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International and Temporal Comparative Analysis of UK and US Drug Safety Regulation in Changing Political Contexts

Research output: Contribution to journalArticle

Original languageEnglish
Article numberdoi.org/10.1016/j.socscimed.2020.113005
Pages (from-to)1-45
Number of pages45
JournalSocial Science & Medicine
Publication statusAccepted/In press - 18 Apr 2020

King's Authors

Abstract

Modern UK drug regulation began in 1971. In view of significant neo-liberal political
reforms to drug regulation in the UK and US since the early 1990s, this article
compares the performance of UK and US drug safety regulation during both 1971-
1992 and 1993-2004, by investigating drug safety withdrawals (DSWs). Combined
quantitative and comprehensive qualitative regulatory case history methodology is
employed to explain comparative trends in DSWs and relate them to the key claims of
central regulatory theories. It is found that there was a dramatic increase in DSWs in
the US during 1993-2004 compared with 1971-1992, and a major increase in the
extent to which drugs withdrawn on safety grounds in the UK were left on the US
market. Analysis reveals that these findings are best explained by changes in
institutional regulatory culture at FDA, consequent upon neo-liberal reforms during
1993-2004, which meant that US regulators adopted more permissive interpretations
of safety signals and associated risk-benefit assessments leading to more unsafe drugs
being approved on to the US market than during 1971-1992. Changes in the UK are
less marked because it already embraced a relatively permissive regulatory culture
during 1971-1992 and neo-liberal reforms post-1992 were more attenuated. It is
concluded that the changes support corporate bias theory, and that, to improve patient
protection, drug safety regulation in the UK and US should shift direction towards the
US regulatory model of 1971-92.

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