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Executive Summary

FDA CME POLICY ADOPTION WOULD STEM "DECLINE IN COMMERCIAL SUPPORT" of continuing medical education activities, Pharmaceutical Manufacturers Association President Gerald Mossinghoff told the agency in a Feb. 24 letter responding to FDA's "Draft Policy Statement on Industry-Supported Scientific and Educational Activities." PMA hopes "that this proposed document, with modifications, will be formally adopted by FDA in the near future," Mossinghoff wrote. "We remain concerned about the decline in commercial support which appears to have resulted from the original concept paper." "A final FDA policy statement, combined with [the Accreditation Council for Continuing Medical Education] Standards and reliance on their enforcement mechanism, should achieve our mutual goal of ensuring that valuable and unbiased educational activities will continue to be made available to practitioners for the benefit of their patients," Mossinghoff said. In the meantime, "industry would like to be advised on whether it can rely on this draft policy statement as guidance on FDA's position until a final version is published." In its specific comments on the proposed policy, PMA focused mainly on "ambiguities" in the language that could be read to limit sponsors' roles in CME more greatly than the association believes was intended. For example, PMA believes that the section on "control of content," as currently written, "may have an unintended and detrimental effect on the release of information regarding new products." The association suggested that "a clarifying statement be added such that the sponsoring company may provide information as appropriate regarding its products, particularly new products for which there may be few if any other sources for such information." The draft policy statement was published Nov. 27 ("The Pink Sheet" Nov. 30, 1992, p. 13). FDA's initial proposal in the CME arena, a "draft concept paper" first floated in October 1991, drew widespread opposition. The revised draft, under which the agency would rely largely on outside accreditation organizations, appears to have won the support of most parties. Merck, for example, said in Feb. 17 comments that "it is particularly pleasing to note that the draft policy reflects an approach to scientific and educational activities that differs in many significant respects from the policy set forth in the 'concept paper'." Of "particular importance to Merck is the fact that the breadth of the original concept paper has been narrowed so that the proposed policy covers only company-sponsored scientific and educational events." In comments on the "concept paper," Merck had called for the agency to exclude publications from the policy statement ("The Pink Sheet" March 9, 1992, p. 5). While publications are not addressed by the revised proposal, FDA still intends to issue a policy covering the topic (see following T&G). While Merck was pleased with many of the changes adopted by FDA, "the company was disappointed that FDA did not modify the concept paper to include a middle ground between activities subject to regulation and those within the safe harbor." Merck believes sponsors should be allowed "greater control in exchange for compliance with enhanced standards regarding content." Programs that do not meet FDA's criteria for independence should be able to avoid regulation as promotions "provided the drug manufacturer fulfills its responsibility of ensuring scientific rigor, objectivity and balance," the company maintained. One of the few comments generally opposing the draft policy was submitted by the Coalition of Healthcare Communicators. "It has been the coalition's continuing concern that any further FDA action to restrict the flow of information on new technologies and therapeutics will have a high potential for deleterious effects on patient care," CHC said. The group urged FDA to continue "its de facto moratorium on any actions based on this policy to permit the various professional and other private-sector initiatives already enacted to take hold."

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