Congress moves to reverse FDA's abortion pill access expansion
H.R. 679 — To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes. · Filed by Diana Harshbarger (R-TN) · 18 cosponsors · Introduced Jan 23, 2025 · Referred to committee
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What it does
This bill would reverse the FDA's January 2023 decision to relax safety requirements for mifepristone (the abortion pill), restoring stricter distribution and use restrictions. It also bars the FDA from adopting any substantially similar relaxed requirements in the future. The bill's primary effect is to make mifepristone harder to access by reimposing prior safety protocols.
Why we flagged it
The bill's operative mechanism is to reverse a regulatory decision that expanded access to a medication. It does not address safety science or new evidence; it is a legislative override of FDA judgment on how to manage a known medication's distribution.
What the text implies
- Reinstates requirement for in-person dispensing and clinical oversight, eliminating mail-based access that the 2023 FDA action had permitted, disproportionately affecting rural and underserved populations.
- Bars FDA from reconsidering or updating REMS based on new safety data or clinical experience, freezing regulatory flexibility and potentially conflicting with FDA's statutory authority to manage drug safety.
The full analysis lists 3 implications of this text.
Who it affects
The bill restricts access to a medication that the FDA determined was safe under relaxed conditions. Citizens who rely on mifepristone for abortion care—particularly those in rural areas, those with limited means, and those facing time-sensitive medical decisions—face reinstated logistical and regulatory barriers.