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# FDA Delays Safety Review of Abortion Pill Mifepristone
- URL: https://www.fdaweb.com/fda-delays-safety-review-of-abortion-pill-mifepristone/
- Published: 2025-12-08T12:00:00.000Z
- Updated: 2026-09-14T15:28:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160344

FDA has reportedly postponed a promised safety review of the abortion drug mifepristone, sources familiar with the matter told [Bloomberg](https://www.bloomberg.com/news/articles/2025-12-08/fda-slow-walking-a-long-awaited-abortion-pill-safety-study?ref=fdaweb.com). The review, originally intended to assess real-world outcomes and risks, has been delayed at the direction of FDA commissioner **Marty Makary** until after the 2026 midterm elections.

“HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug,” Makary and HHS secretary **Robert F. Kennedy Jr.** stated in a 19 letter to Republican attorneys general informing them of the ongoing review. After FDA recently approved another generic version of mifepristone, 17 GOP senators sent Makary a letter seeking updates on the study, expressing concern that the review was progressing too slowly.

FDA’s delay comes as abortion access remains a politically charged issue, particularly ahead of the midterms, the Bloomberg article notes. Analysts suggest postponing the review could limit the impact of abortion policy on voter behavior, especially among moderate Republicans who may support abortion rights.

Additionally, the review is also likely impacted by internal turbulence at CDER, which has seen five leadership changes this year alone. An HHS spokesperson told Bloomberg that the agency is following scientific protocols and denied that political considerations influenced the timeline. “FDA’s comprehensive scientific reviews take the time necessary to get the science right,” the spokesperson said.