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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 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

GENE GREEN, Texas 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

HENRY A. WAXMAN, California (ex officio) 

(II) 

(III) 

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 

1Ms. Borio did not answer submitted questions for the record by the time 

of printing. 

(1) 

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 manuVerDate Mar 15 2010 11:31 Nov 16, 2015 Jkt 037690 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 F:\113THCONGRESS\113182EBOLAMEDSASKOK111215\113182EBOLAMEDSPDFMADE
2 

facturers 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 beVerDate Mar 15 2010 11:31 Nov 16, 2015 Jkt 037690 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 F:\113THCONGRESS\113182EBOLAMEDSASKOK111215\113182EBOLAMEDSPDFMADE
3 

come 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. 

4 

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:] 

5 

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. 

6 

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. 

7 

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 multiagency 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 curVerDate Mar 15 2010 11:31 Nov 16, 2015 Jkt 037690 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 F:\113THCONGRESS\113182EBOLAMEDSASKOK111215\113182EBOLAMEDSPDFMADE
8 

rently 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:] 

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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 efVerDate Mar 15 2010 11:31 Nov 16, 2015 Jkt 037690 PO 00000 Frm 00034 Fmt 6633 Sfmt 6633 F:\113THCONGRESS\113182EBOLAMEDSASKOK111215\113182EBOLAMEDSPDFMADE
31 

fect. 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:] 

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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 

41 

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:] 

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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. 

54 

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-ofthe-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:] 

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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:] 

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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:] 

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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 

80 

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 

81 

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. 

82 

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. 

83 

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 

84 

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 visa-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 

85 

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 

86 

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? 

87 

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? 

88 

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? 

89 

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. 

90 

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? 

91 

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? 

92 

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. 

93 

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 inVerDate Mar 15 2010 11:31 Nov 16, 2015 Jkt 037690 PO 00000 Frm 00097 Fmt 6633 Sfmt 6633 F:\113THCONGRESS\113182EBOLAMEDSASKOK111215\113182EBOLAMEDSPDFMADE
94 

vestigations 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. 

95 

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. 

96 

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 

97 

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—— 

98 

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 

99 

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. 

100 

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. 

101 

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 

102 

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 variVerDate Mar 15 2010 11:31 Nov 16, 2015 Jkt 037690 PO 00000 Frm 00106 Fmt 6633 Sfmt 6633 F:\113THCONGRESS\113182EBOLAMEDSASKOK111215\113182EBOLAMEDSPDFMADE
103 

ety 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 cosponsor 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 DeVerDate Mar 15 2010 11:31 Nov 16, 2015 Jkt 037690 PO 00000 Frm 00107 Fmt 6633 Sfmt 6633 F:\113THCONGRESS\113182EBOLAMEDSASKOK111215\113182EBOLAMEDSPDFMADE
104 

partment 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? 

105 

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 

106 

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. 

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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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