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Tougher Penalties for Counterfeiters Under Consideration

On June 4, Rep. Steve J. Israel (D-NY) introduced the Counterfeit Enforcement Act of 2009 (H.R. 2726). This proposed legislation, which would amend the Federal Food, Drug and Cosmetic Act, increases penalties for the sale of contraband or counterfeit drugs. If passed, this legislation brings to life many of the ideas that the Partnership for Safe Medicines advocates in the Principles for Drug Safety.

Bryan A. Liang, MD, PhD, JDLiang (sm)

On June 4, Rep. Steve J. Israel (D-NY) introduced the Counterfeit Enforcement Act of 2009 (H.R. 2726).  This proposed legislation, which would amend the Federal Food, Drug and Cosmetic Act, increases penalties for the sale of contraband or counterfeit drugs.  If passed, this legislation brings to life many of the ideas that the Partnership for Safe Medicines advocates in the Principles for Drug Safety.  In addition to increasing penalties, the bill calls for several key steps to combating counterfeit drugs, including:

  • Increasing authority for the U.S. Food and Drug Administration (FDA) to issue subpoenas addressing matters that have the potential to threaten public health – including drug counterfeiting operations;
  • Authorizing the FDA to require pharmaceuticals to incorporate anti-counterfeiting technologies;
  • Removing the stay placed on the paper pedigree requirement originally mandated by the Prescription Drug Marketing Act of 1987 for tracking drugs through the pharmaceutical supply chain;
  • Increasing criminal penalties for drug counterfeiters;
  • Increasing funding for FDA inspections, examinations, and investigations of manufacturers; and
    Requiring a pharmaceutical manufacturer to alert the FDA when one of its drugs may have been counterfeited.

Incorporating measures such as this into the FDA's scope will help to close the gaps in our authority to stop drug counterfeiters, both in the United States and aboard.  This type of legislation, if passed, can set an example for regulatory bodies internationally and put the United States in leadership role in the global fight against counterfeit and tainted drugs.  For more information and additional ideas for putting a stop to counterfeit and contraband drug production and distribution, visit www.safemedicines.org

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