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FDA To Speed Up Tamiflu Production

October 24, 2005

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The Food and Drug Administration has announced formation of a "rapid response team" to ensure that antiviral drugs are available in the event there is a pandemic outbreak of avian flu.

The agency said that, while there is no current flu pandemic, the team will help ensure an adequate supply of treatments, such as Tamiflu, and other anti-influenza drugs, for stockpiling in the event there is an outbreak in the United States.

Currently the disease is rare among humans because it cannot be passed human-to-human, only from infected birds to humans. However, the mortality rate among infected humans is close to 50 percent, raising fears of a public health disaster if the virus mutates so that it can be spread among humans.

"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," he said.

Van Eschenbach said the team will address roadblocks to increased manufacturing of products, such as Tamiflu, 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.

Over the weekend many public health officials expressed concern that healthy patients would stockpile the drug, leading to shortages.

Partnering with industry, academia and other government agencies, the FDA said its 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 said it anticipates an increase in the sale of counterfeit or fraudulent treatments. Presently, the agency said it 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 said it 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 said it 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.

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