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NDA SUPPLEMENT REVIEWS ARE TOPIC FOR DISCUSSION BETWEEN PMA AND FDA; PMA REGULATORY AFFAIRS EXECS TO PROPOSE PLAN FOR "MEDICAL" SUPPLEMENTS

Executive Summary

PMA and FDA are preparing to discuss further ways of reducing the number and size of NDA supplement reviews in the new drug evaluation process. The subject of supplemental reviews is the lead item on an agenda for an Oct. 16 meeting between FDA managers in the new drug evaluation area and a group of drug regulatory affairs execs from PMA (Pharmaceutical Manufacturers Association) member companies. The agenda for the Oct. 16 meeting calls for the directors of FDA's drug and biologic review offices, Robert Temple and Elaine Esber, to join with MS&D VP-Regulatory Affairs and Medical Administration Charles Leighton to head a two-hour discussion on NDA supplement review. The agenda describes the topic as "Review and Approval Process of Supplements Requiring Medical Review." By setting up a category of "medical supplements," the agenda item implies that there are other types of supplements which require a different type of technical review. PMA is reportedly developing a proposal on the definition and handling of medical supplements as a point-of-departure for the upcoming meeting. The PMA execs and FDA managers are meeting as part of a continuing dialogue on the NDA review process which developed out of the efforts of the PMA ad hoc committee on FDA affairs (the Lerner Committee). The Oct. 16 meeting will also address the status of clinical format guidelines and review the progress of "dialogue" meetings between industry scientists and FDAers in the Surgical/Dental and Neuropharmacological Divisions. One possible proposal for alleviating the supplemental burden on the new drug evaluation process would entail moving some non-medical supplements from the new drug review divisions to the generic drug review staff. A shift of responsibilities to the Generic Drug Division [in the office of Drug Standards] would be an attempt to make use of the relative efficiency of that group to reduce pressures on the new drug evaluation staff. The generic review staff has a very good efficiency rating, especially in the period since the enactment of the Waxman/Hatch law. Through the generic division, the agency has already cleared applications for approximately 150 post-1962 drugs. The efficient review record of the generic drug staff has drawn a great deal of attention in the drug industry. One outside lawyer, Peter Mathers (Kleinfeld, Kaplan & Becker), for example, interpreted the approval of Lederle's ANDA for leucovorin as a potential precedent for pioneer drug manufacturers to try to use the generic drug division to "free their supplements and their new dosage forms from the reviewing divisions" ("The Pink Sheet" March 10, pg. 4). The move would also take advantage of FDA's resource flexibility in the Generic Drug Division. Because of congressional support for the Waxman/Hatch law, FDA has been able to add staff to the generic review group despite the overall FDA budget restraints. Farming out the non-medical supplements would be consistent with several other approaches for improving review efficiency at FDA, such as using retired MDs to handle some parts of NDAs or contracting with academic centers. The generic drug division has also been considered for handling the chemistry review sections of NDAs. A major obstacle to moving part of the supplemental review process to the generic drug division is the potential impact, or perceived impact, such a transfer would have on ANDA reviews. The move could be attacked as an effort to slow up generic approvals instead of freeing up new drug evaluation resources for new drug reviews -- especially if PMA is viewed as one of the catalysts in the transfer of authority. The supplement load at FDA has long been identified as a target for efficiency reforms. Through the NDA rewrite regs in February 1985, the agency proposed to cut the number of supplements in the review process by reducing the filing requirements for such changes as the addition of alternate analytical methods. However, the amount of supplements filed is still substantial. According to FDA's most recent published figures, in 1984, the agency received almost 3,600 supplements. The supplemental system is further being jammed by submissions of revised labeling that are required to meet FDA format changes and by inactive ingredient listing.
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