FDAnews Drug Daily Bulletin

FDA FORMS 'RAPID RESPONSE TEAM' TO ADDRESS AVIAN FLU THREAT

Nov. 2, 2005
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The FDA has formed a "Rapid Response Team" (RRT) to address the threat of an avian flu outbreak.

The agency will work with the HHS, the NIH, the Centers for Disease Control and Prevention, and industry to increase manufacturing of existing vaccines, develop new treatments, and prevent against the sale of counterfeit or fraudulent treatment, the agency said recently. Andrew von Eschenbach, the acting FDA commissioner, called the effort a "top priority" for the agency.

The RRT will address roadblocks to increased manufacturing of existing vaccines, like Tamiflu (oseltamivir phosphate), with an eye toward increasing production within 12 months. The group will also support the design and conduct of clinical studies to test new potential treatments and may allow such new medications to be available under Emergency Use Authorization. Eschenbach said he believes that, with these changes, new vaccines could be approved within eight weeks.

RRT will also work to deter counterfeiters from selling fake vaccines. This effort would include actively monitoring Internet sites to identify and stop fraudulent activities, aggressive prosecution of offenders, and encouraging manufacturers to use protective packaging to prevent product tampering.
For more information, go to http://www.fda.gov/bbs/topics/NEWS/2005/NEW01248.html