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U.S. Department of Health and Human Services


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Combating Counterfeit Drugs May 2005 Update - Heightened Vigilance and Awareness

  Health Professional Reporting Via MedWatch

  In the Report, we indicated that we would encourage and educate health professionals to use the MedWatch form as a mechanism to report suspect counterfeit drugs to FDA. To make the reporting of suspect counterfeits easier, we changed the instructions for the MedWatch reporting form, both paper and electronic versions, so reporters will know how and when to report suspect counterfeits. We have also amended the MedWatch website description of product problems and added "suspect counterfeit" to the list of product problems to report to FDA using the MedWatch form. FDA staff has promoted the use of MedWatch for reporting suspect counterfeits in numerous speeches to health professional organizations over the past year. A small number of such reports are starting to come in using the MedWatch form.

Next steps: FDA will continue to educate health professionals to use the MedWatch form to report suspect counterfeit drugs.

Counterfeit Alert Network

In the Report, we stated we would create a Counterfeit Alert Network (CAN) and partner with health professional and consumer groups to provide timely and effective notification to their members or constituents of a verified counterfeit event. By signing the CAN co-sponsorship agreement, organizations become CAN partners and agree to deliver time-sensitive messages and information on specific counterfeit incidents and educational messages about counterfeits in general, as well as information about how and when to report suspect counterfeit drug products. In the past year, we have formed the CAN and currently 13 organizations have signed the CAN co-sponsorship agreement.

Also, in the Report, we stated we would develop internal guidelines for the informational contents of outgoing FDA messages that would be useful to communicate a counterfeiting incident to CAN partners. In the past year, we have developed these guidelines, in the form of a template, in collaboration with CAN partners. This template will allow for the efficient preparation and delivery of uniform counterfeit alert messages for partners to further disseminate.

Next Steps: FDA will encourage stakeholders to become members of the CAN and continue to work with CAN partners to be ready to disseminate effective and appropriate counterfeit alerts when needed.

Streamline FDA's Internal Rapid Response to Reports

In the Report, we said that we would streamline our internal processes to respond quickly to reports of suspect counterfeits by improving coordination and communication among all initial responders in the agency. In the past year we amended our internal standard operating procedures and developed a protocol for more efficient internal communication and coordination when a suspect counterfeit drug is reported to the agency, regardless of where the report is received (e.g., MedWatch, an FDA field office, call to the FDA hotline).

Next Steps: No additional action is required.