International and temporal comparative analysis of UK and US drug safety regulation in changing political contexts.

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increase in DSWs in the US during 1993–2004 compared with 1971–1992, and a major increase in the extent to which drugs withdrawn on safety grounds in the UK were left on the US market.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.