Counterfeit Drug Increase Triggers Response by FDA

Published Online: Monday, September 1, 2003

    In response to increasing reports of counterfeit drugs entering the US market, the FDA has launched an intensive new campaign to keep bogus medicines out of the pharmaceutical distribution system. The first phase of the new initiative includes the creation of an internal FDA task force that will investigate and report on how the agency can use new technologies to protect consumers and pharmacists from counterfeit drugs.

    The FDA also will be urging patients to help prevent counterfeiting by limiting their prescription drug purchases to domestic sources. Although drug counterfeiting ?is a relatively rare event? in the United States, some foreign markets are infested with counterfeits, agency officials said. According to the World Health Organization, as much as 8% of the world?s total drug supply today is counterfeit, and in some countries one half of all drugs are bogus.

    ?Although the FDA believes domestic counterfeiting is not widespread, the agency has recently seen an increase in counterfeiting activities as well as a more sophisticated ability to introduce finished dosage counterfeits into the otherwise legitimate drug distribution channels,? federal drug regulators said. ?The FDA has likewise seen its counterfeit drug investigations increase to over 20 per year since 2000, after averaging only about 5 per year through the late 1990s.?

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