U.S. GOVERNMENT PUBLISHING OFFICE

35–127 WASHINGTON : 2019

THE STATE OF U.S. PUBLIC HEALTH BIOPREPAREDNESS: RESPONDING TO BIOLOGICAL 

ATTACKS, PANDEMICS, AND EMERGING INFECTIOUS DISEASE OUTBREAKS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FIFTEENTH CONGRESS 

SECOND SESSION 

FRIDAY, JUNE 15, 2018 

Serial No. 115–140 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

GREG WALDEN, Oregon 

Chairman 

JOE BARTON, Texas 

Vice Chairman 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

JEFF DUNCAN, South Carolina 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

DEBBIE DINGELL, Michigan 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

GREGG HARPER, Mississippi 

Chairman 

H. MORGAN GRIFFITH, Virginia 

Vice Chairman 

JOE BARTON, Texas 

MICHAEL C. BURGESS, Texas 

SUSAN W. BROOKS, Indiana 

CHRIS COLLINS, New York 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

GREG WALDEN, Oregon (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

KATHY CASTOR, Florida 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(III) 

C O N T E N T S 

Page 

Hon. Gregg Harper, a Representative in Congress from the State of Mississippi, opening statement ................................................................................. 1 

Prepared statement .......................................................................................... 3 

Hon. Diana DeGette, a Representative in Congress from the state of Colorado, 

opening statement ................................................................................................ 4 

Hon. Greg Walden, a Representative in Congress from the State of Oregon, 

opening statement ................................................................................................ 5 

Prepared statement .......................................................................................... 7 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 9 

WITNESSES

Rick A. Bright, Ph.D., Director, Biomedical Advanced Research and Development Authority, Deputy Assistant Secretary, Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and 

Human Services ................................................................................................... 11 

Prepared statement .......................................................................................... 14 

Answers to submitted questions ...................................................................... 102 

Anne Schuchat, M.D. (RADM, USPHS), Principal Deputy Director, Centers 

for Disease Control and Prevention, U.S. Department of Health and Human 

Services ................................................................................................................. 24 

Prepared statement .......................................................................................... 26 

Answers to submitted questions 1 ................................................................... 112 

Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious 

Diseases, National Institutes of Health ............................................................. 36 

Prepared statement .......................................................................................... 38 

Answers to submitted questions ...................................................................... 115 

Denise Hinton (RADM, USPHS), Chief Scientist, U.S. Food and Drug Administration ................................................................................................................. 43 

Prepared statement .......................................................................................... 45 

Answers to submitted questions 2 ................................................................... 124 

SUBMITTED MATERIAL

Subcommittee memorandum .................................................................................. 80 

Report of the Independent Panel on the U.S. Department of Health and 

Human Services (HHS) Ebola Response 3

Strategic National Stockpile Estimated Spending Graph .................................... 95 

Statement of the Blue Ribbon Study Panel on Biodefense .................................. 96 

1 The committee did not receive a response to Ms. Schuchat’s submitted 

questions for the record by the time of printing. 2 The committee did not receive a response to Ms. Hinton’s submitted questions for the record by the time of printing. 3 The information can be found at: https://docs.house.gov/meetings/IF/ 

IF02/20180615/108422/HHRG-115-IF02-20180615-SD003.pdf. 

(1) 

THE STATE OF U.S. PUBLIC HEALTH BIOPREPAREDNESS: RESPONDING TO BIOLOGICAL ATTACKS, PANDEMICS, AND EMERGING 

INFECTIOUS DISEASE OUTBREAKS 

FRIDAY, JUNE 15, 2018 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 9:01 a.m., in room 

2123, Rayburn House Office Building, Hon. Gregg Harper (chairman of the subcommittee) presiding. 

Present: Representatives Harper, Griffith, Burgess, Brooks, Collins, Walberg, Walters, Costello, Carter, Walden (ex officio), 

Degette, Schakowsky, Castor, Ruiz, and Pallone (ex officio). 

Also Present: Representative Eshoo. 

Staff Present: Jennifer Barblan, Chief Counsel, Oversight and Investigations; Adam Fromm, Director of Outreach and Coalitions; 

Ali Fulling, Legislative Clerk, Oversight and Investigations, Digital 

Commerce and Consumer Protection; Christopher Santini, Counsel, 

Oversight and Investigations; Jennifer Sherman, Press Secretary; 

Alan Slobodin, Chief Investigative Counsel, Oversight and Investigations; Austin Stonebraker, Press Assistant; Christina Calce, Minority Counsel; Jeff Carroll, Minority Staff Director; Chris Knauer, 

Minority Oversight Staff Director; Miles Lichtman, Minority Policy 

Analyst; C.J. Young, Minority Press Secretary; and Perry Lusk, Minority GAO Detailee. 

OPENING STATEMENT OF HON. GREGG HARPER, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MISSISSIPPI 

Mr. HARPER. Good morning. Today, the subcommittee continues 

its longstanding oversight of the U.S. public health system’s preparedness to respond to biological threats and emerging infectious 

diseases that endanger the public health. The purpose of today’s 

hearing is to hear from top public health experts on the good work 

being done at their agencies to protect the public and to explore 

where improvements need to be made. 

The biological threats facing the United States in today’s global 

society are varied, ever-evolving and, in some cases, intensifying. 

The CDC just reported that the seasonal influenza claimed the 

lives of 172 children during the most recent flu season, making it 

the deadliest seasonal flu season for children on record. 

2 

In recent years, the U.S. has also seen an increase in the number 

of antibiotic-resistant bacteria. Around the world, viruses are 

emerging, adapting and, in some cases, reemerging. Currently, 

there is an Ebola outbreak in West Africa and a Nipah virus outbreak in India that has killed at least 17. 

In recent years, we have also seen humans in China contract the 

H7N9 strain of influenza which has been confined to birds. The 

H7N9 influenza strain is rated by the CDC’s influenza risk assessment tool as posing the greatest risk to cause a public pandemic. 

The 2013 ricin mailings addressed to President Obama and Senator Roger Wicker that originated in my home State of Mississippi, 

as well as the 2001 anthrax mailings and foreign terrorist threats, 

is a reminder of the risk of intentional biological attacks. 

Today’s hearing is especially timely, given that the committee is 

considering bipartisan legislation sponsored by Mrs. Brooks and 

Ms. Eshoo to reauthorize the Pandemic and All Hazards Preparedness Act, PAHPA, which is set to expire at the end of September. 

Passage of PAHPA’s reauthorization would not only provide critical 

certainty for public health agencies and industry partners, it would 

also bring about some much needed reforms. One such reform proposed in the legislation is transferring control of the Strategic National Stockpile from the CDC to HHS’ Office of the Assistant Secretary for Preparedness and Response, to improve management of 

the stockpile. 

A year ago, HHS’ Office of Inspector General reported systemic 

issues with security and inventory management of the stockpile, 

risking CDC’s ability to deploy the stockpile during a public health 

emergency. These issues need to be addressed, as does improving 

the training of State and local stakeholders on deployment of medical countermeasures. 

Administrative reforms are also of interest. For example, are 

there ways to improve the timeliness of the decisionmaking process 

on threat assessments and appropriate countermeasures? Effective 

threat detection has been a subject of committee oversight. In 2016, 

the committee questioned the CDC about the effectiveness of its 

Laboratory Response Network, or LRN, which is responsible for developing assays for public health labs to test for the presence of 

Federal select agents. 

In a May 2017 letter to the committee, the CDC reported that 

the LRN had only developed three assays approved by the FDA to 

detect specific Federal select agents. While the LRN has also had 

those cleared by the FDA under emergency use authorization, after 

nearly 20 years of this program, with about $135 million in funding 

over the last decade, could the LRN have cleared a significantly 

higher number of assays through the most rigorous FDA 510(k) 

process? 

Finally, maintaining public confidence in critical Federal biopreparedness research is essential. In response to safety lapses in 

2014 and to an expert panel’s recommendations, the CDC and FDA 

each formed new offices in 2015 to centralize and elevate oversight 

of laboratory safety, with the directors of those offices reporting directly to the agency head. 

These changes sent a strong message that lab safety was a top 

priority, backed by the clout of direct backing from the agency 

3 

head. Unfortunately, both agencies seem to be backtracking from 

this good direction. 

In the FDA’s case, less than a year after this administration approved the direct report organization—or reorganization, the sudden change is curious and would seem to be a step in the wrong 

direction. So we need to hear more details about the basis for this 

new direction. 

I would like to thank the distinguished members of our panel for 

being here today and for your service to our country. 

I now recognize the ranking member of the subcommittee from 

Colorado, Ms. DeGette, for 5 minutes. 

[The prepared statement of Mr. Harper follows:] 

PREPARED STATEMENT OF HON. GREGG HARPER

Good morning, today the Subcommittee continues its long-standing oversight of 

the U.S. public health system’s preparedness to respond to biological threats and 

emerging infectious diseases that endanger the public health. The purpose of today’s 

hearing is to hear from top public health experts on the good work being done at 

their agencies to protect the public, and to explore where improvements in biopreparedness may still be needed. 

The biological threats facing the United States in today’s global society are varied, 

ever-evolving, and in some cases, intensifying. The CDC just reported that the seasonal influenza claimed the lives of 172 children during the most recent flu season, 

making it the deadliest seasonal flu season for children on record. In recent years 

the U.S. has also seen an increase in the number of antibiotic resistant bacteria. 

Around the world, viruses are emerging, adapting, and in some cases, re-emerging. Currently, there is an Ebola outbreak in West Africa and a Nipah virus outbreak in India, that has killed at least 17 people. 

In recent years, we have also seen humans in China contract the H7N9 strain 

of influenza, which had been confined to birds. The H7N9 influenza strain is rated 

by the CDC’s Influenza Risk Assessment Tool as posing the greatest risk to cause 

a possible pandemic. 

The 2013 ricin mailings addressed to President Obama and Senator Roger Wicker 

that originated in my home state of Mississippi, as well as the 2001 anthrax mailings and foreign terrorist threats, is a reminder of the risk of intentional biological 

attacks. 

Today’s hearing is especially timely given that the Committee is considering bipartisan legislation, sponsored by Ms. Brooks and Ms. Eshoo, to reauthorize the 

Pandemic and All-Hazards Preparedness Act (PAHPA), which is set to expire at the 

end of September. Passage of PAHPA’s reauthorization would not only provide critical certainty for public health agencies and industry partners, it would also bring 

about some much-needed reforms. 

One such reform, proposed in the legislation, is transferring control of the Strategic National Stockpile from the CDC to HHS’ Office of the Assistant Secretary for 

Preparedness and Response to improve management of the Stockpile. A year ago, 

HHS’s Office of Inspector General reported systemic issues with security and inventory management of the Stockpile, risking CDC’s ability to deploy the stockpile during a public health emergency. These issues need to be addressed, as does improving 

the training of state and local stakeholders on deployment of medical countermeasures. 

Administrative reforms are also of interest. For example, are there ways to improve the timeliness of the decision-making process on threat assessments and appropriate countermeasures? 

Effective threat detection has been a subject of Committee oversight. In 2016, the 

Committee questioned the CDC about the effectiveness of its Laboratory Response 

Network (LRN), or LRN, which is responsible for developing assays for public health 

labs to test for the presence of federal select agents. In a May 2017 letter to the 

Committee, the CDC reported that the LRN had only developed three assays approved by FDA to detect specific federal select agents. While the LRN has also had 

assays cleared by the FDA under Emergency Use Authorization, after nearly 20 

years of this program with about $135 million in funding over the last decade, could 

the LRN have cleared a significantly higher number of assays through the more rigorous FDA 510(k) process? 

4 

Finally, maintaining public confidence in critical federal biopreparedness research 

is essential. In response to safety lapses in 2014 and to an expert panel’s recommendations, the CDC and FDA each formed new offices in 2015 to centralize and 

elevate oversight of laboratory safety, with the directors of those offices reporting 

directly to the agency head. These changes sent a strong message that lab safety 

was a top priority backed by the clout of direct backing from the agency head. Unfortunately, both agencies seem to be backtracking from this good direction, in the 

FDA’s case less than a year after this Administration approved the direct-report reorganization. The sudden change is curious, and would seem to be a step in the 

wrong direction. We need to hear more details about the basis for this new direction. 

I would like to thank the distinguished members of our panel for being here today 

and for your service to our country. I now recognize the Ranking Member of the 

Subcommittee from Colorado, Ms. DeGette, for 5 minutes. 

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

Ms. DEGETTE. Thank you, Mr. Chairman. 

I know we agree that preparing this country for a bioincident is 

of critical importance. The threat, as you said, is real and it’s growing. 

In April, the CDC reported that in 2017, Colorado saw 25 cases 

of an antibiotic-resistant bacteria known descriptively as the nightmare bacteria, because 50 percent of those infected by it die. 

Thankfully, those cases were isolated, but the same CDC study 

noted that it’s possible for these germs to ‘‘spread like wildfire.’’ If 

that happens, we need to know that we’re able to respond. 

We’ve looked at this issue in this subcommittee many times over 

the years, as our panel well knows. It’s a regular appearance, and 

I want to thank you for coming again. And again and again, we’ve 

found that the Federal Government has to scramble to address biosafety incidents. 

Those of us who were here during the fall of 2001 vividly recall 

the chaos that a few small envelopes of anthrax caused on Capitol 

Hill. Offices were closed. Buildings were fumigated. Some congressional business was suspended, and thousands of staffers and other 

personnel lined up for days to get tested for exposure. Far worse, 

some of the workers in our Postal Service were infected and died. 

In 2009, we again had to scramble to produce sufficient doses of 

the H1N1 swine flu vaccine to protect against this new strain of 

the disease. 

In 2014, hospitals and healthcare providers were not adequately 

prepared to deal with the arrival of Ebola patients in America. In 

one case, a hospital in Dallas failed to diagnose Ebola in a patient 

who had traveled to West Africa and discharged him. The virus 

was later transmitted from that patient to two healthcare workers. 

In the days and weeks that followed, important questions were 

raised about how this event was handled and were we adequately 

prepared for the larger event. 

And then, of course, in 2015, the Zika outbreak underscored the 

need for the U.S. Government to focus on disease preparedness 

every day. And I know our panel here today does just that. 

I’d like to know today, though, what lessons we’ve learned from 

these incidents, and I want to know how the agencies are using 

what we’ve learned to better prepare for the next crisis, because 

there will be one. 

5 

For example, do we have adequate medical countermeasures in 

place to respond quickly when an outbreak occurs or a toxin is released? Do we have the capacity to quickly deliver these countermeasures to the doctors and nurses who will actually use them? 

And do the healthcare workers understand how to deploy the countermeasures? 

Similarly, research into emerging pathogens and existing pathogens that have mutated is key to helping us quickly respond to new 

and expanding outbreaks. How is this research informing our surveillance and detection methodologies? Are we prioritizing research 

into threats of greatest concern? And are we dedicating adequate 

resources to the threats? 

I also want to hear more about how all of our agencies—CDC, 

ASPR, NIAID and FDA—coordinate their research, surveillance, 

and response efforts. Because while each one of these agencies 

today has a specific valuable role to play in ensuring preparedness, 

nobody can operate effectively alone. 

In fact, one major finding of the Blue Ribbon Panel’s 2015 report 

on biodefense preparedness was these agencies must ensure they’re 

equipped to work together to respond to pandemics. The Blue Ribbon report also found that the Federal Government must dramatically increase the support provided to local jurisdictions to help 

them build and sustain their biodefense capabilities. 

Local providers like hospitals and healthcare workers will be on 

the front lines in a public health emergency. I want to ensure that 

we’re adequately supporting these providers, as well as State and 

local Health Departments, so they are equipped to detect incidents 

when they happen and respond appropriately. 

Mr. Chairman, I’m really hoping we’ll hear today that we’ve 

made tangible, measurable progress in this area, but, again, I urge 

us to revisit the work of the Blue Ribbon Panel and some of its 

findings to determine what more we need to do to better prepare 

the Nation for the threats that we will be discussing today. 

I just can’t thank our panel today enough for the tireless work 

that they put in to keeping America safe. We always have a great 

opportunity to hear from you, and we know that you’re working 

hard. We think by having you come up here and take the time, it 

really helps us represent our constituents, and it helps all of us be 

better prepared for the next emergency that faces us. 

Thank you, and I yield back. 

Mr. HARPER. The gentlewoman yields back. 

The chair now recognizes the chairman of the full committee, the 

gentleman from Oregon, Mr. Walden, for 5 minutes. 

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

Mr. WALDEN. Thank you very much, Mr. Chairman. To all our 

committee members, thanks for your work on this. And to our panelists, thank you, not only for your guidance on this issue, but also 

what we tap into you for along the way. And so we appreciate your 

professionalism and your assistance in our policy debates. 

The topic of biopreparedness really hits home for me. I think I 

was the first Member of Congress to be diagnosed with H1N1 years 

ago. Not a distinction I was glad to get, but one apparently I had. 

6 

But more than that, 30 years ago, a religious group called the 

Rajneeshees moved to Oregon. You may have seen the documentary on Netflix called Wild Country. And if you read Judith Miller’s 

book Germs, you’ll find it was the largest bioterror attack in the 

Nation’s history, but it took the Federal Government a year, I 

think she wrote, to admit that that’s really what it was. They grew 

their own salmonella and then sprinkled it over salad bars in 

Dalles, Oregon, and sickened 751 people, many of whom I know. 

Deliberate biological attacks are just one risk. With more global 

travel, there’s, of course, increased risk of spread of infectious diseases. As we’ve seen with influenza, our vaccines must be constantly updated to keep up with the latest strains. Meanwhile, 

other pathogens can develop antibiotic resistance, and our ability 

to quickly recognize evolving diseases and respond to new outbreaks is reliant on the testing and treatment and capabilities in 

the men and women who do the work that you all oversee. 

Lack of preparation is not an option. A mock pandemic exercise 

hosted last month by Johns Hopkins Center for Health Security 

with a group of current and former government officials, including 

our own colleague Susan Brooks, I’m told was quite eye-opening. 

The exercise resulted in a failure to develop a vaccine within 20 

months, and that led in this exercise to 150 million deaths globally. 

So obviously, we’ve got to do more to be prepared for these types 

of outbreaks. 

So that’s where the reauthorization of the Pandemic and All Hazards Preparedness Act comes in. PAHPA originally was adopted in 

2006. It’s set to expire at the end of September. We intend to move 

forward with legislation prior to that. 

Our Health Subcommittee met just last week to consider a bipartisan discussion draft to reauthorize this law and continues to finetune it. It’s critically important Congress reauthorizes this law in 

time and to make sure that all levels of government are wellequipped to handle, not just current and emerging biothreats, but 

also chemical attacks, radiological emergencies, cybersecurity incidents, and mass casualty events. 

Through letters, hearings, and investigations, the Committee has 

raised numerous issues regarding biological threats to the U.S. and 

our nation’s ability to respond to infectious disease outbreaks. For 

example, the Committee has examined concerns about the CDC’s 

management and the security of the Strategic National Stockpile 

and the capabilities of CDC Laboratory Response Network. The 

Trump administration is set to transfer management of the stockpile from the CDC to the Assistant Secretary for Preparedness and 

Response, known as ASPR. And we look forward to hearing more 

details about how this transfer will work. 

Another area of interest to the Committee is the improvement of 

our biosurveillance capabilities. Innovation in this field could bolster our public health response in the event of an attack or epidemic. So I’ll be interested in learning more about that as well. 

One thing we do know, the Federal Government needs to act 

faster to identify and determine material threats. The Department 

of Homeland Security in March 2018 made a material threat determination for pharmaceutical-based agents such as Fentanyl. It took 

2 years for the DHS to make this designation, yet carfentanil, a 

7 

highly potent form of Fentanyl, was used in a terrorist attack more 

than 15 years ago. So it’s only after that designation is made that 

the Public Health Emergency Medical Countermeasures Enterprise 

can approve countermeasure development and acquisition. If we 

knew about it 15 years ago and it took 2 years to get that designation, we can do better. 

Maintaining public support for critical biopreparedness research 

relies on Federal scientists and researchers working with these diseases and dangerous pathogens in a safe and secure manner. Following several safety lapses at CDC and FDA labs in 2014, both 

FDA and CDC created new offices to oversee and prioritize lab 

safety. These are positive steps. The recent proposals at these 

agencies to lower the status of their lab safety offices raises concerns with this committee. 

So I thank you for being here today. 

And I’d like to yield the balance of my time to Dr. Burgess and 

hopefully to Mrs. Brooks. 

[The prepared statement of Chairman Walden follows:] 

PREPARED STATEMENT OF HON. GREG WALDEN

Mr. Chairman, thank you for holding this hearing. The topic ofbiopreparedness 

hits home for me. Some of you may recall that in 2009 I was diagnosed with 

H1N1—the swine flu. It was reported at the time that I was the first Member of 

Congress to contract swine flu—a distinction I’m not particularly proud of. But 

that’s not all. The first and single largest bioterrorism attack in the U.S. occurred 

in my district. More than 30 years ago, a group of Rajneeshee cult members used 

salmonella to contaminate at least 10 restaurant salad bars in The Dalles, Oregon, 

causing at least 751 people to get ill. 

Deliberate biological attacks are just one risk. With more global travel, there is 

increased risk of the spread of infectious diseases. 

As we’ve seen with influenza, our vaccines must be constantly updated to keep 

up with the latest strain mutations. Meanwhile other pathogens can develop antibiotic resistance. Our ability to quickly recognize evolving diseases and respond to 

new outbreaks is reliant on our testing and treatment capabilities. 

Lack of preparation is not an option. A mock pandemic exercise hosted last month 

by Johns Hopkins Center for Health Security with a group of current and former 

government officials, including our colleague Susan Brooks, was eye opening. This 

exercise resulted in a failure to develop a vaccine within 20 months and led to 150 

million deaths globally. We must do more. We must be prepared for potential outbreaks. 

That’s where the reauthorization of the Pandemic and All-Hazards Preparedness 

Act (PAHPA) comes in. PAHPA, originally adopted in 2006, is set to expire at the 

end of September. Our Health Subcommittee met just last week to consider a bipartisan discussion draft to reauthorize this law and continues to fine tune it. It is critically important Congress reauthorizes this law to ensure that all levels of government are well-equipped to handle not just current and emerging biothreats, but also 

chemical attacks, radiological emergencies, cybersecurity incidents, and mass casualty events. 

Through letters, hearings and investigations, the committee has raised numerous 

issues regarding biological threats to the U.S. and our nation’s ability to respond 

to infectious disease outbreaks. For example, the committee has examined concerns 

about the CDC’s management and security of the Strategic National Stockpile, and 

the capabilities of the CDC Laboratory Response Network. The Trump Administration is set to transfer management of the stockpile from the CDC to the Assistant 

Secretary for Preparedness and Response (ASPR), and we look forward to hearing 

more details about how this transfer will work. 

Another area of interest to the committee is the improvement of our biosurveillance capabilities. Innovation in this field could bolster our public health response 

in the event of an attack or epidemic. I will be interested to learn whether more 

intensive research could help expedite addressing the technical challenges. 

One thing we do know: The Federal Government needs to act faster to identify 

and determine material threats. The Department of Homeland Security (DHS) in 

8 

March 2018 made a material threat determination for pharmaceutical-based agents 

such as fentanyl. It took 2 years for DHS to make this designation. Yet carfentanil, 

a highly potent form of fentanyl, was used in a terrorist attack more than 15 years 

ago. It’s only after that designation is made that the Public Health Emergency Medical Countermeasures Enterprise can approve countermeasure development and acquisition. We must move faster. 

Maintaining public support for critical biopreparedness research relies on federal 

scientists and researchers working with these diseases and dangerous pathogens in 

a safe and secure manner. Following several safety lapses at CDC and FDA labs 

in 2014, both CDC and FDA created new offices to oversee and prioritize lab safety. 

These were positive steps, but recent proposals at these agencies to lower the status 

of their lab safety offices raise concerns. 

I’d like to thank our witnesses for being here with us today. We value the feedback and insight you provide and look forward to today’s discussion. 

Mr. BURGESS. Thank you, Mr. Chairman. 

And this issue is one that is important and timely for this subcommittee. And last week, the Health Subcommittee had a hearing 

on the discussion draft of the Pandemic and All Hazards Preparedness Act authored by Representatives Brooks and Eshoo. At that 

hearing, we heard from witnesses with firsthand experience in 

combating these biological threats to our nation and received input 

on the draft legislation. 

Certainly, our witness panel today is well-known to us and they 

are all experts. I look forward to hearing from our witnesses. 

And I thank you, Mr. Chairman, and I will yield to Mrs. Brooks. 

Mr. HARPER. Maybe with unanimous consent, due to your leadership role in this, 30 seconds. 

Mrs. BROOKS. Thank you, Mr. Chairman. 

And thank you to our witnesses for your work on this public 

health and national security issue. 

Last February, our subcommittee here held a hearing examining 

how we best combat biological threats. And I’m pleased we’re once 

again examining the state of our preparedness as we prepare to reauthorize PAHPA. 

As everyone here knows, it is not a question of if we face a 

threat; it’s a question of again, once again, when we face a threat. 

And we’ve been reminded by the stories that we’ve heard here 

today that these types of incidents have already happened in our 

country over the last decade and a half. 

Created in 1999, the National Stockpile is the repository of vaccines, antibiotics, and supplies used in the event of an attack or an 

outbreak. But HHS OIG, in June of 2017, issued a report identifying serious systemic issues within the CDC’s management of the 

stockpile. 

I look forward to hearing from our witnesses today how we are 

going to ensure that our stockpile is properly managed and that we 

can be prepared as a country for whatever threat we are and may 

face. 

I yield back. 

Mr. HARPER. The chair now recognizes the ranking member of 

the full committee, the gentleman from New Jersey, Mr. Pallone, 

for 5 minutes. 

9 

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

Mr. PALLONE. Thank you, Mr. Chairman. 

Ensuring that our nation is equipped to respond to pandemics, 

natural disasters, and the accidental or intentional release of toxins is a key part of protecting public health. Past work by this committee has suggested that our nation has not always been as prepared as we need to be, so I’m glad that we’re having this hearing 

today, and I hope to hear that we have made tangible progress towards increasing our Nation’s preparedness. 

In 2015, the Blue Ribbon Panel on Biodefense conducted a comprehensive review of the Federal Government’s biopreparedness efforts. The panel found that, ‘‘The Nation is dangerously vulnerable 

to a biological event.’’ It produced an extensive report recommending 30 action items for our public health infrastructure to address. 

While the Blue Ribbon Panel was the most recent high-level commission to examine our nation’s biopreparedness, it was not the 

first. In fact, for many years, experts have warned that our ability 

to respond to biologic and other emerging threats must be improved. 

These recommendations remain important today, because the 

emerging health threats this country faces continue to grow. Just 

this week, officials announced that a child in Idaho had contracted 

bubonic plague. Last year, an outbreak of this plague killed 200 

people in Madagascar. 

In March, we heard at a hearing that the threat of pandemic flu 

is among the greatest concerns in the public health world. And antibiotic resistance also poses a major threat to public health, killing 

23,000 Americans every year and making everyday procedures like 

surgery and chemotherapy increasingly risky. In May, a study 

showed that warming temperatures were associated with higher 

levels of antibiotic resistance in common strains of bacteria. 

Extreme weather events can also lead to serious public health 

emergencies. The hurricanes in Puerto Rico, the Virgin Islands, 

Texas, and Florida last year were a stark reminder of this fact. We 

must be prepared to address threats from all these sources. 

The Blue Ribbon Panel produced many recommendations for improving our biopreparedness, and I hope our witnesses will show 

that we have made real progress. For example, I hope to hear that 

the agencies have established a plan for who will take the lead in 

response to a public health threat and how the efforts will be coordinated. 

Along these same lines, I hope we will learn how CDC, NIH, 

ASPR, and FDA are working together to identify the greatest 

threats and to prioritize the research, surveillance, and response 

capabilities needed to target these threats. 

We must also focus on how these agencies collaborate with State 

and local health departments as well as healthcare providers, such 

as hospitals. These entities are likely to be the first to see patients 

impacted by an infectious disease outbreak or other incident. In 

most cases, they’ll be the ones to dispense countermeasures and to 

treat those impacted. 

10 

In 2014, for example, we witnessed the negative consequences 

that ensued when our healthcare infrastructure was unprepared to 

diagnose and treat patients with Ebola. A hospital failed to detect 

the disease in the patient in Dallas, and that patient later transmitted Ebola to two healthcare workers. This incident led to a serious question about whether we would be able to handle a larger 

scale event or incident. And we must make sure everyone on the 

ground has all the resources they need to respond effectively in 

such a crisis. 

We also want to hear more about how we are conducting surveillance so that when an outbreak happens or a toxin is released, we 

know as soon as possible. While we cannot anticipate every possible new or mutated pathogen, if we can quickly detect when such 

a pathogen has emerged, we can respond much more effectively. 

And along these same lines, I understand the CDC is gathering 

a substantial amount of data from laboratories, public health departments, and clinicians across the country every day. So we must 

ensure that this agency has the resources it needs to effectively use 

and analyze this data as it comes in. 

And finally, I want to hear more about what we’re doing to 

prioritize development of medical countermeasures to help us respond to a biosafety incident. Countermeasures include preventative measures like vaccines as well as therapeutics like antibiotics 

and antivirals. 

BARDA, I understand that you work closely with the private sector to develop many of these products, and I hope that we will hear 

today about how these partnerships have produced useful, safe, 

and effective products that truly address the challenges we face. 

So, Mr. Chairman, I’d like to thank our panel once again for 

being here. Preparing for these threats is certainly not easy, but 

I’m confident that you’re up for the task as long as we do our part 

and provide you with all the resources that you need. 

I yield back, Mr. Chairman. 

Mr. HARPER. The gentleman yields back. 

I ask unanimous consent that the members’ written opening 

statements be made part of the record. Without objection, they will 

be so entered into the record. 

And additionally, I ask unanimous consent that Energy and 

Commerce members not on the Subcommittee on Oversight and Investigations be permitted to participate in today’s hearing. Without 

objection, so ordered. 

I would now like to introduce our witnesses for today’s hearing. 

First, we have Dr. Rick Bright, Director of Biomedical Advanced 

Research and Development Authority and Deputy Assistant Secretary at the Office of the Assistant Secretary for Preparedness and 

Response. Next is Dr. Anne Schuchat, Principal Deputy Director at 

the Centers for Disease Control and Prevention. Then we have Dr. 

Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. Finally, we 

have Rear Admiral Denise Hinton, Chief Scientist at the U.S. Food 

and Drug Administration. 

We welcome all of you. 

And you are each aware that the Committee is holding an investigative hearing and when doing so has had the practice of taking 

11 

testimony under oath. Do you have any objection to testifying 

under oath? 

Let the record reflect that all of the witnesses have reflected that 

they do not. 

The chair then advises you that under the rules of the House and 

the rules of the committee, you’re entitled to be accompanied by 

counsel. Do you desire to be accompanied by counsel during your 

testimony today? 

Let the record reflect that each of the witnesses reflected that 

they do not. 

In that case, if you would please rise and raise your right hand, 

I will swear you in. 

[Witnesses sworn.] 

Mr. HARPER. You are now under oath and subject to the penalties set forth in title 18, section 1001 of the United States Code. 

You may now give a 5-minute summary of your written statement. 

And I will begin with you, Dr. Bright. Welcome back. 

TESTIMONY OF RICK A. BRIGHT, PH.D., DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, DEPUTY ASSISTANT SECRETARY, OFFICE OF THE 

ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; ANNE SCHUCHAT, M.D. (RADM, USPHS), PRINCIPAL 

DEPUTY DIRECTOR, CENTERS FOR DISEASE CONTROL AND 

PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN 

SERVICES; ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH; AND DENISE HINTON 

(RADM, USPHS), CHIEF SCIENTIST, U.S. FOOD AND DRUG ADMINISTRATION 

TESTIMONY OF RICK A BRIGHT, PH.D. 

Mr. BRIGHT. Thank you. 

Chairman Harper, Ranking Member DeGette, and distinguished 

members of the subcommittee, it’s a pleasure to speak today on behalf of our Assistant Secretary for Preparedness Response to discuss the state of the Nation’s health security preparedness. 

I’m Dr. Rick Bright, the Director of the Biomedical Advanced Research and Development Authority, BARDA, and the Deputy Assistant Secretary for Preparedness and Response. 

ASPR’s mission is to save lives and protect Americans from 21st 

century health security threats. BARDA is a component of ASPR 

created to ensure that we have products to protect people from numerous dire threats that we face as a nation. ASPR’s staff is dedicated to preparing for and responding to these threats. 

We are currently coordinating HHS’ response to the Ebola outbreak in the DRC and monitoring H7N9 influenza in China. In 

communities affected by last year’s hurricanes, we’re there for the 

long haul, helping local health officials manage recovery and build 

resilience. 

ASPR coordinates across the Federal Government to support 

State and local partners in emergencies. We enhance medical 

search capacity through our National Disaster Medical System and 

12 

Hospital Preparedness Program, and we oversee the development 

and procurement of medical countermeasures. We’ve made great 

progress in public health preparedness response since Congress established ASPR and BARDA in 2006. 

BARDA was created to bridge government and industry to accelerate the development of life-saving medical countermeasures that 

would not otherwise be available. We use flexible authorities, 

multiyear advanced funding, public-private partnerships, and deep 

technical expertise to push vaccines, drugs, and diagnostics towards FDA approval. In our 12 years, BARDA has formed over 200 

public-private partnerships with industry to accomplish our mission. 

I want to pause for one second to acknowledge the hard work of 

our partners who, together with the U.S. Government, work very 

hard to create a more secure nation with not only products but capabilities to respond when needed. These partnerships have led to 

35 FDA approvals of products that form a protective shield for our 

nation against a range of the most serious CBRN and pandemic 

and emerging infectious disease threats. 

Through Project BioShield, BARDA has supported 27 vaccines, 

drugs, and devices to address national security threats, including 

smallpox, anthrax, botulinum, rad/nuc and chemical exposure. 

Fourteen of these are now in the Strategic National Stockpile for 

use in an emergency, and seven have now achieved FDA approval. 

These outcomes are the spirit of PAHPA: leadership, coordination, 

partnerships, and capabilities, working together to protect our nation. 

While this effort has created life-saving products to be procured 

by the SNS, it has also created challenges to acquire and sustain 

sufficient quantities to address the requirements needed for each 

threat. Critically, each product also represents a company with a 

response capability that must be sustained to ensure we have these 

products available when they’re needed. Project BioShield and the 

SNS together represent a marketplace for these products that 

would otherwise never exist and the products would quickly vanish 

without it. 

PAHPA, ASPR, BARDA, and BioShield have all played valuable 

roles in enhancing our preparedness. However, the threats continue to evolve, and technology to modify and create new deadly 

threats have become simpler. We must modernize our capabilities, 

emphasizing an end-to-end approach, ranging from early detection 

through the last mile of administering vaccines and treatments to 

patients. 

With new technologies and innovation, the time is here to apply 

transformative approaches to these daunting health security problems. Last week, we announced a new initiative called DRIVe, a 

nationwide business-friendly approach to identify, capture, and accelerate life-saving innovation. Using authorities you enacted in 

the 21st Century Cures Act, DRIVe brings together innovators, 

government, and now the investment community to create solutions for today’s threats. 

As you consider reauthorization of PAHPA, important changes to 

BARDA’s authorities would sustain and enhance our capabilities. 

First, advanced appropriations for Project BioShield will attract 

13 

more partners to support our mission. Without this consistent and 

guaranteed market, the companies are reluctant to work with us. 

Second, an authorization of appropriation for BARDA’s pandemic 

influenza program will sustain our domestic flu vaccine production 

capabilities, modernize our vaccine technologies, and bring new 

treatments and faster diagnostics into the homes across America. 

I look forward to working with members of this panel, this subcommittee, your congressional colleagues, and I’m grateful for the 

opportunity to present to you today and look forward to your questions. 

[The prepared statement of Mr. Bright follows:] 

14 


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/5'£1LVft::f.t 

.,. ~v'l:( Written Testimony f House Committee on Energy and Commerce, 

%~E. Subcommittee on Oversight and Investigations 

The State of U.S. Public Biopreparedness: 

Responding to Biological Attacks, Pandemics, and 

Emerging Infectious Disease Outbreaks 

Statement of 

Rick Bright, Ph.D 

Director, Biomedical Advanced Research and Development Authority 

Deputy Assistant Secretary For Preparedness and Response 

ASPR 

ASSISTANT SEt::RET~_Q_l~ 

PREPAREDNESS A:-.ID RESPONSE 

For Release on Delivery 

Expected at 

9:00am 

June 15, 2018 
15 


35127.002

Good morning Chairman Harper, Ranking Member DeGette, and other distinguished Members of 

the Subcommittee. I am Dr. Rick Bright, the Director of the Biomedical Advanced Research and 

Development Authority (BARDA) and the Deputy Assistant Secretary for Preparedness and 

Response (ASPR) at the Department of Health and Human Services (HHS). Thank you for the 

opportunity to testify before you today on behalf of ASPR to discuss the state of our nation's 

preparedness for 21st century health security threats, including biological incidents, as the Energy 

and Commerce Committee prepares to consider the second reauthorization of the Pandemic and 

All-Hazards Preparedness Act (PAHPA). 

My expertise is in developing drugs, vaccines, diagnostics and other medical countermeasures 

(MCMs) for health security threats. In this testimony, I will cover a broader range of ASPR 

programs and activities, including some background on the nature of the health security threats 

facing the United States, the mission and duties of ASPR and BARD A, and our vision for where 

these areas can be strengthened. 

Readiness for 21" Century Health Security Threats: A National Security Imperative 

One of the federal government's fundamental responsibilities is to provide for the common defense 

-to protect the American people, our homeland, and our way oflife. The strength of our nation's 

public health and medical infrastructure, and the capabilities necessary to quickly mobilize a 

coordinated national response to emergencies and disasters, are foundational for the quality of life 

of our citizens and vital to our national security. The health security threats facing the United 

States during the 21st century are increasingly complex and dangerous. Therefore, improving 

national readiness and response capabilities for 21st century health security threats is a national 

security imperative. 

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Additionally, we have witnessed the impacts of naturally occurring outbreaks such as pandemic 

influenza, outbreaks ofEbola and SARS, and the emergence of antibiotic resistant bacteria. ASPR 

is currently engaged in coordinating HHS's response to the Ebola outbreak in the Democratic 

Republic of Congo and monitoring other potential emerging infectious diseases that could cause a 

pandemic, such as the H7N9 influenza strain circulating in China. This year marks the I 00-year 

anniversary of the 1918 influenza pandemic, which killed more people than World War I. During 

that pandemic, more than 25 percent of the U.S. population became sick and 675,000 Americans, 

many of them young, healthy adults, died from the highly virulent influenza virus. As our 

healthcare delivery systems become more networked, cyber-attacks like the 2017 WannaCry 

incident that affected approximately 150 countries remind us that technological advancements 

have trade-offs in the form of new vulnerabilities and risks. Finally, we face extreme weather 

events, such as the recent 2017 hurricane season in which Hurricanes Harvey, Irma, and Maria 

caused an unprecedented amount of damage and destruction, reminding us of the awesome 

destructive power of nature and our vulnerability. 

These are threats that most people would rather not think about. However, when natural disasters, 

disease outbreaks, or attacks occur, the people expect our federal government to be ready to 

quickly respond to save lives and decrease morbidity. Since September 11, 2001, the nation has 

made great progress in building our response capabilities to protect America from health security 

threats; however, we still have much to do. 

Assistant Secretary for Preparedness and Response: Mission & Duties 
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ASPR' s mission is to save lives and protect Americans from 21st century health security threats. 

On behalf of the Secretary of HHS, ASPR leads public health and medical preparedness for, 

response to, and recovery from, disasters and public health emergencies, in accordance with the 

National Response Framework (NRF) (Emergency Support Function (ESF) No. 8, Public Health 

and Medical Services), as well as the National Disaster Recovery Framework (Health and Social 

Services Recovery Support Function). ASPR also supports HHS's role in the delivery of mass 

care and human services in emergencies (NRF ESF No. 6, Mass Care, Emergency Assistance, 

Temporary Housing, and Human Services). 

When ASPR was established by Congress a decade ago in PAHPA, the law's objective was to 

create "unity of command" by consolidating Federal nonmilitary public health and medical 

preparedness and response functions under the ASPR. This approach was modeled on the 

Goldwater-Nichols Act that created the Department of Defense (DoD) combatant commands; the 

impetus was the disorganized and fragmented response to Hurricane Katrina in 2005. 

ASPR coordinates across HHS and the Federal interagency to support state, local, territorial, and 

tribal health partners in preparing for, responding to, and recovering from, emergencies and 

disasters. In partnership with HHS agencies, ASPR works to enhance U.S. medical surge capacity 

by organizing, training, equipping, and deploying HHS public health and medical personnel, such 

as National Disaster Medical System (NDMS) teams, and providing logistical support for HHS 

personnel responding to public health emergencies. ASPR supports readiness at the state and local 

level by coordinating federal grants and cooperative agreements, such as the Hospital Preparedness 

Program (HPP), by programs like the Medical Reserve Corps (MRC), and carrying out drills and 

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operational exercises. ASPR also oversees advanced research, development, and procurement of 

medical countermeasures (e.g., vaccines, medicines, diagnostics, and other necessary medical 

supplies), and coordinates the stockpiling of such countermeasures. As such, ASPR manages 

BARDA, Project BioShield, and the Public Health Emergency Medical Countermeasures 

Enterprise. 

ASPR Priorities for Improving Preparedness, Response, and Recovery 

HHS and ASPR have made significant progress since PAHPA was enacted in 2006 and was 

reauthorized in 2013. However, we still have work to do to ensure we are ready to save lives and 

protect Americans. ASPR has four key priorities for building the necessary readiness and response 

capabilities for 21st century health security threats: 

• First, provide strong leadership, including clear policy direction, improved health security 

threat awareness, and secure adequate resources. 

• Second, seek the creation of a "regional disaster health response system" by better 

leveraging and enhancing existing programs- such as HPP and NDMS- to create a more 

coherent, comprehensive, and capable regional medical emergency response system 

integrated into daily care delivery. 

• Third, advocate for the sustainment of robust and reliable public health security 

capabilities. For ASPR to accomplish its mission, the Centers for Disease Control and 

Prevention (CDC) and other partners need support to quickly detect and diagnose 

infectious diseases and other health security threats. This is critical to rapidly and 

effectively dispensing medical countermeasures in an emergency. 

• Fourth, advance an innovative medical countermeasures enterprise by capitalizing on new 
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authorities provided in the 21st Century Cures Act and advances in biotechnology and 

science. We must develop and maintain a robust supply of safe and efficacious vaccines, 

medicines, equipment, and other materiel to respond to 21st century health security threats, 

as well as the flexible response capabilities needed to handle the unexpected. 

Strong Leadership 

In the area of strong leadership, ASPR should continually evaluate and incorporate national health 

security threats by regularly coordinating with the Director of National Intelligence, the 

Department of Justice, and the Department of Homeland Security to assess current and future 

national health security threats. 

Medical Countermeasures Enterprise 

Congress established BARD A to speed up the availability and use of medical countermeasures 

(MCMs) by bridging the so-called "valley of death" in late stage development where many 

countermeasures for health security threats historically languished or failed. By using flexible, 

nimble authorities, multiyear advanced funding, strong public-private partnerships, and cutting 

edge expertise, BARD A has successfully pushed innovative MCMs, such as vaccines, drugs, and 

diagnostics, through advanced development to stockpiling and commercial availability with FDA 

approval or licensure. 

In the last decade, BARDA's strong partnerships with biotechnology and pharmaceutical 

companies, the National Institutes of Health, and other HHS components have led to 35 FDA 

approvals for 31 unique MCMs addressing chemical, biological, radiological, and nuclear (CBRN) 

threats, pandemic influenza, and emerging and re-emerging infectious diseases. This is a 

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staggering accomplishment in just 12 years. 

BARD A has supported the development of 27 medical countermeasures against Department of 

Homeland Security (DHS)-identified national security threats through Project BioShield, 

including products for smallpox, anthrax, botulinum, radiologic/nuclear emergencies, and 

chemical events. Fourteen of these products have been placed in the Strategic National Stockpile 

and are ready to be used in an emergency and seven have achieved FDA approval. BARD A also 

has supported the development of 23 influenza vaccines, antiviral drugs, devices, and diagnostics 

to address the risk of pandemic influenza. 

Because of these successes and progress, more medical countermeasures than ever before are 

eligible to be procured for the Strategic National Stockpile, thereby creating new challenges in 

terms of acquiring and maintaining sufficient quantities of medical countermeasures to address the 

requirements for identified health security threats. 

Just last week, we announced an exciting new public-private engagement model called DRIVe 

-which is designed to accelerate innovation, address some of the nation's most pressing health 

security challenges, and potentially affect major healthcare markets. 

At a time when synthetic biology and personalized medicine are not just conceivable but attainable, 

the time is right to apply an innovative approach to some of the most daunting, far-reaching health 

security problems, such as sepsis and early diagnosis of infectious diseases. 
21 


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By implementing the authorities you provided to us in the 21st Century Cures Act, we are opening 

our doors to more innovators, and most importantly investors, to catalyze advances in science and 

technology. 

ASPR has recommended important changes to BARD A's authorization of appropriations to meet 

these challenges, including, most notably, additional advanced appropriations for Project 

BioShield, which would help incentivize private industry to dedicate resources to developing 

medical countermeasures to meet the government's national security requirements. Without this 

"guaranteed market," companies are reluctant to incur the costs required to focus development on 

MCMs for CBRN agents that would rely upon a limited government market that may not 

materialize when product development is complete. ASPR has also recommended adding a direct 

funding line for BARDA's pandemic influenza preparedness activities. This authorization of 

appropriations will help sustain domestic influenza vaccine manufacturing capacity, as well as 

support better, faster influenza vaccine technologies and antivirals and rapid response platform 

technologies. 

Regional Disaster Health Response System 

The 2017 hurricane season highlighted the importance of regional healthcare readiness and 

medical surge capacity. ASPR led the public health and medical responses to Hurricanes Harvey, 

Irma, and Maria under the NRF Emergency Support Function No. 8 mission. ASPR worked 

closely with state and territory health officials in affected areas to augment care with NDMS teinns, 

U.S. Public Health Service Commissioned Corps Officers, Department of Veterans Affairs 

personnel and facility support, and DoD transportation, facilities, naval vessels with medical and 

surgical capability, clinicians, and support personnel. Federal personnel under the supervision of 
22 


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HI-IS treated over 36,000 patients, and evacuated nearly 800 patients. HHS deployed over 4,500 

personnel, awarded over 200 contracts, and provided nearly 950 tons of equipment. Today, HHS 

continues to support recovery efforts in impacted communities. 

Despite our progress, each event teaches us that ASPR needs to improve its internal capabilities 

as well as enhance our support for the healthcare infrastructure across the country. As with MCM 

development, the nation's healthcare delivery infrastructure is mostly a private sector enterprise. 

We must better leverage and enhance existing federal programs sueh as HPP and NDMS- to 

create a more coherent, comprehensive, and capable regional medical emergency response system 

integrated into daily care delivery. We call this the foundation of a "regional disaster health 

response system." 

NDMS was created during the Cold War to take care of military casualties from overseas conflicts 

in U.S. civilian hospitals. To modernize NDMS, strengthen capabilities, and ensure NDMS 

continues to provide critical support during and immediately after national public health and 

medical emergencies and national security special events, ASPR is implementing administrative 

changes and has recommended improvements to the NDMS statute to aid in ASPR's efforts to 

modernize this critical asset. 

The Hospital Preparedness Program (HPP) was established after the September 11, 2001 terrorist 

attacks, with the goal of improving the capacity of local hospitals across the country to deal with 

disasters and a large inf1ux of patients in an emergency. Using HPP funding, state grantees initially 

purchased equipment and supplies needed for emergency medical surge capacity. Over time, the 

9 
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program successfully evolved to support local coordinated healthcare coalitions, including 

hospitals, public health facilities, emergency management agencies, and emergency medical 

services providers. Fifteen years after it was established, HPP can be further strengthened to better 

utilize existing resources and enhance healthcare preparedness and response capabilities at the 

local level, and ASPR has recommended modifications to the HPP statute toward this end. 

Conclusion 

As Congress moves forward on the second reauthorization ofPAHPA, we have the opportunity to 

build on the great progress made and further improve our national readiness and response 

capabilities for 21st century health security threats. On behalf of the HHS Assistant Secretary for 

Preparedness and Response, Dr. Bob Kadlec, I want to thank you, again, for your bipartisan 

commitment to this national security imperative, and we look forward to continuing to work 

together to enhance our nation's health security. 1 am happy to answer any questions you may 

have. 

!0 
24 

Mr. HARPER. Thank you, Dr. Bright. 

The chair will now recognize Dr. Anne Schuchat for 5 minutes. 

Welcome. 

TESTIMONY OF ANNE SCHUCHAT, M.D. 

Dr. SCHUCHAT. Thank you. 

Chairman Harper, Ranking Member DeGette, and members of 

the subcommittee, thank you so much for the opportunity to testify 

before you today to describe CDC’s role in preparing, detecting, and 

responding to biological attacks, pandemics, and emerging infectious disease outbreaks. 

Today I’ll highlight CDC’s role in protecting the Nation against 

health threats. I’ll describe our role in three areas: preparedness, 

detection, and response. 

The three themes I’d like you to take away are, first, the work 

CDC does every day in public health lays the foundation for responding to emergencies. Second, the CDC’s world-class scientific 

and medical expertise ensures we’re ready to respond to any threat. 

And third, our longstanding connection to State and local health 

departments ensures that public health systems function effectively, both day-to-day and during emergency response. 

Let me first address how we prepare for emergencies. CDC works 

every day with State and local health departments. In fact, we 

have 590 staff assigned to State and local health departments. We 

fund the Public Health Emergency Preparedness Cooperative 

Agreement Program and the Cities Readiness Initiative. 

Public Health Emergency Preparedness grants go to every State, 

eight territories, and four cities. These funds support staff, enable 

exercises to test and validate capabilities, and pay for laboratory 

and communications equipment. 

The Cities Readiness Initiative funds this nation’s 72 largest cities, to develop and test plans to receive and dispense medical countermeasures from the Strategic National Stockpile. 

CDC expertise helps assure protection of vulnerable populations 

against diverse threats. For example, CDC worked with the American Academy of Pediatrics, the FDA, and other stakeholders to address gaps in existing countermeasures for anthrax in children, 

taking advantage of the agency’s scientific and clinical expertise 

and longstanding relationships with AAP. 

Turning now to detecting threats. The CDC’s lab and surveillance systems are able to detect and identify agents causing illness, 

ranging from infectious agents to chemical or radiation exposures. 

Every year, labs from all over the world send specimens to CDC, 

because they know we’ll be able to identify pathogens that other 

laboratories cannot. 

Rapid identification of disease permits intervention before a 

health threat becomes a crisis. CDC’s Laboratory Response Network maintains an integrated, scaleable, and flexible system of 125 

Federal, State, and local laboratories. The development of this laboratory network established in 1999 has provided a larger capacity 

to test and report more quickly than was previously possible. For 

example, during the Zika virus outbreak response, CDC and our 

Laboratory Response laboratories processed over 207,000 specimens just for Zika. 

25 

Now I’ll turn to response. When there’s a crisis, CDC responds. 

We’re able to rapidly deploy scientific and medical experts anywhere in the world. By the end of the 21-month Ebola response, 

3,700 CDC staff had shifted from their day-to-day duties to assist 

with the response. 1,500 of our staff deployed to West Africa, making over 2,000 trips. Today, we’re responding to a much smaller 

Ebola outbreak in the Democratic Republic of Congo. 

During health emergencies, CDC communicates. For example, 

during the 2009 H1N1 response, CDC held 39 full press conferences and 21 telebriefings. During the Zika response, CDC published 51 morbidity and mortality weekly report articles to make 

sure the public health and healthcare professionals had the latest 

and best information. 

Being able to prepare, detect, and respond to public health 

threats is a top priority for us at CDC. Our preparedness and response capabilities are built on broad and deep scientific, medical, 

and program expertise. Our longstanding partnerships with State 

and local public health authorities ensures an integrated approach 

wherever that approach is needed, resulting in better responses 

and better public health outcomes, which translate to better protection of the people we serve. 

Thank you, and I’ll be happy to answer questions. 

[The prepared statement of Dr. Schuchat follows:] 

26 


35127.011

~S'RRVI~sU 

,.,""..:, ~"1 Written Testimony 

~ Ji? House Energy and Commerce Committee, 

~-- ~1....., Subcommittee on Oversight and 

1}+-~:~<Qa{J Investigations: 

Statement of 

The State of U.S. Public Health 

Biopreparedness: Responding to 

Biological Attacks, Pandemics, and 

Emerging Infectious Disease Outbreaks 

RADM Anne Schuchat, M.D. 

Principal Deputy Director 

Centers for Disease Control and Prevention 

Department of Health and Human Services 

For Release upon Delivery 

Expected at 9 a.m. 

June 15, 2018 
27 


35127.012

Chairman Harper, Ranking Member DeGette, and other members of the subcommittee. I am Rear Admiral Anne 

Schuchat, Principal Deputy Director of the Centers for Disease Control and Prevention (CDC). I appreciate the 

opportunity to be here today to discuss CDC's biopreparedness mission. 

CDC is the eyes and ears of the biopreparedness complex, advancing the health security of the nation by helping 

communities prepare for, detect, and respond to, public health consequences of all hazards. These hazards 

include chemical, biological, radiological, and nuclear (CBRN) threats, natural disasters, and emerging (and reemerging) infectious disease. For 72 years, this has been CDC's core mission. 

CDC draws on expertise from across the agency, including world-class laboratory testing, public health 

surveillance (for disease detection), epidemiology, guidance to healthcare providers, incident management, 

logistics, emergency risk communication, disease control programs, distribution of medical countermeasures, 

human and animal medicine, and responder health and well-being. Our multidisciplinary workforce and 

integrated national and international systems broaden our capacity to detect and respond to any developing 

situation that could affect the health of people in the United States. This ability is enhanced by our long-standing 

relationships and close collaboration with federal, state, territorial, tribal, local, and global partners. 

The CDC's Public Health Emergency Preparedness Cooperative Agreement Program (PHEP) (which includes the 

Cities Readiness Initiative (CRI)) is central to CDC's programs to prepare communities across the nation for the 

next public health emergency. Additionally, CDC's role in the Public Health Emergency Medical 

Countermeasures Enterprise (PHEMCE) is critical to national preparedness for chemical, biological, radiological, 

nuclear threats, and emerging infectious diseases. 

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Public Health Emergency Preparedness Cooperative Agreement Program 

The PHEP cooperative agreement program is the largest CDC state program and provided approximately $600 

million to state, local and territorial public health departments in FY 2017. The program supports these 

jurisdictions to develop plans for public health preparedness and response, and has been instrumental in 

integrating state and local health departments into their jurisdictions' emergency response structures. PHEP 

currently supports 62 awardees- the 50 states, eight territories and freely associated states, and four directly 

funded cities (New York City; Washington, D.C.; Chicago; and Los Angeles). Funding is awarded according to a 

base-plus population formula prescribed by statute, which ensures a minimum amount of funding to each 

awardee. These funds support preparedness and response staff, enable exercises to test and validate 

capabilities, provide training, and pay for laboratory and communications equipment essential to maintaining 

preparedness. In addition, CDC personnel support PHEP awardees by helping to identify and address gaps in 

preparedness capabilities, providing planning resources to ensure the needs of vulnerable populations are 

incorporated into response strategies, and improving response capabilities from experience gleaned during 

public health responses. 

Cities Readiness Initiative (CRI) 

CRI, funded through the PHEP cooperative agreement, enhances preparedness in the nation's 72 largest 

population centers, where nearly 60% of the U.S. population resides. These cities use CRI funds to develop, test, 

and maintain, plans to quickly receive medical countermeasures (MCMs) from the Strategic National Stockpile 

(SNS) and distribute them to local communities. This program, which relies on local boots on the ground, 

enables effective response to large-scale public health emergencies that require life-saving medications and 

medical supplies. 

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Public Health Emergency Medical Countermeasures Enterprise (PHEMCE} 

Through participation in the ASPR-Ied Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), 

CDC works with other HHS agencies and other federal partners to enhance preparedness for chemical, 

biological, radiological and nuclear threats, and emerging infectious disease. CDC brings together its scientific 

expertise and its experience in public health practice to inform the use of preventative measures and treatment 

during a public health emergency. Specifically, CDC subject matter experts from various CDC centers: 

Develop clinical guidance on the use of PHEMCE medical countermeasures- crucial to ensure health 

departments and clinicians know the safest, most effective way to use medical countermeasures. 

Inform operational details for SNS deployment- this includes informing which products should be 

deployed first based on epidemiology and laboratory data and clinical guidance. 

Provide technical expertise to state and local partners for the development and execution of 

deployment and dispensing plans for PHEMCE medical countermeasures. 

Conduct regular operational readiness reviews and exercises with state and local partners to prepare 

them and build their capacity to receive and dispense PHEMCE medical countermeasures. (In FY 2017, 

CDC supported 12 full-scale and tabletop exercises, and trained 3,758 Federal, state, territorial, and local 

emergency responders representing 13 different jurisdictions, on how to receive and distribute products 

from the Strategic National Stockpile). 

Provide regulatory science expertise to inform legal mechanisms (Emergency Use Authorizations, 

Emergency Use Instructions, and Investigational New Drug Protocols) and guidance on the use of MCM 

that have not received FDA approval or the use of FDA approved MCMs for- indications other than 

those included in FDA approval. 

Protecting Vulnerable Populations during Emergencies 

CDC has expertise and programs to promote effective support and care prior to, during, and after a public health 

emergency, for a wide variety of vulnerable populations. CDC's PHEP program requires states to develop 

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emergency plans covering children, pregnant women, and other vulnerable populations such, as those isolated 

due to geography and individuals with disabilities. Subject matter experts within CDC's Children's Preparedness 

Unit champion the needs of children in public health emergencies and have supported 10 responses over the 

past 10 years. CDC also provides guidance to state and local health departments for dosage and administration 

of certain MCMs to certain populations. The Children's Preparedness Unit has recently completed a draft 

implementation plan for the pediatric use of Anthrax Vaccine Adsorbed (AVA) in the case of a large-scale event. 

AVA is the only FDA-licensed human anthrax vaccine in the U.S., but it is not currently approved for use in 

children. This implementation plan provides critical activities to ensure that programs are prepared to, and have 

the resources for, the efficient and safe administration of the vaccine to children. 

Federal Select Agent Program 

The nearly 300 entities in the U.S. that engage in laboratory research on biological select agents and toxins are 

regulated under the Federal Select Agent Program (FSAP), which is jointly managed by CDC and the Animal and 

Plant Health Inspection Service (USDA) to regulate the possession, use, and transfer of biological pathogens and 

toxins (e.g., anthrax, bubonic plague, smallpox, and ricin) that have the potential to pose a severe threat to 

human, animal, and/or plant health. The program aims to ensure that work with these dangerous agents is 

conducted in as safe and secure manner as possible, and that they are stored and transported safely and 

securely. 

World-class scientific expertise in disease progression, epidemiology, and laboratory methods ensures CDC is 

ready and able to detect and develop a response to a broad range of threats, including highly hazardous and 

infectious diseases like Ebola, smallpox, Zika, anthrax, and H7N9 influenza. 
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CDC uses advanced molecular detection techniques that combine next-generation genomic sequencing, highperformance computing, and epidemiology to identify pathogens faster and more accurately. Laboratories from 

all over the world send specimens to CDC because they know CDC will be able to identify pathogens that other 

laboratories cannot. 

Through Advanced Molecular Detection investments, CDC is able to detect outbreaks faster, before they have 

become widespread. These advances are applied in dozens of areas such as food borne disease, influenza, 

antimicrobial resistance, hepatitis, pneumonia, and meningitis. Moreover, CDC shares genetic sequencing 

capabilities with state and local health departments, and funds them to acquire these tools that help them 

respond more quickly and effectively at the local level, lessening the chances that disease outbreaks will spread. 

CDC also maintains unique laboratory capability to rapidly detect exposure to radionuclides and more than 150 

chemical threat agents. This information about human exposure helps public health officials rapidly assess 

health risk, determine the most effective treatment, and reduce additional exposures. 

A Strong Laboratory Response Network 

Rapid identification of disease is critical to addressing public health threats before they become a crisis. This 

requires that high quality specialized laboratory testing be available around the country. CDC's Laboratory 

Response Network is an integrated system of federal, state, and local laboratories that provides early detection 

and characterization of biological, chemical and other public health threats. The linking of laboratories and close 

partnership between laboratorians, epidemiologists and clinicians at CDC, state and local health departments, 

and healthcare facilities ensures the most rapid detection and mitigation of health threats. 

For example, in response to the MERS (Middle East Respiratory Syndrome), Ebola and Zika virus outbreaks, CDC 

provided Laboratory Response Network laboratories across the United States with assays authorized for 

Emergency Use to quickly identify cases of infection during these outbreaks. 

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Another important laboratory network, begun in 2016, is CDC's Antibiotic Resistance Laboratory Network, which 

supports nationwide laboratory capacity to rapidly detect antibiotic resistance in healthcare, food, and 

community settings, and inform local responses to prevent the spread of antibiotic resistant bacteria, and 

protect people. The Antibiotic Resistance Laboratory Network includes seven regional laboratories, the National 

Tuberculosis Molecular Surveillance Center, and laboratories in SO states, five cities, and Puerto Rico. 

Public Health Surveillance 

Public health surveillance-the collection, analysis, and use of data to target public health prevention and 

intervention activities-is the foundation of public health practice at CDC, and continues to represent CDC's core 

work, whether as detective work in the field, or advanced analysis to understand disease transmission. CDC 

uses electronic data systems to monitor population health information around the clock to detect and track 

diseases. For example, following 9/11, CDC invested in using health-related data based on syndromic 

surveillance in Emergency Departments as an early warning system for a bioterrorist attack. Those investments 

are paying dividends, as this information technology system now allows officials to detect a wide range of health 

threats beyond biological attacks, from opioid overdoses to chemical exposures to disease outbreaks. 

To ensure a nationwide surveillance capability, CDC supports surveillance infrastructure, including information 

technology systems, and practice at the state and local levels through the National Notifiable Disease 

Surveillance System, the National Syndromic Surveillance Program, the National Healthcare Safety Network, the 

Emerging Infections Program Active Bacterial Core Surveillance, and components of national influenza 

surveillance. 

Beginning in fiscal year 2016, Congress recognized the large and growing threat of antibiotic resistance and 

appropriated funding for CDC to detect and respond to resistant pathogens, prevent the spread of resistant 

infections, and collaborate with partners to encourage innovation with respect to new prevention strategies. 

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CDC has multiple surveillance systems that can detect and track resistant threats across healthcare, food, and 

community settings. 

CDC's Global Disease Detection Operations Center monitors outbreaks 24/7, assesses their potential risk to the 

United States and communities around the world, and improves global public health surveillance. Since 2017, 

CDC has tracked more than 170 unique diseases globally and identified outbreaks in more than 190 countries. 

CDC works with the 17 Phase 1 and the 14 Phase 2 Global Health Security Agenda partner countries to help 

them build the core public health capacities necessary for identifying and containing outbreaks before they 

become epidemics that could affect us all. The 17 Phase 1 countries receive direct financial support and 

technical assistance from CDC; the 14 additional countries receive only technical assistance from CDC. Our work 

through the Global Health Security Agenda emphasizes four critical areas: surveillance, laboratory, workforce 

development, and rapid response capability. In addition, CDC medical and public health officers staff United 

States Quarantine Stations that are located at 20 United States ports of entry and land-border crossings where 

the majority of international travelers arrive. These health officers are an important defense to prevent the 

introduction into, and spread of infectious diseases in, the United States. 

Respond 

CDC's number one priority during any public health emergency is to protect the health of the public. CDC 

subject matter experts respond regularly to events such as food borne outbreaks, natural occurring anthrax and 

botulism cases, smallpox vaccine adverse event cases, and seasonal influenza. CDC's readiness activities, 

expertise, and infrastructure provides the foundation for all types of public health emergency responses and is 

scalable and can surge to respond to events such as the 2013 meningitis outbreaks. The expertise and systems 

used in such responses can be augmented further for larger public health emergency responses such as the 

2009 H1N1 response, 2014 Ebola response, and the Zika response. 

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State and local public health agencies are the front lines of public health preparedness and response. CDC 

provides ongoing technical assistance and, where requested, on-the-ground personnel and materials to assist 

with response efforts. CDC's established relationships with state and local health departments ensure that dayto-day public health systems function effectively and efficiently, and that emergency response actions are 

appropriate to the threat. These continuous relationships, between and during emergency responses, ensure a 

level of trust and collaboration that cannot be overemphasized. During the stress of an emergency response, 

having a trusted partner you can turn to immediately can mean the difference between life and death for 

patients, and ensures the rapid delivery of public health services, such as vaccinations and clean water, for 

communities. 

CDC experts lead and staff every activation of the agency's Emergency Operations Center (EOC), ensuring 

response activities are effective and efficient. CDC has activated its incident management system for 67 

responses over the last 16 years. During a response, in coordination with and, sometimes at the 

direction/request of the Office of the HHS Assistant Secretary for Preparedness and Response, CDC's EOC rapidly 

deploys scientific experts, coordinates the delivery of supplies and equipment to the incident site, monitors 

response activities, provides resources to state and local public health departments, and disseminates timely 

and accurate information within government, to health care providers and to the public. During the agency's 

Ebola and Zika responses, 3,700 and 1,700 CDC staff participated in the response, respectively. During the Ebata 

response, CDC staff completed over 2,000 field deployments to West Africa. CDC also responds to public health 

events that do not require EOC support. In fiscal year 2017, CDC assisted state, local, and overseas public health 

authorities in 38 epidemiologic investigations of emerging infectious disease outbreaks. In addition, the Global 

Rapid Response Team, stood up following the 2014 Ebola outbreaks, has over 400 ready and rostered experts. 

Since its inception, that team has provided nearly 9,000 person-days of support for response activities. 

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We are committed to continuously improving our response capability. After each activation, whether for a real 

event or exercise, we conduct a thorough after-action review to identify strengths to sustain and areas for 

improvement. Use of this information is key to improving performance for the next incident or event 

Conclusion 

I want to leave the Committee with three primary points about CDC's role in biopreparedness. 

1. Our responses are built on our longstanding partnerships with state, local, and international public 

health authorities; 

2. Our detection capabilities and surveillance programs are based on our broad and deep scientific, 

medical, and programmatic expertise; and 

3. Our response capacity ensures timely aid to state and local public health systems in times of crisis. 

CDC has 72 years of experience in bringing top scientific expertise to health emergencies and remains a trusted 

partner in the United States and around the world. CDC stands ready to do its part to protect the health and 

well-being of the American public and save lives. We cannot necessarily predict the next disaster, but we know 

that being prepared protects health, saves lives, and prevents economic losses. 

Thank you for the opportunity to testify. 

10 
36 

Mr. HARPER. Thank you, Dr. Schuchat. 

The chair will now recognize Dr. Fauci for 5 minutes for your 

opening statement. 

TESTIMONY OF ANTHONY FAUCI, M.D. 

Dr. FAUCI. Thank you very much, Mr. Chairman. 

Chairman Harper, Ranking Minority DeGette, members of the 

committee, thank you very much for giving me the opportunity 

today to present to you the role of the National Institute of Allergy 

and Infectious Diseases in addressing biodefense and emerging infectious diseases. 

Our role in this really dates back many years, but was really solidified following the attacks of 9/11 with the anthrax attacks, 

which prompted us, together with our colleagues at HHS, to develop a strategic plan and a research agenda. For our role in that, 

as you know, the NIH for years, with regard to any emerging infectious disease, is involved in having a number of approaches, stemming from basic and clinical research, research resources for both 

industry and academic communities, with the ultimate goal of developing vaccines, therapeutics, and diagnostics. 

We have been in a very strong partnership with BARDA in developing the concepts for interventions, which were then handed 

over to them for advanced development. 

This slide just shows a representative example of some key 

achievements directed specifically at the category A agents that 

were in our strategic plan. Very briefly, for example, a better 

smallpox vaccine, next-generation vaccines for anthrax, antitoxins 

for botulism, antibiotics for plague, and, interestingly, the development of an Ebola vaccine, which long antedated the outbreak that 

we experienced in West Africa in 2014. 

Having said that, it is important to point out, as we have in the 

past and as shown in this interesting article from Newsday of 2001, 

the worst bioterrorist may actually be nature itself. 

It is interesting to point out, Mr. Chairman, that I have been testifying before this committee for the last 33 years. The first time 

I did, I drew a map, and it’s shown here. And the reason I drew 

the map is I wanted to point out that there would be emerging and 

reemerging infectious diseases. And the first time I testified before 

this committee, I put HIV on the map as shown there. 

Today, the map is the same structurally, but this is what it looks 

like. And these are the emerging and reemerging infectious diseases. Many of them, many of them are curiosities and are not 

really of great public health impact, but others are really important 

and we’ve experienced them recently, such as Ebola, Zika, and the 

threat of a pandemic influenza. 

Now, let’s take one of these, Ebola. You mentioned in your opening statement, as others have, about the West Africa outbreak and 

the recent outbreak in the Democratic Republic of the Congo. It’s 

important that the CDC, the NIH, and other agencies of the Public 

Health Service responded very rapidly there. 

One thing that was proven that’s important is that you can do 

good research in the context of an outbreak. And we developed, 

with others, a vaccine, which is called the VSV vaccine, which was 

first tried in a Phase I trial right in Bethesda at the NIH Clinical 

37 

Center, and then went over to Africa in a Phase II trial. This is 

the vaccine that was used in the ring vaccination program that was 

actually involved in the West Africa outbreak. 

If you then fast forward a couple of years to where we are today, 

with the outbreak in the Democratic Republic of the Congo, we 

have actually learned a lot and are applying what we learned to 

that. Let me give you an example. The experimental vaccine that 

was used in the ring vaccination program has now been deployed 

to the Democratic Republic of Congo, and even as we speak today, 

it is being used in a ring vaccination with 50 rings and 150 vaccinations per ring. 

Interestingly, and as I mentioned before we came, that in 1995, 

there was an outbreak in Kikwit in the Democratic Republic of the 

Congo. To just show you the connection between clinical care and 

research, we brought one of the survivors of Kikwit to Bethesda, 

took their B cells, cloned it, made a monoclonal antibody. And now 

the Democratic Republic of the Congo has asked us to ship that to 

them for their discretion use as a countermeasure in the epidemic. 

So it came full circle that our collaboration with them came back 

with something that perhaps could help them. 

I want to close in the last couple of seconds with influenza. I 

wrote this article just a few months ago, talking about the need for 

a universal flu vaccine. And, in fact, we have developed a strategic 

plan and a research agenda because of the threat, not only of getting a better seasonal flu vaccine, but also a threat of a pandemic. 

And we could only do that with a vaccine that essentially is able 

to protect us against all subtypes of influenza. 

And I’ll close on this last slide—this is not working very well, 

sorry—which is an article that I actually wrote 17 years ago, but 

it’s very relevant today. And what it says is that emerging infections are a perpetual challenge. We’ve always had them, we have 

them now, and we always will have them. So if they are a perpetual challenge and a perpetual risk, we must meet them with 

perpetual readiness and, hopefully, we’ll be able to do that. 

Thank you. 

[The prepared statement of Dr. Fauci follows:] 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES 

NATIONAL INSTITUTES OF HEALTH 

National Institute of Allergy and Infectious Diseases Research Addressing 

Biodefense and Emerging and Re-emerging Infectious Diseases 

Testimony before the 

House Committee on Energy and Commerce 

Subcommittee on Oversight and Investigations 

Anthony S. Fauci, M.D. 

Director of the National Institute of Allergy and Infectious Diseases 

June 15,2018 
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Mr. Chairman, Ranking Member DeGette, and members of the Subcommittee, thank you 

for the opportunity to discuss the research response of the National Institutes of Health (NIH) to 

potential attacks with chemical and radiological/nuclear agents as well as biological threats, 

including emerging and re-emerging infectious diseases. I direct the National Institute of 

Allergy and Infectious Diseases (NIAID), the lead NIH institute for biodefense research. 

The NIH conducts and supports basic and clinical research to better understand the 

biological effects of, and to develop medical countermeasures (MCMs) for, chemical, biological, 

and radiological/nuclear threats. Most of this work is conducted by the NIAID at the NIH. 

NIAID supports basic research on microbiology and immunology as well as applied and clinical 

research to evaluate candidate MCMs including diagnostics, therapeutics, and vaccines. This 

strategic effort includes the pursuit of foundational platform approaches that could be used to 

develop MCMs against multiple threats or pathogens. These platforms include molecular 

biological technologies for vaccines, targeted antibody therapeutics, and broad-spectrum 

antibiotics and antivirals. 

NIH coordinates its biodcfense research with partners in industry, academia, and the 

Federal Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to ensure 

that promising countermeasures for biological, chemical, and radiological public health threats 

can proceed to advanced development. Since fiscal year 2012, NIH has supported the early 

development of more than 20 candidate MCMs for high-priority threats, and ultimately 

transitioned support for those candidate MCMs to the Biomedical Advanced Research and 

Development Authority (BARDA) for advanced development, with the goal of Food and Drug 

Administration (FDA) approval, licensure, clearance, or authorization, and for potential inclusion 

in the Strategic National Stockpile. NIH funding for emerging infectious disease, including 

biodefense, research was approximately $2.6 billion in FY 2017. 

NIH MEDICAL COUNTERMEASURE DEVELOPMENT 

Innovative technologies and approaches supported by NIH are enabling the development 

of new medical countermeasures (MCMs) at an unprecedented pace. High-throughput 

sequencing and platform-based technologies are facilitating the development and manufacture of 

MCM candidates to expedite their clinical evaluation. For example, during the Zika virus 

outbreak in the Americas, NIAID scientists used Zika virus genetic sequence information to 

develop a vaccine candidate that moved from concept to first-in-human trial in less than four 

months likely the shortest development period ever for such a vaccine. The vaccine was 

developed with a readily deployable DNA vaccine platform that is a form of gene-based 

immunization previously employed by NIAID to develop a candidate vaccine for West Nile 

virus. These types of genetic platforms could be used to respond similarly to multiple emerging 

and re-emerging infectious disease threats. 

Other broad-spectrum approaches are being used to advance the development of 

therapeutics that could be used against multiple pathogens. For example, NIAID has supported 

development of broad-spectrum antiviral agents such as BCX4430 (galidesivir), which has 

demonstrated activity against Ebola and other RNA viruses, and broad-spectrum antibacterial 

products, including a compound with activity against the two difrerent bacteria that cause 

tularemia and plague. 
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NIAID continues to explore other inventive approaches to treat or prevent bioterrorism 

threats. Monoclonal antibodies, which precisely bind to a single target, have been used to treat 

certain cancers, infectious diseases, and autoimmune diseases. Monoclonal antibodies also have 

the potential to treat emerging and re-emerging infectious diseases, and as a first line 

intervention to prevent or slow the progress of infectious disease outbreaks as vaccines are being 

developed. A notable example is ZMappTM, a cocktail of three monoclonal antibodies targeting 

Ebola virus. ZMappTM showed promise as a treatment for Ebola virus disease in an NIAIDsupported clinical trial during the 2014-2016 outbreak in West Africa. Another innovative 

approach specific to vaccine development is the use of adjuvants. Adjuvants are valuable tools 

that can boost immune responses to otherwise modestly effective vaccines, and potentially can 

expedite development of vaccines for emerging pandemic threats. NIAID supports programs for 

discovery and development of adjuvants that have led to 50 novel adjuvants and 18 vaccine 

clinical trials. 

NIAID also has invested in critical infrastructure and research resources to encourage the 

development and testing ofbiodefense MCMs. NIAID supports research capacity at highcontainment laboratories where dangerous pathogens can be studied safely. In addition, NIAID 

provides qualified scientists with research resources, including microorganisms, research 

reagents, and preclinical development services that can fill knowledge gaps. These programs 

lower the financial risk for potential commercial partners and expedite the development of 

MCMs. 

These NIH-supported activities are advancing a robust pipeline of candidate MCMs 

needed to ensure the development of safe and effective products to protect the public health. 

Notable successes are outlined below. 

Ebola. NIAID partnered with the government of Liberia to establish the Partnership for 

Research on Ebola Virus in Liberia (PREVAIL). This clinical research partnership enabled a 

series of clinical trials, including studies testing several Ebola virus therapeutic and vaccine 

candidates, among them ZMappTM and the cAd3-EBOZ vaccine developed by the NIAID 

Vaccine Research Center (VRC) in partnership with industry. Several Ebola countermeasure 

candidates developed by NIAID have transitioned to BARD A for advanced development, 

including a novel vaccine approach using two candidate vaccines in a prime-boost regimen. 

NIAID currently is utilizing its expertise in Ebola research to respond to the ongoing Ebola 

outbreak in the Democratic Republic of the Congo (DRC). NIAID is providing technical 

assistance to the DRC-World. Health Organization (WHO) effort to plan and implement a 

research response to the outbreak, including vaccine, therapeutics, and diagnostic research. 

NIAID also has developed as a therapeutic candidate mAb 114, a monoclonal antibody active 

against Ebola. The antibody, which has shown promise in animal testing, was originally isolated 

from a survivor of the 1995 Ebola outbreak in Kikwit, DRC, through a research partnership 

between the NIAID VRC and the DRC's Institut National de Recherche Biomedical e. At the 

request of the Minister of Health of the DRC, NIAID is providing courses ofmAb114 for 

treatment of Ebola Virus Disease, with specific research protocol design to be detennined. 

NIAID also has deployed a team to the National Public Health Laboratory in nearby Brazzaville, 

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Republic of the Congo, to establish additional Ebola diagnostic and sequencing capacity in case 

the epidemic spreads to that country. 

Nipah. NIAID conducts and supports research on countermeasures for Nipah, a deadly 

virus with case fatality rates of 40 to 75 percent. NIAID researchers have developed a candidate 

Nipah vaccine that was shown to protect against infection in a monkey model. NIAID-funded 

researchers, in collaboration with Nil! scientists, discovered a potential monoclonal antibody 

treatment for Nipah virus. This treatment candidate, m I 02.4, effectively protected ferrets and 

non-human primates after exposure to Nipah virus. Based on this research, NIAID is assisting 

with the research response to the ongoing Nipah virus outbreak in India. At the request of the 

WIIO, NIAID researchers have been working with scientists and clinicians from India to develop 

a clinical trial protocol to test the experimental monoclonal antibody m I 02.4 against Nipah virus. 

NIAID researchers also have evaluated an antiviral treatment for Nipah virus in collaboration 

with CDC and industry. This candidate, GS-5734, has been shown to protect against Nipah virus 

disease in monkeys. 

Smallpox. NIA!D supported the early-stage development of a novel smallpox vaccine, 

IMV AMUNE ".and a therapeutic. TPOXX' (tecovirimat), prior to their transition to BARD A 

for advanced development. IMVAMUNE" was shown to produce a superior immune response 

compared to the currently licensed smallpox vaccine. TPOXX" currently is under consideration 

for FDA approval pursuant to the Animal Rule. using pivotal animal model data supported by 

N!A!D. 

Anthrax. NIAID supported the preclinical and clinical development of the anthrax 

countermeasure ANTI liM" (obiltoxaximab). prior to its transition to BARDA for advanced 

development. ANTIIIM" was approved by the FDA in 2016 for the treatment and prevention of 

inhalational anthrax, the deadliest form of the disease. NIAID also has supported the 

development of A V7909, a third-generation anthrax vaccine with a dry formulation that is easy 

to store and has increased shelf life. AV7909 has been transitioned to BARD A for further 

development. 

Pneumonic Plague. NIAID supported critical animal model studies of ciprolloxacin and 

levolloxacin for FDA approval, pursuant to the Animal Rule. as treatments for pneumonic 

plague. In addition, NIA!D scientists conduct foundational research on the bacteria that cause 

plague, and the fleas that transmit them, to understand plague biology and to aid in the design of 

new MCMs. 

Pandemic /nfluen::a. NIAID is partnering with BARDA to support the development of 

vaccine candidates for inl1uenza strains with the potential to cause a pandemic, including H7N9 

avian influenza. NIAID also is working to develop broadly protective, or "universal," inl1uenza 

vaccines that could protect against multiple strains of seasonal and pandemic influenza. NIAID 

recently developed a Strategic Plan to guide research eftorts focused on the design and 

development of universal influenza vaccines. 

Radiological/Nuclear Threats. Nlll investment in radiation/nuclear research revitalized 

physician training and infrastructure for studying radiation injury and developing effective 

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medical countermeasures. Since 2005, NIAID has transitioned 29 radiation/nuclear 

countermeasure candidates to BARD A for advanced development. Recent successes include 

FDA approval ofNEUPOGEN® (filgrastim) and Neulasta® (pegfilgrastim) to treat radiological 

or nuclear injuries. In addition, NIAID is funding animal studies ofNplate® (romiplostim) for 

acute radiation syndrome for consideration for FDA approval under the Animal Rule. 

Chemical Threats. NIAID administers a trans-NIH chemical countermeasures program 

that supports research and development of therapeutics for people exposed to dangerous 

chemicals, including nerve agents such as Sarin and VX; metabolic poisons such as cyanide; 

chemicals affecting the skin, eyes, and mucous membranes such as sulfur mustard; chemicals 

affecting the respiratory tract such as chlorine; and toxic industrial chemicals. NIH recently 

transitioned several candidate therapeutics to BARD A for advanced development, including 

those for nerve agent poisoning (midazolam and galantamine), sulfur mustard exposure (tissue 

plasminogen activator), and inhalation chlorine exposure (R-107 and GSK2798745). 

CONCLUSION 

NIAID has moved strategically toward a MCM research paradigm that features broader, more 

flexible platform technologies. This effort is yielding significant scientific advances that help 

protect against multiple emerging public health threats, whether man-made or naturally 

occurring. Together with academia, industry, and PHEMCE partners, NIAID remains 

committed to meeting public health emergency needs by advancing high-priority research toward 

development ofMCMs for radiological/nuclear, chemical, and biological threats, including 

emerging and re-emerging infectious diseases. 

4 
43 

Mr. HARPER. Thank you very much. 

We now have the privilege of hearing from Rear Admiral Denise 

Hinton. 

Admiral Hinton, you are recognized for 5 minutes. 

TESTIMONY OF REAR ADMIRAL DENISE HINTON 

Admiral HINTON. Thank you. 

Chairman Harper, Ranking Member DeGette, and members of 

the committee, thank you for the opportunity to appear today to 

discuss the state of biopreparedness. 

Medical and public health preparedness and response is critically 

important to the health and security of our nation. And I am 

pleased to be here today to discuss how FDA is working towards 

the shared goal of making sure that we have the medical products 

necessary to protect our nation from a range of public health 

threats, whether naturally occurring, accidental, or deliberate. 

The outbreak of Ebola virus disease in the Democratic Republic 

of the Congo serves as a reminder that biological threats can and 

often do emerge with little to no warning and can rapidly become 

global challenges. I can assure you that FDA is dedicated to helping end this outbreak as quickly as possible, as we are actively engaged in supporting international response efforts. 

FDA plays a critical role in facilitating preparedness for and response to biological threats. Our role focuses largely on facilitating 

the development and availability of medical countermeasures, or 

MCMs, such as vaccines, therapeutics, and diagnostic tests to protect against and respond to these threats. 

Toward that end, we work closely with our HHS partners testifying here with me today as well as other U.S. Government partners, product developers, and nongovernmental organizations to facilitate the development and availability of MCMs. FDA also works 

closely with the Department of Defense to facilitate the development and availability of MCMs to support the needs of our nation’s 

military personnel. 

Prior to joining FDA and the U.S. Public Health Service Commissioned Corps, I proudly served as an officer in the United States 

Air Force. So these efforts are near and dear to me, and we are 

fully committed to closely working with our colleagues at the DOD 

to support the unique needs of the U.S. military personnel. 

At FDA, we have made it a priority to utilize our authorities to 

proactively work with our private sector and government partners 

to help facilitate the translation of discoveries in science and technology into safe and effective MCMs as part of advancing public 

health and strengthening our national security. 

We share Congress’ goal of having safe and effective MCMs 

available in the event that they are needed, and we have made significant progress toward this important goal. For example, since 

2012, FDA has approved, licensed, or cleared more than 120 

MCMs, including supplemental changes to already approved products and modifications to diagnostic devices for a diverse array of 

threats, including anthrax, botulinum toxin, plague, smallpox, and 

pandemic influenza. 

We have also issued more than 60 emergency use authorizations 

since 2005 to enable access to products to respond to threats, inVerDate Nov 24 2008 13:47 Feb 28, 2019 Jkt 037690 PO 00000 Frm 00047 Fmt 6633 Sfmt 6633 U:\MY DOCS\HEARINGS 115\HEARINGS\115-140 CHRIS
44 

cluding for Zika virus, Ebola virus, H7N9 influenza virus, and the 

Middle East Respiratory Syndrome Coronavirus. 

While the close collaboration and coordination among the agencies represented here today has achieved many successes in the development of MCMs, I would emphasize that developing MCMs is 

highly complex and there remain regulatory science gaps that can 

challenge development programs, such as a lack of models and biomarkers to enable the extrapolation of data generated in animal 

models to humans. Without such tools, it is difficult to generate the 

data necessary to support regulatory decisionmaking. 

Addressing these regulatory science gaps remains a high priority 

for the FDA, and we have established a broad and robust portfolio 

of cutting-edge research under our MCMs Initiative regulatory 

science program to develop these tools and to promote innovation 

in the development of MCMs. 

FDA is acutely aware that biothreats can emerge from an accidental release or exposure to threat agents during the course of 

conducting research. As such, we are working to ensure that our 

laboratories and workplaces are operated in a safe and secure manner to protect employees, the surrounding communities, and the 

environment. As the FDA’s chief scientist, I can assure you that 

the laboratory safety is a high priority for me and the agency. 

FDA remains deeply committed to working closely with its partners and fully using the authorities Congress provides to help facilitate and accelerate the development and availability of safe and 

effective medical countermeasures. While we have made significant 

progress, we know that more work remains to be done. We look forward to partnering with Congress and stakeholders as we work together to further enhance biopreparedness. 

Thank you for inviting me to testify today. I look forward to answering any questions you may have. 

[The prepared statement of Admiral Hinton follows:] 

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35127.026

U.S. FOOD & DRUG ADMINISTRATION 

TESTIMONY 

OF 

REAR ADMIRAL DENISE HINTON 

CHIEF SCIENTIST 

FOOD AND DRUG ADMINISTRATION 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

BEFORE THE 

COMMITTEE ON ENERGY AND COMMERCE 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 

UNITED STATES HOUSE OF REPRESENTATIVES 

"THE STATE OF U.S. PUBLIC HEALTH BIOPREPAREDNESS: 

RESPONDING TO BIOLOGICAL ATTACKS, PANDEMICS, AND EMERGING 

INFECTIOUS DISEASE OUTBREAKS" 

.JUNE 15, 2018 

RELEASE ONLY UPON DELIVERY 
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Introduction 

Chairman Harper, Ranking Member DeGette, and members of the committee, thank you for the 

opportunity to appear today to discuss the Food and Drug Administration's (FDA or the Agency) 

efforts to prepare our Nation to respond to biological threats, such as biological weapons and 

naturally-emerging infectious diseases, like pandemic influenza, Zika virus, and Ebola virus. 

Biological threats-whether deliberate, naturally occurring, or accidental--can and often do 

emerge with little to no warning. This was the case with the anthrax attacks of2001, the 2009 

HlNl influenza pandemic, the 2014 Ebola outbreak in West Africa, the emergence of Zika virus 

in 2016, and the recent Ebola outbreak in the Democratic Republic of Congo (DRC), to name 

just a few. 

We are continually reminded that biological threats know no borders, and that biological threats 

can rapidly become global challenges. As such, we must remain vigilant and continue to work to 

optimize our preparedness and response capabilities. 

FDA's Public Health Preparedness and Response Mission 

FDA plays a critical role in facilitating preparedness for, and response to, biological threats (as 

well as chemical, radiological, and nuclear (CBRN) threats). FDA's role focuses largely on 

facilitating the development and availability of medical countermeasures-such as vaccines, 

therapeutics, and diagnostic tests-to protect against, and respond to, these threats. 

FDA works closely with its HHS and other U.S. government partners through the Public Health 

Emergency Medical Countermeasures Enterprise (PHEMCE), as well as with regulated industry 

and non-governmental organizations (NGOs), to sustain and optimize the medical 

countermeasure framework necessary to effectively respond to public health emergencies. FDA 

also works closely with the Department of Defense (DoD) to facilitate the development and 

availability of medical countermeasures to support the unique needs of our nation's military 

personnel. 
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FDA's operations within its medical countermeasures mission cover a broad range of activities 

vital to facilitating the development of, and access to, safe and etiective medical 

countermeasures, including: 

• Reviewing marketing applications for medical countermeasures and approving those that meet 

standards for safety and efficacy; 

• Providing regulatory advice, guidance and technical assistance to sponsors developing medical 

countermeasures, as well as to U.S. government partners, international regulators, and 

international organizations such as the World Health Organization; 

• Supporting efforts to establish and sustain an adequate supply of medical countermeasures, 

including averting supply disruptions when feasible and, in certain situations, allowing products 

to be used beyond their labeled expiration dates when supported by appropriate scientific 

evaluation; 

• Enabling access to medical countermeasures that are not yet approved-when necessarythrough an appropriate mechanism, including through FDA's Emergency Use Authorization 

(EUA) authority; 

• Proactively identifying and resolving regulatory challenges associated with medical 

countermeasure development and ensuring that FDA regulations and policies adequately support 

timely medical countermeasure development and enable preparedness and response activities and 

capabilities; 

• Fostering the professional development of FDA scientists to ensure that FDA personnel maintain 

the skills and abilities to support the medical countermeasure mission; and 

• Supporting regulatory science to create the tools, standards, and approaches necessary to develop 

and assess the safety, efficacy, quality, and performance of medical countermeasures. 

Fostering Medical Countermeasure Development and Availability 

FDA's Medical Countermeasures Initiative (MCMi)-cstablished in 2010--brought enhanced 

resources to FDA that enabled FDA to hire additional expert staff, and to become more deeply 

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and thoroughly engaged in medical countermeasure activities. This program continues to be key 

to providing certainty regarding regulatory pathways for medical countermeasures, advancing 

medical countermeasure regulatory science to support regulatory decision-making, and 

advancing important policies and mechanisms to facilitate the timely development and 

availability of medical countermeasures. 

At FDA, we fully appreciate that the development of medical countermeasures can present 

complex and unique challenges. FDA's increased engagement in medical countermeasure 

activities has helped to resolve many challenges associated with medical countermeasures 

development so that programs continue to move forward. For example, since 2012, FDA has 

approved, licensed, or cleared more than 120 medical countermeasures (including supplemental 

changes to already approved applications and modifications to diagnostic devices) for a diverse 

array of threats including anthrax, botulinum toxin, plague, smallpox and pandemic influenza. 

Thirteen of these medical countermeasures have been approved under the Animal Rule, which 

enables animal efficacy studies to substitute for efficacy trials in humans if the results can 

reasonably be extrapolated to the expected human use. 1 These approvals underscore the critical 

role the Animal Rule and animal studies can play in advancing medical countermeasures for 

some of the most challenging threats. And of note, through the use of regulatory science, FDA 

was able to approve inhalational anthrax therapeutics and a botulism antitoxin for use in children 

as well as adults, despite the fact that ethical concerns precluded studying pediatric patients in 

clinical trials. 

1 To date, a total of 13 medical countermeasures have been approved under the Animal Rule, including inhalational 

anthrax therapeutics, a botulism antitoxin, antibiotics for the treatment and prophylaxis of plague, and treatments for 

acute radiation syndrome, prophylaxis against the lethal effects of soman nerve agent poisoning, and treatment of 

known or suspected cyanide poisoning. 

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In the area of pandemic influenza preparedness, FDA has approved several influenza diagnostic 

tests, which can help facilitate an effective response to an influenza pandemic by rapidly 

identifying infected persons and facilitating appropriate care. In addition, FDA has approved 

several seasonal influenza vaccines, helping increase and sustain pandemic influenza vaccine 

production capacity. These approvals include the first seasonal influenza vaccine produced using 

modern cell culture techniques licensed in the United States, and the first seasonal influenza 

vaccine made through recombinant deoxyribonucleic acid (DNA) technology. Both of these 

vaccines offer an alternative to the egg-based process and a potential for a faster manufacturing 

startup in the event of a pandemic. FDA also approved the first adjuvanted influenza vaccine for 

use in people 18 years of age and older who are at increased risk of exposure to the avian 

influenza HSNI virus subtype contained in the vaccine. This vaccine is not for commercial 

distribution but will be part of the national stockpile in the event it is needed. Furtherniore, FDA 

has continued to collaborate closely with the Biomedical Advanced Research and Development 

Authority (BARD A), the National Institute of Allergy and Infectious Diseases (NIAID), and the 

Centers for Disease Control and Prevention (CDC) on developing avian influenza H7N9 virus 

vaccine candidates. 

Additionally, FDA approved the first intravenous antiviral drug to treat acute, uncomplicated 

influenza infection in adults and expanded its indication to include treatment of children ages 

two years and older. FDA also expanded the indications for use of the influenza antiviral, 

oseltamivir, to treat children as young as two weeks of age. 

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FDA also continues to facilitate the development of products to address antimicrobial resistance, 

including antibacterial drugs to treat patients with antimicrobial resistant infections, vaccines that 

can help prevent the emergence and spread of antimicrobial resistance, and diagnostic tests that 

can help rapidly identify the appropriate treatment for infected individuals. For example, FDA 

has been implementing Title VIII (Generating Antibiotic Incentives Now (GAIN)) of the Food 

and Drug Administration Safety and Innovation Act (FDASIA) since it became law in July 2012. 

GAIN created incentives to help develop new antibacterial and antifungal drugs intended to treat 

serious or life-threatening infections. Those meeting requisite criteria are determined to be 

qualified infectious disease products (QIDPs). 2 FDA has granted 147 QIDP designations 

through the end ofFY 2017-approximately 74 of which were for novel drugs. Since the 

enactment of GAIN, 12 QIDPs have been approved. 

With respect to supporting the development of diagnostic tests for antimicrobial resistant threats, 

FDA and CDC have collaborated to develop the AR Isolate Bank, a centralized repository of 

microbial pathogens with well-characterized resistance profiles. The AR Isolate Bank, which 

currently contains three bacterial isolate panels of pathogens of national medical concern 

(representing more than 160 total pathogens), provides a valuable resource to biotech and 

diagnostic groups in researching, designing, validating and evaluating next generation clinical 

tests. These tests in turn may support earlier diagnosis and development of more effective 

treatment options that can slow antibiotic resistance. As of January 2018, the AR Isolate Bank 

shipped more than 2,000 isolate panels. 

2 A QIDP is defined as an antibacterial or antifungal drug for human use intended to treat serious or life-threatening 

infections, including those caused by an antibacterial or antifungal resistant pathogen, including novel or emerging 

infectious pathogens. 

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There are still regulatory science gaps that can challenge development programs, however, such 

as a lack of animal models to support medical countermeasure development or insufficient 

biomarkers to enable the extrapolation of data generated in animal models to humans. Without 

such tools, it is difficult to generate the data necessary to support regulatory decision making. 

Given the urgency inherent in our medical countermeasure work, addressing these regulatory 

science gaps remains a high priority for the Agency. 

To that end, FDA has established a broad and robust portfolio of cutting-edge research under the 

MCMi Regulatory Science Program to help develop these tools and promote innovation in the 

development of medical countermeasures. A few examples of projects include: supporting the 

development of "organ-on-a chip" models to assess radiation damage in lung, gut, and bone 

marrow, and then using these models to test candidate medical countermeasures; collaborating to 

establish a publicly-available genomic sequence reference database for use by developers 

seeking to validate candidate multiplex in vitro diagnostic tests that could be used to diagnose 

multiple pathogens simultaneously (FDA-ARGOS); developing reference materials for 

developers to use to validate nucleic acid-based and serological diagnostic tests for Zika virus; 

supporting a project to identify and correlate biomarkers of host response to Ebola virus infection 

in animal models and humans to support medical countermeasure development; developing 

methods for obtaining safety and limited efficacy data from patients who receive medical 

countermeasures during public health emergencies; and establishing the Animal Model 

Qualification Program designed to support medical countermeasure development by promoting 

6 
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the development of animal models for use across multiple product applications, thereby 

minimizing duplication of effort and resources. 

FDA is acutely aware that biothreats can also emerge from accidental release or exposure to 

threat agents during the course of conducting research. As such, the Agency works to ensure that 

its laboratories and workplaces are operated in a safe and secure manner to protect employees, 

the surrounding communities, and the envirorunent. This includes ensuring that FDA is in 

compliance with the Select Agent Regulations as well as with Federal, state, and local 

occupational safety and health requirements (as appropriate), and environmental regulations. 

FDA also works to establish and sustain an adequate supply of medical countermeasures. For 

example, FDA supports the Shelf Life Extension Program (SLEP), a Federal fee-for-service 

program, for extending the useful shelf life of military-significant and contingency-use medical 

products, including medical countermeasures that are owned by components of DoD or other 

Federal program participants, such as the Strategic National Stockpile (SNS). 3 FDA laboratory 

personnel test and evaluate drugs submitted for shelf-life extension to ensure stability and quality 

before a shelf-life extension is approved. 

In addition, FDA works to ensure that the U.S. Government is as prepared as possible to rapidly 

deploy medical countermeasures when necessary. For example, FDA has worked with 

government partners to prepare for potential EUA authorization of stockpiled medical 

3 SLEP is designed to defer drug replacement costs fOr date-sensitive stockpiles of drugs by extending their useful shelf life 

beyond the manufacturer's original expiration date. 

7 
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countermeasures against a diverse array of threats including smallpox, anthrax, and pandemic 

influenza. 4 

There are tremendous opportunities to continue to further the development of groundbreaking, 

innovative medical countermeasures, and the Agency intends to fully seize, and build upon, these 

opportunities. 

Responding to Threats 

When threats emerge, FDA works proactively with U.S. government partners, medical product 

developers, and, as necessary, international partners (including the World Health Organization 

(WHO) and international regulatory counterparts) to respond. Key FDA response activities 

include accelerating the development of investigational medical countermeasures, when needed, 

by working with U.S. government agencies that support medical countermeasure development 

and medical product sponsors to clarify regulatory and data requirements. For example, FDA 

continues to work closely with U.S. government agencies, the international community, and 

product developers--providing regulatory advice, guidance, and technical assistance-to 

advance the development and availability of medical products, including vaccines and therapies, 

to address Ebola virus and Zika virus. These activities are essential not only for advancing the 

development of investigational medical countermeasures to respond to ongoing outbreak and 

epidemics, but also to improve response to future outbreaks and epidemics. For example, FDA 

4 To facilitate the issuance of EUAs, FDA has developed a pre-EUA submission process. FDA works with product sponsors or 

government agencies, such as CDC and DoD, to develop prc~EUA packages that will form the basis of an EUA request and 

decision, \\'hen circumstances justify. Prc~EUA packages contain data and information about the safety and efficacy of the 

product, its intended use under an EUA and information about the potential emergency situation that might unfold. 

8 
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worked closely with NIH in response to the 2014 Ebola epidemic in West Africa to design an 

innovative and robust common clinical trial protocol to evaluate the most promising 

investigational products for Ebola. The experience and information gained from those efforts 

have been instrumental in supporting a rapid response to the recent Ebola outbreak in the DRC. 

FDA also works to protect the safety of the nation's blood supply and human cells, tissues, and 

cellular/tissue-based products for transplantation when threats emerge. For example, FDA 

worked closely with developers to make rapidly available two investigational tests for blood 

screening for Zika virus. One of those tests has since been approved. 

Another key FDA response activity to emerging threats is to enable access to investigational 

medical countermeasures, when necessary, through an appropriate mechanism such as under an 

investigational new drug (IND) application, an Emergency Use Authorization (EUA), or under 

expanded access mechanisms when the clinical circumstances warrant. Enabling access to 

available medical countermeasures in response to emerging threats is a high priority for FDA and 

FDA uses its authorities to the fullest to help protect public health. For example, since 2013, 

FDA has issued nearly 40 EUAs to enable the emergency use of in-vitro diagnostic devices for 

H7N9 Influenza virus, Enterovirus D68 (EV-D68), Middle East Respiratory Syndrome 

Coronavirus (MERS-CoV), Ebola virus, and Zika virus. 

FDA also works to protect consumers against fraudulent products claiming to prevent, treat or 

cure conditions associated with emerging threats. 

9 
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Throughout these response activities, FDA works to establish and maintain good lines of 

communication with WHO and regulatory authorities in affected countries, as necessary, to 

enable technical and information exchange, and to make sure that the needs of the affected 

countries are understood and addressed. 

Conclusion 

At FDA, we have made it a priority to proactively work with our private sector and government 

partners to help facilitate the translation of discoveries in science and technology into safe and 

effective medical countermeasures. FDA takes seriously its responsibility to help drive and 

foster innovation as part of advancing public health and strengthening our national security. 

Active FDA involvement is essential to encouraging industry engagement in medical 

countermeasure development. Working closely with its partners and exercising the authorities 

Congress provides to the fullest extent, FDA remains deeply committed to protecting and 

promoting public health, both domestically and abroad, in response to public health threats. 

FDA appreciates Congress's support in continually optimizing its authorities, and providing 

resources, to enable FDA to achieve its public health emergency preparedness and response 

mission. FDA stands ready to work with Congress and stakeholders to enable us to better 

achieve this critical work in our mission to protect the American people. 

Thank you for inviting me to testify today. I look forward to answering any questions you may 

have. 

10 
56 

Mr. HARPER. Thank you very much. 

I ask unanimous consent that the contents of the document binder be introduced into the record and to authorize staff to make any 

appropriate redactions. Without objection, the documents will be 

entered into the record with any redactions that staff determines 

are appropriate. 

It is now time for members to have the opportunity to ask you 

questions, and I will recognize myself for 5 minutes. 

Let me begin by saying that in my 10 years of service in Congress, I don’t know if I’ve ever been at a committee hearing with 

a better lineup of witnesses. And so thank you all for being here. 

We look forward to your responses today. 

And this is a question that will go rather quickly for all of you. 

And for each witness, which biological threat is of greatest concern 

to you and why? Let’s start with Dr. Bright and then go down. 

Mr. BRIGHT. That’s a difficult question. As Dr. Fauci has laid out, 

there are so many threats. They’re constantly emerging. And I wish 

I could take some of them off the table, but they keep coming at 

us. And even more concerning is technology advancing so much 

that they can change the biological threats that we know today into 

something different that we may not be prepared for. 

I think our greatest threat for any of those is our response capabilities and being able to respond to anything that comes our way. 

Mr. HARPER. Dr. Schuchat, is there one biological threat that is 

at the top of your list? I know they’re all important, but is there 

one that gives you the greatest concern? 

Dr. SCHUCHAT. I think influenza needs to be at the top of my list. 

It can affect everyone rapidly and is constantly changing. And with 

pandemics, all of the population of the world can be susceptible. So 

the threat of a pandemic has to be at the top of the list, because 

it can all happen fast. 

Mr. HARPER. Dr. Fauci. 

Dr. FAUCI. My number one and maybe number two and number 

three is influenza also. I agree, for the reasons that Dr. Schuchat 

has mentioned. 

When you have a respiratory virus that can be spread by droplets and aerosol, and then you have the situation if there’s a degree 

of morbidity associated with that, you can have a catastrophe. 

We’ve experienced in real world those types of things. The one that 

we always talk about is the 1918 pandemic which killed between 

50 and 100 million people. 

It is likely that it would be an influenza, but if not influenza, an 

influenza-like respiratory virus. We had a scare with SARS. Fortunately, public health measures were able to contain it, but influenza first or something like influenza is the one that keeps me up 

at night. 

Mr. HARPER. Admiral Hinton. 

Admiral HINTON. Thank you for the question. I would say the 

threat that would keep me up at night would be the unknown. If 

we don’t know what that threat may be, we have to be able to anticipate. So with the emerging spectrum of diseases, it would be the 

unknown that would keep me up at night. 

Mr. HARPER. Thank you. 

57 

For each witness, what area of biopreparedness is of the highest 

priority and why? Dr. Bright. 

Mr. BRIGHT. The area of biopreparedness of the highest priority 

would be the ability to rapidly detect something that has entered 

our community or has been used as a weapon. The sooner we detect something, the sooner we can turn on the machinery and call 

in the capabilities to begin making vaccines and drugs. 

Mr. HARPER. Dr. Schuchat. 

Dr. SCHUCHAT. I would say our global health security would be 

at the top of my list, because, as you know, a threat anywhere is 

a threat everywhere. And I think our greatest vulnerabilities are 

in the weakest countries of the world. 

We saw in Ebola how rapidly West African countries were overwhelmed, and that was an issue for us as well. So I think being 

able to strengthen the ability of every country to be able to prevent, 

detect, and respond to threats is where I’d place my focus. 

Mr. HARPER. Dr. Fauci. 

Dr. FAUCI. I would agree with those two. But let me add an additional one that may not necessarily be my first, is in our ability to 

respond, for example, with a vaccine, the modern day 21st century 

technologies of platform technology, where you don’t have to wait 

6 to 7 months to get a vaccine, where you can really get it out there 

within a period of a couple of months, which is doable if we put 

our mind and our resources to it. 

Mr. HARPER. Thank you. 

Admiral Hinton. 

Admiral HINTON. Our continued efforts in the Ebola, and then 

making sure that we contain it within the specific regions and not 

letting it cross the borders. 

Mr. HARPER. Thank you. 

Dr. Bright, if I could ask you, obviously, the need to rapidly respond to a biological threat is essential. Does the public health system have the capability to deliver and administer medical countermeasures rapidly and effectively in a timely manner as you sit 

there today? 

Mr. BRIGHT. As we sit here today, we are much better and can 

respond much more quickly than we were in the past 10 years. 

We’ve built a national response capability and an international capability incorporating new sciences and technologies. There is a lot 

of room for improvement. It still takes too long to respond to respond adequately to protect everyone in our nation. 

Mr. HARPER. Thank you very much. 

I will now recognize the ranking member, Ms. DeGette, for 5 

minutes for her questions. 

Ms. DEGETTE. Thank you very much. 

Well, building on the question by the chairman just now, Dr. 

Bright, what changes do we need to make to make the system for 

developing countermeasures work more effectively and efficiently? 

ASPR has been a good start, but, you know, where do we need to 

go? 

Mr. BRIGHT. Well, given the 12 years’ experience with ASPR and 

the enterprise, working across government and working with our 

public-private partnerships, we’ve learned a lot in the past 12 

years. Not everything is working as effectively or efficiently—— 

58 

Ms. DEGETTE. So what do we need to do? 

Mr. BRIGHT. We need to improve our communications and our 

transparency and how we bridge our different agencies and bridge 

government with industry. We need to ensure there’s consistency 

in funding and availability so the partners that we work with can 

better align their business models with our government models as 

well. And we need to improve the efficiency at which we communicate and respond to proposals and other contractual mechanisms 

that we use to work with our industry partners. 

Ms. DEGETTE. Are efforts underway being made to do all of those 

things? 

Mr. BRIGHT. Yes, efforts are underway. 

Ms. DEGETTE. And is there something Congress can do to help 

you? 

Mr. BRIGHT. Congress has been very generous with the authorities to date. There are things that we can do to improve our language in our other transactional authorities to be able to work 

more fluidly and flexibly with our industry partners, and we would 

be happy to submit language to assist in that. 

Ms. DEGETTE. We would be delighted to have that language. 

That would really help. 

Dr. Fauci, none of these hearings can go without me asking you 

about what’s going on with pandemic flu. And you had said that 

we are getting closer to being able to develop a universal vaccine. 

And you’ve said that before, because you’ve been trying to do it for 

a long time. 

What does your timeframe look like now and what are the barriers? 

Dr. FAUCI. Congresswoman DeGette, the timeframe really varies 

about the level that you’re talking about. There’s not going to be 

one home run universal flu vaccine. There will be various 

iterations. 

So I would say the timeframe. And I know every time when 

asked about a timeframe, people back off, and I don’t want to get 

in court to be able to say something that’s not going to be able to 

deliver. But since we spoke last, we have put into a Phase 2 trial 

a universal flu vaccine with a company called BiondVax, which is 

a multiple peptide prime followed by a killed vaccine boost. 

Being in a Phase 2 trial means that you’re another step closer 

to getting a product that you’ll be able to use. 

Ms. DEGETTE. Right. 

Dr. FAUCI. So I would think that if you—— 

Ms. DEGETTE. How long is this trial going on for? 

Dr. FAUCI. The trial will probably take—it’s a Phase 2 trial, so 

that probably is going to take at least a year to determine if this 

induces the kind of response that you would predict would have 

some broad protection. 

The first iteration of a universal flu vaccine is not going to be 

against all flu, absolutely. What we’re hoping for is that the first 

iteration will cover, for example, all of a particular type, like all of 

the H3N2s. If we get that successful, then maybe all of the H1N1s. 

There are two major groups of influenzas. The ultimate perfect 

one would be one that covers all of them. I think that’s years and 

59 

years and years away, but the first iteration may be 5 or so years 

away. 

Ms. DEGETTE. And I’ll ask you the same question I asked Dr. 

Bright. What can Congress do to help you? 

Dr. FAUCI. I think Congress has been extraordinary in their positive effect on us in helping us. For example, in the 2018 omnibus, 

we were given an additional $40 million to develop a universal flu 

vaccine, and we’re getting additional money in the proposal of the 

House for our 2019 budget. So you’ve been very supportive and we 

really appreciate it. 

Ms. DEGETTE. We think it’s a high priority. I think I can speak 

for everybody in this room. 

One more question. You’re developing lots of different vaccines: 

smallpox, flu, anthrax, Ebola. How do you prioritize your efforts to 

target the pathogens and toxins that provide the greatest risk? 

Dr. FAUCI. That’s a very good question. We do two things, Congressman. We target specific pathogens based on the threat. If 

you’re talking about a bioterror threat, it’s the intelligence that we 

get. And if you’re talking about the possibility of an emerging infection, it’s very difficult to guess what’s going to come out. 

Ms. DEGETTE. Right. 

Dr. FAUCI. So we know, and it was mentioned in one of the opening statements, that H7N9, for example, if you look at the CDC 

chart, it’s way up there as a threat. So we clearly made an investment of a considerable amount of money to develop a vaccine for 

that. 

But as I mentioned in answer to one of the other questions, it’s 

to develop platform technologies that’s applicable to any disease, as 

opposed to picking out all the diseases and preemptively making a 

vaccine. In other words, making a kind of a vaccine that you could 

easily apply to whatever is the outbreak. 

Ms. DEGETTE. Thank you. Thank you, Mr. Chairman. 

Mr. HARPER. The gentlewoman yields back. 

The chair will now recognize Dr. Burgess for 5 minutes. 

Mr. BURGESS. Thank you, Mr. Chairman, and thanks to our 

panel for being here today. 

Dr. Fauci, I wasn’t going to do it, but you brought it up. And you 

said sometimes you’ll give a timeframe, and then if it doesn’t work 

out, then people will point that out to you. A couple of years ago, 

I think you gave us an 18-month figure on a Zika virus vaccine. 

How close are we today? 

Dr. FAUCI. Thank you for that question. So when you’re proving 

that a vaccine works or not, in the classical way, you have to get 

what’s called an efficacy signal. There has to be infections in the 

community to get an efficacy signal. 

Right now, thankfully for the countries involved, the Zika infections have plummeted almost to very, very few. However, the 

Phase IIb trial that I spoke to you about some months ago is still 

ongoing, and it’s accruing volunteers in the study. So there’s an interesting possibility here. 

Let’s say there are not enough Zika cases to be able to get an 

efficacy signal. We have been in discussions, with a lot of help from 

the FDA, about the possibility that if we get a considerable 

amount, and I say thousands of volunteers with safety data, 

60 

immunogenicity data, namely inducing the kind of response that 

you would predict would be protective, and you bridge it to the animal studies, there’s a possibility that they would at least consider 

that there would be an accelerated approval. You never can guarantee anything, but that’s at least on the table. 

So my short answer to your question, Congressman Burgess, is 

that we are on the road to getting a Zika vaccine, and I feel pretty 

confident about that. 

Mr. BURGESS. And from the FDA’s perspective, that expedited 

approval that was talked about, is that something we can look for? 

Dr. FAUCI. Well, I’ll let the FDA speak for themselves, but you 

never want to anticipate what they’re going to do. You can just give 

them the data and the information that they ask for, but—— 

Mr. BURGESS. I may submit that in writing, because I do want 

to ask you about another—on the golly gee whiz slide that you put 

up with all of the things that can happen to us, enterovirus D68 

was included on that list. 

Dr. FAUCI. Yes. 

Mr. BURGESS. And CDC has put out a paper on acute flaccid myelitis and the incidence of that. And I recognize that it’s low, but 

it does seem to peak every other August. So as we are coming up 

on one of those every other Augusts, do we know any more about 

this illness and why it has had the effect that it has? 

Dr. SCHUCHAT. Yes. The outbreak of severe respiratory disease in 

children from the enterovirus D68 a few years ago was of concern. 

It was contemporary with the outbreak of acute flaccid myelitis. 

Very difficult to confirm that one caused the other, but there’s a 

good probability that they did. 

The family of enteroviruses are known to be able to cause neuropathic problems. And when you have a very common set of infections, it could be that that was a real rare end of the spectrum 

among the common ones. 

So I think we do need to be ready for that. Unfortunately, there 

are so many different enteroviruses that it’s very difficult to pick 

one that you would necessarily focus on for countermeasure development. There’s some work on antivirals that might be promising 

as having a broader protection, but that’s the state of it right now. 

Mr. BURGESS. As you’ll recall, fairly frightening when that did 

occur, the concern we heard from parents. 

Dr. SCHUCHAT. Exactly. It was happening the same time as 

Ebola in Africa. When the President visited CDC, he was briefed 

on Ebola and on enterovirus D68. 

Mr. BURGESS. Admiral Hinton, let me ask you. When Ebola was 

really a much more significant problem, September of 2014, the 

monoclonal antibody ZMapp was in trials, and then FDA put a 

clinical hold on it. My understanding at the time, there was a 

Herxheimer-type reaction that was fairly severe and so we stopped 

looking at it. 

Is there a way—when we’ve got a problem of that order of magnitude going on, I guess I want some reassurance that the regulatory side is not going to interfere with the delivery of what may 

be a very potent tool, because several people have mentioned 

ZMapp. I mean, it’s now a recognized tool in the toolbox. Is that 

correct? 

61 

Admiral HINTON. That’s correct. And Dr. Fauci can please feel 

free to add in, but that is correct. And the FDA is not there to be 

a roadblock; it’s to ensure that the drugs are safe and efficacious. 

So the reasons behind that may not be privy to us, but we do make 

sure that we have safe and effective available drugs on the market 

to treat these and in emergency situations as well. 

Dr. Fauci. 

Dr. FAUCI. So ZMapp was part of a randomized controlled trial 

that was run by the NIH. It was published in The New England 

Journal of Medicine. The results, because of the diminution of cases 

at the time, were very strongly suggestive of efficacy, but not 

enough to be statistically significant. So the trial is technically still 

on. And right now, in DRC, they could use ZMapp either on a trial 

or, if they want, as compassionate use. But it is available. 

Mr. BURGESS. It is available. Thank you all very much. Thanks 

for your testimony this morning. 

Mr. HARPER. The gentleman yields back, who also serves as the 

chair of our Health Subcommittee. 

Mr. BURGESS. Mr. Chairman, I’m also going to ask unanimous 

consent to place into the record the report of the Independent 

Panel of the United States Department of Health and Human Services to the Ebola response from 2015. 

Mr. HARPER. Without objection, so entered. 

[The information has been retained in committee files and can be 

found at https://docs.house.gov/meetings/IF/IF02/20180615/108422/ 

HHRG-115-IF02-20180615-SD003.pdf.] 

Mr. HARPER. The chair now recognizes the gentlewoman from Illinois, Ms. Schakowsky, for 5 minutes. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. I want to agree 

with you, Mr. Chairman, that this is an extraordinary panel. 

Dr. Fauci, 33 years before this committee, that’s a long time, and 

we appreciate you every time we see you. 

I also want Dr.—I looked this up. Dr. Schuchat, it looks like 

you’re about 28 years. Is it more than that? How many? 

Dr. SCHUCHAT. It’s 30 in July. 

Ms. SCHAKOWSKY. OK, 30 in July. And such experience in all of 

you. It’s just really remarkable. I thank all of you for being here 

today. 

I’m particularly concerned about the improper and overuse of 

antibiotics that’s driving the growth of antibiotic resistance around 

the world. I noticed, Dr. Fauci, in your new map with all the lines, 

right at the top was antibiotic resistance on the left there. 

I feel an obligation to raise this issue too for my sister and colleague, the late Louise Slaughter, who was always raising this 

issue. In the United States, somewhere between 20 and 50 percent 

of all antibiotic prescriptions in hospitals are either unnecessary or 

inappropriate. Evidence suggests that antibiotic stewardship programs in hospitals can improve prescribing practices and help reduce the occurrence of antibiotic resistance. 

So I’m interested in hearing more from our witnesses on this program. Whoever wants to go first. Dr. Schuchat. 

Dr. SCHUCHAT. Yes. The problem with antimicrobial resistance is 

a transformational challenge for us because it obviously threatens 

modern medicine. CDC has been investing in efforts to improve 

62 

stewardship of antibiotics, and at this point, by our latest data, two 

out of three hospitals had an antibiotic stewardship program, 

which is a big increase from before. But we think that there’s much 

more to be done. 

In addition, we have 850 hospitals around the country are reporting on their antibiotic use data to the National Healthcare Safety 

Network. So we’re tracking data. 

What we find in the healthcare system is when you track antibiotic use and feed back to clinicians how they’re doing, they can 

improve. A lot of clinicians are test takers, and we like to do really 

well on those tests. And so learning that we’re not doing as well 

as our peers in terms of the appropriateness of our prescribing can 

help improve that. 

We’re also tracking resistance. And we’ve really invested, thanks 

to the congressional support, we’ve been able to invest in much better timely, accurate, quality antimicrobial resistance detection 

around the Nation. It’s where we got those nightmare bacteria reports that we came out with recently. 

So I would say that behavior change in clinicians is difficult, but 

we’re making progress. And a stewardship program in every hospital is a good start, but it takes more than the hospital to make 

that happen. We need the whole plans, the outpatient prescribers 

as well, to be part of the system. 

Ms. SCHAKOWSKY. But you’re saying that we do have a tracking 

system now for clinicians, for hospitals? 

Dr. SCHUCHAT. Right. In our National Healthcare Safety Network, I’m told that 850 hospitals are already reporting to us on 

their antibiotic use. It includes 80 VA hospitals and 30 military 

hospitals. And they’re having that be part of their—it’s voluntary, 

but it’s part of their ability to monitor what’s going on in their own 

institution and then look across institutions. 

Ms. SCHAKOWSKY. What percentage of hospitals does that represent, do you know? 

Dr. SCHUCHAT. I don’t actually have that information, but we 

could get that for you. 

Ms. SCHAKOWSKY. OK. Has the CDC identified any obstacles to 

successfully implementing stewardship programs? If so, how are 

you addressing those? 

Dr. SCHUCHAT. I would say that incorporating the outpatient facilities in the stewardship is important. We also found that rural 

areas, critical areas, we’re challenged in being able to do all the 

things that we recommend in terms of antibiotic stewardship. 

Our program convened a batch of the rural or critical area hospital stewardship leads, who had figured out ways to make a difference, and we’re working with them to share their best practices 

more broadly. So I would say that large hospitals are really on the 

case now, and helping the smaller facilities get up to speed is important. 

Ms. SCHAKOWSKY. Thank you. In the remaining seconds, does 

anybody else—— 

Dr. FAUCI. Yes. How we address antibiotic resistance is really 

governmentwide, and it’s a program called CARB, Combating Antibiotic-Resistant Bacteria, that was established years ago, a few 

years ago, that involves what Dr. Schuchat had mentioned regardVerDate Nov 24 2008 13:47 Feb 28, 2019 Jkt 037690 PO 00000 Frm 00066 Fmt 6633 Sfmt 6633 U:\MY DOCS\HEARINGS 115\HEARINGS\115-140 CHRIS
63 

ing the CDC. It involves the FDA research component from the 

NIH to develop new drugs to understand the mechanisms of resistance to harness the immune system, but also an organization 

called CARB-X, which BARDA has a major role in. 

So maybe, Rick, you want to just mention that briefly. 

Mr. BRIGHT. Very briefly. So since 2010, BARDA has invested 

over a billion dollars in addressing the development of new antibiotics to address antimicrobial resistance. We have, just in the last 

year, had the first antibiotic drug licensed in our program. We have 

several more in Phase 2 and Phase 3. 

We also realized that the early stage pipeline was not sufficient 

to have a stream of new candidates going into advanced stage development. So we did launch a public-private partnership called 

CARB-X, in collaboration with NIAID, also sponsored by Wellcome 

Trust, now Bill and Melinda Gates Foundation in the U.K. Government. So we have now funded 34 different novel technologies to address new mechanisms of action for new antibiotics and vaccines. 

Ms. SCHAKOWSKY. Thank you. My time is up, but I hope that in 

addition to development, that we’re looking at prevention here as 

well. 

Thank you for your courtesy, Mr. Chairman. Thank you. 

Mr. HARPER. Thank you. The gentlewoman yields back. 

The chair will now recognize the chair of the House Ethics Committee and a valuable member of this subcommittee, the gentlewoman from Indiana, Mrs. Brooks, for 5 minutes. 

Mrs. BROOKS. Thank you, Mr. Chairman. 

Dr. Schuchat, and if, Rear Admiral Hinton, if you could pass that 

binder, please, over to Dr. Schuchat. The last page of that binder 

has a chart that I would like to enter into the record and ask unanimous consent to enter into the record. It’s PHEMCE’s budget report for fiscal year 2016–2020. 

Mr. HARPER. Without objection. 

[The information appears at the conclusion of the hearing.] 

Mrs. BROOKS. A large percentage of the CDC’s Strategic National 

Stockpile budget appears to not go to procuring and updating medical countermeasures for the stockpile, but instead, goes to a category entitled nonprocurement costs. And in an effort to inform the 

discussion today, committee staff did ask CDC to provide a breakdown for what is in this nonprocurement, but we never got it. 

Can you please share with us very briefly, and you might need 

to supplement with written response, what makes up the nonprocurement spending for the Strategic National Stockpile? 

Dr. SCHUCHAT. Thanks so much for your question. As you know, 

the Strategic National Stockpile has an inventory of about $7 billion. So the annual appropriation is just a piece of that. Most of the 

dollars that are in the nonprocurement go for sustaining and operating. So that would be the rental space, the security for the warehouses, the staff that work, the salaries for the staff, as well as the 

clinical expertise that’s helping with the guidance on how to use 

the product. 

Mrs. BROOKS. Thank you. Could we get a written breakdown of 

what that is? 

Dr. SCHUCHAT. Absolutely. 

Mrs. BROOKS. Because we could not tell what that was. 

64 

Dr. SCHUCHAT. That should be on its way to you. 

Mrs. BROOKS. Thank you very much. 

Dr. Bright, last year, HHS OIG issued a report after conducting 

five site audits at the various Strategic National Stockpile locations 

over a 2-year period, and they talked about systemic issues, putting 

that $7 billion that was just mentioned into great concern. 

So, Dr. Bright, what actions does ASPR plan to take in the transfer that is anticipated October 1 to ensure the Strategic National 

Stockpile assets will be available in case of public health emergencies? 

Mr. BRIGHT. As you probably know, we have several working 

groups working very closely between CDC and ASPR to evaluate 

various components of the stockpile transfer. So we are still—— 

Mrs. BROOKS. Can I interrupt one second? We just heard, in her 

opening testimony, Dr. Schuchat talk about all the many things 

CDC does relative to public health and these emergencies. And so 

are you going through all of those things to make sure there is coordination? And is that what the working groups are actually 

doing, figuring out what part CDC is going to maintain and what 

part ASPR will have? Is that what the working groups are doing? 

Mr. BRIGHT. Absolutely. There’s five different working groups. 

They’re meeting weekly actually, and some of them have daily communications, to understand the various components, understanding 

how we maintain and sustain the best science and expertise that’s 

currently in the SNS, understanding how we’re building and augmenting the relationship with States and locals to ensure that that 

is also maintained for a robust SNS enterprise. We’re also looking 

at the contracting and the financing. We’re looking at the nonprocurement cost as well. 

We assure you that we are doing everything we can to make sure 

that those nonprocurement costs are supporting the SNS and its 

mission. 

Mrs. BROOKS. I have a question with respect to—I understand 

there have been instances where BARDA—and you mentioned it— 

had to use Project BioShield funds to procure FDA-approved clinical countermeasures or medical countermeasures, because, for 

whatever reason, CDC declined to procure those countermeasures 

for the stockpile. 

How does that uncertainty affect BARDA’s ability to partner 

with industry, and is that being addressed in your working groups? 

Mr. BRIGHT. That uncertainty is critical. As you know, it’s very 

difficult to make these countermeasures. It’s very lengthy, very 

risky, and the companies put aside other very profitable and successful endeavors to work with us in these areas. That marketplace 

assurance is absolutely essential to them working with us. 

So we realize that, as we’ve been more successful with our partners and making additional countermeasures, it has created an additional burden on the SNS. We are working with the SNS at the 

CDC and our internal staff now to make sure that we are able to 

address those lapses or those gaps in communication or transparency to make sure that we have a successful—— 

Mrs. BROOKS. Thank you. I’d also like to enter into the record a 

letter from the Blue Ribbon Study Panel on Biodefense that was 

65 

sent to Dr. Kadlec with a very detailed seven recommendations to 

improve our biodefense posture. 

Mr. HARPER. Without objection. 

[The information appears at the conclusion of the hearing.] 

Mrs. BROOKS. And among those was the need to improve the coordination with State and local partners and to address problems 

that have existed in the past. 

Can you tell us how ASPR plans to engage with State and local 

partners once it assumes control of the stockpile, which is of great 

concern to State and local partners? 

Mr. BRIGHT. I agree that it is an essential part of an effective enterprise, the end-to-end approach, from early detection down to distribution. The State and local and tribal and territorial partners 

are the front line. They are the ones who are distributing and administering the vaccines and treatments. So we are dedicated to 

working with them, making sure they have a voice in the structure, 

in our system, to understand how they need those medical countermeasures and how they need them to be delivered most effectively. 

It doesn’t do us any good to make new drugs and vaccines if 

they’re not suitable for our frontline workers at the State and local 

and tribal and territories to deliver and administer those. 

Mrs. BROOKS. And so they know how to deliver and administer. 

Mr. BRIGHT. Absolutely. 

Mrs. BROOKS. Thank you. With that, I yield back. Thank you for 

your time. 

Mr. HARPER. The gentlewoman yields back. 

The chair will now recognize the gentlewoman from Florida, Ms. 

Castor, for 5 minutes. 

Ms. CASTOR. Thank you, Mr. Chairman. 

Good morning. Last year, Florida recorded 262 known cases of 

Zika. They were overwhelmingly travel-related cases, but of those 

known cases, 136 were pregnant women, and three babies were 

born in Florida with congenital Zika syndrome. Thankfully, those 

statistics are down substantially from 2015 and 2016, but the 

threat to young women of childbearing years and families remains 

very serious. 

A study was just published where researchers from the CDC and 

the Annenberg Public Policy Center determined that most people 

have let their guard down now, that they’re not taking the precautions that they should when it comes to Zika. 

So, Dr. Schuchat, now that you have the results of that study 

and the threat of congenital Zika syndrome remains very serious, 

what do you plan to do to help keep families informed and make 

sure they’re taking all precautions? 

Dr. SCHUCHAT. Thank you. Zika was such a devastating new 

problem to have. For a mosquito bite to be able to cause birth defects, not something that was on any of our radars, really. 

I think you know that, in May, we issued one of our monthly 

high-visibility reports of vital signs on mosquito and tick-borne diseases, which have really been increasing, trying to get that word 

out in advance of the mosquito season so people would take these 

threats seriously. 

We have another report that’s focused on Zika that will be coming out in about 2 months, really highlighting what have we 

66 

learned from the, unfortunately, thousands of pregnancies that 

were complicated by Zika in folks who reside in the 50 States, to 

show what the followups have been and what has happened to the 

babies as they develop. 

We need to make mosquito protection much easier for individuals 

and we need to have better tools for countering mosquitoes, in 

terms of environmentally safe and acceptable tools for them. We 

have been appreciative of the investments in strengthening our 

vector control so that there’s better surveillance for vector-borne 

disease, and also better understanding of resistance patterns so we 

have the right products that can be used. 

Ms. CASTOR. And there must be more we can do to communicate 

to young women and young men, especially now that—I mean, it 

was very strange that Zika became transferable via sex as well. 

So—— 

Dr. SCHUCHAT. Yes. The signs are still up in the airports, but 

people turn them off. So I think continuing to raise concerns is a 

challenge when people become complacent. So it’s sort of our perpetual challenge in prevention. 

Ms. CASTOR. Thank you. 

Responding to public health emergencies requires us to have a 

good understanding of what is happening on the ground in real 

time. And doctors and nurses and others who work directly with 

patients are likely to be the first to interact with individuals affected in a public health emergency. 

How does CDC gather data from these clinicians to detect emerging illnesses and other threats? 

Dr. SCHUCHAT. We have a variety of surveillance systems to try 

to identify both the known threats and then the unknown or the 

new unusual clusters. Most important is for there to be a close connection between the clinical community, the doctors and nurses on 

the front line, and their local and State public health authorities. 

The first cases of West Nile virus disease in New York City were 

detected, there were some animal losses, but it was that link between clinicians and the local health department. So part of our 

day-to-day everyday public health system is vital for the unknown 

emerging—— 

Ms. CASTOR. And CDC has a Laboratory Response Network that 

plays a vital role in biopreparedness by ensuring that we are able 

to quickly diagnose public health threats using rapid testing methods known as assays, but I understand that right now, there are 

no assay kits or rapid tests available for many dangerous pathogens and toxins. 

What is going on here, and what are the barriers to developing 

assays targeting a wide variety of pathogens and toxins? 

Dr. SCHUCHAT. Yes. What I would say is that the Laboratory Response Network, or LRN, is a group of 125 hospitals around the— 

or laboratories around the country that are within a 2-hour drive 

of 85 percent of all of the population. They are equipped to use 

validated, standardized assays to detect a variety of conditions. 

The CDC has the ability to detect and confirm a longer list of the 

select agents and dangerous pathogens, and we prioritize which of 

the detection methods or assays need to be deployed close to where 

people live, which ones can be deployed and maintained centrally, 

67 

because it’s quite expensive to have the standards high enough to 

be able to reproduce the results in all of the 125 hospitals. 

So while there’s 45 select agents, we have assays for nearly all 

of them. Many of those are managed at the CDC or at Regional 

Centers of Excellence, while the 125 laboratories can test for the 

things that we think are the most likely, including things like 

MERS, where we rolled out an emergency use authorization for a 

new diagnostic test for that, Ebola, et cetera, the H1N1 initially. 

So we try to deploy distally the assays for the threats that are the 

most important to have local ability to detect rapidly. 

Mr. BRIGHT. If I can add just a second on that too. That is another area of innovation that BARDA has been focusing on with 

our industry partners is to drive diagnostics, not only out of centralized labs to augment that centralized laboratory network, but 

put the diagnostics in the hands of the physicians in the physician’s office at point-of-care testing. And even go further now, to 

drive diagnostics into the home, so people will know earlier when 

they’ve been infected with something so they can take responsible 

action to either get treated sooner when drugs are more effective 

and also to take activities to reduce the further spread or transmission of that virus. This area is ripe for innovation to augment 

our national laboratory support system. 

Ms. CASTOR. Thank you very much. 

Mr. HARPER. The gentlewoman yields back. 

The chair now recognizes the gentleman from New York, Mr. 

Collins, for 5 minutes. 

Mr. COLLINS. Thank you, Mr. Chairman. 

I want to thank our witnesses and follow up a little bit more on 

the Laboratory Response Network, Dr. Schuchat. I understand 

that’s been around about 9 years or thereabouts, since I think 

1999? 

Dr. SCHUCHAT. Yes, since 1999. 

Mr. COLLINS. Actually, I’ve lost 10 years. Twenty years. I deliberately lost those 10 years, by the way. 

So I know you mentioned 125 labs here in the country, but this 

is, from what I understand also, there’s international labs. We all 

know the key to a lot of this is early detection, whether it was 

Ebola or some other things, SARS, which initially people thought 

they had the flu, even anthrax. But early detection’s the key to 

jumping on top of this, which means the laboratories that are located outside the country. And I know this is a collaborative effort. 

Are you, let’s use the word ‘‘comfortable,’’ and how is that collaboration between the United States and other countries around 

the world—as you mentioned, in many cases, these could be in Africa and other places—for the ability to identify these select 

agents? 

Dr. SCHUCHAT. The Laboratory Response Network is in other 

countries as well, but I would say there’s other means, other laboratories that we collaborate with around the world to help have 

that rapid detection and response. And actually, that’s really what 

the global health security agenda is about, making sure that there 

are abilities to find, stop, and prevent epidemics wherever they 

occur, natural or not. 

68 

And the international collaboration, I think, is strengthened by 

the daily links we have in partnership on other threats. As you 

heard, we’re working on Ebola in DRC right now. The Nipah virus 

detection in India was based on training that CDC had given to the 

laboratory in India years before so that India could recognize that 

pathogen themselves without having to take the time to ship the 

specimens out of the country. 

Mr. COLLINS. So, following up on that, what I would call proficiency testing that we do for all of our labs, whether it’s on influenza or HIV or any of the STDs, I’m assuming there’s also a proficiency testing program related to our LRNs, which is always 

maybe a little more complicated because the 45 select agents are 

not nearly as prevalent as influenza. But can you speak to the proficiency program, how often these laboratories are tested, their 

workers, how their grades are, so that, in fact, we’re comfortable 

that, if there is an outbreak, they’re properly identifying it? 

Dr. SCHUCHAT. Yes. The proficiency testing and assuring the 

quality of the laboratory test is vital. That’s one of the reasons that 

we don’t have assays for every one of the select agents in each of 

the LRN labs, because we want to certify that lab for that test and 

make sure that they maintain their reagents adequately and that 

everyone who’s working on that test is doing it the right way. So 

we really try to prioritize which assays will be run regularly in 

every lab, because we do have to make sure that year in and year 

out, they’re getting the accurate results. Otherwise, it makes no 

sense to run the test. 

Mr. COLLINS. Is that done yearly, more than yearly? How often 

is that done? And does the CDC conduct the proficiency tests themselves or do you use outside agencies like CAP or someone like 

that? 

Dr. SCHUCHAT. Let me get the details on that for the committee 

in followup, because I don’t have all of them myself. 

Mr. COLLINS. OK. Thank you. I think that’s an important piece. 

In the remaining time, Admiral Hinton, egg-based versus cellbased vaccines, could you comment? YIs the FDA looking at—as 

we’re moving forward certainly through our influenza season, are 

you making progress on the cell-based? Are you seeing positive potential there? 

Admiral HINTON. Absolutely. And we actually have both. We 

have the egg-based versus the cell-based vaccines available, and 

continue to do evaluation and work in that area. But both are 

available, both are promising. 

Mr. COLLINS. Because, there’s always been some folks—if anyone 

else would like to comment on potential problems with the eggbased. Are we seeing positive steps in the other or—— 

Admiral HINTON. We are seeing positive steps in the other direction. And then as far as the egg-based, I know we run into issues 

with people having allergens and the like to them and not being 

able to have them. So having different options there to be able to 

provide and treat people with is promising and is available. 

Mr. HARPER. Dr. Fauci. 

Dr. FAUCI. There are other problems with egg-based, which is the 

reason why we’re really trying to get away from egg-based and get 

more towards more advanced platform technologies. 

69 

One of the accidental mismatches that we had in 2016–2017, 

particularly in Australia, was that the virus was chosen for the 

vaccine, was put into eggs, and as it mutated in the eggs as it was 

growing, it mutated so that the virus that came out of the eggs was 

not the virus that you put into the egg. So we had an accidental 

mismatch. 

That doesn’t happen all the time by any means, but the idea of 

having to grow a virus in a 6-month process is something that we 

really need to, as I often say, graduate into the 21st century and 

do it a little bit better with more advanced technologies. 

Mr. COLLINS. Thank you for that. 

Mr. Chair, I yield back. 

Mr. HARPER. The chair is going to allow Dr. Bright to finish his 

response that he wanted to make here quickly. 

Mr. BRIGHT. Thank you very much. I’d like to add just a little 

bit more to that as well. It’s very important to understand the need 

for diversified vaccine production systems for influenza. Influenza’s 

a tricky virus. Eggs have been a reliable vaccine substrate for a 

number of years. We are working to find ways to not only diversify 

and augment our cell-based and recombinant-based influenza vaccines, but also to improve egg-based vaccines. It’s important not to 

completely discard a reliable technology without having a modernized technology to replace that. So we are working with each of the 

manufacturers now to identify ways to make our flu vaccines more 

effective now while we wait for that universal flu vaccine candidate 

in the future. 

Mr. HARPER. The chair will now recognize the gentleman from 

California, Mr. Ruiz, for 5 minutes. 

Mr. RUIZ. Thank you, Mr. Chairman. 

Emerging infectious diseases are a major threat to the health of 

American citizens and to people around the world. This includes 

both new diseases that emerge in populations, as well as previously 

known diseases that re-emerge. In just the past 2 months, for example, we have seen outbreaks of Ebola in the Congo and Nipah 

in Northern India. 

Dr. Schuchat, what steps are we taking to monitor emerging and 

re-emerging infectious diseases in the developing world, and how 

are we partnering with international players on this? 

Dr. SCHUCHAT. Yes. CDC works closely with dozens of ministries 

of health around the world, as well as with international partners 

like the World Health Organization and the World Food Organization to—or the World Animal Health Organization to be able to 

find, stop, and prevent epidemics. 

Mr. RUIZ. Give me an example of how you do that in a very underdeveloped, poor infrastructure nation. 

Dr. SCHUCHAT. Right. As you know, in Liberia, they suffered 

from a devastating outbreak of Ebola in 2014. We have a country 

office in Liberia that’s working closely with them focused on four 

key areas: strengthening laboratory systems, strengthening surveillance, strengthening emergency operation centers and rapid response, and workforce development through the disease detective 

program that we call the field epidemiology training program. 

That means they can shorten the time to recognition of Ebola or 

something else and respond capably. 

70 

Mr. RUIZ. Thank you. 

And in 2014, 2016, the Ebola epidemic killed more than 11,000 

people in West Africa, and we know in October 2014, a physician 

who traveled from West Africa to Dallas in Texas died of Ebola; 

two others that contracted the Ebola virus survived. 

What did we learn from that experience? And what are the 

changes that you’ve made because of that? 

Dr. SCHUCHAT. There are three key lessons learned. One was 

that we need every country to have the ability to find, stop, and 

prevent epidemics, and that’s what we call this Global Health Security Agenda. 

A second thing was that we need the world organizations, the 

global organizations, to be able to surge rapidly when a country’s 

capacity is overwhelmed. And that has actually happened effectively in the Democratic Republic of Congo with this Ebola outbreak recently. 

And the third thing that we’ve learned is that infection control 

is essential; that an issue that is one illness or a couple illnesses 

can amplify into a very large-scale problem when we don’t have 

adequate infection control. That’s important in the United States 

for antimicrobial resistance, it’s important in developing countries 

for TB, and it’s very important for Ebola in SARS. 

Mr. RUIZ. This patient and these two other healthcare workers 

who contracted Ebola, obviously, were in emergency departments, 

went to emergency departments, were treated in emergency departments. The first line of defense against any emerging infection or 

outbreak in the United States is going to be the emergency departments and also the first responders. 

So what are you doing in terms of the CDC to coordinate to make 

sure that they are well-equipped? And then I’m going to ask Dr. 

Bright that same question. 

Dr. SCHUCHAT. Yes. We have a family of efforts to educate and 

keep up-to-date clinicians that include tens of thousands of clinicians regularly getting updates from us, whether it’s through phone 

calls—— 

Mr. RUIZ. It’s hard for very busy clinicians who work in emergency departments, seeing 20 patients at once to—— 

Dr. SCHUCHAT. Right. And that’s—— 

Mr. RUIZ. How do you integrate that into their daily practice? 

Dr. SCHUCHAT. Yes. The system changes are really important. 

When I saw a doctor at Emory last week, before I could even talk 

to anyone, I was asked, Have you traveled out of the country the 

last 3 weeks? It’s actually on their phone line before you make an 

appointment. 

So institutions instituting systemwide checks can help make sure 

that you don’t have problems with human error. 

Mr. RUIZ. Dr. Bright? 

Mr. BRIGHT. Also, I’d like to highlight that ASPR has spent a lot 

of time with our hospital protection program and our healthcare 

coalitions to establish now even a national Ebola training center 

and education center, so we can train the hospital and first responders. 

71 

We now have 178 Ebola assessment hospitals. We have 69 State 

or jurisdictions designated Ebola treatment centers. We have 10 regional Ebola and other special pathogen treatment—— 

Mr. RUIZ. Well, I’m an emergency physician. I have to take 

exams like crazy just to keep my board certifications and my licensing. So I think integrating it as part of their continuing medical 

education and training would be very essential. 

Now, the President’s budget—or the administration wants to 

move the strategic National Stockpile under the ASPR. I’d like to 

ask Dr. Schuchat what are your competitive advantages and why 

should I think about even considering keeping it at the CDC? 

Dr. SCHUCHAT. What I could say is that there’s already been an 

administrative decision to move the stockpile, and so currently, 

CDC is working diligently very closely with ASPR to make that 

transfer as seamless as possible and to mitigate any negative consequences that may have been unintended but that may occur. 

I think the critical areas that we are going to focus on are to 

make sure that State and local support is seamless, and that we 

work with State and local health departments every day on a variety of things and know them and know where our gaps are and 

where we need to make progress. We need to make sure that that 

close relationship continues in a way that doesn’t jeopardize the 

American public. 

Second area is the deep scientific expertise that we have across 

the agency that has contributed to maintenance of the SNS so that 

when we need clinical guidance for children for anthrax countermeasures, we can get that best advice incorporated. We need to 

make sure that that continues, but we are well on the way to executing that seamless transition. 

Mr. HARPER. The gentleman yields back. 

The chair will now recognize the vice chair of the subcommittee, 

the gentleman from Virginia, Mr. Griffith, for 5 minutes. 

Mr. GRIFFITH. Thank you, Mr. Chairman. 

After a series of safety lapses in 2014 involving the mishandling 

of anthrax and smallpox, in response to recommendations from a 

lab safety expert panel, both the FDA and CDC formed new offices 

to provide centralized oversight of laboratory safety and science. 

Rear Admiral Hinton, I have several questions for you regarding 

the FDA’s Office of Laboratory Science and Safety. 

First, how many labs does the FDA have, or oversee? 

Admiral HINTON. The FDA has 56 lab facilities. 

Mr. GRIFFITH. And do you oversee more than that? 

Admiral HINTON. No. 

Mr. GRIFFITH. And are you counting everything in a single building, or is that all your labs combined? 

Admiral HINTON. Those are the facilities. Within those facilities, 

there might be a total of 2,800 rooms, with those rooms being described as a space, an office, a closet. 

Mr. GRIFFITH. Yes, ma’am. 

How many safety inspections of these labs were conducted by the 

OLSS over the past year? 

Admiral HINTON. No inspections have been conducted by OLSS 

in the past year. However, their labs have been inspected by other 

entities. 

72 

Mr. GRIFFITH. OK. Have there been any laboratory-acquired infections at FDA labs during the past year? 

Admiral HINTON. There have been two noted infections within 

the last year. The staff that had acquired those infections have 

been observed and the case is closed. 

Mr. GRIFFITH. All right. And can you get us the reports on those 

two incidences, please? 

Admiral HINTON. I’ll work with my staff to get that to you. 

Mr. GRIFFITH. Thank you very much. 

Likewise, have there been any potential exposures to threat 

agents at FDA labs during the past year? 

Admiral HINTON. Not to my knowledge. No. 

Mr. GRIFFITH. All right. At tab 5 in the document binder is a 

September 2016 letter to the FDA sent the committee indicating its 

intention to hire 13 permanent full-time employees in the Office of 

Laboratory Science and Safety, OLSS. 

The FDA told the committee this week that OLSS is staffed by 

only three permanent full-time employees, and three detailees. 

Why doesn’t the OLSS have the 13 permanent employees that 

were promised in a September letter of 2016? 

Admiral HINTON. Sir, we have put forth the proposal, and as 

soon as we have the dedicated budget for OLSS, we expect for their 

current staff to double. 

They actually have three permanent staff and three detailed 

working on this space. 

Mr. GRIFFITH. That still only puts you at six as opposed to the 

13 that was indicated in 2016. 

Admiral HINTON. I agree. And we note that, and then with the 

approval of the upcoming budget, we will be able to double that 

and they will have the 13 staff. 

Mr. GRIFFITH. The FDA, in the September 2016 letter, committed 

to this committee, and in July of 2017, published a notice in the 

Federal Register evaluating the OLSS so the office would directly 

to the FDA commissioner instead of the chief scientist. 

Earlier this week, the FDA told committee staff that the FDA 

has decided to reorganize again, and that under the new proposal, 

OLSS will no longer be a direct report to the commissioner and will 

report to the chief scientist again, just as they did when we had 

the lapses back in 2014 and contrary to the expert panel’s recommendations. 

I just would like to know, first, is the chief scientist reporting to 

you now? 

Admiral HINTON. I am the chief scientist. But the Director of 

OLSS—— 

Mr. GRIFFITH. Is OLSS reporting to you? 

Admiral HINTON. Yes, sir. 

Mr. GRIFFITH. And then you report on up the line? 

Admiral HINTON. Yes. I do. 

Mr. GRIFFITH. So why did FDA reverse course in less than a year 

and decide to have the OLSS revert back to reporting to the chief 

scientist? 

Admiral HINTON. Well, sir, since that was announced, we have 

had the chance over the past year to observe and to see where it 

might be best fit for the alignment within the office. 

73 

Within the office of the chief scientist, which reports into the office of the commissioner and to the commissioner, we work on cross 

cutting cross-scientific issues to include those within laboratory 

science space. 

So we thought that the OLSS would be best aligned there under 

my direct supervision on their day-to-day activities. The commissioner will be fully apprised of those activities. 

Mr. GRIFFITH. Well, and I certainly mean no disrespect to you, 

but that was the same setup we had when there were problems 

being reported and we had the expert panel come in and give us 

recommendations, which FDA agreed to, and now you all are backtracking. 

I understand some different personnel, but it seems to me we’re 

just creating the same problem we had before. 

I see my time is up, and I have to yield back. Thank you, Mr. 

Chairman. 

Mr. HARPER. The gentleman yields back. 

The chair will now recognize the gentlewoman from California, 

Ms. Walters, for 5 minutes. 

Ms. WALTERS. Thank you, Mr. Chairman. 

Dr. Bright and Dr. Schuchat, either through stockpile procurement or through other means, how do your agencies ensure we 

have sufficient diagnostic test capacity to identify cases of pandemic influenza or other infectious diseases? 

Mr. BRIGHT. In terms of development, so we have worked with 

a number of different manufacturers through the last 10 years to 

develop diagnostics for influenza, not only laboratory-based 

diagnostics, but to standardize and update the point-of-care 

diagnostics for influenza to make sure those are available and in 

the marketplace for use for pandemic and seasonal influenza detection. 

Dr. SCHUCHAT. Yes. And I would say that CDC both develops assays and helps with validation. 

You know, a number of years ago, there were quite a few pointof-care tests for influenza detection, and some of them didn’t perform as well in the field as we had hoped. So we did quite an effort 

of validation comparison, shared the data with FDA, and new labeling and improvements in the tests followed from that. 

So we will develop tests against pandemic or avian flu and other 

high-threat concerns, develop them through to emergency use authorization when appropriate, 501(k) when possible. 

The 501(k) final process is very labor intensive, very expensive, 

and there’s a limited number of our tests that we are able to put 

through to that level. But we do work closely with FDA and 

BARDA on a number of the priority ones. 

Ms. WALTERS. Thank you. 

Dr. Fauci, you mentioned work by the National Institute of Allergy and Infection Diseases to support research involving diagnostic testing. 

From a Homeland Security and public health perspective, multiplex point-of-care technologies are beneficial because they can be 

used to simultaneously test for multiple infectious disease pathogens with a single blood or urine sample. 

74 

Can you tell us about the research NIAID is doing with respect 

to multiplex point-of-care technologies and how these technologies 

enhance our ability to detect material threats and infectious diseases? 

Dr. FAUCI. Thank you very much for that question. 

Yes. We are very heavily involved in that, both with our grantees 

to get concept to develop into something that’s translatable, as well 

as contract. 

There’s multiplex, as you mentioned in your statement, is a very 

important tool of the future now for detecting outbreaks. For example, we have multiplex assays involving a whole series of particular 

types of viruses. For example, the flaviviruses, which are many of 

them that we have, particularly in the Western Hemisphere, that 

we are involved right now in research for the development of a 

multiplex that would essentially cover all of the associated 

flaviviruses, and we’re doing that with a number of other viruses. 

So there’s really a very important, I believe, and aggressive ongoing research program at the NIH, mostly through our grantees and 

contractors. 

Ms. WALTERS. OK. 

Mr. BRIGHT. If I can jump in, the challenge with the beauty of 

multiplex assays is that they can do a lot. And the challenge with 

them is they’re very large instruments generally in centralized laboratories in a hospital or a public health laboratory. 

The innovation that we’re driving today with companies that 

move multiplex assays to point of care into a physician’s office, and 

even to work with those multiplex technologies to push some of 

those now out into the home, one of our greatest challenges with 

our diagnostics for any disease is how long it takes for a patient 

to get to that system and into the system so they can get a sample 

drawn and can get a result. 

Too much time elapses in that. So we’re trying to also use this 

new technology for multiplex point of care to multiplex point of 

need into the home to get people earlier notification to empower patients to get treated sooner. 

Ms. WALTERS. OK. Thank you. 

Rear Admiral Hinton, how many multiplex point-of-care diagnostic tests has the FDA approved for use? 

Admiral HINTON. Thank you for your question, ma’am. 

Work in this area is progressing well at FDA. We’ve cleared more 

than 25 multiplex tests that could be suitable for point-of-care 

tests. 

Ms. WALTERS. OK. And how many others are currently under assessment by the FDA? 

Admiral HINTON. I’ll have to get back to you. I don’t have the 

exact number. 

Ms. WALTERS. OK. Can you describe the range of capabilities 

that these tests have? You know, how many diseases can one multiplex point-of-care diagnostic test detect? 

Admiral HINTON. It can detect many. We can do up to 20—and 

more than—at one time, which is incredibly important, especially 

at the point of care so that we can help to easily detect in order 

to find the best treatment. 

75 

Ms. WALTERS. OK. Thank you, and I yield back the balance of 

my time. 

Mr. HARPER. The gentlewoman yields back. 

The chair will now recognize the gentleman from Georgia, Mr. 

Carter, for 5 minutes. 

Mr. CARTER. Thank you, Mr. Chairman. 

And, Mr. Chairman, I want to echo your comments earlier about 

what an outstanding panel this is. Thank you all for the very important work that you do. It is extremely important to our country, 

and we appreciate it very much. 

Dr. Bright, I want to start with you. Being, of course, from Georgia, I am somewhat concerned, even still, about the move of the 

strategic National Stockpile and the management of that from the 

CDC to ASPR, and I just want to be assured again from you. I’ve 

met Dr. Redfield, and I think he’s doing a great job. Dr. Schuchat 

and I have worked together, and I just can’t say enough good 

things about the CDC and the outstanding work that they do for 

our country. 

And I just want to make sure that they’re still going to have the 

opportunity to stay involved and to be involved in the medical 

counter-measurement development and everything else that goes 

along with the SNS. 

Mr. BRIGHT. Sir, you have my complete assurance. I echo your 

comments about the CDC and the great work they are doing. Many 

people don’t know I got my first start in science at the CDC as an 

ORISE fellow coming from Emory University in Georgia. 

I understand and appreciate the great scientific leadership of the 

CDC and their relationship with state and local and the value of 

that. 

We plan to always include that in our assessment and our programs for the new strategic National Stockpile management. 

Mr. CARTER. We talked on it earlier. One of my colleagues had 

mentioned about the concern particularly that the transfer is not 

disruptive for the state and local agencies. 

What would you suggest that we do to make that as least disruptive as we can? 

Mr. BRIGHT. Well, the most important thing is to recognize the 

value of their voice in the entire process, not just in the transition 

of the management of the SNS, but an entire end-to-end process of 

our efficient response to any emergency or public health emergency 

threat. 

So we already have an intentional working group focusing on the 

state and local and tribal and territory partners and their specific 

needs and their specific interests to make sure those are encapsulated in our management of the SNS. 

Mr. CARTER. Great. 

Dr. Schuchat, would you care to comment on that as well? How 

can well assure that this is not disruptive to our local and state 

communities? 

Dr. SCHUCHAT. I think that change is, by necessity, disruptive, 

and I think our job is to mitigate that disruption so that people 

aren’t harmed. So I think it’s on our radar. We’re working really 

closely together. The Association of State and Territorial Health 

76 

Officers Board was just at CDC yesterday talking to us about how 

we can make sure this all goes as well as possible. 

Mr. CARTER. And let me ask you—I run the risk of being a little 

self-serving here—but wouldn’t it make sense to look at perhaps 

just having ASPR colocate down to Atlanta with the CDC? I recognize you’re part of HHS, but we have to get out of the mindset that 

not everybody’s got to be in Washington, D.C. We have a big country out here. Dr. Bright, I’m looking at you. 

Mr. BRIGHT. We have a big and beautiful country, sir, and I 

agree with you, and there is no intent to move the strategic National Stockpile from Atlanta to Washington, D.C. There might be 

one or two individuals who are located in our ASPR office to ensure 

we have smooth and efficient ongoing communication with the expert staff that is in Atlanta, Georgia. 

Mr. CARTER. OK. Well, that might be a good compromise, and we 

appreciate that very much. 

The Ebola crisis that we had, obviously we learned a lot of lessons there, but I was so proud of the public/private partnership between Emory University and the CDC, and all four patients recovered. 

And I just wanted to know, will you be using that model in the 

future for other pandemics and other risks that we might run into? 

Because we’re very proud of the work that was done at Emory University, and I think it’s a great example of what we can do in the 

future. 

Dr. Schuchat? 

Dr. SCHUCHAT. I would say that CDC benefits tremendously from 

being located right next to Emory, and there’s a really close working relationship. We were fortunate that they such a terrific job in 

the Ebola—in the care of the patients there. 

There’s ongoing collaboration and communication and support. 

I think ASPR may have a more direct role in the hospitals and 

the care of such patients, and Dr. Bright might want to comment. 

Mr. BRIGHT. I also want to make sure that we capitalize and not 

lose that expert and lessons learned from Emory University. 

As you may know, we stood up a National Ebola Training and 

Education Center. It’s based in Nebraska as collaboration with 

Emory University, University of Nebraska, and Bellevue. It is an 

example of one the finest educational centers on Ebola and other 

epidemic treatments in the world now. 

Mr. CARTER. OK. Again, I want to thank all of you for the work 

that you do. Extremely important, and especially shout out to CDC 

and the work that they do. 

Thank you, and I yield back, Mr. Chairman. 

Mr. HARPER. The gentleman yields back. 

The chair will now recognize the gentlewoman from California, 

Ms. Eshoo, for 5 minutes. 

Ms. ESHOO. Thank you, Mr. Chairman, for extending the legislative courtesy to me, since I’m not a member of this subcommittee, 

but I have a great interest in the subject matter, since we’re looking to reauthorize PAHPA and all of the listening to what’s taken 

place in this hearing and the superb testimony from each one of 

you. We’ve made great progress since the legislation was first written in 2006. 

77 

So I’m pleased, but in America, we’re never satisfied with exactly 

where we are. We always want to improve. And so there’s been an 

important pathway of improvement, and I thank each one of you. 

I’m very proud of the two women that are here. Rear Admiral 

Hinton, it’s really a source of pride to me to hear you respond to 

the tough questions that have come your way. To Dr. Schuchat, it’s 

always a pleasure to hear you. Dr. Bright, the partnership with 

BARDA has been a very important one, and I think that you’re 

taking it to new places. 

And to Dr. Fauci, I don’t have any questions to ask you. I wish 

I could canonize you. You are such a gift to our country. You could 

be in the private sector probably making millions of dollars. You’ve 

devoted your entire life to the people of our country, and you make 

the National Institutes of—the NIH really stand for the National 

Institutes of Hope. You’re a leader in that, and I just revere your 

record, your leadership, and what you’ve done and what you continue to do. 

To Dr. Bright, how has restoring BARDA as a contracting authority led to increases in the efficiency and the certainty that surrounds the medical countermeasures at research and development? 

That’s my first question. 

And my second one is, does your agency interpret your existing 

authority to allow the stockpile to invest in countermeasures other 

than those explicitly mentioned in the current statute? 

Maybe start with the second question. 

Mr. BRIGHT. Thank you very much. 

Ms. ESHOO. Do you need any additional authorities? 

Mr. BRIGHT. To be more effective, I believe we need to modify 

some of the authorities that we have to allow us to work more flexibly with our industry. 

Ms. ESHOO. So you don’t need additional authorities? 

Mr. BRIGHT. We don’t need additional authorities. I believe we 

need to modify the authorities that we have. 

Ms. ESHOO. What does that mean, modify the authorities? 

Mr. BRIGHT. Our other transactional authority, for example, does 

have limitations on how we can interface with our industry partners and how they might qualify for that type of partnership. So 

we have a draft of suggested language that might allow us that 

greater flexibility to do so. 

Ms. ESHOO. And have you gotten that to us? 

Mr. BRIGHT. If it hasn’t been sent to you yet, we will make sure 

that it is quickly. 

Ms. ESHOO. Do BARDA’s existing additional authorities promote 

work on the, and it’s been brought up, not only at this subcommittee, but at others, of the antimicrobial resistance and the 

antibiotic development, or does your agency need additional authorities to engage in that work? 

Mr. BRIGHT. We’ve been working with the authorities we have 

since 2010 to address antimicrobial resistance. 

One area of authority that is lacking, we believe, would be beneficial would be a specific authority for the appropriations for pandemic influenza, because there’s a lot of critical work that needs to 

happen in pandemic—— 

Ms. ESHOO. Have you gotten that to us? 

78 

Mr. BRIGHT. I do not have that authority yet. 

Ms. ESHOO. Are you going to make that request of us? 

Mr. BRIGHT. I believe that request has been submitted. I hope so. 

Ms. ESHOO. There was some mention earlier about how important the advanced—I think you might have raised it in your opening statement, on advanced appropriations. I believe that, because 

the Senate has different rules on this, that we will meet the standard that needs to be met. That’s probably the tidiest way for me 

to say it. 

But it is critical, because if you don’t have the advanced appropriations at BARDA, then our partners in the private sector are 

not going to be able to continue the important work that they’re 

doing. 

Mr. BRIGHT. That’s absolutely correct. They are business partners working in long-term cycles and forward-looking cycles, and 

the consistency and assurance of that advanced appropriations allows them to have that assurance that we will still be there doing 

our part so they can plan appropriately as well. 

Ms. ESHOO. Thank you very much to each one of you for what 

you’re doing for our country. You’re all heroes of mine. 

Thank you, Mr. Chairman. Yield back. 

Mr. HARPER. The gentlewoman yields back. 

The chair will now recognize Ranking Member DeGette for concluding remarks. 

Ms. DEGETTE. Thank you very much, Mr. Chairman, for the moment of personal privilege. 

I wanted to bring up another issue that I think is a real crisis 

right now in this country. 

I know we have a lot of HHS agency representatives here, and, 

of course, ASPR is under the purview of HHS. 

Yesterday, our ranking member, Frank Pallone, wrote a letter to 

Secretary Azar about the HHS Office of Refugee Resettlement. And 

these kids who are being taken from their parents at the border, 

and then being put under the auspices of this agency, we have real 

concerns about what’s happening to these children. And we have 

real concerns about their long-term prospects, being taken from 

their parents. 

And, Mr. Chairman, I just wanted to bring this up, because 

you’re going to be getting a request from the minority to have a 

hearing about this, and we would hope that you would seriously 

consider this, because we are quite concerned about the human aspects of this situation. 

Thank you, and I yield back. 

Mr. HARPER. The gentlewoman yields back. 

The chair will recognize Dr. Burgess for a concluding remark. 

Mr. BURGESS. Well, Mr. Chairman, thank you for the recognition. 

I would just point out that this committee, and this subcommittee in particular, has a significant history of oversight on 

the ORR. I do feel obligated to point out this is not the agency that 

makes the decision about whether or not a family unit is kept together, but they are obligated to take care of—whether a child arrives unaccompanied or is separated from their family at the DHS 

facility. But that is the responsibility of, in fact, the Health Subcommittee, and we do take that responsibility very seriously. 

79 

In fact, it was our work in July of 2014 that allowed them to acquire an actual physician to be in those facilities to assess those 

children as they were brought in. 

And it was our committee that raised the question shouldn’t we 

at least have some way of contacting the children after they have 

been placed with a family, at least on a voluntary basis. 

So it was our committee that did that work, and that work will 

continue. I’ve been in contact with both Secretary Azar and with 

the gentleman that runs ORR, and I expect to have robust discussions with them going forward, and I yield back. 

Ms. DEGETTE. If the gentleman will yield, thank you very much, 

and I look forward to working with you on this, because it’s really 

a critical issue, and I’m on that subcommittee, too. Thank you. 

Mr. HARPER. I want to thank each of you for being here. Great 

insights and expertise, and I thank you for participating in today’s 

hearing. 

I remind Members that they have 10 business days to submit 

questions for the record, and I ask that the witnesses agree to respond promptly to any such questions. 

With that, the subcommittee’s adjourned. 

[Whereupon, at 10:58 a.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

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35127.037

E C U.S. HOUSE OF REPRESENTATIVES 

COMMITTEE ON ENERGY AND COMMERCE EST. 1795 

June 13,2018 

TO: Members, Subcommittee on Oversight and Investigations 

FROM: Committee Majority Staff 

RE: Hearing entitled "The State of U.S. Public Health Biopreparedness: Responding 

to Biological Attacks, Pandemics, and Emerging Disease Outbreaks." 

The Subcommittee on Oversight and Investigations will hold a hearing on Friday, June 

15,2018, at 9:00a.m. in 2123 Rayburn House Office Building. The hearing is entitled "The 

State of U.S. Public Health Bio-preparedness: Responding to Biological Attacks, Pandemics, and 

Emerging Disease Outbreaks." 

The purpose of this hearing is to follow up on the past biopreparedness oversight issues 

examined by the Subcommittee, and to receive updates from the agencies on current assessments 

and strategies. This hearing will also highlight the need to reauthorize the Pandemic and AllHazards Preparedness Act (PAHPA), which is due to expire at the end of September 2018. 1 

I. WITNESSES 

• Rick A. Bright, Ph.D., Director, Biomedical Advanced Research and Development 

Authority; Deputy Assistant Secretary, Office of the Assistant Secretary for Preparedness 

and Response, U.S. Department of Health and Human Services; 

• Anne Schuchat, M.D. (RADM, USPHS), Principal Deputy Director, Centers for Disease 

Control and Prevention, U.S. Department of Health and Human Services; 

• Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases, 

National Institutes of Health; and 

• Denise Hinton (RADM, US PHS), Chief Scientist, U.S. Food and Drug Administration. 

1 PAHPA created and expanded programs to enhance the public health system's capacity to monitor and respond to 

public health emergencies. The act expanded programs for state and local public health emergency preparedness 

activities and mandates the use of evidence-based benchmarks and standards to measure levels of preparedness. 

Ass'n of State and Territorial Health Orgs., ASTHO Legal Preparedness Series Emergency Authority & Immunity 

Toolkit- Pandemic and All-Hazards Preparedness Act, http://www.astho.org/ProgramsiPreparedness/Pub!ic-HealthEmergency-Law/Emergency-Authority-and-Immunity-Toolkit/Pandemic-and-All-Hazards-Preparedness-Act-FactSheet/ (last visited June II, 20 18). 
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35127.038

Majority Memorandum for June 15,2018, Subcommittee on Oversight and Investigations 

Hearing 

Page 2 

II. BACKGROUND 

This section will outline four areas of continuing oversight interest in the area of 

biopreparedness: biological threats; detection and diagnostics; development and stockpiling of 

medical countermeasures (MCMs); and science, safety and security oflaboratories in the life 

sciences-biodefense complex. 

A. Biological Threats 

Biological threats fall into three main categories: natural infectious diseases, synthetic 

biology/engineered pathogens, and bioterrorism. Synthetic biology could cause harm either 

intentionally (e.g., an engineered pathogen used in a bioterrorist attack) or accidentally (e.g., 

through the accidental release of dangerous agents from a lab conducting dual use research).2 

In this century, the nation has witnessed the impacts of naturally occurring outbreaks 

such as influenza, Ebola, and SARS.3 Health authorities are currently monitoring other potential 

emerging infectious diseases that could cause a pandemic, such as the H7N9 influenza strain 

circulating in China.4 Further, as recently noted by Department of Health and Human Services 

(HHS) Assistant Secretary for Preparedness and Response (ASPR) Robert Kadlec, "[t]errorist 

organizations such as ISIS and al-Qaida remain determined to attack; further ISIS has 

demonstrated no compunction about using chemical and other unconventional weapons in 

attacks overseas. State actors have already threatened our homeland with nuclear weapons and 

have shown the means to employ both chemical and biological weapons."5 

The Subcommittee explored the growing nature of these biological threats and the need 

for an elevated response at a hearing held on February 12,2016.6 

An attachment to this memorandum provided by the National Institute of Allergy and 

Infectious Diseases (NIAID) shows examples of emerging and re-emerging infectious diseases 

as of June 2018. 

2 Give Well, A conversation with George Paste on February 12, 2014, 

https://www.openphilanthropy.org/sites/default/files/Poste%202-12-14%20%28public%29.pdf (last visited June II, 

2018). George Poste, DVM, PhD., is Director, Complex Adaptive Systems Institute, Arizona State University and 

an ex officio member of the Blue Ribbon Study Panel on Biodefense. 3 See Examining the Reauthorization of the Pandemic and All-Hazards Preparedness Act Before the Subcomm. on 

Health ofthe H. Comm. on Energy and Commerce, !15th Cong. (2018) (written testimony ofHon. Robert Kadlec, 

M.D., Assistant Sec'y for Preparedness and Response, U.S. Dep't of Health & Human Services). 

4 !d. 

5 !d. 

6 See Outbreaks, Attacks, and Accidents: Combating Biological Threats Before the Subcomm. on Oversight and 

Investigations of the H. Comm on Energy and Commerce, !14th Con g. (20 16) Serial No. 114-117. 
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Majority Memorandum for June 15,2018, Subcommittee on Oversight and Investigations 

Hearing 

Page 3 

B. Detection and Diagnostics 

Laboratory Response Network 

The Centers for Disease Control and Prevention (CDC) Laboratory Response Network 

(LRN) is a network of 134 local, state and federal laboratories that can provide the laboratory 

infrastructure and capacity to quickly respond to public health emergencies, and incidents of 

biological and chemical terrorism. The network, established in 1999 and overseen by the CDC, 

enables rapid detection of and response to emerging infectious diseases such as Zika, Ebola and 

influenza, as well as select agents and toxins. All 50 states have at least one member laboratory 

and 85 percent of the U.S. population lives within a two-hour drive of an LRN lab. 

The ability of the LRN to respond to quickly unfolding emergencies is essential and, as 

such, the network was designed to deploy rapid detection technology and laboratory tests (known 

as assays) to quickly test suspicious materials and detect the presence of biological or chemical 

agents in the event of a bioterrorism attack. 

In August 2016, the Committee launched a bipartisan investigation about the current 

capabilities of the CDC LRN, and two additional information request letters followed on October 

26, 2016, and February 28, 2017.7 These letters requested information regarding the LRN's lab 

capacity, funding levels, and laboratory test development. 

In response to questions about funding for the network, the CDC provided documentation 

indicating that spending decreased over the last decade. The LRN's expenditures have gradually 

decreased from $15 million in 2007 to $9 million in 2016. Expenditures for the LRN totaled 

$116.2 million during that 10-year period.8 The CDC has also at times received funding from 

other federal agencies to help support network activities. The Department of Homeland 

Security's Science and Technology Directorate, Department of Defense's Defense Threat 

Reduction Agency and its Joint Program Executive Office, and the Department of Health and 

Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) and 

Biomedical Research and Development Authority (BARD A) have each provided funding for 

LRN support over the last 10 years. Funding has varied year-to-year by agency, but the total 

amount the four agencies have provided to the LRN since Fiscal Year 2008 is $21.5 million.9 

7 Letter from Hon. Fred Upton, Chairman, H. Comm. on Energy and Commerce, et al. to Thomas Frieden, M.D., 

Dir., Centers for Disease Control and Prevention (Aug. II, 20 16) available at https://archivesenergycommerce.house.gov/sites/republ icans.energycommerce.house.gov /files/documents/114/letters/20 160811 CD 

C. pdf; Letter from Hon. Fred Upton, Chairman, H. Comm. on Energy and Commerce and Hon. Tim Murphy, 

Chairman, H. Comm. on Energy and Commerce, Subcomm. on Oversight and Investigations to Thomas Frieden, 

M.D., Dir., Centers for Disease Control and Prevention (Oct 26, 2016) (On file with the Committee); Letter from 

Hon. Greg Walden, Chairman, H. Comm. on Energy and Commerce and Hon. Tim Murphy, Chairman, H. Comm. 

on Energy and Commerce, Subcomm. on Oversight and Investigations to Anne Schuchat, M.D., Acting Dir., 

Centers for Disease Control and Prevention (Feb. 28, 2017) available at https://archivesenergycommerce.house. gov/sites/repub licans.energycommerce.house.gov/files/documents/114/letters/20 170228CD 

C.pdf; 

8 Letter from Anne Schuchat, M.D., Acting Dir., Centers for Disease Control and Prevention, to Hon. Greg Walden, 

H. Comm. on Energy and Commerce. (May 23, 2017) (On file with the Committee). In the letter to the Committee, 

the CDC represented that there may be additional funding sources for the LRN than those it had identified. 

9 !d. 
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In response to questions on lab test development, the CDC provided information about 

the process by which it selects and develops new assays the LRN can use to detect for biological 

agents, toxins and emerging infectious diseases. The CDC has indicated that the Food and Drug 

Administration (FDA) has approved 51 O(k) clearances for four assays and issued emergency use 

authorization for another six assays. 10 Out of a total of 45 select agents affecting humans on the 

current select agents and toxin list, 11 the CDC LRN has assays cleared by FDA under the 51 O(k) 

process for three, after nearly 20 years of the LRN program and more than $135 million in 

funding during the last decade. 12 

Most recently, the CDC arranged for the evaluation and deployment of a Department of 

Defense Ebola Zaire assay by the LRN amid the 2014 Ebola epidemic in West Africa. After the 

2015 Zika outbreak in Brazil, the CDC also began development of an LRN diagnostic for the 

Zika virus. 13 

Biosurveillance 

Two areas ofbiosurveillance of interest to the Subcommittee have been Bio Watch and 

multiplex point-of-care technologies (MPOCTs). BioWatch is an early warning system designed 

to detect a large-scale, covert attack that releases anthrax or other agents of bioterrorism into the 

air. Overseen by the Department of Homeland Security (DHS), the BioWatch program involves 

a system of aerosol collectors deployed in more than 30 cities, as well as laboratory facilities and 

personnel to analyze samples from these collectors. This program relies heavily on CDC, and 

the state and local public health laboratories that are members of the CDC LRN. The program 

aims to reduce the time required to recognize and characterize potentially catastrophic 

aerosolized attacks by monitoring for the presence of certain biological agents considered to pose 

high risk for an aerosolized attack. A committee investigation and a U.S. Government 

Accountability Office (GAO) report found that DHS lacked reliable information about 

BioWatch's technical capabilities to detect a biological attack and therefore lacks the basis for 

informed cost-benefit decisions about upgrades to the system. 14 DHS continues to work on ways 

to upgrade the BioWatch system. 

MPOCTs are technologies that can simultaneously test for more than one type of human 

infectious disease pathogen from a single patient sample (such as blood, urine, or sputum) in one 

run at or near the site of a patient. MPOCTs can enable rapid testing while the patient is at the 

doctor's office, clinic, or other testing location, including the home. From a homeland security 

and public health perspective, MPOCTs are of interest as an early detection tool, and can help 

assess the potential spread and effect of the disease in the case of dangerous pathogens. At the 

10 !d. 

11 See Fed. Select Agent Program, Select Agents and Toxins List, 

https://www.selectagents.gov/selectagentsandtoxinslist.html (last visited June II, 2018). 12 Schuchat, supra note 8. 

"!d. 

14 See Continuing Concerns Over BioWatch and the Surveillance of Bioterrorism Before the Subcom. on Oversight 

and Investigations of the H. Comm. on Energy and Commerce !13th Cong. (2013) Serial No. 113-56; U.S. Gov't 

Accountability Office, Biosurveil/ance: DHS Should Not Pursue Rio Watch Upgrades or Enhancements Until System 

Capabilities Are Established, GA0-16-99 (Oct. 2015) available at https://www.gao.gov/assets/680/673309.pdf. 
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Committee's request, the GAO conducted a technical assessment of MPOCTs. 15 The GAO 

found that MPOCTs have a range of performance characteristics that describe, among other 

things, the ability of the technology to correctly identify the presence or absence of a pathogen. 

Developers identified several technical challenges to developing multiplex assays that can slow 

MPOCT development and raise costs. GAO also identified potential benefits ofMPOCTs 

included improved patient health care and management, more appropriate use of antibiotics, 

improved ability to limit the spread of disease, and health care cost savings. 

C. Development and Stockpiling of Medical Countermeasures 

Public Health Emergency Medical Countermeasures Enterprise 

In 2006, HilS established the Public Health Emergency Medical Countermeasures 

Enterprise (PHEMCE) to coordinate federal efforts to prepare for, and respond to, public health 

emergencies from a MCM pcrspective. 16 

Pursuant to the 2013 Pandemic and All-Hazards Preparedness Reauthorization Act, the 

PHEMCE is led by the ASPR and is comprised of senior leadership from the CDC, the NIAJD at 

the National Institutes of Health (NIH), the FDA, the Department of Defense (DoD), the DHS, 

the Department of Veteran's Affairs (VA) and the Department of Agriculture (USDA). 17 

The PHEMCE's mission components include: 18 

• Requirements Setting: The PHEMCE is responsible for establishing requirements for 

MCMs based on factors such as threat and risk assessments, which are principally 

conducted by the DHS. 

• Early Stage Research: The NIH is the lead federal PHEMCE agency for conducting and 

facilitating research into areas of public health concerns, which could ultimately lead to 

the development of MCMs to diagnose, treat, and prevent a wide-range of public health 

threats. 

• Advanced Development/Manufacturing: The Biomedical Advanced Research and 

Development Authority (BARD A), within HI·IS' ASPR, develops MCMs for emerging 

public health threats and partners with industry to accelerate development and increase 

MCM manufacturing capacity. In the past decade, BARDA's efforts, supported by 

industry and government partnerships, have resulted in 35 FDA approvals for 31 unique 

15 U.S. Gov't Accountability Office, Medical Devices: Capabilities and challenges of technologies to enable rapid 

diagnoses of infectious diseases, GA0-17-347 (Aug. 2017) available at https://www.gao.gov/products/GA0-17-

347. 

16 See 71 C.F.R. § 129 (2006) and U.S. Dep't of Health & Human Services, Assistant Sec'y for Preparedness and 

Response, Public Health Emergency Medical Countermeasures Enterprise, 

https://www.phe.gov/Preparedness/mcm/phemce/Pages/default.aspx (last visited June 11, 2018). 17 42 U.S.C. § 300hh 10. 

"U.S. Dep't of Health & Human Services, Assistant Sec'y for Preparedness and Response, PHEMCE Mission 

Components, https://www.phe.gov/Preparedness/mcm/phemce/Pages/mission.aspx (last updated Feb. 27, 20 15). 
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MCMs for threats to the public health. 19 BARD A has also supported the development of 

27 MCMs against threats that have been identified by the DHS, through Project 

Bioshield, as being national security thrcats. 20 

• Regulatory Science Management: The PHEMCE endeavors to ensure MCMs are safe 

and effective, which is generally the responsibility of the FDA. 

• Procurement I Inventory Management I Stockpiling: The PHEMCE oversees the 

procurement and management ofMCMs to respond to public health threats. Currently, 

the CDC and BARD A are the lead PHEMCE agencies for this mission component. 

• Response Planning, Policy, Guidance and Communication: The PHEMCE, led by 

CDC and ASPR, coordinates federal medical response and communication strategies 

when faced with a public health emergency. 

• Deployment I Distribution I Dispensing I Administration: The CDC and ASPR engage 

and coordinate with state and local partners to facilitate the distribution of MCMs and 

administration of other medical assets in times of public health emergencies. 

• Monitoring I Evaluation I Assessment: The CDC and FDA are the principal PHEMCE 

agencies for monitoring the safety and performance ofMCMs that have been deployed in 

response to public health emergencies response. 

Concerns have been raised about the length of time it takes to classify a hazardous pathogen 

as a material threat and then approve the development of medical countermeasures. According 

to ASPR, it can take upwards of two years for the DHS to designate a pathogen as a material 

threat.21 For example, carfentanil, a highly potent form of fentanyl, was known as a weapon of 

mass destruction after Russian forces used it in the Moscow theatre against Chechen terrorists in 

2002,22 but pharmaceutical-based agents, such as fentanyl, were only recently added as a 

material threat. ASPR would like to reduce the time it takes for the DHS to designate a material 

threat to 90-days or less. 23 After a pathogen is classified as a material threat, PHEMCE can 

approve the development ofMCMs for a material threat. ASPR is currently considering other 

steps that could reduce the timeframe to approve countermeasure development while still 

maintaining an adequate level of input from all PHEMCE partners and experts, and hopes to 

devise a plan to reduce the MCM development time frame by year's end24 

19 Kadlec, supra note 3. 

20 !d. 

21 Briefing by staff, U.S. Dep't of Health & Human Services, Assistant Sec'y for Preparedness and Response with 

staff. H.Comm. on Energy and Commerce, June 11,2018. 22 See, e. g. Erika Kinetz and Maria Danilova, Lethal chemical now used as a drug haunts theater hostages, 

Associated Press, Oct. 8, 2016, https://apnews.com/256605b7679d4a61 bde9a8eac8906ea9. 23 Assistant Sec'y for Preparedness and Response, supra note 21 and E-Mail from staff, Assistant Sec'y for 

Preparedness to staff, H. Common Energy and Commerce (June 12, 2018 9:13am). 24 Assistant Sec'y for Preparedness and Response, supra note 21. 
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Strategic National Stockpile 

The CDC is the primary federal agency responsible for public health surveillance, 

epidemiologic investigations, and public health communications. The CDC is also currently 

responsible for managing the Strategic National Stockpile (SNS), though the President's Fiscal 

Year (FY) 2019 Budget Request transfers SNS management authority from the CDC to HHS' 

ASPR25 

The SNS is a federal repository ofMCMs such as vaccines, antibiotics, and other medical 

supplies that are to be used in public health emergencies. 26 For FY 2018, the SNS received a 

total of$610 million, including supplemental funding included in the omnibus spending bill 

passed earlier this year. Since FY 1999, the federal government has appropriated more than 

$9.15 billion to the SNS, with annual SNS funding levels significantly increasing in the years 

following the September 11, 2001, terror attacks and 2001 anthrax attacks.27 

Through coordination with the PHEMCE, CDC's current responsibilities regarding the 

SNS include MCM procurement, shelflife analysis, and MCM replenishment. In addition, the 

CDC, through its Office of Public Health Preparedness and Response (OPHPR), is also 

responsible for the delivery of MCMs to areas that have been affected by public health 

emergencies. OPHPR also provides training to state and local medical personnel and public 

health officials on how to properly receive and distribute MCMs from the SNS in the case of a 

public health emergency. In 2017, OPHPR provided such training to more than 3,700 state and 

local personnel and led a total of 12 medical emergency simulation exercises. 28 

Stockpile Responses 

25 U.S. Dep't of Health & Human Services, Centers for Disease Control and Prevention, Fiscal Year 2019 

Justification and Estimates for Appropriation Committees, available at 

https://www.cdc.gov/budget/documcnts/fY20 19/fY-20 19-cdc-congressional-justi fication.pdf. 26 42 U.S.C. § 247d-6b. 27 Source: Total tabulated from tables in Congressional Research Service e-mail to staff, H. Comm. on Energy and 

Commerce (June l, 20 18). 28 Centers for Disease Control and Prevention, Public Health Preparedness and Response 2018 National Snapshot, 

available at https://www.cdc.gov/phpr/pubs-links/20 18/documents/20 18 _Preparedness_Report.pdf. 
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Over the last few years, independent audits have raised concerns over CDC's logistical 

management of the SNS. In June 2017, HHS' Office oflnspector General (OIG) issued a report 

which called into question the readiness of the CDC to effectively deploy SNS resources during 

a public health emergency. 29 In its review, OIG identified "systemic issues [that] could put at 

risk approximately $7 billion of Stockpile inventory and negatively affect Stockpile readiness 

during a national emergency."30 The OIG's conclusion was based on a review of findings from 

each of five SNS site audits that covered FYs 2013 and 2014, and additional information related 

to the value of the SNS, security, and funding. 

Questions have also been raised about the SNS Division of State and Local Readiness 

(DSLR), which oversees expenditures of about $8.6 million. The DSLR initiatives are meant to 

ensure that local partners have the resources and training in place to distribute and properly use 

products from the SNS in the event they need to be deployed. ASPR, however, has identified 

concerns with state and local partners' current state of readiness, specifically regarding "last 

mile" distribution and how quickly partners are able to distribute products on the ground after 

receipt from SNS.31 Among the concerns highlighted by ASPR is that state and local partners 

currently do not know what products are in the SNS and therefore do not know how to properly 

deploy the products.32 To improve state and local readiness, ASPR intends to bolster education 

and training programs so local partners and first responders have familiarity with SNS products. 

ASPR also intends to review assessment tools used to rank state and local partners' readiness 

status and to design an array of distribution models that could be implemented by local entities to 

improve their response plans. 33 

Other issues raised regarding the CDC's management of the SNS include instances in 

which the.CDC failed to fund the procurement of an MCM for the SNS after the MCM's 

development and FDA approval.34 For example, there have been instances where BARD A has 

had to use Project Bioshield funding to procure MCMs that have been FDA-approved but were 

not ultimately purchased by the SNS. The reason for this was due to the fact that the government 

has to not only ensure that the specific MCMs remain available, but also must sustain a company 

since they are developing MCMs that do not have a traditional commercial market. Some of the 

MCMs that have been produced in this manner include: anthrax vaccine adsorbed; axibacumab; 

and obiltoxaximab.35 

Recently, members of the Blue Ribbon Study Panel on Biodefense wrote to Dr. Robert 

Kadlec, HHS ASPR, with a number recommendations to enhance the United States' MCM 

infrastructure. Included among the Panel's recommendations were proposed SNS management 

29 U.S. Dep't ofHea1th & Human Services, Office oflnspector Gen., Readiness of CDC's Strategic National 

Stockpile Could Be at Risk in Case of a Public Health Emergency (A-04-16-03554) (June 20 17) available at 

https://oig.hhs.gov/oas/reports/region4/41603 5 54RI B.pdf. 

30 !d. 

31 Assistant Sec'y for Preparedness and Response, supra note 21. 

32 !d. 

33 !d. 34 E-Mail from staff, Assistant Sec 'y for Preparedness to staff, H. Comm on Energy and Commerce (June 12, 2018 

4:02pm). 

35 !d. 
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reforms, which, according to the Panel, were precipitated by the CDC's inadequate management 

of the SNS36 

Pursuant to the President's FY 2019 budget, the transfer of the SNS from the CDC to the 

ASPR will be effective October I, 2018_37 According to HHS, the benefits of moving the SNS to 

ASPR include that: (I) a unified command for the SNS as the reorganization will vest the MCM 

production and stockpiling responsibilities with a single agency; (2) ASPR's mission is more 

targeted than that of the CDC's, enabling it to be a better advocate for the SNS; and (3) ASPR 

has established relationships with state/local emergency responders, who would play a critical 

role in a SNS deployment.38 

National Pre-Pandemic Influenza Stockpile 

In November 2005, the White House Homeland Security Council issued the National 

Strategy for Pandemic Influenza, designating HHS as the department to lead the nation's medical 

response to pandemic influenza.39 According to the CDC, a pandemic influenza occurs when a 

new influenza A virus emerges, usually originating in animals, that is able to easily spread from 

person to person due to lack of effective treatments and acquired immunity.40 The National 

Strategy also emphasized the need to ensure that the nation had an adequate MCM production 

capacity and stockpile to respond to potentially pandemic strains ofinfluenza.41 The Homeland 

Security Council reiterated the importance of having a pre-pandemic MCM stockpile in its 

National Strategy Implementation Plan, which was released in May 2006, categorizing the 

pandemic threat as a national security issue. 42 

BARDA, which was established by the Pandemic and All-Hazards Preparedness Act, is 

responsible for the procurement and management of the nation's pre-pandemic influenza 

stockpile as well as the development of influenza MCMs. BARD A is also tasked with 

accelerating the development and procurement ofMCMs related to chemical, biological, 

radiological, and nuclear threats as well as threats related to emerging infectious diseases.43 

36 Letter from the Blue Ribbon Study Panel on Biodefense to Hon. Robert Kadlec, M.D., Assistant Sec'y for 

Preparedness and Response, U.S. Dep't of Health & Human Services (May 15, 2018) (on file with the Committee). 37 U.S. Dep't of Health & Human Services, Fiscal Year 20I9 Public Health and Social Services Emergency Fund 

Justification of Estimates for Appropriations Committee, available at https://www.hhs.gov/sites/defaultlfiles/fy2019-phssef-cj.pdf. 

38 Id 39 Executive Office of the President of the United States, Homeland Security Council, National Strategy for 

Pandemic Influenza, Nov. 2005 available at https://www.cdc.gov/flulpandemic-resources/pdf/pandemic-influenzastrategy-2005.pdf. 

4

° Centers for Disease Control and Prevention, Influenza (Flu) Questions and Answers, available at 

https://www.cdc.gov/flulpandemic-resources/basics/faq.html (last updated May 15, 2017). 41 Executive Office of the President, supra note 39. 42 Executive Office of the President of the United States, Homeland Security Council, National Strategy for 

Pandemic Influenza Implementation Plan, May 2006 available at https:llwww.cdc.govlflulpandemicresourceslpdflpandemic-influenza-implementation.pdf. 

43 42 U.S.C. § 247d-7e. 
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In June 2017, and at the Committee's urging,44 HHS issued an update to its Pandemic 

Influenza Plan, which was initially published in 2005 and had been last updated in 2009.45 In the 

2017 update, HHS stated that the national pre-pandemic influenza stockpile "satisfies 

requirements for vaccine and adjuvants to address influenza viruses that are assessed to be the 

highest risk for human infection."46 BARD A, in collaboration with other HHS agencies, utilizes 

CDC's Influenza Risk Assessment Tool (IRA T) to assess pandemic risks that are associated with 

emerging novel influenza viruses and make determinations regarding a potential update to the 

pre-pandemic stockpile or the development of new vaccine candidates.47 

CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial 

research to tackle the global rising three of drug-resistant bacteria.48 With more than $500 

million to invest between 2016 and 2021, CARB-X funds the research and development of new 

antibiotics, vaccines, rapid diagnostics and other life-saving products to tackle the global threat 

of drug-resistant bacteria. CARB-X was created in response to the U.S. government's 2015 

Combating Antibiotic Resistant Bacteria (CARB) initiative, and the United Kingdom's 

government's call in 2016 for concerted global effort to address the growing drug-resistance 

public health crisis. Launched on July 28,2016, CARB-X is a cooperative effort between 

BARD A and the NIAID. CARB-X is funded by BARD A and Wellcome Trust, the world's 

largest medical charity which is based in the U.K. 

D. Science, Safety and Security of Laboratories in the Life Sciences-Biodefense 

Complex 

Currently, there are about 1,200 high-containment laboratories in the U.S. conducting 

research on diagnostics and cures for highly dangerous pathogens. For more than a decade, the 

Subcommittee has held hearings and conducted investigations related to the Federal Select Agent 

Program, including on the safe handling of federal select agents and other dangerous pathogens. 

Federal Select Agent Program 

The Federal Select Agent Program regulates the possession, use, and transfer of 

biological Select agents and toxins to ensure laboratory research conducted on the materials is 

done in a safe and secure manner. Sixty-six select agents and toxins that could potentially be 

44 See Letter from the Hon. Greg Walden, Chairman, H. Comm. on Energy and Commerce, eta!., to Hon. Thomas 

Price, M.D., Sec'y, U.S. Dep't of Health & Human Services (Apr. 20, 2017), available at https://archivesenergycommerce.house.gov/sites/republicans.energycommerce.house. gov/files/ documents/20 170420HHS. pdf. 45 U.S. Dep't of Health and Human Services, Pandemic Influenza Plan 20!7 Update (last visited June 7, 2018) 

available at https://www.cdc.gov/flu/pandemic-resources/pdf/pan-flu-report-20 17v2.pdf. 

46 !d. 47 See Letter from Hon. Nicole Lurie, M.D., Assistant Sec'y for Preparedness and Response, U.S. Dep't of Health & 

Human Services to Hon. Fred Upton, Chairman, H. Comm. on Energy and Commerce (Mar. 15, 2016) available at 

https://archivesenergycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/documents/114/letters/20 160229HH 

S%20Response.pdf. 

48 CARB-X, About CARB-X, https://carb-x.org/about/overview/ (last visited June II, 2018). 
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used in bioterrorist attacks including anthrax, smallpox, and plague- are currently regulated 

through the program. Managed jointly by HHS and the USDA, the program provides oversight 

of more than 275 entities that have registered through the program in order to conduct research 

on the hazardous pathogens.49 

The Federal Select Agent Program was established in 1996 through the passage ofthc 

Antiterrorism and Effective Death Penalty Act. The law, passed in the aftermath of the 

Oklahoma City bombing, required HHS to identify a list biological agents and toxins that could 

threaten public health and safety and establish regulations regarding the transfer of those agents. 

The September 11, 200 l, terrorist attacks and the 2001 anthrax mailings led to increased concern 

about the threat ofbioterrorism attacks, and additional restrictions which banned certain 

individuals from transporting or receiving select agents were included in the USA Patriot Act of 

2001. 5

° Congress expanded the program through the passage of the Public Health Security and 

Bioterrorism Preparedness and Response Act of 2002 to include regulation of the transfer and the 

use and possession of select agents and increased safeguards and security requirements. 

Concerns raised by the mishandling of dangerous pathogens prompted the Committee to 

request an assessment of the select agent program by the GAO. In response to the Committee's 

request, the GAO reviewed oversight procedures of the select agent program and issued a report 

in October 2017 that highlighted deficiencies in the program's capabilities. 51 The report raised 

concerns about potential conflicts of interest as the select agent program is not independent from 

all the laboratories it oversees. The report also noted that the program has historically focused 

more on security and preventing thefts of select agents and toxins than on biological safety issues 

within the labs using the pathogens for research. The Subcommittee, which has held multiple 

hearings on the select agent program and safety lapses at federal labs, questioned USDA and 

CDC officials about the GAO report's conclusions and recommendations at a November 2, 2017, 

hearing. 52 

Prioritizing lab science and safety 

Following the 2014 incidents involving anthrax mishandling at the CDC and the 

smallpox discovered in storage for an FDA lab on the NIH campus, federal efforts intensified to 

improve the management of government labs. In particular, an external scientific working group 

recommended improvements to the CDC and FDA for overhauling their lab safety programs. 

This included the recommendation that a program director would be a single point of 

accountability and would have a direct reporting relationship to the head of the agency. When 

StephanS. Monroe, the CDC's Associate Director for Laboratory Science and Safety (ADLSS), 

testified before the Subcommittee in April2016, he said the formation of the director position 

49 Federal Select Agent Program, About Us, https://www.selectagents.gov/about.html (last visited June 11, 2018) 50 See USA Patriot Act of2001, Pub. L. No. 107-56, 115 Stat. 272 (2001). 51 U.S. Gov't Accountability Office, Coordinated Actions Needed to Enhance the Select Agent Program's Oversight 

of Hazardous Pathogens, GA0-18-145 (Oct. 2017) available at https://www.gao.gov/assets/690/687868.pdf. 52 See Concerns Over Federal Select Agent Program Oversight of Dangerous Pathogens Before the Subcom. on 

Oversight and Investigations of the H. Comm. on Energy and Commerce 115th Cong. (2017) available at 

https:l/docs.house.gov/meetingsllF/IF02/20 171102/1 06574/HHRG-115-IF02-Transcript-20171102.pdf. 
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was "the most fundamental change implemented in the wake of the 2014 incidents."53 Further, 

Dr. Monroe noted that the fact that the ADLSS reported directly to the CDC director provided 

"high-level oversight and coordination of critical laboratory policies and operations" across all 

CDC campuses. 

In response to the 2014 safety lapses, 5

4 the FDA's Office of Laboratory Science and 

Safety (OLSS) was formed in order to provide oversight and to improve security and safety 

across all divisions of FDA. The formation of the office was announced in 2016 as a means to 

consolidate oversight responsibilities and standard policies for all FDA laboratories. In 2017, the 

FDA issued a strategic plan outlining the goals of the new office. 

According to the OLSS strategic plan, the office's mission is to: 

• Ensure FDA's laboratories and workplaces are operated in a safe and secure 

manner to protect employees, the surrounding communities, and the environment; 

• Research and disseminate innovative ideas and validated methods for safe and 

secure laboratory practices; 

• Support high-quality (i.e., accurate, reliable, and timely) FDA laboratory results; 

and 

• Promote a culture of shared responsibility and safety. 55 

Just as the ADLSS was organized to directly report to the CDC Director, the OLSS was 

also envisioned to directly report to the FDA Commissioner. A reorganization issued by the 

FDA in 2017 made the OLSS a direct report to the FDA Commissioner. 56 However, the FDA 

now plans to have the OLSS report to the Office of the Chief Scientist instead of directly to the 

Commissioner. 57 

In addition, the budget and staffing for the OLSS have not been consistent. In 2016, the 

FDA informed the Committee that the office's budget for FY 2017 was $5.2 million and that it 

would support 13 full time employees. 5

8 FDA officials subsequently told Committee staff that 

the FY 2017 budget for OLSS was $9 million, but that funding levels would support not just 

53 Laboratory Safety at the Centers for Disease Control and Prevention Before the Subcomm. on Oversight and 

Investigations of the H. Common Energy and Commerce, !14th Cong. (2016) (written testimony ofHon. StephanS. 

Monroe, PhD., Assoc. Dir. for Laboratory Sc.ience and Safety, Centers for Disease Control and Prevention) 

available at https://docs.house.gov/meetings/IF/IF02/20 16042011 04823/HHRG-114-JF02-Wstate-MonroeS20160420.pdf. 

54 Brady Dennis and Lena H. Sun, FDA found more than smallpox vials in storage room, WASH. POST, July 16, 

2014, https://www.washingtonpost.com/nationallhealth-science/fda-found-more-than-smallpox-vials-in-storageroom/20 14/07!16/850d4b 12-0d22-ll e4-8341-b8072b I e7348 _ story.html. 55 U.S. Food and Drug Admin., 2017-2022 Operating Model- Office of Laboratory Science and Safety, Updated 

Oct. 13, 2017, available at https://www. fda.gov/downloads/ AboutFDA/CentersOffices/OC/OLSS/UCM5830 16.pdf. 56 See 82 Fed. Reg. 34540 (July 25, 2017) available at https://www.federalregister.gov/documents/2017/07/25/2017-

15564/office-of-the-commissioner-statement-of-organization-functions-and-delegations-of-authority. 

57 Briefing by staff, U.S. Dep't of Health & Human Services, U.S. Food and Drug Admin. with staff, H. Comm. on 

Energy and Commerce, June 11, 2018. 58 Letter from Dayle Cristinzio, Acting Assoc. Comm'r for Legislation, U.S. Food and Drug Admin., to Hon. Fred 

Upton, Chairman, H. Comm. on Energy and Commerce. (Sept. 9, 2016) (On file with the Committee). 
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OLSS operations (including staff and contractor support) but also the Employee Safety and 

Environmental Management staff that were transferred to OLSS. 59 The FDA later informed the 

Committee that no permanent full-time employees (FTE) were hired by OLSS in FY 2017, rather 

the office recmited 19 individuals through temporary detail assignments and contract support. 60 

In a briefing with Committee staff, the FDA confirmed that the office's FY 2018 budget is $5.6 

million and the FY 2019 budget is $6 million.61 The office currently employs three FTEs and 

three contractors. At this time, FDA has not reported the total number of FDA laboratories to the 

Committee staff. FDA has not yet reported to the Committee the number of audits that OLSS 

has conducted. 

By contrast, the CDC's ADLSS office's FY 2016 budget was $14.5 million and 

supported 34 FTEs. 62 As of this month, the office had 43 FTEs with three slots vacant and 

oversaw audits of laboratories used by 239 teams of scientists. 63 The CDC recently reported to 

Committee staff that it had submitted a proposed reorganization to the Department that would 

eliminate the Associate Director's direct reporting relationship to the Director, and instead would 

report to a Deputy Director64 

III. ISSUES 

The following issues may be examined at the hearing: 

• How timely are the PHEMCE decisions regarding biological threats being made? Can 

the timeliness of these decisions be improved? 

• How can the number of FDA-approved assays for threat agents be increased? 

• Is there adequate oversight to ensure the efficacy of MCMs in the SNS and the prepandemic vaccine stockpile? 

• Are U.S. public health agencies implementing recommendations to improve laboratory 

science and safety? 

59 E-Mail from staff. U.S. Food and Drug Admin. to staff, H.Comm. on Energy and Commerce (May 17,2017, 

3:57pm) (On file with the Committee). 60 E-mail rrom staff, U.S. Food and Drug Admin. to staff, H. Comm. on Energy and Commerce (Aug. 20,2017, 

I 2:50pm) (On file with the Committee). 61 U.S. Food and Drug Admin., supra note 57. 62 Letter rrom Hon. Fred Upton, Chairman, H. Comm. on Energy and Commerce and Hon. Tim Murphy, Chairman, 

H. Comm. on Energy and Commerce, Subcomm. on Oversight and Investigations to Hon. Robert M. Califf, M.D. 

Comm'r, U.S. Food and Drug Admin. (May 18, 2016) (citing E-mail from staff, Centers for Disease Control and 

Prevention to staff, H. Comm. on Energy and Commerce (Apr. 15, 2016)) (On file with the Committee). 63 Briefing by staff, U.S. Dep't of Health & Human Services, Centers for Disease Control and Prevention with staff, 

H. Comm. on Energy and Commerce, June 8, 2018. 64 /d. 
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Majority Memorandum for June 15,2018, Subcommittee on Oversight and Investigations 

Hearing 

Page 14 

IV. STAFF CONTACTS 

If you have any questions regarding this hearing, please contact Alan Slobodin, 

Christopher Santini, or Andrea Noble of the Committee staff at (202) 225-2927. 

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35127.053

r-;;LUE RIBBON 'STUDY PANEl ON SIODEFENSE 

May 15,2018 

The Honorable Robert Kadlec 

Assistant Secretary for Preparedness and Response 

U.S. Department of Health and Human Services 

200 Independence Ave., SW 

Washington, DC 20201 

Re: Transforming medical countermeasure technology and partnerships 

Dear Dr. Robert Kadlec: 

The Blue Ribbon Study Panel on Biodefense recently moderated two roundtables to identify ways to overcome some of 

the most vexing medical countermeasure (MCM) technology, business, and policy challenges across the biological 

threat domain. Private sector pharmaceutical, scientific, academic, and governmental affairs representatives attended 

and were joined at the second meeting by federal officials from the Department of Agriculture (USDA), Department of 

Defense (DOD), Department of Health and Human Services (HHS), and the White House. 

The MCM assets now available to civilians and to military personnel have grown substantially in the last decade. The 

partnerships needed to continue to build these assets to meet persistent and advancing biological threats, however, are 

now at considerable risk. Real and perceived under~investment, unsustained investment, process uncertainty, and 

strategic disparity undermine what must be a vibrant enterprise. We maintain that advancing the national MCM 

infrastructure needed for research, development, and procurement will reduce the risk associated with biological 

warfare, bioterrorism, emerging infectious diseases, and biological accidents. We urge you to demonstrate your 

commitment to this core national security function by advancing the following recommendations. 

1. Integrate animal health into the national security approach to medical countermeasures. The gross 

inequality between human and animal funding levels and the segregation of research between the two sectors 

constitute a national security liability. Many material threats. select agents, and emerging infectious diseases are 

human diseases with veterinary counterparts, some of which regularly cause outbreaks elsewhere in the world in 

livestock and wildlife. Yet conversations about the protection of human health by controlling emerging infectious 

diseases in animal hosts have been extremely limited, and the authority of animal health agencies to regulate has 

been based on animal health, not public health. 

a. Establish a framework for combatting emerging infectious diseases. Most emerging infectious diseases in 

people originate in animals. No MCM were ready when the largest Ebola outbreak the world had ever seen 

-likely caused by a spillover from bats to humans- occurred. In the preceding years, the government had 

not sufficiently determined what to fund with its limited resources. At present, HHS prioritizes efforts to 

address biological threat agents via Department of Homeland Security material threat determinations 

(MTDs), but the U.S. government has not instituted and budgeted for an analogous process for emerging 

infectious diseases. In accordance with Blue Ribbon Study Panel Recommendation 7c (A National 

Blueprint ji1r Biodefen'", 20 15), HHS, in coordination with DOD and USDA, should create a similar 

prioritization framework for emerging infectious disease threats. This framework should address pathogens 

and pathogen families with the potential to cause a catastrophic public health emergency and include agents 

known to infect wildlife and domestic animals. It should drive funding for MCM development and other 

areas (e.g., biosurveillance, response planning) and engage and motivate the private sector to develop and 

manufacture MCM. Funders must establish a vision for an emerging infectious disease MCM enterprise, 

define what constitutes successful emerging infectious disease MCM, and communicate this vision along 

with specific product requirements to industry partners. 
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Blue Ribbon Study Panel on Biodefense Medical Countermeasure Reform Page2 

b. Make USDA part of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE): 

BARD A was envisioned to be part of- not the entire- MCM enterprise. USDA should also participate in 

PHEMCE. Many diseases that could necessitate USDA MCM acquisitions are the same for DOD and HHS. 

USDA also has lessons to share about how it works with industry to develop effective MCM for production 

animals, a market in which the cost must be low and eflicacy must be high. Some veterinary companies are 

already using platforms to develop their animal products, and the veterinary development time line is much 

shorter. This means animal health pharmaceutical companies get products to market earlier. These 

companies also possess extensive experience in areas like animal models and manufacturability that can 

help inform human MCM endeavors. These experiences are relevant and should not be ignored. 

c. Require animal disease risk assessment. USDA should develop a risk assessment for animal diseases and 

work with HHS to assess the risk of diseases with zoonotic potential. USDA should assess the ability of the 

National Veterinary Stockpile to deploy sul1icient MCM to combat high-consequence animal diseases 

within 24 hours of request. USDA should also use these risk assessments to prioritize the pathogens 

identified on the USDA High-Consequence Foreign Animal Diseases and Pests list. USDA should use the 

findings to inform its budget request; drive federal priorities for MCM innovation; and incentivize publicprivate partnerships to develop, transition, approve, license, and procure these products. 

2. Reduce market and process uncertainty at BARD A. Variability and lack of certainty are two of the foremost 

hurdles to expanding industry participation in MCM advanced development and manufacturing. Indeed, these 

hurdles may prove so significant for some companies, even those that have successfully delivered MCM, that 

they may exit the market entirely. Although all biopharmaceutical ventures carry risk, larger companies can 

manage this risk through a balanced portfolio of projects, the most successful of which can yield a high return on 

investment. Pervasive market uncertainty in the far less profitable MCM enterprise makes business endeavors 

unattractive and unsustainable. 

a. Create fiscal certainty. In order to develop national security MCM, industry partners forego potential profit 

margins orders of magnitude higher than for commercial products. These companies need certainty in 

procurement to convince them and their investors that engaging in MCM development makes reasonable 

business sense. The annual appropriations process for advanced development and procurement, and 

dependency on emergency supplemental appropriations for unanticipated threats, make doing business with 

companies that base their operations on multi-year outlooks and planning unsustainable. In accordance with 

Blue Ribbon Study Panel Recommendation 28b (A National Blueprint for Biodefense, 20 15), 

Congress must reinstate the advanced appropriation for Project BioShieid for ten years at a minimum of 

$7.1 billion. Additionally, in accordance with Blue Ribbon Study Panel Recommendation 28c, Congress 

and the HHS Assistant Secretary for Preparedness and Response (ASPR) should address prioritization and 

the need for guaranteed, sustained funding for pandemic influenza preparedness. The appropriation levels 

must be tied to rigorously established MCM requirements based on risk analysis. 

b. Create process certainty: In the last several years, the f IHS Biomedical Advanced Research and 

Development Authority (BARDA) noticeably shifted away from process and partnership toward product. 

Prioritizing products over partnerships has damaged partnerships and preparedness. The rules governing 

BARD A and DOD processes for advanced development and manufacturing should be defined with industry 

partners up front and with far greater clarity and commitment. Companies need to understand when and 

how much of their proposed product the government will procure. as the frequent moving of goalposts 

throughout development and procurement creates an untenable business environment For projects in which 

the government is not interested, federal public health security leaders need to relay that quickly (i.e., white 

papers should be reviewed and comment provided within 45 days). The BARDA process at this stage of 

review should be more like that of the Defense Advanced Research Projects Agency (DARPA), for which 

program managers, not contracting officers, are the central deciding figures. 

3. Accelerate platform technologies. One way to create MCM quickly, safely, and effectively for unpredictable 

emerging infectious diseases and outbreaks is to develop a suite of platfonn technologies. Generally, platform 

technologies rely upon a common manufacturing process backbone that uses a standard process to insert foreign 

genes. By relying upon a well-established manufacturing process and customization though standardized 

processes, platform technologies can reduce the risk associated with development. These production platforms 

may be based on, but not limited to, RNA expression systems; DNA cloning vectors; various virus, plant, or 
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Blue Ribbon Study Panel on Biodefense- Medical Countermeasure Reform Page3 

bacterial expression vectors; and viral-vectored vaccines. With targeted government and industry investments, 

these technologies could come to fruition within three to four years, especially for vaccines and diagnostics. To 

mature the technology, however, the government must mature the way it invests in the technology and ensure that 

partnership and business plans accompany technical plans for leveraging any platform capability. There is 

presently no business model in place that addresses how the government can work with industry to develop MCM 

platforms. At a minimum, elements of certification, expedited review, and the role of the HHS Centers for 

Innovation in Advanced Development and Manufacturing must be addressed. 

a. CertifY platforms: The Food and Drug Administration (FDA) approves products, not platforms. FDA, in 

consultation with DOD, BARDA, and other PHEMCE partners, should establish an MCM platform 

certification process. A regulatory construct that allows for the consideration of a company's novel platform 

as a basis for future MCM products would serve as an industry incentive. Its establishment would 

effectively reduce the risk of future product development using that platform. Determining what constitutes 

a platform will be difficult, but the definition should include a regularized chemistry, manufacturing, and 

controls (CMC) process and standardized general release criteria. The USDA Center for Veterinary 

Biologics policy, "Licensing Guidelines for Production Platform-Based, Non-Replicating, Nonviable 

Products," allows for rapid swapping of closely related immunogenic determinants, and could provide a 

starting point from which FDA could build a platform certification process for human products. 

b. Priority review platforms: The platform certification process described above is likely to be extensive and 

should result in a thorough FDA understanding of the platform technology (e.g., CMC, clinical experience). 

This advanced understanding will enable subsequent review by the FDA under the expedited Priority 

Review process of other products based upon that certified platform. FDA commitment to the accelerated 

approval times associated with Priority Review for subsequent products utilizing a certified platform would 

provide significant incentive for industry to utilize appropriate platform technologies. 

c. Leverage CIADMs,' The HHS ClADMs and the DOD MCM Advanced Development and 

Manufacturing facility (ADM) were envisioned to make such platform-based products a reality. They could 

enable advanced development and manufacturing of platform technologies if aggressively integrated into 

the product development process. They should become places where companies want to go to advance their 

promising technologies. They should shrink development schedules and address significant business 

difficulties. At present, two major challenges prevent this: small companies are concerned about protecting 

their intellectual property when handed over to a privately owned ADM with its own MCM interests, and 

large companies are concerned about risks to their commercial business during regulatory review. The Salk 

Institute, a private nonprofit organization, was essentially the forenmner of what we think of as an ADM 

today, and BARD A should consider Salk's example as it revisits the business model for these kinds of 

facilities. DOD and BARDA should undertake planning for ClADM reconfiguration immediately. Planning 

should include industry and all federal agencies with MCM responsibility. Considerable thought must be 

given to contracting reform (discussed below) as the Federal Acquisition Regulation (FAR)-based, costreimbursable contract system in place does not work. An independent assessment (outside of DOD and 

HHS) of the existing CIADM model is needed to support this rcconfiguration. This planning must consider 

the role of the USDA and its industry partners in using the CIADMs to enable mutually beneficial 

technologies and to keep the facilities in use. 

4. Reform FDA process to develop products faster. We can get closer to on-demand MCM in just a few years and 

investments to improve production cycling by days or weeks are possible. These kinds of advances, however, will 

not provide the same near-tenn relief that FDA could achieved on release testing. Investment in enabling 

technologies must go, therefore, hand in hand with reform of regulatory process. FDA needs to be part of the 

advanced development process early on, describing what it wants to see in a product or an investigational new 

drug. Advances in the speed with which products are marketed should not compromise the FDA's high safety and 

efficacy standards. 

a. Standardize and clarifY regulatory process. The FDA, in collaboration with its upstream development 

government partners, must address development and standardization of regulatory processes that will 

provide needed transparency to MCM developers. The MCM industry needs to understand all elements of 

the process, and the government needs to mitigate the inherent risk. Several areas of regulatory reform 

should be considered- for example, reducing risk associated with clinical trials, and allowing companies to 
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Blue Ribbon Study Panel on Biodefense- Medical Countermeasure Reform Page4 

focus their resources on development. Through P.L. 115-92, Congress authorized DOD to request, and FDA 

to provide, assistance to expedite the FDA review process for MCM for military personnel. DOD and FDA 

have now put a work plan in place to coordinate planning for this process. FDA and BARD A should 

develop a parallel plan. Expedited release testing and a plan for increased usage of emergency use 

authorizations (EUAs) should be addressed as part of this plan. 

b. Expedite release testing: Even with a vaccine platfonn, the response time to produce a vaccine for the 

foreseeable future will be 6-12 months for mass-produced product. While maintaining safety and efficacy 

standards, acceptable FDA release testing during an outbreak might be different from acceptable release 

testing at other times. FDA should consider options. For instance, FDA might release products for use on an 

interim basis with final release testing to follow. FDA might identify suitable surrogates in place of full 

toxicology panels- or at least utilize a process to pre-identify what those surrogates would be. FDA should 

describe what an accelerated schedule would look like in an emergency. This will be especially important 

for platforms that could address multiple infectious diseases. Once in place, manufacturers could then 

propose specific schedules for a given MCM. 

c. Examine increased usage of Emergency Use Authorizations: EUAs are designed for those MCM that are 

sufficiently well characterized to be oflikely clinical benefit in an emergency. FDA essentially certifies that 

a given MCM fulfills EUA requirements. FDA should detennine when more aggressive utilization ofEUAs 

would be appropriate. 

5. Improve contracting authorities. BARD A must be empowered to make decisions in the best interest of 

fulfilling its mission. This means ensuring that the contracting process is as smooth, flexible, and transparent as 

possible. Other Transactional Authority (OTA) is most prominent among the existing contracting authorities that 

would incentivize MCM partnerships, yet it is utilized very rarely and limited by the statute that provided OTA 

authority to BARDA. 

a. Amend the OTA statute. Congress modeled the OTA authority addressed in the Pandemic All-Hazards 

Preparedness Act (PAHPA) after DOD's OT A statute. In its reauthorization of PAHPA, Congress should 

customize OTA authority to fit BARDA's needs. Congress should also remove references to DOD and the 

need for approval by the senior executive for projects above $20 million (as it did previously for DOD). 

OTA contracts should become far more common than they are now, perhaps as common if not more than 

FAR-based contracts. 

b. Adopt OTAfor the CIADMs: FAR-based contracting does not work for rapid response procurements. 

Using OTA for the ADMs is critical to prevent abandonment of partnerships when rapidity is imperative, 

when the science does not go as planned, and when intellectual property and FAR-based requirements arise. 

DOD has adopted this OTA-based model for its ADM. 

c. Move contracting authority back to BARDA. In accordance with Blue Ribbon Study Panel 

Recommendation 29a (A National Blueprint for Biod0fense, 2015), and the 21" Century Cures Act Section 

3082, contracting authority should be the exclusive responsibility of BARD A, not the office of Acquisition, 

Management, Contracts and Grants in the Office of the ASPR. This move must be finalized. 

6. Foster innovation and new capabilities. The government often bases MCM-related plans on budgets instead of 

basing budgets on need. A similar mindset is seen with the government's approach to industry, often issuing 

solicitations to assess existing capabilities, rather than fostering new capabilities to meet national security needs. 

At the time of its authorization in PAHPA, Congress envisioned BARDA to be on the leading edge ofMCM 

innovation. Over the past decade, BARDA has focused on more, well-established, product development 

technologies and investments in technologies closer to full maturity. This approach certainly justified much of the 

development portfolio. Live viral vaccine platforms and therapeutics based on monoclonal antibodies may well 

provide near- to medium-term solutions. Yet BARD A needs to devote sufficient resources to novel and high-risk 

product development activities in parallel with their less risky investments. 

a. Invest in novel and high-risk products. Meeting emerging national security threats will require BARDA 

to employ a high-risk, high-reward model for at least a portion of its investments. Instead of issuing 

solicitations to assess current industry capabilities, agencies should aggressively work with the private 
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Blue Ribbon Study Panel on Biodefense- Medical Countermeasure Reform Page5 

sector to build capabilities to meet national security needs. While investment in tried-and-true 

technologies will remain important, aggressively pursuing technologies that fall outside BARDA's 

comfort zone is imperative. The 2 !"'Century Cures Act authorized the Director of BARD A to engage an 

independent. non-profit innovation partner. BARD A should leverage this opportunity to dedicate 

additional resources to high-risk, high-reward outputs. It should further consider the role of the animal 

sector in providing needed technological advancements. The animal sector has existing markets for 

certain pharmaceuticals (for instance, with respect to coronavimses and influenza viruses, which happen 

to be the most significant viral pandemic threats to the human population) that are lacking in in the 

human sector. A shared interagency approach to planning for, and funding in, such areas could' lead to 

needed innovative breakthroughs. Precedence for interagency funding mechanisms can be found in the 

funding HHS provided to USDA in 2009 to conduct domestic biosurveillance for swine influenza virus, a 

pathogen with minimal health impacts on the animal carrier but large potential impacts on public health. 

b. Invest in rapid diagnostics, The nation needs to invest far more in patient-side, point-of-care diagnostics. 

Diagnostics can guide prioritization of MCM resources, but MCM conversations often refer only to 

vaccines and therapeutics, omitting diagnostics altogether. Rapid diagnostics cannot continue to be an 

afterthought. In accordance with Blue Ribbon Study Panel Recommendation 30a (A National Blueprint 

for Biodejimse, 2015), DOD and BARDA need to invest in rapid diagnostics as a core element of their 

MCM portfolios. This work should identity generalized biomarkers that would enable such technologies. 

c. Drive decision-making witlt ear(v warning and predictive tools. Leadership has yet to embrace 

predictive science as a core capacity that can support traditional and transformative MCM development. 

Advances in genomics and proteomics, risk mapping, and biosurvcillance data analytics should all be 

leveraged to create early warning that could both inform and spare the stockpile. Budget requests and 

corresponding appropriations should support these efforts and ensure that they are an integral part of the 

federal MCM development and procurement strategy by aligning MCM investments with the threats 

identified through early warning programs. 

7. Establish end-to-end enterprise coordination. Although PHEMCE was envisioned as a coordinating body for 

the federal MCM enterprise, it has been too HI· IS-centric to do this effectively. Development of a far more 

forward-looking process -from idea to procurement to dispensing- is needed. As the Office of the ASPR 

reimagines the end-to-end nature of the enterprise, it has an opportunity to address some specific challenges in the 

current construct. 

a. Improve interagency product transitions. Successful research projects at the National Institutes of 

Health, DARPA, or other agencies, must begin competition anew for advanced development- if 

advanced development funding is even available or prioritized. This creates major bureaucratic hurdles to 

product advancement. The National Biodefense Strategy should direct the creation of more streamlined 

interagency transition mechanisms. A wards can be structured to assume transition from one agency to 

the next. 

b. Transfer management oftlte Strategic National Stockpile under specific conditions. In the President's 

Budget Request for FY 2019, the Administration moved management responsibility of the Strategic 

National Stockpile (SNS) from the Centers for Disease Control and Prevention (CDC) to the ASPR. 

CDC management of the SNS has been inadequate, resulting in industry confusion and losses when the 

agency suddenly decided to remove elements from the stockpile that it had previously approved. The 

Administration made this move, in part, to better enable HHS leadership to direct acquisition for, and 

deployment of, the SNS. The move has the potential to create a more cohesive development-todistribution structure and apply more process certainty to procurement decisions. Concems about how 

BARD A and the SNS will interact once the move is finalized, and whether investments made by 

BARD A will inadvertently or intentionally force the SNS to acquire those MCM it developed, must be 

addressed. Congress should authorize the transfer of management of the SNS to the ASPR only if it also 

requires the ASPR to fix SNS-related problems that the CDC and state, local, tribal, and territorial 

(SLTT) partners previously encountered or created, and to put controls in place to prevent automatic 

uptake ofBARDA products by the SNS just to demonstrate BARDA success. Congress should also 

direct the ASPR to establish a meaningful SNS training program for SLTT partners that focuses on more 
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Blue Ribbon Study Panel on Biod4ense- Medical Countermeasure Reform Page6 

than just anthrax, takes SL TT ability to distribute SNS pallets upon receipt into consideration, and does 

not assume distribution will occur the same as in the military. 

c. Produce an MCM response framework. In accordance with Blue Ribbon Study Panel Recommendation 

22a (A National Blueprint for Biodefense, 2015), the Office of the ASPR, CDC, and the Federal 

Emergency Management Agency should, together with non-federal partners, identify requirements and 

capacities needed to achieve successful distribution and dispensing of MCM from the SNS as well as 

from local caches. The framework they develop must address unresolved issues. A progressive and 

innovative approach should push beyond what a given agency might devise and the bureaucratic 

impediments associated with a federal-only distribution system. If implementation exceeds funding 

available through current grant allocations, additional funding must be requested. 

Thank you tor considering these findings and recommendations. Please contact Dr. Asha M. George, Panel Executive 

Director, at (202) 974-2416 or Asha.George@BiodefenseStudy.org with further questions. 

Sincerely, 

CC BARD A Director Rick Bright 

Jenn Alton 

~~· 

Thomas J. Ridget--
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GREG WALDEN, OREGON 

CHAIRMAN 

Dr, Rick A. Bright 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

ClCongre~~ of tbe Wntteb $tate~ 

~ourse of l\eprerswtatibe~ 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RA vsuRN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 (202)225-2927 

(202)225--3641 

July 12,2018 

Director, Biomedical Advanced Research and Development Authority 

Deputy Assistant Secretary, Office of the Assistant Secretary for Preparedness and Response 

U.S. Department of Health and Human Services 

200 Independence Avenue, S.W. 

Washington, DC 20201 

Dear Dr. Bright: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on June I 5, 

2018, to testify at the hearing entitled' "The State of U.S. Public Health Biopreparedness: Responding to 

Biological Attacks, Pandemics, and Emerging Disease Outbreaks." 

Pursuant to the Rules of the Committee on Energy and Commerce, the bearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Thursday, July 26, 2018. Your responses should be mailed to 

Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office 

Building, Washington, DC 20515 and e-mailed in Word format to Ali.Fulling@mail.house,gp_y. 

Thank you again for your time and eff011 preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

(J~~ Gregg Harper 

Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
103 


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House Energy and Commerce Committee 

Subcommittee on Oversight and Investigations 

"The State of U.S. Public Health Biopreparedness: Responding to Biological Attacks, 

Pandemics, and Emerging Infectious Disease Outbreaks" 

Dr. Rick Bright, Director of ASPR's Biomedical Advanced Research and Development 

Authority 

Friday, June 15,2018 

The Honorable Gregg Harper 

1) In the 2017 update to HHS' Pandemic Influenza Plan, HHS provided benchmarks 

for manufacturing and distributing vaccines during declared influenza pandemics. 

HHS stated that it aims to ensure that limited vaccine distribution occurs within 12 

weeks of a pandemic being declared, with distribution sufficient to meet overall 

public demand occurring within 16 weeks. Could you tell us why this process 

seemingly takes so long, and provide any recommendations for improving it? If the 

12 and 16-week benchmarks are HHS's goals, what are our current capabilities? 

ASPR Response: Domestic manufacturing capacity for pandemic influenza vaccine is a critical 

component of pandemic preparedness to ensure vaccine is available as soon as possible after 

emergence of a pandemic virus. ASPR/BARDA has made significant gains in pandemic 

influenza vaccine preparedness over the last 10 years, including supporting the licensure of 

faster, more flexible cell-based, recombinant and adjuvanted influenza vaccines and modernizing 

and expanding domestic manufacturing capabilities. These advancements have dramatically 

increased the domestic influenza vaccine antigen capacity increasing from 60 million doses to 

600 million doses. 

Building on these successes, and to ensure vaccine is available within 12 weeks of pandemic 

declaration, ASPRJBARDA has a multifaceted approach in place. First ASPR/BARDA is 

partnering with companies to support the development of novel technologies that rely less on 

viral growth properties to improve the speed and robustness of vaccine production. For example, 

ASPRJBARDA supported the first licensed recombinant influenza vaccine (Flublok®), and 

ASPRJBARDA continues to fund recombinant vaccine-related efforts, moving away from the 

slow, inflexible production of vaccine in eggs. Second, ASPRJBARDA is supporting the 

sustainment of domestic production capabilities to ensure vaccines are available when necessary. 

Third, ASPRJBARDA is supporting further development of recombinant and cell-based vaccines 

through comparative efficacy clinical studies to expand use indications for a broad range of highrisk and special populations. Fourth, ASPRJBARDA is supporting the addition of currently 

approved adjuvanted influenza vaccines for all ages into both seasonal and pandemic vaccines, 

while also developing additional adjuvant options that provide safe and enhanced effectiveness 

to influenza vaccines that are faster to produce. Lastly, ASPRJBARDA is targeting 

advancements in vaccine delivery and administration to develop new approaches that would 

1 
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reduce reliance on needles and syringes supply chain surge capacity and allow faster and more 

efficient immunization with pandemic vaccine. 

2) In general, what is the shelf-life for the H7N9 influenza strain vaccine that is in 

BARD A's pre-pandemic stockpile that will protect against the 2013 H7N9 strain? 

When was the last time BARD A performed a potency test on these vaccines? 

ASPR Response: The pre-pandemic vaccine made in eggs against the 2013 H7N9 avian 

influenza virus strain is very stable, with over 80% stability as of the last potency test conducted 

November, 2017. The most recent potency testing for the egg based vaccine was performed in 

May 2018 and we are awaiting results of this testing. 

3) How serious of a pandemic threat does the BARDA view the 5th wave H7N9 

influenza strain, currently circulating in China? If a pandemic were to occur, how 

severely would it impact public health? Is BARD A currently overseeing the 

manufacturing of a vaccine for storage in its pre-pandemic stockpile which will 

match this H7N9 influenza strain? 

ASPR Response: BARD A views the 5th wave H7N9 influenza outbreak as a serious concern, as 

reflected by the high Influenza Risk Assessment Tool (IRAT) score assigned by CDC. Since this 

assessment system, which assesses the threat of influenza viruses with pandemic potential, was 

initiated in 20 II, the 5th wave H7N9 strain has the highest Potential Impact Risk of any 

influenza strain evaluated. 

Given the human mortality rate seen to date, if the viruses changed to allow them to spread easily 

between humans, the impact on public health could be catastrophic in the absence of effective 

medical countermeasures such as vaccines. There is also evidence that some H7N9 influenza 

viruses may be resistant to most available antiviral drugs. 

In response, BARD A produced bulk vaccine, currently held in storage, which matches the 5th 

wave H7N9 strain. Additionally, the National Institutes of Health (NIH) and BARDA are 

conducting clinical trials to better understand optimal vaccination approaches in the event mass 

vaccinations are necessary. 

4) How much is BARD A currently spending on CARB-X? Does the agency anticipate 

maintaining this level of spending over the next five years? 

ASPR Response: BARD A established CARB-X in collaboration with the NIH's National 

Institute of Allergy and Infectious Diseases in 2016. CARB-X, an innovative public-private 

partnership that addresses the threat of antibiotic resistant bacteria, has received $85 million in 

support from BARD A over two years. CARB-X is also funded by the Wellcome Trust. In 2018 

the Bill &Melinda Gates Foundation and the United Kingdom Government's Department of 

Health and Social Care joined as funding partners. BARD A's support for new antibiotics and 

diagnostics is critical to address 21st century health security threats including genetically 

engineered bacterial pathogens, complications of bacterial infections as a result of exposure to 

priority threats such as nuclear and chemical agents, and to quickly identify bacterial pathogens 

and their susceptibility to antibiotics. BARD A anticipates continued support based on 

availability of funds. 

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5) What is the PHEMCE's role in making a material threat determination, and how 

can the length of time it takes for such a determination be reduced? 

ASPR Response: The Public Health and Emergency Medical Countermeasure Enterprise 

(PHEMCE), a Federal advisory and coordinating body led by ASPR, does have a role in advising 

on medical countermeasure requirements for national security material threats identified by the 

Department of Homeland Security (DHS). DHS 's newly established Countering Weapons of 

Mass Destruction Office issues material threat assessments (MTAs) and the Secretary of the 

Department of Homeland Security (DHS) issues material threat determinations (MTDs). MTAs 

and MTDs are done in collaboration with other interagency departments, but the responsibility 

for generating these national, strategic overviews and quantification of the threat is identified by 

statute (section 319F-2(c)(2) of the Public Health Service Act (42 U.S.C. 247d-6b(c)(2)), added 

by the Project BioShield Act of 2004") as a DHS authority and responsibility. The PHEMCE 

benefits from these determinations and uses them to forecast medical countermeasure 

requirements (type, quantity, special considerations). ASPR is currently working with other 

PHEMCE interagency partners to evaluate and identify opportunities to streamline and speed up 

these deliberative steps. We would be pleased to brief the Committee on potential process 

improvements after the evaluation is completed. 

6) After ASPR assumes operational control of the Strategic National Stockpile on 

October 1, 2018, what role will CDC play in support of the stockpile's mission? 

ASPR Response: ASPR recognizes and appreciates the tremendous expertise of CDC subject 

matter experts including on infectious diseases, other public health threats, epidemiological and 

laboratory surveillance, as well as understanding of the capabilities of state and local public 

health departments. CDC is an active partner on the PHEMCE, which is led by ASPR and 

provides a venue for sharing information across HHS agencies and with interagency partners 

with a role in medical countermeasures requirement setting, research, development, regulatory 

review, procurement, stockpiling, distribution and use. CDC will remain an active participant in 

all PHEMCE workgroups and committees. 

In order to ensure a smooth transition of the Strategic National Stockpile with no degradation of 

operational capability, ASPR and CDC have set up several joint transition workgroups to 

evaluate all aspects of the program transition. Some of the details involved in the transition have 

not been finalized. However, we would be pleased to provide a full briefing for Committee staff 

at any time before the end of the fiscal year. Subsequent to this hearing, the SNS successfully 

transferred from CDC to ASPR on October 1, 2018. 

CDC will maintain its strong working relationships with state and local public health agencies, 

playing a key role in distribution and dispensing of medical countermeasures. CDC will 

accomplish this by continuing to provide technical guidance and funding through cooperative 

agreements and embedding experts in state and local health departments. Coordination with 

state and local agencies will be enhanced by incorporating ASPR's extensive relationships with 

health care organizations and emergency management agencies. 

Further, to continue to increase collaboration across the Department, ASPR has invited and 

instituted a new senior CDC liaison who is working within the ASPR Immediate Office. 

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7) How prepared are the nation's hospitals to respond to biological threats or 

infectious diseases? What are the most pressing challenges facing nongovernmental health systems and what could we do to improve their response 

capabilities? 

ASPR Response: Since the Hospital Preparedness Program (HPP) was established, investments 

have been made to enhance the overall preparedness of the nation's healthcare infrastructure. 

Initially, HPP supported the procurement of materials and supplies (e.g., generators, masks, etc.) 

that would be used should a community be impacted by a public health or medical event. In 

2012, HPP shifted its focus from purchasing supplies to investing in health care coalitions 

(HCCs). HCCs are groups of health care and response organizations that collaborate to prepare 

for and respond to medical surge events. HCCs inccntivize diverse and often competitive health 

care organizations to work together. During recent events, ranging from mass shootings (e.g., 

Las Vegas, Florida night club), hurricanes (e.g., Matthew, Harvey, Irma, and Maria), and the 

most recent tornados in Iowa, we have witnessed the value of the HCCs in enabling communities 

to quickly assess healthcare capabilities to continue to support communities without requesting 

assistance from the federal government. 

Prior to the 2014 Ebola outbreak in West Africa, the United States did not have an organized, 

systematic approach to preparing for, and responding to, an outbreak of a highly infectious 

pathogen. CDC in collaboration with ASPR developed a tiered approach to prepare U.S. health 

care facilities to safely and rapidly identify, isolate, evaluate, and manage, travelers or patients 

who have possible or confirmed Ebola. This included providing rapid technical assistance to 

hospitals strategically located near airports with a large number of travelers returning from 

Ebola-affected countries and in communities where large numbers of persons from these West 

African countries reside. To support this, HPP provided awardees with approximately $214 

million ofEbola emergency supplemental funding to establish a nationwide, regional treatment 

network for Ebola and other infectious diseases. The funding provided through HPP Ebola 

Preparedness and Response activities is intended to establish the foundation required for the 

nation's health care system to safely and successfully identify, isolate, assess, transport, and treat 

patients with Ebola virus disease or under investigation for Ebola (or other highly infectious 

diseases). Through this mechanism, ASPR awarded cooperative agreements to all 50 states, 

Washington D.C., all U.S. territories and freely associated states, and select metropolitan 

jurisdictions, over a five-year project period. Additionally, ASPR competitively awarded funding 

to 10 regional Ebola and other special pathogen treatment centers (i.e., one in each of the 10 

HHS regions). 

Additionally, to prepare for, and provide safe and successful care of patients with Ebola, HHS (in 

a collaboration between ASPR and CDC) awarded funding to establish a National Ebola 

Training and Education Center (NETEC). The NETEC provides expertise, training, technical 

assistance, peer review, monitoring, and recognition to state health departments, regional Ebola 

and other special pathogen treatment centers, state- and jurisdiction-based Ebola treatment 

centers, and assessment hospitals. NETEC is a consortium of three U.S. health facilities that 

safely and successfully treated a confirmed Ebola patient- Emory University in Atlanta, 

Georgia; University of Nebraska Medical Center/Nebraska Medicine (UNMC) in Omaha, 

4 
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Nebraska; and the New York City Health and Hospitals Corporation/HHC Bellevue Hospital 

Center in New York, New York. 

Going forward and leveraging the best practices from investments made with the Ebola 

supplemental appropriations, ASPR is developing innovative tiered regional demonstration 

projects that can serve as a model for building a regional disaster health response system across 

the country. Subsequent to this hearing, ASPR awarded two grants- Nebraska Medicine in 

Omaha, Nebraska and Massachusetts General Hospital in Boston, Massachusetts to conduct 

pilot projects that show the potential effectiveness and viability of a Regional Disaster Health 

Response System (RDHDS). 

The Honorable Michael C. Burgess 

1) Dr. Bright, in 2010, BARDA established three centers to develop and manufacture 

medical countermeasures, such as vaccines and therapeutics, to protect our citizens 

during public health emergencies. Texas A&M's Center for Innovation in 

Advanced Development and Manufacturing is one of these centers, and was 

intended to focus on surge capacity for flu vaccines. I understand that the initial 

contract period with the Texas facility expires at the end of this month. How does 

BARD A plan to utilize these centers in the future? Will BARD A maintain and grow 

existing partnerships that have the infrastructure to deploy capabilities in the wake 

of a crisis? 

ASPR Response: BARD A established the Centers for Innovation in Advanced Development 

and Manufacturing as public private partnerships in 2012. The program has made important 

investments in the domestic capacity for medical countermeasure production for public health 

emergencies. Each of the three centers in Texas, Maryland and North Carolina were funded to 

establish pandemic influenza vaccine manufacturing surge capacity, core service capabilities, 

and workforce development programs. Program successes include: process updates that resulted 

in a fourfold increase in yield for the domestically-produced cell based inactivated influenza 

vaccine; the development of commercially run facilities in Texas and Maryland; and a wellestablished workforce development program at Texas A&M in College Station, Texas. BARD A 

recently issued a six month extension to the base period for the Texas A&M center to facilitate 

additional partnering opportunities. 

BARD A is currently evaluating how best to sustain and strengthen the domestic medical 

countermeasure manufacturing capabilities needed for the nation to be optimally prepared for 

21" century health security threats. 

2) How do you communicate with centers such as Texas A&M about what medical 

countermeasures they should develop? How involved is BARD A in helping these 

"centers" identify additional partners with whom they can work? 

ASPR Response: Each Center has a designated federal contracting officer representative and 

contracting officer. These officials monitor completion of contract requirements and subsequent 

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task orders that the centers have to meet per the terms of the contract. BARD A also holds 

frequent site visits and regular status calls with each of the Centers and has encouraged potential 

partner discussions through those interactions. Lastly, the Centers are required to maintain other 

commercial business/partnerships to make use of established capacity, to offset costs, and be a 

shared resource. 

The Honorable Frank Pallone, Jr. 

1) With respect to the three types of threats we often hear about- natural, intentional, 

and accidental-to what extent do preparedness efforts for the different types of 

threats overlap? 

ASPR Response: ASPR coordinates with states and local officials before, during, and after 

emergencies to test existing response capabilities. While each incident, whether naturally 

occurring, man-made, or accidental, has its own considerations, there are common requirements 

that spread across all emergencies. Common elements include supporting situational awareness 

and information sharing between and among all supporting officials, supporting and augmenting 

local healthcare entities in treating the impacted population, ensuing critical assets are available 

to communities in need, and supporting the recovery of the community. 

Investing in technologies that have the potential to yield multiple diagnostics, vaccines or 

therapeutics against different pathogens ensures that capabilities are nimble and flexible to 

support vaccines and therapeutics for future threats. Examples of this type of investment are 

how BARDA is supporting development of vaccines against the Ebola Zaire virus. Currently, 

BARD A is supporting two candidates under Project BioShield. There is the potential that same 

vaccine platform used to develop the Ebola Zaire virus vaccines could be used to develop 

vaccines against Ebola Sudan or Marburg viruses, by replacing just one element (glycoproteins). 

In addition, the vaccine platform could be used to express proteins from newly identified 

pathogens and expedite development of a vaccine for clinical trials. 

2) How can we plan long-term therapeutics and vaccines in order to respond to 

outbreaks that we cannot yet anticipate? 

ASPR Response: It often takes I 0 or more years and over $1 billion to develop a new drug or 

vaccine. 

ASPR/BARDA utilizes many of the innovative authorities authorized by amendments made by 

the Pandemic and All-Hazards Preparedness Act to the Public Health Service Act to support 

development of medical countermeasures. Authorities like Other Transaction Authorities (OTA) 

mean ASPR/BARDA can enter into innovative agreements to support development and 

procurement. As an example, the first BARD A OTA was within the broad spectrum 

antimicrobial program. Currently three out of six BARD A OTAs are focused on development of 

antimicrobial products. BARD A has also utilized CARB-X- an innovative public-private 

partnership conducted under a cooperative agreement- to address the threat of antibiotic 

resistant bacteria. CARB-X involves seven partners in the U.S. and U.K. and is backed with half 

a billion dollars in funding. $85 million in BARD A CARB-X investment resulted in nearly $500 

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million in private equity follow on investment. The partnership has 28 different companies 

making novel antibacterial drugs, vaccines, and diagnostics, including eight new classes of 

antibiotics. 

3) BARD A's CARB-X program is developing many nontraditional products at the 

preclinical stage. Can you briefly explain why you have supported these products, 

and what BARD A is doing to make sure that enough products move on to clinical 

trials? 

ASPR Response: Under the National Action Plan for Combating Antibiotic Resistant Bacteria 

(CARB), published by the White House in 2015, ASPR was directed to establish a 

biopharmaceutical accelerator in collaboration with NIH. BARD A established CARB-X in 

collaboration with the NIH's National Institute of Allergy and Infectious Diseases (NIAID), in 

NIH, in 2016. This was two years ahead of the three year milestone to establish the partnership. 

CARB-X is an international consortium offunders including BARD A, NlAID, Wellcome Trust, 

the Bill &Melinda Gates Foundation, and the UK Government's Department of Health and 

Social Care. 

BARD A does not support the product portfolio alone; instead it is a collaborative effort across 

multiple, international organizations. BARD A funds non-traditional products because 

antibiotics are a solution but not the only solution for antibiotic resistant bacteria. In addition, all 

of the candidate products supported under CARB-X can support new treatment options for 

genetically engineered biothreat pathogens or the secondary bacterial infections that will result 

from exposures to threat agents, such as ionizing radiation from a nuclear blast or burn injuries 

resulting from nuclear or chemical agents. 

Five products under the CARB-X portfolio have advanced to phase I clinical trials with more 

expected in the coming years. Candidate products may move into clinical trials when clinical 

trial proposals and data to support investigational new drug status are submitted to the FDA and 

data review does not show prohibitive adverse risk-benefit concerns. BARD A, as a funder and 

as a member CARB-X, works closely with the cooperative agreement awardee's program team to 

make sure that products are meeting the scientific milestones to advance in development. 

4) Can you explain what BARD A is doing to foster public-private partnerships, and 

why this is important? 

ASPR Response: BARDA established and manages the Tech Watch Program 

(https://www.phe.gov/aboutlbarda/Pages/BARDA-techwatch-Mtgs.aspx). Under Tech Watch, 

companies can come and discuss their technologies with BARD A to determine if the product is 

appropriate for BARDA to consider funding in the future. If the program does not align with 

BARD A priorities, we will refer them to other federal agencies that may be able to assist them 

with development. BARDA holds 150-200 Tech Watches per year. 

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BARD A also holds an annual BARD A Industry Day (BID), consistent with its authorities under 

the Public Health Service Act. This meeting brings together BARD A and other PHEMCE 

partners with industry, academic, and non-government organizations. It provides an opportunity 

for BARD A to highlight current and future strategic plans and priorities. BID also provides 

companies the opportunity to discuss their programs and how they might be able to address 

existing or future requirements. 

Lastly, BARD A attends national and international conferences to discuss our portfolio of 

products, potential additional candidates, and our strategic plans. Numerous stakeholders attend 

these conferences allowing for another venue for BARD A to meet with potential partners. 

BARD A cannot develop countermeasures alone. Public-private partnerships are critical to the 

continued success of BARD A and all of the ongoing medical countermeasure development 

initiatives. 

5) ASPR has a number of programs in place, including the Hospital Preparedness 

Program and the Medical Reserve Corps, which are designed to help ensure 

readiness at the state and local level. How do these programs ensure that our frontline responders are able to respond effectively in a public health emergency 

situation? 

ASPR Response: ASPR's mission is to save lives and protect Americans from 21st century 

health security threats. On behalf of the Secretary of HHS, ASPR leads public health and 

medical preparedness for, response to, and recovery from disasters and public health 

emergencies. 

All of ASPR's programs and capabilities work together to create "unity of command" by 

consolidating Federal nonmilitary public health and medical preparedness and response 

functions. ASPR coordinates across HHS and the Federal interagency to support state, local, 

territorial, and tribal health partners. ASPR works to enhance medical surge capacity by 

organizing, training, equipping, and deploying HHS public health and medical personnel, such as 

National Disaster Medical System (NOMS) teams, and providing logistical support for HHS 

personnel responding to public health emergencies. ASPR supports readiness at the state and 

local level by coordinating federal grants and cooperative agreements, such as the Hospital 

Preparedness Program (HPP), by programs like the Medical Reserve Corps (MRC), and carrying 

out drills and operational exercises. For example, HPP prepares the nation's health care system 

to save lives during emergencies and disasters. It is the only source of federal funding for health 

care system readiness. HPP prepares the health care system to save lives through the 

development of health care coalitions (HCCs). HCCs are groups of health care and response 

organizations that collaborate to prepare for and respond to medical surge events. HCCs 

incentivize diverse and often competitive health care organizations to work together, allowing 

them to plan together and respond jointly in emergencies. 

Specific to how ASPR supports first responders, ASPR routinely partners with state and local 

governments, hospitals, and responders to conduct drills and exercises to test various aspects of 

medical response capabilities. Drills and exercises provide opportunities at all levels to examine 

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plans, procedures, and capabilities and to work with all government partners to employ resources 

in response to a specific event or scenario. One recent example is ASPR's Tranquil Terminus 

Exercise that brought together four regions, seven states, eight cities and three federal 

departments to test the nation's ability to transport patients with a highly infectious 

disease. Communities and responders benefitted by having the opportunity to test and rehearse 

plans with all partners participating. They learned from each other as well as identified best 

practices for inclusion in their plans and procedures. 

6. CDC recently concluded an operational readiness review to assess whether state and 

local governments and public health services will be able to effectively get medical 

countermeasures to the appropriate person at the appropriate time. How does 

BARD A work with CDC and health departments to ensure that we develop 

countermeasures with this "last mile" of delivery in mind? 

ASPR Response: Through its active role in PHEMCE, CDC shares information across HHS 

agencies, including ASPRIBARDA, who have a role in medical countermeasures requirement 

setting, research, development, regulatory review, procurement, stockpiling, distribution and use. 

Through this channel, as well as through established direct program-to-program collaborations 

with BARD A, CDC provides input on how countermeasure development can better meet end 

user needs. This includes criteria for how products developed may be stored and packaged to 

improve/simplify stockpiling and distribution, improved product delivery systems, simplified 

dosing considerations, etc. These factors assessed by CDC, impact how products are distributed, 

dispensed/administrated and used. 

9 
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35127.080

GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

([:ongre~~ of tbt Wntttb ~tate~ 

:J!}om.ie of 1\cprel>cntatiucrs 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 ~202) 225-2927 

{2021225-3641 

July 12,2018 

Dr. Anne Schuchat 

Principal Deputy Director 

Centers for Disease Control and Prevention 

1600 Clifton Road 

Atlanta, GA 30329 

Dear Dr. Schuchat: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on June 15, 

2018, to testify at the hearing entitled "The State of U.S. Public Health Biopreparedness: Responding to 

Biological Attacks, Pandemics, and Emerging Disease Outbreaks." 

Pursu~nt to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open tOr ten business days to permit Members to submit additional questions for the recordt which are 

attached. To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Thursday, July 26, 2018. Your responses should be mailed to 

Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office 

Building, Washington, DC 20515 and e-mailed in Word format to Ali.Fulling@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

J::;·~ Gregg Harper 

Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
113 


35127.081

Attachment-Additional Questions for the Record 

The Honorable Gregg Harper 

1. Have there been any laboratory-acquired infections or potential exposures to pathogens at 

CDC labs during this past year? If so, what was the nature of the exposure or infection, 

and were any hospitalizations required as a result? 

2. How serious of a pandemic threat does the CDC view the 5th wave H7N9 influenza 

strain, currently circulating in China? If a pandemic were to occur, how severely would 

it impact public health? 

3. What are the present challenges that are preventing the broader utilization of cell-based 

influenza vaccines, and what steps can be taken to become less reliant on egg-based 

vaccines? What are the advantages of utilizing cell-based influenza vaccines over eggbased ones? 

4. Is there currently an approved anthrax vaccine that can be administered to children? If 

so, what are the dosing guidelines for pediatric administration? If not, are there any 

pediatric anthrax vaccines currently under development, and what is the status of this 

development? 

5. Were any FY 2017 funds for the non· procurement costs of the Strategic National 

Stockpile (SNS) used for any CDC expenses outside of the SNS program? If so, please 

identify the type and amount of these expenses. 

6. How many laboratories currently make up the Laboratory Response Network (LRN)? 

7. How much funding is there for the LRN in FY 2018? 

The Honorable Michael C. Burgess 

I. Dr. Schuchat, in your written testimony you mentioned CDC's use of electronic data 

systems to monitor population health information. How does CDC use and disseminate 

this data such that it can coordinate a timely response? Is the data platform that CDC uses 

integrated or interoperable with other biosurveillance platforms? 

The Honorable Frank Pallone, Jr. 

1. How does CDC ensure that its laboratories are gathering data from as many sources as 

possible? 

a. Do you need additional resources to help you analyze this data more effectively? 

2. Please provide an update on CDC's concerns about the growth of antibiotic resistant 

bacteria? 
114 


35127.082

3. In the case of an emergent biological threat, how does CDC's Emergency Operations 

Center coordinate the response at the front lines, such as at the state and local level? 

4. Please describe how CDC uses its Public Health Emergency Preparedness Cooperative 

Agreement Program to help states and local municipalities identify and address gaps in 

preparedness. Is there anything you need from Congress to make sure this program 

works as intended? 

5. What are the biggest challenges to successfully deploying countermeasures at the state 

and local level? How is CDC addressing these challenges? 

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35127.069

GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

llongrcf)s of tbt llntteb ~tater) 

j!)ou5e of ~epn5entatllle5 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 

July 12,2018 

Dr. Anthony S. Fauci 

Director 

National Institute of Allergy and Infectious Diseases 

National Institutes of Health 

9000 Rockville Pike 

Bethesda, MD 20892 

Dear Dr. Fauci: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on June l 5, 

2018, to testify at the hearing entitled "The State of U.S. Public Health Biopreparedness: Responding to 

Biological Attacks, Pandemics, and Emerging Disease Outbreaks." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Thursday, July 26, 2018. Your responses should be mailed to 

Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office 

Building, Washington, DC 20515 and e-mailed in Word format to Ali.rulling@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

&;;: 

Gregg Harper 

~ Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
116 


35127.070

House Energy and Commerce Committee 

Subcommittee on Oversight and Investigations 

"The State of U.S. Public Health Biopreparedness: Responding to Biological Attacks, 

Pandemics, and Emerging Infectious Disease Outbreaks" 

Friday, June 15, 2018 

The Honorable Gregg Harper 

t. What do we need to do as a country to be better prepared for an outbreak of pandemic 

influenza in the U.S.? 

NIAID response: 

The National Institute of Allergy and Infectious Diseases (NIAID), the lead institute for research on 

influenza at the National Institutes of Health (NIH), is conducting and supporting basic, translational, and 

clinical research that will improve our ability to prepare for and respond to potential pandemic influenza 

outbreaks. A particular challenge in preparing for an outbreak of seasonal or pandemic influenza is that 

current influenza vaccines do not provide protection that is long-lasting or effective against a large 

number of influenza virus strains. To address this challenge, NIAID is prioritizing the development of 

universal influenza vaccine candidates that could provide long-lasting protection against multiple 

influenza strains including those with pandemic potentiaL 

NIAID is galvanizing research efforts to develop universal influenza vaccine candidates and convened 

influenza experts from the U.S. and throughout the world at a research agenda-setting workshop in 2017. 

Following this meeting, NIAID outlined its universal influenza vaccine research priorities in a strategic 

plan that focuses on three key areas: improving knowledge of the transmission and pathogenesis of 

influenza infection; characterizing influenza immunity and immune factors that correlate with protection 

against influenza; and supporting the design of universal influenza vaccines. NIAID is actively engaging 

federal partners, including U.S. Department of Health and Human Services agencies and other key 

domestic and international stakeholders involved in influenza vaccine research, to coordinate and advance 

activities outlined in the strategic plan. For example, NIAID continues to collaborate with the Biomedical 

Advanced Research and Development Authority (BARDA) to advance the development and clinical 

testing of promising inf1uenza vaccine candidates. The additional $40 million in funding for universal 

influenza vaccine research provided through the Consolidated Appropriations Act, 20 I 8 (P .L. 115-141) 

will support targeted research investments for the development of universal influenza vaccines that could 

protect vaccinated individuals against seasonal or pandemic influenza virus strains. 

In addition to pursuing universal inf1uenza vaccine strategies, NIAID is working to develop novel vaccine 

production strategies - such as recombinant DNA manufacturing techniques -that may allow for a more 

rapid production of targeted vaccines in response to newly emerging or changing strains of influenza 

virus than current egg and cell-based technologies. These vaccine production techniques could help to 

speed the availability of vaccines that protect against new or evolving pandemic inf1uenza virus strains. 

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While investing in research to improve inf1uenza vaccines, NIAID also continues to support the 

development of novel diagnostics to rapidly identify inf1uenza viruses, including potential pandemic 

strains, and antiviral drugs that could help to limit inf1uenza morbidity and mortality in a pandemic. 

NIAID will continue to play a key leadership role in seasonal and pandemic inf1uenza outbreak 

preparedness and response efforts by conducting and supporting the basic, translational, and clinical 

research needed to identify and develop effective medical countermeasures. 

2. In your testimony, you mentioned that there will be several iterations of a 'universal' flu 

vaccine. How many universal vaccine candidates are currently being developed at, or 

supported by, NIAID and what strains will they target? Where does this research currently 

stand? How many iterations of a universal flu vaccine does NIAID ultimately envision? 

NIAID response: 

A truly universal influenza vaccine would represent a groundbreaking advance in the fight against 

influenza by providing protection against a number of seasonal and pandemic influenza virus strains. 

NIAJD currently is exploring at least 10 different strategies toward the development of universal 

inf1uenza vaccine candidates. Each of these strategies may have multiple vaccine candidates in various 

stages of development that are being investigated by NIAID intramural researchers or NIAID-supported 

grantees in academia and industry. Notable highlights ofNIAID universal influenza vaccine research 

include the development of a ferritin nanoparticle-based vaccine candidate by the NIAID Vaccine 

Research Center (VRC), Phase I clinical trials of a VRC-developed DNA vaccine candidate using a 

prime-boost strategy with a standard inactivated seasonal inf1uenza vaccine, and the recent launch of a 

NIAID-sponsored Phase II clinical trial to evaluate the M-001 vaccine candidate, which contains several 

inf1uenza fragments recognized by the immune system that are common among multiple influenza virus 

strains. Additionally, NIAID is sponsoring a Phase I clinical trial to evaluate the safety and 

immunogenicity of a prime-boost regimen using an intranasal vaccine candidate followed by a licensed, 

quadrivalent seasonal influenza vaccine. 

We anticipate that progress toward the goal of a universal inf1uenza vaccine will occur in several stages, 

with each intennediary stage represented by several vaccine candidates that protect against progressively 

greater numbers of influenza virus strains. NIAID is pursuing strategies that could protect against all 

strains of a single subgroup of influenza virus, such as the H3N2 strains. This could be considered a 

universal influenza vaccine Version 1.0. As we make progress towards more broadly protective inf1uenza 

vaccines, a Version 2.0 could protect against two or more subgroups of influenza, such as all HINI 

strains and all H3N2 strains. This may lead to developing a universal inf1uenza vaccine candidate that by 

itself could durably protect against all subgroups of influenza, thereby protecting against virtually any 

inf1uenza strain. Each universal influenza vaccine candidate will need to be evaluated over several 

inf1uenza seasons to detennine the level of protection that is induced, and the durability of that protection. 

Version 1.0 of a universal influenza vaccine may be available in a few years, representing an incremental 

improvement on currently available int1ucnza vaccines. A universal inf1ucnza vaccine that covers all 

major inf1ucnza strains may be many years away, with several iterations may be likely needed to 

ultimately achieve a broadly protective vaccine against all or nearly all inf1uenza strains. 

3. What are the present challenges that are preventing the broader utilization of cell-based 

influenza vaccines, and what steps can be taken to become less reliant on egg-based 

vaccines? 

NIAID response: 

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NIAID supports the development of flexible vaccine manufacturing processes, including the use of 

molecular biological techniques, to help shorten manufacturing times and increase production efficiency 

for current and future influenza vaccines. Barriers to the broader utilization of cell-based and recombinant 

technologies to produce influenza vaccines include differences in manufacturing needs, development 

costs, and public awareness of alternatives to egg-based influenza vaccines. 

NIAID is working to address these challenges through the support of basic and translational research for 

the development and manufacture of novel influenza vaccine strategies. NIAID scientists have devised a 

new method to manufacture an experimental whole virus inactivated influenza vaccine using a cell-based 

system. This method would provide another alternative to currently licensed egg-based and cell-based 

influenza vaccines. NIAID researchers also are developing and evaluating an additional cell-based system 

for whole virus influenza vaccine candidates to try to determine the most efficient cell-based system to 

produce influenza vaccines, both in terms of manufacturing time and cost. Data from these NIAIDsupported studies will help improve vaccine manufacturing processes and vaccine efficacy, leading to the 

design of better influenza vaccines. NIAID also has supported studies of improved vaccine strain 

selection and optimized high-yield vaccine strains as part of the Seasonal Influenza Vaccine Improvement 

(SlVI) initiative, an interagency collaboration launched in 2016. 

In addition to supporting the development of innovative seasonal influenza vaccines, NIAID has made a 

strategic shift toward a research paradigm that features broader, more flexible vaccine platform 

technologies such as recombinant DNA manufacturing techniques that can be rapidly mobilized when 

pandemic influenza viruses emerge. NIAID continues to support the early development of candidate 

pandemic influenza vaccine candidates that can be transitioned to BARD A for advanced development, 

with the goal of Food and Drug Administration (FDA) licensure and potential inclusion in the Strategic 

National Stockpile. NIAID also will continue to work closely with industry partners to advance promising 

influenza vaccine candidates, including cell-based and recombinant vaccine strategies. 

The Honorable Michael C. Burgess 

1. Dr. Fauci, the National Institute of Allergy and Infectious Diseases is on the front lines of 

vaccine development, especially in the wake of Ebola and Zika hitting the United States. 

You wrote an article in the Journal of the American Medical Association in November 2017 

that detailed the critical role of biomedical research in pandemic preparedness. Can you 

share with us some of the research approaches NIAID uses to prepare for pandemics, such 

as a new flu strain, that have yet to hit our shores? 

NIAID response: 

As outlined in the 2017 article in the Journal of the American Medical Association, The Critical Role of 

Biomedical Research in Pandemic Preparedness, comprehensive pandemic preparedness requires a 

multifaceted approach. A critical component is biomedical research to support the development of 

vaccines, diagnostics, and therapeutics that may be quickly deployed in response to an emerging or reemerging infectious disease of pandemic potential. NIAID supports a comprehensive portfolio of basic 

research on microbiology and immunology to better understand the mechanisms of pathogenesis and 

immune responses, as well as applied and clinical research to evaluate candidate diagnostics, therapeutics, 

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and vaccines. This strategic effort includes the pursuit of several research approaches, including: ( 1) 

research targeting specific pathogens; (2) prototype pathogen efforts, in which fundamental research to 

understand the disease caused by one pathogen may inform the development of countermeasures for a 

closely related pathogen; and (3) development of platform-based technologies and broad-spectrum 

products that may be easily and quickly deployed against multiple pathogens. NIAID research 

complements other elements of pandemic preparedness by improving understanding of infectious disease 

pathogenesis and by developing candidate medical countermeasures that could be used in a pandemic. 

NIAID supports a broad portfolio of pathogen-specific basic, translational, and clinical research. NIAID 

investments in pathogen-specific research include priority pathogens of the United States Government as 

designated by the Centers for Disease Control and Prevention (CDC), as well as other emerging andreemerging diseases identified as priority pathogens by NIAID. For example, NIAID supported 

development ofml02.4, a candidate monoclonal antibody treatment for Nipah virus infection. NIAID 

also is supporting the development of improved influenza vaccine candidates, including universal 

influenza vaccines that could provide broad protection for a range of pandemic and seasonal influenza 

strains. Additionally, it was an NIAID investment in basic research nearly 40 years ago that enabled the 

development of the novel influenza antiviral Xofluza (baloxavir marboxil), which was approved for use in 

Japan in early 2018 and is currently undergoing FDA priority review for use in the United States. 

NIAID has built upon increased understanding of infectious disease pathogenesis to move strategically 

toward a medical countermeasures research paradigm that features broader, more flexible platform 

technologies that can be used to respond to several biological threats. High-throughput sequencing and 

platform-based technologies are facilitating the development and manufacture of vaccines, targeted 

antibody therapeutics, and broad-spectrum antibiotics and antivirals by significantly decreasing the time 

from identification of a public health threat of an emerging infection to clinical evaluation of candidate 

countermeasures. For example, in 2015-2016 when Zika virus emerged in the Americas, clusters of 

microcephaly and other birth defects were identified, and a Public Health Emergency of International 

Concern was declared by the World Health Organization. NIAID scientists rapidly used Zika virus 

genetic sequence information to develop a DNA-based vaccine candidate that moved from concept to a 

first-in-human trial in less than four months. The experimental DNA-based Zika vaccine, which currently 

is in Phase IIIIIb clinical testing, was developed with a readily deployable DNA vaccine platform that is a 

form of gene-based immunization previously used by NIAID to develop a candidate vaccine for West 

Nile virus. The development of a broadly applicable platform technology facilitated an accelerated 

response to a previously unrecognized public health threat. As mentioned in the 2017 article in the 

Journal of the American Medical Association, NIAID is supporting development of additional vaccine 

platform technologies, including nanoparticle, virus-like particles, and mRNA platforms. NIAID also 

supports development of broad-spectrum therapeutics, including antiviral and antibacterial agents that 

have demonstrated activity against multiple viral or bacterial pathogens. 

Together with academia, industry, and Public Health Emergency Medical Countermeasures Enterprise 

(PHEMCE) partners, NIAID remains committed to meeting public health emergency needs by advancing 

high-priority research to support development of medical countermeasures for emerging and re-emerging 

infectious diseases, including influenza viruses with pandemic potential. NIAID-supported research into 

specific pathogens, prototype pathogens, and the development of platform-based technologies will 

continue to play an essential role in PHEMCE pandemic preparedness and response efforts. 

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The Honorable Frank Pallone, Jr. 

1. How can we plan long-term for therapeutics and vaccines in order to respond to outbreaks 

that we cannot yet anticipate? 

NIAID response: 

NIAID supports a comprehensive portfolio of basic research on microbiology and immunology to better 

understand the mechanisms of pathogenesis and immune response, as well as applied and clinical 

research to evaluate candidate diagnostics, therapeutics, and vaccines. This strategic effort includes the 

pursuit of foundational platfonn approaches that could be used to develop medical countenneasures 

against multiple pathogens. 

NIAID is pursuing the development of platforn1 approaches including molecular biological technologies 

that could be rapidly mobilized to generate candidate vaccines against emerging infectious disease threats. 

For example, during the 2015-2016 Zika virus outbreak in the Americas, NIAID scientists developed a 

novel DNA-based vaccine for Zika virus using viral genetic sequence information. The candidate vaccine 

moved from concept to a first-in-human trial in less than four months, and currently is in a Phase II/IIb 

trial. In order to respond so quickly, NIAID utilized a readily deployable DNA vaccine platform that was 

previously used by NIAID to develop a candidate vaccine for West Nile virus. These types of genetic 

platfonns could be used to respond similarly to multiple emerging and re-emerging infectious disease 

threats. 

NIAID investments in basic, translational, and clinical research also are contributing to the development 

of novel broad-spectrum therapeutics that can target several pathogens. For example, NIAID has 

supported early-stage development of broad-spectrum antiviral agents such as BCX4430 (galidesivir), 

which has demonstrated activity against Ebola and other RNA viruses, and broad-spectrum antibacterial 

products, including a compound with activity against ilie two different bacteria that cause tularemia and 

plague. Such broad-spectrum therapeutics may decrease the time necessary to identify and distribute an 

effective treatment during an outbreak setting. 

NIH, led by the Fogarty International Center and NIAID, also supports the development of research 

infrastructure and partnerships in foreign countries to aid in the identification, monitoring, and response to 

the emergence and reemergence of infectious diseases. Long-standing international investments in disease 

monitoring and response made by NIH were vital in the immediate response to the 2014-2016 Ebola 

outbreak in West Africa and provided critical in-country expertise that helped to contain the spread of the 

disease. In addition, the clinical research partnership between NIAID and the government of Liberia, the 

Partnership for Research on Ebola Virus in Liberia (PREVAIL), demonstrated the ability to do rigorous 

scientific research in developing countries. The PREVAIL partnership enabled in-country clinical trials 

testing of several Ebola virus therapeutic and vaccine candidates, among them the ZMapp TM therapeutic, 

the Merck VSV vaccine, and the cAd3-EBOZ vaccine developed by the NIAID VRC in partnership with 

industry. NIAID, through a partnership with the French National Institute of Health and Medical Research 

(Inserm), the London School of Hygiene and Tropical Medicine, and the host country governments, has 

launched the Partnership for Research on Ebola VACcination (PREY AC), a Phase II clinical trial 

comparing three experimental Ebola vaccination strategies in Mali, Guinea, Sierra Leone, and Liberia. 

Medical countermeasures tested by the PREY AIL partnerships were recently deployed in the Democratic 

Republic of the Congo to help address an Ebola outbreak from May to July 2018, emphasizing the key 

contributions of this effort. NIAID-supported international research partnerships also contribute to the 

development of site infrastructure and sustainable research capacity in developing countries, enhancing 

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global preparedness to respond to unanticipated outbreaks and to conduct clinical research to better 

understand the disease and to test candidate countermeasures during these outbreaks. 

2. In your view, are there specific pathogens or diseases we should be most concerned with? 

a. With so many dangerous pathogens, how do we prioritize research to try to target 

those posing the greatest threat? 

NIAID response: 

NIAID prioritizes research and early-stage development of medical countermeasures against bioterror 

threats and emerging and re-emerging infectious diseases of public health importance. The persistent 

threat of pandemic influenza and other respiratory viruses that may spread quickly and cause significant 

morbidity and mortality, such as severe acute respiratory syndrome coronavirus (SARS-CoV) or Middle 

East respiratory syndrome corona virus (MERS-Co V) remain a particular area of concern. NIAID 

maximizes its efforts to develop effective medical countermeasures against these, and other potential 

emerging and re-emerging diseases, by prioritizing research into broad-spectrum antibiotics and antiviral 

drugs, as well as efficient platform technologies to more rapidly develop vaccines and diagnostics for a 

variety of threat pathogens. 

NIAID'·s efforts to develop a broader, more flexible research paradigm is yielding scientific advances that 

will facilitate public health emergency preparedness and our ability to respond to emerging public health 

threats. NIAID is supporting the development of diagnostics platforms capable of distinguishing between 

several pathogens, as well as broad-spectrum therapeutics, including novel antiviral agents, effective 

against several pathogens. In addition, NIAID is prioritizing the development of several vaccine platforms 

that could be used to quickly develop vaccine candidates against newly identified threats. This includes 

the DNA-based platform used to develop a candidate vaccine against Zika virus that moved from concept 

to a first-in-human trial in less than four months. The development of these and other broad-spectrum 

therapeutics and platfonn technologies remains a NIAID pri01ity. 

In addition to supporting the development of platform technologies and broad-spectrum therapeutics that 

may decrease response time in the event of a pandemic, NIAID also supports a targeted portfolio of basic, 

translational, and clinical research on priority pathogens with pandemic potential, including influenza and 

other respiratory viruses. This includes detailed studies of immune system responses to infection, as well 

as research to better understand the transmission, evolution, and pathogenesis of the viruses to inform the 

development of vaccines, diagnostics, and therapeutics that could be deployed during a pandemic. The 

NIAID Vaccine and Treatment Evaluation Units currently are conducting two Phase II clinical trials of a 

new vaccine candidate to protect against emerging H7N9 influenza virus strains, and NIAID intramural 

scientists are conducting clinical studies of prime-boost vaccine regimens for swine (H l) and avian (H7) 

influenza viruses. 

NIAID is galvanizing research efforts to support the development of universal influenza vaccine 

candidates. A universal influenza vaccine that is effective against both seasonal and pandemic influenza 

strains would be a vital tool to prepare for future pandemics, as well as to improve our ability to prevent 

seasonal influenza. In addition, NIAID is supporting novel antiviral therapies for influenza, including 

RNA polymerase inhibitors, peptide inhibitors, and next-generation neuraminidase inhibitors. NIAID 

support for influenza diagnostics research has led to the development of a rapid molecular in vitro assay 

recently cleared by the FDA to accurately distinguish influenza A fi·om influenza B in nasal swab 

specimens. 

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NIAID continues to make progress against other respiratory viruses with pandemic potential. NIAID is 

supporting early-stage clinical trials of antibodies designed to treat people infected with MERS-Co V, as 

well as development of a vaccine candidate forMERS-Co V based on information from previous vaccine 

studies on SARS-CoV. NIAID-funded researchers also have identified a novel SARS-related virus, swine 

acute diarrhea syndrome coronavirus (SADS-Co V). SADS-Co V was responsible for 25,000 piglet deaths 

in China in 2016-17; however, no infections in humans have been identified. The identification of 

pathogens with zoonotic potential such as SADS-Co V that may emerge as human diseases contributes to 

our preparedness, as it may facilitate early identification if the pathogen becomes capable of causing 

disease in humans. NIAID will continue to prioritize research on pathogens with pandemic potential such 

as influenza and other respiratory viruses and support the development of platform-based technologies 

and broad-spectrum products that may be easily and quickly deployed against multiple pathogens. 

3. Can you briefly explain the barriers that make it harder for scientists to discover new 

antibiotics? 

NIAID response: 

NIAID supports a comprehensive basic research portfolio on antibiotic resistance to aid in the discovery 

of new antibiotics. NIAID antimicrobial resistance research includes the elucidation of major mechanisms 

of pathogenesis, host-pathogen and drug-pathogen interactions, and the identification of new candidate 

antibiotics. NT AID has found that the major challenges in the development of new antibiotics are in the 

later stages of clinical development of these drugs. NIAID has identified three main barriers to the 

advanced development. of new antibacterial therapeutics: 1) the scarcity of new antibacterial drug 

candidates effective against Gram-negative infections; 2) the challenge of enrolling patients in clinical 

trials needed to show efficacy of new therapeutics, especially in the case of Gram-negative drug-resistant 

infections; and 3) a lack of market incentives for pharmaceutical companies to invest in the final stages of 

antibiotic development and licensure. NIAID is working to address these challenges in several ways, 

including through the support of basic, translational, and clinical research to identify and advance 

promising antibacterial candidates to late-stage development. NIAID estimates that more than 25 percent 

of the antibacterial candidates currently in clinical development previously received some form ofNIAID 

support. 

NIAID is addressing these challenges by supporting early-stage development and clinical trials of new 

therapeutics to help offset the investment required to successfully test these therapeutics and bring them 

to market. The NIAID-supported Antibacterial Resistance Leadership Group (ARLG) has supported over 

35 clinical studies investigating new therapeutics, optimized treatment regimens, diagnostic devices, and 

projects on antimicrobial stewardship. The ARLG places a priority on research involving Gram-negative 

bacteria that represent a major antimicrobial resistance threat. NIA!D-supportcd scientists also completed 

two Phase I clinical trials for a new class of antibiotics (CRS3123) to treat Clostridium dijficile infections, 

which are increasingly difficult to treat effectively. In addition, NIAID is supporting clinical trials to 

evaluate the efficacy of new therapeutic candidates, as well as new treatment regimens that utilize 

existing antibiotics in new combinations or regimens. NIAID also has solicited research for the 

development of tools to advance drug discovery of agents against Gram-negative pathogens through the 

"Partnerships for the Development of Tools to Advance Therapeutic Discovery for Select AntimicrobialResistant Gram-Negative Bacteria" program. NIAID is facilitating scientific discussions and partnerships 

to address key questions and challenges in the development of new antibiotics. NIAID and The Pew 

Charitable Trusts sponsored the 2017 scientific workshop entitled, "Challenges in the Discovery of Gram7 
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negative Antibacterials: The Entry & Efflux Problem." The goal of the workshop was to identify next 

steps and opportunities for collaborations to determine factors that affect the entrance of antibiotics into, 

and accumulation within, Gram-negative bacteria to inform the identification and design of new types of 

antibiotics. Resolving these early-stage research qnestions will help address the growing threat of resistant 

Gram-negative bacteria by facilitating the later-stage development of promising new therapeutic 

candidates. 

N!A!D also addresses barriers to the advanced development of new antibacterial therapeutics by helping 

to de-risk antibacterial product development for researchers in industry and academia through targeted 

research support and services. N!A!D supports the National Database of Resistant Pathogens, which 

contains genomic data for more than 205,000 drug-resistant microbes. This database was established by 

the NIH, in partnership with FDA and CDC, as a publicly available resource that scientists from all over 

the world can access to inform the development of novel antibacterial products. NIA!D also funds the 

Centers of Excellence for Translational Research that have recently discovered a new class of antibiotics 

produced by soil-dwelling bacteria. These antibiotics, known as malacidins, have a unique mechanism of 

action that may make the development of resistance less likely. NIAID also supports CARB-X, a unique 

public-private partnership led by BARD A. CARB-X is dedicated to accelerating the development of 

innovative antibacterial products from target/candidate identification and characterization through Phase I 

clinical trials. CARB-X is currently supporting 29 therapeutic candidates, including 11 new classes of 

antibiotics, as well as 6 diagnostics products. To facilitate the discovery and development of promising 

therapeutic candidates, NIAID provides unique no-cost preclinical and clinical services that include 

screening tests for antimicrobial activity and access to research reagents to assist in product testing. 

Additionally, NIAID supported preclinical development and first-in-human Phase I clinical testing of 

VNRX-5!33, a novel beta-lactamase inhibitor (BLI). VNRX-5133 is the first BLI in clinical development 

that inhibits all known classes of beta-lactamases bacterial enzymes involved in resistance to the betalactam class of broad-spectrum antibiotics snch as penicillin. 

NIAID continues to support the development of antibacterial products in collaboration with academia, 

industry, and federal partners. A concerted research effort is required to combat the growing public health 

threat of antibiotic resistance. NJAID remains committed to facilitating the development of new 

antibiotics by supporting innovative research and offsetting the development costs of industry and 

academia. 

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GREG WALDEN, OREGON 

CHAIRMAN 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

ONE HUNDRED FIFTEENTH CONGRESS 

~ongre~g of tbt mntttb $tate~ 

1Ji}ouS'c of l\epnS'entatibe!S 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 

Rear Admiral Denise Hinton 

Chief Scientist 

U.S. Food and Drug Administration 

I 0903 New Hampshire A venue 

Silver Spring, MD 20993 

Dear Admiral Hinton: 

July12,2018 

Thank you for appearing before the Subcommittee on Oversight and Investigations on June 15, 

2018, to testify at the hearing entitled "The State of U.S. Public Health Biopreparedness: Responding to 

Biological Attacks, Pandemics, and Emerging Disease Outbreaks." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Thursday, July 26, 2018. Your responses should be mailed to 

Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office 

Building, Washington, DC 20515 and e-mailed in Word format to Ali.Fulling@mail.house.gov. 

Thank you again for your time and effot1 preparing and delivering testimony before the 

Subcommittee. 

a;~ Gregg Harper 

Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honoi'able Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
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Attachment-Additional Questions for the Recm·d 

The Honorable Gregg Harper 

I. Medical countermeasure (MCM) development can be a costly, time-consuming venture 

for the private sector. It is often one of the reasons why companies are reluctant to enter 

the MCM product space. How could the FDA provide better guidance and get involved 

earlier in the development process to help reduce this burden? 

The Honorable Michael C. Burgess 

I. Pharmaceutical companies face economic barriers to discovering and developing urgently 

needed new antibiotics to address drug resistant infections. I was encouraged by 

Commissioner Gottlieb's announcement earlier this week that FDA is working with CMS 

and other agencies to develop new payment models that would incentivize antibiotic 

research and development and the appropriate use of new antibiotics. Can you describe 

how these new models may work? Does Congress need to provide additional authorities 

or resources? 

The Honorable Frank Pallone, Jr. 

I. When a crisis does occur, what can FDA do to fast-track approval of countermeasures 

like vaccines and therapeutics? 

2. How have GAIN and ADAPT helped FDA to incentivize antibiotic development in the 

private sector?