Department of Justice moves to halt Florida's abortion pill lawsuit

Trump's Department of Justice (DOJ) has filed a legal motion asking a District Court in Texas to stay or dismiss yet another lawsuit seeking to challenge the FDA's approval of the abortion pill — this one filed by the States of Florida and Texas.

Key Takeaways:

• The lawsuit filed by Florida and Texas is challenging the "FDA’s initial approval of mifepristone in 2000, (2) the 2016 action, (3) the 2023 REMS Modification, and (4) FDA’s approval of generic equivalents in 2019 and 2025."

• As has been the case for other lawsuits challenging the FDA's rules and approvals regarding the abortion pill regimen, the Trump administration has asked the court to either stay the lawsuit or dismiss it entirely.

• The DOJ claims that the "FDA’s review will necessarily result in a new agency decision, which could, in turn, obviate the need to consider some or all of Plaintiffs’ claims."

The Details:

DOJ: Court should 'stay' case pending FDA’s mifepristone REMS review

Texas and Florida claim that "inadequate adverse event reporting" led to the undercounting of "true rates of risks associated with chemical abortion drugs," meaning that the risks are "therefore... unknown."

In February of this year, the FDA updated its website, claiming that it is "conducting a safety study of mifepristone" and that the "current agency plan is to have this study done sooner than" the typical year-or-more timeframe.

The DOJ's March 13, 2026 motion in State of Florida v. U.S. Food and Drug Administration argued, "The Court Should Stay This Case Pending FDA’s Mifepristone REMS Review."

"On December 9, 2025, Plaintiffs filed this suit challenging (1) FDA’s initial approval of mifepristone in 2000, (2) the 2016 action, (3) the 2023 REMS Modification, and (4) FDA’s approval of generic equivalents in 2019 and 2025."

The DOJ's March 2026 memorandum also pointed to the FDA's pending review:

Defendants respectfully move that this Court (1) stay this litigation pursuant to its inherent authority during the pendency of the U.S. Food and Drug Administration’s review of the mifepristone Risk Evaluation and Mitigation Strategy or, alternatively, (2) dismiss the Complaint under Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6). The grounds for this motion are set forth in the accompanying memorandum. March 13, 2026

DOJ: If no stay, then dismissal

The March 2026 Memorandum requested that if "if the Court does not stay this case" then "it should dismiss the Complaint for several reasons" including:

• Plaintiffs lack standing

• States’ alleged pocketbook injuries do not establish standing

• States failed to administratively exhaust their claim

• States’ challenges to FDA’s 2000, 2016, and 2019 actions are time-barred

"FDA’s review will necessarily result in a new agency decision, which could, in turn, obviate the need to consider some or all of Plaintiffs’ claims. Any party adversely affected by the new agency decision on mifepristone may seek judicial review at that time," the motion reads.

The Backstory:

The abortion pill, mifepristone (200mg)/Mifeprex, was approved by the FDA in 2000 for the termination of pregnancy in a regimen with a second drug, misoprostol. The abortion pill's mechanism of action blocks progesterone, which deprives the preborn baby of nutrients needed to survive.

• 2011: Following reports of serious adverse events, the drug was placed under a safety system known as REMS.

• 2016: Obama's FDA weakened the REMS by enabling the drug to be used up to 10 weeks gestation and removing the requirement that all adverse events other than death be reported. Those changes were pushed and financed by a pro-abortion coalition.

• 2023: Despite a prohibition under the federal Comstock Act, Biden's FDA eroded the REMS further to remove the in-person dispensing requirement and allow for mail order and pharmacy dispensing of the drug.

It has been made clear in litigation and court rulings that the decision to halt the reporting of non-fatal adverse events (complications) of the abortion pill in 2016 led to the faulty conclusion that the drug is safe, because there was an absence of non-fatal adverse event reports.

The Lawsuits:

In 2022, the Alliance for Hippocratic Medicine (AHM) challenged the FDA's abortion pill approval and erosions of REMS safety regulations. However, in 2024, the U.S. Supreme Court ruled that the plaintiff doctors in AHM did not have standing to sue, and they eventually dropped their challenge.

1. State of Louisiana v. FDA: The case, State of Louisiana v. Food and Drug Administration (FDA), et al. (along with Rosalie Markezich) was refiled in the Western District of Louisiana, Lafayette Division in October of 2025. In December of 2025, Louisiana filed for preliminary injunctive relief.

Louisiana contends that the drug's 2023 REMS (safety regulations) are...

• Arbitrary and capricious

• Violate the Comstock Act

• Cause Plaintiffs’ Current and Future Injuries in Fact

• Cause sovereign harm by facilitating illegal abortions in Louisiana.

• Cause economic harm by directly increasing Louisiana’s Medicaid costs.

Trump's FDA, which recently approved the second generic abortion pill, claimed Louisiana's lawsuit would "short circuit the [FDA]’s orderly review and study of the safety risks of mifepristone." It asked the courts to "stay judicial review" until the FDA completes its own review of the drug, which it claimed could be completed in less than a year.

• February 13, 2026: 21 states file in support of Louisiana, along with another brief from 60 lawmakers.

• February 17, 2026: Louisiana responds, accusing the FDA and the drug manufacturers of "try[ing] to scuttle the case on standing grounds."

• February 24, 2026: The case was heard in federal court before U.S. District Judge David Joseph.

2. State of Missouri v. FDA (which included the states of Idaho and Kansas) requested to intervene in the AHM lawsuit. Judge Matthew Kacsmaryk granted their intervention in January 2024 while the case was on appeal.

May 2025: Trump's FDA moved to dismiss based on improper venue, lack of standing, and failure to exhaust administrative remedies, and because some of their claims were barred by the statute of limitations.

August 2025: Judge Kacsmaryk moved the venue to Missouri.

The three states allege:

• "[T]he FDA cut corners when it removed safeguards from this dangerous drug."

• "Sticking its head in the sand, the FDA eliminated non-fatal reporting requirements for abortion providers based on data collected under the originally approved safety standards, leaving no way to fully evaluate the effects of the newly deregulated regime."

• "The FDA’s actions attempt to create a 50-state mail-order abortion drug economy, undermining state abortion laws in Plaintiff states. It also enabled providers to dispense abortion drugs to residents of Plaintiff States later in pregnancy without follow-up care—causing women to seek emergency services in Plaintiff States for treatment of resulting complications."

March 6, 2026: Danco moved to dismiss. The FDA also filed a motion to stay or dismiss the Missouri lawsuit.

3. State of Florida v. FDA (which included the State of Texas) first petitioned the court to intervene in August 2025. The lawsuit was refiled was  filed in the Northern District of Texas, Wichita Falls Division in December.

The most recent court document reads:

On December 9, 2025, Plaintiffs filed this suit challenging (1) FDA’s initial approval of mifepristone in 2000, (2) the 2016 action, (3) the 2023 REMS Modification, and (4) FDA’s approval of generic equivalents in 2019 and 2025.

Claims made by the two states in refiled court documents were similar to those previously made and detailed by Live Action News:

• The approval process was "political from the start."

• "States have the sovereign power to enact and enforce regulations on abortion."

• "The FDA’s actions seek to enable the violation of state laws restricting abortion."

• Telehealth and mail-order abortion was a "boon for sex traffickers" and mailing abortion pills to men has "facilitated the death[s] of multiple preborn children."

• States "have been forced to divert resources to address the explosion of abortion drugs mailed to their residents by abortionists operating under...'shield laws.'"

• "... The FDA’s actions have inflicted concrete economic injury on states as the payers and insurers of residents’ medical expenses."

• "Chemical abortions are often deleterious to mental health."

• The 2000 approval did not comply with the federal Comstock Act. 

On March 13, 2026, Trump's DOJ filed a motion to stay or dismiss. A March 2026 release published by GenBioPro, which is represented by Democracy Forward Foundation and Arnold & Porter, claims the generic pill manufacturer also filed a motion to intervene and a motion to dismiss in the case.

Things to Note:

HHS can suspend drug's application:

• In response to questions by the court in the Louisiana lawsuit, FDA admitted that "if the Secretary of Health and Human Services finds that a drug presents “an imminent hazard to the public health,” he may suspend the approval of the application (including a supplemental application) 'immediately.' 21 U.S.C. § 355(e)."

Complication data is unreliable:

• Data published to FDA's Adverse Event Reporting System (FAERS) has been relied upon to conclude the drug is "safe." But, despite abortion pill makers having policing power over prescribers of the drug, the abortion industry has for years executed an end-run around adverse event reporting (even before the 2016 reporting changes) by urging women to go to the ER (not back to the medical provider or prescriber) when experiencing abortion pill complications.

• Yet it was only the prescribers — not hospital ER staff — that were contractually obligated to report complications.

Real-world analysis reveals potentially high complication rate:

• Last year, insurance claims data analyzed by the Ethics & Public Policy Center (EPPC) suggested that the failure rate of mifepristone was nearly double what is currently listed on the FDA-approved drug label.

• In March 2026, additional analysis from EPPC suggested "the rate of serious adverse events following a chemical abortion (mifepristone) was significantly higher after the FDA’s in-person dispensing requirement was removed."

Federal Law Prohibits Mailing Abortion Drugs:

• The Federal Comstock Act (18 U.S.C. § 1461) already prohibits the mailing of “any article, instrument, substance, drug, medicine, or thing [that] may, or can, be used or applied for producing abortion[.]”

Go Deeper:

Questions published in Live Action News' "Dear FDA series" ask the FDA:

• Who paid for the removal of abortion pill safety protocols?

• Who is overseeing the abortion pill's prescribers?

• Why are you aiding the breaking of federal laws about abortion?

• Abortion pill manufacturers abet unlawful mailing of drugs into pro-life states