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CME PREPACKAGED PROPOSALS WITH "DETAILED AGENDAS" WORRY FDA

Executive Summary

CME PREPACKAGED PROPOSALS WITH "DETAILED AGENDAS" WORRY FDA because they give potential sponsors a preview of the content of a continuing medical education program, FDA Director of Policy Development & Coordination David Adams told a Coalition of Healthcare Communication meeting in New York City Oct. 28. Adams noted that "if you have a very detailed agenda as to who the speakers are going to be and the particulars of what they're going to talk about, that's a mechanism for looking at content, and, ultimately, by making a decision on whether to fund or not to fund, of controlling or influencing content." Adams' comments clarify earlier agency pronouncements on prepackaged program proposals. FDA Division of Drug Marketing, Advertising and Communications Acting Director Lucy Rose precipitated interest in the subject during a speech at a May 19 Food & Drug Law Institute conference. Rose stated that "detailed proposals are inconsistent with our draft policy statement" ("The Pink Sheet" May 31, T&G-10) and suggested that firms refrain from sponsoring such programs until a policy is developed. Rose's comments were interpreted as referring to details of logistics, implementation and budgeting. Adams told the Oct. 28 meeting "that was not the intention of [Rose's] statement. The agency is certainly not concerned about the kind of information provided in a proposal as to logistics or funding, or things of that sort. I think it's regrettable that there has been some misunderstanding. I'm hopeful that we can clear that up really soon in writing or through some statements in some upcoming programs." Adams said FDA continues to hope to finish its CME policy statement "by the end of the year."
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