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SYNTEX NAPROSYN CONSENT DECREE MANDATES FULL DISCLOSURE

Executive Summary

SYNTEX NAPROSYN CONSENT DECREE MANDATES FULL DISCLOSURE of all financial or material assistance provided by the company for public presentations of promotional or educational materials about the drug. Under the consent decree with FDA filed in San Francisco federal court on Oct. 10 ("The Pink Sheet" Oct. 14, p. 6), Syntex agreed to a package of actions to correct false or misleading advertisements and/or promotions for the nonsteroidal anti- inflammatory Naprosyn (naproxen). Under the consent decree, Syntex has to preclear all its ad and promotional materials with FDA for the next two years. In addition to the FDA scrutiny of all promotional and educational materials and the public disclosure requirements, the consent decree mandates that Syntex run corrective ads in 18 medical journals and on "Lifetime" Medical Television where the false or misleading "arthroprotective"/disease remission ads for Naprosyn were placed and send out one quarter-million "Dear Doctor" corrective letters. With regard to public presentations, video news releases (VNRs) or educational symposia for Naprosyn, the consent decree requires that Syntex "secure an agreement from all persons" presenting material that they publicly disclose: "(a) the nature of their direct and indirect financial relationships with [Syntex] for three years prior to the presentation; and (b) the nature of any assistance or support" from Syntex. That support includes, but is not limited to, the "selection of topics, speakers, or points or emphasis, preparation of outlines, draft manuscripts or talks, audio-visual aids, and data presentations." Syntex also agreed to refrain from any promotional activity for Naprosyn in connection with any of these situations or else identify the events as a promotional event. FDA's disclosure demands on Syntex are representative of the agency's growing desire to make public all commercial affiliations between clinicians, researchers and companies. The Syntex agreement in this regard is less demanding than the agreement between Bristol Labs and the agency. Under that May agreement, FDA is seeking to have Bristol assure that all the affiliations of presenters at symposia sponsored by Bristol money be disclosed in the agenda for those meetings. Bristol maintains that it cannot exert that kind of control over meetings sponsored by third parties ("The Pink Sheet" Sept. 30, p. 8). Regarding other types of promotional materials, Syntex agreed to submit to FDA "at least 30 days prior" to use: a copy of all "proposed written, printed or graphic promotional materials ... including ... videotapes"; a description of all proposed "promotional meetings, special events, and instructions" (including training manuals) "for the use of promotional materials by sales and other representatives engaged in sales activities"; and a description of "all proposed educational, public relations, press and media materials, including video news releases, press kits, press releases, and similar materials, that provide information on the safety and efficacy of the drug." Media materials have to be presented to FDA only at the time of their dissemination.
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