Divergent Paths to Drug Regulation in the United States and the United Kingdom

Abstract

Significant differences in the availability of new medicines in the United States and the United Kingdom became apparent in the 1970s. This article examines the history of drug regulation in the two countries and argues that the divergence was the result of distinctive regulatory approaches that emerged simultaneously throughout the twentieth century. The British approach was based largely on informal, nonstatutory controls, while the American approach relied heavily on centralized regulatory controls. The article argues that the nature of business-government relations has played a significant role in the divergence. The impact of these divergent approaches is apparent in the contemporary regulatory framework, especially with respect to determining the effectiveness of new drugs.