Rapid Response Team to focus on countering potential threat of pandemic flu in the United States

In response to the emerging threat of pandemic (avian) influenza, FDA has announced the formation of a Rapid Response Team to ensure that antiviral drugs are available to citizens in the United States if they are needed. While avian flu has not emerged in this country, the team will help ensure an adequate supply of treatments, such as oseltamivir (Tamiflu, Roche) 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 C. von Eschenbach, MD, acting FDA commissioner. "Using the Rapid Response Team approach, we believe we could review a complete drug application in 6 to 8 weeks."

In partnership with the Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and industry, the Rapid Response Team will work to ensure that necessary measures are taken to provide an adequate and timely supply of antiviral drugs to treat avian flu, if it should emerge in the United States.

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 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 concern, FDA anticipates an increase in the sale of counterfeit or fraudulent treatments. Presently, the agency is not aware of any counterfeit oseltamivir cases in the United States; however, there are initiatives in place to deter counterfeiters and other parties who sell counterfeit products that they say can prevent or treat avian flu.

FDA will continue to work with stakeholders in the US drug distribution system to strengthen the safety and security of the domestic drug supply and will continue to:

The FDA Counterfeit Alert Network is ready and available to help disseminate information in the event of counterfeit incidents. 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 counterfeit products.

In the event of a confirmed counterfeit case in the United States, FDA will also 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 US patients.

To minimize the risk of counterfeit or fraudulent flu treatments, FDA recommends the following: