ABSTRACT
The nature of the relationships between scientific expertise and regulatory decision-making raises questions about citizenship. The sociological conclusion is that scientific expertise in regulatory settings should not be treated as if it operates in a social vacuum. Rather it needs to be related to social interests in a fairly thoroughgoing way — including the construction of regulatory standards and evidential interpretation by reference to standards. The challenge for regulatory settings is how to construct a system of risk-benefit assessment which can accommodate the inevitably socio-political nature of such judgements. The transnational pharmaceutical industry has sought to persuade the major regulatory agencies around the world to harmonize their regulatory standards for drug testing. Many of the expert scientists on the Psychopharmacological Advisory Committee (PDAC) and Institute of Medicine (IoM) were themselves involved in clinical trials with drugs and drug development.
