Emergency Stay Preserving the FDA’s 2023 Mifepristone REMS Pending Review—Irreparable-Harm Limits and Comstock Act Warnings in Danco Laboratories, LLC v. Louisiana

Precedents Cited

1) Alliance for Hippocratic Medicine v. FDA, 78 F. 4th 210 (CA5 2023) (Ho, J., concurring in part and dissenting in part), rev'd on other grounds, 602 U. S. 367 (2024)

Justice Thomas invoked Judge Ho’s statement—“All of this violates the Comstock Act”—to support the proposition that mailing or shipping mifepristone “for producing abortion” fits within 18 U. S. C. §1461 and §1462(c). Although the Supreme Court’s later decision is described as “rev'd on other grounds,” Thomas relied on the Fifth Circuit writing to characterize the underlying conduct as plainly unlawful and therefore incapable of supporting equitable relief premised on lost profits.

2) FDA v. Alliance for Hippocratic Medicine, 602 U. S. 367 (2024)

Justice Alito used this case for two functions: (i) to recount REMS history (in-person dispensing for roughly two decades; nonenforcement in 2021; formal elimination in 2023), and (ii) to explain the legal effect of a §705 suspension. Quoting the Court’s earlier explanation, Alito stressed that a §705 order suspending an amendment generally reverts the operative requirements to the prior REMS regime, allowing continued sales but under the earlier conditions. That understanding undercut the manufacturers’ claims of regulatory chaos and supported Alito’s conclusion that alleged burdens were compliance inconveniences, not irreparable injuries.

3) Dobbs v. Jackson Women’s Health Organization, 597 U. S. 215 (2022)

Alito framed the controversy as an effort to circumvent state abortion prohibitions that Dobbs returned to state control. In his account, the mail-order distribution of mifepristone into Louisiana—bolstered by out-of-state “shield laws”—effectively frustrates Louisiana’s post-Dobbs enforcement choice. While Dobbs did not supply the technical stay standard, it served as the federalism backdrop informing Alito’s description of the public stakes.

4) Hollingsworth v. Perry, 558 U. S. 183 (2010) (per curiam)

Alito cited Hollingsworth for the fundamental requirement that a stay applicant must demonstrate irreparable injury. His dissent treated irreparable harm as a gatekeeping element: without it, the Court should deny a stay “regardless of how they fare on the other stay factors.”

5) Heckler v. Chaney, 470 U. S. 821 (1985)

In a footnote, Alito argued that even if Louisiana wanted to force the FDA to enforce an in-person requirement, the FDA could invoke Heckler to claim that nonenforcement is presumptively “committed to agency discretion” under 5 U. S. C. §701(a)(2), and thus generally unreviewable. This supported his prediction that the Fifth Circuit’s order might not change day-to-day realities for some time.

6) United States v. United Liquors Corporation, 77 S. Ct. 208 (1956) (Reed, J., in chambers)

Alito used this in-chambers decision to argue that alleged harm consisting of inability to engage in unlawful conduct (there, an unlawful conspiracy; here, sales into jurisdictions where “abortifacients are generally illegal”) does not qualify as irreparable injury warranting a stay.

7) Indiana State Police Pension Trust v. Chrysler LLC, 556 U. S. 960 (2009) (per curiam)

This precedent was cited for the principle that granting a stay is an exercise of equitable discretion. Alito used it to frame the inquiry as one where equitable doctrines—clean hands, public interest, and limits on protecting unlawful gains—matter.

8) Liu v. SEC, 591 U. S. 71 (2020)

Alito cited Liu to support the equitable proposition that profits from unlawful activity should be surrendered, not protected. That proposition reinforced his view that lost sales tied to allegedly illegal abortions cannot support emergency equitable relief.

9) Wisconsin Gas Co. v. FERC, 758 F. 2d 669 (CADC 1985) (per curiam)

Alito invoked Wisconsin Gas for the demanding standard that monetary injury typically is not irreparable unless it threatens “the very existence” of the business. He used it to critique the manufacturers’ thin showing on the magnitude and immediacy of any loss.

10) Zedner v. United States, 547 U. S. 489 (2006)

Justice Thomas drew from Zedner the proposition that the public interest is served by reducing an “opportunity to commit crimes.” Treating Comstock violations as the relevant “crimes,” Thomas concluded the public-interest factor decisively cuts against a stay.

Legal Reasoning

A) What the Court did—and did not—decide

The Court’s order grants a stay but provides no reasoning. As a result, the order primarily functions as a case-management device on the emergency docket: it preserves (for now) the regulatory status quo favored by the manufacturers (continued effect of the 2023 REMS changes) while the Fifth Circuit proceeds and potential Supreme Court review remains possible. Because the order is unreasoned and interlocutory, its value as a statement of doctrine is limited; the dissents, however, supply competing accounts of how conventional stay principles apply.

B) Justice Thomas’s dissent: Comstock illegality defeats irreparable harm and the public-interest showing

Thomas’s analysis turns on a threshold characterization: shipping mifepristone for abortion use violates the Comstock Act. He relies on 18 U. S. C. §1461 (mailing) and §1462(c) (express company/common carrier/interactive computer service) and then connects those prohibitions to the distribution chain described in the FDA’s REMS materials (shipping to certified pharmacies, followed by shipment to users).

From that premise, Thomas makes two interconnected stay-factor moves:

• No irreparable harm: Profit loss from a “criminal enterprise” cannot be “legally relevant” irreparable injury.
• Public interest: Courts should not use equitable relief to facilitate conduct that “serve[s] the public interest” to deter, invoking Zedner v. United States.

On this view, the stay standard collapses into legality: if the underlying distribution is criminal, equity cannot intervene to protect it.

C) Justice Alito’s dissent: no imminent irreparable harm because the Fifth Circuit’s §705 suspension likely changes little in practice

Alito’s irreparable-harm analysis does not depend on resolving Comstock’s reach. Instead, he argues that even if one focuses on regulatory consequences, the manufacturers have not shown that the Fifth Circuit’s order will imminently harm them. His reasoning is practical and temporally focused:

• Regulatory reality: The FDA declined to enforce in-person dispensing requirements even before the 2023 REMS changes, and the agency is conducting (and allegedly delaying) an internal safety review.
• Effect of §705: Under FDA v. Alliance for Hippocratic Medicine, suspending the 2023 changes would revert to the prior REMS framework rather than halt sales altogether.
• Inconvenience is not irreparable harm: Updating agreements and distribution logistics might be burdensome but were not quantified or shown to be existential.
• Unlawful-sales theory: To the extent alleged losses are in States where abortifacients are illegal, United States v. United Liquors Corporation and equitable principles (including Liu v. SEC) cut against treating those losses as irreparable.

Alito also situates the dispute in a federalism narrative: post-Dobbs state restrictions (like Louisiana’s) are being bypassed via mail-order abortion, aided by “shield laws” that obstruct interstate investigations, extradition, and cooperation.

D) Tension highlighted by the dissents

The dissents expose two different ways emergency relief can be resisted: (i) a legality-based bar (Thomas: Comstock illegality makes equitable relief inappropriate), and (ii) a practical irreparability bar (Alito: applicants did not show real, imminent harm because enforcement and compliance effects are speculative or manageable). The Court’s grant of a stay, without explanation, leaves it uncertain whether the majority disagreed with one or both frameworks—or simply reached a different assessment of the emergency posture.

Impact

1) Immediate procedural impact

The stay prevents the Fifth Circuit’s suspension from taking effect (for now), thereby keeping the 2023 REMS framework operative while the Fifth Circuit appeal and potential certiorari play out. Practically, that favors continued distribution models that do not require in-person dispensing, at least pending further judicial and administrative action.

2) Substantive signals despite an unreasoned order

Although the order itself is not a reasoned merits precedent, the dissents supply doctrinal and strategic “roadmaps” that can influence future litigation:

• Comstock revival as a litigation axis: Thomas’s dissent invites litigants and courts to treat the Comstock Act as a potentially decisive constraint on interstate medication-abortion distribution, independent of FDA regulatory policy.
• Emergency-docket discipline on irreparable harm: Alito’s dissent reinforces a stringent approach to irreparable-harm showings, especially where the predicted harm depends on uncertain agency enforcement behavior.
• Intergovernmental conflict: The discussion of “shield laws” previews likely clashes among States over information sharing, extradition, and cross-border enforcement—issues not resolved here but increasingly central to post-Dobbs disputes.

3) Prospective doctrinal flashpoints

If the underlying case reaches the merits (in the Fifth Circuit or the Supreme Court), the record described in Alito’s dissent suggests several likely battlegrounds:

• APA arbitrariness review of REMS modifications (including reliance on safety data and explanation adequacy).
• Scope and operation of §705 as an interim remedy against agency action.
• Interaction between FDA regulation and federal criminal statutes (Comstock), and the extent to which one affects the other.
• Federalism and extraterritorial enforcement problems arising from interstate telemedicine and mailing regimes.