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Executive Summary

FDA may be ready to make a major concession in its proposed control of continuing medical education programs by enlisting an outside organization to act as a surrogate for the agency in the monitoring and evaluation of symposia. At a Dec. 11 session of the Food & Drug Law Institute annual meeting, FDA Division of Drug Marketing, Advertising & Communications Acting Director Ann Witt said that FDA is "trying to figure out whether there isn't some way to permit some outside organizations to consider the educational value of particular programs and not require FDA to look at them all." Similarly, at a Dec. 9 press conference at the American Society of Hospital Pharmacists' mid-year meeting in New Orleans, FDA Deputy Commissioner for External Affairs Carol Scheman noted that the agency has been meeting frequently with the American Medical Association and the Accreditation Council for Continuing Medical Education to see how their different approaches to symposia can be coordinated. The separate statements by Witt and Scheman indicate that FDA is making a concerted effort to work out an accommodation with the medical community to permit continued industry support of continuing medical education. ACCME has been asking FDA to accept its guidelines as the controlling standard over CME meetings. While FDA does not appear ready to go that far, the agency does appear willing to delegate to an outside group some of the authority for judging whether programs are acceptably non-promotional. If it chooses to use outside groups to okay CME programs, FDA is likely to designate one organization to handle the evaluations. That group would have to be a nationally recognized and respected organization. FDA officials recently have been stressing that the agency is looking for a way to extricate itself from the direct regulation of CME. The agency recognizes the extent of CME and apparently feels the pressure of negative comments from other levels in the Administration to the initial CME proposal ("The Pink Sheet" Dec. 9, p. 3). Scheman described the current discussions on CME as an effort to identify ways in which the different programs for controlling CME can be made congruent. She acknowledged that the control of off-label information is "a difficult issue" but reported that "in the last week or so" the agency has begun to make progress in addressing it. FDA recently has appointed a task force under Deputy Commissioner Michael Taylor to develop a policy statement on oncology off-label uses. A statement from that group may be forthcoming soon after the new year. The off-label use issue is closely related to FDA's attempt to control seminar presentations. At FDLI, Witt's comments on CME came in response to a question on whether FDA will be changing its policies as stated in its draft concept paper on industry-sponsored CME programs, especially the one stating that "symposia should ordinarily not be repeated." Witt said the issue of repeating CME programs "has been the subject of a great deal of comment and most of it has been to the effect that we really should not try to restrict repetition of programs because many of them are good education and deserve to be repeated." FDA's "one only" rule was discussed at a Nov. 21 meeting of the Pharmaceutical Advertising Council ("The Pink Sheet" Nov. 25, p. 9). When asked whether FDA plans to revise the symposia concept paper in response to concerns that have been raised by the Administration, ACCME and AMA, Witt replied: "I don't know anything about White House concerns." FDA said that it is not backing off from its stated symposia policies in response to criticism, but rather that it is looking at whether it needs to be involved in monitoring CME continually or occasionally. Monitoring by parties directly involved in CME programs would be beneficial since fewer FDA resources would be used, the agency noted. Witt added that "the AMA and ACCME concerns that the policy is too restrictive have been considered." She acknowledged that the agency is "working with both those groups in an effort to see if there is some mechanism by which the ACCME can beef up its own enforcement activities, so that FDA doesn't have to spend a great deal of time worrying about promotion in accredited activities." ACCME has expressed to FDA an interest in becoming more active in evaluating whether CME programs adhere to ACCME's guidelines for commercial support of CME. Currently, ACCME asks CME providers to come in and describe their programs. FDA Chief Counsel Margaret Jane Porter stated at the FDLI meeting that "certain standards" in the concept paper "may not yet be sufficiently clear." She said that "while FDA will not avoid enforcement actions in the interim if it identifies clear violations, it is fully mindful that premature enforcement in areas of unsettled policy may be counterproductive." FDA's Center for Biologics Evaluation & Research is also re- evaluating its recent position on promotional activities. The biologics group at FDA is reviewing its requirement that promotional materials for biological products be precleared with the agency. At the FDLI meeting, CBER Director of Product Certification Sharon Risso said that the preclearance requirement "is being reviewed by our center in attempts to evaluate its utility and its feasibility." Risso pointed out the difficult logistics of the increased new product traffic that CBER anticipates. The agency has to ask itself, Risso said, "Is it feasible to continue preclearance when we have and are expecting an even greater number of new products to hit our doorstep?" The biologics center will also consider how "preclearance and the two other restrictions we have actually affect industry and their operations." The other two requirements are that the manufacturer be listed in promotions and labeling, and that the manufacturer is ultimately responsible for promotional labeling. Bristol-Myers Squibb Assistant Counsel David Bonk stated: "There is every reason to regulate biologic promotion in the same manner as drug promotion." He continued: "It may have been sensible to establish separate treatment for the earlier biological products: blood and traditional vaccines. Biotechnology has blurred the regulatory distinction between drugs and biotech products."

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