The US Food and Drug Administration’s Regulation of Mifepristone

Mifepristone, used with misoprostol, is the most common abortion regimen in the US. It is also a focal point of reproductive health policy and politics, with controversy over its legal status and regulation by the US Food and Drug Administration (FDA).

To characterize the FDA's decision-making with respect to the regulation of mifepristone, with a particular interest in the agency's rationale for establishing, maintaining, or modifying key components of its regulatory approach over time. Evidence Review: Qualitative analysis of 5239 pages of FDA documents obtained through a Freedom of Information Act request, including sponsors' Risk Evaluation and Mitigation Strategy (REMS) assessment reports, FDA review of these reports, internal memos, and regulatory correspondence (2011-2023), supplemented by a review of publicly available information. Review focused on FDA justifications for implementing, maintaining, or modifying postapproval safety measures and the supporting evidence cited.