Missouri, Idaho, and Kansas updated their complaint in an ongoing legal battle against the FDA’s loosened restrictions that eased access to the abortion pill mifepristone, challenging the agency’s most recent approval of a generic version of the drug.
The proposed supplemental complaint, filed in the US District Court for the Eastern District of Missouri, challenges the Food and Drug Administration’s Sept. 30 approval of Evita Solutions LLC’s generic mifepristone, “despite mounting evidence that the drug poses serious” harm to pregnant women, the states said.
“Mifepristone is a high-risk drug that the FDA continues to green-light despite its devastating effects on pregnant women and girls,” the states said in the complaint. “Studies of the real-world use of mifepristone concluded that significant morbidity and mortality have occurred following the use of mifepristone as an abortifacient.”
The three states asked the court to issue a preliminary injunction or a stay that rescinds and vacates the generic drug approval.
The Republican-led states’ ongoing legal battle takes issue with the drug’s mail-order distribution.
FDA Commissioner Marty Makary and US Department of Health and Human Services Secretary Robert F. Kennedy Jr. said in a letter earlier this year that they would open an investigation into the safety and efficacy of mifepristone.
Opponents say FDA decisions made before the Trump administration have expanded access to mifepristone in ways that violate red-state restrictions on abortions and endanger patients, while proponents view the drug as crucial to women’s health.
“Mifepristone is sending women to the hospital with life-threatening complications, and yet drug companies continue pushing new versions of it into the market without basic medical safeguards,” Catherine L. Hanaway, attorney general for Missouri, said in a statement Thursday.
“Mail-order abortion drugs are dangerous when taken without in-person care, and Missouri will not stand by while manufacturers gamble with women’s lives,” she said.
The case is The State of Missouri v. US Food and Drug Administration, E.D. Mo., No, 4:25-cv-01580, proposed supplemental complaint 11/20/25.
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