The reliability of evidential pluralism in drug regulation

Abstract The aim of this paper is to shed light on and critically evaluate the potential impact of evidential pluralism in the realm of pharmaceutical regulation. In the complex landscape of drug evaluation and approval, the role of evidence is pivotal. Firstly, we delve into the role of evidence of mechanisms within drug regulation, with a particular focus on the Accelerated Approval pathway administered by the US Food and Drug Administration. Our analysis reveals that this program, in practice, closely resembles a pluralistic approach to evidence. Secondly, we undertake a thorough examination of the reliability of evidential pluralism within the context of drug regulation. We dissect and discuss the open-cases approach recently put forth by Sung and Holman. While acknowledging its potential merits, we also identify and articulate significant limitations inherent in this approach. Finally, we propose an alternative empirical approach that centres on the real-world outcomes of regulatory programs.