Overview
- Researchers reviewed 264 internal FDA documents totaling 5,239 pages, obtained via FOIA, to track mifepristone regulation from 2011 to January 2023.
- The analysis found FDA leaders generally accepted staff scientists’ evidence-based recommendations and documented repeated conclusions that the drug is safe.
- Two discrete departures from staff advice were identified: retaining a patient agreement form in 2016 and declining to suspend in-person dispensing in 2020 until a court intervened.
- Policy changes culminated in January 2023 with certified pharmacy and mail-order dispensing after studies showed no increase in safety concerns during periods without in-person requirements.
- The findings arrive as federal officials re-review the 2023 dispensing change and as an editorial says the record challenges claims by Robert F. Kennedy Jr. and FDA Commissioner Marty Makary that the agency gave inadequate consideration.