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FDA Consumer magazine

May-June 2004 Issue


Protecting Consumers From Counterfeit Drugs

Drug counterfeiting has been relatively rare in the United States, but the practice has increased in recent years. The Food and Drug Administration has stepped up its efforts to halt drug counterfeiting and has issued a report highlighting critical elements that will help keep the U.S. drug supply safe and secure.

"This report shows how to achieve modern, comprehensive security protections for our drug supply that can keep pace with the increasingly sophisticated threats we face," former FDA Commissioner Mark B. McClellan, M.D., Ph.D., said. "FDA will not rest until we have strong protections in each link of the drug supply chain ... ."

Based on the work of the FDA's Counterfeit Drug Task Force, the report is part of an initiative to include manufacturers, wholesalers, retailers, pharmacists, consumer groups, and other stakeholders in the fight against counterfeiters.

The FDA conducted an average of five counterfeit drug investigations per year through the late 1990s, but that number has risen to more than 20 per year since 2000. In 2003, the FDA investigated counterfeiting of the cholesterol-lowering drug Lipitor (atorvastatin) and Procrit (epoetin alfa), an anemia treatment used in people who have cancer and AIDS.

The report, released by Health and Human Services Secretary Tommy G. Thompson in February 2004, uses a multi-pronged approach to address weaknesses in the drug distribution system. The report's recommendations include:

"Americans must have confidence in their medications even as we face more sophisticated and better organized counterfeit operations," Thompson said. "This task force's report provides a clear roadmap to prevent drug counterfeiting and to quickly catch and stop those who attempt it."

The FDA encourages consumers to purchase drugs only from state-licensed pharmacies that are located in the United States, and to check for changes in the drugs they purchase. Be alert to changes in packaging, labeling, color, taste, shape of pill, or unanticipated side effects. Before buying drugs over the Internet, make sure the Web site has a Verified Internet Pharmacy Practice Sites (VIPPS) seal. Consumers who suspect that a drug is counterfeit should contact the pharmacist who dispensed the drug and the FDA at (800) 332-1088.

To access the FDA's complete report on counterfeit drugs, visit www.fda.gov/oc/initiatives/counterfeit/.

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