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FDA Task Force to Study Counterfeit Drugs

Kate Traynor

The Food and Drug Administration (FDA) announced today that it is launching a new initiative to address the growing problem of prescription drug counterfeiting.

The initiative calls for the creation of an internal FDA task force that will study the use of modern methods, such as bar coding and radio frequency tagging, to combat counterfeiting.

Other items on the task force's agenda include:

  • Examining how FDA can work more effectively with other government agencies, such as the Customs and Border Protection Service and the Treasury Department, which have experience with combating counterfeiting,   
  • Developing "best practices" for distributing and selling drugs,   
  • Studying ways to teach pharmacists and other health care professionals how to identify counterfeit products, and   
  • Working with the drug industry, wholesalers, and community pharmacies to find ways to track drug products through the distribution chain.

According to FDA, the task force will release its initial findings about two months from now and request comments from the public. A final report will be issued four months later.

FDA described counterfeiting in the United States as "a relatively rare event" that the agency wants to address before it becomes a widespread problem, as it is elsewhere in the world. According to FDA, about 10 percent of all drug products in the world are believed to be counterfeits.

FDA reported that it has investigated an average of 20 drug counterfeiting cases each year since 2000, a fourfold increase from the late 1990s. Recent, widely publicized counterfeiting incidents have involved Lipitor, Pfizer Inc.'s atorvastatin calcium cholesterol-lowering product, and Procrit, the epoetin alfa product manufactured by Amgen Inc. and marketed by Ortho Biotech Products, L.P. According to FDA, no deaths are known to have resulted from the use of counterfeit prescription drugs in this country.

Additional information about the anticounterfeiting initiative is available at the FDA Web site.