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Executive Summary

OFF-LABEL USE OF PROVERA, DIDRONEL FOR OSTEOPOROSIS referenced most often in comments sent to FDA in response to the agency's request for data on important off-label uses of approved pharmaceuticals. FDA sent requests to 10 professional societies in May soliciting information on off-label uses ("The Pink Sheet" May 10, T&G-2). The agency has received 41 responses, including submissions from physicians and individuals as well as professional organizations. The off-label use most commonly cited was medroxyprogesterone (Upjohn's Provera) with estrogen for the prevention of osteoporosis in post-menopausal women, followed by Didronel (etidronate) for the treatment and prevention of osteoporosis. Provera is indicated for secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance. Submissions cite two New England Journal of Medicine articles on the use of oral etidronate for osteoporosis. Didronel tablets are marketed by Procter & Gamble Pharmaceuticals for symptomatic Paget's disease and for heterotopic ossification. FDA is planning to publish a Federal Register notice announcing the availability of the information submitted to the agency on off-label uses. The notice is currently awaiting clearance at the agency. Although the American Medical Association did not submit a written response to FDA's request, the organization met with FDA and agreed to forward to the agency sections of quarterly updates of its publication Drug Evaluation that contain off-label use information. Apparently, although some off-label use information in oncology applications was submitted, some oncology organizations were reluctant to submit information out of a concern that if some indications were identified as more important or more common, there would be a rationale to refuse reimbursement of other off- label uses. At the Food and Drug Law Institute's Dec. 14-15 educational conference in Washington D.C., FDA Deputy Commissioner for Policy David Adams noted that the agency will now "assess the information [submitted] to determine which off-label uses appear most promising for inclusion in product labeling." At the FDLI meeting, Adams also discussed FDA guidance in the areas of industry-supported scientific and continuing medical educational activities, and enduring scientific and educational materials. FDA was to publish a final policy statement on the former by the end of the year. However, a citizen's petition protesting the CME policy on the grounds that it would disrupt the "free flow of information regarding off-label uses of FDA-approved drugs and medical devices" ("The Pink Sheet" Nov. 8, T&G-9) is delaying final publication. "While the issues [in the petition] are not new, they are important," Adams commented at the FDLI meeting. "The agency will not be publishing a final policy statement...until it responds to the request in the petition that the agency change the draft policy statement as it was published last November," he concluded. In addition, Adams predicted that a draft policy on enduring scientific and educational materials would not be published until the final CME policy is issued. The guidance on enduring materials is to "provide guidance on, among other things, the safe harbor for submissions of original research in peer-reviewed journals [and] FDA's concerns related to sole-sponsored supplements," Adams noted.

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