Trump FDA seeks pause on abortion pill lawsuit while it reviews drug's risks

The Food and Drug Administration (FDA) under the Trump administration has petitioned a federal court to pause the state of Louisiana's abortion pill lawsuit, which is seeking a review of the 2023 safety regulations on the drug.

The troubling motion comes just days after President Donald Trump and Vice President J.D. Vance spoke to pro-lifers gathered in Washington, D.C., for the annual March for Life. Both men previously stated they would not "block" the abortion pill, which has already ended the lives of over 7.5 million preborn babies since its original FDA approval just over 25 years ago.

Key Takeaways:

• Trump's FDA, which recently approved the second generic abortion pill, claimed Louisiana's lawsuit seeking to put a "stay" on the 2023 REMS safety protocols (which allowed mail-order and pharmacy dispensing of the abortion pill) would "short circuit the [FDA]’s orderly review and study of the safety risks of mifepristone."

• The FDA asked the courts to 'stay judicial review' until the FDA completes its own review of the drug, which it claims will be done in less than a year's time.

The Details:

On January 27, 2026, the FDA petitioned the Court to "stay all proceedings in this matter" while the agency "reviews the mifepristone Risk Evaluation and Mitigation Strategy."

The accompanying memorandum of law reads in part:

The Court should stay further litigation until after FDA’s mifepristone REMS review is complete and deny Plaintiffs’ motion without prejudice....

The rationale for deferring judicial review is simple: the “harm of moving forward” with judicial review of the 2023 REMS Modification outweighs the “harm of holding back.”

... And the same calculus confirms that granting preliminary relief would not be equitable at this time because it would disrupt FDA’s ongoing review.

In addition to a request that the Court "stay this case pending FDA’s review," the FDA's motion asked that the Court "deny Plaintiffs’ motion without prejudice."

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The Trump administration has asked a federal court to pause a Louisiana-led lawsuit seeking national restrictions on the abortion pill mifepristone, arguing that the FDA is already reviewing the drug’s safety and may independently impose new limits—making the case potentially

11:46 PM · Jan 27, 2026

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The Backstory:

Alliance Defending Freedom (ADF) filed the lawsuit, State of Louisiana v. FDA, on behalf of the State of Louisiana and Rosalie Markezich, a woman whose "ex-boyfriend ordered mifepristone from a California doctor, received it by mail, and coerced Rosalie to take it, ending her baby’s life."

The Plaintiffs challenged the 2023 REMS safety regulations on the abortion pill as "unlawful" and are seeking to "restore the in-person dispensing requirement."

The 2023 REMS essentially removed the in-person dispensing requirement for the drug, enabling the deadly abortion pill to be distributed by mail and in pharmacies. This created a 'wild west' of sorts, in which pro-abortion states have begun to shield abortion providers who mail the drugs into pro-life states.

In addition, mail-order dispensing enabled incidents of coercion in which pregnant women were given the deadly pills without their knowledge or consent:

"I felt pressured to take the pills" | Rosalie's Story

FDA to 'reconsider the restrictions on mifepristone'

FDA is citing its own review of the abortion pill (mifepristone) as a reason for requesting the stay, calling "the validity of FDA’s restrictions on mifepristone" a "hotly contested legal and scientific issue that has been the subject of litigation for many years":

Louisiana and Ms. Markezich are not the only plaintiffs to have challenged the current requirements for dispensing mifepristone. Indeed, five other states are challenging either the approval of mifepristone or subsequent actions easing restrictions...And aside from litigation, before the FDA are numerous citizen petitions—citing voluminous material and seeking mutually inconsistent relief, such as suspending approval of the drug, restoring previous REMS requirements, or eliminating the REMS entirely.

Given this widespread debate over the safety of mifepristone, FDA has concluded that the best path forward is for the agency to reconsider the restrictions on mifepristone based on all the evidence before the agency. As noted above, that evidence will include FDA’s own study. FDA has emphasized that it 'is taking care to do this study properly and in the right way.

FDA: Louisiana's request to stay REMS would "short circuit" review

At this time, “FDA continues to work on the collection of the robust and timely data that is necessary for a well-controlled study with adequate statistical power,” the FDA wrote:

Although studies like these “often take approximately a year or more to conduct,” FDA’s current plan is to complete the study “sooner than that timeframe.” And once FDA has analyzed the data from that study (as well as all other evidence before the agency), it will decide whether “substantive changes to the REMS” are necessary.

"Plaintiffs now threaten to short circuit the agency’s orderly review and study of the safety risks of mifepristone by asking this Court for an immediate stay of the 2023 REMS Modification approved three years ago," FDA claimed.

They would have this Court set aside the 2023 REMS Modification—all without the benefit of FDA’s expertise, and even as the agency is already reconsidering the matter in its review. And Plaintiffs’ requested relief may prove as unnecessary as it is disruptive, if FDA ultimately decides that the in person dispensing requirement must be restored.

FDA: Defer judicial review until agency's review is complete

The FDA asked the court to defer judicial review until its review of mifepristone is complete, claiming that "awarding preliminary relief to these Plaintiffs could easily prompt other plaintiffs to seek a conflicting injunction that would sow administrative and judicial chaos."

FDA went on to suggest that if the court hearings continue, it will "waste judicial resources." They alleged that it would not be "far fetched" for a back-and-forth "disruption" in the courts, with one side getting relief and the other filing for conflicting relief.

To prevent that disruption, the Court should exercise its inherent authority to stay this litigation pending the outcome of FDA’s review of the mifepristone REMS. FDA’s review will necessarily result in a new agency decision that could supersede the 2023 REMS Modification, obviating any need to consider the merits of Plaintiffs’ arguments challenging the validity of the 2023 REMS Modification.

Any party adversely affected by the new agency decision on mifepristone may seek judicial review at that time. And in the event of a further REMS modification, adherence to FDA’s normal process will create far less disruption than the abrupt, judicially imposed change sought by Plaintiffs.

FDA: Plaintiffs lack standing to challenge 2023 REMS

In its motion, the FDA claimed the Plaintiffs "lack standing" to challenge the 2023 REMS because these claims are "not traceable" to "defendant" (the FDA):

Louisiana suffers no sovereign injury because it remains free to make and enforce its pro-life policies after Dobbs v. Jackson Women’s Health Org...

Nor are Defendants standing in the way of Louisiana enforcing its abortion laws against out-of state prescribers of mifepristone.

Yet, the Plaintiffs have made several important points describing the harm the 2023 REMS has on the state, on the taxpayers, and on women, including the following:

• "Louisiana has suffered, and continues to suffer, a classic pocketbook injury from the 2023 REMS in the form of hundreds of thousands of dollars in increased Medicaid costs attributable to mifepristone-induced abortions that have required emergency care — costs that would not be incurred but for the 2023 REMS."

• "... Rosalie is not alone. Consider the well-known story of Margaret Carpenter, a New York doctor who mailed mifepristone to a Louisiana woman who forced the drug on her pregnant teenage daughter... The teen faced a medical emergency alone at home, called 911, and was rushed to the hospital in an ambulance after delivering a dead fetus..."

• "[C]onsider data from the Louisiana Department of Health showing that over $92,000 in Medicaid dollars were paid for emergency room care and hospitalization resulting from just two mifepristone-induced abortions in 2025..."

The FDA claimed:

Plaintiffs ask the Court to make the very sort of difficult scientific judgment about the 2023 REMS Modification that Congress entrusted to FDA while the agency itself is considering the same issues.

The agency suggested that if the Plaintiffs prevail before the FDA review is complete, "it could prompt the sponsors of mifepristone to file supplemental applications seeking modifications to the REMS."

The Context:

Three lawsuits involving six states are challenging the expansions of the abortion pill. The Alliance for Hippocratic Medicine (AHM) was the initial challenge; 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.

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

• May 2025: Trump’s Department of Justice (DOJ) called for dismissal of the lawsuit.

• August 2025: States of Texas and Florida first petitioned the court to intervene — and one month later (September 2025), Louisiana along with Rosalie Markezich filed a motion to do the same. Markezich claimed in her complaint that her boyfriend ordered abortion pills from a California provider and coerced her into taking the pills. Her baby died.

• August 2025: Judge Kacsmaryk denied motions by Texas, Florida, and Louisiana and moved the venue to Missouri.

• October 2025: Alliance Defending Freedom (ADF) refiled the lawsuit in State of Louisiana v. FDA (along with Rosalie Markezich) in the Western District of Louisiana, Lafayette Division.

• December 9, 2025: A new lawsuit, State of Florida and the State of Texas v. FDA, was filed in the Northern District of Texas, Wichita Falls Division.

• December 17, 2025: Louisiana filed for preliminary injunctive relief.

• January 27, 2026: FDA filed a motion to stay the case.

Go Deeper:

Live Action recently released a white paper documenting the history and horrors of the abortion pill, including Big Abortion's deliberate and lengthy scheme to hide adverse events from the FDA.