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26–891PDF 2005

ASSESSING THE NATIONAL PANDEMIC FLU

PREPAREDNESS PLAN

HEARING

BEFORE THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

NOVEMBER 8, 2005

Serial No. 109–59

Printed for the use of the Committee on Energy and Commerce

(

Available via the World Wide Web: http://www.access.gpo.gov/congress/house

2

COMMITTEE ON ENERGY AND COMMERCE

JOE BARTON, Texas, Chairman 

RALPH M. HALL, Texas 

MICHAEL BILIRAKIS, Florida 

Vice Chairman 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

PAUL E. GILLMOR, Ohio 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

CHARLIE NORWOOD, Georgia 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

CHARLES W. ‘‘CHIP’’ PICKERING, 

Mississippi, Vice Chairman 

VITO FOSSELLA, New York 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

CHARLES F. BASS, New Hampshire 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

C.L. ‘‘BUTCH’’ OTTER, Idaho 

SUE MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOHN D. DINGELL, Michigan 

Ranking Member 

HENRY A. WAXMAN, California 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, Jr., New Jersey 

SHERROD BROWN, Ohio 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

ALBERT R. WYNN, Maryland 

GENE GREEN, Texas 

TED STRICKLAND, Ohio 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MIKE DOYLE, Pennsylvania 

TOM ALLEN, Maine 

JIM DAVIS, Florida 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

BUD ALBRIGHT, Staff Director 

DAVID CAVICKE, Deputy Staff Director and General Counsel 

REID P.F. STUNTZ, Minority Staff Director and Chief Counsel 

(II) 

C O N T E N T S 

Page

Testimony of: 

Leavitt, Hon. Michael O., Secretary, U.S. Department of Health and 

Human Services; accompanied by William F. Raub, Department of 

Health and Human Services; Anthony S. Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of 

Health; and Julie L. Gerberding, Director, Centers for Disease Control 

and Prevention .............................................................................................. 15

(III) 

(1)

ASSESSING THE NATIONAL PANDEMIC FLU 

PREPAREDNESS PLAN 

TUESDAY, NOVEMBER 8, 2005

HOUSE OF REPRESENTATIVES, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The committee met, pursuant to notice, at 10:10 a.m., in room 

2123, Rayburn House Office Building, Hon. Joe Barton (chairman) 

presiding. 

Members present: Representatives Barton, Hall, Bilirakis, Upton, 

Stearns, Gillmore, Deal, Shimkus, Wilson, Shadegg, Pickering, 

Radanovich, Pitts, Bono, Walden, Terry, Ferguson, Otter, Myrick, 

Sullivan, Murphy, Burgess, Blackburn, Barrett, Gingrey, Dingell, 

Markey, Eshoo, Stupak, Engel, Wynn, Green, Strickland, DeGette, 

Capps, Allen, Schakowsky, Gonzalez, Inslee, and Baldwin. 

Staff present: Nandan Kenkeremath, counsel; Ryan Long, counsel; Chuck Clapton, chief health counsel; Brandon Clark, policy coordinator; Chad Grant, legislative clerk; Alan Slobodin, counsel; 

David Rosenfeld, counsel; John Ford, minority counsel; Dick 

Frandsen, senior minority counsel; Jessica McNiece, minority research assistant; Alec Gerlach, minority staff assistant; and Edith 

Holleman, minority counsel. 

Chairman BARTON. The committee will come to order. 

This morning we are honored to have the Secretary of Health 

and Human Services, the Honorable Michael Leavitt, before us to 

discuss the administration’s concerns and plans to deal with pandemic flu. It is called the Avian Flu. 

We are going to operate under our agreement that when we have 

Cabinet Secretaries testifying, Mr. Dingell and myself and Mr. 

Deal and Mr. Brown will get up to 5-minute opening statements, 

and all other members of the committee will get 1-minute opening 

statements so that we can get to the Secretary and hear his concerns. 

An influenza pandemic has happened before in America, though 

probably not in the living memory of anyone in this room. Still, the 

odds are that it could happen again sometime, and so the Bush administration is certainly correct to send a warning to begin to prepare for the worst. We know that when it occurs, this pandemic 

could lead to widespread sickness, many deaths and serious damage to the Nation’s economy. 

We have an opportunity today to learn what actions we can take 

to prepare for this threat and minimize the risks associated with 

the deadly virus. This is a serious business, even deadly business, 

2

and we are having this hearing to expand our basic knowledge 

about both the disease and the potential cure. 

Authorities, including the President of the United States, are 

worried that the flu virus could spread around the globe. While the 

current strain of Avian Flu does not transmit easily from human 

to human, many scientists believe that it will mutate and be more 

contagious in lethal form. 

In response to this threat last week, the President outlined the 

national strategy. Secretary Leavitt also has released recently an 

updated and detailed Pandemic Influenza Preparedness and Response Plan. 

In today’s hearing, Secretary Leavitt will tell us about the National Strategy for Influenza Preparedness Plan and other actions 

taken by the administration. These include increasing the program 

for global surveillance, cooperation with the international community and developing an H5N1 vaccine. Even though this particular 

vaccine is not the final vaccine for the actual pandemic strain, this 

step is an important step for preparing for surge production of the 

later vaccine. The Department of Health and Human Services is 

also working with State public officials for pandemic planning. 

We are taking steps ourselves here in the Congress. The Public 

Health Security and Bioterrorism Preparedness and Response Act 

that passed the House last year provides improvements in preparedness. We have upgraded the National Strategic Stockpile, and 

we have provided incentives to develop countermeasures to biological threats under Project Bioshield. Some may argue that we failed 

to meet our responsibility by not providing unlimited money to respond to this potential crisis. Too often our response in Washington 

to anything new and challenging is to panic and just throw money 

after it. Too often our response to potential threats is to hide behind the wall of this money. The theory seems to be that every dollar will make the wall higher and thicker, and it will be that much 

safer, and when it gets high enough and thick enough, we can all 

calm down. It is the labor theory of value written into public 

health; the harder we work to spend your money, the healthier you 

will be. But I think wasting taxpayer money will not keep people 

from catching the flu. We need to sort out our real weaknesses 

from our imagined ones and determine where the application of 

money and good sense will actually improve our preparedness and 

stop the flu. 

I particularly want to know how this country can increase our 

current manufacturing capacity for vaccines by creating incentives 

to adopt new production technologies and providing liability protections that will encourage manufacturers to enter this high-risk 

area. These steps will safe lives and money. 

The President is calling on us for legislation to respond to a global health threat. I look forward to hearing the testimony of the Secretary about the administration’s ongoing efforts in working with 

him to develop a plan that delivers good science and good government. I am going to be especially vigilant in trying to come up with 

a plan to pay for whatever the costs initially are to prepare for the 

Avian Flu. 

3

With that, I would like to recognize my distinguished Ranking 

Member, Mr. Dingell of Michigan, for a 5-minute opening statement. 

Mr. DINGELL. Mr. Chairman, good morning, and thank you for 

scheduling this hearing. 

Secretary Leavitt, and your associates, welcome to the committee. 

Mr. Chairman, the threat of a flu pandemic has been known for 

a number of years. I begin by pointing out that we are a bit late 

in our response to the threat. Nevertheless, it is better late than 

never, and the plan issued last week is, in many respects, a good 

start. A good start is not a good ending; nor is it a good result. 

The plan is long on directions and short on resources for nonFederal partners in pandemic preparedness. How are the States to 

pay for a substantial portion of the cost of purchasing enough 

antiviral medication to cover their populations? Where is the funding needed for the States, for the localities and for the private 

health care organizations to fully prepare for a pandemic? Where 

is the money to improve the availability of diagnostics and reagents? And who will develop a national effort to communicate 

with the public, with corporation America and with the health care 

community with specific messages about risks? 

Why it is a good idea to shift so much of the financial burden 

on the individual States, despite the fact that the States are, without exception, ill prepared and lack the resources to comply with 

basic emergency preparedness of planning needs? 

And where is the work that we will be doing with our neighbors 

to the north and south? The American Public Health Association, 

APHA, has said that the public health—rather the Department of 

Health and Human Services Pandemic Influenza Plan could save 

the lives of many Americans in the event of a pandemic; however, 

this plan will not be successful in saving thousands of lives without 

the necessary funding. 

According to APHA, and I continue to quote, there will continue 

to be sufficient funds for States and local governments to fulfill 

their responsibilities as defined in the HHS plan. We will see. 

Similar concerns with the administration’s plan have been expressed by the National Association of City and County Officials. 

They commend the administration’s comprehensive approach to 

pandemic influenza preparations, but they express concerns about 

the amount of proposed Federal resources to help the communities 

to prepare and respond. The National Association of Community 

Health Centers also shares these concerns. 

Mr. Chairman, one thing is clear: When it comes to threats to 

our homeland from public health emergences, there is a very serious preparedness gap in this country. A broadbased public health 

advocacy organization, Trust For America’s Health, has conducted 

an assessment of each of the State’s preparedness for public health 

emergencies, including pandemic flu. They tell us, no State is fully 

prepared to deal with pandemic influenza or, for that matter, a 

range of other public health emergencies. How much would it cost 

State and local governments to be fully prepared for the next pandemic? 

4

The administration’s pandemic plan funding request is limited to just $100 million for State and local public health infrastructure. 

This appears to be a small fraction of what is needed. Spending 

more for State and local public health infrastructure is about more 

than just saving lives; it is a vital aspect of minimizing the ruinous 

cost to our economy in the next pandemic. The administration’s 

plan acknowledges the crucial role of the private sector in the economy in general and particularly in providing life’s necessities, such 

as food, shelter and transportation. How much will it cost the economy if pandemic hits at our current levels of preparedness? 

The tax cuts that have been pushed by my Republican friends 

have put this Nation in a fiscal straitjacket, and the consequences 

of our resulting lack of preparedness could be most dire to our 

health and welfare. We need to be level with the American people 

about what needs to be done, about how much it will cost and who 

will pay for it. 

I hope that this hearing will shed light on these matters. I hope 

it will lay the basis for us to begin to worth together in a bipartisan manner to address the concerns that all of us feel. And I commend you, Mr. Chairman, for holding the hearing. 

I yield back the balance of my time. 

Chairman BARTON. I thank the gentleman. 

The distinguished subcommittee chairman of the Health Subcommittee, Mr. Deal of Georgia. 

Mr. DEAL. Thank you, Mr. Chairman. 

I want to welcome the Secretary and his very distinguished supporting cast who are with him today. We have had several hearings 

previously in our committee, and their testimony has always been 

insightful. 

We are at an important crossroads, I believe, in dealing with this 

issue, not just of Avian Flu, but of the whole issue of vaccines in 

general. Our country finds itself in a situation where, because we 

have not taken appropriate action to provide a climate and an environment in which vaccine producers can produce their vaccines 

profitably and thereby present themselves in our market, that our 

country is now almost devoid of any domestic vaccine producers. 

That is a situation that I believe the Secretary will address, it is 

one that I think is long overdue in our attention here. It probably 

is going to require some rather different approaches from the Congress with regard to the one aspect of the proposal of liability protections in order to encourage these manufacturers to get back into 

the market and to be able to adjust and adapt to the challenges 

that are ahead of us. 

It obviously is a multifaceted issue that is going to be presented 

here today. It is one that in my particular part of the world that 

likes to call itself the poultry capital of the world, it is one that is 

of great importance to us. In fact, Dr. Gerberding, who is there 

with the Secretary, has so kindly agreed in a couple of weeks to 

be a part of a roundtable discussion with the major poultry manufacturers, producers, rather, in my Congressional district to look at 

it from that aspect. And we may find, unfortunately, that the animal—or the poultry side of the issue may be ahead of us on the 

human side of the issue in terms of their determination and their 

willingness to take the necessary steps to protect their product, 

5

that is, the poultry flocks of this country. But it is a coordinated 

effort, both on the poultry side of it in terms of protecting that 

product, which is the transmission that we have seen in most other 

countries, the vehicle, but also from the standpoint of what we can 

do at a Congressional level to deal with the things that make the 

possibility of providing effective vaccines available to the American 

public. And that should be our primary concern, we should put, 

hopefully, politics aside in the light of this very serious threat that 

looms. And I appreciate the Secretary and all of those who are with 

him today being with us. 

And, Mr. Chairman, I would yield back the balance of my time. 

Chairman BARTON. Mr. Deal yield backs. 

I don’t see Mr. Brown here, so we will reserve his right to give 

a 5-minute opening statement when he does arrive. 

And we go to the distinguished member from Massachusetts, Mr. 

Markey, for a 1-minute opening statement. 

Mr. MARKEY. Thank you, Mr. Chairman. 

Mr. Chairman, I am concerned that our country is not as prepared as we need to be in order to effectively carry out this plan. 

Over the last several years, the Bush Administration and Republicans in Congress have hallowed out the very public health infrastructure that we will need in the event of a flu pandemic. In fiscal 

year 2005, President Bush asked Congress to cut $113 million from 

the Centers for Disease Control and Prevention. This included $105 

million in cuts from programs to fund State and local public health 

preparedness. In his fiscal year 2006 budget, President Bush asked 

Congress to cut $531 million from the Centers for Disease Control 

and Prevention.This includes $130 million in cuts and programs to 

fund State and local public health preparedness. 

After years of slashing our State and local public health infrastructure, the Bush Administration is now placing enormous responsibilities on the State and local health authorities that have 

suffered these funding cuts. Our doctors, nurses and emergency 

personnel will do their best to respond to a monumental health crisis if one does occur, but you can’t cram for a pandemic. 

Thank you, Mr. Chairman. 

Chairman BARTON. I thank the gentleman from Massachusetts. 

And we recognize the distinguished subcommittee chairman of 

Energy and Air Quality, Mr. Hall, for a 1-minute opening statement. 

Mr. HALL. Mr. Chairman, we are here to pull together to fight 

a fearful threat to us. And Secretary Leavitt is here to help us, to 

work with us on a situation that we have no answer for. There is 

a lot of talk about the preparedness gap and finger pointing at 

what some people have done or haven’t done. There is a preparedness gap for the Martians attacking us. That hasn’t happened, but 

they would be complaining about it if it did, that you hadn’t done 

anything about the Martians. A renewal of the dangerous biblical 

days when leprosy stopped the world, that might come back again; 

and then there is a preparedness gap there, something politically 

to shake and point fingers at. It might be another rain for 40 days 

and nights and not enough of Noah’s Arks here in the United 

States or in our political districts to help us. 

6

I think there is a lot of reasons to complain about something now 

threatening us, not heretofore in the headlines, but I don’t think 

it is a time do to that or run the President down and point fingers 

when any time we are pointing fingers—a lot of us have been up 

here for 20 or 30 years. We haven’t done anything about it, and to 

point the finger at a President that was in grade school probably 

when we got here or to our Secretary—I thank you for being here 

and plan to work with you to try to get an answer to this that 

seems to be no answer to. Thank you. I yield back. 

Chairman BARTON. The gentleman yield backs. 

And we now go to the distinguished lady from Colorado, Ms. 

DeGette. 

Ms. DEGETTE. Mr. Chairman, some other members were here before I was, and I would certainly yield to them in the order of appearance——

Chairman BARTON. I am just going down——

Ms. DEGETTE. Mr. Green was here first, though. 

Chairman BARTON. All right. 

Mr. GREEN. Depending on the Chairman, I will be glad to defer 

to my colleague. 

Chairman BARTON. I would be happy to recognize either of the 

two distinguished members. 

Mr. GREEN. Why don’t we just go down the line? 

Ms. DEGETTE. I always try to defer to my elders, Mr. Chairman. 

Chairman BARTON. It is good to defer to Texas; I will tell you 

that. 

Ms. DEGETTE. I never go that far. I am from Colorado. 

Mr. Chairman, I want to thank you for having this hearing. 

And I particularly want to thank the Secretary and his staff for 

coming. I know you all are very concerned about this issue. 

But I am more concerned about the fact that we have known 

about the looming Avian Flu epidemic and its potential devastating 

loss of life for years. And I am hoping we can do enough triage that 

we can put together a plan that will be meaningful. I am also hoping that we can do enough triage to develop a vaccine and to develop a plan that will work. 

I was concerned last week when the plan was finally released 

that so much of the burden is put on to the States. We have $100 

million in aid to the States, but we are taking away $130 million 

from other parts of this year’s budget. And the States are in terrible shape, too. I got our State Avian Flu Plan after the Federal 

plan came out last week, and our State plan said the Federal Government was taking care of everything. But the Federal plan says 

the State governments are going to stockpile the Tamiflu and all 

of the other things we need to do. So rather than just be comfortable that we have plans everywhere, we need to make sure that 

the plans are going to work to protect the American public. 

I yield back. 

Chairman BARTON. The gentlelady yield backs. 

The distinguished chairman of the Subcommittee of Telecommunications, Mr. Upton. 

Mr. UPTON. Well, thank you, Mr. Chairman. 

In preparation for this hearing, I have been consulting with a 

number of my county’s public health department medical directors 

7

and administrators to gain a frontline perspective on pandemic flu 

preparedness and what they see as the most pressing need. I am 

going to explore those in my questions, but basically, I have 

learned obviously we need more boots on the ground, particularly 

public health nurses. As one of my directors put it, we may have 

biohazard suits hanging on the wall but no one to don them. We 

may have stockpiles of vaccines but no one to give the shots. 

Second, we need a rational vaccine and antiviral distribution 

process. I have been harping on this for a number of years, but we 

have still failed to put such a system in place. Today, as we sit 

here this morning, my public health departments have not received 

anywhere near the flu vaccine doses that they have ordered and 

need for priority populations, but yet the supermarkets seem to 

have more than enough to hold vaccine clinics for anyone who 

shows up for a shot. And, literally, I have got 9,000 in requests by 

my county. So we have got to figure this out. I look forward to 

working with the Secretary to make sure that we can get a place—

a distribution system into place. 

Chairman BARTON. Mr. Allen. 

Mr. ALLEN. Thank you, Mr. Chairman. 

And thank you, Mr. Secretary, for being here. 

Today we don’t have enough vaccines for Avian Flu because, in 

part, they simply aren’t profitable enough for drug makers. We 

don’t have enough antivirals because patents have forced us to rely 

on the limited production of a single patent holding company. 

At a Government Reform Committee hearing last week, Mr. Secretary, you rejected the possibilities of issuing a compulsory license 

for Tamiflu production if Roche fails to arrange voluntary licenses. 

You said, doing so would remove incentives for future R&D. But as 

we see with vaccines, companies won’t spend on future R&D if they 

can’t promise profits to their shareholders. 

Companies in India, Taiwan, Malaysia, South Korea and elsewhere are preparing to manufacture generic versions of Tamiflu. 

However, Americans will not have access to the antiviral drugs 

produced in those countries because, in 2003, the Bush administration chose to make the U.S. Ineligible to import drugs produced 

under compulsory licenses per WTO rules. That is what the pharmaceutical industry lobbied for, but I believe it has placed our citizens at risk. I look forward to the conversation today. Thank you 

for being here. 

Chairman BARTON. Mr. Stearns. 

Mr. STEARNS. Thank you, Mr. Chairman. 

And let me just read from USA Today, and this is from the 

World Health Organization: It is only a matter of time before an 

Avian Flu virus, most likely H5N1, acquires the ability to be transmitted from human to human, sparking an outbreak of a human 

pandemic influenza. This is the director of the World Health Organization. And then when you go back and realize—this is a quote 

now from the CDC,predicts that a medium-level epidemic would 

kill 207,000 Americans, hospitalize 734,000, sicken about a third of 

the U.S. Population, direct medical costs would be $166 billion, not 

including the cost of vaccination, you realize the seriousness and 

how important this hearing is. 

8

I would point out that we do have a specimen the Secretary indicated that he found in Vietnam. They have a specimen from Vietnam which they have matched with a specimen from the 1918 pandemic and through reverse genetics were able to come up with 

some solutions. So I guess the question is, how do we get that specimen into a vaccine and produced and available for Americans? 

And that is what we are here today about. 

Thank you, Mr. Chairman. 

Chairman BARTON. Thank you. 

Mr. Green. 

Mr. GREEN. Thank you, Mr. Chairman. 

I want to welcome the Secretary and his staff here today. 

I support the administration’s call for additional investment. In 

fact, the effort to have antivirals to cover 75 million people meets 

with the World Health’s Organizations 25 percent of our population. My concerns, like other members have, is that the amount 

of what you are requiring the States to produce, $510 million worth 

of antivirals, I don’t know if my own State of Texas or other States 

have the funding available to be able to do that. We are still investigating, in Houston, Texas, some of this fake flu vaccine given to 

a bunch of our Exxon Mobil employees. So I am concerned about—

to make sure that whatever we do with Tamiflu, that that is the 

correct vaccine. 

Mr. Secretary, I thank you for being in Houston on Labor Day 

with the national emergency, the healthcare issues that we had 

with the Katrina evacuees, and I guess that is the closest I can 

imagine having to triage thousands of people at one time and how 

we were going to do it. I don’t want to see us have to do that with 

antivirals because of the flu, but I also know that we need to be 

prepared for that. And I am glad the committee is having this 

hearing today. 

Thank you, Mr. Chairman. 

Chairman BARTON. Mr. Bilirakis. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. 

Mr. Chairman, I associate myself with many of the remarks, particularly those involving Mars, and certainly not with some of the 

demagoguery. You would think there would be some subjects which 

would not result in some demagoguery. 

But in any case, Mr. Chairman, I guess what I would say, certainly hearing the Secretary earlier today on this subject, my biggest frustrations I think—or certainly among my biggest frustrations and disappointments in the Congress all these years has been 

the fact that we sort of concentrate on putting out fires, and we 

don’t plan on a long-term type of a basis. Something—a problem 

develops in the Middle East, and the cost of gasoline goes up, and 

we have shortages, and all of a sudden we decide to get concerned 

about that subject. Then as soon as the price of that gasoline drops 

and the shortage is no longer there, we sort of forget about that 

particular point and go on to something else. 

Now the same thing we had a couple of years ago; we had a 

shortage of the flu vaccines. And we were concerned about them, 

and we had hearings about them. And I am not really sure what 

all we have done about that to prepare in the future. We know a 

pandemic is coming, and I am just hoping whatever we come up 

9

with here on a bipartisan basis will be something over the long 

hall, not just to put out this particular fire. Thank you. 

Chairman BARTON. Ms. Eshoo. 

Ms. ESHOO. Thank you, Mr. Chairman, for holding this hearing. 

And welcome, Secretary Leavitt—it is good to meet you—and the 

distinguished panel that has come before us before and does magnificent work for our country. 

I think, Mr. Chairman, that the release of the national strategy 

and budget request is a clear demonstration that the administration is taking the pandemic flu seriously, and that is a very important first step to acknowledge what could be on the horizon, and 

then plan for it. 

I think that there are some significant gaps, though, and I will 

raise those during my questioning. I think that there is a theme 

that has been developed so far this day—today in that we are concerned about the resources for States. $100 million any one of us 

would love to have in our checking account, but when you divide 

that by 50, $2 million per State—I am from the State of California; 

$2 million would not go very far. And there are States that are 

poor. And how are they going to be able to handle that? Is the Federal Government going to step in? 

So I think that there are some questions that can go to some of 

the issues that have already been identified so that the administration really will have the strongest plan possible for our country 

which this issue really demands. So I look forward to posing the 

questions and working with my colleagues on the committee, both 

sides of the aisle. We have to address this for the American people. 

I am glad that we are having the hearing, Mr. Chairman, and I am 

delighted with who is going to testify today. They are the best and 

the brightest, that is for sure. Thank you. 

Chairman BARTON. Mrs. Wilson. 

Mrs. WILSON. Thank you, Mr. Chairman. 

Mr. Secretary, thank you as well for being here today. 

I wanted to give you a couple of points just briefly. Our State has 

looked at your plan and thinks that it is better than the plans have 

been in the past, and it is a real improvement from what they have 

seen before. But like most States, New Mexico has a 60-day legislative session coming up, and what they really need—and they have 

gathered for their estate planning effort in late October—is better 

clarity on what the Federal Government expects to do and where 

the State links into that and local communities as well. So we need 

better clarity on where the gaps are and where the lines of demarcation are before this next legislative session. 

The second thing I would ask you to continue to focus on is the 

broader concept of disaster preparedness and how we would respond, making sure the logistics are there. And you and I both 

know that the regional stockpile system is not going to work in a 

pandemic. We have got to figure out how to structure ourselves and 

get things set in advance so that we have the best likelihood of success when it really counts. And we can’t do that on the day. We 

have to do that planning and organization and training and systems development long before the point of crisis. And I look forward to your testimony. 

Chairman BARTON. Gentlelady from California, Mrs. Capps. 

10

Mrs. CAPPS. Mr. Chairman, I wave my opening remarks, but add 

my welcome to Secretary Leavitt, Dr. Gerberding and Dr. Fauci. 

Chairman BARTON. Mr. Strickland. 

Mr. STRICKLAND. Thank you, Mr. Chairman. 

Thank you, Mr. Secretary. I appreciate the fact that you are here 

today. 

I would like to raise an issue that you only touch on very briefly 

in your testimony, and that is the distribution of vaccines. I believe 

that effective distribution is a very important link in the chain, and 

that is something that even today is somewhat problematic. I have 

heard from several doctors in my area telling me that even this 

year they are having a hard time getting their hands on the needed 

vaccine, and they also say that, in their regions, though, large distributors like Wal-Mart and other large retailers seem to have no 

problem getting access to those vaccines in a timely manner. So I 

just call that to your attention. And I am not sure exactly what the 

proper fix would be, but it is something that I think that probably 

needs our attention. And thank you for being here sir. 

And I yield back, Mr. Chairman. 

Chairman BARTON. Mr. Radanovich. 

Mr. RADANOVICH. Thank you, Mr. Chairman. I wave my remarks, but do want to welcome Secretary Leavitt to the hearing. 

Thank you. 

Chairman BARTON. Mr. Pitts. 

Mr. PITTS. Thank you, Mr. Chairman, for convening this hearing 

today on such an important issue. 

While preparing for a pandemic flu requires a wide-ranging and 

comprehensive plan, I hope our witnesses will spend some time to 

address one particular issue, and that is liability protection for vaccine manufacturers. 

On March 31st of this year, HHS issued a 5-year contract to 

Sinofi pasteur to develop and clinically evaluate a new cell culture 

technology that can be used to more rapidly produce vaccines. And 

this contract also establishes plans for creating domestic facilities 

with the capacity to manufacture 300 million doses of a pandemic 

vaccine using cell culture as opposed to the currently licensed process using chicken eggs. And this particular company, U.S. Operations are headquartered in my home State of Pennsylvania where 

it has made vaccines for over 100 years and influenza vaccines for 

well over 30 years. Of course, one of the particular issues facing 

manufacturers like this is the threat of litigation from potential 

outburst effects. Without proper liability protection, the manufacturers cannot move forward with actual testing and development 

on a large-scale production. So I look forward to your testimony on 

this issue. 

And thank you, Mr. Speaker. 

Chairman BARTON. Ms. Schakowsky. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. 

This administration has been looking high and low for not existent weapons of mass destruction, going to war and spending hundreds of billions of dollars because of these phantom weapons. It 

turns out there is weapon of mass destruction; it is called the 

Avian Flu. And this administration has done pathetically little to 

11

protect our people from a killer that could take the lives of 500,000 

Americans. 

Why do we have only enough antivirals on hand to treat 1 percent of the population? Why does the plan spend so little on international surveillance, the equivalent of fighting the war there so 

we don’t have to fight it here? Why does the plan rely so heavily 

and give so little to States, at the same time cutting $130 million 

from State and local health initiatives? Why is one of the first proposals from this administration one to shield drugs from liabilities 

and depriving those injured by the vaccine from fair compensation? 

Why do other countries have better, more detailed plans? And how 

do we justify to the American people these words from our plan, 

quote, It is unlikely that there will be sufficient personnel, equipment and supplies to respond adequately to multiple areas of the 

country for a sustained period of time, unquote? This is not a terrorist attack. This is not a hurricane. This is a long known and certain danger. Can’t America, can’t this administration do better? 

Thank you, Mr. Chairman. 

Chairman BARTON. I thank the gentlelady. 

Mr. Walden. 

Mr. WALDEN. Thank you, Mr. Chairman. 

I want to—it is hard to sit here and listen to all this, and we are 

blaming Bush before even have a flu outbreak, and it just gets a 

little old. 

I want to commend the administration for announcing the international partnership on the avian pandemic. I have my own set of 

concerns. I think we have gotten so far to the point where, when 

a disaster breaks out, wherever it breaks out, we expect the Federal Government to come in and solve our problems immediately. 

The old Boy Scout in me says I need to be a part of that solution; 

I want to be prepared. I don’t think we can create a distribution 

system that will function properly if a third of the population has 

a flu and an enormous number of them are dying from it. So I 

think we also need to look at individual preparedness. I want to 

know how I can get what my family is going to need and what my 

neighbors are going to need in our houses so we can take care of 

ourselves and stop thinking that some government agency is going 

to come in and rescue the day, because I don’t think it is going to 

function in the end the way we would hope it would when a pandemic breaks out, if indeed it does. So I appreciate the plan of the 

administration and look forward to working with you and my colleagues to come up with real solutions. 

Chairman BARTON. The gentleman from Washington. 

Mr. INSLEE. I would just submit that giving everyone a Swiss 

Army knife and a compass is not going to solve this problem. The 

Federal Government is necessary to address this very significant 

threat, and I would just hope that our hearing would focus on two 

issues that I hope we have a chance to ask the Secretary about. 

First, I hope that we take a more aggressive approach to Avian 

Flu in trying to prevent its transmission and the actual transmutation of the virus itself. I think there are several things we can do 

to reduce the prospects of that occurring by attacking it at its 

source in the avian populations before that transition takes place, 

one of which is to develop a biodetection system that can be used 

12

around the world, including developing nations, that can determine 

the presence of even a single virus. And there is technology that 

is on the cusp of becoming commercialized to do that. I hope that 

we can at this hearing talk about how to bring that to the frontline 

right away. 

Second, I hope that we can address the incredible decimation of 

the public health infrastructure in this country. Any of us, we can 

go to any of our districts, in this panel, to our public health officials, and they will tell us, good luck, we don’t have any infrastructure to do it. You go to our public health facilities; they don’t have 

a copy machine. They don’t have a cell phone. I mean, to expect 

our local public officials to deal with this without very significant 

improvements in that infrastructure is really going to be hopeless. 

And with this administration, with all due respect, cutting——

Chairman BARTON. The time of the gentleman is expired. 

Mr. INSLEE. Cutting, it is not the direction we need to go, thank 

you. 

Chairman BARTON. Mr. Terry waives. 

Mr. Ferguson. 

Mr. FERGUSON. Thank you, Mr. Chairman. 

Thank you, Mr. Secretary, for being here today and our other 

panelists. 

Over a year ago, Dr. Gerberding, who is here with us today, 

came before our committee, and we discussed many aspects of what 

would be required to prepare against a pandemic. I said then, I repeated it in multiple hearings we have had, and I will say it again 

here today, we are staring down the barrel of a loaded gun; the gun 

is ready to fire. 

Expert after expert, including the many panelists we have had 

here at our hearings, have said we must not ask if but ask when. 

When will we have a strain of influenza virus that will cause a 

pandemic? And most importantly, will we be ready? 

Mr. Secretary, I thank you and the administration for presenting 

us with a final comprehensive pandemic plan to ensure that our 

country is prepared and protected against a widespread outbreak 

of influenza. 

With all of this focus in the media and the public at large, I 

think there is significant confusion on a number of key points in 

the plan. And I am looking forward to this opportunity to help our 

members learn more. In the end, my constituents and others 

around the country just want to know where they can get their vaccine shot to protect them against Avian Flu when it strikes or 

where they can get other drugs that might protect them in lieu of 

a vaccine. I have told my constituents that we have a two-prong 

strategy, dramatically improve our vaccine technology and the ability to rapidly manufacture it, as well as create a national stockpile 

of existing antiviral medicines. I look forward to hearing from you, 

Mr. Secretary, on our plans to do both of those things, how we are 

going to get the job done to ensure safe and orderly execution of 

the plan when a killer flu strikes. Thank you, I yield back. 

Chairman BARTON. Ms. Baldwin. 

Ms. BALDWIN. Thank you, Mr. Chairman. 

And thank you, Secretary Leavitt. I applaud the administration 

for finally releasing this pandemic flu preparedness plan, and there 

13

are parts of it that I think are very promising, especially with regard to the investment in research. However, I do continue to have 

serious concerns about our state of readiness for a pandemic flu 

outbreak. Put simply, I am concerned this plan is too vague in a 

number of important issues to be reassuring right now. And I know 

this is a work in progress, so I hope we can improve on those. Let 

me just list a few of those concerns and hopefully get into others 

during the questioning. 

The U.S. Isn’t estimated to have sufficient vaccine production capacity for many years. What will we do if the pandemic hits before 

then? The same can be said about our production capacity for 

antivirals. What is the strategy to deal with fear and panic among 

the public? How are States supposed to afford new unfunded mandates that this plan assigns to them? I look forward to the hearing 

today, and hopefully, we will have the opportunity to explore this 

and other issues more fully in question and answer. 

Mr. Chairman, I yield back. 

Mr. DEAL [presiding]. Mr. Shadegg, do you have an opening 

statement? 

Mr. SHADEGG. Thank you, Mr. Chairman. I want to thank you 

for holding this hearing, and welcome our distinguished guests, 

Secretary Leavitt and the other panelists that have joined him. 

This is an important issue, and the President has put it at the 

forefront of our Nation, requesting some $7.1 billion to deal with 

this. I am deeply concerned that we take the appropriate steps. I 

would like to, however, direct my remarks to some of the facts that 

have been stated here and some of the concerns that have been expressed. And one of the concerns has been that we are not spending sufficient monies in this area and that, indeed, to quote one of 

my colleagues on the other side, he says we have been slashing 

spending in this area. For the record, let me just insert what we 

have, in fact, done for the funding of the National Institutes of 

Health over the last 12 years. In 1992/1993, we were spending $8.9 

billion. We have increased every year since then. The subsequent 

year, 1993/1994, $10.3 billion; 1994/1995, $10.5 billion; 1995/1996, 

$11.3 billion; 1997/1998, $12.7 billion; 1998/1999, $13.6 billion; 

1999 to 2000, $15.6 billion; 2001/2002, $17.8 billion; 2001/2003, 

$20.4 billion; 2002/2004, $23.3 billion; 2003/2005, $27 billion; and 

for the current fiscal year, almost $28 billion. That is a growth 

from roughly $9 billion to $27 billion in a span of 12 years. We 

have tripled the amount of money sent to the NIH. Where in that 

we can find a slashing of the spending for these purposes, I don’t 

understand; and how someone can come before this committee and 

use that kind of rhetoric concerns me. I think the facts are important to know. We need to look at this problem seriously and fund 

it appropriately. 

Thank you, Mr. Chairman, I yield back. 

Mr. DEAL. Mr. Gonzalez, do you have an opening statement? 

Mr. GONZALEZ. I waive the opening, thank you. 

Mr. DEAL. He waives. 

Mr. Burgess, do you have one? 

Mr. BURGESS. Thank you, Mr. Chairman, I have a statement 

that I will submit for the record. 

14

But Secretary Leavitt, Dr. Fauci, Dr. Gerberding, Dr. Raub, it is 

good to see you here this morning, I am glad you are here. 

Secretary Leavitt, you will recall, in September, after Hurricane 

Katrina, you visited Dallas, the 17,000 displaced persons who 

showed up there late one evening. The blast facts went out to the 

Dallas County Medical Society, and out of 3,600 physicians registered with the Dallas County Medical Society, 800 showed up for 

that first stay, truly a significant surge capacity that I don’t think 

any of us were aware of, that people that would just show up if 

asked. And part of my concern and one of the reasons I am so 

grateful that you are here and talking with us today is that can 

we—are we going to be able to count on that ability of first responders to show up if we don’t have the ability to protect them, 

whether it be with antivirals, vaccines, gear and what have you? 

As hard as it is for the first responders to show up, their significant 

others may prevent them from showing up. As I know it is very 

well and good to volunteer for something, but I also remember I 

have to go home and ask permission before I actually do that. 

So I thank you for your attention to that. I think it is extremely 

important as we work through this problem and look forward to 

your testimony today. 

Mr. DEAL. Mr. Stupak, do you have an opening statement? 

Mr. STUPAK. Thank you, Mr. Chairman, I do. 

Mr. Chairman, thank you for holding this hearing today on the 

Avian Flu, a topic which Congressman DeGette and I have been 

urging investigation and a hearing on for almost a year now. 

Today we get our first look at the new pandemic flu plan, but 

this hearing should not be the end of our efforts. The committee 

must continue to exercise appropriate oversight of the administration to ensure this 396-page, $7 billion pandemic flu plan adequately protects the American public and funding actually makes 

it out of Washington, DC., Unfortunately, the plan before us, period, is yet another example of the administration taking it, go it 

alone or going with the drug company approach instead of adequately equipping our State officials, doctors, nurses and police officers who will be on the front lines. This plan forces States to pick 

up $500 million of the cost of drugs that may not work. 

Michigan Medicaid is already facing a $420 million cut underneath the reconciliation plan that we will vote for later this week. 

How is Michigan supposed to buy drugs that may not work when 

it struggles to afford drugs for people who are sick today? We saw 

with Hurricane Katrina that plans are only as good as the resources and training to back them up. The 426-page Department 

of Homeland Security plan did little good during Hurricane 

Katrina. 

Pandemic flu could mean Katrina-like third-world health conditions in cities across the Nation for 6 months or longer. It could 

mean over 8 million dead, according to the administration’s scenarios. The bottom line is that, with the pandemic flu, it is no 

longer a matter of if but when. We must make sure we have adequate surveillance and containment in those critical 6 months before there will be a vaccine. That requires more than just plans on 

paper. It requires training, and it requires resources for our States. 

Thank you, Mr. Chairman. 

15

Mr. DEAL. Ms. Blackburn. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

I want to welcome our guests and to let them know that, in Tennessee, from my constituents, there are a few things that I have 

heard. They are very interested in knowing what our preparation 

plan is. And they want to know what the process for vaccination 

will be. And then they want to know what the communication and 

education plan that you are setting forth is going to be for all citizens of our country. If we have a pandemic, they want to know two 

things: Do you have a containment plan? Do you think it would 

work? And how is your management plan put in place to manage 

through a pandemic? 

The other thing that they ask me as we talk about this: How do 

you plan to accomplish this, with respect to the taxpayers’ dollars, 

to their funding, not adding to the deficit? And can you, within 

your existing budget, find a way to accommodate these expenses? 

Thank you so much, and I look forward to your discussion. 

Mr. DEAL. Mr. Barrett indicates he waives. 

Any other member that I have overlooked that has an opening 

statement? 

Well, if not, we are pleased to have Secretary Mike Leavitt, Secretary of Health and Human Services, with us today. 

And Mr. Secretary, with that, we will recognize you for your 

opening statement. Your prepared statement is already a part of 

the record. 

STATEMENT OF HON. MICHAEL O. LEAVITT, SECRETARY, U.S. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACCOMPANIED BY WILLIAM F. RAUB, DEPARTMENT OF HEALTH 

AND HUMAN SERVICES; ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH; AND JULIE L. 

GERBERDING, DIRECTOR, CENTERS FOR DISEASE CONTROL 

AND PREVENTION 

Mr. LEAVITT. Thank you, Mr. Chairman. 

Given that it is part of the record, I will simply summarize with 

half a dozen points. 

The first one is, consistent with what all of you have suggested, 

pandemics happen. They have, over the course of centuries, happened. In the last 300 years, we have had ten of them that have 

been recorded. In the last hundred years, we have had three of 

them, 1968, 1957 and what is now referred to as the Great Influenza in 1918, which took as many as 40 million lives across the 

planet. They are very serious, and no nation can ignore the threat. 

The dilemma that we all face is dealing with this in a way that 

informs but does not inflame; that inspires preparation and preparedness, not panic. The President has put forward the $7.1 billion plan that we are here to talk about today. 

The H5N1 virus that we are currently dealing with is moving 

across the globe, being carried by wild birds, infecting domestic 

flocks. As we speak, the Chinese Army has been deployed to cull 

their flocks. We have had 125, roughly, cases that have been confirmed, and about 64 of them have died. This is a very serious matter. But it is still primarily an animal disease. We do not know if, 

16

in fact, it will make the leap from animal disease to a person-toperson disease, but we do know, at some point in time, a pandemic 

will occur. And so our discussion today isn’t just about the H5N1. 

Our discussion, I hope, can be about pandemic preparedness in 

general. 

Now, second, if I could just give an overview of the President’s 

plan and the plan that we have put forward with HHS. 

The first part is international surveillance. If you could think of 

the world as a vast forest that is dry and susceptible to fire, it only 

takes a spark. If a person is there when the spark occurs, they can 

contain the damage simply by putting it out with their foot. However, if it is allowed to smolder and burn over the course of an hour 

or more, it grows beyond containment. That is precisely the way a 

pandemic works. If we are able to be there when the spark occurs, 

when the virus makes that transition between an animal disease 

and a sustainable person-to-person disease, we are able to contain 

it. And that should be our first line of defense. What that means 

is, we need to have laboratory capacity, professionals from the 

CDC, in the countries where we are likely to see this. And we are 

now moving on that. We have a presence, but we need to expand 

it. 

The second is domestic surveillance. We need the same capacity 

within the United States. We need to know when it arrives and 

how broadly it has arrived. 

The third area deals with communications. Many of you have 

spoken about the fact that we could be dealing with a 1918 biology 

but with a 21st century new cycle, and that is a much different 

proposition than we fought before. We also have the capacity for 

people to travel around the world. So there are some differences between now and 1918 that work against us. We also have some aspects that are very positive. We have much better health care 

today than we did then. So there are offsetting levels of advantage. 

The fourth area is antivirals. The plan calls for 81 million 

courses to be in collective stockpiles. We will get a chance to talk 

about that more later. 

The fifth part is on State and local preparedness. One of the 

unique characteristics of a pandemic is the way it is managed. 

Katrina has been mentioned. We learned a great deal from 

Katrina. Katrina was over Mississippi, Louisiana. It was also part 

of Alabama, but at least it was in a contained area. As broad as 

the damage was, at least it was defined. A pandemic would not be 

a confined or defined area. It would be essentially an unlimited 

area. And it is very likely that we would be dealing with the kind 

of emergency situations we saw in the Katrina area all over the 

country and, in some respects, all over the world. So State and 

local preparedness, as many have mentioned, is of vital importance. 

And I will have a chance, I am sure, to talk more about that later. 

The last part, and what I believe to be the foundation of this 

plan, is nothing short of a complete revitalization of the vaccine 

manufacturing capacity in our country. The good news is we have 

a vaccine. Through the professionals at NIH, we have identified a 

vaccine that produces an immune response that will protect people. 

The bad news: We don’t have the ability to produce it in broad 

enough numbers in a short enough timeframe, and it is because the 

17

vaccine manufacturing business has diminished to a point that that 

is the case. 

Many of you have brought up the annual flu. It is the same problem with the annual flu. What we hold here, I believe, is not just 

an opportunity to protect ourselves from a pandemic flu but, for the 

first time, to literally take off the table the problem we have with 

the annual flu by being able to create a renewed vaccine manufacturing capacity. 

Again, I want to emphasize, our discussion should not be, I hope 

as a Nation, simply about H5N1. Yes, there are very troubling 

signs that we cannot ignore. The certainty or the probability that 

it will transform into a person-to-person sustainable virus is unknown, but we do know pandemics happen and that we need to be 

ready. At some point, a pandemic will occur. Our current state of 

preparedness is not what it needs to be. And today our discussion 

continues. 

We did not just start this conversation a month ago. This pandemic plan has been in place, we have been holding hearings and 

so forth for many, many months. We actually have a vaccine. We 

have people in place. We have the beginning of a surveillance system. So while we are not where we need to be, we are rapidly moving. And I look forward to discussing how we can look to your help 

to continue that discussion. 

[The prepared statement of Hon. Michael O. Leavitt follows:]

PREPARED STATEMENT OF HON. MICHAEL O. LEAVITT, SECRETARY, U.S. DEPARTMENT

OF HEALTH AND HUMAN SERVICES

Good morning, Mr. Chairman, Representative Dingell, and Members of the Committee. I am honored to be here today to present the President’s request for funds 

for the HHS Pandemic Influenza Plan, which is an integral component of the National Strategy for Pandemic Influenza, which the President announced last week. 

In the event that an outbreak of pandemic flu hits our shores, it will surely have 

profound impacts on almost every sector of our society. Such an outbreak will require a coordinated response at all levels of government—Federal, State, and local—

and it will require the participation of the private sector and each of us as individuals. HHS has been a leader in this effort. With this budget request and the release 

of the HHS Pandemic Influenza Plan, we are taking another major step forward to 

improve our preparedness and response capabilities. 

The threat of an outbreak of pandemic influenza is real. An influenza virus strain 

with potential to cause a pandemic of human disease could emerge with little or no 

warning and in almost any part of the world, as occurred 3 times during the 20th 

century. Influenza viruses infect birds, pigs, and other animals, as well as humans. 

The ability of these viruses to cross the species barrier from time to time creates 

the possibility for the appearance of new viral strains that have the potential to be 

highly infectious, readily transmissible, and highly lethal. If a pandemic virus strain 

emerges, it is estimated that upwards of 30 percent of people exposed could become 

infected and the death rate will likely be considerably higher than that seen with 

seasonal influenza. Faced with such a threat, the United States and its international partners will need to respond quickly and efficiently to reduce the scope 

and magnitude of this serious health threat. 

Today’s threat is the H5N1 avian influenza strain, which is spreading widely and 

rapidly in domestic and migratory fowl in Asia and now in Eastern Europe. While 

the virus has not demonstrated the ability to spread efficiently from person to person, it has infected more than one hundred people in Asia and approximately 50 

percent of these known cases have died. The virus is now endemic in many bird species and in several countries, so elimination is not feasible. The feared pandemic 

could become a reality if this virus mutates further, remains highly virulent, and 

acquires the capability to spread as efficiently from person to person as do the commonly circulating virus strains that produce seasonal influenza epidemics. But even 

if H5N1 does not lead to a pandemic, the likelihood of an influenza pandemic at 

18

some point remains high. This is why we need to prepare now in order to swiftly 

and efficiently respond to an outbreak. 

We are taking important steps forward. Last week, I released the HHS Pandemic 

Influenza Plan, which is a blueprint for pandemic influenza preparation and response. The HHS Plan provides guidance to national, State, and local policy makers 

and health departments. The goal is for all involved to achieve a state of readiness 

and quick response. 

The HHS Plan includes an overview of the threat of pandemic influenza, a description of the relationship of this document to other Federal plans and an outline 

of key roles and responsibilities during a pandemic. In addition, the HHS Plan 

specifies needs and opportunities to build robust preparedness for and response to 

pandemic influenza. The preparations made for a pandemic today will have lasting 

benefits for the future. 

A pandemic outbreak will allow very little time to develop new capabilities or 

build surge capacity for response if these efforts are not already in place. Unfortunately, current capacity for domestic manufacture of influenza vaccine and antiviral 

drugs can meet only a small fraction of the need projected for a pandemic response. 

If we are to have the capabilities and capacities needed when a pandemic emerges, 

the investments to bring them about must be made now. That is why the President 

is requesting additional FY 2006 appropriations for HHS totaling $6.7 billion for the 

HHS Pandemic Influenza Plan. Our goals in seeking this funding are to be able to 

produce a course of pandemic influenza vaccine for every American within six 

months of an outbreak; provide enough antiviral drugs and other medical supplies 

to treat over 25 percent of the U.S. population; and ensure a domestic and international public health capacity to respond to a pandemic influenza outbreak. 

First, we must establish the domestic vaccine production capacity our Nation will 

need to protect all Americans within six months of detection of a virus that begins 

to spread efficiently from human to human. In anticipation of an influenza pandemic, we must stockpile in advance sufficient quantities of pre-pandemic vaccine 

that is protective against circulating influenza virus strains with pandemic potential 

in order to be in a position to initiate vaccination of health care workers and frontline workers critical to the pandemic response. These pre-pandemic vaccine stockpiles must be regularly reevaluated and potentially replenished as the pandemic 

virus threat mutates and changes, and as vaccine potency degrades over time. In 

addition, as the virus strains evolve and potentially escape protection by the existing vaccines, newer vaccines that better match the current pandemic strain will 

need to be produced and stockpiled. The Nation must also expand its stocks of 

antivirals, personal protective equipment (masks, gloves, etc.) and other supplies to 

help provide a potentially over-burdened healthcare system with the means to treat 

and care for those who become seriously ill in an influenza pandemic. 

Second, we must enhance the disease surveillance systems both internationally 

and domestically and train the personnel needed to reliably detect an outbreak 

quickly and to accurately determine its lethality and transmissibility. This includes 

obtaining samples of the virus from infected humans and animals and having laboratory capacity, personnel, and supplies necessary to conduct rapid analysis. Surveillance is our early warning system, and faster detection will enable public health 

officials to make recommendations about containment protocols, such as limits on 

travel and the assembly of large groups of people. Faster detection and identification 

of emerging influenza virus strains facilitate the conversion by industry to mass production of pandemic influenza vaccines. Better State, Federal, and international diagnostic laboratory systems will also allow for increased surge capacity needed to 

support front-line medical personnel, and effectively guide the use of scarce drugs, 

vaccines, and other resources. 

Improved surveillance systems, including near real-time collection of data from 

hospital emergency departments in major metropolitan areas through BioSense, will 

allow us to continuously track the spread of the virus and the morbidity/mortality 

it produces and to evaluate the effectiveness or our intervention strategies. This information will be critical to determining the best uses of limited supplies of pandemic influenza countermeasures. We will also track vaccines and immunizations to 

ensure that we maximize its equitable use as well as its effectiveness and safety. 

Third, we must develop in advance domestic and international plans for broad 

public education efforts that are culturally appropriate and provide critical information in ways that acknowledge different levels of health literacy. These efforts before 

and during a pandemic will help guide individual actions to prevent and reduce infection and clarify the need for prioritization of scarce vaccines and antivirals and 

other materials. Our request also includes funding for States and local municipalities to develop and/or update their pandemic influenza response plans and to integrate them with Federal plans. 

19

INFLUENZA VACCINE

The Administration has been aggressively working to be able to acquire, over a 

two-year period, enough H5N1 vaccine and antivirals to protect 20 million people 

should they become infected with the pandemic virus. On July 15, 2005, the Administration submitted an FY 2006 Budget Amendment totaling $150 million to implement our ‘‘20/20’’ plan. This strategy was designed to give us considerable experience with commercial-scale manufacturing of this new vaccine, and provide some 

pre-pandemic vaccine to our stockpile. However, as we are only able to obtain prepandemic vaccine during the few months of the year when influenza vaccine manufacturers are not running at full capacity making the seasonal trivalent vaccine, we 

are severely limited in the quantity of vaccine that we can stockpile. In addition to 

this limitation, since the submission of this Budget Amendment, we received results 

of H5N1vaccine clinical trials funded by NIH. As part of this strategy, the NIH has 

funded clinical trials of H5N1 influenza vaccine—which provided good news and, at 

the same time, sobering news. The good news was that the vaccine we developed 

works—it provides a good immune response that augurs well for protecting people 

against the H5N1 virus. The sobering news was that to achieve the desired immune 

response, the vaccine needed to be six times as potent as the seasonal vaccine—90 

micrograms of the hemagluttinin component instead of 15 micrograms—and that 

two doses are needed for the protective immune response. This has further driven 

home a point of which we were all aware—that the nation’s capacity to produce 

enough 90-microgram doses of pandemic vaccine was woefully inadequate. We need 

an aggressive strategy to achieve the needed domestic vaccine manufacturing capacity as quickly as possible, and to initiate similarly aggressive action to implement 

other immediate preparedness strategies beyond these critical vaccine needs. This 

budget request is just such a strategy, building on the July Budget Amendment and 

responding aggressively to the results of the NIH clinical trials and our growing 

concern that a pandemic could involve hundreds of communities across the United 

States and around the world. 

Of this week’s $6.7 billion funding request, approximately $4.7 billion would go 

toward investments in creating pandemic influenza vaccine production capacity and 

stockpiles that will ensure that enough vaccine will be available to every American 

in the event of a flu pandemic. To accomplish this, HHS will pursue a multi-faceted 

strategy to create, as soon as possible, domestic influenza vaccine manufacturing capacity aimed at producing 300 million courses (two doses of vaccine per person) 

within six months of the onset of an influenza pandemic. With this immediate investment, the increased production capacity and related stockpile expansion will be 

achieved in phases between 2008 and 2013. 

The initial component of this strategy is to expand the number of licensed domestic egg-based influenza vaccine manufacturers from the single one that currently exists. This would give the U.S. the ability to develop a 20 million course (40 million 

doses) pre-pandemic vaccine stockpile by 2009 without disrupting the production of 

annual seasonal influenza vaccine. In the event of a pandemic outbreak, or perhaps 

before, the vaccine stockpile would be used to immunize healthcare workers, frontline responders, vaccine manufacturing personnel, and others critical to the pandemic response. Once this capacity is developed, current egg-based production techniques could then provide about 60 million courses of vaccine within six months of 

an outbreak, or about 20 percent of our goal of 300 million courses within six 

months. 

The ultimate surge capacity goal of 300 million courses of vaccine cannot be 

achieved from egg-based production alone. Our best hope for creating capacity in the 

U.S. for rapidly ramping up vaccine production at any point in time is expansion 

and acceleration of our investment in cell-based influenza vaccines—and much of 

our planned investment goes toward this initiative. While promising, success of cellbased influenza vaccine production and licensure is still years off, and not a guarantee. Therefore, our vaccine capacity expansion strategy invests in both cell-based 

vaccines and the traditional, tried and true egg-based vaccines. Therefore, HHS, in 

collaboration with the vaccine industry and its academic partners, will invest in the 

advanced development of cell-based techniques for manufacturing pandemic influenza vaccines. By financing the establishment of new cell-based vaccine manufacturing facilities that could open in 2010, our plan will develop the surge capacity 

needed to provide for the remaining 80 percent (approximately 240 million courses) 

of the population within six months of a pandemic outbreak. 

The HHS Pandemic Influenza Plan also acknowledges that existing manufacturing facilities can be directed to this effort and finances the retrofitting of existing 

domestic manufacturing facilities that would enable them to convert to production 

of pandemic influenza vaccine production, in an emergency. HHS will establish conVerDate 0ct 09 2002 13:12 May 02, 2006 Jkt 000000 PO 00000 Frm 00023 Fmt 6633 Sfmt 6621 F:\DOCS\26891.TXT HCOM1 PsN: JOEP
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tingency arrangements with vaccine manufacturers in conjunction with the Food 

and Drug Administration so that, at the onset of an influenza pandemic, they will 

be able to readily adapt their facilities either to produce influenza vaccines or to provide a critical function, such as fill and finish bulk vaccine produced by other manufacturers. 

We will also work with industry and academia to support advanced development 

of dose-stretching technologies, such as the use of adjuvants and new vaccine delivery systems. These investments, if successful, will extend the pandemic influenza 

vaccine supply and allow more Americans to receive pandemic vaccines sooner. We 

will also invest in research that may have potential to lead to broad-spectrum vaccines to protect against multiple and emerging strains of influenza viruses. This 

would allow for stockpiling of vaccines that could be useful even as the virus strains 

evolve and change. 

However, as we seek to build domestic manufacturing capacity, we also know that 

the threat of liability exposure is too often a barrier to willingness to participate 

in the vaccine business. As we recognize the desperate need to create and expand 

vaccine manufacturing capacity, we have to remove such deterrents to participation 

by those with the knowledge and experience to accomplish this. It is crucial that 

those engaged in this work be shielded from unwarranted tort suits. Accordingly, 

the Administration is proposing limited liability protections for vaccine manufacturers and providers, with an exception to allow suits to proceed against companies 

who act with willful misconduct. We believe this proposal strikes an appropriate balance of removing the liability risks that dissuade companies from producing pandemic countermeasures, while still retaining appropriate access to court remedies. 

ANTIVIRALS

We also recognize the importance of having available a sufficient supply of stockpiled antiviral drugs to treat and care for infected individuals. For this, we request 

an investment of $1.4 billion. These funds would help us achieve the national goal 

of having available 81 million courses of antivirals, which would be sufficient to 

treat 25 percent of the U.S. population (75 million courses) and a reserve supply 

(6 million courses) that could be used to contain an initial U.S. outbreak. Funding 

would also be used to accelerate development of promising new antiviral drug candidates in collaboration with academia and industry, since none of the antivirals 

today are likely to work perfectly against pandemic influenza. 

Of the 81 million courses, six million courses will be designated to contain the 

first isolated domestic outbreaks. Of the 75 million courses that will be used to treat 

those who are infected with the pandemic virus, HHS would fully fund the procurement of 44 million treatment courses to provide protection to the highest priority 

groups in the event of an influenza pandemic. We will also work with our State 

partners to encourage them to acquire antivirals for rapid use for their populations. 

To help support these States efforts, we would establish contractual arrangements 

with manufacturers of approved antivirals whereby States may purchase up to 31 

million treatment courses and HHS would pay for approximately 25 percent of the 

costs of these drugs. This arrangement will also ensure a more coordinated intergovernmental approach in the acquisition of antiviral drugs and pre-deployment 

stockpiles of antivirals around the nation. A guaranteed acquisition of up to 81 million courses of antiviral drugs will enable manufacturers to make significant expansion in its U.S.-based manufacturing capacity—thereby positioning itself to meet future demands much more readily than currently is possible. 

I have personally been meeting with leaders of relevant vaccine manufacturers to 

determine how they might participate in preparedness for and response to a pandemic. To facilitate the development of new antivirals, HHS will collaborate with 

industrial organizations to develop, obtain approval, and establish commercial production of new antivirals that would help protect the citizens of our Nation. 

DISEASE SURVEILLANCE, PUBLIC HEALTH INFRASTRUCTURE, AND RISK COMMUNICATION

In addition to the production and stockpiling of vaccines and antivirals, enhancing 

domestic and international resources to expand surveillance, strengthening public 

health infrastructure, and effectively communicating with the public about risks of 

an influenza pandemic are important components of the HHS Pandemic Influenza 

Plan, for which we are requesting $555 million. A critical step in enhancing public 

health infrastructure and international collaboration will be to implement and refine surveillance and epidemiological response. These investments will help us detect, investigate, and respond to the onset of a potential influenza pandemic anywhere in the world without delay. Because influenza characteristically spreads beyond country boundaries, we have included in our request funding to be used interVerDate 0ct 09 2002 13:12 May 02, 2006 Jkt 000000 PO 00000 Frm 00024 Fmt 6633 Sfmt 6621 F:\DOCS\26891.TXT HCOM1 PsN: JOEP
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nationally. These funds will follow the evolution of the virus in Asia, detect human 

cases, and help contain outbreaks, where feasible. 

With an enhanced domestic and international early warning system, we will be 

better positioned to mount an immediate emergency response to characterize the 

outbreak; obtain viral samples for analysis and possible vaccine production; and we 

will have a greater chance to prevent, contain, and/or retard the spread of infection. 

The ability to continually analyze data to help predict the further course of the pandemic will help guide the choice and timing of interventions (drugs, vaccine, and 

public health measures) and will help assess the efficacy of these interventions. 

Enhancing our public health infrastructure also includes expanding the science 

base at the Food and Drug Administration, thus allowing for expedited regulatory 

review of pharmaceutical industry initiatives to develop the necessary new vaccine 

technologies, as well as speeding the licensure of the facilities and vaccines produced 

within them. 

Risk communication is another integral part of an effective public health response 

plan. We must have in place the capability to employ effective risk communication 

practices that will guide us in providing the American people with the accurate, 

timely and credible information they will need to protect themselves and help others 

during an influenza pandemic. To ensure that our communications efforts resonate 

with target audiences, we will solicit the public’s active participation and involvement in our efforts to develop relevant, easy-to-understand information and materials regarding influenza in general, and pandemic influenza in particular. To help 

in this effort, we have established a website devoted exclusively to this topic, 

pandemicflu.gov. 

Public participation and involvement may include engaging the public in discussions on State and local community preparedness; assisting communities in developing procedures for disseminating information and guidance for all segments of our 

diverse population; and developing targeted informational tool-kits for distribution 

to particular stakeholders such as educators, physicians, and employers. 

STATE AND LOCAL PARTNERS

Pandemic planning needs to incorporate every department of the Federal government but must also go deeper than that. Every State and local government must 

have a pandemic plan. Unlike most disasters, a pandemic outbreak can happen in 

hundreds or thousands of places simultaneously. The Federal government will play 

an important role, but engaged state and local partners are necessary for our success. Over the coming days, I will be asking the governors, mayors and State and 

local health and preparedness officials to join me in a concern we all must share—

preparing for a pandemic should one happen. Everyone in society has a role. 

For example, the Federal government can deliver stockpiles of medication and 

supplies to a city in the U.S. in a matter of hours—but it is distribution at the State 

and local level that defines victory. In a moment of crisis, if we are not able to deliver pills to people over wide areas in short time frames, lives will be lost. We need 

to create a seamless preparedness network where we are all working together for 

the benefit of the American people. Of the $555 million for surveillance and public 

health infrastructure, our Budget request includes $100 million specifically for State 

and local pandemic preparedness efforts. And, as mentioned previously, we will provide incentives to States to purchase their own stocks of antivirals by allowing them 

to buy off of HHS-negotiated contracts and subsidizing about 25% of the cost. 

The plan and budget request outlined above will greatly improve our short and 

long term preparedness posture. We are well-positioned to implement the plan and 

invest these new resources wisely and effectively only because of the substantial 

pandemic influenza activities already underway at HHS. Scientists at the National 

Institutes of Health and the Food and Drug Administration, working with industry, 

have developed a vaccine that produces an immune response sufficient to provide 

protection from the H5N1 virus. This bodes well for our ability to develop a vaccine 

against a pandemic virus that may evolve from the current H5N1 strain. In September, HHS awarded a $100 million contract to manufacture 3.3 million doses of 

H5N1 vaccine, which at two doses per person would be enough for 1.67 million people. In addition, just last week we announced the award of a $62.5 million contract 

to produce even more vaccine. We have also initiated contracts to secure an adequate supply of specialized eggs to initiate surge production at any time of year. 

This is not a new undertaking. We are making progress, and with your help will 

continue to do so. We realize we are asking for significant funding at a time when 

the Administration and Congress are trying to control spending and reduce the deficit. We have controls in place at the Department, and within the structure of the 

funding request, to ensure that these funds are used wisely and responsibly. We acVerDate 0ct 09 2002 13:12 May 02, 2006 Jkt 000000 PO 00000 Frm 00025 Fmt 6633 Sfmt 6621 F:\DOCS\26891.TXT HCOM1 PsN: JOEP
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knowledge that investing in this plan without perfect knowledge of the future is expensive, and not without risk. However, waiting until a pandemic begins would be 

much more expensive in terms of American lives and economic impact. In our view, 

waiting is not an option. 

I look forward to answering your questions, and more importantly, to working 

closely with you as we move forward together to protect our citizens.

Chairman BARTON. Thank you, Mr. Secretary. 

We do appreciate you and your staff attending today. 

My first question is about Tamiflu. Is Tamiflu, by itself in its 

current configuration, an effective vaccination to the Avian Flu as 

we know it today? 

Mr. LEAVITT. Mr. Chairman, I will respond. I am also going to 

call on my colleagues on occasion. I am able to plunk out a twohand version of the melody, but you can get a full symphony from 

them. But let me respond, first of all, to Tamiflu. 

Tamiflu has become, regrettably, in the popular writings as synonymous with preparedness, and it simply is not. There is no certainty that Tamiflu will work with the H5N1. There are indications 

that it has a very positive effect, but there is no certainty. 

Tamiflu is an antiviral that is given once a person gets sick, but 

it has to be given within 24 to 48 hours for it to have the optimal 

effect. We will, in fact, have the needed doses of Tamiflu. We have 

had direct discussions and negotiations with the developer, the 

manufacturer. But I would like to go to Dr. Fauci to give a little 

more detail on Tamiflu and where it fits in a comprehensive pandemic plan. 

Mr. FAUCI. Thank you, Mr. Secretary. 

Mr. Chairman, Tamiflu, as you heard, is a treatment for influenza, seasonal influenza, and hopefully would have some benefit in 

the pandemic flu. 

First of all, with regard to the broad picture, we consider this as 

one of a multi-component preparedness plan, including the public 

health measures that the Secretary mentioned. The foundation of 

our prevention and our preparedness is really vaccine, as witnessed 

by how we explain that in the plan as well as by the budget itself. 

And then, finally, there are antivirals. 

The issue that we need to make sure we don’t fall into the trap 

of equating on a one-to-one basis that stockpiles of Tamiflu equal 

preparedness, because from a scientific and medical standpoint, 

that may not necessarily be the case. It certainly is the drug, since 

the virus appears to be sensitive to it. It is the only thing that we 

have when you talk about antivirals. We have a couple of classes 

of antivirals. That is the one that appears to be, together with 

Relenza, which is of the same class, the one that we are focusing 

on. But if you look at the history that we have about the use of 

Tamiflu in seasonal flu, A, it needs to be given within 24 to 48 

hours of onset of symptoms, which really is a burden when you 

have a lot of people who come into an emergency room already sick; 

second is that the data show that when you give it within that 

timeframe, it shaves off about 1.5 to, at the most, 2 days of symptoms. So if you were going to have a 7-day illness, you will have 

a 5- to 5.5-day illness. There are no very hard data yet that this 

antiviral will have major impact on the morbidity and the mortality of a pandemic flu. 

Chairman BARTON. So it is not really a solution. 

23

Mr. FAUCI. That is exactly the point we are making. It is the best 

we have, so we need to pursue getting doses and treatment courses 

in our stockpile. And we need to pursue the research endeavors 

that give us an additional number of antivirals that are what we 

call in the pipeline. But to rely on Tamiflu as the sole preventionand-response mechanism, I think, is ill advised. 

Chairman BARTON. Okay. 

Mr. Secretary, as you well know, this committee has got jurisdiction over, I think, almost everything within your agency’s jurisdiction. We have just gone through this in this committee, a process 

to reform Medicaid in which we have a plan that is going to provide some savings over the next 5 years. We are having a hearing 

in the next 2 weeks on Medicare physician reimbursement. Doctors 

of this country are expected to, if we don’t change the law, to receive a 4 percent cut in their reimbursement under Medicare. 

The proposal that you and the President put out on Avian Flu costs a little over $7 billion, I believe, over the next 3 years. As we 

move forward with the legislative package to try to implement or 

modify the Avian Flu proposal, are you willing to work with us to 

find ways to offset the cost of this proposal? 

Mr. LEAVITT. Mr. Chairman, having served as Governor for 11 

years, I know the pressures of budget, and this committee weighs, 

in some ways, complex financial issues. We, of course, are going to 

be anxious to work with the committee in whatever work its going 

to be doing on this and other subjects. 

I would like to emphasize, however, that the President has presented this as an emergency supplemental because he believes it 

to be an emergency. We need to be moving boldly in redeveloping 

this industry. We are not just asking this industry—we are not just 

proposing to fund the industry; we are asking them to put up substantial capital. We are asking them to devote substantial intellectual property. We are asking them to redirect their priorities to accomplish this task. And they need to know with some certainty 

that we are in the game as well, that we all have skin in this game 

and that we are going to accomplish it. 

Now I recognize they are competing priorities and we are anxious 

to be as helpful as we can in looking at the bigger picture. 

Chairman BARTON. Well, I understand that, and I just want you 

to know that if that supplemental came to the floor today and all 

that was in it was this, I would vote against it and would encourage others to vote against it. I don’t think it is fair to ask all the 

other groups in the health care community to work with us to find 

ways to improve efficiency and find savings, and then on this issue, 

which is not yet, it has the potential to be catastrophic, but it is 

not yet catastrophic, that we are just going to waive all of that and 

add to the deficit. With that, I want to yield to my distinguished 

ranking member, Mr. Dingell of Michigan. 

Mr. DINGELL. Mr. Chairman, thank you. Mr. Secretary and your 

distinguished associates, welcome. First question, has the administration estimated what it will cost to State and local governments 

to do what is expected of them in the administration’s plan? 

Mr. LEAVITT. Mr. Dingell, again, having just come from State 

Government, this is a subject I am quite sensitive about and know 

how my former colleague Governors are feeling and how State and 

24

local health officials are feeling. I want to emphasize how important I think it is that we are, in fact, able to accomplish what is 

necessary because this disaster, I know——

Mr. DINGELL. Mr. Secretary, with all respect, I have almost lost 

a minute of my 5 minutes. Can you just answer the question 

please? 

Mr. LEAVITT. If you will notice on that board, Mr. Dingell, you 

will see on the far right, enhanced public health infrastructure and 

international collaboration, $600 million. Roughly, we know that it 

is going to require not just that but devotion of public—or rather 

local resources as well. 

Mr. DINGELL. None of the States and local units of government 

have the resources to carry out these responsibilities. 

Mr. LEAVITT. It is going to require effort on all of our part, and 

I believe a reprioritization on all of our parts well. 

Mr. DINGELL. So the answer is, I think, then, you are telling me 

you don’t really know. 

Mr. LEAVITT. I think it is clear that they don’t. 

Mr. DINGELL. Now Mr. Secretary, do you believe that States—I 

am sorry. In terms of being prepared for the next pandemic, Mr. 

Secretary, do you believe that there is a gap between where the 

States are today and where they need to be in order to fully carry 

out the expectations of the plan that you have set forward? 

Mr. LEAVITT. There are gaps, I believe, in our system generally 

and States and local communities would be among them. 

Mr. DINGELL. Mr. Secretary, would you provide for the committee 

a State by State estimate of the cost of getting fully prepared in 

the next pandemic? Just submit that to the committee as opposed 

to doing it now. 

And Mr. Chairman, I ask you unanimous consent that I be permitted to communicate with the Secretary and that if the answer 

is not available this morning, would be inserted in the record at 

the appropriate time and fashion. 

Chairman BARTON. Without objection, so ordered. 

[The information referred to follows:]

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26891.001
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26891.002
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26891.003
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26891.004
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26891.005
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26891.006
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26891.007
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Mr. DINGELL. Mr. Secretary, the national strategy for pandemic 

influenza refers to novel investment strategies. That is a quote. 

What are these novel investment strategies? 

Mr. LEAVITT. I will ask Dr. Fauci to respond to that in the specific, but I will tell you that in the vaccine area, generally we are 

looking for ways to develop cell culture developments of vaccines in 

addition to expanding capacity on egg based. We are always looking for adjuvant technology which is, I think, Hamburger Helper 

for vaccines. It allows us to take the vaccine and spread it among 

more people and then—so egg, cell and adjuvant. 

Mr. FAUCI. Mr. Dingell, underscoring that, certainly the point 

that the Secretary made, but also that we have been over the last 

decades and decades involved in a rather standard way of make influenza vaccine which as the Secretary mentioned is egg based. 

And the future of that is going to try to grow the virus in a cellbased culture but——

Mr. DINGELL. I am going asking you what time it is Doctor, and 

you are telling me the theory of Sidereal time and you are giving 

me more than I want. What I really want to know is what are 

these novel investment strategies? Because I always have the dark 

suspicion when somebody gives me that, which I know comes from 

the Office of Management and Budget——

Mr. FAUCI. One of them is a novel approach of the—what we call 

the universal vaccine instead of having to change vaccines each 

year, you get the standard immutable component of the virus that 

doesn’t appear to generally induce a strong immune response. If 

you can get that in a form that induces an immune response, the 

strategy may be that you do not have to, each year, chase the flu 

that is a little bit different than the year before. 

Mr. DINGELL. Doctor, with respect, I am going to ask you to submit that answer in writing. 

Mr. FAUCI. Will do. 

Mr. DINGELL. Mr. Secretary, are there estimates of what the flu 

pandemic would cost this country in terms of lost productivity and 

the economic consequences of it? Do you have any idea of what that 

is? 

Mr. LEAVITT. I have seen estimates. They range in large but it 

is hundreds of billions. 

Mr. DINGELL. And essentially, they are sort of wild guesses. But 

would you give us your best wild guess on this matter, please, Mr. 

Secretary? 

Mr. LEAVITT. Mr. Dingell, I would need to submit that to the 

committee. I don’t have a wild guess. 

Mr. DINGELL. And I understand that well. I have some numbers 

here that have been submitted to the committee from a very responsible organization. $510,000 would be imposed on the State for 

the cost of purchasing antiviral medication, $250,000 for contingency planning, surge capacity not funded in the request, improved 

availability of diagnostics and reagents not funded in the requests, 

75 million. 

Now, risk communication, inadequately funded, and that is estimated $150 million. Are those numbers generally right or generally 

wrong? 

33

Mr. LEAVITT. At the risk of giving you more about the time of 

day than you want let me say that, there is 1.4 billion on the 

antivirals, those antivirals are going to be get kept for the most 

part in the States. A billion dollars or roughly 75 percent of the 

antivirals would be placed, done at Federal expense. If we were 

going to the full 81 million courses, the States would need to contribute, the number that you have acknowledged would be in the 

ballpark. 

Mr. DINGELL. Thank you, Mr. Secretary. Mr. Chairman, again, I 

repeat, may I have unanimous consent to submit some questions 

to the Secretary in writing and have both that and Mr. Secretary’s 

response inserted into the record? 

Chairman BARTON. Without objection. 

Mr. DINGELL. Mr. Secretary, gentlemen and ladies, thank you. 

Chairman BARTON. Mr. Upton. 

Mr. UPTON. Thank you, Mr. Chairman, Mr. Secretary, I share 

your alarm and concern that we are not where we need to be, particularly in light of the director general’s comments, the WHO, 

today, when he said that, quoted, it is only a matter of time before 

an avian flu virus, most likely H5N1, acquires the ability to be 

transmitted from human to human, sparking the outbreak of a 

human pandemic influenza. 

And in your testimony, you referenced a new vaccine that is currently in trials. It does not yet have the FDA stamp of approval, 

as I understand it. 

What is your expectation as to how quickly, we would be able to 

get this new vaccine to treat 25 percent of our population and what 

would be the cost? 

3 years? 2 years? If this is looming over our heads now, so, it is 

going to come. I think we both agree it is going to come. So what 

is——

Mr. LEAVITT. Congressman, I am reluctant to use a timeframe 

or—not because I am unwilling to give you one, but sitting today, 

I am not sure I can respond with the specificity your question requires. We would be pleased to respond after it has been calculated. I will tell you, we believe it will be 3 to 5 years before we 

will have cell-based technology. And we are looking at ramping this 

up as rapidly as we can with egg based. Dr. Raub, do you have any 

insight on this? 

Dr. RAUB. Sir, if the requirement today were to produce a vaccine 

against what would be the pandemic virus—not the H5N1, but the 

one that would let’s say derive from it, in a 6-month period, we 

would likely only be able to produce about 13 million doses of the 

vaccine. 

And we project that each person would need 2 doses. So that 

would be coverage for 7 million people—far below what preparedness requires. And therefore, the reason that the primary element 

in the budget proposal is a $4.7 billion investment to revitalize and 

expand the capacity of vaccine production in the country to get 

every citizen covered in that 6-month period. 

Mr. UPTON. So how many dosages does $4 billion get us? 

Dr. RAUB. The plan is in two parts. The plan for the egg based 

production, based on the tried and true technology, would get us 

two things. It would get us approximately 40 million doses of a vacVerDate 0ct 09 2002 13:12 May 02, 2006 Jkt 000000 PO 00000 Frm 00037 Fmt 6633 Sfmt 6602 F:\DOCS\26891.TXT HCOM1 PsN: JOEP
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cine against the H5N1 or something like it, but also, would get us 

the capacity to surge beyond that, when and if the pandemic virus 

occurred. The parallel investment in the cell-based facilities would 

get us the other 80 percent of the surge capacity. So the investment 

is less in buying vaccine now than it is creating the capacity to 

produce vaccine quickly when it is needed. 

Mr. UPTON. Now do we not have, go ahead, Dr. Fauci. 

Mr. FAUCI. We just want to add something that I think is important, because this is a moving target. That is based on the early 

clinical trial data that you need 90 micrograms followed in 4 weeks 

by 90 micrograms, which is about 6 to 12 times larger dose than 

we generally use for seasonal flu. 

There are studies that are ongoing right now on adjuvants that 

might lessen that which would impact on the timeframe we are 

talking about. So that is a very important issue because those data 

are going to be coming out in the next several months. 

Mr. UPTON. I am told that cell-based vaccine production is actually done now in some animal health labs. Is that correct? 

Mr. FAUCI. That is correct. 

Mr. UPTON. So we have the technology we just have to——

Mr. LEAVITT. Cell-based vaccines are used in other areas, but we 

have not achieved it in flu. Okay. The estimate is it will be 3 to 

5 years before we will be able to. 

Mr. UPTON. My last question in my opening statement, I shared 

my frustrations with the current distribution of this year’s flu vaccine. Where are we in terms of looking at some type of new demonstration or new distribution system that we could use for what 

may be coming? And what are the costs associated with moving to 

a different distribution type of system? 

Mr. LEAVITT. I will ask Dr. Gerberding from CDC to respond. 

Ms. GERBERDING. Because we have not been able to substantially 

increase the production of vaccine, even though we now have four 

companies in the market, and actually have at least 20 million 

more doses this year than last year, we cannot have the adequate 

match between the three factors, the demand among people for vaccine, the geographic distribution at the micro level to the doctor or 

the clinic that needs it, and the supply timing coming out of the 

factories over the flu season. The investments that are proposed in 

terms of modernizing our vaccine would allow us to have a robust 

supply and really eliminate a lot of these distribution mismatches 

that are so upsetting to so many people including CDC. 

Mr. UPTON. Thank you. Now my time has expired. 

Chairman BARTON. Mr. Markey. 

Mr. MARKEY. Can I pass? 

Chairman BARTON. Sure. 

Mrs. DeGette. 

Ms. DEGETTE. Thank you Mr. Chairman. In the opening statements, a lot of folks kept talking about this should not be a partisan issue. And I agree. I think it is too important to our constituents and our citizens. And I would note that if you look at the history of avian flu preparedness, the first draft of the plan was presented to Donna Shalala in 1998 under the Clinton administration, 

and then in 2001, when we had the outbreak of avian flu in Southeast Asia, Tommy Thompson was Secretary of HHS. And he, acVerDate 0ct 09 2002 13:12 May 02, 2006 Jkt 000000 PO 00000 Frm 00038 Fmt 6633 Sfmt 6602 F:\DOCS\26891.TXT HCOM1 PsN: JOEP
35

cording to The Washington Post this week, was livid that he didn’t 

have a plan and he wondered why it was taking so long. Then we 

had 2 years after that, no plan, a lot of hearings in Congress, as 

the Secretary alluded to. 

And now, here we have Secretary Leavitt and unfortunately, the 

administration is the administration, and they are the ones that 

are tasked with being ready for this. And it does happen to be the 

Bush administration. So, you know, if Secretary Shalala was here, 

I guess I would be asking her these questions. 

We finally have this plan. I have got it here. It looks like it was 

in development for a long time because it is slick and long and all 

of that. But my question is, Mr. Secretary, why has the plan taken 

so long to finally be released? 

Mr. LEAVITT. The plan is still in development. There are many 

parts to it. And let me describe what I mean. What you see there 

is the HHS medical and public health corps. 

In addition to this, there are currently plans being developed, for 

example, at the Department of Transportation, at the Department 

of——

Ms. DEGETTE. So what you are saying is this isn’t even the full 

plan, right? 

Mr. LEAVITT. There are plans being developed in State and local 

governments. In order to have a national plan, we need to have an 

ongoing planning process. And we have a plan. But it is a plan that 

can be improved and that will get better, we are better prepared 

today than we were yesterday and we will be better prepared tomorrow than we are today. 

Ms. DEGETTE. And let me talk to you about that, because now 

I have the Colorado plan, too, which was actually promulgated in 

2003. It is not as slick. But one thing the Colorado plan says is 

that with the exception of a few antivirals, which I now know don’t 

work for this particular strain of avian flu, the Colorado plan says 

that the Federal responsibility is, Number 1, deployment of federally purchased vaccine and Number 2, deployment of antiviral 

agents in the strategic national stockpile. 

Do most of the States have a similar plan for how they are getting antivirals and vaccines? 

Mr. LEAVITT. Most of the States do have a plan that references 

the Federal stockpiles. 

Ms. DEGETTE. We don’t have a Federal stockpile, do we, Mr. Secretary? 

Mr. LEAVITT. We do. It is just not as big as we want it to be. 

Ms. DEGETTE. How big is it? 

Mr. LEAVITT. We have currently in place or to be received soon 

about 5 million courses of Tamiflu. 

Ms. DEGETTE. Right. And how many courses of Tamiflu do we 

project that we need? 

Mr. LEAVITT. Our first target is to get to 20 million. 

Ms. DEGETTE. By what time? 

Mr. LEAVITT. We will achieve that by the fourth quarter of 2006. 

Ms. DEGETTE. That is with full Federal funding? 

Mr. LEAVITT. We have vendor representations that we will 

achieve that by the fourth quarter of 2006. And we have a target 

36

of 81 million courses, and we have vendor representations that we 

will achieve that by the mid part of 2007. 

Ms. DEGETTE. And my question is, is that with full Federal dollars or is that relying on the State match? 

Mr. LEAVITT. The Federal plan that you have before you would 

put 50 million courses of Tamiflu that would be distributed 

throughout the country that would be at Federal expense. If the 

States chose to go beyond that, then we would participate under 

this plan by subsidizing their purchase by 25 percent and allowing 

them to use the Federal price to do that. 

Ms. DEGETTE. Okay. And the vendors have agreed to that plan? 

Mr. LEAVITT. Well, we have vendor representations that they can 

produce at that level. 

Ms. DEGETTE. And it would be at the Federal price, the 

antivirals that went to the States? 

Dr. RAUB. The concept is doing it through a Federal contract. 

And I don’t believe it is an issue with the vendor. In many ways, 

the larger the order we can make at once, the faster we can get 

delivery because the vendor will invest in new production facilities. 

Ms. DEGETTE. I have just one more question, because I am almost out of time. What happens, say, if Colorado decides to participate in this optional 75/25 percent match, but Wyoming doesn’t. 

What happens if you have a patchwork of States? Isn’t that why 

we need a coordinated Federal approach? 

Mr. LEAVITT. First, let’s remember that Tamiflu is one component of a comprehensive plan. Second, let’s emphasize—I would 

like to emphasize that every State will have access to a stockpile 

of Tamiflu. Some States may decide to have a larger stockpile for 

reasons that are unique to their plan. And if they do choose to do 

so, we are prepared to subsidize their purchase by 25 percent. If 

they choose not to, they will have very significant stockpile of 

Tamiflu available to them. They simply will not have purchased 

more. It will be a judgment call that States needs to make. 

And this is an important part of the plan, because States have 

got to become engaged on this plan. If they can put in their plan 

the Federal Government will take care of it, they are not engaged. 

And they need to be engaged in this. They need to—they can’t be 

counting on the Secretary of HHS to decide whether their local 

school is going to open or close. Likewise, they ought not be counting on the Federal Government, in my judgment, to make certain 

that they can put a pill in everybody’s palm at the right moment, 

because the Federal Government simply——

Ms. DEGETTE. My time is up and you are exactly right. The problem is the States don’t have any resources. And we are just getting 

ready to cut their Medicaid programs by, I think, $10 billion. It is 

a problem all around. And I appreciate your commitment to it. 

Chairman BARTON. Mr. Stearns. 

Mr. STEARNS. Thank you, Mr. Chairman. Dr. Fauci, we have 

about 11 million illegal immigrants in the United States. That is 

what they project, plus or minus. And we have a lot of illegals coming in today. 

How will we screen in the event we have legal immigrants coming, what will we do about the illegal immigrants, in your opinion, 

to protect us, and keep this under control? 

37

Mr. FAUCI. Mr. Stearns, that certainly is not in my area of expertise or activity. So I would have to——

Mr. STEARNS. CDC? 

Mr. LEAVITT. The question you are really asking is better answered by CDC. 

Ms. GERBERDING. Two short perspectives, and we can provide 

more for the record. First of all, we do have responsibility for our 

quarantine stations at the borders and that is where we look for 

people with illness coming into our country by any means. Second, 

in terms of anyone presenting with an illness that may be infectious, our State and local communities have traditionally taken on 

the responsibility of providing the appropriate public health treatments and services for those individuals at their expense. 

Mr. STEARNS. But you would agree, though, at this point a lot 

of people coming in that are illegals every day and we don’t have 

control of our borders. So isn’t that a difficult thing for the United 

States? Doesn’t that even make it more clear why we should control our borders in the event that we have a pandemic in the 

United States, and yet our borders are porous and we have a lot 

of illegals coming in, and we have no idea whether they have the 

avian flu or not? Wouldn’t that be a concern of yours? 

Ms. GERBERDING. It would be a misrepresentation to think that 

this is a border issue because the virus doesn’t understand borders. 

It is really the connectivity from people from one region of the 

world to another regardless of whether they are moving legally or 

illegally. 

Mr. STEARNS. But if the United States had the Tamiflu vaccine 

but Mexico didn’t. Or Mexico didn’t equip their country as well as 

we do, wouldn’t you have Mexico—a lot of these people perhaps 

having this avian flu come into the United States, and you would 

have no way of controlling our borders, and this would represent 

a threat to us no matter what you did. 

Mr. LEAVITT. We are in an active conversation with the health 

ministry and all also the head of State level with Canada and Mexico for that very reason. So. 

Mr. STEARNS. So don’t you have to work in tandem with Canada 

and Mexico so as much as we have to say to ourselves, United 

States must be prepared, if you don’t prepare Mexico, possibly, 

Canada, and you have a lot of people immigrating into Canada and 

from Canada coming in——

Mr. LEAVITT. Actually it needs to go beyond that. The President 

has formed the international partnership for pandemic influenza 

and we now have 88 countries that are a part of an effort to create 

a global or international surveillance system where we are able to 

determine that if it happens in Southeast Asia in a remote village 

of Cambodia that the moment they have it, we need to heard about 

it. And obviously, there are lots of cross pressures, economic cross 

pressures, that work against that. But we are working very hard 

for that reason to assure that we have transparency and cooperation among nations. 

Mr. STEARNS. And the other question I have is dealing with 

Posse Comitatus, the homeland security was looking at this in trying to control the borders. They never did anything with it. In the 

event that we had to mass distribute vaccines, in the event of a 

38

catastrophic outbreak of pandemic influenza, is there any thought 

to relaxing Posse Comitatus and to, as a viable option, to help the 

military deliver the medication, or at least help in the process? 

Mr. LEAVITT. There has not been discussions of that. I will tell 

you that as the others have mentioned, there is a need, at times, 

to be able to deploy in any natural disaster, military assets, primarily for transportation. 

Dr. Raub, do you have anything to add to that? 

Dr. RAUB. Sir, in our preparedness working with our other colleagues in the States on bioterrorism, in our planning with our colleague and other agencies including the Department of Defense 

and States with respect to distributing antibiotics on a bioterrorism 

event, the preferred modality for the Department of Defense is the 

National Guard, with the means where the Department of Defense 

would underwrite a substantial part of the cost of the activation of 

the guard. But it would be under the control of the State officials 

not the Pentagon. 

Mr. STEARNS. In 1918, when we had the pandemic, was the military used at all back then? 

Mr. LEAVITT. Actually in 1918, it was the military through which 

most of it spread, it began in. 

Mr. STEARNS. Thank you, Mr. Chairman. 

Chairman BARTON. Gentleman from Maine, Mr. Allen. 

Mr. ALLEN. Thank you, Mr. Chairman. 

Mr. Secretary, in your previous comments, were included responses to the gentlelady from Colorado that we have the vendor 

is promising 20 million courses by the end of 2006, and 80 million 

courses of Tamiflu by mid 2007. I take the point that Tamiflu isn’t 

the complete answer. But it is the first line of defense. 

How confident are you in those projections? And do you know 

whether or not the vendor—well, first of all, is the vendor Roche? 

Or does this include some other companies being licensed or any 

other steps that you might take? 

Mr. LEAVITT. Roche has made very clear that they do not intend 

for intellectual property issues to become a barrier in their meeting 

those recommendations. And they have indicated a willingness to 

work with other manufacturers who are prepared and willing to do 

so. 

And we have asked the FDA—I have dispatched the FDA to 

work with them and any potential vendor to do so. 

I will tell you that while I am not a chemist, I have pressed hard 

enough on this issue to understand the process. And it is a very 

complicated multi part process that includes, in some cases, rather 

dangerous explosives processing. And it is not likely, in my judgment, nor those who advise me, that we will see any other manufactures of Tamiflu certainly within a year, and more likely, 2 

years. 

And that would be true in this country or in any other country. 

Mr. ALLEN. Well, let me go back. There are companies in other 

countries that are ready, able—well, ready is the question—but 

who have expressed an interest in manufacturing a generic version 

of Tamiflu and are seeking and have been inquiring with Roche. 

The problem I mentioned in my opening is that it seems pretty 

39

clear we have an insufficient manufacturing capacity for anti flu 

drugs today. Would you agree with that? 

Mr. LEAVITT. That is true, yes. 

Mr. ALLEN. Back on August 30, 2003, World Trade Organization 

members adopted the so-called Paragraph 6 agreement. And it 

spelled out the rules by which countries with insufficient manufacturing capacity could import needed pharmaceuticals produced 

under compulsory licenses. The U.S. Government chose to opt out, 

and persuaded—the U.S. Persuaded the EU and Japan and Australia and other countries to opt out of that system. That means 

that if Indian or other companies developed a source of Tamiflu 

that the U.S. Government would not be able to import those 

antivirals into this country. And I guess my question is, does that, 

in retrospect, look like a wise decision or not? 

Mr. LEAVITT. Mr. Allen, let me make clear that in a pandemic 

situation, I think all those who have modeled and studied it believe 

that whatever—you will get what is produced domestically. That is 

one of the reasons we have pushed so hard for Roche to develop 

the domestic manufacturing capacity which they have agreed to do 

and are in the process of developing. I don’t believe that will be an 

issue in a pandemic, because I think people who have it within 

their borders will keep it. 

Mr. ALLEN. That may well be if it is global and not concentrated 

in one country or another. 

Back when we had that Cipro scare—when we had the anthrax 

scare here and Cipro was the available drug to treat it, Secretary 

Thompson said—essentially threatened the compulsory licensing. 

Would you be prepared to do the same? And I grant you, what 

you have said before, I grant you the manufacturing process is long 

and difficult and complicated. But would you prepared to issue a 

compulsory license if Roche failed to provide inadequate authority 

for to expand production here? 

Mr. LEAVITT. I do not contemplate that being a circumstance that 

would present itself. It is important, however, that people in this 

country know we will do everything necessary to protect them. 

Mr. ALLEN. Thank you. One final thing. Back on May 20 of 2004, 

I wrote to the Department seeking information about the Department’s analysis of the U.S. Australian free trade agreement and its 

potential impact on Medicare and Medicaid programs. That intersection is, I think, great importance. I haven’t had a response to 

that. I submitted a question for the record to you at this committee’s hearing on February 15th of this year asking for an update. 

I sent a follow-up letter to HHS on April 20, 2005, also seeking an 

update. I still don’t have a response. 

I would urge you, Mr. Secretary, to respond to that. It is a matter, I believe—the intersection between our health care programs 

and our free trade agreements, I think, is a matter of great importance, and I would very much appreciate a prompt response. 

Mr. LEAVITT. That does not sound like the type of response that 

we aspire to give, and I will follow back up on that. 

Mr. ALLEN. I am sure it is not. Thank you. 

Chairman BARTON. Before I go to Subcommittee Chairman Deal, 

my understanding is that Roche has applied for a license and given 

40

a third party the opportunity to produce its Tamiflu in the United 

States, and that has been approved, isn’t that correct? 

Mr. LEAVITT. They have indicated a willingness to provide licensure for anyone who can meet the standards of production that are 

necessary to produce it. To my knowledge, no license has yet been 

completed. We have, in fact, indicated to them that the FDA would 

work to cooperate and develop that. 

Is there anything that has happened that I don’t know about 

Bill? 

Dr. RAUB. No. 

Chairman BARTON. Subcommittee Chairman Deal. 

Mr. DEAL. Thank you, Mr. Chairman. When we talk about traditional flu, we talk about traditional flu season, which would be the 

fall and into the winter. When we talk about avian flu, does it, 

likewise, have a seasonal threat, or is it a year round threat? 

Mr. LEAVITT. I will ask Dr. Gerberding to respond to that. 

Ms. GERBERDING. There is a seasonal pattern to the avian outbreaks in Asia right now among the poultry. We are coming into 

the high season now where we would expect the most transmission 

in the poultry, and, of course, then secondarily the most transmission to people. Whether or not that pattern would hold true in 

the context of a pandemic is not something we can predict. In the 

last pandemic there was very little seasonality. The pandemic occurred in 2 or 3 waves. And they were relatively independent of the 

season. 

Mr. DEAL. Once the virus is able to obtain the ability to be transmitted from human to human is when the real pandemic threat occurs, as I understand it. 

Does that virus, when it acquires that ability in a mutation, I assume, does it then become immune to the vaccine that was created 

for the original H5N1? Is it a different virus at that point? 

Mr. LEAVITT. I will ask Dr. Fauci to give you the answer. 

Mr. FAUCI. The answer is highly likely yes. So there is a high 

degree of protection of a certain virus. And it changes to become 

more efficient in going human to human. It is likely that it will 

change enough that the protection will diminish. It may not going 

down to zero, but it will be clearly less efficient than it is in protecting against the original virus, which is the reason why we emphasize, including in the plan, that what is critical is not necessarily a vaccine against this H5N1, but building the capacity so 

that when that virus, and we hope it never does, but if and when 

it changes, that the capacity will be building up, that you can take 

that updated version of the virus, plug it into the system and make 

that your vaccine. 

Mr. DEAL. What is the lag time on that component? 

Mr. FAUCI. The lag time on that is generally, traditionally is 

about 6 months when you are dealing with seasonal flu from the 

time you plug in a new vaccine. How long it is going to take to get 

to the doses levels that we need is going to depend on a lot of 

things that I mentioned a few minutes ago are a moving target, 

namely whether or not for example and adjuvant would allow us 

to get to a reasonable dose as opposed to the quite high dose that 

we are dealing with now. 

41

So it could take anywhere from a year or even more or if you 

really have a good system going you could do it. And that is the 

ultimate goal in the plan to get to that 6-month time from the time 

you press the button. We are certainly not there right now. 

Mr. LEAVITT. That includes the manufacturing he is speaking of. 

Were you asking about the development of the virus vaccine itself. 

Mr. DEAL. Both of them yes. 

Mr. LEAVITT. Vaccine would be a shorter period, manufacturing 

would be on top of that. 

Mr. DEAL. For those of us who have children or grandchildren 

who are in schools, we all know that that is one of the environments in which diseases are transmitted and flu is no exception. 

In my household, we have the disease of the week, depending on 

what my granddaughter has picked up in play school for the week. 

Would the decision to have a schoolwide inoculation be a component of, and would that be assisting in preventing any kind of 

spread, not only of this kind of flu, but also other flu viruses, if we 

had a pattern that would inoculate the entire school-based population, and would that also maybe incentivize some of the vaccine 

manufacturers to ramp up to accommodate that? Because I don’t 

think that is the pattern now, is it? 

Mr. LEAVITT. I will ask Dr. Gerberding to answer, and then I 

would like to add to that. 

Ms. GERBERDING. Thank you. The experts in immunization evidence are currently assessing whether or not a school-based program or a universal vaccination of children for seasonal flu is now 

warranted. And it looks like more and more of the data are taking 

us in that direction. 

In the context of a pandemic, we would certainly want to be able 

to immunize people in all kinds of venues, and schools would be a 

logical place, A, because kids are there and it is easily accomplished. But second because children are one of the major forces of 

respiratory illness transmission. They bring these illnesses home to 

their parents and their grandparents. And it really is an important 

hot spot in the community. So that makes a lot of sense. 

Mr. LEAVITT. Go to the next. 

Mr. DEAL. My time is just about out. Quickly, we have invested 

with two manufacturers I believe to develop the H5N1 vaccine at 

the current time, is that correct? 

Mr. LEAVITT. That is correct. 

Mr. DEAL. And are they going to be the primary suppliers that 

we look to for any vaccine? 

Mr. LEAVITT. Actually the strategy we are deploying would call 

for us to look for what was referred to earlier as innovative strategies. We are going to invite the entire marketplace to give us ideas. 

We would then invest in those that were the most promising with 

benchmarks. 

We would then require they bring the benchmark points back 

and we will continue to invest as they continue to show progress. 

Our model calls for us to have multiple manufacturers, four or 

more, in order to get to 300 million courses in the 6-month period 

that we aspire to achieve. 

Mr. DEAL. Thank you, Mr. Chairman. 

Chairman BARTON. Mr. Green of Texas. 

42

Mr. GREEN. Thank you, Mr. Chairman. Mr. Secretary, just before 

Tom Allen left, he is from Maine and my neighbor to my left is 

from California, but my State of Texas, we have 1200 miles of border with Mexico and multiple cities straddling it. I am interested 

in whether the administration has planned a specific consideration 

for surveillance in those local governments or State governments 

along border areas, particularly United States and Mexico, because 

that is our neighbor, I am sure. Mr. Allen is interested in Maine 

and Canada. And what would be the States’ financial responsibility 

with regard to that surveillance, and does the plan afford any special consideration for, again, those local governments that border—

because most of our health care is actually not provided by the 

State. It is by the county health departments or the city health departments along the border, just like it is in my urban area. 

Is there any special consideration for those border areas? 

Mr. LEAVITT. Your question points out the fact that public health 

is a State and local responsibility primarily, and that under current 

circumstances, State and local health departments are required to 

monitor and screen for disease in different ways. It would fall into 

that same category. Obviously if the plan does not make specific 

provision for borders beyond the fact that we have a specific need, 

generally, in those areas. 

Mr. GREEN. There is no other resource for example? Because—

and I always use the example if someone has infectious tuberculosis in Matamoras, Mexico, it will be in Brownsville, Houston, 

Dallas or San Antonio because of the nature. So there won’t be 

anything differently done because of the——

Mr. LEAVITT. Dr. Raub with like to add some to that answer. 

Dr. RAUB. Sir, over the last 3 years, we have had a special 

project for early warning infectious disease surveillance along the 

U.S. Mexican border, not limited to flu, but to other infectious diseases, among others those that could be result of bioterrorism. We 

have been investing about 4 million a year on the U.S. Side 

through our four States, and we made a one-time award about 3 

years ago to our Mexican colleagues of about 5.5 million, such that 

there could be some complementary activities in the six Mexican 

States that border the Rio Grande. That continues to be an effort 

that is not part of this budget, we see it as strongly complementary 

and pertinent to your question. 

Mr. GREEN. I was impressed during Katrina with the amount of 

CDC personnel and the public health services actually came to the 

Houston area and Dallas and to other areas where evacuees were, 

so I would hope they would also be activated if we get to that point 

in the future. 

Mr. Secretary, the plan provides $100 million in funding to the 

States and local jurisdictions to help them develop the preparedness and response plan for the pandemic flu. This is the same time 

the administration this year proposed 130 million cut in the CDC’s 

public health preparedness program. Even with that $100,000 in 

funding for State, local and public health, it would still be a loss 

of $30 million in preparedness. 

How does the administration reconcile this cut to the CDC’s public health and preparedness program with the obvious need for 

State funding to prepare for a pandemic flu? 

43

Mr. LEAVITT. It would be important to reconcile the 130 million. 

It is being referenced as a cut. The reality is it was changed from 

one line to another. It went into a national stockpile and the number and the money literally went from one line item to another. It 

was not a cut. 

I would like to recognize as well that the 100 million that is 

being spoken of is simply to help them update their plans and to 

exercise them. If you look at what is in this plan for State and local 

governments, the billion dollars in antivirals for example, most of 

that will go to States. $600 million listed in the category of surveillance and public health preparedness all be going to States—are 

going into stockpile for the use of States. So to suggest that 100 

million is the limit to which we are working to assist local governments would not be consistent with the facts. 

Mr. GREEN. My last question in 30 seconds is, our community 

health centers are all over the country, and again we are working 

in the Houston area for more. How will they be part of the—will 

they also be a repository or depository for integrated and surveillance and outreach notification and also will they be able to receive 

the avian flu vaccine like any other public health agency? 

Mr. LEAVITT. This—your question, again, points out the importance of having State and local preparedness plans, because the 

community health centers will be an integral part of every one of 

the State’s plans. They will be used differently in every State because every State has a different circumstance. 

Mr. GREEN. So for the few I have, I want to make sure I need 

to go to the our State health commissioner, Dr. Sanchez, to make 

sure they are integrated. I don’t think we will have a problem with 

that. Thank you. 

Mr. BILIRAKIS [presiding]. The Chair recognizes himself. 

Mr. Secretary, we have talked a lot, and you have just now, 

about the roles and responsibilities of the Federal Government and 

of the States and the reason why the States have to be and the 

local governments have to be a large part of the process. But let’s 

go into the roles and responsibilities of individuals in preparing for 

and preventing the spread of a flu pandemic, and I guess I would 

ask, since there have got to be roles and responsibilities that you 

are going to share with us, are we planning, or is HHS contemplating communicating those preventive ideas to the public? 

Mr. LEAVITT. Thank you, Mr. Chairman. Creating a clear sense 

of division of labor is enormously important, because there will be 

so much decentralization. I think generally in our emergency response, it is important to recognize that there will be limits in a 

pandemic to what the Federal Government can do and ought to 

represent it can do. 

That will be true, to some extent, to local and State communities 

as well, and there will be a responsibility for individuals. That is 

endemic in citizenship. 

The personal preparedness, having the ability to sustain oneself 

for a period of a couple of days, for example, would be important 

without going to the grocery store. We live in a 711, 24-hour grocery store mentality where we use it for our pantry as opposed to 

having a small supply of food or having a supply of water, or having a 72-hour kit. All of these things will apply in a pandemic in 

44

the same way as they would for a hurricane or tornado or any 

other medical emergency. 

Mr. BILIRAKIS. Well, basically what you have said is that when 

the American public knows that a pandemic flu is eminent, then 

of course that is when those individual roles would come into play. 

Will there be, or should there be, any roles or responsibilities in 

the meantime between now and then? Let’shope that never happens. But as you have already indicated, I guess it is coming, 

maybe not this particular flu, but something, pandemics will come 

some time in our future, I suppose? 

Mr. LEAVITT. This is a good example of why it is so important 

that we are talking about this in a way that informs but does not 

inflame and that inspires people to prepare, but does not create a 

sense of panic. This is today essentially an animal disease. We 

worry that it could become something else, and if it isn’t this virus, 

it will be something else that will ultimately occur, it is a broad 

pandemic preparedness, a major part of our plan involves how do 

we communicate with people during those periods. 

In many respects, we have the biology that existed in 1918, because we have no human immunity, but at the same time, we have 

a 24-hour news cycle, where people are going to find out about it. 

And the ability to manage that communication is part of what 

every State, every local community needs to deal with, and frankly 

something that we need to be thinking about, both in Congress as 

well as at HHS and throughout the administration. 

Mr. BILIRAKIS. Well, thank you, sir. It is certainly critical that 

Congress play a constructive role in all this. And I am sure there 

must be areas of particular importance in the preparedness plan in 

which Congress could focus to benefit both annually, if you will, 

and anti-influenza preparedness and I am not going to really—

there are a lot of areas that take more than the minutes that I 

have left. But I would hope that maybe you and your great staff 

there would share with us what we can do up here from a legislative standpoint, and any other ways to be helpful in what you are 

planning and your preparedness plan. 

Mr. LEAVITT. Thank you, Mr. Chairman. These plans will continue to develop and improve. One area that is not receiving as 

much attention as it ultimately deserves is animal health. This is 

an animal disease right now. And as long as we can keep it—as 

long as it stays an animal disease, people are, for the most part, 

unaffected. But it has a profound impact economically, and it could, 

in fact, become the source of the problem. So we need to focus on 

animal health as well as human health. 

Mr. BILIRAKIS. Well, sir, Mr. Secretary, questions have been 

asked about the dollars not being adequate as far as the States’ 

roles are concerned. And how much money has been appropriated 

pursuant to the Public Security Act, subsequent appropriations to 

enhance State, local and hospital preparedness under grants from 

the Centers For Disease Control and health resources and services 

administration, and I guess I would ask if you have an answer to 

that, how has this funding helped prepare us up to now for pandemic flu preparedness and how much of that funding has actually 

been used by the States and local governments? 

45

Mr. LEAVITT. Some 3 years ago, the Congress appropriated a $5 

billion amount to go into State and local mass casualty preparation. A good share of that has not yet been drawn by the States. 

We believe that those dollars can, in fact, and should be used to 

enhance their broad preparedness, but every dollar they spend in 

their broad medical preparedness for mass casualty preparedness 

will help on pandemics as well. 

Mr. BILIRAKIS. So that money is available but it hasn’t been 

drawn by the States? 

Mr. LEAVITT. That is correct. 

Mr. BILIRAKIS. That is interesting. Thanks very much Mr. Secretary. Let’s see, Mrs. Eshoo. 

Ms. ESHOO. Thank you Mr. Chairman, Secretary Leavitt and everyone that is here. Thank you, again, for being here. This is an 

very important hearing and discussion. 

Secretary Leavitt, the plan calls for stockpiling 75 million doses 

of the antiviral medications. We have gone through this, but I just 

want to set this down for the record and go back to what I referenced in my opening statement. 

Of that amount, 44 million would be purchased by the Federal 

Government, State and local governments would be responsible for 

75 percent of the cost, it is a 75/25 share, as I understand it, for 

the remaining 1 million doses. 

What I don’t think the plan provides for or doesn’t have any details, on what would happen if a State can’t afford to pay its share 

of the cost? What do you have built into the plan to address that? 

You know, in listening to some of the comments that I have 

heard today, I think that members are leaving out the first description of our country, and that is United. We are not just the States 

of America. We are the United States of America. And over and 

over and over again, our success, in meeting so many of the challenges that have confronted our country, is that we partner, and 

partner strongly with the States. This is not about some big daddy 

handout or States trying to grab what they can. 

You know, some things, might be characterized that way. But 

that is not the best about us. 

So I think that your plan as it is drafted right now, this is isn’t 

a final plan, is it? No. 

Mr. LEAVITT. It is continually being improved. 

Ms. ESHOO. Continually evolving, and we are going to improve 

it. I think this is a real shortcoming. I am not going to ask you to 

answer that. I think that there are many members that have set 

this down. And I think that we can do much better than this. As 

a matter of fact, I think we have to. So, that is my first point. 

Mr. LEAVITT. Would it be helpful if I reconciled or a portion of 

that financially for you? Would you like me to do that in a different 

way. 

Ms. ESHOO. You can write to me about it. Let me get the rest 

of my questions out. 

Mr. LEAVITT. Let me make clear that we are not just leaving our 

States on their own. There will be 50 million courses that will be 

distributed in large measure among the States, and they won’t pay 

for any of that. If a State chooses to go beyond that, we are preVerDate 0ct 09 2002 13:12 May 02, 2006 Jkt 000000 PO 00000 Frm 00049 Fmt 6633 Sfmt 6602 F:\DOCS\26891.TXT HCOM1 PsN: JOEP
46

pared to help them with their responsibility for public health by 

subsidizing it——

Ms. ESHOO. So if they can’t afford that percent, then we are 

going to step? 

Mr. LEAVITT. They will all get a basic allotment of Tamiflu. And 

they will have it available to them. If they, in their planning, conclude, that they would desire to have more, then we will subsidize 

that. And in addition to that, we will have 6 million courses that 

are deployable wherever we need them that haven’t been——

Ms. ESHOO. So regardless of a State’s circumstances—let me take 

Louisiana. 

Mr. LEAVITT. That’s correct. Regardless of their circumstances, 

they will have access. There may be some States——

Ms. ESHOO. Is 50 million enough? How did you come up with the 

50 million? 

Mr. LEAVITT. We came up with it by looking at previous 

pandemics and the percentage of the population generally that is 

infected. But it is impossible to say where those will occur. So we 

are developing a strategy so that we could deploy additional resources if we needed it into an area that was particularly hard hit. 

On the other hand——

Ms. ESHOO. If I might—excuse me for interrupting—I think it is, 

you know, it is broader than this in many ways, because when you 

look at where the split is and the share and what you are describing and what I understand the plan represents, there are not the 

kinds of resources that we hear from, in local government, and on 

the ground at home, where there has been more and more responsibility placed on first responders, on our public health system, and 

so, you know, those are pressures and burdens that are there, you 

are a Governor, you know what this is. I came from county government. I certainly have an appreciation of it. 

So I am emphasizing this, because, you know, if they don’t get 

what they need, then we are not going to have a successful plan, 

period. 

And if I might raise something else, I think my time is just about 

winding down, the plan mentions risk communication is an integral 

part of the effective public health response. Mr. Bilirakis and I 

have introduced legislation on acts, on 211. Only 47 percent of the 

Nation has access to it. And it is a telephone number for community, volunteer, Health and Human Services information and referral. And it is a very important linkage. 

I would ask that you look at the 211 system, and consider, very 

seriously building it into the plan. 

We will, you know, if you haven’t seen the legislation, we will 

make sure you get a good summary or your staff can give it to. Because I think that this is something that could be built in and 

worked to implement different parts of the overall plan that you 

have put forward as secretary. So I would just, you know, note 

that. And I wanted to get to Dr. Fauci. I am not going to have time. 

Dr. Gerberding, the last time you were here——

Mr. BILIRAKIS. The gentlelady’s time has expired. 

Ms. ESHOO. If I might just throw this in or ask that you respond 

to the question that I raised in the hearing that we had on the cuts 

to the CDC and how they would effect. You didn’t have time to——

47

Mr. BILIRAKIS. Can you do that conceivably in writing? 

Ms. ESHOO. That is what I am asking for, in writing, Mr. Chairman. Thank you. 

Mr. BILIRAKIS. The 211 pointforce is a very good one. I just wanted to get clear, if I may follow up with Ms. Eshoo’s. I have asked 

you about the Public Health Security Act and dollars that are 

available there. And as I understand it, approximately 2.5—about 

50 percent of that money is still available, $2.5 billion is available 

for the States to draw on? 

Mr. LEAVITT. 50 percent would be more than it represents. They 

draw, period. They draw part of the 04, they commit it, and so it 

is not—that would be an exaggeration, but it is roughly 20 percent. 

Mr. BILIRAKIS. So that money is available for these purposes that 

we are now talking about, States preparedness? 

Mr. LEAVITT. That is correct. 

Mr. BILIRAKIS. And not drawing on them, and yet we apparently 

hear, and it is true, that the States are not getting enough money 

in there. There are problems there and that sort of thing. But there 

is money sitting someplace there that that they can draw. 

Mr. LEAVITT. This would be a great way for them to use it. 

Mr. BILIRAKIS. Mr. Ferguson—Mr. Walden. 

Mr. WALDEN. There is a news report out today about a new way 

to detect flu that can occur in 11 hours rather than a matter of 

days, and CDC apparently has or has approved. Can any of you describe that for me, because that can certainly make a difference in 

detecting an outbreak? 

Ms. GERBERDING. We are using several new strategies for diagnosis of cases of flu, including a PCR-based rapid test that can diagnose the genome of the organization that doesn’t require you to 

culture it in the test tube. Many of these rapid tests are already 

available commercially, and can be done at the bedside. But what 

is specifically relevant right now is a rapid test that can tell you 

if it is H5 or so, other strain of flu influenza. 

And that test is not being used right now, but the manufacturer 

has made some representations that the test would be useful in 

this regard. We haven’t validated that at CDC. 

Mr. WALDEN. But it is something somebody is working on? 

Ms. GERBERDING. Absolutely. 

Mr. WALDEN. That is good to know. Mr. Secretary, you were a 

Governor for 11 years in Utah. As the administration put together 

this plan, was it done without any consultation with the Governors? 

Mr. LEAVITT. We are in constant discussion with the Governors. 

I do now intend, once the national or the Federal HHS core is in 

place, to begin meeting at the President’s direction with every Governor in every State. We will be having, very shortly, a meeting 

with the Governors or with Governors’ representatives in Washington, and then we will literally be going to communities saying 

to them, here are the components of preparedness. Let’s hold it up 

against where you are and see how we can be helpful. 

It will need to be a broad-based community plan because it is, 

as indicated, it deals with schools, transportation, et cetera. 

Mr. WALDEN. In terms of the international outreach, was it this 

administration’s initiative to pull together this coalition of counVerDate 0ct 09 2002 13:12 May 02, 2006 Jkt 000000 PO 00000 Frm 00051 Fmt 6633 Sfmt 6602 F:\DOCS\26891.TXT HCOM1 PsN: JOEP
48

tries, to be able to identify the outbreak of a pandemic? Was this 

administration the one that organized that? 

Mr. LEAVITT. The President initiated the international partnership. And there are now 88 countries, and, I believe, 12 international organizations that are part and it continues to grow. 

Mr. WALDEN. Do those countries—and I know you may not know 

this for every one, but do they have a flu plan similar to what we 

have or are they developing them? What is the status there? 

Mr. LEAVITT. Some do, but many do not. 

Mr. WALDEN. There is a conference going on in Geneva today, I 

believe some 600 participants. What is our role in that conference? 

Mr. LEAVITT. We have a delegation there. I was in Ottawa last 

week. In the spring, I called the health ministers together from the 

affected countries to begin a conversation. We are—I am leaving 

next week to go into Rome to meet about the seven health ministers of the G-7, plus Mexico. So this is a matter of great international activity, and the United States is very clearly not just contributing, but in many cases leading. 

Mr. WALDEN. I mentioned in my opening comments the need for 

self preparedness, and my friend from Washington sort of made 

light of it about a Swiss army knife and a compass, and that, I 

guess, is fine. It is obviously more than that and that wasn’t what 

I was saying. What about individuals? Most of us, watching what 

is happening, frankly, after Katrina and Rita and other national 

disasters, realize the limitations of the government at any level to 

take care of us when a real problem breaks out. 

What is it we can do individually to protect our families, our 

home—I mean, our neighborhoods. Is it possible to get Tamiflu, 

which could reduce the outbreak—is it possible to get the detection 

tests so we know so we can, I mean, what would it take? What is 

the best thing we can do individually? 

Mr. LEAVITT. Well, Congressman, you have appropriately identified distribution as the place where victory is won. The Federal 

Government can drop stockpiles into a State or community, but it 

is actually getting the pill into the palm of the person that creates 

safety and security. 

This is an issue not just with Tamiflu, but it is an issue in any 

of our stockpile remedies. 

We are currently, exploring 5 different alternatives on how we 

can assure the distribution is done properly. One of them is to have 

stockpiles in local communities. Another is to provide for things, 

such as postal distribution of them. A third is to have first responders of some supply. 

Mr. WALDEN. Are there some of those that could be presupplied 

out or preshipped out to individuals——

Mr. LEAVITT. Those are the alternatives we are looking at. And 

we want to find the best model because, frankly, I am not persuaded that the model of simply having stockpiles around the country will work because you have to get them there so quickly. 

Mr. WALDEN. Here is my concern is that if a third of Americans 

are going to fall ill to this very, very—what could be a very dangerous and deadly disease, it may be that the entire supply lines 

for everything we have are disrupted, from food to medicine to 

medical care. What if a third of the people in the hospital, a third 

49

of the doctors, third of the nurses, third of the fire fighters, are all 

dying from this flu bug? That is why I am so passionate about—

I want to have command and control to the extent—thank you, Mr. 

Chairman. 

Mr. BILIRAKIS. Ms. Capps to inquire. 

Mrs. CAPPS. Thank you, Mr. Chairman. 

Mr. Secretary, a few years ago, I was able to see the emergency 

response, though it was new at that time at HHS, and it was impressive in part because of the ability of the center to track how 

many beds there are at any given moment in every health facility 

around the country. But as I asked then Secretary Thompson, I 

was told that it isn’t able or we are not able to gauge whether or 

not there is adequate staff at each of these health facilities around 

the country to respond to a crisis. 

Now, as we prepare, assess our preparedness for a pandemic, I 

will ask you, how many of the health facilities that I know you can 

document have adequate staff to meet such a need? 

Mr. LEAVITT. We actually had an opportunity to see that system 

tested with Katrina. We were very quickly able to identify many 

thousands of beds in that region, and we were able to track literally on a day-to-bay basis how many of the beds were occupied 

and how many had capacity. 

Our ability to track those—the staffing requirements for them 

was less exact, though it improved as time went on. We actually 

established a command center where we were able to deploy various components of volunteers from one place in the country to another to be able to assist in getting giving respite. 

Mrs. CAPPS. Could I ask you the question then, are we adequately staffed to meet a pandemic at the various facilities now 

around the country? 

Mr. LEAVITT. The difficulty in a pandemic is people would not be 

as anxious to go from one part of the country——

Mrs. CAPPS. Right. So I assume your answer is, no. 

Mr. LEAVITT. Well, I think it would be different from one area 

to the other. 

Mrs. CAPPS. And this is the fact that was made known by the 

American College of Healthcare Executives in October of 2004 

when they reported that 72 percent of the hospitals in this country 

are experiencing a nursing shortage. I am using nurses as an example of health care workers, one of the largest numbers in any 

community. If we are even close to that number, we are a long way 

off from being prepared to respond. 

Now, I want to talk about nursing recruitment and education. 

We are currently spending about $150 million. I don’t believe that 

is enough to address the shortage that we have to meet our needs 

today. Current funding levels fail to meet the growing need for 

nurses. In fiscal year 2004, HRSA was forced to turn away 82 percent of the applicants for the Nurse Education Loan Repayment 

Program and 98 percent of the applicants for the Nurse Scholarship Program due to lack of adequate funding within this part of 

our Federal Government. And in 1974, which was our last serious 

nursing shortage, Congress appropriated in today’s dollars $592 

million, approximately four times what we are spending now. 

50

It is not if we are going to have a pandemic; it is when. We don’t 

know the particular strain, but we do know who we need to have 

in the front lines in every community to respond to this need. So 

I am asking if you would support a substantial increase in nurse 

education funding? 

Mr. LEAVITT. The need for more nurses is well documented. 

Mrs. CAPPS. Could you support an increase in funding? 

Mr. LEAVITT. Well, in the context of large budgets, obviously, 

there is a need for more nurses. I am not in a position——

Mrs. CAPPS. But we have seen budget cuts in this particular 

area. Is that an adequate—is that the kind of response that our 

country needs to see from the Congress? 

Mr. LEAVITT. Well, the need for more nurses is easily documented, and——

Mrs. CAPPS. And I am assuming that because it is well documented—this is one thing that is documented—that I can count on 

your support for increasing—I am saying now to the panel——

Mr. LEAVITT. Well, you can count on my enthusiasm——

Mrs. CAPPS. Enthusiasm and support are very different things. 

Mr. LEAVITT. Obviously, we are dealing with specific budget proposals that will need to be made, and I am not in a position to say 

I will support——

Mrs. CAPPS. You do acknowledge that we have a shortage. 

Mr. LEAVITT. I do. 

Mrs. CAPPS. Thank you. 

I have another topic that I would like to bring up. The President 

has submitted legislation that would give manufacturers of a pandemic flu vaccine liability protection. However, the administration 

has not supported any mechanism for meaningful compensation for 

people who are injured by the vaccine. The last time the President 

called for mass vaccinations—I know because I got one—was when 

the administration launched a smallpox immunization program. 

This program was an almost total failure. And I am generalizing 

from this experience to something we might expect in the future. 

The heroic first responders being asked to risk their health for 

their country were not being given any assurance that they or their 

families would be taken care of in the case of an adverse effect. 

They didn’t sign up as a result, and they refused to be vaccinated. 

We can’t afford to have that happen in a pandemic flu. 

Given that so much less is known about a pandemic flu vaccine, 

the risks are even higher for our first responders—I am speaking 

now of the people who will man the health facilities around the 

country who would also be at risk of exposure. We clearly need to 

compensate first responders if they are harmed when doing what 

we ask of them. 

And with regards to vaccine injuries, one effective model of compensation is the Vaccine Injury Compensation Program for Childhood Vaccines. This is something that exists. This is a no-fault approach which allows people injured by vaccines to receive compensation. I am asking, will this administration support a compensation program that gives fair compensation to people who may 

be injured by a pandemic flu vaccine? 

51

Mr. LEAVITT. The proposal, as it currently exists, deals with the 

liability. I feel confident that the compensation issue will continue 

to be a matter of——

Mrs. CAPPS. Could I get—I think I also may be entitled to an 

extra minute I since I didn’t give an opening statement. 

Mr. DEAL [presiding]. He says you have already been given that. 

Mrs. CAPPS. Well, I feel like this is very essential to moving any 

kind of program—if we are going to put a lot of money toward developing vaccines, we certainly must be thinking about the ways in 

which it is going to be delivered, and that includes not only liability 

to the companies that make it but also compensation for risks that 

are undertaken by those given it. And I would like to have a written response from you as to what we might expect from the administration. If this is a plan in process, this plan that you are here 

to explain, I certainly believe that one essential ingredient to it 

needs to be a compensation plan. 

Mr. LEAVITT. Thank you. 

Mr. DEAL. The gentlelady’s time is expired. 

Mr. Ferguson. 

Mr. FERGUSON. Thank you, Mr. Chairman. 

I thank, again, the Secretary and your colleagues for being here 

again today. This is a very tough, complex issue, and you know it 

better than anybody. And it is going to really require an enormous 

amount of work on all of our part. You have a huge responsibility. 

We have a responsibility to work with you on this, and I very much 

appreciate your and the administration’s willingness to take this on 

because it is so crucially important. 

If you will forgive me, I would like to use my time to make a few 

points. I do have a question when I get to the end of that, but I 

want to make several points that I think are important to make. 

And since we had limited opening statements, I just want to get 

a couple other things on the table. 

Mr. LEAVITT. I will just sit back and enjoy it. 

Mr. FERGUSON. Thank you, I hope you do. 

Earlier, someone was asking you about the acceleration or development of the cell culture technology and how long it would take. 

You had said 3 to 5 years. That is the kind of timeline that we are 

dealing with. So, obviously, we are talking—the plan calls for making a lot of investments in the new technology to get vaccines in 

the pipeline, to get them available and to mass produce them as 

is going to be necessary. Given this extended time line that I think 

we are acknowledging is a part of developing a vaccine, the plan 

also calls for, I think, a billion dollars or a billion and a half, I 

think, for stockpiling of antivirals. We talked about Tamiflu. We 

talked about the role of antivirals. The plan that the administration put forward said that vaccines and antivirals, quote, have the 

potential to significantly reduce morbidity and mortality during a 

pandemic, unquote; and, quote, may also limit viral spread. 

I think we all understand that there is no silver bullet in this. 

I think we all understand that Tamiflu has some limitations, as 

Dr. Fauci talked about before, but also something that everybody 

acknowledges, it is the best thing out there. Given some limited options, it is the best thing we have going for us right now. And when 

we are talking about 3 to 5 years of technology that is going to enVerDate 0ct 09 2002 13:12 May 02, 2006 Jkt 000000 PO 00000 Frm 00055 Fmt 6633 Sfmt 6602 F:\DOCS\26891.TXT HCOM1 PsN: JOEP
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able us get to a vaccine, and when we are talking about, you know, 

the pandemic plan states that vaccines and antivirals are going to 

be in short supply in the event of a pandemic, it states that a pandemic vaccine can only be made once that pandemic virus is identified. That could take 6 months or more. Assuming that the capacity 

for large-scale production of a vaccine is already available, it could 

take 6 months or more once the pandemic hits for us to develop the 

vaccine and then mass produce it. We are talking about a lot of 

lives, and I am not telling you anything you don’t already know. 

It just seems to me antivirals are a crucial tool in preventing the 

spread of this virus and treating patients during the course of the 

pandemic. 

I am sure—I would imagine you saw this op-ed in the Washington Post. It may have been yesterday. I know it was the last 

couple of days. Sebastian Mallaby—I don’t know who this columnist is. I don’t know his background or if it is a man or woman 

even. I don’t know anything about this columnist. Maybe you do. 

And I am going to quote extensively from this column. It says, I 

quote, the United States has failed to get in line early. It has been 

weeks since panicky soccer dads began stockpiling Tamiflu, but the 

government has so far ordered enough of the drug and a similar 

medicine, Relenza, to cover just 1.5 percent of the population. Last 

week’s Avian Flu blueprint from the Bush Administration belatedly 

proposed to procure treatment courses for 75 million Americans. 

Congress has yet to come up with the money, and the plan assumes that the State and local governments will contribute $510 

million to the procurement effort. The scope for argument and 

delay seems endless.Meanwhile, and indeed for the next several 

months, the United States will have no significant stockpiles of 

Tamiflu. If the Feds and the States resolve their burden sharing 

arguments quickly, the earliest conceivable point at which the Nation may have stockpiles equivalent to that of Britain or France appears to be mid 2007. In terms of getting access to Tamiflu, the 

United States has been a failure. 

I want to get your response to that because I don’t know—I want 

to know if that is fair. But also, very quickly, I want to say some 

have suggested, even today, I think my friend, Mr. Allen, suggested 

that just stealing the patent from a company is a good idea, as 

some other countries have suggested we do. Clearly, that may be 

a decent short-term solution, but it is a terrible long-term solution. 

It gives no incentive for anybody to research these problems and 

to look to the future. We are shooting ourselves in the foot if we 

are going to start stealing folks’ patents in the interest of shortterm public health. Clearly, if we have a long-term strategy, if we 

are using real forethought, we don’t need to steal anybody’s patents; we can work with the private sector to make sure that these 

great products that they are investing in and developing are available on a broad scale. So I would love to get your reaction to that, 

to be fair. 

Mr. LEAVITT. First, those who have—some of our friends in other 

nations have ordered large stockpiles. They haven’t got them. They 

have just ordered them. We are in a similar situation in that we 

started ordering Tamiflu before anybody. In December of 2003 and 

2004, we started stockpiling it. 

53

I have been assured by those who make it that we will have a 

sufficient supply of Tamiflu. This is a place where our rhetoric 

needs to inspire preparation and not panic. Now, with respect to other antivirals, of the $1.4 billion you see in this budget, $400 million of it is for the development of new 

antivirals and improved antivirals that could be more specifically 

oriented at the virus we end up dealing with. No one is going to 

develop a new antiviral if they know that we are just going to take 

their patent and start producing it otherwise. That is a very important part of this, is maintaining the integrity of that intellectual 

property. 

Mr. DEAL. The gentleman’s time is expired. 

Mr. Markey, I believe you wish to be recognized at this time. 

Mr. MARKEY. Yes, thank you, Mr. Chairman. 

First of all, Mr. Secretary, congratulations on the program, and 

it is a tremendous advance of where we have been. And I congratulate you for that. 

Again, a couple of questions that were—you know, there are, in 

my opinion, some gaps. I remember in the 1950’s how reluctant my 

mother was to have me take that first polio vaccine shot. And I remember the conversation she had with Sister Superior where Sister was assuring my mother that it was safe. And my mother said, 

how do you know, Sister. And she said, well, the experts tell me. 

And I am sure that conversation goes on all over the country, not 

so much for the nurses or the doctors, but for their children, you 

know, what impact will it have upon their kids. 

So we have a situation here where there is already in place—and 

Mrs. Capps has already referred to it—a program for childhood 

vaccination compensation. This program would not have a compensation program for our children, for our families if something 

went wrong with the vaccination in terms of its impact on family 

members. And so while this other program is universally acclaimed 

as a success, the Child Vaccination Fund, here we are going to 

have a gap on something that is probably considered by parents to 

be even more problematic; that is, with the measles, the mumps 

and rubella, they probably figured, well, most of that has been 

worked out. They figured that out. Here is something that is going 

to be brand new. 

So, Mr. Secretary, how can we work together to have a compensation fund here? Because I am afraid that you will have hundreds of thousands and maybe millions of parents who are going 

to say, I am going to wait for the first year or so for my kid because 

I don’t want to run the risk. Can’t we figure out some way of having a compensation fund so that the family will at least know that 

they will have something there to rely upon that will help their 

family toward something that they don’t want to occur but would 

consider because the government was urging them to take this 

drug that didn’t have the full FDA approval process? 

Mr. LEAVITT. The proposal, as it is currently advanced, is for liability only. 

Mr. MARKEY. Liability for the manufacturer. 

Mr. LEAVITT. And your conversation and others make clear that 

the need for a compensation fund is a discussion that will continue 

and, I feel, will be an active conversation. 

54

Mr. MARKEY. An active—I am sorry. 

Mr. LEAVITT. An active——

Mr. MARKEY. An active conversation. And do you think it will 

bear fruit in the end in terms of putting together a fund? 

Mr. LEAVITT. I know it will be a conversation that we will engage 

in, and we look forward to a conversation on it. 

Mr. MARKEY. Well, I urge you, Mr. Secretary, just from my own 

personal family history. My mother was convinced that if every 

other kid in the school was inoculated, that there was no one from 

whom my brothers and I could catch it. And she made that point 

to Sister Superior, which was not welcomed, and she was essentially sitting in your chair to try and convince my mother, which 

she did, but reluctantly. 

On the issue of Indonesia’s 2-year lapse in notifying the WHO 

that the Avian Flu had already hit their country, it seems to me 

that it goes hand and glove with their membership in the World 

Trade Organization. That is, as we are trying to speed up trade, 

travel, tourism, which is an American interest, you also have these 

concomitant responsibilities on the part of these countries that 

then get the benefits of the World Trade Organization to realize 

that is how disease is going to be spread. And to hide it for a couple of years actually makes a mockery of the World Trade Organization membership. 

So I was just wondering, Mr. Secretary, if we could talk about 

having penalties in the World Trade Organization that harm countries, that penalize countries who don’t comply with WHO requirements, that they immediately notify that there is a pandemic disease that could affect other countries in the world. Do you believe 

that that kind of a linkage makes any sense? 

Mr. LEAVITT. I have met with heads of state and with health 

ministers all over the world, and I know there is a great concern. 

And this is a matter of terrific priority. And I know the State Department is working directly in ways to assure through the partnership that there is cooperation and transparency. 

I will tell you that that, having walked through wet markets and 

sat down on the edge of a bench with farmers in Southeast Asia, 

my biggest concern isn’t what will happen at the national government level. My biggest worry is the cross pressures that are felt by 

farmers in small Southeast Asian countries who depend on it for 

their protein and their livelihood. 

I mentioned earlier, one health minister told me that, last year, 

they had 14,000 deaths from rabies, something we don’t ever see 

or rarely see, I should say, in the United States. I worry that that 

farmer, if he sees 4 or 5 dead chickens, isn’t going to be nearly as 

concerned as that farmer needs to be, and our effort needs to be 

to create an ethic that goes very deep in those nations. 

Mr. MARKEY. My only point is that the only way to create that 

ethic is to let the government know there is going to be an economic penalty at the World Trade Organization, and then they 

have higher incentives to make sure they have a more intrusive, 

enforceable regime within their own countries. And without that 

linkage, I am afraid too many countries will just turn a blind eye. 

But anyway, I thank you for your good work, and I thank all of 

the people who you are working with. 

55

Mr. DEAL. The gentleman’s time is expired. 

Mr. Shadegg, you are next. 

Mr. SHADEGG. Thank you, Mr. Chairman. 

And welcome, Mr. Secretary. I would like to go over the numbers. 

I have actually gotten separate reports regarding the $7.1 billion. 

From my understanding of your testimony here today, that being 

that this is a $7.1 billion emergency appropriation, it is correct that 

we will be appropriating that entire amount this fiscal year; is that 

correct? 

Mr. LEAVITT. You would be authorizing that amount this year 

and appropriating, yes. 

Mr. SHADEGG. Authorizing and appropriating. 

Mr. LEAVITT. It would actually be used in over 3 years, but you 

would be authorizing and appropriating it this year. 

Mr. SHADEGG. So the authorization——

Mr. LEAVITT. You are appropriating this year. 

Mr. SHADEGG. So we would be appropriating the $7.1 billion this 

year. Can you explain to me, just because I need to communicate 

to my constituents, in the given fiscal climate we are in, why that 

full sum is needed this year if it is going to be spent over a period 

of 3 years? 

Mr. LEAVITT. Congressman, we are asking vaccine manufacturers 

to step up with substantial capital of their own, to put substantial 

intellectual property on the table and to redirect many of their 

open priorities. They are simply not going to be willing to do that 

unless it is very clear that the United States government has skin 

in the game and is prepared to respond and can be counted on to 

respond. And the way that certainty is created is if we appropriate 

the money. 

Mr. SHADEGG. And so what you are saying is that they will not 

do the research necessary or the production necessary to have 

these vaccines available if this money isn’t put up in a single lump 

sum this year. 

Mr. LEAVITT. It is my judgment that their investment will not be 

forthcoming unless ours is. 

Mr. SHADEGG. How much of that is related to their concern 

about, if any, about future liability? That is to say, if they were assured that there were no liability at stake, that there was a plan 

or that people given this vaccine would be part of a compensation 

plan so that these manufacturers wouldn’t be at risk, would that 

change the numbers at all? 

Mr. LEAVITT. I have met with each of the manufactures individually, and then the President and I met with them collectively. 

Each of those conversations have made clear to me that there are 

three prerequisites to our success: The first is the liability component. They need to be relieved that their stockholders could be imperiled by rushing some kind of vaccine to market and then having 

to bear the financial burden of that, and there is good reason for 

their concern. 

The second is, they need to know that there is a market for the 

product that is produced, not just this year but on an ongoing 

basis, because we are asking them to put capital up and intellectual property and to give up other opportunities. That is where our 

56

work with the annual flu comes in, to be able to keep that capacity 

going. 

And the third is, they need to have a streamlined regulatory environment in order to meet the deadlines that we are putting forward to create this vaccine fast enough. We can meet all three, but 

we need to meet all three if we are to meet our objectives. 

Mr. SHADEGG. And the $7.1 billion figure is simply one of the 

three, I take it? That is to say——

Mr. LEAVITT. That is right——

Mr. SHADEGG. The liability piece doesn’t produce the number, to 

answer my question. 

Mr. LEAVITT. It is essentially knowing there is a market for it 

and that the United States government is going to be there with 

certainty. 

Mr. SHADEGG. Let me ask a separate question. I think that all 

Americans are concerned about the ability of the government—particularly the Federal Government—to step into these situations 

and solve the problems. Katrina, I think, demonstrated that. Certainly FEMA, as its currently structured, cannot succeed on its 

own. It requires the effort of State and local governments. And it 

requires them to have planned and been prepared to do their job 

so that if they are not prepared and if they have not put plans in 

place and if they don’t have the proper personnel and the proper 

training in place, FEMA can’t succeed on its own. Indeed, one 

would argue it is not equipped to do that mission. 

What have you done or what are you doing kind of in layman’s 

terms for me to give to my constituents to assure that in a worstcase scenario the preplanning has been done not just by Federal officials, but the initial steps toward coordination for State and local 

officials to do their jobs has been done? 

Mr. LEAVITT. Within a matter of weeks, we will have in Washington the first of what will be many meetings with State and local 

officials to begin planning and coordinating the integration of these 

plans. That will include not just meetings in Washington, but we 

intend to take teams from CDC and NIH and from HHS into the 

States to say, here, let us help educate not just your public health 

officials—frankly, public health officials get this—it is being able to 

communicate to the county commissioner and to the city councilmen why this ought to be a priority, why they ought to be worried 

about preparedness and not just a swimming pool. Because until 

they understand why we are concerned about this, they are not 

likely to act. Part of that will need to be a template, saying, here 

is what a prepared community looks like, and here is a way that 

you can evaluate yourself so that a citizen in a local community 

can say, my government is prepared because they meet this criteria. That will take time to put into place, but it is clearly part 

of the plan and an essential part of the victory. 

Mr. SHADEGG. I thank you and your colleagues. 

My time is expired. 

I actually have a comment. I think we have seen in these last 

hurricanes how some communities are prepared, and some aren’t. 

I think in your planning, you need to think through whether or not 

you warn Members of Congress that their State and local officials 

aren’t ready where you have detected, or you warn the local popuVerDate 0ct 09 2002 13:12 May 02, 2006 Jkt 000000 PO 00000 Frm 00060 Fmt 6633 Sfmt 6602 F:\DOCS\26891.TXT HCOM1 PsN: JOEP
57

lation that their State and local officials aren’t ready. Because in 

most instances, in these hurricanes, the State and local officials 

were ready, but sadly, in some other instances they weren’t, with 

tragic consequences. 

Mr. DEAL. The gentleman’s time is expired. 

We do have votes on the floor at this point, four I understand, 

and we will return as soon as those votes are completed, and we 

will complete the questioning by members at that time. So we will 

stand in recess pending the completion of the floor votes. 

[Whereupon, at 12:35p.m., the committee recessed, to reconvene 

at 1:30 p.m., the same day.] 

Mr. DEAL. The committee hearing will come back to order. We 

will have members, I am sure, who will return, but since we have 

some who are here who have not asked questions, we will proceed 

with them. 

Mr. Gonzalez, I believe you would be next. 

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

First of all, to Secretary Leavitt and Dr. Gerberding, I want to 

say thank you so much for coming to San Antonio during the time 

that we were welcoming the evacuees as a result of Hurricane 

Katrina. You all were absolutely wonderful. I know the community 

really, really appreciated it. 

I want to start off by reading from the last page of, The Great 

Influenza: So the final lesson, a simple one yet one most difficult 

to execute, is that those who occupy positions of authority must 

lessen the panic that can alienate all within a society. Society cannot function if it is every man for himself, by definition civilization 

cannot survive that. Those in authority must retain the public’s 

trust. The way to do that is to distort nothing, to put the best face 

on nothing, to try to manipulate no one. Lincoln said that first and 

best. 

So the challenge is great for us, but we have great examples 

throughout history that we can follow. My question really is based 

on information that actually has appeared in editorial pages of the 

San Antonio Express News as well as from our metropolitan health 

director and so on. The first thing is the difference, of course—and 

I know this sounds so elementary, but to get it straight, obviously, 

if we are looking at vaccine, that is immunization. That is prevention. If we are looking at antiviral, that is treatment after the fact. 

What this plan proposes, my understanding, is from the time that 

there is an emergence—and let’s just talk about the Avian Flu—

an emergence of that, that within 6 months somewhere down the 

line—and I am going to piggy-back on what Mr. Ferguson stated 

earlier, it is a little different take on it—that within 6 months, we 

would be able to immunize. We would be able to vaccinate the entire population of the United States. And this is something that appeared in a recent column in the San Antonio Express News. And 

the interview was with our metropolitan health director. And I am 

just trying to understand how you produce and manufacture a vaccine. And it says vaccine production cannot begin until the mutant 

viral strain is isolated, and then it will take 6 to 9 months to conventionally produce the first vaccines. There may also be other 

complications to producing the tens of millions of doses needed. 

Just acquiring the chick embryos needed to produce the vaccines 

58

needed will be a real challenge, the doctor observed, and then there 

is a good possibility that this virus could kill the embryos. Bird flu, 

after all, kills chickens. 

And I was just thinking this in terms, logically speaking, your 

own interpretation of that, whether that is a valid concern that Dr. 

Guerra has there in San Antonio. 

The second part of my question will go to—my understanding 

this whole plan, as important a role as you have, Mr. Secretary, 

and your department, really is going to be under the charge and 

responsibility of Homeland Security. And do you see any problems 

with that? And I know there are some strengths to it, but our experience with FEMA coming under the umbrella with Homeland Security has not been a good experience. And I am just wondering 

what your department, what you would be doing under the worstcase scenario, in other words, what are the minuses to that particular arrangement if, in fact, I am correct in assuming that this 

Department of Homeland Security will be first and foremost in 

charge? 

Mr. LEAVITT. I will ask Dr. Fauci to answer the matter related 

to the vaccines, and then I will deal with the second question. 

Mr. FAUCI. One of the advantages of a new technique called reverse genetics, which is the way we isolated and made the seed 

virus for the current H5N1 vaccine, is that you can actually selectively pull out the various genes that you want from the viruses 

so that you could make your vaccine, is that you can actually cutoff, molecularly, the component of the virus that would kill the 

eggs, the virulent component that would kill it. 

So you might have a broader problem theoretically that viruses 

would kill all the chickens so you wouldn’t have the chickens to lay 

the eggs, but once you have the eggs, you could cleave out that virulent part of the virus that would actually destroy your eggs. 

Mr. LEAVITT. With respect to your second question, once a triggering event has occurred—and we define that in our doctrine in 

the plan as sustained person-to-person transmission of the disease—the National Response Plan will be triggered. Under the National Response Plan, the Secretary of Health and Human Services, 

under ESF-8, has responsibility for medical and public health 

issues, which would be the vast majority of the issues related to 

a pandemic. The Department of Homeland Security would then be 

the coordinator between HHS and other national departments—national government departments, that is to say, the Department of 

Transportation, Department of Defense, Department of State and 

so forth. They act as a coordinator, but quite specifically, under the 

National Response Plan, the Secretary of Health and Human Services has responsibility for public health and medical issues. 

I will tell you that my biggest concern isn’t the coordination 

among the Federal agencies, though I believe we have a long ways 

to go before we have perfected that. My biggest concern is the coordination between HHS and other Federal departments and State 

and local governments. Our plans need to be integrated. A pandemic unique to all natural disasters will need to be managed at 

the State and local level. You don’t want the Secretary of Health 

and Human Services deciding whether the schools in San Antonio, 

Texas, are open. You don’t want the Secretary of Health and 

59

Human Services trying to make a decision on whether a parade 

ought to be held or not. Those are calls that the State and local 

officials need to make. That is the reason we will spend a lot of our 

time over the next several months meeting with State and local officials, connecting them with their own health departments. Because the health people get this, it is the need for us to energize 

the State and local officials to understand the nature of the planning that needs to occur at all levels in society. 

Mr. GONZALEZ. Yes, sir. 

Mr. DEAL. Secretary Leavitt needs to be out of here by 2 p.m., 

so the time is expired. 

And if you don’t mind, I am going to have to call the time, and 

we will try to try to move along so we can accommodate the schedule we promised we would try to adhere to. 

Dr. Burgess, you would be next. 

Mr. BURGESS. Thank you, Mr. Chairman. 

And again, thank you all for being with us yet one more time 

this morning. 

Mr.Secretary, as I understand, the cost—when the President 

talked about it a week ago today, that this cost will actually be 

over a 3-year timeframe, but the authorization, the appropriation 

Chairman Lewis introduced last night, will be for this fiscal year. 

Is there no money in the Bioshield project that we passed 2 years 

ago, or is there no money in HHS? Or Homeland Security to deal 

with an outbreak of illness, such as this, where those—the Chairman talked about offsetting funds; is there any opportunity there? 

Mr. LEAVITT. I will ask Dr. Raub to answer that question specifically, and then I would like to comment on one point. 

Dr. RAUB. On the Bioshield, you may recall the appropriation 

was laid out over a 10-year period, with a plan for various incremental availability of those funds over that time. The concern from 

the administration’s perspective is we gave a very strong signal to 

the industry, especially those involved in developing drugs and vaccines and other medical countermeasures, that this was part of 

that certainty and stability for planning——

Mr. BURGESS. And I do understand that, I don’t want to interrupt you, but time is short. 

Dr. RAUB. And doing that prior commitment. 

Mr. BURGESS. And I realize that we need to make the commitment to the manufacturers, but going forward over time, are there 

perhaps places where we can offset that? 

And actually, if you don’t mind, I am going to ask you to get back 

to us with a written response to that. 

Mr. Secretary, let me ask you, too. We have talked a lot about 

Tamiflu and Relenza this morning, are there newer antivirals out 

there in the pipeline that may come into play in the next year, 2 

or 3? 

Mr. LEAVITT. Yes. And we have included $400 million for their 

development to bring them to the point of manufacturer. 

Mr. BURGESS. One of the older antivirals, Amantadine, which 

was introduced back in the 1980’s, my understanding is that has 

been used extensively in bird populations to prevent an outbreak 

of influenza in bird populations. Is that one of the reasons that 

Amantadine is no longer useful as an antiviral for the H5N1 virus? 

60

Mr. LEAVITT. The short answer is, yes. The long answer can come 

from Dr. Fauci. 

Mr. BURGESS. But before we get to the long answer, let me ask 

a question. Is there a danger inherent in allowing other countries 

to produce the antivirals? If they are not produced to exacting 

standards, do we run the risk of creating viruses that then are 

more resistant to our stockpiles of antivirals? 

Mr. LEAVITT. Short answer is uncertain. The long answer comes 

from Dr. Fauci. 

Mr. BURGESS. Maybe we better have the long answer to that one. 

Mr. FAUCI. I will give you the short answer to the long answer. 

The fact is that the use of any antiviral like Amantadine in trying to prevent infections in chickens almost certainly contributed to 

the resistance of the H5N1 that we currently have to Amantadine 

or Ramantadine, not certainly the only factor, but certainly that is 

a well known factor that when you feed it to chickens, that is the 

first thing. 

With regard to the resistance, there are evolving forms of the 

H5N1, and there are a couple of different subspecies, as it were, 

not all of which were resistant to Amantadine. But the reason for 

the Amantadine resistance that we saw in our hands for the H5N1 

that we isolated was multifactorial. One important factor was that 

you gave it to the chickens inappropriately. 

And when you make an antiviral, you are concerned, I believe, 

Dr. Burgess, if you make it by a company that doesn’t make it very 

well, you may make a weakened form of it. That is certainly theoretically possible that if you don’t have the right strength, for example, you could wind up undertreating and then selecting for resistance. That is not something that I would specifically worry 

about as my high priority, though. 

Mr. BURGESS. In the pandemic plan, in chapter S-5 on page 7, 

we talked about the reverse transcriptase polymerase chain reaction for identifying the virus, but that only being available in State 

health departments and the CDC. I would like—it was referenced 

earlier today, and I would like Mr. Chairman to introduce this for 

the record, a newer rapid test that is now talked about, and just 

underscore that the quicker we can get this type of technology in 

people’s hands who are in the field, I think that is going to be a 

big part of our overall preparedness. 

I guess, Mr. Secretary, in the 10 seconds that are left, where can 

we get the maximum bang for our buck in liability reform in vaccines? 

Mr. LEAVITT. I don’t mean to wast your 10 seconds, but I’m not 

sure I understand your question. 

Mr. BURGESS. Well, if we are going to go with liability reform or 

if we are going to include liability reform as part of this as we go 

forward, what type of liability reform do we need? Where would we 

get the maximum impact to get manufacturers of vaccines back in 

this country in a meaningful way? 

Mr. LEAVITT. Well, we need to have a statutory—the capacity for 

the Secretary to provide a statutory shield to liability to the manufacturer. 

Mr. DEAL. The gentleman’s time is expired. 

Mr. BURGESS. I thank the Chair for his indulgence. 

61

Mr. DEAL. Mr. Stupak, you are next. 

Mr. STUPAK. Thank you, Mr. Chairman. I thank the witnesses 

for being here today. 

With the traditional flu, it seems like the victims are the young 

or the old or those with a low immune system. In the pandemic of 

1918, the victims there were usually young people who were previously healthy. Have you developed what kind of attack is going 

to be—what subgroup of our population is going to be vulnerable 

to this H5N1 virus? 

Mr. LEAVITT. Dr. Gerberding? 

Ms. GERBERDING. It is not predictable. And what we have seen 

in Asia so far is that there is a disproportion affliction of young 

healthy people, but part of that is because those are the people who 

have the most contact with the sick chickens. And that is the primary mode of transmission right now. But you can’t the say for 

sure. 

Mr. STUPAK. Okay. The H5N1 virus, when it hits, like other 

pandemics, it will come in waves, will it not? You will have the 

H5N1 virus, and then maybe a couple months later, you will get 

a new viral subtype that could come off from this; is that correct? 

Mr. LEAVITT. Dr. Fauci. 

Mr. FAUCI. Not necessarily. That is what happened in 1918. But 

as Dr. Gerberding said about lack of predictability, you really can’t 

predict. You can have it in one blast or you can have——

Mr. STUPAK. Are we seeing any subtype yet? 

Mr. FAUCI. There are more than one H5N1; it is evolving. If you 

look at the one we isolated a year and a half ago in 2004 and the 

one that is now spreading in some of the chicken flocks——

Mr. STUPAK. It is completely different. 

Mr. FAUCI. Not completely different, but it is an evolved virus. 

Mr. STUPAK. If there is going to be like these different waves, 

when we talked a lot about personal responsibility and being ready 

in 72 hours, that wouldn’t really work if we are going to have wave 

after wave of this stuff coming through an area; is that correct? 

Mr. LEAVITT. It is. As we study the pandemic of 1918, it is clear 

that there are waves, and it will affect different communities at different times, and it is possible that it would affect one community 

at a different time. 

But in terms of the capacity for public health officials to manage 

in that community, it is likely that many communities could go 

through a period where those traditional public health tools would 

be used, one of which could be restriction of movement under certain circumstances. 

Mr. STUPAK. Let me ask you this, it is my understanding your 

short-term strategy on the vaccine, it is the H5N1 vaccine; you are 

producing that now. And if I heard Dr. Fauci testify earlier—I 

thought you said that you don’t know if it will work once it mutates 

from human to human; is that correct? 

Mr. LEAVITT. We know that the virus will mutate. We know that 

means that the vaccine that we are creating now will not be of optimal effectiveness, but it will be the best we have, and it will allow 

us to give at least first responders——

62

Mr. STUPAK. So then I take it the vaccine we have now has been 

not been tested for efficacy but probably more for safety and only 

on small population groups. 

Mr. LEAVITT. Dr. Fauci should respond to that. 

Mr. FAUCI. Since there is no flu around that you can test it for 

its clinic efficacy, the parameter of efficacy is, if it induces an immune response, the characteristic of which would be predictive of 

protection, and the answer to the question then is, yes, it has induced an immune response that would be predictive of protection. 

Mr. STUPAK. In what kind of a population? From children to 

older adults? 

Mr. FAUCI. Right now—that is a good question. We tested it in 

healthy young adults less than 64 years old. We are currently testing it in individuals older than 65, and in December, we will start 

it in children. 

Mr. STUPAK. What is the number of people you need to have a 

long-term study? Will it be based on number, or are you going to 

base it upon the vaccine and different strains you get out of it? 

Mr. FAUCI. It is statistically significant—since this is considered 

by the FDA as a strain change with many of the characteristics of 

the seasonal flu that we look at every year, there are many similarities, the numbers that are in the trial now are about 450 per 

phase or stage of trial. 

Mr. STUPAK. Mr. Secretary, you said your concern is liability, capacity and streamlined regulations. On liability, we already have 

a VaccineInjury Compensation Fund; do we not? 

Mr. LEAVITT. This is part of the ongoing conversation as to 

whether or not it is liability and compensation, and that is in fact 

an ongoing conversation. 

Mr. STUPAK. But other vaccines, we put them under the Vaccine 

Injury Compensation Fund, why not this one? Why do we have to 

have some special deal? We didn’t do it with Cipro when the Anthrax scare was here? 

Mr. LEAVITT. You mean on liability? 

Mr. STUPAK. Yes. 

Mr. LEAVITT. Well, I think the idea is to provide in some fashion 

a capacity of the Secretary to grant that——

Mr. STUPAK. Why do you need it if we already have a compensation fund? 

Mr. LEAVITT. Apparently, the statute does not extend far enough 

that I have the authority to do it, and it requires a statutory extension. 

Mr. DEAL. The gentleman’s time is expired. 

Ms. Blackburn, you are next. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. And thank you all 

for your time and for being here with us today. 

I have got just a couple of questions that I wanted to kind of see 

where you were. In listening to your responses today from all of 

you, it seems like that if we were to have a pandemic, that one of 

the things that we will be addressed with is individuals figuring 

out if they have the Avian Flu or another flu and being able to decide who actually is infected and who is not. Therefore, you could 

separate your population if there was a quarantine needed or if you 

needed specific treatment in some way. 

63

And I had read in your testimony where you said that 48 State 

and local public health departments had received the PCR training, 

real time PCR training to detect its H5N1-7 subtypes of flu; am I 

correct on that? 

Mr. LEAVITT. Dr. Gerberding would be a better authority on that. 

Ms. GERBERDING. We can give you the geographic distribution of 

the capabilities by laboratory response network laboratory, but in 

general, that is correct. 

Mrs. BLACKBURN. But you have that testing—what I am trying 

to get at here is this: Do you have a test or a technology that can 

go in, that is going to be readily available that these individuals 

can administer and you can quickly divide your population as to 

who has the flu and who does not have the flu so that you know 

what universe of patients that you are dealing with? Do you have 

that technology or that test available, and are people instructed on 

how to use this and how to follow through? 

Ms. GERBERDING. The clinicians and public health workers are 

including these specific issues in their plans; this is part of the 

guidance that is included in the department’s plan that was put 

forward. But the short answer is, we do not need to rely on a specific H5 test in order to be able to do it under real live circumstances. Once we know we have H5 in the community, the decisions will be based on other grounds, not on a specific case-contact 

basis. 

Mrs. BLACKBURN. Okay. So you are telling me you do not have 

a specific test. 

Ms. GERBERDING. We do have a specific test, but we would not 

need to use it on a person-to-person basis. 

Mrs. BLACKBURN. Okay. Just in identifying the community where 

the flu is present. 

Ms. GERBERDING. There are many clinical situations where we 

would want to know specifically what we are dealing with, so it is 

hard to give you a concise answer. It is a very situational problem. 

Mrs. BLACKBURN. Okay. Thank you. 

Mr. Leavitt, I want to come back to the affordability of the plan. 

I know that the budget for HHS this year, your mandatory spending is $584.4, and you have got $67.9, and then next year we are 

approving $672.5 billion, and your discretionary is $67.1. In all this 

money, are you telling me you can’t find a way to help divide this 

expense out and focus on a part of this? Because we have got $2.8 

billion for the cell culture technology, which I agree with you is a 

good thing to move forward on, but in all of your budget, can you 

not prioritize? Can your department not look for some savings and 

some efficiencies this year and next year and come up with this 

money so that we are not asking the taxpayer for another $7 billion 

dollars? Frankly, my constituents have just about had it with the 

one more thing and the one more thing and the one more thing. 

I had a constituent say, instead of nickel and diming me to death, 

I feel like you guys are billion dollaring us to death. So are there 

savings there? Is there a way that you can afford this within your 

structure? 

Mr. LEAVITT. As you pointed out, the great share of the HHS 

budget is tied up into programs that involve entitlements. The discretionary portion of our budget, which is around 10 percent of it, 

64

is tied to other priorities that the Congress thought were of sufficient importance that they appropriated them. I recognize the tension that is involved here, particularly when you are moving forward with a substantial supplemental, and we are prepared to——

Mrs. BLACKBURN. So you have nowhere you can find a savings? 

Mr. LEAVITT. Well, the President has proposed this as an emergency supplemental because he felt it was an emergency and because he believes, as I do, that it is necessary for us to make very 

clear to those that we are asking to put up complimentary capital 

and intellectual property and opportunity, that they have the certainty necessary to move forward. 

Mrs. BLACKBURN. Thank you. 

I yield back, Mr. Chairman. 

Mr. DEAL. I thank the gentlelady. 

Ms. Schakowsky is next. 

Ms. SCHAKOWSKY. Thank you. Let me just say that my constituents are concerned about expenditures, too, but they ask me about 

the $6 billion a month we are spending in Iraq and the $70 billion 

in this budget that goes for tax breaks largely for people who don’t 

need it. And just for the record, so you know, they want to be protected from the flu and don’t think that these kinds of health care 

expenditures are out of line. 

I have a couple of areas of questioning. I want to just associate 

myself with some of the concerns that were raised about State and 

local funding and the expectations for the States and localities and 

the lack of resources. I don’t want to go further than that, just to 

say that I agree with those concerns. 

I wanted to ask about the liability protection. My understanding 

is that it is—the concern is that there won’t be enough—that the 

shortage in part is because there is not liability protection; just a 

yes or no, is that——

Mr. LEAVITT. Yes. 

Ms. SCHAKOWSKY. Well, I just wanted to say that—just give a 

couple—Dr. Ornstein, who was for 12 years head of the vaccine 

programs at Centers for Disease Control said liability was never 

the issue. I have not seen liability as a major problem with the flu 

supply to date. The National Vaccine Advisory Committee determined the shortage did not come about because of liability concerns. I don’t want to get you in trouble, Dr. Fauci, but there is 

a quote that says, it is only a very small part of the problem, and 

even Pharma played down the lawsuit issue for the flu vaccine. 

But my understanding is that this bill does not limit its application only to new vaccines used in pandemic context or even a bioterrorist context. The bill’s provision provides that any drug, device 

or biological product used to, quote, diagnose, mitigate, prevent or 

treat a potential pandemic may qualify for protection. And then it 

doesn’t stop there. I understand the bill also applies to any existing 

device, drug or biological product used, quote, to diagnose, mitigate, 

prevent or treat a side effect of another vaccine. So would that 

mean, for example, that if Tamiflu qualifies for protection under 

the bill because it is a potential treatment for the Avian Flu, and 

an individual takes a pain reliever like, say, Vioxx to treat serious 

side effects caused by Tamiflu, that both Tamiflu and Vioxx would 

be protected under the bill? 

65

Mr. LEAVITT. Actually, that is a legal interpretation that I am 

not prepared to make. But I do think it is important to suggest 

that your constituent would not want the legal liability issue to 

stand in the way of being able to have a treatment, and that is 

what this is about. 

Ms. SCHAKOWSKY. But you are suggesting that it would stand in 

the way of a treatment. And what I wanted to say was that the 

experts in the field are saying that liability protection is actually 

a small part and that, in fact, a much larger part has been the low 

profit margins that vaccines provide, unpredictable demand and 

complexities of the manufacturing process, all those things which 

I can understand that we need to deal with. But this is a small 

part. There were questions before about what happens to first responders, for example, who take the drug. This is a concern, too. 

And we saw, as Representative Capps said, they didn’t want to 

take the smallpox vaccine, and it is just interesting to me that 

there was such a rush to protect manufacturers here, and millions 

of people who could be affected on the other end are not even considered at all, especially when there is so little evidence, it seems 

to me, that this is the problem that is causing a shortage. 

Mr. LEAVITT. The proposal is put forward to provide a capacity 

to manufacture vaccines. Now I have met with all of the vaccine 

manufacturers directly and personally. I met with them as a group 

with the President. And they have made it abundantly clear that 

they are not able to step forward to do this without protection from 

liability. And they have reason to feel that way. If you look back 

over the previous times where we have done this, it is clear that 

there is risk, if you——

Ms. SCHAKOWSKY. Let me ask one other—I know that is your position, but let me ask one other area that I am very concerned 

about, and that is the issue of how much we are spending on international surveillance. And the New York Times said only $251 million, a tiny fraction, would be used to help foreign nations improve 

their ability to detect and control flu outbreaks. 

It does seem like, ifwe stop there or help to contain it there, before it comes here, that that makes sense, and out of $7.1 billion, 

that seems like a small amount. I wonder if you would comment 

on that. 

Mr. LEAVITT. The system needs to be enhanced. We have a substantial presence already, particularly in Southeast Asia. The 

world is a big place, and there are substantial parts of the world 

we know nothing about. We know nothing about what is going on 

in North Korea. Burma is another example where the conditions 

are similar to what is going on in any one of the Southeast Asian 

countries. And we have essentially no contact there. So there are 

limits in our capacity to develop surveillance, even though we do 

need to enhance it. 

Ms. SCHAKOWSKY. I would hope Romania, Indonesia, Vietnam, 

places we do have relationships with. Thank you. 

Mr. DEAL. Ms. Baldwin would be next. 

Mr. Secretary, if you are at the point that you need to leave, we 

will certainly understand. If the other members could stay, perhaps 

we can complete the hearing with their presence. 

66

Mr. LEAVITT. I will stay as long as I can. I think I have another 

5 minutes. 

Mr. DEAL. Ms. Baldwin. 

Ms. BALDWIN. Thank you, Mr. Chairman. 

A couple of very quick questions, and then a broader question. 

We had lots of questions that have gotten at this, but I am not sure 

it has been asked this directly, so let me do so. Is it the operating 

assumption, Mr. Secretary, that in the event of a pandemic, if we 

don’t manufacture the vaccines or the treatments, the antivirals 

here in the United States, that those treatments and vaccines will 

not be available to us? 

Mr. LEAVITT. Yes. 

Ms. BALDWIN. Okay, I just wanted to get that on the record. 

A couple other quick questions. 

Does anyone—do you know what the over-the-counter cost for a 

full dose of Tamiflu would be today? And second, in your negotiations with vendors, what sort of cost savings have you realized in 

those negotiations? 

Mr. LEAVITT. I do not know the so-called rack price. It has fluctuated with supply and demand. We are realizing, in our negotiations with them, substantial savings, and it will depend entirely on 

the size of the order we ultimately place. 

One of the conversations we have had in this hearing and in others is, why are we not ordering large volumes? We have to have 

an appropriation in our hand under the rules of procurement in 

order to do that. Now, other nations, who have no more Tamiflu 

than we do, they have been able to place orders because they don’t 

have that procurement restriction; we do. And that is one of the 

reasons we are here asking that an appropriation be made so that 

we can both get our order in and try to advance ourselves in that 

queue. The bigger the order, the more muscular you can afford to 

be in terms of how you position yourself in the market. 

Ms. BALDWIN. And I appreciate that from your earlier testimony, 

and I know many are very anxious to have an order placed because, obviously, they are not manufacturing it until we do so. 

You had talked earlier under questioning about, I think, the figure of around 50 million doses of Tamiflu. What sort of price would 

you be able to achieve if that was the order that was placed? 

Mr. LEAVITT. Well, I would only be speculating because we are 

in the process of negotiating, and it would be inappropriate for me 

to guess. 

Ms. BALDWIN. Well, I know the company has been forthcoming 

about some of those figures——

Mr. LEAVITT. Well, I would be anxious to see that. 

Ms. BALDWIN. The broader questions I wanted to pose really deal 

with the parallel epidemic of fear and panic that typically accompany something like what we are describing. And I would argue 

that, even today, there is significant public anxiety about the Avian 

Flu, particularly as we discuss it in a very open manner. It is hard 

to turn on the television without seeing stories about this. And 

there have been stories about members of the public beginning to 

stockpile their own Tamiflu, if you will. I would like to really hear 

you describe a little bit more about the administration’s strategy 

for dealing with fear, with panic, the sort of steps that we can take 

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now. And I reflect that lots of irrational behavior occurred around 

the AIDS epidemic when it began 2 decades ago in the early 1980’s; 

when the Anthrax attacks in our country created a lot of panic, 

fear and irrational behavior. So I am wondering if you could elaborate on what assumptions you are making about public reaction to 

news of an outbreak in the U.S., whether you have done any sort 

of modelling? What other agencies are involved in that type of 

planning? What is your proactive public education strategy? I know 

you have launched the pandemicflu.gov website, but what other 

outreach are you doing with the media, who will probably be some 

of the first points of contact for average citizens? And also, getting 

down to the grassroots, your ability to inform and educate 

nonhealthcare professionals in local organizations, local government. 

Mr. LEAVITT. I will comment generally, and I will ask Dr. Raub 

and Dr. Gerberding to supplement. 

The first principle is that it will happen instantly. Once there is 

news of a person-to-person transmittable event, there will be broad 

concern. 

The second principle is that it needs to be rooted in good information. Mr. Gonzalez read from the book, The Great Influenza, and 

one of the lessons I took from that in my numerous readings was 

that people just need to know the truth. We need to tell it as it 

is. We need to tell the truth as we know it, and let people draw 

conclusions. 

Now the whole foundation needs to be a desire to—an aspiration 

to communicate. We need to inform but not inflame; we need to inspire preparation, not panic. And that comes primarily with good 

information. 

Now Dr. Raub and Dr. Gerberding can talk to you a little bit 

about the specifics. We are going into great detail, having materials 

prepared, things ready so that they can be deployed at the moment 

they are needed and not having to do it in the 2 or 3 days after 

an event. 

Ms. GERBERDING. From the beginning of the preparedness grant 

investments that followed Anthrax, we have recognized how critical 

communication was to our success, and CDC has a program called 

the Emergency Risk Communication Curriculum that is available 

online to anyone who wants to learn it. It is a beautiful curriculum. 

And we have trained public information officers all over the country so that they can support their Governors and their mayors. 

We are doing the kinds of research that you have recommended 

with focus groups. Just on my BlackBerry I have something from 

a Gallup poll that we commissioned just to understand what people 

are thinking about pandemic flu right now today. What are their 

fears? What is their knowledge? What are their confusions? And 

the Secretary said absolutely the most important thing, which is to 

tell the truth and to get them information out there, what we 

know, what we don’t know, what we are doing about it. 

My experience has been, with Anthrax and SARS and a few 

other public health threats in the last couple of years, that while 

there are some people who will panic or who will find it difficult 

to do what we would like them to do, generally people behave reVerDate 0ct 09 2002 13:12 May 02, 2006 Jkt 000000 PO 00000 Frm 00071 Fmt 6633 Sfmt 6602 F:\DOCS\26891.TXT HCOM1 PsN: JOEP
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markably rationally if they trust the credibility of the communications support that they have. 

The single most important and desired communicator about a 

health threat is not us at this table; it is the clinician that the person already trusts. So we are specifically working on projects with 

the AMA and other organizations to help the clinician at the local 

level really be the broker of information and reassurance and advice to people at the front lines of this program. 

Mr. DEAL. I better cut it off at that point. 

Mr. Inslee, you are next. 

Mr. INSLEE. Thank you. I wanted to ask about the preemptive 

strike we could maybe try to strike against Avian Flu itself, since 

that is the source potentially of this problem. 

There are some new technologies that at least three companies 

are looking at for an airborne detection system of single viruses to 

be used to try to detect this so it can be eliminated in these flocks: 

Research International, they are a Washington company; Miso Systems in New Mexico; Smith Detection. In Maryland, I think Research International actually has a system that can find a single 

bacteria and believe it is capable of having one ultimately to have 

a single virus. 

Could you comment on those efforts? What we are doing to promote those, whether you think it is a viable strategy and what we 

can do to advance that? 

Mr. LEAVITT. I will ask Dr. Raub to comment; he will be more 

conversant. 

Dr. RAUB. I believe, as Dr. Gerberding indicated before, there is 

a continuing interest on our part in newer and better and more 

rapid diagnostic methods, and certainly the ones you are describing 

fall in that category. In this particular case, there is an equally 

strong interest in the Department of Agriculture, as with us, because much of the surveillance of the animal stock, especially 

chickens, would be with the USDA. There is also interest in the 

Department of the Interior, the Fish and Wildlife Service are the 

ones that track what happens in the migratory bird populations 

and the like. So there is a potential significant use of this kind of 

methodology, and we are interested in seeing it——

Mr. INSLEE. Does the plan have a number attached to it for the 

development of that technology? 

Dr. RAUB. No, sir, it doesn’t. 

Mr. INSLEE. Shouldn’t it? 

Dr. RAUB. In this particular case, because of the emergency nature of the supplemental, we focused on the vaccine and the drugs, 

but the regular appropriation process includes continuing investment in development of diagnostic methods, but it is just not in 

this particular budget. 

Mr. INSLEE. Well, I encourage all of us to try to figure out whatever the fastest procedural way to get that investment made. For 

a very small investment, it seems to me to be an appropriate thing 

for us to do about what could be a significant threat. And I hope 

to work with you in that effort. If it is not in the supplemental, 

which I would like it in, I hope that you could support an effort 

ultimately to get it somewhere. 

69

Let me ask you about this issue of what households can do. We 

have had a little interchange about what you can do individually 

to protect yourself and the like. And I don’t want to belittle the importance for household protection, having 3 days supply of water, 

food, radio for earthquakes, storms, whatever; all of us need that 

even if the flu never takes off. But I would suspect and some were 

arguing that that would sort of replace a very vigorous Federal response to this, both on a proactive and a response mechanism. And 

by saying that, I want to appreciate the President’s trying to alert 

the Nation to this potential situation and at least proposing one 

possible response to it because I think this is a very significant 

threat. And I just want to make sure that we are on the same 

page, that we are not expecting an individual response to this to 

diminish in any way what should be our Federal responsibility. 

Mr. LEAVITT. I would like to assure you we are not. I will tell 

you my biggest concern is that all that has been said about the 

Federal plan will be viewed by State and local communities as we 

have got it covered. Well, no one has got this covered on their own. 

This is going to require every element. A virus is a network enemy, 

and it requires a network response. If we use a mainframe response, to borrow a computer term, to try to compete with a network enemy, we lose. A network trumps a mainframe. And that 

means Federal—and by that, I mean to imply every department of 

the Federal Government. It includes State and local governments 

integrated with the Federal plan. It includes communities. It also—

and by that, I mean to imply corporate interests as well as nonprofit interests, and it also includes, in my mind, individuals. Now 

no part of that network can stand alone, and no part of the network can stand without the other part. 

Mr. INSLEE. I appreciate that comment, particularly with regard 

to the county local public health services. I think in my opening 

comment I noted that they have been substantially degraded over 

the last several decades. And I hope that you will be alert, as the 

budget cycle goes through, to ways we can beef up their infrastructure, not just to the flu problem, but some of the others as well. 

And I have to tell you, I am very concerned that we are going 

into this risk with a local infrastructure which has been so oriented 

toward the real terrorism threat that it has diminished our local 

response to this potential threat. We looked at sort of an earthquake response in Washington; about 90 percent of the Federal dollars are now to terrorism rather than earthquakes. And I just hope 

that you are vocal on the need for local infrastructure, the nurses 

on duty, the communications system on duty, the epidemiologists 

on duty ready to go, because it will be too late once it happens. 

Mr. LEAVITT. Mr. Chairman, I see the light is on, but can I respond to that? 

Mr. DEAL. Surely. 

Mr. LEAVITT. At some point, we will look back on this period, and 

H5N1 will have either triggered a pandemic or it will not. What 

are the chances it will? I don’t know. There are clearly warning 

signs that we are appropriately responding, I believe, to. But there 

is a pretty good possibility that it won’t. At that point, people are 

going to say, oh, they overreacted or they may say they were out 

crying wolf. That will not be the case. Because I believe whether 

70

H5N1 is the triggering point for the—the triggering virus for a 

pandemic or not, through the implementation of this plan, we have 

an opportunity to become a safer and better prepared nation. We 

will leave this period with new cell-based technology that will save 

millions of lives. We will leave this period with the annual flu—

with the capacity to manufacture an annual flu virus that will save 

tens of thousands of lives every year. We will leave this period with 

improved preparation among State and local governments. We will 

leave this period having an international surveillance system that 

will allow us to better identify disease wherever it is in the world. 

We will leave this period with the piece of mind knowing, whenever 

a pandemic comes, that we are prepared. So I pray that H5N1 isn’t 

the virus. If it is, we will deal with it in the best way we can according to the preparation we have achieved. If it doesn’t, let us all 

look back on this period as the time we made America a better and 

safer place. 

Mr. INSLEE. And we will leave with an airborne virus detection 

system. Thanks very much. 

Mr. DEAL. Mr. Engel, you are next. 

Mr. ENGEL. Thank you, Mr. Chairman. 

And Mr. Secretary, and the other witnesses thank you for staying and listening to all our questions. 

I just want to make a very brief comment which you don’t need 

to comment on, but I say this a lot because I feel so deeply about 

it. I know that there is State matching, and some of my colleagues 

have wondered about how the States are going to be able to do this. 

The Medicaid program is costly, and the Federal match ranges 

from 50 to 77 percent, and States are only going to receive a 25 

percent match a year. And again, I just want to say that our orientation, the administration’s orientation, which I think is very 

wrong, in stressing tax cuts again and again and again over moneys for programs that are important is really wrong. And while I 

appreciate that there is a lot of Federal money going into this program and I don’t denigrate it at all, I think, again, we are going 

to be asking the States to incur a greater burden, and that would 

not have been the case if we weren’t robbed of our ability to fund 

good programs because of the tax cuts for the wealthy. I just think 

it is a wrong orientation. You don’t have to comment on that, but 

I need to say that. 

There are a lot of questions that have been asked, and I want 

to ask you a question a little bit down the line. I know that, every 

year, of course, we get our flu shots, and we are told that there is 

guessing in terms of which shots, what to put into the flu shot. I 

am wondering if, down the line, since you are saying that the emphasis has to be on the pandemic flu, which I agree, what happens 

down the line a year or 2 down the line with the regular other vaccines? Are we—because we are concentrating so much on the pandemic flu, what will happen to our concentration on the others? 

36,000 Americans die average per year from complications of the 

other flus, and I am just wondering how you integrate the two. 

Mr. LEAVITT. One of the real opportunities for gain in terms of 

our public health infrastructure is the capacity to have sufficient 

vaccine manufacturing capability that virtually all Americans 

would have access to an annual flu vaccine. That will be—I don’t 

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even want to call it a byproduct because it is a fundamental objective of this plan to enhance that capability, and it is a necessary 

part because if we have the need or the capacity to surge for a pandemic, we have to keep that capacity warm, or in other words, keep 

it active and maintained. And we will use that capability to substantially improve the number of people in this country who get an 

annual flu vaccine. 

Mr. ENGEL. So what you are saying is that resources, essentially, 

you don’t foresee resources being targeted away from the others as 

well? 

Mr. LEAVITT. In fact, dual purpose. By creating a pandemic capacity, we automatically create the capacity to enrich our delivery 

ability on annual flu. 

Mr. ENGEL. All right. Well, thank you. I know you have been 

very patient. And let me just comment on something that you mentioned to the previous question; I couldn’t agree with you more. If 

it should come to pass that the epidemic is not as great as it may 

be and people will say that you and others were crying wolf, I 

think if we are going to make an error—which wouldn’t really be 

an error—we would err on the side of caution. And I don’t think 

that any American believes that if this doesn’t happen, that we expended time or effort and energy on it. And I know you have been 

working very hard on it, and I want to personally thank you. 

Mr. LEAVITT. We should all remember how the parable of the boy 

who cried wolf turned out; the wolf came. 

Mr. ENGEL. Thank you, Mr. Secretary. 

Mr. DEAL. Well, thank you. 

And Secretary Leavitt, we thank you for your presence here. 

And Dr. Gerberding, Dr. Fauci, and Dr. Raub, thank you all for 

being here and for your patience during this hearing. I think it has 

been really a very effective hearing and one that exposed a lot of 

questions and answers that all of us need to have exposure to. 

Thank you all very much. The hearing is adjourned. 

[Whereupon, at 2:18 p.m., the committee was adjourned.]

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