Section 705 Stays When FDA Concedes Procedural Deficits: State Standing and the Public Interest Against Unlawful REMS Deregulation

Case: State of Louisiana v. FDA (5th Cir. May 1, 2026) (No. 26-30203)
Court: United States Court of Appeals for the Fifth Circuit
Posture: Motion for stay pending appeal under 5 U.S.C. § 705 of FDA’s 2023 REMS for mifepristone

1. Introduction

This Fifth Circuit decision arises from the post-Dobbs v. Jackson Women's Health Organization, 597 U.S. 215 (2022), regulatory landscape. After Dobbs “returned the regulation of abortion to the states,” the Executive Branch directed agencies to “expand access to . . . medication abortion” through Exec. Order No. 14076, 87 Fed. Reg. 42053 (July 8, 2022).

The Food and Drug Administration (FDA) progressively reduced the “guardrails” governing mifepristone through REMS (Risk Evaluation and Mitigation Strategies), culminating in the 2023 REMS, which removed any in-person dispensing requirement and allowed online prescribing and mail dispensing. Louisiana—through its Attorney General and a co-plaintiff—filed an APA challenge, alleging FDA’s safety rationale was unsupported by sound data, and documenting alleged downstream effects: illegal medication abortions in Louisiana and Medicaid expenditures for emergency care associated with complications.

The district court found Louisiana (i) had standing, (ii) was likely to succeed on the merits, and (iii) faced irreparable harm, yet it denied interim relief after balancing equities and public interest, and it stayed the case while FDA conducted a “comprehensive review.” Louisiana appealed and sought a stay pending appeal under 5 U.S.C. § 705.

Key issues:

  • Whether Louisiana must first seek a stay from the district court under Fed. R. App. P. 8.
  • Whether Louisiana failed to administratively exhaust its claims.
  • Whether Louisiana has Article III standing (sovereign injury; Medicaid expenditures).
  • Whether the § 705 stay factors favor postponing the effective date of the 2023 REMS pending appeal.
  • Whether the practical nationwide effect of a § 705 stay conflicts with Trump v. CASA, 606 U.S. 831 (2025).

2. Summary of the Opinion

The Fifth Circuit (Duncan, J.) granted Louisiana’s motion to stay the 2023 REMS under 5 U.S.C. § 705 pending appeal. It held:

  • FRAP 8: Louisiana was not required to re-seek a stay in district court because doing so would have been “impracticable” after the district court already denied a § 705 stay and stayed the entire case. (Whole Woman's Health v. Paxton, 972 F.3d 649 (5th Cir. 2020)).
  • Exhaustion: Administrative exhaustion was not required; the court relied on reasoning from All. for Hippocratic Med. v. FDA (Alliance I), No. 23-10362, 2023 WL 2913725 (5th Cir. Apr. 12, 2023), and All. for Hippocratic Med. v. FDA (Alliance II), 78 F.4th 210 (5th Cir. 2023), rev'd on other grounds, 602 U.S. 367 (2024).
  • Standing: Louisiana showed (i) sovereign injury because the 2023 REMS “sanctions and facilitates” conduct intended to undermine Louisiana’s abortion restrictions, and (ii) financial injury through Medicaid expenditures for emergency care allegedly linked to out-of-state prescribed mifepristone.
  • Merits & irreparable harm: Louisiana made a “strong showing” of likely APA success and irreparable harm; FDA did not contest merits and had conceded “procedural deficits.”
  • Equities & public interest: Neither the public nor FDA has an interest in enforcing likely unlawful regulation; FDA’s ongoing review does not justify leaving the challenged regime in place indefinitely.
  • Nationwide effect: The practical nationwide effect of a § 705 stay is not in tension with Trump v. CASA, which addressed equitable relief and expressly did not resolve APA vacatur/remedy questions.

3. Analysis

3.1 Precedents Cited

A. The mifepristone litigation backdrop: the “Alliance” cases

  • FDA v. All. for Hippocratic Med. (Alliance III), 602 U.S. 367 (2024)
    The Supreme Court reversed earlier Fifth Circuit decisions on standing grounds (physicians lacked standing). The Fifth Circuit here distinguished Alliance III on injury causation/attenuation: unlike doctors’ speculative monetary injuries in Alliance III, Louisiana offered “hard evidence” of Medicaid outlays tied to emergency care allegedly caused by out-of-state mifepristone. The court also emphasized Alliance III did not address state Medicaid injuries.
  • All. for Hippocratic Med. v. FDA (Alliance I), No. 23-10362, 2023 WL 2913725 (5th Cir. Apr. 12, 2023) and All. for Hippocratic Med. v. FDA (Alliance II), 78 F.4th 210 (5th Cir. 2023), rev'd on other grounds, 602 U.S. 367 (2024)
    Although reversed on standing, the panel treated their reasoning on exhaustion and APA defects as persuasive and applicable. Substantively, Alliance II supplied the template APA critiques: FDA’s reliance on a lack of adverse-event reports after eliminating reporting requirements, and FDA’s reliance on literature it admitted did not affirmatively support the mail/remote model.
  • All. for Hippocratic Med. v. FDA, 668 F. Supp. 3d 507 (N.D. Tex. 2023), vacated, 117 F.4th 336 (5th Cir. 2024) (mem.)
    Provided procedural history for prior preliminary injunction proceedings (context for the deregulation timeline and challenges).

B. Standards governing stays and interim APA relief

  • Wages & White Lion Invs., L.L.C. v. FDA, 16 F.4th 1130 (5th Cir. 2021) and Tex. League of United Latin Am. Citizens v. Hughs, 978 F.3d 136 (5th Cir. 2020)
    These cases supply the Fifth Circuit’s four-factor test for a § 705 stay: strong likelihood of success, irreparable harm, balance of harms, and public interest.
  • Valentine v. Collier, 956 F.3d 797 (5th Cir. 2020) (per curiam)
    Cited for the proposition that the first two factors (likelihood of success and irreparable harm) are “the most critical.”
  • Nken v. Holder, 556 U.S. 418 (2009)
    Cited for the stay framework and emphasis on likelihood of success and irreparable harm.
  • Airlines for Am. v. Dep't of Transp., 110 F.4th 672 (5th Cir. 2024)
    Used for the “merge” principle: balance of harms and public interest considerations overlap when the government opposes the requested stay.

C. Procedure: when a party must first seek relief in the district court

  • Fed. R. App. P. 8
    The opinion reads FRAP 8’s “moving first in the district court” as the “ordinary” practice, not a hard jurisdictional prerequisite, where doing so would be “impracticable.”
  • Whole Woman's Health v. Paxton, 972 F.3d 649 (5th Cir. 2020) and Homans v. City of Albuquerque, 264 F.3d 1240 (10th Cir. 2001)
    Support the idea that repeating an application would be “pointless” and thus excused.

D. Administrative exhaustion

  • Wash. Ass'n for Television & Child. v. FCC, 712 F.2d 677 (D.C. Cir. 1983) and Tesoro Refin. & Mktg. Co. v. FERC, 552 F.3d 868 (D.C. Cir. 2009)
    Provide the general rule against raising claims for the first time in court, and the “clearly useless” exception. The Fifth Circuit applies the persuasive reasoning of Alliance I/Alliance II to conclude exhaustion was satisfied/pointless because FDA was “committed to implementing” the challenged approach (and would not administratively stay the 2023 REMS).

E. Standing: sovereign injury and state fiscal injury

  • Deanda v. Becerra, 96 F.4th 750 (5th Cir. 2024)
    Restates Article III standing: injury traceable to defendant and likely redressable.
  • Texas v. United States, 809 F.3d 134 (5th Cir. 2015) and Alfred L. Snapp & Son, Inc. v. P.R. ex rel. Barez, 458 U.S. 592 (1982)
    Central to the sovereign-injury theory: a state has a sovereign interest in “the power to create and enforce a legal code.” The Fifth Circuit characterized the 2023 REMS as “federal interference with the enforcement of [Louisiana] law.”
  • First Choice Women's Res. Ctrs., Inc. v. Davenport, No. 24-781, slip op. (U.S. Apr. 29, 2026) and Diamond Alt. Energy LLC v. EPA, 606 U.S. 100 (2025)
    Used to validate “commonsense inferences” about third-party behavior for standing causation—here, the predictable response of out-of-state providers expanding access into restrictive states.
  • Washington v. FDA, 108 F.4th 1163 (9th Cir. 2024)
    Cited (and distinguished) for the proposition that a federal action does not automatically create standing merely because it makes policing state law harder; the Fifth Circuit said this case is different because the 2023 REMS affirmatively “sanctions and facilitates” the very conduct undermining state law.
  • Wyoming ex rel. Crank v. United States, 539 F.3d 1236 (10th Cir. 2008) and Maine v. Taylor, 477 U.S. 131 (1986)
    Support standing where federal action/legal interpretation interferes with a state’s ability to enforce its statutes.
  • Texas v. United States, 50 F.4th 498 (5th Cir. 2022)
    Provides the fiscal-injury theory: state expenditures for emergency medical services constitute an injury for standing.
  • Biden v. Nebraska, 600 U.S. 477 (2023)
    Cited for the principle that if at least one plaintiff has standing, the suit may proceed (the panel did not need to decide whether Markezich had standing).

F. Merits review under the APA: arbitrary and capricious decisionmaking

  • FCC v. Prometheus Radio Project, 592 U.S. 414 (2021)
    Supplies the “reasonable” / “reasonably explained” benchmark for APA review.
  • Motor Vehicle Mfrs. Ass'n of the U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) and Burlington Truck Lines, Inc. v. United States, 371 U.S. 156 (1962)
    Provide the canonical requirement of a rational connection between facts found and choices made—used to characterize FDA’s reliance on literature it admitted was inadequate as a “textbook” arbitrary-and-capricious problem.
  • Sw. Elec. Power Co. v. EPA, 920 F.3d 999 (5th Cir. 2019)
    Used to rebut the notion that courts are incompetent to review science-laden regulations: courts must ensure the agency examined relevant data and explained itself.

G. Public interest and unlawful agency action; nationwide practical effect; Supreme Court backstop

  • Louisiana v. Biden, 55 F.4th 1017 (5th Cir. 2022)
    Cited (through Alliance II) for the proposition that neither the government nor the public has an interest in enforcing unlawful action.
  • Hill Dermaceuticals, Inc. v. FDA, 524 F. Supp. 2d 5 (D.D.C. 2007)
    Cited for the public interest in preventing unsafe drugs from entering the market.
  • Career Colleges & Schs. of Tex. v. Dep't of Educ., 98 F.4th 220 (5th Cir. 2024)
    Used to reject delay-based arguments on irreparable harm (ongoing, unrecoverable costs can satisfy the standard) and for the proposition that § 705 relief need not be limited to the parties.
  • BST Holdings, L.L.C. v. OSHA, 17 F.4th 604 (5th Cir. 2021) and NFIB v. OSHA, 595 U.S. 109 (2022)
    Cited to explain that parallel nationwide litigation and potential inconsistent outcomes are common; courts must decide cases before them, with the Supreme Court as arbiter.
  • Trump v. CASA, 606 U.S. 831 (2025)
    The panel treated CASA as addressing equitable relief, not APA vacatur/postponement. It relied on CASA’s footnote stating it did not resolve whether the APA authorizes vacatur.

3.2 Legal Reasoning

A. The Fifth Circuit’s core doctrinal move: elevating legality and irreparability over “wait-for-the-agency” deference

The district court’s unusual posture—finding likely unlawfulness and irreparable harm yet staying the case so the agency could review itself—set up the appellate court’s central intervention. The Fifth Circuit’s analysis treats FDA’s ongoing review as not a reason to keep an allegedly unlawful rule operative. In the panel’s view, that would create a perverse incentive: an agency could “forestall judicial review of admittedly unlawful regulations merely by promising to review them in the future,” with no definite endpoint (FDA “could not say when that review might be complete” and was still collecting data).

B. Standing as “interference with enforcement” plus concrete state expenditures

The opinion is particularly significant for how it frames a state’s standing to challenge federal drug-dispensing policy when it conflicts with state abortion laws. The panel articulated two independent injury theories:

  • Sovereign injury: Relying on Texas v. United States, 809 F.3d 134 (5th Cir. 2015), and Alfred L. Snapp & Son, Inc. v. P.R. ex rel. Barez, 458 U.S. 592 (1982), the court held Louisiana has a sovereign interest in enforcing its legal code. It found the 2023 REMS did not merely create incidental enforcement burdens (distinguishing Washington v. FDA, 108 F.4th 1163 (9th Cir. 2024)), but instead “sanctions and facilitates” conduct “with the express purpose of undermining” Louisiana’s restrictions. The causal chain is supported through “commonsense inferences” about third-party provider behavior (citing First Choice Women's Res. Ctrs., Inc. v. Davenport and Diamond Alt. Energy LLC v. EPA).
  • Financial injury: Under Texas v. United States, 50 F.4th 498 (5th Cir. 2022), Medicaid expenditures for emergency care qualify as injury. Louisiana’s evidence of $92,000 in Medicaid costs linked to complications, coupled with FDA label statistics on emergency care rates, supported traceability and the likelihood of recurrence. The panel distinguished FDA v. All. for Hippocratic Med. (Alliance III), 602 U.S. 367 (2024), as involving more speculative physician financial injuries rather than documented state outlays.

C. Merits: why the panel viewed the 2023 REMS as likely arbitrary and capricious

The panel adopted and re-applied the reasoning of All. for Hippocratic Med. v. FDA (Alliance II), 78 F.4th 210 (5th Cir. 2023), and All. for Hippocratic Med. v. FDA (Alliance I), 2023 WL 2913725, to the 2023 REMS:

  • “No adverse events” reasoning built on a hollowed-out reporting system: FDA allegedly gave “dispositive weight” to limited FAERS data, while FDA had previously eliminated the requirement to report serious adverse events (other than fatalities). The panel treated that as internally irrational: an agency cannot remove reporting and then cite the absence of reports as evidence of safety.
  • Literature the agency admitted was insufficient: FDA relied on literature regarding remote prescription, despite stating it was “not adequate on [its] own” to establish safety—an archetypal State Farm/Burlington Truck Lines problem (no rational connection between acknowledged evidentiary limits and the regulatory choice).

FDA “does not contest” this factor on the stay motion and had itself characterized prior approvals as having a “lack of adequate consideration.” That concession played a major role in the court’s equities/public-interest calculus.

D. Irreparable harm: sovereignty and sovereign immunity

The panel treated Louisiana’s sovereign harm—undermining its chosen legal protection for unborn life—as inherently irreparable (“cannot be regained by legal remedy”). It also concluded the financial harm is irreparable because FDA is protected by sovereign immunity (citing Alliance II), making monetary recovery unavailable.

E. Balancing equities and the public interest: “no interest in unlawful agency action”

The Fifth Circuit rejected the district court’s emphasis on FDA’s interest in continuing review and Danco’s financial interests. It reiterated: “[N]either the FDA nor the public has any interest in enforcing a regulation that violates federal law.” (Alliance II, 78 F.4th at 251). The panel also invoked safety-related public interest concerns (Hill Dermaceuticals, Inc. v. FDA).

The court further rejected three district-court concerns:

  • Courts are not deciding “morality” or second-guessing science: The case is an APA challenge; courts routinely ensure agencies examined relevant data and explained themselves (Sw. Elec. Power Co. v. EPA).
  • Agency review should not displace interim relief: A stay does not impede review; it simply prevents allegedly unlawful rules from continuing while review drags on.
  • Parallel lawsuits/inconsistency risk: Not a reason to avoid deciding; Supreme Court review remains available (BST Holdings, L.L.C. v. OSHA; NFIB v. OSHA).

F. Scope and “nationwide effect” under § 705 and the CASA point

The panel acknowledged that a § 705 stay “as a practical matter” can have nationwide effect because it “temporarily voids the challenged authority” (citing Alliance II and Career Colleges & Schs. of Tex. v. Dep't of Educ.). It rejected the suggestion that this conflicts with Trump v. CASA, 606 U.S. 831 (2025), noting CASA explicitly limited itself to equitable relief and did not resolve APA remedial questions (CASA, 606 U.S. at 846 n.10).

3.3 Impact

The decision’s most durable effects are likely to be procedural and remedial, not limited to the mifepristone context:

  • State standing blueprint in post-Dobbs federalism disputes: The opinion strengthens the theory that states can establish standing where federal policy functionally “interferes” with enforcement of state abortion restrictions—especially when the federal action is designed to expand access across state lines—and when states can document concrete fiscal spillovers (Medicaid costs).
  • Constraint on “agency self-review” as a reason to deny interim relief: When an agency concedes “procedural deficits” and cannot provide a near-term endpoint for review, the decision treats that as weighing for interim relief, not against it.
  • Reinforcement of § 705 as a powerful, potentially nationwide pause mechanism: The court confirms that § 705 stays can have nationwide operational effects and are not necessarily limited to party-specific relief—while also insulating that conclusion from CASA by categorizing CASA as an equitable-relief case.
  • Signals to regulated entities/intervenors: Financial and compliance interests (here, Danco’s asserted losses) may carry less weight when the challenged regime is recent and when the countervailing interests include sovereignty and public safety.

4. Complex Concepts Simplified

  • REMS (Risk Evaluation and Mitigation Strategies): Special safety restrictions FDA can require for certain drugs—e.g., who may prescribe, where the drug may be dispensed, and what monitoring/reporting is required. Statutory basis: 21 U.S.C. § 355-1(f)(3).
  • APA “arbitrary and capricious” review: Courts do not decide whether the agency’s policy is best; they ask whether the agency examined relevant data and provided a reasoned explanation. If the agency relies on missing data it helped create, or on studies it admits do not support its conclusion, that can be arbitrary. (See Motor Vehicle Mfrs. Ass'n of the U.S., Inc. v. State Farm Mut. Auto. Ins. Co.).
  • 5 U.S.C. § 705 stay: A tool allowing courts to postpone an agency action’s effective date during judicial review. It functions like a pause button while the case proceeds, assessed under a four-factor test (likelihood of success, irreparable harm, balance of harms, public interest).
  • Standing (Article III): The plaintiff must show a concrete injury caused by the defendant that the court can likely remedy. Here, Louisiana asserted (i) interference with enforcement of state law (sovereign injury) and (ii) unrecoverable Medicaid spending (financial injury).
  • “Nationwide effect” vs “nationwide injunction”: The court distinguished practical nationwide consequences of an APA-based stay/vacatur mechanism from the separate controversy over equitable nationwide injunctions discussed in Trump v. CASA.

5. Conclusion

The Fifth Circuit’s order in State of Louisiana v. FDA establishes a clear interim-relief principle: where a state demonstrates strong likelihood of success and irreparable harm from a federal agency’s action—especially when the agency effectively concedes “procedural deficits” and cannot commit to a timely fix— the equities and public interest ordinarily favor a 5 U.S.C. § 705 stay rather than permitting the challenged regime to persist under the banner of ongoing agency review.

The opinion is also notable for its standing analysis. It treats a state’s sovereign interest in enforcing its abortion-related legal code and its documented Medicaid expenditures as sufficient injuries traceable to the challenged federal deregulation, distinguishing the Supreme Court’s physician-standing holding in FDA v. All. for Hippocratic Med. (Alliance III). Finally, it reinforces the Fifth Circuit’s view that APA stay/vacatur-type remedies may have nationwide practical effects and that Trump v. CASA does not foreclose that result.