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

Abstract

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.