International Comparative Analysis and Explanation in Medical Sociology: Demystifying the Halcion Anomaly

The US drug regulatory authority, the Food and Drug Administration (FDA) is often thought to demand higher standards of consumer protection from drug manufacturers than its British counterparts, the Medicines Control Agency (MCA) and the Committee on the Safety of Medicines (CSM). Yet since 1991 the MCA has banned one of the most prescribed tranquillisers, Halcion, while it remains approved by the FDA and on the market in the United States. This article attempts to explain the Halcion anomaly and questions explanations proposed by previous sociological research in the field. Broad societal influences, such as the role of the mass media, the increasing threat of litigation regarding drug injury and deregulatory politics are considered to be unlikely explanations. Rather, microsociological processes concerning the internal organisation of the drug regulatory authorities and the interaction between that organisation and technical analyses of safety data are found to be the key explanatory factors.