Danco Asks Supreme Court To Halt Mifepristone Order

The emergency application asks the justices to freeze a Fifth Circuit ruling that would restore in-person dispensing limits while Louisiana's FDA challenge continues.

WASHINGTON, D.C. - Danco Laboratories asked the Supreme Court on Saturday to block a Fifth Circuit order that would restore national in-person dispensing limits for mifepristone, the abortion and miscarriage medication at the center of another emergency fight over federal drug regulation.

The company, which makes Mifeprex, filed an emergency stay application in Supreme Court docket 25A1207 after the Fifth Circuit granted Louisiana's request to stay the FDA's 2023 Risk Evaluation and Mitigation Strategy change while the appeal proceeds. Danco also asked for an immediate administrative stay while the justices consider the full application.

The dispute turns on who controls access rules for an FDA-approved drug after Dobbs v. Jackson Women's Health Organization: the federal agency that approved mifepristone in 2000, states that restrict abortion, or courts reviewing whether the agency explained its safety judgment under the Administrative Procedure Act.

The Story So Far

The FDA approved mifepristone in 2000 and later placed the drug under a REMS program, according to the agency's 2023 Center for Drug Evaluation and Research summary review. The 2023 change removed a requirement that patients obtain mifepristone in person and allowed dispensing by certified pharmacies, including mail-order pharmacies, when other REMS conditions were met.

FDA reviewers said they considered REMS assessment data, adverse event reports, and published literature before approving the change. The agency acknowledged limits in some mail-dispensing studies, but concluded that the overall record supported removing the in-person requirement while keeping prescriber certification, patient agreement forms, pharmacy certification, and other controls.

"Therefore, to reduce the burden imposed by the REMS, the Mifepristone REMS Program should be modified to remove the in-person dispensing requirement." - FDA Center for Drug Evaluation and Research, 2023 summary review

Louisiana challenged the 2023 REMS change under the Administrative Procedure Act in 2025, according to the Fifth Circuit order included in Danco's Supreme Court appendix. The state argued the FDA's mail-dispensing policy made it easier for out-of-state prescribers to send mifepristone into Louisiana despite state abortion restrictions.

What's Happening Now

The Fifth Circuit panel, Judges Leslie Southwick, Stuart Kyle Duncan, and Kurt Engelhardt, granted Louisiana's request to stay the 2023 REMS change while the appeal continues. Judge Duncan wrote that Louisiana had standing and that the FDA's action likely failed arbitrary-and-capricious review.

"By ending the in-person dispensing requirement, FDA opened the door for mifepristone to be remotely prescribed to Louisiana women. The record shows that the policy now facilitates nearly 1,000 illegal abortions in Louisiana per month." - Fifth Circuit order in State of Louisiana v. FDA, May 1, 2026

The panel also said the 2023 REMS was likely unlawful because the agency did not adequately justify removing the in-person dispensing requirement. In a sentence now likely to anchor Danco's emergency response, the court called the FDA action "a textbook example of arbitrary and capricious agency action."

Danco told the Supreme Court that the Fifth Circuit order would disrupt the existing regulatory structure for Mifeprex before final appellate review. The company's application says it is an intervenor-defendant alongside federal defendants and asks the justices to keep the 2023 rules in place while the litigation continues.

"Danco respectfully files this application to stay the judgment of the United States Court of Appeals for the Fifth Circuit." - Danco Laboratories emergency stay application, May 2, 2026

The immediate question is procedural. The Supreme Court can issue an administrative stay quickly, request responses from Louisiana and the federal government, deny relief, or keep the Fifth Circuit order frozen while the justices weigh a fuller stay request.

The Conservative View

Louisiana Attorney General Liz Murrill and Alliance Defending Freedom framed the Fifth Circuit order as a state-law enforcement victory. ADF said Louisiana asked the court to stop mail-order mifepristone from reaching states that protect unborn children while the appeal proceeds.

ADF Of Counsel Erin Hawley said the FDA's 2023 decision was not a neutral safety judgment, but an attempt to override state abortion restrictions after Dobbs. Her statement argued that restoring in-person dispensing protects both women and state authority.

"The Biden FDA's unlawful authorization of mail-order abortion drugs was meant to nullify state laws that protect life." - Erin Hawley, Alliance Defending Freedom Of Counsel

Murrill said the ruling ends what she described as illegal mail-order abortion-pill access into Louisiana during the case. ADF's statement also cites Rosalie Markezich, a Louisiana woman represented by ADF attorneys, as an example of coercion risks that the group says grow when pills are obtained remotely.

"Today, that nightmare is over thanks to the hard work of my office and our friends at Alliance Defending Freedom." - Liz Murrill, Louisiana Attorney General

The Progressive View

The ACLU said the Fifth Circuit order would restore a nationwide requirement that patients obtain mifepristone in person at a health center, rather than by mail or through a certified pharmacy after telemedicine care. The group said that change would affect abortion and miscarriage care even in states where abortion remains legal.

Julia Kaye, senior staff attorney for the ACLU Reproductive Freedom Project, said the order would hit patients who already face travel, privacy, disability, or safety barriers. The ACLU also cited telemedicine use data and said more than one in four U.S. abortion patients use telemedicine.

"Anti-abortion politicians have just made it much harder for people everywhere in the country to get a medication that abortion and miscarriage patients have been safely using for more than 25 years." - Julia Kaye, ACLU Reproductive Freedom Project senior staff attorney

The ACLU said the Fifth Circuit ruling would affect care beyond abortion because mifepristone is also used in miscarriage treatment. Its statement said patients could be forced to travel long distances to pick up a pill if the Supreme Court does not block the order.

Other Perspectives

The institutional dispute is narrower than the political fight. The FDA said in 2023 that removing the in-person dispensing requirement was justified by its review of the safety record and that other REMS requirements would remain. The Fifth Circuit said Louisiana was likely to show the agency did not adequately explain that decision.

Danco's position focuses on regulatory stability and emergency relief. The company argues that the Fifth Circuit should not force immediate national changes to a drug's distribution rules before the Supreme Court can review the legality of the order.

A libertarian reading centers on administrative power and federalism. One side argues the FDA should not use national drug rules to blunt state abortion laws; the other argues states should not use emergency litigation to change FDA access rules for patients in every state before final judgment.

Photo by U.S. Food and Drug Administration, via Wikimedia Commons (public domain)

Economic Implications

The direct economic stakes fall on patients, providers, pharmacies, and manufacturers rather than broad financial markets. If the Fifth Circuit order takes effect nationally, clinics and telemedicine providers would have to adjust workflows around in-person pickup, pharmacy dispensing, and patient travel, according to the ACLU's description of the practical effects.

Danco's emergency application frames the business impact as regulatory disruption for Mifeprex, not just litigation risk. The company says the Fifth Circuit order would alter the federal regime under which the product is prescribed and dispensed while the appeal is still pending.

The scale matters because medication abortion is no longer a small part of abortion care. The Guttmacher Institute's Monthly Abortion Provision Study said there were about 642,700 medication abortions in the formal U.S. health care system in 2023, accounting for 63% of all abortions in that system, up from 53% in 2020.

By the Numbers

• 25A1207: The Supreme Court emergency docket number for Danco's stay application.
• 2023: The year FDA made the REMS change that removed the in-person dispensing requirement permanent.
• Nearly 1,000: The Fifth Circuit's description of monthly illegal abortions in Louisiana that it said the policy facilitates.
• 642,700: The number of medication abortions in the formal U.S. health care system in 2023, according to the Guttmacher Institute.
• 63%: Medication abortions' share of U.S. abortions in the formal health care system in 2023, according to Guttmacher.

What People Are Saying

"Based on the literature identified by our review, dispensing mifepristone by mail from the clinic or from a mail order pharmacy does not appear to jeopardize the efficacy of medical abortion." - FDA Center for Drug Evaluation and Research, 2023 summary review

"This is a textbook example of arbitrary and capricious agency action." - Fifth Circuit order in State of Louisiana v. FDA, May 1, 2026

"This was a reckless political action that destroys unborn life, puts women's safety in serious jeopardy, and completely subverts state law." - Erin Hawley, Alliance Defending Freedom Of Counsel

"If the U.S. Supreme Court does not block this ruling, the Fifth Circuit's order will upend how miscarriage and abortion care are currently delivered across the country." - American Civil Liberties Union statement, May 2026

The Big Picture

The Supreme Court's first move may decide whether the Fifth Circuit order changes mifepristone access immediately or stays on hold while briefing continues. The federal government may also file its own emergency application or response, because the challenged action is an FDA rule.

The case gives the justices another emergency-stage test of abortion policy after Dobbs, but the legal question arrives through administrative law. Louisiana says the FDA failed to justify a national mail-dispensing policy that undermines state abortion restrictions. Danco and abortion-access advocates say the Fifth Circuit order would impose nationwide consequences before the legality of the 2023 REMS is finally resolved.

If the Court grants an administrative stay, the existing 2023 REMS framework remains in place for now. If it denies relief, patients, prescribers, certified pharmacies, and manufacturers will face a rapid shift back toward in-person dispensing while the Fifth Circuit appeal continues.