Florida, Texas Again Sue FDA Over Abortion Pill Approvals (2)

The federal Food and Drug Administration acted unlawfully when it approved, then eased safety restrictions on, the abortion-inducing drug mifepristone, Florida and Texas say in a new lawsuit against the agency.

The states are asking the US District Court for the Northern District of Texas to declare unlawful and set aside five agency actions, including mifepristone’s 2000 approval, changes allowing the drugs to be sent through the mail and distributed by pharmacies, and two approvals of generic versions. These actions violated the Administrative Procedure Act because they were arbitrary, capricious, an abuse of discretion, and not in accordance with law, the state said.

The “approval and deregulation of abortion drugs have placed women and girls in harm’s way,” leading to complications ranging from severe bleeding to death, the states said. “These are tragic but predictable consequences of prioritizing politics over public health,” they said.

Medication abortion has long been widely used. Guttmacher Institute said that over 60% of US abortions in 2023 involved medication abortion, up from 53% in 2020. What’s more, in an earlier US Supreme Court battle over the drug, a number of medical groups banded together in a brief to defend access to the medication.

In September, after promises from the Trump administration to review mifepristone safety and efficacy, the FDA surprised many by greenlighting another generic version, triggering anti-abortion conservatives to criticize the agency.

In Tuesday’s lawsuit, Florida and Texas say this year’s generic approval, along with another one from 2019, ran afoul of the Federal Food, Drug, and Cosmetic Act as “they lacked the clinical investigations, adequate testing, sufficient information, and substantial evidence to show the safety and effectiveness of mifepristone under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof as required” under US Code.

The FDA didn’t immediately respond to a request for comment.

Delayed Data

The case is one of several that have challenged the approval, sale, and distribution of abortion-inducing pills, including one recently transferred from Texas to Missouri.

Florida and Texas had tried tacking on to that case to establish venue before it transferred, though the judge shot down the request as the case changed venues. Louisiana had likewise tried intervening.

Louisiana then sued in the US District Court for the Western District of Louisiana in an effort to stop the mailing of mifepristone into its state.

The issue is reaching a head now that the pills are the top method of ending a pregnancy throughout the US, and leading anti-abortion states are adopting measures to keep pills from crossing their borders.

The states alleged the agency improperly used an accelerated approval process to bring mifepristone to market during the Clinton administration. Subsequent changes lifting restrictions on mailing the drugs violate another federal law, the Comstock Act, they said.

The lawsuit comes as reports surfaced that the FDA was delaying a long-awaited review of mifepristone safety data.

FDA commissioner Marty Makary and US Department of Health and Human Services Secretary Robert F. Kennedy Jr. previously told lawmakers and state attorneys general that they were reviewing the drug.

Plans to reconsider mifepristone safety coincided with the release of a widely criticized report from the conservative think tank the Ethics & Public Policy Center. According to the EPPC study, 1 in 10 users of the drug experienced an adverse event.

The Florida and Texas attorney generals’ offices represent the states.

The case is Florida v. US Food & Drug Admin., N.D. Tex., No. 25-cv-126, complaint filed 12/9/25.