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Executive Summary

FDA GUIDE ON COMPANY-SPONSORED DRUG EDUCATION/PROMOTION programs could be ready in the next two weeks. A draft version of the informal guideline on what the agency considers acceptable bounds for drug company-sponsored educational programs, symposia and seminars is on the desk of FDA Advertising and Labeling Division Director Ken Feather. Feather told an April 7 symposium on company-sponsored medical education and public relations in New York City that FDA "might be issuing some kind of document" that "will not be official guidelines" but "one of our informal kind of thinking documents to let people react to and see where we might be going." The agency previously has issued some documents which have outlined FDA thinking on the subject. The symposium was organized by the Physicians World Communications Group. In a recent speech to a Pharmaceutical Manufacturers Association "Marketing Session," the FDAer indicated broadly what the agency considers appropriate company involvement in sponsoring continuing medical education forums or promotional programs. Feather told the PMA group: "FDA has always recommended that seminars and symposia be held under the auspices of a university, a medical school or professional association with that body, through an editorial board, having responsibility for selecting speakers and, perhaps, topics to be discussed." He noted that the school or association's editorial board "should also be responsible for editing and disseminating written materials based on the seminar." The "sponsoring firm should have little or no influence in this process," Feather emphasized, adding: "We recognize that even this does not absolutely insure that a seminar will be unbiased. As good science, though, it certainly goes a long way in that direction." Ex-FDAer and now Washington, D.C. attorney William Vodra (Arnold & Porter) called Feather's outline an ideal and not the reality of how the agency views these types of programs. He offered the symposium "a few safeguards" on how companies in practice can avoid running afoul of FDA in their sponsorship efforts. "I don't think the FDA guidelines to date have been terribly helpful in terms of their articulation, especially in the preapproval mode," Vodra maintained, adding: "The FDA practice is far more useful in terms of explaining what the FDA is looking at. And FDA in practice has divided the world in to two parts: there are promotional activities and there are educational activities." If a company-sponsored program is educational, "they put it on one pile and forget about it," Vodra maintained. However, "if it's promotional then they are going to start scrutinizing and if it then runs afoul, then FDA will take regulatory action." According to his analysis of FDA actions to date, the agency distinguishes between promotional and educational programs by looking at six factors: "content of the material; the context; the audience (both primary and ultimate); the medium of the program; its rationale or justification; and the sponsor's actual intent." The safeguards, Vodra said, include trying to "build in, whenever you can, free and open presentations and discussions; that is, allow feedback, allow interaction. That may be harder with written materials," he noted, suggesting that "in that case, you may want to have some sort of independent reactors to papers." In addition, Vodra said: "Have some sort of peer review process for papers. And what that entails may be quite different in this context than is normal for [professional] journals. Journals usually ask for review of whether it makes sense but not the underlying data. Here you may want to have some further presentation of underlying data," Vodra suggested. "And finally," he cautioned, "avoid blatantly promotional activities."

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