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Executive Summary

PMA/AMA DISCUSSIONS ON USE OF OUTSIDE PHYSICIANS IN FDA DRUG APPROVAL PROCESS are under way; the two groups met to discuss the issue on June 27. The use of outside medical expertise to speed up NDA reviews has been endorsed in concept by both FDA Com. Young and HHS Secty. Bowen. The June 27 meeting between the Pharmaceuical Mfrs. Assn. and the American Medical Assn. was the first time the idea has been discussed directly by the two groups. The two organizations reportedly discussed the possibility of physician residency or internship programs at FDA, recruitment of physicians for full-time positions, and the use of retired physicians to assist in the NDA review process. The idea of recruiting outside expertise to FDA to assist in NDA reviews first surfaced in Com. Young's Action Plan, released last July. The plan proposed a fellowship program to bring in academic scientists on a part-time basis. The plan also noted that FDA would seek to increase the use of consultants and try to recruit full-time scientists to carry out both scientific research and regulatory activities. HHS Secty. Bowen expressed interest in the use of retired MDs in the NDA review process at PMA's annual meeting in April ("The Pink Sheet" April 14, p. 12). PMA's committee to study improvements in FDA's approval process plans to meet with AMA again and then with FDA. The committee, headed by Roche's Irv Lerner, has been meeting with FDA to discuss the NDA review process since last July. FDA has also met with representatives from the Institute of Medicine to discuss that group's possible role in NDA reviews ("The Pink Sheet" Oct. 7, T&G-1).

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