The political dynamics of citizenship, innovation, and regulation in pharmaceutical governance

Abstract

This article provides an analysis of the regulation of innovative pharmaceuticals in the EU and the United States, particularly fast-track or accelerated review and marketing approval mechanisms therein since 1995. Specifically, consideration is given to whether that regulation is best characterized by “disease politics”, “pluralist” pressure politics, “corporatist” partnership with industry, “clientele pluralism” leading to industrial capture of the regulatory state, or “arms-length” separation of interests and values. It is argued that the predominant driving forces that explain the nature and implementation of these mechanisms are the pharmaceutical industry, the legislature and the Executive in the United States, and the industry and the Commission in the EU, rather than patient pressure. Furthermore, evidence regarding the regulation of case-study drugs suggests that the generation of these regulatory reforms by industry and deregulatory political agendas does not coincide with patients' interests. The EU and US drug regulatory systems seem to be converging in these respects.