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.

Keywords:

• drug regulation
• FDA: EMA
• accelerated approval

Acknowledgements

Thanks to regulators, patient/consumer organizations, industry and others who gave up time to be interviewed and/or help with locating documentary sources, and to the UK Economic and Social Research Council for funding the research.

Notes

1. This article is not directly concerned with regulatory processes involving cost-effectiveness as these are outside the responsibilities of the FDA and EMEA.

2. Interview with (first) former member of EU's regulatory Committee for Proprietary Medicinal Products (CPMP).

3. Interview with senior FDA medical reviewing officer.

4. Interviews with Commission official at DG Enterprise, and (first) former member of CPMP.

5. Interview with Commission official at DG Enterprise.

6. Interviews with former member of CPMP, Commission official at DG Enterprise, senior FDA scientist and manager and another senior FDA scientist.

7. Interview with (second) former member of CPMP.

8. Interviews with four (second to fifth) former members of CPMP.