    [House Hearing, 114 Congress]
    [From the U.S. Government Publishing Office]

          EXAMINING THE U.S. PUBLIC HEALTH RESPONSE TO THE ZIKA VIRUS

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

                                    HEARING

                                   BEFORE THE

                  SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                     OF THE

                        COMMITTEE ON ENERGY AND COMMERCE
                            HOUSE OF REPRESENTATIVES

                        ONE HUNDRED FOURTEENTH CONGRESS

                                 SECOND SESSION

                                   __________

                                 MARCH 2, 2016

                                   __________

                               Serial No. 114-124

     [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

          Printed for the use of the Committee on Energy and Commerce

                            energycommerce.house.gov

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                       COMMITTEE ON ENERGY AND COMMERCE

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

                  Subcommittee on Oversight and Investigations

                            TIM MURPHY, Pennsylvania
                                     Chairman
    DAVID B. McKINLEY, West Virginia     DIANA DeGETTE, Colorado
      Vice Chairman                        Ranking Member
    MICHAEL C. BURGESS, Texas            JANICE D. SCHAKOWSKY, Illinois
    MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
    H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
    LARRY BUCSHON, Indiana               JOHN A. YARMUTH, Kentucky
    BILL FLORES, Texas                   YVETTE D. CLARKE, New York
    SUSAN W. BROOKS, Indiana             JOSEPH P. KENNEDY, III,
    MARKWAYNE MULLIN, Oklahoma               Massachusetts
    RICHARD HUDSON, North Carolina       GENE GREEN, Texas
    CHRIS COLLINS, New York              PETER WELCH, Vermont
    KEVIN CRAMER, North Dakota           FRANK PALLONE, Jr., New Jersey (ex
    JOE BARTON, Texas                        officio)
    FRED UPTON, Michigan (ex officio)

                                 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. Kathy Castor, a Representative in Congress from the State of
      Florida, opening statement.....................................     5
    Hon. Michael C. Burgess, a Representative in Congress from the
      State of Texas, opening statement..............................     5
    Hon. Fred Upton, a Representative in Congress from the state of
      Michigan, prepared statement...................................   143

                                   Witnesses

    Nicole Lurie, M.D., Assistant Secretary for Preparedness and
      Response, U.S. Department of Health and Human Services.........     8
        Prepared statement...........................................    11
        Answers to submitted questions                                  144
    Thomas Frieden, M.D., Director, Centers for Disease Control and
      Prevention.....................................................    21
        Prepared statement...........................................    23
        Answers to submitted questions...............................   148
    Anthony Fauci, M.D., Director, National Institute of Allergy and
      Infectious Diseases, National Institutes of Health.............    31
        Prepared statement...........................................    33
        Answers to submitted questions...............................   155
    Luciana Borio, M.D., Assistant Commissioner, Counterterrorism
      Policy, U.S. Food and Drug Administration......................    44
        Prepared statement...........................................    46
        Answers to submitted questions...............................   159
    Timothy Persons, Ph.D., Chief Scientist, U.S. Government
      Accountability Office..........................................    55
        Prepared statement \1\
    Peter Hotez, M.D., Ph.D., Dean, National School of Tropical
      Medicine, Baylor College of Medicine, President, Sabin Vaccine
      Institute, and Texas Children's Hospital Endowed Chair in
      Tropical Pediatrics............................................    78
        Prepared statement...........................................    80
        Answers to submitted questions...............................   167
    Lawrence O. Gostin, J.D., Linda D. and Timothy J. O'Neill
      Professor of Global Health Law, Georgetown University Law
      Center.........................................................    90
        Prepared statement...........................................    92
        Answers to submitted questions...............................   171
    Joseph Conlon, M.S., Technical Advisor, American Mosquito Control
      Association....................................................   105
        Prepared statement...........................................   108
        Answers to submitted questions...............................   181
    Jeanne Sheffield, M.D., Director, Division of Maternal-Fetal
      Medicine, Johns Hopkins School of Medicine.....................   122
        Prepared statement...........................................   124
        Answers to submitted questions...............................   187

    ----------
    \1\ Mr. Person's testimony is available at: http://
      docs.house.gov/meetings/if/if02/20160302/104594/hhrg-114-if02-
      wstate-personst-20160302.pdf.

          EXAMINING THE U.S. PUBLIC HEALTH RESPONSE TO THE ZIKA VIRUS

                                  ----------

                            WEDNESDAY, MARCH 2, 2016

                      House of Representatives,
          Subcommittee on Oversight and Investigations,
                              Committee on Energy and Commerce,
                                                        Washington, DC.
        The subcommittee met, pursuant to call, at 10:15 a.m., in
    room 2322 Rayburn House Office Building, Hon. Tim Murphy
    (chairman of the subcommittee) presiding.
        Members present: Representatives Murphy, Burgess, Griffith,
    Brooks, Mullin, Hudson, Collins, Cramer, Castor, Tonko, Clarke,
    Kennedy, Welch, and Pallone (ex officio).
        Also present: Representative Bilirakis.
        Staff present: Brittany Havens, Oversight Associate,
    Oversight and Investigations; Charles Ingebretson, Chief
    Counsel, Oversight and Investigations; Tim Pataki, Professional
    Staff Member; Chris Santini, Policy Coordinator, Oversight and
    Investigations; Alan Slobodin, Deputy Chief Counsel, Oversight
    and Investigations; Sam Spector, Counsel, Oversight and
    Investigations; Dylan Vorbach, Deputy Press Secretary;
    Christine Brennan, Minority Press Secretary; Jeff Carroll,
    Minority Staff Director; Waverly Gordon, Minority Professional
    Staff Member; Ryan Gottschall, Minority GAO Detailee; Chris
    Knauer, Minority Oversight Staff Director; Una Lee, Minority
    Chief Oversight Counsel; Elizabeth Letter, Minority
    Professional Staff Member; Andrew Souvall, Minority Director of
    Communications, Outreach and Member Services; and Kimberlee
    Trzeciak, Minority Health Policy Advisor.

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

        Mr. Murphy. Good morning. We are here for the subcommittee
    on Oversight and Investigations for the Committee on Energy and
    Commerce for a hearing called ``Examining the U.S. Public
    Health Response to the Zika virus.''
        This morning we'll be examining this other public health
    crisis affecting the Western Hemisphere, that Zika virus. This
    virus of mosquito-borne pathogen is currently rampaging through
    South and Central America, and in total has spread to more than
    48 countries and territories.
        While as of late February there have been no known locally-
    acquired mosquito-borne cases reported in the Continental U.S.,
    over 100 travel-associated Zika virus cases have been
    identified in over 20 states. Outside of the 50 states local
    mosquito-borne transmissions have been reported in Puerto Rico,
    the U.S. Virgin Islands, and American Samoa. Public health
    officials in the U.S. are bracing for the time when Zika passes
    from a traveler with Zika in his or her blood to a local
    mosquito, and then to another person.
        Only about one and five people with Zika infection exhibit
    symptoms, most of which are mild and flu-like. Of greater
    concern is growing evidence of a link between Zika infection
    and microcephaly, a congenital birth defect in infants born to
    infected mothers, as well as Guillain-Barre Syndrome, an immune
    disorder that can result in temporary paralysis. On this basis,
    the World Health Organization recently declared Zika a public
    health emergency of international concern.
        The virus may also be transmitted through blood
    transfusions and sex, leaving the Center for Disease Control to
    issue interim guidelines for prevention of sexual transmission,
    and the Food and Drug Administration to take steps to reduce
    the risk to the U.S. blood supply.
        Thus far, there has been only one reported case in the U.S.
    of a child born with microcephaly to a mother with travel-
    associated Zika virus. However, other pregnant American women
    have become infected with Zika. Our understanding of how the
    virus may impact a developing child during pregnancy is nearly
    non-existent. We can, however, reasonably assume that a virus
    affecting development of the brain on a large scale leading to
    microcephaly in the first trimester will also impact
    significant developmental functions for infants, toddlers, and
    children exposed to the Zika virus. These include my concerns
    for developmental disorders of difficulty with learning,
    primary sensory and sensory integration, memory, attention,
    concentration, behavior, mood, language, motor, and others.
        Given all of the unknowns the importance of acting now to
    protect pregnant women and women of reproductive age from
    exposure to Zika virus cannot be overstated. However, we must
    be equally concerned with protecting infants and children with
    developing brains and not wait 5 to 10 years for symptoms to
    appear before we take action to protect, to track, and to
    treat.
        To help prepare for and respond to Zika, the Administration
    recently requested Congress provide over $1.8 billion in
    emergency funding. The request includes support to states, U.S.
    territories, the International Community for Mosquito Control,
    virus testing, and expanding surveillance and response
    activities. It also supports efforts to build upon existing
    resources to develop a vaccine for Zika.
        While the Administration's request has worthy aims, it's
    one-off emergency funding approach like the $6 billion for
    Ebola emergency funding demonstrates a reactionary posture
    towards public health preparedness rather than a strategic one.
    We want a strategic posture.
        On February 12th, this subcommittee held a hearing
    examining the federal government's preparedness for biological
    threats focused on the finding of the Blue Ribbon Study Panel
    on Biodefense. The panel concluded that the federal government
    is ill prepared to handle future biological threats, an
    alarming conclusion because since 2002 infectious disease
    outbreaks, epidemics, and pandemics have emerged with
    increasing frequency, and Zika is just the latest example of
    this trend.
        The Administration's response to Zika raises very serious
    questions. There are no commercially available diagnostic tests
    for Zika, nor has a vaccine been developed. In the absence of
    these measures, mosquito control is the nation's critical
    defense. However, mosquito control in the U.S. is a patchwork
    of 700 mosquito abatement districts depending on the state,
    county, and city funding and personnel with varying
    capabilities. This unorganized hodgepodge could leave the U.S.
    vulnerable to a rapid outbreak of Zika. The Administration has
    not explained how its emergency request will address issues
    with vector control. We want to work with the Administration to
    solve that problem.
        Public Health Departments and the CDC are using two Zika
    diagnostic tests only available for U.S. labs. As the
    Government Accountability Office testimony makes clear, these
    tests have serious limitations, including the ability to either
    detect Zika or to be able to distinguish Zika from other
    viruses.
        In addition, the confirmatory testing for Zika detection is
    used only by CDC and a few labs, is cumbersome and not suitable
    for screening a large number of individuals. This very limited
    capacity for confirmatory testing is very troubling when we
    consider the expected surge and the demand for Zika testing as
    we reach the warmer months. Again, the Administration must
    explain its plan to address this testing capacity issue.
        Once again as with Ebola, we are assured that Zika will not
    be a significant problem in the U.S., and while Dr. Anthony
    Fauci of NIH has stated that it is unlikely the U.S. will have
    a major Zika outbreak, other experts differ. In his written
    testimony to this committee, Dr. Peter Hotez of Baylor School
    of Medicine notes the experience of Texas showed a Dengue
    outbreak occurred in the poorest areas of Houston and other
    Gulf Coast cities vulnerable to Zika.
        This morning we'll be taking testimony from a panel of
    federal witnesses and experts, including the Assistant
    Secretary for Preparedness and Response at HHS, the Director of
    CDC, the Director of the National Institute of Allergy and
    Infectious Diseases at NIH, the Acting Chief Scientists of FDA,
    as well as the Chief Scientist of the GAO. Welcome. We will
    then hear from a second panel featuring specialists in tropical
    and maternal fetal medicine, mosquito control, and global
    health law.
        I want to thank all our witnesses for joining us this
    morning and look forward to hearing your testimonies.
        I now recognize, since Ms. DeGette is not here, we're
    promoting her to the Ranking Member Pro Tempe of the
    subcommittee, Ms. Castor of Florida, for 5 minutes.
        [The statement of Mr. Murphy follows:]

                     Prepared statement of Hon. Tim Murphy

        This morning, we will be examining a public health crisis
    afflicting the Western Hemisphere. The Zika virus, a mosquito-
    borne pathogen rampaging through South and Central America,
    advances menacingly toward the U.S. The Zika virus has spread
    to more than 48 countries and territories. While as of late
    February there had been no known locally acquired mosquito-
    borne cases reported in the continental U.S. states, over 100
    travel-associated Zika virus disease cases have been identified
    in over 20 states. Outside of the 50 states, local mosquito-
    borne transmission has been reported in Puerto Rico, the U.S.
    Virgin Islands, and American Samoa. Public health officials in
    the U.S. are bracing for the time when Zika passes from a
    traveler with Zika in his or her blood to a local mosquito, and
    then to another person.
        Only about one in five people with Zika infection exhibit
    symptoms, most of which are mild and flu-like. Of greater
    concern is growing evidence of a link between Zika infection
    and microcephaly, a congenital birth defect in infants born to
    infected mothers, as well as Guillain-Barre AE1 Syndrome, an
    immune disorder that can result in temporary paralysis. On this
    basis, the World Health Organization recently declared Zika a
    ``public health emergency of international concern.''
        The virus may also be transmitted through blood
    transfusions and sex, leading the Centers for Disease Control
    (CDC) to issue interim guidelines for prevention of sexual
    transmission and the Food and Drug Administration (FDA) to take
    steps to reduce the risk to the U.S. blood supply. Thus far,
    there has been only one reported case in the U.S. of a child
    born with microcephaly to a mother with travel-associated Zika
    virus; however, other pregnant American women have become
    infected with Zika. Our understanding of how the virus may
    impact a developing child during pregnancy is nearly non-
    existent. Given all of the unknowns, the importance of acting
    now to protect pregnant women and women of reproductive age
    from exposure to Zika virus cannot be overstated.
        To help prepare for and respond to Zika, the Administration
    recently requested Congress to provide over $1.8 billion in
    emergency funding. The request includes support to states, U.S.
    territories, and the international community for mosquito
    control, virus testing, and expanding surveillance and response
    activities. It also supports efforts to build upon existing
    resources to develop a vaccine for Zika.
        While the Administration's request has worthy aims, its
    one-off emergency funding approach, like the $6 billion for
    Ebola emergency funding, demonstrates a reactionary posture
    towards public health preparedness rather than a strategic one.
    On February 12th, this Subcommittee held a hearing examining
    the federal government's preparedness for biological threats,
    focused on the findings of the Blue Ribbon Study Panel on
    Biodefense. The panel concluded that the federal government is
    ill-prepared to handle future biological threats--an alarming
    conclusion because, since 2002, infectious disease outbreaks,
    epidemics, and pandemics have emerged with increasing
    frequency. Zika is just the latest example of this trend.
        The Administration's response to Zika raises very serious
    questions. There are no commercially available diagnostic tests
    for Zika, nor has a vaccine been developed. In the absence of
    these measures, mosquito control is the nation's critical
    defense. However, mosquito control in the U.S. is a patchwork
    of 700 mosquito-abatement districts dependent on state, county,
    or city funding and personnel, with varying capabilities. This
    unorganized hodgepodge could leave the U.S. vulnerable to a
    rapid outbreak of Zika. The Administration has not explained
    how its emergency request will address issues with vector
    control.
        Public health departments and the CDC are using two Zika
    diagnostic tests only available for U.S. labs. As the
    Government Accountability Office's testimony (GAO) makes clear,
    these tests have serious limitations, including the ability to
    either detect Zika or to be able to distinguish Zika from other
    viruses. In addition, the confirmatory testing for Zika
    detection is used only by CDC and a few labs, is cumbersome,
    and not suitable for screening a large number of individuals.
    This very limited capacity for confirmatory testing is very
    troubling when we consider the expected surge in the demand for
    Zika testing as we reach the warmer months. Again, the
    Administration must explain its plan is to address the testing
    capacity issue.
        Once again, as with Ebola, we are assured that Zika will
    not be a significant problem in the U.S. While Dr. Anthony
    Fauci of the NIH has stated that it is unlikely that the U.S.
    will have a major Zika outbreak, another expert differs. In his
    written testimony to the committee, Dr. Peter Hotez, of Baylor
    School of Medicine, notes that the experiences of Texas showed
    dengue outbreaks occurred in the poorest areas of Houston and
    other Gulf Coast cities vulnerable to Zika.
        This morning we will be taking testimony from a panel of
    federal witnesses, including the Assistant Secretary for
    Preparedness and Response at HHS, the Director of CDC, the
    Director of the National Institute of Allergy and Infectious
    Diseases at NIH, the Acting Chief Scientist of FDA, as well as
    the Chief Scientist of the GAO.
        We will then hear from a second panel featuring specialists
    in tropical and maternal-fetal medicine, mosquito control, and
    global health law. 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 her opening statement.

      OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF FLORIDA

        Ms. Castor. Well, thank you, Mr. Chairman, for calling this
    important hearing, and I want to thank all of our expert
    witnesses who are here today for everything that you do to keep
    American families healthy and safe.
        So many of my neighbors across the State of Florida, and
    the Gulf Coast, and Puerto Rico are very concerned with the
    impacts of the Zika virus. We want our states and our
    communities to be well prepared and we want to better
    understand the impacts of the virus.
        In Florida, CDC has confirmed the Zika case count is now up
    to 44 cases. All of these cases are travel-related, so there
    are no locally-acquired cases in Florida. Overwhelmingly,
    people who have traveled to Brazil and Latin America to visit
    family and friends, or travel on business or for pleasure have
    contracted the virus and have brought it back. Fortunately, the
    Zika symptoms are not severe but there is a great concern for
    emerging evidence to support the association between Zika and
    microcephaly in infants born to mothers who contracted the Zika
    virus during pregnancy.
        I'm also especially concerned with the American citizens in
    Puerto Rico because we now have 117 confirmed cases. It is the
    most affected area in the United States, and the CDC predicts a
    sharp rise. Again, family and friends who travel back and forth
    from Puerto Rico to the U.S. want to know what the impacts are
    and how they can be better prepared, especially as spring and
    summer approach. That's going to bring larger and more active
    mosquito populations. The U.S. must be prepared to quickly
    address local transmission within Puerto Rico, the Gulf Coast,
    and the entire United States.
        I'm also particularly concerned with the weakening of our
    public health infrastructure across the country. After the
    Great Recession, I saw very significant cuts in the State of
    Florida, but Florida is not alone. We have those cuts and
    weakenings to public health departments and public health
    infrastructure. And I think Ebola was something of a wake-up
    call, but the Zika virus and other viruses, diseases, we've got
    to be better prepared. I agree with Chairman Murphy, a much
    more robust prevention strategy would be in our best interest.
        For the Zika virus, addressing the crisis requires a
    multidimensional response, including accelerating the research,
    development, and procurement of vaccines and diagnostics,
    providing emergency assistance to states. Thank you, CDC, for
    what you've done in responding quickly to the State of
    Florida's request, and we've got to enhance our surveillance
    capacity.
        Thank you, again. I look forward to your testimony. I yield
    back.
        Mr. Murphy. Thank you. Now we'll take Mr. Upton's
    testimony, and for the record recognize Dr. Burgess for 5
    minutes.

    OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
                  IN CONGRESS FROM THE STATE OF TEXAS

        Mr. Burgess. Thank you, Chairman, thank you for the
    recognition, thank you for having this hearing this morning,
    thanks to our witnesses. We always learn so much when we have a
    panel like this in front of us, and today I'm sure will be no
    exception.
        This virus continues to spread through the Americas and it
    really has become clear that this is a direct threat to our
    public health and our public safety. So I'm in contact with
    people back in my state, and my county health officials, and
    one of the things that they've expressed to me is concern over
    the flexibility and the scalability of federal aid at the state
    level, so I'm actually interested in hearing from our panel
    about that this morning. Obviously, I share that concern. It is
    important that state and local agencies, as well as the local
    docs on the ground have the ability to fight what they need to
    fight and not have barriers from us at the federal level.
        You know, Ebola happened in our backyard in north Texas,
    and many ways we thought we were prepared, but in some ways we
    turned out not to be prepared. So I guess I'm interested this
    morning; yes, I want the reassurances that we're prepared, but
    I really also want to hear what were the Lessons Learned when
    we went through the Ebola crisis in September and October of
    2014, and what is the applicability of those lessons to what's
    going on on the ground today. A variety of other questions
    concerning the testing and the development of tests for this
    illness. And, obviously, I'm terribly interested, Dr. Fauci, in
    the pathogenesis of the illness as it affects pregnancies, both
    miscarriages and infants who are born affected, and very
    interested in learning the status of the vaccine development.
        Thank you, Mr. Chairman. I will yield back my time.
        Mr. Murphy. Anybody else on our side wish to take any time?
    If not, Mr. Pallone on his way but what we'll do is we will
    begin our testimony, or begin that process. When he comes in,
    we may interrupt after one of you speak.
        Let me introduce the panel, start off with this. We have
    Dr. Nicole Lurie, Assistant Secretary for Preparedness and
    Response with the Department of Health and Human Services; Dr.
    Thomas Frieden, Director of the Centers for Disease Control and
    Prevention; Dr. Anthony Fauci, Director of the National
    Institute of Allergies and Infectious Diseases at NIH; Doctor,
    is it Luciano or Luciana?
        Dr. Borio. Luciana.
        Mr. Murphy. Luciana Borio, Acting Chief Scientist at FDA;
    and Dr. Timothy Persons, Chief Scientist at the U.S. Government
    Accountability Office. Welcome everyone for being here.
        You're aware that the committee is holding an investigative
    hearing and when so doing has the practice of taking testimony
    under oath. Do any of you have any objections to taking
    testimony under oath? Seeing no objections, the Chair then
    advises you that under the rules of the House and the rules of
    the committee you're entitled to be advised by counsel. Do any
    of you desire to be advised by counsel during your testimony
    today?
        Dr. Borio. No.
        Mr. Murphy. No one wants that, so in that case would you
    all please rise, raise your right hand. I'll swear you in.
        [Witnesses sworn.]
        Mr. Murphy. Thank you. You are now all under oath and
    subject to the penalties set forth in Title 18, Section 1001 of
    the United States Code. We'll have you give a 5-minute opening
    statement. Mr. Pallone, do you want to give yours now or do you
    want to wait until we do some of the panel? We can go right to
    your opening statement.
        Mr. Pallone. It's up to you.
        Mr. Murphy. Well, let's make a smooth transition. If you're
    ready, we'll do that now, and then I'll call on Dr. Lurie. We
    just did the swearing in so you're aware of what we did. So Mr.
    Pallone is recognized for 5 minutes.
        Mr. Pallone. Thank you, Mr. Chairman, and the witnesses
    today for joining us to discuss the Zika virus and what the
    federal government is doing to respond to the threat.
        Zika represents a serious threat to global health and
    security and we must address that threat decisively both at
    home and abroad. It's suspected of causing a multitude of
    devastating birth defects, most notably microcephaly, a
    condition which babies are born with severe brain defects. In
    adults, the virus has been associated with Guillain-Barre AE1
    Syndrome which can result in paralysis and even death. Although
    scientists are not able to say definitively that Zika is the
    cause, evidence is mounting each day to support a causal
    relationship between the virus and these serious health
    conditions.
        The Zika virus is spreading explosively through the
    Americas with active local transmission in 31 countries and
    territories. The Pan American Health Organization predicts that
    the virus will eventually spread to every country in the
    Americas except perhaps Canada and Chile.
        The crisis in Puerto Rico could become particularly severe
    as Zika is expected to infect one in five Puerto Ricans, and
    given the territory's debt crisis and inability to fund even
    the most basic health services robust assistance from the
    federal government will be absolutely crucial to contain the
    virus and protect as many pregnant women as possible.
        As spring and summer approaches we must also be prepared to
    address local transmission of Zika within the Continental
    United States, particularly in southern states where the
    mosquitoes that carry the disease are common.
        As Dr. Hotez on our second panel has previously noted,
    ``Local transmission of Zika in the U.S. will likely
    disproportionately affect poor neighborhoods in the southern
    states where inadequate window screening, standing water, and
    imperfect waste disposal provide ideal mosquito breeding
    grounds, and addressing Zika will require a multidimensional
    public health response. It must include accelerating research,
    development, and procurement of vaccines and diagnostics,
    providing emergency assistance to states and the U.S.
    territories, and enhancing our surveillance capacity to track
    the Zika virus in people and in mosquitoes.''
        The Administration has requested emergency funding to
    address each of these components, and I look forward to hearing
    more about the details of this request today. Unfortunately,
    the Republican chairs of the House Appropriations Committee
    have declined to fund the Administration's request and have,
    instead, called upon the agencies to divert unobligated Ebola
    funds. I believe this decision is shortsighted and would
    increase health risks both at home and abroad.
        As our witnesses will make clear today, Ebola remains and
    will continue to remain a threat to human health for the
    foreseeable future. It could reemerge at any point, and as
    we've seen it can cause outbreaks that decimate economies,
    trigger widespread panic, and result in a tragic loss of human
    life.
        NIH is using its Ebola funds to conduct essential ongoing
    research including the development of an Ebola vaccine, and CDC
    is continuing to conduct its global efforts to combat the Ebola
    Virus on the ground. Shortchanging these efforts would damage
    our ability to effectively respond to both Zika and Ebola, as
    well as to any future threats. The remaining Ebola funds are
    largely committed to the global health security agenda, a
    multi-year effort to keep Americans safe by strengthening the
    capacity of developing countries to prevent, detect, and
    respond to emerging epidemics.
        Let's not forget how Ebola managed to spiral out of
    control. To build an effective global system for containing
    infectious disease we must make sure that the poorest and most
    vulnerable countries have the surveillance capacity to identify
    outbreaks and respond quickly, and fighting Zika will not be
    easy. Like Ebola, it thrives in impoverished communities and
    its heaviest burden falls on vulnerable populations least able
    to respond. The disease is difficult to track as most people
    infected with Zika experience no symptoms, and the research
    agenda is extensive given how little we know about the disease.
    But I'm confident that our federal agencies are up to the task
    as long as Congress does its part and provides the necessary
    resources. And I hope that all my colleagues on both sides of
    the aisle recognize the importance of these investments and
    that we'll be able to work together in a bipartisan manner to
    address the Zika threat in the coming weeks.
        Thank you, Mr. Chairman. I yield back.
        Mr. Murphy. Thank you. Now we'll go and proceed with the
    testimony. We'll start with you, Dr. Lurie. You know how this
    works; watch your lights and try and keep it at 5 minutes.
        Thank you very much. You may proceed.

       STATEMENT OF NICOLE LURIE, M.D., ASSISTANT SECRETARY FOR
    PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN
     SERVICES; THOMAS FRIEDEN, M.D., DIRECTOR, CENTERS FOR DISEASE
    CONTROL AND PREVENTION; ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL
        INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL
         INSTITUTES OF HEALTH; LUCIANA BORIO, M.D., ASSISTANT
       COMMISSIONER, COUNTERTERRORISM POLICY, U.S. FOOD AND DRUG
     ADMINISTRATION; TIMOTHY PERSONS, Ph.D., CHIEF SCIENTIST, U.S.
                    GOVERNMENT ACCOUNTABILITY OFFICE

                       STATEMENT OF NICOLE LURIE

        Dr. Lurie. Thanks. Good morning, Chairman Murphy, Ms.
    Castor, and distinguished members of the subcommittee. I'm Dr.
    Nicole Lurie, the Assistant Secretary for Preparedness and
    Response, and thank you for the opportunity to talk to you
    today about yet another emerging threat, the Zika virus.
        While we don't yet know everything we need to know about
    Zika, as a primary care physician and as a mom, I know how
    deeply concerning what we're all learning is. As you know, ASPR
    was established almost a decade ago by the Pandemic and All
    Hazards Preparedness Act in part to overhaul the government's
    approach to emergencies that threatens the public's health,
    whether naturally occurring or manmade. Since that time and
    with the support of Congress including many of you, ASPR has
    done just that, developing a flexible set of capabilities to
    quickly adapt to challenging threats, including Ebola, MURS,
    and now Zika virus.
        Since early reports of the potential link between Zika
    virus and microcephaly, HHS has taken proactive and as
    scientific evidence has mounted increasingly targeted actions
    to protect the American people. Today I'll highlight three
    areas in which ASPR's work is critical.
        First, our central role is to coordinate across HHS and
    beyond ensuring that all components have the latest information
    and best scientific evidence to inform key decision making, and
    that all are driving toward the same goals.
        Second, ASPR has a mandate to develop the most promising
    medical countermeasures through the Biomedical Advanced
    Research and Development Authority or BARDA. I know this
    committee is aware of how successful BARDA has been producing
    22 licensed products and support nearly 200 countermeasure
    candidates over the years.
        Third, ASPR is clearing longstanding obstacles to progress
    in this area, such as agreements on virus sample sharing and
    close collaboration with regional and international partners.
    You should know that well before the first case of Zika in the
    U.S. in early January, I convened the HHS Disaster Leadership
    Group to coordinate our preparedness efforts. This group is
    made up of leaders from across HHS including CDC, NIH, and FDA,
    and it ensures that the department's senior leaders have shared
    awareness and the ability to make timely, informed, and
    coordinated decisions during emergencies. We've convened this
    group for every emergency and it will continue to meet
    throughout this crisis.
        Similarly, on December 2nd of last year I directed the
    Public Health and Medical Countermeasure Enterprise or PHEMCE
    to conduct a comprehensive review of its portfolio to identify
    candidate products with the potential to stop transmission of
    Zika.
        This committee is well aware that the best ideas for
    medical countermeasures won't translate into the drugs,
    vaccines, diagnostics we need without investment. The BARDA
    component of ASPR is tasked with transitioning promising
    medical countermeasures through advanced development and across
    the so called valley of death toward FDA approval. In the case
    of Zika we've established three countermeasure priorities,
    vaccines, diagnostics that can detect both acute and previous
    infections, and insuring a blood supply that's safe by
    developing blood screening tests for Zika, and techniques for
    virus inactivation in blood.
        Because access to virus samples is critical for developing
    diagnostics and vaccines, we've worked across government to
    successfully establish sample sharing and vaccine development
    agreements, including with Panama and Brazil, respectively.
    We've also established a mechanism to address international
    requests for assistance because we recognize that health
    security knows no borders.
        While we move forward aggressively to prepare for the
    threat of Zika, many of our efforts will depend on new
    resources. The Emergency Supplemental Request includes funds
    for CDC, which is responsible for the bulk of the public health
    response, for medical countermeasure development, and for
    contingencies that may arise over the course of the response.
        For countermeasures we've been successful in moving from a
    reactive model of preparedness to a proactive one, building on
    strong day to day systems and a flexible set of capabilities to
    do this. The same goes for state and local health departments
    which is why preparedness for all hazards is so important.
        A lesson from both H1N1 and Ebola was the need for flexible
    funding to insure that we can move quickly as other departments
    can so that something that starts as a crisis does not become a
    full-blown emergency. The contingency fund included in the
    President's supplemental request addresses this overarching
    need; enabling us, if needed, to make emergency procurements or
    quickly take other actions that become necessary but that we
    cannot currently anticipate.
        In sum, HHS has mounted a proactive and coordinated
    response to the Zika virus, building on Lessons Learned from
    previous challenges, and the domestic preparedness
    infrastructure we've worked so hard to establish. Congressional
    approval of the Administration's funding request will provide
    critical resources to improve our ability to prevent, detect,
    respond, and rapidly adjust to Zika and other emerging vector-
    borne infectious diseases.
        Thank you again for inviting me here. I look forward to
    your questions.
        [The statement of Dr. Lurie follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you, Dr. Lurie.
        Now, Dr. Frieden, you're recognized for 5 minutes.

                        STATEMENT OF TOM FRIEDEN

        Dr. Frieden. Thank you very much, Chairman Murphy,
    Representative Castor, and members of the subcommittee.
        At the outset, I want to make a few key points. First,
    we're literally still discovering new things every day about
    Zika. CDC has about 600 staff currently working on this
    response. We're activated at Level 1, the highest level of our
    emergency operations center. We have staff in Brazil, Colombia,
    Puerto Rico, and other parts of the world looking at and
    learning from a developing situation.
        Zika is new, and new diseases can be scary particularly
    when they affect the most vulnerable among us. And it's also
    particularly scary because in Puerto Rico today cases are
    doubling every week. By April we're likely to see widespread
    transmission in Puerto Rico, and by June, mosquito season is
    likely to start in parts of the U.S. where the mosquito that
    can spread Zika is present. There's a limited window of
    opportunity to take action. When we look at chikungunya which
    affected Puerto Rico, started in 2014, within 2 months it was
    all over the island, within 8 months one out of four adults
    were infected. If that pattern is followed with Zika we could
    see hundreds of thousands of infections by the end of the year.
        CDC is working 24/7 to respond to this, learning more about
    the link with microcephaly, Guillain-Barre AE1 Syndrome,
    improving diagnostics, looking at ways to optimize vector
    control with current tools. This is the latest in a series of
    unpredicted and unpredictable health threats. What is
    predictable is that there will be more health threats, and
    that's why it's so important that we continue to improve the
    ability of countries around the world to find, stop, and
    prevent health threats.
        Now, first, what do we know about Zika? You've outlined,
    Mr. Chairman, other members some of the key facts here. It's
    been around since 1947. We didn't know it could cause outbreaks
    until 2007. It was thought to cause mostly mild disease. It
    spread primarily by the Aedes aegypti mosquito. This is the
    cockroach of mosquitoes. It lives indoors, it lives in the
    shade, it is hard to kill, and it's very effective at spreading
    diseases. That's why Dengue and Chikungunya and other diseases
    spread by it can spread so explosively.
        What is really new and unprecedented is the link to
    microcephaly. It's been more than 50 years since a pathogen
    causing microcephaly or other severe birth defects was
    identified that would do so on such a broad level. And as far
    as we know, never before has there been a mosquito-borne cause
    of a severe fetal malformation.
        The link to Guillain-Barre AE1 Syndrome looks increasingly
    certain. Studies published this week, if replicated would
    basically prove that link, and it wouldn't be surprising. We've
    seen Guillain-Barre AE1 Syndrome after a wide variety of
    infections. But microcephaly, the complication of microcephaly
    is truly unanticipated, potentially catastrophic, and
    permanent, the very definition of the need for an emergency
    supplemental response.
        Fundamentally, there are four different patterns of spread.
    First, among travelers, some of them pregnant. And we have 40
    million people going to and from Zika-affected areas each year.
    Second, sexual partners. This is why we issued guidance to
    reduce the risk of sexual transmission. Third, possible cases
    and clusters in parts of the U.S. that have the mosquito
    vectors present. That's why we need to scale up our support for
    those entities. Fourth, areas likely to have widespread
    transmission around the world, and especially in parts of the
    U.S., including Puerto Rico, that have had large outbreaks of
    Dengue.
        The supplemental is critically important for CDC to respond
    as part of a whole of government response. The request of CDC
    is for $828 million in three categories: urgent support for
    Puerto Rico, a response in the Continental U.S., and
    international support, as well.
        There are many very concerning diseases out there whether
    it's Ebola, SARS, MURS, or the next HIV. We can't let down our
    guard. Supplemental funding is essential for us to do several
    things, including reducing the risk to pregnant women by
    finding out more and doing more especially in Puerto Rico and
    other areas where it may spread widely, by finding where
    mosquitoes are spreading in the U.S., and better controlling
    them, by establishing a registry for birth defects and
    improving the monitoring of pregnant women, by supporting
    states and territories directly to improve prevention and
    management of cases, diagnosis of patients, increased
    laboratory capacity, and implement key interventions. This is a
    critically important and urgent need, and I look forward to
    answering your questions. And thank you for the invitation to
    appear before you today.
        [The statement of Dr. Frieden follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you, Dr. Frieden.
        Dr. Fauci, you're recognized for five minutes.

                       STATEMENT OF ANTHONY FAUCI

        Dr. Fauci. Mr. Chairman, Ms. Castor, members of the
    committee, first I want to thank you for giving me the
    opportunity to discuss with you today the role of the National
    Institute of Allergy and Infectious Diseases and the NIH in
    general in the research endeavor to address this. As you know,
    the NIH is part of a multi-component aspect of the Department
    of Health and Human Services, and we're responsible primarily
    for the research for the development of countermeasures.
        As I have told this committee in past hearings, the dual
    mandate of the Institute is somewhat unique among NIH
    institutes because although we, like others, have the
    responsibility of developing a robust basic and clinical
    protocol and agenda in all of the areas for which we're
    responsible, for us it happens to be infectious diseases,
    microbiology, and immunology. However, we also have the unique
    dual mandate of being able to respond very rapidly to emerging
    threats. And as a matter of fact, that's exactly what we're
    doing right now.
        I had the opportunity and the privilege to write this
    perspective in the New England Journal of Medicine in January
    in which I said exactly what Mr. Chairman said in his opening
    statements, that this is yet again another threat, another
    arbovirus threat. If you historically over the last couple of
    decades we had West Nile, we have chikungunya, we have dengue,
    and now we have Zika. And as Tom said just a few moments ago,
    we're going to have others, so it's very important for us to
    have as part of the overall effort a research component to be
    able to develop the response. And as shown on this slide it's
    multifaceted. We do everything from basic research to
    fundamental clinical research and clinical trials. We do
    provide, not very well appreciated, the research resources for
    pharmaceutical companies, as well as for academics who want to
    get into the field of studying this disease, and we're already
    negotiating with a number of them.
        The bottom line of it all, and the end game is to develop
    diagnostics, therapeutics, and vaccines. I just want to spend a
    minute or so going through some of the things that we are now
    addressing.
        First, natural history. We were discussing just a couple of
    moments ago, it's very important to understand the true natural
    history, not only of the disease, symptomatic versus
    asymptomatic. Can an asymptomatic person who's infected and
    pregnant actually have a baby who is a microcephalic baby, or a
    baby that has a congenital defect? We need to study that. we
    also need to have cohort studies to understand how this has
    evolved. What we call pathogenesis of disease is trying to
    understand how this disease evolves. We did this with Ebola, we
    did this with HIV, and we're planning to do that with Zika.
        Another is the fundamental basic research. We know an awful
    lot about viruses like HIV, like chikungunya, like dengue. We
    need to know a lot more about Zika. Luckily, it's related to
    some of those diseases.
        Also, the immune response. We don't understand a lot about
    the immune response. The immune response is generally helpful.
    We know with dengue that immune response can actually enhance
    disease. We need to know the protection against Zika, and
    whether or not there are any deleterious effects. And also, we
    need to establish animal models.
        You mentioned vector control. We do have basic research
    collaborations with pharmaceutical companies and individual
    investigators looking at novel ways to have vector control.
    You've heard of several of these such as Wolbachia infection of
    mosquitoes or genetic modification of mosquitoes.
        Also in diagnostics, the CDC has taken the role in
    developing and now distributing widely some of the diagnostics
    that are available, but we still need high specific, easy to
    perform diagnostics that can tell an important question. To
    tell if someone is infected is relatively easy. We do a PCR,
    it's highly specific. The question that is really on everyone's
    mind is, have I been infected and if so, how long ago? And that
    is something that needs specificity because the current
    available antibody tests tend to cross-react with diseases that
    are prevalent in these societies, particularly dengue.
        Now the issue that we're really concentrating much of our
    effort on is the issue of vaccines, and we now do have a couple
    of candidates that we're looking at putting into a Phase 1
    trial, hopefully by the end of this summer and early fall,
    which will take a couple of months to determine if, in fact,
    they're safe and do they induce an immune response that will
    allow us to go to the next phase of the response, which is an
    efficacy phase. And we have a number of candidates that I'll be
    happy to talk to the group about during the question period.
        One I want to bring up in particular, and that is why we
    have what we call vaccine platforms, things that we have
    experience with. An example is, we developed a vaccine for West
    Nile virus several years ago. It was safe, and it induced a
    good immune response. Unfortunately, there was no company that
    was particularly interested in partnering with us. I don't
    think we're going to have that problem now because we have a
    number of companies that are interested. But what we've done is
    we've taken that DNA platform and done a very simple thing;
    we've pulled out the gene of West Nile and we stuck in the gene
    of Zika, and we're going to be starting a Phase 1 trial, as I
    mentioned, hopefully. And then finally, we have our screening
    assays for the development of therapeutics we're going to be
    looking at because, obviously, therapeutics are a very
    important part.
        So I'll close with this last slide, reiterating what Dr.
    Frieden, and Dr. Lurie, and I said, that these threats will
    continue to confront us. And I want to thank the committee for
    your interest and support of us during these periods. Thank
    you.
        [The statement of Dr. Fauci follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

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

                       STATEMENT OF LUCIANA BORIO

        Dr. Borio. Good morning, Chairman Murphy, Representative
    Castor, and members of the subcommittee. Thank you for the
    opportunity to discuss the FDA's actions to respond to the Zika
    virus outbreak.
        FDA is working closely with our partners to help minimize
    the impact of yet another tragic outbreak. Last month I had the
    privilege of traveling to Brazil, my country of birth, with a
    small HHS delegation to meet with the Brazilian Minister of
    Health and several of his senior officials. The engagement was
    extremely productive. In particular, FDA and ANVISA,
    Brazilian's National Regulatory Agency, committed to working
    very closely and reach convergence in the areas of vaccine
    development and diagnostic tests.
        FDA is working to help protect the safety of our nation's
    blood supply, to facilitate the development and availability of
    blood donor screening and clinical diagnostic tests, to support
    the development and investigation of vaccines and therapies, to
    review a proposal for the use of innovative strategy involving
    genetically engineered mosquitoes to enhance vector control,
    and to protect the public from fraudulent products. To help
    mitigate the risk of Zika transmission from blood transfusions,
    FDA issued guidance recommending important measures to keep our
    nation's blood supply safe. And just yesterday, FDA issued new
    guidance with recommendations to reduce a risk of transmission
    of Zika by human cellular and tissue-based products are used in
    medical procedures.
        I'm happy to report that last week we issued the first
    emergency use authorization for a test developed by the CDC. We
    continue to work very interactively with the CDC and several
    diagnostic companies, several diagnostic companies to support
    development of additional tests.
        The association between Zika, microcephaly, and other pro-
    pregnancy outcomes results in a very serious and challenging
    situation for pregnant women who test positive for Zika virus
    infection. Just last week, CDC reported that among nine
    pregnant travelers with laboratory confirmed Zika virus
    infection there were two early pregnancy losses, two elective
    terminations, and one infant with severe microcephaly at birth.
    It is not difficult to imagine the fear, uncertainty, and
    anguish these women and their families likely experienced;
    therefore, it is essential that diagnostic tests for Zika virus
    provide accurate results.
        In recent weeks we have seen an increased interest by
    clinical laboratories to develop their own tests for Zika. We
    share the goal of expanding the availability of good tests, and
    to support these efforts FDA developed simple templates that
    developers can use to submit data to the FDA for expedited
    review, but FDA is urging developers to work with us to insure
    that their tests meet the standards for accuracy and precision.
    And I need to make clear that FDA will not hesitate to take
    appropriate action to prevent the use of tests that did not
    meet our standards.
        FDA is actively engaged with NIH and BARDA to help
    accelerate the development of vaccines, and as we did during
    the Ebola epidemic we will do all we can to facilitate access
    to investigation of vaccines through appropriate clinical
    trials as quickly and safely as possible.
        Finally, we are reviewing a proposal for a field trial to
    determine whether the release of a genetically engineered line
    of Aedes aegypti mosquitoes will suppress the local Aedes
    aegypti mosquito population in the release area of Key Haven,
    Florida. We are preparing to very soon release for public
    comment a Draft Environmental Assessment regarding the
    potential impacts of this proposed field trial.
        In closing, FDA is deeply engaged and fully committed to
    sustaining our aggressive response activities to mitigate the
    impact of Zika. Thank you.
        [The statement of Dr. Borio follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you, Dr. Borio.
        Now, Dr. Persons is recognized for 5 minutes.

                      STATEMENT OF TIMOTHY PERSONS

        Mr. Persons. Thank you, Mr. Chairman, Ms. Castor, and
    members of the subcommittee. I'm pleased to be here today to
    discuss GAO's preliminary observations on Zika virus disease.
    I'll summarize our findings of the four topics you asked us to
    examine; specifically, one, the epidemiology and transmission
    of Zika including what's known about its link to microcephaly
    and neurological diseases. Two, the current diagnostic and
    testing methods for Zika. Three, the methods for mosquito
    control. And, four, the proposed federal research agenda as it
    relates to Zika virus and disease.
        With regard to epidemiology and transmission, while several
    countries noted over here on this graphic have reported
    outbreaks of Zika virus disease, unanswered questions remain
    regarding the epidemiology and transmission of the disease.
    Accurate information on the incidents of Zika is lacking. Five
    primary reasons for this are first, about 80 percent of persons
    who are infected do not show clinical symptoms resulting in
    potentially significant underestimation of the true incidence
    of infection. Second, since many of the remaining 20 percent of
    those who manifest clinical symptoms may not go to a physician
    because the symptoms are mild, the true incidence of disease is
    potentially significantly under-reported. Third, an accurate
    count of the number of cases of Zika virus disease requires a
    consistent standardized international case definition; however,
    at the moment different countries have different definitions,
    thus complicating epidemiological analysis and research.
    Fourth, on February 1st of this year the World Health
    Organization acknowledged that there was no international
    standard surveillance case definition for microcephaly.
    Problems with changing case definitions, lack of sufficient
    information on underlying causes of brain pathology, and lack
    of baseline data make it difficult to accurately determine the
    increase of microcephaly in Brazil, and how much stems from the
    Zika virus. And fifth, the lack of approved diagnostic tests
    complicates our understanding of the virus and may hinder our
    response to the current outbreak.
        With regard to detection and testing, currently no
    commercially available test exists for Zika, as the Chairman
    pointed out. The FDA recently issued an emergency use
    authorization for an antibody-based test for the Zika virus;
    however, the main limitation is the inability to differentiate
    between infection with Zika and infection with other closely
    related flaviviruses such as dengue. Since closely related
    flaviviruses such as dengue may also be present in regions
    where Zika has broken out, the use of this test could
    incorrectly identify non-Zika virus associated infections, thus
    risking extra burden on laboratory and health care systems, and
    distorting epidemiological analyses.
        With regard to mosquito control, because Zika virus disease
    cannot yet be prevented by drugs or vaccines, controlling the
    vector remains a critical factor in mitigating the spread of
    the virus, and hence disease. GAO identified three categories
    of mosquito control. First, standing water treatment. Second,
    insecticides. And third, emerging technologies.
        The WHO determined that maintaining vector control after a
    disease subsides is complicated by dwindling resources. In the
    United States, vector control methods are under state and local
    jurisdictions which determine the method to use by local needs
    and factors. Emerging control technologies include the use of
    biologicals, genetically modified mosquitoes, and auto
    dissemination traps. According to the scientific literature
    these technologies show some promise in studies and field
    trials but would need to be part of an overarching integrated
    mosquito control strategy.
        With regard to the federal research agenda, the NIH and CDC
    have identified several high priority areas for research; for
    example, linkages between Zika and microcephaly, improving
    diagnostic tests and vaccine development. Efforts in these
    areas are necessarily ambitious but agencies may face
    challenges in implementing this agenda. For example, given the
    number of known cases in the U.S. is so few, NIH and CDC may
    have to rely on the cooperation of other countries to account
    for a sufficient number of cases to carry on the proposed
    research. However, data from other countries may differ because
    of differing definitions of Zika virus disease and
    microcephaly.
        Turning to vaccine development, NIH officials told us that
    given their experience with the development of a vaccine for
    dengue fever, a vaccine for Zika could be ready in 3 to 4
    years. Zika virus disease poses new challenge to vaccine
    development testing especially on pregnant women for whom
    several barriers to developing and testing vaccines exist.
    Overcoming these barriers may extend the time for vaccine
    testing and approval, and the information we have from NIH in
    our prior work suggests that developing a Zika virus vaccine
    may take longer than currently anticipated.
        In conclusion, GAO's past work including, for example, our
    recent analysis on Swine Enteric Coronavirus Disease outbreaks
    in pigs has shown some similarities such as a lack of validated
    diagnostic tests, immature mechanisms for reporting the disease
    and no approved vaccine. These preliminary observations on the
    Zika virus point to a persistent and urgent need for a
    proactive, agile, integrated, and coordinated set of programs
    in research and development including epidemiological studies,
    mosquito control, testing capabilities, modeling and
    simulation, and vaccine development, especially in light of
    other emerging diseases such as chikungunya and dengue which
    spread via the same mosquito vectors as Zika, and which also
    pose a risk to human health.
        Mr. Chairman, Ms. Castor, members of the subcommittee, this
    concludes my prepared remarks. I'd be happy to respond to any
    questions that you or other members may have at this time.
    Thank you.
        [Mr. Person's written statement has been retained in
    committee files and can be found at: http://docs.house.gov/
    meetings/if/if02/20160302/104594/hhrg-114-if02-wstate-personst-
    20160302.pdf.]
        Mr. Murphy. Thank you. I thank all the panel for your
    information. Now we'll begin questioning. I'll begin with 5
    minutes myself.
        Dr. Lurie, under the Pandemics and All Hazards Preparedness
    Act and its reauthorization, the Assistant Secretary for
    Preparedness response was create a lead federal official for
    coordinating these health emergencies. My understanding,
    Secretary Burwell designated you as Lead Federal Official for
    coordinating the response with Flint and Ebola. Am I correct?
        [No response.]
        Mr. Murphy. Has she named you the Lead Federal Official for
    the Zika response?
        Dr. Lurie. So in terms of the Zika response, ASPR's role as
    it usually is, is to coordinate for her and on her behalf
    policy issues and other issues related to the Zika response.
    ASPR is very actively fulfilling that role, as you heard in my
    testimony. As part of that role, the CDC has primary
    responsibility for the operational public health response, and
    Dr. Frieden has the lead for that.
        Mr. Murphy. So is that how it's going to break down, the
    Lead Federal Official will be Dr. Frieden, and not you, or do
    we----
        Dr. Lurie. ASPR has coordinating responsibility on behalf
    of the Secretary for this. The primary response is an
    operational public health response and that's what CDC does day
    in and day out.
        Mr. Murphy. We just want to make sure we have some sense of
    how this is working out.
        Dr. Lurie. Yes, absolutely.
        Mr. Murphy. Dr. Persons, what are the concerns associated
    with the assay recently authorized by the FDA for emergency
    use?
        Mr. Persons. Yes, thanks, Mr. Chairman. The test is called
    the MAC-ELISA test. Its main concern is just its cross-
    reactivity with other flaviviruses, as other witnesses have
    pointed out. So you can tell that you have a related flavivirus
    but you cannot have the specificity to say you have Zika with
    assurance, unless or until you have the RT PCR basis to back
    you up and do that.
        Mr. Murphy. But is all this going to put an extra burden on
    the labs and health care systems, and will that distort some of
    our analysis then if we can't fully do that?
        Mr. Persons. That is, indeed, a risk to the system.
        Mr. Murphy. Dr. Frieden, do you want to comment on that,
    too?
        Dr. Frieden. Just to clarify, the IGM that was FBUA
    approved by FDA in wonderful excellent time with good
    collaboration, that test we believe is accurate, particularly
    in people less likely to have been exposed to dengue. There is
    a second test that we do which is a neutralization assay, a
    PRNT on the IGM positive, so we would in some cases, depending
    on the combination of the IGM and the PRNT be able to say we
    believe it is definitively Zika. In other cases we can say only
    that it's a flavivirus that may or may not----
        Mr. Murphy. So we can get a false positive if they've been
    exposed to dengue. Is that what happens, Dr. Borio?
        Dr. Borio. Well, just for clarity, is that the emergency
    authorization is not just for the ELISA test, the one that
    causes the cross-activity. The authorization is for the ELISA
    test and a confirmatory test done at CDC. We will have very
    high standards for the UA.
        Mr. Murphy. I'm aware of that, and you had elaborated this
    point, too. I just want to find out if we have enough capacity
    in our public health labs and health care system to handle what
    the GAO is concerned about with this emergency response. If we
    don't, we need to know that as Congress.
        Dr. Frieden. So we are concerned about the capacity in
    terms of the number of tests. Our laboratories have been
    working around the clock for the PCR. We've produced more than
    370,000 of them. We think that's ample for the MAC-ELISA. We're
    up around 100,000 level. It could be that in some places, in
    some areas individuals who want to be tested will not be able
    to be tested until we further scale up production and roll out
    validation of the state labs.
        Mr. Murphy. Let me make sure I understand this. So if we're
    also currently trying to develop a vaccine and some people who
    have been exposed to Zika virus will be immune to it. And is
    that the avenue? I guess, Dr. Fauci, this is your area. Is that
    the avenue by which will help us determine a vaccine, if some
    people have developed their own immunity? Does that give us
    some other ideas of where to go with this? Am I down the right
    road there?
        Dr. Fauci. Yes. I think in a vaccine trial it depends on
    what stage of the trial. When you're in a Phase 1 trial those
    are people who are completely normal. That's the thing I was
    mentioning that would start at the end of the summer. When you
    get into a trial in the field in Brazil, obviously you're going
    to want to know people who were pre-exposed, as well as people
    who were not exposed as a subgroup of the study. The
    fundamental study will be to determine the extended safety and
    some degree of efficacy in a Phase 2A2B. As a subset of that
    group, you'd want to know what the response would be in those
    who were previously exposed, perhaps asymptomatically, versus
    those who were never exposed.
        Mr. Murphy. And so where we are now, we don't have the
    capacity and you're asking Congress for help because we just
    don't have the capacity to handle this. Right, Dr. Frieden?
        Dr. Frieden. There are many things that we will not be able
    to do or do at scale without the emergency supplemental.
        Mr. Murphy. And this will delay our responsiveness and
    detection in developing a vaccine until we get this level
    higher? We all agree with that?
        Dr. Fauci. Agreed.
        Mr. Murphy. Thank you. Ms. Castor, recognize you for 5
    minutes.
        Ms. Castor. Thank you. The Zika outbreak began in Brazil
    nearly a year ago, and it's rapidly spread across the Americas.
    I'm very concerned by the virus' recent arrival in Puerto Rico
    and its rapid spread there. News reports earlier this week said
    there are well over 100 confirmed cases of Zika in Puerto Rico,
    and that the number is almost sure to rise over the next few
    weeks.
        Dr. Frieden, can you give us an update on the situation in
    Puerto Rico? What should we expect to see there in the coming
    weeks? And then could you go into greater detail on the current
    diagnostic tools in Puerto Rico, and whether or not they differ
    in Brazil and across the Americas?
        Dr. Frieden. Thank you very much. In Puerto Rico we have
    basically the 1-2 punch of Zika and similar viruses. We have
    the mosquito that can spread the virus, and we have a human
    environment without screens and air conditioning widely
    available that lead to explosive spread of viruses spread by
    this mosquito. So as I mentioned earlier, we have chikungunya
    which spreads by the same mosquito. One out of four adults
    became infected with it within 8 months of the introduction of
    that virus to the island.
        In terms of the diagnostic tests, the tests are the same
    but they perform differently in different places depending on
    what the individuals there have been exposed to. So first off,
    as Dr. Fauci mentioned, the test for active infection, that's
    straightforward and accurate, so if someone is sick, they have
    fever, then between the onset of symptoms or maybe a day or two
    before until about four to seven days after symptom onset, that
    test will be positive and it's definitive. But past that period
    it's much more challenging to determine whether someone was
    previously infected with Zika. That requires looking at
    antibodies, and the EUA that the FDA approved on Friday allows
    us to do that in a way that looks at the IGM or short-term
    antibody response which may become positive within the first
    week, and stay positive for some as yet undetermined period of
    time, it could be months. And then to confirm that with a test
    that actually grows the virus and sees if it is inhibited by
    the patient's own serum, the neutralization assay. So it's an
    algorithm-based testing. CDC has a dengue branch in Puerto
    Rico. We currently have all 50 of our people from that branch
    plus another 25 from the rest of CDC on the island now working
    hard on every aspect of the response.
        Ms. Castor. Dr. Fauci, Dr. Borio, do you want to add
    anything on the diagnostics?
        Dr. Fauci. No, but we will do better. As Dr. Frieden said,
    this is what we have right now, but we are all of us trying
    very hard to develop a much more specific test that would
    answer the question directly that everyone is concerned with.
    But for what we have now, that's what we're talking about.
        Dr. Lurie. I would only add that we've been really
    approached by a whole array of companies who are now actively
    working to develop their own diagnostic tests. We're in a
    position to provide them support and to work closely in
    collaboration with FDA to make a smooth, easy path if those
    diagnostics are effective.
        Ms. Castor. Thank you. And, Dr. Frieden, Puerto Rico has
    seen recent outbreaks of other related infectious diseases in
    Puerto Rico. What have those outbreaks taught us about Puerto
    Rico's public health infrastructure and its capacity to
    respond?
        Dr. Frieden. Well, I think it's fair to say that mosquito
    control, the capacity is very limited. In addition, the
    challenges of controlling this mosquito are very great so even
    though there have been efforts to reduce spread of dengue and
    chikungunya, they have had very little, if any, impact on the
    actual disease spread.
        Ms. Castor. I understand that the FDA has issued guidance
    on blood donation calling on blood banks in areas where Zika is
    locally transmitted to import blood from regions without an
    outbreak, instead of using local donations. Dr. Borio, what
    does that mean for Puerto Rico? Does it affect their ability to
    provide medical care to their residents?
        Dr. Borio. So FDA's guidance meets an important public
    health need, which is to keep the nation's blood supply safe.
    In areas with active transmission, the guidance does require
    whole blood and blood components to be imported from areas
    without active virus transmission until a diagnostic test that
    can be used to screen the blood supply is available. So there
    is a potential that our guidance could impact in theory the
    supply of blood to areas of active transmission.
        That being said, that should not be the case in Puerto Rico
    because we have been working very closely with our partners,
    Puerto Rico health officials, CDC, and Dr. Lurie's office to
    mitigate the impact of our guidance. And Dr. Lurie may have
    more to add on that.
        Ms. Castor. Well, I note that the President's emergency
    budget request includes $225 million for grants in technical
    assistance for Puerto Rico and other U.S. territories facing
    Zika outbreaks. Is that going to get to the heart of the
    matter?
        Dr. Frieden. That is crucially important for us to be able
    to mount a robust response, and the sooner the better.
        Ms. Castor. Thank you very much. Thank you, Mr. Chairman.
        Mr. Murphy. Yes, just a follow-up. Would you say that
    Florida and Texas are probably some of our highest risk states?
        Dr. Frieden. Yes, we've seen clusters of dengue and
    chikungunya in Florida or Texas, and because of the presence of
    the vector we anticipate that these could be areas where we
    might see clusters of local transmission.
        Mr. Murphy. OK.
        Ms. Castor. In fact, Mr. Chairman, there was recently a map
    published in the national newspaper and it had Florida in
    bright red, so it's definitely gotten everyone's attention, so
    this is very timely. Thank you.
        Mr. Murphy. I will then recognize the doctor from Texas to
    follow up there. Dr. Burgess, you're recognized for 5 minutes.
        Mr. Burgess. Thank you. And again, thanks to our panel for
    being here today, and we always do learn so much when you come
    in to talk with us.
        So, Dr. Frieden, let me just ask you, after talking to my
    folks on the ground back in Denton County yesterday, what
    constraints has the CDC placed on states when it comes to the
    expenditure of preparedness Ebola dollars to combat Zika?
        Dr. Frieden. We have several different funding streams
    available that includes the Public Health Emergency
    Preparedness dollars. Those I believe but would have to
    confirm, we have indicated to states that they can use for the
    Zika response.
        Mr. Burgess. Those dollars should be able to travel freely
    between missions?
        Dr. Frieden. That's the PHEP, the Public Health Emergency
    Preparedness grants. For the Ebola dollars, I would have to get
    back to you.
        Mr. Burgess. And please do, because that is important. And
    we're hearing stuff about funding. I get that. It always come
    up in this subcommittee, and I'm not immune to that. But, Dr.
    Frieden, let me just ask you, the travel restrictions, Tier 2
    travel advisory right now for countries in the Caribbean and
    Central America, and South America. Is that correct?
        Dr. Frieden. Yes.
        Mr. Burgess. What is the reluctance to go to Tier 3
    restrictions?
        Dr. Frieden. There's not really a reluctance. It's a
    question of what's appropriate to the circumstances. We're not
    saying that nobody should go; we're saying that women who are
    pregnant should consider not going. And similarly in other
    situations.
        Mr. Burgess. You're asking us for more money. OK, I get
    that, and you're saying it's an emergency. I might believe you
    more that it's an emergency if you would be willing to say and
    we really don't want you to go down there. The State
    Department, when I talk to them they say oh, we rely entirely
    on the CDC, but they're also not assigning women of
    reproductive age to those outposts. So there's kind of a
    disconnect there.
        Dr. Frieden. What we feel is we need to give people
    information and allow them to make the choices. We've heard of
    situations where someone is going back for a funeral or a very
    important personal event, and so we say you shouldn't go, but
    we also say we understand there are some circumstances in which
    women will go. And in those circumstances we provide the
    information on how they can best protect themselves with
    mosquito repellant and other means.
        Mr. Burgess. Again, it just seems logical that nonessential
    travel really should be circumspect right now.
         Dr. Fauci, let me just ask you a question, because going
    back several years to what was called the Swine Flu outbreak,
    and we talked on several occasions during that. I remember the
    conference call that occurred during March Madness of 2009, and
    I remember talking to you during the August recess about the
    availability for the vaccine was a few weeks away. It wasn't
    quite going to be there for the start of school, but it would
    be a week or two after, so the middle of September. So that's a
    6-month time frame if I'm doing my math correctly that you were
    able to identify the genetic sequence of the virus, reverse
    engineer a vaccine, test it, assure its safety and efficacy,
    and get it to school teachers on the second week of school.
    That's pretty impressive.
        Dr. Fauci. Right.
        Mr. Burgess. And why are we different with this? Is this
    just because it's a different virus?
        Dr. Fauci. Yes. Well, what you have with influenza was a
    strain change and a production to have over 150 million doses
    available over that period of time. What we're talking about
    right now, as I mentioned, and if I may, let me just clarify--
    --
        Mr. Burgess. Sure.
        Dr. Fauci [continuing]. What is a feasible time frame
    within the context of there are always vicissitudes when you're
    dealing. So we have this couple of candidates, two or three
    that are likely going to go into a Phase 1 trial in 2016. The
    one I mentioned as a prototype because it seems to be
    temporally ahead of the others, is one that we think by the end
    of the summer we'll have enough, and we have our own pilot
    plant where we're making doses. We're working very closely with
    the FDA colleagues on trying to make sure we get that same
    smooth transition that they helped us with when we went into
    the Phase 1 trial with Ebola. So let's say we start at the end
    of the summer/the beginning of the fall, it's likely it will
    take a few months, similar to the Ebola Phase 1 where you know
    if it's safe and it can induce an immune response.
        In 2017, likely in the first couple of months, if the
    epidemic is still raging in South America, that's very
    important for a vaccine trial.
        Mr. Burgess. Sure.
        Dr. Fauci. Because we're now in a trial, not a
    distribution. We'll likely get an answer of its efficacy very
    quickly. When I say quickly, I say 8 to 10 months, at which
    point then you make a decision, you look at the data and you
    decide what kind of regulatory decision or not you're going to
    make.
        Remember with Ebola, by the time we were ready to go with
    the vaccine the cases due to the CDC and other efforts had gone
    all the way down, and there were very few cases to be able to
    prove efficacy. I don't think we're going to see that because
    nobody anticipates that this outbreak is going to just
    disappear in Brazil.
        Mr. Burgess. Correct.
        Mr. Murphy. Thank you.
        Mr. Burgess. Well, I do appreciate that, and I've got a
    number of questions. And certainly after communicating with my
    folks back home, this is going to be an ongoing evolving
    difficulty, and I really would appreciate the ability to
    interact with all of you as things develop. Thank you, Mr.
    Chairman.
        Mr. Murphy. Thank you. The gentleman's time has expired.
    Recognize Mr. Pallone for 5 minutes.
        Mr. Pallone. Thank you, Mr. Chairman.
        I'm going to talk about the money, too. The President
    submitted the $1.9 billion request for Zika that directs funds
    to areas that the agencies have identified as priorities. But,
    of course, the House Republicans have thus far declined to fund
    the Administration's request; instead, calling upon the
    agencies to divert unobligated Ebola funds to finance the Zika
    response. And I believe this decision is ill-advised, and it
    will force federal agencies to either compromise the critical
    work that they're doing in other areas, or shortchange the
    federal response to Zika and Ebola. So let me ask questions in
    this regard.
        Dr. Frieden, can you explain to us what you plan to do with
    the agency's remaining Ebola funds?
        Dr. Frieden. Ebola is not over. As of today, 84 CDC top
    staff are in West Africa responding to the Ebola outbreak. Last
    month labs in West Africa tested approximately 10,000 samples
    for Ebola. It was only in January that we had the most recent
    Ebola case in Sierra Leone, so we're still actively responding
    and tracking. And as you noted in your remarks, the Ebola
    supplemental funds also directed CDC to work over a 5-year
    period to strengthen the systems around the world that could
    find, stop, and prevent other health threats such as Zika
    before they spread widely so that we can learn more rapidly
    about them and protect Americans more effectively.
        Mr. Pallone. All right. Let me go to Dr. Fauci, same
    questions. What do you expect to do with the Agency's remaining
    Ebola funds, and why is it important that the Agency complete
    this work?
        Dr. Fauci. Well, the NIH was given $238 million from the
    Ebola supplement. We only have less than $10 million left. We
    have about $9 million left, and we have ongoing studies, both
    the survivor study, as well as the next phase of the vaccine
    study, so quite frankly, Mr. Pallone, we don't have any Ebola
    money to switch over. Right now what I'm doing in anticipation
    of hopefully the approval of the supplement, is I'm moving
    money from other areas right now to get a start on the things
    that I just mentioned to Dr. Burgess; namely, the vaccine and
    other components. So we're using money that we have to shift
    around from other places. We don't have any really substantial
    money that's left on Ebola.
        Mr. Pallone. So let me ask both of you, Dr. Frieden or Dr.
    Fauci, if Congress does not move quickly to fund the Zika
    supplemental the way the President has requested, how will the
    agencies meet the demands of fighting the Zika epidemic? How
    will this affect the other work that you do?
        Dr. Frieden. Well, first off we're already drastically
    scaling back the work we're doing on other diseases, such as
    dengue and tick-borne disease because we're devoting those
    staff to the Zika response, even the area of birth defects
    which usually considered to be an area that would respond to an
    emergency. We've been pulling staff to work on this who would
    otherwise be working on a series of other challenges in that
    field.
        And without the supplemental we won't be able to most
    effectively reduce the threat against pregnant women by
    learning more and doing more to protect them. We won't be able
    to rapidly improve our awareness of where the mosquito
    populations are in the U.S., and to control them before
    mosquito season. We won't be able to establish a robust birth
    defects registry to further understand this, or initiate and
    follow-up on critical studies to understand key unknowns, such
    as for babies born to mothers with infection who don't have
    microcephaly, do they have other severe problems? That's going
    to be a many month and many year undertaking that has to be
    started now or we'll lose the opportunity to do it most
    effectively. And we won't be able to support states and
    territories in their ability to rapidly increase their
    effectiveness here to the extent that we would like to.
        Mr. Pallone. Dr. Fauci, do you want to add to that?
        Dr. Fauci. Yes, Mr. Pallone. Ditto what Dr. Frieden said
    about not being able to do several of the things that I showed
    on the slide of our research agenda. But one of the additional
    things that also worries me about not getting the supplement is
    that we are now starting to forge partnerships with the
    pharmaceutical companies that are getting quite interested in,
    and they're linked to BARDA, and we're all working together to
    try and push to develop products.
        If it turns out we don't get the supplement, we will be
    viewed as an unreliable partner, and we don't want that because
    we had that, you might remember, when we were doing the
    biodefense issues years and years ago where we would start
    partnering with the pharmaceutical companies, and when it
    looked like we weren't going to get a particular amount of
    partnership money, they pulled back. And that would be the
    worst thing in the world for us, is to have the pharmaceutical
    companies think we're not a reliable partner.
        Mr. Pallone. Thank you, gentlemen.
        Mr. Murphy. Thank you. Now recognize Mr. Griffith for 5
    minutes.
        Mr. Griffith. Thank you, Mr. Chairman.
        Dr. Borio, as you mentioned in your opening the FDA is
    currently considering an application for a field trial with
    genetically engineered mosquitoes that would take place in the
    Florida Keys. Can you update us on where it stands today with
    your agency, and when you expect the Florida field trial to
    start? And I'm going to leap forward in an attempt to save a
    little bit of time because you know we're limited. Does the FDA
    have sufficient legal authority to expedite the review process
    for this product given the current Zika emergency? And if not,
    what additional authorities are needed?
        Dr. Borio. We do have the authorities, and we are
    expediting the review of this. And like I said, very soon we
    hope to release for public comment the Environmental Assessment
    and associated findings.
        Mr. Griffith. Do you have the ability since there's an
    emergency to truncate or eliminate the public comment before
    you do the field trials, particularly in light of the fact that
    the particular modification of the mosquito has been tested in
    a number of countries in tropical environments?
        Dr. Borio. Mr. Griffith, it's very important for us to go
    through the process and include the period of public comment.
    We need to give the public an opportunity to comment on the
    Environmental Assessment given the significant attention that
    this novel technology has generated, especially in the
    communities for the proposed sites. So it is true that there
    have been many field releases done, especially in Brazil. I
    learned more about them when I was there last week. The data
    seems to be promising in terms of reducing the mosquito
    populations in those small field trials, but we need to go
    through our process. And we are greatly expediting the process.
        Mr. Griffith. In light of the concerns in the Commonwealth
    of Puerto Rico, is it possible to expand, do you have the
    authority to expand and maybe look at a field site not only in
    Florida, but also in Puerto Rico? And since you have not yet
    opened the public comment you're going to go through that
    process, have public comment there, as well?
        Dr. Borio. So if the company and public health authorities
    in Puerto Rico are interested in that, we would be very
    supportive of the process. So the geography might be a little
    bit different from the field trial that is being proposed, so
    the company would have to submit the assessment for that--
    anything that may be different for the new field trial. But we
    will look to create efficiencies as much as possible.
        Mr. Griffith. As I understand it, it's been a multiple
    year, I want to say 4 but don't hold me to that, years in
    getting to this point. Would they have to go through that same
    process in Puerto Rico, or is there some way that we could
    shorten that time period up extensively so the tests could be
    going simultaneously?
        Dr. Borio. I understand that's the case, and what I can
    tell you is that this is being greatly expedited now. And I
    believe that where we are today in the process, that it would
    not be a protracted process to be able to rapidly assess the
    request for a field trial elsewhere.
        Mr. Griffith. All right, I do appreciate that.
        Dr. Fauci and Dr. Frieden, you all have been involved
    somewhat in this with the genetically engineered mosquito. How
    is your agency assisting the company that's developed this
    novel technology? It looks like it's trials of 5,000 people,
    lots of mosquitoes. Looks like it's been about 90 percent
    effective in some of the areas it's been tried in.
        Dr. Frieden. We have a number of vector control experts who
    have consulted with the company and others, listened to them as
    well as provided our input. I think one of the challenges is
    the issue of scalability. These particular mosquitoes don't fly
    very far, so you may have to release millions upon millions of
    them every short distance in order to get the knockdown.
        The other thing that's very important to understand is,
    this mosquito is so tricky that even when we've seen very large
    knockdowns in mosquito populations, we haven't necessarily seen
    commensurate reductions in human infections, so it'll be
    important to look at both of those factors.
        Mr. Griffith. And while it could just be other factors. I
    do know in one situation some of the disease that they carry
    was knocked down substantially, but there may have been some
    other factor involved. It's hard to eliminate all the other
    factors, as well. I do appreciate that, as well.
        I do think it's something we ought to look at. It's pretty
    exciting stuff, and it's got to be a whole lot easier to
    release millions of mosquitoes than it is to go door to door
    with pesticides. Did you have something you want to say,
    doctor?
        Dr. Fauci. Yes. Actually, we've been negotiating and
    discussing with Oxytech, the company that involved with that.
        Mr. Griffith. Yes.
        Dr. Fauci. And looking at trying to make sure we correlate
    what Dr. Frieden was saying, the decrease in mosquitoes with
    actually a decrease in disease because it may be that that we
    don't really have that exact correlate. You really want to
    prove that before you start doing a massive thing, because
    scalability is really going to be a major problem. And you
    don't want to scale up unless you know it works.
        Mr. Griffith. And I have a follow-up question for you
    that's off subject, but U.S. Pharmacopeia is looking at allergy
    injections for folks and trying to change some of those rules,
    and they may have some right. But have they consulted with you
    about that?
        Dr. Fauci. Nothing to do with Zika.
        Mr. Griffith. Nothing to do with Zika. But since you're
    involved with the Institute of Allergy and Infectious Diseases,
    I thought I'd ask.
        Dr. Fauci. I'm sorry. I was taken by surprise with that.
        Mr. Griffith. But they have not consulted----
        Dr. Fauci. Not to my knowledge. They may have consulted
    with my staff, but not directly with me.
        Mr. Murphy. If you need to think about that, you can get
    back to him on a time. Thank you. Now recognize Ms. Clarke for
    5 minutes.
        Ms. Clarke. Thank you very much, Mr. Chairman. I thank our
    panelists today. It's good to see you again, Dr. Frieden.
        This question is for Dr. Frieden, Dr. Lurie, and Dr. Fauci.
    Just as a bit of background, it's my understanding that the
    majority of people infected with the Zika virus will remain
    asymptomatic. However, 20 percent of those infected will
    experience symptoms which range from fever to GBS, which can
    leave persons paralyzed.
        Though so far there have been no local transmission of the
    virus in the Continental U.S., does CDC expect to see local
    transmission in the U.S. as the mosquito population increases
    this summer? While the mosquitoes that carry Zika are common in
    southern states, they can range as far north as my home
    district of Brooklyn, New York. Your location, as well as lack
    of access to air conditioning increases one's chance of coming
    in contact with the virus, as was pointed out by Dr. Frieden in
    discussing the situation in Puerto Rico.
        Many of my constituents living in the Brownsville section
    of my district in Brooklyn are very low income, and likewise
    the low income communities of the south has some of the highest
    concentrations of poverty in the United States, and tend to
    lack access to air conditioning. In the south not only do these
    communities lack access to air conditioning, but they also lack
    access to health insurance as many southern governors have
    chosen not to expand Medicaid coverage under the ACA. If they
    do get sick with the Zika virus, having access to care may
    become problematic. The bottom line is that economically
    distressed Americans will likely be the ones most impacted by
    the spread of Zika were that to manifest.
        With that in mind here's my question. What are we going to
    do to assist low income and disadvantaged communities to
    prevent being infected in the first place, as well as spread
    the word of the virus in their communities especially since
    Zika can be sexually transmitted?
        Dr. Frieden. Thank you very much. Our primary concern or
    most urgent concern is places like Puerto Rico which are likely
    to see widespread transmission. In addition, we're advising
    pregnant women and their sexual partners to use condoms if the
    sexual partner has come from an area where there has been Zika
    transmission.
        Furthermore, there are parts of the U.S. that have a
    secondary vector, the albopictus mosquito, the tiger mosquito
    is much more widely distributed, but it appears to be much less
    effective at spreading Zika. So unlike aegypti, which bites
    multiple people, bites only humans, lives indoors, albopictus
    is less of a threat. It appears that it can spread Zika, and
    dengue, and other viruses but much less efficiently than the
    other virus. So our goal with the supplemental funding would be
    to provide resources for states and local communities to both
    reduce the risk of mosquito-borne transmission where that is at
    higher risk, and also to respond to cases so that people who
    come back with Zika minimize their chances of being bitten by a
    mosquito, and thereby initiating a chain of transmission.
        Ms. Clarke. And my hope is that there will be a lot of
    public information, education, particularly as the summer hits,
    especially in a place like New York where you have that
    international mix and blend of individuals.
        Dr. Fauci and Dr. Frieden, the CDC expects to see local
    transmissions of the Zika virus at some point in the
    Continental U.S. Currently, the south has the highest number of
    people living with HIV in the United States, over 40 percent of
    those living in the south are HIV positive. I'd like to know
    how the Zika virus impacts with those living with HIV? Do we
    expect to see some more serious symptoms in HIV positive
    individuals who are infected with Zika? Do we have a sense of
    that yet?
        Dr. Frieden. I'll let Dr. Fauci continue, but I would say
    the primary issue we see at this point is to pregnant women
    regardless of HIV status with the risk of birth defects.
        Dr. Fauci. Yes. If you look at the historical analogies
    with other flaviviruses, we have not seen a serious difference
    at all in an HIV infected versus non-HIV infected person with
    that kind of--however, I'm glad you brought that point up, Ms.
    Clarke, because that's part of natural history studies. When
    you do natural history studies of cohorts you will be able to
    get subgroups of that who are HIV positive or not, and actually
    definitively answer your question, as opposed to saying our
    impression is that there really is not. But just to reiterate
    what Dr. Frieden said, we really focus on the pregnant women.
    That's the real target issue here.
        Ms. Clarke. Very well. Mr. Chairman, I yield back.
        Mr. Murphy. The gentlewoman yields back. Now recognize Mr.
    Hudson for 5 minutes.
        Mr. Hudson. Thank you, Mr. Chairman, and thank you to the
    panel for this very informative discussion.
        It was mentioned that there are clusters of dengue in
    Florida and Texas. It got me thinking, just in terms of folks
    coming across our southern border. There's been a lot of
    discussion about different diseases and other public health
    concerns.
        Dr. Frieden, is this also a concern that folks coming
    across the border could be bringing Zika with them? Is that
    something we're looking at?
        Dr. Frieden. Well, on the one hand we know that Zika and
    other diseases do spread largely because of human migration.
    But, in fact, there are 40 million Americans or 40 million
    people from the U.S. who travel to Zika-affected areas each
    year and then travel back, and so the number on the border
    crossing will be a very minute proportion of that.
        What we have seen is in some communities that are
    essentially across the border, for example, Brownsville and
    Matamoros in Texas, when dengue spread it spread in both parts,
    but it spread eight times more in Matamoros because it was more
    crowded and had less access to air conditioning.
        Mr. Hudson. I understand. Dr. Lurie, what role will
    mosquito or vector control play in our response to Zika?
        Dr. Lurie. Well a we talk about this paradigm of prevent,
    detect, respond, prevention is key, so mosquito vector control
    has got to underpin our efforts for the foreseeable future for
    Zika, and also for other vector-borne diseases.
        Mr. Hudson. Well, there are currently 700 mosquito control
    districts across the United States at the state and local
    level. What role should the federal government play in mosquito
    control?
        Dr. Frieden. One of the areas that we would like to enhance
    and for which we need supplemental funding is to better
    understand the capacity of mosquito control districts, and to
    support improvement of that capacity, and better linkage of the
    mosquito control districts with the health departments and
    environmental departments, whatever is most effective within
    that state or county. They often bridge multiple counties and
    they may not always be well integrated, but in effective vector
    control programs for vector-borne disease you may need an
    integration of the public health staff and the mosquito control
    staff to identify the places or even the houses to target. And
    that's really important, and one of the areas that we want to
    urgently improve.
        Mr. Hudson. When you talk about houses to target are you
    talking about spraying insecticide?
        Dr. Frieden. Yes.
        Mr. Hudson. Is that the effective way to----
        Dr. Frieden. Both insecticide and what's called larvicide
    that kills the developing mosquito.
        Mr. Hudson. OK. Well, because the mosquito that carries
    Zika breeds in small pools of water often indoors near houses,
    aggressive trash cleanup and removal is something that's been
    talked about as one of the most effective ways. Do you envision
    a federal role in terms of trash cleanup and those sort of
    things, or is it more information----
        Dr. Frieden. No. I mean, we really want to support state
    and local entities with technical guidance. We also recognize
    that reduction in breeding sites, cleanups is important, it's
    high profile, but it's very difficult, as you pointed out with
    mosquitoes that can breed in the amount of water of a bottle
    cap. It can be extremely difficult to be effective, so it is a
    component of integrated vector control strategies. We do think
    that is a state and local responsibility, but we have, I
    believe, a responsibility to provide technical guidance, best
    practices, and catalytic funding to try to improve that,
    especially when something as unanticipated and potentially
    devastating as Zika is upon us.
        Mr. Hudson. So the funding request doesn't cover any of
    those type activities. It's more just the coordination and
    information?
        Dr. Frieden. We would have some support for local vector
    control, mostly along the lines of rapidly surging in if
    there's an area that's not able to do it, and for a particular
    cluster by establishing rapid response teams, sharing best
    practices, identifying resources that can be shared among
    jurisdictions.
        At CDC more than 60 percent of our funding or thereabouts
    goes out to state and local entities. We exist to support the
    front lines at the state and local government, but what we do
    at CDC is to develop the tools, the science, the things like
    the test kits for Zika that we then distribute to and support
    local entities to use.
        Mr. Hudson. Makes sense. Is it possible to predict or
    anticipate using surveillance or other means what the next
    emerging infectious disease would be?
        Dr. Frieden. There are many people who would tell you yes.
    My own belief is probably not, because there are so many
    possibilities. Just to give you a sense, I just returned from a
    trip to Africa looking at some of our programs there. I've
    recently spoken with our teams in India. They've identified two
    tick-borne viral hemorrhagic fevers, this is Congo Crimean
    Hemorrhagic Fever and Kyasanur Forest Disease that are much
    more widely distributed than anyone knew before. So whether
    we're going to have now a tick that could bite you and you
    could have a bleeding disease that kills you, I don't know if
    that's going to come next. But no one, I think, would have
    predicted that H1N1 would have come from Mexico, or MURS from
    the Middle East, or Ebola widely distributed in West Africa, or
    Zika causing birth defects.
        Mr. Hudson. Thank you. Mr. Chairman, I'm out of time. I
    yield back.
        Mr. Murphy. Thank you. Now recognize Mr. Tonko for 5
    minutes.
        Mr. Tonko. Thank you, Mr. Chairman. Thank you to our
    witnesses for providing very valuable information.
        I'm encouraged by our government's rapid response to the
    Zika virus, and the assistance we have provided and are
    continuing to provide in the areas most affected by the
    outbreak. This in my opinion underscores one of the most
    important messages we hear every time we have a hearing on
    disease outbreak, and that is that we have to be prepared for
    what we can't predict.
        So with that in mind, Dr. Frieden, how is our response on
    Zika, and our continued response on Ebola preparing us for the
    next emerging threats?
        Dr. Frieden. We use the framework of prevention, detection,
    response. Those are three core areas of what we need to do both
    in this country and around the world. Prevention may be things
    like better vaccines or reduced risk of spread of Ebola and
    other diseases in hospitals. Detection is about laboratory
    networks, as well as disease detectives or epidemiologists, and
    tracking systems so we know how common certain conditions are
    and can quickly detect an increase, whether it's in
    microcephaly or other conditions. And response, the ability to
    have rapid response teams that can be on the ground within
    hours or days and have the tools needed to assess the situation
    and mitigate to the greatest extent science allows.
        Mr. Tonko. Thank you. And how are we assisting our state
    and local health departments in their preparedness, and
    certainly their response efforts? What can we do to coordinate
    the response across all levels of government?
        Dr. Frieden. There are many aspects of the response which
    are critically important to be coordinated. For example, we
    provide diagnostic tests, we work with health care providers,
    we inform of the latest scientific evidence about it. And with
    the supplemental request we would be able to be much more
    robust and involving many parts of state government around the
    U.S., and within states strengthening the hands of state and
    local health departments in their ability to provide services,
    education, information, and interventions to address the spread
    of Zika, and to reduce the risk.
        Dr. Lurie. If I might----
        Mr. Tonko. Sure, Dr. Lurie.
        Dr. Lurie [continuing]. Add that one of the most important
    components of this is being sure that our day-to-day public
    health system is strong so that it can do this detection. If
    you start from a low level each time and we build and then let
    it decay it doesn't really make any sense. Our country has a
    pretty good history of national attention deficit disorder when
    it comes to preparedness and maintaining a strong public health
    infrastructure, and a strong preparedness system is going to be
    key both for this outbreak and for all the questions about how
    we are going to deal with the next outbreak. Those day to day
    systems are critical.
        Mr. Tonko. Thank you. And it seems as though keeping each
    one of those independent bodies strong and functioning then
    provides for a better sense of coordination. And infectious
    diseases that are threats out there need to be addressed in a
    way that addresses individual states and individual nations. No
    one can escape some of those impacts, so I think coordination
    is important. And the key to containing those infectious
    diseases is to contain them at their source, I would think. So
    the coordination here, I agree, is very important.
        Dr. Lurie. Yes. No, thank you for that, and that's the job
    of my office, to do that coordination.
        One of the things that we also do is think about Lessons
    Learned from other outbreaks. And as I said earlier, one of the
    things that has characterized challenges in our response
    whether it was to H1 or to Ebola is that Congress was very
    generous in providing supplemental funds, but we can't move out
    quickly and prevent a crisis before it becomes an emergency
    unless we have some kind of a contingency fund to be able to
    get going at the beginning.
        We've shortened the time dramatically between when Congress
    is able to approve funding and when we can get it out the door,
    but each one of those things still creates a lag. I work with
    FEMA all the time, and you know that when a Presidential
    emergency is declared and the Stafford Act is activated, money
    moves right away. At HHS, we don't have that kind of a response
    fund to respond to public health emergencies, and that's
    something that I think we're very focused on.
        Mr. Tonko. OK. That's good information to have. And
    finally, Dr. Frieden, how does our assistance in Latin American
    countries as they grapple with Zika help keep America safer,
    Americans safer?
        Dr. Frieden. The more quickly we can understand Zika from
    our work in Latin America and the Caribbean the better for
    those countries and the better for Americans. This is where
    it's spreading now, this is where the evidence is. That's why
    we have teams on the ground in Brazil and Colombia, and we're
    working side by side in partnership with those countries and
    others. We disseminated our diagnostic test to countries around
    the world, and we learn together so we're safer together.
        Mr. Tonko. Thank you very much. Mr. Chair, I yield back.
        Mr. Murphy. Thank you. Now recognize Mr. Collins for 5
    minutes.
        Mr. Collins. Thank you, Mr. Chairman. I want to thank the
    panel.
        I've just got a couple of questions. Certainly, in the
    past, whether it was dengue fever or West Nile, the threat was
    there, but nothing like what we potentially have here with Zika
    and the link to the microcephaly. So if a woman is tested and
    she tests positive, I'm trying to--is there a treatment today?
    There isn't, so for a pregnant woman to be diagnosed with Zika
    is a very bad, stunningly bad day for her, her family, and the
    potential of which----
        Dr. Frieden. That's why we've worked very closely with the
    American College of Obstetricians and Gynecologists. We've
    provided detailed guidance in conjunction with ACOG. They've
    sent that out to their members as well, and we provided
    information so that as soon as we know more information we
    provide that to clinicians, as well as women.
        Mr. Collins. So here's a question. We do know, there's been
    some studies done that there's some women that have a history
    of breast cancer in their families, and some women will decide
    to forego the test for fear of what the test will show,
    especially if there may not be a treatment. So if you're a
    pregnant woman and there is no treatment if you test positive,
    there are women who just for their own sanity would opt to not
    be tested.
        Dr. Frieden. We leave that up to the pregnant woman and
    her----
        Mr. Collins. Well, I know, but----
        Dr. Frieden [continuing]. Clinician, but we do find that
    there's a great desire on the part of pregnant women to be
    tested. And it's not that there's nothing that can be done. For
    example, we would want to insure that that infant were
    delivered in a facility that has advanced care capacity to
    provide the intensive support that it might need. Dr. Fauci?
        Dr. Fauci. Actually, just to confirm that what we're
    seeing, the anxiety associated with people who are traveling
    there, there is a great need to know. We're not seeing denial.
    There are people who really want to know as much information as
    we can give them. And as Dr. Frieden said, we leave the
    individual response to that information up to the individual
    and their physician, but they are really very much in desire of
    information, which is what we're trying to get them. This
    relates to the answer to the question about ultimately getting
    a highly specific and sensitive test to tell you if, in fact,
    you were infected.
        Mr. Collins. So to lead to that, now I'm assuming the rapid
    tests that people are looking at are all antibody tests pretty
    much.
        Dr. Fauci. Well, as we said you have to ask are you
    infected now? That's not an antibody test, that's a molecular
    PCR test. The test that people are more in desire of, they go
    and come back and say I know that 80 percent are likely
    asymptomatic, so I don't know if I were infected or not.
        Mr. Collins. What was your----
        Dr. Fauci. They want to know an antibody test. Right?
        Mr. Collins. That's correct. So I'm assuming the industry
    is looking at the rapid tests, are in fact antibody tests.
    They're not going to pick it up pre-antibody but----
        Dr. Fauci. Right.
        Mr. Collins. I'm assuming that's what's being done.
        Dr. Fauci. A lot of activity is trying to develop an
    antibody test that's highly specific for Zika and doesn't
    cross-react with other similar viruses.
        Mr. Collins. All right. So like in HIV where you've got
    some false positives, there's the Western Blot that will look
    for P24 protein or something like that.
        Dr. Fauci. Right.
        Mr. Collins. Is there such a protein in Zika?
        Dr. Fauci. You could actually--in fact, Dr. Frieden will
    just explain it, so why don't you go ahead about the----
        Dr. Frieden. There are several proteins in Zika that are
    specific to Zika. However, they're not that dissimilar from
    similar proteins with dengue and Yellow Fever, so there can be
    cross-reactivity. But we can give as of today a definitive
    diagnostic result to a person with prior infection in some
    circumstances. In other circumstances where there's more cross-
    reactivity in the serum it's more difficult.
        Mr. Collins. But I was hearing from GAO or others that some
    of these confirmatory tests, they are not widely available.
        Dr. Frieden. Right.
        Dr. Fauci. What you can do to make it specific is that you
    can actually--and this is what our grantees are working on
    right now, is that if you look at the molecule for dengue,
    which is the most likely bad actor of cross-reactivity, and you
    look at the molecule of Zika, you could mutate out of Zika
    those components that are common between Zika and dengue and
    still have a protein that's left that the only thing it has is
    things that are highly specific to Zika. That's what we're
    working on right now. We don't have that, but that's----
        Mr. Collins. So now one last question in the last few
    seconds. If somebody has antibody, they progress to that state,
    they do a PCR test. Wouldn't the PCR test still identify the--
    --
        Dr. Lurie. No.
        Dr. Fauci. No. The virus is gone within days of infection,
    within 7 to 10 days it's gone. So once the virus is cleared you
    could do PCR all you want, you won't get anything.
        Mr. Collins. Interesting. All right. Well, thank you for
    that update, especially on what we ultimately need is--I mean,
    if there's possibly some treatment if someone tests positive.
    Appreciate the information.
        Mr. Murphy. Thank you. The gentleman's time has expired.
    Now recognize Mrs. Brooks of Indiana for 5 minutes.
        Mrs. Brooks. Thank you, Mr. Chairman, and thank you so much
    for holding this important hearing.
        I think what you were just talking about, Dr. Fauci and Dr.
    Lurie, I'm curious about what is BARDA, and HHS, and NIH doing
    to support and facilitate these platform-based technologies
    that you're referring to against the known and emerging
    threats? You've kind of talked about it a little bit, but what
    are you actually doing to support platform technologies? Dr.
    Lurie, you want to start?
        Dr. Lurie. Sure, great question. So, back in 2010 when we
    took a look at the countermeasure industry and decided to
    pivot, we decided to move away from one bug/one drug to these
    platform technologies, so we are actually now engaged with a
    host of vaccine development companies, we have open
    solicitations to work with them. We are providing technical
    assistance on the use of platforms specifically. The same thing
    with diagnostics and tests in that regard. We built these
    Centers for Advanced Development and Manufacturing. One of them
    is in your home state, and they also are positioned to use
    various platform technologies to make vaccines so that when a
    candidate is ready they would be the kind of place that you
    could actually do the scale up, development, the pilot lot
    manufacturing, and potentially even with technology transfer be
    able to, when they're ready, manufacture large volumes of
    vaccines. So Dr. Fauci's group and mine are working extremely
    actively, talk every day to be sure these hand-offs are ready
    and the platforms are ready.
        Mrs. Brooks. Thank you. Dr. Fauci, anything else you want
    to add to that?
        Dr. Fauci. Yes. Actually some examples, just for your
    information. You have the DNA platform which we've worked with
    BARDA on. We have the vector platform, the VSV vector where you
    insert the gene of a particular virus. We did it with Ebola,
    we're doing it right now with Zika. You have nanoparticles,
    ferrite nanoparticles so there are all things that can be
    transferred across all infections, and that's what we mean by a
    platform, something that you could say this is the way we're
    going to go, and we're going to stick in the appropriate
    infection. Once you have those and you have a good solid group
    of platforms you're going to cut down very, very significantly
    the amount of time it takes to go after a particular infection.
        Mrs. Brooks. And is there anything we need to be doing to
    encourage this so it does go faster?
        Dr. Fauci. Yes. I think that we need some money.
        Mrs. Brooks. Let me ask Dr. Lurie about money. Speaking of
    money.
        Dr. Lurie. Yes.
        Mrs. Brooks. I'm confused because the President requested
    just $350 million for the special reserve fund for FY 2017, and
    the language that was included in the President's request would
    expand the allowable use for the SRF. This was a reduction in
    funds, if I'm not mistaken. It was a reduction in funds for the
    SRF, and so how is it that the President can put that in his
    budget, reduce those funds, and yet we're still needing to do
    all of these things we need to do with respect to other threats
    like anthrax or smallpox?
        Dr. Lurie. So there's no question at all that the funding
    is critically important. You know, BARDA gets----
        Mrs. Brooks. But, Dr. Lurie, why did the President request
    a reduced amount of funding?
        Dr. Lurie. Because it provided additional flexibility for
    advanced research and development funds so that we could move
    forward with those platforms. Right now the Special Reserve
    Funds are limited to being able to purchase things that are
    material threats on the material threat determination, and our
    pretty profound need right now is in the advanced research and
    development area.
        Mrs. Brooks. And so you're not concerned about the level of
    funding with respect to material threats.
        Dr. Lurie. Oh, we----
        Mrs. Brooks. You believe it's sufficient?
        Dr. Lurie. No, we are always concerned that we can do the
    job we need to do for the American people and having enough
    money to be able to procure for bio threats. As you know, in
    the multi-year budget we've got a 5-year projection of what it
    is that we need. We believe that for Fiscal Year '16 or '17,
    sorry, that we have sufficient funds to procure the
    countermeasures that will be ready.
        Mrs. Brooks. Thank you. Dr. Frieden, I'm very concerned
    about the stockpiling, the strategic national stockpile, and
    could you talk to me about things that BARDA, CDC can do to
    improve the effectiveness, the coordination of the strategic
    national stockpile because I don't think we're ready.
        Dr. Frieden. Well, we've been optimizing the stockpile for
    some time. We're able to deliver----
        Mrs. Brooks. What does that mean?
        Dr. Frieden. We're able to now deliver products to more
    places more quickly. We're also looking at how to get as much
    protection for our dollar as possible in terms of the mix of
    products in the stockpile. And we're also looking at the
    different threats that we may face to make sure that we have a
    balanced portfolio to be able to address those that might be
    the greatest risk to Americans.
        Mrs. Brooks. Based on the hospitals and the folks I talked
    to back home we seem to lurch from crisis to crisis and I'm
    very concerned that we are still not ready. Thank you, I yield
    back.
        Mr. Murphy. Gentlewoman yields back. Now recognize Mr.
    Bilirakis of Florida for five minutes.
        Mr. Bilirakis. Thank you very much, Mr. Chairman. Thanks
    for allowing me to participate in this subcommittee. Appreciate
    it and thanks for holding the hearing.
        The Zika outbreak like global issues especially pressing in
    Florida and other Gulf States given that these locations are
    vulnerable to the spread of Zika. In Florida we already have
    two cases in Hillsborough County, one of the counties that I
    represent.
        A question for Dr. Borio. You mentioned innovation
    strategies being proposed to help suppress virus-carrying
    mosquitoes. It is my understanding that FDA is currently
    considering an application for a field trial with genetically
    engineered mosquitoes in Florida. The question is, could you
    update us on where the field trial application stands today,
    and when the earliest starting date could be?
        Dr. Borio. Thank you. So we are working to soon release for
    public comment the Draft Environmental Assessment that the
    company developed. We work closely with EPA and CDC in
    reviewing the materials, so hopefully very soon it will be
    released. Once we have an opportunity to review the comments we
    receive from the public, then we'll make a final decision
    regarding the application. We're expediting the process. It's
    part of our Emerging Infectious Disease Task Force in response
    to Zika, so our--the reviewers involved in this technology are
    part of our Emergency Response Task Force, so we're doing
    everything we can to move this as expeditiously as we can.
        Mr. Bilirakis. Well, give me an estimate.
        Dr. Borio. Yes. I'm unable to give an estimate at this time
    because it really will depend a little bit on the volume and
    interest from the public. We are working those----
        Mr. Bilirakis. Well, I'm sure there's a great deal of
    interest based on what my constituents tell me.
        Dr. Borio. Yes, it has been an area of tremendous interest,
    and including some opposition. I think, you know, what we don't
    right now is where the public stands in the setting of Zika and
    the new developments associated with Zika. So we're doing
    everything we can to move this very quickly. We're
    collaborating across government with CDC and EPA. We'll learn a
    great deal about this technology also during my visit to Brazil
    last week, last month, so what I can tell you right now is that
    we are prepared to move very quickly on this.
        Mr. Bilirakis. Thank you. Next question. You mention FDA's
    emergency use of authorization referencing diagnostic tests.
    Would FDA be able to use an emergency use authorization to
    advance the use of this technology should the Secretary declare
    a public health emergency? So if you can answer that question.
        Dr. Borio. Our EUA authority is currently limited to human
    products, not to animal products. And this technology is
    regulated under our animal drug regulations, so it's separate,
    so we do not have currently authorities on emergency
    authorization for animal drugs.
        Mr. Bilirakis. OK, next question. Are there other
    innovative products or strategies being proposed that you're
    aware of, and able to discuss at this time?
        Dr. Borio. I would like to defer those answers to my
    colleagues from CDC.
        Mr. Bilirakis. Please, please, please.
        Dr. Frieden. There are a variety of other mosquito control
    approaches that are being considered. One is simply to optimize
    our currently available products. And we think there's
    considerable progress that we could make by doing that,
    different ways of applying different combinations of products,
    different ways of assessing mosquito populations after the
    application of these products. That's very important and needs
    to be done.
        In addition, there are new tools that are exciting. One of
    them is the genetically modified mosquitoes that you mentioned.
    Another is Wolbachia, a bacteria that infects mosquitoes and
    then can reduce their life expectancy and their ability to
    spread disease. This has been done on a pilot basis. But,
    again, the question about all of them are are they scalable,
    will they reduce human disease, are they practically
    implemented? And NIH is doing work in this area, as well.
        Mr. Bilirakis. Anyone else wish to comment on this? Thank
    you.
        Right now there are three tests I understand for detecting
    Zika during different stages of infection. It is my
    understanding that Florida and a few other jurisdictions are
    able to utilize the RT PCR test to detect infection. However,
    given that those who are infected often don't show symptoms, it
    seems crucial that we are able to disseminate diagnostic
    capabilities such as the antibody testing to state and local
    authorities. So what hurdles do we face in increasing access to
    these diagnostic tests nationwide?
        Dr. Frieden. We're working around the clock to do that.
        Mr. Bilirakis. Yes, go ahead.
        Dr. Frieden. Excuse me. We've already produced 375,000 of
    the realtime PCR. We've got roughly 15 to 20 states already
    approved for use of that. Now with the IGM EUA just last
    Friday, we expect to have another 15 or 20 states approved for
    that. That's where most of the returning travelers live and
    we'll continue to produce them. We've been able to accelerate
    our production capacity at CDC so that we can increase the
    proportion of the need that's met, but we recognize that there
    may be a period of weeks or a month or two where people who
    want the test can't get it. We're in active discussions as is
    BARDA and other parts to encourage the private sector to do
    more in this area. But right now, the CDC developed a test
    which scientists at CDC spent years working on, is the best
    thing out there in terms of what's available. And we're working
    around the clock to make it more widely available.
        Mr. Bilirakis. All right. Well, thank you very much, Mr.
    Chairman. I appreciate it. I yield back.
        Mr. Murphy. I know we're done with this. I know Ms. Clarke
    has 1 minute. She'd like to ask one more question for 1 minute.
        Ms. Clarke. Thank you, Mr. Chairman. Thank you for your
    indulgence.
        Clearly, there's still a lot more to learn about the Zika
    virus. No doubt the public health response to Zika virus will
    be complex and require coordination at the global, regional,
    and national level. While the response to Zika may evolve, one
    thing is clear; governments and international organizations
    must commit to funding and providing access to comprehensive
    reproductive health services to meet the needs of communities
    during this public health emergency and far beyond.
        Preventing pregnancy and the spread of the disease is
    desired by women in their childbearing age as has been
    suggested already in Brazil during this outbreak. As a follow-
    up to Congressman Collins' line of questioning, what more can
    the CDC be doing, or what else can Congress do to support the
    CDC to help women prevent unintended pregnancies, if so
    desired, and prevent continued spread of this disease through
    possible sexual transmission?
        Dr. Frieden. Thank you. As you noted, about half of the
    pregnancies in the U.S., and about two-thirds of pregnancies in
    Puerto Rico are unintended. We do not issue advice to women on
    whether or not to get pregnant. We don't think that's our role.
    We do provide information so that women, their families, and
    their providers can make a decision about whether to use
    effective contraception. We provide guidelines for which
    methods of contraception are most effective, and how those
    might be used. This is basically the approach that we're
    taking, is providing information.
        Mr. Murphy. Thank you. Dr. Burgess would like 1 minute.
        Mr. Burgess. And, Dr. Frieden, if we can just talk one
    second about the spraying issue. You and I have talked about
    this a lot in the past, straight spraying, aerial spraying.
    Obviously for this mosquito it is a little bit different, and
    as I understand it, it's backpacks and going into yards and
    gardens. So is the CDC developing any guidance for our local
    public health offices as to what they can and cannot do, or can
    and cannot expect? As far as local spraying, is it always going
    to require consent to go on property? Do people need to
    identify when they have an ill person at home so that those
    areas can be perhaps on heightened surveillance?
        Dr. Frieden. We've looked at all of these issues and
    compared experiences across jurisdictions. We have a public
    health law project which provides information and advice to
    jurisdictions on models and what's possible in different
    places. I do think that there are ways to optimize current
    mosquito control practices, and that's one of the things that
    we need to rapidly accelerate, and for which the supplemental
    request would be used.
        Mr. Burgess. Do people have the ability to actually get the
    insecticide themselves and use it in their homes if they don't
    want the CDC coming in with backpacks?
        Dr. Frieden. The CDC wouldn't go in with backpacks, but
    this a thing that we're looking at quite actively. It depends
    on mosquito resistance. We're currently doing studies in Puerto
    Rico to see which products the mosquitos are resistant to, and
    we found that for some there's 100 percent resistance, for
    others they're largely susceptible. And it'll depend on what
    those results are for whether that could be done in exactly
    what you mentioned, showing people here's where you need to
    spray. Here are the products that work, is one approach that
    we're considering.
        Mr. Burgess. Thank you. Thank you, Chairman.
        Mr. Murphy. I want to thank this panel for your work. We
    have a second panel coming up here. As you know, other members
    may have questions for you, so I ask members to submit the
    questions and then please respond in a prompt manner. I'm sure
    we'll be following up with all of you by phone, by visits, by
    other hearings. This is critically important for our nation's
    health, so thank you so much for attending today.
        And while this panel is stepping away and we're preparing
    the next panel to come to the table, I'll begin the
    introductions of Panel Two.
        We have with us today Dr. Peter Hotez, the Dean of the
    National School of Tropical Medicine at Baylor. He's also
    President of the Sabin Vaccine Institute and Endowed Chair in
    Tropical Pediatrics at Texas Children's Hospital. Second, we
    have Lawrence Gostin, Linda D. and Timothy J. O'Neill Professor
    of Global Health Law at Georgetown University Law Center. Next
    we have Joseph Conlon, Technical Advisor to the American
    Mosquito Control Association, and Dr. Jeanne Sheffield,
    Director of the Division of Maternal-Fetal Medicine at the
    Johns Hopkins School of Medicine. And as soon as we have our
    panel seated; again, it'll be Dr. Hotez, Lawrence Gostin,
    Joseph Conlon, and Dr. Jeanne Sheffield, I'll begin with some
    of the parts here.
        Let me just say to the panelists, you are aware that the
    committee is holding an investigative hearing. When doing so it
    has the practice of taking testimony under oath, so if you
    could all please be seated, I'll swear you in. Do any of you
    have any objections to testifying under oath? Seeing no
    objections, the Chair then advises you that under the rules of
    the House and the rules of the committee you are entitled to be
    advised by counsel. Do any of you desire to be advised by
    counsel during testimony today? No, say no then.
        In that case if you would please rise and raise your right
    hand, I'll swear you in.[Panel sworn.]
        Mr. Murphy. Thank you. All the panelists have affirmed
    that, so now you're under oath and subject to the penalties set
    forth in Title 18, Section 1001 of the United States Code.
        We will now ask each of you to give a 5-minute summary of
    your opening statement. Dr. Hotez, you are recognized first.
    Please make sure you're turned on, bring the mic close to you,
    and watch for the red light. Thank you.

    STATEMENT OF PETER HOTEZ, M.D., Ph.D., DEAN, NATIONAL SCHOOL OF
    TROPICAL MEDICINE, BAYLOR COLLEGE OF MEDICINE, PRESIDENT, SABIN
    VACCINE INSTITUTE, AND TEXAS CHILDREN'S HOSPITAL ENDOWED CHAIR
    IN TROPICAL PEDIATRICS; LAWRENCE O. GOSTIN, J.D., LINDA D. AND
     TIMOTHY J. O'NEILL PROFESSOR OF GLOBAL HEALTH LAW, GEORGETOWN
    UNIVERSITY LAW CENTER; JOSEPH CONLON, M.S., TECHNICAL ADVISOR,
    AMERICAN MOSQUITO CONTROL ASSOCIATION; JEANNE SHEFFIELD, M.D.,
     DIRECTOR, DIVISION OF MATERNAL-FETAL MEDICINE, JOHNS HOPKINS
                           SCHOOL OF MEDICINE

                        STATEMENT OF PETER HOTEZ

        Dr. Hotez. Mr. Chairman, Representative Castor, and members
    of the subcommittee, I thank you for giving me the opportunity
    to speak today. I'm Dean of the National School of Tropical
    Medicine at Baylor College of Medicine. I also head a product
    development partnership that makes neglected tropical disease
    vaccines that the big pharmaceutical companies won't make
    because they're vaccines for the diseases of the poorest
    people.
        For my remarks about Zika today, I want to focus on my
    perspective living and working in the Gulf Coast of the United
    States, and our unique vulnerability to Zika epidemics, and why
    I believe that this spring or summer Zika could begin affecting
    pregnant women living in economically distressed areas of
    Texas, Louisiana, Mississippi, Alabama, and Florida. And why I
    worry that by the end of this year we could see microcephaly
    cases appearing on the Gulf Coast. I also want to talk a little
    bit about some of the hurdles in vaccine development if there's
    time.
        The reason I'm concerned particularly about the Gulf Coast
    is because the Gulf Coast is unique in that it's the only part
    of the United States with the possible exception of Tucson,
    Arizona that has the Aedes aegypti mosquito. That's the
    mosquito that's now mostly responsible for transmission all
    over Latin America and the Caribbean, so it's Aedes aegypti
    that we mostly have to be concerned about. But my other reason
    I'm concerned about the Gulf Coast, and one not really being
    talked about enough is extreme poverty. I mean, the reason why
    we're seeing Zika in Pernambuco State and Recife in Brazil is
    because that's the poorest area, one of the poorest areas of
    Brazil. It is the epicenter, not just of Zika, but all of
    Brazil's neglected tropical diseases. It's where we see
    lymphatic filariasis, that's where we see schistosomiasis. And
    the reason there's so much Zika there is when you--and it
    doesn't take much to understand it. You an just view one of the
    poor communities, you see no window screens, holes in the
    window screens, but it's also the environmental degradation
    around the area. You see discarded tires, you see plastic
    containers filled with water, and all of those factors combine
    to make the perfect storm, and why Pernambuco is such a deadly
    place in terms of microcephaly cases and Zika.
        It's the same reason why I'm very worried about Haiti. I
    know we're mostly focusing on the United States, but I'd just
    like to make the point that I think Haiti is going to be
    decimated by Zika. UNICEF estimates there's 264,000 pregnant
    women every year in Haiti, so we could be looking at more than
    100,000, maybe 200,000 pregnant women with Zika in their first
    or second trimester. We could be looking at tens of thousands
    of cases of microcephaly in Haiti, in a country that basically
    has no health system. So this is a humanitarian catastrophe
    that's unfolding in front of our eyes, and I really don't see
    any significant global action right now happening in Haiti.
        And the reason I'm particularly worried about the U.S. Gulf
    Coast, dengue actually caused outbreaks in Houston in 2003,
    2004, and 2005. That was worked on by our National School of
    Tropical Medicine. The reasons are clear, we have Aedes
    aegypti, but where this is most happening are in the poor areas
    of Houston, so the historic African American wards like the
    Fifth Ward in Houston where I can take you there just a minute
    off the highway. This is not hard to find, and what I'll show
    you are dilapidated housings with no window screens, holes in
    the window screens. You'll see discarded tires all along the
    side of the road filled with organic debris and water, and the
    Aedes aegypti mosquito likes nothing more than discarded tires
    along the side of the road.
        Right now our Harris County Mosquito Control Division is
    finding Aedes aegypti mosquitoes. Those numbers are going to
    start to climb beginning April and into May, and I'm quite
    worried that we won't learn that there's going to be a Zika
    outbreak until we start seeing microcephaly cases towards the
    end of the year. So what do we need to do about this?
        First of all, I think the U.S. Government needs a more
    active role in coordinating what's going on in Haiti, or what's
    not going on in Haiti, working with the Organization of
    American States and WHO. Remember this is a disease we can
    fight. Between 1947 and 1962 we eradicated the Aedes aegypti
    mosquito from the Western Hemisphere for most of Latin America.
    We did it by old-fashioned mosquito control programs and being
    aggressive by draining water sources. The Aedes aegypti
    mosquito was eradicated in 18 Latin American countries and
    resulted in dramatic reductions in dengue and yellow fever.
        Equally important, we need a coordinated response to combat
    the threat of Zika on the Gulf Coast. This means surveillance
    of mosquitos and Zika detection. Beyond mosquito control we
    need to collect the garbage, we need to get rid of the
    discarded tires and standing water in poor neighborhoods,
    provide pregnant women living in poverty with adequate screens
    for their homes. This approach goes beyond the health sector
    and beyond the remits of the CDC. It could require involvement
    of Housing and Urban Development, EPA, even Homeland Security.
    Remember, even if a few babies are born with microcephaly on
    the Gulf Coast it will be talked about in the same context as
    Katrina, it will be talked about in the same context as the BP
    Oil spills; so, therefore, I urge this committee to
    aggressively pursue policies to protect that region. Thank you.
        [The statement of Dr. Hotez follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you, doctor. Your time has expired. We'll
    come back to you.
        Professor Gostin, you're recognized next for five minutes.

                      STATEMENT OF LAWRENCE GOSTIN

        Mr. Gostin. Thank you, Mr. Chairman Murphy, Representative
    Castor, and the House subcommittee. I'm going to discuss four
    is very briefly. First is the President's supplemental
    appropriation. Secondly, how we continually under-invest and
    the financing of these kinds of ongoing threats. Third, our
    public health measures like travel isolation, quarantine. And
    fourth is child, maternal, and reproductive services.
        First in terms of the President's appropriation which I
    strongly support. So why act now? Well first, as you've heard
    from the first panel, there's a clear and present danger to the
    United States and our hemisphere. The United States is the
    global health leader, humanitarian leader, and we are the major
    leader in our own hemisphere in the Americas and the Caribbean.
    We also have our own domestic homeland to protect.
        We remember when Ebola arose here in Dallas and other
    places, how ill-prepared we were, and the public would not
    accept that. Ebola taught us a vital lesson to act quickly, act
    decisively, mobilize funding, and attack the hazard as its
    source. There have been four global commissions since Ebola. I
    was a member of two of them, and they have strongly urged us to
    act and act now.
        I remember during the Ebola appropriations and when the
    President sent military forces and the Department of Defense
    into West Africa. I was on PBS News Hour and they asked me what
    I thought, and I said I was very proud of America, and I think
    we need to be proud of America now in our response to Zika.
        Should we take Ebola funding for Zika? I think we should
    not. We would be robbing Peter to pay Paul. This is still a
    major threat in West Africa. We promised to rebuild and
    strengthen the decimated health system in West Africa, and
    America's word is its bond, and its leadership should never be
    placed in doubt. And that should be on a bipartisan basis, in
    my opinion.
        Zika, moreover, has a deep moral as well as a health
    dimension. I'm a public health ethicist, and if you had a
    hearing, for example, nine months from now and there was a
    mother with a microcephalic child here and we failed to act
    decisively now, I think the American public would find that
    unacceptable.
        From financing, we have continually underestimated our
    financing needs. I was a member of the National Academy of
    Science's Global Health Risk Framework Commission. They said
    that an Ebola epidemic, a SARS epidemic, an influenza epidemic,
    and now Zika could affect up to 10 percent of global GDP in the
    affected areas, and the commission suggested that there was an
    estimated $60 billion loss to GDP every year expected with $6
    trillion in the 20th century, in the 21st century. With that,
    the President's $1.8 billion supplemental appropriation to me
    looks modest and would reap great benefits. I would also
    support a contingency fund so that we don't have to mobilize
    funds in the midst of an epidemic.
        Third are public health measures. I believe that the CDC
    was absolutely right in its travel advisory for pregnant women.
    In fact, the CDC went further than the World Health
    Organization. I think it was right to do that. I think any of
    us if we had a daughter who asked us if she were pregnant
    should she go to a Zika-affected country, we would tell her
    what the CDC is telling her, that she should consider
    postponing that travel. But I would not go further and have
    travel restrictions or bars, isolations, quarantines, or border
    controls, some of which were used during Ebola, some
    successfully, but many not. I think there would also be
    Constitutional challenges appropriately to many of those
    measures.
        And then, finally, I believe that we need to be very
    attentive to child, maternal, and reproductive services. Pope
    Francis supported the use of contraception particularly in
    relation to Zika. We have women in the United States and in
    Puerto Rico that need reproductive services and health care
    services for them and their children, and we shouldn't let them
    down if they're under-insured or uninsured.
        So I thank you, Mr. Chairman and the committee for your
    clear recognition of this health threat facing the United
    States and the Americas, and for your leadership in this
    regard.
        [The statement of Mr. Gostin follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you, Professor.
        Now we're going to turn to Mr. Conlon, who I also
    understand was an entomologist in the United States Navy for a
    couple of decades.
        Mr. Conlon. Indeed.
        Mr. Murphy. So thank you.

                       STATEMENT OF JOSEPH CONLON

        Mr. Conlon. Thank you. Good morning, Mr. Chairman and
    members of the subcommittee, Representative Castor. My name is
    Joseph Conlon. I'm a retired U.S. Navy Medical Entomologist and
    I serve as the Technical Advisor for the American Mosquito
    Control Association, and I welcome this opportunity to provide
    a mosquito control perspective to the deliberations of this
    committee.
        The recent introduction and spread of Zika virus in the
    Western Hemisphere has reawakened in the United States an
    appreciation of mosquitoes as not just nuisances, but
    transmitters of devastating diseases. And I use the term
    ``reawakened'' advisedly for mosquito-borne diseases such as
    malaria, dengue, yellow fever were once quite common in the
    United States and, indeed, played a major part in shaping our
    nation's destiny. These diseases no longer claim victims in the
    United States as a matter of course largely due to the
    exemplary efforts of organized mosquito control agencies in
    conjunction with an enlightened and effective public health
    infrastructure. But even more mosquito-borne diseases are a
    mere 7-hour flight from our shores, and our public health
    agencies must be prepared to meet these challenges that they
    will eventually present.
        Zika virus is thought to be primarily transmitted from
    human to human by the bite of an infected Aedes aegypti and
    possibly Aedes albopictus species of mosquitoes. Of these,
    Aedes aegypti has been primarily responsible for transmitting
    the disease due, in part, to its preference by humans both day
    and night and its predilection for biting the lower extremities
    out of sight. Moreover, females frequently take multiple
    partial blood meals often from different individual humans, not
    only increasing the likelihood of feeding on an infectious
    human, but also leading to single infectious females
    potentially feeding on and infecting multiple humans within a
    relatively short time period. This is unique.
        Both Aedes aegypti and Aedes albopictus, the Asian Tiger
    mosquito are notoriously difficult to kill and/or prevent. They
    live inside our houses under furniture, beds, in closets. Their
    eggs can withstand months of drying and their young can develop
    in water containers as small as a discarded soda bottle cap.
    Virtually any collection of stagnant water in containers, tree
    holes, leaf axles, et cetera can serve as an egg-laying habitat
    for these species. Thus, draining wet areas does not prevent
    their development around our homes and yards.
        Aedes aegypti has been found in isolated areas of
    California and along the southern tier of states up into
    Georgia and South Carolina. Aedes albopictus is a bit more
    cold-hardy and its range includes those states but extends
    northward to Illinois and New York. States within this range
    have excellent integrated mosquito control programs in some
    areas, but mosquito control outside of their jurisdictions is
    spotty. Indeed, many potential ports of entry throughout the
    United States have limited or no mosquito control available and
    there is a pressing need for funding to establish sustainable
    mosquito control programs in these areas if outbreaks are to be
    contained.
        Successful mosquito control is based first and foremost on
    a comprehensive knowledge of the vector in order to exploit its
    vulnerabilities. All prevention and control strategies are
    based on this knowledge; however, the cryptic nature of Aedes
    aegypti makes normal surveillance and control strategies
    problematic. This demands that mosquito control in the 734
    established districts and over 1,100 municipal programs be
    improved in the following seven areas: improved mosquito
    surveillance tools for adult Aedes aegypti; availability of
    pesticide resistance testing kits and accurate rapid diagnostic
    tests for arboviral agents and trapped mosquitoes; faster
    communications about protocols between public health
    laboratories and mosquito control programs; funding to
    underwrite new data call-ins that might influence a pesticide
    registrant's decision to keep proven products on the market;
    funding for field validation of new control modalities such as
    lethal overtraps; intracellular controls using Wolbachia;
    genetically modified mosquitoes; new active ingredients such as
    dopamine receptor agonists to name a few. We also need a
    national strategy to elicit sustained public participation in
    removing and draining containers used by Aedes aegypti as
    position sites. Also identifying areas at risk of Zika
    transmission, assisting to the extent possible any federal
    programs, underwriting the startup of new vector control
    programs in impoverished areas at risk.
        The federal government has several mechanisms available to
    help these needs if funds already authorized were to be
    appropriated. Three in particular come to mind. First, the
    expanded laboratory capacity program of CDC for funding
    increases in arboviral testing capacities. Second, the Mosquito
    Abatement for Safety and Health Act by which local governments
    could receive matching federal funds up to $100,000 for the
    establishment and/or enhancement of mosquito abatement
    programs, and $100 million total for building sustainable
    programs where they do not exist. The funding for this was
    authorized but never appropriated. Third, the Food Quality
    Protection Act which authorizes the use of federal funds when
    the cost of new data for public health pesticides was more than
    their producers could afford putting their registration at
    risk.
        The national capacity to control mosquito-borne disease at
    present and in the future will largely depend on the extent to
    which these support programs or their functional equivalent in
    the President's February 22nd Emergency Supplemental Fund
    Request are implemented. Increased tourism, travel, and trade
    make continual introductions of exotic diseases carried by
    mosquitoes virtually inevitable. Resources for prevention and
    control programs must be made available and employed so that
    future cases of exotic diseases can be contained and eliminated
    before their establishment and spread.
        The President's recent request for emergency supplemental
    funding for Zika prevention and control tangibly addresses our
    acknowledgment of current shortfalls in mosquito-borne disease
    control capability and seeks avenues to remedy them towards our
    shared goal of protecting the American people from exotic
    diseases. The American Mosquito Control Association agrees. Our
    citizenry deserves no less. Thank you.
        [The statement of Mr. Conlon follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you, Mr. Conlon.
        Dr. Sheffield, you're recognized for 5 minutes.

                     STATEMENT OF JEANNE SHEFFIELD

        Dr. Sheffield. Thank you. Chairman Murphy, Ms. Castor and
    representatives, I'd like to thank you for the opportunity
    today to testify before you on the effects of Zika virus in
    pregnant women and how clinicians are responding to this virus
    threatening the United States and the rest of the Americas.
        The Zika virus epidemic is a unique situation. It is a mild
    disease in adults in most cases, of little consequence to date
    other than the uncommon but potentially devastating
    complication of Guillain-Barre AE1 Syndrome. However, maternal
    Zika infection during pregnancy can have enormous consequences
    to the developing fetus. Zika has received international
    attention predominantly because of its effect on the developing
    fetus, specifically the association with microcephaly,
    significant effects on brain growth and development, and ocular
    abnormalities. Thus, much of the focus so far of current
    efforts has been on the management of the at-risk patients.
        You've heard extensive testimony about the origin of this
    virus and its spread over the last six decades, so I won't
    repeat myself or repeat that information for the sake of time.
    While the Continental United States has not identified a case
    of local transmission of Zika, there is a growing number of
    confirmed travel-related cases, several of these in pregnant
    women as we've heard about. While transmission of Zika virus is
    primarily through the infected mosquito, transmission may also
    rarely occur through infected blood in laboratory accidents,
    vertical transmission from a pregnant mother to the fetus has
    been confirmed, and finally cases of sexual transmission of
    Zika from an infected person to an uninfected sexual partner is
    increasingly being documented.
        Data regarding Zika virus infection in pregnancy are
    limited, and it is imperative that resources are directed to
    elucidating the pathophysiology of the infection on pregnancy,
    rate of fetal transmission, influence of timing in infection
    and relation to pregnancy on fetal manifestations of the
    disease, and long-term consequences of fetal infection. While
    it is unknown at this time if pregnant women are more
    susceptible to Zika virus, the disease itself does not appear
    any worse in pregnant women compared to non-pregnant women.
    Zika infects pregnant women in any trimester, and the virus has
    been found in multiple different tissues from fetal losses,
    amniotic fluid, the placenta, and the brain of infected
    neonates.
        The Brazilian outbreak of virus was associated with a
    significant rise in microcephaly. Microcephaly itself is
    diagnosed when the head is significantly smaller than what
    would be expected for the sex and gestational age of the
    infant. There are many causes of microcephaly, average rate is
    about 2 to 12 per 10,000 live births in the United States.
    There are multiple etiologies or multiple causes, chromosomal
    abnormalities, genetic abnormalities, toxin exposures such as
    mercury, alcohol exposure during pregnancy, and in the case of
    Zika, also other infections such as cytomegalovirus and
    rubella.
        The reason microcephaly develops in association with Zika
    is currently under investigation. Infants with microcephaly can
    have multiple long-term complications depending on the severity
    of the microcephaly and the associated abnormalities: seizures,
    developmental delay, including speech and motor abnormalities
    are just a few of these complications. There is no known cure,
    and treatments are very limited depending on what the etiology
    is of the microcephaly. Significant resources are going to have
    to be focused on the long-term care of these affected infants.
        Since the microcephaly association was first noted several
    months ago, we now know that there's multiple other
    abnormalities, and I've detailed these in my written testimony.
    Soon after the association of Zika virus infection and fetal
    microcephaly was identified, the Centers for Disease Control
    and Prevention set up a health alert and brought together
    subject matter experts including arbovirus virologists, public
    health personnel, and obstetrics and gynecologists with
    expertise in infectious disease and pregnancy. While data were
    very limited at that time, interim guidelines were rapidly
    developed to inform physicians caring for pregnant women,
    management strategies were disseminated, and educational
    materials describing preventative measures were made widely
    available not just to physicians but to the general public.
    These guidelines have been updated several times as new
    information has been elucidated. As was mentioned, the American
    College of OBGYN and also the Society for Maternal-Fetal
    Medicine have played a very integral part in the development
    and dissemination of this information, and I will be glad to
    answer any questions related to the management of these
    patients.
        Zika virus infection is now a notifiable disease allowing
    for better surveillance of disease burden. The CDC has
    developed a pregnancy registry with confirmed Zika infection in
    the United States. They actually released a report on Friday
    that was briefly mentioned earlier detailing the initial
    results of 257 Zika tests performed for pregnant women in the
    report, 3 percent were positive. The nine women that were
    positive, two electively terminated, two had a miscarriage or
    first trimester loss, one delivered an infant with severe
    microcephaly, and two pregnancies are ongoing, two pregnancies
    have delivered and so far there are no known effects to the
    infant. One woman was infected in a third trimester and
    delivered a healthy infant. So while this initial report is an
    important first step, much more is needed for the physician to
    be able to effectively counsel pregnant women at risk for
    infection. Support for both national and international research
    targeting key populations such as pregnant women is imperative.
    Until effective treatments and/or a vaccine are developed,
    prevention of maternal infection is necessary to prevent the
    devastating consequences of fetal infection. Thank you.
        [The statement of Dr. Sheffield follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you, doctor. I'll now recognize myself
    for 5 minutes of questions.
        First, Dr. Sheffield, has any of the medical academies or
    the AMA come out with any recommendations with regard to asking
    mothers and keep ing the record if they have traveled to any
    areas where Zika virus is known?
        Dr. Sheffield. I think that's actually a superb question,
    and we talked about it quite extensively. My hospital, Johns
    Hopkins, we have developed a very comprehensive screening tool
    with a list of the countries and territories that are currently
    affected, and we are trying to spread this information out to
    multiple other centers. When I talk to other colleagues from
    around the country they are doing the same thing. So very
    similar to Ebola, we're working on a screening questionnaire.
        Mr. Murphy. So would you say at this point, should it be a
    standard that OBGYNs and pediatricians ask that question of
    mothers, if they have traveled to during pregnancy?
        Dr. Sheffield. Absolutely.
        Mr. Murphy. And with regard to that, and this is whether or
    not they had symptoms, just if they traveled there or nearby.
        Dr. Sheffield. Whether they traveled. The pregnant women
    regardless of symptoms require testing.
        Mr. Murphy. Even if in second or third trimester, of
    travel.
        Dr. Sheffield. Yes, sir.
        Mr. Murphy. I mean, I know myself as a psychologist, worked
    for many years with developmentally delayed children that
    there's a lot of long-term intellectual motor and sensory
    complications. I must admit, I'm also concerned that
    regardless, because we don't know yet all the route of what
    happened to this virus with the developing brain, that I wonder
    even if an infant or a young child is also infected with the
    Zika virus, the outcome on the brain, we simply don't know
    that. Am I correct?
        Dr. Sheffield. I think that is actually one of the big
    concerns, is that even if you're infected in the third
    trimester, have no evidence at delivery of microcephaly or
    neurologic abnormalities, the long-term follow-up of these
    babies is imperative because we don't know what the long-term
    consequences are going to be.
        Mr. Murphy. That's correct. I agree with you there.
        Dr. Hotez, you've been critical what you call the
    narrative. We've been mostly hearing from the U.S. Government
    that the Continental U.S. is a wealthy place with few of the
    risk factors contributing to the rapid spread of the arbovirus
    infection such as Zika, dengue, and chikungunya in Latin
    America and the Caribbean. But as a specialist in tropical
    disease based in a major Gulf Coast urban center, why do you
    disagree with that narrative that we shouldn't worry as much?
        Dr. Hotez. Thank you for that question. The reason is we
    have poor people in this country, we have 20 million Americans
    that live at half the U.S. poverty level. We now have 1.65
    million families that live on less than $2 a day according to
    the University of Michigan Center for Poverty. And what we're
    finding is something very interesting about the world's
    neglected diseases, that currently most of the world's
    neglected diseases, which include Zika, are actually found in
    wealthy G20 countries, but it's the poor living among the
    wealthy that account to it for this. So the G20 countries
    account for most of the world's worm infections, and dengue,
    and chagas disease, and leishmaniasis. We have 12 million
    Americans now living with a neglected tropical disease in the
    United States, most of them in the American south, most living
    along the Gulf Coast. For all the reasons that I mentioned in
    my previous testimony that we know that poor areas are
    particularly vulnerable. I have pictures.
        Mr. Murphy. But even with that, I only have a minute, 50
    seconds. I want to ask, and then we can look at those later.
    But even so, I don't know how far these mosquitoes may travel
    in their lifetime, get a wind. Do we have any idea? Mr. Conlon,
    is it miles?
        Mr. Conlon. Not in the case of Aedes aegypti and Aedes
    albopictus. Their ranges are about 100 to 200 meters from where
    they actually breed.
        Mr. Murphy. I see. And along these lines, too, does anyone
    know if the virus can live in the water in which they breed,
    and can the virus be transmitted for an adult to offspring?
    Just to help the American public understand this. Does anybody
    know?
        Mr. Conlon. To my knowledge, it can't reside in water.
    However, it is vertically transmitted from the mosquito, the
    adult mosquito to their offspring, so they're born with it.
        Mr. Murphy. That's disturbing, too. In your testimony, Mr.
    Conlon, you also observed that malaria and yellow fever, both
    mosquito-borne diseases were once quite prevalent, but that
    today they no longer claim victims due to the efforts of the
    Organized Mosquito Control Agencies. How is this accomplished?
    And the infrastructure given is pretty disjointed. How can we
    improve that?
        Mr. Conlon. Well, as Dr. Hotez mentioned, there are many
    places in the United States that do have socioeconomic
    conditions that are conducive to the spread of these types of
    diseases. Those conditions were quite evident back in the past
    in places like Norfolk, places like Louisiana, all throughout
    Louisiana. There were a number of different areas that these
    got transmitted. Dengue fever was first discovered in
    Philadelphia, Pennsylvania, so we should not rely upon the
    south to be the potential breeding ground for these things, but
    anywhere that poverty occurs where you've got difficulties in
    trash removal, you've got certain socioeconomic conditions
    conducive to keeping water containers inside. Those can really
    hurt.
        I want to emphasize, though, that mosquito control is
    conducted on an integrated basis and we should not think that
    there is any silver bullet for this. We've got to utilize all
    the tools that are at our disposal in order to keep these
    diseases from establishing. We need a number of different
    modalities.
        Mr. Murphy. Thank you. I'm out of time. Now turn to Ms.
    Castor for 5 minutes.
        Ms. Castor. Thank you. Well, thank you all very much. In
    addition to the previous panel, you all have really given
    everyone a wake-up call about what has to be done. And I'm more
    convinced than ever that we've got to move this supplemental
    appropriation, and it can't get bogged down in the typical
    congressional budget battles. We need to move it as quickly as
    possible.
        And, Dr. Gostin, I wanted to thank you for emphasizing the
    moral imperative for the Congress to act quickly. And Dr.
    Hotez, I think you're absolutely right to raise the issue of
    Haiti right now and the consequences because there hasn't been
    much discussion about Haiti. And I think they are particularly
    at risk. I think we can do better in mobilizing the
    international aid community and religious community that have
    so many initiatives there.
        I want to focus back on pregnant women because it appears
    that the impact and the connection to microcephaly came as
    something of an unwelcomed surprise. Dr. Sheffield, you've been
    very involved in drafting the guidelines for the CDC, the
    Society of Maternal-Fetal Medicine, and ACOG. Can you go into
    greater detail on the science and what we know?
        Dr. Sheffield. So when the guidelines were first drafted--
    very soon after the reports initially came out about the
    microcephaly, they called a group of people together, and we
    freely admitted--I was not a Zika expert at the time. I knew
    very little actually about the Zika virus infection. However,
    the group of us had done a lot of work over the years with
    other infections and how it affects pregnancy, such as
    cytomegalovirus, and so the group of us that came together at
    the request of the CDC kind of looked at what data was
    available to us with the understanding of what happens with
    other viruses, and drafted just the original, the initial
    guidelines, which have subsequently been updated every time new
    data comes out. But the guidelines initially, if you look back
    a couple of months ago when they first came out, they were
    essentially screen everybody that traveled, and we talked a
    little bit about how to screen, the diagnostic tools that we've
    already talked about earlier today, and then ultrasound looking
    for actual fetal abnormalities, particularly in the head.
        Ms. Castor. What's going on here? With other infectious
    diseases in maternal health, what--are there any other diseases
    where we've seen similar impacts to the fetus or child that
    would develop microcephaly?
        Dr. Sheffield. This virus is fascinating because this virus
    is very neurotropic. It likes the brain, it likes the fetal
    brain and nervous tissue obviously in adults since we're
    talking about Guillain-Barre AE1 Syndrome, but it is very
    neurotropic. There aren't a lot of other viruses that affect
    the developing fetus that is so specific to the nervous system,
    or to the brain. There are other viruses such as rubella, one
    of the most devastating viruses out there that cause multiple
    fetal abnormalities, but it causes abnormalities in multiple
    different systems. Same with some of the other viruses and
    parasites that will affect a pregnant woman. This one so far
    has been very, very focused on brain and neurologic
    abnormalities.
        Ms. Castor. OK. So we're going to need extensive research
    on all that, and that is just starting. Is that right?
        Dr. Sheffield. Absolutely.
        Ms. Castor. Is that how you would characterize it? So let's
    drill down on the recommendations for maternal health. Because
    in the Western Hemisphere, as Dr. Hotez says, we are so
    interconnected, Florida to Brazil, and Latin America and
    Colombia, and Puerto Rico, to Mexico, to Haiti. It's just
    millions and millions of families, travelers where you're just
    not going to be able to talk about travel bans of things like
    that, so you've got to give folks the most constructive
    recommendations. So talk about citizens of the U.S. and Puerto
    Rico, what you're advising them right now if they are of
    childbearing age and intend to get pregnant?
        Dr. Sheffield. So right now myself as I'm sitting across
    the table from one of my pregnant women that is considering
    traveling and my colleagues across the country are all pretty
    much following the ACOG, SMFM, and CDC guidelines, which is if
    you have a pregnant woman that is interested in traveling to a
    Zika affected area currently we, one, recommend against it. If
    they do have to travel there is excellent education out there
    about prevention of mosquito bites because if they do travel,
    it all becomes prevention because, again, there is no
    treatment, and there's no vaccine currently available. So for
    right now it is prevention. So we spend a lot of time if they
    do have to travel talking about preventative measures, and
    there again is a lot of information on the CDC Web site for
    that.
        We also, if they come back from travel, and this is where a
    lot of my patients are coming in, as two months ago they never
    heard of Zika virus. They've all traveled down to an affected
    area and they're coming back suddenly in a panic after seeing
    everything that's happened. And those are the ones where we
    have testing available. Again, not perfect as we've heard, but
    it's what we have available, and then ultrasound or evaluation.
        Ms. Castor. Could you name those specific areas so that we
    have that?
        Dr. Sheffield. The specific areas for the evaluation?
        Ms. Castor. The travel to.
        Dr. Sheffield. Oh, travel to. So the CDC has a linked Web
    site of travel notice, and they keep updating it. Every time a
    new country or a new territory comes up, they update that list.
    Last I saw it was about 30 or so countries and territories, and
    it's online. It's very easily accessible, and actually we
    update it for our clinicians. We have the link right there in
    clinic. They click on it, they pull it up, and they're able to
    say OK, where did you travel? All right, you're on the list.
        Ms. Castor. But Brazil.
        Dr. Sheffield. Brazil, Colombia, Puerto Rico, though Cuba
    is not on it, we actually have tested one patient that's
    traveled from Cuba, so we're talking about the Caribbean.
        Ms. Castor. And it's not going to be a static list. That
    list is going to change.
        Dr. Sheffield. No, it is frequently. It's actually
    frequently updated as new countries are reporting.
        Ms. Castor. Thank you.
        Mr. Murphy. Thank you. Yes, that list is available on CDC's
    Web site. It's quite extensive, throughout the Caribbean,
    Central America, South America, Mexico. Other issues coming up,
    too, for the summer Olympics, as well.
        Mr. Collins, you're recognized for 5 minutes.
        Mr. Collins. Thank you, Mr. Chairman. I want to thank the
    panel as well. Maybe following up on Ms. Castor's comments.
        I think what a lot of us are worried about is there is no
    vaccine, and if somebody does test positive there's no
    treatment, and it's somewhat disturbing but Dr. Sheffield, that
    some women would even choose to terminate the pregnancy. But
    picking up on that, education to me, because we're not going to
    have a vaccine tomorrow or next week, and we'll have better
    diagnostics before we're going to have vaccines and treatments.
    So I'm thinking education, guidelines, pamphlet, with a sense
    of urgency into the physicians' offices. I don't know how many
    typical doctors right now have this information in their
    waiting room, but a lot of times we think we're invincible,
    from what I'm hearing. So a couple of questions: do we have
    even an idea, a 25-year old woman who--she's got 15 years or
    longer to be in her childbearing years. How long if she's
    infected, so she gets the Zika virus, she's not pregnant. She
    waits X period of time. Is that 1 year, 2 years, 10 years,
    never? Do we have any idea?
        Dr. Sheffield. So right now the guidance is if you travel
    to an area you're not pregnant, we're recommending people wait
    at least 4 weeks. The reason for that is the incubation period
    is about up to 2 weeks. The viremic time period where the virus
    can cross to the placenta and then to the fetus is somewhere
    around 7 to 10 days.
        Mr. Collins. Yes, but what I'm getting at is, OK, she's
    tested positive. She's not pregnant. How long would a woman who
    knows she's had the Zika virus, she was infected. Should she
    wait to consider having children? Is it never, or is it 1 or 2
    years? Do we have any guidelines in that area?
        Dr. Sheffield. We don't. Right now we're saying about four
    weeks, but that is based on, again, very, very limited data.
    That's where we desperately need information coming out of
    Brazil, and Colombia, and some of the U.S. studies that are---
        Dr. Hotez. It'll be important to determine if Zika is going
    by the same play book as something like dengue where the virus
    is in your system for a couple of weeks, and then it's gone.
    And that's probably the likely scenario. There is evidence
    that, for instance, West Nile virus can sometimes persist in
    the kidneys for periods of months or years, but that appears to
    be an exception----
        Mr. Collins. So even though someone may be antibody
    positive, the virus, like you're saying with dengue, has
    cleared the bloodstream. You're saying then at that point it's
    to the best of your knowledge they would no longer be infecting
    a fetus?
        Dr. Sheffield. To the best of our knowledge, yes.
        Dr. Hotez. Right.
        Mr. Collins. That's very good news, actually, if there's
    such a thing as good news here.
        Dr. Hotez. It's about the only good news about this virus.
        Mr. Collins. Yes. But if it clears, which is the difference
    in HIV and some others, because it doesn't clear. Yes, sir?
        Mr. Gostin. The other thing to consider is for women who
    are considering getting pregnant but are not pregnant now, what
    we tell them, because they won't necessarily go to their
    physician's office. That's why, in addition to education in the
    doctor's office, I think we need to do public health
    information campaigns to advise young women about what their
    risks are so that they can make well-informed decisions. And
    this is particularly important with the Rio Olympics that are
    looming, because although it will be the Southern Hemisphere's
    winter, there still will be active transmission. And they'll be
    coming then to the northern height of the summer where we could
    then see local transmissions here. So those are all kinds of
    things to consider in addition to the fact that, as you've all
    said, you have so much interchange between Puerto Rico, other
    U.S. territories.
        Mr. Collins. So if there is one absolute, I'm assuming the
    one absolute is a pregnant woman should not travel to those
    areas, because you're saying they could be third trimester and
    we don't know. So would that at least be a fair absolute;
    you're pregnant. You just stay away?
        Dr. Sheffield. I'm a physician. We never deal in absolute--
    --
        Mr. Collins. Well, sometimes you need absolutes.
        Dr. Sheffield. But we do strongly recommend they not
    travel.
        Dr. Hotez. The problem will come and what happens in the
    summer when the Gulf Coast of Texas or Florida becomes an area
    included in the travel ban zone, and then we're going to----
        Mr. Collins. That would be a nightmare.
        Dr. Hotez. That would be a nightmare.
        Mr. Collins. Total nightmare.
        Dr. Hotez. That's a real----
        Mr. Collins. But thank you for your testimony. This
    education is absolutely critical for us, as well as the public.
    And I want to thank the Chairman for holding this hearing, and
    thank the witnesses for your testimony. I yield back.
        Mr. Murphy. Thank you. Ms. Castor, going to recognize you
    for an additional couple of minutes here, 5 minutes.
        Ms. Castor. Thank you very much.
        In some of the countries experiencing outbreaks many do not
    have access to primary health services; that means limited
    access to family planning, as well. Dr. Hotez, it's fairly
    plain but would you explain to everyone why it is in the best
    interest of Americans and American families that we tackle the
    disease in Brazil, and in Puerto Rico, and other places in the
    Western Hemisphere?
        Dr. Hotez. Well, thank you for that question. I think
    what's becoming clear is the Gulf Coast of the United States is
    part of the same eco-zone that the Caribbean and Central
    America is. There's a homogeneity there, especially in our
    impoverished areas. I can take you through parts of the Fifth
    Ward of Houston and you might think you're in Port Au Prince or
    Tegucigalpa, and so we have to realize that what is happening
    in Haiti and in Central America is the same vulnerability as
    the Gulf Coast, and take that accordingly.
        Ms. Castor. Dr. Gostin.
        Mr. Gostin. Yes. It's a very good, actually, because one of
    the things we've learned with SARS, with Ebola, with so many
    novel infectious diseases, and it's more true, or at least as
    much true with Zika is that we can't just be defensive in the
    United States. You actually have to go to the source of the
    infection; that, in other words, to protect ourselves we also
    need to protect the people and the ecosystem, and the mosquito
    population.
        Ms. Castor. So what should we be doing, what should the
    U.S. be doing to insure that women in these countries have
    access to family planning services during this crisis?
        Mr. Gostin. Well, I believe that for health reasons and for
    moral reasons we should encourage it. There are particular
    countries that have told women not to become pregnant for a
    year, 2 years, and more. And as Pope Francis said, we need to
    give them the tools to be able to achieve that goal. And, of
    course, if they do have infants, then we need to give the
    mother maternal health care, we need to give the child
    services. I think it's very important. And, of course, it's
    important in Puerto Rico because Puerto Rico is going through a
    major financial crisis, bankruptcies. It's Medicaid system is
    in shambles. And part of the President's appropriation request
    is to support that and it seems to me that as a territory of
    the United States it's very important. But also because of the
    interchange of travel between people in Puerto Rico and the
    United States.
        Ms. Castor. Dr. Sheffield, give us the practical advice of
    doctor to patient you would give on family planning in the
    impacted areas.
        Dr. Sheffield. So practically speaking, I am an advocate of
    providing effective contraception in order to, as you
    mentioned, provide a tool to prevent pregnancy if the woman so
    desires, if she does have to travel to Zika-affected areas. So
    if I have a woman that is not pregnant and is not interested in
    becoming pregnant in the near future, we do talk contraception,
    particularly if she is traveling down to Zika-affected areas.
        Ms. Castor. And then there's also been the discovery that
    Zika also poses a risk through sexual transmission, so it's not
    just women. We must also target communications and resources to
    men who may carry and spread the Zika virus. Dr. Sheffield,
    what guidance would you offer to men traveling to areas with
    active Zika transmission?
        Dr. Sheffield. So this has kind of thrown a wrench in it in
    our discussions over the last month or so. Now that sexual
    transmission has been confirmed and we are discovering more and
    more cases of sexual transmission, again all of them so far
    have been male to female transmission as was mentioned earlier.
    Our counseling right now is if you are a male who has a
    pregnant female partner, when you come back from travel from a
    Zika-affected area use condoms or actually abstain from sexual
    practice; however, if you don't abstain, use condoms. And we're
    using the word, consistently and correctly use the condoms, and
    trying to prevent transmission. It may not be 100 percent
    unless it's true abstinence, but it at least provides some
    protection.
        Ms. Castor. It's a very important message for the millions,
    and millions, and millions of our neighbors who travel across
    the Americas and in the Western Hemisphere, so thank you all
    very much for your testimony today.
        Mr. Murphy. Thank you. I want to follow up with a couple of
    questions, as well. First of all, with regard to this you're
    recommending, obviously, abstain from travel, abstain from
    other contact here. Does anyone know if airlines, and cruise
    ships, and travel agents are spreading that word, as well?
    Professor Gostin?
        Mr. Gostin. They have not yet, but what we saw with Ebola
    was that even before governments were implementing policies,
    the airline industry was doing that. This is a major financial
    issue for the industry, as well, particularly again because of
    the large travel to the Olympics and others, people canceling
    their flights, so I think it's very important for the United
    States Government and other governments to work with the
    airline industry to make sure that they follow the best public
    health advice.
        Mr. Murphy. Certainly advise that. Mr. Conlon, with regard
    to this, many times people travel to areas and then go to a
    resort area. One would assume that there would be some
    different sort of vector control there versus another part of
    the community. Do you have any advice on that?
        Mr. Conlon. In places in the Caribbean that do have vector
    control capabilities in the resort areas, it tends to be rather
    problematic, even more so than in the United States. I would
    recommend that people, and particularly males that are going
    into this area, utilize EPA registered repellants. They do work
    against all these mosquitoes, and they just need to follow
    label recommendations. But I would caution everyone to make
    sure they're EPA registered. There's a lot of mosquito
    repellant products out there that have rather iffy data sets
    supporting them, so EPA has taken into consideration that
    they're safe to use and they're effective at least four hours
    when utilized properly. What you do is you reduce human
    mosquito contact, no problem with the disease.
        Mr. Murphy. So it isn't just the matter of looking at what
    islands and countries to avoid, but it doesn't necessarily give
    me confidence that even if it is a four or five star resort
    that they necessarily have full vector control. And if you
    still go there, to use some sort of mosquito repellant, so
    there's multiple levels.
        Mr. Conlon. Absolutely. And I would also say that if you're
    going to a resort that's got an 18-story hotel you can find
    Aedes aegypti at 18 stories. They go up through the elevator
    shafts.
        Mr. Murphy. OK. In your testimony you also noted the
    American Mosquito Control Association is currently developing
    guidelines specifically geared towards aegypti and albopictus.
    What will these guidelines focus on, and when will they be
    ready, and how do you see them being put to use?
        Mr. Conlon. Well, hopefully, we're going to get them ready
    by about April, but one can never know when you're talking
    about dealing with volunteers. We're specifically going to try
    to shift our control paradigms and our recommendations from
    reactive, which is oftentimes larvicide. Larvicide are not
    going to be the answer with this mosquito, primarily because we
    generally use larvicide because the larvae are contained in a
    small area, they're easy to get at, they're easy to kill, and
    then they spread out as adults, and make it difficult for us to
    deal with them with regard to adulticides. In the case of this
    mosquito, though, larvicide are not going to be the answer
    because they're occurring in the same area where the adults
    are, so you might as well kill the adults in addition to. So
    we're going to focus more on the adulticide issues, we're going
    to focus more on trying to get community support, elicit
    community support to get rid of the habitat. This is a human
    problem. This not necessarily an Aedes aegypti problem. We're
    creating the problem, and we need to be conversant in creating
    the solution, as well.
        Mr. Murphy. All right, thank you. Dr. Sheffield, what do we
    know currently about the risk of a Zika infection passing from
    an asymptomatic mother to a child during pregnancy? It can
    still happen?
        Dr. Sheffield. We think it can. There haven't been
    excellent documented cases yet of an asymptomatic mother
    passing to an infant, or passing to her fetus. That being said,
    we are assuming that it could happen, and so the
    recommendations are the same whether you're symptomatic or
    asymptomatic.
        Mr. Murphy. And, again, that's something the OB and the
    pediatricians should always in screening questions, where have
    you been? So how frequently should pregnant women who could
    have had an asymptomatic Zika infection be tested for the
    virus?
        Dr. Sheffield. So right now when a pregnant woman comes
    back from a Zika-affected area, we're doing the initial test.
    We're doing the PCR, RT-PCR if she is symptomatic. If she is
    asymptomatic, we are doing the IGM and the plaque-reducing
    neutralizing antibody test. If that is negative, we still are
    following up the fetus with serial ultrasounds. If the
    ultrasound becomes abnormal, we will retest a mother that
    initially tested negative, and we will offer amniocentesis to
    test the fetus, also.
        Mr. Murphy. And do we have the capacity to handle all those
    tests?
        Dr. Sheffield. Right now we have not been turned down on a
    test. Maryland actually is able to do the test. It's the one of
    the states that's able to do the test. However, when we start
    rolling this out to all 50 states, I think that is a large
    question, is if every pregnant woman who travels needs to be
    tested at least once, do we have the capacity? And then you
    start looking at the asymptomatic, or the symptomatic men and
    testing. I think that is a concern.
        Mr. Murphy. Is it possible also for the Zika virus to be
    transmitted through a breast-feeding mother to her infant?
        Dr. Sheffield. So that's an excellent question. For breast-
    feeding mothers, so far they have found Zika RNA in the breast
    milk, so we know that at some point the virus has made it to
    the breast milk. That being said, there have been no cases of
    transmission from breast milk. There also have not been active
    virus identified from the breast milk, so we know that there's
    parts of virus there. That's why the PCR comes back positive.
    But as of right now we haven't found active virus in breast
    milk.
        Mr. Murphy. Well, I want to thank this panel and the
    previous panel. This is very sobering and, quite frankly, very
    frightening stories we have heard today about a very real
    nightmare of the spread of Zika virus. And we don't have the
    answers yet, we don't have the tests yet, we don't have the
    solutions, and I don't even think we know all the consequences
    yet of what this does to adults, to infants, and what we'll see
    in the future with children, whether it is those who have been
    affected in utero with the virus, or those who may have been
    affected during early childhood, because we don't know what
    that could do to the developing brain, as well. So we'll
    monitor this very closely.
        We thank you and the other panelists for your information
    on this. So I'd like to thank the witnesses and the members who
    have attended today. Thank you, Ms. Castor, for stepping in
    here.
        I remind all members they have 10 business days to submit
    questions for the record. I ask that the witnesses all agree to
    respond promptly to the questions. And with that, this hearing
    is adjourned. Thank you.
        [Whereupon, at 12:56 p.m., the subcommittee was adjourned.]
        [Material submitted for inclusion in the record follows:]

                     Prepared statement of Hon. Fred Upton

        Mr. Chairman, thank you for holding this hearing on the
    U.S. public health response to the Zika virus.
        Since January, bipartisan committee staff has been
    examining our public health preparedness for Zika through
    meetings with federal agencies, state health departments,
    public laboratories, international organizations, experts in
    tropical diseases and mosquito control, as well as other key
    stakeholders.
        While there has yet to be a confirmed case of mosquito-to-
    human Zika transmission across the 50 states, this may only be
    a matter of time. Meanwhile, we must confront the tragic
    incidence of microcephaly in babies born to women that acquired
    the infection from travel abroad. We must work diligently to
    reduce the chance of sexual transmission as well as
    contamination of the national blood supply.
        Our understanding of the virus is growing by the day.
    However, there are still many questions that remain to be
    answered before we can be assured that we are doing our utmost
    to protect the American people from this and future pandemics.
    Of particular concern is the disorganization of mosquito
    control systems and the limited capacity for lab testing to
    diagnose Zika.
        Zika is another example demonstrating the need for greater
    preparedness. Zika is one of the emerging biological threats
    that formed an important part of the inquiry of the Blue Ribbon
    Study Panel on Biodefense, discussed at a hearing before this
    Committee several weeks ago. The panel's findings should serve
    as an urgent reminder of the need to build capacity--and
    improve coordination--at all levels of government to address
    present and future public health crises, whether of manmade or
    natural origin.
        The federal witnesses testifying before us this morning are
    uniquely positioned to discuss how the federal response to Zika
    has been formulated, expand upon the $1.9 billion requested of
    Congress on February 22 under the emergency supplemental
    appropriation, and address how it builds upon the lessons
    learned from responses to past outbreaks, such as Ebola. Our
    GAO witness will add his preliminary observations on the
    contours of a successful domestic, regional, and global
    response, and our second panel will feature non-government
    perspectives that will assist us in identifying crucial
    questions for further study.
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