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U.S. Department of Health and Human Services


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Combating Counterfeit Drugs May 2005 Update - International Collaboration

In the Report, we recognized that counterfeit drugs are a worldwide concern, and we stated that we would collaborate with foreign stakeholders to develop strategies to deter and detect counterfeits globally. In February 2004, the World Health Organization (WHO) hosted a meeting to discuss an approach for developing global strategies for combating counterfeit drugs. FDA participated in this meeting and supports WHO's efforts in this area. It was decided at the WHO meeting that a concept paper would be drafted with a proposed strategy to address this problem. In March 2005, we attended the 4 th Pan American Conference on Drug Regulatory Harmonization held by the Pan-American Health Organization (PAHO) where a report was presented and recommendations were discussed regarding combating counterfeit drugs in the Americas. FDA's counterfeit drug initiative is consistent with the recommendations of the PAHO report.

FDA's Office of Criminal Investigations (OCI) continues to work with foreign law-enforcement agencies directly and through Interpol on individual international counterfeit cases.

OCI also has provided training on counterfeit drugs to foreign law-enforcement, customs and judicial officers from various parts of the world through the U.S. Patent and Trademark Office (PTO) Intellectual Property Enforcement Academy. In addition, in the past year, several individual countries have sought FDA's insights, advice, and/or training on combating counterfeit drugs. Although the approaches that we outlined in the Report were specific to the U.S. drug distribution system, many of the principles outlined in the Report are applicable generally.

Next Steps: To the extent that resources permit, FDA will continue to work with international organizations, foreign law enforcement agencies, and individual governments to provide training and advice concerning drug counterfeiting and to collaborate on coordinated strategies to combat the problem of counterfeit drugs globally.