Toward a Jurisprudence of Drug Regulation

Journal of Law, Medicine and Ethics 42 (2):244-262 (2014)

Abstract

Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that flow from clinical trials — whether positive (i.e., product approvals) or negative (i.e., abandoned products, product refusals, and withdrawals) — are open to outside scrutiny. Further, a jurisprudence of drug regulation is needed. I develop two arguments motivated by (1) innovation concerns and (2) the value of good governance in support of openly publishing all final decisions for approved, abandoned, refused, and withdrawn products. After articulating why greater transparency in regulatory decision-making is needed, I distil four essential features of a jurisprudence of drug regulation that prescribe policy changes in terms not only of the transparency of regulatory outcomes and the underlying reasoning, but also regulatory organization

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