Missouri Attorney General Catherine Hanaway filed a federal lawsuit Thursday challenging the Food and Drug Administration’s approval of a new generic version of the abortion drug mifepristone.
Hanaway is arguing that the decision endangers women by allowing unchecked mail-order distribution without basic medical safeguards.
The suit, joined by Kansas and Idaho, seeks to block the September 30 approval of the generic product from Evita Solutions and restore pre-2016 safety standards for the drug, including requirements for in-person medical evaluations to detect life-threatening conditions like ectopic pregnancies.
Hanaway, a Republican, said the lawsuit supports Missouri’s ongoing multi-state challenge against the FDA’s rollback of safety protections mandated by Congress for mifepristone, which is used in the abortions. The abortion pill has killed multiple women and injured countless thousands.
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“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,” Hanaway said. “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.”
The drug’s labeling warns that about 1 in 25 women who take chemical abortion drugs end up in the emergency room, with many experiencing severe hemorrhaging, infection or requiring surgery. The numbers are higher, with one massive study showing 11% of women face dangerous complications.
Complications are more frequent with mail-order distribution, which lacks personalized medical oversight, according to the lawsuit.
Federal law prohibits mailing abortion drugs, but distributors and telehealth networks have developed a system to ship mifepristone to all 50 states without in-person screening, follow-up care or emergency support, the suit alleges. This practice undermines state laws in Missouri, Kansas and Idaho, and burdens their hospitals and taxpayers with treating resulting complications.
“No caring physician would call mifepristone ‘as safe as Tylenol.’ That claim was always false,” Hanaway said. “Women are ending up in emergency rooms, and manufacturers know it. If the FDA is reevaluating the brand-name drug’s safety, then it needs to stop rubber-stamping new mail-order generic versions before more women are hurt.”
The lawsuit contends the FDA approved the Evita Solutions generic without new safety studies, relying instead on prior changes that eliminated in-person evaluations and follow-up visits, allowed pharmacy dispensing and permitted remote prescriptions and direct mailing.
Missouri hospitals have reported rising numbers of women seeking emergency care for complications from out-of-state or mail-order chemical abortions. The states are asking the court to enjoin mail-order distribution nationwide, halt the new generic’s market entry and hold manufacturers and distributors accountable for violating state laws.
“Every woman deserves real medical care, not a dangerous pill in a mailbox,” Hanaway said. “Our lawsuit demands accountability from manufacturers and distributors and places women’s health above political pressure.”
During a recent press call, Sen. Josh Hawley, R-Mo., called on the FDA to “follow the science to put back safety guardrails” and questioned the agency’s partnerships with abortion-pill manufacturers, including Evita Solutions.
Separately, Sen. Bill Cassidy, R-La., said he and other Republican senators have demanded answers from the FDA about the approval but have received no response.










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