Safe Drug or Unsafe Criminal Act? The Mifepristone Showdown at the Supreme Court

Danco Laboratories, L.L.C. v. Louisiana | Nos. 25A1207, 25A1208 | Decided May 14, 2026 | Docket Link: Here

Overview: The Supreme Court blocked the Fifth Circuit's nationwide order reinstating mifepristone's in-person dispensing requirement, preserving mail-order and telehealth distribution while Louisiana's APA challenge to the FDA's 2023 REMS proceeds.

Question Presented: Whether the Fifth Circuit's §705 order suspending the FDA's 2023 mifepristone REMS changes should remain in effect pending appeal.

Posture: District court denied preliminary relief; Fifth Circuit reversed, suspending 2023 REMS nationwide under §705.

Main Arguments:

• Mifepristone Manufacturers (Applicants):

(1) Louisiana lacks Article III standing — the 2023 REMS does not regulate Louisiana, and its sovereign and Medicaid-cost injuries depend on attenuated third-party choices the Court rejected in Alliance and Texas;

(2) The FDA's removal of the in-person requirement rested on 15 studies covering 55,000 patients and consistent adverse-event data showing no safety concerns;

(3) The Fifth Circuit's order upends five years of settled distribution infrastructure, inflicting irreparable harm on manufacturers, patients, providers, and 20 states supporting the current REMS.

• Louisiana (Respondent):

(1) Louisiana holds sovereign standing — approximately 1,000 violations of its abortion laws occur monthly, each constituting an injury to its sovereignty under Stevens, reinforced by $92,000 in Medicaid costs and $17,000 in enforcement outlays;

(2) The FDA itself refuses to defend the 2023 REMS, conceding it reflected "inadequate consideration," and three separate Fifth Circuit panels found the APA challenge likely meritorious;

(3) Neither the public nor the FDA holds any interest in perpetuating an agency action the agency itself admits lacked adequate study, and the manufacturers' desire for higher profits does not constitute irreparable harm.

Ruling: 7–2. The Court issued an unsigned (per curiam) order granting the stay applications, blocking the Fifth Circuit's May 1, 2026 order.

Justice Thomas filed a dissenting opinion (unjoined). Justice Alito filed a separate dissenting opinion (unjoined). Stay granted pending disposition of the Fifth Circuit appeal and any timely certiorari petition.

Majority Reasoning: (1) The per curiam order provided no reasoning — the Court granted the stay applications without explaining which factors it found satisfied; (2) The order specified only procedural mechanics: what it stayed, conditions for termination, and the timeline; (3) The absence of reasoning left unresolved whether the Court credited the manufacturers' standing arguments, the APA merits defense, or the equities analysis.

Separate Opinions:

(1) Justice Thomas (dissenting): Mifepristone manufacturers derive their claimed injury from profits earned through a "criminal enterprise" violating the Comstock Act (18 U.S.C. §§1461, 1462). No court should protect revenue flowing from federal felonies.

(2) Justice Alito (dissenting): The manufacturers failed to demonstrate irreparable injury. The FDA won't enforce the old rules, the manufacturers devoted only 3 of 80-plus pages to irreparable harm, and lost sales in states banning abortion cannot count as cognizable injury because equity demands surrender of profits from unlawful activity.

Implications: This stay preserves nationwide mail-order and telehealth mifepristone distribution while the Fifth Circuit appeal and potential certiorari proceedings unfold. The unresolved standing question — whether states can challenge federal deregulation through sovereign-injury and downstream-cost theories — carries transformative potential for administrative law far beyond mifepristone.

Thomas's invocation of the Comstock Act signals at least one Justice views existing federal law as criminalizing mail-order mifepristone distribution regardless of FDA approval. The FDA's silence and its admission of "inadequate consideration" leave the agency's ultimate posture uncertain, giving Louisiana potent ammunition on the merits.

The Fine Print:

• 5 U.S.C. §705: "On such conditions as may be required and to the extent necessary to prevent irreparable injury, the reviewing court … may issue all necessary and appropriate process to postpone the effective date of an agency action or to preserve status or rights pending conclusion of the review proceedings."
• 18 U.S.C. §1461 (Comstock Act): Bans using "the mails" to ship any "drug … for producing abortion."

Primary Cases:

• FDA v. Alliance for Hippocratic Medicine (2024): Unanimous Court held anti-abortion doctors lacked Article III standing to challenge the mifepristone REMS — the chain of causation from FDA regulation to downstream medical costs stretched too far and too speculatively.
• United States v. Texas (2023): Court rejected states' claims that federal immigration enforcement policies caused cognizable Article III injuries through indirect effects on state revenues and spending — downstream costs from federal policies do not automatically confer standing.