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FDA GUIDELINES UNNECESSARY FOR ACCME-ACCREDITED SYMPOSIA, PMA MAINTAINS IN DEC. 20 COMMENTS; ALTERNATIVE GUIDES FOR NON- ACCREDITED CONFERENCES URGED

Executive Summary

The Pharmaceutical Manufacturers Association is arguing that FDA's draft guidelines on medical symposia are unnecessary given that the Accreditation Council for Continuing Medical Education (ACCME) already has its own guidelines for accrediting scientific and medical symposia. In a Dec. 20 letter to FDA on the agency's proposed CME policy, PMA suggested that FDA "rely on the ACCME for monitoring and enforcement of the current ACCME guidelines." The association maintained that "new FDA rules governing such activities are not needed at this time and would be counterproductive." The association is commenting on a policy concept paper on scientific interchange, that FDA floated in October ("The Pink Sheet" Oct. 28, p. 3). In extended comments on the FDA draft policy, PMA maintained that ACCME accreditation "should be considered adequate assurance that commercial interests will not unduly influence the content of educational and scientific programs" and "will ensure that ACCME- accredited activities are independent." The association noted that current ACCME guidelines provide that the accredited provider, not the funding company, is responsible for "content, quality and scientific integrity" of accredited programs, and that they reflect 1991 revisions supported by PMA, the American Medical Association and others prohibiting companies from paying for physician travel and lodging costs. PMA said it is prepared to work with ACCME to "enhance" enforcement of the council guidelines. Any FDA guidance on industry-sponsored educational activities, PMA said, "should not apply to ACCME-accredited activities as governed by the current ACCME guidelines." FDA is already considering the difficulties involved in enforcing the guidelines and is looking to outside professional organizations, including ACCME and the AMA, to monitor CME programs ("The Pink Sheet" Dec. 16, p. 3). However, FDA has publicly expressed concern that ACCME currently does not have the resources necessary adequately to enforce the guidelines. FDA also has said that while it is interested in finding a suitable professional organization to self-regulate symposia, the agency is not willing to water down the guidelines in response to outside pressure. PMA also recommended alternative guidelines for symposia not accredited by ACCME that would substitute disclosure and independence in place of FDA's rules to assure the objectivity of scientific interchange. The association said its recommendations "clearly establish the conditions under which company-sponsored symposia are independent" and "recognize that the responsibility for addressing objectivity, balance, and scientific rigor rests with the symposium provider . . . responsible for program topics, content, faculty and materials." Under PMA's proposal, "the identity of the company funding the symposium is to be disclosed to attendees along with the existence of any financial relationships between symposium presenters and organizers with an interest in the subject of the program, including drug companies." Furthermore, PMA recommended that sponsoring companies be permitted "to make suggestions as to program topics and speakers so long as the independent provider retains control over the selection of topics and speakers." PMA acknowledged that its accredited/non-accredited dichotomy applies only to symposia sponsored by third parties and "does not address scientific and educational activities presented by pharmaceutical companies without involvement of third-party providers." PMA suggested that "such activities would reflect a third approach to scientific exchange." In its letter to the agency, PMA argued that the draft policy is too broad in scope and "should be revised and limited to acceptable relationships between sponsors and providers of non- accredited scientific and educational symposia." In particular, the association suggested that FDA's policy should not address written publications, medically oriented television programs, educational videotapes and other media. Because the proposal's criteria "are framed in terms of symposia and similar forms of medical educational activities," PMA asserted, "many criteria in the concept paper are simply inappropriate for print and electronic media." For example, the association argued, the proposed "prohibition against independent educational programs being repeated is inconsistent with the intended use of these materials. No medical education provider would prepare a videotape knowing that the tape could be shown once." The association maintained that FDA's "proposed prohibition against repeating performances is simply misguided." PMA argued that "limiting programs to a single presentation is wasteful of limited medical education time, resources and funding." In light of "the AMA and PMA policy that drug companies should not pay for physicians to travel to attend medical educational activities," PMA asserted that "a no-repeat rule is also inefficient and unrealistic." The comments also oppose FDA's draft prohibition against all "relationships" with providers that might allow "influence over the content of the activity." PMA argued that "such a broad preclusionary policy is unnecessary and may well interfere with the availability of participants who would substantially contribute to a program being objective, balanced or scientifically rigorous." If presenters have financial relationships with the sponsor, "those relationships should be disclosed by some appropriate means," PMA recommended. The association contended that the FDA concept paper's limitation of industry's involvement to "an unrestricted grant" in educational programs "could well cause pharmaceutical companies to restrict or withhold funding of CME programs in the future." PMA opposed FDA's proposal to limit symposia topics to diseases and a variety of treatments only. The association commented that "specific disease conditions and their related symptomatology, and specific modalities of treatment, are legitimate topics for independent scientific exchange." The association reasoned that "if the independent provider presents a program that is objective and balanced, even a focused topic can be presented without deviating from legitimate regulatory goals." The comments also seek to relax the proposal's prohibitions against all company involvement in programs. "Rather than preclude drug company involvement in 'any activities' associated with the program, as the concept paper does," PMA asserted that "reasonable guidance would acknowledge that a drug company may assist the program activity but require that the provider be responsible for program content and materials." The Coalition of Healthcare Communicators in Dec. 20 comments contended that "much of the education funded by pharmaceutical companies will cease to exist if" the FDA concept paper becomes guidelines or regulations. The coalition -- a group of advertising, public relations, marketing and publication associations -- argued that "the issuance of additional guidelines from FDA now, before the impact of those from the AMA, [the American Association of Family Physicians] and ACCME have been fully assessed, are unnecessary and will result in dramatic reductions in educational programs, to the detriment of physicians and . . . patients." Executive Director Jack Angel wrote that "placing final content control in the hands of duly constituted groups of physician experts will achieve FDA's objectives" of fairness and balance without the concept paper's "unworkable and unnecessary" bias against involvement by sales, marketing and public relations personnel in scientific interchange. FDA's draft stated that involvement of company marketing personnel would signify a program's promotional intent.

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