Progress in New Drug Regulation

Abstract

Since the enactment of the Drug Amendments of 1962, there has been no progress in reform of new drug regulation for three reasons. The recommendations for reform have come from outside FDA, and thus have had no leverage or clout. Congress has no interest in reforming drug regulation. The FDA bureaucracy has no incentive to reform the system. Progress in new drug regulation will therefore be extremely difficult in the future and may not be achievable.