In a legal and political battle that has captured national attention, three Republican-led states—Missouri, Kansas, and Idaho—are intensifying their efforts to restrict access to the abortion pill mifepristone, following the U.S. Food and Drug Administration’s (FDA) recent approval of a new generic version. The lawsuit, announced on November 20, 2025, by Missouri Attorney General Catherine Hanaway, specifically targets the FDA’s September 30 approval of Evita Solutions’ generic mifepristone, a move that has drawn sharp criticism from conservative leaders and ignited fresh debate over the future of abortion access in the United States.
According to Reuters, the lawsuit seeks to block the FDA’s most recent generic approval and to reinstate pre-2016 safety standards for mifepristone, including prohibiting its distribution through the mail. The states argue that the FDA acted improperly when it eased restrictions on the abortion pill, such as allowing it to be prescribed remotely and shipped directly to patients. The suit, now assigned to U.S. District Judge Cristian Stevens in St. Louis, comes after a previous version was dropped by anti-abortion groups following a 2024 Supreme Court ruling on legal standing.
Mifepristone, which was first approved by the FDA in 2000, is used in more than 60% of U.S. abortions within the first 10 weeks of pregnancy. The pill is typically followed by misoprostol to complete a medication abortion. Over the years, the FDA has loosened restrictions on mifepristone. Initially, it could only be taken in front of a physician or clinician and only through seven weeks of pregnancy. Later, the approved window was extended to 10 weeks, and requirements for in-person administration and injury reporting were relaxed. In 2021, the FDA allowed the drug to be distributed by mail, a decision that has since been a flashpoint in the abortion debate.
Missouri Attorney General Hanaway, in a press release cited by Live Action News, argued that these loosened restrictions have come at a cost. "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 stated. She further contended, "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."
The lawsuit also takes aim at the FDA’s approval of Evita Solutions’ generic mifepristone, which Hanaway claims was granted without requiring new safety studies and relies on what she calls unsafe changes made in previous years. The filing asserts, "The supply of mifepristone will increase, the cost will decrease, and the number of chemical abortions will rise in Plaintiff States and across the nation." The states argue that the increased availability and lower cost of the drug will lead to a rise in chemical abortions, undermining their efforts to protect unborn life and maternal health.
Federal law, specifically the Comstock Act, prohibits the mailing of abortion drugs. However, as Live Action News reports, a nationwide mail-order abortion economy has developed, shipping these drugs to women in all 50 states without ensuring they receive in-person screening, follow-up care, or emergency medical support. This, Hanaway’s office contends, directly undermines state laws and burdens hospitals, emergency rooms, and taxpayers.
The safety of mifepristone remains a deeply contentious issue. According to the pro-life Guttmacher Institute, doctor-prescribed abortion pills have declined in states where abortion remains legal—a notable shift after years of rising numbers, largely attributed to the increased use of abortion pills. The Institute’s data, however, only captures abortions within states that do not fully protect preborn children, such as Texas. It does not account for abortion pills shipped into states with strict abortion bans from states with so-called shield laws, which block cooperation with out-of-state investigations and make tracking the drugs’ origins difficult.
Additionally, the numbers do not include pills distributed by illegal or unlicensed networks, whose activities are intentionally hidden from oversight. As a result, the true scale of abortion pill use—especially in states with restrictive laws—remains elusive. Despite official prescription numbers showing a decline, underground distribution may be much higher than reported.
Health concerns about mifepristone have fueled much of the legal and political action. Live Action News reports that over 1 in 10 women who take abortion pills end up in the emergency room, and that mifepristone’s known complications include severe cramping, contractions, heavy bleeding, nausea, vomiting, diarrhea, abdominal pain, and headaches. One cited study found the abortion pill to be four times more dangerous than a first-trimester surgical abortion, while another found serious adverse events occur at a rate approximately 22 times higher than what the FDA’s label reports. Despite these findings, the abortion industry continues to assert that the pill is "safer than Tylenol," a claim Hanaway dismisses outright: "No caring physician would call Mifepristone ‘as safe as Tylenol.’ That claim was always false. Women are ending up in emergency rooms, and manufacturers know it."
Meanwhile, the landscape for abortion access is shifting. The Guttmacher Institute reports an 8% decline in women traveling out of state for abortion in the first half of 2025 compared to the same period in 2024, a trend partly attributed to the increased availability of mail-order abortion pills and dwindling funds for abortion-travel networks. Data from the Texas Health and Human Services Commission indicates that the number of Texans traveling out of state for abortion dropped from 7,844 in 2023 to 7,010 in 2024—a 10% decline. While some see this as a victory for pro-life advocates, others note that thousands of Texans are still seeking abortions in states with fewer restrictions.
Looking ahead, the Woman and Child Protection Act (WCPA) is set to take effect in Texas on December 4, 2025. The law aims to crack down on abortion pill trafficking into the state, directly challenging shield laws and equipping authorities with new tools to shut down both overt and underground pill operations. Proponents of the WCPA hope it will lead to a meaningful drop in illegal abortion pill distribution, while critics argue it will further restrict access to reproductive healthcare.
The legal battle is also playing out on the federal stage. According to Live Action News, some abortion rights advocates and major outlets like The New York Times are calling on Congress to pass federal laws legalizing abortion nationwide, overriding state-level restrictions like the WCPA. At the same time, pro-life groups are urging the Trump administration to enforce the Comstock Act and halt the mailing of abortion pills across the country.
Evita Solutions, the manufacturer at the center of the current lawsuit, maintains that it "believes that all people should have access to safe, affordable, high-quality, effective, and compassionate healthcare, including abortion care," as reported by Reuters. The FDA, for its part, has stated that federal law requires approval of generic drugs when applications prove they are identical to brand-name versions. However, the agency and Evita did not respond to requests for further comment.
As the case moves forward in federal court, the outcome will likely have far-reaching implications for abortion access, states’ rights, and the role of federal agencies in regulating reproductive healthcare. With both sides entrenched and the stakes high, the nation watches closely as the fight over mifepristone enters a new and uncertain chapter.
