14. Department of Health and Human Services · Notable
Reinstate pre-2016 safety protocols for Mifeprex and its generics
Printed page 459 14. Department of Health and Human Services
“Reinstate earlier safety protocols for Mifeprex that were mostly eliminated in 2016 and apply these protocols to any generic version of mifepristone. A bare-minimum policy of limiting abortion pills to the pre-2016 policy of 49 days gestation, returning to the pre-2021 in-person dispensing requirement, and returning to requiring prescribers to report all serious adverse events, not just deaths, to the drug sponsor would increase women’s health and safety.”
What has happened
- Not started
None of the three pre-2016 protocols the Quote names has been reinstated. The REMS document approved 2025-09-30 sets no gestational-age limit (the 70-day limit lives in the labeling, not the 49-day pre-2016 one), imposes no in-person dispensing requirement, and still requires prescribers to ensure only "that any deaths are reported to the Mifepristone Sponsor" rather than all serious adverse events. The one in-window modification added a third generic to the program.
Research log
What was searched, and what didn’t count as evidence
Research notes
- The Mifepristone Shared System REMS was read directly at REMS@FDA. accessdata.fda.gov opened for us even though fda.gov and the rest of HHS’s sites did not, which is how this cluster was settled without a web search.
- The REMS update history shows exactly five modifications since 2019 and one inside the window (2025-09-30, “Modified to add ANDA 216616”).
- Action
- reinstate
- Object
- pre-2016 Mifeprex safety protocols
- ID
- 1235