Deficits, Expectations and Paradigms in British and American Drug Safety Assessments

Prising Open the Black Box of Regulatory Science

Bibliographic Data

ID5336986
AuthorsJohn Abraham (0000-0003-3643-0128, University of Sussex), Julian Abraham (0000-0003-0643-0274, University of Sussex, J.W.Abraham@ sussex.ac.uk), Courtney Davis (0000-0002-9425-9886, University of Sussex)
Year2007
Volume32
Issue4
Pages399-431
Publication date2007-07-01
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueScience Technology & Human Values (JOURNAL)
Journal identifiersISSN: 0162-2439 • E-ISSN: 1552-8251
PublisherSAGE Publications Inc (PUBLISHER)
DOI10.1177/0162243907301002
OpenAlexW2118920134
LanguageEN
Citations received23
References cited34

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in the United Kingdom, while denied marketing approval in the United States on safety grounds, and then subsequently withdrawn from the UK market on those grounds.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

Government regulation · Nonsteroidal · Pharmaceutical industry · Political science · Politics · Public relations · Regulatory science · Sociology · Historical Medical Research and Treatments · Law · Medicine · Pharmaceutical industry and healthcare · Pharmacovigilance and Adverse Drug Reactions · Pharmacology

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