JAMA Clinical Reviews A Conversation About the FDA's Regulation of Mifepristone
Jan 12, 2026
In this insightful discussion, G. Caleb Alexander, a practicing internist and epidemiologist at Johns Hopkins, dives into the complex regulation of mifepristone, the widely used abortion drug. He sheds light on FDA approval standards, the unique challenges posed by political scrutiny, and key regulatory moments since its approval. Alexander highlights the importance of transparency through Freedom of Information Act requests and addresses ongoing legal battles impacting access. His nuanced analysis reveals the intersection of science and policy in reproductive health.
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Context Shapes Drug Safety Rules
- The FDA tailors safety requirements to context because a drug's risk varies by use and setting.
- REMS targets a small subset of drugs where additional controls optimize safe use.
Regulatory Evolution Since Approval
- Mifepristone was approved in 2000 and moved into REMS in 2011 after earlier Subpart H oversight.
- The shift reflected evolving post-approval safety management rather than new safety failures.
Use FOIA To Reveal Regulatory Records
- Use the Freedom of Information Act to examine FDA decision-making and obtain internal reports.
- Persist through the lengthy FOIA process because transparency enables rigorous regulatory research.