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72–882 2012

SWINE FLU OUTBREAK AND THE U.S. FEDERAL 

RESPONSE 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

APRIL 30, 2009 

Serial No. 111–33 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

PARKER GRIFFITH, Alabama 

ROBERT E. LATTA, Ohio 

(II) 


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(III) 

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

JOHN D. DINGELL, Michigan 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JAN SCHAKOWSKY, Illinois 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JANE HARMAN, California 

CHARLES A. GONZALEZ, Texas 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


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(V) 

C O N T E N T S 

Page 

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

New Jersey, opening statement .......................................................................... 1 

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

Hon. Nathan Deal, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 8 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 9 

Prepared statement .......................................................................................... 10 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, prepared statement ...................................................................................... 14 

Hon. Anna G. Eshoo, a Representative in Congress from the State of California, prepared statement .................................................................................. 84 

Hon. Ed Whitfield, a Representative in Congress from the Commonwealth 

of Kentucky, prepared statement ....................................................................... 85 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, prepared statement .................................................................................. 86 

WITNESSES

Rear Admiral W. Craig Vanderwagen, MD, Assistant Secretary for Preparedness And Response, U.S. Department of Health and Human Services ........... 18 

Prepared statement .......................................................................................... 21 

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

Rear Admiral Anne Schuchat, MD, Acting Deputy Director for Science and 

Public Health Program, Centers for Disease Control and Prevention, Assistant Surgeon General, U.S. Public Health Service, U.S. Department of 

Health and Human Services ............................................................................... 26 

Prepared statement .......................................................................................... 29 

Joshua M. Sharfstein, MD, Principal Deputy Commissioner and Acting Commissioner, Food and Drug Administration, U.S. Department of Health And 

Human Services ................................................................................................... 36 

Prepared statement .......................................................................................... 40 

SUBMITTED MATERIAL

Fact sheet, National Response Network ................................................................ 87 

1 Mr. Vanderwagen did not respond to submitted questions for the record. 


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(1) 

SWINE FLU OUTBREAK AND THE U.S. 

FEDERAL RESPONSE 

THURSDAY, APRIL 30, 2009 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:10 a.m., in Room 

2123, Rayburn House Office Building, Hon. Frank Pallone, Jr., 

[chairman of the subcommittee] presiding. 

Present: Representatives Pallone, Dingell, Eshoo, Green, 

DeGette, Capps, Schakowsky, Baldwin, Weiner, Matheson, Gonzalez, Barrow, Christensen, Sarbanes, Murphy of Connecticut, 

Space, Sutton, Braley, Waxman (ex officio), Deal, Shimkus, Shadegg, Blunt, Murphy of Pennsylvania, Blackburn, Gingrey, and Barton (ex officio). 

Staff Present: Phil Barnett, Staff Director; Karen Nelson, Health 

Policy Director; Bruce Wolpe, Senior Advisor; Karen Lightfoot, 

Communications Director; Earley Green, Chief Clerk; Jennifer 

Berenholz, Deputy Clerk; Tim Westmoreland, Consultant; Steve 

Cha, Professional Staff Member; Sarah Despres, Counsel; Naomi 

Seiler, Counsel; Ruth Katz, Chief Public Health Counsel; Alvin 

Banks, Special Assistant; Caren Auchman, Communications Associate; Lindsay Vidal, Special Assistant; Elana Leventhal, Legislative Assistant; Mitch Smiley, Special Assistant; Aarti Shah, Minority Counsel; Ryan Long, Minority Chief Health Counsel; and Chad 

Grant, Minority Legislative Analyst. 

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

Mr. PALLONE. The meeting of the subcommittee is called to 

order. Today we are having a hearing on 2009 H1N1 flu outbreak 

and the U.S. Federal response. 

I have to warn you, I have to get used to this new definition and 

not use ‘‘swine flu’’ I understand anymore. 

The subcommittee is meeting to discuss the ongoing 2009 H1N1 

flu outbreak and the U.S. Federal response, and the purpose of today’s hearing is to hear from our Nation’s lead agencies to learn 

the what, when and where about this outbreak and also to discuss 

next steps in the Federal response in reporting and reacting to this 

potential crisis. 

Today we have invited rear Admiral W. Craig Vanderwagen, assistant secretary for preparedness and response; Dr. Joshua 


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Sharfstein, who is the acting commissioner of the Food and Drug 

Administration; and Rear Admiral Anne Schuchat, who is interim 

deputy director for the Science and Public Health Program at the 

Centers for Disease Control and Prevention. 

And I want to thank each of you for taking time out of your extremely busy schedule to come and help educate Congress and the 

public about this very serious public health emergency and highlight areas where further support may be necessary. 

Now let me tell my colleagues that, because the witnesses are on 

the front line of our ongoing efforts to report and react to the 2009 

H1N1 flu outbreak, I am cognizant time is of the essence, and they 

are needed at their respective offices. Therefore, I have asked all 

members of the committee to not make an opening statement but 

instead submit their statements for the record so we can get 

straight to our witnesses and make the best use of their limited 

time. 

Without objection, Members will have 5 days to submit their 

written statements for inclusion in the hearing record. 

I am going to recognize, though, the committee Chair and subcommittee Chairs and the ranking members for remarks. 

And we will begin with Mr. Deal. 

[The prepared statement of Mr. Pallone follows:] 


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OPENING STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. DEAL. Thank you, Mr. Chairman. 

And thank you, distinguished members of our panel. 

I think we all want to know how to evaluate and know where 

we are in the ongoing effort to respond to the H1N1 flu situation, 

and I appreciate the efforts of the chairman and the members of 

this subcommittee to give us this opportunity to hear update information on what is truly a dynamic and obviously rapidly changing 

situation. I recognize the importance of the roles that each of our 

witnesses play in responding to this public health threat. And so 

I am going to keep my comments as brief as possible. 

I recall, not too very long ago, this committee was having hearings when we were concerned about the bird flu. And many of the 

concerns and expressions of preparation necessities that we talked 

about then I am sure are applicable here today. 

As our witnesses will attest, the threat of a global influenza epidemic or flu pandemic is one of the greatest public threats that we 

face today. From speaking with experts in the field, both in this 

most recent as well as the most recent past experience with this, 

we have all said it is not a question of if a flu pandemic will hit, 

it is a question of when, and I suppose now, what strain will it be? 

And I believe is our responsibility as Members of Congress to ensure that the public is protected from this threat as soon as possible, and that we take the necessary steps to mitigate its spread 

and of course the heightened risk, and it is certainly something 

that is high on our priorities. 

And there is no silver bullet. We all know that. But we do want 

to know what is being done? What should be done? What role can 

we play? I am encouraged by the rapid response of the Federal and 

State authorities who are working closely in conjunction with the 

private sector to develop solutions to the flu situation that we are 

facing. And in addition to these efforts, I think we have to continue 

to look for the vulnerabilities that leave the American public at 

risk. 

I have been told that this morning Vice President Joe Biden said 

in an interview that he would advise members of his family to 

avoid commercial air travel, subways and other locations where 

transmission of flu from person to person is easy. This seems somewhat contrary to the administration’s recent statements, and I 

hope that we can clarify that in this hearing today. Also I hope 

that we can see how the administration has looked at all available 

options in dealing with this matter. 

We certainly need to know how to advise our constituents with 

regard to all of the issues of travel, crossing our national boundaries and all of the things that go with that. This is a very distinguished group, and I feel sure that you can answer these questions 

and many, many more. Thank you for being here. 

And thank you, Mr. Chairman, for the time. 

Mr. PALLONE. Thank you, Mr. Deal. 

Chairman Waxman. 


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

Mr. WAXMAN. Thank you very much, Mr. Chairman. 

I thank you for holding this hearing. 

It seems to me that at this hearing we must accomplish two 

things. We should get a clear statement to the public about the flu 

outbreak from the Nation’s leading health authorities. And I am 

pleased that our witnesses are here today to provide that. 

We should find out if there are other things, short term and long 

term, that Congress can do to help in their current and future response. There is much that we cannot know at this point about this 

flu. We don’t know how infectious is the virus or how sick people 

will get or how widespread it will be, but there is one thing that 

can be known; we are better situated to face the outbreak now than 

we would have been 10 years ago. Because of the public health 

work, the planning, the stockpiles, the building of epidemiological 

systems, we are better prepared to limit the reach and severity of 

the epidemic in the U.S. than we would have been. 

Fewer people will likely get sick than if this same virus had hit 

in the 1990s. And there is one thing we can confidently predict. We 

need to do more. For decades, health professionals have been warning us that we are taking the work of the public health system for 

granted. The system is generally understaffed, under-equipped and 

underfunded. 

The President has requested an additional $1.5 billion to respond 

to this flu outbreak. And I am sure the Congress will appropriate 

these funds. But that should not be the end of our efforts. We 

should not wait for public health emergencies to come up with ad 

hoc responses. We should upgrade our public health programs. We 

should provide them with a firm and reliable foundation of funding, 

and I hope from this pandemic flu outbreak, we can finally learn 

the lesson that public health work saves both money and lives. 

I appreciate the witnesses here, and I particularly want to thank 

Dr. Sharfstein for being here. He was an important staffer, not on 

this committee but on the Oversight Committee. But it is a rare 

opportunity to have him on the other side of the table. And I am 

pleased that he is here, and I am pleased he is in the position that 

he is now holding. 

And I thank the other two doctors for being with us as well. We 

are looking forward to your testimony. 

[The prepared statement of Mr. Waxman follows:] 


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Mr. PALLONE. Thank you, Chairman Waxman. 

Chairman Dingell. 

Mr. DINGELL. You are very kind Mr. Chairman. Thank you. 

I would ask unanimous consent to insert my full statement into 

the record. 

But I would like to look back on two things. One, the fact that 

we have been starving our capabilities of addressing problems of 

this kind, and we are now are looking at the consequences of that 

situation. And I would like to observe that the last time we had 

this kind of serious problem, we had the same kind of potential for 

a panicky response which I am observing might be the case again 

today. The result of that was the hideous set of consequences in 

which the lawyers held swine flu seminars to discuss how it was 

that they were going to represent plaintiffs and how the situation 

was going to create the maximum revenue for the plaintiffs and for 

the lawyers. 

I hope that we will have a more measured, thoughtful response, 

bottom line a more careful approach and that, from the past 

events, we will learn that we have to do these things in a more 

sensible, prudent, provident and continuing manner. 

Thank you, Mr. Chairman. 

[The prepared statement of Mr. Dingell follows:] 


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Mr. PALLONE. Thank you, Chairman Dingell. 

We will go to the witnesses. 

I did want to mention, though, that Congressman Anthony Weiner called me last weekend. I think you had a number of cases actually in a school in your district and asked that we have this hearing. Obviously a number of members requested it. But I did want 

to acknowledge his quick action, calling me on the cell phone on 

Sunday and his concern obviously because of the number of cases 

in the school and his district. 

Let me introduce our panel, and this is the order you are going 

to be speaking. I guess it is a little different from the way you are 

sitting there. First, we have Rear Admiral W. Craig Vanderwagen, 

who is a physician and assistant secretary for preparedness and response. 

And next is Rear Admiral Anne Schuchat, who is also a physician and interim deputy director for the Science and Public Health 

Program at the Centers for Disease Control and Prevention. 

And last is Joshua M. Sharfstein, who is also a physician and 

acting commissioner of the Food and Drug Administration. 

We are asking you for basically 5-minute statements, and they 

will become part of the record. 

STATEMENTS OF REAR ADMIRAL W. CRAIG VANDERWAGEN, 

MD, ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; REAR ADMIRAL ANNE SCHUCHAT, MD, ACTING DEPUTY DIRECTOR FOR SCIENCE AND PUBLIC HEALTH PROGRAM, CENTERS FOR DISEASE CONTROL AND PREVENTION, 

ASSISTANT SURGEON GENERAL, U.S. PUBLIC HEALTH SERVICE, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; 

AND JOSHUA M. SHARFSTEIN, MD, PRINCIPAL DEPUTY COMMISSIONER AND ACTING COMMISSIONER, FOOD AND DRUG 

ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Mr. PALLONE. And we will start with Admiral Vanderwagen. 

STATEMENT OF REAR ADMIRAL W. CRAIG VANDERWAGEN, MD 

Mr. VANDERWAGEN. Good morning Chairman Pallone and Representative Deal and thank you for this opportunity to visit with 

you. 

I offer greetings and thanks from our new Secretary Sebelius for 

this opportunity to assure that both arms of the U.S. Government 

of the three are working together and that we can share experiences, concerns and strategies for how we will address this opportunity. 

Over the past week, you have seen extraordinary efforts on the 

part of Health and Human Services and the rest of the Federal 

Government. For the past 5 years, HHS and the U.S. Government 

made many investments, thanks to the support of Congress, in the 

Nation’s preparedness for pandemic influenza. 

Now while the sequence of the events that we have dealt with 

in the last week, and I will remind you we are talking about essentially a week ago yesterday recognizing two cases in California to 

now phase 5 in the WHO environment, the events of the past week 


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have proven the value of the efforts that you supported, which included the development of community plans, the acquisition of 

medical countermeasures, the development of now diagnostics, and 

the numerous exercises and response plans at all levels of government. 

I would like to take an opportunity also to acknowledge and 

thank Secretary Napolitano for her continued leadership in this environment. She stepped forward very effectively as the principal 

Federal official here, and we work under her guidance overall. Our 

new Secretary engaged immediately. She reported to the office yesterday morning, and in fact, she was briefed in doing press discussions yesterday morning almost immediately. She is actively involved and concerned about these matters and directing our activities as well. 

Today I am joined by my colleagues who currently serve in the 

HHS leading the response. 

I want to say just a thing or two about the assistant secretary 

for preparedness and response. Congress in 2006 established the 

authority for this responsibility with the notion that this office 

would be the principal adviser for the Secretary on public health 

and medical preparedness and response for health emergencies. 

And indeed, that is what we are executing at this time. 

We are trying to work to assure that there is a coherent HHS 

approach to public health and medical preparedness and that our 

response capabilities are coordinated, that the relevant activities of 

all the operating divisions of Health and Human Services, Centers 

for Disease Control, Food and Drug Administration, the National 

Institutes of Health and others are being conducted in a coherent 

and targeted way on behalf of and subject to the authority of our 

new Secretary. 

Our office also serves as the principal entity that coordinates 

interagency activities between Health and Human Services and 

other Federal Departments and agencies, the White House, and 

State and local officials responsible for public health, emergency 

and medical disaster response. 

In the event of a public health emergency such as the 2009 H1N1 

flu outbreak or other medical disasters, Health and Human Services serves as the Federal Government’s lead for all of the Emergency Support Function 8, that is the public health and medical response capabilities under the National Response Framework. As 

the Department’s lead for that ESF 8 or Emergency Support Function 8, our office works closely with Homeland Security and FEMA 

to coordinate all Federal assistance to supplement States, territorial governments, tribal and local resources in response to public 

health and medical care needs. 

We manage the Secretary’s Operations Center in the Humphrey 

building so that the Secretary has moment-by-moment situational 

awareness and the ability to lead, coordinate and direct, as appropriate, the health assets that are deployed in support of States. 

The response and coordination for the H1N1 flu outbreak is 

going well. You will hear from Dr. Schuchat how our lead operational entity at this point, that is the Centers for Disease Control, 

is moving forward according to plan, adjusting to reality as it inVerDate Mar 15 2010 04:00 Apr 26, 2012 Jkt 072882 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 E:\HR\OC\A882.XXX A882

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trudes, but doing an exceptionally good job of moving forward to 

manage this event. 

The United States Government is focused on saving lives, slowing the transmission of the disease, and mitigating the consequences of this disease. Those are our strategic objectives. Using 

the guidelines prepared within our pandemic influenza playbooks 

and plans, we have been able to more clearly communicate our 

goals, objectives and strategies to our Federal, State and local partners, so that we understand what they expect, they understand 

what they can expect from us, and that makes a ton of difference 

in making operations flow and flow well. 

As you know, the World Health Organization raised the world 

wide pandemic alert to phase 5, which is characterized by confirmed person-to-person spread of a new influenza virus and able 

to cause community level outbreaks, and Dr. Schuchat I am sure 

will talk about that in more detail. But prior to that WHO action, 

we issued several key declarations, including a nationwide Public 

Health Emergency Declaration and four Emergency Use Authorizations, which I think Dr. Sharfstein will talk about in his discussion 

with you. These authorizations were issued to make certain 

diagnostics available to public health and medical personnel, to 

allow for the use of certainly antiviral products and for the use of 

certain N95 respirators. 

In response to requests received from affected States, HHS recently released antiviral medications from the Strategic National 

Stockpile to a large number of States. Additionally, Health and 

Human Services continues to evaluate community mitigation 

guidelines in those areas where cases have been confirmed through 

laboratory analysis, and as this outbreak progresses, we will continue to assess these and other guidelines to assure that they are 

appropriately based on the available science. Over the coming days, 

we will continue to work with our Federal, State, local and international public health and medical partners to address the needs 

of this outbreak. 

Many assets, and you will hear elements of this from my two 

counterparts, are working to develop a vaccine for this virus. NIH, 

CDC, FDA and ASPR are all working together to work this process 

and to avoid the very dilemma that Mr. Dingell outlined for us. 

We will work with several manufacturers to continue to prepare 

reference strains from which viral seeds for vaccine production and 

clinical trials can be made. We will not only focus on the immediate 

response requirements but also those that may lie ahead. As this 

potentially becomes more of a medical care problem, we will see 

challenges in the medical care system. We are already actively in 

communication with our colleagues at the State and local level, in 

hospitals, in emergency rooms, and in primary care settings to anticipate the implementation of their plans for addressing these 

matters and how we can support, enhance and fill gaps that may 

arise in that setting. With that, I will conclude my statement, and 

you can hear from Dr. Schuchat. 

[The prepared statement of Admiral Vanderwagen follows:] 


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Mr. PALLONE. Thank you. I assume that I am supposed to reference you as Doctor rather than Admiral. Do you prefer that? 

Ms. SCHUCHAT. ‘‘Dr. Schuchat.’’ That is fine. 

Mr. PALLONE. Dr. Schuchat. 

STATEMENT OF REAR ADMIRAL ANNE SCHUCHAT, MD 

Ms. SCHUCHAT. Good morning, Mr. Chairman and members of 

the subcommittee. 

I am Dr. Anne Schuchat, the Acting Deputy Director for Science 

and Program at the Centers for Disease Control and Prevention, 

and I appreciate the opportunity to update you on current steps we 

are taking to respond to this unique and serious influenza outbreak. 

Our hearts go out to the people in the communities within the 

United States and Mexico and around the world who have been impacted by this new strain of influenza virus. People are concerned, 

and we are concerned, too. We are responding aggressively at the 

Federal, State, and local levels to understand the complexities of 

the outbreak and to implement control measures. Our aggressive 

actions are possible in many respects because of the investments 

and the support of the committee and the Congress and the hard 

work of State and local officials on the frontline around the country. 

Flu viruses are extremely unpredictable, making it hard for us 

to anticipate the course that this outbreak will have with any certainty. We do expect increases in the number of cases, the number 

of States that are affected and the severity of illness. Amid this uncertainty, we hope to be clear in communicating what we do know 

and acknowledging the uncertainties, clearly communicating what 

we are doing to protect the health of Americans and help Americans understand the steps that they can take themselves to protect 

their own health and that of their families and their communities. 

Influenza arises from a variety of sources. And in this case, we 

have determined that we have a novel 2009 H1N1 virus circulating 

in both the U.S. and Mexico that contains genetic pieces from four 

different virus sources. Additional testing is being done on the 

virus, including a complete genetic sequencing. CDC has determined that this virus is contagious. It is spreading from human to 

human similarly to seasonal influenza, likely through coughing or 

sneezing. Sometimes people may become infected by touching 

something with flu virus on it and then touching their mouth or 

nose. 

There is no evidence to suggest that this virus has been found 

in swine in the United States, and there have been no illnesses attributed to handling or consuming pork. There is no evidence that 

you can get this new influenza virus from eating pork or pork products. 

I want to reiterate that, as we look more intensively for cases, 

we are finding more cases. We fully expect to see not only more 

cases but also a greater severity of illness. The specific numbers 

are less important in understanding the outbreak than the more 

general patterns that we observe that will help us guide our interventions. Aggressive actions are being taken here as well as 

abroad. We are working very closely with State and local public 


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health officials around the U.S. on the investigation and to implement control measures. We have provided both technical support 

on epidemiology and laboratory efforts for confirming cases. And we 

are working with the World Health Organization, the Pan American Health Organization and the Governments of Mexico and Canada on this outbreak. There is a tri-national team that is working 

in Mexico right now to better understand the outbreak and to enhance surveillance and lab capacity so that we can better address 

critical questions, such as why the cases in Mexico appear to be 

more severe than what we are seeing initially here in the United 

States. And we are working very closely with HHS and other Federal partners to ensure that our efforts are coordinated and effective. 

CDC has issued many health advisories for individuals, health 

care practitioners, schools and communities, and these continue to 

evolve as our understanding of the situation changes. On Monday, 

CDC issued a travel health warning for Mexico recommending that 

travelers postpone nonessential travel to Mexico. We are also evaluating information from other countries, and we will update travel 

notices as necessary. 

As always, people with flu or flu-like symptoms should stay at 

home and should not attempt to travel. In fact, a key message that 

we have for people is that there is a role for everyone to play when 

an outbreak like this is occurring. At the individual level, it is important for people to understand how each of us can prevent respiratory infections. Frequent hand washing is an effective way to 

reduce transmission. If you are sick, stay home. I can’t tell you how 

many times I have said that this week. If your children are sick, 

have a fever or a flu-like illness, they shouldn’t go to school. And 

if you are ill, you shouldn’t go on an airplane or any public transport to travel. Taking personal responsibility for these things will 

help reduce the spread for this new virus as those measures also 

help reduce the spread of other respiratory infections. 

It is also important for people to think ahead to think about 

what they would do if their outbreak deepens in their community. 

Communities, businesses, schools and local government should 

plan now for what to do if cases appear where you live or work. 

For example, parents should prepare for what they would do if 

faced with temporary school closures. We also have additional community guidance so that clinicians, laboratory scientists and other 

public health officials will know what to do should they see cases 

in their community. All of these specific recommendations, as well 

as our regular updates, are posted on the CDC’s website at 

www.CDC.gov. 

CDC maintains this Nation’s strategic National Stockpile of 

medications for the eventuality that they may be needed in a situation such as we face today. As part of our pandemic preparedness 

efforts, the U.S. Government has purchased extensive supplies of 

antiviral drugs. And our preliminary testing indicates that the 

virus is susceptible to the drugs we have in our stockpile. We are 

releasing one-quarter of the States’ share of antiviral drugs and 

personal protective equipment to help States prepare to respond to 

the outbreak along with the necessary FDA emergency use authorities to facilitate their effective use. Distribution has already begun, 


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starting with States where we already had confirmed cases and the 

Department of Defense and individual States have also stockpiled 

these antiviral drugs. 

Whenever we see a novel strain of influenza, we begin the steps 

to work toward the development of a vaccine in case one is needed. 

The CDC is working to develop a vaccine seed strain specific to this 

novel virus, which is the first step in vaccine manufacturing. We 

have initiated steps so that, should we need to manufacture a vaccine, we can work towards that goal very quickly. And rapid 

progress is being made possible through the combined forces of 

CDC, NIH, FDA, BARDA and the manufacturing community. 

Finally, it is important to recognize that, with the strong support 

of the Congress, there have been enormous efforts in the U.S. to 

prepare for this kind of outbreak and for a full pandemic. Our detection of this strain in the United States came as a result of that 

investment. And our enhanced surveillance and laboratory capacity 

are critical to understanding and mitigating this threat. 

While we must remain vigilant throughout this and subsequent 

outbreaks, it is important to recognize that, at no time in our Nation’s history have we been more prepared to face this kind of challenge. As we face the challenges in the weeks ahead, we look forward to working closely with the subcommittee to best address the 

evolving situation. 

Thank you. 

[The prepared statement of Admiral Schuchat follows:] 


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Mr. PALLONE. Thank you, Dr. Schuchat. 

Dr. Sharfstein. 

STATEMENT OF JOSHUA M. SHARFSTEIN, MD 

Dr. SHARFSTEIN. Thank you Chairman Pallone, Ranking Member 

Deal, Ranking Member Barton, Chairman Waxman, chairman Dingell and other members of the committee, thank you for having this 

hearing. 

I am Dr. Joshua Sharfstein, principal deputy commissioner and 

acting commissioner of the U.S. Food and Drug Administration. 

FDA protects the public health in this type of situation by facilitating access to safe and effective human and animal drugs, human 

biological products and devices. FDA is part of a team led by the 

Department of Health and Human Services. Working closely with 

the Department, our sister agencies, other U.S. Government agencies, the World Health Organization and foreign governments, we 

are responding to this threat. 

I appreciate this opportunity to discuss the agency’s response, including our approval of several Emergency Use Authorizations earlier this week and the efforts of several internal FDA teams. 

Let me turn to the Emergency Use Authorization. Section 564 of 

the Food, Drug and Cosmetic Act which was added by the Project 

BioShield Act in 2004 which permits the FDA Commissioner to 

issue an Emergency Use Authorization following a determination 

and declaration of a Public Health Emergency. This allows the use 

of an unapproved product or an approved product for an unapproved use and in a declared emergency. 

Mr. PALLONE. Dr. Sharfstein, I think some of the members are 

having a hard time hearing you. 

Dr. SHARFSTEIN. I was talking about Emergency Use Authorizations. And FDA can issue these in an emergency under four conditions: First, we have defined that the agent can cause a serious or 

life-threatening disease or condition; second, based on the totality 

of the scientific evidence, it is reasonable to believe the product will 

be effective against a disease or condition; third, that the known 

and potential benefits of the use outweigh the known and potential 

risks; and fourth, that there is no adequate and approved available 

alternative. 

This past Sunday, the acting HHS Secretary did issue a Public 

Health Emergency declaration and then followed that with declarations justifying the emergency use of certain antivirals, in vitro 

diagnostics and personal respiratory protection devices. 

Let me briefly describe these Emergency Use Authorizations that 

FDA went ahead and issued as a result or following that declaration. Two of them pertain to drugs. Tamiflu is a drug approved, it 

is oseltamivir, for the treatment of uncomplicated illness due to influenza and prevention of influenza in patients 1 year and older. 

Relenza is approved to treat acute, uncomplicated illness due to influenza in adults and children 7 and older who have been symptomatic for less than 2 days and for the prevention of influenza in 

adults and children 5 years and older. 

One of these Emergency Use Authorizations allows for Tamiflu 

also to be used to treat and prevent influenza in children under 1 

year. In addition, under both authorizations, both of these medicaVerDate Mar 15 2010 04:00 Apr 26, 2012 Jkt 072882 PO 00000 Frm 00042 Fmt 6633 Sfmt 6633 E:\HR\OC\A882.XXX A882

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tions may be distributed with information pertaining to emergency 

use to large segments of the population without complying with the 

label requirements that otherwise are applicable to dispensed 

drugs. They may be distributed by a broader range of health care 

workers, including some public health officials and volunteers, in 

accordance with the State and local laws and public health emergency responses that I know are being planned around the country. 

The third one related to a PCR flu panel diagnostic test for the 

CDC, which allowed the CDC to distribute to public health labs 

around the country a diagnostic test that can presumptively diagnose this particular infection. 

And for all of these Emergency Use Authorizations, the way it 

worked is CDC applied; we worked very closely with CDC over the 

weekend to make sure everything was there to get the right information to people; and then we approved them on Monday starting 

early in the morning. This particular diagnostic test amplifies the 

viral genetic material. A positive result indicates presumptive infection. A negative result by itself does not exclude the possibility 

of infection. 

The fourth authorization permits HHS to deploy certain disposable respirators in the Strategic National Stockpile for use to reduce exposure to airborne germs. These products, when used properly and in accordance with information that is provided, may help 

reduce the chances of getting sick. They do not eliminate the risk 

of illness or death. They should always be used in conjunction with 

other control measures, such as frequent hand washing, and should 

done consistently with the advice and guidance provided by the 

CDC and other public health authorities. 

Let me just turn for the last minute to talk about how FDA has 

organized itself to respond to this challenge. As soon as we became 

aware of this last week, I asked Dr. Jesse Goodman, FDA’s acting 

chief scientist and deputy commissioner for Scientific and Medical 

Programs to coordinate and lead FDA’s efforts. Dr. Goodman is a 

world expert in infectious disease. He previously directed the Center For Biologics and has extensive experience in issues related to 

influenza vaccine production and evaluation. 

We have changed the way FDA is managed for this process. We 

are using an incident management approach with Dr. Goodman as 

the leader, which includes seven substantive teams that are crosscutting and include staff from across the FDA and all FDA centers. 

These teams work with the Department, CDC, other agencies, national and international partners, and they are the vaccine team, 

the antiviral team, the in vitro diagnostics team, the personal protection team, the blood team, the shortage team, and the consumer 

protection team. We also, in the incident management approach, 

have an operations section, a logistics section, and a communication section. We have senior level health, international, and legal 

advisors. 

Let me very briefly explain how these teams work. The vaccine 

team is working to facilitate the availability of a safe and effective 

vaccine to protect the public from the 2009 H1N1 flu virus as soon 

as possible. Now, having that vaccine ready is the goal of the team. 

There is a completely separate question, and that is going to depend on the status of the epidemic of whether and who that vaccine 


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would be recommended for. But for FDA, we want to have a vaccine that is safe, effective and available as quickly as possible. 

Part of this team starts in the lab. We are growing the vaccine 

and trying to genetically engineer a reference strain that could be 

used for vaccine development. We are already preparing a re-agent 

that will be needed to help manufacturers produce and test the 

vaccine. We are trying to think through what clinical evidence 

would be necessary before we can conclude that the vaccine is effective. This team is working with BARDA and HHS to have extensive consultation with the vaccine industry already as this goes forward. 

I actually went out and met with the vaccine team earlier this 

week. They are scientists. They are physicians. They realize how 

much is at stake for this country. 

There is the antiviral team, whose goal is to identify and evaluate antiviral drugs to prevent and treat illness and to facilitate access to these medications. This is the team that led the effort to 

review the Emergency Use Authorizations with CDC. They are also 

in extensive communications with manufacturers about other options to treat this infection, particularly if it becomes severe, and 

is working very closely with other regulatory agencies around the 

world. This team used its expertise to identify the right dose for 

kids under 1, and we are hearing from a lot of countries around 

the world about how they did that. 

We have an in vitro diagnostics team that approved the tests 

that I was talking about that CDC is distributing. It is already 

working with manufacturers on the availability of other tests as 

well as current diagnostics just for basic identification of influenza. 

The personal protective equipment team did the mask Emergency Use Authorization, and they are also in continuous contact 

with the key manufacturers to make sure that we can get the appropriate supplies of these products for the American people. 

There is a blood team. The blood team is dedicated to the safety 

and availability of blood products needed for transfusion by the 

American public during this outbreak. The main focus of the blood 

team is to make sure there is adequate blood just in general because blood is so important for so many different people and patients around the country in that the response to this just doesn’t 

reduce the number of donors, but they are also starting to think 

through whether there is any potential risk of the blood supply, 

and they are engaging other regulatory agencies. So far they are 

not, there is nothing that they are recommending in terms of particular controls based on their understanding of influenza. 

We have a shortage team that is working very closely with manufacturers to, particularly around the issue of how they can expand 

production of key medications, as well as working with HHS and 

others about spot shortages that are occurring. 

And finally, we have a consumer protection team that cross cuts 

across all the different parts FDA to monitor for scams, dangerous 

products, and things that may be marketed that could cause harm 

to people as they are worried about this situation. 

So, in conclusion, FDA is fully committed and engaged in protecting the public’s health during this difficult time. Among us are 

laboratory scientists, medical reviewers, epidemiologists, product 


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experts and field inspectors. We will bring every skill and every resource we have to this critical mission. 

Thank you very much for the opportunity to testify today. I welcome your ideas and your questions. 

[The prepared statement of Dr. Sharfstein follows:] 


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Mr. PALLONE. Thank you, Dr. Sharfstein. 

I thank all of the panelists. 

We will now have 5-minute questions from the members. And I 

will start with myself. 

And I wanted to ask, Dr. Schuchat, you mentioned the precautions people can take to protect themselves. But could you 

elaborate further, and let me just ask, what kinds of symptoms 

should people be alert to? Naturally, people look to their families, 

and you get all kinds of things; should I go to a doctor? Should I 

wear a mask? You don’t necessarily have to comment on that. But 

what are the symptoms that they should be alert to? And what 

about going to the doctor? Does it make sense to go to a doctor? 

You don’t want to overwhelm the doctors’ offices either. 

Ms. SCHUCHAT. The symptoms of this new strain of influenza 

virus are similar to the symptoms of seasonal influenza. And they 

include high fever, body aches, cough, sore throat. Those sorts of 

things. Unfortunately, the symptoms of influenza are very nonspecific, and they can be caused by lots of other things. It is important 

for people to use judgment. If you are really sick, you need to make 

sure you consult your health care provider. And if your children are 

ill, the same thing. But it is also important to recognize that this 

is a time where we don’t want the worried well flooding the emergency rooms. We really do need to be careful about that kind of 

thing. 

One of the emphasis areas has been diagnostic tests to help us 

differentiate this new virus from other illness. And so we are very 

pleased that this Emergency Use Authorization went forward, and 

the States are now prepared to differentiate this new flu virus from 

other things. 

But in general, mild illness, you really are able to stay home and 

self-care. And illness that is a little bit more severe, you want to 

make sure you contact your health care provider. In particular, in 

areas where there hasn’t been any recognized disease yet, we want 

people to let their health care provider know if they have these 

sorts of symptoms and have traveled to one of the areas that is affected. 

Mr. PALLONE. You mentioned Mexico. I mean, I do see, well, people mention Mexico; I do see on TV you know people in Mexico 

wearing masks. That doesn’t make, maybe it does in, Mexico but 

here, that is a little severe, isn’t it? 

Ms. SCHUCHAT. We think there are a variety of interventions 

that will help reduce the risk of respiratory infections. And we do 

feel for the people in Mexico who are in a difficult circumstance 

now and really doing everything they can think of to try to protect 

themselves. 

Here we have issued guidance for the mask use, for different circumstances. And we update our guidance as we get new information on our Website. But I think it is important to say that guidance is going to be different in different areas. The New York City 

area was having an outbreak in a school that was fairly large, and 

their guidance was really targeted at the circumstances on the 

ground. 

CDC is trying to issue guidance and updated guidance very frequently for the country. But we recognize that the local authorities 


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have the best information on their circumstances. And we really 

want people to know what is going on in your own community; 

what do your local authorities say? And really use us as a technical 

support to those local entities. 

Mr. PALLONE. Let me ask Dr. Sharfstein about the vaccination. 

I seem to recall, I don’t know if it was at the briefing yesterday or 

that they said that it probably wouldn’t be available for everyone 

until maybe November at the earliest, possibly not until January. 

I remember in 2004 when we had a major shortage of the seasonal 

flu vaccine, and at the time, the public health officials were saying, 

if we faced a pandemic, we wouldn’t have adequate vaccine capacity. Can you explain what the government has done to increase the 

vaccine manufacturing capacity, and where are we now? 

I mention that I don’t know where I heard that November to 

January. It might have been at the briefing we had yesterday 

but—— 

Mr. SHARFSTEIN. I am happy to answer that. In 2004, there were 

only about 60 million doses of vaccine for the flu that year because 

of the problem that one of the manufacturers had. And in addition, 

the infrastructure was relatively weak, and there wasn’t the capacity if there was a pandemic to be making another vaccine. But because of the committee’s efforts and the Federal Government’s efforts and FDA’s efforts, there has been a tremendous shift since 

that time. I will go through a couple of issues. 

One is that there was funding appropriated to strengthen the 

vaccine infrastructure, and one way to talk about that is eggs. Flu 

vaccine is made in eggs. And in 2004, there weren’t extra eggs. 

There was just the eggs for the regular flu vaccine. But HHS has 

gone out and contracted. They have extra flocks. And we have gone 

to a year-round egg availability. So there aren’t any months where 

eggs aren’t available. So that reduces most of the time that people 

were worried about in 2004 would be the delay. 

On FDA’s side, FDA aggressively went out and solicited other 

companies to be making the flu vaccine for the U.S. market and 

used an accelerated approval approach to bring online three new 

manufacturers. So, this year, I think the capacity is around 130 or 

140 million doses instead of just 60 in 2004, with additional manufacturing capacity potentially out there. And all the companies already engage with us in how to make the vaccine and the eggs 

available. 

I was hearing that we now have the capacity where we had 

200,000 eggs a day only during the flu vaccine season; that that 

has gone up considerably, maybe as much as 500,000 eggs a day 

year round. So right now, the capacity in the system and the availability of the manufacturers to make vaccine is so much better 

than 2004. 

The challenge is, and why people are talking about different 

dates to when it could become available, has to do more with the 

virus than anything else. There are several steps to make a vaccine 

and test a vaccine, and each of those has its own uncertainties. If 

everything goes extremely well, we will all be happy. But we don’t 

know if everything will go extremely well. You could have a problem creating the virus initially, a problem growing the virus. And 

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erates the immune response you are looking for, or else it may 

have to be reformulated. 

So I think the position is, to explain, is that the infrastructure 

we are building on is extremely strong, particularly compared to 

where we were in 2004. But we are dealing with an unknown 

virus, one that hasn’t been turned into a vaccine before, and there 

is a lot of uncertainty about how that will go. But it is really a scientific uncertainty. I think the basic infrastructure to succeed is 

there. 

Mr. PALLONE. Okay, thank you. 

Mr. Deal. 

Mr. DEAL. Dr. Vanderwagen, first of all, I would like to ask you, 

how did the administration arrive at the $1.5 billion as the figure 

that the request was made for? How would that money be distributed? To which agencies? What would those agencies be allowed to 

use that money for? And are there other funds that HHS can currently draw on to deal with this matter? 

Mr. VANDERWAGEN. Thank you, Mr. Deal. Good question. 

When we analyzed the potential demand for additional 

antivirals, we looked at the cost of production of vaccine. We looked 

at the cost of potential medical supplies should we have a wider, 

more severe event in the medical environment. When we look at a 

number of those issues, the cost requirements can be fairly significant. I think the President’s intent was, given that there are all 

those potential uses, depending upon how this thing progresses, 

that this was a place to start. 

I think the majority of that would be looking at such things as 

additional medications, additional development costs associated 

with the vaccine and getting it to the point where we have a safe 

and effective vaccine, and providing some support to local and 

State requirements for preparedness. I think those are the kinds 

of issues that we are looking at in terms of where that funding 

would go. 

Mr. DEAL. You are not allowed to cough during this hearing. I 

am joking. You are not allowed to cough during this hearing. 

Mr. VANDERWAGEN. Oh, well, it is allergies in my case. 

So the universe of need could be quite large, much larger than 

that figure in fact. But this is a way for us to look at some of the 

known things that we think we are going to need to take care of. 

We are currently replenishing our stockpile for those amounts. And 

we are considering that. We have funds inside the Department we 

might be able to use to cover that, so that is a decision point that 

we are examining right now. 

If we want to cover so those antivirals that we already sent to 

the States and replenish that, we may have funding available to 

us internally to do that. But beyond that, if we are going to start 

talking about wider support antivirals, it will be a very difficult 

challenge to find funding within the existing HHS appropriations 

for that. 

Mr. DEAL. So part of it would go to facilitate FDA’s more rapid 

response to approving vaccines, for example, for this particular 

thing, is part of what I hear you say. Is that right? 

Mr. VANDERWAGEN. Well, the short answer is yes. NIH will conduct clinical studies for safety and efficacy in partnership with 


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FDA. That takes funding support. We would be looking at beginning to develop the pilot lots. That costs money to do that particular clinical trial. In series, we would be looking to try to ramp 

up vaccine commercial production capacity while those tests are 

undertaken. Those all have costs associated with them. 

Mr. DEAL. Dr. Sharfstein, from the FDA point of view, I have 

been told, and I think the chairman alluded to this as well, that 

if we are developing a vaccine specifically for the H1N1 virus, that 

it could be done as a separate vaccine for that. And I have been 

told it would take maybe 4 months to get that, from the time you 

arrived at what you think the formula needs to be, about 4 months 

to get it to its production stage. Is that generally about right? 

Dr. SHARFSTEIN. First of all, let me follow up on what you said 

before. There may be extra funds FDA needs, but I want to assure 

you that everything we think needs to be done is being done. And 

the management structure we have in place is really pushing the 

staff, and everybody is completely committed to doing everything 

we need to do to meet these different goals on each team as quickly 

as possible. 

Four months is one possible scenario. But what it really depends 

on is how this virus behaves in a vaccine. I will just give you an 

example. We have to combine it with other viruses in order to get 

it to grow fast enough. Then it has got to eventually be grown in 

bulk. And then it has to be tested in people to see how much of 

it produces an immune response. If you do the first test, and it 

doesn’t show the right—it may be the first test as a couple different 

options, but based on that data you have to look at it, because our 

goal is both an effective vaccine and a safe vaccine. So it is going 

to depend. Since we are not going to be waiting for eggs, that was 

actually one of the biggest problems in 2004—— 

Mr. DEAL. I hate to interrupt you, but my time is about out. I 

want to ask you one other thing. 

My understanding is that, each year, in the seasonal vaccines, 

that you choose up to maybe three different strains. I assume this 

was not one of the strains that was anticipated to be included in 

the seasonal vaccine simply because you didn’t, first of all, anticipate it; secondly you have not had the time to ramp up for it. Are 

you so far along I assume in the seasonal vaccine process that, if 

you were to be able to come up with a vaccine for this, that it 

would not be allowed to be included in the seasonal vaccines but 

would have to be a separate vaccination program? Is that a correct 

assumption? 

Mr. SHARFSTEIN. That is an excellent question. You are right 

that it was not in the flu vaccine that had been prepared because 

people weren’t aware of the virus’s existence. And right now, we 

are basically developing with the manufacturers the ability to 

make a vaccine. And then there has to be some strategic decisions 

made over the next few weeks. One of those decisions is going to 

be whether to make this as a stand-alone vaccine, to combine it 

with other vaccines, and that in part has to do with the manufacturing capacity. If you make a single stand-alone vaccine, you can 

make more of it. And in part that is going to depend on how much 

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So there are a lot of factors out there. And what FDA does is it 

works with the CDC, the World Health Organization and an advisory committee of experts to look at all the evidence, look at what 

we know about how this vaccine looks to us as well as what we 

know about the manufacturing capacity, and then there will be a 

recommendation about how this integrates with the seasonal flu. 

So it might, you know, it is too early right now to have an answer. But it is an excellent question. And I think probably within 

a few weeks, we will be able to know more and be able to give a 

better answer. 

Mr. PALLONE. Thank you, Mr. Deal. 

Chairman Waxman. 

Mr. WAXMAN. Thank you, Mr. Chairman. 

Dr. Schuchat, I would like to explore with you how this virus is 

different from other flu viruses. Most people are familiar with the 

fact that we have an annual vaccine to deal with the flu that might 

be in the flu season. And we are in the middle of all this where 

the flu season is pretty much over. 

Every year, millions become ill, about 36,000 die from the regular seasonal flu in this country. But this new H1N1 flu does appear to be different. And I still recognize we have a lot to learn. 

But I am hoping you can clear up a few questions. Can you explain 

what the H1N1 flu is, and how it is different from the seasonal flu? 

Is this virus easily transmitted from person to person? And do we 

know how dangerous this virus is? 

Ms. SCHUCHAT. Thank you. 

This is a new virus that humans have not had before. There are 

H1N1 A influenza viruses that we get every year as part of seasonal flu. But this is a new H1N1 strain that we hadn’t found before in all of the banks of strains that we have looked at. It is a 

very unusual one. It has four genetic components in it: one that 

comes from swine from north, from North America; one that comes 

from swine from Europe and Asia; a third part that has human origins; and a fourth part that has bird origins. 

So it is a very unusual virus. And we don’t believe that humans 

have experienced it before until these cases that we are seeing. 

It does appear to be easily transmissible in terms of the information we have already here in the United States as well as in Mexico. But we don’t have good information about how dangerous it is. 

It is a very important issue. In Mexico, we are getting more data 

about the severity. In the U.S., we are in early days, but really trying to understand how severe it is. We are taking it very seriously. 

Mr. WAXMAN. On the news shows, there is a constant comparison 

to the pandemic flu in 1918 which did such devastation. And it is 

worrisome when we hear about this comparison because that virus 

affected not just the very young and very old but also affected otherwise healthy adults. Early reports suggest that many of these 

people who are being hospitalized in Mexico were apparently young 

and otherwise healthy as well. I know it is early, but can you tell 

us in what ways this might be similar to 1918? 

Ms. SCHUCHAT. A worrisome sign from the early reports in Mexico was the age of the patients and the apparent young, healthy 

adults. That did ring a bell from the circumstances back in 1918. 

So far the cases we have had here in the United States that have 


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been laboratory confirmed are relatively young also. I think our 

median age is 22 right now. 

But, again, we are beginning to collect more information and 

these things could change quite a bit. There are some very different 

circumstances from 1918. Today we have antiviral drugs that treat 

flu. We also have the antibiotics or antibacterial drugs that treat 

the kinds of secondary bacterial pneumonias that we think played 

a role in the 1918 devastation. We have better health-care circumstances. We have much better communication, and hopefully 

more skilled leadership who is doing the communication. 

One of the really important things in addressing something like 

this is making sure that people have good information and that our 

interventions are not worse than the virus itself. 

Mr. WAXMAN. Even if we assume that this virus is as bad as that 

one in 1918, these modern medical advances will be helpful in 

treating patients, we are not going to see the same kind of death 

and terrible results that we saw then when we didn’t have vaccines, we didn’t have antivirals, we didn’t have the whole infrastructure of communication that we now have. 

Ms. SCHUCHAT. I think the circumstances are much better today 

to respond to this kind of thing. I also want to introduce the uncertainty that every new strain is different and we really need to 

learn as we go about how this one will behave. We also are mindful 

of circumstances in other parts of the world which may not be as 

fortunate as ours. 

Mr. WAXMAN. Would this virus possibly mutate in the next several months? 

Ms. SCHUCHAT. Influenza viruses can mutate frequently, and we 

need to keep our eye on them. During the regular seasonal flu, we 

test strains throughout the season. Often we find changes in the 

resistance patterns of the virus. We are very happy that the original strains that we have tested are sensitive to the Tamiflu and 

Relenza that is in our stockpile, but we need to keep looking at 

that and also look at the antigenic or immune properties, because 

that will feature into what vaccine will be useful. So they do mutate and we need to keep our eye on that. 

Mr. WAXMAN. Thank you. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Chairman Waxman. Mr. Gingrey. 

Dr. GINGREY. Mr. Chairman, thank you. First of all, let me just 

associate myself with the comment that our Chairman Emeritus, 

John Dingell, made in his opening remarks in regard to not overreacting to the point that we create a pandemic of panic. And I want 

to thank our panelists. I think already some comments have been 

made to that regard. 

And yesterday when Secretary Sebelius and Napolitano and, Dr. 

Schuchat, you were there as well—it is very reassuring to Members 

of Congress to get the feeling that we indeed are prepared. The remarks that we heard from Dr. Sharfstein, of course, just add to 

that. I feel good about it. 

I think what occurred in 2003, 2004 in regard to the fear of an 

avian influenza pandemic led to a $6 billion emergency appropriation. And as you have pointed out, a lot of that money went toward 

making sure that a stockpile of Tamiflu and Relenza was beefed up 

to something like 50 million courses, not just one dose, but courses 


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of treatment. And also the three or four pharmaceutical companies 

who had maybe been in the domestic business of manufacturing 

vaccine, but because of liability and no reimbursement for the vaccines that were never given, it was not a very cost-effective business for them. We helped with that, with grants and some of that 

money was spent in that way. 

And then it is my understanding—this goes with what Ranking Member Deal mentioned as far as the $1.5 billion, Dr. 

Vanderwagen—that 1.3 billion of that original 6 is still available. 

And I want to ask this question about that particular amount of 

money. President Obama, I think, had no choice because he doesn’t 

want to get Katrina’d, you know; the media frenzy about this issue 

leaves him no choice but to say, well, look, we are not going to go 

to sleep at the switch and we are going to appropriate this money. 

But if, Dr. Sharfstein, if we decide that it is not really appropriate, 

not really necessary to go forward with the development of that 

vaccine specifically against this H1N1 flu—we won’t call it swine 

flu—then maybe at some point when this is all said and done, it 

turns out to be a mild disease and people kind of go back to their 

normal living and they are not shutting down schools because one 

child is sick, and they are not avoiding the subways and taking 

commercial airline flights—I mean, you know, we are getting to the 

point where I fear that we are getting ourselves in a frenzy and 

it is inappropriate. So if this thing turns out not to be the real bad 

pandemic that everybody fears it could be, then I would hope that 

the money that is not spent to develop this vaccine will go back to 

John Q. Taxpayer, go back into the general Treasury or whatever, 

and not just stay there for the next 10 years when it is really not 

needed. 

I don’t want to underplay this. I am a physician member. I don’t 

want to have egg on my face a month from now. But I do agree 

with Chairman Emeritus Dingell, we don’t want to overreact here. 

And I think Dr. Schuchat mentioned that yesterday, and again 

today, and I would like for all of you to comment on that a little 

bit, if you would. 

Ms. SCHUCHAT. I think it is really important to recognize the uncertainty that we have, that influenza can be very unpredictable, 

that evolution of the situation in the past week has had many worrisome aspects, but that we are acting aggressively. And I think 

that we really do need to make sure that we are able to aggressively respond. 

An important issue, I think, is that the investments that were 

made in the past few years for pandemic preparedness have greatly 

strengthened our response to seasonal influenza. And as was mentioned, 36,000 Americans die every year from seasonal influenza. 

So it is likely that flexible programming of emergency funds would 

be flexibly applied to strengthening our work against the seasonal 

flu, which is such a killer in America. 

Dr. SHARFSTEIN. I think that your point is very well taken, and 

we heard about the analogy of the 1918 flu, but some people have 

also been discussing the 1976 swine flu situation. And in looking 

back on that, some historians said that might have been an instance where people overreacted. And the lessons, I think, that 

were drawn from that experience was that you have got to separate 


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out the preparation for the possible worst-case scenario from actually implementing it, and that people in looking back felt like 

maybe because they had a vaccine, they had to use it. And I think 

it is very clear now that those two things have got to be separated. 

In the end, it is going to be okay if we have a vaccine but it turns 

out not to be a pandemic. We just don’t want to be in a situation 

where we have a pandemic and we don’t have a vaccine. 

Mr. VANDERWAGEN. And the last comment—just to finish out 

your threesome here, sir—I think that we are now down to about 

600 million remaining. And most of those, as you know, we received special milestone payment authority under the Pandemic 

and All Hazards Preparedness Act for acquisition of materials and 

so on. That balance is really already sort of precommitted as part 

of those milestone payments which are going for diagnostics, new 

antivirals in case we develop resistance to the existing antivirals, 

and to support some other vaccine analysis that is ongoing. So it 

is committed in the milestone payments stream for those products 

that are in development. 

Mr. PALLONE. Thank you. We just have one vote. I am going to 

try to proceed with questions. I am going to see if there is some 

way we can work it out so that we don’t have to break, but I don’t 

know if that is possible. But in the meantime, we will proceed to 

Chairman Dingell. 

Mr. DINGELL. Mr. Chair, I thank you for your courtesy and I 

commend you for the hearing. I have several questions I would like 

to have for the record. And I would ask unanimous consent that 

the responses be inserted into the record at the appropriate place 

and fashion. 

The first one: Who is going to be the lead agency? Is it going to 

be HHS or is it going to be the Department of Homeland Security? 

Mr. VANDERWAGEN. The simple answer is for public health and 

medical activities, it is Health and Human Services; for the wider 

response, if it involves energy, transportation, security, et cetera, 

that is all in the hands of DHS. We all work as a coherent team 

under their leadership. 

Mr. DINGELL. Do you have a memorandum of understanding to 

finding how that is going to be done? 

Mr. VANDERWAGEN. Yes, sir. There is a National Response 

Framework. 

Mr. DINGELL. Would you please submit that for the record? 

[The information appears at the conclusion of the hearing.] 

Mr. DINGELL. How is this budget going to be expended? Would 

you submit to us a statement of how the money is going to be expended, if you please? 

Now, the States are going to have a very severe problem. My 

home State of Michigan has a budget deficit which it has been announced is going to go to a billion dollars after some very savage 

efforts to cut back on the expenditures. How much of this money, 

this billion and a half dollars, is going to go to the States to be expended through their agencies, for what purposes? 

Ms. SCHUCHAT. I think these matters are being evaluated and 

the Office of Management and Budget is intending to submit something soon with those types of allocations. 

Mr. DINGELL. So the answer is we don’t know? 


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Ms. SCHUCHAT. Exactly. 

Mr. DINGELL. I am assuming that the answer is you do not yet 

have a defined budget structure? 

Ms. SCHUCHAT. [Witness nods in the affirmative.] 

Mr. DINGELL. There is no nod button on the reporter’s response. 

The answer is yes; is that right? 

Mr. VANDERWAGEN. Yes to what, sir? 

Mr. DINGELL. What is the potential for this flu outbreak to reach 

pandemic levels? 

Ms. SCHUCHAT. The World Health Organization elevated the 

phase yesterday to Phase 5, which is the second highest phase. But 

here in the United States, we have already been acting as if it were 

a full-blown pandemic in terms of our response, aggressively preparing for widespread disease in many communities. We don’t 

know if that will actually happen. But we are seeing sustained 

transmission in a few communities. We don’t yet have severe illness, or lots of severe illness, but we fear that we may have additional severe cases as we have with seasonal flu. 

Mr. DINGELL. I would like to have you submit to the committee 

as soon as you can, what assistance the Federal Government is 

going to be providing the State and local units of government to enable them to address their responsibilities in this matter of flu. I 

ask unanimous consent that be inserted into the record at the appropriate place. 

Mr. Skelton. I note that FDA is currently using three products 

whose use is being vigorously monitored. The Secretary was granted emergency use under the 2004 Project Bioshield law to clear the 

unapproved use of particular products in the event of an emergency. The Secretary is exercising this authority for two drug products and one diagnostic test. What are the considerations in deciding to clear the products for use of young children and adults? This 

is for Dr. Sharfstein. 

Mr. SHARFSTEIN. Sure. Thank you for the question. The basic 

considerations are set out in the law. And then I will tell you how 

we applied it in this case: that, first of all, there is a serious or lifethreatening condition. We know that is the case. 

Second, that the totality of the scientific evidence makes it reasonable to believe that the product may be effective. 

Third, that the known and potential benefits of the use outweigh 

the money in and potential risks. 

And fourth, there is no adequate approved and available alternative. 

Now, for kids, the only thing that is done differently under the 

emergency use authorizations is for Tamiflu, where it permits the 

use under age 1. And it is an excellent question because you think 

how did FDA decide that that was okay, how did you figure out a 

dose? It was not in the original label. And it turns out FDA has 

been looking at this for a couple of years and has been working 

very closely with NIH and the company to get data on under age 

1. 

And there was actually a study that was done, FDA reviewed the 

study, and even over the weekend got additional data from the 

company involving more than 750 infants from Japan and also 


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some German data. There was a study that was organized out of 

NIH which was specifically for kids— 

Mr. DINGELL. Please submit the rest of our question for the 

record. 

Mr. SKELTON. I would like to know if your agency has a regular 

on-the-shelf plan to address these kinds of problems when they 

arise; yes or no? 

Mr. PALLONE. Chairman Dingell, if I could just interrupt and tell 

the members what we are going to do is continue because of the 

time constraints of our public health witnesses here. And then Mrs. 

Capps, as our vice chair, is going to come back and replace me so 

I can go vote. So you will have about 8 minutes left if you want 

to leave now and come back—I don’t mean the witness, I am talking about the members. We are just going to continue. 

I apologize for interrupting, Mr. Chairman. 

Mr. DINGELL. I will repeat the question. I would appreciate you 

submitting for the record, one, the answer: Do you have an on-theshelf plan. You are nodding yes? 

Mr. VANDERWAGEN. Yes is the answer. 

Ms. SCHUCHAT. Yes, all of us do. 

Mr. DINGELL. All three of you? 

Mr. VANDERWAGEN. Yes. 

Mr. DINGELL. Does that include working with the Department of 

Homeland Security? 

Mr. VANDERWAGEN. Yes. 

Mr. DINGELL. And do they have one? 

Mr. VANDERWAGEN. Yes. 

Mr. DINGELL. Would you submit those plans to us for the record, 

please? 

Mr. VANDERWAGEN. Can do. 

Mr. DINGELL. Mr. Chairman, I thank you. 

Mr. PALLONE. Next is Mr. Murphy. 

Mr. MURPHY of Pennsylvania. Thank you, Mr. Chairman. I want 

to thank all the distinguished panelists. I am learning a great deal 

here. I am not a physician. I am a psychologist and I understand 

panic. And I need to ask you some questions, and I am not meaning to embarrass anyone, but I think it is very important that you 

get some official statements out for this. 

Is anyone from any of your departments recommending that any 

American citizens avoid airplanes, buses, elevators, confined 

spaces; or do you think that perhaps we should not be saying that 

right now? 

Ms. SCHUCHAT. We are recommending that people defer nonessential travel to Mexico. We are recommending that people who 

are sick not get on airplanes or public transportation, and I think 

there may have been a misstatement. 

Mr. MURPHY of Pennsylvania. Do you all agree with that? We 

will let it stand at that. But I do think it is important that we let 

people know this. Every year when there is a flu in this country, 

many people die, sadly, from that. But the main thing is to understand that you are working this issue very hard, and I appreciate 

what you are doing. 

However, it is a concern about anytime people will use transportation. And I am wondering as part of your plan, we have the 


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transportation security system set up. Every airport has lots of 

poachers and lots of issues, and I am wondering if you are recommending people not travel if they are sick, stay home if they are 

sick. The airports are a particularly important area because that 

is where you have people who may be ill traveling across the country and spreading this. 

Is this part of your plan to also include that as a location for 

other public information posters perhaps at airports? And added to 

that, anything you are advising airlines with regard to if they see 

passengers come to the airport that appear to be sick? 

Ms. SCHUCHAT. Yes, we have been issuing both guidance as well 

as developing materials. We have also started to hand out the yellow card, the travel health alert notices, at airports and other ports 

for people who are traveling to know what signs to look for and 

what to do if they do become ill. And we are certainly—we actually 

just recently issued guidance for airline crews if they were caring 

for someone who was ill, what are the steps they need to take. And 

we will continue to update those kind of guidances. 

Mr. MURPHY of Pennsylvania. Will this include information that 

airport security or airline workers, if they see someone who appears to be ill before they get on the plane, perhaps tell them not 

to fly? 

Ms. SCHUCHAT. Yeah. That is right. We actually do already have 

quite a bit of intervention in terms of education for the travel 

worker, the customs and border protection personnel, as well as a 

good relationship with the airline industry. We have developed a 

greater collaboration during the SARS problem to really be able to 

make sure people working in that profession could recognize the 

issues and address them. 

Mr. MURPHY of Pennsylvania. And one other thing, and open up 

to other comments as well, certainly we are aware of those things 

that our parents taught us: You cover your mouth if you sneeze; 

if you are sick you stay home; you wash your hands. I see you have 

your little bottle there. You have been using that very effectively, 

Doctor. 

But are there things that you advise people not to do? For example, should people go out and get Tamiflu and just start taking it? 

Should people start taking antibiotics if they have some in their 

medicine cabinet? What kind of things are not a good idea for people to do? I wonder if you could comment on that. 

Ms. SCHUCHAT. At this point we are recommending that drugs 

like Tamiflu, which is an anti-flu viral—or antiviral drug against 

the flu, or antibiotics against bacterial infections, be taken under 

a doctor’s advice. 

Mr. MURPHY of Pennsylvania. Are antibiotics useful at all with 

the flu? 

Ms. SCHUCHAT. Influenza is a viral infection and antibiotics treat 

bacterial infections. Some people suffering influenza can later develop a secondary or late-onset pneumonia caused by a bacteria. So 

there are circumstances laid on following influenza where antibiotic 

treatment might be necessary, but this would all be under a doctor’s advice. 

Mr. MURPHY of Pennsylvania. Again I am asking the panel this. 

Some people may call their doctor now and say, can you give me 


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a prescription for antibiotics? I have got some in the medicine cabinet when I was sick last year, should I start taking them? What 

would you all advise? 

Mr. VANDERWAGEN. We would advise people not to self-medicate; 

that they should seek consultation with their physician before they 

take any medical intervention. And we are advising them that this 

is a doctor-patient relationship that has to be worked through, 

rather than just arbitrarily deciding to medicate yourself. 

Mr. MURPHY of Pennsylvania. Do you agree with that, too, Doctor? 

Mr. SHARFSTEIN. Yes. 

Mr. MURPHY of Pennsylvania. I appreciate that it is important 

that—I don’t want people to take this too lightly nor too seriously, 

as we had the SARS issue, as we had the avian influenza issue. 

These are good important issues that people need to be addressing, 

and I do appreciate the important medical comments and information we would be sending out to Americans. Thank you so much. 

Mr. SHARFSTEIN. I would just add that people can contact their 

local health departments also to understand what things may be 

accessible. 

Mrs. CHRISTENSEN. [presiding] Thank you. The Chair now recognizes Congressman Green for 5 minutes. 

Mr. GREEN. Thank you, Madam Chairman. And again, I want to 

thank you. I have a district in Houston, a very urban district, and 

people go back and forth to Mexico literally every day. But I appreciate the measured response, but also the planning, because our 

Governor just announced a disaster declaration because of the 

issues. 

We have two schools now, public schools, Hamilton Middle School 

and Harvard Elementary School. Because of a child, they have shut 

down the schools. So they are being very cautious. And that is the 

encouraging—all of our directors are planning to do that, I think. 

One of the concerns I have is that because of the experience a 

few years ago when we didn’t have the development of the regular 

flu vaccine—and I think Congressman Deal may have mentioned it. 

You are not recommending slowing the production of the flu vaccine that we know we typically would be receiving in the fall. This 

would be a separate injection, if we get to that point? 

Mr. SHARFSTEIN. Right now there is no recommendation to slow 

the production. However, as we understand more about the virus, 

the threat of the new virus, that could potentially change, but it 

will be a decision that is made with a lot of external input from 

a lot of very smart people thinking about what the best balance is 

going to be. 

Mr. GREEN. I know HHS is releasing 25 percent of the strategic 

reserve of the 50 million treatment course of antiviral drugs, 

Tamiflu and Relenza, in the strategic national stockpile. It is my 

understanding these will be available to all States, prioritizing distributions to the affected States; is that correct? 

Ms. SCHUCHAT. Yes, that is right. We have released 11 million 

of the 44 million doses that were designated for the State or project 

areas, and all of the States will be receiving those. Already 11 have 

either received or are en route, I think. 


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Mr. GREEN. I guess my concern is that in Texas we are seeing 

actually pharmacies who are running out because of prescriptions. 

And I am glad that is happening. 

Mr. VANDERWAGEN. Recall that the principles under which we established that stockpile was a partnership with States and that the 

goal was for we in the States to be able to cover 25 percent of the 

population for treatment of active disease. That was the principles 

under which that acquisition was really driven. And most of the 

States bought their share. There are a half dozen States or so that 

did not. But we are still providing a pro rata share to all the States 

in that event. But it is about treatment for people who are sick. 

Mr. GREEN. Okay. I know Texas has 840,000, 7-day course of 

antiviral medication, and I heard we qualify for an additional 

650,000. Is that generally correct? Do you know on a State-by-State 

basis? 

Ms. SCHUCHAT. I guess actually I want to correct what I said. 

What I know is that we have completed the shipments to nine 

States and six of the States completed receipts of shipments in the 

last 24 hours, but we are continuing to work through the listing. 

So I don’t know the doses. 

Mr. GREEN. Okay. If you could get that information back to our 

office. I know Congressman Gonzalez from San Antonio would 

share the same concern, my colleagues on the Republican side. 

Mr. SHARFSTEIN. There is one thing I want to mention, to be 

clear. You said some pharmacies were having shortages. And the 

medicine going into the States is going through the public health 

side, not directly to the pharmacies, and it will be up to the local 

and State public health plans how that medicine gets distributed. 

Mr. GREEN. Well, I guess—I have a daughter who is an infectious disease fellow at the University of Texas medical branch, and 

she told me Galveston—which is not our district—all the pharmacies in Galveston County were out of the prescriptions. But I 

don’t know about in Harris County, which is Houston, where Galveston is separate. 

What role should the State play in the distribution of these 

drugs? It is going through the public health like we have and that 

is where I am getting my information, is from the State Health 

Commission. 

Ms. SCHUCHAT. Each of the States has a plan for how they are 

going to do their distribution. So we look to them to let local folks 

know how it is going to work. But that has been part of the States’ 

pandemic efforts. 

Mr. GREEN. In my last 49 seconds, I know the answer to the 

question on the H1N1 vaccine and how quickly we can get a development is a couple of months. Two months seems a fairly short 

time frame for a vaccine to both be tested and it is safe for individuals, whereas Tamiflu was recently labeled to show adverse psychological effects. What precautions is the FDA taking to monitor 

adverse effects from this new vaccine that we are developing now? 

Mr. SHARFSTEIN. Just on Tamiflu, there is a team that is looking 

specifically at Tamiflu adverse effects. For the flu vaccine, it depends if it is—you know, from the manufacturing standpoint, there 

is a chance that this will just be produced according to the regular 

manufacturing approach; in which case, you know, every year it 


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has to be done pretty quickly because every year the flu vaccine is 

different. If a different approach has to be taken, that will raise different types of oversight issues. But in all those things, assuring 

that the risks are outweighed by the benefits and that we think it 

is a safe vaccine is really the point of our involvement. 

Mr. GREEN. Okay. Thank you, Madam Chair. 

Mrs. CHRISTENSEN. Thank you. Mrs. Blackburn of Tennessee is 

recognized for questions. 

Mrs. BLACKBURN. I want to again thank you all for your patience 

for being with us yesterday, Dr. Schuchat, and then for you all 

being here this morning to help answer these questions. We are 

concerned. 

In my district in Tennessee we now have a Williamson County 

case and a Shelby County case. So as you can imagine, as this 

started to make its way into the news last evening and this morning, I am hearing from parents and from constituents and medical 

care providers and health care providers with some questions. And 

one of the questions that has been asked of me—and if you can provide some guidance on how best to answer this, I think it would 

be helpful. 

The way the process, the way we understand the process, when 

a doctor takes a culture, that goes to a State lab. When a State lab 

suspects that this culture has either the H1 or the N1 and they decide that there is probable cause that it could be the H1N1 strand, 

then it comes to the CDC for confirmation. 

Then my question is: Number one, how many of those cultures 

do you have waiting for confirmation? And number two, once that 

culture makes it to you, how long does it take for you to provide 

that confirmation? 

Ms. SCHUCHAT. Part of our planning has to be make sure that 

we have adequate staff day and night for something like this. And 

the laboratory staff in the influenza division have been doing—we 

have had shifts throughout the night, throughout the weekend. But 

we have also taken steps to increase the capacity at the State public health labs with these kits that were recently approved for shipment and started to be shipped on Monday. It was incredibly quick, 

so that more and more State and local areas will be able to do that, 

confirmatory testing on site. 

We are not working with a backlog. We are really working 

around the clock to make sure that information that is so critical 

for local decision-making is available. We have made many contingency plans for the surge idea so that the State and locals have 

some capacity through the public health laboratory network. And 

also we have got some agreements with commercial labs to help 

with surge of specimens for sort of—— 

Mrs. BLACKBURN. Is it fair to say you all turned this around in 

a day, or a matter of hours? What is the time frame there? 

Ms. SCHUCHAT. There are several steps. You know, a doctor will 

take a test and make it a positive rapid result or make it a suspicious result; forward that onto the State or local laboratory where 

the strain needs to grow and additional things happen, although 

now they have these PCR tests that are more rapid. At that result, 

things get sent to us. 


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Sometimes the shipping is even one of the longer steps, although 

we have been really expediting that, and then it is several hours 

upon receipt in the CDC lab before results would be available. 

Things may change over the days ahead as increasing numbers of 

cases are detected, and we really need to make some triage decisions. But at this point, with new States wondering do we have 

this or not, we are really prioritizing that kind of question that is 

going to make a difference for a school district, for instance. 

Mrs. BLACKBURN. Dr. Sharfstein. 

Mr. SHARFSTEIN. Just to follow, CDC just did an unbelievable job 

basically inventing a lab test for this, that could be shared with the 

States within a couple of days, and FDA worked with them so that 

all the instructions were there, all the quality assurance procedures are there. And now the State public health lab network, 

which was sort of created to be ready for exactly this, they have 

the kit. So for somebody in your county, really it should go to—to 

the State lab and they are the ones making the diagnosis. Those 

samples shouldn’t even have to go to CDC anymore. And that was 

all done so quickly to be able to give them that capacity. 

Mrs. BLACKBURN. That is great. So individuals should know 

within a day, 2 days? What would be the answer? 

Mr. SHARFSTEIN. That is probably going to depend on the policies 

of the State. But the test itself doesn’t take more than a few hours. 

It is a question of how they are handling the— 

Mrs. BLACKBURN. And you have both the public labs and the private labs involved in this process? 

Ms. SCHUCHAT. It wouldn’t be the hospital labs. The public State 

labs or some of the bigger city labs are part of this public lab network. There are a couple of commercial laboratories that aren’t 

doing that special testing, but they are ready for surge of the original testing. 

Mrs. BLACKBURN. I have got one other question and we may not 

have time for you to answer it. But we have had questions from 

several people. This is not flu season in the U.S., and this seems 

to be a very strong strand; and as we move into the warmer 

months, it may naturally dissipate. But your expectation for when 

we move into flu season in November, how do we best prepare for 

a resurgence? Do you think it will come back? Will we have a vaccine by that time? What is the preparation strategy for next year’s 

flu season? 

Ms. SCHUCHAT. These are really important issues. We are mindful that things may look like they are getting better, but we might 

have a resurgence in the fall. There are many steps being taken 

to anticipate that, and part of the efforts of evaluating production 

of a vaccine is with that in mind. Also looking to the southern 

hemisphere for what happens there, because they typically have a 

reverse season from us, and then also understanding the evolution 

of the virus during the next bit of time. 

While flu season is pretty much over in most communities here 

in the U.S., it is not completely over everywhere. But you are right 

that we usually don’t see cases in the summer, except in people 

coming back from the southern hemisphere, and then we will be 

mindful in the fall. 


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Mr. SHARFSTEIN. I would say we would like to have a vaccine as 

soon as we can get one, and even if it—let us say you have a vaccine and it doesn’t come back in the fall, that is okay. We don’t 

want to be in a situation where you have a serious problem and 

you have stopped making the vaccine for some reason. So the plan 

is to prepare for the worst. 

Mrs. BLACKBURN. Thank you so much. Thank you, Madam 

Chairman. 

Ms. CHRISTENSEN. Thank you. The Chair now recognizes the vice 

chair of the full committee, Ms. DeGette, for questions. 

Ms. DEGETTE. Thank you, Madam Chair. I want to congratulate 

all of you and your agencies for the aggressive efforts and smooth 

preparations you are taking here. I have been on this committee 

now for 12 years and remember quite well the hearings that we 

had in 1993, 1994 and 1995. In fact, I have been urging our leadership to have additional hearings so that we can see the progress. 

And I am gratified to hear that we have made progress. 

I do have a few questions, though, about what will happen. My 

first question is: Do we have a sense of what the incubation period 

of this virus is? 

Ms. SCHUCHAT. We are looking at these new cases and the numbers change day to day. Recently, I would say conservatively, 2 to 

5 days or maybe 1 to 5 days. The idea is that it is a relatively rapid 

transmission from one person to another. 

Ms. DEGETTE. One thing I think is that—you know, I have a 

high school freshman in Denver, and I think at high schools and 

colleges all around the country, many of the students are concerned 

that if they or someone they knew went to Mexico some weeks ago, 

that that could still be incubating. I think that is important to say. 

Although, of course, it can be transmitted from person to person 

here. 

My second question is: I am concerned about the fact that while 

we have come a long way over the last few years, as Dr. Sharfstein 

was describing about developing the egg-based vaccines, I am concerned that we still have not been able to move to a cell-based production. And I am wondering if you can talk about what the status 

is of development of a cell-based vaccine? 

Mr. SHARFSTEIN. Sure. There has been a tremendous investment 

in cell-based technology, so that was done in parallel with getting 

the eggs up to—capacity up so that the seasonal—so that the eggbased vaccine could be produced relatively quickly. There are companies that make cell-based vaccines and FDA is working very 

closely with them. 

Ms. DEGETTE. Are you working closely with them to develop cellbased vaccines around this new H1N1 virus? 

Mr. SHARFSTEIN. Yes, in the sense that we are discussing that 

with them. But I think the sense that I am getting is because we 

have a licensed process for the egg vaccine and because we have 

the eggs, that we have a terrific potential capacity to make plenty 

of vaccine with the traditional approach, rather than have to—and 

that would be our preference, because we know all the steps in the 

process. 

Ms. DEGETTE. Except for the fact, Doctor, that if it truly does 

turn into a pandemic, then having 160 million doses by next JanuVerDate Mar 15 2010 04:00 Apr 26, 2012 Jkt 072882 PO 00000 Frm 00071 Fmt 6633 Sfmt 6633 E:\HR\OC\A882.XXX A882

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ary, or whenever, is not going to be sufficient even for the U.S. population, much less around the world. And so it is great in the short 

term, but ultimately we are going to need to move to that cellbased vaccine? 

Mr. SHARFSTEIN. Your point is very well taken. I think a couple 

of things to say, that is why we are having the conversations with 

them, and that is the future and that is why there is such an investment. 

Ms. DEGETTE. But it is not going to be the future for this particular strain, correct? 

Mr. SHARFSTEIN. I don’t want to rule that out. That is under discussion. What I have heard from the vaccine team is that they believe there is a tremendous potential. And it is probably—the potential is larger 160 million doses. That 160 million doses are trivalent vaccine, meaning that three strains—so it is actually probably somewhere around triple that. Plus— 

Ms. DEGETTE. But efforts are being made to move to the cell vaccine, even with this— 

Mr. SHARFSTEIN. Right. 

Ms. DEGETTE. My next question is: Is there some potential that 

this virus could mutate in the summer months, between now and 

the fall, when we think we might see a resurgence? Dr. Schuchat. 

Ms. SCHUCHAT. Yes, that is possible. And that is why we will be 

continuing to look at it. Just to clarify, the planning assumptions 

were to have capacity to be able to produce enough vaccine for 300 

million people, assuming two doses. And there are lots of things to 

be sorted out about how much quantity we are going to need that 

will influence what the real capacity is. 

Ms. DEGETTE. Right. But, again, I am concerned because if, with 

this old egg-based technology—like I say, I think we have come a 

long way. I am not trying to be critical. But heaven forbid, the 

virus mutates between now and the fall, then we have to develop 

a new vaccine and keep with the egg-based technology. We may not 

have a vaccine developed until next spring, and I think that is worrisome to all of us. Dr. Vanderwagen. 

Mr. VANDERWAGEN. Let me add one or two things to what Dr. 

Sharfstein has offered you. We think 600 million doses is achievable in a 6-month time frame. We think that is achievable both in 

egg-based, with some cell-based augmentation. Part of Congress’ 

investment, all the money that was talked about in flu investments, 1.3 billion went to the development of cell-based cultures. 

We have two large plants that are in very late stage of construction. They are close to inspection. And we have made significant 

progress with them. Will they be ready by January? I don’t know 

that they will exactly be ready by January, but we know from the 

existing infrastructure we could probably generate a monovalent— 

600 million doses in a 6-month time frame. 

Ms. DEGETTE. Thank you. Mr. Chairman, I would hope these 

witnesses and their agencies would continue to keep this committee 

apprised of their development of the cell-based vaccines and their 

development of the doses as we move forward in the coming 

months. 

Mr. PALLONE. [presiding] I would appreciate that and I am sure 

they will. 


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Ms. DEGETTE. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you. Our vice chair, Mrs. Capps. 

Mrs. CAPPS. Thank you, Mr. Chairman. And thanks to each of 

you. You have been spending a lot of time in the last couple of days 

here on Capitol Hill, and it is very valuable for us to have your expertise and to be kept abreast of what is going on. 

A different set of questions from me, please. The recommendation 

for people—and I will address this to you, Dr. Vanderwagen. All of 

you have comment—but I want to just sort of go from topic to topic. 

I have three. The recommendation is if you have the symptoms, 

call your health provider. Forty-seven million Americans don’t have 

regular access to health care. It seems likely that if this progresses 

and becomes worse, emergency rooms and hospitals, other public 

places, are going to be on the frontline of receiving all of these patients, because they would be the first place and the only place 

many people could turn. 

Our emergency rooms are already overflowing and it is clear that 

responding to a pandemic would be more than they could handle 

under existing circumstances. Our goal now, simultaneously, is to 

work toward providing health care for all Americans, access to 

health care. 

In the meantime, I want a comment from you on what kind of 

emergency coverage—do you recommend a particular plan that we 

could speedily enact to provide coverage in this case of an emergency? 

Mr. VANDERWAGEN. Well, ma’am, I really appreciate your linkage 

between preparedness and health security and health reform, because I think they intertwine in a way that people don’t always realize, and I appreciate that. Medical surge is a function of people, 

facilities, supplies, equipment and systems. And what we have seen 

with investments that Congress has appropriated to us in hospital 

preparedness is the emergence of systems that rely on the fact that 

no one place is going to be able to manage the flow. 

So how do we work collectively to share that flow in a way that 

takes the burden off? We have seen extraordinarily good examples 

of this in a wide variety of states: Illinois, Minnesota, North Carolina, et cetera. These are best practices that have been put in place, 

that these States have already done a significant job of analyzing 

people, equipment, facilities. Those are the kind of best practices 

we would extend to communities that are still trying to find the answer to that problem. The emergency assistance impacts between 

States also offers us ways for hospital care, not so much emergency 

department evaluation, but for hospital care. There are good models out there and best practices that we can share with communities. 

Mrs. CAPPS. Thank you. And, Mr. Chairman, I would hope that 

we could keep this discussion going as the days go, in case there 

is a way that we should be responsive to you as well. 

Now, another challenge, Dr. Schuchat, for the provider in the 

household. You are calling on people to stay home if they are ill 

to prevent the spread of the H1N1 flu. But millions of people work 

every day but don’t have any sick leave, don’t have any time that 

they can take; and with this economic uncertainty, they are very 

reluctant to stay home from work, and to work with symptoms and 


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have to send their kids to school because there is no one to stay 

at home. This is going to be difficult to contain the flu. 

We do have legislation in the works. Senator Kennedy and Congresswoman DeLauro are planning to reintroduce the Healthy 

Families Act. I am cosponsoring it. And that would guarantee 7 

sick days a year. 

First of all, you could help us with support of that kind of legislation for the next event, and maybe if you have any thoughts of 

what you or we could do together to respond to this crisis. 

Ms. SCHUCHAT. Just a few comments. Health in the workplace 

and health in the family is very important. It is a central component of public health. And we did see during the SARS epidemic 

that in Canada some of the hospitals were really taxed trying to 

figure out how to make sure that health care workers, including 

contract employees would stay home, whether furloughs needed to 

be used. And it was a very difficult circumstance to make sure that 

health was taking a front seat and that the rules could be worked 

out. So we would just be supportive in making sure that health is 

addressed. 

Mrs. CAPPS. Thank you. I have one final question and there is 

not a lot of time for it, and maybe some ongoing conversation about 

this. It is to any of you, because workforce shortages are something 

that you are experiencing in every one of your agencies and all of 

our local and State public health facilities. Eleven thousand public 

health workers are due to be laid off because of State budget cuts, 

attrition over the past year. This is exactly who you are depending 

on, even as we speak for solutions. Do you recommend any suggestions for us to help you do this or to recruit more or to implement 

anything? 

Mr. SHARFSTEIN. A month ago I was the local health officer in 

Baltimore, Maryland, working with Congressman Sarbanes and 

others. And I think your point is very well taken that a lot of the 

things that are being planned at the Federal level really depend on 

the State and local public health authorities to implement. The 

emergency use authorizations that we granted have a very clear 

role for State and locals and how they hand out medicines that 

may be important to people. Eventually if there is a vaccine that 

will be delivered through the public health infrastructure, and ensuring that that infrastructure is strong is extremely important, 

and I know it is very important to the administration. 

Mrs. CAPPS. My time is up, but there is more to talk about. 

Thank you very much, Mr. Chairman. 

Mr. PALLONE. Thank you. Mr. Blunt. 

Mr. BLUNT. Thank you, Mr. Chairman. I have a couple of questions here. One, I got an e-mail from my daughter late last night 

who lives in Kansas City and it involves her, but even more importantly—just as importantly, involves my grandchild. I guess I 

ought to think about how I say that. And the e-mail from her is 

a confirmed case of swine flu in Kansas City. On a scale of 1 to 

10, how concerned should we be? Anybody want to give an answer 

to that? 

Ms. SCHUCHAT. People like your daughter are concerned and so 

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gressive steps to address the challenges and we do feel that we 

have been exercising and planning for this kind of circumstance. 

There are lots of things everybody can do in the community and 

the family, as well as in schools and workplaces. So I think that 

this is a serious situation and we all really need to get ready for 

some uncertainty, to stay aware. It is great that your daughter 

knows exactly what is going on where she is and that guidance 

from the local and State authorities will probably help her understand what is going on there and what the next steps are if your 

grandchildren’s school is closed, for instance, or really what are the 

plans. 

Mr. BLUNT. It is called swine flu, but is there any concern about 

the food supply at all? I think it is important to clarify that, and 

you may have already. But if you wouldn’t mind repeating that for 

me. 

Ms. SCHUCHAT. Sure. There is no evidence that swine in the 

United States have this new virus. There is no evidence that eating 

pork or pork products gives you this infection. The USDA is aggressively looking at the issue both here and working with Mexico as 

well. And I would say that we don’t have any reason to believe that 

eating pork gives you this particular infection. 

Mr. BLUNT. We have no reason to believe we have any problem 

in any part of the U.S. food supply? 

Ms. SCHUCHAT. No. This isn’t an infection that we think is foodborne. 

Mr. VANDERWAGEN. Our veterinarian colleagues over at Agriculture call this human flu, because it doesn’t occur—they don’t see 

it in pigs, so they are calling it human flu. 

Mr. BLUNT. I think that is a good thing to understand because 

there is some reaction at the grocery store to what they think. 

The other question I would have: On Amy Blunt’s scale of 1 to 

10, assuming 10 is the most concerned, it seemed to me that the 

Vice President was there this morning at the 10 level when he said 

he would advise people not to get on planes, his own family, or 

even on subways. I am sure that is not the official position of the 

government. 

Would somebody reiterate what must be, for a repetitive response, the official position of the government on that topic? 

Ms. SCHUCHAT. We have advised people to defer non-essential 

travel to Mexico. We have advised people who are ill with respiratory symptoms and fever not to go to work or school or not to 

get on an airplane or public transport. But we do not have recommendations to stay away from those transport methods if you 

don’t have respiratory symptoms, and I am looking forward to getting on an airplane later today to go back to Atlanta. 

Mr. BLUNT. Well, most of us will get on airplanes later today, 

too, to go back to Atlanta or Missouri, as I will—or other places— 

and I would hope that the commerce and the travel of the country 

don’t shut down based on advice from the government. I yield back, 

Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Blunt. Mr. Weiner. 

Mr. WEINER. Thank you, Mr. Chairman. Let me just pick up on 

that a little bit. You know, I think you will forgive our constituents 

for being a little whip-sawed by the news and images that they get. 


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And I represent the district that has half of all of the confirmed 

cases in the country. And, you know, to watch some to the imagery 

on television, to listen to even official channels. To listen to the 

head of the health policy at the European Commission, in theory 

someone who is supposed to be pretty level-headed say it is not a 

question of whether people die, but more a question of how many. 

Will it be hundreds or thousands or tens of thousands? You will 

forgive some of my constituents for wanting to get into the fetal position and bathe in Purel after hearing things like that. 

And let me say that it is in contrast to the way you all have presented yourselves. So, too, the health officials in New York City 

who may have made a more sober assessment. But just to put a 

finer point on the question Mr. Blunt asked, focusing on subways. 

Just to instruct New Yorkers to avoid the subways is to in many 

cases to instruct them not to make a living, not to travel around 

their hometown. It is the very way that we communicate with one 

another and the way we get to and from. 

If you are not one of the 96 confirmed cases, if you don’t feel like 

you have got the flu, can you just say with clarity about subways, 

it is safe to get on a subway? We would encourage you to get on 

a subway, and if there was a subway to Atlanta, you would take 

it? 

Ms. SCHUCHAT. The only people we are saying should avoid 

crowded circumstances or airplanes, for instance, are people with 

fever and respiratory symptoms. We also think it is important for 

local authorities to be giving the guidance for the community. They 

understand the way the—the ground truth. And we know that the 

New York City Health Department is fantastic it is and really is 

providing good guidance. 

Mr. WEINER. Can I ask you, how good a job did the Mexicans do 

on letting you know what was going on? There was a report in today’s Washington Post that lays out the tick-tock of notification 

that seems clear that the 24-hour rule was violated by a magnitude 

of a couple of weeks. Apparently, our Department of Health and 

Human Services, which oversees the CDC, found out about the 

Mexican outbreak about the same time the rest of us did, on the 

television on the 24th. 

It strikes me that that window of time is valuable and it strikes 

me that in fact it could have helped—well, maybe prevented some 

or at least gotten us a couple of weeks or a few days at least jump 

on this. How would you grade the Mexican response up to now? 

Ms. SCHUCHAT. The Mexican community and government are 

coping with a very difficult circumstance right now. And the focus 

of our attention is providing technical support to help them respond to the situation. I can say that I don’t have all the information—I don’t think anyone does yet— about all the circumstances 

leading up to where we are. But it is important to note that increases in respiratory illness happen quite frequently, and they can 

have lots of different explanations. 

And as I understand it, the original increases that they were seeing were believed to be due to regular influenza. Most respiratory 

infections don’t actually get a specific diagnosis, and we see lots of 

changes in the numbers that don’t pan out to be anything quite serious. 


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Here in the U.S., because of our investments, we promptly recognized these very unusual strains of influenza and issued an 

MMWR dispatch after the first two that we had seen. But I think 

the circumstances in Mexico right now, the focus really needs to be 

on helping with the response. 

Mr. WEINER. Could I say, you know, it is—traditionally the influenza outbreak happens in cold weather. And I know there is some 

disagreement on why exactly that is. Maybe we are all together 

much more. 

Are we rooting for a particularly hot stretch here? Would that 

help us? Should we be trying to be outdoors more? Is the coming 

summer months, is it helpful to us? Is it not clear that it is helpful? 

If there is a high pollen count, does that mean perhaps we should 

be more careful? Are there any weather-related indicators, since 

this is kind of a counterintuitive strain, it is hitting younger people 

more. Are there things about it that we have learned so far that 

give us an indication that the weather might be on our side here? 

Ms. SCHUCHAT. We think from the past and from seasonal flu, 

that we don’t see much influenza in the summer months, and so 

we hope that will be the case. But every influenza expert that I 

hear from really cautions me in anything I say to remind people 

how unpredictable influenza can be, and especially a new strain. So 

we do optimistically hope that things will get better because of the 

season. But we need to be attentive for the fall afterwards. 

Mr. WEINER. Thank you. Thank you, Mr. Chairman. 

Mr. SHARFSTEIN. I would just say, if we can get time, that really 

helps with the vaccine production. And the point about how each 

virus is different is extremely important about vaccine production. 

And I think just to clarify, I think the idea that a certain amount 

of vaccine will be ready in a certain amount of time—those predictions really can’t be made now until we understand more about 

this particular vaccine, this virus. 

Mr. PALLONE. Thank you. Next is the gentleman from Maryland, 

Mr. Sarbanes. 

Mr. SARBANES. Thank you, Mr. Chairman. First I want to say 

how impressed I am with the response that you and your staff have 

made to this situation. There has been a calmness and professionalism to it that I think is having the desired and appropriate 

effect on the public, and I know that will continue. So thank you 

for that. 

I also want to echo those who are welcoming Dr. Sharfstein to 

his new position. As he indicated, we have worked together closely 

in Baltimore. We suffered a great loss that he is now here, but the 

country is certainly gaining by his appointment. 

Dr. Schuchat, you mentioned—and I was intrigued by this—that 

the number of cases is not something you are so much interested 

in as the patterns that you see emerging. And I wondered if you 

could describe a little bit more what you mean by that? What are 

the patterns that you are looking for and what do those patterns 

tell you about the progress of this disease? 

Ms. SCHUCHAT. We are working closely with some of the State 

and local health—public health officials who are on the frontline of 

responding to this, to really understand the epidemiology: who is 

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ness; how does it look like the infection is spreading; and how 

transmissible is it? So those are things we are evaluating in some 

of the on-the-ground circumstances in the U.S. as well as with our 

Mexican and Canadian partners. 

Those types of investigations can help us understand what kinds 

of interventions will be most effective. We would love those investigations to show us that disease is becoming milder. But we need 

to be ready for the idea that the disease is becoming more severe. 

So rather than focus too much on individual numbers, we know 

that numbers are going to be varying, that information is in flux, 

that we have just decided at the CDC, once a day we will update 

the numbers, and we are really focusing on the actions and activities. So the patterns are really at an early phase, understanding 

which populations are at the greatest risk, how transmissible is the 

virus and then the severity. 

Mr. SARBANES. Is it a combination of the patterns and numbers 

that would also advise as to when a community ought to be taking 

a particular action, shutting the schools in a community and so 

forth? 

Ms. SCHUCHAT. That is right. We have guidance about when 

there is illness—a confirmed illness in a school, that we recommend that that school be closed temporarily while things are 

being reevaluated. But there could be triggers that would prompt 

a more aggressive approach beyond that. There are other community interventions, such as eliminating mass gatherings or really 

implementing social distancing, asking people to work from home 

and to really avoid crowds. 

I was in Beijing during the SARS epidemic and they intensively 

instituted those, and they really helped. But that was a very different circumstance. So I think the pattern will tell us whether 

more aggressive measures are needed. We are really trying to 

strike a balance in making sure the interventions are not worse 

than the virus, because there is a balance in all of these interventions. 

Mr. SARBANES. Let me ask you a different question. There has 

been a lot of discussion and focus on sort of tracing back this virus 

to a specific geographic origin. Is that the right perspective to 

have? I mean, is it the case that this disease will be appearing, as 

it were, spontaneously in a lot—in a number of different locations, 

or does it make—because when I hear people discuss they found 

new cases, and the next question always is, did you have contact 

with somebody who recently traveled to—but that can’t be the only 

intention of the inquiry, right? 

Ms. SCHUCHAT. Yes. That is right. I think in the initial day, 

there was an intense focus on contact with animals and then a little bit after, contact with Mexico. We are at a different point where 

there are lots of exposures that are being looked at. And, really, the 

intense look for cases is so that interventions around those cases, 

and where they work or at school, can be imposed. 

So for those other sectors that are focusing on tracing back and 

where did this all start, that can be important information for future planning. But I think the public health community here in the 

United States is really focusing on what we can do to reduce illness 

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ventions like vaccine, should we go that route. And, really, the 

focus of our goal is to reduce illness and slow transmission, not to 

find the source. 

Mr. SARBANES. Mr. Chairman, can I ask Dr. Sharfstein? It will 

be a 15-second question. 

Mr. PALLONE. Sure. 

Mr. SARBANES. I appreciate it. My understanding is that the flu 

strains we experienced this past winter did not respond particularly well to Tamiflu; is that correct? 

Mr. SHARFSTEIN. Yes. 

Mr. SARBANES. But that we are seeing at least initially this 

strain is responding. So I guess that is a lucky thing in a sense, 

right? Because it could very well be that this strain also would not 

be responding, and so I am just putting that in the happy coincidence category. Is that fair to do? 

Mr. SHARFSTEIN. Yes. But there are always a few qualifiers. We 

know, I think, looking at it genetically and in the lab, that it looks 

like there is activity against the virus. That doesn’t necessarily 

mean that every patient, as soon as they get it, gets better. In fact, 

it is more effective the earlier you get it in treatment. In people 

who are quite ill it can set up all sorts of problems in their body 

that even getting rid of the virus can’t help anymore. So there is 

a qualifier there. 

The other qualifier is that it is possible that a resistance may 

emerge, and that is something I know the CDC is very interested 

in, is watching very closely. That could have recommendations for 

treatment that could change, could change recommendations for 

treatment. So we are starting off with some—a little bit of good 

news there. But it is going to depend on how this whole thing 

unfolds. 

Mr. SARBANES. Thank you. Thank you. 

Mr. PALLONE. Thank you. The gentleman from Iowa, Mr. Braley. 

Mr. BRALEY. Thank you, Mr. Chairman. I want to thank all the 

witnesses for being here. But, Dr. Schuchat, I want to start with 

you and follow up on your answer to Mr. Blunt’s question about the 

reality of this virus and its impact on our food supply. You said 

there is no evidence that swine in the United States have this 

virus, which is a standard answer on the CDC Web site in response 

to concerns about food safety issues. And if you go to the CDC Web 

site there is a specific question: Can people catch swine flu from 

eating pork? And the answer says there is no evidence that swine 

influenza can be transmitted through food. And yet your Web site 

is the Web site of all of the organizations here, including the WHO, 

that continues to identify this as swine flu. And on the Web site, 

it also makes reference to the fact that this is a new strain of flu 

that consists of a mixture of genetic material from swine, avian 

and human influenza virus. 

I come from a State that is a leading pork producer in this country and in the world, and this outcry over the alleged connection 

between food safety and this virus is having an enormous economic 

impact on pork producers in Iowa, North Carolina, and all over this 

country. 

So is there a plan to change the Web site and refer to this by 

its appropriate scientific name, Influenza A, substrain H1N1? 


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Ms. SCHUCHAT. Our new information will have the new terminology. Our communication teams are focusing on critical information for health care providers, for families and so forth. So we do 

intend to make sure that the many, many thousands of Web site 

pages that we have already put up in the past week become 

amended. But the critical focus of the people in place right now is 

developing the new information that people need. 

We understand the concerns and are very mindful in our communication going forward, and really need to—people are working 24 

hours a day. There are communication experts in there. It is really—I mean, I don’t want to be impolite, but I just want to say that 

our priorities are the public health information being out there 

quickly and accurately. And going forward, we will do the best that 

we can. 

Mr. BRALEY. I appreciate that. No one appreciates that more 

than I do. But I am also concerned, because I was at the congressional briefing yesterday, and when you go to the CDC’s Web site, 

what you find is a page, the first page, that says swine influenza. 

And on that page, there are probably at least 10 references to 

swine influenza. And when your agency is one of the most critical 

public information dispensers in the Federal Government, it feeds 

this misperception if you don’t address this issue immediately. 

And my point is that these other agencies are not using that terminology, and it is for a reason. So I would just encourage you, 

knowing that you are not in charge of the communications division 

at CDC, to emphasize to them the importance of making that 

change as quickly as possible. Would you agree to do that? 

Ms. SCHUCHAT. We will do the best that we can. 

Mr. BRALEY. Now, one of the other concerns I have is the impact 

on workplace safety, because one of the things that OSHA has done 

is prepared a handbook guidance on preparing workplaces for an 

influenza pandemic. 

Have any of the three of you had an opportunity to review that 

pamphlet to determine whether it consists of the most up-to-date 

information to help prepare workplace environments to deal with 

the potential influenza pandemic? Dr. Sharfstein. 

Dr. SHARFSTEIN. I haven’t personally looked at it, but we have 

an employee health part of our team on personal protective equipment, and I know they have been talking to OSHA. The FDA part 

that oversees devices because that is really what it is, the mask 

and that kind of thing, relates directly to OSHA and I know that 

our team and OSHA have been talking about the different authorizations that the FDA has made, how that intersects with what 

OSHA needs to do to protect workers. 

Mr. VANDERWAGEN. Mr. Braley, I think most of the elements of 

HHS have worked closely with OSHA. Most specifically NIOSH, 

the National Institutes of Occupational Safety and Health, which 

is part of the CDC, has been working extremely closely with OSHA 

to assure that we are aligning any health guidance that we are 

bringing forward out of our department and gets accounted for in 

their documents. We have worked very closely on with them on 

masks. We have worked very closely with them on a variety of 

things over the last 2 or 3 years. 


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So I tell you we are lashed up pretty good with the OSHA folks 

vis-a-vis assuring that we have a common message and a common 

set of principles. 

Mr. BRALEY. Thank you. 

Mr. PALLONE. Thank you. Next is the gentlewoman from Wisconsin, Ms. Baldwin. 

Ms. BALDWIN. Thank you, Mr. Chairman. Thank you to our panel 

of witnesses today. I want to join in the sentiments that have been 

expressed by some of my colleagues about the very good job that 

has been done identifying and tracking this outbreak and the communications to the Congress as we are trying to learn more and 

work hand in hand with you in your mission. I think an outbreak 

like this exposes the strengths and weaknesses in our public health 

system. 

Dr. Vanderwagen, you talked about the system as sort of people, 

supplies, equipment, facilities, and systems, and I have been working with a number of my colleagues on both sides of the aisle on 

trying to address our public health system and strengthen it in 

some areas where I think that there are some weaknesses. I want 

to probe into two of those areas. One is relating to our State lapse 

of hygiene, and I guess I would start with you, Dr. Schuchat, and 

would like to hear your feedback on how it is these days working 

with the States to track and monitor this disease. 

And I ask the question because in my examination of the issue, 

and this is based on a 2007 survey by the Council of State and Territorial Epidemiologists, showing that 16 States are still completely 

paper based, 20 States are still using manual reporting that is Web 

based, and only two State public health laboratories in the country 

have bidirectional data flow that can both send and receive laboratory messages. 

I understand also that technology is not yet deployed that would 

support new pathogen discovery and rapid electronic exchange of 

public health information, national bacterial and viral databases 

for DNA fingerprinting of infectious disease organisms, things like 

that. If you tell me how things are going and how those technological upgrades being deployed in our labs might help. 

Ms. SCHUCHAT. You know, the promise of information technology 

is huge and unfortunately it hasn’t gotten applied to public health 

infrastructure as rapidly and as in some of the business community, and I think we are not where we would like to be in that area. 

You know, in doing this investigation we have just yesterday I 

think got electronic reporting from the States coming in, which was 

exciting for us because it has been a long time coming but that is 

just for this investigation but not for everything. You know there 

are huge opportunities in that to really increase the efficiency of 

how public health works. 

Mr. VANDERWAGEN. And ma’am, the comments I made to the 

member from California apply here as well, that as we think about 

health reform and we think about preparedness, it is not just a 

matter of hospital services concerns here. I think these issues are 

going to need to be thought through as part of that context as well. 

Ms. BALDWIN. Let me follow up with some of the personnel challenges we are dealing with. Certainly as States and local governments have real budget squeezes I know that they have had to 


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shift around staff in order to deal with this outbreak. I don’t have 

the specific question right now on the staffing of labs of public hygiene. As I said, I am working on bipartisan legislation. We have 

introduced a bill called Strengthening America’s Public Health Systems Act, which deals with the technology and the personnel there. 

I want to focus quickly on another area of personnel workforce 

shortage, both present and looming, and that is with regard to public health veterinarians. While we have probably, I want to say, 

about 85,000 veterinarians in the Nation, I think my figures say 

only a little over 4,000 are food animal predominant, some with a 

mixed practice. The number of veterinarians in public, corporate or 

federal positions, which includes teaching, research, military, inspection and food safety, is just under 15,000. And the projections 

are that we will have a significant increase in demand as we move 

forward for these professionals and a significant shortfall now and 

as we move forward. 

Dr. Vanderwagen, could you talk to us a little about the role of 

public health veterinarians with regard to this outbreak and are 

you seeing that the shortage of public health veterinarians in the 

U.S. and around the world is having an impact now? 

Mr. VANDERWAGEN. Yes, ma’am, and you read my eyes. My dad 

was the chief veterinarian for the State of California, and so I grew 

up in a home with a public health veterinarian, large animal practitioner to start. I think it is critically important that we think in 

terms of one medicine. There are many more species with health 

issues than humans and even though we focus heavily on humans, 

and I think appropriately so, it is our species, notwithstanding that 

we are at extreme risk from a variety of diseases that emerge from 

the animal environment, and without the kind of knowledge that 

public health veterinarians bring with regards to animal-based diseases that have zoonotic; that is, transmissibility from animals to 

humans, as an underlying principle, we end up flying blind on a 

significant number of challenges that our health security may be 

confronting. 

So I think it is critically important that we think about that 

workforce and that we embrace the notion that there is more to 

health than simply that of humans alone. 

Mr. PALLONE. Thank you. The gentlewoman from the Virgin Islands, Mrs. Christensen. 

Mrs. CHRISTENSEN. Thank you Mr. Chairman. Dr. Vanderwagen, 

you can’t get away from me. You know this, right? 

My first question is to Dr. Sharfstein. On the food panel diagnostic tests, are those available to the Territories like my own and 

those in the Caribbean and those in the Pacific? Do we have the 

assurance that we have the availability of those tests? 

Dr. SHARFSTEIN. I am also actually going to ask Dr. Schuchat to 

answer that. FDA made that available to the group of labs that 

CDC requested, which is this network. 

Ms. SCHUCHAT. Yes. I was just trying to verify. We have been 

shipping the test kits to public health laboratories that are either 

part of the laboratory response network or similar public health 

labs. And so I don’t actually know. I believe it is likely, but I will 

need to check, and we can get you that information. The idea is 

that the public health laboratories be able to, that have gone 


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through the appropriate training and are part of this system, be 

able to perform these tests. 

Mrs. CHRISTENSEN. I would suspect that ours is in Puerto Rico. 

But the Pacific is much more difficult. 

Ms. SCHUCHAT. Absolutely. 

Mrs. CHRISTENSEN. They shouldn’t have to go all the way to Hawaii. And so that is my concern. Would you pronounce your name 

for me? 

Ms. SCHUCHAT. It is Schuchat. 

Mrs. CHRISTENSEN. So Dr. Schuchat and Dr. Vanderwagen, and 

you know this already but all during my time on the Committee 

on Homeland Security I have been concerned about the inequities 

and the deficiencies in the public health system in certain parts of 

our country, communities that are rural, Indian reservations, poor 

communities, communities of color, and they are very vulnerable. 

And it is often said that when the rest of America gets a cold, we 

get pneumonia. 

So my question is knowing this, what special efforts are being 

made to ensure that these communities have what they need given 

that their infrastructure, the poor health infrastructure in terms of 

hospitals have closed, less labs, less providers? What is being done 

to reach to these vulnerable communities? 

Ms. SCHUCHAT. You know, this is a huge issue in health in general. In terms of the new influenza virus investigation and response, one of the teams that we have stood up is a vulnerable populations team that is really trying to address the appropriate outreach and planning for communities that may be harder hit. 

Mr. VANDERWAGEN. Well, Mrs. Christensen, it is so good to see 

you again really because I think we have a great dialogue that is 

important. With regards to Indian Country because you know that 

is— 

Mrs. CHRISTENSEN. I see your watch and your ring. 

Mr. VANDERWAGEN. With regards to Indian Country, at least for 

those Indian people that are provided service funded or directly 

provided by Indian Health Service, they are on our daily policy 

calls. They are on our ESF 8 calls on a daily basis so that the most 

recent and clear communication can be transmitted through that 

system to people who are dependent on those health systems. 

The tribal leaders are actually here in town today to talk to HHS 

about budgetary considerations and concerns, and we will listen 

and respond the best we can. 

Mrs. CHRISTENSEN. Thanks. Great. And Dr. Schuchat and Dr. 

Sharfstein, you said that this virus is a new virus but it has genetic material from four known viruses, various origins. What, if 

anything, does this mean in terms of the severity of the illness, 

what you would predict, our possible level of prior immunity and 

the development of the vaccine? Are those four pieces of genetic 

material make it any easier to deal with? 

Ms. SCHUCHAT. The virus is new, and we don’t—although it is 

H1N1, it is different from the human H1N1s that are part of seasonal flus that many of us have been exposed to or vaccinated 

against with the seasonal flu vaccine. We can’t predict with certainty what this virus will do. So the four components only tells us 

really—it just tells us it is new. There is a possibility there might 


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be some cross protection in certain subpopulations. And it is the 

kind of thing we are looking into. But you know since we have tested many, many thousands of strains and have never seen it, it is 

novelty that is the most concern. 

Mr. Sharfstein. And I agree completely, and the only thing I 

would add is the question has been raised is whether people who 

got the flu vaccine this year have any extra protection against this. 

And I don’t think that question has fully been answered. It is one 

of the things that the CDC is looking into. The initial tests which 

test one type of immunity did not show any cross reactivity, but 

there is a potential there and I think it is going to be an important 

question to answer about it. I think in general the answer is you 

can understand what the virus is but to understand how it behaves 

you just have to watch how it behaves. It is just hard to determine 

that just from the genes alone. 

Mrs. CHRISTENSEN. My time is up. Thank you. Thank you, Mr. 

Chairman. 

Mr. PALLONE. Thank you. The gentlewoman from Illinois, Ms. 

Schakowsky. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. I want to add to 

the chorus of thanks. I think that the response has been really 

comprehensive. And we have on our Web site now a link to yours 

so that people can get the best and the latest information and we, 

I think a lot of Members, are doing that right now. 

We now have in Illinois 19 suspected cases, is it? 17 probable 

cases in Illinois. The one school that was closed in Illinois is in my 

district at the Kilmer School. I don’t know if any of those have been 

confirmed. Do you know that? 

Ms. SCHUCHAT. No, I don’t have the details of that. And I certainly feel for the folks in your district who are coping with such 

a challenge. 

Ms. SCHAKOWSKY. I wanted to ask you about if and when we 

have immunizations and vaccinations for, if not immunizations but 

vaccinations, most States’ Medicaid programs provide some coverage for adult beneficiaries in situations like this. And some 

States have exempted some populations from the nominal copay, 

pregnant women, children. I realize that this is impacting a somewhat different population. 

Do you think that in certain public health problems like the current one it would be good policy to exempt all Medicaid beneficiaries from cost sharing for vaccines and maybe for other things 

as well, but are related to this outbreak? And I am just wondering 

how that might impact the numbers of people who are able to access the care that they need. 

Mr. VANDERWAGEN. I think, and I can’t answer you definitively, 

ma’am, but I would suggest that the considerations are that when 

we have this kind of an issue, it is about our population and our 

citizens as a whole and less about individual benefits and services. 

We need to think about what can and should we do to serve our 

whole population. That is a little different mode than the way we 

think about medical care and health services in the country generally, which is about care for that one-on-one patient. Here we 

have to assure that our whole population is protected in the face 

of the challenge. 


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Does that mean we should promote a waive policy? That is for 

people above my pay grade. But I think there is a real public 

health argument that says we have to think about population and 

not just think in terms of limited individual benefits, which would 

suggest that we should cover everyone for those threats. 

Ms. SCHAKOWSKY. Right. Individuals, however, when seeking 

care think about their own situation and whether or not they are 

covered and whether or not they should be going to the doctor and 

whether they can afford to go to the doctor. And so I think we have 

to think about how we convey that people who may have it should 

seek the care that they need. 

Ms. SCHUCHAT. It is important in this kind of circumstance to 

eliminate the barriers to people presenting who need to be either 

cared for or whom interventions would need to be initiated. It has 

been a challenge in a lot of infectious disease outbreaks where communities sort of go underground and are fearful about presenting 

for care or the ability to pay. So it is very difficult with infectious 

diseases which don’t respect what insurance card you have, and I 

think we really want to have a public health approach that will 

help the communities. 

Mr. VANDERWAGEN. I echo what she said. 

Ms. SCHAKOWSKY. Let me ask another question. I wonder if 

someone can describe the process for data sharing between Mexico 

and the United States. My understanding is that we have a number of unanswered questions, whether Mexico is in the first or second wave of illness, the percentage of people dying from the flu 

compared to the percentage of people who are infected, et cetera. 

Ms. SCHUCHAT. I am happy to say that we, the CDC, are part 

of a trinational team that is on the ground in Mexico, Mexicans, 

U.S. workers, and Canadians who are working on the epidemiology 

and laboratory aspects of investigating and responding to this concern. Information is getting better now, but information in this 

kind of outbreak is really difficult even in the best of circumstances. Information can be sketchy at the beginning, and we 

need to hone in on the details. 

And in particular, before you have a good laboratory test, it is 

hard to tell what is going on with people with pneumonia or severe 

respiratory illness. And so one of the goals of the trinational team 

is to strengthen the laboratory capacity in Mexico so they can detect this new strain right there without having to shift to the U.S. 

or Canada or elsewhere. 

So I think we are getting much better information and cooperation. I mean the cooperation has been good, but the information 

quality is improving by the day. 

Ms. SCHAKOWSKY. Thank you. 

Dr. SHARFSTEIN. I can just add that FDA is collaborating with 

the FDA equivalent in Mexico around some of the recommendations that have been made in the United States that would be applicable, like what the right dose is for young children. 

Ms. SCHAKOWSKY. Thank you. 

Mr. PALLONE. Thank you. Ms. Eshoo. 

Ms. ESHOO. Mr. Chairman, thank you for having such a timely 

hearing on such an important subject. I have so many things that 

I want to say and ask, but this is my—these are—first of all, thank 


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you for the magnificent work you do at each one of your agencies. 

I think they are all parts of the jewels in the crown of America’s 

health system that needs help in so many ways but, boy, do we depend on the work that is done out of these agencies. 

Here is my sensibility that people are being, and it may have 

been said earlier by members when I wasn’t here when the hearing 

began, the American people are inundated by the blaring, glaring 

headlines and, as one of the staffers said behind me, that the only 

break that they had from swine flu was Senator Specter switching 

parties. That was the news break and now we are back to swine 

flu. I am not diminishing what all of this represents, the seriousness of it. But I think that what people need to hear over and over 

again are the really commonsense steps of responsibility that they 

need to exercise, washing our hands 1,000 times a day, the 

coughing, the sneezing, making sure that we cover our faces. 

I think on this issue of air travel in the United States, I am pretty sensitive about this. I have commuted across the country now 

every single weekend for 16-1/2 years. And as my mother would 

say, I don’t know who has raised some people, but they don’t cover 

their faces when they sneeze or they cough. Now this is voluntary 

for the airlines to say something. But if they can remind everyone 

to fasten their seatbelts in the eventuality that something can happen to us if there is a drop, I think that that should be part of the 

text and that our government ask in very strong, firm tones, we 

don’t need to pass a law on this, but I think the director or the Secretary of Transportation, along with health officials, should get on 

the phone and have a conference call with all of the airlines and 

say, please, we are asking you to make this public health announcement at the beginning of every flight. Because the proximity 

of human beings one to another on a plane is far different. 

Now I have been told that walking down the hall one of the 

house doctors was telling me that if someone coughs or sneezes, it 

is 6 feet. I sit pretty close to people on the plane. So do all of you. 

So I would ask that you do that. Get that ball rolling, and I think 

that that is in terms of prevention really important. 

I wanted to ask the following, and that is in the 109th Congress 

Representative Rogers of Michigan and myself introduced legislation, and we were successful, because it became law, it was the Biodefense and Pandemic Drug Development Act, it is called BARDA, 

to create—you are all nodding—a new office within HHS. What is 

the nexus between that office, the work that it has done, and this 

swine flu that evidently really doesn’t come from pigs? 

Mr. VANDERWAGEN. Ma’am, I will answer that fairly simply. 

BARDA has always worked across the Department to assure that 

the NIH discovery research and the FDA oversight responsibilities 

get brought into the mix as we do advanced development. Over the 

last 4 years, what has happened is that BARDA, through their 

funding, brought us the first licensed H5N1 vaccine. They brought 

about the kind of vaccine production changes that Dr. Sharfstein 

referred to where we have a warm base, if you will, that will allow 

us to ramp up— 

Ms. ESHOO. That is very good news. The good news is that the 

House, in our economic recovery package, included increased funds 

for this. But the Senate took them out. I don’t think they are going 


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to be feeling so good about that right now with what is going on. 

Maybe one of them is tuned into this hearing tonight when they 

are home sitting on their sofa. 

So let me ask this question. We just have 4 seconds left. Can you 

explain how the CDC and the Federal Government plan to administer a flu vaccine and, given that many of those who, so far, from 

what I have read, that are infected are children, is this going to 

be performed in schools and will it be a mandatory vaccine? 

Ms. SCHUCHAT. There is an answer to only some of those questions. But the States have been planning around countermeasure 

response assessments and they have done exercise drills with seasonal flu vaccine in terms of how will they administer promptly, 

get the kind of information—— 

Ms. ESHOO. You are saying they will probably use that same 

model? 

Ms. SCHUCHAT. Correct. And they are also making sure they 

have ways to find out who has gotten one dose because there is a 

good chance you will need two doses of this. So there are Statebased planning efforts around those models. 

Ms. ESHOO. Well, again, Mr. Chairman, this is a timely hearing. 

I thank all of you, the great professionals, health professionals of 

our country, and we have learned a lot today. And I think we really 

have to be very sensible about this as the science and the scientists 

and the medical community take the lead. But we just have to 

hammer home what people can do to be responsible all day long 

every day, and I think that is going to equip them with a sense of 

a little, some sense of reassurance on this. 

Thank you. 

Mr. PALLONE. Thank you, Ms. Eshoo. The gentlewoman from 

Ohio, Ms. Sutton. 

Ms. SUTTON. Thank you, Mr. Chairman. And thank you very 

much for your testimony and even more importantly for what you 

are doing to try and deal with this situation and keep the public 

safe. I come from Ohio. We have one confirmed case, and it is in 

my district. The case arises in a child who traveled with his family 

to Mexico over spring break. And the situation is that the school 

has been closed, and I know that the CDC, Dr. Schuchat, recommends that—the language I see here recommends strong consideration of school closure of the schools with a confirmed case or a 

suspected case that has been epidemiologically linked to a confirmed case. 

The first question I have is, why do you stop short of saying close 

the school? 

Ms. SCHUCHAT. I do think that we are evolving our guidance over 

time and some things may become clearer or stronger over time. 

At the time of the initial drafting of guidance, there was quite a 

bit of debate because illness that we had been seeing was fairly 

mild, and there was a question of balance. I think it is really—I 

think it is in there, but we meant to have in the guidance information about the local authorities having the best information or respecting their ability to make decisions that were either more stringent or less stringent than ours. But I do think at this point we 

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firmed or is highly suspect until we have more time to understand 

what is going on. 

So we are probably a little bit more aggressive than when that 

was written. 

Ms. SUTTON. And to follow up, I should say that the superintendent in the school district did close the school. So I commend 

him strongly for doing that. This is a case that, as I say, a child 

traveling with their family, there are other siblings who go to other 

schools who are not, you know, exhibiting the symptoms of the 

swine flu. What is the recommendation there in that situation? 

Ms. SCHUCHAT. At the present time what we have suggested is 

that the intervention be targeted at the school where the child with 

illness is, that additionally that gatherings associated with that facility be closed, but recognizing that there is a lot of variation in 

local realities. A school district in New York City is very different 

than a school district in a small town, and really respecting the 

ability of the local authorities to assess the situation and the practicality, the issues of what is possible. We really want to make sure 

that our interventions are not having more adverse impact than 

the virus itself. But we also are being mindful that we don’t know 

as much as we want to know so far about this particular virus and 

we are probably being more aggressive than others would think we 

should be in order to protect people. 

Ms. SUTTON. And isn’t it correct that unless a person is exhibiting the symptoms themselves that the danger of transmission is 

not present? 

Ms. SCHUCHAT. Unfortunately there are no absolutes. And what 

we think about from seasonal flu is that you may be able to spread 

infection a day before you have symptoms yourself and so, you 

know, it is one of those circumstances where we wish it were simple and we wish there was a very specific symptom and we wish 

that everyone who is infectious knows they are infectious and can 

stop from spreading to others. But we are at early days with this 

virus. It is a new one. And we don’t know whether it will be most 

infectious later on in illness or what. 

With the SARS epidemic we were really fortunate actually that 

most of the spread occurred when people were really, really sick, 

not in those early days. But when you have infections that are 

transmissible before they are symptomatic, before a person is 

symptomatic, those are really tricky, and that is the case with measles in fact. People think if I don’t vaccinate my child it is okay and 

my child can’t spread the infection to somebody else, I will know 

when they are sick and keep them home. But you can actually 

spread measles before you even know you have it. So this is one 

of those challenges with infectious diseases and why we are being 

pretty aggressive in our interventions now. 

Ms. SUTTON. Okay, and I could, and this goes back to a lot of 

what we have heard here about common sense about people staying home when they are sick and the like, but the people I represent, they are hard-working people and they are not, they don’t 

stay at home with a sneeze because you just, it is very difficult. 

But could you just explain and stress the importance of people who 

aren’t feeling well staying home, their kids staying home and, 


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frankly, you know, the implications to employers, too, and why it 

is to their benefit that obviously those folks stay home? 

Ms. SCHUCHAT. Some of the interventions that we are recommending are inconvenient. We actually did an effort in our planning a couple of years ago to address the public. We did public engagement in several communities to understand what people, average citizens were willing to do, if there were risks of something like 

a pandemic happening what was the trade-off in terms of personal 

flexibilities in the social protections. And through that we learned 

that there was support for many more aspects, I think, of this community mitigation strategy than I think some of us would have expected. But there is a balance. And we would really like to understand what is the severity, what is likely to be happening, before 

we really reduce people’s lives. 

Ms. SUTTON. Thank you. I appreciate it. 

Mr. PALLONE. Thank you. This completes our questioning. But I 

just really want to thank again for being here. I thought it was 

very helpful to us. You have heard several members say that they 

would like you to keep in touch with us, but certainly I will express 

that as well. Hopefully things do not, you know, really get to the 

pandemic stage but obviously we might at some point ask you to 

come back again. I hope that is not necessary. 

We also have a policy where probably within the next 10 days 

you could get additional questions from members to answer in writing, and so we would appreciate a response. But again thank you 

very much and Godspeed in what you are doing. And without further objection, the subcommittee hearing is adjourned. 

Thank you. 

[Whereupon, at 12:50 p.m., the subcommittee was adjourned.] 

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