The opinion
Case: 26-30203 Document: 119-1 Page: 1 Date Filed: 05/01/2026
United States Court of Appeals
for the Fifth Circuit
_____________
No. 26-30203
_____________
State of Louisiana, by & through its Attorney General, Liz Murrill;
Rosalie Markezich,
Plaintiffs—Appellants,
versus
Food & Drug Administration; Marty Makary, Commissioner,
U.S. Food and Drug Administration; Richard Pazdur, in his official
capacity as Director, Center for Drug Evaluation & Research, U S Food & Drug
Administration; United States Department of Health and
Human Services; Robert F. Kennedy, Jr., Secretary, U.S.
Department of Health and Human Services,
Defendants—Appellees,
versus
Danco Laboratories, L.L.C.; GenBioPro, Incorporated,
Intervenors—Appellees.
________________________________
Appeal from the United States District Court
for the Western District of Louisiana
USDC No. 6:25-CV-1491
________________________________
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Before Southwick, Duncan, and Engelhardt, Circuit Judges.
Stuart Kyle Duncan, Circuit Judge:
In Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215
(2022), the Supreme Court returned the regulation of abortion to the states.
In response, the Biden Administration directed federal agencies to “expand
access to . . . medication abortion.” Exec. Order No. 14076, 87 Fed. Reg.
42053 (July 8, 2022). The next year, the Food and Drug Administration
(FDA) formally altered its safety guidelines for the abortion drug
mifepristone. Under the new regulation, the drug could now be prescribed
online and dispensed through the mail, without any need for an in-person
visit to a doctor.
In 2025, Louisiana challenged the new regulation in federal court
under the Administrative Procedure Act (APA). It argued that FDA’s
justifications for remotely dispensing mifepristone were based on flawed or
nonexistent data. It also documented how the new regulation had resulted in
numerous illegal abortions in Louisiana and in Louisiana paying thousands in
Medicaid bills for women harmed by mifepristone. Louisiana sought a stay of
the regulation while the litigation proceeded.
In response, FDA conceded it had failed to adequately study whether
remotely prescribing mifepristone is safe. But the agency resisted staying the
regulation, arguing it was in the midst of a comprehensive review of
mifepristone protocols. The agency, however, could not say when that
review might be complete and admitted it was still collecting data.
The district court agreed that Louisiana was likely to win its challenge
to the mifepristone regulation and was suffering irreparable harm from it.
Nonetheless, the court declined to stay the regulation based on its balancing
of the equities and the public interest. Louisiana appealed to our court and
sought a stay pending appeal under 5 U.S.C. § 705.
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We grant the stay.
I
We briefly describe (A) FDA’s actions with respect to mifepristone,
(B) prior challenges to those actions, and (C) the present suit.
A
FDA determines whether drugs are safe and effective before they can
be marketed in the United States. See Federal Food, Drug, and Cosmetic Act,
ch. 675, 52 Stat. 1040 (1938) (FDCA); FDA v. All. for Hippocratic Med.
(Alliance III), 602 U.S. 367, 374–75 (2024). In that role, FDA may conclude
that a drug requires enhanced guardrails—such as prescription only by
“health care providers” or “in certain health care settings.” 21 U.S.C.
§ 355-1(f)(3). Such guardrails are called Risk Evaluation and Mitigation
Strategies, or REMS.
When FDA approved mifepristone in 2000, the REMS allowed only
doctors to prescribe it after “three in-person visits” and directed they report
serious adverse events. Alliance III, 602 U.S. at 375. Since then, the guardrails
have been progressively lowered. In 2016, FDA announced that nurse
practitioners could prescribe mifepristone after only one in-person doctor
visit and that doctors needed to report only fatalities (the “2016
Amendments”). Id. at 375–76. In 2021, FDA stopped enforcement of the
one-visit requirement, thus allowing mifepristone to be dispensed “through
the mail . . . or through a mail-order pharmacy” (the “2021
Non-Enforcement Decision”).1 That “removal of the in-person dispensing
requirement” was formalized in 2023 (the “2023 REMS”). All. for
Hippocratic Med. v. FDA (Alliance II), 78 F.4th 210, 226 (5th Cir. 2023), rev’d
1
FDA also approved GenBioPro’s generic mifepristone for use in 2019. Alliance
III, 602 U.S. at 376.
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on other grounds, 602 U.S. 367 (2024); Risk Evaluation and Mitigation Strategy
(REMS) Single Shared System for Mifepristone 200 MG, FDA (Jan. 2023),
https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_
2023_01_03_REMS_Full.pdf.
B
In 2022, a group of physicians providing pregnancy-related healthcare
brought an APA challenge to the 2000 mifepristone approval, the 2016
Amendments, and the 2021 Non-Enforcement Decision. See All. for
Hippocratic Med. v. FDA, 668 F. Supp. 3d 507, 560 (N.D. Tex. 2023), vacated,
117 F.4th 336 (5th Cir. 2024) (mem.). After the district court granted a
preliminary injunction, our court affirmed in part, ruling plaintiffs were likely
to win their challenge to the 2021 Non-Enforcement Decision. See All. for
Hippocratic Med. v. FDA (Alliance I), No. 23-10362, 2023 WL 2913725, at
*17–18, 17 n.5 (5th Cir. Apr. 12, 2023); Alliance II, 78 F.4th at 227, 247–51.2
The Supreme Court reversed, however, on the grounds that the plaintiff
physicians lacked standing. Alliance III, 602 U.S. at 396–97.
In September 2025, FDA began a comprehensive review of
mifepristone, including the 2023 REMS. When announcing the review,
FDA conceded the “lack of adequate consideration underlying the prior
REMS approvals.” The review is not complete—as of April 2026, the
agency reports it is still collecting data.3
2
We also explained that the 2021 Non-Enforcement Decision “remains in force”
because it was formalized by the 2023 REMS. Alliance II, 78 F.4th at 248.
3
See Questions and Answers on Mifepristone for Medical Termination of Pregnancy
Through Ten Weeks Gestation, FDA, https://www.fda.gov/drugs/postmarket-drug-safety-
information-patients-and-providers/questions-and-answers-mifepristone-medical-
termination-pregnancy-through-ten-weeks-gestation.
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C
In October 2025, the State of Louisiana and Rosalie Markezich
(collectively, “Louisiana”) challenged the 2023 REMS under the APA.
The district court allowed mifepristone manufacturers Danco and
GenBioPro (collectively, “Danco”) to intervene as defendants.
Louisiana moved to preliminarily stay the 2023 REMS under 5
U.S.C. § 705. The district court declined, however. Despite finding
Louisiana had standing, was likely to succeed on the merits, and was suffering
irreparable harm, the court found the balance-of-the-equities and public-
interest factors favored denying a stay.
As to the equities, the court reasoned that FDA has a strong interest
in continuing its scientific review of mifepristone and that the intervenor
companies have a “substantial financial interest” in selling the drug. While
acknowledging Louisiana’s “great interest” in stopping the inflow of out-of-
state mifepristone, the court thought the drug would “likely continue” to
reach Louisianans regardless of a stay, like other illegal drugs. It also
emphasized that Louisiana retained “many meaningful, boots-on-the-ground
law enforcement mechanisms to mitigate its sovereign and financial harms
while FDA completes its ongoing review.”
As to the public interest, the court acknowledged that the public has
no interest in continuing unlawful agency action and that FDA “does not
defend its decision-making [in the 2023 REMS] on the merits.”
Nonetheless, the agency desired “a stay [of the case] to complete a fulsome
review” of mifepristone. The court also noted “multiple parallel lawsuits”
challenging the 2023 REMS and worried about the “substantial risk of
inconsistent judicial outcomes.” Finally, while again acknowledging the
“deficiencies” in the 2023 REMS, the court believed it was “ill-equipped”
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to evaluate the validity of an in-person dispensing requirement, “particularly
where FDA has thus far failed to even collect the data necessary” to do so.
The court therefore declined Louisiana’s request to stay the 2023
REMS. Instead, the court granted FDA’s request to stay the entire case so
the agency could “complete its review.” The court warned, though, that
“FDA has an obligation to act with all deliberate speed to review its past
actions and complete a thorough analysis that addresses the deficiencies it
has acknowledged.”
Louisiana appealed and moved for a stay of the 2023 REMS pending
appeal under 5 U.S.C. § 705.
II
Under 5 U.S.C. § 705, courts 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.”
A party seeking a stay under § 705 must show (1) it is strongly likely
to succeed on the merits; (2) it will be irreparably harmed without a stay;
(3) its harm is not outweighed by harm to other parties; and (4) the public
interest favors a stay. Wages & White Lion Invs., L.L.C. v. FDA, 16 F.4th 1130,
1135–36 (5th Cir. 2021); Tex. League of United Latin Am. Citizens v. Hughs,
978 F.3d 136, 143 (5th Cir. 2020). The first two factors are the most critical.
Valentine v. Collier, 956 F.3d 797, 801 (5th Cir. 2020) (per curiam).
III
Louisiana contends the district court misapplied the § 705 stay
factors. Specifically, it argues the court abused its discretion in ruling that the
last two factors outweighed its successful showing on the first two. FDA’s
response does not address the merits—i.e., whether its removal of
mifepristone’s in-person dispensing requirement was arbitrary and
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capricious. Instead, it argues that Louisiana should have first asked the
district court for a stay. It then argues, contrary to the district court’s ruling,
that Louisiana lacks standing. For its part, Danco argues Louisiana lacks
standing, failed to administratively exhaust its claims, and fails all four stay
factors.
We address each of these arguments in turn.
A
We first address the two threshold arguments that Louisiana
(1) should have first asked the district court for a stay and (2) failed to
administratively exhaust its claims. Both arguments fail.
1
FDA contends that, under Federal Rule of Appellate Procedure 8,
Louisiana was required to first ask the district court for a stay pending appeal.
See Fed. R. App. P. (FRAP) 8(a)(1)(A), (C). We disagree. While that it
is the “ordinar[y]” practice, see FRAP 8(a)(1), it is not required if “moving
first in the district court would be impracticable,” see id. FRAP
8(a)(2)(A)(i). Here, it was.
Not only had the district court already denied Louisiana’s motion to
stay the 2023 REMS under § 705, but the court had also stayed the entire
case pending completion of FDA review. Given that, it would have been
“pointless” to ask the district court to stay the 2023 REMS pending appeal.
Whole Woman’s Health v. Paxton, 972 F.3d 649, 653 (5th Cir. 2020); see also,
e.g., Homans v. City of Albuquerque, 264 F.3d 1240, 1243 (10th Cir. 2001)
(“[W]e have excused this requirement where another application to the
district court would serve little purpose.”).
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2
Danco argues Louisiana failed to administratively exhaust its claims.
“As a general rule, claims not presented to the agency may not be made for
the first time to a reviewing court,” Wash. Ass’n for Television & Child. v.
FCC, 712 F.2d 677, 680 (D.C. Cir. 1983), unless “resort to administrative
remedies [would be] clearly useless,” Tesoro Refin. & Mktg. Co. v. FERC, 552
F.3d 868, 874 (D.C. Cir. 2009) (alteration in original) (quotation omitted).
Our court previously rejected this argument in Alliance I and II. See
Alliance I, 2023 WL 2913725, at *15–16; Alliance II, 78 F.4th at 255. True,
those decisions were reversed on standing, see Alliance III, 602 U.S. at
396–97, but their reasoning on exhaustion was persuasive. As they
concluded, these challenges were “properly exhausted,” Alliance I, 2023 WL
2913725, at *15, because FDA’s denials of citizen petitions discussed the
2021 Non-Enforcement Decision and “show[ed] that FDA was committed
to implementing these changes,” Alliance II, 78 F.4th at 255. Danco gives us
no reason to think that, today, FDA would administratively stay the 2023
REMS, which formalized the 2021 decision. Ibid.
Accordingly, we reject the argument that Louisiana was required to
administratively exhaust its claims before bringing this suit.
B
We turn to standing. Louisiana must show it “has suffered an injury
traceable to the defendant which the court’s judgment would likely redress.”
Deanda v. Becerra, 96 F.4th 750, 755 (5th Cir. 2024).
On appeal, FDA and Danco dispute the district court’s ruling that
Louisiana has standing. Specifically, they contend that by removing
mifepristone’s in-person dispensing requirement, the 2023 REMS caused
no injury either to Louisiana’s sovereignty or its treasury. We disagree.
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1
First, sovereign injury. Louisiana has a “sovereign interest in the
power to create and enforce a legal code.” Texas v. United States, 809 F.3d
134, 153 (5th Cir. 2015) (quotation omitted).4
With certain exceptions, Louisiana law bans administering,
prescribing, procuring, or selling a drug like mifepristone to end the life of an
unborn human being. See La. Stat. Ann. § 40:1061(C) (2022) (“No
person may knowingly administer to, prescribe for, or procure for, or sell to
any pregnant woman any medicine, drug, or other substance with the specific
intent of causing or abetting the termination of the life of an unborn human
being.”).5
An avowed purpose of the 2023 REMS was to expand access to
medication abortion. See Exec. Order No. 14076, 87 Fed. Reg. 42053 (July 8,
2022) (in the wake of Roe’s overruling, directing federal agencies to “expand
access to . . . medication abortion” by “protect[ing] healthcare service
delivery and promot[ing] access to . . . abortion”). Predictably, the regulation
has had that effect in Louisiana, despite the fact that its laws ban the practice.
4
See also Alfred L. Snapp & Son, Inc. v. P.R. ex rel. Barez, 458 U.S. 592, 601 (1982)
(explaining a state’s “exercise of sovereign power over individuals and entities within the
relevant jurisdiction . . . involves the power to create and enforce a legal code, both civil
and criminal”); Kentucky v. Biden, 23 F.4th 585, 599 (6th Cir. 2022) (explaining national
vaccine mandate “implicates states’ power to make and enforce policies and regulations,
as well as states’ traditional prerogative to superintend their citizens’ health and safety”).
5
See also La. Stat. Ann. § 14:87.1(1)(a)(i) (2022) (defining “abortion” or
“induced abortion” to include “[a]dministering, prescribing, or providing any
abortion-inducing drug, potion, medicine, or any other substance, device, or means to a
pregnant female”); id. § 14:87.1(2)(a) (defining “[a]bortion-inducing drug” as “any drug
or chemical, or combination of drugs or chemicals, or any other substance when used with
the intent to cause an abortion”); id. § 14.87.1(1)(b)(i)–(v) (excluding from definition of
“abortion” various procedures, including for saving unborn child’s or mother’s life or for
removing ectopic and medically futile pregnancies).
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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.
This evidence also easily shows causation and redressability. As the
district court explained, “out-of-state medical providers” have responded to
the 2023 REMS by “expanding mifepristone access to pro-life states like
Louisiana in ways that [are] entirely predictable.” That should surprise no
one: after all, ensuring out-of-state medical providers could prescribe
mifepristone to women in states that restrict abortion was a goal of the
regulation. See, e.g., First Choice Women’s Res. Ctrs., Inc. v. Davenport, No.
24-781, slip op. at 12 (U.S. Apr. 29, 2026) (confirming “courts may make
‘commonsense inferences’ when assessing Article III standing, including
inferences about ‘third party behavior’” (quoting Diamond Alt. Energy LLC
v. EPA, 606 U.S. 100, 116 (2025))). Finally, a decision in Louisiana’s favor
would redress this injury because mifepristone could no longer be remotely
prescribed to Louisianans.
FDA and Danco counter that the 2023 REMS only makes it “more
difficult to police” violations of Louisiana law. Not so. The policy does not
merely “increase[] crime or disorder, or impose[] indirect compliance costs
for state law enforcement.” Washington v. FDA, 108 F.4th 1163, 1177 (9th
Cir. 2024). Rather, the 2023 REMS sanctions and facilitates conduct with
the express purpose of undermining Louisiana’s legal restrictions on
abortion. The regulation creates an effective way for an out-of-state
prescriber to place the drug in the hands of Louisianans in defiance of
Louisiana law.
In sum, the agency’s 2023 REMS causes “federal interference with
the enforcement of [Louisiana] law,” which gives Louisiana standing to
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challenge it. Texas, 809 F.3d at 153; see also Wyoming ex rel. Crank v. United
States, 539 F.3d 1236, 1242 (10th Cir. 2008) (“injury-in-fact” shown when
federal agency’s legal interpretation “interfere[d] with Wyoming’s ability to
enforce its legal code”); Maine v. Taylor, 477 U.S. 131, 137 (1986) (“[A] State
clearly has a legitimate interest in the continued enforceability of its own
statutes.”).
2
Next, financial injury. A State’s “expenditures in providing
emergency medical services” constitute an injury for standing purposes.
Texas v. United States, 50 F.4th 498, 518 (5th Cir. 2022).
Louisiana identifies $92,000 it paid in Medicaid costs from two
women who needed emergency care in 2025 from complications caused by
out-of-state mifepristone. Such costs will almost certainly continue because
nearly 1,000 women monthly—many of whom are on Medicaid—have
mifepristone-induced abortions in Louisiana.
Confirming this, FDA’s 2023 mifepristone label reports that 2.9 to
4.6 percent of women prescribed mifepristone in-person will require
emergency care. See Alliance I, 2023 WL 2913725, at *10 (FDA’s “own
documents . . . prove that emergency room care is statistically certain in
hundreds of thousands of cases”). Remotely dispensing the drug will only
exacerbate those risks, as the district court found. See DC Dkt. No. 1-10 at 35
(“[T]he literature suggests there may be more frequent ED/urgent care
visits related to the use of mifepristone when dispensed by mail . . . .”).
Accordingly, Louisiana has shown that it suffers financial injury caused by
the 2023 REMS.
Despite acknowledging that “Medicaid costs constitute an Article III
injury,” FDA and Danco argue that the relation between out-of-state
mifepristone and Louisiana’s costs is too attenuated. Both rely on Alliance
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III, which held that the link between the challenged regulations and plaintiff
doctors’ monetary injuries was “too speculative or otherwise too
attenuated.” 602 U.S. at 390. That case is distinguishable, however.
As the Supreme Court explained in Alliance III, the doctors failed to
prove that FDA’s deregulation of mifepristone caused them to divert time
from other patients or that it produced higher insurance costs. Id. at 390–91.
But Alliance III had no reason to address whether the agency’s actions would
cause States to pay higher Medicaid costs. Id. at 391. Here, Louisiana showed
that they do. Unlike the doctors in Alliance III, Louisiana provided hard
evidence linking thousands of dollars in Medicaid costs to care stemming
from out-of-state mifepristone. As the district court correctly held, that
“alone [is] sufficient to establish Louisiana’s standing.”
* * *
In sum, on either theory Louisiana has shown it has standing to
challenge the 2023 REMS.6
C
We turn to the § 705 factors.
1
First, likelihood of success on the merits. Nken v. Holder, 556 U.S. 418,
434 (2009). Louisiana must make a strong showing that the 2023 REMS was
not “reasonable” or “reasonably explained.” FCC v. Prometheus Radio
Project, 592 U.S. 414, 423 (2021).
6
We therefore need not consider whether Markezich also has standing. See Biden
v. Nebraska, 600 U.S. 477, 489 (2023) (“If at least one plaintiff has standing, the suit may
proceed.”).
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This factor plainly favors Louisiana and FDA does not contest it. To
the contrary, as the district court explained, the agency “essentially
acknowledged APA procedural deficits with respect to mifepristone” by
“stating that [its] intention to review the mifepristone regulatory framework
was precipitated by ‘the lack of adequate consideration underlying the prior
REMS approvals.’”
Based on the same defects, our court has previously concluded that
FDA’s actions here were likely unlawful. See Alliance II, 78 F.4th at 249–51;
Alliance I, 2023 WL 2913725, at *16–18. That reasoning squarely applies to
the 2023 REMS and we briefly summarize it.
First, in relaxing mifepristone’s in-person dispensing requirement,
FDA gave “dispositive weight” to the lack of adverse-event data in a
reporting system (known as “FAERS”). Alliance II, 78 F.4th at 249. The
problem? FDA had previously eliminated the requirement to report
mifepristone’s adverse events to FAERS. Ibid. Obviously, “[i]t’s
unreasonable for an agency to eliminate a reporting requirement for a thing
and then use the resulting absence of data to support its decision.” Ibid.
(quoting Alliance I, 2023 WL 2913725, at *17).7
Second, FDA “relied on various literature relating to remote
prescription of mifepristone—despite FDA’s admission that the literature
did not affirmatively support its position.” Alliance II, 78 F.4th at 250. The
7
Danco points out that federal law requires manufacturers report to FDA known
adverse events. See 21 U.S.C. § 355(k)(1); 21 C.F.R. §§ 314.80, 314.81. We rejected this
argument in Alliance II. See 78 F.4th at 247, 249–50. In short, Danco’s reporting
requirements are “significantly different than the ones that were removed,” insofar as
Danco “had no direct relationship with Mifeprex patients and little ability to track
[adverse] events.” Id. at 247. As Alliance II concluded, “Danco’s residual reporting
requirements do not cure this APA violation.” Ibid.; see also id. at 250 (explaining that
“Danco’s data was exactly the same as the data FDA obtained from FAERS”).
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agency explained the literature was “not adequate on [its] own to establish
the safety of the model of dispensing mifepristone by mail.” Ibid. (quotation
omitted). This is a textbook example of arbitrary and capricious agency
action. See, e.g., Motor Vehicle Mfrs. Ass’n of the U.S., Inc. v. State Farm Mut.
Auto. Ins. Co., 463 U.S. 29, 52 (1983) (“The agency must explain the
evidence which is available, and must offer a ‘rational connection between
the facts found and the choice made.’” (quoting Burlington Truck Lines, Inc.
v. United States, 371 U.S. 156, 168 (1962))).
Accordingly, like the district court, we conclude Louisiana has
strongly shown a likelihood of winning its APA challenge to the 2023
REMS.
2
Second, irreparable harm. See Nken, 556 U.S. at 434; Louisiana v.
Biden, 55 F.4th 1017, 1033–34 (5th Cir. 2022).
We agree with the district court that Louisiana has shown it is
suffering irreparable harm, largely for the same reasons Louisiana has shown
injury for standing purposes.
As discussed, the 2023 REMS injures Louisiana by undermining its
laws protecting unborn human life and also by causing it to spend Medicaid
funds on emergency care for women harmed by mifepristone. Both injuries
are irreparable.
Every abortion facilitated by FDA’s action cancels Louisiana’s ban
on medical abortions and undermines its policy that “every unborn child is
human being from the moment of conception and is, therefore, a legal
person.” La. Stat. Ann. § 40:1061.1(A)(1) (2022). Once lost, that
sovereign prerogative of protecting unborn life cannot be regained by legal
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remedy. And because FDA “is entitled to sovereign immunity,” Alliance II,
78 F.4th at 251, Louisiana’s financial harms are also irremediable.
FDA’s only response is that Louisiana cannot prevail on this factor
because it lacks any “Article III injury.” We have already rejected that
argument, however.8
Accordingly, like the district court, we conclude that Louisiana has
shown that it is irreparably harmed without a stay.
3
We turn to the balance-of-harms and public interest factors. Nken, 556
U.S. at 434. These factors “merge when the government opposes” a stay.
Airlines for Am. v. Dep’t of Transp., 110 F.4th 672, 677 (5th Cir. 2024)
(quotation omitted).
Louisiana argues the district court erred by finding its irreparable
harms are outweighed by FDA’s interest in continuing its review and
Danco’s financial interests in selling mifepristone. We agree.
Once again, our court has spoken persuasively to this point before.
“[N]either the FDA nor the public has any interest in enforcing a regulation
that violates federal law.” Alliance II, 78 F4th at 251 (citing Louisiana, 55
F.4th at 1035). We have now three times found that the agency’s progressive
relaxation of mifepristone’s guardrails likely lacked a basis in data and
scientific literature. FDA itself now concedes the regulations were marred
by “procedural deficits” and a “lack of adequate consideration.” The public
8
Danco argues Louisiana waited too long to sue and seek a stay. That is beside the
point. Louisiana has shown the 2023 REMS causes it daily irreparable harm by
undermining its laws and costing it irremediable Medicaid funds. “Those costs are
ongoing . . . and more than sufficient to satisfy the irreparable harm standard in this
circuit.” Career Colleges & Schs. of Tex. v. Dep’t of Educ., 98 F.4th 220, 237 (5th Cir. 2024).
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interest is not served by perpetuating a medical practice whose safety the
agency admits was inadequately studied. Indeed, the public interest demands
the opposite. See Alliance II, 78 F.4th at 253 (explaining “the public interest
is disserved by a drug that does not afford adequate protections to its users”);
see also Hill Dermaceuticals, Inc. v. FDA, 524 F. Supp. 2d 5, 12 (D.D.C. 2007)
(“[T]he public interest weighs strongly in favor of preventing unsafe drugs
from entering the market.”).
For its part, Danco points to a stay’s effect on its compliance costs and
mifepristone profits. While we acknowledge a stay would impose costs on
Danco, cf. Alliance II, 78 F.4th at 252, the company exaggerates by predicting
a stay would destroy any “valid legal framework for distributing” the drug.
To the contrary, a stay would only pause a method of prescribing
mifepristone that began five years ago and was formally approved only three
years ago. Cf. Alliance I, 2023 WL 2913725, at *20 (doubting that post-2016
deregulation was “so critical to the public given that the Nation operated—
and mifepristone was administered to millions of women—without them for
sixteen years following the 2000 Approval”). And, in any event, Danco’s
potential financial losses pale beside Louisiana’s sovereign interest in its laws
protecting the unborn and the public’s interest in not exposing women to
unsafe medical procedures.
The district court raised various concerns about the equities and
public interest. We do not find that any of them tip the balance against
Louisiana, however.
First, the district court cautioned it was “not a forum for resolving
moral or policy disagreements” nor for adjudicating “scientific and medical
judgments committed by Congress to an agency with specialized
knowledge.” All quite true. This case, however, does not ask courts to
resolve such matters. Despite dealing with the charged subject of abortion, at
16
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No. 26-30203
bottom the case is an APA challenge to a regulation, a task courts routinely
undertake. See, e.g., Sw. Elec. Power Co. v. EPA, 920 F.3d 999, 1013 (5th Cir.
2019) (explaining that, while courts may not second-guess an agency’s
“evaluation of complex scientific data,” they must “ensure that the agency
examined the relevant data and articulated a satisfactory explanation for its
action” (quotations omitted)).
Second, the district court emphasized the importance of FDA’s being
able to “complete a fulsome review” and “proper science-driven
evaluation” of mifepristone protocols. Again, quite true. However, this
challenge involves the existing 2023 REMS, not FDA’s ongoing review.
Granting a stay would do nothing to prevent FDA from completing its review
of mifepristone’s safety protocols.
And consider what spurred that review: the agency’s concession that
its prior evaluation of mifepristone—including the 2023 REMS—was
marred by “procedural deficits” and a “lack of adequate consideration.” As
Louisiana points out, it “makes no sense to deny preliminary relief on the
grounds that agency action is so unlawful that the agency openly concedes a
review is necessary.” That would mean an agency could forestall judicial
review of admittedly unlawful regulations merely by promising to review
them in the future. And here FDA cannot even say when its review will
conclude—perhaps over a year from now because it has not finished
collecting data.9
Finally, the district court was concerned that, because “this case
arises amid multiple parallel lawsuits across the country,” there is “a
9
See Questions and Answers on Mifepristone for Medical Termination of Pregnancy
Through Ten Weeks Gestation, FDA, https://www.fda.gov/drugs/postmarket-drug-safety-
information-patients-and-providers/questions-and-answers-mifepristone-medical-
termination-pregnancy-through-ten-weeks-gestation.
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No. 26-30203
substantial risk of inconsistent judicial outcomes on a question of nationwide
importance.” That risk is inevitable in such litigation, however. See, e.g., BST
Holdings, L.L.C. v. OSHA, 17 F.4th 604, 610 (5th Cir. 2021) (observing
OSHA’s covid vaccine mandate was challenged “in federal courts of appeals
across the nation”). It does not absolve courts from deciding the cases before
them. If disagreement emerges, we have a Supreme Court. See NFIB v.
OSHA, 595 U.S. 109, 117 (2022) (agreeing with us that “the Secretary lacked
authority to impose the [covid vaccine] mandate”).
It is true, as the district court noted, that a § 705 stay “would, as a
practical matter, have a nationwide effect.” See Alliance II, 78 F.4th at 254
(explaining “a stay [under § 705] temporarily voids the challenged
authority”). 10 We do not agree, however, that this result is somehow in
tension with Trump v. CASA, 606 U.S. 831 (2025), as the district court
suggested. In CASA, the Supreme Court plainly said it was addressing only
equitable relief and not remedies under the APA. See id. at 846 n.10
(“Nothing we say today resolves the distinct question whether the [APA]
authorizes federal courts to vacate federal agency action.”).
In sum, we conclude that the balance of equities and public interest
weigh in Louisiana’s favor.
IV
Accordingly, IT IS ORDERED that the motion to stay the 2023
REMS under 5 U.S.C. § 705 pending appeal is GRANTED.
IT IS FURTHER ORDERED that the alternative motion for
injunction pending appeal is DENIED AS MOOT.
10
See also Career Colleges, 98 F.4th at 255 (“Nothing in the text of Section 705, nor
of Section 706, suggests that either preliminary or ultimate relief under the APA needs to
be limited to [parties].”).
18