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Executive Summary

The Pharmaceutical Manufacturers Association is pressing FDA to clarify its definition of acceptable "scientific interchange" through some form of official statement -- beyond the current de facto podium regulation through speeches and journal articles. PMA is in the unusual position of seeking regulation because of the combined effect of FDA's forceful advertising crackdown and Commissioner Kessler's warnings about promotional activities in the guise of seminars. The industry has taken both the actions and warnings to heart and is becoming reluctant to fund new continuing medical education ventures. A dozen members of PMA's board of directors discussed scientific interchange and symposia guidelines and FDA's process for developing those guidelines during an Aug. 15 meeting with Kessler and other FDA officials at the agency's downtown D.C. offices. The meeting was requested by PMA to address FDA's regulation of drug promotions, in general, and scientific activities, in particular (see box next page for a list of the PMA representatives at the Aug. 15 meeting). In a June 17 letter requesting the meeting, PMA President Mossinghoff urged Kessler "to establish a process for interested parties to have meaningful dialogue with FDA staff before agency policy statements are finalized for publication." Kessler noted at a June Drug Information Association meeting that before the agency adopts a final policy on scientific activities, it will "seek the advice of industry, consumers and the medical community." Contending that there is a lack of "agreed-upon terminology" between industry and FDA, as well as among companies, Mossinghoff said that "development of a clear policy statement on scientific interchange versus promotion is contingent on developing clearer definitions of independence, disclosure, fair balance, etc." The two major issues between FDA and PMA are (1) whether the existing voluntary guidelines (developed by the American Medical Association and the Accreditation Council of Continuing Medical Education) will suffice to set the rules for symposia and (2) if FDA decides to set separate guidelines, what type of process will the agency follow. PMA has been pointing out the ACCME guidelines to FDA during recent meetings with agency officials. For example, in a June 5 letter to FDA Division of Marketing, Advertising and Communications Acting Director Ann Witt, PMA VP Health Care Systems Karen Williams referred to the ACCME guidelines. "We worked jointly to update and strengthen these guidelines in order to assure the independence of program content and the disclosure of company support," Williams said. The ACCME guidelines dovetail in some respects with FDA's recent pronouncements about symposia rules. The two most recent public explanations of FDA's current symposia position are statements by Commissioner Kessler in a July journal article and at the DIA meeting in June. In the article, the commissioner said that participants in educational meetings "must insist" on being able to discuss the merits of competing products or to present opposing views ("The Pink Sheet" July 22, p. 16). Kessler's statement on independence differs only slightly in emphasis from one in the ACCME guidelines: "Presentations must give a balanced view of all therapeutic options." The ACCME guidelines add: "Use of generic names will contribute to this impartiality. If trade names are used, those of several companies should be used rather than only that of a single sponsoring company." Physicians participating in symposia should also "insist" that the source of sponsorship be disclosed and the extent to which a commercial sponsor has control over the seminar's material, Kessler said in the article. The ACCME guidance states that "commercial support must be acknowledged in printed announcements and brochures; however, reference must not be made to specific products." ACCME's policy says that "in an activity offered by an accredited sponsor it is not permissible to provide for travel, lodging, honoraria, or personal expenses for attendees." AMA also has been fleshing out its ethical guidelines issued in December of last year. A recent addendum to those guidelines more directly addresses payment to physicians for presentations at seminars and acceptable levels of entertaining at medical meetings (see related story, p. 6). AMA is also reportedly working on a concept of acting as a clearinghouse for industry funding of continuing medical education -- collecting money from a number of drug companies and then disbursing it to sponsors of seminars. One PMA board member reportedly mentioned the concept at the meeting with PMA. At the Aug. 15 meeting, PMA representatives requested that FDA give industry an opportunity to contribute to the development of the agency's evolving policies on symposia, direct-to-consumer advertising of prescription drugs, and on nontraditional media such as video news releases. Kessler is understood to have asked the association what procedure for commenting it would prefer: a public hearing; the notice-and-comment approach of a Federal Register rule; or monthly meetings between the agency and representatives of industry. PMA VP Williams has been lobbying FDA staff for a version of the industry-agency exchange which took place between PMA and the Health Care Financing Administration in the earliest stages of developing the Medicaid rebate contracts earlier this year. That form of cooperation, however, may be better suited to contract development than to the development of promotional rules which may call for a more open and public process. FDA would be taking an unusual political risk to work privately with the industry on a promotional regulatory policy. In her June 5 letter to FDA, Williams reiterated PMA's "deepest concern" that the creation of "FDA policy be accomplished through an open process which affords industry and other affected parties adequate opportunity to express their views and provide input and reactions to your proposals." She offered the names of the HCFA officials with whom PMA worked on the rebate contracts as references for FDA to check. "I'm sure," Williams said, "they would agree that the process was less burdensome than the alternative, and produced a more effective result than could otherwise have been achieved." During a May meeting between PMA marketing section members and FDA's Witt, the issue of whether FDA's policies would be more effective if they were promulgated in the form of guidelines or regulations was discussed. "There are advantages and drawbacks with either approach, depending on the breadth of the topic and the degree of specificity and clarity which may be possible in the policy itself," Williams' letter says. She suggested that Witt "would be in a better position to decide on the proper vehicle after you have received feedback on whether or not your proposed policy is readily understandable and clear in the context of more or less diverse practices within the industry." FDA staff continue to work on a scientific exchange policy as one of its top priorities for this calendar year. The agency's Division of Marketing, Advertising and Communications is said to be devoting the majority of its manpower to developing a draft policy on scientific educational programs. The division is striving to meet Kessler's publicly stated goal of having a guidance on scientific activities "in place by the end of the year -- this year." FDA's focus on regulation of scientific educational programs places the development of policies on direct-to-consumer advertising and video news releases on the back burner. The policy on scientific activities may mention FDA's position on press releases. FDA has been moving toward a more rigorous position on press releases, viewing any releases which mention a company's drug in any context to be labeling that therefore must comply with FDA regs. The agency is considering issuing a letter to companies that would serve as a reminder that press releases that refer to specific drug products are considered labeling and should be submitted to FDA for preclearance. FDA said that it has never insisted that all such press releases be submitted to the agency. However, FDA believes that industry is aware that such releases are considered by the agency to be labeling. FDA recently sent a letter to drug marketers declaring that video news releases that mention the use of an identifiable drug must be provided to FDA for review before they are disseminated ("The Pink Sheet" July 29, In Brief). During the meeting, PMA members reiterated the general concern within industry about the growing public perception that most drug advertising and promotional campaigns violate FDA regulations. The PMA representatives maintained that only a small proportion of industry promotions can be questioned and that the whole industry is being tarred unfairly. Reportedly, Kessler said he understands industry's concern about its reputation in the advertising area, but the commissioner emphasized that FDA will not allow violative drug promotions. The PMA contingent continues to express fears that the negative image from the ad actions will have a spillover effect on drug approvals. However, FDA's record to date this year does not indicate that. FDA has approved 12 new molecular entities. At this juncture last year, the agency had cleared nine NMEs and finished the year with 23 approvals ("The Pink Sheet" Aug. 12, p. 8). FDA is not focusing exclusively on breakthrough and orphan products either. The agency is bringing out a number of new competitors in already well-defined market segments. For example, three ACE inhibitors were okayed this year: Hoechst's Altace, Bristol-Myers Squibb's Monopril and Ciba-Geigy's Lotensin. PMA DIRECTORS MEET WITH FDA COM. KESSLER Pharmaceutical Manufacturers Association contingent attending Aug. 15 meeting on drug promotion with FDA Commissioner Kessler and other agency officials. Irwin Lerner, president & CEO, Hoffmann-La Roche; Digby Barrios, president & CEO, Boehringer Ingelheim; Gilbert Cloyd, Div. manager, Norwich Eaton Pharmaceuticals; Theodore Cooper, chairman & CEO, Upjohn; Gavin Herbert, chairman & CEO, Allergan; Hubert Huckel, chairman, Hoechst-Roussel Pharmaceuticals; Louis Mattis, chairman, president & CEO, Sterling Drug; Joseph Mollica, president & CEO, DuPont Merck Pharmaceutical; Eugene Step, exec VP & president, Pharmaceutical Div., Eli Lilly; Philip Tracy, president & CEO, Burroughs Wellcome; Douglas Watson, president, Pharmaceuticals Div., Ciba-Geigy; Robert Wilson, vice chairman, Johnson & Johnson; Daniel McIntyre, assistant to John Stafford, chairman, PMA Board of Directors, American Home Products; Kenneth Berkowitz, VP & director, Public Affairs, Hoffmann-La Roche; Robert Allnutt, exec VP, PMA; Bruce Bennan, senior VP & General Counsel, PMA (NEW LINE)Karen Williams, VP, Health Care Systems, PMA

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