A comparative analysis of risk management strategies in European Union and United States pharmaceutical regulation

Abstract

Analyses of risk management within prescription pharmaceutical regulation are rare. We present the first comparison of pharmaceutical risk regulation between the EU's centralised supranational ‘state’ and another country, the US. Drawing on documentary and interview-based research on case-study drugs and risk management, we argue that ‘risk colonisation’, neo-liberal governmentality, and pressure from powerful industry interests have combined to produce permissive, rather than precautionary, risk management within pharmaceutical regulation, though more so in the US than Europe. Product labelling is central to pharmaceutical risk management by communicating risks to doctors and patients, but can also legitimate permissive regulatory approval, especially when new drugs offer no therapeutic advance. Such neo-liberal risk management was practised by both the American and European regulatory agencies. However, the FDA, more willingly than EU regulators, used risk communication, warnings, and patient monitoring to maintain on the market pharmaceuticals with severe/life-threatening risks, such as liver and cardiac toxicity, despite growing evidence of their incapacity to prevent harm. Senior EU regulators were sceptical about risk-managing toxic drugs during post-marketing, rather than simply removing them from the market. EU regulators’ more precautionary application of pharmaceutical risk management than the FDA offers some support for the ‘flip-flop’ hypothesis, which asserts that US environmental and consumer product risk regulation was more precautionary during the 1970s and early 1980s, but since then Europe has become more precautionary. However, such support does not necessarily apply to drug regulation overall. The supranational EU regulatory system has been more resistant to neo-liberal governmentality, ‘risk colonisation’, and the pressure of industry interests. We suggest that this is because EU regulators’ practice of regulatory science has greater autonomy from political ideology and institutional interests than its American counterpart.

Keywords:

• risk
• risk management
• risk colonisation pharmaceuticals
• regulatory regimes
• flip-flop

Acknowledgements

Thanks to the UK Economic and Social Research Council (ESRC) for funding this research, and to two anonymous referees for their comments on a previous draft.

Notes

1. Pharmacovigilance is the study and monitoring of adverse drug effects to detect, assess, understand, and prevent them. Mainly associated with, but not confined to, Phase IV of a drug's lifecycle.

2. The ICH, which was launched in 1990, comprises the regulatory agencies and pharmaceutical industry associations of the EU, Japan, and the US: ostensibly to harmonise techno-scientific drug regulatory standards across these three regions (Abraham and Reed 2001).

3. In the late 2000s, these EU regulatory bodies changed their names slightly to the European Medicines Agency (EMA) and the Committee for Human Medicinal Products (CHMP).

4. The elevation of liver enzymes, such as transaminases, in liver function tests indicates liver-cell damage (FDA 2000).

5. Bilirubin is a yellow breakdown product of red blood cells passed to the liver.

6. Q and T refer to points on electrocardiograph readings.