[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]


                 EXAMINING MEDICAL PRODUCT DEVELOPMENT 
                   IN THE WAKE OF THE EBOLA EPIDEMIC

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                               __________

                           NOVEMBER 19, 2014

                               __________

                           Serial No. 113-182
                           
                           
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           


      Printed for the use of the Committee on Energy and Commerce

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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman

RALPH M. HALL, Texas                 HENRY A. WAXMAN, California
JOE BARTON, Texas                      Ranking Member
  Chairman Emeritus                  JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky               FRANK PALLONE, Jr., New Jersey
JOHN SHIMKUS, Illinois               BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania        ANNA G. ESHOO, California
GREG WALDEN, Oregon                  ELIOT L. ENGEL, New York
LEE TERRY, Nebraska                  GENE GREEN, Texas
MIKE ROGERS, Michigan                DIANA DeGETTE, Colorado
TIM MURPHY, Pennsylvania             LOIS CAPPS, California
MICHAEL C. BURGESS, Texas            MICHAEL F. DOYLE, Pennsylvania
MARSHA BLACKBURN, Tennessee          JANICE D. SCHAKOWSKY, Illinois
  Vice Chairman                      JIM MATHESON, Utah
PHIL GINGREY, Georgia                G.K. BUTTERFIELD, North Carolina
STEVE SCALISE, Louisiana             JOHN BARROW, Georgia
ROBERT E. LATTA, Ohio                DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington   DONNA M. CHRISTENSEN, Virgin 
GREGG HARPER, Mississippi            Islands
LEONARD LANCE, New Jersey            KATHY CASTOR, Florida
BILL CASSIDY, Louisiana              JOHN P. SARBANES, Maryland
BRETT GUTHRIE, Kentucky              JERRY McNERNEY, California
PETE OLSON, Texas                    BRUCE L. BRALEY, Iowa
DAVID B. McKINLEY, West Virginia     PETER WELCH, Vermont
CORY GARDNER, Colorado               BEN RAY LUJAN, New Mexico
MIKE POMPEO, Kansas                  PAUL TONKO, New York
ADAM KINZINGER, Illinois             JOHN A. YARMUTH, Kentucky
H. MORGAN GRIFFITH, Virginia
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Ohio
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina

                                 7_____

                         Subcommittee on Health

                     JOSEPH R. PITTS, Pennsylvania
                                 Chairman
MICHAEL C. BURGESS, Texas            FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
ED WHITFIELD, Kentucky               JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois               ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan                LOIS CAPPS, California
TIM MURPHY, Pennsylvania             JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee          JIM MATHESON, Utah
PHIL GINGREY, Georgia                GENE GREEN, Texas
CATHY McMORRIS RODGERS, Washington   G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey            JOHN BARROW, Georgia
BILL CASSIDY, Louisiana              DONNA M. CHRISTENSEN, Virgin 
BRETT GUTHRIE, Kentucky                  Islands
H. MORGAN GRIFFITH, Virginia         KATHY CASTOR, Florida
GUS M. BILIRAKIS, Florida            JOHN P. SARBANES, Maryland
RENEE L. ELLMERS, North Carolina     HENRY A. WAXMAN, California (ex 
JOE BARTON, Texas                        officio)
FRED UPTON, Michigan (ex officio)

                                  (ii)
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     1
    Prepared statement...........................................     2
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     2
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................     3
    Prepared statement...........................................     5
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................     5
Hon. Fred Upton, a Representative in Congress from the State of 
  Michigan, prepared statement...................................   106

                               Witnesses

Anthony S. Fauci, Director, National Institute of Allergy and 
  Infectious Disease, National Institutes of Health, Department 
  of Health and Human Services...................................     6
    Prepared statement...........................................     9
    Additional material submitted for the record.................    21
    Answers to submitted questions...............................   108
Luciana Borio, Director, Office of Counterterrorism and Emerging 
  Threats, Food and Drug Administration, Department of Health and 
  Human Services.................................................    30
    Prepared statement...........................................    32
    Answers to submitted questions \1\...........................   117
Stephen C. Redd, Senior Advisor for Ebola Response, Centers for 
  Disease Control and Prevention.................................    40
    Prepared statement...........................................    42
    Answers to submitted questions...............................   118
Robin A. Robinson, Director, Biomedical Advanced Research and 
  Development Authority, Office of the Assistant Secretary for 
  Preparedness and Response, Department of Health and Human 
  Services.......................................................    53
    Prepared statement...........................................    55
    Answers to submitted questions...............................   123

                           Submitted Material

Statement of November 19, 2014, by Novavax, submitted by Mr. 
  Pitts..........................................................    68
Article of October 7, 2014, ``Ebola Vaccine--An Urgent 
  International Priority,'' by Rupa Kanapathipillai, et al., New 
  England Journal of Medicine, submitted by Mr. Pitts............    71
Article of November 19, 2014, ``How to upgrade Ebola fight,'' by 
  Andrew von Eschenbach and Paul Howard, USA Today, submitted by 
  Mr. Pitts......................................................    75

----------
\1\ Ms. Borio did not answer submitted questions for the record 
  by the time of printing.

 
EXAMINING MEDICAL PRODUCT DEVELOPMENT IN THE WAKE OF THE EBOLA EPIDEMIC

                              ----------                              


                      WEDNESDAY, NOVEMBER 19, 2014

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:35 a.m., in 
room 2123, Rayburn House Office Building, Hon. Joseph R. Pitts 
(chairman of the subcommittee) presiding.
    Members present: Representatives Pitts, Burgess, Murphy, 
Blackburn, McMorris Rodgers, Lance, Cassidy, Guthrie, Griffith, 
Bilirakis, Ellmers, Barton, Capps, Green, Barrow, Castor, and 
Waxman.
    Staff present: Clay Alspach, Chief Counsel, Health; Brenda 
Destro, Professional Staff Member, Health; Brad Grantz, Policy 
Coordinator, Oversight and Investigations; Sydne Harwick, 
Legislative Clerk; Brittany Havens, Legislative Clerk; Carly 
McWilliams, Professional Staff Member, Health; Katie Novaria, 
Professional Staff Member, Health; Alan Slobodin, Deputy Chief 
Counsel, Oversight; Heidi Stirrup, Health Policy Coordinator; 
Tom Wilbur, Digital Media Advisor; Ziky Ababiya, Democratic 
Staff Assistant; Eric Flamm, Democratic FDA Detailee; Hannah 
Green, Democratic Policy Analyst; Amy Hall, Democratic Senior 
Professional Staff Member; Karen Nelson, Democratic Deputy 
Committee Staff Director for Health; and Rachel Sher, 
Democratic Senior Counsel.
    Mr. Pitts. The subcommittee will come to order. The Chair 
will recognize himself for an opening statement.

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    The world is currently experiencing the largest Ebola 
outbreak in history. The worldwide death toll is at least 5,177 
people, according to the World Health Organization's November 
14 situation report. Although the initial response to the Ebola 
outbreak was slow, it is now a top priority for the global 
public health community, including the United States.
    At today's hearing, the subcommittee will examine an 
important aspect of the Ebola crisis, medical product 
development. As Ebola spreads, therapeutics are desperately 
needed to prevent, diagnose, and treat the disease. Federal 
agencies and drug and device manufacturers are hurrying to find 
treatments, vaccines, and diagnostics for this deadly disease. 
Adding to the frustration, none of the medications with the 
most promise are FDA-approved and therefore must be tested in 
clinical trials, which will take time.
    In light of the Nation's substantial investment in public 
health emergency preparedness, many are wondering why no proven 
Ebola medications are currently available and what the Federal 
Government is doing to expedite their approval: Specifically, 
what is FDA doing to accelerate their review of products? How 
is BARDA assisting companies to prepare for clinical trials? 
What is the plan for manufacturing? And how and where will 
these medical products be distributed once they are approved or 
cleared?
    Questions are also being asked about the administration's 
recent $6.18 billion emergency appropriations request, 
including how much of the request is for development of medical 
products and how previous funding requests have been allocated 
and spent. I would like to thank all of our witnesses for being 
here today. I look forward to hearing your testimony.
    [The prepared statement of Mr. Pitts follows:]

               Prepared statement of Hon. Joseph R. Pitts

    The world is currently experiencing the largest Ebola 
outbreak in history. The worldwide death toll is at least 5,177 
people, according to the World Health Organization's November 
14th situation report.
    Although the initial response to the Ebola outbreak was 
slow, it is now a top priority for the global public health 
community including the United States. At today's hearing, the 
subcommittee will examine an important aspect of the Ebola 
crisis--medical product development.
    As Ebola spreads, therapeutics are desperately needed to 
prevent, diagnose, and treat the disease. Federal agencies and 
drug and device manufacturers are hurrying to find treatments, 
vaccines, and diagnostics for this deadly disease. Adding to 
the frustration, none of the medications with the most promise 
are FDA-approved, and therefore, must be tested in clinical 
trials, which will take time.
    In light of the Nation's substantial investment in public 
health emergency preparedness, many are wondering why no proven 
Ebola medications are currently available and what the Federal 
Government is doing to expedite their approval.
    Specifically, what is FDA doing to accelerate their review 
of products, how is BARDA assisting companies to prepare for 
clinical trials, what is the plan for manufacturing, and how 
and where will these medical products be distributed once they 
are approved or cleared?
    Questions are also being asked about the administration's 
recent $6.18 billion emergency appropriations request, 
including how much of the request is for development of medical 
products, and how previous funding requests have been allocated 
and spent.
    I would like to thank all of our witnesses for being here 
today, and I look forward to their testimony.

    Mr. Pitts.And I will yield the remainder of my time to our 
vice chair, Dr. Burgess.

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

    Mr. Burgess. Thank you, Mr. Chairman. And thank you for 
holding this hearing.
    Thank you to our witnesses for agreeing to testify with us 
today. This is now number whatever of a series of hearings on 
the Ebola outbreak that this committee and other committees 
have conducted. As I mentioned yesterday in our Oversight and 
Investigations Subcommittee hearing, one of the things that I 
think has become abundantly clear in dealing with this crisis 
is that all of us ought to bear a lot of humility because this 
virus is different from things we have seen in the past and 
doesn't always behave the way we expect it to, but this hearing 
today is not about looking at the past. It is looking at the 
future and looking toward additional lines of defense, vaccines 
and therapeutics and diagnostics to aid in the fight of this 
epidemic.
    I can remember in medical school when I read that smallpox 
was over, that the last cases had been eradicated, and we would 
never have to deal with the illness again. And the way it was 
over was by a combination of epidemiologic studies and 
isolation, but also vaccination, so anyone who was exposed to 
the illness, the ring around them, the ring vaccination 
approach, was used so that any contacts were not just 
identified, but they were also vaccinated. And that did prove 
extremely effective in halting the progress of what at that 
time was a very terrible disease. And it wasn't in fact until I 
was elected to Congress that I realized that smallpox was in 
fact not eradicated, and we still had to be concerned about it.
    But the point is that development of a vaccine will 
significantly aid in the fight against this illness. And for 
our aid workers and for our soldiers going to Western Africa to 
be on the front lines, we really do owe them the development of 
a vaccine so that they can feel protected as they, in fact, go 
forward to do good for their fellow humans.
    I can't underscore the significance of people who are 
coming back who certainly want to know not only are they 
protected while they are away, but they are not bringing 
something back to their families, and particularly important I 
know to the men and women in the Armed Forces who are serving 
in Western Africa currently trying to help stem the flow of the 
epidemic.
    I hope to hear this morning about the FDA utilizing a 
commonsense risk profile when evaluating diagnostics and 
vaccinations. On my visits down to Presbyterian Hospital the 
last couple of weeks, certainly I learned that the FDA was 
accommodating with hearing requests from people who were on the 
front lines of treating patients. For that, I am grateful. And 
I would like to hear what, going forward, what we can look to 
as far as help from the regulatory side.
    Thank you, Mr. Chairman, for having the hearing, and I will 
yield back.
    Mr. Pitts. The Chair thanks the gentleman.
    Now recognize the ranking member of the full committee, Mr. 
Waxman, 5 minutes for an opening statement.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Waxman. Thank you very much, Mr. Chairman.
    The Ebola epidemic in West Africa is a devastating public 
health crisis. To date, more than 5,000 people have died from 
the disease and over 14,000 people have been infected, 
according to the Centers for Disease Control and Prevention. 
Many more cases are expected as this crisis overwhelms the 
affected countries' public health systems.
    We have a responsibility to help end this outbreak, not 
only to help alleviate the suffering of those in West Africa 
but also to prevent this devastating illness from spreading 
further. And we must take actions now to prevent outbreaks like 
this from occurring again in the future.
    Today's hearing will focus on one important piece of this 
goal, drug and vaccine development for treatment and prevention 
of Ebola. We need to look closely at why there are essentially 
no effective medicines or vaccines for this devastating 
illness.
    In the United States, we rely on the pharmaceutical 
industry to discover, develop, and deliver new medicines to 
patients. This system works because there is a sufficient 
patient population that needs new medicines, our healthcare 
system can pay for the new treatments, and the industry can 
thereby recoup its investment. But Ebola is different. The need 
for the drug is sporadic. The U.S. patient population is almost 
nonexistent. And the countries with the most Ebola patients 
cannot afford to pay high prices.
    So this is an instance in which the private market does not 
work. With Ebola, the Federal Government must drive the 
development of medicines by working with pharmaceutical 
companies. At our last hearing, we heard that the Federal 
agencies have indeed stepped up their efforts. The committee 
has also heard from companies with promising drug diagnostic or 
vaccine candidates who told us that the Government has been 
acting as an effective partner. For our Federal agencies to 
continue to support the development of these products, Congress 
must provide increased funding now and ensure the stability of 
that funding going forward. That is why I support President 
Obama's emergency request. The request would provide the 
resources needed immediately to strengthen the ability of U.S. 
public health systems to respond to Ebola and address the 
current outbreak in West Africa. It includes over $400 million 
for NIH, FDA, and BARDA, the Biomedical Advanced Research and 
Development Authority, to support the development, manufacture, 
and testing of Ebola diagnostics, therapeutics, and vaccines, 
and the request also sets the groundwork to strengthen global 
health systems to better prevent, detect, and respond to future 
disease outbreaks. Congress must act on this request promptly, 
but we also need to make sure that this isn't a one-time 
funding increase in the wake of an emergency. We should avoid a 
cycle in which we let our guard down once the immediate public 
health crisis passes and don't renew our efforts until the next 
emergency occurs and we find ourselves unprepared again. This 
kind of boom-bust approach to preparedness simply does not 
work. We must ensure that we establish a continuous operation 
and provide continuous funding so we are prepared for the next 
outbreak. I thank the witnesses for being here today and for 
your tireless efforts to help alleviate the suffering of those 
afflicted by the Ebola outbreak in West Africa.
    Mr. Chairman, we need to do everything we can. At the 
minimum, we need to support the President's request so we can 
have this country do what is necessary in Africa and here at 
home to address this crisis. Yield back my time.
    [The prepared statement of Mr. Waxman follows:]

               Prepared statement of Hon. Henry A. Waxman

    The Ebola epidemic in West Africa is a devastating public 
health crisis. To date, more than 5,000 people have died from 
the disease and over 14,000 people have been infected, 
according to the Centers for Disease Control and Prevention. 
Many more cases are expected as this crisis overwhelms the 
affected countries' public health systems.
    We have a responsibility to help end this outbreak, not 
only to help alleviate the suffering of those in West Africa, 
but also to prevent this devastating illness from spreading 
further. And we must take actions now to prevent outbreaks like 
this from occurring again in the future.
    Today's hearing will focus on one important piece of this 
goal: drug and vaccine development for treatment and prevention 
of Ebola. We need to look closely at why there are essentially 
no effective medicines or vaccines for this devastating 
illness.
    In the United States, we rely on the pharmaceutical 
industry to discover, develop, and deliver new medicines to 
patients. This system works because there is a sufficient 
patient population that needs new medicines, our healthcare 
system can pay for the new treatments, and the industry can 
thereby recoup its investment.
    But Ebola is different. The need for the drug is sporadic, 
the U.S. patient population is almost nonexistent, and the 
countries with the most Ebola patients cannot afford to pay 
high prices.
    So this is an instance in which the private market does not 
work. With Ebola, the Federal Government must drive the 
development of medicines by working with pharmaceutical 
companies.At our last hearing, we heard that the Federal 
agencies have indeed stepped up their efforts. The committee 
has also heard from companies with promising drug, diagnostic, 
or vaccine candidates who told us that the Government has been 
acting as an effective partner.
    For our Federal agencies to continue to support the 
development of these products, Congress must provide increased 
funding now and ensure the stability of that funding going 
forward.
    That is why I support President Obama's emergency request. 
The request would provide the resources needed immediately to 
strengthen the ability of U.S. public health systems to respond 
to Ebola and address the current outbreak in West Africa. It 
includes over $400 million for NIH, FDA, and BARDA, the 
Biomedical Advanced Research and Development Authority, to 
support the development, manufacture, and testing of Ebola 
diagnostics, therapeutics, and vaccines. And the request also 
sets the groundwork to strengthen global health systems to 
better prevent, detect, and respond to future disease 
outbreaks. Congress must act on this request promptly.
    But we also need to make sure this isn't a one-time funding 
increase in the wake of an emergency. We should avoid a cycle 
in which we let our guard down once the immediate public health 
crisis passes and don't renew our efforts until the next 
emergency occurs, and we find ourselves unprepared again. This 
kind of ``boom/bust'' approach to preparedness simply does not 
work. We must ensure that we establish a continuous operation--
and provide continuous funding--so we are prepared for the next 
outbreak.
    I thank the witnesses for being here today and for your 
tireless efforts to help alleviate the suffering of those 
afflicted by the Ebola outbreak in West Africa.

    Mr. Pitts. The Chair thanks the gentleman.
    I now recognize the vice chair of the full committee, Mrs. 
Blackburn, 5 minutes for an opening statement.

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF TENNESSEE

    Mrs. Blackburn. Thank you, Mr. Chairman.
    We now have about 15,000 cases and over 5,000 deaths in 
this 2014 Ebola outbreak. It is the worst since the virus was 
discovered in 1976, and we are hearing some good news out of 
Liberia, some mixed results out of the region. And in light of 
this outbreak, there should be an intensive effort to find and 
approve a treatment or, better yet, a vaccine to prevent Ebola. 
And Dr. Burgess has spoken so well about that and our concerns.
    Now, the FDA and the FDA Priority Review Voucher Program 
was authorized by Congress in 2007 to incentivize the 
development for neglected tropical diseases. And although 
Congress did provide FDA with the ability to add diseases to 
this list through rulemaking, the process still takes time. 
That is why I have introduced H.R. 5729, which would add the 
filoviruses to the list of diseases included in the Priority 
Review Voucher Program. This family includes all known strains 
of Ebola as well as the related Marburg viruses.
    And I want to recognize and thank my cosponsors on this 
bipartisan legislation: Representatives Green, Butterfield, 
McCaul, and Fleischmann. I also ask for the support of the rest 
of the committee members. This is an issue that needs and 
deserves our attention. And we stand ready to work with you. We 
welcome you as our witnesses today.
    And Mr. Chairman, I would yield the remaining time to 
whomever would like it.
    Mr. Pitts. Does anyone seek time?
    Mrs. Blackburn. I yield back.
    Mr. Pitts. The Chair thanks the gentlelady.
    That concludes our opening statements. Members' opening 
written statements will be made a part of the record.
    We have one panel today. On our panel, we have today Dr. 
Anthony Fauci, Director of the National Institute of Allergy 
and Infectious Diseases of the National Institutes of Health; 
Dr. Luciana Borio, Director, Office of Counterterrorism and 
Emerging Threats, U.S. Food and Drug Administration; Rear 
Admiral Stephen Redd, senior adviser for Ebola response, 
Centers for Disease Control and Prevention; and Dr. Robin 
Robinson, Director, Biomedical Advanced Research and 
Development Authority at the Office of the Assistant Secretary 
for Preparedness and Response, U.S. Department of Health and 
Human Services.
    Thank you for coming. Your written testimony will be made a 
part of the record. You will have each 5 minutes to summarize 
your testimony, and we will begin with you, Dr. Fauci. you are 
recognized for 5 minutes for your opening statement.

STATEMENTS OF ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF 
ALLERGY AND INFECTIOUS DISEASE, NATIONAL INSTITUTES OF HEALTH, 
    DEPARTMENT OF HEALTH AND HUMAN SERVICES; LUCIANA BORIO, 
DIRECTOR, OFFICE OF COUNTERTERRORISM AND EMERGING THREATS, FOOD 
    AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
 SERVICES; STEPHEN C. REDD, SENIOR ADVISOR FOR EBOLA RESPONSE, 
CENTERS FOR DISEASE CONTROL AND PREVENTION; ROBIN A. ROBINSON, 
    DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT 
 AUTHORITY, OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS 
     AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN SERVICES

                 STATEMENT OF ANTHONY S. FAUCI

    Mr. Fauci. Thank you very much, Chairman Pitts, Vice 
Chairman Burgess, Ranking Member Waxman.
    I appreciate the opportunity to address you today on the 
role of the National Institute of Allergy and Infectious 
Diseases in the research which is addressing our response to 
the Ebola virus disease epidemic. This particular effort--
interestingly, not fully appreciated--actually began many years 
ago following the attacks on 9/11 at the World Trade Center and 
at the Pentagon, which the following month were followed by 
anthrax attacks through letters to the United States Congress 
and the press, which triggered a multi-agency Government effort 
to address the medical countermeasures for bioterror. And as 
shown on this slide, there was a research agenda in which a 
variety of pathogens were identified to be the high-risk 
pathogens for bioterror attacks. And if you look on the bottom 
of the slide, there is anthrax, botulism, plague, smallpox, 
tularemia, but the viral hemorrhagic fevers are listed 
prominently there, including Ebola.
    Years ago, we made the decision that not only would we need 
to be prepared for deliberate attacks in the form of bioterror 
but for the natural emergence and reemergence of these 
infectious diseases, so the biodefense agenda was merged into 
an agenda for naturally emerging and reemerging infections, and 
so the NIH put on a multifaceted effort that ranged from 
fundamental basic research through clinical research and the 
provision of resources for academic investigators and 
industries, with the result in mind of ultimately developing 
countermeasures in the form of diagnostics, therapeutics, and 
vaccines. And, as represented on this committee, what we had 
was a variety of agencies synergizing with each other. The NIH 
doing the concept and early product development, advanced 
development on the part of BARDA, which you will hear from Dr. 
Robinson soon, the commercial manufacturing, and finally the 
regulatory guidance and review by the FDA. Using this 
framework, we have products now that are in the various stages 
of the process of development.
    I bring to your attention two that are most important, and 
that is Ebola vaccines in which we started the early phase I 
trials at the NIH on September the 2nd. We have completed 
enrollment and vaccinations. We have the early results of the 
product of the GSK Vaccine Research Center showing minimum 
adverse events and good immunogenicity. Soon behind that is the 
VSV or NewLink product, which entered phase I trials soon after 
the September initiation of trials at the NIH. And they are 
both now being studied at the NIH and by the Walter Reed Army 
Medical Center. There are a couple of others behind them, and 
we hope to begin Phase II/III trials for efficacy in West 
Africa by the very early part of next year, likely the first 
week or so in January. My deputy is currently in Liberia now 
determining the logistics of the trial.
    In addition, there are therapeutics that are in 
development. Here is a list of some of them. I don't have time 
to go through all of them. But each of these in one form or 
another has been given on a compassionate basis to individuals 
who have been stricken with Ebola virus disease.
    The one point I want to make to this committee is that we 
do not know if any of them work or how toxic any of them are, 
which really cries out for the kinds of clinical trials which 
we are currently designing to determine in a definitive manner 
the safety and efficacy of these products.
    I would like to close in the last minute to also bring to 
the attention of this committee that the NIH also has a Special 
Clinical Studies Unit at our Clinical Center in Bethesda. And 
we are designated, as shown on the map, as one of the three 
designated Ebola treatment facilities, along with our 
colleagues at Emory and at Nebraska. On the lower right is a 
picture of the Clinical Center, and you won't recognize me, but 
on the left-hand part of the slide is a picture of me as I was 
getting ready to go into the room to help take care of Nina 
Pham, who was a patient at the Clinical Center. And I am happy 
to say I think we already know that, as shown on this last 
slide, we were very happy and fortunate to have the opportunity 
to discharge her a couple of weeks ago. There is a picture of 
her on the left, and on the right is a picture of the nurses 
who helped us take care of her.
    That is the end of my testimony, Mr. Chairman. I will be 
happy to answer questions later on.
    [The prepared statement of Mr. Fauci follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Mr. Pitts. The Chair thanks the gentleman.
    Dr. Borio, you are recognized for 5 minutes for an opening 
statement.

                   STATEMENT OF LUCIANA BORIO

    Ms. Borio. Good morning, Chairman Pitts and members of the 
subcommittee. Thank you for the opportunity to appear before 
you today to discuss FDA's response to the Ebola epidemic. My 
colleagues and I are determined to do all we can to help 
expedite the availability of safe and effective medical 
products for Ebola. The challenges posed by this epidemic are 
unprecedented, and the compassion and commitment demonstrated 
by the healthcare providers caring for patients with Ebola 
represent the best of humanity.
    As you know, currently there are no treatments or vaccines 
that have been shown to be safe and effective for Ebola. The 
desire and need for specific treatments and vaccines are 
overwhelming, and we are taking extraordinary steps to speed 
the development, manufacture, and availability of these medical 
products. We are reviewing data as they are received. FDA took 
only a few days to allow vaccine studies to proceed. We are 
supporting the World Health Organization by providing technical 
assistance and advice on scientifically sound, ethical, and 
efficient clinical trials. We are working with our 
international regulatory counterparts to achieve regulatory 
harmonization and efficiencies in the review of investigational 
products for Ebola, and we are leveraging our authorities. We 
issued, for example, emergency authorizations for six 
diagnostic tests for Ebola.
    Product development is proceeding at a very accelerated 
pace, and there is tremendous hope that some of these 
investigational products will help patients, but as Dr. Fauci 
just mentioned, these candidates are still in the early stages 
of development for Ebola. And it is possible that some may hurt 
patients, and others may have little or no effect. The fastest 
and most definitive way to assess their safety and efficacy is 
through properly designed clinical trials.
    FDA is working with our NIH colleagues and investigators 
from the Emory University Hospital, Nebraska Medical Center to 
implement a flexible and innovative clinical trial protocol 
that would allow companies and clinicians to evaluate multiple 
investigational products for Ebola under a common protocol. 
This will create efficiencies. Our goal is to ensure accrual of 
interpretable data and generate actionable results in the most 
expeditious manner. Until such trials are established, we will 
continue to enable access to investigational products through 
special mechanisms, such as compassionate use. As you know, 
every Ebola patient in the U.S. has been treated with at least 
one investigational product. We have approved such requests for 
compassionate use within a matter of hours.
    But just last week, WHO reviewed the data on the use of 
investigational products administered to patients under this 
type of mechanism. They found the data derived did not permit 
an evaluation of efficacy. This simply underscores the 
critically important need to establish properly designed and 
scientifically valid trials to determine whether these products 
help, hurt or have little or no effect. What we learn from 
these trials will have an impact on generations to come.
    More than 300 FDA staff are engaged in response activities, 
and without exception, everyone has been proactive, thoughtful, 
and adaptive to the complex range of issues that we are facing. 
There is still a lot of work to do, but we are fully committed 
to this response. We will continue to leverage our authorities 
to the fullest extent to facilitate development and 
availability of safe and effective medical products for Ebola. 
And our decisions are always based on science, and I can assure 
you that we will continue to move as fast as the science 
allows. Thank you very much.
    [The prepared statement of Ms. Borio follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Mr. Pitts. The Chair thanks the gentlelady.
    Now recognize Admiral Redd for 5 minutes for an opening 
statement.

                  STATEMENT OF STEPHEN C. REDD

    Mr. Redd. Good morning, Chairman Pitts, Ranking Member 
Waxman, and members of the subcommittee. It is a pleasure to be 
here to have the opportunity to describe the current epidemic 
of Ebola in West Africa, what CDC is doing to respond there as 
well as here in the United States, and I will talk briefly 
about the work we are doing to support vaccine evaluation in 
West Africa.
    Ebola, since its identification in 1976, is the same 
disease. The situation is very different in West Africa from 
prior outbreaks, but the disease itself is similar with the 
same symptoms, the same incubation period, the same spread 
through infected bodily secretions, and control measures that 
are being implemented to identify, isolate, and treat cases and 
track contacts. Although the purpose of this hearing is 
countermeasures, as we have heard, their availability can't be 
assured in the immediate future, so, for the near term, we are 
going to be applying those traditional public health measures.
    I would note that the administration has requested $1.83 
billion for CDC to help respond to the Ebola outbreak. This is 
critical for three areas of work. The first is the immediate 
response in the affected countries, the highly affected 
countries, to extinguish the epidemic at its source. The second 
is to improve the ability in the U.S. to identify and treat 
cases. And the third is to increase the public health emergency 
response capabilities in vulnerable nations throughout the 
world, the Global Health Security Agenda.
    In West Africa, as we have heard, there are slightly more 
than 15,000 cases right now that have been reported, 5,700 
deaths. These have been spread through two primary means: 
exposure to secretions through unsafe care, either in the 
community or in medical settings, and through unsafe burials. 
The situation is different in the three most highly affected 
countries, but I would note that even in Liberia, where we have 
seen signs of leveling off, that there are still 200 to 300 
cases being reported each week, so it is way too early to 
celebrate.
    Two countries have controlled imported cases with stopping 
chains of transmission both in Senegal and in Nigeria. We are 
now working on a new situation in Mali. There are six cases 
that have involved two funerals and over 400 contacts that are 
being traced, and so we are very concerned about the situation 
in Mali right now. And with the end of the rainy season, there 
is increased possibility of spread to neighboring countries; 
particularly Cote d'Ivoire is a country of concern.
    We used to say that this outbreak was bigger than all other 
outbreaks combined, but actually, in the past 2 weeks, there 
have been as many cases as there had been in all the previous 
outbreaks, and the current outbreak in West Africa is about 30 
times larger than the largest previous outbreak.
    I will turn now to U.S. preparedness. We have been working 
hard to prepare here before the first imported cases, and we 
have altered our plans as the situation has evolved. I will 
note just a couple of things that we have implemented. There is 
inbound screening of passengers that have traveled from West 
Africa to the United States in five airports. All travelers 
from those countries have to pass through these airports. Mali 
has been added to that list as of this past Monday. Those 
individuals are tracked for 21 days, their entire potential 
incubation period, so that if they do develop symptoms, they 
can be routed quickly to a place that can diagnose them and 
treat them.
    I will turn now just briefly to countermeasure development. 
As Dr. Fauci mentioned, there are vaccine trials being planned 
for West Africa. CDC is planning to work collaboratively with 
BARDA, FDA, and NIH on a trial in Sierra Leone using a 
different study design than the one that will be conducted by 
NIH. These are complementary and increase the chances of 
getting information on safety and effectiveness as quickly as 
possible.
    I would just like to close with as long as there are cases 
in West Africa, there will be a risk of cases occurring in the 
United States. It is an important reminder that we are at risk 
when other countries lack basic capabilities. The 
administration's request underscores the urgent need to work in 
these vulnerable areas. I thank the committee for its interest 
in Ebola, and we hope to have your support with the emergency 
funding. That concludes my testimony.
    [The prepared statement of Mr. Redd follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Mr. Pitts. The Chair thanks the gentleman.
    Now recognize Dr. Robinson, 5 minutes for an opening 
statement.

                 STATEMENT OF ROBIN A. ROBINSON

    Mr. Robinson. Good morning, Chairman Pitts, Vice Chairman 
Burgess, Vice Chairwoman Blackburn, and Ranking Member Waxman, 
and distinguished members of the subcommittee. Thank you for 
the opportunity to speak with you today about our Government's 
Ebola response efforts. BARDA, created by the Pandemic and All-
Hazards Preparedness Act in 2006, is the Government agency with 
the full-time responsibility to support advanced development 
and procurement of novel and innovative medical 
countermeasures, such as vaccines, therapeutic drugs, 
diagnostics, and medical devices for the entire Nation. I am 
here today to update you on the progress that we have made on 
Ebola medical countermeasure response activities.
    BARDA has used several overarching principles to guide us 
through previous public health emergencies, like the H1N1 
pandemic, H7N9 outbreaks in China last year, and is now 
applying them to the current Ebola epidemic response.
    First, BARDA exists to address the medical consequences of 
biothreats and emerging infectious diseases. Ebola represents 
both.
    Second, BARDA works with our Federal partners here to 
transition medical countermeasures from early development into 
advanced development towards ultimate FDA approval. Today, 
BARDA has transitioned one Ebola therapeutic candidate and 
three Ebola vaccine candidates from early development in NIH 
and DOD into advanced development with three more therapeutic 
candidates and one more vaccine candidate under consideration.
    Third, BARDA, in concert with our Federal partners, 
utilizes public-private partnerships with industry to ensure 
that we have countermeasures to protect our citizens. Today we 
are working with both small and large biotechnology and 
pharmaceutical companies in public-private partnerships, 
collaborating with other countries and NGOs, and providing 
actual staff to help WHO in their efforts.
    BARDA, fourthly, has established a medical countermeasure 
infrastructure to assist product developers on a daily basis 
and to respond immediately in a public health emergency. To 
name a few, today BARDA is utilizing our nonclinical studies 
network to conduct critical animal challenge studies to 
evaluate new Ebola monoclonal antibody and therapeutic 
candidates; our Centers for Innovation in Advanced Development 
and Manufacturing to expand production of Ebola monoclonal 
antibodies as they become available; our Fill Finish 
Manufacturing Network to fill both Ebola antibody and vaccine 
products into vials; our new Clinical Studies Network to help 
CDC plan and conduct vaccine clinical trials in Sierra Leone 
early next year, as Dr. Redd said; and our modeling unit to 
coordinate Federal and international modeling efforts for 
evolving Ebola epidemiology and interventions. These 
investments that you and we have made since 2010 to create this 
infrastructure are now playing a major role in the Nation's 
response to the current Ebola epidemic.
    BARDA supports large-scale production of medical 
countermeasures as a response measure for public health 
emergencies. Today BARDA is working with our industry partners 
to scale up production of Ebola vaccines and monoclonal 
antibodies to ensure commercial scale manufacturing will be 
possible when needed. Specifically, we have implemented a 
three-pronged approach to maximize the production of promising 
Ebola monoclonal antibodies, like ZMapp. First, we awarded a 
contract in September to Mapp Biopharmaceuticals for 
development and manufacture of ZMapp produced by Kentucky 
Bioprocessing using tobacco plant-based technologies. This 
product candidate has been provided to non-Ebola infected 
persons under an EID with FDA's assistance. Efforts to optimize 
production have already seen a nearly twofold increase in 
production yield, and the clinical trials for this product are 
on track to start in January 2015 being conducted by the NIH.
    Because the present manufacturing process is at pilot 
scale, we are expanding manufacturing capacity by enlisting the 
help of other tobacco plant biopharmaceutical companies, 
including those associated with ADMs.
    Lastly, we are trying to increase antibody production by 
partnering with several companies, including Genentech and 
Regeneron, who make monoclonal antibodies at commercial scale 
routinely for other diseases and have developed innovative 
state-of-the-art monoclonal antibody technologies and mammalian 
cells. We are on track now to test these new Ebola antibodies 
early next year in animals and, if successful, in human 
clinical trials shortly thereafter. Additionally, we will weigh 
the results of ongoing NIH animal challenge studies to 
determine whether we support advanced development of two Ebola 
antiviral drug candidates.
    With respect to vaccines, BARDA is supporting the 
development of several vaccine candidates from Profectus for 
clinical trials next year and NewLink Genetics for product 
development and commercial scale-up manufacturing. With 
additional funds, we will be able to support commercial 
manufacturing scale up and further clinical trials for other 
promising Ebola vaccine candidates from GlaxoSmithKline, 
Johnson and Johnson, and Bavarian Nordic to ensure we have 
vaccines when they are needed.
    Finally, together, we face significant challenges in the 
coming weeks and months as the Ebola epidemic evolves, clinical 
trials start, and manufacturing improvements are implemented. 
Be assured, we are doing all that can be done, and I thank you 
for your help over the years, and I look forward to your 
questions. Thank you.
    [The prepared statement of Mr. Robinson follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Mr. Pitts. The Chair thanks the gentleman.
    That concludes the opening statements.
    I have a UC request to put in the record a letter from 
Novavax and an article from the New England Journal of 
Medicine.
    Without objection.
    [The information follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]   
       
                
    Mr. Pitts. I have one more. An article by Andrew von 
Eschenbach and Paul Howard entitled, ``How to Upgrade Ebola 
Fight.''
    Without objection, so ordered.
    [The information follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
           
    Mr. Pitts. I will begin the questioning and recognize 
myself for 5 minutes for that purpose.
    Dr. Robinson, the President's request for emergency Ebola 
response funding includes $157 million for BARDA for immediate 
response to manufacture vaccines and therapeutics. The request 
does not specify or specifically mention if any of these funds 
would be used for the development of rapid diagnostic tests to 
identify Ebola. Of the $157 million that was requested in 
emergency funding, how much do you plan to dedicate for the 
development of such tests?
    Mr. Robinson. Thank you for the question, Chairman Pitts. 
BARDA actually has funds in its ARD program for diagnostics and 
will be using those funds for development of diagnostics, as 
many of these diagnostic devices will have applicability not 
only for Ebola but for other biothreats.
    Mr. Pitts. OK. To all the panelists, I understand that HHS 
has reached out to the private sector, which includes a company 
from my home State of Pennsylvania, in order to expedite 
medical countermeasure products. How have companies responded 
to your request? We will just go down the line. We will start 
with Dr. Robinson.
    Mr. Robinson. To date, we have 152 different companies that 
have come to BARDA and gone through our TechWatch program, 
telling us about what their product candidates can do and not 
do. And we have either asked them to submit proposals or 
directed them to our colleagues at NIH, or even FDA, CDC, and 
DOD if funding is more directed toward discovery and early 
development. So we have had a robust response at this point.
    Mr. Pitts. Admiral?
    Mr. Redd. We receive a number of requests each day, about 
20 per week. We generally, for most of those, route them either 
to BARDA or to NIH or to FDA, depending on the particular 
issue. Apart from countermeasures, we have had a very vigorous 
interaction with the private sector on the donation side. It 
has been very helpful in our response in West Africa.
    Mr. Pitts. Dr. Borio?
    Ms. Borio. We have quite a bit of interest from companies. 
We direct them to the appropriate review divisions to explain 
the process. We are clearly prioritizing those companies for 
which NIH, BARDA, and DOD are supporting. We also had quite a 
bit of interest from the diagnostic industry. We did a lot of 
outreach for them and to explain the EUA process, and that has 
also paid off because we have now seen increased interest 
incoming through the FDA for the development of diagnostic 
technologies.
    Mr. Pitts. Dr. Fauci?
    Mr. Fauci. Very similar, Mr. Chairman, literally a couple 
per day that get directly referred to us as well as secondary 
referrals from the FDA or CDC or BARDA when they go to them, 
and then they send it to us. We have a division in my institute 
where we have one component of it that essentially spends full 
time working with industry trying to sort out the things that 
we can help bring forward for them or things that we might 
essentially say are not really relevant to what we are doing. 
Most of them have a positive aspect that we pursue, sometimes 
immediate, and sometimes it is going to take a year or so to 
work it out, but we are very, very closely involved with 
industry in this.
    Mr. Pitts. Thank you.
    Dr. Borio, PAHPRA strengthened FDA's current emergency use 
authority and provided the agency more flexibility to get 
products to the public in an emergency. I was glad to see the 
FDA issue an EUA last week for a diagnostic test related to the 
ongoing Ebola epidemic. Would you please provide more details 
on the agency's use of these new authorities for Ebola? Are 
there more tests or therapies that may become available soon to 
healthcare workers on the front lines?
    Ms. Borio. Well, I can't underscore how important the new 
authorities have been for us to be able to respond as fast as 
we have, specifically with the diagnostics. Since the first EUA 
was issued back in August for the DOD-developed test and that, 
again, we were able to do that because of these new 
authorities, and they were critical to be able to put 
diagnostics in West Africa as well as rapidly deployed within 
the laboratory response in our work at CDC. We will continue to 
make use of those authorities as needed.
    Mr. Pitts. Is FDA currently examining utilizing trial 
designs that would ensure that all participants receive the 
vaccine?
    Ms. Borio. So, Dr. Fauci, would you like to discuss the 
clinical trial designs for vaccine?
    Mr. Fauci. Yes. We feel very strongly, Mr. Chairman, that 
in order to definitively determine the safety and efficacy of a 
vaccine which you will, after all, be giving to normal, healthy 
people, that you have to have a trial in which not every single 
person gets the vaccine at the same time because if that is the 
case, you will never know whether a vaccine works. We are doing 
a randomized controlled trial in Liberia. The CDC will be doing 
what is called a step wedge trial in Sierra Leone. I just want 
to point out to the committee that there were calls back about 
a month or two ago of distributing the vaccine widely in West 
Africa without a control group, had we done that, the downturn 
in Liberia now would have been attributed to the vaccine when, 
in fact, it was a downturn, and there was no vaccine. So that 
is the reason why we have got to be careful to make sure we 
have a control group.
    Mr. Pitts. Thank you. My time has expired.
    The Chair recognizes the ranking member, Mr. Waxman for 5 
minutes of questions.
    Mr. Waxman. Thank you, Mr. Chairman.
    Earlier this month, the administration requested $6.2 
billion to enhance the U.S. Government response to the Ebola 
outbreak. The request included $400 million for NIH, FDA, and 
BARDA to support the development, manufacture, and testing of 
Ebola diagnostics, therapeutics, and vaccines.
    Dr. Borio, how would FDA use the additional funds in the 
administration's budget request to advance diagnostics, 
therapeutics, and vaccines to deal with Ebola?
    Ms. Borio. Well, thank you. So since----
    Mr. Waxman. Could you speak a little louder or right into 
the mike?
    Ms. Borio. Sure. So more than 300 FDA staff have been 
involved in this response, and they represent tremendous 
scientific expertise to be able to support this robust pipeline 
of Ebola products. They have been working full time, all hands 
on deck, at a very accelerated pace to be able to sustain, and 
part of the reason why we would be able to respond so rapidly 
is because of the recent support that this Congress has given 
us in the last few years through the countermeasures 
initiative.
    Now, to be able to continue to sustain the aggressive 
response that we think we will need in the foreseeable future, 
we do need additional resources to hire additional staff so 
that we can continue doing what we are doing and see the 
results that we are seeing.
    Mr. Waxman. Thank you. Dr. Fauci, give us a brief overview 
of how NIH would use the funds included in the request for your 
agency.
    Mr. Fauci. Thank you for the question, Mr. Waxman.
    The NIH, of the amount that you mentioned, is asking for 
$238 million. That will be divided into--for example, one big 
chunk of that is $56 million to conduct the Phase II-III trial, 
the randomized controlled trial in Liberia, and there is a 
certain amount to do the secondary and tertiary candidates 
should that candidate fail, and then there is a chunk of money 
to go for diagnostics and therapeutics. We have, as Dr. Borio 
mentioned, a common protocol to test all of the therapeutics 
that you saw on that list there in one way or another. That 
takes tens of millions of dollars, to do those kinds of trials. 
All of that together is the $238 million request from the NIH.
    Mr. Waxman. I was recently at a conference where people 
were looking at the ideas for faster cures, getting new 
therapeutics out to people right away. And they said that if 
they could eliminate some of those trials that FDA now requires 
and get their product out faster, it would lower the price and 
save people's lives. And one person even argued, why not let 
the individual make the decision how much of a risk they are 
going to take. How would you respond to that idea?
    Mr. Fauci. I would disagree with that completely, Mr. 
Waxman, because having had considerable experience in the 
testing of therapeutic agents and vaccines, I think there is an 
assumption and an understandable emotional desire when you have 
a lot of pain and suffering to just give medications to people. 
There are a couple of things wrong with that. First of all, 
experience tells us that a substantial proportion of those 
might turn out to not only be not effective but might actually 
be toxic. And the thing you learn as a physician on your first 
day in medical school is, first, do no harm. And despite the 
dramatic nature of the situation, we really need to determine 
if they work, and that is the reason why our common protocol 
allows us to determine whether something is safe and effective.
    Mr. Waxman. Well, thank you.
    To support the clinical trials as well as more widespread 
use of any therapeutics and vaccines that are proven to safe 
and effective, we will need to be able to quickly increase 
their production.
    Dr. Robinson, can you discuss how the emergency funding 
request would help BARDA support expanded manufacturing for 
promising therapeutics and vaccine candidates.
    Mr. Robinson. Yes, sir, Mr. Waxman. We are funding, right 
now, the commercial scale production at NewLink--going forward 
with that to be able to produce, instead of tens of thousands 
of doses, hundreds of thousands or even millions of doses going 
forward. Additionally, with funding that has been requested we 
would be able to do that with also GlaxoSmithKline and even J&J 
and Bavarian Nordic.
    On the therapeutic side, we certainly are doing that with 
ZMapp right now by expanding other production facilities and 
going a different way with what we call CHO mammalian cell 
production with the other manufacturers and to produce those 
new antibodies and then be able to have those made at 
commercial scale so we could have thousands of those treatment 
courses available immediately.
    Mr. Waxman. Mr. Chairman, if you will allow me, I wanted to 
ask Dr. Redd, there is a $621 million for CDC for the domestic 
response. Can you describe how you plan to use these funds?
    Mr. Redd. Yes, sir, thank you. The work would support the 
ability to improve what we are doing now, identifying cases, 
getting them to treatment rapidly. So it would provide funding 
for laboratory development, for improving workforce capacity, 
improving biosafety, improving hospital infection control, and 
assuring that personal protective equipment is available for 
the staff that are providing care to these patients.
    Mr. Waxman. OK, thank you.
    Thank you, Mr. Chairman.
    Mr. Pitts. The Chair thanks the gentleman.
    Now recognize the vice chair of the full committee, Mrs. 
Blackburn, 5 minutes for questions.
    Mrs. Blackburn. Thank you, Mr. Chairman.
    And, again, thank you all. This is something we have got to 
get a handle on, and I think you probably realize from 
listening to our questions, our constituents are very 
frustrated with the way that much of this has been approached 
with the lack of--seeming lack of preparedness that our Federal 
agencies had, even though they had been hearing about this for 
months, and then, of course, the fact that our U.S. military, 
my constituents from the 101st, had to be sent over to build 
hospitals and to train medical workers. So it is good to hear 
that you all are engaging the private sector and that you are 
beginning to work forward on this.
    Dr. Fauci, you referenced the slides at the beginning in 
your testimony. You know, you mentioned the length of time that 
you all had focused on this, going back to 2001. I would like 
to encourage you, during that time, time doesn't equal results, 
basically. And the slow movement of the bureaucracy in 
preparing to address these category A situations that you 
outlined is frustrating. And it does show a lack of 
flexibility. So that flexibility is going to be important going 
forward, and it is something Congress is going to hold you 
accountable for.
    The private sector moves at a faster pace.
    And, Dr. Robinson, I was pleased to hear you say that you 
are engaging with the private sector as you are seeking a way 
to move forward with this.
    Let me ask you, do you have any, Dr. Robinson, any American 
pharmaceutical companies that have, in accordance with FDA's 
IND program, Investigational New Drug Program, sought emergency 
export provisions and requested recognition from HHS that an 
emergency situation exists in West Africa that warrants the 
export of an IND that could be helpful in fighting Ebola?
    Mr. Robinson. Not to my knowledge, but I would ask my 
colleague Dr. Borio to help with that.
    Ms. Borio. So this provision has been used to export ZMapp 
to Liberia, this export provision. And there has been interest 
expressed by additional companies to export investigational 
product to Liberia using this export provision, and we are 
currently working with HHS and the companies to----
    Mrs. Blackburn. OK. So, Dr. Borio, I am like Mr. Waxman, I 
can hardly hear you. It is very difficult to hear you here on 
the dais. So you are saying that only one company, ZMapp, has 
requested recognition?
    Ms. Borio. No, I am saying that this provision, this export 
provision has been used by one company, ZMapp, to get the 
product to Liberia at the request of the Liberian Government.
    Mrs. Blackburn. OK. So you all have approved only one, and 
the only one you have approved is ZMapp?
    Ms. Borio. This provision does not--one company has met the 
requirements for the export provision, and the product was 
exported to Liberia. We have received interest and questions 
from additional companies about how to make use of this export 
provision, and we are working with HHS----
    Mrs. Blackburn. OK, let me interrupt you then. How long 
does it take through this to get recognition, for a company to 
get recognition? Because my understanding is there are other 
companies that are there, and I do have the letter from the 
Liberian Ambassador that was dated October 22nd, seeking other 
options, therapies, and drugs to move forward in this program. 
So how long will it take you all through this program? Dr. 
Borio or Dr. Robinson, either one, what is the estimated time 
that it will take somebody to get through this program?
    Ms. Borio. So for products that are under review at FDA for 
which we have substantial information already in the product, 
we are able to move very fast, and we are working hard to 
resolve the situation for the products for which we have very 
little information, but our intent is to be able to support 
export a product when the company is----
    Mrs. Blackburn. Dr. Borio, I hate to interrupt you again. 
What we are looking for is a time frame. You know, are you 
talking about 1 month, 2 months, 6 months? What do you 
anticipate? How much energy are you going to put into this to 
save countless lives? How quickly do you think you can move 
this forward? That is what we are looking for is more of a time 
frame, please, if you can.
    Ms. Borio. I appreciate the intent of moving 
investigational product to those countries. I would just--I 
don't know that to save countless lives--we do not have 
information on these products' safety and efficacy. Our intent 
is to support the request of Liberian or West African 
governments to receive investigational product and our intent 
of course is to support companies that are interested in 
exporting product and----
    Mrs. Blackburn. I need to interrupt you. My time has 
expired, but I am going to ask you to please submit in writing 
a timeline, an orderly process timeline that will give us an 
idea of how quickly you anticipate these products are going to 
be able to be available for emergency export.
    I yield back.
    Ms. Borio. Thank you.
    Mr. Pitts. The Chair thanks the gentlelady.
    Now recognize the gentlelady from Florida, Ms. Castor, 5 
minutes for questions.
    Ms. Castor. Thank you, Mr. Chairman.
    Thank you all for being here today and for everything you 
are doing and your teams are doing to combat the Ebola threat 
and especially containing and stopping the threat from West 
Africa.
    And Dr. Fauci, last time you were here, I mispronounced 
your name, and I apologize, and I will not do it again.
    The ongoing Ebola threat in West Africa is a reminder of 
the importance of drug and vaccine development when it comes to 
fighting these viral threats and the keyrole played, our 
leadership here in America, the key role played by the U.S. 
Government. While Americans are bombarded by advertisements for 
various pharmaceuticals because we have an open and competitive 
marketplace for drugs in America, Ebola is entirely different. 
Development of therapeutics and vaccines for Ebola and similar 
diseases is entirely driven by Government activity because the 
market for these treatments is small and sporadic and because 
affected countries cannot pay high prices for these drugs, and 
yet there is a lot at stake. We tend to pay attention to the 
U.S. Government's role in times of crisis, but we have got to 
constantly look ahead to foresee potential medical threats long 
before they appear. So I would like to hear, Dr. Fauci and Dr. 
Robinson, how do your agencies identify which infectious 
diseases and biological hazards are top priorities? How do you 
anticipate what the threats of the future are?
    Mr. Fauci. Well, we can start off by saying that it is 
impossible to accurately predict what the next outbreak will 
be. You can have a pretty good idea that looming there in the 
background is the possibility of there being a pandemic 
influenza. And that is what we prepare for continually. We are 
trying to improve our abilities vis-a-vis influenza vaccines, 
particularly our efforts in trying to develop a universal flu 
vaccine that you don't have to make every time you get a new 
strain, as opposed to what we literally have to do every year 
when we change strains as the virus drifts, and sometimes, with 
a pandemic, it would shift.
    Regarding something like Ebola, which started off in our 
mind as a threat of bioterror and then, as I mentioned in my 
opening statement, became a potential threat of a natural 
emergence because we have seen it emerge 24 times since 1976, 
The way you prepare for that is to do the kind of research, 
fundamental basic clinical research, to develop 
countermeasures.
    I might bring up also the question that Ms. Blackburn asked 
about how long it took to develop an Ebola vaccine. We had been 
working on that since 2001, 2002, and we were kind of like the 
lone wolf on that. We could not get industry even slightly 
interested in that. So although they can turn out to be quicker 
than the Government, they did not want to step up to the plate. 
And it was only just literally a year or so ago that we got the 
first big company to partner with us, which is the reason why 
we have a vaccine right now. So we were looking around very 
aggressively to have partners in industry and could not find 
one, which is one of the reasons, if not the reason, why we 
don't have a further advancement on our vaccine effort right 
now.
    Ms. Castor. Dr. Robinson?
    Mr. Robinson. So the other part to that is that the 
prioritization of biothreats and then other manmade threats is 
done through the Department of Homeland Security providing 
material threat assessment determinations, and then the Public 
Health Emergency Medical Countermeasures Enterprise actually 
goes through a prioritization--in our Strategy and 
Implementation Plan that came out in 2012 and is being updated 
this year--actually goes through that prioritization process. 
Right now, everything that have been threats are highly there, 
except the ones that we have actually been able to make medical 
countermeasures, such as botulinum antitoxins--and to a certain 
extent with our anthrax and smallpox medical countermeasures--
which we have actually been able to make great progress through 
those. But the others are still there, and they still have all 
high priority.
    As Dr. Fauci said, these product candidates were early in 
development and as they have progressed, and if we had not had 
any outbreaks, we would have been picking up normally several 
of these anyway--but because of that, now we have actually 
moved forward to help the industry compress the time frame to 
be able to develop and produce these vaccine candidates and 
therapeutics from 2 years or 3 years down to a year and a half 
and maybe even 12 months. And so, by working together, we are 
actually able to do that with our colleagues at FDA and NIH.
    Ms. Castor. Thank you.
    My time has expired.
    Mr. Pitts. The Chair thanks the gentlelady.
    Now recognize Dr. Burgess 5 minutes for questions.
    Mr. Burgess. I thank the chairman for the recognition.
    Dr. Fauci, let me just take a minute again and thank you 
for taking care of our nurse, your patient, Nina Pham. It was 
incredible to watch the press conference and see her conveyed 
back home to her family that was waiting and just appreciate 
everything you did to assist her in her recovery.
    I mean, I will speak to some of the same frustration you 
have heard up here this morning, and I so appreciate the fact 
that there is a vaccine that was on a clinical trial. In fact, 
I think I was in Mr. Pitts' district for a field hearing in 
August. And the head of GlaxoSmithKlein was there and talked 
about literally next week we are going to start this clinical 
trial. And I am grateful for that. I appreciate the 
difficulties they have in getting the vaccine to the country 
because of the technical considerations surrounding the care 
and feeding of that vaccine and how it has to be stored, but 
even the acceleration by 1 month of the Phase II clinical 
trials, going from January to December, with the rapidity with 
which this disease is striking down people in Western Africa, I 
mean, that 1 month could translate into hundreds, if not 
thousands, of lives, so that is--yes, the country has made a 
significant investment in getting us all to this point, but we 
are anxious to move beyond where we are right now because it 
does seem that we have arrived at this point in history without 
the tools, and Dr. Fauci, not a criticism, but just a question 
as far as--and I appreciate your statements on randomized 
clinical trials, and I realize those are the gold standard 
under which we all live, but for people who are self-identified 
as traveling to Western Africa, who voluntarily would like to 
receive a vaccine prior to going, is there any mechanism for 
them to be part of those clinical trials?
    Mr. Fauci. The answer is yes because in the Phase I trials, 
a certain proportion of them have been actual healthcare 
workers predominantly. I think if you want to get into now the 
Phase II or III, depending upon whether you are in Sierra Leone 
or you are in Liberia, if you sign up for a trial, you will be 
assigned to one or the other of a limb of a trial. If it is a 
randomized controlled trial, it will be double blind; you won't 
know what limb you are in. If it is a step wedge, it is a 
different design that sort of phases in different groups, so 
there really depends on the trial itself.
    I do want to point out, Mr. Burgess, that when you are 
talking about a vaccine, as you well know from your experience, 
it is different than a therapy for someone who is sick. When 
you are dealing with a vaccine, you are dealing with giving it 
to a normal person, who can do many other things to avoid 
getting infected in the sense of the personal protective 
equipment, et cetera. When you are dealing with a therapy for a 
person who is already sick, that is when you get the 
compassionate use approach that the FDA has been quite flexible 
in granting for the therapies.
    Mr. Burgess. Let me just ask a question of anyone on the 
panel, and maybe the CDC is the best person to ask the question 
to. How many people--are there any persons currently under 
treatment in any of the Ebola facilities in this country, or 
have all those persons been discharged or unfortunately died?
    Mr. Redd. I believe, at the current moment, there are no 
patients in any of the units in the U.S.
    Mr. Burgess. And, Dr. Borio, you remember we had a hearing 
I was allowed to attend on the Foreign Affairs Committee in 
September, and the concern came up about a clinical hold on one 
of the therapeutics that was under development.
    Where are we today with releasing that compound from a 
clinical hold?
    Ms. Borio. Federal law and FDA regulations preclude me from 
discussing specifics about the product in question. I have 
asked the company permission to disclose specifics, but the 
permission was denied.
    And but what I can tell you, because it has been reported 
by the company itself, is that development of product may 
continue in patients who are infected with Ebola. And to my 
knowledge, development has not been hampered by the partial 
clinical hold in healthy volunteers.
    Mr. Burgess. And so that drug is then available for 
compassionate use in an Ebola patient?
    Ms. Borio. The drug is available for compassionate use in 
patients with Ebola and for clinical studies in patients with 
Ebola.
    Mr. Burgess. And how--at the FDA, how are you going about 
evaluating the risk profile of therapeutics given the high 
mortality rate of this illness?
    Ms. Borio. So, clearly, it is very important to take into 
consideration the seriousness of the disease and to be able to 
properly evaluate the potential benefits and the risks, and 
that is what our expert reviewers and team of urologists, 
pharmacologists, our toxicologists will do for every product.
    Mr. Burgess. And I hope you are prepared to share some of 
that information with us. As time goes by, I think that would 
be extremely useful.
    And, Mr. Chairman, let me just say, of course, we have got 
the Cures Initiative also going on in the background, and many 
of the lessons learned with how drug development has occurred 
or the regulatory effect--or the effects of the regulatory 
agencies on drug development I think can be instructive for us 
as we work through the Cures Initiative. So, again, I hope you 
will be willing to come back and share that information as we 
go through this process.
    Ms. Borio. It would be my pleasure.
    Thank you.
    Mr. Burgess. Thank you, Mr. Chairman.
    I yield back.
    Mr. Pitts. The Chair thanks the gentleman.
    Now recognize the gentleman from Texas, Mr. Green, 5 
minutes for questions.
    Mr. Green. Thank you, Mr. Chairman, and I appreciate you 
having the hearing today, and I want to thank our witnesses for 
testifying.
    While we are seeing some progress in response to the deadly 
Ebola virus, much needs to be done in the months ahead to keep 
Americans safe and develop much needed vaccines and treatments.
    Dr. Borio, I want to thank the FDA, because we deal with 
them--we have dealt with them as long as I have been on this 
committee. I understand that the FDA has been given--has given 
24 hours' notice to some of the Ebola patients that has come 
into our institutions and on possible, you know, drugs to be 
able to cure it, and I just appreciate the FDA with that kind 
of quick response and--because, again, if you are at that 
level, you know, people will be able to say, ``Well, do 
whatever you can.'' And I appreciate the FDA; 24 hours is 
really great, and that is what I have heard from the medical 
personnel.
    You may be aware that a bipartisan group of colleagues and 
I, Representatives Blackburn, Butterfield, and McCaul, have 
introduced a bill to allow the FDA to add Ebola to the FDA's 
Priority Review Voucher Program. This program was authorized in 
2007 to promote the development of new treatments and vaccines 
for neglected tropical diseases. Our legislation would add 
Ebola to the list of eligible diseases, creating a new tool to 
advance the development of new treatment and vaccines.
    Do you believe that this sort of incentive might encourage 
further private investment in this effort?
    Ms. Borio. I don't know that it would, but we remain 
interested in working with Congress and any incentives that may 
help develop these products. And in the meantime, we will 
continue to do all we can to provide those incentives, 
including, for example, we did recently an orphan drug 
designation for one of the products to--as an incentive. So we 
think that it is important, clearly, for products such as these 
to have as many incentives as we can.
    Mr. Green. Do you know of any other incentives that might 
be useful in attracting further private sector investment and 
vaccine research in the development for Ebola or other 
infectious diseases.
    Ms. Borio. I would be happy to give it some thought and I 
will get back to you if I----
    Mr. Green. OK. I appreciate it, and thank you.
    Dr. Fauci, in earlier testimony you talked about the 
linkage between the Ebola drug and vaccine development and the 
National Institute of Allergy and Infectious Disease. And I am 
glad our Government and the private sector are stepping up to 
the challenge of developing vaccines and other treatments for 
Ebola. I want to make sure we are also paying attention to 
other tropical diseases that are emerging.
    In my City of Houston and elsewhere along the Gulf Coast, 
we held a 21st Century--I take that back. We held a 21st 
Century Cures roundtable in Houston recently. Chagas disease is 
one example of what is known as a neglected tropical disease. 
It has caused serious heart disease and even death if left 
untreated. While no one in Houston has contracted Ebola as of 
yet, several Houston residents have been diagnosed with Chagas, 
and recently these were not people who had travelled outside 
the U.S. to places where Chagas is widespread. In the past, NIH 
has supported regional centers of excellence in emerging 
infectious diseases, but the neglected tropical diseases were 
never a significant aspect of that initiative.
    Would you be willing to work with me and the committee to 
find a way to support similar regional centers of excellence in 
these neglected tropical diseases?
    Mr. Fauci. We certainly would take that into consideration, 
Mr. Green. In fact, you are referring to my good friend Dr. 
Peter Hotez, who is there now running that effort with Chagas 
disease. He was formerly here at GW, and we have had a very 
close collaboration with him, and I would be more than happy to 
sit down with you and him and talk about the possibilities in 
this regard.
    Mr. Green. Glad to, and I know Dr. Burgess was at that 
meeting, so was our colleague in the Houston area, Congressman 
Olson, and be glad to work with you.
    Mr. Chairman, that is all the questions I have, and I yield 
back my time.
    Mr. Pitts. The Chair thanks the gentlemen.
    Now recognize the gentleman from Pennsylvania, Dr. Murphy, 
5 minutes for questions.
    Mr. Murphy. Thank you, Mr. Chairman.
    Dr. Fauci, it is my understanding that some enrolled in 
vaccine trials will be given placebos, of course. Can you 
discuss any ethical dilemmas this is going to create, and if 
there is a plan to treat those individuals who may receive the 
placebo?
    Mr. Fauci. A randomized, controlled, double-blind trial is 
a classical paradigm for the determination of the safety and 
efficacy of vaccines. It has gone through the strictest ethical 
review----
    Mr. Murphy. I understand that. I am just referring to--I 
don't question that. I just want to make sure that things are 
in place to monitor closely and treat those who may still show 
up with systems, either with the vaccine or without the 
vaccine.
    Mr. Fauci. Absolutely.
    Mr. Murphy. I want to present some of the concerns raised 
yesterday during the hearing that I chaired in Oversight and 
Investigations.
    When we heard from Ken Isaacs of Samaritan's Purse, the 
group's doctors and medical aid workers have been in West 
Africa fighting the outbreak for a long time. He noted, like 
other health experts, that there is a lot of unknowns with 
Ebola and, of course, pointed out that, for example, 95 percent 
of Ebola cases incubate within 3 weeks and then emerge, but as 
a New England Journal of Medicine article noted, 5 percent may 
not emerge until some 42 days later.
    We have heard there has been some 341 mutations of the 
virus. This obviously underscores there is a lot we don't know 
about Ebola, and we need to be humble about that.
    So other things Mr. Isaacs raised was that what would 
happen if this continues to spread; Africa and other portions 
of India were some of the key features.
    Now, in a book that Dr. Frieden recommended I read, ``House 
on Fire,'' about smallpox, at that time, when they started to 
use the vaccines, it was also very vigorous on isolation. So 
much so the way they contained people was they even put guards 
around the homes of those with smallpox, would not let them 
travel anywhere, and made sure no one came in contact with 
them.
    So in order to--in moving forward on this, do you see any 
move forward in terms of dealing with restrictions and 
containment in the villages in Africa and also travel to the 
United States as part of this?
    Mr. Fauci. Well, they are two separate issues, Mr. Murphy. 
One is a patient who is sick with Ebola. Those patients, by 
routine protocol, go into strict isolation. So that is not a 
problem.
    When you are dealing with an asymptomatic person who you 
are suspecting might have Ebola, that is a different story. 
Unlike smallpox, we know that you do not get Ebola unless you 
come into direct contact with body fluids----
    Mr. Murphy. Not true, because there have been cases where 
people have been wearing the personal protective gear but have 
still gotten Ebola. There have been cases where people have 
been asymptomatic but have had positive tests. There is people 
who have been symptomatic and have negative Ebola tests. So I 
want to stop you because you have, in the past, made 
condescending statements about people who talk about the what-
ifs.
    Doctor, we are in the business of what-ifs. You are in the 
business of what-ifs as a clinician, as a scientist, and so are 
we. We have to ask these questions. And I am deeply, deeply 
concerned if we continue down this path of arrogance and hubris 
in saying, ``We got this,'' because we don't.
    Because it was also pointed out in ``House on Fire,'' if 
smallpox came again to the United States, just one case would 
send people into a panic. We want to help here. And I am 
pleased that you are moving forward vigorously and the FDA is 
moving forward vigorously on these vaccine trials, but I also 
want to make sure that--there is going to be billions of people 
who don't have the vaccine. And as we are moving forward on 
this, I want to make sure that we are doing all we can to 
maintain a high defense perimeter so that people who have been 
exposed Ebola are not traveling throughout Europe and the 
United States without other restrictions.
    Now, in yesterday's hearing, it almost sounded like, in 
some ways, that people are spiking the ball that we don't have 
cases in the United States. But let's face it, we will have 
more, and I want to make sure that we are following up.
    I mean, New York City is saying they want $20 million just 
to deal with the one case and tracking 500--dealing with 500 
people there. So these costs are going to go up.
    So a long way of getting to this point, I want to find out, 
are you going to continue to coordinate the vaccine trials 
along with other aspects of quarantining, of looking at travel, 
of dealing with travel issues, so this does not spread to other 
people who don't have the vaccine?
    Mr. Fauci. The answer is yes. We will do everything within 
the scientific data that we know, the experience and the 
realization that there are things that we don't know to do the 
things that you say.
    Mr. Murphy. Well, with regard to the scientific data, how 
many cases would it take to overwhelm the system in the United 
States today?
    Mr. Fauci. I can't give you a number on that, but certainly 
if we have a major outbreak, the kind that we have----
    Mr. Murphy. We only have, like, 10 bed spaces. Right?
    Mr. Fauci. Well, we are----
    Mr. Murphy. I am not talking about thousands of people 
getting it. My point is, let's continue to be humble about 
this. Let's continue to understand there is a lot we don't know 
and move forward and work as a team on this. We want to help, 
but I want to just make sure that we are not just telling 
people, ``We got this and everything's fine at this point.'' We 
still have a lot we have to learn.
    I recognize my time is up, and I yield back.
    Mr. Pitts. The Chair thanks the gentleman.
    Now recognize the gentleman from New Jersey, Mr. Lance, 5 
minutes for questions.
    Mr. Lance. Thank you, Mr. Chairman, and good morning to the 
distinguished panel.
    You have mentioned in your testimony that this is an 
unprecedented global health crisis, and over the course of the 
past several months, there has been widespread confusion over 
hospital best practices, travel protocols, and even treatment 
options. The distinguished panel sits before the committee 
today representing four distinct agencies that have been tasked 
with addressing the crisis. I would ask the members of the 
panel, how can we ensure that there is no overlap or redundancy 
in your work?
    Dr. Fauci.
    Mr. Fauci. Well, when you talk about overlap, we do have 
mandates and missions that I believe are synergistic and not 
overlapping or duplicative, and I tried to explain that on the 
slide that I showed. If you look at the NIH's responsibilities 
for the development of concepts, fundamental basic and clinical 
research to try and understand the disease and the early part 
of the development of the countermeasures. So you have BARDA, 
who is involved in the advanced development. You have CDC, 
whose main mandate is the surveillance and disease control as 
opposed to the development of countermeasures as we do, and you 
have the FDA as the regulatory agency. So I think it is a 
pretty good flow of synergy, as opposed to overlap and 
duplication.
    Mr. Lance.  Others on the panel?
    Ms. Borio. I will just add that we all have our roles, and 
we work very, very closely together, and we talk several times 
a week, several times a day sometimes. We have each other on 
speed dial. So I believe that we are doing everything we can to 
move in synergy and not duplicate each other's work.
    Mr. Lance. Thank you.
    Mr. Redd. I am probably going to say what you have already 
heard, but I think that the two things are there are specific 
lanes of effort, but where there are borders or interfaces, we 
work very closely to make sure that the work we are doing is 
supportive rather than unnecessarily duplicative.
    Mr. Lance. Thank you.
    Dr. Robinson.
    Mr. Robinson. Yes. I mean, this is not our first time at 
this. We have done this from H1N1 to H7N9 last year and now 
this year, and have built up that infrastructureto talk with 
one another and to actually know what our budgets are and what 
our strengths are where we can actually tap into one another.
    Mr. Lance. Thank you.
    Regarding the point you raised on budgets, has the panel 
been asked or your agencies been asked to provide information 
to the administration regarding its recent funding request?
    Mr. Fauci. That is how the budget was developed, actually. 
We were asked by the administration to make a proposal for what 
we felt was necessary for us to accomplish our mission to 
address the Ebola outbreak in West Africa, as well as here 
potentially in the United States, and each of us submitted a 
budget proposal, which then ultimately went forth after review 
at the administration level to the Congress, where we testified 
a week or so ago to the Senate Appropriations Committee.
    Mr. Lance. Others on the panel, you were involved in the 
budget request? Others?
    Mr. Redd. Yes, along with OMB to coordinate the request 
through the Department.
    Mr. Lance. Dr. Robinson?
    Mr. Robinson. Absolutely.
    Mr. Lance. Thank you.
    Have you developed action plans specifying how and where 
the money would be spent if it is approved?
    Mr. Fauci. Yes, sir. When you make a budget proposal, you 
have to delineate each of the line items. For example, as I 
mentioned in a response to a question from Mr. Waxman, the NIH 
request is $238 million. So it just wasn't a bulk request for 
238. There was $56 million for the performance of Phase II-III 
trials. There was $76 million for this and $23 million for 
that. So they were line item by line item.
    Mr. Lance. And is that true of the other agencies as well?
    Ms. Borio. It is for us.
    Mr. Redd. Yes, sir.
    Mr. Robinson. Absolutely.
    Mr. Lance. Thank you.
    I think it is important for the public to know as we move 
forward in the appropriations process as to how the money will 
be spent and where the money will be spent. And certainly we 
want to work together in a cooperative fashion in our oversight 
role, and I certainly wish all of you well as we overcome this 
tremendous health challenge, not only to this country but 
really to the entire world.
    Thank you very much, and I yield back the balance of my 
time.
    Mr. Pitts. The Chair thanks the gentleman.
    I would like to apologize to the gentlelady from 
California. I didn't notice you come in.
    I would like to recognize the gentlelady from California, 
Ms. Capps.
    Mrs. Capps. Thank you, Mr. Chairman.
    I want to take one minute to sing the praises of my 
professional colleagues, nurses, because nurses have really 
been at the front lines of the Ebola response, both 
domestically and abroad. And I want to take a moment to 
highlight their service.
    Unfortunately, this also means that some nurses have been 
infected during their selfless care for other people. The two 
nurses infected in Dallas highlighted the important concerns 
about the effectiveness or non-effectiveness of existing 
training and guidelines for U.S. healthcare workers treating 
Ebola patients.
    I was pleased to see the CDC issue new guidelines October 
20th calling for better training and equipment and adopting 
practices successfully in place now at hospitals at Nebraska 
Medical Center, Emory, and the NIH. I think we can all agree we 
wish they had come out sooner. It is critical, however, that 
the CDC continue to be a leader in setting guidelines to 
protect our healthcare workers and contain the spread of Ebola.
    So, Dr. Redd, since the adoption of the CDC's new 
guidelines, what has the reaction from hospitals been? Given 
that guidelines issued by the CDC are voluntary, do you see 
that hospitals are cooperating in the implementation of these 
stricter measures?
    Mr. Redd. I think the reaction has been extraordinarily 
positive. That has been seen in the number of people that have 
participated in training in the use of the new guidelines, in 
the responses we have gotten from the visits that we have made 
to hospitals through States to work on hospital preparedness.
    I think the one concern is the availability of personal 
protective equipment, something that we are working on shoring 
up, but that is probably the major concern.
    Mrs. Capps. I want to follow up with that topic because I 
visited two hospitals in my district, and PPE, or the personnel 
protective equipment, has had such a surge in demand 
following--and particularly now following your guidelines, in 
addition to growing demand by other entities worldwide, and 
what can we do to help with the PPE supply so that--is CDC--and 
can it ensure the availability of it? Are you working on that?
    Mr. Redd. Yes, ma'am. I think there actually are different 
efforts that have different time horizons. It is--part of our 
budget request is for personal protective equipment. In the 
short term, we want to be sure that hospitals that would be 
treating patients have a supply that is sufficient for a short 
term----
    Mrs. Capps. Right.
    Mr. Redd And then there is an ability to acquire personal 
protective equipment from distributors, from the community, and 
then there is a supply in the Strategic National Stockpile that 
can shore up. So a layered approach to be sure that there is 
personal protective equipment available for the care of the 
patient.
    Mrs. Capps. And that is--the administration's request for 
$6.2 billion to enhance the Government's response, is that 
critical, then, you see to this being able to be carried out?
    Mr. Redd. Yes, ma'am. It is a part of that request.
    Mrs. Capps. Good. And I could--just anecdotally--and the 
hospitals that I visited in my district corroborate that 
getting supplies is really high on their minds at that level, 
as well as the designation of some regional hospitals so that--
as you have said, we are going to see more cases, Dr. Fauci, 
you mentioned. We need to be ready for them.
    I wanted to turn to Dr. Borio, and with respect to the FDA, 
we all, of course, when this outbreak occurs, wish there were 
more effective treatments and vaccines already available. And 
we have heard there are several companies at work on such 
medicines, but they are not yet ready. Your testimony mentioned 
some of the hurdles that drug developers face. Would you 
discuss this in a little deeper depth?
    Ms. Borio. So, for these types of products for Ebola, I see 
two major challenges for developers. One has to do with the 
fact that the pre-clinical work has to be done--most of it has 
to be done in high containment BSL-4 laboratories. So, by 
default, this is going to be a public/private partnership. 
Nobody can really go at it alone.
    And, for subsequent phases, as we are witnessing now with 
this epidemic, the clinical testing is quite challenging 
because these outbreaks tend to occur sporadically in 
unpredictable fashion and in areas of the world where very 
limited healthcare infrastructure. And that has to be built up 
a little bit before clinical investigations can take place. So 
these are pretty two large hurdles for the----
    Mrs. Capps. Absolutely. I am running out of time, but I 
wanted to know if you are trying any of the products on people 
yet? Is there--have we reached that stage?
    Ms. Borio. So we are working with NIH and investigators in 
Nebraska and Emory to be able to establish the common clinical 
trial protocol to be able to most effectively and expediently 
evaluate our safety and efficacy. They are not quite in the 
phase of clinical investigations yet. All the use has been done 
under compassionate use.
    Mrs. Capps. OK. Thank you.
    Mr. Pitts. Chair thanks the gentlelady.
    And now recognizes the gentleman from Louisiana, Dr. 
Cassidy, 5 minutes for questions.
    Mr. Cassidy. This is a great panel. I apologize, as I will 
ask your questions to be concise, otherwise there is just no 
hope I will get through my 20 minutes of questions.
    Dr. Fauci, it is implied, but not explicitly stated, are 
the antibodies elicited neutralizing?
    Mr. Fauci. Yes. The antibodies that we----
    Mr. Cassidy. What is the window period between exposure to 
vaccine of the virus and antibody development?
    Mr. Fauci. Later than usual. It probably takes, I would 
say, at least 12 days into the course, and maybe 7 or 8 days 
following the initiation of symptoms before you see good IgM 
and IgG responses.
    Mr. Cassidy. Now you--and you say good, but is it 
detectable--good pre-supposes a certain titer, but can you see 
low titer, perhaps nonprotective, at some point prior to that?
    Mr. Fauci. You do, but it is very, very low, and you 
don't----
    Mr. Cassidy. OK. I am sorry.
    Mr. Fauci [continuing]. Couple of days.
    Mr. Cassidy. I am sorry. Now, you mention that the only way 
to determine--and I am all for case control trial--excuse me, 
for double-blind studies. But it does seem to me having a 
mortality rate approaching 50 to 90 percent, you can actually 
differentiate between a downturn because of good infection 
control and that which is due to vaccination by looking at 
antibody titers.
    If you have less prevalence of disease and there are no 
antibody markers, it is clearly a case it is infection control. 
It is not subclinical cases in something which has 50 to 90 
percent mortality. Is that a fair statement?
    Mr. Fauci. Right.
    Mr. Cassidy. Now, Dr. Jenner, way back when he did cowpox 
for smallpox, I am always stuck, did not do a double blind 
study. He just basically saw he gave cowpox vaccine, and there 
was less smallpox. There was a mortality rate of 25 percent. So 
the efficacy was quickly recognized.
    Now, knowing that you have plenty of lead-in time to do a 
case control analysis of a population to see what is the 
background of certain incidences, it does seem to me that you 
could do a study which would be single arm or maybe just 
different doses of vaccine, but which would have a case 
control, if you will, of a historical control as opposed to one 
which must be double blind.
    Mr. Fauci. I disagree with you, sir, because if we had done 
that a couple of months ago, which we were criticized for not 
doing--why don't we just go out and let the vaccine out 
following Phase I--if I had done that in September and October, 
the downturn in Liberia would have bene ascribed to the 
vaccine.
    Mr. Cassidy. No, you would have looked at antibodies, and 
you would have seen that there was a decreased prevalence of 
antibody production.
    Mr. Fauci. With all due respect, sir, you are talking about 
someone who is infected and has an antibody response. You know 
they are infected. You don't need an antibody response to tell 
you that.
    Mr. Cassidy. But let me ask you, is it subclinical cases, 
or is it the absence of infection that has caused the downtown?
    Mr. Fauci. Downturn in antibodies?
    Mr. Cassidy. You said in Liberia, there is less prevalence 
of disease.
    Mr. Fauci. Correct.
    Mr. Cassidy. Now, was it subclinical cases, or is it the 
absence of infection that has caused this----
    Mr. Fauci. I don't know what you mean by subclinical cases.
    Mr. Cassidy. As in people who are exposed to the virus but 
do not get sick.
    Mr. Fauci. Yes. When you say exposed, do they get infected? 
There is a difference. You can get exposed and not get 
infected. If you are infected----
    Mr. Cassidy. If you mean exposed and not infected, then, my 
gosh, we are actually doing something good there.
    I am assuming that there is a--not splitting hairs, but let 
me just construct it this way. If somebody has exposure to the 
virus, is infected in some way, but it is subclinical, they 
will have still have antibody titer.
    Mr. Fauci. Right.
    Mr. Murphy. Now, we can look at a downturn in infection, we 
know it is either due to less transmissibility and people 
actually getting infected; it is due to an increased number of 
subclinical cases; or in the case of a vaccine, it might be 
that vaccine was protective.
    Mr. Fauci. Right.
    Mr. Murphy. So it seems like the antibody titer would give 
you clues as to whether or not it is the vaccine giving 
beneficial effect or whether it is a decrease in infection 
rate.
    Mr. Fauci. Well, there is one premise that you said that I 
don't accept, and that is that there are subclinical 
infections. The----
    Mr. Cassidy. In that case, it makes it simpler, because if 
there are no subclinical infections, that means that if there 
is a downturn prevalence of disease, it is either the vaccine 
or it is infection control.
    Mr. Fauci. It is infection control. There is no doubt in my 
mind that it is infection control.
    Mr. Cassidy. OK. That is a fair statement.
    Now, it does seem as if we could give the immunization in a 
single arm study, and we could compare it to historical 
controls.
    Mr. Fauci. But how can you compare it to historical 
controls if, while you are doing it, the infection rate is 
going down? You have a changing scene as you are doing the 
trial.
    Mr. Cassidy. Does the vaccine elicit IgMs?
    Mr. Fauci. It does.
    Mr. Cassidy. Oh, it does?
    Mr. Fauci. It does.
    Mr. Cassidy. OK. And--well, let me revisit that and let me 
go on to Mr. Robinson.
    I am struck by, Dr. Robinson, I am struck by the amount of 
money that is being requested. And it does seem as if, for 
example, the CDC is already getting $716 million for global 
control, global--$416 million for global health, and it is 
getting $1.3 billion for public health preparedness and 
responsiveness on the State level. Presumably, this money is 
over on top that. It seems like the same programs could be 
repurposed to accomplish this goal. Obviously, we are in a time 
of fiscal constraint. Is the fiscal constraint--my gosh, this 
is a lot of money. Why can't we use the money we already have, 
knowing that we want to do everything we can, but is what we 
have adequate to do what we need to do?
    Mr. Robinson. So, with the $157 million that BARDA 
requested in the President's budget request----
    Mr. Cassidy. I am looking specifically at the global 
health. That is what I have been before. The global health is 
getting $416 million now.
    Mr. Robinson. That is Dr. Redd, not----
    Mr. Cassidy. Yes. I am sorry.
    Mr. Redd. Yes, sir. We are using that money. This money 
would be requested to----
    Mr. Cassidy. I accept that, but you already have money. Can 
it not be repurposed for that--why do we need additional? Can 
you not repurpose what you have already received?
    Mr. Redd. Well, that money is--let me--I think that it 
probably is a question that needs to be answered more 
specifically than I am going to be able to right no in terms of 
what those funds are being used for now and what the new funds 
would be used for.
    Mr. Cassidy. Well, how many PPEs are we purchasing?
    Mr. Redd. With the funds that we have right now, we have 
purchased--our aim is to have enough PPE for----
    Mr. Cassidy. But how many is that?
    Mr. Redd. It is enough to take care of----
    Mr. Cassidy. Is it a million? Is it 100,000? Is it 60,000?
    Mr. Redd. $2.7 million, and that is enough PPE for 250 
patient days of care.
    Mr. Cassidy. OK. It seems like a lot.
    Mr. Redd. It is expensive.
    Mr. Cassidy. OK. I am out of time. I yield back. Thank you.
    Mr. Pitts. Chair thanks the gentleman.
    And before I recognize Brett Guthrie, just mention that 
this morning announcements were made, and our vice chair, Dr. 
Burgess, will chair the new committee chairman, taking Lee 
Terry's place. And Brett Guthrie will take his place as vice 
chairman of the Health Subcommittee. So look forward to working 
with you.
    Mr. Guthrie, you are recognized 5 minutes for questions.
    Mr. Guthrie. Thank you, Mr. Chairman.
    Thank you for those comments, and will enjoy working with 
you, as well.
    Dr. Robinson, I represent central Kentucky. I have 
Owensboro, which is Kentucky BioProcessing, and I have watched 
them for quite a while using tobacco plants. Of course, what we 
are talking about was ZMapps not Kentucky Burley, but using 
tobacco plants is good. And it is something that we have been 
real pleased to see develop in our area. And just was there 
last month with Leader McConnell to get an update after the 
ZMapp stories had come forward. And the production of ZMapp 
through a plant-based process is a little time consuming and 
led to a recent shortfall of doses. It necessarily wasn't in 
their plan to have all this out there ready because they were 
still in trials, but it is my understanding there are currently 
about 80 doses of ZMapp available and more being produced. And 
I know that BARDA is working on a final decision--this is my 
question--on increasing ZMapp production and the final decision 
is due soon. Do you have an update on that decision of 
increasing ZMapp production?
    Mr. Robinson. Yes, sir. Back in September, we actually 
awarded Mapp Biopharmaceutical, which subcontracted to Kentucky 
Bioprocess in the production of six campaigns or six lots of 
ZMapp product. They have finished the first one. I am not sure 
80 is exactly the right number, because we actually--it may be 
a little less than that, but the second campaign is going well, 
and that is why I reported today that we saw almost a twofold 
increase in product yield. In the succeeding lots, we think 
that we will see even more improvement.
    Going forward, the funding that we have asked for is 
actually to help them do more improvements all across the board 
in the manufacturing process such that they can have more 
product available sooner.
    The product they are making right now that actually has 
been in the first campaign will be in the first clinical trial 
studies that the NIH will be doing.
    Mr. Guthrie. OK. Thanks.
    But I--and I would ask that as you make sure that proven, 
manufacturing processes are considered into all routes of the 
production, are there other people doing it, and I know this 
has been a proven manufacturing process, and not put all of our 
eggs in one basket.
    I do want to talk about the funding, and this is--I know it 
is within your budget. We have an infrastructure capable of 
developing, testing, and producing medical counter measures 
with partners. We just discussed ZMapp, which is a positive 
example of products in the system's pipeline. And I also 
understand that promising vaccines are being scaled up and will 
be manufactured commercially.
    And what is BARDA's strategy to pay for this? You testified 
2015 funds were only sufficient until December of 2014, which 
is right around the corner, and the commercial production of 
ZMapp would not be possible in that lifetime. The White House 
has asked for $6 billion in emergency requests, and only $175 
million for BARDA, barely enough for a fraction of these 
efforts. So can you outline how you are going to scale these 
manufacturing processes up for these products within that 
limit?
    Mr. Robinson. Yes. Well, $157 million was in our request, 
and we want to thank Congress for providing $58 million already 
to us in the continuing resolution anomaly. So we already have 
that money, and we actually have used that, not only for ZMapp, 
but also to go forward with the development of new Ebola----
    Mr. Guthrie. Is this new request going to be sufficient to 
scale up the----
    Mr. Robinson. Yes. Not only for the therapeutics, but also 
for the vaccines with the proposals that we actually have in 
hand with the manufacturers and are negotiating and will be 
announcing soon.
    Mr. Guthrie. OK. I am going to ask you one more question, 
then.
    It is my understanding that authority over all BARDA 
contracts is controlled by the Office of Acquisition Management 
Contracts and Grants and the Office of the Assistant Secretary 
of Preparedness and Response.
    When we have heard from medical countermeasures, MCM, 
developers that this cumbersome arrangement has created 
confusion, unnecessary delays and uncertainty. Regarding the 
time sensitive review of BARDA's medical countermeasures 
developing contracts, would you prefer if BARDA was allowed to 
negotiate, manage, and award its own advance R&D contracts as 
it has done in the past?
    Mr. Robinson. So, BARDA originally did actually have the 
contracting authority. In 2009, the contracting office was 
moved over to the Office of the Assistant Secretary for 
Preparedness and Response. Going forward, we would consider any 
actions that would help expedite the review and execution of 
these accounts.
    Mr. Guthrie. My understanding we moved the money back but 
not the authority. So the statutory authority is still in the 
other--you would like to have that authority back?
    Mr. Robinson. We would consider that and many other efforts 
that go forward. Whatever would work, actually.
    Mr. Guthrie. But it would speed up development of processes 
if you did or critical medical countermeasures?
    Mr. Robinson. It might, but I will say, though, that our 
contracting shop has done Herculean efforts in a number of 
different public health emergencies, including H1N1, where they 
actually moved contracts extremely fast. So I think they are 
very able.
    Mr. Guthrie. Well, that was my question. You wouldn't be 
able to do this without having to have this other step in the 
process. You think you are capable and able to do that, and you 
prefer to do it without the other----
    Mr. Robinson. I think they are capable, and are actually 
doing that right now with the Ebola epidemics.
    Mr. Guthrie. Thank you. I appreciate that, and I yield 
back.
    Mr. Burgess [presiding]. Gentleman yields back.
    The Chair recognizes Mr. Griffith, 5 minutes for your 
questions, please.
    Mr. Griffith. I appreciate it, Mr. Chairman.
    I did note with some interest just a minute ago Mr. Guthrie 
mentioned that ZMapp's being grown in a tobacco plant. He said 
it wasn't the Burley that he grows in his district. My district 
grows all kinds of tobacco, and if you all need more plants 
grown, I got a bunch of farmers know how to grow tobacco and 
can do it very efficiently.
    That being said, the Pandemic and All Hazards Preparedness 
Reauthorization Act requires the FDA to finalize its guidance 
to industry regarding the development of animal models to 
support the approval, clearance or licensure of 
countermeasures. Of course, clarifying how these products may 
be tested in animals is critical to developers as human trials 
are rarely possible. In March of this year, FDA requested an 
additional 6 months to finalize this guidance.
    Dr. Borio, when do you expect this important guidance to be 
finalized?
    Ms. Borio. It is very important to finalize this guidance. 
On the bright side, I have to say that the guidance has been 
well accepted by industry and academics. It is in circulation. 
We had a lot of consultation prior to putting this guidance 
together, and we are moving as if this guidance is final, but 
it is very important, I know, to finalize it. It is a priority 
for us.
    Mr. Griffith. All right. I appreciate that.
    Do you have any estimate of time? Six months? A year?
    Ms. Borio. I would like to finalize it as fast as I can.
    Mr. Griffith. Yes, ma'am. I appreciate that. Thank you.
    Dr. Fauci, I understand that several thousands of Ebola 
viruses samples cannot be transported to NIH, CDC and other 
Government labs in the U.S. Because the CDC on behalf of the 
U.S. Government has not reached agreements with the countries 
of origin to permit the shipment and research of the samples. I 
would also note that, on November 5th of this year, Reuters 
reported U.S. Ebola researchers plead for virus samples.
    I would have to assume that the NIH has a strong interest 
in getting these Ebola virus samples out of West Africa and 
over to NIH labs and other Government labs. Am I correct in 
that?
    Mr. Fauci. Yes. It is important for us to get samples to be 
able to examine them and do the appropriate genomic sequencing.
    Mr. Griffith. And that way, you can have a better idea of 
whether or not it is mutating and how fast it is mutating. 
Isn't that correct?
    Mr. Fauci. Correct.
    Mr. Griffith. And they also would be helpful in creating 
diagnostic tests. Is that correct?
    Mr. Fauci. Well, certainly you want to match the virus to 
the diagnostic tests and vice versa.
    Mr. Griffith. And likewise, you want samples from as many 
of the countries affected as you can get, particularly Sierra 
Leone and Liberia because they may have different strains. Is 
that correct?
    Mr. Fauci. Well, I am not saying different strains. When 
you say different strain, that is a big difference. The strain 
is the Ebola Zaire strain. There may be some slight 
modifications depending upon mutations, but it is not going to 
be a different strain.
    Mr. Griffith. OK. And I used--that is what happens when you 
are a country lawyer trying to mess with medical terms, but 
what you are after is to see if it is mutating and what is 
going on----
    Mr. Fauci. Correct.
    Mr. Griffith [continuing]. Is that correct?
    Mr. Fauci. Correct.
    Mr. Griffith. And so if you only get it from one area, you 
may not be able to see all the mutations that are occurring. Is 
that accurate?
    Mr. Fauci. You are absolutely correct. You need a wide 
range of isolates from different places.
    Mr. Griffith. All right. And what is the biggest concern 
about mutations in the Ebola virus? And obviously, I know that, 
you know, how much more contagious is it is or how much more 
deadly it is, but what can you tell me about that as well as 
those obvious ones.
    Mr. Fauci. Yes. From a practical standpoint, something that 
is feasible is that it could mutate and make the diagnostic 
tests a little bit less sensitive, or when you make a vaccine 
that would make a particular response against a virus, it may 
not be as avidly binding to the virus when you are looking for 
protection.
    There is always out there this issue, is it going to change 
so much that it dramatically changes its modality of 
transmission, namely, what you have read about in the 
newspapers about becoming a respiratory borne virus? Certainly, 
that is not impossible, but that is a very, very unlikely 
scenario, simply because in the history of viruses, it really 
would be unprecedented that a virus, by mutation, would 
completely change the method by which it is transmitted. So 
although we always look for that and keep it up as a 
possibility, it is unlikely. It is more likely that it would 
have some impact on the accuracy of the diagnostic test.
    Mr. Griffith. And let me ask about that, and it is probably 
too early for you to answer, but is that possibly one of the 
concerns with the doctor that was recently brought back to 
Nebraska, that originally the tests indicated he didn't have 
the disease, and then later it was clear that he did--he was 
symptomatic when they did the test, but he didn't test 
positive. Now, I understand there are always errors and 
mistakes and things happen, but is that one of the concerns 
that----
    Mr. Fauci. It is, sir, but I think it is something more 
likely, because we have experienced this before, it is likely 
that it wasn't that there was anything wrong between the match 
between the test and the virus but that when he got his first 
test, his level of virus was so low in his body that the test 
wasn't sensitive enough to pick it up. And when you wait a 
couple of days the way they did, they got a positive test. So 
there was no problem with the diagnostic test. It was likely 
that his level of virus was doing this and then started to go 
up. So when they did the first test, it might have been quite 
low, and then when they did it a few days later, it was high 
enough to pick up.
    Mr. Griffith. And how many days was it, because I thought I 
had read somewhere that it may have been close to a week.
    It was 4 days.
    Mr. Fauci. Four days.
    Mr. Griffith. All right. I see my time is up, and I 
appreciate your answers.
    And I yield back.
    Mr. Burgess. Gentleman yields back.
    At this time the Chair now recognizes the gentlelady from 
North Carolina, 5 minutes for questions, please.
    Mrs. Ellmers. Thank you, Mr. Chairman.
    And thank you to our panel for being here on this issue. I 
know we are all very motivated to move forward on treatments 
and cures, vaccines for Ebola and certainly so many other 
diseases.
    And I just want to say right off the bat that I had the 
pleasure of hosting a 21st Century Cures Initiative roundtable 
discussion in my district. Dr. Robinson was kind enough to come 
to it and attend. It was very well attended. It was wonderful 
information that we accrued, and it basically all had to do 
with vaccines. It was right about the time that the Ebola 
situation was really starting to come to the forefront, so it 
has now become so timely.
    I do want to start off by asking Dr. Robinson a question, 
and this gets back to the funding request of $157 million. I 
just want to make sure that we all understand the process.
    When the initial trials are being run and when there is a 
drug that is being investigated, looked at for success, it is 
still in the NIH space. Is that correct?
    Mr. Robinson. So NIH will fund a preclinical study, and 
then the transition in the Phase I studies is when NIH funds 
that, and then we go with the subsequent studies afterwards.
    In parallel to that, though, there is the development of 
the vaccine, the vaccine manufacturing process, the analytical 
tools--actually being able to lot release the vaccine and to be 
able to do the subsequent Phase II and Phase III----
    Mrs. Ellmers. So there is a little bit of a simultaneous--
you know, between BARDA and----
    Mr. Robinson. We hand off, actually, and I can give you 
other examples with other vaccines, which--we actually do this, 
where we actually handle the manufacturing, and the NIH handles 
the Phase 1 clinical studies. Again, looking at our strengths, 
so that then it is a seamless transition as it goes forward.
    Mrs. Ellmers. And I guess that is the question. What I am 
looking for is, I want to make sure that there isn't 
necessarily a clear stopping point and then BARDA comes in so 
that we can actually be moving forward.
    So, keeping in mind the funding request, how many vaccine 
candidates do you believe BARDA will be able to support when we 
look at this? And I know we have been talking about a few 
numbers, but if you could give us a----
    Mr. Robinson. So, with the funding request that we have, we 
will be able to provide funding for four vaccine candidates of 
the five that NIH has and DOD have supported previously.
    Mrs. Ellmers. OK. So four----
    Mr. Robinson. Four of the five.
    Mrs. Ellmers. Four of the five. OK. And then to the 
question, too--and, there again, this is just me trying to 
understand the process. So, from that point on, will HHS be the 
purchaser of the Ebola vaccine?
    Mr. Robinson. So at such time that a decision has been 
made, when we know that the vaccine has been well tolerated, 
that the vaccine works, and that there is real need to do so, 
then HHS will be certainly one of the purchasers of the 
vaccine. There will be others, including GAVI, that will 
actually mobilize the overall global effort to purchase 
vaccines.
    Mrs. Ellmers. OK. Thank you.
    Dr. Fauci, I would like to ask a little bit about some of 
the public-private partnerships that NIH and the private sector 
have been undergoing with the Ebola vaccine, especially when we 
are talking about the medical countermeasures against the 
threat.
    Can you describe to us the National Institute of Allergy 
and Infectious Disease moving forward? What can we do a better 
job working with BARDA, that the National Institute of Allergy 
and Infectious Disease can work better with BARDA? Is there 
something that we can do to move that process forward in a more 
efficient manner?
    Mr. Fauci. Yes, Mrs. Ellmers, I don't think so. We work 
pretty well, not only on Ebola--as Robin said, we have done 
this movie before. We did it with pandemic flus. We did it with 
regular flus. We did it with MERS and SARS, et cetera. So we 
have a long history of working pretty well interdigitating 
between ourselves and BARDA.
    Mrs. Ellmers. Great. So you feel very confident in the 
process as it is right now, then, as far as that?
    Mr. Fauci. Well, we always can do better.
    Mrs. Ellmers. Right.
    Mr. Fauci. I don't want to go on the record for that, but I 
can tell you that I feel pretty good about how the interaction 
between BARDA and FDA and ourselves has gone.
    Mrs. Ellmers. Working very well.
    Mr. Fauci. And the CDC, because they are involved in the 
front end with it.
    Mrs. Ellmers. Right. Exactly.
    OK. I have just a moment. Well, I will tell you what. I am 
just going to stop there because I think my line of questioning 
would be too lengthy, and, again, I just want to say thank you 
all of you for being here on this issue.
    Mr. Burgess. Gentlelady yields back her time.
    The Chair recognizes the gentleman from Florida, Mr. 
Bilirakis, 5 minutes for your questions, please.
    Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it 
very much.
    And I appreciate the testimony by the panel today, and I 
have a couple questions.
    I recently held a roundtable in my district to discuss 
Ebola with local officials and first responders. I wanted to 
see if they received the training and resources available to 
adequately diagnosis and, of course, treat any infected 
patients.
    During the roundtable, a few questions came up, and I 
wonder if I can get a response.
    Admiral Redd, I was told the CDC had only designated one 
lab in Florida. I represent the Tampa Bay area, and the lab, 
apparently, is located in Miami to verify possible cases of 
Ebola. They were concerned that this might be impractical since 
it is impossible to transfer potentially infected blood by 
mail. Will more labs be allowed to verify cases specifically in 
my State of Florida, and why was Miami chosen?
    Mr. Redd. So thank you for the question.
    The laboratories that are--that CDC works with to do the 
reference diagnostic test for Ebola are part of the Laboratory 
Response Network. So those laboratories have training in a wide 
variety of diseases, and so that is the group that CDC has 
worked with.
    As far as transport, in general, that is handled by courier 
rather than mail to get the specimens as quickly as possible to 
a laboratory that can do the test that has all of the quality 
control and the sensitivity that is necessary.
    Mr. Bilirakis. So there are no other labs that qualify in 
this instance in the State of Florida?
    Mr. Redd. I am not sure if there is another Laboratory 
Response Network laboratory in Florida. I could get back----
    Mr. Bilirakis. Can you please get back to me on that?
    Mr. Redd. In general, the State health laboratory----
    Mr. Bilirakis. It is a huge State, as you know.
    Mr. Redd. Yes, do that test, and so there are a limited 
number in the country, as you noted.
    Mr. Bilirakis. Thank you.
    This is for the panel. President Clinton and President Bush 
both had a special assistant for biodefense on the National 
Security Counsel. That individual ran an annual simulation for 
pandemic influenza and graded agency performances. I was an 
original co-sponsor of legislation in a previous Congress to 
create a permanent special assistant position.
    Would a permanent special assistant position for biodefense 
allow for better coordination in planning for future outbreaks, 
and for the panel?
    Mr. Redd. I think the system that we have in place now is 
working very well. So I think that would be my personal 
recommendation. I don't think we have a policy on that.
    Mr. Bilirakis. Do we have a clear figure in command?
    Admiral Redd. Mr. Klain is the coordinator across all of 
the Government for the response. He works on the policy issues 
and is really helping to identify the things that need to be 
done and make sure they get done as quickly as possible.
    Mr. Bilirakis. Does anyone else want to give their opinion 
on that?
    Mr. Fauci. If you exclude Ebola and talk about just how we 
handle things in general, and then I will mention, as Steve 
did, about the current Ebola response coordinator, the ultimate 
responsibility for that is in Homeland Security. So the 
Homeland Security advisor, Lisa Monaco, and that is the reason 
why, early on in the epidemic, when we were talking about the 
White House coordination, it was with Lisa Monaco. Then when it 
became clear that this was a full-time job, that she had other 
responsibilities, and that is the reason why we then brought in 
Ron Klain, who is the Ebola response coordinator, because this 
became a full-time job, and--but, in general, prior to Ebola 
and likely after Ebola, it will still stay at the level of the 
Homeland Security.
    Mr. Bilirakis. OK. Next question for the panel, again, is 
there a national biodefense plan for future outbreaks? Who 
would like to respond first?
    Mr. Fauci. It is part of the second slide that I showed was 
the bio defense agenda still holds true, and it involves 
multiple agency. It involves ASPR, which includes BARDA, FDA, 
CDC, and NIH, and that is just for HHS. We also have 
collaborations with the Department of Defense and the 
Department of Homeland Security. So that was developed soon 
after 9/11, and that agenda still holds true.
    Mr. Bilirakis. So there is a plan in place?
    Mr. Fauci. Yes.
    Mr. Bilirakis. Anyone else want to comment on that?
    Mr. Robinson. So the National Health Security Strategy is 
being updated--I think it is every 2 years--but that has 
already been put into place, and that is where we actually--
these action plans can fall down from or cascade down from.
    Mr. Bilirakis. OK. Thank you very much.
    I guess my time--I have got about 4 seconds. I will yield 
back. Thank you.
    Mr. Burgess. Gentleman yields back his time.
    I am just going to ask a couple follow-up questions. I ask 
unanimous consent to do that.
    Without objection, so ordered.
    Dr. Fauci, that was a fascinating exchange between you and 
Dr. Cassidy, and I actually enjoyed that very much. It was one 
of the most instructive 90 seconds that I have seen on this 
committee in the 10 years that I have been here.
    But it did raise a question in my mind. It is pretty much--
well, not--shouldn't say that, but the use of convalescent 
serum, for example, in Brantly's case, hard to know whether 
that was what really helped or not, but it seems to be 
attractive enough that it is continuing to be used, but does 
the use of convalescent serum in any way cloud the antibody 
picture that then you have to look at when you are 
reconstructing responses to this illness?
    Mr. Fauci. The answer is no. It doesn't cloud it, because 
the circumstances, Mr. Burgess, that you would use convalescent 
serum is someone who is sick and you are trying to bring the 
level of virus down. So it doesn't matter if it clouds the 
ongoing endogenous IgM and IgG response to the person. That 
becomes almost irrelevant because it is clear that that 
response may not be adequate to suppress the virus without 
help. So the convalescent serum is from someone who has already 
hopefully peaked.
    Now, one of the problems that we are facing in evaluating 
convalescent serum is that it isn't a static level of antibody. 
It goes up, and it comes down. So if you transfuse convalescent 
serum late in the game, you may not have very good tiers. So 
one of the things we are trying to do in the broad study of 
convalescent serum is to make sure we titrate it and know 
exactly what we are giving to someone, as opposed to guessing 
that this person might having a high titer and this person 
might have a low titer. So that is one of the questions that we 
are addressing.
    Mr. Burgess. So you are attempting to quantify it?
    Mr. Fauci. Yes. Exactly.
    Mr. Burgess. And then, Dr. Borio, does that require 
compassionate use? Does the FDA need to give approval for the 
use of convalescent serum?
    Ms. Borio. So, today, the use of convalescent serum in the 
U.S. has been done under compassionate use.
    Mr. Burgess. So all of those cases that have been treated 
in the United States hospitals have been compassionate use?
    Ms. Borio. Yes. And I just wanted 2 seconds with regard 
to--you know, there are major questions about the benefit of 
convalescent plasma, and, again, it just underscores the 
importance of doing proper clinical investigations because we 
do not want to come into the next outbreak, you know, with the 
same questions we have today about the benefit of convalescent 
plasma because it is a laborious type of therapeutic to 
administer.
    Mr. Burgess. Let me just ask you, and this, of course, is 
something that weighs heavily on my mind, having been in north 
Texas when the outbreak occurred. I mean, I share everyone 
else's concern about travel and restrictions, but what really 
keeps me up at night is that unknown person who is going to 
walk in the back door of an emergency room in any of our 
communities across the country, and the entire cascade of 
events that happened in Dallas could be revisited.
    Do you think we are any better prepared, or have we 
informed people? Do you think there is better awareness, or are 
we still just as vulnerable as we were on September 25th?
    Dr. Fauci. Yes, sir.
    Mr. Fauci. I think there is a big difference now. The 
awareness of the importance of a travel history, I think, 
should have been embedded, but certainly now is embedded in 
everyone's mind so that if someone comes into even the smallest 
facility with symptoms that are suggestive of Ebola, it is 
almost instinctive now that you are going to ask, ``Have you 
had any recent travel, wherever that may be?'' If they say 
``West Africa,'' a big red flag goes up, and that is why the 
CDC right now, working with the State and local health 
authorities, are trying to say that not every hospital in the 
United States should be able to take care intensively of an 
Ebola patient, but you should at least be able to recognize and 
temporarily isolate them until you get the proper 
transportation to a facility that can. So I think, Dr. Burgess, 
that we are very, very different than we were a couple of 
months ago.
    Mr. Burgess. Yes. I just hope we don't have short memories.
    Mr. Fauci. Yes.
    Mr. Burgess. Let me just ask for the entire panel, is there 
any development in your agencies in the past week that you 
would like to highlight or note as this committee concludes?
    Mr. Redd. Yes, I am actually going to answer the previous 
question that one thing that we have done also----
    Mr. Burgess. Yes.
    Mr. Redd [continuing]. To make sure that that situation 
that you described doesn't happen is track all of the 
individuals who travel from West Africa so that if a person 
does develop symptoms, they are in touch with the health 
department, with CDC, and we can route them to a place where 
they will get the kind of care that they need. That is not 
really the last week, but that is something that is getting 
better and better.
    Mr. Burgess. And that is a 24-hour-a-day contact that they 
have available to them?
    Mr. Redd. Yes, sir.
    Mr. Burgess. Dr. Robinson?
    Mr. Robinson. It may seem like a small milestone, but it is 
a big one for us because our Fill Finish Manufacturing Network 
that was only set up 2 years ago--actually yesterday we awarded 
a task order, the first task order to actually put ZMapp into 
vials--and so over the next couple of weeks, the bulk product 
will be going from Kentucky to Indiana and to Nanotherapeutics 
and Baxter, and they will be filling it into the proper 
containers and making it available then to the NIH to do the 
first clinical studies in January. So, for us, it actually 
shows it is happening right now.
    Mr. Burgess. Yes, that is big news. I appreciate you 
sharing that with the subcommittee.
    Oh, sorry, Dr. Fauci?
    Mr. Fauci. Just one comment, Dr. Burgess, that I would like 
to make because it has come up several times in the hearing, 
and in fact Mr. Murphy had said that sometimes when I, he heard 
that when I respond to a question like this, I do it in a 
condescending way. It isn't so. We are very sensitive to the 
situation that is going on right now in Africa. And we want to 
do two things: no harm and help people. And that is what drives 
the need to do the kinds of trials that, in fact, may seem to 
some to be insensitive because they have a control arm, but I 
have to tell you from decades of experience of things that have 
gone wrong when you don't get the right answer, it is not 
because we are insensitive and it is not because we are 
arrogant. We really feel very strongly that we want to help 
people and, on the way, not hurt people, and that is very 
important. So I just wanted to make sure--he isn't here, I 
wanted to get it on the record so that----
    Mr. Burgess. I appreciate you sharing that with us, and I 
did recognize that you had wanted to say something, and we 
moved on on the panel, and I actually thank you for bringing 
that to our attention. That is a very important point.
    And we on this subcommittee do appreciate your service at 
the NIH. It is something the country would be at a loss 
without.
    And thank all of you for sharing with us today. I remind 
members they have 10 business days to submit questions for the 
record. I ask the witnesses to respond to the questions 
promptly. Members should submit their question by the close of 
business on Friday, December 5th.
    Without objection, the subcommittee is adjourned.
    [Whereupon, at 12:31 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

                 Prepared statement of Hon. Fred Upton

    Today the committee is holding its third hearing on the 
Ebola epidemic in West Africa. This is a global threat, and we 
need to work together--Congress, government agencies, and 
product developers--to successfully combat this epidemic. Today 
we focus on medical product development, including treatments, 
vaccines, and diagnostics, related to Ebola. We'd like to get a 
better understanding of where we are in the development of 
these products and what more we need to do to help treat those 
who are sick, prevent further spread, and prevent another 
outbreak in the future.
    We will hear from experts from the Food and Drug 
Administration, National Institutes of Health, Centers for 
Disease Control and Prevention, and Biomedical Advanced 
Research and Development Authority about how these agencies are 
working with product sponsors on the design and operation of 
clinical trials, manufacturing, and distribution.
    We will also examine how various Government agencies are 
working together to ensure that products are developed and 
deployed as quickly and safely as possible. Finally, we'd like 
to hear more from the agencies on how they plan to utilize 
existing products and help with the development of new products 
both here and abroad.
    In 2013, Congress enacted the Pandemic and All Hazards 
Preparedness Reauthorization Act in an effort to ensure that we 
are prepared to respond to an epidemic--just like the very 
situation we are confronted with today. The law authorizes 
funding for the purchase of medical countermeasures and 
increased support for advanced research and development of 
potential medical countermeasures, and it requires more 
coordination and prioritization among the agencies represented 
today in product development.
    As we continue to evaluate our response to the ongoing 
Ebola outbreak, it is important that we understand how that law 
has helped in responding to this epidemic and if there are 
areas Congress may need to reevaluate. Our work will continue 
to ensure we are doing whatever it takes to keep Americans 
safe.
    I appreciate all of you being here today to testify on this 
important issue.

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