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U.S. Department of Health and Human Services

Drugs

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Counterfeit Drugs Task Force February 2004 Update - APPENDIX A: COUNTERFEIT ALERT NETWORK CO-SPONSORSHIP AGREEMENT

BACKGROUND

The U.S. Food and Drug Administration (FDA) is committed to informing the public, particularly consumers, pharmacists, other health care professionals, wholesalers, and others involved in the U.S. drug distribution system, about counterfeit drug incidents in a timely manner and educating these parties on ways to identify and prevent counterfeits from entering into this system. To increase awareness of counterfeit drugs and safeguard the nations drug supply, FDA will create 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. FDA also will develop and execute informational strategies for specific audiences to ensure that the messages reach the largest number of interested people possible through the network. The network will be called the "Counterfeit Alert Network."

The goals of the Counterfeit Alert Network include, but are not limited to:

  • disseminating alert messages to a wide audience about specific counterfeit drug incidents in the U.S. and measures to take to minimize exposure (e.g., recall information);
  • outlining the roles and responsibilities of consumers, pharmacists, other health professionals, and wholesalers must play to identify counterfeit drugs, report suspect counterfeit drugs, and prevent them from entering the U.S. distribution system; and
  • developing a network of national organizations, consumer groups, and industry representatives to help disseminate the information.

 

[INSERT CO-SPONSOR ORGANIZATION INFORMATION]

IMPORTANCE OF THE PARTNERSHIP TO FDA AND [ORGANIZATION]

This partnership will increase the potential audience of FDA's important notifications about specific counterfeit drug incidents and messages about how and when to report suspect counterfeit drugs. By distributing FDA-developed messages through the [ORGANIZATION] information system, these messages can reach more than [#] people.

RESPONSIBILITIES OF FDA AND [ORGANIZATION]

FDA will develop targeted messages, with a particular focus on consumers, pharmacists, and other health care professionals when a counterfeit drug is found in the U.S. distribution system. FDA will also develop educational and informational materials about how to detect a counterfeit drug, what to do if a drug is believed to be counterfeit, how to report the suspect counterfeit to the FDA, and ways to minimize the risk of receiving a counterfeit drug. These materials may include: web-based documents, print ads, posters, prepared newspaper articles, fact sheets, consumer brochures/pamphlets, and informational packets. FDA will provide any logistical and technical support, such as writing, layout, designing, and preparing illustrations for the products.

FDA will ensure that all materials are cleared through the Agency and the U.S. Department of Health and Human Services before releasing material to the [ORGANIZATION] for public distribution FDA will provide these materials in a format (hard copy, digital, or electronic) that [ORGANIZATION] can use, as appropriate, to create, manufacture, and/or have printed in enough quantities to distribute to various audiences. FDA will not be responsible for any costs outside of the materials already produced by FDA.

[ORGANIZATION] will distribute in a timely manner FDA's notifications about specific counterfeit incidents as an alert through an active messaging system (separate email or fax alert correspondence). [ORGANIZATION] will facilitate the ability of their members/subscribers/website visitors to report suspect counterfeit drug products to FDA, e.g., via a link to the FDA Counterfeit Drugs webpage or FDA's MedWatch webpage. [ORGANIZATION] will distribute relevant FDA -educational messages about counterfeits, covering such issues as awareness, recognition, prevention, tracking, and authentication of drug products.

The [ORGANIZATION] will pay for the cost, if any, of printing materials, posting materials on its website, email distribution, renting ad space, and securing print placement in magazines and newspapers, as appropriate. [ORGANIZATION] will make clear, in any solicitation for funds to cover its share of the distribution costs that it, not FDA, is asking for the funds. [ORGANIZATION] will not imply that FDA endorses any fundraising activities in connection with the event. [ORANIZATION] will make clear to donors that any gift will go solely toward defraying the expenses of [ORGANIZATION], not FDA.

FDA and the [ORGANIZATION] will develop a dissemination plan that outlines where and how the educational materials and alert messages about specific counterfeit incidents will be distributed to various audiences.

FDA and the [ORGANIZATION] will review this agreement in two (2) years from the original date of this agreement, but either party to this agreement can terminate its participation at any time by notifying the other party of its intent to do so in writing.

CHARGES

The [ORGANIZATION] will not sell any educational materials related to this joint effort. [ORGANIZATION] will not impose an enrollment or registration fee for subscribers to receive this information.

INDEPENDENTLY SPONSORED PORTIONS AND ENDORSEMENTS

All materials and efforts related to the Counterfeit Alert Network will be jointly sponsored. FDA staff will not be used to develop, promote, or otherwise support any event that is independently sponsored by the co-sponsor, although official announcements and brochures may contain factual references to the available materials and Counterfeit Alert Network messages.

The [ORGANIZATION] will not use the name or logo of FDA except in factual publicity. Factual publicity includes materials provided to [ORGANIZATION] on FDA's program and Counterfeit Alert Network materials. Such factual publicity shall not imply that the involvement of FDA serves as an endorsement of the general policies, activities, or products of the [ORGANIZATION]. Where confusion could result, a disclaimer should accompany publicity to the effect that no endorsement is intended. The [ORGANIZATION] will clear all publicity materials with FDA to ensure compliance.

RECORDS

Records concerning this partnership shall account fully and accurately for any financial commitments and expenditures of FDA and [ORGANIZATION]. Such records shall reflect, at a minimum, the amounts, sources, and uses of all funds.

PUBLIC AVAILABILITY

This co-sponsorship agreement, as well as any financial records for this partnership, shall be publicly available.

CO-SPONSORSHIP GUIDANCE

FDA and the [ORGANIZATION] will abide by the memorandum of August 8, 2002, "Co-sponsorship Guidance," issued by the Associate General Counsel for Ethics.

 


__________________________ ___________________
DATE
FDA Signee

 


_________________________ ___________________
[NAME] DATE
[TITLE]
[ORGANIZATION]

 

__________________________ ___________________
Director, Ethics and Integrity Staff DATE
Office of Management and Programs
Office of Management
Food and Drug Administration