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

Mattia Andreoletti, David Teira

Research output: Contribution to journalArticlepeer-review


Over the last decade, philosophers of science have extensively criticized the epistemic superiority of randomized controlled trials (RCTs) 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.

Original languageEnglish
Pages (from-to)1093-1115
Number of pages23
JournalScience Technology and Human Values
Issue number6
Publication statusPublished - Nov 1 2019


  • epistemology
  • governance
  • markets/economies
  • philosophy of medicine
  • philosophy of science
  • politics
  • power

ASJC Scopus subject areas

  • Anthropology
  • Social Sciences (miscellaneous)
  • Philosophy
  • Sociology and Political Science
  • Economics and Econometrics
  • Human-Computer Interaction


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