The Real Problem of Fake Medications

Salmonella outbreaks from peanuts and tomatoes are scary enough, but consider the repercussions of contaminated medications people take several times a day. The Food and Drug Administration reported that 95 Americans died from ingesting tainted blood-thinning medication last year. The FDA believed the drug, heparin, was “intentionally contaminated” in China—a main source of counterfeit medicines.

The FDA defines counterfeit medicines as “fake or copycat medicines” that may be contaminated, contain the wrong active ingredients, or contain the wrong amount of ingredients. The FDA Counterfeit Drug Task Force is currently improving their ability to track and trace medications in a manner similar to tracking systems proposed to speed contaminated food recalls. Ilisa Bernstein, director of pharmacy affairs in the Office of the Commissioner at the FDA, explained the new efforts at the American Enterprise Institute’s “The Global Impact of Fake Medicine” event yesterday.

The Prescription Drug Marketing Act of 1987 requires drug distributors to record the chain of custody, or pedigree, of drugs to increase accountability and transparency, but its implementation is challenging, Bernstein said. Radio-frequency Identification tags, small bar codes, and other electronic technologies are currently used to track drug products, but some companies are slow to adopt them. In addition to boosting traceability, the United States can toughen penalties for counterfeit drug manufacturers to discourage the practice, Bernstein said.

Image: NSF

Tags: FDA

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