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Pandemic Flu Rapid Response Team Created by FDA,
Warns of Fake Treatments
Team to help expedite vaccine, new drugs to fight
avian (bird) flu
Oct. 24, 2005 - In response to the emerging threat
of pandemic (Avian) influenza, the Food and Drug Administration (FDA)
today announced the formation of a Rapid Response Team to ensure that
antiviral drugs are available to the American people - in particular
high risk senior citizens, in the event they
are needed. The agency also issued a warning about possible fake drugs
and fraudulent treatments it suspects will emerge.
While there is no current flu pandemic, the team
will help ensure an adequate supply of treatments, such as oseltamivir
phosphate (Tamiflu) and other anti-influenza drugs, for stockpiling in
the event there is an outbreak in the United States.
"Making sure Americans are protected against an
outbreak of Avian flu is one of FDA's top priorities," said Andrew von
Eschenbach, MD, Acting FDA Commissioner. "Using the Rapid Response Team
approach, we believe we could review a complete drug application in six
to eight weeks. Americans can be certain that FDA has the best
scientific minds working together to ensure we have enough Tamiflu and
other medications and to quickly get it to doctors and patients, if ever
necessary."
In partnership with the Department of Health and
Human Services, Centers for Disease Control and Prevention, National
Institutes of Health, and industry, the Rapid Response Team will work to
ensure every necessary measure is taken to provide an adequate and
timely supply of antiviral drugs to treat Avian flu, if it should emerge
in the United States.
The Rapid Response Team will address roadblocks to
increased manufacturing of products, such as Tamiflu (oseltamivir
phosphate), already proven effective against Avian flu. It is
anticipated that Tamiflu production can be in full gear within 12
months, with substantial product available, should it be needed.
Partnering with industry, academia and other
government agencies, the team will support the design and conduct of
clinical studies to test new potential treatments for Avian influenza.
In the event of a pandemic, such new medications could be made available
under Emergency Use Authorization.
In addition, the team will facilitate the
development and availability of safe and effective vaccines that could
help protect Americans against a future pandemic, including from Avian
flu. These efforts include measures to help increase vaccine
manufacturing capacity and production of currently licensed vaccines
using Avian flu strains, and facilitating and evaluating studies that
use new technologies.
As the threat of pandemic flu emerges as a public
health threat, FDA anticipates an increase in the sale of counterfeit or
fraudulent treatments. Presently, the agency is not aware of any
counterfeit Tamiflu cases in the United States, however, there are
initiatives in place to deter counterfeiters and parties who sell
fraudulent or phony products to treat or prevent Avian flu.
FDA will continue to work with stakeholders in the
U.S. drug distribution system to strengthen the safety and security of
the domestic drug supply and will continue to:
• Actively monitor internet sites and will partner
with internet service providers to identify and stop fraudulent
activity.
• Aggressively seek out and prosecute those who
seek to prey on innocent people in a time of crisis.
• Encourage pharmaceutical manufacturers to take
advantage of new technologies that provide protective packaging and
other features to ensure the product is both authentic and has not been
tampered with.
The FDA Counterfeit Alert Network is ready and
available to help disseminate information in the event of counterfeit
incident. The Counterfeit Alert Network is a partnership between FDA and
numerous organizations that have agreed to distribute FDA approved
messages to their members about counterfeits on a timely basis to assure
rapid action to minimize the risk of exposure to counterfeits. In the
event of a confirmed counterfeit case in the U.S., FDA will send an
Alert to these partners. FDA will send out an FYI notice to partners if
a counterfeit incident is confirmed elsewhere in the world that could
affect U.S. patients.
To minimize the risk of counterfeit or fraudulent
flu treatments, the FDA recommends the following:
• Consumers should buy medicines only from U.S.
state-licensed pharmacies.
• When buying medicines over the Internet,
consumers should look for the National Association of Boards of Pharmacy
VIPPS seal. This seal tells consumers that the web site has been
certified, and if people want to buy a medicine on line, this is a
legitimate pharmacy to purchase it from.
• Only use medicine that has been prescribed for
you by your doctor and do not rely on websites that will provide you
with a prescription for the medicine without a true doctor-patient
relationship.
The agency will continue to collaborate with state
and local health departments to educate consumers about the dangers of
fraudulent treatments and preventions for Avian flu. For more
information on seasonal and pandemic flu, check these web sites:
•
Pandemic Flu (HHS)
•
Pandemic Flu (CDC)
•
Seasonal Flu (NIAID)
•
Seasonal Flu (FDA)
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