On the normative foundations of pharmaceutical regulation

I argue that behind the 1962 Food and Drug Administration Act we find a combination of two normative principles: a liberal argument for the protection of pharmaceutical markets (in terms of quality control) and a paternalist argument for the protection of pharmaceutical consumers (in terms of drug safety and efficacy). These normative intuitions go hand in hand with the choice of regulatory testing standards: depending on the values the regulator wants to protect, she will avail herself of different testing methods. I explore two potential justifications for regulatory paternalism, in terms of risk aversion and impartiality. I defend our current regulatory arrangement against socialist and libertarian critiques.