The Health Hazards of Counterfeit Drugs

Counterfeit drugs are a global problem. There’s no single solution to curbing the availability of falsified, substandard and unregistered drugs, but a report issued earlier this month by the Institute of Medicine (IOM) is a meaningful effort to acknowledge and address the problem. The IOM is an independent, nonprofit organization that provides unbiased and authoritative advice to decision makers and the public.

As reported on FDA Law Blog, the report, “Countering the Problem of Falsified and Substandard Drugs,” discusses, among other issues, the poor quality of drug ingredients and the lack of global regulation.

The report makes 12 recommendations international regulatory authorities should follow to combat the proliferation of this bad medicine throughout the world. Among them are:

  • Adopt universal definitions for “substandard,” “falsified ,” and “unregistered” drugs.
  • Establish and strengthen governmental systems to identify substandard, falsified and unregistered drugs.
  • Create “investment vehicles” for drug manufacturers who are interested in upholding international standards.
  • Promote government support in low- and middle-income countries for stronger international manufacturing and quality-control standards.
  • Fund public education campaigns on the dangers of falsified and substandard medicines.
  • Implement stronger licensing standards for wholesalers and distributors, and establish a public database of licenses to be maintained by FDA.
  • Authorize and fund a “mandatory track and trace” system to be implemented by FDA.

This is all very stiff-sounding, bureaucratic stuff, and if you’re wondering why you should care, consider this: Counterfeit drugs are a public health hazard. (The IOM prefers to separate problematic drugs into the terms “falsified,” “substandard” or “unregistered.”) They are, as defined by the FDA, fake medicine.

Such drugs might be contaminated, like the steroid injections last year that caused an outbreak of meningitis. They might contain the wrong or no active ingredient. They might contain the right active ingredient but at the wrong dose. Some of effects of taking counterfeit drugs are merely irritating, but some are lethal.

As more foreign countries manufacture drugs taken by Americans, we have more exposure to unregulated businesses whose processes and premises don’t meet our standards and are beyond our reach. The global problem is our problem.

As FDA Law Blog interprets the IOM, “falsified” drugs “carry a false representation of identity or source or both”; they’re often substandard, which means they vary from country to country, and can range from a legitimate product in fake packaging, or a fake product in legitimate packaging.

“Substandard” drugs “do not meet the specifications given in the accepted pharmacopeia [that’s like a drug recipe book-pharmaceutical products described by their formulas and methods of preparation] or in the manufacturer’s dossier.” The complication is that what’s considered “substandard” varies from country to country, despite the fact that many countries adhere to international pharmacopeias.

“Unregistered” drugs are “not granted market authorization in a country.” Unregistered drugs are also often substandard, and distributed outside the normal, regulated distribution channels.

FDA Law Blog applauds the IOM efforts, but identifies some problems in turning the recommendations into reality. Here are two:

Creating a centralized public database of suspended and revoked wholesale pharmaceutical licenses in collaboration with existing state licensing boards would be a “one-stop shop” for the public good, but how the FDA would implement such a large program is unknown. The Prescription Drug Marketing Act (PDMA) already supports a state system of wholesale and manufacturer licensure, but there’s no federal licensure system. And the FDA would have to rely on the states to provide timely data.

Creating a mandatory track and trace system an old idea that has gone nowhere. “We can only imagine,” says FDA Law Blog, “the regulatory quagmire and backlash from industry trying to comply with a federal pedigree, along with myriad state pedigrees.”

Stronger regulation and quality oversight in other countries can only benefit the quality of products coming into the U.S., and progress toward a global solution to an increasingly global problem would be encouraging.

But until there’s a strong and sustained global effort to regulate the quality and delivery of prescription drugs, patients should do what they can to ensure they’re getting what they’re supposed to be getting. To learn how to buy and use medicine safely, see the FDA’s guidelines. And see our recent blog about the risks of buying drugs online.

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