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S. HRG. 111–970 

DEFENDING AGAINST PUBLIC HEALTH THREATS 

HEARING 

BEFORE A

SUBCOMMITTEE OF THE 

COMMITTEE ON APPROPRIATIONS 

UNITED STATES SENATE 

ONE HUNDRED ELEVENTH CONGRESS 

SECOND SESSION 

SPECIAL HEARING 

SEPTEMBER 29, 2010—WASHINGTON, DC 

Printed for the use of the Committee on Appropriations 

( 

Available via the World Wide Web: http://www.gpo.gov/fdsys 
(II) 

COMMITTEE ON APPROPRIATIONS 

DANIEL K. INOUYE, Hawaii, Chairman 

PATRICK J. LEAHY, Vermont 

TOM HARKIN, Iowa 

BARBARA A. MIKULSKI, Maryland 

HERB KOHL, Wisconsin 

PATTY MURRAY, Washington 

BYRON L. DORGAN, North Dakota 

DIANNE FEINSTEIN, California 

RICHARD J. DURBIN, Illinois 

TIM JOHNSON, South Dakota 

MARY L. LANDRIEU, Louisiana 

JACK REED, Rhode Island 

FRANK R. LAUTENBERG, New Jersey 

BEN NELSON, Nebraska 

MARK PRYOR, Arkansas 

JON TESTER, Montana 

ARLEN SPECTER, Pennsylvania 

SHERROD BROWN, Ohio 

THAD COCHRAN, Mississippi 

CHRISTOPHER S. BOND, Missouri 

MITCH MCCONNELL, Kentucky 

RICHARD C. SHELBY, Alabama 

JUDD GREGG, New Hampshire 

ROBERT F. BENNETT, Utah 

KAY BAILEY HUTCHISON, Texas 

SAM BROWNBACK, Kansas 

LAMAR ALEXANDER, Tennessee 

SUSAN COLLINS, Maine 

GEORGE V. VOINOVICH, Ohio 

LISA MURKOWSKI, Alaska 

CHARLES J. HOUY, Staff Director 

BRUCE EVANS, Minority Staff Director 

SUBCOMMITTEE ON DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND

EDUCATION, AND RELATED AGENCIES

TOM HARKIN, Iowa, Chairman 

DANIEL K. INOUYE, Hawaii 

HERB KOHL, Wisconsin 

PATTY MURRAY, Washington 

MARY L. LANDRIEU, Louisiana 

RICHARD J. DURBIN, Illinois 

JACK REED, Rhode Island 

MARK PRYOR, Arkansas 

ARLEN SPECTER, Pennsylvania 

THAD COCHRAN, Mississippi 

JUDD GREGG, New Hampshire 

KAY BAILEY HUTCHISON, Texas 

RICHARD C. SHELBY, Alabama 

LAMAR ALEXANDER, Tennessee 

Professional Staff 

ERIK FATEMI

MARK LAISCH

ADRIENNE HALLETT

LISA BERNHARDT

MICHAEL GENTILE

ALISON PERKINS-COHEN

BETTILOU TAYLOR (Minority) 

SARA LOVE SWANEY (Minority) 

JENNIFER CASTAGNA (Minority) 

Administrative Support 

TERI CURTIN
(III) 

C O N T E N T S 

Page 

Opening Statement of Senator Tom Harkin ......................................................... 1 

Statement of Kathleen Sebelius, Secretary, Department of Health and Human 

Services ................................................................................................................. 4 

Prepared Statement of ..................................................................................... 7 

2009 H1N1 Pandemic Influenza ............................................................................. 7 

Medical Countermeasures (MCMs) ........................................................................ 7 

MCM Review ............................................................................................................ 8 

Recommendations .................................................................................................... 9 

Implementation of the Recommendations ............................................................. 11 

Strategic Investor Fund and Development Authority .......................................... 12 

Pandemic Influenza Preparedness Activities ........................................................ 13 

MCM Spend Plan ..................................................................................................... 15 

H1N1 Vaccine .......................................................................................................... 16 

Transferring Funds From HHS to DOD ................................................................ 18 

Statement of Colonel Randall J. Larsen, USAF (Ret.), Chief Executive Officer, 

Weapons of Mass Destruction Center, Washington, DC ................................... 19 

Prepared Statement of ..................................................................................... 21 

Statement of Eric A. Rose, M.D., Chief Executive Officer and Chairman, 

Siga Technologies; Co-Chair, Alliance for Biosecurity, Washington, DC ........ 25 

Prepared Statement of ..................................................................................... 27 

Statement of Andrew T. Pavia, M.D., FAAP, FIDSA, Chief, Division of Pediatric Infectious Diseases, University of Utah; Chair, Infectious Diseases 

Society of America’s Pandemic Influenza Task Force, Salt Lake City, 

Utah ...................................................................................................................... 30 

Prepared Statement of ..................................................................................... 32 

(1) 

DEFENDING AGAINST PUBLIC HEALTH 

THREATS 

WEDNESDAY, SEPTEMBER 29, 2010 

U.S. SENATE,

SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN

SERVICES, AND EDUCATION, AND RELATED AGENCIES, 

COMMITTEE ON APPROPRIATIONS, 

Washington, DC. 

The subcommittee met at 2:35 p.m., in room SD–124, Dirksen 

Senate Office Building, Hon. Tom Harkin (chairman) presiding. 

Present: Senators Harkin, Pryor, Specter, and Cochran. 

OPENING STATEMENT OF SENATOR TOM HARKIN

Senator HARKIN. The Appropriations Subcommittee on Labor, 

Health, Human Services, and Education, and Related Agencies, 

will come to order. 

It’s sometimes said that, while the Defense Appropriations Subcommittee defends America, this subcommittee actually defines 

America. For the most part, that’s true. This subcommittee also defends America in one very important area, and that’s public health. 

Funding provided by this subcommittee is what pays for the Nation’s medical countermeasures (MCM), including the drugs, medicines, and devices that protect Americans against bioterrorism, 

pandemic influenza, and other emerging infections. This subcommittee has taken that responsibility very seriously, and we can 

point to important advances. But, America still remains vulnerable 

to an epidemic or a bioterrorism attack. 

A good example is pandemic flu. Since fiscal year 2006, this sub- committee has provided $15 billion—$15 billion—to improve pandemic preparedness in the United States. Many of these investments paid off during last year’s H1N1 outbreak. For example, an 

improved surveillance system allowed us to detect the new strain 

very quickly. Second, State and local public health agencies had 

more capacity than ever to administer vaccines. Third, we stockpiled antivirals, such as Tamiflu, which allowed us to treat patients 

who’d already gotten sick with the flu. 

But, despite all those improvements, a continuing vulnerability 

is our dependence on egg-based technology to produce influenza 

vaccines. This contributed to serious delays in the development and 

manufacture of the H1N1 vaccine. Indeed, the vaccine didn’t become widely available until after the flu season had already 

peaked. Fortunately for us, H1N1 was milder than expected. But, 

we may not be so lucky the next time. 
2 

Another example is anthrax. It’s been almost 10 years since letters laced with anthrax were sent through the U.S. mail. Future 

attacks remain a very real threat. Yet, we are still using the same 

anthrax vaccine that was developed 40 years ago. 

One reason that we’ve been slow to prepare for such threats is 

that we need a stronger partnership with biotech companies that 

could produce countermeasures such as the next-generation anthrax vaccine. There’s a problem, and that is this: The Federal 

Government is the only buyer for these countermeasures. So, we 

have to work closely with small biotech companies to make sure 

they have the capacity to do what we’re asking of them. Right now, 

this partnership doesn’t seem to be working as well as it should. 

This summer, Secretary Sebelius released a plan—a very comprehensive plan—to address these various challenges and to take 

a comprehensive approach to improving our Nation’s countermeasures. For that, Madam Secretary, we are all very grateful for 

your leadership in this area. 

Some of what the Secretary has proposed will require this subcommittee’s approval, since it requires transferring or redirecting 

unobligated balances for pandemic flu and Project BioShield. This 

hearing, therefore, is an opportunity both to take stock of how prepared we are as a Nation to meet the threats that confront us in 

this area, and to evaluate the administration’s plan for addressing 

these issues. We will hear from Secretary Sebelius, as well as a 

panel of experts from outside the Government. 

And before we begin, I’ll turn to Senator Cochran for an opening 

statement. 

Senator COCHRAN. Mr. Chairman, thank you for convening this 

hearing to consider our Nation’s important obligation of defending 

against threats to public health. 

The Department of Health and Human Services (HHS) monitors 

and recommends how we go about discharging this important responsibility to defend our country against bioterrorism and other 

public health threats. We’re pleased to welcome the Secretary of 

HHS, Kathleen Sebelius, to the subcommittee hearing, and we look 

forward to working with her to help develop and implement plans 

to enhance this Nation’s investment in MCM and public health preparedness. 

We have other witnesses, as well, who are coming before the subcommittee today, and we look forward to hearing the testimony of 

all of our witnesses. 

Thank you. 

Senator HARKIN. Thank you, Senator Cochran. 

Senator Specter wanted to—— 

Senator SPECTER. Well, thank you, Mr. Chairman. I had asked 

for an opportunity to say a few words, because, regrettably I cannot 

stay for the hearing. 

But, this is a very important project that will be discussed today, 

and something that you and I and many have worked on. But, 

flexible manufacturing has been high on my agenda for a long 

time, when I used to chair the subcommittee. And a portion of my 

concern is State-oriented, because UPMC is a major player, and 

seeks to engage in the competitive bidding. And we’re just at the— 
3 

really, at the second inning of a very long process here. But, I 

wanted to express a couple of concerns. One concern is over the $1.2 billion ceiling for funding over the 

next 25 years, because the analysis which I have seen indicates 

that will be insufficient. That goes to about $48 million a year. And 

some people are talking about $300 million. I think that’s probably 

too high, perhaps way too high. There have been some discussions 

about $100 million. But, I wanted to raise that issue, and would 

hope that would be addressed by the Secretary during the hearing 

today. 

The other subject of concern is the thrust of having the recipient 

of the contract to build a facility cooperate with other research entities to produce more vaccines with greater flexibility as these 

threats arise, and there’s a concern that these entities will be in 

competition with one another and will not be interested in the high 

level of cooperation which would best suit the Government, best 

suit the public interest. 

So, I raise these two considerations at the outset. 

I thank the Secretary for the attention she has given to this matter. I have talked to her about it on several occasions. I even talked 

to two people who are higher up on the chain of command than is 

the Secretary about the matter. They call them the Vice President 

and the President. And I’ve talked to many people who are lower 

on the chain of the command. And I—the principle of equality is 

important, and very often somebody far down on the chain of command can be as influential as somebody at the top of the chain of 

command. Some say that the staffs run the Senate. I don’t think 

they run all the Senators, but they are very, very influential. 

But, I wanted to call those couple of matters to the attention of 

the Secretary and the subcommittee. And, while I’ll be working 

with Secretary Sebelius much more, because we have a very 

lengthy lame duck session—I heard it was going to last until December 15—but, I just want to thank her for what she’s done, especially coming to Philadelphia on the first Sunday in August of the 

year 2009, when the first of the raucous town meetings occurred. 

And she and I were there that day, speaking to a group of lawyers. 

The organizer was a Philadelphia lawyer who asked me to speak. 

They finally got a better speaker, but I was second because the 

president of the association’s from Kansas, and knew the Secretary, 

and was able to get a high-quality speaker without an honorarium. 

And since she was coming to town—when I say a ‘‘high-quality 

speaker,’’ Madam Secretary, that’s because Senators don’t charge 

honoraria; we’re not permitted to. But, since she was coming to 

town, she decided to hold a town meeting. And since I was in town 

with her at the same lunch, I was asked to join her. And it was 

historic, and you were terrific. 

Thank you, Mr. Chairman. 

Senator HARKIN. I have to get a video of that one, then. 

Thank you very much, Senator Specter. 

Secretary Kathleen Sebelius became the 21st Secretary of HHS 

on April 29, 2009. In 2003, she was elected as Governor of Kansas 

and served in that capacity until her appointment as Secretary. 

Prior to her election as Governor she served as the Kansas State 

insurance commissioner. She is a graduate of Trinity Washington 
4 

University, just up the street from here, and the University of Kansas. 

Madam Secretary, welcome. And your statement will be made a 

part of the record in its entirety. Please proceed as you so desire. 

STATEMENT OF KATHLEEN SEBELIUS, SECRETARY, DEPARTMENT OF 

HEALTH AND HUMAN SERVICES 

Secretary SEBELIUS. Well, thank you so much, Chairman Harkin 

and Senator Cochran and Senator Pryor. I’m sorry that Senator 

Specter had to leave. He doesn’t advertise it much, but he is also 

a Kansan. He was born and raised in Russell, Kansas, and was the 

debate champion of his high school. So, it was great to be with him 

at the town hall in Philadelphia. And I appreciate the opportunity 

to be here and talk a bit about our recent review of the MCM Enterprise and some recommendations we have about how we can 

move forward. 

As you all know well, we don’t really know where the next public 

health crisis is going to come from. It could be a dirty bomb in a 

subway car, it could be a naturally occurring superbug that’s resistant to all treatments, it could be a biological weapon that we’ve 

never seen before, assembled from the building blocks of life by a 

terrorist in a lab. And, as we’ve seen, it could be a naturally occurring novel strain of the influenza virus. 

So, I had my introduction to MCM less than an hour after I was 

sworn in on April 29, when I went and was briefed, by John Brennan in the situation room, on the rapidly expanding H1N1 virus, 

which was beginning to appear, not only in the United States, but 

in other nations. And we had a rapid and coordinated response 

across government, made possible in large part by the efforts of 

this subcommittee, Mr. Chairman, who had been directing resources and planning and preparedness dollars over a series of 

years so that we would be ready to respond. 

So, with the first pandemic in 40 years, the good news is, we 

were able to develop and distribute a safe vaccine. The bad news 

is that our production peaked 3 weeks after the peak of the flu season, so we were still not able to respond in a timely fashion. 

So, we knew we needed to do better, and the President encouraged our Department to look at not only what occurred during the 

H1N1, but to use it as an opportunity to review the entire MCM 

Enterprise. And so, we launched that study in December 2009. 

As you know, countermeasures are vaccines, antivirals, antibiotics, pharmaceuticals, diagnostics, and the medical equipment 

that are the most direct and effective defense in any public health 

crisis. So, I asked Dr. Nicky Lurie, who’s our ASPR—to lead the 

review. And we engaged not only all of our departments and entities in HHS, but also reached out to our local and State health departments, who had been great partners in the flu response, to industry groups, to venture capital experts, academics, scientists, and 

our partners in the Department of Defense (DOD), as well as 

biotech developers around the country, to help us analyze sort of 

where we are and where the glitches are in the system. 

And we found that the pipeline that we rely on to provide critical 

countermeasures is, unfortunately, full of leaks and chokepoints 

and dead-ends. And, in an age of new threats, where delays cost 
5 

lives, we aren’t developing and manufacturing new countermeasures fast enough. And, Mr. Chairman, you referred to both the 

flu and the anthrax situation as two examples of that. So, at a moment when the most dangerous threat may be something we’ve 

never seen before, we don’t have the flexibility to adapt. And our 

challenge is to get from where we are today to the goal that the 

review laid out, a Nation with, and I quote, ‘‘The nimble, flexible 

capacity to produce MCM rapidly, in the face of any attack or 

threat, known or unknown, including a novel, previously unrecognized, naturally occurring, emerging infectious disease.’’ That’s 

where we need to be as a Nation. And our plan, which we have 

submitted to this subcommittee and to Congress, is a step to getting us there. 

We think it’s important to focus on five major areas where we 

begin to act now to make big improvements in public health defenses: 

First, upgrade regulatory science at the Food and Drug Administration (FDA), to modernize product development and evaluation. 

By identifying and solving scientific problems earlier, we can take 

products across the finish line faster, confident in their safety and 

effectiveness. And I would say, Mr. Chairman, that we used some 

of these new techniques in the production of the H1N1 vaccine, 

brought the companies to the table at a much earlier stage, and I 

think it’s one of the reasons we were able, in record time, to get 

that vaccine into the production lines. 

Second, want to work with highly experienced developers—and 

this is what Senator Specter referenced—to establish facilities capable of providing core, advanced development and manufacturing 

services here in the United States. So, on September 15, we released a draft solicitation for new centers of innovation for advanced development and manufacturing facilities. These will be 

new plants, here in the United States, to develop flexible manufacturing platforms, giving us a dependable source of surge capacity 

for flu vaccine, as well as the ability to manufacture other MCM, 

so we don’t have to rely on foreign producers, as we did during the 

H1N1 crisis. 

We released the draft for comment, and anticipate producing the 

final solicitation before the end of the year. And, in fact, next week 

we have interested parties coming in for 3 days of discussion so we 

can home in on what are the real strategies for the best possible 

request for proposal. 

The centers also can serve as a resource for small biotech companies with big ideas that can help them get the manufacturing and 

regulatory support they need to get the products to market. Just 

this week, we’ve awarded eight contracts to businesses, with the 

goal of developing innovative tools and techniques that improve numerous aspects of the MCM pipeline, from increasing the shelf life 

of the flu vaccine to advanced disease surveillance. 

The third area where we think we need to turn our focus is doing 

more to nurture the discoveries at their earliest stages by taking 

full advantage of the world-class resources and years of experience 

at the National Institutes of Health (NIH). We’ll aggressively seek 

out those ideas and discoveries that have the best potential to fuel 

the product pipeline. And to assure that no breakthroughs sunset 
6 

with the publication of a paper in a scientific journal, we want to 

be more proactive in harnessing the ideas and incubating new 

products. 

Fourth, reducing the time it takes to get flu vaccines to people 

by producing vaccine seed strains that grow better and by modernizing potency and sterility testing methods. 

These are some of the steps recommended in the President’s 

Council of Advisors on Science and Technology report, and they’ll 

ensure we’re better prepared for flu seasons to come. The Centers 

for Disease Control and Prevention (CDC), FDA, Biomedical Advanced Research and Development Authority (BARDA), and NIH 

are already engaged in a planning framework to address each of 

these needs. 

And, again, Mr. Chairman, I want to recognize your leadership 

and support in this area. You have been a champion of this for 

years, and it’s something we take very seriously. 

And finally, we’re exploring the possibility of launching a nonprofit venture capital firm that can support critical financial and 

business planning to small companies with big ideas that have the 

potential to improve our public health preparedness. In the coming 

years, HHS will direct nearly $2 billion in preparedness funds to 

these five areas, helping us build a MCM enterprise with a solid 

base of discovery, clear regulatory pathway, and the agile manufacturing that’s necessary if we’re going to be able to respond to any 

threat at any time. 

We’ve also submitted an amendment to the fiscal year 2011 

President’s budget to provide the new authorities where they’re 

needed. 

So, coming off this review, we hit the ground running. We just 

awarded a contract to a California company to create next-generation ventilators for use during a potential health emergency or pandemic. And today we’re announcing further investment in our ongoing international cooperative agreement with the World Health Organization to support global pandemic influenza vaccine preparedness, a partnership that improves health safety, both here and 

abroad. 

In the end, if a product fails to make it into our national stockpiles, it should only be based on its failure to meet our stringent 

standards for safety, efficacy, or quality, and not because we failed 

to provide the needed business, regulatory, and technical support 

for success. 

Mr. Chairman, there’s an old saying in sports, that most victories 

are actually won on the practice field, when no one is watching. 

And we feel in the same way how successfully we respond to tomorrow’s public health crisis when the spotlight’s on actually determined by how hard we work behind the scenes to build a 21st century countermeasures enterprise that can respond quickly and effectively to any threat. 

PREPARED STATEMENT

So, we’ll continue to look for ways to build, not just a stronger 

countermeasures enterprise, but a stronger end-to-end public 

health response, all the way from disease surveillance to administering MCM to people in our cities and towns. 
7 

1The Public Health Emergency Medical Countermeasure Enterprise Review is available 

online at: http://www.phe.gov/Preparedness/mcm/enterprisereview/Pages/default.aspx. 

I look forward to working with you, Mr. Chairman, and your subcommittee, and again want to applaud this subcommittee for your 

focus and attention on this over the last number of years. 

[The statement follows:] 

PREPARED STATEMENT OF KATHLEEN SEBELIUS

Chairman Harkin, Senator Cochran, and members of the subcommittee, thank 

you for the opportunity to discuss the Department of Health and Human Services 

(HHS) recent review and recommended initiatives to improve our medical countermeasures enterprise.1

Our greatest responsibility in Government is keeping the American people safe. 

We have always maintained a powerful military that can guard against conventional threats. But in today’s world, the range of threats is ever-widening to include 

biological, chemical, nuclear, and radiological hazards in addition to the conventional threats. The next public health emergency could be a dirty bomb set off in 

a subway system. It could be a biological weapon we’ve never seen before, assembled 

by a terrorist in a lab. And, as we have seen, it could be naturally occurring novel 

strain of influenza virus. 

2009 H1N1 PANDEMIC INFLUENZA

Right after I was sworn in as Secretary of HHS, I was briefed by John Brennan, 

the President’s Advisor for Homeland Security and Counterterrorism, on 2009 H1N1 

influenza, and immediately found myself immersed in the national need to respond 

to this new threat. Fortunately, HHS was already in the process of rapidly responding to 2009 H1N1, working in close partnership with virtually every part of the Federal Government under a national preparedness and response framework. We characterized the new virus, disseminated the information to researchers and public 

health officials, and developed and began shipping to States a new test to diagnose 

cases of the infection. We distributed antiviral drugs to the States from the Strategic National Stockpile. We also completed key steps in the vaccine development 

process—preparing a virus strain for vaccine production, contracting with manufacturers for vaccine, performing necessary clinical trials, and licensing multiple 2009 

H1N1 influenza vaccines. After close collaboration with State and local authorities 

and healthcare providers, we began the voluntary national vaccination program in 

October. HHS was in constant communication with State health officers and hospital administrators to monitor stress on the healthcare system and to be prepared 

in case Federal medical assets were necessary to augment State and local surge capabilities. 

We responded as quickly as possible to the H1N1 emergency, and the speed of 

these efforts was due in large part to the prior investments in pandemic preparedness. I would like to thank this subcommittee for its support in this area over the 

past 4 years. We did, however, experience challenges with the vaccine manufacturing and availability. No matter how quickly we responded, we were still dependent on vaccine technology from the 1950s, relying on the virus to grow in eggs. We 

also had to depend, in part, on foreign vaccine manufacturers, which meant there 

were two instances in which our vaccine deliveries were delayed in order to meet 

another country’s vaccine needs first. HHS had already taken steps to expand domestic vaccine manufacturing with the opening of a new cell-based influenza vaccine 

manufacturing facility in North Carolina in November 2009. But, further action was 

needed to provide a more robust and nimble domestic manufacturing surge capacity. 

We continue the process of that investment today. 

MEDICAL COUNTERMEASURES (MCMS)

The success of a response to a public health crisis depends on many factors, including the expertise of our healthcare workforce, the capacity of our Nation’s hospitals, the ability of Federal, State, local, tribal, and community partners to coordinate, and the engagement of the public. The success of a response also greatly depends on medical countermeasures. These are the medical treatments, vaccines, 

diagnostics, personal protective equipment, and nonpharmaceutical aids like ventilators that help reduce the spread of infections, reduce health consequences, and ultimately save lives. In a public health crisis, medical countermeasures are typically 

our most direct and often our most effective response. 
8 

Medical countermeasures take years to develop, are very expensive, and must follow the rigorous development and regulatory pathway to demonstrate safety and efficacy. Unlike the drugs destined for everyday or frequent use, the countermeasures 

needed for biodefense threats in many cases may have greater development risks, 

due largely to the absence of significant commercial markets and the difficulty in 

demonstrating efficacy in the absence of human clinical trials. 

The Federal Government has invested considerable resources over the past 10 

years in expediting the development of these products. However, it was apparent 

from both the 2009 H1N1 experience and the paucity of medical countermeasure 

candidates moving from early to advanced development that we needed a better understanding of how the Federal Government and industry are generating new products. We realized that the greatest danger we may face is a microbe that we have 

never seen before and for which we do not yet have a medical countermeasure. We 

clearly need the capacity to develop a medical countermeasure quickly. 

MCM REVIEW

Recognizing this need, with the encouragement and strong support of President 

Obama, I called for a comprehensive review of our entire medical countermeasure 

enterprise in order to transform these efforts into the highly responsive and flexible 

system we know we need. In order to get the 21st century products essential for 

our national security, we understood that we must invest in 21st century technical 

approaches as well as 21st century financial, legal, and regulatory frameworks that 

nurture a viable commercial sector and create incentives for companies to build 

these advanced countermeasures. In his 2009 State of the Union address, the President called for a renewal of our national capability to respond to bioterrorism and 

infectious disease. 

The review was led by HHS’s Assistant Secretary for Preparedness and Response 

(ASPR), Dr. Nicole Lurie. She was joined by representatives from across HHS (the 

Office of the ASPR, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Office of the Assistant Secretary for Financial Resources, the Office of the Assistant 

Secretary for Planning and Evaluation, the Office of the Assistant Secretary for Legislation, and the National Vaccine Program Office; Federal interagency partners (the 

Department of Agriculture, the Department of Defense (DOD), the Department of 

Homeland Security, and the Department of Veterans Affairs); and the Executive Office of the President to dissect the issues, identify critical gaps, and respond to the 

challenges that would be uncovered as the review proceeded. 

The review was conducted in multiple stages. First, we analyzed a large body of 

work on medical countermeasure development, financial and market incentives, and 

procurement of science. We looked at how the needs of the medical providers are 

considered in the design of MCM products, and which mechanisms are employed to 

get products to those providers. Second, the successes and failures of the MCM enterprise were examined in order to identify the critical components for success and 

impediments to realizing our goals. In addition, we interviewed numerous opinion 

leaders, representatives from the pharmaceutical and biotechnology industry, members of the investment community, and leaders in State and local public health for 

their views on the role of HHS in MCM development. A series of meetings and 

workshops were conducted, including: a 2-day workshop hosted by the Institute of 

Medicine’s Forums on Public Health Preparedness and Drug Development, a town 

hall meeting at the National Association of County and City Health Officials Preparedness Summit, and a meeting with leaders of the President’s Council of Advisors on Science and Technology. Finally, the ASPR, on my behalf, asked the National Biodefense Science Board, an HHS Federal Advisory Committee, to convene 

a workshop to review the overall strategic management, leadership, and accountability structure of the MCM enterprise. 

I released the review, The Public Health Emergency Medical Countermeasures 

Enterprise Review: Transforming the Enterprise to Meet Long-Range National 

Needs, last month. This review highlights the need for the MCM enterprise to adopt 

a new strategy that incorporates our ability to rapidly and flexibly respond to a new 

or unknown threat balanced against our longstanding requirements for producing 

MCMs to counter identified threats. This new strategy is articulated through the 

following vision statement: Our Nation must have the nimble, flexible capacity to 

produce MCMs rapidly in the face of any attack or threat, known or unknown, including a novel, previously unrecognized, naturally occurring emerging infectious 

disease. 

The principle at the heart of this strategy is that our public health response is 

only as strong as its weakest link. So, using it as a guide, we have worked to up-
9 

grade our entire end-to-end response, from how we assess and identify threats to 

how we distribute and administer products to counter those threats in cities and 

towns across the country. That is why we will continue to look for ways to build— 

not just a stronger countermeasures enterprise with a solid base of discovery, a 

clear regulatory pathway, and agile manufacturing—but also a stronger public 

health response all the way from disease surveillance to administering countermeasures to people in our cities and towns. 

RECOMMENDATIONS

The MCM review recommends five new infrastructure initiatives as well as other 

enhancements to the MCM enterprise. The review found that the unique products 

required by the public health emergency medical countermeasure enterprise are not 

of general commercial interest to the major pharmaceutical companies, due to the 

risks and opportunity costs to produce and receive approval for products with very 

limited commercial market value. The Federal Government often partners with 

smaller pharmaceutical or biotechnology companies, many of whom would benefit 

from additional resource or management investments to become successful and reliable entities. We came to realize that we need to provide a variety of supports to 

ensure the viability of these partners. In the end, if a product fails to make it into 

our national response capability, it should only be based on its failure to meet our 

stringent standards for safety, efficacy or quality, and not because we failed to provide the needed business, regulatory, and technical support for success. We also realized that the approach to the threats of the future requires building a ‘‘capabilitybased’’ system that can quickly adapt to a rapidly emerging or sudden, novel threat. 

21st Century Regulatory Science 

The first infrastructure investment, which enjoyed nearly universal support, is the 

strengthening of regulatory science at the FDA. 

We heard from stakeholders that one of the greatest risks to successfully developing a product was the uncertainty associated with the complex regulatory process 

that governs the approval of these particular drugs, vaccines, and diagnostics. 

FDA has been testing and producing cutting-edge products using science that’s 

decades-old and it is prudent to invest in providing the FDA with the tools, models, 

methods, and knowledge necessary to 21st century technologies and assist industry 

in reviewing and regulating these new products. 

As part of this initiative, FDA is launching a new program entitled, Advancing 

Regulatory Science for Public Health, designed to augment the tools used to assess 

the safety, efficacy, and quality of medical products, with a particular focus on 

MCMs. The FDA will create new Action Teams to work with those manufacturers 

who are developing the high-priority products and platforms. This strategy is based 

on an approach that worked well several years ago when the United States licensed 

its vaccine for smallpox, ACAM 2000. The Action Teams, composed of experts from 

across the FDA, will work with sponsors to identify and help resolve scientific issues 

as early and efficiently as possible, and to facilitate more rapid evaluation of these 

high-priority candidate products. Finally, the FDA will launch a collaborative 

project with other HHS and interdepartmental members of the MCM enterprise to 

resolve several of the real challenges that have been identified for these types of 

products. For example, one of these challenges is the difficulty in using the Animal 

Efficacy Rule. This rule allows appropriate studies in animals in certain cases to 

provide substantial evidence of effectiveness in humans of new MCMs against biological threats. 

These initiatives will both give our world-class FDA scientists the cutting-edge resources they need to analyze promising new discoveries faster as well as help industry navigate the complex regulatory processes to ensure that safe, effective, and 

high-quality products are ready for our use. The FDA has already begun to identify 

areas of needed scientific investment via internal discussions with science leaders 

from among its various centers, as well as the processes and metrics they will use 

to track return on this investment. 

Flexible Manufacturing and Advanced Development Core Services Partnerships 

The second initiative we are investing in is the development of flexible manufacturing capable of producing the next generation of medical countermeasures. 

As noted previously, the Federal Government often partners with smaller pharmaceutical or biotechnology companies in the development of medical countermeasures. Many of these companies would benefit from technical expertise and 

guidance in scaling up from small to large production and in the approval of an 

MCM product. Further, many of these innovators do not have the capital or experience to construct and operate commercial-scale manufacturing facilities. 
10 

To fill this need, HHS will establish Centers for Innovation in Advanced Development and Manufacturing. These centers will provide a variety of core services to 

less-experienced innovator companies with federally supported medical countermeasure candidates through public-private partnerships with fully integrated pharmaceutical partners. HHS will coordinate these core services with regulatory science 

assistance and other services already provided by the Federal Government, such as 

clinical studies and animal-challenge model development. In addition, these centers 

will be expected to fill the remaining gap in domestic pandemic influenza vaccine 

manufacturing and surge capacity, utilizing new recombinant and molecular platform technologies. Last, the manufacturing output from these centers will be coordinated by HHS with a domestic network of fill-finish manufacturers to ensure that 

the first and last doses of vaccine or other medical countermeasure become available 

as soon as possible. These centers are expected ultimately to aid in controlling the 

costs of developing and procuring medical countermeasures in emergencies and of 

stockpiling. The centers will provide development and pilot-manufacturing activities 

for vaccine candidates, allowing their associated costs to be absorbed into the center’s operating budget and thereby reducing the total amount of the R&D contract. 

Similarly, the costs for commercial-scale manufacturing of MCMs destined for stockpiling in the Strategic National Stockpile will be lower than the costs under the current fixed-price contracts. 

The centers will be managed by the Biomedical Advanced Research and Development Authority (BARDA) within ASPR in coordination with other HHS agencies 

and the DOD. BARDA issued a draft solicitation earlier this month to seek public 

comment and engagement in this envisioned public-private partnership capability. 

We expect that the final solicitation will be available by the end of the year, and 

that competitive contracts will be awarded in 2011. 

Accelerating Discovery and Translation of Product Concepts 

The third initiative we will invest in is nurturing discoveries in their earliest 

stages. 

The Federal Government has invested heavily in a strong, vibrant basic research 

and discovery program with the ultimate goal of translating important scientific discoveries into licensed medical countermeasures. However, most individual scientific 

discoveries do not lead directly to an identifiable product. Scientists may make a 

discovery without realizing that it could be turned into a useful countermeasure, or, 

if they do see its potential, they may have trouble attracting private investment 

with an uncertain commercial development path to market. The Conception Acceleration Program at NIH’s National Institute of Allergy and Infectious Disease 

(NIAID) aims to change that dynamic. 

A key component of this initiative will be Early Development Teams, that will 

work closely with partner agencies and programs (NIH, CDC, DOD, ASPR/BARDA, 

and FDA) and with academic researchers, biotechnology companies, and large pharmaceutical companies. NIH, and especially NIAID, has a broad capability to scout 

the emerging science that comes from its investments. These teams will be responsible for scouring grant portfolios for discoveries that could have applicability to 

medical countermeasure development. They will be empowered to leverage both additional funding and access to a wide range of NIH core services to foster these potential solutions into promising medical countermeasure candidates. Where necessary, staff could even play a matchmaking function with other investment organizations, the Centers for Innovation in Advanced Development and Manufacturing, 

or biotechnology and pharmaceutical firms. Such an approach represents a new and 

potentially transformational model of advancing our science investments at NIH, 

and could enable benefits far beyond the realm of MCMs. NIAID is in the process 

of identifying the number and level of skilled personnel that need to be dedicated 

to this effort. 

Modernizing Pandemic Influenza Vaccine Manufacturing 

Fourth, we will invest in our domestic manufacturing surge capacity. 

The emergence of a novel pandemic strain of influenza virus is a continuous 

threat to human health. In addition to the experiences of 2009, we are ever vigilant 

to the possibility that avian influenza H5N1 or other circulating virus strains may 

become highly transmissible and virulent in humans. Our experience with 2009 

H1N1 taught us that we need to respond even faster to an emerging pandemic. Although we were able to manufacture and distribute a safe vaccine faster than in 

previous years, domestic manufacturing surge capacity needs to be expanded and 

accelerated. 

The MCM Enterprise review, along with a parallel study conducted by the President’s Council of Advisors on Science and Technology to improve influenza vaccine 
11 

manufacturing, identified immediate needs and opportunities to shorten vaccine production timelines. We need better methods for potency assays and sterility testing, 

optimized virus seed strains, additional development of diagnostic devices, and expanded capacity to fill and finish vaccine. The review also recommends that HHS 

support the development of at least three new influenza vaccine candidates whose 

manufacture does not depend on virus grown in eggs or cells. This initiative is already underway through collaborative efforts by ASPR/BARDA, NIH, FDA, CDC, 

and the industrial and academic communities. 

Strategic Investor Fund 

The fifth initiative we have identified is a strategic investment fund for new medical countermeasure technologies. 

Biotechnology companies are often founded with a promising novel technology, but 

without the resources and business acumen necessary to fully develop and license 

their idea into a marketable product. As I described above, the large manufacturers 

in the private sector often choose to not invest the needed capital and management 

expertise in these entrepreneurial endeavors due to the many risks inherent in medical countermeasure development, especially with firms or technologies whose products have no market outside that currently needed for Federal Government stockpiles. We discovered that this same set of problems led the intelligence community 

and the Department of the Army to each establish ‘‘strategic investor’’ organizations, In-Q-Tel and On Point, respectively, which help in partnering Federal Government needs with companies that are developing technical approaches that match 

those needs, and which are also capable of producing commercially viable spinoffs, 

or multi-use products, based on that technology. 

The administration’s fiscal year 2011 budget amendment transmitted to Congress 

in August included authorization for HHS to use an independent strategic investor 

that would nurture biotechnology companies by providing the needed capital and 

business expertise to yield a successful product for Government needs. The mission 

of the envisioned MCM Strategic Investor (MCMSI) would be the development of 

novel technologies that have the potential for sustainable commercial applications 

to the commercial market and the MCM public health enterprise. In addition to its 

own investments, the MCMSI could potentially leverage other private capital, provide expert consultation, and link promising companies with potential partners in 

the private sector. The MCMSI is envisioned as a private, not-for-profit corporation 

operating outside the Federal Government, but it would still work closely with NIH, 

BARDA, DOD, and our other Federal partners. 

Management, Administration, and Accountability 

The review also found that while some program management components are 

working quite well, better management and administration would provide more 

clarity and predictability, as well as less risk to development partners. These include: improving coordination across the agencies involved in the MCM enterprise, 

speeding up the contracting process or using more flexible transaction authorities, 

clearly setting and prioritizing broad enterprise goals, and coordinating the process 

of product development itself, from initial concept development to product use. 

IMPLEMENTATION OF THE RECOMMENDATIONS

We have re-allocated $1.9 billion in funding already appropriated for pandemic influenza and the procurement of medical countermeasures under Project BioShield 

to begin implementing these recommendations. This includes: 

—$170 million to promote regulatory innovation and investment in regulatory 

science at the FDA; 

—$678 million to build domestic flexible manufacturing infrastructure and advanced development core services; 

—$33 million to support promising efforts and translation of concepts and research at NIH; 

—$822 million to address immediate development needs related to pandemic influenza vaccines, antiviral drugs, and diagnostics; and 

—$200 million to explore alternative capital market mechanisms. 

The administration has submitted an amendment to the fiscal year 2011 President’s budget to provide new authorities where needed. Specifically, new authority 

is required to support the efforts at FDA, the efforts at DOD, and the MCMSI. 

HHS has begun developing implementation plans for each of the initiatives and 

enhancements described above. Some have progressed more than others, based on 

the complexity and novelty of the new efforts. The HHS senior leaders from CDC, 

FDA, NIAID and ASPR, working with colleagues at DOD, have conducted strategic 

reviews of our major product portfolios for smallpox, anthrax and radiological/nu-
12 

2 Available online at: http://www.phe.gov/Preparedness/planning/authority/nhss/Pages/default.aspx. 

clear threats. They have identified priority actions to further enhance the production and eventual distribution of these medical countermeasures, looking as well at 

economies that can be realized so we may be better stewards of the public funding 

for this capability. As previously noted, BARDA released a draft solicitation to support Centers of Innovation for Advanced Development and Manufacturing. 

BARDA has also awarded new contracts recently for the development of products 

that could be used as medical countermeasures to known or unknown threats as 

well as having a possible commercial market. BARDA awarded a contract to develop 

an antibiotic that could be used against two possible types of bioterrorism (plague 

and tularemia) as well as common infections that are becoming resistant to antibiotics. BARDA also awarded a contract to continue developing a new way to treat 

an illness caused by exposure to a nuclear blast; this treatment potentially could 

be used for other blood disorders and complications of cancer. BARDA is also expected to award a contract for the development of a next-generation ventilator as 

part of all-hazards preparedness generally, and pandemic influenza specifically. 

As we transition to this improved approach to medical countermeasure development, we see opportunities for advances in other areas of public health—new vaccines for neglected diseases, rapid response for emerging naturally occurring infectious diseases, and new approaches to treating drug-resistant bacteria in hospitals 

or other settings. This strategy aligns with our concepts under the National Health 

Security Strategy,2 which was developed to galvanize efforts to minimize the health 

consequences associated with significant health incidents and achieve a national vision of health security. The advances coming out of the medical countermeasure enterprise may ultimately address day-to-day needs as well as the ever-widening 

threats of biological, chemical, nuclear, and radiological hazards. 

CONCLUSION

I called for a review of the MCM enterprise recognizing that we need to incorporate 21st century technology along with 21st century financial, legal, and regulatory frameworks in order to have the medical countermeasures necessary to defend against the diverse threats we face. The review focused primarily on our ability 

to take an idea or concept in research and move it quickly to producing an approved 

medical countermeasure. But, we recognize that our ability to respond begins with 

the rapid identification of a new event through public health or medical surveillance 

and the ability to identify the requirements of an MCM—how much we will need, 

for what part or parts of the population. A medical countermeasure is successful 

only if it reaches the right population at the right time. We must rely on surveillance capabilities and feedback from end—users incorporated at the beginning of development cycle. 

The review identifies a variety of initiatives and opportunities to accomplish these 

intended goals with the ultimate vision of a nimble, flexible capacity that the nation 

can rely on to produce medical countermeasures rapidly in the face of any attack. 

As I mentioned earlier, in the end, if a product fails to make it into our national 

response capability, it should only be based on its failure to meet our stringent 

standards for safety, efficacy or quality, and not because we failed to provide the 

needed business, regulatory and technical support for success. By moving toward a 

21st century countermeasures enterprise with a strong base of discovery, a clear 

regulatory pathway, and agile manufacturing, we will be able to respond faster and 

more effectively to public health threats. 

Thank you for this opportunity to speak with you today on this important subject. 

I look forward to answering your questions. 

STRATEGIC INVESTOR FUND AND DEVELOPMENT AUTHORITY

Senator HARKIN. Thank you, Madam Secretary, for that statement. And thank you for taking the lead in this endeavor. 

I think the plan is a good plan, from what I’ve been able to read 

about it and to take a look at it. I’ll be anxious to follow its development to see what kind of input you get on your request for proposals that you’ve put out there. 

But, I do have some, kind of, concerns about a few elements of 

this. Help me think about this. We worked very hard to establish 
13 

BARDA a few years ago, and this subcommittee has funded it to 

get it going. But, I don’t understand how this fund—the Strategic 

Investor Fund—— 

Secretary SEBELIUS. Sure. 

Senator HARKIN [continuing]. I’m talking about—how that would 

work different from BARDA, because BARDA was basically set up 

to provide funds to small companies, promising companies with 

good ideas. That was a lot of talk, we had a lot of discussion about 

that. And so, it sounds like that’s the same thing as this Strategic 

Investor Fund (SRF). So, who—how does it differ? And who runs 

it? Does BARDA run it, or does NIH run it? I can’t quite get a handle on that one. 

Secretary SEBELIUS. Well, Mr. Chairman, the way that the strategic investor fund is envisioned is similar to some entities that 

exist in the national security realm, so the CIA has In-Q-Tel, and 

NASA has the Red Planet Capital Fund. And they are really to 

make capital investments at an earlier point in the process. 

BARDA will remain as the commitment to industry that there is 

a purchaser for the products that are going to be developed. I think 

the missing link—and Congress was wise to identify it and fill it— 

was that there’s very little appetite in the commercial market for 

making a product unless there’s some indication that somebody will 

buy the product. 

So, BARDA was funded and is still essential to demonstrate that 

the Government is a willing buyer, that there are resources set 

aside, that this won’t be a commercial venture without some ability 

to actually sell the product. And—what we have found, though, is 

that some of these small companies actually can’t—don’t have the 

capital to get to the marketplace. They can’t get the product idea 

all the way through the pipeline. And some have a great idea, but 

lack the business planning and strategy. 

So, with the capital in the strategic investor, with a kind of public-private partnership, using the assets of our NIH scientists, of 

FDA, we would be able to actually streamline the process, help 

move the ideas to the market, where BARDA could become a purchaser. So, I think they actually are complementary, not duplicative. 

Senator HARKIN. Okay. I think I get that. BARDA would be the 

purchaser, but this fund would be the investor—— 

Secretary SEBELIUS. Or at least help—yes—direct capital, business plans, ideas, marketing strategies. 

Senator HARKIN. Hmmm. Hmmm. 

Secretary SEBELIUS. And, as I say, In-Q-Tel and a couple of the 

other national security enterprises have done that very successfully. The national security government officials identify a missing 

piece of equipment or strategy. In-Q-Tel helps to work with the private market to actually produce what’s needed; and then, at the 

end of the day, you know, the DOD becomes the purchaser. 

PANDEMIC INFLUENZA PREPAREDNESS ACTIVITIES

Senator HARKIN. Let me just shift, a little bit, here, to pandemic 

flu. We don’t—obviously, we don’t know what some of these new 

strains of bugs that you mentioned in your testimony—I may have 

mentioned in mine, too—that might come down, or bioterrorism, or 
14 

something. But, we do know flu is here. We have the common 

strain of flu, that happens every year, but we know there are a lot 

of other strains of flu out there: the bird flu, H5N1, and H1N1, and 

a lot of variations thereof. And we know they’re floating around out 

there. So, we’re going to have that. I mean, we just know that 

that’s going to hit us. How big, we don’t know. As I said, H1N1 

wasn’t as big as we thought it was going to be, fortunately. But, 

we don’t know how big next—we know it’s going to happen, we just 

don’t know how big. 

Secretary SEBELIUS. Right. 

Senator HARKIN. So, therefore—I’m concerned, because this subcommittee put a lot of money—$15 billion through this subcommittee, since fiscal year 2006—for pandemic preparedness activities. One-point-nine billion was used to develop cell-based or recombinant vaccines. And I can remember visiting with people a few 

years ago about that, and moving ahead. We put—HHS awarded 

$487 million to Novartis for a cell-based manufacturing facility in 

North Carolina. I thought—I heard the plant was open, but now 

I’m told it won’t be ready to operate until 2013. Also, none of the 

influenza vaccines licensed for use in the United States are cellbased, but they are currently licensed in Europe. 

So, why—what’s the problem with getting them licensed in the 

United States if they’re licensed in Europe? And, why aren’t we 

further along in the area of cell-based or recombinant-based vaccines, which can be turned around a lot more rapidly, of course, 

than egg-based vaccines? 

Secretary SEBELIUS. Well, Mr. Chairman, again, I think you’re 

absolutely right, that the subcommittee has been focused on a series of investments, starting really in fiscal year 2006. And we do 

have doses of H5N1 purchased and in the stockpile, knowing that 

that flu is still killing people, it is circulating. There still isn’t 

human-to-human transfer, luckily, but we are very much aware 

that that’s a very real threat. So, some of the funding is actually 

preparing, in case that were to be present here. 

And, in terms of the cell-based technology that we’re moving 

ahead on currently, you’re absolutely right, all of the flu vaccine up 

to date has been developed with egg-based technology. But, HHS 

did, with the pandemic funding that was provided, support the construction of the new Novartis cell-based manufacturing facility in 

North Carolina. The ribbon was cut in November 2009. It is scheduled to be on line to apply for licensure early in 2011, we hope in 

the first quarter of next year, for cell-based, seasonal vaccine, and 

the licensed vaccine is expected to be manufactured and marketed 

for the 2011–2012 flu season. 

So, we’re actually very much on track. They got to get it up and 

running, they got to get it licensed. And it will be capable of producing 150 million doses of vaccine within 6 months. So, this seriously ramps up our domestic capacity, and that’s also very good. 

In terms of recombinant vaccine, we did issue a contract to Protein Sciences in September 2009 for advanced development of their 

recombinant protein vaccine, and the company is working towards 

licensure again in 2011. We think that is on track. They are expected to begin to manufacture and market their vaccine again for 
15 

the 2011–2012 flu season. Right now they’re saying they can 

produce 50 million doses in about 4 months. 

So, both of those entities are up and running. It takes a number 

of years in the pipeline, but your funding, several years ago, has 

gotten us to that place. And, as I said, we just issued a draft solicitation, this month, which will also come out of the preparedness 

funding, to have these new centers of innovation for advanced development and manufacturing that Senator Specter has indicated 

a great deal of interest in. 

What we find is that a flu-only facility is too limited. What we’re 

talking about looking at in the future, in two to three centers, is 

what they call a ‘‘flexible platform.’’ So, it could be used as surge 

capacity for flu vaccine, should that be needed. It also could, essentially, begin with anthrax vaccine, to H5N1 vaccine, to have another MCM. So, it wouldn’t be solely dedicated to the flu, but have 

the ability, really, to mix and match, give us the ability to respond 

to something that we don’t really know is coming. 

So, we plan to award the contracts by the—have the request for 

proposal out by the end of this year. We want each of those facilities to produce at least 50 million doses of cell-based or recombinant vaccine within 4 months. So, that will be the criteria around 

which we’re looking. So, we’re leaping over egg-based to either cell, 

or ideally recombinant, and one is in—already looking at licensure 

next year, and the other two or three will be up and running, hopefully, fairly quickly. 

Senator HARKIN. Very good. Thank you, Madam Secretary. 

Senator Cochran. 

MCM SPEND PLAN

Senator COCHRAN. Madam Secretary, I was looking at the funding amounts that this subcommittee has already recommended and 

have been approved by Congress, and looking then at how the 

funds have been used. You stated, in your testimony, that there 

may be unspent funds that you are now attempting to reallocate, 

or propose to reallocate. 

Have you come to some understanding, with the leadership in 

Congress, as to who goes first, who makes the decision? Do you 

have to get approval? Or do you have license just to start a program and start—sending this money out to beneficiaries or hospitals or public health officials? 

Secretary SEBELIUS. Senator Cochran, the plan that I just outlined is based on reprogramming about $2 billion of the preparedness funding which was dedicated to HHS by Congress and has already been approved for preparedness. And what we’re doing, after 

our analysis of where the countermeasure pipeline glitches exist, is 

suggesting that we would be better served, rather than continuing 

to fund the traditional pipeline, to look at areas where there were 

real gaps. So, more manufacturing capacity in the United States 

regulatory science in FDA and NIH, the areas where I outlined. 

There are a couple of those areas, Senator, that we will need specific congressional approval, because we don’t have the authorization; and that’s the amendment that we requested as part of the 

2011 budget. So, until Congress actually gives us the green light 

for the strategic investor or some of the new authorities within the 
16 

FDA, we will not be able to direct the funds there. But, the rest 

of this funding is actually approved for preparedness, and we have 

notified the appropriate committees that that’s the intent, and produced a spend plan to go along with that. 

H1N1 VACCINE

Senator COCHRAN. I’m curious, also, to know about how much 

money we spent in defending against an H1N1 virus that may 

have been over-advertised, in terms of its threat to general public 

health. Did we waste a lot of money by sending money out to State 

and local health authorities, or in letting them decide how to use 

the money? Or was there a national plan, with specifics included 

in the plan, as to how the funds were to be spent? 

Secretary SEBELIUS. Actually, Senator, I think that plan that allowed us to move vaccine to about 85 million people in a very rapid 

timeframe was based on years of planning that had been done. I— 

as a former Governor, I was one of the beneficiaries of preparedness funding, which allowed us to gather private industry and our 

public health officials together, and go through exercises: What if 

we had a pandemic? Little did I know that I would be sworn in as 

Secretary when we had the pandemic that I had been previously 

preparing for. 

So, our plan with H1N1 followed, really, the strategies. State and 

local health departments were major partners. And I would say 

that the new part of the strategy was how we rapidly enhanced the 

distribution system. We went from what was a fairly limited number of providers who were used to giving children vaccines in the 

past, to greatly enhancing that. Because one of the key targets 

were children. 

So, school-based clinics and mobile clinics and some of the open 

doors, I think, were not ones that had been typically planned for. 

But, there was definitely—at every point along the way, States, in 

order to draw down funds, had to provide to our Department very 

specific planning documents for what they would do with the 

money, where it was going to go. Providers had to be involved and 

included. We had weekly calls. 

I think the good news is that, in spite of the very alarming early 

days, where it appeared that, you know, this could mirror a 1918 

situation, the virus itself proved to be, thank God, less lethal than 

it could have been. But, I don’t think there’s any question that 

those partnerships, that distribution system, the outreach network, 

was not only money well spent for H1N1, but really helped to rebuild an infrastructure for a public health system that will serve 

us well, the next hurricane, flood, fire, or disaster that we’re going 

to have, because those are exactly the same folks who need to respond. 

Senator COCHRAN. I wonder, based on your experience so far as 

Secretary of HHS, and also your experience as Governor, do you 

have any recommendations to the subcommittee for language that 

might be included in an appropriations bill that would help improve the way we are using Federal dollars in an effort to defend 

against influenza outbreaks, or any other public health challenge 

that we may face? 
17 

Secretary SEBELIUS. Well, Senator, I think that some of the 

strategies, that are outlined in some of the recommendations in the 

lengthier report that we presented, at least deals with the portion 

of the MCM response that is scientific discovery to stockpile. What 

we’re continuing to do is really this end-to-end look. Is our surveillance system up to speed? I mean, do we know about outbreaks 

quickly enough in the United States or around the world? How do 

we get that information? What is that public health infrastructure? 

All the way through to how we distribute the products. You know, 

what’s the fastest way to get to people? I think that analysis is still 

going on. 

And we would love to work with you. We will look for that language and get it to you. Because I don’t think there’s any question 

that each time we go through one of these experiences—I mean, 

this was the first pandemic in 40 years—that we need to be informed and make sure that we update all of our systems along the 

way. 

I can tell you, I am concerned, and continue to be concerned, and 

pleased that there are funds again for the State and local level. In 

this budget downturn, I don’t think there’s any question that 

there’s been a real hit on the public health infrastructure around 

the country. A lot of State health departments have less staff than 

they did; a lot of emergency planners at the State and local level 

have been cut back. So, that is of concern. And we are trying to 

pay close attention to that as we anticipate what could come our 

way. Because—you know, we can have all the great products and 

ideas here, but, absent the ability to actually get them into communities across this country in a rapid and efficient fashion, there’s 

still a real problem. 

Senator COCHRAN. What was the name of that book? We had the 

author of the book. Was it Barry who wrote about the influenza 

100 years ago, or whatever—— 

Secretary SEBELIUS. Oh, the 1918? Yes. 

Senator COCHRAN. And it was interesting experience, learning 

from him, through his research and writing that book—— 

Secretary SEBELIUS. You bet. 

Senator COCHRAN [continuing]. And everything, some of the 

things that had been overlooked, that you would think a civilized 

society, and advanced as we were, as wealthy as we were, would 

have learned from that experience better than we did. I wonder if 

you’ve had a chance to read that book. It’s a few years old now. 

Secretary SEBELIUS. I have, and I’ve actually had a chance to 

meet a bit with the author. We also talked, at the beginning of the 

influenza outbreak, with a lot of the officials who were involved in 

the 1970s with what appeared to be—it was a novel strain of the 

flu. There was a major vaccination effort, and the disease never 

spread anywhere. 

So, to try and learn, again, how—you know, what they learned, 

and didn’t learn, I think it’s wise to make sure that, each time we 

have these experiences, we’re better informed by it, and, you know, 

update our strategies. And that’s what this is about, to use some 

of the money that had been appropriated and allocated for preparedness, study what went right and what went wrong, and try 
18 

to redirect it to what we think are more appropriate and timely opportunities. 

Senator COCHRAN. Thank you very much. 

Secretary SEBELIUS. Sure. 

Senator HARKIN. Well, Madam Secretary, thank you very much. 

Like I said, we have—I’ve gone over this with our staff. On your 

plan, it—there are a couple of things on which you do need signoff 

here. I think that we’d be very supportive of the plan, but, I must 

just tell you, forthrightly, so that you can go back and tell the Office of Management and Budget (OMB), that—— 

Senator COCHRAN. Nobody can tell OMB. 

TRANSFERRING FUNDS FROM HHS TO DOD

Senator HARKIN. Well—you can tell them this. You can tell them 

that I just—that this proposed transfer to the DOD is one exception, and that—I might as well just be up front with you, I’m not 

going to sign off on it. That’s $200 million. I just—in all my years 

here, I’ve never heard of anything like transferring money from 

HHS to DOD. I’ve heard it the other way around, maybe, once in 

a while. But, never that way. And with all of the demands that we 

have at NIH, at CDC, and all of the other demands that we have 

here—we’re having a hard time with our budgets—I think DOD 

could come up with the $200 million. I really do, Madam Secretary. 

I don’t expect you to respond to that, but I thought I would be fair 

and be up front with you so that they would know that they would 

have to do some further planning on that money. 

Secretary SEBELIUS. I will convey your message—— 

Senator HARKIN. I appreciate that—— 

Secretary SEBELIUS [continuing]. Mr. Chairman. 

Senator HARKIN [continuing]. Very much. Thank you very much, 

Madam Secretary. 

Secretary SEBELIUS. Thank you. 

Senator HARKIN. And if you have anything else to add to—— 

Secretary SEBELIUS. I just look forward to working with you as 

we move along. We will certainly, as we continue this review, continue to report back to the subcommittee. And again, look forward 

to working with you on the authorities that we may need for—— 

Senator HARKIN. Great. 

Secretary SEBELIUS [continuing]. Some of these—— 

Senator HARKIN. Great. 

Secretary SEBELIUS [continuing]. Novel ideas. 

Senator HARKIN. Thank you very much. 

Secretary SEBELIUS. Thank you. 

Senator HARKIN. Thank you, Madam Secretary. 

Now we’ll move to our second panel. Colonel Randall Larsen, 

U.S. Air Force, Retired. Colonel Larsen is the CEO of the Weapons 

of Mass Destruction Center—a not-for-profit research organization 

that he founded, along with former Senators Bob Graham and Jim 

Talent. He previously served as the executive director of the Congressional Commission on the Prevention of Weapons of Mass Destruction, Proliferation, and Terrorism. Colonel Larsen served for 

32 years in both the Army and Air Force; received his bachelor degree from Texas State University and his master degree in national 

security studies from the Naval Postgraduate School. 
19 

We have Dr. Eric Rose, M.D. Dr. Rose is the CEO and chairman 

of Siga Technologies, which develops antivirals against possible bioterrorism agents. He is also the co-chair of the Alliance for Biosecurity. Dr. Rose received both his undergraduate and medical degrees 

from Columbia University. 

And Dr. Andrew T. Pavia is the Chief of the Division of Pediatric 

Infectious Diseases at the University of Utah Health Sciences Center. He’s also the chair of the Pandemic Influenza Task Force of the 

Infectious Disease Society of America. Dr. Pavia received his B.A. 

and M.D. from Brown University. 

Welcome. Thank you all for being here. And your testimonies will 

be made a part of the record in their entirety. I ask if you could 

sum them up in 5 minutes or so. I would appreciate it. And we’ll 

jut go in the order in which I said, here. 

We’ll start with Colonel Larsen first. Welcome to the subcommittee. And thank you for all of your service. 

Colonel Larsen. 

STATEMENT OF COLONEL RANDALL J. LARSEN, USAF (RET.), CHIEF 

EXECUTIVE OFFICER, WEAPONS OF MASS DESTRUCTION CENTER, WASHINGTON, DC 

Colonel LARSEN. Mr. Chairman, vice chairman, you asked me to 

provide an assessment on the threat of bioterrorism. Let me be 

clear: Bioterrorism is a serious threat, and it will become even 

more so if we don’t take appropriate actions. 

Senators Bob Graham, Jim Talent, and I agree with the assessment in the National Security Council document signed by President Obama in 2009. On page 1 of that document, it stated that 

bioterrorism could place at risk the lives of hundreds of thousands, 

and cause $1 trillion in economic disruption, per event. The details 

of that threat are contained in my prepared statement, so I won’t 

focus on that in my oral testimony. But, my concern is, Mr. Chairman, that there are a lot of senior leaders—not this room—but 

there’s a lot of senior leaders in the legislative and executive 

branch that do not understand this threat, that you and I know 

very well. 

And I accept part of the responsibility for that. I’m an educator, 

run a think tank, and that’s what we’re supposed to be doing, is 

educating senior leaders, and make sure you have the facts to 

make these very difficult decisions. 

I get a lot of senior leaders asking me, ‘‘Why don’t we just prevent this bioterrorism?’’ Well, you and I know we can’t do that. 

That is the proper strategy for nuclear terrorism, but it will not 

work against bioterrorism. The genie’s out of the bottle. We’ve 

known that since Dr. Josh Lederberg and George Whiteside put out 

this report in 2001. This is nothing new. So, we must focus on what 

Senator Graham calls the response side of this equation. If Senator 

Graham was here, he’d have a big chart up here like this, with his 

links about what we need to do. He loves this chart and explains 

it very well. 

What we can do, if we properly fund these programs, and manage them, Mr. Chairman, vice chairman, we can push the decimal 

point to the left, is how Senator Graham describes it. We won’t 

count casualties in hundreds of thousands, or tens of thousands, or 

even thousands. We can push it down to a level of what we lose 
20 

on highways on 3-day weekends. Still be a tragedy for those families, but it will not be a weapon of mass destruction, and it won’t 

change the course of history. That’s a realistic goal that we can 

achieve. 

Now, let me give you two examples, since this is the Appropriations Committee, where Senator Graham, Talent, and I have a few 

problems with this. One of the things that Senator Graham loves 

to talk about here is environmental cleanup. Now, the reason that 

the President’s document talked about $1 trillion per event—you 

know, if they put a pound of dry powdered anthrax in New York 

City subway, we have no clue how long it’ll take to clean it up. We 

know that the British tested anthrax weapons on the island of 

Gruinard, off the coast of Scotland, in 1944. Took four decades to 

clean up that island. 

Now, sir, do you know how much we’re spending on clean-up research at the Environmental Protection Agency (EPA) to clean up 

anthrax? Half of what we will spend next year on Marine Corps 

marching bands. Sir, I think we need to think about priorities. Now 

sir, I’m a big fan of military bands, probably the reason I spent 32 

years in the military is because I saw the Marine Corps Band when 

I was a young boy in the cornfields of Indiana. But, sir, think about 

that. Half of what we spend on Marine Corps marching bands is 

what we’re going to spend to figure out how to clean up the New 

York City subway. I think it’s 800 miles of subway up there. 

That’s one problem. The other one is, the funding of this MCM. 

Now, we—you know, we gave an—WMD Commission gave an ‘‘F’’ 

to bioresponse preparedness, in the report card that came out in 

January. The fact that we were using 60-year-old technologies to 

make important vaccines like H1N1 was one of the reasons that 

Senator Graham and Talent and the commissioners gave that ‘‘F’’. 

But, I have three questions about this initiative. Because we 

think the strategy is great, and Senator Graham, Talent, and I, we 

fully support it. But, three questions for you: 

First of all, who’s in charge? I believe that was the question you 

asked the Secretary. I really would like to know. In fact, I have a 

bigger question. Who’s in charge, Mr. Chairman, Mr. Vice Chairman, of the architecture, the enterprise of biodefense for America? 

To the best of my ability and study, there’s about 24 presidentially 

appointed, Senate-confirmed individuals with some responsibility 

for biodefense. Not one of them has it for a full-time job, and nobody’s in charge. 

Now, maybe it’s because I spent 32 years in the military. I like 

that authority, responsibility, and accountability. Kind of easy to 

define, so you can do the oversight of that. With no one in charge, 

I just don’t know who’s going to do that. 

My second problem is, we don’t have an integrated plan. It’s 

great strategy. And maybe they haven’t had enough time, so we’ll 

give them a break on that. We need that integrated plan to work 

with the private and public sector—there’s a great model for how 

we developed penicillin, just before World War II, that made such 

a big difference in saving GIs’ lives. We need to figure out how to 

do that better. I’m sure these gentlemen will talk about that. 

And third, are we going to properly fund this? Now, Senator 

Graham and Senator Talent, last year, sent letters to you, sent let-
21 

ters to a lot of congressional leaders, and the White House, saying, 

‘‘We think BARDA was only funded at 10 percent of what were realistic requirements.’’ Now, there were some people who pushed 

back, and said, ‘‘We know BARDA’s doing—not doing a very good 

job. They’re not delivering products.’’ Well, our response to that 

was, ‘‘If you funded the U.S. Air Force at 10 percent of their requirements, they probably wouldn’t deliver everything you wanted, 

either.’’ 

Sir, I make these statements, not as a scientist or a physician 

or as a public health expert—I spent many years, like you did, flying airplanes—but, I have studied national security for four decades. And, sir, the serious threats that we’ll face in the coming decade are not going to come from missiles, tanks, or bullets, in my 

opinion; they’re going to come from infectious disease, going to 

come from Mother Nature. We know that for a fact, and I think 

there’s high probability we’re going to see attacks, manmade attacks, that’ll cause epidemics in our country. 

PREPARED STATEMENT

Preparing for these events means we must develop faster diagnostic capabilities, like the Secretary talked about, better, safer, 

less expensive, and more rapidly produced vaccines and therapeutics. Mr. Chairman, Mr. Vice Chairman, they’re critically important for our children and grandchildren, whether we suffer a biological attack or not, from terrorists. These will be no-regret investments that you make in America. 

Thank you. 

[The statement follows:] 

PREPARED STATEMENT OF COLONEL RANDALL J. LARSEN, USAF (RET.) 

Mr. Chairman, I speak today on my own behalf, but based on knowledge I have 

acquired during the past decade. I previously served as the chairman, Department 

of Military Strategy and Operations at the National War College, and the founding 

director of the Institute for Homeland Security. Last year, I served as the executive 

director of the Congressional Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, and currently serve as the CEO of The WMD 

Center, a not—for—profit research and education organization that former Senators 

Bob Graham (D-FL) and Jim Talent (R-MO) created as a follow-on to continue the 

work of the WMD Commission—and there is much work to do. 

Our first mission at the WMD Center is to ensure that senior leaders in both the 

public and private sectors understand the threat of 21st century bioterrorism—a 

subject not well understood by many leaders in both the legislative and executive 

branches of Government. I have concluded this based upon the actions and inactions 

of the Federal Government. 

In the past year, there have been numerous attempts to raid the BioShield Strategic Reserve Fund for nondefense programs. 

Organizations, such as the Food and Drug Administration (FDA) are not seen as 

critical components on America’s national security team. Considering the threats we 

face, both from both from bioterrorism and newly emerging diseases, FDA needs to 

be funded with the same vigor as the Pentagon’s latest weapons systems. Unfortunately, it’s not. 

No one is in charge of America’s biodefense enterprise. No individual has responsibility, authority, and accountability for a program that is vital to America’s longterm national security. To the best of my knowledge, there are more than two dozen 

presidentially appointed, Senate-confirmed individuals with some responsibility for 

biodefense. Yet, not one of them has it for a full-time job, they answer to no one 

in common, and no one is in charge. I do not think that is the organizational structure that will lead to success. 

Mr. Chairman, I am convinced that if senior leaders understood the threat we 

face today, and even more importantly, the threat we will face tomorrow, there 
22 

would be someone in charge of America’s biodefense enterprise, and a clear policy 

and sufficient funds would be available to properly defend America. 

The threat of bioterrorism we face today is far different than that of the 20th century. During the Cold War, only nation-states were capable of producing sophisticated biological weapons. However, as the biotechnical revolution began to accelerate in the latter days of the 20th century, the Defense Science Board 

(DSB)recognized the national security implications of these rapid changes in the 

seminal DSB report, Biological Defense, June 2001. The technology that had once 

been limited to major powers was rapidly becoming available to small nations and 

some non-state actors. 

‘‘. . . major impediments to the development of biological weapons—strain availability, weaponization technology, and delivery technology—have been largely eliminated in the last decade by the rapid global spread of biotechnology. There is no 

way the United States can control the spread of rapidly advancing biotechonology.’’ 

(page 18) 

What was unknown to the members of this DSB was the fact that while they were 

preparing their report al Qaeda terrorists in Afghanistan and Malaysia were in the 

process of developing anthrax weapons for use in the United States. Thankfully, al 

Qaeda did not complete their weapons development program before 9/11, and shortly after 9/11, U.S. troops discovered and dismantled the laboratories. 

Nobel Laureate, Dr. Joshua Lederberg and Dr. George Whitesides, the former 

chairman of the chemistry department at Harvard University, co-chaired this DSB 

task force. More than 9 years have passed since they warned us about the national 

security implications of the rapid changes in biotechnology. Those 9 years represent 

several generations—a great leap forward in biotechnology. The vast majority of 

these new capabilities represent good news for our families and Nation in terms of 

medical care and public health; however, there is also a dark side to this rapid 

progress. 

Mr. Chairman, I am concerned that many leaders in the legislative and executive 

branches of the Federal Government do not understand the dark side of this 

progress—the nature of current and future threats of bioterrorism. There are four 

key issues that are not well understood: 

—history of biowarfare, including the former U.S. offensive biowarfare program; 

—the current technologies available to non-state actors; 

—the interest of terrorist organizations in using biological weapons; and 

—and the fact that this is not an intractable problem. 

For the past 11 years, I have provided briefings on bioterrorism in a course sponsored by the Joint Staff’s Anti-Terrorism and Force Protection directorate (J–34) to 

more 3,500 senior military officers. More than 70 percent of these officers filled out 

the critiques at the end of my presentation, and by far, the most common statement 

on these critiques is: ‘‘Why hasn’t anyone told me about this?’’ 

Considering the fact that so many senior military officers are not well versed on 

this threat, it should be of no surprise that individuals outside the field of national 

security are even less well-informed. To properly understand the threat of 21st century bioterrorism, it is essential to have a basic understanding of the history of the 

use of bioweapons. 

In virtually all cases, biological weapons have been used in a terroristic mode— 

to attack civilian populations. They are not reliable weapons on the battlefield. They 

would be of little value if there was a strong wind, bright sunlight, rain, or any combination thereof. However, if one’s goal is to attack a city, and there is no specific 

date and time to do it, then they can become very effective tactical or strategic 

weapons. 

When I discuss 250 years of biological terrorism in my presentations, beginning 

with British soldiers giving Native Americans blankets contaminated with smallpox, 

to German agents attempting to infect horses and mules in our ports during World 

War I, and the Japanese dropping bombs filled with plague-infested fleas on Chinese cities, I say that the theories of these early day bioterrorists were sophisticated, but their technologies were not. 

During the early days of the Cold War the United States, the Soviet Union, Great 

Britain, and other nations reached a point where technology finally caught up with 

the level of theory. This was demonstrated in numerous tests in the United States, 

and by the fact that in the 1960s, many of America’s war plans included the use 

of biological weapons. 

I find it surprising how few citizens, and even senior military officers, actually 

know that America had a powerful offensive biological warfare capability until Richard Nixon unilaterally shut down America’s offensive of program on November 24, 

1969. 
23 

When America’s offensive biological warfare program began in the 1940s, it was 

low-tech and not capable of producing weapons of mass destruction. Major investments were made in the 1950s and significant advances were made in technical capabilities. By the late 1960s, America’s capabilities for the use of biological warfare 

was rapidly approaching the equivalence of nuclear weapons (in terms of casualties). 

After America’s unilateral disarmament in 1969, the United States led the effort 

to get all nations to sign the Biological Warfare and Toxin Convention. After signing 

this treaty, the Soviet Union then ramped up their offensive program, eventually 

re aching a level almost beyond imagination. With more than 50,000 scientists and 

engineers working across 11 time zones in scores of facilities the Soviets managed 

to hide most of this capability from Western intelligence agencies. While the U.S. 

offensive program had produced hundreds of pounds of weapons-grade pathogens, 

the Soviets were producing hundreds of metric tons. 

What is not well understood from this history is the fact that bio warfare is not 

just theory. Tests conducted in the United States, the Soviet Union and Great Britain confirmed beyond any doubt the capability of pathogens to serve as either tactical or strategic weapons against civilian targets—counter-value targets in Cold 

War terminology. There is no question that in the 1960s, 1970s, and 1980s this capability was only available to nation-states. What is not well understood, however, 

is the same capability is now available to virtually any nation, and for many terrorist organizations, both international and domestic. 

It was nearly a decade ago that Drs. Lederberg and Whitesides stated that the 

rapid advances in biotechnology had reached the point where non-State actors were 

capable of producing these terrible weapons. The briefings given by various Government agencies to the WMD Commission during the past 2 years made it clear that 

further advances in the biotechnical revolution have made the production of sophisticated biological weapons by non-State actors even less challenging than in 2001. 

Those who say that it is still too difficult for terrorists to produce and deliver sophisticated biological weapons are either unaware of the extraordinary advances in biotechnology and the recent Government studies that demonstrate these capabilities, 

or have some other agenda that they wish to champion. 

Mr. Chairman, four things must occur for a terrorist organization to develop and 

deliver a sophisticated biological weapon. First they must acquire a sample of the 

deadly pathogen such as anthrax or plague. How would a terrorist organization acquire such deadly pathogens? For the past few weeks there has been a naturally 

occurring outbreak of anthrax in humans and cattle in Bangladesh. This is not terribly uncommon in many developing countries. In fact, it even occurs in the United 

States. In the summer of 2008, Ted Turner lost 278 buffalo to anthrax on his ranch 

in Montana. The buffalo died because they ate grass in a pasture that contained 

anthrax spores in the soil. On Monday, a state of emergency was declared in a village in Southern Russia’s Krasnodar Territory over an anthrax outbreak in dairy 

cattle. If terrorists wanted to find a sample of Yersinia pestis, the bacteria that 

causes plague, they would not have great difficulty finding it in many locations west 

of the Mississippi River in the United States. Prairie dogs in West Texas and rats 

above the 5,000-foot level in the Rocky Mountains often carry this deadly pathogen. 

Earlier this week, the Chinese reported an outbreak of plague in humans in southwestern Tibet. 

Obtaining samples of deadly pathogens is not particularly difficult. In fact, all but 

two of the 80∂ pathogens on the Select Agent List exist in nature. Pathogens that 

cause anthrax, plague, tularemia, Ebola, Marburg, Venezuelan Equine Encephalitis, 

Q-Fever, and dozens of others can be obtained and isolated from diseased animals 

or humans. 

The second step in creating a terrorist bioweapon is production. Taking a small 

sample of one of these pathogens from nature and producing enough material suitable for use as a weapon is a standard process used in various industries including 

pharmaceutical, agriculture, and pesticide. All of the equipment and supplies required for production are available on various sites on the Internet at very reasonable prices. 

The third step, and the part that has always been most challenging in creating 

a biological weapon, is getting material to the proper particle size for airborne release. The most effective way to disseminate a biological weapon is to spray either 

a liquid or dry powdered form of a pathogen into the air. When in the proper particle size, the pathogen will enter the human respiratory system and then move directly into the blood stream where it leads to systemic illness. 

In the 1960s and 1970s it took superpower technology to create the proper particle 

size without causing harm to the bacteria or virus being disseminated. Today it is 

standard off-the-shelf technology used in the pharmaceutical and agriculture communities. Techniques far more sophisticated than what was used in the highly clas-
24 

sified U.S. offensive program are now openly discussed in highly respected scientific 

publications such as Journal of Aerosol Medicine and Pulmonary Drug Delivery, and 

openly discussed at major conferences hosted by organizations such as the American 

Association for Aerosol Research (AAAR). The AAAR conference schedule for October in Portland, Oregon, will include tutorials on Aerosol Mechanics I & II (http:// 

aaar.conference2010.org/content/tutorials). 

These scientific publications and organizations are incredibly important to medical research. They are important aspects of the biotechnical revolution that will 

make the lives of our children and grandchildren healthier and better protected 

from both chronic and infectious diseases that plagued our parents and grandparents. But we must understand, this same technology can be used to make weapons. We must also remember what Drs. Lederberg and Whitesides told us in 2001: 

‘‘There is no way the United States can control the spread of rapidly advancing 

biotechonology.’’ (Nor should we try. It would only succeed in reducing our defensive 

capabilities, and cause serious, perhaps irreparable damage to our important biotech 

industries.) 

The fourth and final step is delivery. In October 2001, the U.S. Congress witnessed a very low-tech and generally ineffective method of disseminating a biological 

weapon—the U.S. Postal Service. On the other hand, using spray devices available 

in most agriculture stores, and also available for sale on the Internet, to disseminate 

a few pounds of dry-powdered anthrax, most particularly in an indoor environment 

such as the subway or indoor sports arena, would have the enormous consequences 

of a weapon of mass destruction. 

What are those consequences? They were best stated on page 1 of the November 

2009 National Security Council document, National Strategy for Countering Biological Threats. 

‘‘The effective dissemination of a lethal biological agent within an unprotected 

population could place at risk the lives of hundreds of thousands of people. The unmitigated consequences of such an event could overwhelm our public health capabilities, potentially causing an untold number of deaths. The economic cost could exceed one trillion dollars for each such incident. In addition, there could be significant societal and political consequences that would derive from the incident’s direct 

impact on our way of life and the public’s trust in Government.’’ 

There are some who say terrorists prefer to use bombs, and point to such recent 

attempts as we witnessed on Christmas Day and in May in Times Square. Without 

question the vast majority of terrorists will continue to use conventional weapons. 

Those weapons are certainly capable of producing dramatic results for terrorists, 

such as what we all watched unfold in Mumbai; however, terrorist use of conventional weapons will not change course of history. An event, such as described in the 

November 2009 NSC report would change the course of history—not only for us, but 

for our children and grandchildren. 

For those who say terrorists have no interest in biological weapons, I guess they 

just ignore the Aum Shinrikyo attempts in 1994–1995 to produce biological weapons 

in Japan and disregard the al Qaeda bioweapons program. For a recent terrorist 

perspective on bioweapons, I suggest you watch a short video at this Web site: 

http://www.youtube.com/watch?v=M32M-2B2mz8. It was broadcast repeatedly on Al 

Jazeera TV in February 2009 and has been viewed on the Internet more than 

80,000 times. 

Perhaps some of the confusion comes from assessments by the Intelligence Community (IC) on the bioterrorism threat. The IC will tell you they have little or no 

information of any terrorist group developing biological weapons capability. That 

should not be surprising. 

During 15 years of the Cold War, the IC failed to appropriately identify the massive Soviet biowarfare program that consisted of 50,000 scientists and technicians 

working in scores of laboratories across 11 time zones. (This was the size of the Soviet’s offensive biowarfare program after they signed the Biological Warfare and 

Toxin Convention.) The IC also missed al Qaeda’s anthrax programs in Afghanistan 

and Malaysia, and they missed the Aum Shinrikyo biowarfare and chemical weapons programs. Thankfully, both of the Aum’s weapons programs were plagued with 

technical errors when they went from small-scale to large-scale production. 

Do we really think there is a high probability the IC will find a half-dozen individuals working in a make-shift laboratory (standard bio lab equipment purchased on 

the Internet in a facility no larger than a two-car garage) in a remote village in the 

tribal regions of Pakistan or Sana, Yemen, or the suburbs of New York City? That 

is the size and scale of a facility required to produce bioweapons, according a study 

(BACUS) done by the Defense Threat Reduction Agency in 1999 that determined 

there would be no perceptible ‘‘intelligence signature’’ of such an operation. 
25 

For the threat of bioterrorism, the IC can provide us with sound strategic intelligence information on intent, but little or no tactical level information: status of a 

bioweapons program of a specific terrorist organization or the time and location of 

a planned attack. 

I think we all understand that there are people and organizations out there that 

want to kill large numbers of Americans. The WMD Commission said there are two 

ways to do that, nuclear and biological, and by far, biological is easier. If the senior 

leaders in the Congress and administration understood the biological capabilities 

now available—and even more troubling, what will be available in the next couple 

of years—to small terrorist groups, there would be no requirement for hearings such 

as these. Biodefense would be a top priority, and we would be making rapid 

progress in defending our cities, communities, and families. 

I sometimes think the reason some leaders are hesitant to take the recommended 

actions, is that they believe the problem is intractable-it is so difficult and complex, 

that ‘‘there is nothing we can do’’. There is no question that biodefense in the 21st 

century is difficult and complex, but the fact is, there are actions we can take to 

remove bioterrorism from the category of weapons of mass destruction (WMD). 

We cannot realistically prevent bioterrorism, but if we develop robust response capabilities, we will effectively remove bioterrorism from the category of weapons of 

mass destruction. We will be able ‘‘to move the decimal point to left’’ in that number 

from the November 2009 NSC report. We will not count casualties in the hundreds 

of thousands, or tens of thousands, or even in the thousands. We can move the casualty count down to the scale of what we lose on America’s highway on a 3-day 

weekend—most certainly it would still be a tragedy, but not a WMD that would 

change the course of history. 

The threat of bioterrorism will not diminish in the years ahead unless we take 

the required actions to build a robust and nimble resilience capability that includes: 

—near real-time detection and diagnosis of disease outbreaks; 

—situational awareness and effective communication of actionable information, 

rapid development, and production of medical countermeasures; 

—timely countermeasure distribution and dispensing; 

—surge medical care delivery to treat the sick and protect the well; and 

—environmental cleanup and remediation. 

If Senators Bob Graham and Jim Talent were here today, they would tell you that 

sufficient and continued funding in support of these programs will not only lead us 

to a point where bioterrorism can be removed from the category of WMD, it will 

also provide a deterrent against attack, and just as importantly, that these are all 

‘‘no-regret investments.’’ Building a system that provides for rapid diagnosis of disease, whether naturally occurring or manmade; better, faster, and less expensive 

vaccines and therapeutics; and far greater capacity for surge operations in our hospitals and clinics are the types of investments we should be making for our children 

and grandchildren. On that, we can all agree. 

Last month the President recommended an initiative to improve our system for 

developing MCMs. It is, perhaps, the single most important factor for removing bioterrorism from the category of WMD, but to make it work we need to understand 

that organizations responsible for this new initiative—Health and Human Services/ 

BARDA, National Institutes of Health, and the Food and Drug Administration are 

now critical elements of our national security community—no less important than 

the Department of Defense, the IC, and the Federal Bureau of Investigation. 

Mr. Chairman, the threat of bioterrorism is real and will only increase over time. 

As Drs. Lederberg and Whitesides wrote back in 2001, there is no way to stop the 

biotechnical revolution that will place ever-increasing asymmetric power in the 

hands of terrorists. However, that same revolution in technology can be used by 

America to remove bioterrorism from the category of WMD. The decision will be 

yours. 

I look forward to your questions. 

Senator HARKIN. Colonel Larsen, thank you very much. Very 

stimulating presentation. 

Dr. Rose. 

STATEMENT OF ERIC A. ROSE, M.D., CHIEF EXECUTIVE OFFICER AND 

CHAIRMAN, SIGA TECHNOLOGIES; CO-CHAIR, ALLIANCE FOR 

BIOSECURITY, WASHINGTON, DC 

Dr. ROSE. Mr. Chairman, Mr. Vice Chairman, I’m Eric Rose. I’m 

the co-chair of the Alliance for Biosecurity and the CEO of Siga 
26 

Technologies. It’s a pleasure to be with you today to provide you 

with our impression of the HHS report on the PHEMCE Enterprise 

review. 

The Alliance for Biosecurity is a collaboration among pharmaceutical and biotechnology companies that are focused on biodefense countermeasures. My company, Siga Technologies, is in 

late-stage development of a smallpox antiviral drug, and therefore, 

I can give you a firsthand perspective of how well our Federal Government is working with small, private-sector biodefense companies like ours. 

I’ve submitted written testimony for the record. At the outset, I 

would like to make three simple points: 

First, the BARDA Advanced Development Program is bearing 

fruit. While many have criticized the perceived slow pace of development of needed novel biodefense countermeasure, our experience 

is that the Federal investment in biodefense is generating important novel countermeasures less than 7 years after BioShield enactment, and also just 4 years after the creation of BARDA. And that, 

I think, you should take in a context, that typical drug development now takes 10 to 15 years for a new drug or vaccine. So, there 

is a trickle, but that pipeline is beginning to flow. We, at Siga, are 

now producing commercial-scale validation batches of our smallpox 

antiviral drug candidate, which we hope will soon be added to the 

strategic national stockpile. 

Second, the administration’s proposed enhancement of FDA regulatory science innovation and capacity, along with additional funding, is very welcome to our community. While the FDA is not within the jurisdiction of this subcommittee, we do want to note that 

we are particularly pleased with the emphasis placed on the review 

on enhancing FDA’s essential role. Therefore, we strongly support 

the administration’s August 20 budget amendment request to 

transfer available balances from prior pandemic influenza appropriations to modernize FDA regulatory science. 

Third, full funding of the BioShield Strategic Reserve Fund ensures that there is an oasis, and not a mirage, on the other side 

of the valley of death of advanced development. And this is absolutely critical to the success of small biotech companies who rely 

on private investment to initiate product development. 

While we appreciate the need to find offsets for other new spending in order to reduce the Federal budget deficit, I can tell you that 

every time there is a proposal to transfer unobligated balances out 

of the SRF for other purposes, it sends shock waves through the 

private-sector companies involved in this arena, and it shakes our 

investors’ confidence that we desperately rely upon to nurture 

these projects through the early phases of development. 

BARDA’s rapidly growing advanced development pipeline is indicative of the strong interest that small companies have in biodefense. However, our success relies upon a reliable and a committed customer. We share and support the overall goal of the review, and the Alliance is thankful to have been consulted by the 

ASPR, Dr. Nicky Lurie throughout the process. We are particularly 

also pleased to see the review include plans for HHS to increase 

transparency, communication, and predictability within the contracting and procurement processes, and across agencies. Further, 
27 

we were encouraged that the review included a commitment to develop a 5-year budget plan for the entire MCM enterprise, expand 

the advanced development program, and increase staff levels. 

There are also some elements of concern to us. We were disappointed that the review did not propose fully funding the advanced development program that Colonel Larsen just referred to— 

it’s still grossly underfunded—nor outline a process for restoring 

funding to the SRF beyond 2013, or otherwise providing long-term 

and stable funding for the procurement of MCM. 

We support plans for the sustainability enterprise, but caution 

that investments must be made up front in order to guarantee success over the long term. In addition, to reiterate, the SRF should 

not be depleted for other uses, including proposals put forth in the 

review. For this reason we’re concerned that the administration’s 

August 20 budget amendment request included the transfer of $200 

million to DOD that you referred to, and we’re delighted to hear 

your candid and quick response. 

And also, the $200 million transfer from the SRF to establish a 

new countermeasures strategic investment firm. We’re supportive 

of a technical center of excellence, but, as you’ve concluded, the 

transfer from DOD, we think, is just wrong. 

We think that an independent strategic investment firm for innovation in MCM may have some merit, although little concrete information has been provided to evaluate the value of this initiative, 

and I think the whole nature of early stage development of biological products, drugs, and vaccines is very different from information 

technologies and electronics technologies that are part of In-Q-Tel. 

It seems highly misguided, however, to create a strategic investment firm to incentivize entry into this space by de-incentivizing 

private investment through depletion of the SRF. That combination 

just does not make sense. 

Particularly with the SRF, also, we were very pleased to see the 

bipartisan effort on the part of 17 Senators, over the summer, who 

wrote specifically to the Senate leadership about the multiple—essentially to counter the multiple efforts to raid the SRF, and we 

were very, very grateful for their support. 

PREPARED STATEMENT

Finally, we urge the subcommittee to work closely with the administration to clarify, execute, and adequately fund the programs 

needed to sustain the PHEMCE enterprise, and our Alliance is 

committed to working with the Congress, the administration, and 

others, of course, to make the countermeasures enterprise a success. 

We’re very grateful for your attention and consideration, and appreciate the invitation here. 

[The statement follows:] 

PREPARED STATEMENT OF ERIC A. ROSE

SUMMARY

The Alliance for Biosecurity respectfully submits testimony to the Senate Labor, 

Health and Human Services, and Education, and Related Agencies Appropriations 

Subcommittee regarding the Department of Health and Human Services’ (HHS) report—Public Health Emergency Medical Countermeasures Enterprise Review: 
28 

Transforming the Enterprise to Meet Long-Range National Needs (Countermeasure 

Enterprise Review) for the ‘‘Defending Against Public Health Threats’’ hearing on 

September 29, 2010. 

We very much appreciate being invited to appear today before the subcommittee 

to discuss this important report and thank you for the consideration of our views. 

The Alliance for Biosecurity is a collaboration among pharmaceutical and biotechnology companies that are working in the public interest to improve prevention 

and treatment of severe infectious diseases—particularly those diseases that present 

global security challenges. The Alliance promotes a stronger, more effective partnership between Government, the biopharmaceutical industry, and other stakeholders 

in order to advance their shared goal of developing critically needed medical countermeasures (MCMs). 

Bioterrorism and emerging infectious diseases present an extraordinary and potentially grave threat to public health and national security. One of the most effective ways to improve our national preparedness for these threats is through the development of drugs, vaccines, and diagnostics, called MCMs, that can be distributed 

in the event of an emergency. The Federal Government has a central role to play 

in developing these MCMs and the Alliance stands ready to work with the administration, Congress, industry, and other stakeholders in our shared mission to identify, create, and obtain MCMs to protect citizens against bioterrorist attacks and potentially destabilizing emerging infectious diseases. 

Positive Elements of the Countermeasure Enterprise Review 

We share and support the goal of the Countermeasure Enterprise Review, which 

is ‘‘a modernized countermeasure production process where we have more promising 

discoveries, more advanced development, more robust manufacturing, better stockpiling, and more advanced distribution practices.’’ We support the intention of the 

Review and look forward to working with the subcommittee and the administration 

to further evaluate some of the initiatives included in the report as well as other 

ideas that will help to sustain and further develop the biodefense enterprise. 

The Alliance is thankful to have been consulted by the Assistant Secretary for 

Preparedness and Response, Dr. Nicole Lurie, throughout the course of this important review. In addition to in-person meetings, we submitted a White Paper on 

March 2, 2010, that incorporated a number of core recommendations, including the 

need to (i) improve the procurement and contracting process to more effectively promote development of MCMs; (ii) improve the speed and efficiency of regulatory 

interactions between private industry and the U.S. Government; and (iii) improve 

coordination among the Food and Drug Administration (FDA), Centers for Disease 

Control and Prevention, Biomedical Advanced Research and Development Authority 

(BARDA), and other relevant agencies around the development and approval of 

MCMs. 

Therefore, the Alliance was particularly pleased to see the Countermeasure Enterprise Review include plans for HHS to increase transparency, communication, and 

predictability within the contracting and procurement processes and across agencies. We hope that this includes transparency regarding setting requirements and 

specific information such as a target product profile as early as possible and is publicly disclosing allowable requirement and population threat analyses information. 

Further, we were encouraged that the Review included a commitment to develop 

a 5-year budget plan for the entire MCM enterprise, expand the advanced development program, and increase staff levels. We welcome these enhancements and feel 

strongly that the MCM enterprise and our Nation’s preparedness will benefit from 

increased communication, development of a 5-year budget, continuity, and transparency. We hope the administration will include such a coordinated long-range 

budget plan as part of the 2012 President’s budget. 

The Alliance was also pleased with the emphasis placed on enhancing FDA regulatory innovation, science, and capacity in the Review, as well as the recognition of 

the importance of optimizing the legal and policy framework for MCM oversight and 

approval. Therefore, we support the administration’s August 20 budget amendment 

request to make available balances from prior pandemic influenza appropriations to 

modernize FDA ‘‘regulatory science.’’ We believe that this new approach to regulatory science must focus on the agency’s ‘‘animal rule’’ in order to make it an effective mechanism for the approval of needed countermeasures in the numerous instances where human testing of drugs and vaccines is unfeasible and/or unethical. 

This focus requires the addition of substantial manpower to the agency to meet the 

complex needs of this space, and the training of regulatory personnel to facilitate 

their understanding of the unique national security and public health issues that 

chemical, biological, and nuclear threats represent. 
29 

Elements of Concern Regarding the Countermeasure Enterprise Review 

The Alliance’s March White Paper also included a core recommendation to ‘‘improve predictability and ensure the availability of consistent, robust funding for the 

development of MCMs.’’ Indeed, this is essential to ensuring that the MCM enterprise is successful. We were disappointed that the Countermeasure Enterprise Review did not propose fully funding the advanced development program at BARDA, 

nor outline a process for restoring funding to the Special Reserve Fund (SRF) beyond 2013 or otherwise providing long-term and stable funding for the procurement 

of MCMs. We support plans for the sustainability of the Enterprise, but caution that 

investments must be made up front in order to guarantee success over the long 

term. 

As you know, in 2004, Congress—recognizing that the country was relatively unprepared for the aftermath of an attack with CBRN agents—passed the Project BioShield Act (Public Law 108–276), which established the SRF. In the Project BioShield Act, Congress described the purpose of the SRF as procuring products to 

‘‘treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security.’’ 

Congress appropriated $5.6 billion for this purpose in 2004 to remain available until 

2013. Since that time several critical MCMs have been purchased and stored in the 

Strategic National Stockpile with SRF funds. 

Predictability and availability of robust funding for the advanced development 

and procurement of MCMs is one of the most important signs to industry and to 

private investors that the Government is serious about moving the MCM initiative 

forward. Although there are a number of initiatives listed in the Review that may 

help the MCM enterprise in the long term, there was little mentioned about immediate funding. Since advanced development is the most expensive part of MCM development, it must be funded at a higher level. In addition, the SRF should not be 

depleted for other uses, including proposals put forth in the Countermeasure Enterprise Review. 

Private sector firms cannot invest in product development, which requires 10 to 

15 years and hundreds of millions of dollars, unless they are reasonably certain that 

a market will exist for their product when it is finished. The SRF serves as a concrete demonstration of the Federal Government’s commitment to procuring MCMs. 

Diminishing or eliminating the SRF would call into question the credibility of that 

commitment, and by doing so make it difficult for the private sector to remain in 

the countermeasure business. While this would significantly affect these companies 

and their employees, it would be a much larger setback for the country as a whole. 

For this reason, we are concerned that the administration’s August 20 budget 

amendment request included the transfer of (i) $200 million from the SRF to the 

Department of Defense (DOD) in order to establish a Technical Center of Excellence 

for Advanced Development and Manufacturing; and (ii) $200 million from the SRF 

to establish a new MCM strategic investment firm. 

Establishment of a ‘‘Technical Center of Excellence’’ for advanced development 

and manufacturing of MCMs is a laudable goal. However, DOD intends to dedicate 

significant funding to the development of platform technologies and the advanced 

development and manufacturing of novel countermeasures. We support this initiative but oppose transferring SRF funds to support it. As previously stated, depleting 

the SRF now raises a number of concerns. Any flexible manufacturing initiative 

should be funded apart from the SRF with new resources, which do not compete 

with funding for advanced development at BARDA. Lastly, it is important to ensure 

that all existing manufacturing capacity is being effectively and efficiently deployed 

before investing in the creation of new capacity. 

Likewise an independent strategic investment firm for innovation in MCM, ‘‘to 

provide necessary support for small innovators and increase the odds of moving innovation into successful development’’ may have some merit although little concrete 

information has been provided to evaluate the value of this initiative. It seems 

somewhat paradoxical, however, to deplete the SRF—the primary signal of a Government market for MCMs—in order to create a strategic investment firm to promote innovation of MCMs. Such an action would send, at best, a confusing signal 

to industry and private investors, and could have the impact of discouraging further 

investment in MCMs under development. Additionally, it is premature to transfer 

funds to create a new investment firm when the administration has not decided on 

the model, structure, or objectives of such a firm. 

The Alliance urges the subcommittee to work closely with the administration to 

clarify, execute an adequately fund the programs needed to sustain the PHEMCE 

enterprise as the initiatives included in the Countermeasure Enterprise Report are 

further developed and implemented. The Alliance is committed to working with Con-
30 

gress, the administration, and others to make the countermeasure enterprise a success. We thank you for your attention and consideration. 

Senator HARKIN. Thank you very much, Dr. Rose. 

And now we turn to Dr. Pavia. 

Dr. Pavia. 

STATEMENT OF ANDREW T. PAVIA, M.D., FAAP, FIDSA, CHIEF, DIVISION OF PEDIATRIC INFECTIOUS DISEASES, UNIVERSITY OF 

UTAH; CHAIR, INFECTIOUS DISEASES SOCIETY OF AMERICA’S 

PANDEMIC INFLUENZA TASK FORCE, SALT LAKE CITY, UTAH 

Dr. PAVIA. Senator Harkin, Senator Cochran, thank you very 

much for this opportunity to speak to you on behalf of the 9,000 

members of the Infectious Disease Society of America (ISDA). 

Unlike Colonel Larsen, I am an infectious disease physician, a 

scientist, and a pediatrician—not much of a pilot, but—I appreciate 

this opportunity to comment on the matters before us. 

IDSA commends Secretary Sebelius for undertaking the comprehensive review of our MCM Enterprise. As a final report makes 

abundantly clear, there are many components, organizations, factors, and barriers that are vital to the successful development of 

countermeasures, their deployment and use. And, although it was 

intentionally left out of the review because of its scope, investments 

in the U.S. public health system at the Federal, State, and local 

level are urgently needed. 

The recent H1N1 pandemic demonstrated the importance of 

being able to rapidly develop countermeasures—and these include 

vaccines, antimicrobial drugs, and diagnostics—and the importance 

that we be able to develop our responses to biological threats, 

whether those be the ones that we anticipate easily, such as pandemic influenza or anthrax, or new and unrecognized threats. And 

an example that I want to bring to your attention is the emergence 

of antimicrobial resistance, whether it be influenza that’s resistant 

to Tamiflu, or bacteria that are resistant to all available antibiotics. 

There have been a number of recent reviews that have looked at 

the MCM Enterprise, in addition to that done by the Secretary. All 

have identified similar barriers and opportunities for improvements. Many of these recommendations mirror policy improvements that IDSA has suggested over the past several years. We’ve 

put before you our reports from 2004 on ‘‘Bad Bugs, No Drugs’’ and 

on ‘‘Pandemic Influenza’’—‘‘Pandemic and Seasonal Influenza, Principles for Action,’’ from 2007. Many of these recommendations will 

be critical if they can be accomplished, but the proof is in their actual implementation. 

We’re pleased that HHS is taking a comprehensive approach. As 

you pointed out in your opening remarks, an effective countermeasure system is one that doesn’t focus on individual agents, but 

that can flexibly respond to a variety of threats, and do so quickly 

and efficiently, with good stewardship of our resources. 

We’ve recently experienced an influenza pandemic, which was, 

thankfully, the mildest of the last 100 years. Part of why it was 

mild was because of the investments that were made in planning 

and preparation. We produced a vaccine in record time, let’s not 

forget, and yet, that still was not enough, and it was not soon 

enough. 
31 

This was a mild pandemic, by all measures, but that means that 

it only killed 9,000 to 18,000 Americans; it put some 300,000 in the 

hospital; it killed 1,200 children, some of whom died in my hospital 

in front of my eyes. 

So, a mild pandemic is still a major threat. A moderate or severe 

pandemic is one that we have to be prepared for. And it is indeed 

inevitable, as people have already mentioned. What we don’t know 

is when it will emerge and how severe it will be. And what we have 

in our power to do something about is whether or not we will be 

prepared for it. 

The threat of antimicrobial resistance is, in fact, intimately 

linked to the threat of pandemics and bioterrorism. In influenza 

pandemics, people die of secondary bacterial infections, not just of 

influenza virus; and in recent years, Methicillin-resistant Staphylococcus aureus, or MRSA, has been the major killer after influenza. Moreover, the antibiotic resistance genes that are emerging 

naturally can fairly easily be engineered into bioweapons, such as 

anthrax. And a moderately competent graduate student can do it 

with a modicum of funds and a decent laboratory. 

Several factors have resulted in the dearth of new MCM in development, and these include the lack of financial incentives; insufficient risk-sharing, because of the high rate of failure of new products; regulatory uncertainty; insufficient federally supported research; and lack of coordination across all components of the MCM 

measure, as Colonel Larsen has mentioned. 

To create sustainable MCM R&D, we have to determine the right 

combination of financial incentives and risk-balancing and -sharing 

that will allow industry to invest and to succeed. The strategic investment firm envisioned by the MCM report is one potential tool, 

and IDSA supports it. But, other mechanisms are also needed. We 

caution, however, that the initial funding level proposed for the 

strategic investment firm is unlikely to result in useful countermeasures. Other funding and additional mechanisms need to be integrated. 

All reviews identify potential barriers from regulatory uncertainty. FDA must develop clear and achievable regulatory pathways for review and approval of new MCM. This will require investment. While not the purview of this subcommittee, it’s critical 

that Congress fund the desperately needed improvements in regulatory science and capacity for public health measures at FDA. 

The investments made over the past several years have limited 

the impact of pandemic flu, but large gaps remain. IDSA appreciates the generous funding that this subcommittee has provided 

over recent years, as it did in the supplemental appropriations bill. 

However, we strongly believe that preparedness for influenza and 

other public health emergencies requires a consistent and predictable stream of funding. We support at least $1.7 billion in 

multiyear appropriations for BARDA for fiscal year 2011 to fund 

the development of new countermeasures. 

We also recognize a need for a clinical-trials infrastructure that 

will allow the further clinical development of these MCM. Successful examples exist for HIV/AIDS and for cancer. We need to learn 

from these examples that have been successful, and integrate that 

into the MCM enterprise. 
32 

Improved management structure has already been mentioned. 

It’s featured in the Secretary’s report. Some of the tools that are 

laid out, including the early development teams at NIH and the action teams proposed at FDA, are promising approaches, but there 

does need to be coordinated leadership. 

PREPARED STATEMENT

The danger posed to the United States by biological threats, including pandemic influenza, biologic weapons, emerging infections, 

is really very real and very great. Continued thoughtful, efficient 

investment in the science, in filling the pipeline, evaluating and licensing countermeasures, and efficient management of the enterprise, will provide Americans with the protection that they expect 

and deserve. 

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

[The statement follows:] 

PREPARED STATEMENT OF ANDREW T. PAVIA

The Infectious Diseases Society of America (IDSA) appreciates this opportunity to 

speak before the Senate Labor, Health and Human Services (HHS), and Education, 

and Related Agencies Appropriations Subcommittee as you examine our Nation’s 

readiness and ability to deal with public health threats, particularly through the development of countermeasures to address biodefense, pandemic influenza, and 

emerging infectious diseases. My name is Andrew Pavia, MD, FIDSA, FAAP. I am 

an infectious diseases specialist and the George and Esther Gross Presidential Professor and Chief of the Division of Pediatric Infectious Diseases at the University 

of Utah. I am the chair of IDSA’s Pandemic Influenza Task Force. I am also a member of the National Biodefense Science Board, which was created under the authority of the Pandemic and All-Hazards Preparedness Act, to provide expert advice and 

guidance to the HHS Secretary and the HHS Assistant Secretary for Preparedness 

and Response (ASPR) to prepare for, and respond to, public health emergencies resulting from chemical, biological, nuclear, and radiological events, whether naturally 

occurring, accidental, or deliberate. 

IDSA represents more than 9,000 infectious diseases physicians and scientists devoted to patient care, prevention, public health, research, and education. Our members care for patients of all ages with serious infections, including meningitis, pneumonia, tuberculosis (TB) and HIV/AIDS, emerging infections like the 2009 H1N1 influenza virus, food-borne diseases caused by salmonella, campylobacter, and escherichia coli (E. coli), and diverse infections caused by antimicrobial-resistant bacteria, such as methicillin-resistant staphylococcus aureus (MRSA), enterococcus, E. 

coli, salmonella, pseudomonas aeruginosa, klebsiella pneumoniae, acinetobacter 

baumannii, and the newly emerging New Delhi metallo-beta-lactamase (NDM–1). 

NDM–1 is an enzyme that makes bacteria resistant to a broad range of antibacterial 

drugs. It was first identified in December 2009 in a patient hospitalized in New 

Delhi with an infection caused by Klebsiella pneumoniae. It has since rapidly spread 

to other areas of the world, and three cases recently have been reported in the 

United States. IDSA’s testimony will primarily focus on new medical countermeasures essential to address pandemic influenza and antimicrobial-resistant infections. 

HHS’ End-to-End Countermeasure Review 

IDSA commends HHS Secretary Kathleen Sebelius and the administration for undertaking the comprehensive end-to-end review of our medical countermeasures enterprise. As the final report (The Public Health Emergency Medical Countermeasure 

Enterprise Review: Transforming the Enterprise to Meet Long Range National 

Needs), prepared by the ASPR, Nicole Lurie, MD, MSPH and her staff, makes clear, 

there are many components and organizations which are critical to the development, 

deployment and use of medical countermeasures, including urgently needed investments in the U.S. public health system. The goal of an efficient and effective medical countermeasure enterprise is to be able to rapidly produce effective responses, 

not only to known threats or biologic attacks, but to previously unrecognized threats 

and emerging infectious diseases. 
33 

We are pleased that the administration is taking a comprehensive approach to developing a medical countermeasure strategy. Many of the recommendations in HHS’ 

end-to-end review mirror policy improvements IDSA has suggested over the past 

several years, including in our 2004 report ‘‘Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates, a Public Health Crisis Brews’’, which called attention to the dry 

antibacterial pipeline and the need for the U.S. Government to financially support 

and incentivize the development of novel antibacterial drugs. The administration’s 

report also reflects several recommendations found in IDSA’s 2007 report, ‘‘Pandemic and Seasonal Influenza Principles for U.S. Action.’’ In this report, IDSA recommended that HHS and ASPR move quickly to: 

—Strengthen pandemic vaccine efforts by establishing a Multinational Pandemic 

Influenza Vaccine Master Program; 

—Strengthen anti-infective pharmaceutical research and development and stockpiling efforts; 

—Improve quality and availability of diagnostic tools for influenza; 

—Accelerate development of countermeasures to prevent, treat, and diagnose pandemic influenza through additional legislative action and continue to streamline 

regulatory approval processes; 

—Update plans for countermeasure distribution and prioritization of use; 

—Expand vaccine uptake, stabilize vaccine manufacture, and test and evaluate 

vaccine distribution plans during annual influenza seasons; 

—Protect the healthcare workforce during a pandemic; 

—Build national, regional, and local healthcare systems capable of responding to 

mass casualty events; 

—Develop and test community mitigation measures; 

—Improve and coordinate influenza surveillance; 

—Continue to strengthen leadership, international collaboration, and communication; and 

—Allocate significant and sustainable funding for long-term planning and action. 

The implementation of these policy improvements is essential to reduce the threat 

Americans and the world community faces from the public health threats of greatest 

concern. Copies of IDSA’s Bad Bugs, No Drugs report and the Pandemic and Seasonal Influenza Principles for U.S. Action document are available through IDSA’s 

Web site at: http://www.idsociety.org/10x20.htm and http://www.idsociety.org/influenza.htm. Additionally, IDSA is hosting a meeting on January 27–28, 2011, ‘‘Seasonal and Pandemic Influenza 2011’’, where the influenza principles will be reviewed and further updated to include lessons learned from the novel H1N1 influenza pandemic, with a focus on specific actions and timelines. 

Pandemic Influenza and Antimicrobial Resistance 

Infectious diseases and public health experts believe that another influenza pandemic is inevitable. The key questions that remain are when it will occur, which 

influenza virus will cause the pandemic, how severe it will be, and whether the 

world will be ready. Experts also are extremely concerned about the growing threat 

of antimicrobial-resistant infections. The need for novel products (drugs, diagnostics, 

and vaccines) to address these threats is urgent. 

There are three types of influenza viruses, classified as A, B, or C, based on their 

protein composition. Public health experts are most concerned with type A influenza 

virus. Pandemic influenza typically is a virulent new strain of human influenza that 

causes a global outbreak of serious illness. Four influenza pandemics have occurred 

during the past 100 years: the 1918–1919 ‘‘Spanish flu,’’ the 1957–1958 ‘‘Asian flu,’’ 

the 1968–69 pandemic or ‘‘Hong Kong flu’’ and the H1N1 pandemic from 2009–2010. 

The 2009 H1N1 influenza pandemic proved to be the mildest of these in overall 

deaths, killing an estimated 9,000 to 18,000 Americans according to CDC estimates. 

The virus did not develop resistance to oseltamivir (Tamiflu), the only widely available antiviral to treat influenza. Focusing solely on the number of deaths, however, 

masks the overall impact of the H1N1 pandemic. More than 1,200 children younger 

than 18 died of H1N1 influenza and between 200,000 and 400,000 Americans were 

hospitalized. 

The 2009 H1N1 influenza pandemic was perhaps a best case scenario. If a pandemic similar in virulence to the 1918 influenza strain were to occur, up to 2 million 

Americans could die and the number of hospitalizations and need for intensive care 

unit beds would overwhelm our healthcare system and cripple our infrastructure. 

On the issue of antimicrobial-resistant infections, the CDC has described antimicrobial resistance as ‘‘one of the world’s most pressing health problems’’, while the 

World Health Organization (WHO) calls it ‘‘one of the three greatest threats to 

human health.’’ Infectious diseases physicians agree. NDM–1, for example, poses a 

new threat of great concern and illustrates how antimicrobial-resistant infections 
34 

will continue to emerge wherever antimicrobial drugs are used. NDM–1 also illustrates how a drug-resistant organism created in one area of the world can quickly 

threaten all regions. The costs due to antimicrobial resistance, both in the numbers 

of lives lost or devastated and in economic terms, are exceedingly high. Drug-resistant bacteria, such as MRSA-resistant E. coli, Acinetobacter baumannii and Clostridium difficile (c. diff.) currently affect many hospitalized patients and a growing 

number of people in the community, including healthy athletes, parents, working 

people, and children. CDC reports that nearly 2 million healthcare-associated infections (HAIs) and 90,000 HAI-related deaths occur annually in the United States. 

Most of these infections and deaths involve antimicrobial-resistant bacteria. The direct and indirect economic costs associated with antimicrobial-resistant infections 

are also enormous in terms of dollars spent, length of hospital stay, and loss of productivity. A recent study indicated that annually in the U.S. antimicrobial-resistant 

infections are responsible for more than $20 billion in excess healthcare costs, more 

than $35 billion in societal costs, and more than 8 million additional hospital days. 

Antimicrobial resistance is a critical issue in viral diseases as well. In 2008, the 

dominant circulating seasonal influenza strain had become resistant to oseltamivir 

(Tamiflu) leaving limited options for treatment. For now, this strain has largely disappeared, but if it re-emerges we have few drugs in the pipeline to deal with the 

threat. 

There also is an alarming connection between influenza and antimicrobial-resistant bacterial infections. In addition to the morbidity and mortality caused by the 

influenza virus itself, many people with influenza will develop life-threatening secondary bacterial infections, many of which are resistant to antibacterial drugs. In 

recent years, MRSA has been the most lethal cause of postinfluenza bacterial infections. 

Re-engineering the Pandemic Influenza Vaccine Production Enterprise 

As we stated in our 2007 Pandemic and Seasonal Influenza Principles for U.S. Action, IDSA believes the widespread use of a pandemic vaccine should be the central 

strategy for protection of human health during a pandemic event. IDSA supports 

a coordinated effort led by the Federal Government working with public and private 

partners and the international community to outline a comprehensive approach that 

will coordinate, and strengthen vaccine research and development, increase production capacity, accelerate licensure, guarantee equitable global distribution, and monitor vaccine performance and safety. 

In August 2010, the President’s Council of Advisors on Science and Technology 

(PCAST) issued a report focused on re-engineering the pandemic influenza vaccine 

production enterprise. In its report, the PCAST emphasized that existing technology 

for influenza vaccine will never deliver enough vaccine in time to respond to a pandemic. However, they said that targeted investments in key areas could shorten by 

weeks the time needed to produce enough doses. They found that the development 

of new types of influenza vaccines is of critical importance, and no single new technology has a high likelihood of success. To ensure success of one, we must pursue 

several potential vaccine strategies simultaneously. The PCAST recommendations 

provide a blueprint to significantly increase our Nation’s ability to produce vaccine 

in a timely manner. The recommendations would speed up not only flu vaccines, but 

also a number of other medical countermeasures against infectious diseases that 

could emerge naturally or as the result of a bioterrorism attack. 

Although the PCAST did not determine anticipated costs for the projects required 

to make the improvements necessary to re-engineer the influenza vaccine production 

enterprise and has not attempted to allocate the share of financial responsibility to 

be borne by the governmental agencies or the companies, they did state that it is 

fair to assume an initial $1 billion in Federal funds—and at least similar sums over 

the subsequent few years—would be required to make the changes that will allow 

the Nation to mount a vigorous effort that can protect its population as well as possible in the event of another pandemic, an event that could have catastrophic consequences. 

On-going strong investment in pandemic vaccine technologies is justified on a 

cost-benefit basis, in part because large numbers of lives could be saved through relatively inexpensive improvements in current methodologies and in part because 

Federal investments in influenza pandemic response would speed development of 

technical platforms and production facilities that would support medical countermeasures against a variety of other dangerous pathogens. 

Antimicrobial and Diagnostics Discovery and Development 

The development of both antiviral and antibacterial drugs as well as point-of-care 

diagnostics must be treated as priorities in the U.S. medical countermeasure devel-
35 

opment strategy. In IDSA’s view, there is an urgent need to address the factors that 

have resulted in a dearth of new antimicrobials and other countermeasures in development. These include: 

—Lack of financial incentives of sufficient strength to make companies choose to 

engage; 

—Regulatory uncertainty caused by the lack of consistent approval pathways and 

limited regulatory scientific resources at the Food and Drug Administration 

(FDA); 

—Insufficient federally supported research and development efforts; and 

—Lack of a coordinated management structure. 

In addition, as pointed out in the end-to-end medical countermeasure review, lack 

of coordination between Federal agencies and complex contracting regulations add 

additional barriers. 

To create a sustainable, national and global medical countermeasures R&D enterprise, it is necessary to determine the right combination of financial incentives 

(‘‘push’’ and ‘‘pull’’ mechanisms) to entice industry to invest and to help companies, 

big and small, with innovative technology to succeed. Examples of the push incentives are grants, contracts, and tax credits. Examples of the pull incentives are milestone payments, guaranteed markets, liability protection, patent extensions or data 

exclusivity, and prizes. These incentives are intended to change the ‘‘return on investment’’ or net present value calculation of countermeasures to make them more 

competitive with other medical products. The strategic investment firm envisioned 

by the medical countermeasure review report also supports the development of highpriority products by sharing the risk of development with companies. The HHS report highlights the need for the strategic investment firm to first focus on novel 

antimicrobials to address drug-resistant infections. IDSA wholeheartedly supports 

this effort. We caution, however, that the proposed initial funding level for the strategic investment firm is $200 million, which is wholly insufficient to increase the 

likelihood of bringing successful antimicrobial drugs and other medical countermeasures to the marketplace. We also strongly believe that additional ‘‘push’’ and 

‘‘pull’’ incentives are needed, particularly to address the withering antibacterial 

pipeline, and urge Congress to act quickly to pass strong legislation in this area. 

Risk sharing and incentives that stimulate the development of new rapid 

diagnostics also should be adopted. 

FDA must quickly assure a clear regulatory pathway for the review and approval 

of new countermeasures. For many years, industry representatives have identified 

regulatory uncertainty as one of the primary obstacles to new antibacterial development, in particular. IDSA acknowledges the strong commitment expressed by current FDA leaders and staff to address the multi-faceted problem of regulatory uncertainty. Despite good faith meetings, workshops, and advisory committee meetings, 

the situation today for antibacterial review and approval appears no better than it 

was at this time last year. In some respects, the level of uncertainty has increased. 

In its medical countermeasure review report, HHS identified a critical need to upgrade FDA science and regulatory capacity. HHS hopes to make a significant investment to provide FDA scientists with the resources they need to develop faster ways 

to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market. This year, IDSA, FDA, the National Institute 

of Allergy and Infectious Diseases (NIAID), and pharmaceutical companies have 

begun to participate in an important effort being led by the Foundation of the National Institutes of Health (FNIH) to study new endpoints that will more easily 

demonstrate antibacterial effectiveness. The FNIH effort is promising, but to develop this knowledge and quickly implement changes in the regulatory process requires people and money. This spring, IDSA testified in support of additional funding to allow FDA to hire additional staff to develop much needed clinical trial guidance documents and to fund Critical Path Initiatives specific to antimicrobial drug 

development. We also requested $13.25 million to support a focus on new antibiotics 

within FDA’s new regulatory science initiative with the National Institutes of 

Health. 

We recognize the strains on the Federal budget due to the economic crisis and 

the budget deficit, but significantly increased Federal research dollars are urgently 

needed to advance scientific knowledge about pandemic influenza and antimicrobial 

resistance, as well as to support countermeasure discovery and development. IDSA 

has for the past several years supported consistently strong funding for these activities throughout HHS. We appreciate that this subcommittee has provided substantial funding for pandemic influenza response, as it did last year in the supplemental 

appropriations bill. However, IDSA strongly believes that some pandemic preparedness efforts require funding over multiple years. For example, companies consid-
36 

ering investing in countermeasures development need assurance that the financial 

commitment will be secure in future years or they will not engage. 

We strongly support significantly boosting funding for HHS’ Biomedical Advanced 

Research and Development Authority (BARDA). This year, IDSA testified in support 

of at least $1.7 billion of multi-year appropriations for BARDA in fiscal year 2011 

to fund the development of new therapeutics, diagnostics, vaccines, and other technologies, including antimicrobials. Such funding would significantly enhance 

BARDA’s support of countermeasures through the advanced stages of development, 

as well as BARDA’s flexibility to partner effectively with industry. IDSA also wishes 

to see BARDA take a much stronger role in advancing the development of new 

antimicrobials and related diagnostics to detect, identify, and treat pathogens that 

presently are affecting a significant number of Americans in hospitals annually. 

With modern molecular biology techniques, the resistance genes found in these 

highly resistant ‘‘superbugs’’ can be readily introduced into bioweapons such as anthrax or tularemia. Specific to NIAID research funding for antibacterial resistance 

and antibacterial discovery research, this year IDSA testified in support of a substantial funding increase in these areas for fiscal year 2011 to a total of $500 million. Current NIAID funding levels in these areas are extremely limited in IDSA’s 

view and do not match the threats we face from antibacterial-resistant infections. 

Moreover, to further strengthen the countermeasures pipeline, we must invest in 

appropriate infrastructure for clinical trials. Such clinical trials infrastructure 

should be flexible and agile, with the ability to rapidly respond to new or re-emerging infections as they arise. Further, it must balance both pediatric and adult unmet 

infectious diseases needs. We are gratified to see NIAID taking steps to achieve part 

of this goal, as NIAID is broadening its AIDS Clinical Trials Group (ACTG) to expand its tuberculosis and, likely, its hepatitis C clinical research portfolios. Earlier 

this year, IDSA urged NIAID to build clinical trials infrastructure in areas beyond 

HIV/AIDS including to address serious bacterial, viral (particularly influenza), and 

fungal infections. The creation of an NIAID-funded in-patient clinical trials network 

in these areas will help to create an environment supportive of high-quality research, incorporating experienced investigators and study sites, robust statistical 

support, specialized laboratories (e.g., pharmacokinetics, immunology) and organizational structures to support clinical trials. Such additional clinical trials infrastructure could contribute substantially to the critical need for advancements in the diagnosis and treatment of drug-resistant bacterial infections, pandemic and seasonal 

influenza, and other serious infections. Furthermore, the clinical trial infrastructure 

we have proposed fits squarely within and is supportive of HHS’ medical countermeasure review effort. IDSA believes such additional infrastructure is urgently 

needed. 

The global H1N1 pandemic is a striking reminder of the importance of making 

sustained investments in research as well as public health infrastructure. Investments made over the past several years in surveillance, vaccine capacity and preparedness clearly limited the impact of the H1N1 pandemic. However, in other 

areas the pandemic showed our continued vulnerabilities. These include early international detection, and rapid production and distribution of vaccines, and antivirals 

that are appropriate for critically ill patients. The threat of another pandemic remains. The Nation’s public health system must maintain robust disease surveillance, epidemiologic investigation, education and outreach, and communications capacity. 

Strengthening Leadership, Coordination, and Management Structure 

In 2007, IDSA called for strengthened leadership and collaboration in influenza 

preparedness. We called for HHS and the Federal Government to clarify lines of authority and key responsibilities, involve technical experts and stakeholders, issue 

and update national standards for planning, and continue to lead international collaborative efforts related to pandemic preparedness. HHS responded and many improvements were considered and implemented. The PCAST report recommends that 

the administration further strengthen its management structure by vesting authority with the ASPR at HHS to coordinate and task component agencies at HHS with 

supporting and implementing the influenza vaccine recommendations. In addition, 

it recommends that HHS create a small advisory committee comprised of representatives from the biotechnology, pharmaceutical and investment communities, to 

guide the HHS’s engagement with industry. This coincides with the recommendation in HHS’s end-to-end medical countermeasure review that changes are needed 

in how the enterprise is managed to greatly strengthen its decisionmaking. The review suggests that HHS identify a leader who would work with program leaders and 

managers across the span of medical countermeasure development activities as well 

as with commercial partners and other key stakeholders. The congruence of these 
37 

three recommendations emphasizes the critical role of integrated and coordinated 

planning between all levels of government in pandemic preparedness and medical 

countermeasure development. 

Having the necessary infrastructure in place to both monitor and respond to current and emerging antimicrobial-resistant infections also will play a crucial role in 

ensuring that we are protecting the health and safety of our citizens. Congress 

began to address this need several years ago when it passed legislation that became 

section 319E, ‘‘Combating Antimicrobial Resistance’’ of the Public Health Service 

Act. This law directed the Secretary to establish an Antimicrobial Resistance Task 

Force to coordinate Federal programs relating to antimicrobial resistance. This Task 

Force developed the Public Health Service Action Plan to Combat Antimicrobial Resistance, published in 2001, which has not been sufficiently funded. Comprehensive 

legislation introduced in the Senate during the last Congress and in the House of 

Representatives in each of the last two Congresses, the Strategies to Address Antimicrobial Resistance (STAAR) Act (H.R. 2400 in the 111th Congress), will advance 

the key elements in the Federal Action Plan and authorize adequate funding for 

these strategies. The STAAR Act strengthens existing efforts by establishing within 

HHS an Antimicrobial Resistance Office (ARO). The director of this new office also 

will serve as the director of the existing interagency task force to facilitate the coordination of activities. The legislation also would establish a Public Health Antimicrobial Advisory Board comprised of infectious diseases and public health experts 

who will provide much-needed advice to the ARO director and interagency task 

force. 

Finally, the bill, when enacted and sufficiently funded, will strengthen existing 

surveillance, data collection, and research activities as a means to reduce the inappropriate use of antimicrobials, develop and test new interventions to limit the 

spread of resistant organisms, and create new tools to detect, prevent, and treat 

drug-resistant ‘‘bad bugs.’’ 

Conclusion 

It is easy to dismiss hyperbolic news reports because of sensationalism and inaccuracies, but the danger posed to the United States by biological threats, including 

pandemic influenza, biologic weapons and emerging infections, including antimicrobial-resistant infections, is very real and very great. Continued thoughtful investment in science, filling the pipeline, evaluating and licensing countermeasures 

and efficient management of the enterprise will provide Americans with the protection they expect and deserve. IDSA stands ready to assist this subcommittee and 

the Federal Government in any way that we can, and we are grateful for this opportunity to express our views. 

Thank you. 

Senator HARKIN. Thank you again, Dr. Pavia. 

And thank all of you for your testimonies, and for your work in 

this field, and your leadership in this field. 

Colonel Larsen, is anthrax the major threat that we have that 

we should be worried about with regard to bioterrorism? Is it anthrax, or is it something maybe we don’t know about? 

Colonel LARSEN. That’s a very good question. It’s very difficult to 

answer. I worry about anthrax. It’s the only one that’s really persistent. 

Senator HARKIN. Because what you just told me—— 

Colonel LARSEN. We’re going to have a hard time cleaning it up. 

We don’t know how to—— 

Senator HARKIN [continuing]. About four decades, then—— 

Colonel LARSEN. We don’t know how to do it. 

Senator HARKIN. Yes. 

Colonel LARSEN. It’s deadly. But, it’s not contagious. You know, 

Eric may tell you smallpox is the worst one, because—I’ve run exercises that—with Senator Nunn, several years ago, looking at 

smallpox. The fact that it’s contagious, we’re a highly mobile society, unvaccinated; that is. 

April, I was up in J. Craig Ventner Institute, and they were 

showing me some of the amazing things they were doing up there 
38 

just a month before they announced that—you know, a new organism that had a computer for a parent. I’m not worried about people in caves doing that now. Those are the best scientists in the 

world at the best laboratory. But, 5 years from now? And the decisions you’re going to make, in this next year, are going to tell us 

what kind of defense we have in 5 years. So, I would feel—I would 

sleep better tonight if I know we were ready for 1960-style bio-attacks, which is anthrax. Or plague. 

Senator HARKIN. You can see that—obviously, the problem that 

confronts us is, there are a lot of threats out there. And, you know, 

you can’t have 100 percent protection against everything. I mean, 

you just—it’s impossible. So, we have to sort of think about what 

are the priority areas, knowing full well that we can’t guarantee 

absolute, 100-percent protection against anything. But, we can try 

to lessen the possibility of a bioterrorist attack. We can lessen that, 

but we can’t completely do away with it. And then we can do what 

we can to build up our responses to it. That’s what you’re talking 

about: how we respond to that. 

Colonel LARSEN. I’ll go back to what I call my bible, what Dr. 

Josh Lederberg, Nobel Prize winner, was talking about, ‘‘Bug to 

Drug in 24 Hours.’’ When he wrote that, in 2001, that was science 

fiction. That does not have to remain science fiction. 

You know, when H1N1 was discovered in southern California, 

within 2 weeks they did genetic mapping and had an antiviral that 

was better than Tamiflu. In 2 weeks. That’s a lot of progress we’ve 

made in the last decade. 

So, we can’t build vaccines for everything that’s out there, you’re 

absolutely right. But, we’ve got to figure out how to respond quickly, and make vaccines and therapeutics a lot faster, which is why— 

the one little statement I left out here is, when it comes to national 

security, today the FDA, NIH, and BARDA are just as important 

as DOD and the intelligence community. And we need to understand that, and fund them appropriately. 

Senator HARKIN. Yes. I—— 

Colonel LARSEN. Because the funding you’re going to approve 

now is what kind of defense my kids and grandkids are going to 

have 5, 10 years from now, sir. 

Senator HARKIN. Well, I agree with that. I—you know, we’ve 

tried to get BARDA going, and now we’ve got this. And I’m still 

wrestling with who’s in charge. 

Now—you said that, too, but who do you think should be in 

charge? 

Colonel LARSEN. I’ll give you two answers. Because I work very 

closely with Senator Graham and Talent. They wrote a letter to 

President Obama, and they said, ‘‘This is so important that the 

Vice President of the United States should be in charge of all WMD 

activities here.’’ 

I mentioned that in a hearing at the Judiciary Committee last 

month, and Senator Kyl said, ‘‘Well, you know, the Vice President’s 

a pretty busy guy.’’ 

I said, ‘‘I know that, but tell me one thing more important than 

defending America against weapons of mass destruction.’’ 

He’s the only person that can look—because there are so many 

Cabinet Secretaries involved in this enterprise of biodefense—he’s 
39 

the only person in this town—other than the President, and he is 

kind of busy—he’s the only person that can look at Cabinet Secretaries and say, ‘‘Do this,’’ and they say, ‘‘Yes, sir.’’ Now, that’s going 

a long way. He’d need more of a staff. That’s Senator Graham and 

Senator Talent’s answer, I thought I’d give you that, because 

they’ve written that several times. 

I would just like to see a special assistant for biodefense in the 

White House. We had that in the Clinton administration, we had 

that in the Bush administration. We don’t have that today. There 

is no special assistant to the President for biodefense. That would 

be a good start. I’d be happy with that. Somebody to coordinate 

that interagency community. 

So, somewhere between Senator Graham and Senator Talent 

saying the Vice President, and my recommendation is at least a 

special assistant to the President. 

Senator HARKIN. And was it special assistant for bioterrorism? 

Colonel LARSEN. For biodefense, yes, sir. 

Senator HARKIN. Oh, biodefense. 

Colonel LARSEN. Yes, sir. That was Dr. Ken Bernard, back in the 

Clinton administration; Dr. Bob Kadlec, in the Bush administration. That position doesn’t exist today. 

Senator HARKIN. Okay. 

For all three of you, I have been in this subcommittee personally 

involved in trying to really promote cell-based and recombinantbased vaccine production. Well, I get frustrated at the slow pace of 

this, but I think things—they do take time. I’ll just ask you. How 

do you feel—all three of you—feel about the state of our—right 

now, and where we are, in terms of moving to cell-based and recombinant-based vaccine production? Are we dragging our heels? 

Are we on track, sort of? Could we be faster? How about this idea 

that cell-based are licensed in Europe but not in the United States? 

So, Dr. Rose, go ahead. 

Dr. ROSE. Yes. Sure. I think there’s a disconnect between the 

pace of advancement of the technology, which is rapid, and the regulatory response to that technology, which I think has been relatively slow. And I think that pace is quickening. 

I visited a company in Israel, earlier this year, that has portable, 

disposable bioreactors, using carrot cells and tobacco cells, where 

they’re making biological drugs in these kinds of incubators, at cost 

that’s about one-tenth the production costs of similar agents made 

in mammalian cells. 

The particular advantage, too, is that mammalian viruses, animal viruses, don’t contaminate vegetable cells. So, there’s a safety 

advantage to it. But, when the regulators look at this, they still 

look at it from the perspective of safety issues with regard to animal cells. 

And the other issue is just with regard to safety, the necessary 

clinical trials. Protein Sciences firm was alluded to earlier by Secretary Sebelius. They’ve developed an insect-cell-based flu vaccine 

that actually was rejected by a panel when it was presented for use 

in seasonal flu, on the argument that the several thousand patients 

in which it had been tested, without a safety problem, was just 

simply not enough to reach that conclusion. And I think—you 

know, licensure there, I think, arguably, would have sped up, for 
40 

the next flu pandemic, the availability of the insect cell base, because it would have allowed it to establish itself that much earlier, 

commercially. 

Senator HARKIN. Dr. Pavia? 

Dr. PAVIA. Yes. So, I would agree with the points that Dr. Rose 

made about regulatory and clinical trials being a holdup. There’s 

also scientific hurdles that emerge. One recombinant technology or 

another may sound terrific when it’s first demonstrated as a proof 

of concept. But, attempts to scale up sometimes lead to antigen 

that doesn’t work as well, difficulty with contamination, so that 

when we go after one candidate, it doesn’t always deliver on the 

promise. Just like in drugs, there’s a high failure rate. 

The other issues that we haven’t really talked about are the economics. Influenza vaccine, while not perfect, and slow for seasonal 

use, is produced relatively efficiently. It’s inexpensive. The capital 

investment to bring some of these new technologies to market is 

very large. The cost of a dose of vaccine with the new technologies 

is going to be higher. And the incentive hasn’t always been there 

to bring out a somewhat improved influenza vaccine that’s going to 

cost more, when the demand isn’t clear, much as we need it for 

more rapid response and for pandemic capacity. 

Senator HARKIN. Colonel Larsen. 

Colonel LARSEN. Sir, you’ve heard from two scientists. All I can 

say is, the chief scientist at the WMD Commission last October was 

8 months pregnant, and in the State of Maryland, she could not get 

an H1N1 vaccine, even though she was in the highest risk group. 

So, from my perspective, we are not where we need to be, sir. 

Senator HARKIN. Why aren’t they licensed here? I’m sorry, I 

should—why—what’s the problem with licensure here? Someone—— 

Dr. PAVIA. One would hear, you know, this perhaps more clearly 

from the FDA, but when you produce a new vaccine in a new technology, it usually requires a different way to measure its potency. 

There are unanswered questions about the best way to prove safety. And we just don’t know what measures need to be taken to look 

at the safety of something produced in insect cells. And so, these 

regulatory hurdles in the United States are set higher, perhaps for 

good reasons. But, FDA has not been able to respond to these as 

quickly as they should, and in part, as was pointed out in Secretary 

Sebelius’s review, they lack some of the scientific basis for making 

these decisions right now. 

Senator HARKIN. I’ll think about that. 

Senator Cochran. 

Senator COCHRAN. Mr. Rose, in your testimony you mention that 

the Alliance for Biosecurity has been recommending to the ASPR 

to improve predictability and assure availability of funding for the 

development of MCM. What would be the impact of the successful 

development of such a—an entity if a stable funding stream is not 

provided by the Federal Government? 

Dr. ROSE. Right now, there’s no question that the free market is 

not enough of an incentive, or a funder, provider of either capital 

for starting up, or funds for advanced development, for companies 

to advance products in this space. I think BARDA is a splendid and 

very effective addition, but getting it started—it’s not easy to spend 
41 

$400 million a year on advanced development, and do it wisely. 

But, the—BARDA has a terrific leader, the size of the agency has 

grown exponentially in just the last few years, and the size of its 

research portfolio has increased dramatically. 

I think you shouldn’t underestimate the quality of the work that 

you’ve already done to put this in motion. But, the nature of this 

is such that making a new antiviral drug or a new vaccine is not 

something that happens on a timeframe of weeks and even years. 

It’s a multiyear process that requires the underlying science to be 

handled, the creation of new chemical entities—be they proteins, 

vaccines, small molecules, and the like—that target new targets 

that are abundant now, that have been identified with basic research at institutes like the NIAID. Then it requires setting up a 

manufacturing capability and clinical trials to document effectiveness, or not. And in the case of agents against things like smallpox 

and anthrax, you can’t do human efficacy testing, because it’s not 

ethical and it’s not practical. 

So, it is very, very complicated, complex, long-leadtime work. 

And you’ve already, I think, had the good judgment to fund it. I 

think, repeatedly, we see that people want to pull the plug, thinking there’s something wrong with this process because you’re not 

seeing, you know, drugs for Ebola, drugs for some of the hemorrhagic fevers, and some of the newer vaccines, that you want to 

see. But, they’re coming. And they’re a lot further along than they 

were just a couple of years ago, because of this mechanism. And, 

if anything, I’d say, stay the course in that regard. 

Senator COCHRAN. Thank you very much for that analysis. 

Dr. Pavia, in your statement you mentioned the use of pandemic 

vaccine in a widespread way should be the central strategy, as I 

understood, it for the protection of human health during a pandemic. Do you think the Federal Government needs to be the lead 

on this, or should we create some other body to be in charge? 

Dr. PAVIA. Senator, I think that—it’s very clear that, in a severe 

pandemic, we would need to be able to vaccinate everyone in a 

rapid fashion, and that would require a very large manufacturing 

capacity, as well as the platforms, the new techniques that would 

produce the vaccine quickly enough. I don’t think that, at present, 

market forces will either deliver a manufacturing capacity that 

would make 300 to 600 million doses available a year, nor is it 

clear that it—that, all by themselves, they will allow the development of these new technologies. So, I think there’s a vital role that 

the Federal Government has to play in facilitating both the science 

that will allow new products to be developed, and then nurturing 

them along. 

And, at the other end, I think the Federal Government has a role 

in providing enough manufacturing capacity on U.S. soil that we’re 

not dependent on foreign manufacturers in the event of an emergency. And you’ve already made investments in this. And you 

should realize that the investment in egg-based manufacturing, in 

Pennsylvania, paid off in a large way. Without that, most of the domestic production that we had during this last pandemic wouldn’t 

have occurred. And two of the foreign manufacturers with whom 

the Government contracted did not deliver the full amount of vaccine that they contracted for. 
42 

Senator COCHRAN. Colonel Larsen, what is your reaction to that 

question? 

Colonel LARSEN. Well, sir, I—you know, I’m pretty conservative 

on the fiscal side, being a fourth-generation Indiana corn farmer, 

and—but, I tell you, how many B–2 bombers would we have built 

if we had relied on the private-sector free-market economy? There 

are certain things that are so important for national security that 

that’s what we have to do up here. And I think we have to rely 

on the talent and the brainpower and some of the creativity, but 

this is a national security issue. We would never have built a single 

B–2 bomber if we’d a just told those companies, ‘‘Well, you can just 

go out and do it all on your own, and if you get something the FAA 

approves and the Air Force likes, then we’ll give you your first dollar.’’ 

So, this—I mean, that’s my point—this is a national security 

issue. That’s how I see it. 

Senator COCHRAN. Well, thank you. 

I think this was a very worthwhile hearing, and your contributions have been very helpful. And I think we’ll—I hope—have some 

influence as we go about making the decisions on priorities for 

funding and carrying out our duty to help protect the security interests and the health of our American public. 

Thank you. 

Senator HARKIN. I would also say thank you to the panel, and 

again for all the work that you do and the leadership you provide. 

I was reading your testimonies last night, and then following you 

today, and then—I just—I can’t help but think that it’s not streamlined enough, in terms of who’s in charge, and who does what, and 

who reports to whom, and who gets the finances to do this. Kind 

of a mishmash of things. And, quite frankly, I just—I think we’re 

relying too much on the FDA. 

Now, before all the press runs out of here and say, ‘‘Harkin 

wants to diss the FDA’’—we’re about to pass a new food safety bill. 

It’s got great bipartisan support. It’s being held up a little bit, but 

it’s going to pass. It’s got industry support and consumer support, 

and everybody, and it’s long overdue. We haven’t done—had a 

food—a change in our inspection systems—it’s been over three decades. But, that job goes—a lot of that goes—to FDA. It’s not agriculture, it’s FDA. So, we’re going to ask them to do more. 

And we’re not going to give them the funds or the personnel to 

do that. It’s—you know, we’ll give them a little bit, maybe, but not 

much. And it just seems to me, FDA’s got so much on their plate 

that they really can’t give this the kind of focus that it should. 

So, I’m just—I’m just thinking out loud here—is it FDA, or do 

we need to take something out of the FDA, something, maybe, out 

of DOD, that would be put under BARDA, and let BARDA be the 

one, the lead agency? At least that’s what I thought the concept 

was of BARDA, that they would be the lead agency, working with 

scientists, manufacturers, people like the colonel, and others, that 

think about all these things. And then they would then have lineitem authority, in terms of looking at licensure, which I’m—still 

don’t understand why we can’t get over that, why we can’t have it 

faster—and doing some of the things that FDA now is charged with 

the responsibility of doing. Because FDA just—institutionally, I 
43 

don’t know that they can do it. It’s just—because they’ve got so 

much to do, and they have other responsibilities, and mostly 

they’re focused on drugs that we take; you know, drug development 

for new drugs for illnesses and things like that. This is not the biggest thing on their plate. But, in terms of the country itself, it’s 

probably one of the biggest things we’ve got confronting us right 

now. 

So, I don’t know, I just keep thinking that we need some restructuring here—not for restructuring’s sake, but to make it more efficient, to make the line items—make the line authority better, and 

to speed up some of the things that we have to—we just have to 

speed these things up faster than what we’re doing. 

So, I don’t mean to just pick on FDA, but just recognizing the 

reality that FDA simply can’t do all the things we’re asking them 

to do. They just can’t do it. And that’s why, I thought, we set up 

BARDA. 

And so, I will be looking at that, both from the standpoint of this 

subcommittee, but also the authorizing committee, in the next reauthorization bill that comes up. When is that? Aha, next year. 

Senator HARKIN. So, next year we’ll look at the reauthorization, 

because I just—I think now’s time to take stock and think, on the 

reauthorization, do we need to do some realignment here? And I’ll 

take into consideration the Vice President. I never thought about 

that, the—maybe we don’t think about the Vice President that 

much. I mean, you know—what’s that old saw about—— 

Senator COCHRAN. I don’t think I’m going to get into this. 

Senator HARKIN [continuing]. Some guy said that—he had two 

sons—one went off to the South Pacific, and the other became Vice 

President, and neither was heard from again. 

Dr. ROSE. Can I comment on the FDA? 

Senator HARKIN. Yes. 

Dr. ROSE. Because I think that your comments are thoughtful 

and important, and where we are now is not working. But, I think 

that the proposal that HHS is making now is a very substantive 

and important change that they’re proposing, particularly the funding issue. 

I mean, what we see, in our interactions with the FDA, is, 

they’re just quite short-handed, and their ability to respond to realtime science is hampered by their lack of manpower. This whole 

issue of regulatory science, I think, is an important issue, but I 

think there’s also an issue of regulatory culture, because there are 

some things—particularly if you’re using things like the animal 

rule—the level of proof of efficacy of a drug for a measure that you 

can’t test in humans is just not going to be the same standard of 

certainty. That doesn’t mean you can’t make a judgment based on 

a body of evidence. But, I think there’s an enormous reluctance to 

recognize the limitations and still act. And that culture change, I 

think, needs to be part of the FDA change, as well. 

But, delaying that, I think, would be a big problem. 

Senator HARKIN. See, now, you and I are coming at this a little 

differently. You want to change the culture at FDA. And I’ve been 

here long enough to think I’m not certain we can do that. I mean, 

it’s just—it’s just very difficult to do that, okay? It’s just difficult. 

Yes. 
44 

Colonel LARSEN. Sir, I think leadership is one way to do that. 

And I know Dr. Peggy Hamburg has said we’ve got to stop looking 

at things in black and white and the various shades of gray, which 

is some of the things that Eric’s talking about. And so, I have great 

confidence in what she’s saying. 

I am intrigued about your comments, though, because I went 

through this, sir, with Goldwater Nichols, which is one of the finest 

things that ever came out of the U.S. Senate, in terms of national 

security. And we didn’t do away with the Army, Air Force, Navy, 

and Marines, but we did build a structure where they could work 

together far better. 

Senator HARKIN. That’s right. 

Colonel LARSEN. And maybe what FDA needs the most is enough 

money to do the job properly. They’re too small today. And you said 

that yourself, sir. 

Senator HARKIN. That’s absolutely true. For all that we put on 

their plate. 

Colonel LARSEN. Yes. 

Dr. ROSE. I’ve proposed that the FDA actually create a center for 

biodefense, like CDER, like CBER, where there’s actual leadership—— 

Senator HARKIN. Okay. 

Dr. ROSE [continuing]. At a higher level. Because our experience 

is that, when you bring these complicated products to the FDA, by 

and large the review is done—I’m a surgeon by trade—before it’s 

done by the intern, instead of having senior leadership engaged in 

the actual review early on, looking at the raw data. And I think 

that having a full-blown center, where there’s a leader that is responsible for signing off and guiding this, I think, could be very 

helpful. 

Senator HARKIN. Now, that’s a good idea. I like that. You got 

anything more on paper on that at all, any suggestions? Or are you 

just—— 

Dr. ROSE. We’ll make sure you get it. 

Senator HARKIN. Or are you just thinking about that right now? 

Dr. ROSE. No—well, I’ve proposed at the IOM in February, but— 

there, it got shot down, but I hear it’s getting some traction. 

I still think it’s a good idea. 

Senator HARKIN. I kind of like it. Yes, get me some stuff on that, 

will you? 

Dr. ROSE. Yes. 

Senator HARKIN. Get it to my staff? 

Dr. ROSE. Sure. 

Senator HARKIN. Before our reauthorization comes up. 

Dr. ROSE. Sure. 

Senator HARKIN. I’d like to start thinking about it now, and looking at it. 

Dr. ROSE. Yes. 

Senator HARKIN. Yes. Okay. Well, anything else anybody want to 

add to what we’ve said? 

If not—— 

Yes. 

Dr. PAVIA. No, I’d echo what Eric Rose suggested, in that you 

can’t have the same people evaluating a drug for high blood pres-
45 

sure that are evaluating a crucial drug for biodefense or for an influenza pandemic, and yet, we need professionals to look at the 

safety and efficacy. I think it can be done within FDA, but not in 

the current structure. And I think Dr. Hamburg has some very 

good ideas for redoing this. But, it may require some statutory and 

legislative changes to let them do that and to apply appropriate 

standards that match the risk that we’re facing. 

CONCLUSION OF HEARING

Senator HARKIN. Well, thank you all very much. I thought this 

was very interesting and intellectually challenging, and you gave 

us some good ideas and suggestions, and we appreciate it very 

much. 

And I look forward to getting that from you, Dr. Rose, about this 

new structure. 

So, thank you all very much. 

Anything else? No. 

The subcommittee will stand recessed. 

[Whereupon, at 4:03 p.m., Thursday, September 29, the hearing 

was concluded, and the subcommittee was recessed, to reconvene 

subject to the call of the Chair.] 

Æ