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U.S. Department of Health and Human Services

Drugs

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Counterfeit Drug Task Force Report October 2003 - EXECUTIVE SUMMARY

FDA Commissioner Mark McClellan established the Counterfeit Drug Task Force in July 2003 as part of FDA's heightened battle against the growing threat of counterfeit drugs. Commissioner McClellan charged the Task Force with developing recommendations for achieving four fundamental goals: (1) preventing the introduction of counterfeit drugs, (2) facilitating the identification of counterfeit drugs, (3) minimizing the risk and exposure of consumers to counterfeit drugs, and (4) avoiding the addition of unnecessary costs on the prescription drug distribution system, or unnecessary restrictions on lower-cost sources of drugs.

The Task Force has reached several interim conclusions. First, there is no single "magic bullet" against the growing number of sophisticated counterfeiters; rather, a multi-pronged strategy to secure the drug supply could be much more difficult for counterfeiters to overcome than any single method. It could also be less costly, because a “one-size-fits-all" approach is unlikely to work for all parts of the complex prescription drug supply system. Second, although drug counterfeiters today are more sophisticated and better organized than ever before, there are many new technologies and approaches that have the potential to prevent and contain counterfeit drug threats. While most of these new approaches have not yet been fully developed, implemented, and tested, they hold the promise of a more secure drug distribution system in the years ahead. Third, because many of these promising ideas have not been fully developed, the Task Force believes that an opportunity for broad public comment is essential to guide its further work.

Consequently, the interim report contains a series of potential options that might be part of a multi-pronged approach to combat counterfeit drugs. The potential options are based on what the Task Force has learned to date from reports, other governmental agencies, and individual stakeholders (e.g., state governments, trade associations, consumer groups, drug manufacturers, wholesale distributors, pharmacies, consumers, academicians, manufacturers of anti-counterfeiting technologies).

The interim report also contains background information compiled by the Task Force on the U.S. drug distribution system and the vulnerabilities that facilitate the introduction of counterfeit drugs into the system.

The background sections also discuss how specific factors, such as emerging anti-counterfeiting technologies, industry business practices, public awareness, and the dissemination of information, affect the ability to deter and detect counterfeit drugs.

The discussion of the U.S. drug distribution system and these specific factors provide the context and basis for the potential options proposed for consideration by the Task Force. These options are in the areas of:

  • Technology;
  • Regulatory requirements and secure business practices;
  • Rapid alert and response systems;
  • Education and public awareness; and
  • International issues.

Because a principal goal of this report is to stimulate public discussion of the most cost-effective way to keep the drugs used by Americans secure, these options are posed as potential options and are accompanied by a number of questions for the public, highlighting areas where the Task Force wishes to obtain further comment to inform its final report.