Rules versus Standards: What Are the Costs of Epistemic Norms in Drug Regulation?

Science, Technology, and Human Values 44 (6):1093-1115 (2019)
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Abstract

Over the last decade, philosophers of science have extensively criticized the epistemic superiority of randomized controlled trials for testing safety and effectiveness of new drugs, defending instead various forms of evidential pluralism. We argue that scientific methods in regulatory decision-making cannot be assessed in epistemic terms only: there are costs involved. Drawing on the legal distinction between rules and standards, we show that drug regulation based on evidential pluralism has much higher costs than our current RCT-based system. We analyze these costs and advocate for evaluating any scheme for drug regulatory tests in terms of concrete empirical benchmarks, like the error rates of regulatory decisions.

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Drug Regulation and the Inductive Risk Calculus.Jacob Stegenga - 2017 - In Kevin Christopher Elliott & Ted Richards (eds.), Exploring Inductive Risk: Case Studies of Values in Science. New York: Oup Usa. pp. 17-36.

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Author Profiles

David Teira
Universidad Nacional de Educación a Distancia

Citations of this work

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References found in this work

The sociology of science: theoretical and empirical investigations.Robert King Merton - 1973 - Chicago: University of Chicago Press. Edited by Norman W. Storer.
Evaluating evidence of mechanisms in medicine.Veli-Pekka Parkkinen, Christian Wallmann, Michael Wilde, Brendan Clarke, Phyllis Illari, Michael P. Kelly, Charles Norell, Federica Russo, Beth Shaw & Jon Williamson - 2018 - Dordrecht, Netherlands: Springer. Edited by Brendan Clarke, Phyllis Illari, Michael P. Kelly, Charles Norell, Federica Russo, Beth Shaw, Christian Wallmann, Michael Wilde & Jon Williamson.

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