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Report Addresses Problem of Fake and Substandard Drugs

Institute of Medicine calls for international ‘code of practice’ (Feb. 13)

A report released Feb. 13 by the Institute of Medicine (IOM) — part of the National Academies of Sciences — has formulated several approaches to mitigating the global problem of substandard, falsified, and counterfeit (SFC) pharmaceuticals and the products used in their manufacture. Specifically, the report:

  • Identifies the weaknesses in the supply chain that allow SFC drugs to circulate
  • Explains the public health consequences — to patients and at the population level — of SFC drugs and how to measure those consequences
  • Identifies areas where the convergence of standards could contribute to stronger regulatory actions
  • Describes global regulatory processes (e.g., track-and-trace and authentication) that distinguish genuine and high-quality drugs from fake or substandard drugs and identifies factors that could be used for additional scrutiny of the genuineness of a product
  • Explains how detection, sampling, and analytical methods can be best implemented to stop the circulation of harmful drugs
  • Assesses the effectiveness of regulatory approaches around the globe, including prevention, detection, track-and-trace, compliance, and enforcement actions

According to the report, the current political climate is not conducive to a “hard law” solution to the problem of SFC drugs, such as a multilateral treaty. The report suggests, however, that an international Code of Practice would offer a “soft law” solution that could give member nations — including the U.S. — clear, consistent guidelines and benchmarks for their work against SFC drugs. The report states that the World Health Organization (WHO) should take charge of developing such a code, in consultation with the World Customs Organization (WCO), the United Nations Office on Drugs and Crime (UNODC), and other stakeholders.

In a related announcement, FDA Commissioner Margaret A. Hamburg commended the IOM for its recommendations.

“The IOM report spotlights a critical global public health issue,” Hamburg said. “Falsified and substandard medicines adversely affect the lives of millions around the world, and the issue must be elevated to the highest levels of international discourse.”

The IOM’s newly released report was commissioned by the FDA in 2011.

Sources: National Academies Press; February 13, 2013; and FDA; February 13, 2013.

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