Learning from Prozac: A Case Study on Reforming the FDA Drug Approval Process

Abstract

The law, focused as it is on making final determinations and settling issues one way or another, continually lags behind science, which concentrates on an evolving understanding of various phenomena through constant enhancement of current understandings of existing realities. Thus, a drug approval process, which obviously deals with scientific issues of drug development, cannot always keep pace with scientific understandings of drug development. The law is flexible and capable of accommodating new understandings, though; therefore, consideration of the scientific issues involved in drug development and approval is appropriate and ought to be undertaken as much as possible in order to develop legal answers that are as accurate as they can be at any given time.