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Executive Summary

GENERIC DRUG COMPANY EXECS TO MEET WITH FDA TOPSIDERS ON OCT. 21 as part of the agency's effort to provide executives from the regulated industry with a better understanding of drug approval process at the working level. The generic drug industry meeting will be between about two dozen representatives of GPIA (Generic Pharmaceutical Industry Association) companies and 20 FDAers. It is one of a series of meetings that FDA Commissioner Young is urging the agency managers to have with their counterparts in the private sector. In February, FDA held a similar meeting with CEOs from the brandname drug industry. No formal agenda has been set for the Oct. 21 meeting. From FDA's perspective, the function of the meeting is to provide company heads an opportunity to meet agency topsiders and to learn about FDA's regulatory review process. For example, directors from some of the divisions under New Drug Evaluation are expected to attend the meeting. Those divisions, which usually handle full NDAs, are sometimes consulted during the course of ANDA review. FDA officials expected to attend the meeting include: Deputy Commissioner John Norris; Office of Drug Research and Review Director Robert Temple, MD; Office of Drug Standards Director Peter Rheinstein, MD, and/or Deputy Director James Morrison; and Generic Drug Division Director Marvin Seife, MD. FDA management from the Division of Bioequivalence, the Office of Compliance, and the Office of Epidemiology and Biostatistics are also scheduled to attend. GPIA members scheduled to attend the meeting include the heads of Barr, Biocraft, Bolar, Chelsea, Danbury, Geneva Generics, Lemmon, Mylan, Par and Zenith.

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