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U.S. Department of Health and Human Services


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1. What FDA sought comment on:

Enhancing FDA's internal processes for responding to and investigating reports of suspected counterfeit products

2. What the Comments Said:

The comments unanimously supported any efforts by the agency to rapidly respond to reports of suspect counterfeit drugs.

3. Discussion:

FDA takes reports of suspect counterfeit products very seriously. The agency is proud of its investigative tools and talents and its quick response to the public health needs when a counterfeit has been reported and has been confirmed. To improve this process, the agency evaluated its policies and procedures for responding to reports of counterfeit drugs to determine if FDA's response could be more efficient. Although FDA has had many positive experiences in responding and working with manufacturers and the public, FDA identified several ways to further enhance coordination and communication among all initial responders within the agency.

Because different parts of the agency throughout the country may receive the potential counterfeiting report, in some instances, it may take time for the information to flow to the appropriate people who need it to respond efficiently. Therefore, FDA has established an FDA-wide rapid response protocol for suspect counterfeit drugs that will ensure that specified persons/offices/divisions within the agency are notified and engaged as soon as possible after the report is made to the agency. Policies and procedures have been or will be amended to reflect this streamlined information flow and coordination of agency response.


Increased coordination and communication will help FDA to initiate rapidly any criminal or civil investigation, as well as to assess the health hazard of the counterfeit situation so the public health response can be launched.

4. FDA Conclusion:

To respond rapidly to a report of a suspect counterfeit, FDA is further streamlining its internal processes to respond quickly to reports of suspect counterfeit drugs by improving coordination and communication among all initial responders in the agency.

  • FDA intends to amend its internal SOPs, where appropriate, to provide for more rapid response when a suspect counterfeit is reported;
  • FDA intends to build on lessons learned from working with manufacturers in past counterfeiting experiences to determine how industry/agency collaboration can and should be strengthened.