Interpellative sociology of pharmaceuticals: problems and challenges for innovation and regulation in the 21st century

Abraham, John and Davis, Courtney (2007) Interpellative sociology of pharmaceuticals: problems and challenges for innovation and regulation in the 21st century. Technology Analysis and Strategic Management, 19 (3). pp. 387-402. ISSN 0953-7325

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Abstract

This paper develops a framework with which to interrogate how well pharmaceutical innovation and regulation are performing to produce drugs that improve health. That framework comprises five key dimensions: therapeutic advance of drug product innovations; safety standards in drug testing; use of surrogate measures of clinical benefit; independence of regulatory agencies; and public access to regulatory science. It is concluded that: more demanding regulatory intervention is required in order to increase the proportion of drug innovation that actually offers therapeutic benefits over existing products; drug regulatory agencies need much greater independence from the pharmaceutical industry; the erosion of safety standards since 1990 needs to be reversed; accelerated approvals of drugs based on surrogate, rather than clinical endpoints, require much greater critical attention; and much more extensive public access to regulatory science is required in order for regulatory decision-making to be thoroughly accountable to the public and the wider scientific community.

Item Type: Article
Additional Information: Informed by ESRC-funded international empirical research (ESRC Ref L218252001), this article proposes a new sociological approach to technological innovation and regulation by going beyond descriptive accounts of how stakeholders have `constructed their worlds' to interrogate how those constructions compare with the publicly declared goals and rationales for pharmaceutical innovation and regulation. Authors' contribution was equal in all respects.
Schools and Departments: School of Law, Politics and Sociology > Sociology
Depositing User: John Abraham
Date Deposited: 06 Feb 2012 20:11
Last Modified: 28 Mar 2012 15:36
URI: http://srodev.sussex.ac.uk/id/eprint/24604
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