Missouri sues FDA over generic mifepristone approval citing safety risks

Missouri Attorney General Catherine Hanaway announced Thursday that the state is expanding its fight against mail-order abortion pills, targeting the recently approved generic version of mifepristone that she claims is sending women to hospitals with “life-threatening complications” and being pushed onto the market without “basic medical precautions.”

The filing challenges the Food and Drug Administration’s (FDA) Sept. 30 approval of generic mifepristone manufactured by Evita Solutions, arguing that the drug’s risks are “well documented and worsen with further studies.”

The lawsuit alleges that manufacturers rely on “weakened safety standards” that were “originally designed to catch dangerous conditions such as ectopic pregnancy” and can only be determined through an in-person medical examination.

“Mifepristone sends women to the hospital with life-threatening complications, but pharmaceutical companies continue to introduce new versions of it without basic medical precautions,” Hanaway said. “Mail-order abortion drugs are dangerous when taken without personal care, and Missouri will not remain silent while manufacturers gamble with women’s lives.”

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The lawsuit builds on Missouri’s multi-state fight against what officials claim is the FDA’s “elimination of critical safety protections” surrounding mifepristone.

Federal law has long banned abortion pills from being sent by mail, but distributors and telehealth networks have set up a nationwide system that distributes the pills to women in every state, often without in-person medical screening or follow-up care.

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

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Misoprostol, sol and mifepristone abortion medication. (Robyn Beck/AFP via Getty Images)

Hanaway pointed to the drug’s labeling, which states that about 1 in 25 women who take a chemical abortion drug end up in the emergency room, and many experience bleeding, infection or require surgery. Complications are even more common when the pills arrive through the mail without medical supervision, he said.

“No caring doctor would say mifepristone is ‘as safe as Tylenol,'” he said. “This claim has always been false. Women end up in emergency rooms, and manufacturers know it. If the FDA is reevaluating the safety of the brand-name drug, it needs to stop stigmatizing new mail-order generic versions before more women are harmed.”

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

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

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, the company behind the generic drug targeted in Hanaway’s lawsuit.

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Sen. Bill Cassidy, R-La., said he and other Republican senators have requested answers from the FDA about its decision to approve the new drug but have 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.