Missouri sues FDA over generic mifepristone approval citing safety risks

Missouri Attorney General Catherine Hanaway announced Thursday she is expanding the state’s fight against mail-order abortion pills, targeting a recently approved generic version of mifepristone that she argues sends women to hospitals with “life-threatening complications” and is being pushed into the marketplace without “basic medical safeguards.”

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

The lawsuit alleges manufacturers have relied on “weakened safety standards” that were “originally designed to catch dangerous conditions such as ectopic pregnancies,” which can only be identified through an in-person medical exam.

“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.”

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

Federal law has long banned the mailing of abortion drugs, yet distributors and telehealth networks have built a nationwide system that delivers the pills to women in every state, often without in-person medical screenings 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 stop drugmakers and distributors from mailing abortion pills nationwide in violation of federal law.

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Hanaway pointed to the drug’s labeling, which notes that roughly 1 in 25 women who take chemical abortion drugs end up in the emergency room and many suffer hemorrhaging, infection or require surgery. She said complications are even more common when the pills come through the mail without medical oversight.

“No caring physician would call mifepristone ‘as safe as Tylenol,’” she said. “That claim was always false. 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.”

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

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During a recent press call, Sen. Josh Hawley, R-Mo., urged 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 demanded answers from the FDA about its decision to approve the new drug but have yet to receive 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.