[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]


 
            SWINE FLU OUTBREAK AND THE U.S. FEDERAL RESPONSE 

=======================================================================

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             APRIL 30, 2009

                               __________

                           Serial No. 111-33


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov

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                    COMMITTEE ON ENERGY AND COMMERCE

                 HENRY A. WAXMAN, California, Chairman

JOHN D. DINGELL, Michigan            JOE BARTON, Texas
  Chairman Emeritus                    Ranking Member
EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
RICK BOUCHER, Virginia               FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
  Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
JANE HARMAN, California              LEE TERRY, Nebraska
TOM ALLEN, Maine                     MIKE ROGERS, Michigan
JAN SCHAKOWSKY, Illinois             SUE WILKINS MYRICK, North Carolina
HILDA L. SOLIS, California           JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas           TIM MURPHY, Pennsylvania
JAY INSLEE, Washington               MICHAEL C. BURGESS, Texas
TAMMY BALDWIN, Wisconsin             MARSHA BLACKBURN, Tennessee
MIKE ROSS, Arkansas                  PHIL GINGREY, Georgia
ANTHONY D. WEINER, New York          STEVE SCALISE, Louisiana
JIM MATHESON, Utah                   PARKER GRIFFITH, Alabama
G.K. BUTTERFIELD, North Carolina     ROBERT E. LATTA, Ohio
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin 
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont

                                  (ii)
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan            NATHAN DEAL, Georgia,
BART GORDON, Tennessee                   Ranking Member
ANNA G. ESHOO, California            RALPH M. HALL, Texas
ELIOT L. ENGEL, New York             BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    HEATHER WILSON, New Mexico
DIANA DeGETTE, Colorado              JOHN B. SHADEGG, Arizona
LOIS CAPPS, California               STEVE BUYER, Indiana
JAN SCHAKOWSKY, Illinois             JOSEPH R. PITTS, Pennsylvania
TAMMY BALDWIN, Wisconsin             MARY BONO MACK, California
MIKE ROSS, Arkansas                  MIKE FERGUSON, New Jersey
ANTHONY D. WEINER, New York          MIKE ROGERS, Michigan
JIM MATHESON, Utah                   SUE WILKINS MYRICK, North Carolina
JANE HARMAN, California              JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas           TIM MURPHY, Pennsylvania
JOHN BARROW, Georgia                 MICHAEL C. BURGESS, Texas
DONNA M. CHRISTENSEN, Virgin 
    Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
  























                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................
    Prepared statement...........................................
Hon. Nathan Deal, a Representative in Congress from the State of 
  Georgia, opening statement.....................................
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................
    Prepared statement...........................................
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, prepared statement................................
Hon. Anna G. Eshoo, a Representative in Congress from the State 
  of California, prepared statement..............................
Hon. Ed Whitfield, a Representative in Congress from the 
  Commonwealth of Kentucky, prepared statement...................
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, prepared statement.............................

                               Witnesses

Rear Admiral W. Craig Vanderwagen, MD, Assistant Secretary for 
  Preparedness And Response, U.S. Department of Health and Human 
  Services.......................................................
    Prepared statement...........................................
    Answers to submitted questions \1\...........................
Rear Admiral Anne Schuchat, MD, Acting Deputy Director for 
  Science and Public Health Program, Centers for Disease Control 
  and Prevention, Assistant Surgeon General, U.S. Public Health 
  Service, U.S. Department of Health and Human Services..........
    Prepared statement...........................................
Joshua M. Sharfstein, MD, Principal Deputy Commissioner and 
  Acting Commissioner, Food and Drug Administration, U.S. 
  Department of Health And Human Services........................
    Prepared statement...........................................

                           Submitted Material

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

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


            SWINE FLU OUTBREAK AND THE U.S. FEDERAL RESPONSE

                              ----------                              


                        THURSDAY, APRIL 30, 2009

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:10 a.m., in 
Room 2123, Rayburn House Office Building, Hon. Frank Pallone, 
Jr., [chairman of the subcommittee] presiding.
    Present: Representatives Pallone, Dingell, Eshoo, Green, 
DeGette, Capps, Schakowsky, Baldwin, Weiner, Matheson, 
Gonzalez, Barrow, Christensen, Sarbanes, Murphy of Connecticut, 
Space, Sutton, Braley, Waxman (ex officio), Deal, Shimkus, 
Shadegg, Blunt, Murphy of Pennsylvania, Blackburn, Gingrey, and 
Barton (ex officio).
    Staff Present: Phil Barnett, Staff Director; Karen Nelson, 
Health Policy Director; Bruce Wolpe, Senior Advisor; Karen 
Lightfoot, Communications Director; Earley Green, Chief Clerk; 
Jennifer Berenholz, Deputy Clerk; Tim Westmoreland, Consultant; 
Steve Cha, Professional Staff Member; Sarah Despres, Counsel; 
Naomi Seiler, Counsel; Ruth Katz, Chief Public Health Counsel; 
Alvin Banks, Special Assistant; Caren Auchman, Communications 
Associate; Lindsay Vidal, Special Assistant; Elana Leventhal, 
Legislative Assistant; Mitch Smiley, Special Assistant; Aarti 
Shah, Minority Counsel; Ryan Long, Minority Chief Health 
Counsel; and Chad Grant, Minority Legislative Analyst.

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

    Mr. Pallone. The meeting of the subcommittee is called to 
order. Today we are having a hearing on 2009 H1N1 flu outbreak 
and the U.S. Federal response.
    I have to warn you, I have to get used to this new 
definition and not use "swine flu" I understand anymore.
    The subcommittee is meeting to discuss the ongoing 2009 
H1N1 flu outbreak and the U.S. Federal response, and the 
purpose of today's hearing is to hear from our Nation's lead 
agencies to learn the what, when and where about this outbreak 
and also to discuss next steps in the Federal response in 
reporting and reacting to this potential crisis.
    Today we have invited rear Admiral W. Craig Vanderwagen, 
assistant secretary for preparedness and response; Dr. Joshua 
Sharfstein, who is the acting commissioner of the Food and Drug 
Administration; and Rear Admiral Anne Schuchat, who is interim 
deputy director for the Science and Public Health Program at 
the Centers for Disease Control and Prevention.
    And I want to thank each of you for taking time out of your 
extremely busy schedule to come and help educate Congress and 
the public about this very serious public health emergency and 
highlight areas where further support may be necessary.
    Now let me tell my colleagues that, because the witnesses 
are on the front line of our ongoing efforts to report and 
react to the 2009 H1N1 flu outbreak, I am cognizant time is of 
the essence, and they are needed at their respective offices. 
Therefore, I have asked all members of the committee to not 
make an opening statement but instead submit their statements 
for the record so we can get straight to our witnesses and make 
the best use of their limited time.
    Without objection, Members will have 5 days to submit their 
written statements for inclusion in the hearing record.
    I am going to recognize, though, the committee Chair and 
subcommittee Chairs and the ranking members for remarks.
    And we will begin with Mr. Deal.
    [The prepared statement of Mr. Pallone follows:]

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

    Mr. Deal. Thank you, Mr. Chairman.
    And thank you, distinguished members of our panel.
    I think we all want to know how to evaluate and know where 
we are in the ongoing effort to respond to the H1N1 flu 
situation, and I appreciate the efforts of the chairman and the 
members of this subcommittee to give us this opportunity to 
hear update information on what is truly a dynamic and 
obviously rapidly changing situation. I recognize the 
importance of the roles that each of our witnesses play in 
responding to this public health threat. And so I am going to 
keep my comments as brief as possible.
    I recall, not too very long ago, this committee was having 
hearings when we were concerned about the bird flu. And many of 
the concerns and expressions of preparation necessities that we 
talked about then I am sure are applicable here today.
    As our witnesses will attest, the threat of a global 
influenza epidemic or flu pandemic is one of the greatest 
public threats that we face today. From speaking with experts 
in the field, both in this most recent as well as the most 
recent past experience with this, we have all said it is not a 
question of if a flu pandemic will hit, it is a question of 
when, and I suppose now, what strain will it be? And I believe 
is our responsibility as Members of Congress to ensure that the 
public is protected from this threat as soon as possible, and 
that we take the necessary steps to mitigate its spread and of 
course the heightened risk, and it is certainly something that 
is high on our priorities.
    And there is no silver bullet. We all know that. But we do 
want to know what is being done? What should be done? What role 
can we play? I am encouraged by the rapid response of the 
Federal and State authorities who are working closely in 
conjunction with the private sector to develop solutions to the 
flu situation that we are facing. And in addition to these 
efforts, I think we have to continue to look for the 
vulnerabilities that leave the American public at risk.
    I have been told that this morning Vice President Joe Biden 
said in an interview that he would advise members of his family 
to avoid commercial air travel, subways and other locations 
where transmission of flu from person to person is easy. This 
seems somewhat contrary to the administration's recent 
statements, and I hope that we can clarify that in this hearing 
today. Also I hope that we can see how the administration has 
looked at all available options in dealing with this matter.
    We certainly need to know how to advise our constituents 
with regard to all of the issues of travel, crossing our 
national boundaries and all of the things that go with that. 
This is a very distinguished group, and I feel sure that you 
can answer these questions and many, many more. Thank you for 
being here.
    And thank you, Mr. Chairman, for the time.
    Mr. Pallone. Thank you, Mr. Deal.
    Chairman Waxman.

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

    Mr. Waxman. Thank you very much, Mr. Chairman.
    I thank you for holding this hearing.
    It seems to me that at this hearing we must accomplish two 
things. We should get a clear statement to the public about the 
flu outbreak from the Nation's leading health authorities. And 
I am pleased that our witnesses are here today to provide that.
    We should find out if there are other things, short term 
and long term, that Congress can do to help in their current 
and future response. There is much that we cannot know at this 
point about this flu. We don't know how infectious is the virus 
or how sick people will get or how widespread it will be, but 
there is one thing that can be known; we are better situated to 
face the outbreak now than we would have been 10 years ago. 
Because of the public health work, the planning, the 
stockpiles, the building of epidemiological systems, we are 
better prepared to limit the reach and severity of the epidemic 
in the U.S. than we would have been.
    Fewer people will likely get sick than if this same virus 
had hit in the 1990s. And there is one thing we can confidently 
predict. We need to do more. For decades, health professionals 
have been warning us that we are taking the work of the public 
health system for granted. The system is generally 
understaffed, under-equipped and underfunded.
    The President has requested an additional $1.5 billion to 
respond to this flu outbreak. And I am sure the Congress will 
appropriate these funds. But that should not be the end of our 
efforts. We should not wait for public health emergencies to 
come up with ad hoc responses. We should upgrade our public 
health programs. We should provide them with a firm and 
reliable foundation of funding, and I hope from this pandemic 
flu outbreak, we can finally learn the lesson that public 
health work saves both money and lives.
    I appreciate the witnesses here, and I particularly want to 
thank Dr. Sharfstein for being here. He was an important 
staffer, not on this committee but on the Oversight Committee. 
But it is a rare opportunity to have him on other side of the 
table. And I am pleased that he is here, and I am pleased he is 
in the position that he is now holding.
    And I thank the other two doctors for being with us as 
well. We are looking forward to your testimony.
    [The prepared statement of Mr. Waxman follows:]
    Mr. Pallone. Thank you, Chairman Waxman.
    Chairman Dingell.
    Mr. Dingell. You are very kind Mr. Chairman. Thank you.
    I would ask unanimous consent to insert my full statement 
into the record.
    But I would like to look back on two things. One, the fact 
that we have been starving our capabilities of addressing 
problems of this kind, and we are now are looking at the 
consequences of that situation. And I would like to observe 
that the last time we had this kind of serious problem, we had 
the same kind of potential for a panicky response which I am 
observing might be the case again today. The result of that was 
the hideous set of consequences in which the lawyers held swine 
flu seminars to discuss how it was that they were going to 
represent plaintiffs and how the situation was going to create 
the maximum revenue for the plaintiffs and for the lawyers.
    I hope that we will have a more measured, thoughtful 
response, bottom line a more careful approach and that, from 
the past events, we will learn that we have to do these things 
in a more sensible, prudent, provident and continuing manner.
    Thank you, Mr. Chairman.
    [The prepared statement of Mr. Dingell follows:]******** 
INSERT 1-1 ********
    Mr. Pallone. Thank you, Chairman Dingell.
    We will go to the witnesses.
    I did want to mention, though, that Congressman Anthony 
Weiner called me last weekend. I think you had a number of 
cases actually in a school in your district and asked that we 
have this hearing. Obviously a number of members requested it. 
But I did want to acknowledge his quick action, calling me on 
the cell phone on Sunday and his concern obviously because of 
the number of cases in the school and his district.
    Let me introduce our panel, and this is the order you are 
going to be speaking. I guess it is a little different from the 
way you are sitting there. First, we have Rear Admiral W. Craig 
Vanderwagen, who is a physician and assistant secretary for 
preparedness and response.
    And next is Rear Admiral Anne Schuchat, who is also a 
physician and interim deputy director for the Science and 
Public Health Program at the Centers for Disease Control and 
Prevention.
    And last is Joshua M. Sharfstein, who is also a physician 
and acting commissioner of the Food and Drug Administration.
    We are asking you for basically 5-minute statements, and 
they will become part of the record.

STATEMENTS OF REAR ADMIRAL W. CRAIG VANDERWAGEN, MD, ASSISTANT 
  SECRETARY FOR PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF 
  HEALTH AND HUMAN SERVICES; REAR ADMIRAL ANNE SCHUCHAT, MD, 
 ACTING DEPUTY DIRECTOR FOR SCIENCE AND PUBLIC HEALTH PROGRAM, 
 CENTERS FOR DISEASE CONTROL AND PREVENTION, ASSISTANT SURGEON 
GENERAL, U.S. PUBLIC HEALTH SERVICE, U.S. DEPARTMENT OF HEALTH 
  AND HUMAN SERVICES; AND JOSHUA M. SHARFSTEIN, MD, PRINCIPAL 
  DEPUTY COMMISSIONER AND ACTING COMMISSIONER, FOOD AND DRUG 
  ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

       STATEMENT OF REAR ADMIRAL W. CRAIG VANDERWAGEN, MD

    Mr. Vanderwagen. Good morning Chairman Pallone and 
Representative Deal and thank you for this opportunity to visit 
with you.
    I offer greetings and thanks from our new Secretary 
Sebelius for this opportunity to assure that both arms of the 
U.S. Government of the three are working together and that we 
can share experiences, concerns and strategies for how we will 
address this opportunity.
    Over the past week, you have seen extraordinary efforts on 
the part of Health and Human Services and the rest of the 
Federal Government. For the past 5 years, HHS and the U.S. 
Government made many investments, thanks to the support of 
Congress, in the Nation's preparedness for pandemic influenza.
    Now while the sequence of the events that we have dealt 
with in the last week, and I will remind you we are talking 
about essentially a week ago yesterday recognizing two cases in 
California to now phase 5 in the WHO environment, the events of 
the past week have proven the value of the efforts that you 
supported, which included the development of community plans, 
the acquisition of medical countermeasures, the development of 
now diagnostics, and the numerous exercises and response plans 
at all levels of government.
    I would like to take an opportunity also to acknowledge and 
thank Secretary Napolitano for her continued leadership in this 
environment. She stepped forward very effectively as the 
principal Federal official here, and we work under her guidance 
overall. Our new Secretary engaged immediately. She reported to 
the office yesterday morning, and in fact, she was briefed in 
doing press discussions yesterday morning almost immediately. 
She is actively involved and concerned about these matters and 
directing our activities as well.
    Today I am joined by my colleagues who currently serve in 
the HHS leading the response.
    I want to say just a thing or two about the assistant 
secretary for preparedness and response. Congress in 2006 
established the authority for this responsibility with the 
notion that this office would be the principal adviser for the 
Secretary on public health and medical preparedness and 
response for health emergencies. And indeed, that is what we 
are executing at this time.
    We are trying to work to assure that there is a coherent 
HHS approach to public health and medical preparedness and that 
our response capabilities are coordinated, that the relevant 
activities of all the operating divisions of Health and Human 
Services, Centers for Disease Control, Food and Drug 
Administration the National Institutes of Health and others are 
being conducted in a coherent and targeted way on behalf of and 
subject to the authority of our new Secretary.
    Our office also serves as the principal entity that 
coordinates interagency activities between Health and Human 
Services and other Federal Departments and agencies, the White 
House, and State and local officials responsible for public 
health, emergency and medical disaster response.
    In the event of a public health emergency such as the 2009 
H1N1 flu outbreak or other medical disasters, Health and Human 
Services serves as the Federal Government's lead for all of the 
Emergency Support Function 8, that is the public health and 
medical response capabilities under the National Response 
Framework. As the Department's lead for that ESF 8 or Emergency 
Support Function 8, our office works closely with Homeland 
Security and FEMA to coordinate all Federal assistance to 
supplement States, territorial governments, tribal and local 
resources in response to public health and medical care needs.
    We manage the Secretary's Operations Center in the Humphrey 
building so that the Secretary has moment-by-moment situational 
awareness and the ability to lead, coordinate and direct, as 
appropriate, the health assets that are deployed in support of 
States.
    The response and coordination for the H1N1 flu outbreak is 
going well. You will hear from Dr. Schuchat how our lead 
operational entity at this point, that is the Centers for 
Disease Control, is moving forward according to plan, adjusting 
to reality as it intrudes, but doing an exceptionally good job 
of moving forward to manage this event.
    The United States Governments are focused on saving lives, 
slowing the transmission of the disease, and mitigating the 
consequences of this disease. Those are our strategic 
objectives. Using the guidelines prepared within our pandemic 
influenza playbooks and plans, we have been able to more 
clearly communicate our goals, objectives and strategies to our 
Federal, State and local partners, so that we understand what 
they expect, they understand what they can expect from us, and 
that makes a ton of difference in making operations flow and 
flow well.
    As you know, the World Health Organization raised the world 
wide pandemic alert to phase 5, which is characterized by 
confirmed person-to-person spread of a new influenza virus and 
able to cause community level outbreaks, and Dr. Schuchat I am 
sure will talk about that in more detail. But prior to that WHO 
action, we issued several key declarations, including a 
nationwide Public Health Emergency Declaration and four 
Emergency Use Authorizations, which I think Dr. Sharfstein will 
talk about in his discussion with you. These authorizations 
were issued to make certain diagnostics available to public 
health and medical personnel, to allow for the use of certainly 
antiviral products and for the use of certain N95 respirators.
    In response to requests received from affected States, HHS 
recently released antiviral medications from the Strategic 
National Stockpile to a large number of States. Additionally, 
Health and Human Services continues to evaluate community 
mitigation guidelines in those areas where cases have been 
confirmed through laboratory analysis, and as this outbreak 
progresses, we will continue to assess these and other 
guidelines to assure that they are appropriately based on the 
available science. Over the coming days, we will continue to 
work with our Federal, State, local and international public 
health and medical partners to address the needs of this 
outbreak.
    Many assets, and you will hear elements of this from my two 
counterparts, are working to develop a vaccine for this virus. 
NIH, CDC, FDA and ASPR are all working together to work this 
process and to avoid the very dilemma that Mr. Dingell outlined 
for us.
    We will work with several manufacturers to continue to 
prepare reference strains from which viral seeds for vaccine 
production and clinical trials can be made. We will not only 
focus on the immediate response requirements but also those 
that may lie ahead. As this potentially becomes more of a 
medical care problem, we will see challenges in the medical 
care system. We are already actively in communication with our 
colleagues at the State and local level, in hospitals, in 
emergency rooms, and in primary care settings to anticipate the 
implementation of their plans for addressing these matters and 
how we can support, enhance and fill gaps that may arise in 
that setting. With that, I will conclude my statement, and you 
can hear from Dr. Dr. Schuchat.
    [The prepared statement of Admiral Vanderwagen 
follows:]******** INSERT 1-2 ********
    Mr. Pallone. Thank you. I assume that I am supposed to 
reference you as Doctor rather than Admiral. Do you prefer 
that?
    Ms. Schuchat. "Dr. Schuchat." That is fine.
    Mr. Pallone. Dr. Schuchat.

          STATEMENT OF REAR ADMIRAL ANNE SCHUCHAT, MD

    Ms. Schuchat. Good morning, Mr. Chairman and members of the 
subcommittee.
    I am Dr. Anne Schuchat, the acting deputy director for 
science and program at the Centers for Disease Control and 
Prevention, and I appreciate the opportunity to update you on 
current steps we are taking to respond to this unique and 
serious influenza outbreak.
    Our hearts go out to the people in the communities within 
the United States and Mexico and around the world who have been 
impacted by this new strain of influenza virus. People are 
concerned, and we are concerned, too. We are responding 
aggressively at the Federal, State, and local levels to 
understand the complexities of the outbreak and to implement 
control measures. Our aggressive actions are possible in many 
respects because of the investments and the support of the 
committee and the Congress and the hard work of State and local 
officials on the frontline around the country.
    Flu viruses are extremely unpredictable, making it hard for 
us to anticipate the course that this outbreak will have with 
any certainty. We do expect increases in the number of cases, 
the number of States that are affected and the severity of 
illness. Amid this uncertainty, we hope to be clear in 
communicating what we do know and acknowledging the 
uncertainties, clearly communicating what we are doing to 
protect the health of Americans and help Americans understand 
the steps that they can take themselves to protect their own 
health and that of their families and their communities.
    Influenza arises from a variety of sources. And in this 
case, we have determined that we have a novel 2009 H1N1 virus 
circulating in both the U.S. and Mexico that contains genetic 
pieces from four different virus sources. Additional testing is 
being done on the virus, including a complete genetic 
sequencing. CDC has determined that this virus is contagious. 
It is spreading from human to human similarly to seasonal 
influenza, likely through coughing or sneezing. Sometimes 
people may become infected by touching something with flu virus 
on it and then touching their mouth or nose.
    There is no evidence to suggest that this virus has been 
found in swine in the United States, and there have been no 
illnesses attributed to handling or consuming pork. There is no 
evidence that you can get this new influenza virus from eating 
pork or pork products.
    I want to reiterate that, as we look more intensively for 
cases, we are finding more cases. We fully expect to see not 
only more cases but also a greater severity of illness. The 
specific numbers are less important in understanding the 
outbreak than the more general patterns that we observe that 
will help us guide our interventions. Aggressive actions are 
being taken here as well as abroad. We are working very closely 
with State and local public health officials around the U.S. on 
the investigation and to implement control measures. We have 
provided both technical support on epidemiology and laboratory 
efforts for confirming cases. And we are working with the World 
Health Organization, the Pan American Health Organization and 
the Governments of Mexico and Canada on this outbreak. There is 
a tri-national team that is working in Mexico right now to 
better understand the outbreak and to enhance surveillance and 
lab capacity so that we can better address critical questions, 
such as why the cases in Mexico appear to be more severe than 
what we are seeing initially here in the United States. And we 
are working very closely with HHS and other Federal partners to 
ensure that our efforts are coordinated and effective.
    CDC has issued many health advisories for individuals, 
health care practitioners, schools and communities, and these 
continue to evolve as our understanding of the situation 
changes. On Monday, CDC issued a travel health warning for 
Mexico recommending that travelers postpone nonessential travel 
to Mexico. We are also evaluating information from other 
countries, and we will update travel notices as necessary.
    As always, people with flu or flu-like symptoms should stay 
at home and should not attempt to travel. In fact, a key 
message that we have for people is that there is a role for 
everyone to play when an outbreak like this is occurring. At 
the individual level, it is important for people to understand 
how each of us can prevent respiratory infections. Frequent 
hand washing is an effective way to reduce transmission. If you 
are sick, stay home. I can't tell you how many times I have 
said that this week. If your children are sick, have a fever or 
a flu-like illness, they shouldn't go to school. And if you are 
ill, you shouldn't go on an airplane or any public transport to 
travel. Taking personal responsibility for these things will 
help reduce the spread for this new virus as those measures 
also help reduce the spread of other respiratory infections.
    It is also important for people to think ahead to think 
about what they would do if their outbreak deepens in their 
community. Communities, businesses, schools and local 
government should plan now for what to do if cases appear where 
you live or work.
    For example, parents should prepare for what they would do 
if faced with temporary school closures. We also have 
additional community guidance so that clinicians, laboratory 
scientists and other public health officials will know what to 
do should they see cases in their community. All of these 
specific recommendations, as well as our regular updates, are 
posted on the CDC's website at www.CDC.gov.
    CDC maintains this Nation's strategic National Stockpile of 
medications for the eventuality that they may be needed in a 
situation such as we face today. As part of our pandemic 
preparedness efforts, the U.S. Government has purchased 
extensive supplies of antiviral drugs. And our preliminary 
testing indicates that the virus is susceptible to the drugs we 
have in our stockpile. We are releasing one-quarter of the 
States' share of antiviral drugs and personal protective 
equipment to help States prepare to respond to the outbreak 
along with the necessary FDA emergency use authorities to 
facilitate their effective use. Distribution has already begun, 
starting with States where we already had confirmed cases and 
the Department of Defense and individual States have also 
stockpiled these antiviral drugs.
    Whenever we see a novel strain of influenza, we begin the 
steps to work toward the development of a vaccine in case one 
is needed. The CDC is working to develop a vaccine seed strain 
specific to this novel virus, which is the first step in 
vaccine manufacturing. We have initiated steps so that, should 
we need to manufacture a vaccine, we can work towards that goal 
very quickly. And rapid progress is being made possible through 
the combined forces of CDC, NIH, FDA, BARDA and the 
manufacturing community.
    Finally, it is important to recognize that, with the strong 
support of the Congress, there have been enormous efforts in 
the U.S. to prepare for this kind of outbreak and for a full 
pandemic. Our detection of this strain in the United States 
came as a result of that investment. And our enhanced 
surveillance and laboratory capacity are critical to 
understanding and mitigating this threat.
    While we must remain vigilant throughout this and 
subsequent outbreaks, it is important to recognize that, at no 
time in our Nation's history have we been more prepared to face 
this kind of challenge. As we face the challenges in the weeks 
ahead, we look forward to working closely with the subcommittee 
to best address the evolving situation.
    Thank you.
    [The prepared statement of Admiral Schuchat 
follows:]******** INSERT 1-3 ********
    Mr. Pallone. Thank you, Dr. Schuchat.
    Dr. Sharfstein.

             STATEMENT OF JOSHUA M. SHARFSTEIN, MD

    Mr. Sharfstein. Thank you Chairman Pallone, Ranking Member 
Deal, Ranking Member Barton, Chairman Waxman, chairman Dingell 
and other members of the committee, thank you for having this 
hearing.
    I am Dr. Joshua Sharfstein, principal deputy commissioner 
and acting commissioner of the U.S. Food And Drug 
Administration.
    FDA protects the public health in this type of situation by 
facilitating access to safe and effective human and animal 
drugs, human biological products and devices. FDA is part of a 
team led by the Department of Health and Human Services. 
Working closely with the Department, our sister agencies, other 
U.S. Government agencies, the World Health Organization and 
foreign governments, we are responding to this threat.
    I appreciate this opportunity to discuss the agency's 
response, including our approval of several Emergency Use 
Authorizations earlier this week and the efforts of several 
internal FDA teams.
    Let me turn to the Emergency Use Authorization. Section 564 
of the Food, Drug and Cosmetic Act which was added by the 
Project BioShield Act in 2004 which permits the FDA 
commissioner to issue an Emergency Use Authorization following 
a determination and declaration of a Public Health Emergency. 
This allows the use of an unapproved product or an approved 
product for an unapproved use and in a declared emergency.
    Mr. Pallone. Dr. Sharfstein, I think some of the members 
are having a hard time hearing you.
    Dr. Sharfstein. I was talking about Emergency Use 
Authorizations. And FDA can issue these in an emergency under 
four conditions: First, we have defined that the agent can 
cause a serious or life-threatening disease or condition; 
second, based on the totality of the scientific evidence, it is 
reasonable to believe the product will be effective against a 
disease or condition; third, that the known and potential 
benefits of the use outweigh the known and potential risks; and 
fourth, that there is no adequate and approved available 
alternative.
    This past Sunday, the acting HHS Secretary did issue a 
Public Health Emergency declaration and then followed that with 
declarations justifying the emergency use of certain 
antivirals, in vitro diagnostics and personal respiratory 
protection devices.
    Let me briefly describe these Emergency Use Authorizations 
that FDA went ahead and issued as a result or following that 
declaration. Two of them pertain to drugs. Tamiflu is a drug 
approved, it is oseltamivir, for the treatment of uncomplicated 
illness due to influenza and prevention of influenza in 
patients 1 year and older. Relenza is approved to treat acute, 
uncomplicated illness due to influenza in adults and children 7 
and older who have been symptomatic for less than 2 days and 
for the prevention of influenza in adults and children 5 years 
and older.
    One of these Emergency Use Authorizations allows for 
Tamiflu also to be used to treat and prevent influenza in 
children under 1 year. In addition, under both authorizations, 
both of these medications may be distributed with information 
pertaining to emergency use to large segments of the population 
without complying with the label requirements that otherwise 
are applicable to dispensed drugs. They may be distributed by a 
broader range of health care workers, including some public 
health officials and volunteers, in accordance with the State 
and local laws and public health emergency responses that I 
know are being planned around the country.
    The third one related to a PCR flu panel diagnostic test 
for the CDC, which allowed the CDC to distribute to public 
health labs around the country a diagnostic test that can 
presumptively diagnose this particular infection.
    And for all of these Emergency Use Authorizations, the way 
it worked is CDC applied; we worked very closely with CDC over 
the weekend to make sure everything was there to get the right 
information to people; and then we approved them on Monday 
starting early in the morning. This particular diagnostic test 
amplifies the viral genetic material. A positive result 
indicates presumptive infection. A negative result by itself 
does not exclude the possibility of infection.
    The fourth authorization permits HHS to deploy certain 
disposable respirators in the Strategic National Stockpile for 
use to reduce exposure to airborne germs. These products, when 
used properly and in accordance with information that is 
provided, may help reduce the chances of getting sick. They do 
not eliminate the risk of illness or death. They should always 
been used in conjunction with other control measures, such as 
frequent hand washing, and should done consistently with the 
advice and guidance provided by the CDC and other public health 
authorities.
    Let me just turn for the last minute to talk about how FDA 
has organized itself to respond to this challenge. As soon as 
we became aware of this last week, I asked Dr. Jesse Goodman, 
FDA's acting chief scientist and deputy commissioner for 
Scientific and Medical Programs to coordinate and lead FDA's 
efforts. Dr. Goodman is a world expert in infectious disease. 
He previously directed the Center For Biologics and has 
extensive experience in issues related to influenza vaccine 
production and evaluation.
    We have changed the way FDA is managed for this process. We 
are using an incident management approach with Dr. Goodman as 
the leader, which includes seven substantive teams that are 
cross-cutting and include staff from across the FDA and all FDA 
centers. These teams work with the Department, CDC, other 
agencies, national and international partners, and they are the 
vaccine team, the antiviral team, the in vitro diagnostics 
team, the personal protection team, the blood team, the 
shortage team, and the consumer protection team. We also, in 
the incident management approach, have an operations section, a 
logistics section, and a communication section. We have senior 
level health, international, and legal advisors.
    Let me very briefly explain how these teams work. The 
vaccine team is working to facilitate the availability of a 
safe and effective vaccine to protect the public from the 2009 
H1N1 flu virus as soon as possible. Now, having that vaccine 
ready is the goal of the team. There is a completely separate 
question, and that is going to depend on the status of the 
epidemic of whether and who that vaccine would be recommended 
for. But for FDA, we want to have a vaccine that is safe, 
effective and available as quickly and possible.
    Part of this team starts in the lab. We are growing the 
vaccine and trying to genetically engineer a reference strain 
that could be used for vaccine development. We are already 
preparing a re-agent that will be needed to help manufacturers 
produce and test the vaccine. We are trying to think through 
what clinical evidence would be necessary before we can 
conclude that the vaccine is effective. This team is working 
with BARDA and HHS to have extensive consultation with the 
vaccine industry already as this goes forward.
    I actually went out and met with the vaccine team earlier 
this week. They are scientists. They are physicians. They 
realize how much is at stake for this country.
    There is the antiviral team, whose goal is to identify and 
evaluate antiviral drugs to prevent and treat illness and to 
facilitate access to these medications. This is the team that 
led the effort to review the Emergency Use Authorizations with 
CDC. They are also in extensive communications with 
manufacturers about other options to treat this infection, 
particularly if it becomes severe, and is working very closely 
with other regulatory agencies around the world. This team used 
its expertise to identify the right dose for kids under 1, and 
we are hearing from a lot of countries around the world about 
how they did that.
    We have an in vitro diagnostics team that approved that 
tests that I was talking about that CDC is distributing. It is 
already working with manufacturers on the availability of other 
tests as well as current diagnostics just for basic 
identification of influenza.
    The personal protective equipment team did the mask 
Emergency Use Authorization, and they are also in continuous 
contact with the key manufacturers to make sure that we can get 
the appropriate supplies of these products for the American 
people.
    There is a blood team. The blood team is dedicated to the 
safety and availability of blood products needed for 
transfusion by the American public during this outbreak. The 
main focus of the blood team is to make sure there is adequate 
blood just in general because blood is so important for so many 
different people and patients around the country in that the 
response to this just doesn't reduce the number of donors, but 
they are also starting to think through whether there is any 
potential risk of the blood supply, and they are engaging other 
regulatory agencies. So far they are not, there is nothing that 
they are recommending in terms of particular controls based on 
their understanding of influenza.
    We have a shortage team that is working very closely with 
manufacturers to, particularly around the issue of how they can 
expand production of key medications, as well as working with 
HHS and others about spot shortages that are occurring.
    And finally, we have a consumer protection team that cross 
cuts across all the different parts FDA to monitor for scams, 
dangerous products, and things that may be marketed that could 
cause harm to people as they are worried about this situation.
    So, in conclusion, FDA is fully committed and engaged in 
protecting the public's health during this difficult time. 
Among us are laboratory scientists, medical reviewers, 
epidemiologists, product experts and field inspectors. We will 
bring every skill and every resource we have to this critical 
mission.
    Thank you very much for the opportunity to testify today. I 
welcome your ideas and your questions.
    [The prepared statement of Dr. Sharfstein follows:]******** 
INSERT 1-4 ********
    Mr. Pallone. Thank you, Dr. Sharfstein.
    I thank all of the panelists.
    We will now have 5-minute questions from the members. And I 
will start with myself.
    And I wanted to ask, Dr. Schuchat, you mentioned the 
precautions people can take to protect themselves. But could 
you elaborate further, and let me just ask, what kinds of 
symptoms should people be alert to? Naturally, people look to 
their families, and you get all kinds of things; should I go to 
a doctor? Should I wear a mask? You don't necessarily have to 
comment on that. But what are the symptoms that they should be 
alert to? And what about going to the doctor? Does it make 
sense to go to a doctor? You don't want to overwhelm the 
doctors' offices either.
    Ms. Schuchat. The symptoms of this new strain of influenza 
virus are similar to the symptoms of seasonal influenza. And 
they include high fever, body aches, cough, sore throat. Those 
sorts of things. Unfortunately, the symptoms of influenza are 
very nonspecific, and they can be caused by lots of other 
things. It is important for people to use judgment. If you are 
really sick, you need to make sure you consult your health care 
provider. And if your children are ill, the same thing. But it 
is also important to recognize that this is a time where we 
don't want the worried well flooding the emergency rooms. We 
really do need to be careful about that kind of thing.
    One of the emphasis areas has been diagnostic tests to help 
us differentiate this new virus from other illness. And so we 
are very pleased that this Emergency Use Authorization went 
forward, and the States are now prepared to differentiate this 
new flu virus from other things.
    But in general, mild illness, you really are able to stay 
home and self-care. And illness that is a little bit more 
severe, you want to make sure you contact your health care 
provider. In particular, in areas where there hasn't been any 
recognized disease yet, we want people to let their health care 
provider know if they have these sorts of symptoms and have 
traveled to one of the areas that is affected.
    Mr. Pallone. You mentioned Mexico. I mean, I do see, well, 
people mention Mexico; I do see on TV you know people in Mexico 
wearing masks. That doesn't make, maybe it does in, Mexico but 
here, that is a little severe, isn't it?
    Ms. Schuchat. We think there are a variety of interventions 
that will help reduce the risk of respiratory infections. And 
we do feel for the people in Mexico who are in a difficult 
circumstance now and really doing everything they can think of 
to try to protect themselves.
    Here we have issued guidance for the mask use, for 
different circumstances. And we update our guidance as we get 
new information on our Website. But I think it is important to 
say that guidance is going to be different in different areas. 
The New York City area was having an outbreak in a school that 
was fairly large, and their guidance was really targeted at the 
circumstances on the ground.
    CDC is trying to issue guidance and updated guidance very 
frequently for the country. But we recognize that the local 
authorities have the best information on their circumstances. 
And we really want people to know what is going on in your own 
community; what do your local authorities say? And really use 
us as a technical support to those local entities.
    Mr. Pallone. Let me ask Dr. Sharfstein about the 
vaccination. I seem to recall, I don't know if it was at the 
briefing yesterday or that they said that it probably wouldn't 
be available for everyone until maybe November at the earliest, 
possibly not until January. I remember in 2004 when we had a 
major shortage of the seasonal flu vaccine, and at the time, 
the public health officials were saying, if we faced a 
pandemic, we wouldn't have adequate vaccine capacity. Can you 
explain what the government has done to increase the vaccine 
manufacturing capacity, and where are we now?
    I mention that I don't know where I heard that November to 
January. It might have been at the briefing we had yesterday 
but--
    Mr. Sharfstein. I am happy to answer that. In 2004, there 
were only about 60 million doses of vaccine for the flu that 
year because of the problem that one of the manufacturers had. 
And in addition, the infrastructure was relatively weak, and 
there wasn't the capacity if there was a pandemic to be making 
another vaccine. But because of the committee's efforts and the 
Federal Government's efforts and FDA's efforts, there has been 
a tremendous shift since that time. I will go through a couple 
of issues.
    One is that there was funding appropriated to strengthen 
the vaccine infrastructure, and one way to talk about that is 
eggs. Flu vaccine is made in eggs. And in 2004, there weren't 
extra eggs. There was just the eggs for the regular flu 
vaccine. But HHS has gone out and contracted. They have extra 
flocks. And we have gone to a year-round egg availability. So 
there aren't any months where eggs aren't available. So that 
reduces most of the time that people were worried about in 2004 
would be the delay.
    On FDA's side, FDA aggressively went out and solicited 
other companies to be making the flu vaccine for the U.S. 
market and used an accelerated approval approach to bring 
online three new manufacturers. So, this year, I think the 
capacity is around 130 or 140 million doses instead of just 60 
in 2004, with additional manufacturing capacity potentially out 
there. And all the companies already engage with us in how to 
make the vaccine and the eggs available.
    I was hearing that we now have the capacity where we had 
200,000 eggs a day only during the flu vaccine season; that 
that has gone up considerably, maybe as much as 500,000 eggs a 
day year round. So right now, the capacity in the system and 
the availability of the manufacturers to make vaccine is so 
much better than 2004.
    The challenge is, and why people are talking about 
different dates to when it could become available, has to do 
more with the virus than anything else. There are several steps 
to make a vaccine and test a vaccine, and each of those has its 
own uncertainties. If everything goes extremely well, we will 
all be happy. But we don't know if everything will go extremely 
well. You could have a problem creating the virus initially, a 
problem growing the virus. And then when you make the vaccine, 
you have to test it to see if it generates the immune response 
you are looking for, or else it may have to be reformulated.
    So I think the position is, to explain, is that the 
infrastructure we are building on is extremely strong, 
particularly compared to where we were in 2004. But we are 
dealing with an unknown virus, one that hasn't been turned into 
a vaccine before, and there is a lot of uncertainty about how 
that will go. But it is really a scientific uncertainty. I 
think the basic infrastructure to succeed is there.
    Mr. Pallone. Okay, thank you.
    Mr. Deal.
    Mr. Deal. Dr. Vanderwagen, first of all, I would like to 
ask you, how did the administration arrive at the $1.5 billion 
as the figure that the request was made for? How would that 
money be distributed? To which agencies? What would those 
agencies be allowed to use that money for? And are there other 
funds that HHS can currently draw on to deal with this matter?
    Mr. Vanderwagen. Thank you, Mr. Deal. Good question.
    When we analyzed the potential demand for additional 
antivirals, we looked at the cost of production of vaccine. We 
looked at the cost of potential medical supplies should we have 
a wider, more severe event in the medical environment. When we 
look at a number of those issues, the cost requirements can be 
fairly significant. I think the President's intent was, given 
that there are all those potential uses, depending upon how 
this thing progresses, that this was a place to start.
    I think the majority of that would be looking at such 
things as additional medications, additional development costs 
associated with the vaccine and getting it to the point where 
we have a safe and effective vaccine, and providing some 
support to local and State requirements for preparedness. I 
think those are the kinds of issues that we are looking at in 
terms of where that funding would go.
    Mr. Deal. You are not allowed to cough during this hearing. 
I am joking. You are not allowed to cough during this hearing.
    Mr. Vanderwagen. Oh, well, it is allergies in my case.
    So the universe of need could be quite large, much larger 
than that figure in fact. But this is a way for us to look at 
some of the known things that we think we are going to need to 
take care of. We are currently replenishing our stockpile for 
those amounts. And we are considering that. We have funds 
inside the Department we might be able to use to cover that, so 
that is a decision point that we are examining right now.
    If we want to cover so those antivirals that we already 
sent to the States and replenish that, we may have funding 
available to us internally to do that. But beyond that, if we 
are going to start talking about wider support antivirals, it 
will be a very difficult challenge to find funding within the 
existing HHS appropriations for that.
    Mr. Deal. So part of it would go to facilitate FDA's more 
rapid response to approving vaccines, for example, for this 
particular thing, is part of what I hear you say. Is that 
right?
    Mr. Vanderwagen. Well, the short answer is yes. NIH will 
conduct clinical studies for safety and efficacy in partnership 
with FDA. That takes funding support. We would be looking at 
beginning to develop the pilot lots. That costs money to do 
that particular clinical trial. In series, we would be looking 
to try to ramp up vaccine commercial production capacity while 
those tests are undertaken. Those all have costs associated 
with them.
    Mr. Deal. Dr. Sharfstein, from the FDA point of view, I 
have been told, and I think the chairman alluded to this as 
well, that if we are developing a vaccine specifically for the 
H1N1 virus, that it could be done as a separate vaccine for 
that. And I have been told it would take maybe 4 months to get 
that, from the time you arrived at what you think the formula 
needs to be, about 4 months to get it to its production stage. 
Is that generally about right?
    Dr. Sharfstein. First of all, let me follow up on what you 
said before. There may be extra funds FDA needs, but I want to 
assure you that everything we think needs to be done is being 
done. And the management structure we have in place is really 
pushing the staff, and everybody is completely committed to 
doing everything we need to do to meet these different goals on 
each team as quickly as possible.
    Four months is one possible scenario. But what it really 
depends on is how this virus behaves in a vaccine. I will just 
give you an example. We have to combine it with other viruses 
in order to get it to grow fast enough. Then it has got to 
eventually be grown in bulk. And then it has to be tested in 
people to see how much of it produces an immune response. If 
you do the first test, and it doesn't show the right--it may be 
the first test as a couple different options, but based on that 
data you have to look at it, because our goal is both an 
effective vaccine and a safe vaccine. So it is going to depend. 
Since we are not going to be waiting for eggs, that was 
actually one of the biggest problems in 2004--
    Mr. Deal. I hate to interrupt you, but my time is about 
out. I want to ask you one other thing.
    My understanding is that, each year, in the seasonal 
vaccines, that you choose up to maybe three different strains. 
I assume this was not one of the strains that was anticipated 
to be included in the seasonal vaccine simply because you 
didn't, first of all, anticipate it; secondly you have not had 
the time to ramp up for it. Are you so far along I assume in 
the seasonal vaccine process that, if you were to be able to 
come up with a vaccine for this, that it would not be allowed 
to be included in the seasonal vaccines but would have to be a 
separate vaccination program? Is that a correct assumption?
    Mr. Sharfstein. That is an excellent question. You are 
right that it was not in the flu vaccine that had been prepared 
because people weren't aware of the virus's existence. And 
right now, we are basically developing with the manufacturers 
the ability to make a vaccine. And then there has to be some 
strategic decisions made over the next few weeks. One of those 
decisions is going to be whether to make this as a stand-alone 
vaccine, to combine it with other vaccines, and that in part 
has to do with the manufacturing capacity. If you make a single 
stand-alone vaccine, you can make more of it. And in part that 
is going to depend on how much of it you need to develop the 
immune response.
    So there are a lot of factors out there. And what FDA does 
is it works with the CDC, the World Health Organization and an 
advisory committee of experts to look at all the evidence, look 
at what we know about how this vaccine looks to us as well as 
what we know about the manufacturing capacity, and then there 
will be a recommendation about how this integrates with the 
seasonal flu.
    So it might, you know, it is too early right now to have an 
answer. But it is an excellent question. And I think probably 
within a few weeks, we will be able to know more and be able to 
give a better answer.
    Mr. Pallone. Thank you, Mr. Deal.
    Chairman Waxman.
    Mr. Waxman. Thank you, Mr. Chairman.
    Dr. Schuchat, I would like to explore with you how this 
virus is different from other flu viruses. Most people are 
familiar with the fact that we have an annual vaccine to deal 
with the flu that might be in the flu season. And we are in the 
middle of all this where the flu season is pretty much over.
    Every year, millions become ill, about 36,000 die from the 
regular seasonal flu in this country. But this new H1N1 flu 
does appear to be different. And I still recognize we have a 
lot to learn. But I am hoping you can clear up a few questions. 
Can you explain what the H1N1 flu is, and how it is different 
from the seasonal flu? Is this virus easily transmitted from 
person to person? And do we know how dangerous this virus is?
    Ms. Schuchat. Thank you.
    This is a new virus that humans have not had before. There 
are H1N1 A influenza viruses that we get every year as part of 
seasonal flu. But this is a new H1N1 strain that we hadn't 
found before in all of the banks of strains that we have looked 
at. It is a very unusual one. It has four genetic components in 
it: one that comes from swine from north, from North America; 
one that comes from swine from Europe and Asia; a third part 
that has human origins; and a fourth part that has bird 
origins.
    So it is a very unusual virus. And we don't believe that 
humans have experienced it before until these cases that we are 
seeing.
    It does appear to be easily transmissible in terms of the 
information we have already here in the United States as well 
as in Mexico. But we don't have good information about how 
dangerous it is. It is a very important issue. In Mexico, we 
are getting more data about the severity. In the U.S., we are 
in early days, but really trying to understand how severe it 
is. We are taking it very seriously.
    Mr. Waxman. On the news shows, there is a constant 
comparison to the pandemic flu in 1918 which did such 
devastation. And it is worrisome when we hear about this 
comparison because that virus affected not just the very young 
and very old but also affected otherwise healthy adults. Early 
reports suggest that many of these people who are being 
hospitalized in Mexico were apparently young and otherwise 
healthy as well. I know it is early, but can you tell us in 
what ways this might be similar to 1918?
    Ms. Schuchat. A worrisome sign from the early reports in 
Mexico was the age of the patients and the apparent young, 
healthy adults. That did ring a bell from the circumstances 
back in 1918. So far the cases we have had here in the United 
States that have been laboratory confirmed are relatively young 
also. I think our median age is 22 right now.
    But, again, we are beginning to collect more information 
and these things could change quite a bit. There are some very 
different circumstances from 1918. Today we have antiviral 
drugs that treat flu. We also have the antibiotics or 
antibacterial drugs that treat the kinds of secondary bacterial 
pneumonias that we think played a role in the 1918 devastation. 
We have better health-care circumstances. We have much better 
communication, and hopefully more skilled leadership who is 
doing the communication.
    One of the really important things in addressing something 
like this is making sure that people have good information and 
that our interventions are not worse than the virus itself.
    Mr. Waxman. Even if we assume that this virus is as bad as 
that one in 1918, these modern medical advances will be helpful 
in treating patients, we are not going to see the same kind of 
death and terrible results that we saw then when we didn't have 
vaccines, we didn't have antivirals, we didn't have the whole 
infrastructure of communication that we now have.
    Ms. Schuchat. I think the circumstances are much better 
today to respond to this kind of thing. I also want to 
introduce the uncertainty that every new strain is different 
and we really need to learn as we go about how this one will 
behave. We also are mindful of circumstances in other parts of 
the world which may not be as fortunate as ours.
    Mr. Waxman. Would this virus possibly mutate in the next 
several months?
    Ms. Schuchat. Influenza viruses can mutate frequently, and 
we need to keep our eye on them. During the regular seasonal 
flu, we test strains throughout the season. Often we find 
changes in the resistance patterns of the virus. We are very 
happy that the original strains that we have tested are 
sensitive to the Tamiflu and Relenza that is in our stockpile, 
but we need to keep looking at that and also look at the 
antigenic or immune properties, because that will feature into 
what vaccine will be useful. So they do mutate and we need to 
keep our eye on that.
    Mr. Waxman. Thank you. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, Chairman Waxman. Mr. Gingrey.
    Dr. Gingrey. Mr. Chairman, thank you. First of all, let me 
just associate myself with the comment that our Chairman 
Emeritus, John Dingell, made in his opening remarks in regard 
to not overreacting to the point that we create a pandemic of 
panic. And I want to thank our panelists. I think already some 
comments have been made to that regard.
    And yesterday when Secretary Sebelius and Napolitano and, 
Dr. Schuchat, you were there as well--it is very reassuring to 
Members of Congress to get the feeling that we indeed are 
prepared. The remarks that we heard from Dr. Sharfstein, of 
course, just add to that. I feel good about it.
    I think what occurred in 2003, 2004 in regard to the fear 
of an avian influenza pandemic led to a $6 billion emergency 
appropriation. And as you have pointed out, a lot of that money 
went toward making sure that a stockpile of Tamiflu and Relenza 
was beefed up to something like 50 million courses, not just 
one dose, but courses of treatment. And also the three or four 
pharmaceutical companies who had maybe been in the domestic 
business of manufacturing vaccine, but because of liability and 
no reimbursement for the vaccines that were never given, it was 
not a very cost-effective business for them. We helped with 
that, with grants and some of that money was spent in that way.
    And then it is my understanding--this goes with what 
Ranking Member Deal mentioned as far as the $1.5 billion, Dr. 
Vanderwagen--that 1.3 billion of that original 6 is still 
available.
    And I want to ask this question about that particular 
amount of money. President Obama, I think, had no choice 
because he doesn't want to get Katrina'd, you know; the media 
frenzy about this issue leaves him no choice but to say, well, 
look, we are not going to go to sleep at the switch and we are 
going to appropriate this money. But if, Dr. Sharfstein, if we 
decide that it is not really appropriate, not really necessary 
to go forward with the development of that vaccine specifically 
against this H1N1 flu--we won't call it swine flu--then maybe 
at some point when this is all said and done, it turns out to 
be a mild disease and people kind of go back to their normal 
living and they are not shutting down schools because one child 
is sick, and they are not avoiding the subways and taking 
commercial airline flights--I mean, you know, we are getting to 
the point where I fear that we are getting ourselves in a 
frenzy and it is inappropriate. So if this thing turns out not 
to be the real bad pandemic that everybody fears it could be, 
then I would hope that the money that is not spent to develop 
this vaccine will go back to John Q. Taxpayer, go back into the 
general Treasury or whatever, and not just stay there for the 
next 10 years when it is really not needed.
    I don't want to underplay this. I am a physician member. I 
don't want to have egg on my face a month from now. But I do 
agree with Chairman Emeritus Dingell, we don't want to 
overreact here. And I think Dr. Schuchat mentioned that 
yesterday, and again today, and I would like for all of you to 
comment on that a little bit, if you would.
    Ms. Schuchat. I think it is really important to recognize 
the uncertainty that we have, that influenza can be very 
unpredictable, that evolution of the situation in the past week 
has had many worrisome aspects, but that we are acting 
aggressively. And I think that we really do need to make sure 
that we are able to aggressively respond.
    An important issue, I think, is that the investments that 
were made in the past few years for pandemic preparedness have 
greatly strengthened our response to seasonal influenza. And as 
was mentioned, 36,000 Americans die every year from seasonal 
influenza. So it is likely that flexible programming of 
emergency funds would be flexibly applied to strengthening our 
work against the seasonal flu, which is such a killer in 
America.
    Dr. Sharfstein. I think that your point is very well taken, 
and we heard about the analogy of the 1918 flu, but some people 
have also been discussing the 1976 swine flu situation. And in 
looking back on that, some historians said that might have been 
an instance where people overreacted. And the lessons, I think, 
that were drawn from that experience was that you have got to 
separate out the preparation for the possible worst-case 
scenario from actually implementing it, and that people in 
looking back felt like maybe because they had a vaccine, they 
had to use it. And I think it is very clear now that those two 
things have got to be separated.
    In the end, it is going to be okay if we have a vaccine but 
it turns out not to be a pandemic. We just don't want to be in 
a situation where we have a pandemic and we don't have a 
vaccine.
    Mr. Vanderwagen. And the last comment--just to finish out 
your threesome here, sir--I think that we are now down to about 
600 million remaining. And most of those, as you know, we 
received special milestone payment authority under the Pandemic 
and All Hazards Preparedness Act for acquisition of materials 
and so on. That balance is really already sort of precommitted 
as part of those milestone payments which are going for 
diagnostics, new antivirals in case we develop resistance to 
the existing antivirals, and to support some other vaccine 
analysis that is ongoing. So it is committed in the milestone 
payments stream for those products that are in development.
    Mr. Pallone. Thank you. We just have one vote. I am going 
to try to proceed with questions. I am going to see if there is 
some way we can work it out so that we don't have to break, but 
I don't know if that is possible. But in the meantime, we will 
proceed to Chairman Dingell.
    Mr. Dingell. Mr. Chair, I thank you for your courtesy and I 
commend you for the hearing. I have several questions I would 
like to have for the record. And I would ask unanimous consent 
that the responses be inserted into the record at the 
appropriate place and fashion.
    The first one: Who is going to be the lead agency? Is it 
going to be HHS or is it going to be the Department of Homeland 
Security?
    Mr. Vanderwagen. The simple answer is for public health and 
medical activities, it is Health and Human Services; for the 
wider response, if it involves energy, transportation, 
security, et cetera, that is all in the hands of DHS. We all 
work as a coherent team under their leadership.
    Mr. Dingell. Do you have a memorandum of understanding to 
finding how that is going to be done?
    Mr. Vanderwagen. Yes, sir. There is a National Response 
Framework.
    Mr. Dingell. Would you please submit that for the record?
    [The information appears at the conclusion of the 
hearing.]******** COMMITTEE INSERT ********
    Mr. Dingell. How is this budget going to be expended? Would 
you submit to us a statement of how the money is going to be 
expended, if you please?
    Now, the States are going to have a very severe problem. My 
home State of Michigan has a budget deficit which it has been 
announced is going to go to a billion dollars after some very 
savage efforts to cut back on the expenditures. How much of 
this money, this billion and a half dollars, is going to go to 
the States to be expended through their agencies, for what 
purposes?
    Ms. Schuchat. I think these matters are being evaluated and 
the Office of Management and Budget is intending to submit 
something soon with those types of allocations.
    Mr. Dingell. So the answer is we don't know?
    Ms. Schuchat. Exactly.
    Mr. Dingell. I am assuming that the answer is you do not 
yet have a defined budget structure?
    Ms. Schuchat. [Witness nods in the affirmative.]
    Mr. Dingell. There is no nod button on the reporter's 
response. The answer is yes; is that right?
    Mr. Vanderwagen. Yes to what, sir?
    Mr. Dingell. What is the potential for this flu outbreak to 
reach pandemic levels?
    Ms. Schuchat. The World Health Organization elevated the 
phase yesterday to Phase 5, which is the second highest phase. 
But here in the United States, we have already been acting as 
if it were a full-blown pandemic in terms of our response, 
aggressively preparing for widespread disease in many 
communities. We don't know if that will actually happen. But we 
are seeing sustained transmission in a few communities. We 
don't yet have severe illness, or lots of severe illness, but 
we fear that we may have additional severe cases as we have 
with seasonal flu.
    Mr. Dingell. I would like to have you submit to the 
committee as soon as you can, what assistance the Federal 
Government is going to be providing the State and local units 
of government to enable them to address their responsibilities 
in this matter of flu. I ask unanimous consent that be inserted 
into the record at the appropriate place.
    Mr. Skelton. I note that FDA is currently using three 
products whose use is being vigorously monitored. The Secretary 
was granted emergency use under the 2004 Project Bioshield law 
to clear the unapproved use of particular products in the event 
of an emergency. The Secretary is exercising this authority for 
two drug products and one diagnostic test. What are the 
considerations in deciding to clear the products for use of 
young children and adults? This is for Dr. Sharfstein.
    Mr. Sharfstein. Sure. Thank you for the question. The basic 
considerations are set out in the law. And then I will tell you 
how we applied it in this case: that, first of all, there is a 
serious or life-threatening condition. We know that is the 
case.
    Second, that the totality of the scientific evidence makes 
it reasonable to believe that the product may be effective.
    Third, that the known and potential benefits of the use 
outweigh the money in and potential risks.
    And fourth, there is no adequate approved and available 
alternative.
    Now, for kids, the only thing that is done differently 
under the emergency use authorizations is for Tamiflu, where it 
permits the use under age 1. And it is an excellent question 
because you think how did FDA decide that that was okay, how 
did you figure out a dose? It was not in the original label. 
And it turns out FDA has been looking at this for a couple of 
years and has been working very closely with NIH and the 
company to get data on under age 1.
    And there was actually a study that was done, FDA reviewed 
the study, and even over the weekend got additional data from 
the company involving more than 750 infants from Japan and also 
some German data. There was a study that was organized out of 
NIH which was specifically for kids--
    Mr. Dingell. Please submit the rest of our question for the 
record.
    Mr. Skelton. I would like to know if your agency has a 
regular on-the-shelf plan to address these kinds of problems 
when they arise; yes or no?
    Mr. Pallone. Chairman Dingell, if I could just interrupt 
and tell the members what we are going to do is continue 
because of the time constraints of our public health witnesses 
here. And then Mrs. Capps, as our vice chair, is going to come 
back and replace me so I can go vote. So you will have about 8 
minutes left if you want to leave now and come back--I don't 
mean the witness, I am talking about the members. We are just 
going to continue.
    I apologize for interrupting, Mr. Chairman.
    Mr. Dingell. I will repeat the question. I would appreciate 
you submitting for the record, one, the answer: Do you have an 
on-the-shelf plan. You are nodding yes?
    Mr. Vanderwagen. Yes is the answer.
    Ms. Schuchat. Yes, all of us do.
    Mr. Dingell. All three of you?
    Mr. Vanderwagen. Yes.
    Mr. Dingell. Does that include working with the Department 
of Homeland Security?
    Mr. Vanderwagen. Yes.
    Mr. Dingell. And do they have one?
    Mr. Vanderwagen. Yes.
    Mr. Dingell. Would you submit those plans to us for the 
record, please?
    Mr. Vanderwagen. Can do.
    Mr. Dingell. Mr. Chairman, I thank you.
    Mr. Pallone. Next is Mr. Murphy.
    Mr. Murphy of Pennsylvania. Thank you, Mr. Chairman. I want 
to thank all the distinguished panelists. I am learning a great 
deal here. I am not a physician. I am a psychologist and I 
understand panic. And I need to ask you some questions, and I 
am not meaning to embarrass anyone, but I think it is very 
important that you get some official statements out for this.
    Is anyone from any of your departments recommending that 
any American citizens avoid airplanes, buses, elevators, 
confined spaces; or do you think that perhaps we should not be 
saying that right now?
    Ms. Schuchat. We are recommending that people defer 
nonessential travel to Mexico. We are recommending that people 
who are sick not get on airplanes or public transportation, and 
I think there may have been a misstatement.
    Mr. Murphy of Pennsylvania. Do you all agree with that? We 
will let it stand at that. But I do think it is important that 
we let people know this. Every year when there is a flu in this 
country, many people die, sadly, from that. But the main thing 
is to understand that you are working this issue very hard, and 
I appreciate what you are doing.
    However, it is a concern about anytime people will use 
transportation. And I am wondering as part of your plan, we 
have the transportation security system set up. Every airport 
has lots of poachers and lots of issues, and I am wondering if 
you are recommending people not travel if they are sick, stay 
home if they are sick. The airports are a particularly 
important area because that is where you have people who may be 
ill traveling across the country and spreading this.
    Is this part of your plan to also include that as a 
location for other public information posters perhaps at 
airports? And added to that, anything you are advising airlines 
with regard to if they see passengers come to the airport that 
appear to be sick?
    Ms. Schuchat. Yes, we have been issuing both guidance as 
well as developing materials. We have also started to hand out 
the yellow card, the travel health alert notices, at airports 
and other ports for people who are traveling to know what signs 
to look for and what to do if they do become ill. And we are 
certainly--we actually just recently issued guidance for 
airline crews if they were caring for someone who was ill, what 
are the steps they need to take. And we will continue to update 
those kind of guidances.
    Mr. Murphy of Pennsylvania. Will this include information 
that airport security or airline workers, if they see someone 
who appears to be ill before they get on the plane, perhaps 
tell them not to fly?
    Ms. Schuchat. Yeah. That is right. We actually do already 
have quite a bit of intervention in terms of education for the 
travel worker, the customs and border protection personnel, as 
well as a good relationship with the airline industry. We have 
developed a greater collaboration during the SARS problem to 
really be able to make sure people working in that profession 
could recognize the issues and address them.
    Mr. Murphy of Pennsylvania. And one other thing, and open 
up to other comments as well, certainly we are aware of those 
things that our parents taught us: You cover your mouth if you 
sneeze; if you are sick you stay home; you wash your hands. I 
see you have your little bottle there. You have been using that 
very effectively, Doctor.
    But are there things that you advise people not to do? For 
example, should people go out and get Tamiflu and just start 
taking it? Should people start taking antibiotics if they have 
some in their medicine cabinet? What kind of things are not a 
good idea for people to do? I wonder if you could comment on 
that.
    Ms. Schuchat. At this point we are recommending that drugs 
like Tamiflu, which is an anti-flu viral--or antiviral drug 
against the flu, or antibiotics against bacterial infections, 
be taken under a doctor's advice.
    Mr. Murphy of Pennsylvania. Are antibiotics useful at all 
with the flu?
    Ms. Schuchat. Influenza is a viral infection and 
antibiotics treat bacterial infections. Some people suffering 
influenza can later develop a secondary or late-onset pneumonia 
caused by a bacteria. So there are circumstances laid on 
following influenza where antibiotic treatment might be 
necessary, but this would all be under a doctor's advice.
    Mr. Murphy of Pennsylvania. Again I am asking the panel 
this. Some people may call their doctor now and say, can you 
give me a prescription for antibiotics? I have got some in the 
medicine cabinet when I was sick last year, should I start 
taking them? What would you all advise?
    Mr. Vanderwagen. We would advise people not to self-
medicate; that they should seek consultation with their 
physician before they take any medical intervention. And we are 
advising them that this is a doctor-patient relationship that 
has to be worked through, rather than just arbitrarily deciding 
to medicate yourself.
    Mr. Murphy of Pennsylvania. Do you agree with that, too, 
Doctor?
    Mr. Sharfstein. Yes.
    Mr. Murphy of Pennsylvania. I appreciate that it is 
important that--I don't want people to take this too lightly 
nor too seriously, as we had the SARS issue, as we had the 
avian influenza issue. These are good important issues that 
people need to be addressing, and I do appreciate the important 
medical comments and information we would be sending out to 
Americans. Thank you so much.
    Mr. Sharfstein. I would just add that people can contact 
their local health departments also to understand what things 
my be accessible.
    Mrs. Christensen. [presiding] Thank you. The Chair now 
recognizes Congressman Green for 5 minutes.
    Mr. Green. Thank you, Madam Chairman. And again, I want to 
thank you. I have a district in Houston, a very urban district, 
and people go back and forth to Mexico literally every day. But 
I appreciate the measured response, but also the planning, 
because our Governor just announced a disaster declaration 
because of the issues.
    We have two schools now, public schools, Hamilton Middle 
School and Harvard Elementary School. Because of a child, they 
have shut down the schools. So they are being very cautious. 
And that is the encouraging--all of our directors are planning 
to do that, I think.
    One of the concerns I have is that because of the 
experience a few years ago when we didn't have the development 
of the regular flu vaccine--and I think Congressman Deal may 
have mentioned it. You are not recommending slowing the 
production of the flu vaccine that we know we typically would 
be receiving in the fall. This would be a separate injection, 
if we get to that point?
    Mr. Sharfstein. Right now there is no recommendation to 
slow the production. However, as we understand more about the 
virus, the threat of the new virus, that could potentially 
change, but it will be a decision that is made with a lot of 
external input from a lot of very smart people thinking about 
what the best balance is going to be.
    Mr. Green. I know HHS is releasing 25 percent of the 
strategic reserve of the 50 million treatment course of 
antiviral drugs, Tamiflu and Relenza, in the strategic national 
stockpile. It is my understanding these will be available to 
all States, prioritizing distributions to the affected States; 
is that correct?
    Ms. Schuchat. Yes, that is right. We have released 11 
million of the 44 million doses that were designated for the 
State or project areas, and all of the States will be receiving 
those. Already 11 have either received or are en route, I 
think.
    Mr. Green. I guess my concern is that in Texas we are 
seeing actually pharmacies who are running out because of 
prescriptions. And I am glad that is happening.
    Mr. Vanderwagen. Recall that the principles under which we 
established that stockpile was a partnership with States and 
that the goal was for we in the States to be able to cover 25 
percent of the population for treatment of active disease. That 
was the principles under which that acquisition was really 
driven. And most of the States bought their share. There are a 
half dozen States or so that did not. But we are still 
providing a pro rata share to all the States in that event. But 
it is about treatment for people who are sick.
    Mr. Green. Okay. I know Texas has 840,000, 7-day course of 
antiviral medication, and I heard we qualify for an additional 
650,000. Is that generally correct? Do you know on a State-by-
State basis?
    Ms. Schuchat. I guess actually I want to correct what I 
said. What I know is that we have completed the shipments to 
nine States and six of the States completed receipts of 
shipments in the last 24 hours, but we are continuing to work 
through the listing. So I don't know the doses.
    Mr. Green. Okay. If you could get that information back to 
our office. I know Congressman Gonzalez from San Antonio would 
share the same concern, my colleagues on the Republican side.
    Mr. Sharfstein. There is one thing I want to mention, to be 
clear. You said some pharmacies were having shortages. And the 
medicine going into the States is going through the public 
health side, not directly to the pharmacies, and it will be up 
to the local and State public health plans how that medicine 
gets distributed.
    Mr. Green. Well, I guess--I have a daughter who is an 
infectious disease fellow at the University of Texas medical 
branch, and she told me Galveston--which is not our district--
all the pharmacies in Galveston County were out of the 
prescriptions. But I don't know about in Harris County, which 
is Houston, where Galveston is separate.
    What role should the State play in the distribution of 
these drugs? It is going through the public health like we have 
and that is where I am getting my information, is from the 
State Health Commission.
    Ms. Schuchat. Each of the States has a plan for how they 
are going to do their distribution. So we look to them to let 
local folks know how it is going to work. But that has been 
part of the States' pandemic efforts.
    Mr. Green. In my last 49 seconds, I know the answer to the 
question on the H1N1 vaccine and how quickly we can get a 
development is a couple of months. Two months seems a fairly 
short time frame for a vaccine to both be tested and it is safe 
for individuals, whereas Tamiflu was recently labeled to show 
adverse psychological effects. What precautions is the FDA 
taking to monitor adverse effects from this new vaccine that we 
are developing now?
    Mr. Sharfstein. Just on Tamiflu, there is a team that is 
looking specifically at Tamiflu adverse effects. For the flu 
vaccine, it depends if it is--you know, from the manufacturing 
standpoint, there is a chance that this will just be produced 
according to the regular manufacturing approach; in which case, 
you know, every year it has to be done pretty quickly because 
every year the flu vaccine is different. If a different 
approach has to be taken, that will raise different types of 
oversight issues. But in all those things, assuring that the 
risks are outweighed by the benefits and that we think it is a 
safe vaccine is really the point of our involvement.
    Mr. Green. Okay. Thank you, Madam Chair.
    Mrs. Christensen. Thank you. Mrs. Blackburn of Tennessee is 
recognized for questions.
    Mrs. Blackburn. I want to again thank you all for your 
patience for being with us yesterday, Dr. Schuchat, and then 
for you all being here this morning to help answer these 
questions. We are concerned.
    In my district in Tennessee we now have a Williamson County 
case and a Shelby County case. So as you can imagine, as this 
started to make its way into the news last evening and this 
morning, I am hearing from parents and from constituents and 
medical care providers and health care providers with some 
questions. And one of the questions that has been asked of me--
and if you can provide some guidance on how best to answer 
this, I think it would be helpful.
    The way the process, the way we understand the process, 
when a doctor takes a culture, that goes to a State lab. When a 
State lab suspects that this culture has either the H1 or the 
N1 and they decide that there is probable cause that it could 
be the H1N1 strand, then it comes to the CDC for confirmation.
    Then my question is: Number one, how many of those cultures 
do you have waiting for confirmation? And number two, once that 
culture makes it to you, how long does it take for you to 
provide that confirmation?
    Ms. Schuchat. Part of our planning has to be make sure that 
we have adequate staff day and night for something like this. 
And the laboratory staff in the influenza division have been 
doing--we have had shifts throughout the night, throughout the 
weekend. But we have also taken steps to increase the capacity 
at the State public health labs with these kits that were 
recently approved for shipment and started to be shipped on 
Monday. It was incredibly quick, so that more and more State 
and local areas will be able to do that, confirmatory testing 
on site.
    We are not working with a backlog. We are really working 
around the clock to make sure that information that is so 
critical for local decision-making is available. We we have 
made many contingency plans for the surge idea so that the 
State and locals have some capacity through the public health 
laboratory network. And also we have got some agreements with 
commercial labs to help with surge of specimens for sort of--
    Mrs. Blackburn. Is it fair to say you all turned this 
around in a day, or a matter of hours? What is the time frame 
there?
    Ms. Schuchat. There are several steps. You know, a doctor 
will take a test and make it a positive rapid result or make it 
a suspicious result; forward that onto the State or local 
laboratory where the strain needs to grow and additional things 
happen, although now they have these PCR tests that are more 
rapid. At that result, things get sent to us.
    Sometimes the shipping is even one of the longer steps, 
although we have been really expediting that, and then it is 
several hours upon receipt in the CDC lab before results would 
be available. Things may change over the days ahead as 
increasing numbers of cases are detected, and we really need to 
make some triage decisions. But at this point, with new States 
wondering do we have this or not, we are really prioritizing 
that kind of question that is going to make a difference for a 
school district, for instance.
    Mrs. Blackburn. Dr. Sharfstein.
    Mr. Sharfstein. Just to follow, CDC just did an 
unbelievable job basically inventing a lab test for this, that 
could be shared with the States within a couple of days, and 
FDA worked with them so that all the instructions were there, 
all the quality assurance procedures are there. And now the 
State public health lab network, which was sort of created to 
be ready for exactly this, they have the kit. So for somebody 
in your county, really it should go to--to the State lab and 
they are the ones making the diagnosis. Those samples shouldn't 
even have to go to CDC anymore. And that was all done so 
quickly to be able to give them that capacity.
    Mrs. Blackburn. That is great. So individuals should know 
within a day, 2 days? What would be the answer?
    Mr. Sharfstein. That is probably going to depend on the 
policies of the State. But the test itself doesn't take more 
than a few hours. It is a question of how they are handling 
the--
    Mrs. Blackburn. And you have both the public labs and the 
private labs involved in this process?
    Ms. Schuchat. It wouldn't be the hospital labs. The public 
State labs or some of the bigger city labs are part of this 
public lab network. There are a couple of commercial 
laboratories that aren't doing that special testing, but they 
are ready for surge of the original testing.
    Mrs. Blackburn. I have got one other question and we may 
not have time for you to answer it. But we have had questions 
from several people. This is not flu season in the U.S., and 
this seems to be a very strong strand; and as we move into the 
warmer months, it may naturally dissipate. But your expectation 
for when we move into flu season in November, how do we best 
prepare for a resurgence? Do you think it will come back? Will 
we have a vaccine by that time? What is the preparation 
strategy for next year's flu season?
    Ms. Schuchat. These are really important issues. We are 
mindful that things may look like they are getting better, but 
we might have a resurgence in the fall. There are many steps 
being taken to anticipate that, and part of the efforts of 
evaluating production of a vaccine is with that in mind. Also 
looking to the southern hemisphere for what happens there, 
because they typically have a reverse season from us, and then 
also understanding the evolution of the virus during the next 
bit of time.
    While flu season is pretty much over in most communities 
here in the U.S., it is not completely over everywhere. But you 
are right that we usually don't see cases in the summer, except 
in people coming back from the southern hemisphere, and then we 
will be mindful in the fall.
    Mr. Sharfstein. I would say we would like to have a vaccine 
as soon as we can get one, and even if it--let us say you have 
a vaccine and it doesn't come back in the fall, that is okay. 
We don't want to be in a situation where you have a serious 
problem and you have stopped making the vaccine for some 
reason. So the plan is to prepare for the worst.
    Mrs. Blackburn. Thank you so much. Thank you, Madam 
Chairman.
    Ms. Christensen. Thank you. The Chair now recognizes the 
vice chair of the full committee, Ms. DeGette, for questions.
    Ms. DeGette. Thank you, Madam Chair. I want to congratulate 
all of you and your agencies for the aggressive efforts and 
smooth preparations you are taking here. I have been on this 
committee now for 12 years and remember quite well the hearings 
that we had in 1993, 1994 and 1995. In fact, I have been urging 
our leadership to have additional hearings so that we can see 
the progress. And I am gratified to hear that we have made 
progress.
    I do have a few questions, though, about what will happen. 
My first question is: Do we have a sense of what the incubation 
period of this virus is?
    Ms. Schuchat. We are looking at these new cases and the 
numbers change day to day. Recently, I would say 
conservatively, 2 to 5 days or maybe 1 to 5 days. The idea is 
that it is a relatively rapid transmission from one person to 
another.
    Ms. DeGette. One thing I think is that--you know, I have a 
high school freshman in Denver, and I think at high schools and 
colleges all around the country, many of the students are 
concerned that if they or someone they knew went to Mexico some 
weeks ago, that that could still be incubating. I think that is 
important to say. Although, of course, it can be transmitted 
from person to person here.
    My second question is: I am concerned about the fact that 
while we have come a long way over the last few years, as Dr. 
Sharfstein was describing about developing the egg-based 
vaccines, I am concerned that we still have not been able to 
move to a cell-based production. And I am wondering if you can 
talk about what the status is of development of a cell-based 
vaccine?
    Mr. Sharfstein. Sure. There has been a tremendous 
investment in cell-based technology, so that was done in 
parallel with getting the eggs up to--capacity up so that the 
seasonal--so that the egg-based vaccine could be produced 
relatively quickly. There are companies that make cell-based 
vaccines and FDA is working very closely with them.
    Ms. DeGette. Are you working closely with them to develop 
cell-based vaccines around this new H1N1 virus?
    Mr. Sharfstein. Yes, in the sense that we are discussing 
that with them. But I think the sense that I am getting is 
because we have a licensed process for the egg vaccine and 
because we have the eggs, that we have a terrific potential 
capacity to make plenty of vaccine with the traditional 
approach, rather than have to--and that would be our 
preference, because we know all the steps in the process.
    Ms. DeGette. Except for the fact, Doctor, that if it truly 
does turn into a pandemic, then having 160 million doses by 
next January, or whenever, is not going to be sufficient even 
for the U.S. population, much less around the world. And so it 
is great in the short term, but ultimately we are going to need 
to move to that cell-based vaccine?
    Mr. Sharfstein. Your point is very well taken. I think a 
couple of things to say, that is why we are having the 
conversations with them, and that is the future and that is why 
there is such an investment.
    Ms. DeGette. But it is not going to be the future for this 
particular strain, correct?
    Mr. Sharfstein. I don't want to rule that out. That is 
under discussion. What I have heard from the vaccine team is 
that they believe there is a tremendous potential. And it is 
probably--the potential is larger 160 million doses. That 160 
million doses are trivalent vaccine, meaning that three 
strains--so it is actually probably somewhere around triple 
that. Plus--
    Ms. DeGette. But efforts are being made to move to the cell 
vaccine, even with this--
    Mr. Sharfstein. Right.
    Ms. DeGette. My next question is: Is there some potential 
that this virus could mutate in the summer months, between now 
and the fall, when we think we might see a resurgence? Dr. 
Schuchat.
    Ms. Schuchat. Yes, that is possible. And that is why we 
will be continuing to look at it. Just to clarify, the planning 
assumptions were to have capacity to be able to produce enough 
vaccine for 300 million people, assuming two doses. And there 
are lots of things to be sorted out about how much quantity we 
are going to need that will influence what the real capacity 
is.
    Ms. DeGette. Right. But, again, I am concerned because if, 
with this old egg-based technology-- like I say, I think we 
have come a long way. I am not trying to be critical. But 
heaven forbid, the virus mutates between now and the fall, then 
we have to develop a new vaccine and keep with the egg-based 
technology. We may not have a vaccine developed until next 
spring, and I think that is worrisome to all of us. Dr. 
Vanderwagen.
    Mr. Vanderwagen. Let me add one or two things to what Dr. 
Sharfstein has offered you. We think 600 million doses is 
achievable in a 6-month time frame. We think that is achievable 
both in egg-based, with some cell-based augmentation. Part of 
Congress' investment, all the money that was talked about in 
flu investments, 1.3 billion went to the development of cell-
based cultures. We have two large plants that are in very late 
stage of construction. They are close to inspection. And we 
have made significant progress with them. Will they be ready by 
January? I don't know that they will exactly be ready by 
January, but we know from the existing infrastructure we could 
probably generate a monovalent--600 million doses in a 6-month 
time frame.
    Ms. DeGette. Thank you. Mr. Chairman, I would hope these 
witnesses and their agencies would continue to keep this 
committee apprised of their development of the cell-based 
vaccines and their development of the doses as we move forward 
in the coming months.
    Mr. Pallone. [presiding] I would appreciate that and I am 
sure they will.
    Ms. DeGette. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you. Our vice chair, Mrs. Capps.
    Mrs. Capps. Thank you, Mr. Chairman. And thanks to each of 
you. You have been spending a lot of time in the last couple of 
days here on Capitol Hill, and it is very valuable for us to 
have your expertise and to be kept abreast of what is going on.
    A different set of questions from me, please. The 
recommendation for people--and I will address this to you, Dr. 
Vanderwagen. All of you have comment--but I want to just sort 
of go from topic to topic. I have three. The recommendation is 
if you have the symptoms, call your health provider. Forty-
seven million Americans don't have regular access to health 
care. It seems likely that if this progresses and becomes 
worse, emergency rooms and hospitals, other public places, are 
going to be on the frontline of receiving all of these 
patients, because they would be the first place and the only 
place many people could turn.
    Our emergency rooms are already overflowing and it is clear 
that responding to a pandemic would be more than they could 
handle under existing circumstances. Our goal now, 
simultaneously, is to work toward providing health care for all 
Americans, access to health care.
    In the meantime, I want a comment from you on what kind of 
emergency coverage--do you recommend a particular plan that we 
could speedily enact to provide coverage in this case of an 
emergency?
    Mr. Vanderwagen. Well, ma'am, I really appreciate your 
linkage between preparedness and health security and health 
reform, because I think they intertwine in a way that people 
don't always realize, and I appreciate that. Medical surge is a 
function of people, facilities, supplies, equipment and 
systems. And what we have seen with investments that Congress 
has appropriated to us in hospital preparedness is the 
emergence of systems that rely on the fact that no one place is 
going to be able to manage the flow.
    So how do we work collectively to share that flow in a way 
that takes the burden off? We have seen extraordinarily good 
examples of this in a wide variety of states: Illinois, 
Minnesota, North Carolina, et cetera. These are best practices 
that have been put in place, that these States have already 
done a significant job of analyzing people, equipment, 
facilities. Those are the kind of best practices we would 
extend to communities that are still trying to find the answer 
to that problem. The emergency assistance impacts between 
States also offers us ways for hospital care, not so much 
emergency department evaluation, but for hospital care. There 
are good models out there and best practices that we can share 
with communities.
    Mrs. Capps. Thank you. And, Mr. Chairman, I would hope that 
we could keep this discussion going as the days go, in case 
there is a way that we should be responsive to you as well.
    Now, another challenge, Dr. Schuchat, for the provider in 
the household. You are calling on people to stay home if they 
are ill to prevent the spread of the H1N1 flu. But millions of 
people work every day but don't have any sick leave, don't have 
any time that they can take; and with this economic 
uncertainty, they are very reluctant to stay home from work, 
and to work with symptoms and have to send their kids to school 
because there is no one to stay at home. This is going to be 
difficult to contain the flu.
    We do have legislation in the works. Senator Kennedy and 
Congresswoman DeLauro are planning to reintroduce the Healthy 
Families Act. I am cosponsoring it. And that would guarantee 7 
sick days a year.
    First of all, you could help us with support of that kind 
of legislation for the next event, and maybe if you have any 
thoughts of what you or we could do together to respond to this 
crisis.
    Ms. Schuchat. Just a few comments. Health in the workplace 
and health in the family is very important. It is a central 
component of public health. And we did see during the SARS 
epidemic that in Canada some of the hospitals were really taxed 
trying to figure out how to make sure that health care workers, 
including contract employees would stay home, whether furloughs 
needed to be used. And it was a very difficult circumstance to 
make sure that health was taking a front seat and that the 
rules could be worked out. So we would just be supportive in 
making sure that health is addressed.
    Mrs. Capps. Thank you. I have one final question and there 
is not a lot of time for it, and maybe some ongoing 
conversation about this. It is to any of you, because workforce 
shortages are something that you are experiencing in every one 
of your agencies and all of our local and State public health 
facilities. Eleven thousand public health workers are due to be 
laid off because of State budget cuts, attrition over the past 
year. This is exactly who you are depending on, even as we 
speak for solutions. Do you recommend any suggestions for us to 
help you do this or to recruit more or to implement anything?
    Mr. Sharfstein. A month ago I was the local health officer 
in Baltimore, Maryland, working with Congressman Sarbanes and 
others. And I think your point is very well taken that a lot of 
the things that are being planned at the Federal level really 
depend on the State and local public health authorities to 
implement. The emergency use authorizations that we granted 
have a very clear role for State and locals and how they hand 
out medicines that may be important to people. Eventually if 
there is a vaccine that will be delivered through the public 
health infrastructure, and ensuring that that infrastructure is 
strong is extremely important, and I know it is very important 
to the administration.
    Mrs. Capps. My time is up, but there is more to talk about. 
Thank you very much, Mr. Chairman.
    Mr. Pallone. Thank you. Mr. Blunt.
    Mr. Blunt. Thank you, Mr. Chairman. I have a couple of 
questions here. One, I got an e-mail from my daughter late last 
night who lives in Kansas City and it involves her, but even 
more importantly--just as importantly, involves my grandchild. 
I guess I ought to think about how I say that. And the e-mail 
from her is a confirmed case of swine flu in Kansas City. On a 
scale of 1 to 10, how concerned should we be? Anybody want to 
give an answer to that?
    Ms. Schuchat. People like your daughter are concerned and 
so are we at CDC and so is the government. But we are taking 
aggressive steps to address the challenges and we do feel that 
we have been exercising and planning for this kind of 
circumstance.
    There are lots of things everybody can do in the community 
and the family, as well as in schools and workplaces. So I 
think that this is a serious situation and we all really need 
to get ready for some uncertainty, to stay aware. It is great 
that your daughter knows exactly what is going on where she is 
and that guidance from the local and State authorities will 
probably help her understand what is going on there and what 
the next steps are if your grandchildren's school is closed, 
for instance, or really what are the plans.
    Mr. Blunt. It is called swine flu, but is there any concern 
about the food supply at all? I think it is important to 
clarify that, and you may have already. But if you wouldn't 
mind repeating that for me.
    Ms. Schuchat. Sure. There is no evidence that swine in the 
United States have this new virus. There is no evidence that 
eating pork or pork products gives you this infection. The USDA 
is aggressively looking at the issue both here and working with 
Mexico as well. And I would say that we don't have any reason 
to believe that eating pork gives you this particular 
infection.
    Mr. Blunt. We have no reason to believe we have any problem 
in any part of the U.S. food supply?
    Ms. Schuchat. No. This isn't an infection that we think is 
food-borne.
    Mr. Vanderwagen. Our veterinarian colleagues over at 
Agriculture call this human flu, because it doesn't occur--they 
don't see it in pigs, so they are calling it human flu.
    Mr. Blunt. I think that is a good thing to understand 
because there is some reaction at the grocery store to what 
they think.
    The other question I would have: On Amy Blunt's scale of 1 
to 10, assuming 10 is the most concerned, it seemed to me that 
the Vice President was there this morning at the 10 level when 
he said he would advise people not to get on planes, his own 
family, or even on subways. I am sure that is not the official 
position of the government.
    Would somebody reiterate what must be, for a repetitive 
response, the official position of the government on that 
topic?
    Ms. Schuchat. We have advised people to defer non-essential 
travel to Mexico. We have advised people who are ill with 
respiratory symptoms and fever not to go to work or school or 
not to get on an airplane or public transport. But we do not 
have recommendations to stay away from those transport methods 
if you don't have respiratory symptoms, and I am looking 
forward to getting on an airplane later today to go back to 
Atlanta.
    Mr. Blunt. Well, most of us will get on airplanes later 
today, too, to go back to Atlanta or Missouri, as I will--or 
other places--and I would hope that the commerce and the travel 
of the country don't shut down based on advice from the 
government. I yield back, Mr. Chairman.
    Mr. Pallone. Thank you, Mr. Blunt. Mr. Weiner.
    Mr. Weiner. Thank you, Mr. Chairman. Let me just pick up on 
that a little bit. You know, I think you will forgive our 
constituents for being a little whip-sawed by the news and 
images that they get. And I represent the district that has 
half of all of the confirmed cases in the country. And, you 
know, to watch some the imagery on television, to listen to 
even official channels. To listen to the head of the health 
policy at the European Commission, in theory someone who is 
supposed to be pretty level-headed say it is not a question of 
whether people die, but more a question of how many. Will it be 
hundreds or thousands or tens of thousands? You will forgive 
some of my constituents for wanting to get into the fetal 
position and bathe in Purel after hearing things like that.
    And let me say that it is in contrast to the way you all 
have presented yourselves. So, too, the health officials in New 
York City who may have made a more sober assessment. But just 
to put a finer point on the question Mr. Blunt asked, focusing 
on subways. Just to instruct New Yorkers to avoid the subways 
is to in many cases to instruct them not to make a living, not 
to travel around their hometown. It is the very way that we 
communicate with one another and the way we get to and from.
    If you are not one of the 96 confirmed cases, if you don't 
feel like you have got the flu, can you just say with clarity 
about subways, it is safe to get on a subway? We would 
encourage you to get on a subway, and if there was a subway to 
Atlanta, you would take it?
    Ms. Schuchat. The only people we are saying should avoid 
crowded circumstances or airplanes, for instance, are people 
with fever and respiratory symptoms. We also think it is 
important for local authorities to be giving the guidance for 
the community. They understand the way the--the ground truth. 
And we know that the New York City Health Department is 
fantastic it is and really is providing good guidance.
    Mr. Weiner. Can I ask you, how good a job did the Mexicans 
do on letting you know what was going on? There was a report in 
today's Washington Post that lays out the tick-tock of 
notification that seems clear that the 24-hour rule was 
violated by a magnitude of a couple of weeks. Apparently, our 
Department of Health and Human Services, which oversees the 
CDC, found out about the Mexican outbreak about the same time 
the rest of us did, on the television on the 24th.
    It strikes me that that window of time is valuable and it 
strikes me that in fact it could have helped--well, maybe 
prevented some or at least gotten us a couple of weeks or a few 
days at least jump on this. How would you grade the Mexican 
response up to now?
    Ms. Schuchat. The Mexican community and government are 
coping with a very difficult circumstance right now. And the 
focus of our attention is providing technical support to help 
them respond to the situation. I can say that I don't have all 
the information--I don't think anyone does yet-- about all the 
circumstances leading up to where we are. But it is important 
to note that increases in respiratory illness happen quite 
frequently, and they can have lots of different explanations.
    And as I understand it, the original increases that they 
were seeing were believed to be due to regular influenza. Most 
respiratory infections don't actually get a specific diagnosis, 
and we see lots of changes in the numbers that don't pan out to 
be anything quite serious.
    Here in the U.S., because of our investments, we promptly 
recognized these very unusual strains of influenza and issued 
an MMWR dispatch after the first two that we had seen. But I 
think the circumstances in Mexico right now, the focus really 
needs to be on helping with the response.
    Mr. Weiner. Could I say, you know, it is--traditionally the 
influenza outbreak happens in cold weather. And I know there is 
some disagreement on why exactly that is. Maybe we are all 
together much more.
    Are we rooting for a particularly hot stretch here? Would 
that help us? Should we be trying to be outdoors more? Is the 
coming summer months, is it helpful to us? Is it not clear that 
it is helpful? If there is a high pollen count, does that mean 
perhaps we should be more careful? Are there any weather-
related indicators, since this is kind of a counterintuitive 
strain, it is hitting younger people more. Are there things 
about it that we have learned so far that give us an indication 
that the weather might be on our side here?
    Ms. Schuchat. We think from the past and from seasonal flu, 
that we don't see much influenza in the summer months, and so 
we hope that will be the case. But every influenza expert that 
I hear from really cautions me in anything I say to remind 
people how unpredictable influenza can be, and especially a new 
strain. So we do optimistically hope that things will get 
better because of the season. But we need to be attentive for 
the fall afterwards.
    Mr. Weiner. Thank you. Thank you, Mr. Chairman.
    Mr. Sharfstein. I would just say, if we can get time, that 
really helps with the vaccine production. And the point about 
how each virus is different is extremely important about 
vaccine production. And I think just to clarify, I think the 
idea that a certain amount of vaccine will be ready in a 
certain amount of time--those predictions really can't be made 
now until we understand more about this particular vaccine, 
this virus.
    Mr. Pallone. Thank you. Next is the gentleman from 
Maryland, Mr. Sarbanes.
    Mr. Sarbanes. Thank you, Mr. Chairman. First I want to say 
how impressed I am with the response that you and your staff 
have made to this situation. There has been a calmness and 
professionalism to it that I think is having the desired and 
appropriate effect on the public, and I know that will 
continue. So thank you for that.
    I also want to echo those who are welcoming Dr. Sharfstein 
to his new position. As he indicated, we have worked together 
closely in Baltimore. We suffered a great loss that he is now 
here, but the country is certainly gaining by his appointment.
    Dr. Schuchat, you mentioned--and I was intrigued by this--
that the number of cases is not something you are so much 
interested in as the patterns that you see emerging. And I 
wondered if you could describe a little bit more what you mean 
by that? What are the patterns that you are looking for and 
what do those patterns tell you about the progress of this 
disease?
    Ms. Schuchat. We are working closely with some of the State 
and local health--public health officials who are on the 
frontline of responding to this, to really understand the 
epidemiology: who is more likely to become ill; what are the 
clinical characteristics of illness; how does it look like the 
infection is spreading; and how transmissible is it? So those 
are things we are evaluating in some of the on-the-ground 
circumstances in the U.S. as well as with our Mexican and 
Canadian partners.
    Those types of investigations can help us understand what 
kinds of interventions will be most effective. We would love 
those investigations to show us that disease is becoming 
milder. But we need to be ready for the idea that the disease 
is becoming more severe. So rather than focus too much on 
individual numbers, we know that numbers are going to be 
varying, that information is in flux, that we have just decided 
at the CDC, once a day we will update the numbers, and we are 
really focusing on the actions and activities. So the patterns 
are really at an early phase, understanding which populations 
are at the greatest risk, how transmissible is the virus and 
then the severity.
    Mr. Sarbanes. Is it a combination of the patterns and 
numbers that would also advise as to when a community ought to 
be taking a particular action, shutting the schools in a 
community and so forth?
    Ms. Schuchat. That is right. We have guidance about when 
there is illness--a confirmed illness in a school, that we 
recommend that that school be closed temporarily while things 
are being reevaluated. But there could be triggers that would 
prompt a more aggressive approach beyond that. There are other 
community interventions, such as eliminating mass gatherings or 
really implementing social distancing, asking people to work 
from home and to really avoid crowds.
    I was in Beijing during the SARS epidemic and they 
intensively instituted those, and they really helped. But that 
was a very different circumstance. So I think the pattern will 
tell us whether more aggressive measures are needed. We are 
really trying to strike a balance in making sure the 
interventions are not worse than the virus, because there is a 
balance in all of these interventions.
    Mr. Sarbanes. Let me ask you a different question. There 
has been a lot of discussion and focus on sort of tracing back 
this virus to a specific geographic origin. Is that the right 
perspective to have? I mean, is it the case that this disease 
will be appearing, as it were, spontaneously in a lot--in a 
number of different locations, or does it make--because when I 
hear people discuss they found new cases, and the next question 
always is, did you have contact with somebody who recently 
traveled to--but that can't be the only intention of the 
inquiry, right?
    Ms. Schuchat. Yes. That is right. I think in the initial 
day, there was an intense focus on contact with animals and 
then a little bit after, contact with Mexico. We are at a 
different point where there are lots of exposures that are 
being looked at. And, really, the intense look for cases is so 
that interventions around those cases, and where they work or 
at school, can be imposed.
    So for those other sectors that are focusing on tracing 
back and where did this all start, that can be important 
information for future planning. But I think the public health 
community here in the United States is really focusing on what 
we can do to reduce illness and death and slow spread, giving 
time for more definitive interventions like vaccine, should we 
go that route. And, really, the focus of our goal is to reduce 
illness and slow transmission, not to find the source.
    Mr. Sarbanes. Mr. Chairman, can I ask Dr. Sharfstein? It 
will be a 15-second question.
    Mr. Pallone. Sure.
    Mr. Sarbanes. I appreciate it. My understanding is that the 
flu strains we experienced this past winter did not respond 
particularly well to Tamiflu; is that correct?
    Mr. Sharfstein. Yes.
    Mr. Sarbanes. But that we are seeing at least initially 
this strain is responding. So I guess that is a lucky thing in 
a sense, right? Because it could very well be that this strain 
also would not be responding, and so I am just putting that in 
the happy coincidence category. Is that fair to do?
    Mr. Sharfstein. Yes. But there are always a few qualifiers. 
We know, I think, looking at it genetically and in the lab, 
that it looks like there is activity against the virus. That 
doesn't necessarily mean that every patient, as soon as they 
get it, gets better. In fact, it is more effective the earlier 
you get it in treatment. In people who are quite ill it can set 
up all sorts of problems in their body that even getting rid of 
the virus can't help anymore. So there is a qualifier there.
    The other qualifier is that it is possible that a 
resistance may emerge, and that is something I know the CDC is 
very interested in, is watching very closely. That could have 
recommendations for treatment that could change, could change 
recommendations for treatment. So we are starting off with 
some--a little bit of good news there. But it is going to 
depend on how this whole thing unfolds.
    Mr. Sarbanes. Thank you. Thank you.
    Mr. Pallone. Thank you. The gentleman from Iowa, Mr. 
Braley.
    Mr. Braley. Thank you, Mr. Chairman. I want to thank all 
the witnesses for being here. But, Dr. Schuchat, I want to 
start with you and follow up on your answer to Mr. Blunt's 
question about the reality of this virus and its impact on our 
food supply. You said there is no evidence that swine in the 
United States have this virus, which is a standard answer on 
the CDC Web site in response to concerns about food safety 
issues. And if you go to the CDC Web site there is a specific 
question: Can people catch swine flu from eating pork? And the 
answer says there is no evidence that swine influenza can be 
transmitted through food. And yet your Web site is the Web site 
of all of the organizations here, including the WHO, that 
continues to identify this as swine flu. And on the Web site, 
it also makes reference to the fact that this is a new strain 
of flu that consists of a mixture of genetic material from 
swine, avian and human influenza virus.
    I come from a State that is a leading pork producer in this 
country and in the world, and this outcry over the alleged 
connection between food safety and this virus is having an 
enormous economic impact on pork producers in Iowa, North 
Carolina, and all over this country.
    So is there a plan to change the Web site and refer to this 
by its appropriate scientific name, Influenza A, substrain 
H1N1?
    Ms. Schuchat. Our new information will have the new 
terminology. Our communication teams are focusing on critical 
information for health care providers, for families and so 
forth. So we do intend to make sure that the many, many 
thousands of Web site pages that we have already put up in the 
past week become amended. But the critical focus of the people 
in place right now is developing the new information that 
people need.
    We understand the concerns and are very mindful in our 
communication going forward, and really need to--people are 
working 24 hours a day. There are communication experts in 
there. It is really--I mean, I don't want to be impolite, but I 
just want to say that our priorities are the public health 
information being out there quickly and accurately. And going 
forward, we will do the best that we can.
    Mr. Braley. I appreciate that. No one appreciates that more 
than I do. But I am also concerned, because I was at the 
congressional briefing yesterday, and when you go to the CDC's 
Web site, what you find is a page, the first page, that says 
swine influenza. And on that page, there are probably at least 
10 references to swine influenza. And when your agency is one 
of the most critical public information dispensers in the 
Federal Government, it feeds this misperception if you don't 
address this issue immediately.
    And my point is that these other agencies are not using 
that terminology, and it is for a reason. So I would just 
encourage you, knowing that you are not in charge of the 
communications division at CDC, to emphasize to them the 
importance of making that change as quickly as possible. Would 
you agree to do that?
    Ms. Schuchat. We will do the best that we can.
    Mr. Braley. Now, one of the other concerns I have is the 
impact on workplace safety, because one of the things that OSHA 
has done is prepared a handbook guidance on preparing 
workplaces for an influenza pandemic.
    Have any of the three of you had an opportunity to review 
that pamphlet to determine whether it consists of the most up-
to-date information to help prepare workplace environments to 
deal with the potential influenza pandemic? Dr. Sharfstein.
    Dr. Sharfstein. I haven't personally looked at it, but we 
have an employee health part of our team on personal protective 
equipment, and I know they have been talking to OSHA. The FDA 
part that oversees devices because that is really what it is, 
the mask and that kind of thing, relates directly to OSHA and I 
know that our team and OSHA have been talking about the 
different authorizations that the FDA has made, how that 
intersects with what OSHA needs to do to protect workers.
    Mr. Vanderwagen. Mr. Braley, I think most of the elements 
of HHS have worked closely with OSHA. Most specifically NIOSH, 
the National Institutes of Occupational Safety and Health, 
which is part of the CDC, has been working extremely closely 
with OSHA to assure that we are aligning any health guidance 
that we are bringing forward out of our department and gets 
accounted for in their documents. We have worked very closely 
on with them on masks. We have worked very closely with them on 
a variety of things over the last 2 or 3 years.
    So I tell you we are lashed up pretty good with the OSHA 
folks vis-a-vis assuring that we have a common message and a 
common set of principles.
    Mr. Braley. Thank you.
    Mr. Pallone. Thank you. Next is the gentlewoman from 
Wisconsin, Ms. Baldwin.
    Ms. Baldwin. Thank you, Mr. Chairman. Thank you to our 
panel of witnesses today. I want to join in the sentiments that 
have been expressed by some of my colleagues about the very 
good job that has been done identifying and tracking this 
outbreak and the communications to the Congress as we are 
trying to learn more and work hand in hand with you in your 
mission. I think an outbreak like this exposes the strengths 
and weaknesses in our public health system.
    Dr. Vanderwagen, you talked about the system as sort of 
people, supplies, equipment, facilities, and systems, and I 
have been working with a number of my colleagues on both sides 
of the aisle on trying to address our public health system and 
strengthen it in some areas where I think that there are some 
weaknesses. I want to probe into two of those areas. One is 
relating to our State lapse of hygiene, and I guess I would 
start with you, Dr. Schuchat, and would like to hear your 
feedback on how it is these days working with the States to 
track and monitor this disease.
    And I ask the question because in my examination of the 
issue, and this is based on a 2007 survey by the Council of 
State and Territorial Epidemiologists, showing that 16 States 
are still completely paper based, 20 States are still using 
manual reporting that is Web based, and only two State public 
health laboratories in the country have bidirectional data flow 
that can both send and receive laboratory messages.
    I understand also that technology is not yet deployed that 
would support new pathogen discovery and rapid electronic 
exchange of public health information, national bacterial and 
viral databases for DNA fingerprinting of infectious disease 
organisms, things like that. If you tell me how things are 
going and how those technological upgrades being deployed in 
our labs might help.
    Ms. Schuchat. You know, the promise of information 
technology is huge and unfortunately it hasn't gotten applied 
to public health infrastructure as rapidly and as in some of 
the business community, and I think we are not where we would 
like to be in that area. You know, in doing this investigation 
we have just yesterday I think got electronic reporting from 
the States coming in, which was exciting for us because it has 
been a long time coming but that is just for this investigation 
but not for everything. You know there are huge opportunities 
in that to really increase the efficiency of how public health 
works.
    Mr. Vanderwagen. And ma'am, the comments I made to the 
member from California apply here as well, that as we think 
about health reform and we think about preparedness, it is not 
just a matter of hospital services concerns here. I think these 
issues are going to need to be thought through as part of that 
context as well.
    Ms. Baldwin. Let me follow up with some of the personnel 
challenges we are dealing with. Certainly as States and local 
governments have real budget squeezes I know that they have had 
to shift around staff in order to deal with this outbreak. I 
don't have the specific question right now on the staffing of 
labs of public hygiene. As I said, I am working on bipartisan 
legislation. We have introduced a bill called Strengthening 
America's Public Health Systems Act, which deals with the 
technology and the personnel there.
    I want to focus quickly on another area of personnel 
workforce shortage, both present and looming, and that is with 
regard to public health veterinarians. While we have probably, 
I want to say, about 85,000 veterinarians in the Nation, I 
think my figures say only a little over 4,000 are food animal 
predominant, some with a mixed practice. The number of 
veterinarians in public, corporate or federal positions, which 
includes teaching, research, military, inspection and food 
safety, is just under 15,000. And the projections are that we 
will have a significant increase in demand as we move forward 
for these professionals and a significant shortfall now and as 
we move forward.
    Dr. Vanderwagen, could you talk to us a little about the 
role of public health veterinarians with regard to this 
outbreak and are you seeing that the shortage of public health 
veterinarians in the U.S. and around the world is having an 
impact now?
    Mr. Vanderwagen. Yes, ma'am, and you read my eyes. My dad 
was the chief veterinarian for the State of California, and so 
I grew up in a home with a public health veterinarian, large 
animal practitioner to start. I think it is critically 
important that we think in terms of one medicine. There are 
many more species with health issues than humans and even 
though we focus heavily on humans, and I think appropriately 
so, it is our species, notwithstanding that we are at extreme 
risk from a variety of diseases that emerge from the animal 
environment, and without the kind of knowledge that public 
health veterinarians bring with regards to animal-based 
diseases that have zoonotic; that is, transmissibility from 
animals to humans, as an underlying principle, we end up flying 
blind on a significant number of challenges that our health 
security may be confronting.
    So I think it is critically important that we think about 
that workforce and that we embrace the notion that there is 
more to health than simply that of humans alone.
    Mr. Pallone. Thank you. The gentlewoman from the Virgin 
Islands, Mrs. Christensen.
    Mrs. Christensen. Thank you Mr. Chairman. Dr. Vanderwagen, 
you can't get away from me. You know this, right?
    My first question is to Dr. Sharfstein. On the food panel 
diagnostic tests, are those available to the Territories like 
my own and those in the Caribbean and those in the Pacific? Do 
we have the assurance that we have the availability of those 
tests?
    Dr. Sharfstein. I am also actually going to ask Dr. 
Schuchat to answer that. FDA made that available to the group 
of labs that CDC requested, which is this network.
    Ms. Schuchat. Yes. I was just trying to verify. We have 
been shipping the test kits to public health laboratories that 
are either part of the laboratory response network or similar 
public health labs. And so I don't actually know. I believe it 
is likely, but I will need to check, and we can get you that 
information. The idea is that the public health laboratories be 
able to, that have gone through the appropriate training and 
are part of this system, be able to perform these tests.
    Mrs. Christensen. I would suspect that ours is in Puerto 
Rico. But the Pacific is much more difficult.
    Ms. Schuchat. Absolutely.
    Mrs. Christensen. They shouldn't have to go all the way to 
Hawaii. And so that is my concern. Would you pronounce your 
name for me?
    Ms. Schuchat. It is Schuchat.
    Mrs. Christensen. So Dr. Schuchat and Dr. Vanderwagen, and 
you know this already but all during my time on the Committee 
on Homeland Security I have been concerned about the inequities 
and the deficiencies in the public health system in certain 
parts of our country, communities that are rural, Indian 
reservations, poor communities, communities of color, and they 
are very vulnerable. And it is often said that when the rest of 
America gets a cold, we get pneumonia.
    So my question is knowing this, what special efforts are 
being made to ensure that these communities have what they need 
given that their infrastructure, the poor health infrastructure 
in terms of hospitals have closed, less labs, less providers? 
What is being done to reach to these vulnerable communities?
    Ms. Schuchat. You know, this is a huge issue in health in 
general. In terms of the new influenza virus investigation and 
response, one of the teams that we have stood up is a 
vulnerable populations team that is really trying to address 
the appropriate outreach and planning for communities that may 
be harder hit.
    Mr. Vanderwagen. Well, Mrs. Christensen, it is so good to 
see you again really because I think we have a great dialogue 
that is important. With regards to Indian Country because you 
know that is--
    Mrs. Christensen. I see your watch and your ring.
    Mr. Vanderwagen. With regards to Indian Country, at least 
for those Indian people that are provided service funded or 
directly provided by Indian Health Service, they are on our 
daily policy calls. They are on our ESF 8 calls on a daily 
basis so that the most recent and clear communication can be 
transmitted through that system to people who are dependent on 
those health systems.
    The tribal leaders are actually here in town today to talk 
to HHS about budgetary considerations and concerns, and we will 
listen and respond the best we can.
    Mrs. Christensen. Thanks. Great. And Dr. Schuchat and Dr. 
Sharfstein, you said that this virus is a new virus but it has 
genetic material from four known viruses, various origins. 
What, if anything, does this mean in terms of the severity of 
the illness, what you would predict, our possible level of 
prior immunity and the development of the vaccine? Are those 
four pieces of genetic material make it any easier to deal 
with?
    Ms. Schuchat. The virus is new, and we don't--although it 
is H1N1, it is different from the human H1N1s that are part of 
seasonal flus that many of us have been exposed to or 
vaccinated against with the seasonal flu vaccine. We can't 
predict with certainty what this virus will do. So the four 
components only tells us really--it just tells us it is new. 
There is a possibility there might be some cross protection in 
certain subpopulations. And it is the kind of thing we are 
looking into. But you know since we have tested many, many 
thousands of strains and have never seen it, it is novelty that 
is the most concern.
    Mr. Sharfstein. And I agree completely, and the only thing 
I would add is the question has been raised is whether people 
who got the flu vaccine this year have any extra protection 
against this. And I don't think that question has fully been 
answered. It is one of the things that the CDC is looking into. 
The initial tests which test one type of immunity did not show 
any cross reactivity, but there is a potential there and I 
think it is going to be an important question to answer about 
it. I think in general the answer is you can understand what 
the virus is but to understand how it behaves you just have to 
watch how it behaves. It is just hard to determine that just 
from the genes alone.
    Mrs. Christensen. My time is up. Thank you. Thank you, Mr. 
Chairman.
    Mr. Pallone. Thank you. The gentlewoman from Illinois, Ms. 
Schakowsky.
    Ms. Schakowsky. Thank you, Mr. Chairman. I want to add to 
the chorus of thanks. I think that the response has been really 
comprehensive. And we have on our Web site now a link to yours 
so that people can get the best and the latest information and 
we, I think a lot of Members, are doing that right now.
    We now have in Illinois 19 suspected cases, is it? 17 
probable cases in Illinois. The one school that was closed in 
Illinois is in my district at the Kilmer School. I don't know 
if any of those have been confirmed. Do you know that?
    Ms. Schuchat. No, I don't have the details of that. And I 
certainly feel for the folks in your district who are coping 
with such a challenge.
    Ms. Schakowsky. I wanted to ask you about if and when we 
have immunizations and vaccinations for, if not immunizations 
but vaccinations, most States' Medicaid programs provide some 
coverage for adult beneficiaries in situations like this. And 
some States have exempted some populations from the nominal 
copay, pregnant women, children. I realize that this is 
impacting a somewhat different population.
    Do you think that in certain public health problems like 
the current one it would be good policy to exempt all Medicaid 
beneficiaries from cost sharing for vaccines and maybe for 
other things as well, but are related to this outbreak? And I 
am just wondering how that might impact the numbers of people 
who are able to access the care that they need.
    Mr. Vanderwagen. I think, and I can't answer you 
definitively, ma'am, but I would suggest that the 
considerations are that when we have this kind of an issue, it 
is about our population and our citizens as a whole and less 
about individual benefits and services. We need to think about 
what can and should we do to serve our whole population. That 
is a little different mode than the way we think about medical 
care and health services in the country generally, which is 
about care for that one-on-one patient. Here we have to assure 
that our whole population is protected in the face of the 
challenge.
    Does that mean we should promote a waive policy? That is 
for people above my pay grade. But I think there is a real 
public health argument that says we have to think about 
population and not just think in terms of limited individual 
benefits, which would suggest that we should cover everyone for 
those threats.
    Ms. Schakowsky. Right. Individuals, however, when seeking 
care think about their own situation and whether or not they 
are covered and whether or not they should be going to the 
doctor and whether they can afford to go to the doctor. And so 
I think we have to think about how we convey that people who 
may have it should seek the care that they need.
    Ms. Schuchat. It is important in this kind of circumstance 
to eliminate the barriers to people presenting who need to be 
either cared or for whom interventions would need to be 
initiated. It has been a challenge in a lot of infectious 
disease outbreaks where communities sort of go underground and 
are fearful about presenting for care or the ability to pay. So 
it is very difficult with infectious diseases which don't 
respect what insurance card you have, and I think we really 
want to have a public health approach that will help the 
communities.
    Mr. Vanderwagen. I echo what she said.
    Ms. Schakowsky. Let me ask another question. I wonder if 
someone can describe the process for data sharing between 
Mexico and the United States. My understanding is that we have 
a number of unanswered questions, whether Mexico is in the 
first or second wave of illness, the percentage of people dying 
from the flu compared to the percentage of people who are 
infected, et cetera.
    Ms. Schuchat. I am happy to say that we, the CDC, is part 
of a trinational team that is on the ground in Mexico, 
Mexicans, U.S. workers, and Canadians who are working on the 
epidemiology and laboratory aspects of investigating and 
responding to this concern. Information is getting better now, 
but information in this kind of outbreak is really difficult 
even in the best of circumstances. Information can be sketchy 
at the beginning, and we need to hone in on the details.
    And in particular, before you have a good laboratory test, 
it is hard to tell what is going on with people with pneumonia 
or severe respiratory illness. And so one of the goals of the 
trinational team is to strengthen the laboratory capacity in 
Mexico so they can detect this new strain right there without 
having to shift to the U.S. or Canada or elsewhere.
    So I think we are getting much better information and 
cooperation. I mean the cooperation has been good, but the 
information quality is improving by the day.
    Ms. Schakowsky. Thank you.
    Dr. Sharfstein. I can just add that FDA is collaborating 
with the FDA equivalent in Mexico around some of the 
recommendations that have been made in the United States that 
would be applicable, like what the right dose is for young 
children.
    Ms. Schakowsky. Thank you.
    Mr. Pallone. Thank you. Ms. Eshoo.
    Ms. Eshoo. Mr. Chairman, thank you for having such a timely 
hearing on such an important subject. I have so many things 
that I want to say and ask, but this is my--these are--first of 
all, thank you for the magnificent work you do at each one of 
your agencies. I think they are all parts of the jewels in the 
crown of America's health system that needs help in so many 
ways but, boy, do we depend on the work that is done out of 
these agencies.
    Here is my sensibility that people are being, and it may 
have been said earlier by members when I wasn't here when the 
hearing began, the American people are inundated by the 
blaring, glaring headlines and, as one of the staffers said 
behind me, that the only break that they had from swine flu was 
Senator Specter switching parties. That was the news break and 
now we are back to swine flu. I am not diminishing what all of 
this represents, the seriousness of it. But I think that what 
people need to hear over and over again are the really 
commonsense steps of responsibility that they need to exercise, 
washing our hands 1,000 times a day, the coughing, the 
sneezing, making sure that we cover our faces.
    I think on this issue of air travel in the United States, I 
am pretty sensitive about this. I have commuted across the 
country now every single weekend for 16-1/2 years. And as my 
mother would say, I don't know who has raised some people, but 
they don't cover their faces when they sneeze or they cough. 
Now this is voluntary for the airlines to say something. But if 
they can remind everyone to fasten their seatbelts in the 
eventuality that something can happen to us if there is a drop, 
I think that that should be part of the text and that our 
government ask in very strong, firm tones, we don't need to 
pass a law on this, but I think the director or the Secretary 
of Transportation, along with health officials, should get on 
the phone and have a conference call with all of the airlines 
and say, please, we are asking you to make this public health 
announcement at the beginning of every flight. Because the 
proximity of human beings one to another on a plane is far 
different.
    Now I have been told that walking down the hall one of the 
house doctors was telling me that if someone coughs or sneezes, 
it is 6 feet. I sit pretty close to people on the plane. So do 
all of you. So I would ask that you do that. Get that ball 
rolling, and I think that that is in terms of prevention really 
important.
    I wanted to ask the following, and that is in the 109th 
Congress Representative Rogers of Michigan and myself 
introduced legislation, and we were successful, because it 
became law, it was the Biodefense and Pandemic Drug Development 
Act, it is called BARDA, to create--you are all nodding--a new 
office within HHS. What is the nexus between that office, the 
work that it has done, and this swine flu that evidently really 
doesn't come from pigs?
    Mr. Vanderwagen. Ma'am, I will answer that fairly simply. 
BARDA has always worked across the Department to assure that 
the NIH discovery research and the FDA oversight 
responsibilities get brought into the mix as we do advanced 
development. Over the last 4 years, what has happened is that 
BARDA, through their funding, brought us the first licensed 
H5N1 vaccine. They brought about the kind of vaccine production 
changes that Dr. Sharfstein referred to where we have a warm 
base, if you will, that will allow us to ramp up--
    Ms. Eshoo. That is very good news. The good news is that 
the House, in our economic recovery package, included increased 
funds for this. But the Senate took them out. I don't think 
they are going to be feeling so good about that right now with 
what is going on. Maybe one of them is tuned into this hearing 
tonight when they are home sitting on their sofa.
    So let me ask this question. We just have 4 seconds left. 
Can you explain how the CDC and the Federal Government plan to 
administer a flu vaccine and, given that many of those who, so 
far, from what I have read, that are infected are children, is 
this going to be performed in schools and will it be a 
mandatory vaccine?
    Ms. Schuchat. There is an answer to only some of those 
questions. But the States have been planning around 
countermeasure response assessments and they have done exercise 
drills with seasonal flu vaccine in terms of how will they 
administer promptly, get the kind of information--
    Ms. Eshoo. You are saying they will probably use that same 
model?
    Ms. Schuchat. Correct. And they are also making sure they 
have ways to find out who has gotten one dose because there is 
a good chance you will need two doses of this. So there are 
State-based planning efforts around those models.
    Ms. Eshoo. Well, again, Mr. Chairman, this is a timely 
hearing. I thank all of you, the great professionals, health 
professionals of our country, and we have learned a lot today. 
And I think we really have to be very sensible about this as 
the science and the scientists and the medical community take 
the lead. But we just have to hammer home what people can do to 
be responsible all day long every day, and I think that is 
going to equip them with a sense of a little, some sense of 
reassurance on this.
    Thank you.
    Mr. Pallone. Thank you, Ms. Eshoo. The gentlewoman from 
Ohio, Ms. Sutton.
    Ms. Sutton. Thank you, Mr. Chairman. And thank you very 
much for your testimony and even more importantly for what you 
are doing to try and deal with this situation and keep the 
public safe. I come from Ohio. We have one confirmed case, and 
it is in my district. The case arises in a child who traveled 
with his family to Mexico over spring break. And the situation 
is that the school has been closed, and I know that the CDC, 
Dr. Schuchat, recommends that--the language I see here 
recommends strong consideration of school closure of the 
schools with a confirmed case or a suspected case that has been 
epidemiologically linked to a confirmed case.
    The first question I have is, why do you stop short of 
saying close the school?
    Ms. Schuchat. I do think that we are evolving our guidance 
over time and some things may become clearer or stronger over 
time. At the time of the initial drafting of guidance, there 
was quite a bit of debate because illness that we had been 
seeing was fairly mild, and there was a question of balance. I 
think it is really--I think it is in there, but we meant to 
have in the guidance information about the local authorities 
having the best information or respecting their ability to make 
decisions that were either more stringent or less stringent 
than ours. But I do think at this point we think it is very 
prudent to close schools where a case has been confirmed or is 
highly suspect until we have more time to understand what is 
going on.
    So we are probably a little bit more aggressive than when 
that was written.
    Ms. Sutton. And to follow up, I should say that the 
superintendent in the school district did close the school. So 
I commend him strongly for doing that. This is a case that, as 
I say, a child traveling with their family, there are other 
siblings who go to other schools who are not, you know, 
exhibiting the symptoms of the swine flu. What is the 
recommendation there in that situation?
    Ms. Schuchat. At the present time what we have suggested is 
that the intervention be targeted at the school where the child 
with illness is, that additionally that gatherings associated 
with that facility be closed, but recognizing that there is a 
lot of variation in local realities. A school district in New 
York City is very different than a school district in a small 
town, and really respecting the ability of the local 
authorities to assess the situation and the practicality, the 
issues of what is possible. We really want to make sure that 
our interventions are not having more adverse impact than the 
virus itself. But we also are being mindful that we don't know 
as much as we want to know so far about this particular virus 
and we are probably being more aggressive than others would 
think we should be in order to protect people.
    Ms. Sutton. And isn't it correct that unless a person is 
exhibiting the symptoms themselves that the danger of 
transmission is not present?
    Ms. Schuchat. Unfortunately there are no absolutes. And 
what we think about from seasonal flu is that you may be able 
to spread infection a day before you have symptoms yourself and 
so, you know, it is one of those circumstances where we wish it 
were simple and we wish there was a very specific symptom and 
we wish that everyone who is infectious knows they are 
infectious and can stop from spreading to others. But we are at 
early days with this virus. It is a new one. And we don't know 
whether it will be most infectious later on in illness or what.
    With the SARS epidemic we were really fortunate actually 
that most of the spread occurred when people were really, 
really sick, not in those early days. But when you have 
infections that are transmissible before they are symptomatic, 
before a person is symptomatic, those are really tricky, and 
that is the case with measles in fact. People think if I don't 
vaccinate my child it is okay and my child can't spread the 
infection to somebody else, I will know when they are sick and 
keep them home. But you can actually spread measles before you 
even know you have it. So this is one of those challenges with 
infectious diseases and why we are being pretty aggressive in 
our interventions now.
    Ms. Sutton. Okay, and I could, and this goes back to a lot 
of what we have heard here about common sense about people 
staying home when they are sick and the like, but the people I 
represent, they are hard-working people and they are not, they 
don't stay at home with a sneeze because you just, it is very 
difficult. But could you just explain and stress the importance 
of people who aren't feeling well staying home, their kids 
staying home and, frankly, you know, the implications to 
employers, too, and why it is to their benefit that obviously 
those folks stay home?
    Ms. Schuchat. Some of the interventions that we are 
recommending are inconvenient. We actually did an effort in our 
planning a couple of years ago to address the public. We did 
public engagement in several communities to understand what 
people, average citizens were willing to do, if there were 
risks of something like a pandemic happening what was the 
trade-off in terms of personal flexibilities in the social 
protections. And through that we learned that there was support 
for many more aspects, I think, of this community mitigation 
strategy than I think some of us would have expected. But there 
is a balance. And we would really like to understand what is 
the severity, what is likely to be happening, before we really 
reduce people's lives.
    Ms. Sutton. Thank you. I appreciate it.
    Mr. Pallone. Thank you. This completes our questioning. But 
I just really want to thank again for being here. I thought it 
was very helpful to us. You have heard several members say that 
they would like you to keep in touch with us, but certainly I 
will express that as well. Hopefully things do not, you know, 
really get to the pandemic stage but obviously we might at some 
point ask you to come back again. I hope that is not necessary.
    We also have a policy where probably within the next 10 
days you could get additional questions from members to answer 
in writing, and so we would appreciate a response. But again 
thank you very much and Godspeed in what you are doing. And 
without further objection, the subcommittee hearing is 
adjourned.
    Thank you.
    [Whereupon, at 12:50 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

                                 
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