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Executive Summary

FDA "deference" to continuing medical education providers is not a "guarantee of safe harbor" from agency regulation of industry-sponsored scientific exchange, FDA Policy Development and Coordination Staff Acting Director David Adams told the third national conference on CME in Chicago Oct. 8. In discussing FDA's evolving policy on regulation of CME, Adams noted that the agency has signaled its willingness to defer to outside accrediting organizations that meet standards of independence, disclosure and scientific rigor. However, Adams cautioned, "the concept of deference must not be confused with the concept of safe harbor." " Even a capable and aggressive accrediting organization cannot ensure that a regulated company and an eager provider will never manage to turn an ostensibly educational activity into an illegal drug advertisement," Adams said. "Agency reliance and deference, thus, cannot be absolute because the agency cannot abdicate its statutory obligation to regulate the promotional activities of companies marketing products within its jurisdiction," Adams said. The FDAer added: "Although the agency generally focuses its regulatory attention on the supporting companies rather than on the providers of the activities, one must not forget that a provider that chooses to act as a promotional agent for a supporting company has potential liability, regardless of accredited status." Although accreditation "can play an important role in ensuring that...standards are met, agency deference should not be viewed as a requirement for safe harbor," Adams continued. The only "safe harbor" is "for activities that meet the substantive requirements of the agency's long-standing policy" that programs be independent and truly educational, regardless of whether they are accredited. "Thus, deference is not a shield from liability and should not be viewed as a safe harbor," Adams said. "The deference proposed by the agency approach that we hope will support the growing efforts of the health care community to exercise greater oversight with regard to industry-supported activities. It is an approach that we hope will lessen FDA's involvement, or even remove the agency totally, from this oversight function." Adams' remarks apparently are intended to correct a misperception of FDA's new direction with the CME policy. The agency does not want too much significance put on the lack of a final, written policy on seminars. FDA is trying to reaffirm its regulatory interest in seminars and symposia. The agency first indicated that it would be willing to use outside organizations to accredit CME programs through public statements made in December. At that time, FDA initiated discussions with the Accreditation Council for Continuing Medical Education. A May 5 revised draft of the policy included a section about FDA reliance on outside accrediting groups ("The Pink Sheet" June 15, p. 10). Adams also emphasized that FDA is willing to work with any outside group that meets its standards, not just ACCME. "Any nationally recognized accrediting organization for health care professionals is welcome to work with the agency to agree on goals and demonstrate a capacity to ensure independent and nonpromotional programs." The final CME policy statement is unlikely to spell out a formal procedure for FDA to certify accrediting groups. The agency instead will make decisions on a case-by-case basis when a particular group has demonstrated that it meets the standards that will be listed in the policy. The section on agency reliance on outside accrediting groups is likely to be less detailed than that included in the May 5 draft, FDA said.

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