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GOVERNMENT
COUNTERFEIT DRUGS
Threat of fakes is growing, but many technologies could fight the problem
BETTE HILEMAN
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McClellan
FDA PHOTO |
The problem of counterfeit drugs getting into the U.S. is growing, threatening consumers and manufacturers, according to FDA. The response to this problem was the topic of a standing-room-only meeting held by the FDA last week in Bethesda, Md.
The meeting's purpose was to enable individuals, organizations, and other stakeholders to present information on all aspects of FDA's initiative against fake pharmaceuticals. Representatives from government agencies, pharmaceutical firms, industry organizations, public interest groups, and especially vendors of anticounterfeit technologies spoke. Specifically, they addressed the recommendations in FDA's anticounterfeiting task force report released in September (C&EN, Oct. 13, page 49).
FDA Commissioner Mark B. McClellan noted that the number of cases of drug counterfeiting has increased sharply over the past few years. Counterfeiters have become more sophisticated, he said, often producing fakes that appear identical to real products. Large supplies of counterfeit drugs are being manufactured and distributed by well-funded and elaborately organized criminal networks, he observed.
However, McClellan said, many new technologies, such as radio-frequency identification chips on individual packages, can be used to authenticate and track drugs from the point of manufacture to the point of dispensing.
In many respects, McClellan said, "the pharmaceutical industry is behind other industries, such as the fragrance industry," in efforts to fight counterfeiting. "This is a moving game," he said. "We will constantly need to think about whether we have multiple layers of security in place," just as the money supply is protected by more than 20 embedded technologies, he explained. "I am confident we can stay ahead of those who are out to make a fast buck" endangering the health of Americans, he concluded.
FDA will accept comments on its interim report until Nov. 3. The report will be finalized in January 2004. |