[Senate Hearing 111-104]
[From the U.S. Government Publishing Office]
S. Hrg. 111-104
2009 H1N1 VIRUS
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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
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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
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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
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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
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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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