Missouri Sues FDA to Block Abortion Drug Expansion
Caroline MolloyAs 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.”
