Project 2025 Tracker / What’s done, what’s next

14. Department of Health and Human Services · Major

Withdraw FDA approval of chemical abortion drugs

Attempted

458 14. Department of Health and Human Services

“Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. … The FDA is statutorily charged with guaranteeing the safety and efficacy of drugs and therefore should withdraw this drug that is proven to be dangerous to women and by definition fatally unsafe for unborn children.”

What has happened

  1. Attempted

    The Secretary of HHS and the FDA Commissioner had pledged, in a September 2025 letter to Republican state attorneys general, to conduct a full review of mifepristone's safety — the administration's one concrete step toward reversing the approval. It runs alongside the opposite: FDA approved a second generic mifepristone, which the agency said it had "very limited discretion" to refuse. The approval of mifepristone has not been withdrawn, and the review had not been completed as of 2026-08-27.

Research log

What was searched, and what didn’t count as evidence

Research notes

  • The Primary source for the safety-review pledge — the September 2025 Kennedy/Makary letter to Republican attorneys general — is published on hhs.gov, which refused to open for automated requests, and fda.gov refused or returned missing pages as well. Both are leads, which is why a Secondary source carries this event. The event is dated to the NPR/AP report rather than to the letter because no allowlisted source that could be opened gives the letter’s exact date.
  • Negative searches run 2026-08-27: Federal Register full-text “mifepristone” since 2025-01-20 — 2 documents, neither an FDA action on the approval (a VA rule reinstating abortion exclusions, and an HHS OCR guidance rescission).
  • Litigation leads, none of them readable without authentication (CourtListener docket pages refused to open for us and its API’s allowance was used up at the time): Louisiana v. U.S. Food & Drug Administration, W.D. La. 6:25-cv-01491, filed 2025-10-03 (https://www.courtlistener.com/docket/71544002/louisiana-v-u-s-food-drug-administration/); its appeal, State of Louisiana v. FDA, 5th Cir. 26-30203, docketed 2026-04-14 (https://www.courtlistener.com/docket/73207799/state-of-louisiana-v-fda/); and State of Missouri v. U.S. Food and Drug Administration, E.D. Mo. 4:25-cv-01580, filed 2025-10-23 (https://www.courtlistener.com/docket/71733114/state-of-missouri-v-us-food-and-drug-administration/). Those cases seek to restrict distribution, not to withdraw the approval, and a court restricting the REMS would not be the FDA withdrawal this Recommendation asks for.
Action
withdraw
Object
FDA approval of mifepristone and chemical abortion drugs
ID
1233