Texas and Florida have launched a sweeping new challenge to the Food and Drug Administration’s approval and deregulation of abortion pills, accusing federal health officials of putting politics over women’s safety and violating multiple federal laws to push chemical abortions nationwide.
In a 120-page complaint filed in the Northern District of Texas, the states of Florida and Texas sued the FDA and the Department of Health and Human Services as well as FDA Commissioner Martin Makary, CDER Director Richard Pazdur, and HHS Secretary Robert F. Kennedy Jr. in their official capacities.
The lawsuit targets the agency’s original 2000 approval of the abortion drug mifepristone (Mifeprex), later generic approvals in 2019 and 2025, and a series of major rule changes that loosened safeguards and enabled mail-order chemical abortions.
The states argued that the FDA’s actions have “placed women and girls in harm’s way” by authorizing a two-drug regimen—mifepristone followed by misoprostol—that intentionally ends the life of an unborn child and carries serious risks to mothers, including severe bleeding, undetected ectopic pregnancy, sepsis, emergency surgery, and in some cases death.
The states are asking the court to set aside the challenged approvals and dispensing changes as unlawful under the Administrative Procedure Act, the Food, Drug, and Cosmetic Act, the pediatric research statute (PREA), and the federal Comstock Act.
The complaint traces what it calls the political origins of mifepristone’s approval back to President Bill Clinton’s promise to abortion activists to bring the RU‑486 pill to the U.S. market.
It cites internal Clinton-era memoranda from HHS describing mifepristone as a “political issue” important to “pro-choice and women’s groups” and warning that delaying approval could “weaken [the administration’s] political base.”
According to the lawsuit, the administration pressured the European patent-holder to transfer rights to the Population Council, which then timed its application so that the FDA could approve the drug after the 1996 elections.
To meet those political goals, the lawsuit says, the FDA used Subpart H—an expedited pathway reserved for drugs treating “serious or life-threatening illnesses” and offering a meaningful therapeutic edge—to approve Mifeprex in 2000, despite the fact that pregnancy is not a disease and surgical abortion already existed.
The complaint alleges the clinical trials were not blinded, randomized, or properly controlled and that the FDA lacked adequate data to conclude mifepristone was safe and effective under real-world conditions, making the 2000 approval arbitrary, capricious, and contrary to law.
Recognizing the risks, the FDA’s 2000 approval came with strict conditions later formalized in a Risk Evaluation and Mitigation Strategy (REMS), including a 49-day gestational limit, in-person dispensing by a qualified physician, three required office visits, and mandatory reporting of serious adverse events such as hospitalization and transfusion.
The FDA itself, the complaint noted, said these safeguards were “necessary” to ensure the drug’s benefits outweighed its risks of serious complications.
The states argued that beginning under President Barack Obama and accelerating under President Joe Biden, the FDA systematically dismantled these protections without the required safety evidence.
In 2016, the agency extended use to 70 days’ gestation, eliminated the in-clinic misoprostol visit and the in-person follow-up exam, allowed non-physicians to dispense the pills, and dropped most adverse-event reporting—all without new, adequate, and well-controlled studies under the loosened conditions or a lawful pediatric safety assessment.
After 2020, the FDA went further, authorizing abortion drugs to be shipped by mail and dispensed at retail pharmacies rather than medical offices.
Florida and Texas say those 2021 and 2023 “dispensing changes” openly conflict with the federal Comstock Act, which prohibits mailing or common-carrier delivery of items “designed, adapted, or intended for producing abortion.”
They argue that the FDA had a duty to align its regulations with those criminal prohibitions, including by restricting the upstream distribution of abortion pills from manufacturers to prescribers, but instead “gutted” the remaining REMS in defiance of federal law.
The complaint also targets the FDA’s 2019 and 2025 generic approvals of mifepristone, saying the agency “piggybacked” on the flawed Mifeprex approval without resolving underlying safety and legal problems and thus exceeded its authority under the Food, Drug, and Cosmetic Act.
Florida and Texas devote a significant section to claims under the Pediatric Research Equity Act (PREA), accusing the FDA of unlawfully waiving or retroactively recharacterizing pediatric study requirements when it first approved mifepristone. The 2000 approval, they point out, purported to “waive” pediatric studies, even though the statute allows waivers only in limited circumstances and requires specific findings that were never made.
Years later, in 2016, FDA claimed it had not waived the requirement after all but instead extrapolated from adult data to post-menarchal girls—a move the states say was illegal, because pregnancy is not a “disease” and the underlying adult studies were not “adequate and well-controlled.”
The suit argued that approving widespread use in minors without proper pediatric assessment was arbitrary, capricious, and beyond the agency’s statutory authority.
Texas and Florida say they have sovereign and quasi-sovereign interests in protecting their citizens, enforcing pro-life laws, and preventing avoidable harms and healthcare costs from dangerous federal drug policies. They highlight data showing high complication rates for chemical abortions and note that the FDA’s own labeling predicts roughly one in 25 users will require emergency care, with at least one woman in the U.S. dying each year from abortion pill complications.
The states have asked the court to declare the 2000 approval of Mifeprex, the 2016 “major changes,” the 2019 and 2025 generic approvals, and the 2021–2023 mail and pharmacy dispensing changes unlawful and to vacate them under the Administrative Procedure Act.
If the states succeed, access to abortion pills nationwide—including via mail-order distribution—could be dramatically curtailed or halted entirely.
