Mifepristone Safety Review

At his March 2025 Senate confirmation hearing, Dr. Marty Makary pledged to take “a solid, hard look at the data” on mifepristone, the abortion medication, working with the agency’s career scientists. The promise was an attempt to satisfy anti-abortion groups and lawmakers who had opposed his nomination.

The review quickly became a live political fight. The FDA under Makary approved a second generic version of mifepristone, which angered anti-abortion activists; per STAT reporting cited across the resignation coverage, anti-abortion groups and some Republican lawmakers then accused him of “slow-walking” the safety review. The review was still unresolved when Makary resigned on May 12, 2026.

His nominated successor, Heidi Overton, told senators in September 2026 that she would “follow statutory guidelines” and “review the evidence” without committing to particular outcomes. The mifepristone review therefore remains an active, unresolved fight under the agency’s acting and future leadership — one of the few Makary-era controversies still awaiting a definitive outcome.

Timeline

• March 6, 2025: At his Senate confirmation hearing, Makary pledges “a solid, hard look at the data” on mifepristone.
• 2025–2026: FDA approves a second generic mifepristone; anti-abortion groups and some Republican lawmakers accuse Makary of slow-walking a safety review, per STAT reporting.
• May 12, 2026: Makary resigns with the review unresolved.
• September 2026: Nominee Heidi Overton tells senators she would “follow statutory guidelines” and “review the evidence,” without committing to outcomes.