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U.S. Department of Health and Human Services

Drugs

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Counterfeit Drug Task Report February 2004 Update - CREATION OF A COUNTERFEIT ALERT NETWORK FOR INFORMATION DISSEMINATION AND EDUCATION

1.  What FDA sought comment on:

  • Whether a counterfeit alert network should be created through use of existing, or newly developed, communication tools, that allow reception, dissemination, and sharing of information about counterfeit drugs in a timely manner; 
  • What are the capabilities of current communication network, what a communication network should have in order to part of a counterfeit alert network, and costs associated with developing or adapting current systems.

2. What the Comments Said:

The agency received many comments supporting the creation of a counterfeit alert network. Most of the comments suggested that the agency take steps to build on existing networks and several comments offered their organizations' distribution lists or network as a conduit for the counterfeit alert network. The agency was advised that the counterfeit alert network should not be overused in order to avoid 'alert fatigue,' which could create indifference or doubt regarding the importance of the messages. The agency was encouraged to consider cost-effective public/private partnerships to design communication strategies and facilitate efforts to standardize anti-counterfeit communications and to augment and coordinate communication systems. A detailed discussion of the comments is in Appendix B.

3. Discussion:

The FDA is committed to informing the public, particularly consumers, pharmacists, other health professionals, wholesalers, and others involved in the U.S. drug distribution system, about counterfeit drug incidents in a timely manner. FDA is also committed to educating them about ways to identify and prevent counterfeits from entering into this system. To increase awareness of counterfeit drugs and safeguard the nations drug supply, FDA is creating a network of national organizations, consumer groups, and industry representatives to deliver time-sensitive messages and information about specific counterfeit incidents and educational messages about counterfeits in general. The network is called the "Counterfeit Alert Network."

Partners in the Counterfeit Alert Network will be required to enter into a co-sponsorship agreement with FDA that lays out roles and responsibilities. Partners agree to disseminate the FDA time-sensitive messages to their members/subscribers/readers in the manner outlined in the co-sponsorship agreement, to partner in delivering educational messages, and in the case of health professionals, provide a link to the MedWatch website to report suspect counterfeits. A copy of the co-sponsorship agreement can be found in Appendix C.

The agency plans to maintain a list (as it does now) of additional health professional, consumer, and industry organizations, and media outlets to notify when an actual counterfeit incident is confirmed and what steps to take to minimize risks and remove the product from the U.S. distribution system. This will help ensure the widest possible distribution to the appropriate audience(s).

FDA met with consumer groups, pharmacy groups, and physician groups to determine the type of information that would be most useful to receive from FDA in the event of a counterfeiting incident. FDA intends to create templates for standardizing the format and content of health professional and consumer information in the event of a counterfeit incident that can guide outreach efforts in an efficient manner, while assuring the flexibility FDA needs to formulate the messages.

4. FDA Conclusions:

FDA will create a Counterfeit Alert Network that links together and enhances existing counterfeit notification systems, to provide for timely and effective notification to health professionals and consumers of a counterfeit event.

  • FDA is creating a counterfeit alert network to partner with national healthcare organizations, consumer groups, and industry representatives to deliver time-sensitive messages about specific counterfeit incidents and educational messages about counterfeits in general, and information about how and when to report suspect counterfeit drug products;
  • FDA plans to develop and execute multi-media informational strategies for specific audiences to ensure that the messages reach the largest number of interested people possible through the network;
  • FDA plans to develop internal guidelines for the informational contents of outgoing FDA messages that will be most useful to communicate a counterfeiting incident to individual stakeholder groups.