[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]




         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

                               __________


                     U.S. GOVERNMENT PRINTING OFFICE
                             WASHINGTON: 2005        
26-891PDF

For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512-1800  
Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001



                    COMMITTEE ON ENERGY AND COMMERCE

                      JOE BARTON, Texas, Chairman

RALPH M. HALL, Texas                 JOHN D. DINGELL, Michigan
MICHAEL BILIRAKIS, Florida             Ranking Member
  Vice Chairman                      HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RICK BOUCHER, Virginia
PAUL E. GILLMOR, Ohio                EDOLPHUS TOWNS, New York
NATHAN DEAL, Georgia                 FRANK PALLONE, Jr., New Jersey
ED WHITFIELD, Kentucky               SHERROD BROWN, Ohio
CHARLIE NORWOOD, Georgia             BART GORDON, Tennessee
BARBARA CUBIN, Wyoming               BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
HEATHER WILSON, New Mexico           BART STUPAK, Michigan
JOHN B. SHADEGG, Arizona             ELIOT L. ENGEL, New York
CHARLES W. ``CHIP'' PICKERING,       ALBERT R. WYNN, Maryland
Mississippi, Vice Chairman           GENE GREEN, Texas
VITO FOSSELLA, New York              TED STRICKLAND, Ohio
ROY BLUNT, Missouri                  DIANA DeGETTE, Colorado
STEVE BUYER, Indiana                 LOIS CAPPS, California
GEORGE RADANOVICH, California        MIKE DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire       TOM ALLEN, Maine
JOSEPH R. PITTS, Pennsylvania        JIM DAVIS, Florida
MARY BONO, California                JAN SCHAKOWSKY, Illinois
GREG WALDEN, Oregon                  HILDA L. SOLIS, California
LEE TERRY, Nebraska                  CHARLES A. GONZALEZ, Texas
MIKE FERGUSON, New Jersey            JAY INSLEE, Washington
MIKE ROGERS, Michigan                TAMMY BALDWIN, Wisconsin
C.L. ``BUTCH'' OTTER, Idaho          MIKE ROSS, Arkansas
SUE MYRICK, North Carolina
JOHN SULLIVAN, Oklahoma
TIM MURPHY, Pennsylvania
MICHAEL C. BURGESS, Texas
MARSHA BLACKBURN, Tennessee

                      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)



 
         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, 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.
    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 
non-Federal 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?
    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, 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.
    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 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.
    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 
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.
    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 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 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 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.
    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.
    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, in fact, it will make the leap from 
animal disease to a person-to-person 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 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 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 front-line 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.
                           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 pre-pandemic 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, front-line 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 cell-based 
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 contingency 
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 
inter-governmental 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 internationally. 
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 
acknowledge 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 
two-hand 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.
    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 prevention-and-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 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:]
    [GRAPHIC] [TIFF OMITTED] T6891.001
    
    [GRAPHIC] [TIFF OMITTED] T6891.002
    
    [GRAPHIC] [TIFF OMITTED] T6891.003
    
    [GRAPHIC] [TIFF OMITTED] T6891.004
    
    [GRAPHIC] [TIFF OMITTED] T6891.005
    
    [GRAPHIC] [TIFF OMITTED] T6891.006
    
    [GRAPHIC] [TIFF OMITTED] T6891.007
    
    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 cell-based 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?
    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 vaccine 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, according 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 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?
    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 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 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 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.
    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.
    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?
    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 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?
    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 prepared 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----
    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 countries, 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 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.
    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?
    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 enable 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 short-term 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.
    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.
    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.
    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 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 worst-case 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 population 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 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 worst-case 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 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?
    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.
    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----
    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.
    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, 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?
    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.
    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 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 remarkably 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.
    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 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 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.]