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U.S. Department of Health and Human Services


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Counterfeit Drug Task Force Report: May 2005

Combating Counterfeit Drugs: A Report of the Food and Drug Administration Annual Update

May 18, 2005

On February 18, 2004, FDA issued a Report entitled "Combating Counterfeit Drugs: A Report of the Food and Drug Administration." The comprehensive Report highlights several measures that can be taken to better protect Americans from counterfeit drugs. These measures address six critical areas:

  • Securing the actual drug product and its packaging
  • Securing the movement of the product as it travels through the U.S. drug distribution chain
  • Enhancing regulatory oversight and enforcement
  • Increasing penalties for counterfeiters
  • Heightening vigilance and awareness of counterfeit drugs
  • Increasing international collaboration

Over the past year, we have worked with manufacturers, wholesalers, pharmacies, consumer groups, technology specialists, standard-setting bodies, State and Federal agencies, international governmental entities, and others to advance the measures outlined in the Report. Significant progress is being made in many of these areas. Although we continue to believe that the U.S. drug supply is among the safest in the world, more work needs to be done to further implement these measures and further secure our nation's drug supply.

In 2004, FDA's Office of Criminal Investigations (OCI) initiated 58 counterfeit drug cases, a significant increase from the 30 cases initiated in 2003. We believe that this is in part due to an increased awareness and vigilance at all levels of the drug distribution chain as a result of the Combating Counterfeit Drugs Report released last year. In addition, this increase in investigations is due to increased referrals from and coordination with other state and federal law-enforcement agencies and communication with drug manufacturers.

Fortunately, most of the counterfeit drugs at issue did not reach consumers because we focused our limited resources and developed proactive investigations that enabled us to identify components of counterfeit products and interdict finished counterfeit drug products before they entered domestic distribution.

Although the number of counterfeit drug cases has increased and the threat to the public health is real, most of the suspect counterfeits that we discovered in 2004 were found in smaller quantities, compared to those found in 2003. Most of these drugs were destined for the black market or internet distribution, rather than for widespread distribution in the nation's drug supply chain.


link to long description of Counterfeit Drug Cases Opened by FDA per Year 1997-2004
Previously reported data for FY 1997-2003 were revised due to new information
indicating involvement of counterfeit drugs in other previously uncounted criminal investigations.