FDA approves new generic mifepristone; conservatives object
The FDA has approved a new generic version of mifepristone from Evita Solutions — cleared for use through 10 weeks of pregnancy, with the company having filed its application about four years ago and expecting a January 2026 launch. The decision prompted conservative backlash, with Sen. Josh Hawley saying he has “lost confidence” in FDA leadership, urging a return to prior safety protocols and criticizing Evita’s messaging, and groups such as Students for Life and Marjorie Dannenfelser also condemning the approval. HHS spokesperson Andrew Nixon said the agency has limited discretion on generic approvals and noted a continued HHS/FDA safety review, which he said is being led by Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary.
🔍 Key Facts
- The FDA has approved a new generic version of mifepristone manufactured by Evita Solutions.
- Evita’s product is approved for medication abortion through 10 weeks of pregnancy; the company expects to launch the generic in January 2026.
- Documents posted to the FDA website show Evita Solutions filed its generic application roughly four years ago.
- Conservative lawmakers and groups — including Sen. Josh Hawley, Students for Life Action and Marjorie Dannenfelser — publicly criticized and expressed outrage over the approval.
- Sen. Josh Hawley posted on X and told Fox News Digital he has “lost confidence” in FDA leadership, singled out Evita’s messaging (including language about “normalize abortion” and a refusal to define “woman”), urged restoring prior (Trump‑era) medication‑abortion safety protocols, and said a promised “top‑to‑bottom” FDA safety review was not completed.
- HHS and FDA spokespeople (including HHS spokesperson Andrew Nixon) said the agencies have limited statutory discretion when approving generics and noted a continued HHS/FDA safety review, which reports say is being led by HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary.
📰 Sources (4)
- Identifies the approved manufacturer as Evita Solutions specifically.
- Notes Evita filed its generic application four years ago per documents posted to the FDA website.
- Reports the company expects to launch the generic in January 2026.
- Quotes Sen. Josh Hawley and Students for Life Action criticizing the approval and includes an FDA spokesperson explanation that the agency has limited discretion on generic approvals.
- Identifies the approved generic manufacturer as Evita Solutions.
- States Evita’s product is approved to end pregnancies through 10 weeks.
- Notes Evita Solutions filed its FDA application roughly four years ago (per FDA posting).
- Reiterates and quotes HHS spokesperson Andrew Nixon on the statutory constraints for generic approvals and reports continued HHS/FDA safety review led by Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary.
- Provides contemporaneous conservative reactions and named quotes (Sen. Josh Hawley, Students for Life, Marjorie Dannenfelser).
- Sen. Josh Hawley (R‑Mo.) publicly condemned the FDA decision, posting on X and giving on‑the‑record remarks to Fox News Digital that he has 'lost confidence' in FDA leadership.
- The article highlights specific Evita Solutions messaging (language about 'normalize abortion' and refusing to define 'woman' in its materials) as part of the senator's criticism.
- Hawley urged restoring prior (Trump‑era) safety protocols for medication abortion and framed the approval as occurring despite a promised 'top‑to‑bottom' FDA safety review that he says has not been completed.