FDA AND INDUSTRY/CME PROVIDER TASK FORCE ARE DEVELOPING TWO VERSIONS OF GUIDELINES FOR INDUSTRY-SUPPORTED CME: VOLUNTARY MONITORING COULD SUFFICE

FDA and the Task Force on Industry/CME Provider Collaboration are working separately and together on two versions of guidelines for drug company-supported educational activities. The projects are progressing simultaneously and both could be made available for comment during March. A third draft of the task force's guidelines will be distributed to CME accrediting groups for comments within a couple of weeks. FDA is revising its draft concept paper on scientific interchange, which was issued in October, and should have a new version out in the "next few weeks," FDA Deputy Commissioner for Policy Michael Taylor reported Feb. 26 at a Food & Drug Law Institute meeting on drug advertising and promotion. The revised concept paper will include clarifications of major issues such as repeating continuing medical education programs. The industry/CME provider task force is working on a uniform set of standards or guidelines that incorporate a number of the existing CME control proposals. At the FDLI meeting, Wyeth-Ayerst Labs VP for Medical Affairs and Medical Director Marc Deitch, MD, said that the industry/CME provider task force will try to bring together elements from the Accreditation Council for Continuing Medical Education's guidelines on industry-supported programs, concepts from FDA's October proposal, and concerns of the Pharmaceutical Manufacturers Association and other parties. FDA is represented on the task force by three liaison members and is being kept informed on the industry efforts to produce a set of voluntary guidelines. However, the agency is continuing down its own path to ensure that standards for differentiating between scientific/educational activities and promotions are established. For the last three months, FDA has been indicating a willingness to work with industry and the medical community to reach an acceptable compromise on the policing of promotions at scientific sessions. Two of the issues that the voluntary guidelines presumably will have to address are how violations will be treated and how monitoring will be handled. Taylor addressed part of that question at the FDLI meeting. He observed that FDA may permit accrediting groups for CME providers to take responsibility for monitoring industry-sponsored programs in lieu of FDA oversight. FDA wants "to see if established and recognized accreditation processes can be a mechanism for assuring that company-supported CME that is designed to be independent is in fact conducted independently," Taylor said. "If an independent CME program is adequately monitored by an appropriate accrediting body, it might be possible for FDA to focus its monitoring and enforcement activities elsewhere." The FDA official noted that "we are discussing these ideas with ACCME and representatives of other interested groups." He added: "I am hopeful we can arrive at a basis for according much of the accredited CME in this country a wide berth as far as regulatory scrutiny is considered." FDA Division of Drug Marketing, Advertising & Communications Director Ann Witt first disclosed this approach at FDLI's annual meeting late last year ("The Pink Sheet" Dec. 16, p. 3). Witt told a National Health Lawyers Association meeting Feb. 28 that until it publishes its final policy, FDA only will take actions against firms for "egregious" symposia promotions. FDA intends to broaden the scientific interchange policy to apply to a wide range of products. FDA Policy Development and Coordination Staff Director David Adams pointed out that the final policy on industry-supported educational programs will "apply to all therapeutic products," including biologics and medical devices. Emphasizing the changes that the agency is making in the original proposal, Adams noted that with regard to repeat sessions of symposia, FDA is "not contemplating a blanket prohibition on repeat performances. What we'll probably end up with is...a position of having to look at these decisions on repeat performances on a case by case basis." The agency also is going to try to place the focus of the guidelines on the marketer, Adams noted. "One of the things we're going to have to make clear is that the policy objective is to regulate the conduct of the supporting company and its agents," Adams said. FDA is not trying to "regulate the behavior of the providers who put on the programs, nor to regulate the behavior of the speakers who have not appeared on behalf of a company," Adams maintained. FDA "will make clear that the policy applies only to activities related to products [in which] the supporter has a marketing interest," Adams said. "If the supporter pays for a program that does not relate to its products, there should be no labeling or advertising issue." Another issue that FDA wants to clarify, Taylor said, is "that if a program is established as, and remains, independent of sponsor control, the supporting company will not be held responsible for its content, even if the independently selected speakers turn out to make unbalanced or even biased presentations." As outlined in the draft concept paper, a written agreement between the company and the provider that the program will be an independent, nonpromotional activity should provide the company protection from liability, FDA's Taylor suggested. Adams noted that the revised concept paper will clarify "what should go into the terms of the written agreement." As part of the agency's recent effort to tone down the reaction of industry and the medical community to the scientific interchange policy, FDA drug advertising division staffer David Banks recently indicated that FDA will try to limit the liability of firms that make good faith efforts in sponsoring CME ("The Pink Sheet" Feb. 10, T&G-11). A number of industry representatives at the FDLI session described the impact of the October concept paper on symposia. The issues addressed in the concept paper were referred to as the "39 points of darkness" by Hoffmann-La Roche Public Affairs VP Kenneth Berkowitz. "The best thing that could happen," he declared, "is that FDA removes itself from the whole area of CME provided that independence remains the key criteria." Berkowitz added that "the current ACCME guidelines lay out appropriate parameters concerning CME and should be supported by the agency as they are currently supported by industry and the medical community." The Roche exec expressed concern that the industry effort to come to an agreement with FDA might make voluntary guidelines unacceptable. Berkowitz expressed concern that "we don't end up with changed ACCME guidelines that adopt all of the objectionable concerns we have in the FDA concept paper." To dramatize the restraining effect of the scientific interchange policy, Johnson & Johnson Associate General Counsel Peter Bewley provided "theoretical advice" on how industry should operate if FDA does not make significant changes in its concept paper policy. Discussing symposia held under the auspices of an academic group with corporate funding, Bewley warned that "in the current environment, since the FDA may hold us responsible for what those institutional suppliers provide, we ought to think hard about being involved with them at all." Also, Bewley cautioned that "we need to be very, very careful about the kinds of symposia that we contract for with commercial suppliers. The agency doesn't like commercial suppliers; it's very clear from the concept paper." He stated: "If we're going to use commercial suppliers for continuing medical education, we ought to limit those symposia to approved labeling." Bewley said that companies should not disseminate symposia videotapes and audiotapes. Firms "should not support those kinds of activities," he stated. "If we do support them, then we should edit them to assure that the only information that is conveyed in those kinds of materials is information consistent with labeling." The J&J attorney recommended that companies should not publish papers that are presented at a symposium in one document, like a journal supplement. He advised firms to "limit that kind of supplement to approved uses of approved products." Providing a general piece of advice, Bewley said that "we subject ourselves to an incredible regulatory risk if we do anything outside the labeling with new and important scientific information in the [CME] arena today, so don't do it." Bewley added: "In light of the enforcement possibilities arrayed against you, err on the side of safety and conservatism." J&J has been visible during the recent round of promotional inquiries. The company reportedly has been the subject of a Justice Department investigation into promotions of Retin-A for the unapproved use of preventing photoaging ("The Pink Sheet" June 17, 1991, p. 7). J&J sponsored a press conference in January 1988 at which researchers discussed the results of a photoaging study.