Supreme Court of the United States — Alito, J., dissenting (Nos. 25A1207 / 25A1208): CitationClerk

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Cite as: 608 U. S. ____ (2026) 1

ALITO, J., dissenting

SUPREME COURT OF THE UNITED STATES

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No. 25A1207

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DANCO LABORATORIES, LLC v. LOUISIANA, ET AL.

ON APPLICATION FOR STAY

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No. 25A1208

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GENBIOPRO, INC. v. LOUISIANA, ET AL.

ON APPLICATION FOR STAY

[May 14, 2026]

JUSTICE ALITO, dissenting.

The Court's unreasoned order granting stays in this case

is remarkable. What is at stake is the perpetration of a

scheme to undermine our decision in Dobbs v. Jackson

Women's Health Organization, 597 U. S. 215 (2022), which

restored the right of each State to decide how to regulate

abortions within its borders. Some States responded to

Dobbs by making it even easier to obtain an abortion than

it was before, and that is their prerogative. Other States,

including Louisiana, made abortion illegal except in narrow

circumstances. See, e.g., La. Rev. Stat. Ann. §40.1061

et seq. But Louisiana's efforts have been thwarted by cer-

tain medical providers, private organizations, and States

that abhor laws like Louisiana's and seek to undermine

their enforcement.

These medical providers and private organizations have

developed an operation enabling women in Louisiana and

other States that restrict abortions to place an online order

for a pill called mifepristone that induces abortion. See,

e.g., Aid Access, Get Abortion Pill Online in Louisiana – Or-

der Here, https://aidaccess.org/en/page/2934664/where-can-

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DANCO LABORATORIES, LLC v. LOUISIANA

ALITO, J., dissenting

i-buy-the-abortion-pill-online-in-louisiana (archived at

https://perma.cc/NW2Z-M4B9). After an order is placed,

the drug is mailed to women in Louisiana. The manufac-

turers of the drug, including Danco and GenBioPro, are ob-

viously aware of what is going on yet nevertheless supply

the drug and reap profits from its felonious use in Louisi-

ana.

One might think that Louisiana could stop or impede this

out-of-state interference in its law enforcement by bringing

civil actions or criminal charges against the participants in

this scheme. But States have effectively blocked these ef-

forts by enacting so-called "shield laws," which prevent Lou-

isiana from visiting any adverse legal consequences on the

perpetrators. See, e.g., N. Y. Exec. Law §837–x (barring

state officials from cooperating with other States' efforts to

take civil or criminal action relating to illegal abortions);

N. Y. Educ. Law §6810.1-a (exempting mifepristone from

the requirement that prescription labels bear the prescrib-

ing medical provider's name); see also App. to Opposition to

Applications for a Stay or Vacatur 462–463 (La. App.) (re-

porting that New York Governor Kathy Hochul has refused

to extradite a doctor who allegedly prescribed and sent

abortifacients into Louisiana). As a result, more abortions

now occur each month in Louisiana than they did before

Dobbs. La. App. 519. By one count, nearly 1,000 abortions

occur there each month. Ibid.

This scheme would not have been possible under FDA

regulations had the federal government not taken steps in

2021 and 2023 to facilitate mail-order abortions. Since the

FDA first approved mifepristone in 2000, the drug has been

subject to "Risk Evaluation and Mitigation Strategies"

(REMS) to ensure that its benefits outweigh its risks. See

21 U. S. C. §355–1. For two decades, REMS for mifepris-

tone required that patients meet in person with a medical

provider to administer the drug. FDA v. Alliance for Hip-

pocratic Medicine, 602 U. S. 367, 375–376 (2024). In 2021,

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Cite as: 608 U. S. ____ (2026) 3

ALITO, J., dissenting

however, the FDA adopted a policy of nonenforcement as to

the in-person-dispensing requirements. Id., at 376.

The following year, after our decision in Dobbs, the Biden

Administration announced that it would "use every lever"

it had to "ensure every American has access to . . . medica-

tion abortion that has been approved by the FDA for over

20 years," an obvious reference to mifepristone. La. App.

244. The FDA pulled one of those levers in 2023 when it

formally eliminated the in-person-dispensing requirement

in the mifepristone REMS, removing a signifcant regula-

tory barrier from schemes to undermine Dobbs.

Since then, the Secretary of Health and Human Services

has admitted that the FDA gave inadequate consideration

to patient safety when it approved the 2023 REMS. La.

App. 478. Because concerns have arisen "about the safety

of mifepristone as currently administered" under the 2023

REMS, the Secretary announced that the FDA would con-

duct a study to determine whether changes to the REMS

are needed. Ibid. Nevertheless, the FDA has not yet acted,

and the 2023 REMS remain in place.

In an effort to stop ongoing schemes to subvert its abor-

tion laws, Louisiana sued the FDA under the Administra-

tive Procedure Act. Citing the Secretary's concerns about

the 2023 REMS, the State challenges the removal of the in-

person-dispensing requirement for mifepristone as arbi-

trary, capricious, and unlawful. La. App. 4, 46–50. The

District Court denied Louisiana's request for interim relief,

but the Fifth Circuit suspended the 2023 changes pending

appeal. Louisiana v. FDA, ___ F. 4th ____ (CA5 2026); see

5 U. S. C. §705. Danco and GenBioPro then filed these stay

applications, and the FDA takes no position on this matter,

even though it concerns the question whether an important

rule that it has found to be flawed will remain in force for

some unknown period of time.

I would deny the applications because, as things now

stand, the manufacturers have failed to show that they face

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ALITO, J., dissenting

irreparable injury, without which this Court may not grant

a stay. Hollingsworth v. Perry, 558 U. S. 183, 190 (2010)

(per curiam). Unless the Fifth Circuit's order spurs the

FDA into moving on its safety review, there is no indication

that the Fifth Circuit's order will adversely affect the man-

ufacturers whatsoever in the near future. All the evidence

is to the contrary. In the two years before the 2023 REMS

changes, the FDA declined to enforce the in-person-dispens-

ing requirement, and the FDA seeks to maintain that sta-

tus quo until it completes an internal safety review of the

mifepristone REMS, which is unlikely to end this year. See

Defendant's Memorandum in Support of Motion to Stay the

Case and in Response to Plaintiffs' Motion for Preliminary

Relief in Louisiana v. FDA, No. 6-25-cv-1491 (WD La.), ECF

Doc. 51, pp. 4, 11–12. Indeed, there is evidence that FDA

leadership has told agency officials to delay that safety re-

view for at least six months. La. App. 556. So, at present,

it is most unlikely that the manufacturers would be at all

affected by the Fifth Circuit's order for quite some time.

That could conceivably change if the Fifth Circuit's order

were left in place and the FDA were spurred to speed up its

safety review, but our disposition of this application cannot

be predicated on the assumption that that will occur.

We must instead proceed on the basis of what is known

at present, and without any current indication that the

FDA plans to resume enforcing the in-person-dispensing re-

quirement, there is no reason to believe that the manufac-

turers could not continue their current distribution prac-

tices.*

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* In that event, it would be unlikely that Louisiana (or anyone else)

could force the FDA's hand. The FDA would have a plausible argument

that its nonenforcement reflects a decision "committed to agency discre-

tion," 5 U. S. C. §701(a)(2), and would thus be immune from judicial re-

view under Heckler v. Chaney, 470 U. S. 821 (1985). In fact, the FDA

previously made this very argument about its nonenforcement of the in-

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ALITO, J., dissenting

If the FDA were to execute an abrupt about-face and com-

mence enforcement of the in-person-dispensing require-

ment, the manufacturers could promptly reapply for stays

at that time. But even were that to happen, the manufac-

turers have not shown that they would suffer irreparable

injury. The manufacturers spent just 3 of their 80-plus

pages of applications trying to make this showing. See Ap-

plication to Stay in No. 25A1207, pp. 35–36; Application to

Stay in 25A1208, p. 35. To the extent that the manufactur-

ers address this issue at all, they refer mostly to regulatory

uncertainty that would result from a suspension of the 2023

REMS changes. Yet they fail to explain why the effect of

the Fifth Circuit's order is not simply to restore the pre-

2023 REMS, under which the manufacturers successfully

operated for years. As we have already explained in FDA

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

a §705 order suspending the FDA's changes to REMS allows

a manufacturer to continue selling a drug subject to the pre-

vious set of regulatory requirements. 602 U. S., at 377.†

The manufacturers contend that resuming compliance

with those requirements would involve inconvenient pro-

cesses, such as updating prescriber agreements or adjust-

ing pharmacy-distribution operations. But without any

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person-dispensing requirement. See Defendants' Opposition to Plain-

tiffs' Motion for a Preliminary Injunction in Alliance for Hypocritic Med-

icine v. FDA, No. 2:22-cv-223 (ND Tex.) ECF Doc. 28, p. 20 (citing Heck-

ler). For these reasons, the manufacturers have not shown that they face

any imminent risk of irreparable harm.

† In arguing to the contrary, Danco relies on an FDA declaration in the

Alliance for Hippocratic Medicine litigation. See Application to Stay in

No. 25A1207, p. 35. But that declaration does not dispute that a §705

order causes the REMS "to revert to those in place prior to" the chal-

lenged amendments. App. to Application to Stay in FDA v. Alliance for

Hippocratic Medicine, O. T. 2022, No. 22A902, p. 113a. Rather, the dec-

laration simply explains that the manufacturers would need to take ad-

ditional steps to come into compliance with the old rules. Id., at 113a–

116a.

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ALITO, J., dissenting

effort to show the extent of these burdens, such inconven-

iences are insufficient to constitute the requisite showing of

irreparable harm.

GenBioPro makes a passing reference to the possibility of

lost sales. See Application to Stay in 25A1208, p. 35. But

lost sales in States where abortifacients are generally ille-

gal are not "irreparable injuries" that can justify granting a

stay. See United States v. United Liquor Corporation, 77

S. Ct. 208, 210 (1956) (Reed, J., in chambers) (denying a

stay when the alleged irreparable injury was the defend-

ant's inability to engage in conduct that amounted to an un-

lawful conspiracy). Our decision to grant a stay is an exer-

cise of equitable discretion, Indiana State Police Pension

Trust v. Chrysler LLC, 556 U. S. 960, 961 (2009) (per cu-

riam), and equity demands that profits from unlawful ac-

tivity be surrendered, not protected, see Liu v. SEC, 591

U. S. 71, 79–80 (2020). As for States where abortion is le-

gal, neither Danco nor GenBioPro explains why mifepris-

tone sales would dry up if the in-person-dispensing require-

ment resumed. And even if the Fifth Circuit's order

affected sales in those States to some degree, the manufac-

turers do not establish that the lost profits would be so sig-

nificant as to constitute irreparable injury. See Wisconsin

Gas Co. v. FERC, 758 F. 2d 669, 674 (CADC 1985) (per cu-

riam) (holding that a private party must show a threat to

"the very existence of [its] business" to establish irreparable

injury).

Because the manufacturers have not shown that they

face any imminent risk of irreparable injury, the Court

must deny these applications regardless of how they fare on

the other stay factors. I therefore respectfully dissent.

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