Trump DOJ seeks to halt abortion pill lawsuit filed by three states

The Trump Administration's Department of Justice (DOJ) has filed a motion to stay ongoing litigation in an abortion pill lawsuit filed by the States of Missouri, Kansas, and Idaho against the Food and Drug Administration (FDA) while the agency's review of the drug continues.

The FDA and the abortion pill's manufacturers are requesting dismissal of the case entirely if the court will not issue a stay.

The move — which followed arguments before a U.S. District Court in a separate lawsuit filed by the State of Louisiana seeking an injunction on the 2023 REMS safety rule changes — prompted immediate outrage from pro-lifers, who accused the "Trump-Vance DOJ [of] "Sid[ing] With Abortion Drug Dealers Again."

Key Takeaways:

• The DOJ is asking a U.S. District Court to stay a lawsuit brought by Missouri, Kansas, and Idaho against the FDA for changing the abortion pill's safeguards.

• The states claim the REMS changes violate their sovereignty, causes them financial harms, and more. The removal of the in-person requirement for dispensing the drug regimen has led to numerous serious secondary issues these states are facing.

• The DOJ claims the lawsuit will "short-circuit" the FDA's ability to conduct an orderly review of the risks of the abortion pill.

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.

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.

Today, insurance claims data analyzed by the Ethics & Public Policy Center (EPPC) suggests that in the real world, the failure rate of mifepristone is nearly double what is currently listed on the FDA-approved drug label.

This information, along with the FDA's erosions of safety requirements for the abortion pill, has prompted multiple lawsuits, including Missouri's.

The Details:

In its filing, the DOJ claimed:

• The Plaintiffs' challenge "to FDA’s 2016 action is barred by the statute of limitations,"

• Despite Plaintiffs' allegations that "the challenged actions cause serious harms to women," these allegations do "not suffice to establish Article III standing."

The DOJ added:

Missouri, Kansas, and Idaho suffer no sovereign injury because they remain free to make and enforce their pro-life policies after Dobbs v. Jackson Women’s Health Org...

Nor are Defendants standing in the way of Intervenor Plaintiffs enforcing their abortion laws against out-of-state prescribers of mifepristone.

The States’ allegations about Medicaid costs rely on an even more attenuated chain of causation that the Supreme Court rejected in Alliance.

The FDA added that "if the Court does not stay this case, it should be dismissed."

Quick Recap:

The states of Missouri, Kansas, and Idaho 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."

The Other Side:

DOJ Acknowledges Abortion Pill Review

Arguing on behalf of the FDA, the DOJ acknowledged in its motion that a review of the abortion pill is necessary:

Protecting the health and safety of pregnant women is of paramount importance. To that end, on September 19, 2025, the Secretary of Health and Human Services and the Commissioner of Food and Drugs announced that the Food and Drug Administration (FDA) is reviewing the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, a drug approved for medical abortion....

The Secretary and the Commissioner explained that this review — which will include a study undertaken by FDA itself — is “informed by the lack of adequate consideration underlying prior REMS approvals.”

FDA’s review is rooted in the agency’s commitment “to protecting the health and safety of pregnant women” and “ensur[ing] . . . decisions are grounded in Gold Standard Science and rigorous, transparent, and objective evidence.”

Court Concerns Over Safety Erosions

"FDA’s decision to review the REMS for mifepristone is consistent with concerns foreshadowed by the Fifth Circuit in Alliance for Hippocratic Medicine v. FDA," the Court document read.

Those concerns are, as stated:

• Although ultimately reversed on jurisdictional grounds, the Fifth Circuit held that FDA erred in failing to consider the “cumulative effect” of changes, approved in 2016, to the REMS and labeling for mifepristone or “explain[] why it declined to do so.”

• The court also faulted FDA for approving, in 2016, the elimination of a requirement that certified prescribers report nonfatal, serious adverse events without first considering how other changes approved in the same supplement might affect the drug’s safety profile.

• And the court held that, in calling for the removal of the requirement that mifepristone be dispensed in person in certain healthcare settings (known as the “in-person dispensing requirement”) in December 2021, FDA erroneously “gave dispositive weight to adverse event data in” FDA’s Adverse Event Reporting System despite limitations of that data—including that, since 2016, prescribers were no longer required to report non-fatal serious adverse events to the sponsors....(faulting FDA’s reliance on studies that had “significant limitations” and “did not affirmatively support” eliminating the in-person dispensing requirement).

It continued:

In deciding to launch a new review of the mifepristone REMS, FDA recognized that mifepristone’s conditions of use are a hotly contested legal and scientific issue that has been the subject of litigation for many years. Missouri, Kansas, and Idaho are not the only plaintiffs to have challenged the current conditions of use for mifepristone.

Indeed, three other states are challenging either the approval of mifepristone or subsequent actions easing restrictions...

DOJ claim: Plaintiffs 'threaten to short-circuit the agency’s orderly review'

The DOJ wrote in part:

FDA has concluded that the best path forward is for the agency to undertake its review based on all the evidence before the agency.... Missouri, Kansas, and Idaho... threaten to short-circuit the agency’s orderly review and study of the safety risks of mifepristone.

They would have this Court set aside the FDA actions modifying the conditions of use (including the REMS) and approving generic equivalents as far back as 2016—without the benefit of FDA’s new review of the mifepristone REMS. And Intervenor Plaintiffs’ requested relief may prove as unnecessary as it is disruptive, if, for example, FDA ultimately decides that the REMS requirements previously in place must be restored.

Moreover, awarding relief to these Plaintiffs could easily prompt other plaintiffs to seek a conflicting injunction that would sow administrative and judicial chaos....The prospect of conflicting injunctions is hardly far-fetched.

"To prevent that disruption, the Court should exercise its inherent authority to stay this litigation pending the outcome of FDA’s review," the DOJ added.

Timeline:

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.

• November 2023: Missouri, Kansas, and Idaho moved to intervene in AHM as plaintiffs.

• January 2024: while the case was on appeal, the district court (per Judge Kacsmaryk) granted their intervention.

• October 2024: A lawsuit was filed by Missouri Attorney General Andrew Bailey, alongside GOP attorneys general in Kansas and Idaho, asking a judge in Texas to order the FDA to reinstate restrictions on mifepristone.

• January 2025: Judge Matthew Kacsmaryk ruled that the states of Missouri, Kansas, and Idaho could intervene in the AHM lawsuit and file a complaint in Amarillo, Texas.

• 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.

• May 2025: The Ethics and Public Policy Center (EPPC) published an analysis, “The Abortion Pill Harms Women

The Bottom Line:

The abortion pill is the number one killer of preborn children today, ending the lives of an estimated 2,000 or more preborn babies each day. For that reason alone, the abortion pill should be removed.

However, a state's sovereignty to enforce pro-life legislation, federal prohibitions on the mailing of abortion drugs, and the abortion pill's harms to women should also be considered.