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Missouri Attorney General Kathryn Hanaway announced Thursday that she is expanding the state’s fight against mail-order abortion pills, targeting the recently approved generic version of mifepristone, arguing that it is sending women to hospitals with “life-threatening complications” and that it is being pushed onto the market without “basic medical safeguards.”
The filing challenges the Food and Drug Administration’s (FDA) September 30 approval of generic mifepristone manufactured by Avita Solutions, arguing that the drug’s risks are “well documented and continuing to worsen with further study.”
The lawsuit alleges that manufacturers relied on “weak safety standards” that were “originally designed to catch dangerous conditions such as ectopic pregnancy” that can only be identified through an individual medical examination.
“Mifepristone is sending women to the hospital with life-threatening complications, and yet drug companies are bringing new versions of it to 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 when manufacturers gamble with women’s lives.”
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by Missouri Governor Mike Kehoe on August 19 in Jefferson City, Mo. Kathryn Hanaway speaks to reporters after the announcement of her appointment as the state’s next Attorney General. (AP Photo/David A. Lieb)
The case is based on a multi-state challenge from Missouri, which officials allege the FDA has “eroded critical safety protections” around mifepristone.
Federal law has long banned the mailing of abortion drugs, yet distributors and telehealth networks have created a nationwide system that delivers the pills to women in every state, often without personal medical screening or follow-up care.
Missouri, along with Kansas and Idaho, is asking the court to block the new approvals, reinstate pre-2016 safety standards that require individual medical evaluations and prevent drug manufacturers and distributors from shipping abortion pills nationwide in violation of federal law.
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Misoprostol, bayan and mifepristone abortion drugs. (Robin Beck/AFP via Getty Images)
Hanway pointed to the drug’s labeling, which reads that about 1 in 25 women who take chemical abortion drugs go to the emergency room and many have bleeding, infection or require surgery. He said complications become even more common when pills arrive through the mail without medical oversight.
“No point-of-care physician would say mifepristone is as safe as Tylenol,” she said. “That claim was always false. Women are going to emergency rooms, and the manufacturers know it. If the FDA is reevaluating the safety of a brand-name drug, it needs to stop rubber-stamping new mail-order generic versions before more women are hurt.”
Hanaway’s petition comes as Republican lawmakers in Washington are pressuring the FDA to tighten oversight of abortion pills and reinstate safety guardrails that were rolled back in recent years.
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Mifepristone pills at a Planned Parenthood clinic in Iowa. (AP Photo/Charlie Niebergel)
During a recent press call, Sen. Josh Hawley, R-MO, urged the FDA to “follow the science to put safety guardrails back” and questioned the agency’s partnerships with abortion-pill makers, including Avita Solutions, the company behind the generic drug targeted in Hanway’s lawsuit.
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Senator Bill Cassidy, R-La., said he and other Republican senators have sought answers from the FDA about the decision to approve the new drug, but have not yet received a response.
Avita Solutions did not immediately respond to Fox News Digital’s request for comment.
Fox News Digital’s Leo Briceño contributed to this report.