Pharmaceutical Manufacturers Association

Executive Summary

Asks FDA Commissioner Kessler in July 31 letter to "withdraw" the Center for Drug Evaluation and Research's proposed policy to allow agency approval of indications over sponsors' objections. PMA contended that the policy, set forth in a Jan. 15 memo and expected to be published this month in the Federal Register ("The Pink Sheet" Aug. 3, p. 7), may discourage sponsors from pursuing early development of what they consider minor indications for fear that the agency will approve the minor indications and "relegate" major indications to efficacy supplements, which are perceived as being approved more slowly.