Abstract
In this paper I focus on the FDA regulation of medical treatments. As a
matter of fact, since the advent of drug regulation in 1962, we have a
variety of standards for testing the safety and the efficacy of
treatments and products. I want to make explicit the reasons for
explaining that variety. Here I argue that medical regulatory schemes
are grounded on an implicit socio-political consensus on the risks
involved by different medical interventions: the bigger the threat, the
stricter the testing standards. Finally, by analysing the concept of
risk, I claim that, from the point of view of regulators, innovative
drugs might be not very different from medical devices or even surgical
procedures, therefore lower testing standards are more defensible than
what critics usually think.