District Judge Matthew J. Kacsmaryk issued a preliminary injunction suspending the approval of mifepristone on April 7, 2023; on appeal by the government to the Fifth Circuit, the Fifth Circuit partially reverted Kacsmaryk's injunction, allowing the drug's 2000 approval to stand, but putting on hold changes to the FDA's distribution rules on the drug that were put in place in 2016, including distribution by mail.

On April 13, that judge issued another order, purporting to force FDA to maintain approval regardless of the Texas or Fifth Circuit ruling.

The Supreme Court of the United States ruled unanimously on June 13, 2024 that the Alliance did not have association standing under Article III to bring a case, since neither AHM nor the groups it represented had shown injury.

[6][7] Another REMS change was made in January 2023, allowing pharmacies approved by mifepristone manufacturers to also distribute the drug.

[3][9][10][11][12][13] In order to restrict abortions, several states also passed laws imposing additional regulation on dispensing of mifepristone-misoprostol.

[22] The original defendants are the FDA, Commissioner of Food and Drugs Dr. Robert Califf, Principal Deputy Commissioner Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research Dr. Patrizia Cavazzoni, the Department of Health and Human Services, and HHS Secretary Xavier Becerra.

Kacsmaryk then ruled that the Administrative Procedure Act's six-year statute of limitations—which would normally have started in 2016, when one of the plaintiff's review petitions was rejected—was "reopened" in 2016 and again in 2021, when the FDA increased access to the drug.

First, they stated that their primary author, James Studnicki of the Charlotte Lozier Institute, itself the research branch of the Susan B. Anthony Pro-Life America organization, did not properly cite his potential conflict of interest in performing the studies.

[29][30][note 3] Late on April 12, 2023, a three-judge panel of the Fifth Circuit—consisting of Judges Catharina Haynes, Kurt D. Engelhardt, and Andrew Oldham—issued an order regarding the stay motion.

The opinion stated that "it would be difficult for [the FDA] to argue that" the 2016 changes to the REMS "were so critical to the public given that the Nation operated—and mifepristone was administered to millions of women—without them for sixteen years following the" original approval, and thus that that was no reason to put them on hold.

The limitations remained on hold with the federal government appealing the decision to the United States Supreme Court.

[43] Some, including Senator Ron Wyden (D–OR) and Congresswoman Alexandria Ocasio-Cortez (D–NY), called for the Biden administration to ignore the ruling and continue to distribute mifepristone, while others, such as Senators Chuck Schumer (D–NY) and Patty Murray (D–WA), cautioned that the government should allow the appeals process to proceed before taking any action to avoid risking the judicial process.

Kacsmaryk is a "devout Christian" and reliably conservative jurist, who has struck down several Biden administration policies on issues of immigration, LGBT rights, and abortion.

[46][48][49] Media outlets noted that Kacsmaryk's opinion contained several instances of language employed by anti-abortion movements.

"[52][53] Axios wrote that Kacsmaryk's ruling "strays from offering accurate health information from some of the largest medical organizations in the nation".

[51] The Washington Post described Kacsmaryk's ruling as repeatedly citing data collected from researchers affiliated with the anti-abortion Charlotte Lozier Institute, and also "cites research based on anonymous blog posts, cherry picks statistics that exaggerate the negative physical and psychological effects of mifepristone, and ignores hundreds of scientific studies attesting to the medication's safety.

[54] The American Psychological Association instead reported: "Large longitudinal and international studies have found that obtaining a wanted abortion does not increase risk for depression, anxiety, or suicidal thoughts.

[note 5] The Washington lawsuit had been raised due to changes in the REMS for mifepristone in January 2023, restricting the previously open access of the drug.

Justices Alito and Thomas were seen to support that there was standing and asked questions related to the rationale for overriding the FDA.

The Alliance's claims that it might treat patients who suffered complications from using mifepristone were also rejected, as Kavanaugh wrote "Federal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences — and therefore breaks any chain of causation between FDA’s relaxed regulation of mifepristone and any asserted conscience injuries to the doctors.

[67][68] Near the end of 2024, the states of Idaho, Kansas and Missouri filed a new lawsuit in the Northern District of Texas to challenge the FDA's newer rules on offering mifepristone via telemedicine and other aspects.