FDA approves new generic mifepristone; conservatives object
The FDA approved a generic version of mifepristone from Evita Solutions for use through 10 weeks of pregnancy — the company filed its application about four years ago and expects to launch the product in January 2026. The decision drew sharp conservative criticism (including Sen. Josh Hawley, Students for Life and Mike Pence), while the White House and HHS/FDA said they were following statutory requirements and not endorsing the drug even as a broader agency safety review continues.
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Health
🔍 Key Facts
- The FDA approved a new generic mifepristone manufactured by Evita Solutions; the product is approved to end pregnancies through 10 weeks.
- Evita Solutions filed its FDA application roughly four years ago (per FDA postings) and expects to launch the generic in January 2026.
- Conservative figures and groups mounted immediate backlash: Sen. Josh Hawley publicly condemned the approval (posting on X and telling Fox News he has “lost confidence” in FDA leadership), Students for Life and Marjorie Dannenfelser issued criticisms, and former Vice President Mike Pence called the approval a “complete betrayal of the pro‑life movement.”
- Hawley specifically pointed to Evita Solutions’ messaging (including language about “normalize abortion” and refusing to define “woman”), urged reinstating prior (Trump‑era) medication‑abortion safety protocols, and said a promised “top‑to‑bottom” FDA safety review has not been completed.
- HHS and FDA spokespeople said the agencies have limited discretion under statute when reviewing generic applications; HHS also reported a continued safety review led by HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary.
- The White House (press secretary Karoline Leavitt) said FDA and HHS were following the law in approving the generic and emphasized the decision is “not an endorsement” of the drug.
📰 Sources (5)
WATCH: FDA and HHS not endorsing generic abortion pill they just approved, White House says
New information:
- White House press secretary Karoline Leavitt publicly stated the FDA and HHS were merely following the law in approving the generic and that the decision is "not an endorsement" of the drug.
- Includes a short video of Leavitt’s remarks and cites conservative backlash, including a statement from Mike Pence calling the approval a "complete betrayal of the pro-life movement."
FDA approves another generic abortion pill, prompting outrage from conservatives
New information:
- 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.
FDA approves another generic abortion pill
New information:
- 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).
Hawley blasts FDA approval of new abortion drug, cites safety and trust concerns
New information:
- 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.