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Counterfeit Drugs: FDA Suggests New Counter Measures

BY ALM Staff
October 16, 2003

The FDA's Counterfeit Drug Task Force issued its interim report on October 2. It contains potential options for a multi-pronged approach to combat counterfeit drugs. In recent years, the FDA has seen an increase in the number and sophistication of efforts to introduce counterfeit drugs. The FDA noted at the time the report was issued that the problem of counterfeit drugs is being treated separately from the problem of unapproved and potentially unsafe drugs that are being imported via the Internet and other unregulated international channels. Under current law, those drugs are purchased outside of U.S. and foreign consumer protection systems, so they are “buyer beware” products that have traveled outside of the regulatory protections of the legal U.S. drug distribution system.

Final Report Due Soon

The Task Force's final report on ways to combat drug counterfeiting is due in early 2004. The potential options in the interim report were premised on three interim conclusions: 1) There is no single “magic bullet” against the growing number of sophisticated counterfeiters; rather, a multi-pronged strategy to secure the drug supply could be much more difficult for counterfeiters to overcome than any single method; 2) Although drug counterfeiters today are more sophisticated and better organized than ever before, there are many new technologies and approaches that have the potential to prevent and contain counterfeit drug threats; and 3) Because many of these promising ideas have not been fully developed, the Task Force will need to seek broad public comment to guide its further work.

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