JAMA

Science, not ideology, steered FDA’s mifepristone policy

January 16, 2026

A JAMA review of 5,239 FDA documents (2011–2023) identified five pivotal regulatory moments for mifepristone: adoption of the Risk Evaluation and Mitigation Strategy (REMS) framework (2011), reevaluation of REMS (2013), label change (2015), pandemic-related adjustments (2020–2021), and comprehensive REMS reassessment (2021). Across these junctures, FDA decisions were consistently grounded in safety data and staff scientists’ recommendations, with minimal political influence despite litigation and evolving practice standards.

Clinical takeaway: FDA oversight of mifepristone has been cautious and evidence-based, supporting its continued safety profile.

Source:

Dilek S, et al. (2026, January 12). JAMA. The US Food and Drug Administration's Regulation of Mifepristone. https://pubmed.ncbi.nlm.nih.gov/41525083/