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Drug counterfeiting: A new Rx for curbing fake meds

The FDA offers a new plan to protect the nation's prescription medications.

Editorial. March 22/29, 2004.

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In some countries, concern about the proliferation of fake or phony prescription medications is a sad fact of life. Not so in the United States. Here, a network of state and federal regulation and enforcement over time has afforded patients considerable confidence and peace of mind.

Still, there is no room for complacency.

Recently, the Food and Drug Administration has seen a jump in U.S. cases involving drug counterfeiting. From the late 1990s until 2000, the FDA typically investigated between four and six such cases annually. In 2002, the number rose to 22.

The agency sees this phenomenon as a warning signal. Well-organized criminal operations are attempting to introduce into the marketplace drug products that resemble their legitimate counterparts but contain inactive or incorrect ingredients, are in improper doses or are otherwise contaminated.

Stanching this nefarious trend is a public health and patient care imperative. Doing so will require getting ahead of the problem. After all, patients should rest assured that the prescriptions they fill and the medications they take will improve their health -- not do harm.

That's why the American Medical Association supports the FDA's new blueprint to step up anti-counterfeiting efforts. The plan, outlined in a report released Feb. 18, offers aggressive measures to combat this problem before it becomes widespread. Physicians play a critical part.

Overall, the FDA is advancing a range of safeguards, from taking advantage of new track-and-trace technologies to follow drugs through the distribution chain to enhancing regulatory activity, increasing penalties for wrongdoing and heightening vigilance by health professionals and consumers. To this end, the agency will develop a system that helps ensure reporting of counterfeit drugs, and that strengthens the ability of the FDA, other regulatory agencies and stakeholders to respond rapidly.