14. Department of Health and Human Services · Notable
Restore the mifepristone REMS in-person dispensing requirement
Printed page 458 14. Department of Health and Human Services
“As an interim step, the FDA should immediately restore the REMS by removing the in-person dispensing requirement to eliminate dangerous tele-abortion and abortion-by-mail distribution.”
What has happened
- Not started
The in-person dispensing requirement has not been restored. The Mifepristone Shared System REMS was modified once inside the window, on 2025-09-30, and the change was to add a third product (Evita Solutions, ANDA 216616) to the program. The REMS document approved that day still provides for dispensing "by or under the supervision of certified prescribers, or by certified pharmacies on prescriptions issued by certified prescribers", the arrangement that permits mail dispensing.
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 (www.accessdata.fda.gov), which could be read even though www.fda.gov and the rest of the HHS family could not, so this cluster was settled without relying on web search results.
- The REMS update history shows exactly five modifications since 2019 and one inside the window (2025-09-30, “Modified to add ANDA 216616”).
- The safety review pledged in September 2025 is tracked on #1233, which is recorded as attempted; nothing has come of it in the REMS.
- Action
- restore
- Object
- mifepristone Risk Evaluation and Mitigation Strategy (REMS)
- ID
- 1234