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

journal contribution
posted on 2023-06-07, 19:16 authored by John Abraham, Courtney Davis
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in the United Kingdom, while denied marketing approval in the United States on safety grounds, and then subsequently withdrawn from the UK market on those grounds.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.

History

Publication status

  • Published

Journal

Science, Technology, and Human Values

ISSN

0162-2439

Publisher

SAGE Publications

Issue

4

Volume

32

Page range

399-431

Department affiliated with

  • Sociology and Criminology Publications

Notes

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R000237658), this is the first article using sociological case-study analysis comparing pharmaceuticals approved and withdrawn in one jurisdiction, but non-approved elsewhere, in the modern drug regulatory period.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.

Full text available

  • No

Peer reviewed?

  • Yes

Legacy Posted Date

2012-02-06

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