Health
FDA boosts efforts to find fake drugs
■ Electronic "track and trace" methods are examined as a way to halt the growing problem of counterfeit pharmaceuticals.
By Susan J. Landers — Posted March 8, 2004
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Washington -- The Food and Drug Administration will rely on improved technology as well as alerting physicians in its battle to keep the U.S. drug supply safe from counterfeit medications, according to a Feb. 18 report.
Although the FDA believes this criminal activity is not widespread, there has been an increase in sophisticated counterfeiting of some of the most widely used and costly pharmaceuticals. After averaging about five investigations per year through the 1990s, FDA investigations increased to more than 20 per year since 2000.
Thus, the report by the agency's task force provides "a clear roadmap to prevent drug counterfeiting and to quickly catch and stop those who attempt it," said Health and Human Services Secretary Tommy Thompson.
The document was strongly supported by the AMA.
"While relatively rare in the United States, the practice of counterfeiting drugs is growing," said AMA Trustee Edward L. Langston, MD. "To combat this problem before it becomes widespread, the United States must act aggressively by adopting new anti-counterfeiting technologies, improving secure business practices and implementing other measures."
The FDA plans to examine such technology as radio chips that will allow for easier tracking of products and the incorporation of at least two types of anti-counterfeiting technologies in drug packaging. Modern "track and trace" technology should be in use by 2007, said Thompson.
Meanwhile, the agency has scheduled a workshop on March 17 to explore such options in depth.
Physicians will play an important role in the new effort, according to the report. The agency's MedWatch safety information and adverse event reporting program will be expanded to emphasize the reporting of suspected counterfeits.
"The AMA has long been a partner in the FDA's drug-reporting program, MedWatch," said Dr. Langston. "We look forward to working with the FDA to educate physicians on how to identify and report counterfeit drugs. We are also eager to help alert physicians when the FDA identifies counterfeit drugs in the market."
