and highly expensive. There have been estimates that 
the lifetime care of a microcephalic baby who actually survives 
could be measured in the millions of dollars.
    Babies who are microcephalic and have severe defects very 
often do not live beyond a certain limited period of time. And 
during that period of time, the amount of medical care that's 
required, the amount of time, both emotional and physical, 
that's invested in the family is extraordinary. So it's a very 
difficult and tragic situation that's both emotionally 
difficult and highly expensive.
    Mr. Pallone. Well, unlike other countries, in the United 
States we're fortunate to have these elite public health 
agencies, like CDC and NIH, as well as a strong public health 
infrastructure to prevent outbreaks from becoming full-blown 
epidemics.
    But, Dr. Fauci, why is a strong public health 
infrastructure in this country often key to avoiding the types 
of epidemics that we see play out in other parts of the world?
    Dr. Fauci. I'm sorry. I didn't hear the last--why is it----
    Mr. Pallone. Well, in other words, my impression is that 
because we have such great public health agencies, we're able 
to prevent Zika outbreaks from becoming full-blown epidemics.
    Dr. Fauci. Right. Yes.
    Mr. Pallone. And that's not necessarily true in the rest of 
the world. So, you know, if you wanted to just comment on----
    Dr. Fauci. Sure.
    Mr. Pallone [continuing]. How we're able to avoid these 
epidemics because of our public health infrastructure.
    Dr. Fauci. Well, as infectious diseases and public health 
officials, as some of us--maybe all of us--at the table are, 
you'll never be able to prevent an outbreak of a new infection 
like Zika or Ebola. The trick is to prevent it from becoming an 
epidemic or a pandemic.
    And I think the reason that we do so well is because of 
just what you've alluded to, Mr. Pallone, that we have in place 
systems. And I think I can add a tip of the hat to the CDC, 
because we have, in our Nation, unquestionably the best public 
health agency in the world by far.
    And that's one of the reasons why we have the capability of 
doing what they do so well, is to identify, to track, and to 
control. And they've done that with virtually every threatening 
outbreak that we've had and have done an extraordinary job. And 
not every country in the world has that capability.
    Mr. Pallone. You know, with this in mind, of course, 
President Trump has proposed slashing Medicaid by over 800 
billion. I believe this would decimate the Medicaid program, 
which plays a key role in our public health infrastructure. And 
cutting Medicaid would also further reduce our ability to 
provide care to those who may need it as a result of Zika, 
especially pregnant women and children born with microcephaly.
    So, Mr. Chairman, you know, again, I think we should be 
building up our healthcare infrastructure to prepare and 
respond to Zika. And it's of the utmost importance that we 
ensure access to the care and services that will be necessary 
to mitigate this threat.
    Dr. Petersen, very quickly, you mentioned contraceptives, 
but what about preventive care in general in our efforts to 
combat the Zika threat, not just the contraceptives but the 
preventive care?
    Dr. Petersen. Well, first, we're trying to link pregnant 
women who may have been exposed to the virus to effective care 
through our Zika Care Connect program, which we funded in a 
number of States and areas to do.
    Again, we think that the best way to deal with Zika is to 
prevent it. And for that reason, we have issued travel 
advisories to more than 62 countries, and they're still 
working--trying to get the right epidemiology to advise women 
appropriately on what measures they could take to prevent Zika 
virus, as well as what areas may or may not be safe to travel 
to to prevent Zika virus infection.
    Mr. Pallone. All right. Thank you.
    Thank you, Mr. Chairman.
    Mr. Murphy. Thank you.
    I now recognize Mr. Barton for 5 minutes.
    Mr. Barton. Thank you, Mr. Chairman.
    I would just point out to my good friend from New Jersey 
that what we've done with Medicaid is simply slow the rate of 
growth that we are going to save some money over a 10-year 
period. We're not cutting Medicaid. So I just want to set the 
record straight on that.
    We seem to have the top people from all the various medical 
agencies that are fighting or investigating the Zika virus. 
Which one of you would be considered the number one official in 
charge of the research? Somebody answer.
    Dr. Fauci. So I'm not sure what you mean by ``in charge of 
research.'' The NIH is the primary agency responsible for the 
research associated with what we're talking about today. The 
CDC is the agency predominantly responsible for the public 
health issues of detecting, preventing, and responding.
    BARDA is involved in helping the pharmaceutical companies, 
and all of us develop products that are in intervention, such 
as diagnostic therapeutics. So there isn't one person that does 
all of that.
    Mr. Barton. So there's no one in charge.
    Dr. Fauci. Well, there is, because at the Department of 
Health and Human Services, all of this is under the PHEMCE, 
which is the Public Health Emergency Medical Countermeasures 
Enterprise, that involves BARDA, NIH, and CDC, and FDA.
    Mr. Barton. But that person's not here?
    Dr. Fauci. That person's not sitting here, but there is a 
person that does that.
    Mr. Barton. So there is somebody that is----
    Dr. Fauci. Yes, the Assistant Secretary for public health, 
for prevention and response.
    Mr. Barton. I'm not trying to be argumentative. It would 
just seem to be, given the seriousness of this particular virus 
and the priority that we put upon funding to try to find a 
vaccine for it, that there would be a unified approach as 
opposed to all the various groups, all of which have super 
motives doing their own thing.
    Dr. Fauci. Right. We have the Acting Deputy Assistant 
Secretary here. So, Rick, do you want to comment?
    Dr. Bright. I can add to that, what Dr. Fauci is explaining 
as well, yes. So the PHEMCE enterprise is chaired by the 
Assistant Secretary for Preparedness Response, the ASPR.
    Right now, we have an acting ASPR, Dr. George Korch. In 
2015 and early 2016, our ASPR actually was very proactive in 
leaning forward and coordinating a meeting across HHS called a 
disaster leadership group. In early December 2015, we had that 
first meeting.
    In early January of 2016, we had additional meetings that 
included our partners across the PHEMCE organization, which is 
outside of the HHS department actually.
    Mr. Barton. Well, this individual--does that individual 
have the authority to direct funding to the various agencies?
    Dr. Bright. That individual has the responsibility for the 
coordination and alignment of the activities to assure that we 
are working as efficiently as possible in reducing duplication 
so the resources are used most efficiently.
    Mr. Barton. I'm not sure I understand that answer.
    Dr. Fauci. The Congress gives us, individually, our 
resources.
    Mr. Barton. So we----
    Dr. Fauci. Right.
    Mr. Barton [continuing]. Through the authorization and the 
appropriation process, we fund each agency----
    Dr. Fauci. Yes.
    Mr. Barton [continuing]. And then this individual 
coordinates?
    Dr. Fauci. Correct.
    Mr. Barton. Well, I guess my bottom-line question is, since 
you're on the front lines, each of those individuals here, do 
you believe that we have a unified approach and that money is 
not being spent in duplicative efforts?
    Dr. Fauci. Yes, I believe we do. In fact, if you look at 
the Zika response that we've had right from the very beginning, 
as well as the Ebola response, we actually had the Secretary of 
HHS involved frequently on, like, weekly conference calls, and 
in the real hot part of it, multiple per-week conference calls.
    But the description that Rick just mentioned is the 
Assistant Secretary for Preparedness and Response, the ASPR, is 
the one individual that coordinates what we do--BARDA, FDA, 
NIH, and CDC--and that's been the case throughout the 
outbreaks.
    Mr. Barton. OK. I've only got about 30 seconds.
    Dr. Fauci, you're certainly the senior person here in terms 
of service. You didn't really give a direct answer to Chairman 
Walden's question about when we might expect an effective 
vaccine. Can you give us a little more definitive, next 2 
years, next year, 3 to 5 years? You put some charts up in your 
testimony. Just give us kind of a ballpark figure. I'm not 
holding you to the exact date and second, and just generically.
    Dr. Fauci. Yes. A long time ago, a Secretary of HHS gave a 
ballpark figure for an HIV vaccine, and I think she's still 
regretting having said that. So I'm not going to give you a 
time when we'll have a Zika vaccine, except to say that the 
process for getting to that vaccine is right on time. And I 
would think it would be measured in several years at the most 
and maybe a couple of years at the best.
    Mr. Barton. That's good enough for me.
    Dr. Fauci. OK.
    Mr. Barton. Thank you, Mr. Chairman.
    Mr. Murphy. Thank you.
    Ms. Castor, you're recognized for 5 minutes.
    Ms. Castor. Thank you, Mr. Chairman.
    GAO's report today identified several areas of concern with 
our country's ability to surveil, track, and respond to Zika. 
Dr. Persons, is it accurate that the Zika virus case counts 
likely underestimated the total number of Zika infections, and 
would you explain that?
    Dr. Persons. That's correct. When you talk about the Zika 
virus, a person can be infected but then not have symptoms in 
four out of five times. So 80 percent of the folks walking 
around are called human reservoirs and may not know they have 
that, and that's where the risk of mosquito control, person-to-
person, and/or sexual transmission.
    Ms. Castor. Right. So given these challenges, how will we 
be able to conduct predictive modeling to forecast the number 
of cases in the future and prepare for an outbreak?
    Dr. Persons. It's going to be a matter of collecting high-
quality data, taking models that are currently in existence and 
trying to modify them. There are, for example, computational 
models on sexually transmitted diseases. There's computational 
models on mosquito-borne and vector-borne diseases, but never 
the twain shall meet until this point. And so that is going to 
be a key focus in terms of getting data for that and then 
testing those models against the datasets as the epidemiology.
    Ms. Castor. That's not something that we should start and 
stop. We need a consistent pathway forward.
    Dr. Persons. Consistent research will be required for 
something this complex.
    Ms. Castor. And, Dr. Petersen, I'm aware that there were a 
number of presumptively positive Zika tests that never went 
onto confirmatory testing. How many of those are out there?
    Dr. Petersen. I do not have an exact number, but one of the 
biggest problems we actually had was in Puerto Rico, because 
what we found in Puerto Rico is because people who had a 
previous exposure to dengue--which 90 percent of the population 
there has--even the confirmatory test could not--for the 
antibody test--could not separate--even wasn't good enough to 
differentiate dengue from Zika.
    Ms. Castor. So was that an issue confined to Puerto Rico, 
or did we have a presumptively positive Zika test here in the 
U.S. that also didn't go onto confirmatory testing?
    Dr. Petersen. The vast majority of women in the Continental 
United States, we were able to confirm the antibody test result 
simply because most of those women did not have previous 
exposure to dengue, which then causes the test to cross-react.
    Ms. Castor. So how did you decide which specimens would get 
tested or not?
    Dr. Petersen. So in the Continental United States, we 
tested them all with a confirmatory testing as part of the 
algorithm. In Puerto Rico, we found out that didn't work, and 
so we stopped that confirmatory test with a test known as the 
PRNT.
    Ms. Castor. OK. Since the States and all of the agencies 
started keeping track of how many--since we started keeping 
track, how many cases of babies born with birth defects tied to 
Zika have there been?
    Dr. Petersen. Right. Well, one of--I do not have that 
number off the top of my head. I can get back to you with that. 
What we do know is that this is an ongoing process, because 
many of the women that have been infected so far have not 
delivered yet. And so this is an ongoing process of----
    Ms. Castor. Certainly, the CDC would have, to date, just 
since we started keeping track, the number of cases of 
microcephaly and other birth defects tied to Zika, knowing that 
we have to monitor these babies probably for many years.
    Dr. Petersen. So I think it's very important to monitor 
these women as they deliver and see the ultimate impact on 
their fetuses, both at delivery and long-term consequences. We 
do know that in the U.S. territories, there's been more than 
3,700 women that we've identified who have become infected 
during their pregnancy and about 1,700 in the Continental 
United States.
    Ms. Castor. Right. I have--based upon the CDC update last 
week, we've had about 5,640 pregnant women with a known Zika 
virus. And I was just trying to get to how many we have today 
born with birth defects, and so if you can please provide that.
    And these are heartbreaking consequences for these 
families. And I do know, based upon recent research, that they 
are calling this a spike in birth defects across America 
because of Zika. Would you characterize it that way?
    Dr. Petersen. I think there is a spike of infections--I 
mean, of these birth defects simply because this outbreak was 
so large last year and these women are now delivering.
    I was just handed the answer to your question.
    Ms. Castor. OK.
    Dr. Petersen. And in Puerto Rico, they're currently 
reporting 35 cases with birth defects and 72 in the Continental 
United States. However, we know from our studies that about 10 
percent of the women who were infected during pregnancy will go 
on to deliver a baby that has been affected by Zika virus.
    Ms. Castor. There are so many other questions, Mr. 
Chairman. I look forward to the committee's continued attention 
to this. Thank you.
    Mr. Murphy. Thank you.
    I now recognize Mr. Griffith for 5 minutes.
    Mr. Griffith. Thank you very much, Mr. Chairman.
    And I'm going to start with Dr. Bright. In your just 
general info on BARDA, it says: BARDA meets its mission by 
supporting product innovation, advanced development, 
acquisition and stockpiling, and building manufacturing 
infrastructure.
    Given the threat of emerging, infectious mosquito-borne 
diseases, would BARDA's mission for developing medical 
countermeasures also include the development of mosquito-
control technology?
    Dr. Bright. Thank you for that question. It is a very 
important question. And currently, the short answer is no, our 
scope does not include a vector control. However, we have been 
monitoring it very closely as an innovation in vector control 
and are considering is there data to support that vector 
control can also be associated as a medical countermeasure in 
the reduction of the disease. And so we are working closely 
with the companies to better understand those technologies.
    Mr. Griffith. That's interesting, and I'll see what I can 
figure out, but I agree. It's probably something that ought to 
be in your wheelhouse, so to speak.
    I'm going to switch and jump off of some of the issues that 
we've heard today. And Dr. Petersen talked about the situation 
in Puerto Rico a few minutes ago related to dengue and the 
testing to determine whether or not Zika is there when you have 
a population that has been exposed to dengue.
    And, Dr. Fauci, that raises the question, when you were 
testifying about the vaccines and the DNA vaccine where you 
take a part of the gene of the Zika virus and the body then 
responds to the protein, because of the close relationship with 
other diseases like dengue and chikungunya, does that mean that 
there's a possibility, and should we be looking for it, that 
the vaccine, for one, will inadvertently or maybe intentionally 
create a vaccine for all three of those diseases which are so 
closely related?
    Dr. Fauci. Well, we should be so lucky. But unfortunately, 
that's not the case. Because even though there's cross-
reactivity of antibodies, for example, from Zika to other 
flaviviruses like dengue and yellow fever, there's not cross-
protection. So if you have an antibody against one, you don't 
protect against, even though they can be confused in a 
laboratory test. They're not physiologically protective.
    But having said that, Mr. Griffith----
    Mr. Griffith. I was hoping.
    Dr. Fauci. Well, wait a minute, hope springs eternal. 
Because having said that, there is work going on right now to 
actually try and develop a universal flavi vaccine where the 
component of the vaccine that you present to the body is a 
common part of the flavivirus that actually is in all the 
flaviviruses. Whether or not that part is going to induce a 
protective response is unclear, but there is work thinking 
exactly as you're thinking right now: Can you actually get a 
universal--the same ways we're trying for universal influenza 
vaccine.
    Mr. Griffith. All right. I appreciate that. Thank you.
    Dr. Petersen, you raised the issue, of course, about Puerto 
Rico and dengue, and they, of course, had so much exposure last 
year to Zika that they won't show as much exposure this year 
because such a large percentage of the population was already 
exposed. And I was just wondering, what work is being done.
    And I'm going to switch gears on you just slightly, so bear 
with me. I read a report and was somewhat concerned that--even 
though it was a very small study that--back in March, the 
American College of Cardiology said that there's a link between 
Zika and heart disease. And since we have a large population 
that was, in fact, exposed to Zika, is there any work being 
done to see if there's a larger study that could be done to 
determine what the links between Zika and heart disease, if 
any, are out there?
    Dr. Petersen. We do not have a specific study looking at 
heart disease--looking at that link between heart disease and 
Zika. What we are looking at is of the general spectrum of 
syndromes associated with infection with the Zika virus, heart 
disease being just one of them.
    There's a variety of neurological conditions that we're 
looking at as well. So it's part of a longer, larger effort to 
look at the complete spectrum of disease manifestations with 
Zika virus.
    Mr. Griffith. And when you say you're looking at other 
neurological issues, that's not just in newborns or the fetus. 
Is that correct?
    Dr. Petersen. Correct.
    Mr. Griffith. All right. I appreciate that.
    Dr. Persons, GAO reports that the grant funds awarded for 
mosquito control may not make it to some local control 
districts and that the CDC does not directly monitor mosquito 
control entities for the use of grant funds.
    Assuming that is correct, what do we need to do to make 
sure that the money we're spending is actually being monitored 
and it actually goes to where we think it's going, which is to 
control mosquitos?
    Dr. Persons. I just thank you for the question, Mr. 
Griffith. I think persistent oversight, guidance, perhaps 
changes in policy in terms of the rules or the structure in 
which CDC does these block grants so that they can be 
specifically targeted only for mosquito control efforts and not 
for other things that a State may wish to sponsor, I think is--
--
    Mr. Griffith. I appreciate it.
    Dr. Petersen, I'm sorry, I'm out of time. So I would give 
you a chance, but I don't have the time to respond, so I have 
to yield back. Or to give you a response.
    Mr. Murphy. Thank you.
    Ms. Schakowsky, you're recognized for 5 minutes.
    Ms. Schakowsky. Thank you.
    First, let me apologize. I'm the ranking Democrat on a 
hearing that's going on upstairs, and so I apologize that I 
missed your testimony.
    Given the importance of developing a Zika vaccine, hundreds 
of millions of Federal dollars have been obligated to conduct 
clinical trials. I understand there's 32 vaccine candidates 
that are being studied in the U.S., and the U.S. Government has 
helped to partially or fully fund a number of those vaccine 
candidates.
    So it's my understanding also that the drug manufacturer 
Sanofi has received over $40 million from the U.S. Army to 
conduct a phase 2 trial for one of the vaccines, with the 
possibility of accessing up to 130 million more in taxpayer 
funding for phase 3 trials. All told, nearly $300 million of 
Federal dollars have been obligated for vaccine development to 
date. So stick with me for a minute.
    While it's critical that we develop and manufacture an 
effective vaccine to combat Zika virus, it's just as critical 
that the vaccine be available to everyone who needs it. I'm 
also very concerned that Sanofi recently rejected the Army's 
request for a, quote, ``fair,'' unquote, price for the vaccine.
    Earlier this year, I led 10 of my House colleagues in 
sending a letter to the Army raising concerns about their plans 
to issue an exclusive license to Sanofi for the vaccine that 
U.S. taxpayers helped develop. In addition, Governor Edwards of 
Louisiana, one of the States that has been hit hardest by the 
Zika virus, sent a letter to the Army that raised similar 
concerns.
    I'd like to ask unanimous consent to enter both of these 
letters into the record.
    Mr. Murphy. Could we review this? I'm assuming that would 
be OK, without objection.
    Ms. Schakowsky. OK. Dr. Fauci, given the enormous 
investment of taxpayer dollars into the development of a Zika 
vaccine, do you agree that we need to use every tool of the 
Federal Government to ensure that the vaccine is affordable?
    Dr. Fauci. The answer to that question is yes, but it is a 
complicated issue, Congresswoman, as you well know, because we 
don't really have the mechanisms to influence pricing of a 
product, even products in which we make a major investment for 
the development of.
    Certainly, we feel, as scientists and public health 
officials, that the work that we do in the development of 
vaccines should be available to everyone and anyone who needs 
it. So, if you're asking is that the answer to the question, it 
is absolutely, I feel that we need to do that. Whether or not 
we have mechanisms in place right now to guarantee that, I 
don't think we do.
    Ms. Schakowsky. But it is true, isn't it, that vaccines are 
most effective when the vast majority of the public is 
immunized? So if it's priced out of reach of many, won't this 
be a problem in getting control of the whole disease?
    Dr. Fauci. Sure. Yes, it would, obviously, it would be. I 
mean, if you cannot vaccinate the people who need it--and you 
correctly said that a vaccine, particularly in an outbreak 
situation, the more people that get vaccinated, the more 
control you get over the outbreak. So I agree with you that 
it's essential, to the extent that we can do that, to vaccinate 
where appropriate as many people as we possibly can.
    Ms. Schakowsky. It's just a big concern to me since the 
Army actually said that they would not guarantee a fair price, 
and yet we're prepared to use taxpayer dollars to lay out 
perhaps as much as $130 million----
    Dr. Fauci. Right.
    Ms. Schakowsky [continuing]. To them potentially without 
any ability to control that.
    Let me just raise another concern. It's important also to 
remember the damaging impact that the repeal bill that just 
passed the House of ObamaCare and the Trump budget would have 
on Medicaid and our ability to respond to public health crises, 
like another Zika outbreak.
    The per-capita cap included in both the--in TrumpCare and 
the Trump budget would make it nearly impossible for States to 
expand services and the number of eligible individuals during a 
public health emergency, as Michigan did during the Flint water 
crisis.
    Moreover, under a per-capita cap, there is simply no way 
any State could provide access to a high-priced drug to all of 
its Medicaid beneficiaries. And depending on how the final Zika 
vaccine is priced, Medicaid programs could already face 
challenges in trying to pay for the drug, and those problems 
would only be compounded if Medicaid was drastically 
restructured as Republicans have called for.
    As this committee investigates the public health response 
to the Zika virus and considers how we might prepare for future 
challenges, it's critical to remember the important role that 
Medicaid has played in responding to public health emergencies 
and the devastating effect that Republican proposals to cap 
Medicaid would have on our ability to respond to those 
emergencies.
    I yield back.
    Mr. Murphy. Thank you.
    Dr. Burgess, you're recognized for 5 minutes.
    Mr. Burgess. Thank you, Mr. Chairman.
    And I would just point out that Bill Clinton, in 1995 and 
1996, proposed a per-capita cap for Medicaid because he was 
worried about running out of other people's money. And he was 
praised by the editorial board of the New York Times at the 
time, and every Democratic Senator then sitting wrote a letter 
to the President wishing him success in that endeavor.
    So I actually have a question that I'm going to ask, but 
it's going to be for the record. We did hear comments about an 
emergency fund proposed by one of the appropriators. And for 
just general purposes, we are an authorizing committee. We're 
not an appropriating committee.
    The difference between authorizers and appropriators--and, 
of course, at the NIH and the CDC you know this--the difference 
between authorizers and appropriators is there are no buildings 
named for authorizers. But we are the authorizing committee, 
and I think we have already authorized that that Representative 
DeLauro asks for.
    And I'm referencing now a compilation of the U.S. Code from 
January 4, 2012, title 42, chapter 6(a), subchapter 2, Powers 
and Duties, under part B in general: ``The Secretary shall 
award competitive grants or cooperative agreements to eligible 
entities to enable such entities to improve surge capacity and 
enhance community and hospital preparedness for public health 
emergencies.''
    So I believe the authorizing language is already there. And 
so my question that I'm going to submit to you for the record 
is, is that a correct statement? Do you feel that you have the 
authorization that you need and now we need to pay attention to 
the appropriations side of this? Or is, indeed, there different 
authorizing language that you would require?
    Dr. Petersen, let me just ask you, because you--I wasn't 
going to bring this up, but then you referenced it and so you 
provoked me, and now I'm going to do it. You said the best way 
to deal with this disease is to prevent it. And I agree with 
that. I agree wholeheartedly. And when you said that, I went on 
your Web site and I looked at your Zika page and I looked at 
your travel warnings.
    And can I just tell you, they're muted. Someone talked 
about the computational models for the dispersion of this virus 
throughout various populations. I don't think there was any 
computational model that predicted what happened in the country 
of Brazil a few years ago. I mean, I think it caught people by 
surprise. I don't think the computational models for Ebola 2 
years ago quite conformed to what people thought they would.
    So while I'm sympathetic to the fact that computational 
models can help, my concern is, especially with Zika--I mean, 
I'm one of two States where Zika has been locally transmitted. 
But, I mean, these are rare, rare, rare conditions. Most of the 
people that get Zika had to go somewhere and get it and then 
bring it home to Texas or Florida. Is that not correct, Dr. 
Petersen?
    Dr. Petersen. That has been the experience to date as true.
    Mr. Burgess. And, again, along your lines of wanting to 
prevent it is the best strategy, and I agree with that, I'll 
just say, I think we should be doing more as far as educating 
the public. When we've had discussions with the State 
Department and your agency, it seems to be this: We're pointing 
to each other to do the work. Someone needs to tell people 
don't go if you don't want this disease, particularly at 
certain times of the year.
    Now, I recognize that there's certain altitudes you can go 
to and won't be affected, but generally it is not a good idea, 
particularly if you're in a family that is contemplating a 
pregnancy somewhere in the future. Maybe you might not want to 
do this.
    Dr. Borio, let me just ask you--and I know we've talked 
about this before, but it has been some time ago. And you had 
in your written testimony the issue of vector control with the 
Oxitec mosquito.
    And there was great concern last summer, this was a public 
health emergency that was declared by the President, and yet 
the difficulty with getting the technology for that genetically 
modified mosquito into areas where it could actually help, it 
seemed to be very difficult.
    In the 1950s, they eradicated the screw-worm fly--and I 
don't recommend googling that during brunch--but they 
eradicated the screw-worm fly rather effectively with using 
that same type of technology, maybe a little bit different now 
than it was then, but terribly effective.
    And one of your statements says that perhaps there's 
guidance coming from the FDA that we could approach this in a 
different way now than what we did last August?
    Dr. Borio. Thank you for your question, Dr. Burgess.
    So, you know, first, I would just like to stress how 
important vector control is, and it's an area of unmet need. 
It's quite challenging to control the vectors that we need to 
control, as we were till last year, in the areas of local 
transmission. And as a physician and scientist, I have to 
stress that this technology seems very promising, and it really 
deserves to be evaluated more thoroughly. It's in early 
development, but it deserves its chance to show whether it can 
assist in this area of unmet need.
    The company had a plan to do a field trial in the area of 
Key Haven, Florida, last year. And for a variety of reasons, 
including significant resistance by the population that voted 
against in the local area, the study did not proceed. We 
continue to maintain a very open line of communication with the 
company to explore additional studies.
    In the meantime, we have published draft guidance that 
would transfer the authority for oversight of this technology 
to the EPA, and we are in the comments period right now. We're 
reviewing comments received.
    But the goal for this draft guidance would be to provide a 
more consistent and cohesive framework for regulating these 
types of technologies under a more, you know, consistent 
regulatory agency, which really has a lot of responsibility for 
vector control when they're for pesticides.
    Mr. Burgess. Thank you.
    Mr. Murphy. Before I recognize Mr. Tonko, Ms. DeGette, you 
have a request.
    Ms. DeGette. I just wanted to renew Ms. Schakowsky's 
request for--unanimous consent request for the two letters, 
which I agree with them, but also just to make the record 
complete for Sanofi's response dated May 22, 2017.
    Mr. Murphy. Without objection, those will be accepted.
    [The information appears at the conclusion of the hearing.]
    Mr. Murphy. Mr. Tonko, you're recognized for 5 minutes.
    Mr. Tonko. Thank you, Mr. Chair.
    I'd like to look at the diagnostic testing of Zika. To 
effectively respond to a Zika epidemic, we must be able to 
determine who is infected. But diagnostic testing of Zika 
remains one of the most pressing challenges. There's a number 
of diagnostic tests authorized by FDA, but these tests have 
limitations.
    GAO's report today identified these challenges. 
Specifically, GAO stated that certain tests detect the presence 
of a virus, which may or may not be Zika.
    So, Dr. Borio, why has it been difficult for some tests to 
isolate the Zika virus?
    Dr. Borio. Sure. So these are--there's inherent scientific 
challenges with developing diagnostic tests for Zika, 
especially the serological tests. But I think it's important to 
recognize that all of the tests that have been authorized by 
the FDA meet performance standards, all of these tests. And if 
used appropriately, as recommended by the CDC, these tests 
perform well and should be able to give an answer to patients 
about whether they've been exposed or infected with Zika virus.
    The only remaining challenge today with the tests that are 
available really has to do with the population in Puerto Rico, 
which, as Dr. Petersen explained, because of coinfection with 
other flaviviruses it may not be really possible to make a 
definitive diagnosis.
    Other than that, we have developed--you know, used the 
limitations of the performance of these tests, but relied on 
algorithms to be able to give us the answers we need. They all 
meet standards.
    Mr. Tonko. OK. Thank you.
    And, Dr. Borio, I also understand that the window during 
which the Zika virus can be detected is relatively short. How 
does that complicate diagnostic testing?
    Dr. Borio. Sure. So the window really impacts on the 
utility of the molecular-based test, the PCR-based test, which 
is able to detect a virus in the clinical specimen in the acute 
period of infection. If the window is so limited, it's possible 
that all the tests might miss detecting the virus when it's 
present.
    For that reason, the CDC algorithm recommends that for 
those patients for the population that is being tested, a 
negative test should be followed by the serology test, which 
measures the antibodies against Zika.
    Mr. Tonko. Thank you.
    Dr. Persons, according to your report, a total of 15 
diagnostic tests are authorized and vary in their performance. 
But your audit found a number of issues with developing 
accurate diagnostic tests. So my question is, why is it key 
that when an infectious disease confronts the U.S. we quickly 
develop an effective diagnostic test?
    Dr. Persons. Yes. So thank you, Mr. Tonko, for the 
question. The answer is simple in terms of the efficacy of the 
diagnostics goes right to the data that feeds into the 
epidemiology, which feeds into the clinical treatment, which 
feeds into the modeling and things that might be required to be 
more predictive and proactive in these things. So it's all a 
system that's complex and adaptive, but it hangs together. And 
diagnostics are very important to this conversation.
    Mr. Tonko. So what does it mean for our overall 
preparedness that there were these difficulties regarding 
diagnostic test development for the Zika virus?
    Dr. Persons. I think it just means that in taking a more 
proactive approach, we need to try and get--a lot of our 
recommendations are really data or information providing 
oriented.
    For example, if you're a manufacturer, you need to get 
well-curated data samples to understand, you know, which one 
contains Zika, in this case, which one does not, so you're 
really getting down to those very important metrics on 
performance.
    Also, just getting out to the user, so whenever you have 
the best available science and those numbers, those test 
results from the diagnostic testing regime, that they get put 
out to the user base so they efficiently are able to compare 
apples to apples and do a risk-based analysis at the point of 
care on which ones might be available and might best be used.
    Mr. Tonko. Are there other things that we should be doing 
differently?
    Dr. Persons. As I mentioned before, I just think the idea 
of a more proactive framework on doing that data is gold in 
this case, so really focusing on that. Putting resources on 
that data is not going to come for free, but maybe being more 
expansive about which data you might be able to get.
    Again, having a framework for the rapid divulgence of 
science and best available competitive science as well as 
information to the marketplace so that they can develop rapidly 
and go through the regulatory process under EUA in this case.
    Mr. Tonko. Thank you very much.
    Mr. Chair, I yield back.
    Mr. Murphy. Thank you.
    Before we recognize the next, Dr. Burgess, you have a UC 
request.
    Mr. Burgess. Mr. Chairman, I ask unanimous consent to 
insert an article from the journal Obstetrics & Gynecology on 
emerging infectious diseases.
    Mr. Murphy. Without objection, we'll include that article 
in the record.
    [The information appears at the conclusion of the hearing.]
    Mr. Murphy. Mr. Collins, you're recognized for 5 minutes.
    Mr. Collins. Thank you, Mr. Chairman. I want to thank the 
witnesses.
    If I'm a young woman watching this hearing, I want to ask a 
few questions because there might still be some confusion. So, 
Dr. Borio, if a woman wants to know if she has contracted Zika, 
would you simultaneously recommend she get a PCR test and an 
ELISA test, I mean, just to pick up either the antibodies or in 
the PCR?
    Dr. Borio. Dr. Petersen might correct me, but my 
understanding is that if a woman who is at risk for Zika 
infection is pregnant, she should be tested. And the algorithm 
requires that she will have a PCR-based test, and if it's 
negative, it'll be followed up with a serology test. And that 
way----
    Mr. Collins. So you wouldn't do them simultaneously. You'd 
make her come back a second time?
    I mean, if the PCR test is negative--I mean, clearly that--
it may have just passed her bloodstream, and then would she 
have to come back and have another test done? Why wouldn't we 
do them----
    Dr. Petersen. Both tests could be done on the same blood 
sample, so it would not necessarily require her to come back.
    Mr. Collins. OK. So the protocol would be they draw her 
blood, they test it with the PCR test. If that comes back 
positive, well, then she knows she's been infected. If it comes 
back negative, using the same sample, she doesn't have to come 
in again. Protocol would be to run through an ELISA.
    Dr. Petersen. Right. Well, it's complicated, but there's 
actually two different scenarios. Somebody that has symptoms--
as opposed to an asymptomatic pregnant woman. For somebody who 
has symptoms, the algorithm depends on the time that they 
present to medical care after their symptoms develop. That will 
determine what algorithm is actually used.
    For an asymptomatic pregnant woman, the current guidelines 
suggest that she has an IgM test first and an antibody test 
followed by a PCR test. We are reconsidering those 
recommendations at the current time, and we expect to have a 
new algorithm in the upcoming weeks as new information becomes 
available.
    So we are working actually on trying to streamline the 
testing algorithm to try and make it both simpler for the woman 
as well as the physician ordering the test.
    Mr. Collins. I mean, I would think there's a lot of 
asymptomatic women that just want the peace of mind and that 
that would be a fairly normal thing.
    So another question maybe, Dr. Petersen. We've heard that 
if a woman is tested positive for Zika, she's not pregnant, do 
you have a timeframe during which she would feel comfortable or 
safe in getting pregnant subsequent? Is it 3 months, 6 months, 
a year? Or at what point in time would a young woman who has 
tested positive for Zika feel comfortable getting pregnant?
    Dr. Petersen. Well, there's two issues here. One issue is 
does infection before conception actually lead to birth 
defects, and that answer is still not known. We have no 
evidence that that's the case so far, but out of an abundance 
of caution, we are advising women to wait--I can't remember the 
exact number--2 to 3 months--8 weeks. Sorry. Thank you, Tony--8 
weeks to conceive after potential exposure.
    Mr. Collins. Again, that would be good information.
    Now, Dr. Fauci, you did mention, you know, the individual 
thought we might have an HIV vaccine at some point, which we 
don't. So HIV is an RNA-based virus, so is influenza, so is 
Zika. So on these viruses that tend to mutate, like that's why 
we have to come up with a different strain of influenza year 
after year after year and--what would be different about Zika 
compared to something like influenza or HIV where we wouldn't 
have a single definitive vaccine, but yet would have to keep 
looking at potential mutations each season?
    Dr. Fauci. That's a very good question. And there is a big 
difference between the mutations of the RNA virus influenza and 
the mutations of viruses like dengue, like Zika, like yellow 
fever.
    The mutations that are associated with influenza have a 
major impact on the efficacy of a vaccine. So you can have 
mutations that have no impact on the virus' phenotype, namely 
what the virus looks like and how the body sees it. That's not 
the case with influenza. When influenza makes those mutations, 
you almost always have to get a new vaccine. That's the reason 
why we get a new vaccine every season practically.
    But when you have other RNA viruses, like flaviviruses, 
when they mutate, they tend to have mutations that don't have a 
functional effect, usually. I mean, you'll have an exception to 
that, but the mutations that generally occur with flaviviruses 
are mutations that don't impact with the vaccine.
    So, for example, yellow fever is an RNA virus. That will 
have mutations. If you do sequences of one versus the other, 
you will always see mutations because RNA viruses like to 
mutate. The critical issue is, is the mutation functionally 
relevant? And for the most part, for the ones we're talking 
about today, they're not functionally relevant.
    Mr. Collins. So that should give us all a little more 
optimism----
    Dr. Fauci. Yes.
    Mr. Collins [continuing]. Related to Zika compared to 
things like influenza.
    Dr. Fauci. You're right. You're absolutely correct.
    Mr. Collins. Thank you for that clarification.
    I yield back.
    Mr. Murphy. Congressman Ruiz is recognized next for 5 
minutes.
    Mr. Ruiz. Thank you very much.
    I'm really glad that we're having this hearing. It's the 
right topic at the right time. We really sincerely and 
genuinely have to learn from the past and what we did the first 
time so that we don't make mistakes that are detrimental to 
people. And why is that important? Because these are real 
people who have to take the burden of the human toll.
    And what's most distressing to me and we know most 
distressing to all of us, but me as a physician and now as a 
father, is the toll it has on children that are born with 
microcephaly, the developmental problems, the lifelong distress 
and concern and stress on that kid and the neighborhood and the 
parents, not to mention, the illnesses that may appear on 
adults and kids that we still don't know yet but that confirms 
with Guillain-Barre, heart disease, and other things that may 
appear 10, 15, 20 years down the road.
    So I want to focus on the funding and the approach to 
pandemics. First, Dr. Petersen, did you get what you asked for? 
Did the CDC get what they asked for in the initial round? And 
if not, what was the gap?
    Dr. Petersen. The CDC got a sufficient amount of funding to 
then mount a very robust response to the outbreak. It wasn't 
what we asked for, but it was sufficient to certainly 
prioritize resources to the highest risk areas, such as Puerto 
Rico, Texas, Florida, et cetera.
    Mr. Ruiz. So when you say that you didn't get what you 
asked for and yet you say that you have to do the research that 
you need, if you don't get what you ask for, if you don't get 
what you need, then that can delay the research that needs to 
be done in order to expedite a vaccine, expedite treatment, 
expedite understanding. Correct?
    Dr. Petersen. I think what's important to know----
    Mr. Ruiz. No. I'm asking about whether or not the funds 
that you get on the front end will affect the time it takes to 
develop a vaccine and the treatment and the research to 
understand how to combat it better. Is that correct?
    Dr. Petersen. Yes.
    Mr. Ruiz. Yes. And what are the consequences, therefore, 
meaning that if you don't have a vaccine, if you don't have a 
treatment, if you don't understand, then we can be a year, 2 
years, 3 years delayed in making sure that we're prepared the 
next time this happens.
    Dr. Fauci, I want to talk about the response and the 
approach that we did on the last pandemic that approached our 
territories and also in the U.S. There is a difference between 
the wait-and-see approach because we just don't have enough 
information, we don't know what this is going to look like, or 
the rapid-response prevention so that we can contain a pandemic 
at the site so it doesn't spread and have a human toll, whether 
it's in the territories, in the U.S.
    Tell me why the wait-and-see approach with pandemics is the 
wrong approach to treat a pandemic.
    Dr. Fauci. Well, it depends, sir, what you mean by ``wait-
and-see,'' to do what? With regard to the vaccine, which I'm 
responsible for, we didn't wait to see anything. The virus was 
isolated. It was----
    Mr. Ruiz. The wait-and-see approach in terms of, once you 
identify, do we go and respond to contain the virus or do we 
wait to see how virulent and how intense or how rapid it will 
spread?
    Dr. Fauci. Well----
    Mr. Ruiz. Do you wait to contain and see what happens, or 
do you want to go rapid response to prevent it at the scene?
    Dr. Fauci. OK. So that's a question that's a CDC question, 
and the CDC didn't wait. And I'll hand it over to Dr. Petersen 
because----
    Mr. Ruiz. No. I'm not saying they waited. I'm talking about 
our ability to fund the programs initially. It was Congress 
that waited to give the funds.
    Dr. Fauci. Well--OK. So if you're talking about funding, 
then let's just go back and reframe the answer. When we were 
aware of the difficulty--both the CDC and ourselves and the FDA 
and BARDA--we actually proposed a budget for each of us that 
the President asked for, and we didn't get that until months 
later. However----
    Mr. Ruiz. There was some delay time. And I think that the 
point I'm making is that there's a latency, and sometimes you 
don't see the immediate effects of a virus until later through 
the years, and that all depends on the virus. It's not as 
gruesome as the Ebola.
    Let me take a step back and look at the big picture. If you 
were a Zika virus and you wanted to wreak havoc on this world 
and you wanted to infect as many adults and as many children as 
possible, then you would want to decrease funding to stop or 
slow down the development of a vaccine, the treatment, or 
mosquito vector transmission prevention programs, and you would 
want to decrease funding in the NIH budget and the CDC budget.
    If you were a Zika virus and you wanted to infect as many 
women and children as possible, then you would think about 
maybe finding a way to deny coverage for maternity care or make 
it optional----
    Mr. Murphy. The gentleman's time has expired.
    Mr. Ruiz [continuing]. And even oral contraceptives. And 
that's exactly what we have to think about.
    Mr. Murphy. The gentleman's time has expired. I think the 
gentleman should be careful with the accusations you're saying 
on that.
    Who's next?
    Mr. Walberg, you're recognized for 5 minutes.
    Mr. Ruiz. For the Zika virus, maybe.
    Mr. Walberg. Thank you, Mr. Chairman.
    Dr. Fauci, while much has been learned about Zika virus, we 
talked about that today, many unknowns remain. With regard to 
research into the link between the Zika virus and microcephaly, 
is there any research about other factors? For example, since 
mercury has been linked to microcephaly for microcephaly cases 
in northeast Brazil, is any research being conducted on the 
levels of methylmercury and the mothers of the microcephaly 
babies?
    Dr. Fauci. To my knowledge, Mr. Walberg, the idea of 
looking at mercury as a factor in this is not being done, and I 
believe--not I believe--I know the reason why we're not 
focusing on that is that the evidence that the virus itself is 
capable of causing these defects is now pretty overwhelming as 
being the cause. Now, the idea of there being other secondary 
cofactors, there's no evidence offhand that there are any other 
contributing factors such as mercury.
    Mr. Walberg. OK. Well, similarly then, is any research 
being conducted into the effect that a previous infection with 
another flavivirus, such as dengue or chikungunya, could have 
on the rate of severity of microcephaly?
    Dr. Fauci. Yes. That is a good question and a good point. 
And the answer is, we are looking now from an epidemiological 
cohort study of individuals who have prior exposure, because 
there is this phenomenon that may or may not be relevant, we 
don't know, of antibody enhancement, at least in individuals 
who get infected with one form of dengue, one serotype and then 
another serotype. There's no solid evidence that preexisting 
response to one flavivirus like dengue has an impact on another 
flavivirus like Zika or yellow fever. There's no evidence yet 
that that's the case, but we are looking at that.
    Mr. Walberg. OK. Thank you.
    Mr. Petersen, what research has the CDC undertaken or what 
research do you plan to undertake into the link between Zika 
and microcephaly and other birth defects?
    Dr. Petersen. Right. So I think we've definitively 
established that Zika virus causes microcephaly, and I agree 
with Dr. Fauci, the studies we've done have not identified 
other cofactors, to date, that would influence that progression 
towards severe diseases in infants.
    It's important that we--to know that we really don't 
understand the full spectrum of Zika virus infection and its 
effect on fetuses and children born to mothers exposed to the 
Zika virus. So it's important that we continue our birth 
defects registries, as Dr. Fauci has mentioned, both here and 
in the U.S. territories so that we can really establish the 
full spectrum of diseases, disease outcomes associated with 
this virus.
    Mr. Walberg. Dr. Persons, could you identify some critical 
challenges that could likely arise with the next emerging 
infectious disease outbreak?
    Dr. Persons. So, yes, thank you for the question. The 
critical challenges we would see, again, is if we're more 
reactive, you're going to see a lot of the same sort of things. 
If it's particularly in the case of mosquito-borne, we're going 
to be much more reactive in terms of how we're dealing with 
that. We're going to be surging this way and lurching that way 
as an entire system. You're going to have a lot of rush to try 
and do something, and then, of course, that's always 
counterbalanced against the idea of getting, you know, getting 
data but then getting quality data and then acting upon that 
data and building your response effectively. So those are the 
things that we think will continue to happen.
    Mr. Walberg. OK. I yield back.
    Mr. Murphy. Mrs. Walters, you're recognized for 5 minutes.
    Mrs. Walters. I would like to thank the chairman for 
holding this hearing and the witnesses for their comments.
    On March 31, the California Department of Public Health 
announced that two breeds of mosquitoes that can carry the Zika 
virus have been found in 10 California counties, and my 
district is located in one of those 10 counties.
    Dr. Fauci, just recently, it was determined in Laos that 
there is a third mosquito more prevalently found throughout the 
United States that can carry the Zika virus. Is this correct?
    Dr. Fauci. Yes, that is correct, Mrs. Walters, but I think 
it's important to point out, since this subject always comes 
up, that the demonstration of the potential of a particular 
mosquito that can transmit the virus is not necessarily 
correlated with that mosquito in the field transmitting it.
    Right now, it's very clear that the overwhelming dominant 
mosquito that is responsible for this is the Aedes aegypti. 
Even though there have been studies in the lab where you take a 
group of mosquitoes of different species and you see if, in 
fact, the virus can survive in those mosquitoes, and the answer 
is yes, there are multiple mosquito types that can. The 
question is, will they, in fact, in the field do that? And 
there's very strong doubt that that is the case right now.
    Mrs. Walters. So would you say that this would present any 
additional risk to the United States?
    Dr. Fauci. No. I wouldn't say zero, but I think that what 
we've seen over the past now 2 years is the dominance of the 
Aedes aegypti mosquito. And if you look at, for example, the 
risk that we've seen now in Florida and in Texas, the 
mosquitoes that are in that area, the Gulf Coast area, are the 
Aedes aegypti mosquitoes, and it is almost certain that that's 
the mosquito that's doing the kind of local transmission that 
we've seen in Florida and the local transmission that we've 
seen in Texas.
    Mrs. Walters. OK. While the Department of Public Health has 
acknowledged that the transmission risk of Zika throughout the 
State of California is low, we must still be diligent in 
combatting the spread of invasive mosquitoes. Part of that 
includes education efforts that encourage residents to focus on 
controlling mosquito growth through proactive measures like 
eliminating all indoor and outdoor standing water and using 
window screens. Significant strides have been made, but more 
work and outreach is needed to avoid a Zika epidemic.
    Dr. Bright, what role has mosquito or vector control played 
in our response to Zika in the United States?
    Dr. Bright. Thank you for your question. So right now, the 
CDC has had the lead on vector control and understanding vector 
control and repellants and insecticides, and their use and how 
it will impact and reduce the spread of Zika.
    BARDA has not been focused, at this point, as a vector 
control as a form of a medical countermeasure, so we haven't 
supported those areas, but CDC has the lead on other vector 
control.
    Mrs. Walters. What would you say that the role of the 
Federal Government should play in mosquito control?
    Dr. Bright. I believe if the data would support that vector 
control and reduction of mosquitoes carrying the disease that 
can cause significant public health impact, then there would be 
a significant role for the Government to ensure that that 
medical countermeasure or that approach is used as an effort to 
reduce the transmission of that disease.
    I do not think at this point we have a significant amount 
of data that show clearly that even if you reduce the 
population of certain mosquitoes, it correlates with a 
reduction of disease in those areas. So we need to get 
additional data in that area.
    Mrs. Walters. OK. Is spraying insecticide an effective 
solution when dealing with breeds that carry Zika?
    Dr. Bright. I don't have data on that. I would defer to my 
CDC colleague, Dr. Petersen, to address that.
    Dr. Petersen. What we do know is that in Florida, the 
mosquito-control efforts that we did there appear to have 
stopped the outbreak in south Florida. It's important to know 
that spraying pesticides is just one part of a comprehensive 
strategy to mitigate against vector-borne diseases such as Zika 
virus.
    Mrs. Walters. OK.
    I yield back the balance of my time. Thank you.
    Mrs. Brooks [presiding]. The Chair now recognizes the 
gentleman from Pennsylvania for 5 minutes.
    Mr. Costello. Thank you. Currently, there is not a specific 
therapy or vaccine approved for the Zika virus by FDA, but 
several vaccines are in various stages of development, with one 
experimental vaccine currently in phase 2 trials being tested 
in humans.
    Dr. Fauci, that's correct?
    Dr. Fauci. Yes.
    Mr. Costello. And are there preliminary test results for 
the vaccine that is in the phase 2 trial?
    Dr. Fauci. Yes. So right now, the data that we have so far 
in the DNA vaccine, the one to which you're referring, Mr. 
Costello, is that clearly there are no safety red flags. The 
signal that we're having is that there does not seem to be any 
safety issues.
    In the phase 1 study, in the early part of the phase 2 
study, it has become clear that this vaccine induces the kind 
of response that you would predict from an extrapolation from 
the animal model that it would be protective. In other words, 
the titers of antibody are high enough that are induced by this 
vaccine that you would make a prediction, if it acts like the 
virus acts in the nonhuman primate model, that it would be 
protective upon exposure.
    Mr. Costello. And this question may have been asked, I 
apologize if it has, an updated timeline as to the completion 
of the vaccine that is in the phase 2.
    Dr. Fauci. Sure. The phase 2a, and now we're going to go 
into 2b in a few months, is scheduled for about 2,500 
individuals. That may go up to 5,000 individuals. The timeline 
of when you're going to get an efficacy signal is very variable 
because it depends on two things: one, what the inherent 
efficacy of the vaccine is, because a very effective vaccine is 
going to give you a signal more quickly. The other probably 
more important determining factor is going to be how much 
infection there is in the community in which you're testing.
    So if there's a very, very low level of Zika this coming 
season, particularly, for example, in the summer in Puerto 
Rico, it may take a few years before you get enough cases in 
the vaccine versus placebo to say it works. So that's the 
reason why, when I answered a similar question, I said it's 
really unpredictable. It can be as soon as a couple of years, a 
year and a half, 2, or as far as 3 or 4 or 5 years.
    Mr. Costello. Thank you.
    Does anyone else have anything to add to that?
    If not, I'll yield back.
    Mr. Burgess. Will the gentleman yield?
    Mr. Costello. I'd like to yield my time to Dr. Burgess.
    Mr. Burgess. Dr. Fauci, in 2014 when we were dealing with 
Ebola at the end of August, early September, that we were about 
at this phase with the Ebola vaccine, then the Ebola epidemic 
sort of went away, do we have an Ebola vaccine at this point, 
based on the work that was done in September of 2014?
    Dr. Fauci. Yes. And then I'll get to it just in a sec the 
difference between those two, and they're really quite 
different.
    So with Ebola, when we did a randomized placebo-controlled 
trial in Liberia, by the time we got it going and there were 
enough individuals in Liberia, it just stopped. There were no 
cases. So you couldn't test the efficacy of it. The similar 
vaccine--the same one--was used in a ring vaccination trial in 
Guinea. It wasn't the design of a trial to definitively prove 
that something worked, but it looked really good from the 
standpoint of the data.
    So we do have vaccine candidates, one of which has some 
considerable data that it looks like it might be effective, but 
we haven't definitively proven that yet. And right now, we're 
doing a trial in Guinea and in Liberia comparing two vaccines: 
the VSV vaccine, which was the one that was used in the ring 
vaccination study in Guinea, versus what's called an adenovirus 
plus an MVA boost from Johnson & Johnson, and we're comparing 
those two.
    Just one last word about the differences between the two is 
that Ebola is the kind of disease, there's an outbreak, and 
then it goes away. Just like we've seen right now in West 
Africa. When you have a mosquito-borne virus like flavivirus, 
it almost certainly is not going to disappear completely. So we 
may not have enough cases of Zika in Puerto Rico this summer or 
in Brazil the next few seasons, but it isn't going to go to 
zero. And that's the big difference between Ebola and this 
flavivirus.
    Mr. Burgess. Let me just ask you one other question. Are 
you to the point with the Ebola vaccine that you can 
communicate to Dr. Bright that he ought to consider the 
purchase of that vaccine for the national stockpile?
    Dr. Fauci. I'd yield that to Dr. Bright, but I think his 
answer is going to be no.
    Dr. Bright. Actually, we were quite encouraged by the 
progress in the development and the data supporting the Ebola 
vaccines. Again, some of these vaccines could be considered for 
use in the ongoing outbreak now we're seeing in the Democratic 
Republic of the Congo.
    Mr. Burgess. But part of the issue is, I guess, what Dr. 
Fauci said, it was hot as a pistol in August of 2014 and then 
it's not. So for the utility of BARDA to be able to purchase to 
provide that substrate that the companies that are 
manufacturing need the dollars to purchase their product, 
that's you, right?
    Dr. Bright. Yes. So, actually, at least one of these 
vaccines we do plan to transition over to purchase for the 
strategic national stockpile for Project BioShield support in 
this coming fiscal year, in the next fiscal year. It's 
important to remember that Ebola is not just a public health 
threat, it is also a national security threat. It is considered 
and has been deemed a material threat determination. And so we 
do support the use of those vaccines and procurement of those 
with Project BioShield.
    Mr. Burgess. Thank you for clarifying.
    Ms. Chairwoman, I yield back.
    Mrs. Brooks. Thank you.
    The Chair will now recognize myself for 5 minutes.
    And staying on that line of questioning, Dr. Bright, as you 
know, specific language was included in last year's 21st 
Century Cures to restore the contracting authority back to 
BARDA as it had been originally executed when the authority was 
established. And our intent was, in reaffirming the underlying 
statute, was to remove unnecessary layers of bureaucracy, 
increase your flexibility, and make sure BARDA can be nimble in 
making those development decisions without being second-guessed 
and slowed down through the extraneous layers of review which 
caused the delays and uncertainty.
    And so now that this is law or again it has been made law, 
what's been the impact of this provision specifically on 
getting development contracts in place on Zika virus?
    Dr. Bright. Thank you for your question. And that's a very 
important area. And we actually are very grateful that Congress 
has recognized the need for improved efficiency, especially 
improved efficiency in our contracting ability and working with 
industry to be able to move as quickly and nimbly as possible 
to respond to emerging threats and in our daily work for other 
threats that we address for our Nation.
    We are grateful for the 21st Century Cures Act and its 
passage. To date, it has not been implemented yet, as we are 
waiting for the permanent ASPR to take position hopefully in 
the near term, and we will be able to work hand-in-hand with 
that ASPR for full implementation of every provision in the 
21st Century Cures Act.
    Mrs. Brooks. So it's actually because the ASPR individual 
has not been named, confirmed, that is holding up the execution 
and use for Zika vaccine?
    Dr. Bright. We are working very hard at drafting proposals 
for the ASPR to consider. As you know, BARDA is a part of the 
ASPR, the Assistant Secretary for Preparedness Response, and so 
it's critical that we have that permanent ASPR in place to 
ensure that what we're putting in place for long-term is going 
to be coordinated and work hand-in-hand with the vision of that 
ASPR.
    We have not yet implemented and changed the contracting 
authority back to BARDA at this point; however, we are working 
as efficiently as we can with the ASPR's office of contracting 
to be able to move forward.
    Mrs. Brooks. OK. And I guess I'd just like to make sure I 
understand, because that provision was signed into law, and so 
it's unknown when a permanent ASPR--there's an acting ASPR 
individual, is there not?
    Dr. Bright. There is an acting ASPR, yes.
    Mrs. Brooks. And do we not have the Secretary of Health and 
Human Services in place that's been in place for some time, 
does the Secretary realize that that part of the law has not 
been implemented yet?
    Dr. Bright. I'm not able to speak on behalf of the 
Secretary, but I do know the Secretary recognizes the 
importance of efficiency and the importance of our ability to 
work with industry as efficiently and nimbly as possible. I do 
know that the acting ASPR is working with us on proposals, but 
we have not moved forward in implementing that yet.
    Mrs. Brooks. Do we have a timeframe on which the acting 
ASPR is going to, you know, put this matter before the 
Secretary?
    Dr. Bright. I do not have a timeframe on that.
    Mrs. Brooks. OK. How much money was provided to BARDA in 
2016 through the emergency funding to assist in the development 
of a Zika vaccine?
    Dr. Bright. In 2016, BARDA received $132 million, and that 
was distributed for vaccines and diagnostics and our pathogen 
reduction technologies. So vaccine specifically in 2016, we 
spent about $94 million.
    Mrs. Brooks. And can you describe then how BARDA did use 
these funds for the development of the vaccines, the 94 
million?
    Dr. Bright. Yes. Those funds were to support the 
technologies we have in our portfolio now, four different 
companies, who are working on Zika vaccines, and it supported 
the development and the initial manufacturing of those vaccine 
candidates and the movement of those vaccine candidates into 
phase 1 clinical studies. It was with the additional funds we 
received in fiscal year 2017 from the Zika supplemental, an 
additional $245 million, they were able to put to work to move 
those vaccines and diagnostic candidates into midstage phase 2 
clinical trials. And at that point, that is as far as we can 
move with the funding that we have.
    Mrs. Brooks. Thank you. And I'm going to switch very 
briefly.
    Dr. Borio, one thing we have not brought up and you brought 
up in your testimony, can you please describe the impact, as 
quickly as possible, of the Zika outbreak on the blood supply 
and how those blood supplies are currently being screened?
    Dr. Borio. So this is an area that we have worked very 
early on to mitigate the threat to the blood supply. Initially, 
before a screening test became available in the areas of Puerto 
Rico, for example, BARDA was very proactive and helped us 
ensure adequate blood supply to Puerto Rico, so the blood 
supply was imported into the island from the Continental United 
States. Eventually, blood donor screen tests became available 
under IND, and those were deployed.
    It became apparent last year that, with a number of 
travelers returning to the U.S., pretty much the entire 
continent was at risk of the blood supply of the entire United 
States, and we implemented guidance to make sure that all the 
blood supply then was screened for Zika.
    Mrs. Brooks. Thank you. Thank you. My time is up.
    I now call on Mr. Carter of Georgia for 5 minutes.
    Mr. Carter. Thank you, Madame Chair, and thank all of you 
for being here. Folks, what we do up here is important, but 
what you do is lifesaving, and we recognize that. We appreciate 
all your efforts of that.
    I have the honor and privilege of representing the entire 
coast of Georgia, over 100 miles of coastline where a third of 
the saltwater marsh in the country on the Atlantic Coast is 
located. We have mosquitoes. We have them bad. We're concerned 
about this, and I think rightfully so.
    I've had the opportunity to visit a number of mosquito 
control centers in our area, particularly in the two most 
populus counties in the coastal region, and they're doing a 
great job. I dare say that we could not, regardless of Zika, 
just the mosquito problem, we could not inhabit that area if we 
didn't have mosquito control, so it's extremely important.
    I wanted to ask just a couple of questions real quick. And, 
first of all, I have a question, Dr. Petersen, about the 
pregnancy register and registry, because from what I 
understand, and staff has told me, that there's some concerns 
that possibly it's not fully effective and that the outcomes 
that--and we're not getting the outcomes that we should in the 
people that are listed.
    Have you got any concerns with it? Is there anything we can 
do to assist you to help with any problems you might be having 
with it?
    Dr. Petersen. I think that the pregnancy registry so far 
has been very effective in terms of trying to figure out what 
the risks of Zika virus infection in the mother is on their 
developing fetus. What we really don't know and what we need 
continued support for is trying to figure out the whole 
spectrum of the illness associated with this virus. And that's 
just going to take time.
    Because what we know now is that some of the babies that 
may appear completely normal actually aren't. And so trying to 
figure out over a period of time and long enough followup is 
exactly needed to determine what the whole clinical spectrum of 
this disease actually is.
    Mr. Carter. What's the problem between the territory and 
Puerto Rico and America? I understand there's a significant 
difference there in the registry. Is there a reason for that or 
is there a concern there?
    Dr. Petersen. Right. So in the beginning, of course, we 
didn't really know much about the clinical syndrome associated 
with Zika. In the Continental United States, we took a very--
used a very broad definition to try and capture all the 
potential outcomes associated with this infection. Puerto Rico, 
on the other hand, used a very narrow definition. They were 
really focused on the most severe cases of microcephaly. And so 
that led to some discrepancies in numbers between the 
Continental United States and Puerto Rico.
    However, we have reconciled this. Puerto Rico is now using 
our case definition for congenital Zika syndrome and will be 
reporting out shortly similar numbers to what we have in the 
Continental United States.
    Mr. Carter. OK. All right.
    Dr. Borio, I want to ask you about public-private 
partnerships and how we can use them to speed up the vaccines 
and the development to market. Have you had experience with 
these? Is this something that does help that we can work on?
    Dr. Borio. Sure. The FDA has established public-private 
partnerships. I mean, this is very much a model that we work 
with to support the vaccine development. We have an important 
role as regulators, and we have to maintain some firewalls 
between us and the development.
    Mr. Carter. Right.
    Dr. Borio. But I have to explain to you that, you know, our 
technical teams are deeply involved with all the different 
working groups that are developing vaccines and providing very 
much, in realtime, feedback and active guidance----
    Mr. Carter. Very quickly, any hurdles that you see that 
perhaps we can assist you with?
    Dr. Borio. No. We deeply appreciate the support we have. We 
feel like we have the authorities today. And this year, we 
received resources to be able to support the Zika response. 
We're in pretty good shape. Thank you.
    Mr. Carter. Good, good.
    Very quickly, Dr. Bright, I wanted to ask you, it's my 
understanding in your testimony you mentioned that you're 
working with a company in Brazil to come up with a vaccination. 
Just out of curiosity, their regulations and their licensing 
arrangements and clinical trial requirements, et cetera, et 
cetera, are they significantly different from what we have here 
in America? Can you see of anything that we can do better here 
in America to help along this line?
    Dr. Bright. Thank you. They have an independent regulatory 
authority, ANVISA. We've worked with the companies in Brazil 
for the last 10 years in developing, manufacturing, and vaccine 
development capacity for pandemic influenza and other vaccines, 
and we've also noticed they are very closely collaborating with 
our U.S. FDA. So there's an agreement between our U.S. FDA and 
the Brazilian regulatory authority that allows them to exchange 
information and best practices and protocols to accelerate the 
development of vaccines, actually in our country, as well as 
theirs.
    Mr. Carter. I'm encouraged to hear that. In fact, I want to 
compliment all of you. I'm encouraged by what I've heard today, 
and I appreciate your work on this. And from what I'm hearing, 
we're making progress. So thank you very much.
    And I yield back.
    Mrs. Brooks. Thank you.
    The Chair now recognizes the gentleman from Florida, Mr. 
Bilirakis, for 5 minutes.
    Mr. Bilirakis. Thank you, Madame Chair. I appreciate it. 
Thank you for allowing me to sit in on the hearing, because I'm 
not on this subcommittee, so I really appreciate it. And I want 
to thank the panel too. I'm from the State of Florida, so 
obviously we've been affected by the Zika virus, so I 
appreciate all your assistance. I have a few questions.
    Dr. Persons, could you discuss how we can best streamline 
agency coordination to prevent bureaucratic overlap and 
redundancies, which can lead to waste and unnecessary delays 
and hamper the effectiveness of response?
    Dr. Persons. Thanks, Mr. Bilirakis. So I appreciate the 
question.
    Mr. Bilirakis. Sure.
    Dr. Persons. I'll answer it in two ways. One is GAO has a 
standard manual for internal controls, and it's called the 
Green Book. So just the efficacious implementation of those 
internal control standards, which primarily often have to do 
with interdepartmental communication and things which often is 
at the core of this. As you know, all the agencies here have 
very important--they're doing very important work, very 
important roles in things, but that systematic look at 
something and being able to coordinate is easy to say but 
harder to do and yet very important and critical to a timely 
response.
    The second answer I would say is related to just our 
overall work. GAO, as you may know, does work on overlap and 
duplication, and so we have a standing methodology on looking 
at what constitutes overlap, duplication, or even fragmentation 
among Federal programs. That report just went out recently, and 
there's methodology behind the thinking on that that might be 
commendable to this conversation.
    Mr. Bilirakis. Thank you.
    Next question for Dr. Bright. With a coordinated 
interagency response, are there interagency goals that drive 
responsive preparedness strategies? If so, what are those 
goals?
    Dr. Bright. Our goals. So our Assistant Secretary 
coordinates all of our research efforts and response efforts to 
the Zika response and other public health emergencies. And so 
we established, early on in the outbreak, an awareness of the 
Zika outbreak that we would have interagency alignment and 
vaccine production and diagnostic production and other 
countermeasure development. And we established and drafted HHS-
wide, U.S. Government-wide goals to achieve the milestones for 
those vaccines and diagnostics.
    Mr. Bilirakis. Thank you.
    Dr. Petersen, CDC established a Zika registry last year. 
What data is captured in this registry? How is this data being 
utilized?
    Dr. Petersen. So we gather data on evaluations that are 
done on the mother and fetus throughout pregnancy, and 
importantly, also on the condition of the fetus and medical 
consequences of infection following birth. We hope to continue 
this work and to follow these infants born to mothers infected 
during pregnancy to determine what the full impact of the virus 
infection in the mother actually is on the fetus. And that's 
still an open question.
    Mr. Bilirakis. OK. What's the value to researchers of 
tracking beyond 1 year or tracking 5 years? What are the 
benefits to that?
    Dr. Petersen. Well, I think the benefits are primarily, 
number one, telling people what to expect. Two is to provide 
appropriate medical care and social services for those infants 
in this condition.
    Mr. Bilirakis. So you would recommend tracking 5 years as 
opposed to just one?
    Dr. Petersen. Recommend follow--excuse me?
    Mr. Bilirakis. Yes, you would recommend the 5 years?
    Dr. Petersen. I think we need to follow these infants up 
for, you know, probably 5 years or possibly even longer, 
depending on what we find.
    Mr. Bilirakis. Even longer? Very good. Thank you very much. 
Good information.
    Dr. Persons, earlier this year, the administration released 
a brief budget outline that proposed a coordination point for 
Zika-related activity. Can you share observations on how such a 
central coordinating point could help?
    Dr. Persons. So, yes, thank you for the question. I think 
this again is--this incidence with Zika as an emerging 
infectious disease is one of a kind, and it's unique in one 
way, but we've seen the pattern before. And so I think as you 
shift more toward a stronger central coordinating factor, I 
would say, for example, there's the importance Dr. Fauci 
mentioned earlier on ASPR and that within or interdepartmental 
coordination with HHS is certainly critical. There's also sort 
of a whole-of-Government thing that I think was on display when 
the previous administration had appointed an Ebola czar back 
during the Ebola timeframe, just because there are oftentimes 
things, even outside of big HHS and all the important work 
they're doing, there's often whole-of-Government response that 
may involve, for example, DOD, or in this case with mosquito-
borne vector disease, you're talking about the regulator of 
pesticides, EPA, or various other things.
    So I think there's some potential commendable thinking on 
what that central function coordinating might look like even in 
the whole-of-Government sense on something this complex and 
this rapidly evolving.
    Mr. Bilirakis. OK. I want to thank all of you for your 
efforts, and I look forward to working with you. We can combat 
this virus. So I really appreciate the testimony.
    And I yield back, Madame Chairwoman. Thank you.
    Mrs. Brooks. Thank you to our colleague from Florida.
    And to close out----
    Ms. Castor. Yes. Madame Chair, I wanted to thank you and 
Congressman Murphy for organizing this hearing on Zika, and 
thanks to all of our expert panelists.
    We've got to remain vigilant and address the funding cliff 
that's coming up, and also the elephant in the room today with 
the Trump budget; we're never going to be able to protect our 
families and businesses across this country if we don't keep 
America as the world leader in medical research and in disease 
prevention. Proposed cuts to things like CDC's Center on Birth 
Defects would come at the exact wrong time when we're seeing an 
increase in birth defects largely driven by Zika.
    Democrats and Republicans came together in the last funding 
bill and said we are the world leader, and we're going to keep 
it that way in medical research and disease prevention. And I 
trust that we can all work together to keep it that way again. 
And thank you again.
    Mrs. Brooks. And I'd like to thank all of the witnesses. 
Thank you for your incredible dedication. And I'd like to thank 
all of your agencies for continuing to work together in the 
most efficient and most effective way, because the issue of 
Zika is obviously not going away. Issues of other infectious 
diseases, whether it's Ebola in West Africa, whether it's 
cholera in Yemen and other diseases, we must make sure that we 
as a Government are keeping our citizens safe, that we're 
learning as much as we can based on all of the outstanding work 
of your agencies. And we will continue to work with you to make 
sure that you do have the resources that you need.
    And in conclusion, I'd like to thank all the witnesses and 
Members that participated in today's hearing. Remind Members 
they have 10 business days to submit questions for the record. 
I ask that the witnesses all agree to respond promptly to those 
questions.
    And the subcommittee is adjourned. Thank you.
    [Whereupon, at 12:37 p.m., the subcommittee was adjourned.]
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