On the Normative Foundations of Pharmaceutical Regulation

  • David TeiraEmail author
Part of the Boston Studies in the Philosophy and History of Science book series (BSPS, volume 338)


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.



I am grateful to the editors, Bennett Holman and Julian Reiss for their detailed comments on a previous draft. My research was funded by the grant FFI2014-57258-P The paper was written during my stay at the Instituto de Investigaciones Filosóficas (UNAM, Mexico) with a PREI grant that I gratefully acknowledge. I thank Atocha Aliseda and various audiences at UNAM for their insightful discussion.


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© Springer Nature Switzerland AG 2020

Authors and Affiliations

  1. 1.Universidad Nacional de EducaciónMadridSpain

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