[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
energycommerce.house.gov
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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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