Deficits, expectations and paradigms in British and American drug safety assessment: prising open the black box of regulatory science

Abraham, John and Davis, Courtney (2007) Deficits, expectations and paradigms in British and American drug safety assessment: prising open the black box of regulatory science. Science, Technology, and Human Values, 32 (4). pp. 399-431. ISSN 0162-2439

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Abstract

This article examines the regulation of nonsteroidal anti-inflammatory drugs (NSAIDs), with particular focus on products approved for marketing in the United Kingdom, while denied marketing approval in the United States on safety grounds, and then subsequently withdrawn from the UK market on those grounds. Using international comparison of regulatory data never before accessed outside government and companies, together with interviews with relevant industry scientists and regulators, the article demonstrates the importance of regulatory expectations, deficits and paradigms. It is argued both that these sociological concepts can be enriched by their application to detailed comparative case study of regulatory science, and that they provide an important policy-relevant framework with which to understand discrepant drug regulatory processes in a sociohistorical context. It is found that regulatory expectations and paradigms may be regarded as mediating factors between political culture and structural interests, on the one hand, and the outcomes of regulatory science (including deficits), on the other.

Item Type: Article
Additional Information: Based on ESRC-funded (ESRC Ref R000237658), this is the first article using sociological case-study analysis comparing pharmaceuticals approved and withdrawn in one jurisdiction, but non-approved elsewhere, in the modern drug regulatory period. Methodologically, the article is innovative in using appeals procedures and threats of litigation to access knowledge about regulatory science previously withheld by governments and industry, thereby altering the freedom of information policies in the UK and the US. The evidence so adduced implies the need to expand, disaggregate and re-think the sociology of science concepts of paradigms, expectations and deficits, respectively. 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 18:13
Last Modified: 20 Jun 2012 15:31
URI: http://srodev.sussex.ac.uk/id/eprint/15293
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