[Senate Hearing 111-104]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 111-104
 
                            2009 H1N1 VIRUS

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



                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                            SPECIAL HEARING

                      MAY 7, 2009--WASHINGTON, DC

                               __________

         Printed for the use of the Committee on Appropriations


  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html

                               __________



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                      COMMITTEE ON APPROPRIATIONS

                   DANIEL K. INOUYE, Hawaii, Chairman
ROBERT C. BYRD, West Virginia        THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont            CHRISTOPHER S. BOND, Missouri
TOM HARKIN, Iowa                     MITCH McCONNELL, Kentucky
BARBARA A. MIKULSKI, Maryland        RICHARD C. SHELBY, Alabama
HERB KOHL, Wisconsin                 JUDD GREGG, New Hampshire
PATTY MURRAY, Washington             ROBERT F. BENNETT, Utah
BYRON L. DORGAN, North Dakota        KAY BAILEY HUTCHISON, Texas
DIANNE FEINSTEIN, California         SAM BROWNBACK, Kansas
RICHARD J. DURBIN, Illinois          LAMAR ALEXANDER, Tennessee
TIM JOHNSON, South Dakota            SUSAN COLLINS, Maine
MARY L. LANDRIEU, Louisiana          GEORGE V. VOINOVICH, Ohio
JACK REED, Rhode Island              LISA MURKOWSKI, Alaska
FRANK R. LAUTENBERG, New Jersey
BEN NELSON, Nebraska
MARK PRYOR, Arkansas
JON TESTER, Montana
ARLEN SPECTER, Pennsylvania

                    Charles J. Houy, Staff Director
                  Bruce Evans, Minority Staff Director
                                 ------                                

     Subcommittee on Agriculture, Rural Development, Food and Drug 
                  Administration and Related Agencies

                     HERB KOHL, Wisconsin, Chairman
TOM HARKIN, Iowa                     SAM BROWNBACK, Kansas
BYRON L. DORGAN, North Dakota        ROBERT F. BENNETT, Utah
DIANNE FEINSTEIN, California         THAD COCHRAN, Mississippi
RICHARD J. DURBIN, Illinois          CHRISTOPHER S. BOND, Missouri
TIM JOHNSON, South Dakota            MITCH McCONNELL, Kentucky
BEN NELSON, Nebraska                 SUSAN COLLINS, Maine
JACK REED, Rhode Island
MARK PRYOR, Arkansas
ARLEN SPECTER, Pennsylvania
DANIEL K. INOUYE, Hawaii
  (ex officio)

                           Professional Staff

                             Galen Fountain
                        Jessica Arden Frederick
                             Dianne Nellor
                      Fitzhugh Elder IV (Minority)
                        Stacy McBride (Minority)

                         Administrative Support

                            Molly Barackman


                            C O N T E N T S

                              ----------                              
                                                                   Page
Statement of Senator Herb Kohl...................................     1
Statement of Senator Sam Brownback...............................     2
Statement of Tom Vilsack, Secretary, Department of Agriculture...     3
2009 H1N1 Outbreak...............................................     3
Surveillance.....................................................     4
Price Impacts....................................................     5
Trade Impacts....................................................     5
Prepared Statement of Tom Vilsack................................     6
Statement of Joshua M. Sharfstein, M.D., Principal Deputy 
  Commissioner and Acting Commissioner, Food and Drug 
  Administration, Department of Health and Human Services........    10
Tamiflu..........................................................    11
Flu Diagnostic Kit...............................................    11
Incident Management Approach.....................................    11
In Vitro Diagnostics.............................................    12
Personal Protective Equipment....................................    12
Blood Team.......................................................    13
Prepared Statement of Joshua M. Sharfstein.......................    14
FDA 2009 H1N1 Flu Virus Response.................................    14
Vaccine Development..............................................    18
Maintaining Foreign Markets......................................    20
Predictions for Fall.............................................    20
Zoonotic Diseases................................................    21
Border Surveillance..............................................    22
Pork Consumption.................................................    23
Trade Status.....................................................    24
Imports of Poultry Products......................................    24
Outreach.........................................................    25
Antiviral Medication.............................................    26
Antiviral Vaccine................................................    27
American Market for Pork Products................................    28
Virus Components.................................................    29
Vaccine Planning.................................................    29
International Assistance.........................................    31


                            2009 H1N1 VIRUS

                              ----------                              


                         THURSDAY, MAY 7, 2009

        U.S. Senate, Subcommittee on Agriculture, Rural 
            Development, Food and Drug Administration, and 
            Related Agencies, Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10 a.m., in room SD-124, Dirksen 
Senate Office Building, Hon. Herb Kohl (chairman) presiding.
    Present: Senators Kohl, Pryor, Brownback, and Bennett.


                     statement of senator herb kohl


    Senator Kohl. Good morning and we thank you all for being 
here today. I would like to personally welcome Senator 
Brownback who is a new ranking member of the subcommittee. It 
is very good to have Senator Brownback and his knowledge and 
experience with us.
    We also, of course, would like to welcome Secretary Vilsack 
and Dr. Sharfstein to this Committee Hearing.
    In a normal year gentleman, your first appearance before 
this subcommittee would focus on the administration's budget 
request, which coincidentally, is being released today as you 
know. But we're going to ask you to come back for that once we 
have had a chance to study the budget and use this previously 
reserved time to hear from you on the steps the USDA and FDA 
are taking in response to the H1N1 outbreak, and we thank you 
both for being here in that regard.
    The past 2 weeks Americans have witnessed lots of media 
coverage of the flu outbreak. In speaking with Secretary 
Napolitano yesterday, she indicated that it has not turned out 
to be as severe as we originally feared. The immediate sense of 
crisis, fortunately, seems to be passing.
    We are no longer calling for schools to close, and the fear 
many people had in recent days should be subsiding at this 
time. But we still need to be vigilant as we all know, and if 
history is any guide, the second wave has historically been 
even more lethal.
    But as of today there is good news, the number of new cases 
in Mexico is slowing. It seems to be a milder strain than 
previously thought. Hospitalization rates are comparable to the 
regular flu. Existing drugs have been effective. And finally, 
there has been good coordination among all levels of Government 
here in the United States and the messages given to the public 
have been consistent and timely.
    But we all know there is more to be done. We need to work 
to spread accurate information about this flu and that it is 
not ``swine flu''. Our food supply is safe and no one should be 
closing their borders to United States meat. Secretary Vilsack, 
that is one of your jobs.
    We also need to make sure we have a vaccine for this, as 
well as the seasonal flu that will come around in the fall, and 
to make sure that it is safe, effective, and that there is 
enough for everyone. Dr. Sharfstein, that will be your job.
    So, we look forward to hearing from you both after any 
statement from Senator Brownback that he wishes to make at this 
time, Senator Brownback.


                   statement of senator sam brownback


    Senator Brownback. Thank you very much Mr. Chairman, it is 
a pleasure to join you here. I saw my colleague, and a former 
ranking member, Bob Bennett, in the elevator on the way up and 
he was handing me the reins as the ranking member and I'm 
delighted to be here. Being from the State of Kansas, this is 
an important topic for us. It is an important topic for all of 
the country, but certainly the Agriculture Subcommittee is one 
that a lot of people watch, and I'm looking forward to serving 
with you and getting your advice on any of the NBA playoffs. 
I'm sure you would know those as well as this topic.
    This is a key topic in front of us on the H1N1. In early 
April doctors in California detected this new and unique 
influenza strain in two young children and immediately began 
working with officials at the Centers for Disease Control, and 
to determine the origin and makeup of this influenza strain. 
After identifying the strain as a novel H1N1 influenza and 
tracing it to a significant outbreak in Mexico it became clear 
that health officials were dealing with a serious situation of 
global importance. This outbreak is a true test of our Public 
Health Response System. And by all accounts it is working. The 
Department of Health and Human Services, working with State 
health departments has been able to quickly identify and 
respond to this virus, antiviral drugs that are effective in 
treating this type of influenza have been shipped to all 50 
States and provided to Mexico to assist in the situation there. 
In addition, efforts are underway to develop a vaccine that 
would be ready for the Fall flu season if it is necessary. Each 
sector of our public health infrastructure is mobilized to 
combat H1N1 influenza.
    While we have appropriately focused on the public health 
aspects of the situation we must not forget that the initial 
naming of this virus had erroneously caused concern that pork 
products pose a threat to public health, resulting in a decline 
in the pork market. I know the Secretary being from Iowa is 
critically aware of that. And I have to say, Mr. Chairman, my 
background in the trade field and working with the initial 
opening up of foreign meat markets to the United States to beef 
and pork exports, too often what we see taking place in a 
situation like this is another country using this as an excuse 
to block our products.
    We have seen this happen in a dozen, a number of different 
health situations that are not a health concern to the 
population. So, we have seen to date 20 countries have placed 
trade restrictions on U.S. pork products that are healthy, that 
are safe, and I think these are just being used as trade 
barriers to our products pure and simple.
    Mr. Secretary, I am certain you share that view, and I am 
certain you are on top of this to push to reopen these markets, 
because this just happens all too often, and as a result our 
prices for pork in the United States have declined over 15 
percent. So it has a real impact in already a difficult 
marketplace for our producers.
    It is a huge public health concern. Dr. Sharfstein, we will 
look forward to your work and your comments on this. And it is 
one that we are going to be very supportive of your team and 
the efforts to make sure that we handle this in the best 
possible and effective way that we can.
    Thank you, Mr. Chairman.
    Senator Kohl. Thank you very much Senator Brownback. We 
have with us this morning Senator Mark Pryor, who is a member 
of the subcommittee now. Thank you for being here, and make any 
statement you wish.
    Senator Pryor. Thank you Mr. Chairman, I don't have any 
statement, but thank you both for your leadership on this issue 
and I look forward to hearing from the panel, thank you.
    Senator Kohl. Thank you. Secretary Vilsack, we'll take your 
statement, please.
STATEMENT OF TOM VILSACK, SECRETARY, DEPARTMENT OF 
            AGRICULTURE
    Secretary Vilsack. Thank you very much Mr. Chairman and 
good morning to you and to Senator Brownback and Senator Pryor. 
I appreciate the opportunity to testify. I have with me today 
as well, Dr. John Clifford, Chief Veterinarian for the Animals 
and Plant Health Inspection Service of the Department of 
Agriculture, as well as Mr. Jim Miller, Under Secretary for 
Farm and Foreign Agriculture Services, and Dr. Kenneth 
Peterson, Assistant Administrator for the Food Safety and 
Inspection Service.
    Before I begin I would like to express my sympathy and that 
of the USDA and our concern for all of those who have lost 
loved ones as a result of this flu, as well as those who have 
been sickened by it. I recognize that many Americans are 
worried about this virus and I want to assure them, and you, 
that Federal, State and local governments are working closely 
together to respond to the emergence of this virus.


                           2009 h1n1 outbreak


    The appearance of the 2009 H1N1 flu virus in humans and the 
associated concerns for animal health underscore the 
interdependent nature of human and animal health and the need 
for a one medicine approach to animal health surveillance. This 
emphasis is certainly true in USDA, and it is how we view our 
role in animal health safety, a role in which we are concerned 
with not only animal health, but with the optimal health of 
people, animals, and our environment.
    Today I would like to emphasize several points relating to 
the flu outbreak. One, it is absolutely safe to consume pork 
products. Two, USDA is involved in surveillance and vaccine 
development for swine. Three, USDA is well prepared should we 
detect the 2009 H1N1 flu virus in U.S. swine. And finally, USDA 
is working hard to keep markets open for pork products.
    I have been saying since day one and will continue to 
reiterate that pork and pork products are safe, and the 
American food supply is safe. Experts at the USDA and the 
Centers for Disease Control and Prevention have carefully 
examined this issue and found no evidence that this flu virus 
can be transmitted by food. It is important that consumers 
understand that you cannot contract this flu from eating pork 
or pork products. We are reiterating this message not only to 
the general public and industry, but to our trading partners 
and organizations such as the U.S. Commodity Futures Trading 
Commission and the Chicago Mercantile Exchange, in order to 
assure markets that U.S. pork is safe, and to protect 
producers, livelihoods.
    Another point I want to reiterate is that there is no 
evidence that this virus is in U.S. swine. We continue to take 
steps to verify that there are no signs of this virus in our 
swine herd, including working with State animal health 
officials, private practitioners, and our own Federal 
veterinarians in the field. However, it is important to note 
that because of the inherent qualities of influenza, there 
could be transmission from humans to swine.
    In fact, Canadian Food Inspection Agency officials have 
confirmed that swine from a herd in Alberta, Canada tested 
positive for the strain currently causing illness in humans. 
Canada has handled this situation appropriately and taken the 
necessary steps and precautions. No sick swine have left the 
farm, and animals and premises have been quarantined. We are 
working closely with our counterparts in Canada to keep abreast 
of the situation. This emphasizes the critical importance that 
pork producers be vigilant and understand and accept 
appropriate bio-security measures.
    Vigilance is something we use at USDA, and we have an 
effective safeguarding system in place that utilizes 
surveillance, testing and monitoring to ensure diseases are 
kept out of the livestock industry. Just as our safeguarding 
system has been proven successful in the past, we are confident 
that our efforts, combined with those of our industry partners, 
will alert us to any possible disease in U.S. swine.


                              surveillance


    USDA is prepared. So while USDA's routine safeguarding 
efforts for animal disease are ongoing, we do recognize the 
need to be responsive to the heightened concerns surrounding 
this flu, and are undertaking additional measures around 
surveillance and research to reassure consumers, producers and 
the public.
    To ensure early detection should the H1N1 flu be introduced 
into U.S. swine and because this particular strain has human 
health implications, we have accelerated implementation of a 
swine influenza surveillance program, which we began developing 
in July of 2008 in cooperation with the CDC and other 
stakeholders.
    Dr. Clifford is here if you wish to talk more about this. 
If we were to detect an unusual case of swine influenza, USDA 
would take a series of swift and appropriate actions to contain 
the virus and protect animal and human health while the virus 
was being identified.


                             price impacts


    Following the escalating media attention regarding the 2009 
H1N1 influenza over the weekend of April 25 and 26, the pork 
industry has encountered as Senator Brownback indicated, an 
over 15 percent decline in the average cash based price for 
hogs. Prior to that weekend USDA reported a weighted average 
base price of $61.03 per hundredweight paid for barrows and 
gilts on a carcass basis. As of May 5 that price decreased to 
$50.95 per hundredweight, a decline of over $10 per head for 
pork producers. By comparison, the average base price was 
$75.07 a year ago, or a 32 percent decline in price.
    Although the decline in pork prices has not been as large, 
the wholesale pork carcass cutout value decreased by 5.5 
percent April 24 to May 5.


                             trade impacts


    Now let me turn your attention for just a minute to the 
international market for U.S. pork and other meat and poultry 
products. As you know, exports are vital to the success of U.S. 
meat and poultry industry. For example in 2008 total U.S. pork 
exports were $4.7 billion.
    When I first became aware of the 2009 H1N1 flu situation, 
one of the first steps I took was to instruct each of our 
Foreign Agricultural Service's representatives in other 
countries to reach out to all of our major trading partners to 
keep their markets open. Through this network of overseas 
posts, FAS worked quickly to remind the appropriate foreign 
ministries and key foreign officials that discovery of this 
virus in humans is not a basis for restricting imports of 
commercially produced U.S. meat and pork products. We wanted to 
make sure our trading partners knew that this is not a food 
safety issue and that we expected them to make decisions 
regarding the importation of U.S. pork based on sound science 
and internationally accepted rules. Because of our swift 
action, we have been able to significantly mitigate the impact 
on our international markets.
    To reinforce our commitment, Ambassador Kirk and I put out 
a joint statement again urging our trading partners to make 
decisions based on scientific evidence and in accordance with 
their international obligations. We will continue to work with 
the U.S. Trade Representative's office to send a very strong 
and unified message in this regard.
    One of our key markets we immediately contacted was Japan. 
Japan is the number one export market for U.S. pork, with trade 
worth over $1 billion a year. We are particularly pleased with 
the Japanese response, which was a very strong and unequivocal 
a confirmation that U.S. pork products are safe and there is no 
reason to restrict imports into their country.
    Official and unofficial bans were quickly lifted in 
numerous countries, due largely to USDA's outreach efforts. For 
example, all Central American markets that initially closed are 
reported to have been reopened to U.S. pork products.
    I'm disappointed that China and Russia have imposed 
restrictions in reaction to H1N1. These restrictions account 
for the bulk of the impacts on exports. China had a record 
shipment of $273 million, roughly 6 percent of our exports in 
2008. However, the pre H1N1 forecast expected 2009 shipments to 
be a bit lower.
    Russia has banned all meats from some States, thus 
impacting not only pork, but also beef and poultry. Pork 
exports to Russia were valued at $414 million, accounting for 9 
percent of our trade. Our USDA posts overseas have taken every 
opportunity to reach out at every level of both the Chinese and 
Russian governments. The message they are delivering is clear, 
U.S. pork and pork products are safe and these markets should 
be reopened consistent with international guidelines.
    We will continue to focus our efforts on reopening these 
markets.
    In closing I want to emphasize that USDA will continue to 
work with other government agencies, industry, and our 
counterparts around the world to monitor the situation and 
assure the public and our trading partners that U.S. pork is 
safe. I must reiterate that indeed our products and our pork 
are safe. We are moving swiftly to make sure that we understand 
the science behind this virus, have the tools in place to 
detect and identify it, and respond appropriately if needed. 
You also have my assurance that USDA will continue to press our 
trading partners to remove restrictions on U.S. products and 
that restoring the international market for U.S. meat and 
poultry is a top priority.


                           prepared statement


    That concludes my statement Mr. Chairman, I look forward to 
working with members and staff of this committee and will be 
glad to answer questions you might have later.
    [The statement follows:]

                   Prepared Statement of Tom Vilsack

    Mr. Chairman and distinguished Members of this Committee, I 
appreciate the opportunity to testify before you today on the 2009-H1N1 
influenza. I have with me today Dr. John Clifford, Chief Veterinarian 
for the Department of Agriculture (USDA), Mr. Jim Miller, Under 
Secretary for Farm and Foreign Agricultural Services, and Dr. Kenneth 
Petersen, Assistant Administrator for the Food Safety and Inspection 
Service.
    Before I begin, I would like to express my sympathy and concern for 
those who have lost loved ones to the 2009-H1N1 flu, as well as to 
those who have been sickened by the virus. I recognize that many 
Americans are worried about this virus, and want to assure you that 
Federal, State, and local governments are working closely together to 
respond to the emergence of this virus.
    The appearance of the 2009-H1N1 flu virus in humans and the 
associated concerns for animal health underscore the interdependent 
nature of human and animal health and the need for a ``one medicine'' 
approach to animal health surveillance. This emphasizes how we at USDA 
view our role in animal health safeguarding--a role in which we are 
concerned not only with animal health, but with the optimal health of 
people, animals, and our environment.
    Today I would like to emphasize several points related to the 2009-
H1N1 flu outbreak. One--let me be absolutely clear: it is safe to 
consume pork products. Two--USDA is involved in surveillance and 
vaccine development for swine. Three--USDA is well prepared should we 
detect the 2009-H1N1 flu virus in U.S. swine. And finally--USDA is 
working to keep markets open for pork products.
    Before I discuss these points, I would like to note that when I 
reference ``2009-H1N1 flu,'' I am referring to the novel flu virus 
currently causing human illness, not flu viruses typically found in 
swine. There has been some confusion about why this virus is different 
from flu viruses we have seen before, so I'd like to provide a brief 
explanation.
Ecology of Influenza A Viruses
    Influenza type A viruses are widely distributed in birds and 
mammals including humans. These viruses are sub-typed by surface 
proteins referred to as H and N. The primary types seen in humans are 
H1, H2 and H3, and in swine they are H1 and H3. The current virus of 
concern is an H1N1 subtype.
    The genetic codes inside the virus further distinguish the 
subtypes. If viruses from 2 or 3 different species (for example bird, 
swine and human) infect the same person or animal, they can mix and 
create a new influenza A virus. Several of the gene segments in this 
2009-H1N1 flu virus have previously been identified in swine influenza 
viruses, so it was initially called a swine influenza virus. However, 
this virus is different from other type A influenzas because of its 
unique combination of genes.
    It is also important to understand that when genes are re-combined, 
as has happened with this 2009-H1N1 flu virus, the behavior of the 
virus changes. It may lose potential to infect or cause disease in its 
original host (in this case, swine) or it may become more transmissible 
to another host. This 2009-H1N1 flu virus has become fairly efficient 
in transmission among humans, as the spread of cases in this current 
outbreak has demonstrated. Now that we've discussed the science behind 
this virus, I'd like to talk about our approach to this situation.
U.S. Pork is Safe
    I have been saying this since day one and will continue to 
reiterate that pork and pork products are safe--the American food 
supply is safe. Experts at USDA and the Centers for Disease Control and 
Prevention (CDC) have carefully examined this issue and found no 
evidence that this 2009-H1N1 flu virus can be transmitted by food. It 
is important that consumers understand that there is no evidence that 
you can contract this flu from eating pork and pork products. We are 
reiterating this message not only to the general public and industry, 
but to trading partners and organizations such as the U.S. Commodity 
Futures Trading Commission and the Chicago Mercantile Exchange, in 
order to assure markets that U.S. pork is safe and to protect 
producers' livelihoods.
    Another point I want to reiterate is that there is no evidence of 
the 2009-H1N1 virus in U.S. swine. We continue to take steps to verify 
that there are no signs of this virus in our swine herd, including 
working with State animal health officials, private practitioners, and 
our own Federal veterinarians in the field. However, it's important to 
note that because of the inherent qualities of influenza, there could 
be transmission from humans to swine.
    In fact, Canadian Food Inspection Agency (CFIA) officials have 
confirmed that swine from a herd in Alberta, Canada, tested positive 
for the 2009-H1N1 strain currently causing illness in humans. A 
Canadian carpenter who had been in Mexico, upon return, was exhibiting 
flu-like symptoms, did work on this Alberta farm, and subsequently 
swine on the farm became ill. Consequently, as a precaution, people 
with flu-like symptoms should not interact with swine, and swine 
showing influenza symptoms should be kept away from the public and 
brought to the attention of State animal health authorities or USDA. 
Canada has handled this situation appropriately and taken the necessary 
steps and precautions. No sick swine have left the farm, and the 
animals and premises have been quarantined. We are working closely with 
our CFIA counterparts to be kept abreast of the situation. This 
emphasizes the critical importance that pork producers be vigilant and 
understand and practice accepted biosecurity measures.
    Vigilance is something we are used to at USDA, and we have an 
effective safeguarding system in place that utilizes surveillance, 
testing, and monitoring to ensure diseases are kept out of the 
livestock industry. What people outside of the livestock industry may 
not realize is that swine influenza, though not the 2009-H1N I strain, 
is actually endemic in the United States, and that USDA, as well as the 
swine industry, have a long history of successfully dealing with this 
virus. And just as our safeguarding system has proven successful in the 
past, we are confident that our efforts, combined with those of our 
industry partners, will alert us to any possible disease in U.S. swine.
USDA is Prepared
    So, while USDA's routine safeguarding efforts for animal disease 
are ongoing, we do recognize the need to be responsive to the 
heightened concern surrounding the 2009-H1N1 flu virus, and are 
undertaking additional measures around surveillance and research to 
reassure consumers, producers and the public.
    To ensure early detection should the 2009-H1N1 flu be introduced 
into the U.S. swine population, and because this particular strain has 
human health implications, we have accelerated implementation of a 
swine influenza virus surveillance program, which we began developing 
in July 2008 in cooperation with CDC and other stakeholders. We have 
asked laboratories to send any swine influenza virus isolates that are 
difficult to subtype with current reagents or known to be associated 
with human illness to our National Veterinary Services Laboratories 
(NVSL). To provide additional capacity to further characterize these 
submissions, we will be working with National Animal Health Laboratory 
Network (NAHLN) laboratories to provide additional diagnostic 
assistance.
    USDA's laboratories are ready, and are prepared to address 
potential findings of 2009-H1N1 flu in swine. We are growing virus to 
meet potential future diagnostic needs and determining if USDA can 
detect this strain with the screening test we currently use to detect 
avian influenza. NAHLN laboratories already use and are familiar with 
the avian influenza test and have been trained and proficiency tested, 
so they are prepared to use this test to screen for swine flu once this 
determination has been made.
    To test swine for the virus, you need to swab their nasal passages 
when they are sick and shedding the virus. If the animals are not 
showing signs of sickness, the likelihood of detecting the virus is 
low. If the screening test shows that the animal does have a type A 
influenza virus, further tests, known as genetic sequencing, must be 
done to distinguish one influenza virus type and subtype from another. 
This genetic sequencing, which looks at the DNA-makeup of the virus, is 
conducted by NVSL in Ames, Iowa, as well as selected laboratories with 
this capability.
    Laboratories with this sequencing capability conduct genetic 
sequencing on more than 500 swine influenza virus samples each year. 
USDA has contacted these laboratories and asked them to review their 
databases for their current and past sequencing analyses. The results 
of these reviews, including the most recent swine influenza season, 
revealed no detections of the 2009-H1N1 strain currently causing 
illness in humans.
    If we were to detect an unusual case of swine influenza, USDA would 
take a series of swift and appropriate actions to contain the virus and 
protect animal and human health while the virus was being identified. 
First, USDA and its State and industry partners would identify any 
infected or exposed animals and quarantine those animals. Second, USDA 
would take blood and tissue samples and would determine the virus type 
(i.e., H1N1) at a State diagnostic laboratory or the National 
Veterinary Services Laboratories in Ames, Iowa. Third, if we confirm 
that a sample is indeed positive for the 2009-H1N1 influenza, APHIS and 
State animal health officials will immediately begin an epidemiological 
investigation to determine any other herds that may have been exposed 
to the affected animals. This highlights the need to have significant 
producer participation in the National Animal Identification System 
(NAIS), which would make traceability much more effective if we do need 
to engage in a traceback effort related to this disease.
Enhancing our Understanding of the Virus and Increasing our 
        Capabilities
    To better understand and prepare to respond to a disease such as 
the 2009-H1N1 flu virus, it is important to understand its 
epidemiology. To that end, USDA has agreed, at the request of the 
United Nations Food and Agriculture Organization (FAO), to send a 
laboratory diagnostic expert to Mexico as part of an international team 
studying the epidemiology of the 2009-H1N1 flu outbreak. It is our hope 
that with a better understanding of the disease's incidence and 
distribution, we can tailor our preparations more appropriately to the 
specific virus.
    Additionally, our National Animal Disease Center (NADC), which has 
conducted research on swine influenza since 1978, is studying the 2009-
H1N1 flu virus with the end goal of developing a rapid and specific 
diagnostic test to target the unique genes in the 2009-H1N1 flu virus. 
This new test would be applied to samples that screen positive for any 
swine influenza virus. Even before the 2009-H1N1 case in swine was 
announced, scientists at NADC planned to inoculate pigs with the new 
virus to determine if it causes disease in pigs and how easily it is 
transmitted from pig to pig. We still plan to follow this course of 
action. The information obtained in these studies will be crucial for 
the U.S. swine industry to prepare for infection of swine herds with 
the new virus and their potential consequences, including spread of the 
virus to swine workers and others exposed to infected swine.
    NADC scientists are also initiating critical new research to 
determine if current vaccines or previous exposure to current strains 
of swine influenza virus will provide protection against the 2009-H1N1 
influenza virus. The results of these studies will provide important 
information on how vulnerable the U.S. swine population is to the new 
virus. We will also work with the swine industry to generate and 
produce new efficacious vaccines to provide protection to pigs against 
the disease. An outbreak of this virus in the U.S. swine production 
system could further exacerbate the potential for viral spread and 
replication in the human population, in addition to costing the swine 
industry millions of dollars. All research will be conducted using 
appropriate biosecurity protocols.
    Speaking of biosecurity, it is imperative that we take steps to 
prepare and protect U.S. swine from a potential 2009-H1N1 flu outbreak. 
We are reaching out to industry and encouraging them to intensify 
existing biosecurity practices. This includes not loaning/borrowing 
equipment or vehicles to/from other farms; permitting only essential 
workers and vehicles to enter the farm; disinfecting shoes, clothes, 
and hands of swine workers; thoroughly cleaning and disinfecting 
equipment and vehicles; and avoiding visiting other farms without 
proper cleaning and disinfection. In addition, we are working closely 
with our State and industry partners to ensure that officials take 
appropriate steps to protect themselves should they need to investigate 
suspect animals.
Impacts on the U.S. Swine Industry
    Following the escalating media attention regarding the 2009-H1N1 
influenza over the weekend of April 25-26, the pork industry has 
encountered a 16.5 percent decline in the average cash base price for 
hogs. Prior to that weekend, USDA reported a weighted average base 
price of $61.03 per hundredweight paid for barrows and gilts on a 
carcass basis. As of May 5, that price decreased to $50.95 per 
hundredweight, a decline of over $20 per head for pork producers. By 
comparison, the average base price was $75.07 a year ago, or 47.3 
percent higher than the current price.
    Although the decline in pork prices has not been as large, the 
wholesale pork carcass cutout value decreased by 5.5 percent from April 
24 to May 5. While the USDA estimated pork carcass cutout stood at 
$59.28 per hundredweight prior to that weekend news cycle, the value 
declined to $56.01 by May 5. In comparison, the cutout was $76.63 a 
year ago, or 36.8 percent higher than now.
    Softening demand and declining pork prices have resulted in reduced 
slaughter rates. Estimated hog slaughter for the week ending May 2, 
2009, was 2,018,000 head, a drop of 4.2 percent from the previous week 
and 2.3 percent from the same period a year ago.
Reassuring Trading Partners
    Now let me turn to the situation in regard to the international 
market for U.S. pork and other meat and poultry products. As you know, 
exports are vital to the success of U.S. meat and poultry. For example, 
in 2008, total U.S. pork exports were approximately $4.7 billion.
    When I first became aware of the 2009-H1N1 flu situation, one of 
the first steps I took was to instruct the Foreign Agricultural Service 
(FAS) to reach out to all of our major trading partners to keep their 
markets open. Through its network of overseas posts, FAS worked quickly 
to remind the appropriate foreign ministries and key foreign officials 
that the discovery of this virus in humans is not a basis for 
restricting imports of commercially produced U.S. meat and pork 
products. We wanted to make sure our trading partners knew that this is 
not a food safety issue and that we expect them to make any decisions 
regarding the importation of U.S. pork based on sound science and 
internationally accepted rules. Because of our swift action, we have 
been able to significantly mitigate the impact on our international 
markets.
    To reinforce our commitment, Ambassador Kirk and I put out a joint 
statement again urging our trading partners make decisions based on 
scientific evidence and in accordance with their international 
obligations. USDA will continue to work with the U.S. Trade 
Representative's office to send a very strong and unified message.
    One of the key markets we immediately contacted was Japan. Japan is 
the number one export market for U.S. pork, with trade worth well over 
$1 billion a year. We were particularly pleased with the Japanese 
response, which was a very strong and unequivocal confirmation that 
U.S. pork products are safe and there is no reason to restrict imports 
into their country.
    Official and unofficial bans were quickly lifted in numerous 
countries, due largely to USDA outreach efforts. For example, all 
Central American markets that initially closed are reported to have 
reopened to U.S. pork exports.
    FAS works closely with the international organizations, FAO, World 
Animal Health Association (OIE), and the CODEX to ensure that all 
countries have a strong set of science-based guidelines for use in 
these types of situations.
Conclusion
    In closing, I want to emphasize that USDA will continue to work 
with other government agencies, industry, and our counterparts around 
the world to monitor the situation and assure the public and our 
trading partners that U.S. pork is safe. I must reiterate that U.S. 
pork and pork products are safe. We are moving swiftly to make sure 
that we understand the science behind this virus, have the tools in 
place to detect and identify it, and respond appropriately if needed. 
You also have my assurance that USDA will continue to press our trading 
partners to remove restrictions on U.S. products and that restoring the 
international market for U.S. meat and poultry is a top priority.
    That concludes my statement. I look forward to working with Members 
and staff of the Committee and we will be glad to answer questions you 
may have.

    Senator Kohl. Thank you very much, Secretary Vilsack. Dr. 
Sharfstein.
STATEMENT OF JOSHUA M. SHARFSTEIN, M.D., PRINCIPAL 
            DEPUTY COMMISSIONER AND ACTING 
            COMMISSIONER, FOOD AND DRUG ADMINISTRATION, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Dr. Sharfstein. Thank you Chairman Kohl, Senator Brownback, 
Senator Pryor for the opportunity to testify today. Let me also 
say Secretary Vilsack, it is terrific to meet you, the FDA 
supports completely your message on the safety of pork products 
and we share USDA's mission of assuring a safe food supply for 
Americans. I also should say we've had, in my 5 weeks on the 
job so far, just a terrific relationship with your staff at 
USDA collaborating on a whole range of food safety projects and 
I think there is just so much exciting and worthwhile to be 
done through that collaboration.
    Among its other responsibilities, FDA protects public 
health by facilitating access to safe and effective human and 
animal drugs, human biological products and devices. This 
mission has been put to the test by the H1N1 situation in the 
last couple of weeks. Since the beginning of the outbreak when 
we became aware on Thursday, April 23, FDA has worked closely 
within HHS, with our sister HHS agencies, with USDA, other 
government agencies, the World Health Organization and foreign 
governments to address this serious challenge. I appreciate the 
opportunity to discuss FDA's response, including our approval 
of several emergency use authorizations and the efforts of 
internal FDA response teams.
    I want to just start by explaining that the most public 
thing that FDA did, which was to issue several emergency use 
authorizations, this concept was part of the Bio-Shield Act of 
2004. An emergency use authorization allows the use of an 
unapproved product or of an approved product for an unapproved 
use in a declared emergency. To authorize this emergency use 
FSA must find that the agent in this case, the flu virus, One, 
can cause a serious or life threatening disease or condition. 
Two, that based on the totality of the scientific evidence it 
is reasonable to believe that the product may be effective 
against the disease or condition. Three, that the known and 
potential benefits of the product's use outweigh the known and 
potential risks, and four, there is no adequate, approved and 
available alternative.
    On Sunday, April 26 the Acting HHS Secretary issued a 
nationwide public health emergency declaration in response to 
human infections discovered from the 2009 H1N1 flu virus. In 
the days that followed the Acting Secretary issued 
justifications justifying emergency use of certain antivirals, 
in vitro diagnostics, and personal respiratory devices. And FDA 
followed very quickly with several emergency use 
authorizations. Two of these were for medications, for Tamiflu 
and Relenza, two antiviral drugs.

                                TAMIFLU

    For Tamiflu, FDA approved, on an emergency basis, the use 
of this medication for children under age one and we had the 
first dosing for that age group. In addition, under emergency 
authorizations both medications may be distributed with 
information pertaining to emergency use to large segments of 
the population without complying with the label requirements 
otherwise applicable to dispensed drugs. For example both 
medications may also be distributed by a broad range of health 
care workers, including public health officials and volunteers, 
in accordance with applicable State and local laws or public 
health emergency responses.
    It was this emergency declaration that allowed the 
stockpile to ship so quickly. FDA worked literally around the 
clock over the weekend and I signed those emergency 
authorizations at 3 a.m. in the morning on Monday morning, so 
that stockpile could begin to ship as they had scheduled.

                           FLU DIAGNOSTIC KIT

    The third one was for diagnostic kit. It was the PCR flu 
panel diagnostic test that CDC put together to allow other 
labs, other than the CDC lab, to accurately diagnose this new 
infection. FSA approved this initially and then amended the 
authorization to allow the use of different sample types, such 
as throat swabs and different reagents for this test so that 
the supplies remain adequate. This was also approved that first 
night so that immediately CDC could begin distributing this 
test with all of the appropriate instructions to labs around 
the country.
    The fourth one that we did right up front was around masks, 
and FDA received an emergency use authorization, permitting the 
use of N95 masks by the general public from the Strategic 
National Stockpile in accordance with CDC's guidance on how 
these masks should be appropriately used.
    Taking together these authorizations helped CDC and State 
and local responders to take the actions needed to help meet 
the medical and public health threat, getting these products to 
patients and communities in need.
    I just want to give you a little bit of a background on how 
FSA was able to do this so quickly and so effectively, I think. 
And that is that we changed the management structure of the 
Agency in order to handle the H1N1 situation.
    As soon as we became aware I asked Mr. Jesse Goodman, FDA's 
Acting Chief Scientist and Deputy Commissioner for Scientific 
and Medical Programs, to lead FDA's efforts. Dr. Goodman is an 
international expert on biologics, he used to oversee the 
Biologics Center at FDA during the period where they 
significantly increased the number of flu vaccine manufacturers 
selling into the United States. He has tremendous experience in 
flu vaccine development and evaluation.

                      INCIDENT MANAGEMENT APPROACH

    He's leading an incident management approach, which is a 
different type of leadership approach than the usual kind of 
organizational chart at FDA. This approach ultimately put 
together seven substantive teams which are cross-cutting and 
include staff from the FDA as needed. All of the FDA Centers 
are engaged in the work on H1N1.
    These teams work with the Office of the Assistant Secretary 
of HHS for Preparedness and Response, the CDC, other HHS 
agencies, and national and international partners. The teams 
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.
    The incident command kind of approach is what is used by 
emergency agencies, it was originally developed to fight fires 
and is now widely adopted across the Federal Government. It 
also includes an operations section, a logistics section, a 
communications section that coordinates external relations, and 
has senior level health, international and legal advisers.
    Very briefly I'm just going to tell you about what the 
teams are working on now. The vaccine team has a goal of 
facilitating the availability of the safe and effective vaccine 
to protect the public from the 2009 H1N1 flu virus as soon as 
possible in the event that it is needed. And this work goes all 
the way from the lab, where FDA grows the virus, tries to 
genetically reengineer a reference strain of the virus that 
could be used for vaccine production, to getting reagents to 
test the potency of the vaccine, which involves sheep, 
antibodies for that are apparently produced from sheep. All the 
way to helping you design the clinical trials or advise in the 
clinical trials that would be used to test the potency of the 
vaccine and the effectiveness of the vaccine. All the way 
through approving the final vaccine.
    And that team is engaged with the NIH in BARDA, which does 
the purchasing of the vaccine for the Federal Government.
    Then there is the antiviral team. This is the team that 
approved the emergency use authorizations that first weekend 
for the two antiviral drugs, and they have been working very 
hard on identifying other products that may be needed under an 
emergency use. For example, right now there are no intravenous 
flu medications that are approved for use. So that team is 
working with manufacturers of promising products to see whether 
it might make sense to do an emergency use authorization in 
case that would become necessary because there would be so many 
sick patients.
    Like the vaccine team, this team is working closely with 
colleagues around the world. They got a lot of calls when this 
team put together the dosing for kids under age one based on 
their expertise in the science of drugs in the human body, and 
the rest of the world is very interested in following that and 
has been using their recommendations.

                          IN VITRO DIAGNOSTICS

    The in vitro diagnostics team, is the one that led the 
development of the tests, and they are regularly communicating 
with other manufacturers about other tests that could get 
approved.

                     PERSONAL PROTECTIVE EQUIPMENT

    The personal protective equipment team, oversaw the 
emergency use authorization on disposable N95 respirators and 
is working with manufactures on the current demand for 
respirators, meaning the N95 masks, and they are working with 
CDC on public communications.

                               BLOOD TEAM

    We have a blood team. The main focus of the blood team is 
to ensure that the blood supply remains robust during this 
period. That people, if they were to get too many people sick, 
maybe the blood levels would drop. But they are also looking at 
if there is any potential that the virus could have any safety 
concerns for the blood supply, and so far there has not been 
any significant problems identified.
    We have a shortage team, which is solely devoted to 
identifying shortages, working with manufacturers of approved 
drugs to make sure that they can get their capacity up and 
going. Thinking a couple steps ahead about where there might be 
bottlenecks in the distribution process and how FDA can help.
    And finally, we have a consumer protection team, which has 
the goal of protecting consumers from fraudulent and 
potentially dangerous FDA regulated products or other 
promotions for products that claim to diagnose, prevent, 
mitigate, treat or cure the flu virus. And, in fact, we have 
already found a number of these where people are promoting 
things that are potentially dangerous in the guise of treatment 
for H1N1 influenza. They have taken enforcement action and the 
promotions have been halted.
    I just want to take one second to thank the subcommittee 
for the funding in 2006, which really was critical to FDA 
getting to this point. Where FDA's current efforts are built on 
a foundation that has been really built over the last 5 years. 
2004 there was a major flu vaccine shortage, and Congress and 
the administration at the time really took that very seriously. 
FDA worked very hard to increase the number of manufacturers in 
the market from where we were down to one injectable flu 
vaccine manufacturer, they are now up at, I think, five, and 
that included a whole number of investments that were only made 
possible because of actual supplemental fiscal year 2006, $20 
million to FDA. That paid for a special review team that went 
out and inspected the vaccine facilities quickly to get them 
online faster, including a second major facility, domestic 
facility, that's Sanofi Pasteur, just got the approval from FDA 
yesterday. And it is going to double their manufacturing 
capacity for injectable flu vaccine in the United States from 
50 million to 100 million doses of seasonal flu vaccine a year. 
That facility approved yesterday is going to be available in 
case there is large scale production of H1N1 virus vaccine. And 
it is no exaggeration to say that that supplemental 
appropriation, the foresight that this subcommittee had in 
moving that forward, is directly related to the fact that we 
are starting from a pretty strong foundation.

                           PREPARED STATEMENT

    So, to conclude I would just say that it has been a real 
pleasure for me as someone who is relatively new, very new to 
FDA, to see what the Agency is capable of, and its response to 
this challenge. The FDA is fully committed and engaged in 
protecting the public's health. Among us are laboratory 
scientists, medical reviewers, epidemiologists, product 
experts, and field inspectors. We will bring every skill and 
resource we have to this critical mission.
    Thank you very much for the opportunity to testify. I look 
forward to your questions.
    [The statement follows:]

               Prepared Statement of Joshua M. Sharfstein

Introduction
    Chairman Kohl and members of the subcommittee, I am Dr. Joshua M. 
Sharfstein, Principal Deputy Commissioner and Acting Commissioner at 
the U.S. Food and Drug Administration. Among its other 
responsibilities, FDA protects the public health by facilitating access 
to safe and effective human and animal drugs, human biological 
products, and devices. Recognizing the global nature of public health 
issues, we collaborate with foreign counterpart regulatory agencies and 
international organizations to carry out our mission.
    FDA plays a vital role in the Nation's preparedness for, and 
response to, challenges such as the one presented today by the 2009 
H1N1 Flu Virus. FDA is part of a team led by the Department of Health 
and Human Services. Since the beginning of the 2009 H1N1 Flu Virus 
outbreak on Thursday, April 23, FDA has worked closely with HHS, our 
sister HHS agencies, other U.S. government agencies, the World Health 
Organization (WHO), and foreign governments.
    I appreciate the opportunity to discuss FDA's response, including 
our approval of several emergency use authorizations and the efforts of 
internal FDA response teams.
                    fda 2009 h1n1 flu virus response
Emergency Use Authorizations
    Section 564 of the Federal Food, Drug, and Cosmetic Act, which was 
added by the Project BioShield Act of 2004 (Public Law 108-276), 
permits the FDA Commissioner to issue an Emergency Use Authorization 
following a determination and declaration of a public health emergency, 
provided certain statutory criteria are met. An Emergency Use 
Authorization allows the use of an unapproved product or of an approved 
product for an unapproved use in a declared emergency. To authorize the 
emergency use of a product, FDA must generally find that the agent (in 
this case, the 2009 H1N1 Flu Virus):
  --can cause a serious or life-threatening disease or condition
  --that based on the totality of the scientific evidence available it 
        is reasonable to believe that the product may be effective 
        against the disease or condition
  --that the known and potential benefits of the product's use outweigh 
        the known and potential risks, and
  --that there is no adequate, approved, and available alternative.
    Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act 
provides that, before an Emergency Use Authorization may be issued, the 
Secretary of HHS must declare a public health emergency justifying the 
authorization based on one of three grounds. One of these is, ``a 
determination by the Secretary of a public health emergency under 
section 319 of the Public Health Service Act that affects, or has a 
significant potential to affect, national security, and that involves a 
specified biological, chemical, radiological, or nuclear agent or 
agents, or a specified disease or condition that may be attributable to 
such agent or agents.''
    On Sunday, April 26, 2009, the Acting HHS Secretary issued a 
nationwide public health emergency declaration in response to recent 
human infections from a newly discovered influenza A virus, the 2009 
H1N1 Flu Virus. In the days that followed, the Acting Secretary issued 
declarations justifying emergency use of certain antivirals, in vitro 
diagnostics, and personal respiratory protection devices.
    On April 27, 2009, FDA issued four Emergency Use Authorizations in 
response to requests from the Centers for Disease Control and 
Prevention (CDC). Two of these Emergency Use Authorizations extend the 
circumstances in which two FDA-approved drugs, Relenza and Tamiflu, can 
be used to treat and prevent the 2009 H1N1 Flu Virus. A third Emergency 
Use Authorization makes available an rRT-PCR test for diagnosing 
infection with the virus. The fourth authorizes the emergency use of 
certain personal respiratory protection devices, specifically certain 
disposable respirators certified by CDC's National Institute for 
Occupational Safety and Health, known as N95 respirators. FDA later 
approved a fifth EUA for a diagnostic panel for laboratory screening.
    By statute, these authorizations expire in one year unless 
previously revoked by FDA. However, the authorizations can be renewed 
if the conditions giving rise to the determination and declaration 
continue to exist.
    Tamiflu has previously been FDA approved to treat uncomplicated 
illness due to influenza and prevent influenza in patients 1 year and 
older. Relenza had been approved to treat acute uncomplicated illnesses 
due to influenza in adults and children 7 years and older who have been 
symptomatic for less than 2 days, and to prevent influenza in adults 
and children 5 years and older.
    One of the emergency use authorizations now allows for Tamiflu also 
to be used to treat and prevent influenza in children under one year. 
In addition, under the emergency authorizations, both medications may 
be distributed with information pertaining to emergency use to large 
segments of the population without complying with the label 
requirements otherwise applicable to dispensed drugs. Both medications 
may also be distributed by a broader range of health care workers, 
including some public health officials and volunteers, in accordance 
with applicable State and local laws or public health emergency 
responses.
    The primary Emergency Use Authorization for the rRT-PCR 2009 H1N1 
Flu Panel diagnostic test allows the CDC to distribute the 2009 H1N1 
Flu Panel test to public health and other qualified laboratories that 
have the needed equipment and the personnel who are trained to perform 
and interpret the results. FDA amended this authorization to allow the 
use of different sample types, such as throat swabs and different 
reagents for this test to help ensure that supplies of this test remain 
adequate.
    The H1N1 test amplifies the viral genetic material from a human 
sample. A positive result indicates that the patient is presumptively 
infected with the 2009 H1N1 Flu Virus, but it does not identify the 
stage of infection. A negative result does not, by itself, exclude the 
possibility of 2009 H1N1 Flu Virus infection.
    The Emergency Use Authorization for certain disposable respirators 
permits HHS to deploy these products from the Strategic National 
Stockpile for use by the general public, including individuals 
performing work-related duties, to help reduce exposure to airborne 
germs during this emergency. These products, when used properly and in 
accordance with information that is provided, may help reduce the 
chances of getting sick. They do not eliminate the risk of illness or 
death. They should always be used in conjunction with other infection 
control measures, such as frequent hand washing, and other measures 
recommended by CDC and State and local public health authorities. 
Finally, this emergency use authorization only relates to requirements 
under the Food, Drug and Cosmetic Act, not other requirements such as 
the standards for safety in the workplace administered by the 
Department of Labor.
    Taken together, these authorizations helped enable CDC and State 
and local responders to take actions needed to help meet the medical 
and public health threat, getting these products to patients and 
communities in need.
The FDA's Efforts on 2009 H1N1 Flu Virus
    As soon as we became aware of the 2009 H1N1 Flu Virus outbreak, 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 on the 2009 H1N1 Flu Virus. Dr. Goodman previously 
directed FDA's Center for Biologics Evaluation and Research and is a 
world-recognized infectious disease expert with extensive experience in 
issues related to influenza vaccine development and evaluation.
    Dr. Goodman leads an incident management approach that now includes 
seven substantive teams, which are cross-cutting and include staff from 
across the FDA as needed. All of FDA's Centers are engaged in this 
important work.
    These teams work with the Office of the Assistant Secretary for 
Preparedness and Response (ASPR), CDC, other HHS agencies, and national 
and international partners. The teams include: Vaccine Team, Antiviral 
Team, In Vitro Diagnostics Team, Personal Protection Team, Blood Team, 
Shortage Team, and the Consumer Protection Team.
    The incident management structure also includes an operations 
section, a logistics section, and a communications section that 
coordinates external relations, including media, legislative, 
stakeholders, international, and Web site development. The incident 
management structure also includes FDA senior-level health, 
international, and legal advisers.
    I would like to provide a brief summary of the focus of each team. 
This management approach is flexible and likely to change over time. It 
has already changes in response to evolving events.
Vaccine Team
    Surveillance for novel strains of influenza is ongoing. If 
epidemiological data suggest the emergence of a novel human influenza 
virus, we have the infrastructure to begin work in the event that a 
vaccine needs to be manufactured for the novel strain. 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, in the event that it is needed.
    Members of the team are working collaboratively with CDC and other 
partners in efforts to grow and genetically engineer the 2009 H1N1 Flu 
Virus in the laboratory for possible use in a vaccine. FDA is also 
beginning to prepare reagents that will be essential to help 
manufacturers produce and test the vaccine. The Vaccine Team also is 
working with CDC, NIH and other WHO centers on laboratory studies that 
may help us better understand this new virus, including whether 
seasonal flu vaccines may provide some protection against the 2009 H1N1 
Flu Virus.
    At the policy level, the Vaccine Team is fully engaged in 
discussions with the Biomedical Advanced Research and Development 
Authority (BARDA), a component of ASPR in HHS. These discussions also 
include the National Institutes of Health (NIH) and manufacturers on 
the issue of designing and initiating clinical trials to evaluate the 
immune response to vaccines derived from the 2009 H1N1 Flu Virus and on 
options for vaccine production and dosage regimens. FDA is a WHO/Pan 
American Health Organization collaborating center and is working 
closely with WHO on vaccine issues, including testing and development 
of seed strains in preparation for vaccine development. FDA is also 
fully engaged with its sister regulatory agencies throughout the world. 
In collaboration with CDC, FDA is also preparing to monitor the safety 
of the vaccine, were it to be utilized.
Antiviral Team
    The goal of the Antiviral Team is to identify and evaluate 
antiviral drugs that can be used to prevent and treat illness caused by 
the 2009 H1N1 Flu Virus and to facilitate access to these medications. 
This team led FDA's efforts to issue the April 27, 2009, Emergency Use 
Authorizations for Relenza and Tamiflu. In addition, the team is in 
communication with manufacturers to explore potential investigational 
options for treatment of the 2009 H1N1 Flu Virus. Like the Vaccine 
team, the Antiviral Team is working closely with our colleagues in 
other HHS agencies and with our sister regulatory agencies throughout 
the world, including, Mexico, Canada, the European Union, Australia, 
and Singapore.
In Vitro Diagnostics Team
    The goal of the In Vitro Diagnostics Team is to identify and 
evaluate in vitro diagnostics that can help test for the 2009 H1N1 Flu 
Virus. This team led FDA's efforts to issue the April 27, 2009, 
Emergency Use Authorization for the rRT-PCR test developed by CDC. This 
team regularly communicates with ASPR, BARDA and manufacturers 
regarding potential shortages with the FDA-approved rapid influenza A 
test.
Personal Protective Equipment Team
    This team works to facilitate the availability of personal 
protective equipment that may help reduce the risks from exposure to 
the 2009 H1N1 Flu Virus. This team led the efforts to issue the April 
27, 2009, Emergency Use Authorization for disposable N95 respirators. 
The team regularly communicates with manufacturers regarding current 
demand and ability to increase production if needed to meet expected 
demands. The team is working with CDC on public communications about 
appropriate use of various forms of respiratory protection.
Blood Team
    The Blood Team is dedicated to the safety and availability of blood 
and blood products needed for transfusion by the American public during 
this influenza outbreak. Though we have no evidence to date that the 
2009 H1N1 Flu Virus has affected our blood supply, we are monitoring 
both supply and safety, and working closely with HHS, our sister 
agencies in HHS, blood banks, and other blood and infectious disease 
experts.
Shortage Team
    The Shortage Team works to facilitate the availability of antiviral 
drugs to the American public. The team participates in daily calls with 
the ASPR's Biomedical Advanced Research and Development Authority and 
manufacturers to assess current needs and availability of these 
products. FDA has alerted consumers to the possibility of spot 
shortages in the consumer market and to encourage appropriate 
purchasing practices, and will be referring private individuals, 
including health care providers, to their State and local health 
departments to obtain information about product availability in their 
locale.
Consumer Protection Team
    This team has the goal of protecting consumers from fraudulent and 
potentially dangerous FDA-regulated products or other promotions for 
products that claim to diagnose, prevent, mitigate, treat, or cure the 
2009 H1N1 Flu Virus.
    FDA considers the promotion and sale of products that have not been 
approved, cleared or otherwise authorized by FDA to diagnose, mitigate, 
prevent, treat or cure H1N1 Flu virus to be a potentially significant 
threat to the public health. Many of these deceptive products are being 
sold over the Internet through illegitimate web sites. The operators of 
these web sites take advantage of the public's concerns about H1N1 
influenza and their desire to protect themselves and their families. 
The fraudulent products come in all varieties and could include dietary 
supplements or other food products, or products purporting to be drugs, 
devices or vaccines.
    FDA has an aggressive strategy to identify, investigate, and take 
action against individuals or businesses that wrongfully promote 
products in an attempt to take advantage of this current public health 
emergency. In addition, on April 30, FDA asked the public to 
voluntarily report suspected criminal activity, Websites and other 
promotions for products that claim to diagnose, prevent, mitigate, 
treat or cure the 2009 H1N1 influenza virus. As a further effort, on 
May 1, FDA issued a joint announcement with the Federal Trade 
Commission alerting the public to be wary of deceptive products that 
may be offered for sale over the Internet via illegitimate web sites. 
On May 4, FDA began posting a list of any firm issued a warning letter 
for such practices.
Fiscal Year 2006 Influenza Pandemic Funding
    During fiscal year 2006, this subcommittee had the foresight to 
appropriate $20 million to FDA for pandemic influenza preparedness in 
an emergency supplemental appropriation. The fiscal year 2006 
appropriation allowed FDA to invest in priorities that are critical to 
America's preparedness for an influenza pandemic. This $20 million 
supplemental became part of FDA's base resources in the Vaccine Program 
and allowed FDA to achieve a higher state of preparedness for events 
like 2009 H1N1 flu virus outbreak. I would like to report to you on 
what FDA achieved with the fiscal year 2006 funding and how the work 
begun in 2006 makes us better prepared for today's response to the 2009 
H1N1 flu virus.
    FDA invested pandemic influenza supplemental funding in three key 
areas: strengthening our capacity to expedite the development of flu 
vaccines, conducting essential monitoring and inspection of flu vaccine 
manufacturers, and conducting FDA-wide pandemic planning and 
preparedness activities.
Strengthening FDA Capacity to Expedite Flu Vaccine Development:
    Within FDA's Center for Biologics Evaluation and Research (CBER), 
FDA expanded its capacity to expedite development, evaluation and 
licensing of additional flu vaccines and manufacturing facilities to 
meet pandemic preparedness needs. The expanded science capacity funded 
through the supplemental allowed CBER to work, in collaboration with 
ASPR/BARDA, on science, product review, and product guidance to 
facilitate the development and evaluation of new technologies, 
including recombinant and cell-based technologies. Increased funding 
also allowed CBER to develop better tools and systems for monitoring 
the safety and effectiveness of vaccines. With these resources, CBER 
provided highly interactive advice to manufacturers on product 
development and worked closely with ORA on inspection issues for 
vaccine manufacturing facilities.
    CBER constructed high containment facilities to safely grow and 
genetically engineer pandemic influenza viruses and support vaccine 
development. CBER also expanded its testing program to speed the 
release and distribution of influenza vaccines and expanded its 
capacity to produce and distribute reagents to manufacturers. Reagents 
are used to determine the potency of influenza vaccines.
    CBER scientists developed new methods and techniques to 
characterize influenza vaccines and to measure protective immune 
responses, which help assess the effectiveness of pandemic influenza 
vaccines. CBER also defined an accelerated approval pathway for both 
annual and pandemic influenza vaccines based on the immune response, 
and we worked expeditiously to evaluate new vaccines and enhance 
manufacturing quality.
    In April 2007, FDA licensed the first vaccine to immunize 
individuals against H5N1 avian influenza, and this accomplishment was 
in part due to the investments in the 2006 pandemic supplemental. For 
the 2008-2009 influenza season, a record 146 million doses of seasonal 
influenza vaccine produced by six licensed manufacturers were available 
for distribution in the United States. CBER staff is working with 
public health partners and manufacturers to develop globally 
coordinated and expedited approaches to vaccine production, to develop 
new molecular tools to evaluate these vaccines, and to conduct 
collaborative research projects.
Monitoring and Inspection of Flu Vaccine Manufacturers
    The fiscal year 2006 Pandemic Flu Supplemental allowed Team 
Biologics, a joint effort of Office of Regulatory Affairs field 
operations and CBER, to conduct annual inspections of influenza virus 
vaccine manufacturing facilities. These annual inspections have helped 
to carefully monitor production practices and quality, with the goal of 
detecting potential problems early and, wherever possible, intervening 
to address them to better prevent future disruptions in supply or 
effects on final product quality.
FDA-Wide Pandemic Planning and Preparedness
    To strengthen our preparedness for an influenza pandemic, FDA's 
Office of Crisis Management led the effort to create FDA preparedness 
plans and conduct a functional exercise to text our preparedness. The 
exercise occurred in October 2008 and involved more than 600 FDA staff 
from FDA offices across the Nation. In this exercise, we confirmed 
FDA's ability to conduct essential functions with reduced staff. We 
also tested FDA's IT system with a large number of employees accessing 
the FDA network simultaneously from home or another remote location. 
The October 2008 exercise provided invaluable lessons, and we are 
benefiting from those lessons during the 2009 H1N1 Flu Virus outbreak.
    Finally, the 2006 Pandemic Influenza funding also allowed FDA to 
put plans in place intended to ensure continuity of operations during a 
pandemic. FDA, including CBER, installed dedicated servers, 
applications, laptops and other software and hardware to support 
critical personnel that must respond to an outbreak. The goal was to 
make certain that crucial data and applications for pandemic response 
are available on a 24/7 basis. FDA also strengthened the system on 
which we rely on for pandemic flu tracking, status, and reporting. We 
also enhanced systems and infrastructure that help integrate and 
expedite work flow for vaccine development, laboratory screening and 
testing, and adverse reporting.
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 resource we have to this 
critical mission.
    Thank you very much for the opportunity to testify today. I welcome 
your ideas and your questions.

                          VACCINE DEVELOPMENT

    Senator Kohl. Thank you Dr. Sharfstein, if it takes 4 to 6 
months as we understand it to develop an effective vaccine, we 
will be into fall before we know it. Do you anticipate that you 
will be in a position to have a flu vaccine available by that 
time, if necessary?
    Dr. Sharfstein. The way I've been thinking about that 
question is to separate out into two separate issues. One is 
the manufacturing capacity and what the system can do, and the 
other is the virus and the unknowns about the virus.
    Because of the investments that have been made the 
manufacturing capacity is very robust. The question is how the 
virus is going to behave, and it is impossible to make 
predictions at this point. The first stage is to get a very 
good reference screen of the virus, it is growing well and can 
be used to turn into seed lots for vaccine. And that is the 
stage we are in now. That has to be completed to get to the 
next stage.
    When you get to seed lots and those pilot amounts of 
vaccine that can be made by the manufacturers, then it has to 
be tested for potency, chemically, and then tested in humans.
    Those tests could show, boom it works right away. You know, 
the humans do well. They have a good immune response to it and 
now it is ready for wholesale manufacturing if that is what we 
want to do.
    But it could also say, wait a second, there is a problem 
with the immune response, you know, we've got to go back and 
figure out what we need to do to boost the immune response so 
that it actually works. And we don't know exactly how that is 
going to go.
    So, I know that there is a lot of interest in saying it is 
going to be 4 to 6 months, it is going to be 4 months, what is 
the exact production. The truth is, each of these steps has its 
own uncertainties, and when you are dealing with a completely 
new virus you are not sure. It could be that every step moves 
very quickly. It could be that there is a particular step which 
causes a big challenge and we have to figure out a way around 
it.
    So, I think the good news is we have the capacity. Once the 
technical things are solved the capacity to produce the vaccine 
is there, but there are a lot of unknowns. There is also the 
unknown of whether we would recommend the vaccine. You know in 
1976 there was a decision, very quickly after a new flu virus 
was identified, to make and also give the vaccine right away. 
The President announced that he wanted everyone to get a 
vaccine, it was February 1976 that the new virus was identified 
at the time and the President announced, I think in March, that 
he wanted everyone to be inoculated in the fall.
    That is not the approach that we're taking now. We want to 
be prepared with the vaccine, but there may be a separate 
decision based on the way the epidemic is, the other factors, 
what we know about the vaccine at the time. We are going to 
wait to make a decision whether to recommend it.
    So, I'm sorry that was not as, you know as clear an answer 
as I would like to give. I think we are confident that the 
manufacturing base is there. We believe we are putting all of 
the expertise we can into it, but there are going to be number 
of uncertainties as we go through in order to be able to answer 
when the vaccine will be available and whether we will even 
recommend it.
    Senator Kohl. Are you saying that we first have to 
determine what particular kind of a vaccination we need, and 
that will be determined once an outbreak starts occurring? We 
can then figure out, but then in a sense it is too late; isn't 
it?
    Dr. Sharfstein. No, I think we're at full scale, right now 
our efforts are full steam ahead to make a vaccine. But we 
don't know exactly what type of vaccine to make until we test 
it in people to find out whether it works.
    So, for example how much of the flu virus antigen goes into 
each vial? We don't know that. If you have a certain amount of, 
like the material for flu vaccine and you don't know exactly 
how much, you wouldn't know how much goes in each vial until we 
do the testing to see how people respond to it.
    So there are a whole bunch of technical questions before 
you figure out what kind of--we're going to be working on that 
before the fall. So that is going on full steam ahead. But how 
that resolves itself will determine whether a vaccine is 
available in September, or October, or November, or how much is 
available, you know, and when.
    There are just these outstanding technical questions. It is 
really true in any flu season, but it is particularly true now 
because it is a brand new virus, people don't know exactly how 
it will behave in all these tests until we actually do the 
tests.

                      MAINTAINING FOREIGN MARKETS

    Senator Kohl. Secretary Vilsack, what more do you 
anticipate doing to be sure, beyond statements and urgings that 
our foreign markets don't get closed to us?
    Secretary Vilsack. Senator, we are working in a combination 
of steps. First and foremost I think it is important for us to 
continue reiterating at all levels that our pork products are 
safe and that there should not be any restrictions.
    So, we are consistently, on a daily basis, particularly in 
China and Russia, conveying that message. We are updating them 
on the science. We are updating them on what we know about this 
virus to reassure them that there is no scientific basis for 
bans.
    Second, we are working with international organizations to 
ensure that statements from those international organizations 
are supportive of what we are saying, that our pork products 
are safe. Whether it is the WHO, or the OIE, or the FAO, we are 
working with a variety of international organizations to make 
sure that those statements are consistent and that they are 
repeated on almost a daily basis.
    We are working with Ambassador Kirk to determine whether or 
not, as Senator Brownback suggested, there are other issues 
this is tied to, or tied in with, and if so, whether or not 
those can be rectified as well.
    So, there is an ongoing process. We are working with our 
Canadian partners to also send a very strong and consistent 
message. That message is resonating and we are beginning to 
break through. Central American countries are a good example. 
We have continued to emphasize Japan's attitude about this, 
because I think it is instructive to other Asian nations. So, 
it is a combination of factors.
    And the more we know about this situation, the more we 
continue to talk about it and educate and inform. At this point 
in time that is the strategy that we are utilizing.
    Senator Kohl. Thank you. Senator Brownback.

                          PREDICTIONS FOR FALL

    Senator Brownback. Thanks Mr. Chairman. A couple of 
questions that seem to really bounce around a lot on the flu 
situation Dr. Sharfstein is the idea that this is going to, the 
potential for this to get worse in the fall. It's like you get 
a bump of flu and then it takes off once it gets to incubate or 
mutates. When will we get some sense or, do you get a sense 
about that, at an earlier stage? Does that just come on you? 
Can you develop any thought as to whether that will indeed 
happen?
    Dr. Sharfstein. That is an excellent question. I think that 
there are several ways to try to get a sense of it. One is sort 
of the biological way to study the virus and see whether it is 
mutating. And so the CDC has been sequencing different viruses 
that people are getting from around the country. And they have 
not found dangerous mutations at this point.
    Now, everybody knows that can change. In addition there is 
surveillance of a number of hospital emergency departments, so 
the CDC was able to say, you know, when this all started in 
these States, these emergency departments are seeing more 
respiratory illness, it is probably the flu. But they also were 
able to see that it was not that severe, very quickly.
    I think the CDC will be right on top of any changes in the 
severity, given the nature of the surveillance that they have. 
And some of their surveillance systems they are getting 
literally information on every patient in certain emergency 
departments. Confidentially, without identifying information, 
but they are getting information that allows them to kind of 
draw a picture of how severe the situation is.
    I think that this is a situation where we have to hope for 
the best, but prepare for the worst. And given the experience 
of the flu virus in previous seasons, the fact that it does get 
worse and like Chairman Kohl said, it could come back with a 
voracity in the fall, that's why all the agencies are really 
working full steam ahead on preparing a vaccine.
    Senator Brownback. Does it come back with a voracity 
because it mutates?
    Dr. Sharfstein. It is a couple factors. It is going to 
probably pass around the world, so you'll see it. One scenario 
is it doesn't exactly go away, it may go to the Southern 
hemisphere during their flu season. That will actually be a key 
sign to see what it is like there, before it comes back here.
    Part of it is that it can mutate. The other thing is that 
for some, I think not entirely known reason, the flu really 
does transmit better during flu season. And I'm not sure there 
is an exact answer as to why. Some people think it is because 
people are indoors more in the cold. That could be another 
factor. But if more people get it, more vulnerable people get 
it. And there will be, you know, many more people dying. Rather 
than a time when there is just less transmission overall.
    So, I think the third thing is, you know I've been 
testifying and meeting with Dr. Fauci from NIH, who you know, 
is a world expert on these things. He is, I think, really 
making the point of being very humble when it comes to a new 
virus and what can happen. We know the fact that it is new 
means we're not sure what could happen and we better just be 
prepared and watch it very carefully.

                           ZOONOTIC DISEASES

    Senator Brownback. For both of you gentlemen, this is 
another zoonotic disease, I remember the last head of CDC 
telling me that 10 of the last 12 major health concerns we have 
had have been zoonotic, where it is animal to humans that it 
jumps and can go back and forth. Are we sufficiently invested 
in research on how to handle these zoonotic diseases that seem 
to be the most ferocious on us?
    Secretary Vilsack. Senator, let me first of all say that in 
the summer of 2008 we began an extensive research project 
involving swine flu and various strains that we were aware of 
in an effort to try to learn more about the impact of this 
particular influenza. As a result of that work we are in a 
position to integrate this recent strain and we're going to 
accelerate our efforts to try to learn more about it.
    So, in a sense we began that research in July 2008. We 
continue this 2-year project, which is a combination of work 
between us and CDC to understand more about the mechanics, if 
you will, of the flu.
    I will say that it is fairly obvious that the amount of 
resources that have been dedicated to USDA and to animal 
research generally has been relatively flat in terms of 
investment over the last several years.
    And so that has required us to prioritize and to make 
decisions about what gets researched and how. And, of course, 
we get a great deal of instruction from members of Congress 
about concerns that they have that are particular to their 
region, and very important to agricultural production and 
livestock production.
    We will hopefully have an opportunity with a new 
administration to take a look at the structure of our research 
program.
    Senator Brownback. But you're going to have to do them back 
and forth. This is going to be both animal and human that the 
research needs to take place and you're going to have to work 
with CDC and other places to make sure these are, they go back 
and forth.
    Secretary Vilsack. And the flu project is, in fact, a joint 
project between CDC and USDA. So we are working in concert with 
CDC on that particular project and there are a number of 
interagency hearings and memoranda that we have entered into. 
So that work has started and will continue. And we are going to 
make sure that we prioritize the research as best we can with 
the resources that are provided to us.
    Dr. Sharfstein. If I can just say before I took this job I 
was the Health Commissioner in Baltimore city for 3 years, and 
the public health world is very clear that there needs to be a 
lot of attention to the issue that you're raising. The West 
Nile Virus, as you may know, was really evident in birds and it 
took quite a while for people to realize that there was 
something new going on in birds, and that was actually 
transmitted over into humans.
    I would say in addition to the basic research, to 
understand that the surveillance systems and bridging the 
surveillance systems between animal diseases and human 
diseases, is something that at a public health level is 
extremely important. And you know, it is something that I think 
the CDC probably at the Federal level has a big interest in. 
Especially given the very kind of cautionary tale of what 
happened with West Nile.

                          BORDER SURVEILLANCE

    Senator Brownback. Mr. Chairman, just one final thought to 
Secretary Vilsack: I have had other members raise to me that we 
have a number of agricultural workers coming into the United 
States from around the world, but particularly from Latin 
America, and concern about the flu virus, and I presume that is 
something you're going to be looking at, or ICE will be looking 
at and concerned and watching taking place, right? I appreciate 
your thoughts on it.
    Secretary Vilsack. Senator, first I think it is fair to say 
that significant aspects of agriculture are dependent on 
seasonal workers. And it will be important for us to continue 
to be vigilant at the borders as Homeland Security currently 
is, to ensure that the people coming into this country, from 
wherever they are coming in, as Dr. Sharfstein suggested this 
is a global issue, so it really doesn't make any difference 
where they are coming from they can be carriers. So, we need to 
continue to be vigilant at the borders at all points of entry 
for all people coming into this country. And I have been 
working with Secretary Napolitano to ensure that there is 
adequate training and adequate understanding of what to look 
for. And she has indicated to me that they are working very, 
very hard to make sure that the people who are suspected of 
this are, in fact, stopped and potentially questioned and 
possibly quarantined for a period of time.
    Senator Brownback. It is a tough issue because we need a 
lot of support and help within the agricultural industry, but 
it also has to be, you know safe, that is safety first.
    Secretary Vilsack. It is a balance absolutely. It doesn't 
do much good for the market if we have situations like this.
    Senator Kohl. Thank you, Senator Brownback. Senator Pryor.

                            PORK CONSUMPTION

    Senator Pryor. Thank you Mr. Chairman. I'd like to start 
with you Dr. Sharfstein, on the World Health Organization. They 
recently said that pork products from infected meat should not 
be consumed by people. Their comments, as far as I understand 
it, seem more cautious and maybe even at odds with what USDA, 
or the food agricultural organization, the world organization 
for animal health and others have said.
    Can you talk about the science of that for a minute?
    Dr. Sharfstein. Sure. My understanding is that the WHO has 
been pretty clear, so I want to hear from you more what the 
specific concern is, but I understand that they have said that 
influenza viruses are not known to be transmissible to people 
through the eating process of pork or other food products 
derived from pigs. That this virus has not been shown to be 
transmissible to people through eating pig meat or other 
products derived from pigs. And that heat treatments commonly 
used in cooking meat will readily inactivate any viruses 
potentially present in raw meat products. And that pork and 
pork products handled in accordance with good hygienic 
practices will not be a source of infection.
    So, from what I have heard from the team inside FDA is that 
WHO has been pretty good on this.
    Senator Pryor. You guys are pretty much on the same page 
then?
    Dr. Sharfstein. Yes, yes. I think there has been--I don't 
know if you know anything about that?
    Secretary Vilsack. Senator, if I might clarify. I think 
yesterday there was a question that was hypothetically answered 
and responded to by someone from WHO that suggested as your 
question indicated. Today there has been a clarification made 
by WHO that is very consistent with what the Doctor just 
indicated, which is that pork products are safe and safe for 
consumption. And that there really is no scientific reason for 
banning pork or pork products. And we are working very, very 
hard, Senator, very hard, to make sure that all of the 
international organizations are very consistent with their 
language. We appreciate their renaming this after the media 
basically took the name swine flu. We appreciate their 
assistance. But it was clarified today, and it was an 
unfortunate circumstance which led to that.

                              TRADE STATUS

    Senator Pryor. That is great. That is helpful. I must be 
working on yesterday's news, but thank you very much. And let 
me ask you, Secretary Vilsack, if I may as a follow-up, right 
now as it currently stands how many countries are either 
banning our pork from North America, or seriously contemplating 
that, do you know?
    Secretary Vilsack. Senator, I want to make sure I get the 
number right. Twenty-two countries have banned pork products or 
pork, either from our country totally, or from various 
individualized States within the country. That number was 
larger, as I indicated earlier, Central American countries have 
indicated a desire to ban and they have reversed that.
    We are continually working, as I indicated earlier in 
response to the chairman's question, we are continually working 
with the U.S. Trade Representative, and with international 
organizations, with our own field offices, with our Foreign 
Agriculture Service to convey a very consistent and clear 
message. And we are going to continue to do that.
    I think we are beginning to have some success. And I think 
the fact that there are several countries that have reversed 
bans, or several countries that were considering them that 
didn't go through, or perhaps modified what they were doing is 
an indication that we have had some success, but we have got 
more work to do.

                      IMPORTS OF POULTRY PRODUCTS

    Senator Pryor. Do you have any indication that that number 
22 will go down in the next week so or? Or do you know that 
yet?
    Secretary Vilsack. I don't know that. Our hope is it does 
go down and as I said earlier, we have been focusing 
specifically on China and Russia because those are the two 
large importers of our pork and pork products. We have been 
working daily with ministries in those two countries to provide 
them up-to-date information and respond to questions that they 
have.
    We know that our Canadian counterparts are doing the same 
and we hope that in the short term those situations which are, 
and decisions which are not based on science, and not based on 
international rules are reversed.
    Senator Pryor. Thank you. I have just one more question, 
Mr. Chairman, and that is, it is a follow-up to Secretary 
Vilsack, and that is that I know in the omnibus appropriation 
there was a section 727 added on the House side, that basically 
prohibits funding from being used to establish or implement a 
rule that would allow for importing poultry products from 
China.
    And I know you have been in discussions with China about 
pork and imports, exports from the United States into China 
about pork, and there is this section 727, do you have any 
indication that China is, you know, part of their contemplation 
on this is just retaliation for 727?
    Secretary Vilsack. Senator, I have no specific knowledge of 
that, but to amplify, we are working very, very hard with 
Members of Congress who have concerns about food safety, to 
reassure them that we can take steps and will take steps to 
make sure the products that are imported from China into our 
country are, in fact, safe.
    We're in the process now of preparing and providing some 
information to Members of Congress at their request, to begin 
that process of reassuring them. I will be meeting with the 
Chinese minister I think next week, and I'm sure this will be a 
topic of conversation as will the pork ban, if it is still in 
place when the minister arrives.
    Senator Pryor. Thank you both.
    Secretary Vilsack. Thank you, sir.
    Senator Kohl. Thank you, Senator Pryor. Senator Bennett.

                                OUTREACH

    Senator Bennett. Thank you very much, Mr. Chairman. Mr. 
Secretary and Dr. Sharfstein, let me thank you for following up 
on what Senator Pryor talked about. Let me thank you for your 
effort to make sure that the people understand that this does 
not come from eating of pork products.
    We have a significant industry, the pork industry in Utah, 
and they have been affected by the publicity here. People think 
back of Avian flu when people wouldn't eat chicken, indeed I 
traveled in parts of the world during that period of time and 
you could not buy scrambled eggs for breakfast at some of the 
supposedly best hotels in the world, because everybody was 
afraid of the connection to the birds and they were 
slaughtering huge populations of birds, chickens, whatever it 
might be throughout Asia.
    Can we keep that publicity up, that we don't need to 
slaughter pigs, that we don't need to avoid bacon wrapped 
burgers at Wendy's, or wherever it is you can buy that. All of 
these things are not an enormous danger.
    Secretary Vilsack. Senator, I can assure you that every day 
we are reinforcing that message, and we're doing it in the 
context of reminding the people of this country, when other 
countries ban or place unfair restrictions on trade that it not 
only impacts the pork producers in that respect, but it also 
potentially dampens consumer activity here in America.
    And I want to take this opportunity by virtue of your 
question, to remind all of America that there are hardworking 
farm families that are playing by the rules, working hard every 
day to put food on our tables, and through no fault of theirs, 
absolutely no fault of theirs, and because of a mis-messaging 
from, and a convenience on the part of those reporting all of 
this, they are now suffering a significant financial hardship 
and stress.
    We will reiterate every day, pork products are safe, safe 
to consume, and safe to import. We will continue to do that 
until this crisis has passed.

                          ANTIVIRAL MEDICATION

    Senator Bennett. Thank you. I appreciate that statement and 
the passion behind it, as I share that.
    Now, I understand the chairman raised with you the question 
of how long it takes to develop an antiviral vaccine before I 
came in.
    As part of your incident management approach you have a 
shortage team that attempts to spot shortages in the consumer 
market of antivirals. Can you give us an overall view of where 
you think some of the shortages are, in addition to your answer 
to the chairman's question about timing, there is always the 
question about distribution. Again, going back to the 
experience with avian flu, we had the concern that, well 
there's enough here, but there's not enough there. And could 
you just reassure us all, or inform us all if reassurance is 
too strong a word, of what the various problems would be and 
how quickly you think you can get them revolved.
    Dr. Sharfstein. Sir, I'm happy to answer that. Let's talk 
about the medicines to treat flu and then the vaccine second.
    Senator Bennett. Right.
    Dr. Sharfstein. The medicines to treat flu, there is, the 
government invested and I'm sure through your committee, or 
through the Senate, a significant amount of money in building 
up stockpiles of antiviral drugs.
    Senator Bennett. Right.
    Dr. Sharfstein. 50 million or so courses for the United 
States. And so far we're not even touching the top of that in 
terms of use. A quarter of the State's supplies have already 
been in the process, or have already been distributed to the 
States. And so in the public side there are a tremendous amount 
of resources that have already been mobilized. And if the 
problem were to become worse, people who needed the treatment 
would be able to get it. Up to quite, it would have to be an 
extremely severe problem to really be pressing that.
    It doesn't look like it's going to be that any time soon.
    At the same time the manufacturers are actually ramping up 
production in concert with FDA where, you know, if they need to 
use a new distributor, or something like that, we are going out 
and making sure that they are all set so that they can keep 
doing that. And we actually had a whole bunch of product that 
just needs to be put into packs, so they have been doing that.
    So, they are actually meeting, increasing production for 
the longer term, and we have the stockpile.
    In the private side, which is what the pharmacies have, 
there have been spot shortages, so in a particular area a 
pharmacy may sell out of Tamiflu as people might go and try to 
get prepared and have some at home, or something like that.
    There are some attempts to reduce that on the private side. 
The companies are working with suppliers and our team helps 
them spot those shortages, but what people should know is, even 
if they can't get it at their pharmacy right now, their public 
health department has a lot of it. And there is not an overall 
shortage of these antivirals right now at all.

                           ANTIVIRAL VACCINE

    On the vaccine side, it relates to, as I was saying before, 
the complexity of the vaccine. We have the infrastructure to 
make a lot of vaccine, and actually one of the smartest 
investments that was made by the Federal Government was 
actually the chickens. There are flocks that were purchased to 
make eggs just in case of a pandemic might happen, and if there 
was no pandemic those eggs go into cakes and the Government 
gets part of the money back.
    And those eggs are basically sitting around making, I'm 
sorry, those chickens are sitting around making eggs, making 
eggs and now it is like their moment. And those eggs are going 
to be able to be used. It was 5 years ago when there was a flu 
vaccine shortage. People were very concerned about the egg 
supply. And people thought, depending on the time of year, if 
the pandemic hits, it will take months to be able to get eggs, 
even to begin to make the flu vaccine. But now we've got a 
ready supply of eggs. And because it is an egg based vaccine 
for the most part still, those eggs can go right into the 
process, the plant that FDA licensed yesterday can be used for 
that. And really the manufacturing capacity is there. The 
question is going to be more about the virus, how it behaves in 
clinical studies, how it behaves in the grower tanks. And 
that's going to determine whether, you know, how many months it 
takes, or how much vaccine is available how quickly. There are 
some just unanswered scientific questions because it is a new 
vaccine. But the good news is the manufacturing capacity, the 
eggs, all that is there. And we are working with NIH and CDC to 
think a couple steps ahead. We are helping things along. Even 
though we don't have the pilot lots for clinical studies, what 
would a clinical study look like? Let's get it all set up in 
advance, and then as soon as we have the pilot lots we can do 
it.
    So, we're going to try to facilitate everything we have and 
have the only, you know, delays, or not really delays, the only 
steps be the scientific steps, and not, you know, we've got the 
eggs, we have got the facilities. We are going to have all of 
the designs of the studies, all that will be ready to go.
    We just have to, you know, get the best minds and the best 
science working on the vaccine itself.
    Senator Bennett. Thank you for that. I think that is a very 
helpful review for the public to understand. So, let me 
summarize and then you tell me whether or not I'm right or 
wrong.
    I like the word you used earlier when you say we're very 
humble with respect to this, which means we're not predicting, 
oh, everything is going to be under control, and we're smart 
enough to have everything figured out. We are very humble. But 
at the same time it sounds as if we are really quite well 
prepared. So that if it does, in fact, turn into a pandemic, as 
there are some indications that it might, that we are taking 
all the steps we need to take to deal with it.
    Is that a fair summary of what you are trying to tell us 
this morning?
    Dr. Sharfstein. I think that is an excellent summary. Much 
better than I said.
    Senator Bennett. Thank you, Mr. Chairman.
    Senator Kohl. Thank you. I am trying to follow that to 
another point. Are you suggesting that we will be prepared for 
an outbreak this fall if it occurs?
    Dr. Sharfstein. I think that we are, I anticipate that 
there will be everything done to prepare for an outbreak this 
fall. But because of the humble issue, because we don't know 
exactly what an outbreak could look like, we don't know about 
what could happen in vaccine production process, whether this 
virus is going to behave differently, I don't want to give any 
guarantees.
    I do think that we have the infrastructure and the capacity 
so that if things play out like we think they will, we will be 
able to have a good protection for almost any circumstance. 
But, you know, I think we have to recognize that this is a new 
situation. And you know, just think about how much this has 
changed over the past couple weeks when it first started, you 
know, it looked like one thing and now people are thinking it 
looks like another thing, and it probably will take a couple 
more, people will look at it differently over the next few 
weeks. We are just going to have to, you know, live with a 
little bit of uncertainty in this.
    But I do think that the foundation for preparation is 
extremely strong. The resources we have, the manufacturing 
capacity, the partnerships with private industry, the expertise 
in the Federal Government, all of these things are working very 
hard to, you know, do everything possible to be prepared. And 
that personally makes me have some degree of confidence about 
it. But I do think we have to balance that with the fact that 
this is a new virus.

                   AMERICAN MARKET FOR PORK PRODUCTS

    Senator Kohl. Secretary Vilsack, has there been a 
precipitous decline in the American market for pork products?
    Secretary Vilsack. Senator, we have not seen a significant 
decline, and I appreciate the fact that American consumers have 
taken our message to heart. But any time you have the kind of 
publicity that this particular influenza has received, and the 
concern that has been spread globally about it, you always are 
concerned and worried that it might. Clearly, pork producers 
have suffered, and will continue to do so until we get this 
turned around.
    And so we are very, very conscious of the stress that this 
industry currently has. We are in the process of obviously 
looking at ways in which we can be of assistance and help.
    Senator Kohl. How did it happen that this thing has been so 
mischaracterized to the American public?
    Secretary Vilsack. I think part of the problem was, and Dr. 
Clifford could probably do a better job of explaining this, the 
makeup of this particular flu is multifaceted, and 
unfortunately in the early, early days of reporting, the media 
latched onto one, but not the only component of this flu as a 
way of describing it. And once it got described in that way, it 
became a bit difficult to redescribe it.
    We have seen consistency within Federal Government. We've 
seen consistency with our State partners. We have been in 
contact with State agricultural commissioners and secretaries 
and they have re-enforced the message.
    We have seen consistency from our Nation's Governors, we've 
also seen consistency now with the message on international 
partners as well. And we are going to continue to reinforce the 
message. But I think part of it had to do with sort of the 
makeup of the flu. But Doctor, if you could, if I might.
    Senator Kohl. Dr. Clifford.

                            VIRUS COMPONENTS

    Dr. Clifford. Thank you Chairman Kohl. Actually, this 
particular virus as Secretary Vilsack has indicated has 
different components. Many of these components have been found 
in swine, but this particular virus is made up of avian, human 
and swine components. And when these things get into a 
particular species, then they get kind of tagged, when they are 
first found they are tagged with that species as being swine 
flu, or avian flu or human flu.
    So, this particular virus has both Euro-Asian lineage that 
has been found in avian species that was transferred to pigs. 
And then the United States, the North American part of this, 
has been found has reassorted from humans, chickens and swine 
and has been in the swine population. So, it has reassorted 
itself. And where that occurred we don't know. We don't know if 
it occurred in swine initially, or not. But all indications are 
that there has been no findings of this particular virus in the 
U.S. swine population to date. There has been no reported cases 
of this in Mexico.
    And we have just had the first case identified in Canada, 
where it was associated with humans passing it to pigs. So, 
this appropriately should be tagged really more of a human flu 
because it is passing from human to human.
    Senator Kohl. Senator Brownback.

                            VACCINE PLANNING

    Senator Brownback. Dr. Sharfstein, I was looking at the 
notes here that there is a good possibility this fall we may 
ask people to get vaccinated for two different types of flu?
    Dr. Sharfstein. I think it is premature to be thinking 
about what could happen this fall. I think that I was talking a 
little bit before about 1976 when right after the new virus 
came on the scene all of the health agencies, even the 
President were saying, we know exactly what is going to happen 
6 months from now. I think everybody looks back on that as a 
mistake that was made by everyone who was involved, in that 
they didn't adopt their thinking to the nature of the vaccine 
and the nature of the epidemic at the time.
    And I think that we're going to have to walk through a 
bunch of decisionmaking points. How much vaccine gets made. It 
will be a decision that is made a little bit later, once we 
know what the right vaccine to make is.
    Senator Brownback. True, but you have got to make that 
within a timeframe that you can produce a new vaccine.
    Dr. Sharfstein. Absolutely.
    Senator Brownback. And you're already producing, are you 
already producing a fall vaccine for a normal influenza?
    Dr. Sharfstein. Yes, that is already being produced.
    Senator Brownback. That is already being produced now.
    Dr. Sharfstein. That is in full scale production right now. 
Probably more vaccine than we have ever had before.
    Senator Brownback. So, you will have to make the cut point, 
or the call on this for H1N1 by when?
    Dr. Sharfstein. Well, I think right now they are producing 
the reference strain, which is the strain that grows into the 
actual vaccine. The way you make the vaccine is you take the 
key elements of this new virus that are new, that need to be 
stimulating the immune system for the response. You are going 
to take those out and you plug it into another flu virus that 
grows really fast and is a good strain for a vaccine.
    So, it is actually like you create this new virus to make, 
then it gets treated and killed for the injectable, or dealt 
with differently for the live attenuating.
    So, that process is going on now to develop a reference 
strain that could be used. Then you've got to make the pilot 
lots. Then you've got to develop your strategy, and then there 
is a moment that comes when, and you'll have to take a look 
when you are at that moment, when you are done with the 
seasonal flu vaccine supply, are in the middle, is there still 
some seasonal to be done? Do we want to interrupt that or not?
    Senator Brownback. When is that decision point?
    Dr. Sharfstein. The decision point----
    Senator Brownback. What time?
    Dr. Sharfstein. Probably within the next 1 to 2 months, I 
think.
    Senator Brownback. That you've got to make the call whether 
or not to vaccinate for H1N1?
    Dr. Sharfstein. No, that call is not getting made till the 
fall. But the call about whether to immediately switch over 
production is probably going to have to be made within the next 
1 to 2 months.
    Senator Brownback. What if the call is made we should do 
both? We should do it, because we lose what 35,000 people a 
year to flu?
    Dr. Sharfstein. Right. We're going to have----
    Senator Brownback. If you don't vaccinate for that you 
could have more people die of the normal flu.
    Dr. Sharfstein. That's why it is going to be in part a 
tough decision. But you should know that the seasonal flu 
vaccine for this fall is well into production. Those doses will 
be there, tens of millions of doses. So, we're really only 
talking about the tail end there.
    Whether we cut off the tail end of that production. We are 
going to have a lot of seasonal flu vaccine no matter what this 
fall. It is a question of whether you have to cut off the tail 
end to switch over. That will be a call that will have to be 
made, probably in the next 1 to 2 months.
    Then the decision to vaccinate is going to be made probably 
in the fall. Let's say the decision is made to make a whole lot 
of H1N1 vaccine. That is still different from the decision to 
recommend that people get it.
    Senator Brownback. I understand. I am just trying to get, 
what I hear you saying then is that you will get your 
production for the normal flu season, you are going to try to 
do everything early so you've got it. And then the switch over, 
that will be done in a month or two, that you switch over the 
H1N1 turning the production machinery toward that?
    Dr. Sharfstein. Right. I would say that the regular flu 
vaccine is already in production. And it is nothing different 
than what was already happening. This is the season for that. 
And then only when you're ready to go to production for the 
H1N1 does it become a decision that you make and that will 
depend on when we're actually ready. As that decision 
approaches we'll be able to look at the seasonal flu vaccine 
supply and say, are we 80 percent done, are we 90 percent done; 
are we 100 percent done? And then it is not even an issue. But 
that decision will come when that decision needs to be made, 
based on whether we're at that point with the production 
process.
    Senator Kohl. Gentlemen, does the USDA or FDA have a role 
to play in the Southern hemisphere with respect to manpower and 
supplies and the flu?
    Dr. Sharfstein. I can answer for FDA, definitely. There are 
a couple different levels. One is that we're in contact with 
regulatory agencies around the world about the appropriate way 
to treat this, and all the different products and tests, and 
the things that have been licensed or authorized I should say, 
by FDA.
    And in addition through CDC we're going to been keenly 
interested in what is happening there, in terms of what it 
means for how severe it could be in the United States in the 
fall. That will affect a lot of issues that relate to the 
vaccine production.
    Senator Kohl. Secretary Vilsack.

                        INTERNATIONAL ASSISTANCE

    Secretary Vilsack. Senator, we have specifically offered 
help to Mexico through the Food and Agricultural Organization 
of the United Nations and we will continue to offer that help. 
We also have APHIS contacts and communication and attaches in 
countries throughout the world. They are prepared to serve as 
local contacts to animal health service organizations and 
operations in foreign countries. If we receive any requests for 
assistance and help as it relates to this, we will do 
everything we can to the extent we can to provide help and 
assistance and technical assistance.
    I'm sure that as we learn more about this from the research 
that is now taking place, we will be in a position to share 
what we know with scientists and researchers in other 
countries.

                         CONCLUSION OF HEARING

    Senator Kohl. Well, we thank you for being here today, it 
has been informative and instructive. And I think we have a 
sense of comfort that you are really on top of it and doing 
everything you can and that you have a sense of confidence that 
we are going to be successful. Thank you for being here.
    [Whereupon, at 11:12 a.m., Thursday, May 7, the hearing was 
concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]

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