FDA ADOPTION OF ACCME SYMPOSIA GUIDELINES, SELF-REGULATION BY INDUSTRY & MEDICAL PROFESSION URGED BY MMD's LYONS; FDA's WITT ARGUES NECESSITY OF FDA OVERSIGHT
FDA should adopt the guidelines of the Accreditation Council for Continuing Medical Education on industry-supported medical symposia in order to "avoid redundancy, confusion and intrusion," Marion Merrell Dow President Fred Lyons suggested at an Oct. 8-10 conference on industry-supported CME hosted by the American Medical Association in Chicago. "I'd like to suggest that the FDA drop its activities in developing their own guidelines and adopt the guidelines of the Accreditation Council for CME," Lyons remarked. The MMD exec asserted that ACCME "has caught and surpassed the agency's efforts over the years to adopt guidelines in this important area. It would help everyone to avoid redundancy, conflict and intrusion." Lyons suggested that FDA delay enforcing its symposia policy and allow ACCME, medicine and industry to self-regulate CME program compliance with the ACCME guidelines and AMA's guidelines on industry gifts to physicians. The latest version of the ACCME guidelines on commercial support of continuing medical education programs, which were revised in March, become effective in 1992. Lyons said that the industry and the medical profession have made "some progress" in enforcing the new guidelines, "but only the first step." He declared: "What we need is a clear cut process . . . understood by all." Lyons suggested a system where violations would be reported to the ACCME, "who . . . in turn [would] address the individual provider, sponsor and sponsoring institution [and] if necessary address the [Pharmaceutical Manufacturers Association] and let the PMA address the individual companies, as already set up." The MMD exec suggested that FDA give the self-enforcement approach "a chance to work." He added that FDA could enter the picture in the case of repeat violators. Such a process, Lyons asserted, "would permit the FDA to fulfill its statutory role in promotion without intruding on the educational area" and allow "the ACCME, medicine and industry to keep . . . the house of education in order through our own mechanisms." In order effectively to evaluate whether CME programs are in compliance, Lyons recommended that ACCME establish a mechanism for auditing CME. "We need a proactive and responsive audit process to tell how well the system is working [and] how well the standards are adhered to." He noted that "the ACCME has that responsibility," but that the group may not have the manpower for such a program. Lyons suggested that industry could provide financial assistance to ACCME for an auditing program. "If its necessary to contract with a public accounting firm or something of that nature, [then] those of us who participate in CME are in a position through some type of a fee basis to support [the process]," Lyons said. He noted that the idea of an auditing system was discussed at last year's AMA conference on CME ("The Pink Sheet" Sept. 24, 1990, p. 18). American Academy of Family Physicians VP-Educational and Scientific Affairs Daniel Ostergaard, MD, also questioned the need for FDA involvement in the regulation of medical symposia. "I am struck by the perpetually imminent FDA regulations," Ostergaard said, "and the fact that they seem to be becoming decreasingly necessary as the other two compartments [industry and medicine] seem to be getting more in shape." Responding to criticism of the agency's increased role in regulating symposia, FDA ad division Acting Director Ann Witt told the conference: "One thing that I'm afraid you're going to have to live with . . . is that FDA is in the business of regulating prescription drug promotion. We have no choice about that. That's a statutory mandate. As long as promotion continues in CME, we will continue to regulate in that area. Right now, there is a lot of it in CME." Witt expressed FDA's support for peer review and accreditation of CME programs that help establish the independence of such programs from industry sponsors. However, Witt noted, "it's our feeling that the enforcement activities of the AMA and the ACCME are not either sufficiently in place or not sufficiently rigorous to significantly and consistently reduce the introduction of marketing roles into some educational programs, and for that reason we, at this point, cannot rely exclusively on these systems of peer review or accreditation." Ciba-Geigy Pharmaceuticals Division President Douglas Watson expressed his belief that over the past year industry has made substantial progress in complying with the guidelines. "Ciba-Geigy has already demonstrated its commitment to operate within the new guidelines by cancelling or postponing major meetings and completely eliminating entire project areas to ensure compliance," he reported. "Most other pharmaceutical companies are doing the same thing."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth