Missouri sues FDA over generic mifepristone approval citing safety risks

Missouri Attorney General Katharine Hanway announced Thursday that she is expanding the state’s fight against mail-order abortion pills, taking aim at the recently approved generic version of mifepristone that she says sends women to hospitals with “life-threatening complications” and is pushed onto the market without “basic medical safeguards.”

The filing challenges the FDA’s Sept. 30 approval of Evita Solutions’ generic mifepristone, arguing that the drug’s risks are “well documented and worsen with further study.”

The lawsuit alleges that manufacturers relied on “weak safety standards” that were “originally designed to detect serious conditions such as ectopic pregnancy,” which can only be identified through an in-person medical examination.

“Mifepristone sends women to the hospital with life-threatening complications, and yet pharmaceutical companies continue to push new versions of it onto the market without basic medical safeguards,” Hanaway said. “Mail-order abortion medications are dangerous when taken without personal care, and Missouri will not stand idly by while manufacturers gamble with women’s lives.”

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The case hinges on Missouri’s multi-state challenge to what officials claim is the FDA’s “dismantling of critical safety protections” surrounding mifepristone.

Federal law has long banned mail-in abortion medications, but distributors and telehealth networks have built a national system to deliver the pills to women in every state, often without in-person medical exams or follow-up care.

Missouri, joined by Kansas and Idaho, is asking the court to block the new approval, restore pre-2016 safety standards that required in-person medical evaluations, and prevent drug makers and distributors from mailing abortion pills across the country in violation of federal law.

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Misoprostol, left, and the abortion medications mifepristone. (Robin Beck/AFP via Getty Images)

Hanaway pointed to the label on the medication, which states that approximately 1 in 25 women who take chemical abortion medications end up in the emergency room and many suffer bleeding, infection or require surgery. Complications are more common when pills come through the mail without medical supervision, she said.

“No doctor can prescribe mifepristone as safe as Tylenol,” she said. “This claim has always been false. Women are ending up in emergency rooms, and the manufacturers know it. If the FDA is re-evaluating the safety of brand-name medication, it should stop certifying new, mail-order generic versions before more women are harmed.”

Hanaway’s filing comes as Republican lawmakers in Washington continue to pressure the Food and Drug Administration to tighten oversight of abortion pills and restore safety barriers that have been rolled back in recent years.

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Mifepristone tablets at a Planned Parenthood clinic in Iowa. (AP Photo/Charlie Nebergall)

During a recent press call, Sen. Josh Hawley, R-Mo., urged the FDA to “follow the science to bring back safety barriers” and questioned the agency’s partnerships with abortion pill manufacturers, including Evita Solutions, the company behind the generic drug targeted in Hanaway’s lawsuit.

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senator Bill Cassidy, Republican of Los Angeles, said he and other Republican senators had demanded answers from the Food and Drug Administration about its decision to approve the new drug but had not yet received a response.

Evita Solutions did not immediately respond to Fox News Digital’s request for comment.

Fox News Digital’s Leo Briceno contributed to this report.