As red states and blue states battle over abortion regulations, the Show-Me State is charging a federal health agency with endangering the lives of women and unborn children and demanding that approval for a generic brand of the abortion pill be reversed. In late September, the Food and Drug Administration (FDA) quietly approved a generic version of the abortion drug mifepristone, inspiring outrage and drawing criticism from physicians and even Republican senators, who decried the move. The approval of a generic version of mifepristone, manufactured by Evita Solutions LLC, comes as the FDA is conducting a safety review of the brand-name mifepristone already available, Mifeprex.

Missouri Attorney General Catherine Hanaway (R) filed a lawsuit last week, challenging the abortion drug’s expansion. “This generic drug, produced by Evita Solutions LLC (Evita), is subject to the same REMS and labelling as the brand drug, Mifeprex, which is produced by Danco Laboratories, LLC (Danco),” Hanaway charged in the lawsuit, noting the numerous harmful side effects caused by Mifeprex. “The generic drug is chemically identical to Danco’s Mifeprex and GenBioPro, Inc.’s generic mifepristone. Consequently, this generic drug produces the same side effects, the same consequences, and the same devastating impact on women and girls nationwide.”

In order for a generic version of a drug to be approved by the FDA, Hanaway observed, the manufacturer “must show, among other things, that (a) the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug have been previously approved for a drug listed and (b) the drug product is chemically identical to the approved drug.” She continued, “This allows the generic drug manufacturer to rely on the FDA’s finding of safety and effectiveness for the reference drug.” The attorney general charged, “The labeling and REMS requirements governing mifepristone products are not based on rigorous review of health and safety risks the drug pose. To approve Evita’s generic drug, the FDA relied on only the unlawful and untested 2016 Major Changes labeling and the unlawful 2021/2023 Removal of the In-Person Dispensing Protection.”

In other words, in approving the generic brand of the abortion drug, the FDA relied on the same flawed safety standards and regulations (called REMS) that it is now investigating in relation to the name-brand abortion drug, Mifeprex. “Evita’s generic mifepristone tablets are chemically identical to Danco’s Mifeprex and GenBioPro’s generic mifepristone. Accordingly, Evita’s generic mifepristone brings with it the same side effects, risks, and harms to pregnant women and girls as Mifeprex and GenBioPro,” Hanaway pointed out. “Just as the FDA’s unlawful 2019 ANDA Approval led to an increase in the number of women obtaining chemical abortions, the FDA’s 2025 ANDA Approval will increase accessibility to chemical abortions,” she emphasized. “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.”

“Plaintiffs experience harm from the use of chemical abortions,” Hanaway wrote. “Accordingly, the FDA’s approval of another generic drug with the same chemical composition as Danco’s Mifeprex and GenBioPro’s generic mifepristone, aggravates and worsens Plaintiffs’ harms as it increases the accessibility of this dangerous drug to the detriment of pregnant women and children.” She charged that the “FDA lacked legal authority when issuing the 2025” approval of the generic abortion drug. “The FDA’s actions seek to enable the violation of state laws restricting abortion, as described in the Amended Complaint. But a federal agency cannot disregard applicable state law or seek to enable and encourage what state law expressly prohibits, so the FDA lacked legal authority and acted arbitrarily and capriciously when issuing the 2025 ANDA Approval,” Hanaway wrote. “Therefore,” the approval of the generic mifepristone “must be held unlawful, stayed, set aside, vacated, and preliminarily and permanently enjoined under the APA and the Court’s inherent equitable power to enjoin ultra vires actions…”

Appearing on Monday night’s episode of “Washington Watch,” Hanaway discussed what she hopes to achieve with the lawsuit and the threat mifepristone poses to women and unborn children. “Specifically, we’re asking that the courts halt the sale [of the generic version of mifepristone] until such time as there is a requirement that physicians be involved in delivering this care,” the attorney general reported. “There is a lot of harm being done to women. There’s a lot of harm being done to babies. There are alternatives to this that are much more responsible,” she continued. “And I would just ask that the FDA reconsider its approval of this drug and really think about the risk of just these pills showing up in the mail to these women coming from who knows what source, often sources outside the United States, and to protect these women and to protect the unborn and withdraw the approvals of these drugs.”

“We are very concerned about, particularly the drug mifepristone, which, you know, causes a chemical abortion often later in pregnancy, and that these women right now are not required to be seeing a doctor,” Hanaway said, referring to the weakening of the REMS guidelines surrounding the abortion drug. “And we’re terribly concerned for the health of the women, not only the fact that they’re terminating pregnancy, but that there’s real risk to the woman, that she could have side effects that could be life-threatening,” she continued. “Hospitals are seeing women who obviously have gone through this very traumatic experience of terminating a pregnancy, but then their body has to deal with the deceased fetus and expel that from their body,” the attorney general observed. “When it doesn’t go well, they may bleed out, they may seize, they may have a stroke. It’s a real threat to these women and their wellbeing, and if they don’t understand that it is the direct result of this drug, they might not seek medical attention right away.”

“I think it’s tragic that our culture has come to a point where a drug that ends the life of a baby is something that is sacrosanct and being protected by people,” Hanaway lamented. “If any other drug was killing people at a rate out of — well, killing anyone, and here we have it’s pretty much 100% effective against the babies. But then, to have one out of every 25 women having real critical health crises as a result, there’d be an uproar. And certainly the trial lawyers would be at the front of the line to capitalize on that.”

In comments to The Washington Stand, Joy Stockbauer, policy analyst at Family Research Council’s Center for Human Dignity, affirmed, “The pro-life movement absolutely wants to see the FDA revoke its approval for this new generic form of mifepristone, as well as all other approved forms.” She explained, “The latest data shows that 11 percent of women who take this drug experience serious complications from it. These complications are in addition to the emotional and spiritual trauma inflicted on a woman by undergoing an abortion at her own home, delivering her deceased unborn child into a toilet and being left to determine on her own whether her symptoms are serious.” Stockbauer continued, “Furthermore, it’s absurd to add more forms of mifepristone to the market when the versions already out there are being trafficked between states in violation of state and federal law, aiding countless abusers in forcing abortions on mothers without their consent or knowledge.”