FDA CME POLICY NO LONGER LISTS CRITERIA FOR ACCREDITING GROUPS TO WHICH AGENCY WOULD DEFER; CONTINUING MEDICAL EDUCATION DRAFT POLICY PUBLISHED NOV. 27

FDA is no longer attempting to define "major accrediting organizations" to which it would be willing to defer in its "Draft Policy Statement on Industry-Supported Scientific and Educational Activities," published in the Nov. 27 Federal Register. "The agency, in an exercise of its administrative discretion, will seek to rely to the extent possible on major accrediting organizations to monitor company-supported educational activities conducted by their accredited providers and ensure that such activities are independent and nonpromotional," the draft policy states. A previous draft of the policy, dated May 5, set out its criteria for accrediting organizations to act as quasi-surrogates for regulation. FDA listed organizational characteristics expected of such groups as well as specific policies and procedures they should follow. The agency first indicated that it would seek to rely on outside accrediting bodies in December 1991. The agency came to that conclusion after receiving over 200 comments on its first draft CME policy, released in October 1991 ("The Pink Sheet" Oct. 28, 1991, p. 3). The agency began working with the Accreditation Council for Continuing Medical Education at that time, and ACCME eventually tightened its standards of accreditation to provide the model used in the May 5 draft ("The Pink Sheet" May 4, p. 5). FDA has indicated a willingness to work with accrediting groups other than ACCME. In October, FDA Policy Development and Coordination Staff Acting Director David Adams invited CME groups to "work with the agency to agree on goals and demonstrate a capacity to ensure independent and nonpromotional programs" ("The Pink Sheet" Oct. 19, p. 6). The Nov. 27 draft policy is otherwise substantially the same as the May 5 draft. FDA is still emphasizing written agreements between industry sponsors and CME providers as a means to "ensure that their activities will not be subject to regulation" ("The Pink Sheet" June 15, p. 10). One interesting refinement to the May proposal is a statement on unapproved uses that FDA wants to be part of written agreements between sponsors and providers. "The provider agrees that if unapproved (unlabeled) uses are discussed, the provider will require that presenters disclose that the product is not approved in the U.S. for the use under discussion," the final draft states. The Nov. 27 draft also clarifies that "individuals who are involved in promotion of a company's products may not function in the role of independent provider [of a CME program], but could be selected by an independent provider to function as a speaker or moderator." Given the lack of substantial alterations to the May 5 draft, the delay in publication of the final version appears largely to be the result of a dilatory review at the departmental level as well as sensitivity to continued industry and CME provider resistance to the need for such a policy to exist. Noting that earlier drafts of the CME policy "sparked considerable debate," FDA said it "recognizes that the delicate balance reflected in this draft between the need for industry-supported scientific and educational activities and the need to regulate industry labeling and advertising will not end that debate." FDA "thus invites comments with regard to all issues raised in this policy statement. These comments may include suggestions of possible alternative approaches (e.g., whether companies should be allowed greater influence or control over educational activities, whether the agency should expend resources in oversight of such activities, whether repeat performances should be subjected to different scrutiny, whether or not companies should be held strictly liable for misleading content in such activities or have a duty to correct misinformation that poses a significant risk to public health)." The deadline for comment is 60 days after publication. After assessing the comments, the agency will publish a final policy statement.