Overview
- Fifty-one Republican senators urged HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to suspend distribution of mifepristone as an “imminent hazard” and to reinstate in-person prescribing and dispensing that would end telehealth and mail-order access.
- Sens. Susan Collins and Lisa Murkowski were the only Republicans who did not sign the letter.
- The FDA recently approved Evita Solutions’ generic mifepristone (ANDA 216616) as bioequivalent to Mifeprex and said it will operate under the single, shared REMS that must be fully functional before interstate distribution begins.
- An HHS spokesman said federal law gives the FDA very limited discretion on generic approvals, and administration officials described the decision as a legal obligation rather than an endorsement.
- Access policies are also being tested in court, with Louisiana suing over telehealth rules and a long-running attorneys general case moved to Missouri, while Evita projects market availability in January 2026.