The filing challenges the Food and Drug Administration\u2019s (FDA) Sept. 30 approval of a generic mifepristone<\/a> produced by Evita Solutions, arguing that the drug\u2019s risks are “well-documented and worsening with further study.”<\/p>\n 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.<\/p>\n “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\u2019s lives.”<\/p>\n HAWLEY BLASTS FDA APPROVAL OF NEW ABORTION DRUG, CITES SAFETY AND TRUST CONCERNS<\/a><\/p>\n Catherine Hanaway speaks to reporters after Missouri Gov. Mike Kehoe announced her appointment as the state\u2019s next attorney general, Aug. 19, in Jefferson City, Mo. (AP Photo\/David A. Lieb)<\/p>\n The case builds on Missouri\u2019s multi-state challenge to what officials allege is the FDA\u2019s “dismantling of critical safety protections”<\/a> surrounding mifepristone.<\/p>\n 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.<\/p>\n 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.<\/p>\n FLORIDA CITES MAFIA LAW, HITS PLANNED PARENTHOOD WITH SUIT OVER CLAIM ABORTION PILL ‘SAFER THAN TYLENOL’<\/a><\/p>\n Misoprostol, left, and mifepristone abortion medication. (Robyn Beck\/AFP via Getty Images)<\/p>\n Hanaway pointed to the drug\u2019s labeling, which notes that roughly 1 in 25 women who take chemical abortion drugs<\/a> 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.<\/p>\n “No caring physician would call mifepristone \u2018as safe as Tylenol,\u2019” 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\u2019s safety, then it needs to stop rubber-stamping new mail-order generic versions before more women are hurt.”<\/p>\n Hanaway\u2019s filing comes as Republican lawmakers in Washington continue pressing the FDA to tighten oversight of abortion pills<\/a> and restore safety guardrails rolled back in recent years.<\/p>\n ARREST WARRANT ISSUED FOR CALIFORNIA DOCTOR IN LOUISIANA ABORTION PILL CASE<\/a><\/p>\n Mifepristone tablets at a Planned Parenthood clinic in Iowa.\u00a0 (AP Photo\/Charlie Neibergall)<\/p>\n 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\u2019s partnerships with abortion-pill manufacturers, including Evita Solutions, the company behind the generic drug targeted in Hanaway\u2019s lawsuit.<\/p>\n![\"Catherine](\"https:\/\/www.newsbeep.com\/ie\/wp-content\/uploads\/2025\/11\/missouri-fda-generic-abortion-pill-lawsuit-001.jpg\")
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