The Politics of Drug Regulation

Abstract

The issue of who decides which drugs an individual may take is political. The politics of drug regulation differ from other areas in that such regulation is seldom of high political visibility, yet proposals for change receive considerable attention. Although there are substantial economic stakes in the politics of drugs, the contest is generally over the non-economic issue of whose expertise should be entrusted with the final decision. Unlike other areas of politics, the FDA has not been “captured” by the industry, nor is there a closed club of bureaucrats, drug manufacturers, and doctors controlling the process of drug regulation. Finally, drug regulatory policy changes very slowly. In order to modify this situation a group of hardworking, persistent policymakers in Congress must be convinced that public welfare requires change, academia must make the changes respectable, the administration must make them possible, industry must help, and, most importantly, a dramatic drug-related crisis must arise to motivate the system.