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12/24/2003

Be Alert for Unlicensed Influenza Vaccine, FDA Says

Kate Traynor

The Food and Drug Administration (FDA) announced yesterday that it is investigating reports that "unusual suppliers" are hawking unlicensed influenza vaccine to U.S. health care providers.

FDA said in a statement that its investigations involve reports of unlicensed vaccine being offered for sale as well as "individuals who are not licensed health care professionals" administering "questionable" influenza vaccine to patients. The problem is apparently an attempt to profit from the current national influenza vaccine shortage, according to the agency.

FDA noted that it worked recently with the Florida Department of Health to prevent the entry of an unlicensed influenza vaccine into the United States. According to a report in today's New York Times, this incident involved a half million doses of a foreign vaccine of "unknown quality and content" that had been offered for sale to the state of Florida.

Three influenza vaccines are currently licensed for use in the United States: Fluzone, by Aventis; Fluvirin, by Evans Vaccines; and FluMist, by MedImmune. FDA cautioned health care providers to obtain these products from reputable, reliable sources.

Joseph Deffenbaugh, director of Public Health and Quality in ASHP's Practice Standards and Quality Division, echoed FDA's advice for purchasers of influenza vaccine and other drug products: "Don't be tempted to buy from somebody you don't know," he said.

Deffenbaugh also reminded purchasers to "be wary of low-price offers" for any product as well as solicitations from unfamiliar sellers offering products that are in short supply.

FDA stated that it is dealing promptly with reports of influenza-vaccine profiteering and wants consumers and health care providers to report to the agency all "suspicious offers or practices" related to the vaccine.