Petition for Writ of Certiorari — Danco Laboratories, L.L.C., Petitioner v. Alliance for Hippocratic Medicine, et al.

APPENDIX

TABLE OF CONTENTS

Page

APPENDIX A—Fifth Circuit’s Opinion

(Aug. 16, 2023) .................................................... 1a

APPENDIX B—Supreme Court’s Opinion on

Applications for Stay

(Apr. 21, 2023) ................................................. 111a

APPENDIX C—Fifth Circuit’s Stay Order

(Apr. 12, 2023) ................................................. 116a

APPENDIX D—District Court’s

Memorandum Opinion and Order

(Apr. 7, 2023) ................................................... 164a

APPENDIX E—Statutory Provisions Involved:

5 U.S.C. § 705 .................................................. 250a

5 U.S.C. § 706 .................................................. 250a

i

1a

APPENDIX A

_________

UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

_________

No. 23-10362

_________

ALLIANCE FOR HIPPOCRATIC MEDICINE; AMERICAN

ASSOCIATION OF PRO-LIFE OBSTETRICIANS &

GYNECOLOGISTS; AMERICAN COLLEGE OF

PEDIATRICIANS; CHRISTIAN MEDICAL & DENTAL

ASSOCIATIONS; SHAUN JESTER, D.O.; REGINA FROSTCLARK, M.D.; TYLER JOHNSON, D.O.; GEORGE

DELGADO, M.D.,

Plaintiffs-Appellees,

versus

U.S. FOOD & DRUG ADMINISTRATION; ROBERT M.

CALIFF, Commissioner of Food and Drugs; JANET

WOODCOCK, M.D., in her official capacity as Principal

Deputy Commissioner, U.S. Food and Drug

Administration; PATRIZIA CAVAZZONI, M.D., in her

official capacity as Director, Center for Drug

Evaluation and Research, U.S. Food and Drug

Administration; UNITED STATES DEPARTMENT OF

HEALTH AND HUMAN SERVICES; XAVIER BECERRA,

Secretary, U.S. Department of Health and Human

Services,

Defendants-Appellants,

versus

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DANCO LABORATORIES, L.L.C.,

Intervenor-Appellant.

_________

Appeal from the United States District Court

for the Northern District of Texas

USDC No. 2:22-CV-223

_________

Filed: 08/16/2023

_________

Before Elrod, Ho, and Wilson, Circuit Judges.

Jennifer Walker Elrod, Circuit Judge:

This complicated administrative law appeal

concerns the regulation of mifepristone, a drug used

to cause abortion. The United States Food and Drug

Administration approved mifepristone for use in 2000

under the brand name Mifeprex. At the same time,

FDA imposed a number of conditions designed to

prevent the drug from causing serious medical side

effects. FDA amended those conditions in 2016,

generally lightening the prior protections. It then

approved a generic version in 2019. And in 2021, FDA

announced that it would not enforce an agency

regulation requiring mifepristone to be prescribed and

dispensed in person. The agency ultimately removed

that requirement from mifepristone’s conditions for

use.

The subject of this appeal is those four actions: the

2000 Approval, 2016 Amendments, 2019 Generic

Approval, and 2021 Non-Enforcement Decision. They

are challenged by the Alliance for Hippocratic

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Medicine—an association of doctors who research,

teach, and advocate for ethical medical practices—

several similar organizations, and several individual

doctors. At bottom, the Medical Organizations and

Doctors contend that FDA overlooked important

safety risks in approving mifepristone and amending

its restrictions. They assert that FDA’s actions were

unlawful under the Administrative Procedure Act.

The Organizations seek relief on behalf of their

members, many of whom are OB/Gyns or emergencyroom doctors. Many women face severe complications

as a result of taking mifepristone. The Doctors allege

that they are harmed when they treat those kinds of

patients.

According to the Doctors, when they treat women

who are experiencing complications after taking

mifepristone, they are required to perform or complete

an abortion, or otherwise required to participate in a

process that facilitates abortion. They maintain that

personally conducting those procedures violates their

sincerely held moral beliefs. The Doctors also contend

that treatment of mifepristone patients diverts time

and resources away from their ordinary patients,

causes substantial mental and emotional distress,

and exposes them to heightened malpractice risk and

increased insurance costs.

Seeking to prevent those alleged injuries, the

Medical Organizations and Doctors moved for

preliminary injunctive relief. The district court

granted the motion, but rather than entering a

traditional injunction, the court stayed the effective

date of each of the challenged actions under 5 U.S.C.

§ 705. FDA appealed, as did Intervenor Danco

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Laboratories, LLC, the pharmaceutical company that

distributes Mifeprex.

After extensive briefing and oral argument, we hold

that the district court’s stay order should be

VACATED in part and AFFIRMED in part. We

conclude that the Medical Organizations and Doctors’

claim as to the 2000 Approval is likely barred by the

statute of limitations. Accordingly, that component of

the district court’s order must be VACATED. This

means that, until final judgment, Mifeprex will

remain available to the public under the conditions for

use that existed in 2016.

We also VACATE the portion of the order relating to

the 2019 Generic Approval because the Medical

Organizations and Doctors have not shown that they

are injured by that particular action. The generic

version of mifepristone will also be available under

the same conditions as Mifeprex.

We AFFIRM the components of the stay order that

concern the 2016 Amendments and the 2021 NonEnforcement Decision. Those agency actions—which

generally loosen the protections and regulations

relating to the use of mifepristone—will be stayed

during the pendency of this litigation.

Finally, we note that our holding is subject to the

prior order of the Supreme Court, which stayed the

district court’s order pending resolution of this appeal

and disposition of any petition for writ of certiorari.

Danco Lab’ys, LLC v. All. for Hippocratic Med., 143 S.

Ct. 1075 (2023) (mem.).

I. Background

This case arises under the Federal Food, Drug, and

Cosmetic Act and related amendments. 21 U.S.C.

5a

ch. 9. The Department of Health and Human Services

is charged with responsibility for implementing that

law, and has delegated that obligation to FDA, its

subagency. Id. § 393. The relevant events center on

the particular duty of approving new drugs.

The approval process begins with a new drug

application. Id. § 355(a). At this stage, it is the

applicant’s burden to prove that the proposed drug is

safe and effective. The Act directs FDA to deny a new

drug application if, among other reasons, the

applicant fails to include tests and data that show that

the drug “is safe for use under the conditions

prescribed, recommended, or suggested in the

proposed labeling”; if “any other information” before

FDA tends to show that the drug is not safe; or if

“there is a lack of substantial evidence that the drug

will have the effect it purports or is represented to

have under the conditions for use prescribed,

recommended, or suggested in the proposed labeling

thereof.” Id. § 355(d); see 21 C.F.R. § 314.125

(regulations expanding on those requirements).

Certain new drug applications may be designated

for “accelerated approval.” 21 C.F.R. § 314 subpt. H.

This category applies to drugs treating “serious or lifethreatening illnesses” and that “provide meaningful

therapeutic benefit to patients over existing

treatments.” Id. § 314.500. The regulations also

require FDA to impose “postmarketing restrictions”

where necessary to ensure the drug is used safely. Id.

§ 314.520(a). Relevant here, the agency may mandate

that the drug be administered at “certain facilities or

[by] physicians with special training or experience,” or

that “specified medical procedures” be used. Id.

§ 314.520(a)(1), (a)(2).

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FDA has explained that it will consider accelerated

approval in two situations: where the agency can

reliably estimate effectiveness using a “surrogate

endpoint”; and where FDA “determines that a drug,

effective to the treatment of a disease, can be used

safely only if distribution or use is modified or

restricted.” 57 Fed. Reg. 58942, 58942 (Dec. 11, 1992).

The agency has understood approval under Subpart H

as also satisfying the general approval conditions

provided by the Food, Drug, and Cosmetic Act. See id.

(“Drugs or biological products approved under these

procedures will have met the requisite standards for

safety and effectiveness under the [Act] . . . and, thus,

will have full approval for marketing.”).

In March of 1996, an entity known as the Population

Council applied for FDA to approve mifepristone as a

new drug, as part of a two-drug regimen designed to

cause abortion.1 The regimen works like this: First, a

pregnant woman takes mifepristone, which

suppresses the production of the hormone

progesterone. Progesterone is needed for the

pregnancy to continue; it prepares and maintains the

uterine lining and stimulates the production of

nutrients. After taking mifepristone, a patient takes

misoprostol, which causes the uterus to cramp and

expel its contents.

As part of the new drug application, the Population

Council relied on three clinical studies, one conducted

1

The Population Council is a non-profit organization. Roussel

Uclaf—the French pharmaceutical company that originally

developed mifepristone—donated the American patent rights to

the Population Council in 1994. The Population Council then

granted Danco an exclusive license to manufacture and

distribute Mifeprex in the United States.

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in the United States and two conducted in France. The

studies purported to show that mifepristone was

effective in the majority of cases, under the conditions

imposed in each study. Those conditions included: an

ultrasound to verify gestational age and diagnose

ectopic pregnancies; that prescribing physicians have

experience performing surgical abortions and have

admitting privileges at a nearby hospital; that the

testing facilities be located close to a local hospital;

and a four-hour monitoring period after taking

misoprostol.

Although mifepristone was effective for most

patients, the studies showed a trend of adverse events

for some women. According to FDA, “surgical

intervention” was required in 7.9% of the subjects in

the American trial and 4.5% of subjects in the French

trials. The reasons for surgery included heavy

bleeding, infection, incomplete abortion, and ongoing

pregnancy—meaning that the embryo or fetus

continued to grow and develop.

FDA approved the new drug application in

September 2000. The letters that the agency sent to

the Population Council explained that the approval

was “under Subpart H.” FDA Approval Memorandum

to Population Council at 6 (Sept. 28, 2000). This was

for two reasons. First, FDA understood Mifeprex to be

a drug that treated a serious or life threatening

illness. Id. (“FDA has determined that the

termination of an unwanted pregnancy is a serious

condition within the scope of Subpart H. The

meaningful therapeutic benefit over existing surgical

abortion is the avoidance of a surgical procedure.”).

And second, Subpart H was required because

Mifeprex could not be administered safely without

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imposing certain use restrictions. Id. (“Subpart H

applies when FDA concludes that a drug product

shown to be effective can be safely used only if

distribution or use is restricted . . . .”).

In order to address the safety risks discussed above,

FDA imposed several safeguards. First, it required

the following black-box warning:

If Mifeprex results in incomplete abortion,

surgical intervention may be necessary.

Prescribers should determine in advance

whether they will provide such care themselves

or through other providers. Prescribers should

also give patients clear instructions of whom to

call and what to do in the event of an emergency

following administration of Mifeprex.

Approval Memorandum at 2. FDA also set the

following controls on the use and prescription of

Mifeprex:











Only women whose pregnancies have a

gestational age of forty-nine days or less are

eligible;

Only physicians can prescribe Mifeprex;

All prescribing physicians must be able to

assess gestational age, diagnose ectopic

pregnancies,

and

“provide

surgical

intervention in cases of incomplete abortion

or severe bleeding” or have arranged for

another physician to provide such care;

Prescription must occur in person; and

Prescribers

must

report

any

“hospitalization, transfusion, or other

serious event[] to the sponsor.”

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Id. at 1, 6. Finally, FDA required three doctor’s-office

visits, which are summarized as follows. The patient

first takes mifepristone at the doctor’s office. Three

days later, she returns to the office to take

misoprostol. Finally, the patient visits the doctor for a

follow-up appointment, to determine whether the

drug has successfully terminated the pregnancy and

to screen for any adverse effects.

In August of 2002, the American Association of ProLife Obstetricians and Gynecologists (a party to the

instant case) and several other similar organizations

filed a citizen petition, asking FDA to revoke its

approval of mifepristone. See 21 C.F.R. § 10.30. The

petition argued that mifepristone was not safe to use

under the approved conditions. FDA reviewed the

petition over the next fourteen years, ultimately

denying it in 2016.

Two significant developments occurred in the

meantime. First, in 2007, Congress amended the

Food, Drug, and Cosmetic Act. See Food and Drug

Administration Amendments Act of 2007, Pub. L. No.

110-85, tit. IX, § 901, 121 Stat. 823, 922–43. The

amendment authorizes FDA to require a “risk

evaluation and mitigation strategy” (REMS) if it

determines that such a strategy is “necessary to

ensure that the benefits of the drug outweigh the risks

of the drug.” 21 U.S.C. § 355-1(a)(1). The Act further

allowed FDA to impose use restrictions via the REMS,

like

physician

qualifications

or

reporting

requirements. Id. § 355-1(f). The law also regarded all

drugs approved before the Act as having an approved

REMS. See Amendments Act § 909(b), 121 Stat. at 950

(“A drug that was approved before the effective date

of this Act is . . . deemed to have in effect an approved

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risk evaluation and mitigation strategy under section

505-1 of the [Act].”).

Then in 2011, FDA approved a REMS for

mifepristone, imposing essentially the same

restrictions as those FDA required when it approved

Mifeprex in 2000. The REMS included four essential

parts: a general summary, medication guide,

prescriber agreement, and patient agreement. The

medication guide explains how to use mifepristone

and the risks associated with doing so. Mifepristone

REMS at 4–6 (June 8, 2011). The prescriber

agreement requires prescribers to promise to follow

FDA’s restrictions. Id. at 7–8. And the patient

agreement is a form that women must sign prior to

using mifepristone; it obliges a patient to confirm that

she meets the conditions for using mifepristone and

acknowledge the risk of adverse events. Id. at 9–10.

The mifepristone REMS was later amended in several

respects. But its general form—the summary, medical

guide,

prescriber’s

agreement,

and

patient

agreement—remains the same.

In 2016, FDA addressed Mifeprex in two respects.

First, it denied the 2002 citizen petition, defending

Mifeprex’s safety and effectiveness as approved in

2000. Second, FDA approved a supplemental new

drug application by Danco. That application

requested a number of amendments to Mifeprex’s

REMS that FDA described as “major” and

“interrelated.” FDA Summary Review of 2016

Amendments at 5 (Mar. 29, 2016). Those changes

included:



Increasing the maximum gestational age

from forty-nine days to seventy days;

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









Allowing non-physicians to prescribe

mifepristone;

Removing the requirement that the

administration of misoprostol and the

subsequent follow-up appointment be

conducted in person;

Eliminating prescribers’ obligation to report

non-fatal adverse events;

Switching the method of administration for

misoprostol from oral to buccal; and

Changing the dose of mifepristone (600 mg

to 200 mg) and misoprostol (400 mcg to 800

mcg).

Id. at 2, 26. FDA also pointed to a number of studies

as evidence that Mifeprex would be safe and effective

despite the amendments. Id. at 5–17.

Several years later, in 2019, the American

Association

of

Pro-Life

Obstetricians

and

Gynecologists and American College of Pediatricians

filed a citizen petition challenging the 2016

Amendments. The petition generally requested that

FDA restore the restrictions it imposed in 2000.

Separately, in April of 2019, FDA approved an

“abbreviated new drug application” by GenBioPro,

Inc. for a generic version of mifepristone. To assess

whether the drug was safe, the agency relied on the

same data that it had relied upon for the 2000

Approval and 2016 Amendments regarding Mifeprex.

FDA then took several notable steps in 2021. In

April, it announced that, in connection with the

COVID-19 pandemic, the agency would not enforce

the in-person dispensing requirement. Effectively,

this allowed mifepristone to be prescribed remotely

and sent via mail.

12a

[FDA] intends to exercise enforcement

discretion during the COVID-19 [pandemic]

with respect to the in-person dispensing

requirement of the Mifepristone REMS

Program,

including

any

in-person

requirements that may be related to the

Patient Agreement Form. Further . . . [FDA]

intends to exercise enforcement discretion

during the COVID-19 [pandemic] with respect

to the dispensing of mifepristone through the

mail either by or under the supervision of a

certified prescriber, or through a mail-order

pharmacy when such dispensing is done under

the supervision of a certified prescriber.

FDA Letter to American College of Obstetricians and

Gynecologists at 2 (Apr. 12, 2021). Later that year,

FDA stated that it would adopt the change on a

permanent basis. It then amended mifepristone’s

REMS (which applies to Mifeprex and the generic

version) in January of 2023 to formalize the removal

of the in-person dispensing requirement. FDA Br. at

11.

Finally, in December of 2021, FDA denied the 2019

citizen petition. According to FDA, the agency

“undertook a full review of the Mifepristone REMS

Program” and ultimately concluded that the drug was

safe to use as amended. FDA Denial Letter to

American College of Obstetricians and Gynecologists

at 6 (Dec. 16, 2021). FDA specifically addressed its

reasons for removing the in-person dispensing

requirement. Id. at 25–36.

***

Against this background, the Medical Organizations

and Doctors filed the instant complaint in district

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court. As relevant here, they alleged that each FDA

action—the 2000 Approval, 2016 Amendments, 2019

Generic Approval, and 2021 Non-Enforcement

Decision—violates the Administrative Procedure Act.

Danco intervened to represent its interest as the

manufacturer and distributor of Mifeprex in the

United States. GenBioPro filed an amicus brief before

this court but did not intervene or otherwise

participate in the litigation, either in the district court

or on appeal.

The Medical Organizations and Doctors filed a

motion for a preliminary injunction. The district court

held a hearing on the matter and granted the motion

in part. All. for Hippocratic Med. v. FDA, ___ F. Supp.

3d ___, 2023 WL 2825871 (N.D. Tex. Apr. 7, 2023). For

relief, the court “stayed” the “effective date” of FDA’s

actions under 5 U.S.C. § 705.

FDA and Danco appealed and moved to stay the

district court’s order pending appeal. A motions panel

of this court stayed the district court’s order in part.

All. for Hippocratic Med. v. FDA, No. 23-10362, 2023

WL 2913725 (5th Cir. Apr. 12, 2023). The panel stayed

the portion of the district court’s order relating to the

2000 Approval but did not disturb the other

components of the order—regarding the 2016

Amendments, 2019 Generic Approval, and 2021 NonEnforcement Decision. FDA and Danco then applied

to the Supreme Court for a full stay of the district

court’s order, which was granted. Danco Lab’ys, LLC

v. All. for Hippocratic Med., 143 S. Ct. 1075 (2023)

(mem.). The Court further provided that its stay of the

district court’s order would extend through the

request for a petition for certiorari, if any:

14a

The April 7, 2023 order of the United States

District Court for the Northern District of

Texas, case No. 2:22–cv–223, is stayed pending

disposition of the appeal in the United States

Court of Appeals for the Fifth Circuit and

disposition of a petition for a writ of certiorari,

if such a writ is timely sought. Should certiorari

be denied, this stay shall terminate

automatically. In the event certiorari is

granted, the stay shall terminate upon the

sending down of the judgment of this Court.

Id. at 1075. The parties then fully briefed the ultimate

question of whether the district court erred in issuing

the stay order. Over thirty amici filed separate briefs

on various topics. Oral argument was held on May 17,

2023, in which each side was allowed forty minutes to

present its argument, double the ordinary allotted

time. We now consider the merits of the appeal.

II. Standing

Before considering the Medical Organizations and

Doctors’ claims, we must determine whether they

have standing to assert them; an injunction is always

improper if the district court lacked jurisdiction. Cruz

v. Abbott, 849 F.3d 594, 598–99 (5th Cir. 2017). At this

stage, it is the plaintiffs’ burden to “make a ‘clear

showing’ that they have standing to maintain the

preliminary injunction.” Barber v. Bryant, 860 F.3d

345, 352 (5th Cir. 2017) (quoting Winter v. Nat. Res.

Def. Council, Inc., 555 U.S. 7, 22 (2008)). And so the

Medical Organizations and Doctors must satisfy the

three basic elements of standing: injury, traceability,

and redressability. Lujan v. Defs. of Wildlife, 504 U.S.

555, 560 (1992).

15a

Standing in this appeal turns principally on the

“injury” prong. The Medical Organizations and

Doctors seek prospective relief, so they must establish

future injury. To do that, they must show that “the

threatened injury is ‘certainly impending,’ or there is

a ‘substantial risk’ that the harm will occur.” Susan

B. Anthony List v. Driehaus, 573 U.S. 149, 158 (2014)

(quoting Clapper v. Amnesty Int’l USA, 568 U.S. 398,

414 n.5 (2013)). As those standards indicate, the

plaintiffs must show that the threat of future injury is

sufficiently likely. The Supreme Court has thus

rejected standing theories that rely “on a highly

attenuated chain of possibilities” or that “require

guesswork as to how independent decisionmakers will

exercise their judgment.” Clapper, 568 U.S. at 410,

413.

Even so, a “substantial risk” does not require that

the threatened injury be “literally certain.” Id. at 414

n.5; see Lujan, 504 U.S. at 564 n.2 (acknowledging

that imminence “is concededly a somewhat elastic

concept”); Babbitt v. United Farm Workers Nat’l

Union, 442 U.S. 289, 298 (1979) (requiring that the

plaintiff “demonstrate a realistic danger of sustaining

a direct injury”); Kolender v. Lawson, 461 U.S. 352,

355 n.3 (1983) (“a credible threat”); Frame v. City of

Arlington, 657 F.3d 215, 235 (5th Cir. 2011) (“a

sufficiently high degree of likelihood”). Instead, a

plaintiff seeking prospective relief need only show

that future injury is “fairly likely.” Crawford v. Hinds

Cnty. Bd. of Supervisors, 1 F.4th 371, 376 (5th Cir.

2021); accord Arcia v. Fla. Sec’y of State, 772 F.3d

1335, 1341 (11th Cir. 2014) (“a realistic probability”).

In assessing whether the threatened injury is fairly

likely to occur, evidence of prior injury is especially

16a

probative. See Crawford, 1 F.4th at 376 (citing Los

Angeles v. Lyons, 461 U.S. 95, 102 (1983)). Said

another way, it “is not unduly conjectural” to use the

“predictable effect” of the defendant’s prior actions as

a method to predict what will happen in the future.

Apple Inc. v. Vidal, 63 F.4th 1, 17 (Fed. Cir. 2023)

(quoting Dep’t of Com. v. New York, 139 S. Ct. 2551,

2566 (2019)). Injuries that are “one-off” instances or

“episodic” in nature do not move the needle much.

Crawford, 1 F.4th at 376. But where the causes that

produced the first injury remain in place, past-injury

evidence bears strongly “on whether there is a real

and immediate threat of repeated injury.” O’Shea v.

Littleton, 414 U.S. 488, 496 (1974); see Crawford, 1

F.4th at 376; accord In re Navy Chaplaincy, 697 F.3d

1171, 1176–77 (D.C. Cir. 2012) (“The prospect of

future injury becomes significantly less speculative

where, as here, plaintiffs have identified concrete and

consistently-implemented policies claimed to produce

such injury.”).

Finally, a group of plaintiffs need not show that

more than one of them is likely to be injured. “If at

least one plaintiff has standing, the suit may proceed.”

Biden v. Nebraska, 143 S. Ct. 2355, 2365 (2023) (citing

Rumsfeld v. F. for Acad. and Institutional Rts., Inc.,

547 U.S. 47, 52 n.2 (2006)).

A. Associational Standing

1. Factual Predicate

The Medical Organizations and Doctors chiefly rely

on associational standing. That is, the organizations

contend that they have standing because their

members are likely to sustain injuries as a result of

FDA’s actions. See Hunt v. Wash. State Apple Adv.

17a

Comm’n, 432 U.S. 333, 343 (1977). We conclude that

the Medical Organizations and Doctors have made a

“clear showing” that their members face injury with

sufficient likelihood to support entering a preliminary

injunction. Barber, 860 F.3d at 352.

The standing theory forwarded here rests on several

basic premises, which are recited as follows.

Mifepristone causes adverse effects for a certain

percentage of the women who take it. Those adverse

events are traceable to FDA because it approved the

drug. And hundreds of the Medical Organizations’

members are OB/Gyns or emergency-room doctors

who treat women who experience severe adverse

effects.

The Doctors are allegedly injured when they treat

mifepristone patients. They offer four reasons why

that is so. First, when a doctor treats a woman

suffering from a mifepristone complication, he or she

will often be required to perform or complete an

abortion. And even if not, the doctor must participate

in the medical treatment that facilitates an abortion.

The Doctors allege that being made to provide this

treatment conflicts with their sincerely held moral

beliefs and violates their rights of conscience.

Second, treating mifepristone patients imposes

mental and emotional strain above what is ordinarily

experienced in an emergency-room setting. Third,

providing emergency treatment forces the Doctors to

divert time and resources away from their ordinary

patients, hampering their normal practice. And

fourth, the Doctors allege that mifepristone patients

involve more risk of complication than the average

patient, and so expose the Doctors to heightened risk

of liability and increased insurance costs.

18a

The Organizations reason that, given the millions of

women who take mifepristone, the number of women

who experience complications from taking the drug,

and the high number of the Organizations’ members

who treat such women, their members are likely to

continue to treat women suffering complications as a

result of mifepristone. For the reasons listed above,

providing that treatment will injure the Doctors.

Thus, the Medical Organizations (via their members)

are likely to be injured by FDA’s actions. We first

examine the evidence supporting those contentions.

a. Adverse Effects

FDA and Danco do not dispute that a significant

percentage of women who take mifepristone

experience adverse effects. From Mifeprex’s initial

approval to subsequent amendments to the REMS,

FDA has acknowledged that a certain fraction of

patients would require surgery due to miscellaneous

complications. Approval Memorandum at 1; see also

2011 Mifepristone REMS at 5 (“[A]bout 5-8 out of 100

women taking Mifeprex will need a surgical procedure

to end the pregnancy or to stop too much bleeding.”).

Similarly, as explained by the motions panel, the

required patient agreement discloses that “the

treatment will not work” in “about 2 to 7 out of 100

women” who use mifepristone. All. for Hippocratic

Med., 2023 WL 2913725, at * 5.

To be sure, not every woman who experiences

complications will present to the emergency room or

require surgery and/or some other form of urgent care.

But many will. According to the most updated REMS

medication guide, in studies conducted in the United

States, between 2.9% and 4.6% of women visited the

emergency room after taking mifepristone. Mifeprex

19a

Prescribing Information at 8 tbl.2 (Jan. 2023). Some

women experience especially severe conditions, such

as sepsis (.02%) or hospitalization relating to abortion

(.04% to .06%), and some women require a blood

transfusion because of heavy bleeding (.03% to .05%).

Id.2

The data FDA cited in its 2000 approval memo is

similar. For the American clinical trial, surgical

intervention was required for 7.9% of women (4.5% for

the French studies). Approval Memorandum at 1. Of

that percentage, 1.2% of women required surgery due

to heavy bleeding (.3% for France) and .12% required

a blood transfusion (.11% for France). Id. FDA and

Danco agree that over five million women have taken

Mifeprex since it was first approved. These figures

show that thousands of women, and as many as

hundreds of thousands, have experienced serious

adverse effects as a result of taking the drug, and

required surgery or emergency care to treat those

effects.

The Medical Organizations contend that their

members treat women who suffer serious

complications after taking mifepristone. These

doctors submitted declarations testifying to their

experience giving this sort of emergency care. For

example, Dr. Christina Francis recounted an instance

where a patient took mifepristone at approximately

2

To be clear, we do not understand the Medical Organizations

and Doctors’ standing theory as applying only to women who

present to the emergency room with severe complications such

as those listed above. Rather, they also contend that they are

injured by treating women who experience less urgent medical

side-effects because such treatment forces the doctor to

participate in the abortion process.

20a

ten weeks gestation. The woman experienced serious

complications and the doctor was forced to perform a

surgical abortion because the drug failed to terminate

the pregnancy:

[T]he patient presented back at our emergency

room with heavy vaginal bleeding and unstable

vital signs as a result of taking chemical

abortion drugs. One of my partners was able to

detect a fetal heartbeat. Due to the amount of

bleeding that she was experiencing and

evidence of hemodynamic instability, however,

my partner had no choice but to perform an

emergency D&C. The patient needed to be

hospitalized overnight for close observation

after the D&C.

Not only did my partner need to provide several

hours of critical care for this patient, but my

partner also needed to call in a back-up

physician to care for another critically ill

patient. And because the preborn baby still had

a heartbeat when the patient presented, my

partner felt as though she was forced to

participate in something that she did not want

to be a part of—completing the abortion.

Dr. Francis Declaration ¶ 13. Dr. Francis also testified

to another example where a woman had developed an

infection as a result of using mifepristone:

After taking the chemical abortion drugs, [the

patient] began having very heavy bleeding

followed by significant abdominal pain and a

fever. When I saw her in the emergency room,

she had evidence of retained pregnancy tissue

along with endometritis, an infection of the

uterine lining. She also had acute kidney

21a

injury, with elevated creatinine. She required a

dilation and curettage (D&C) surgery to finish

evacuating her uterus of the remaining

pregnancy tissue and hospitalization for

intravenous (IV) antibiotics, IV hydration, and

a blood transfusion.

Id. ¶ 12.3 Dr. Ingrid Skop also testified to caring for

many women experiencing severe complications due

to mifepristone:

In my practice, I have cared for at least a dozen

women who have required surgery to remove

retained pregnancy tissue after a chemical

abortion. Sometimes this includes the embryo

or fetus, and sometimes it is placental tissue

that has not been completely expelled. I have

cared for approximately five women who, after

a chemical abortion, have required admission

for a blood transfusion or intravenous

antibiotics or both.

For example, in one month while covering the

emergency room, my group practice admitted

three women to the hospital. Of the three

women admitted in one month due to chemical

abortion complications, one required admission

to the intensive care unit for sepsis and

3

At oral argument, Defendants discounted the relevance of

this instance because the patient obtained mifepristone from

outside of the country. Mifeprex is only marketed and distributed

in the United States, so the incident almost certainly did not

involve FDA-approved Mifeprex. We agree that the evidence is

not as probative as other examples— discussed below—that

involve brand name mifepristone. But the incident still supports

the proposition that mifepristone sometimes causes severe

adverse events.

22a

intravenous antibiotics, one required a blood

transfusion for hemorrhage, and one required

surgical completion for the retained products of

conception (i.e., the doctors had to surgically

finish the abortion with a suction aspiration

procedure).

Dr. Skop Declaration ¶¶ 17–18, 22. She also described

one occurrence where a woman’s mifepristone

prescriber did not offer surgical care in response to

heavy bleeding. That, in turn, required Dr. Skop to

perform the follow-up surgical procedure:

In my office, I treated one young woman who

had been bleeding for six weeks after she took

the chemical abortion drugs given to her by a

doctor at a Planned Parenthood clinic. After

two follow-ups at Planned Parenthood, during

which she was given additional misoprostol but

not offered surgical completion, she presented

to me for help. I performed a sonogram,

identified a significant amount of pregnancy

tissue remaining in her uterus, and performed

a suction aspiration procedure to resolve her

complication.

Id. ¶ 23. Dr. Nancy Wozniak also described a serious

complication in detail, in which the patient was at risk

of bleeding to death:

One of my patients, who was about nine weeks

pregnant, had previously been treated by

hospital staff for a pulmonary embolism with

anti-coagulants. She was advised that she could

not seek a chemical abortion because it was

contraindicated due to the medications; yet the

woman left the hospital and sought an abortion

at Planned Parenthood of Indiana.

23a

The woman was given mifepristone by the

doctor at Planned Parenthood and took the

drug. The woman called an Uber for a ride

home from Planned Parenthood. The woman

began to experience bleeding and other adverse

side effects from the mifepristone. The woman’s

Uber driver did not take her home because she

was so ill and instead brought her to the

hospital’s emergency department.

At the hospital, the woman came under my

care. The woman had not yet taken the second

abortion drug, misoprostol. I treated the

patient for the adverse effects she suffered and

told her not to take the misoprostol given to her

by Planned Parenthood because of the grave

risk that she could bleed out and die. The

woman had a subsequent ultrasound, which

showed that her unborn child was still alive. I

advised the internists treating this patient to

avoid administering certain medications that

could harm the patient and her unborn child.

Dr. Wozniak Declaration ¶ 24. The risk of

complications, the Medical Organizations say, is only

heightened in the case of ectopic pregnancy. Dr. Skop

testified about the dangers of taking mifepristone

under that condition:

[A]pproximately 2% of pregnancies are ectopic

pregnancies, implanted outside of the uterine

cavity. Chemical abortion drugs will not

effectually end an ectopic pregnancy because

they exert their effects on the uterus, which

leaves women at risk of severe harm from

hemorrhage due to tubal rupture, in need of

emergent surgery or potentially at risk of

24a

death. Failure to perform an ultrasound prior

to prescribing abortion drugs will cause some

women to remain undiagnosed and at high risk

for these adverse outcomes.

Dr. Skop Declaration ¶ 29; see also Dr. Barrows

Declaration ¶ 18.

According to the Medical Organizations and

Doctors, these are examples of medical cases that

occur across the county. The occurrences extend not

just to the declarants, they say, but to all of the

Organizations’ members who are doctors. The

Organizations offered testimony from representatives

of the American College of Pediatricians, American

Association

of

Pro-Life

Obstetricians

and

Gynecologists, Christian Medical and Dental

Associations, and Catholic Medical Association—each

of whom explained that their membership includes

thousands of doctors and hundreds of OB/Gyns and

emergency-room doctors. See Dickerson Declaration

¶¶ 3, 13; Dr. Harrison Declaration ¶ 8; Dr. Barrows

Declaration ¶ 5; Dr. Van Meter Declaration ¶ 8. Given

the large number of women who experience serious

medical complications due to mifepristone, and the

large number of association members who are

emergency-room doctors, the Medical Organizations

argue, it is highly likely that one or more of their

members will be required to provide emergency care

to a mifepristone patient in the near future.

b. Doctors’ Injuries

The Medical Organizations and Doctors present

evidence of four ways they are injured by providing

emergency care to women who used mifepristone.

First, that treatment violates their conscience rights,

putting them in a position where they must perform

25a

or complete an abortion even though doing so is

contrary to their moral beliefs. As described by one

doctor:

The FDA’s expansion of chemical abortion . . .

harms my conscience rights because it could

force me to have to surgically finish an

incomplete elective chemical abortion. I object

to abortion because it ends a human life. My

moral and ethical obligation to my patients is to

promote human life and health. But the FDA’s

actions may force me to end the life of a human

being in the womb for no medical reason.

Dr. Skop Declaration ¶ 34. And multiple doctors

testified that others they knew have been required to

complete a failed chemical abortion against their

consciences, or to provide related care. Dr. Francis

Declaration ¶ 13; cf. Dr. Barrows Declaration ¶ 26.

Second, treating mifepristone patients imposes

considerable mental and emotional stress on

emergency-room doctors. This is due to the unique

nature of chemical abortions, which, according to the

plaintiff-doctors, frequently cause “regret” or

“trauma” for the patients and, by extension, the

physicians. Alliance Br. at 18. Dr. George Delgado

testified that his work with such patients is “some of

the most emotionally taxing work I have done in my

career.” Dr. Delgado Declaration ¶ 14; see also

Dickerson Declaration ¶ 14; Dr. Skop Declaration

¶ 33; Dr. Wozniak Declaration ¶ 17.

Third, the Doctors are injured because they must

divert time and resources away from their ordinary

practice to treat mifepristone patients. In particular,

the Doctors describe this treatment as often requiring

26a

extended physician attention, blood for transfusions,

and other hospital resources. As one doctor testified:

When I must perform surgery [for]

complications from chemical abortions, this

takes attention away from my other patients.

As a hospitalist, I am often supervising

multiple laboring patients on labor and

delivery. When I am called to the operating

room to address an emergency resulting from

chemical abortion, this necessarily means I

may not be immediately available if an

emergency should occur with one of my laboring

patients.

Dr. Skop Declaration ¶ 32; see also Dr. Francis

Declaration ¶ 12 (“I spent several hours with [my

patient] the day of her surgery/hospital admission,

keeping me from my primary patient responsibilities

in the labor and delivery unit and requiring me to call

in an additional physician to help cover those

responsibilities.”); Dr. Harrison Declaration ¶ 30

(“Patients who suffer complications from chemical

abortions require significantly more time and

attention from providers than the typical OB/Gyn

patient requires.”). This diversion of resources, the

Doctors say, directly harms their medical practices.

See Dr. Harrison Declaration ¶¶ 27–30.

Fourth, such patients involve more risk than the

average emergency room patient, which exposes the

Doctors to greater malpractice liability and increased

insurance costs. See Dr. Barrows Declaration ¶ 23

(testifying that providing emergency treatment to

women suffering complications because of taking

mifepristone puts doctors in “riskier, emergent

medical situations”); Dr. Jester Declaration ¶ 20

27a

(“These situations are naturally higher risk for both

the patient and for the physician providing care.”).

The more mifepristone patients the Doctors treat, the

higher their liability and greater their injury. See Dr.

Barrows Declaration ¶¶ 21–24; Dr. Jester Declaration

¶¶ 20– 21; Dr. Johnson Declaration ¶ 15. Having

examined the factual basis for the Medical

Organizations and Doctors’ claims, we now answer

the question of whether they have associational

standing to assert those claims.

2. Analysis

a. Imminent Injury

We conclude that the Medical Organizations and

Doctors have made a “clear showing” of associational

standing. Barber, 860 F.3d at 352. To begin, it is

“fairly likely” that the Doctors—both those who

testified and those who are members of the Medical

Organizations but did not testify— will continue

treating women who experience severe complications

after taking mifepristone. Crawford, 1 F.4th at 376.

FDA’s own data shows that a definite percentage of

women who take mifepristone will require emergency

room care, be it a blood transfusion, a surgery to

complete a failed abortion or ongoing pregnancy, or

some other complication. The data further shows that

millions of women take mifepristone. And the Medical

Organizations testified that hundreds of their

members are OB/Gyns and emergency-room doctors

who care for women in these circumstances. The

Medical Organizations and Doctors therefore face a

“substantial risk” of future injury. Susan B. Anthony

List, 573 U.S. at 158.

28a

That risk is supported by the fact that many Doctors

have already been required to treat patients

experiencing complications due to mifepristone.

Lyons, 461 U.S. at 102. These are not merely “one-off”

instances. Crawford, 1 F.4th at 376. On the contrary,

FDA’s data and the Doctors’ testimony show that

women will continue to present to the emergency room

after taking mifepristone, requiring urgent

treatment. That trend is not speculative—it is

“predictable” and “consistent[].” Vidal, 63 F.4th at 17;

In re Navy Chaplaincy, 697 F.3d at 1176. And it does

not matter that the foundation of the Doctors’

standing rests, in part, on “choices made by

independent actors.” Lujan, 504 U.S. at 562. That

concern is alleviated where, as here, “third parties will

likely act in predictable ways.” Dep’t of Com., 139 S.

Ct. at 2566.

It is worth repeating that the Medical Organizations

and Doctors are not required to show that it is

“literally certain” that they will be injured. Clapper,

568 U.S. at 414 n.5. They need only show a

“substantial risk” that injury will occur. Susan B.

Anthony List, 573 U.S. at 158; see also United Farm

Workers, 442 U.S. at 298 (“a realistic danger”);

Kolender, 461 U.S. at 356 n.3 (“a credible threat”);

Arcia, 772 F.3d at 1341 (“a realistic probability”). At

this preliminary-injunction stage, they have carried

their burden. All. for Hippocratic Med., 2023 WL

2913725, at *8.

FDA and Danco’s primary objection to the Medical

Organizations and Doctors’ standing theory is that it

is speculative and inconsistent with the Supreme

Court’s decision in Summers v. Earth Island Institute,

555 U.S. 488 (2009). We disagree. For one thing,

29a

testimony was offered from multiple doctors who have

personally given emergency care to women suffering

complications from mifepristone. Dr. Francis

Declaration ¶¶ 12–13; Dr. Skop Declaration ¶¶ 17–18,

22; Dr. Jester ¶ 17. Given those prior instances, and

given mifepristone’s continued availability, the

Medical Organizations reason that these members are

reasonably likely to be injured again. The record

amply supports that claim.

Moreover, it is not speculative to base standing on

the likelihood that some members of a discrete group,

but not all, will be injured. To be sure, the record must

be specific enough to establish that a group of

members who claim future injury are really at risk.

But the evidence before us meets that standard. The

Medical Organizations and Doctors have proven up

each link in the chain of causation—that a percentage

of women who take mifepristone will suffer serious

medical complications; that hundreds of the Medical

Organizations’ members are physicians who treat

patients in those circumstances; that many of the

Doctors have in fact treated such patients; and that

providing such treatment causes the Doctors to

violate their rights of conscience, sustain mental and

emotional distress, divert time and resources away

from their ordinary practice, and incur additional

liability and insurance costs. Contrary to what FDA

and Danco argue, the conclusion the Doctors draw

from that data is not speculative.

And the Medical Organizations’ standing argument

does not conflict with Summers. The problem in that

case was not that plaintiffs’ standing theory was

invalid. It was that the organizational plaintiffs failed

to prove that their members would be injured.

30a

Summers concerned parks administered by the

federal Forest Service. The Forest Service issued a

regulation allowing it to sell burned timber and

conduct fire-remediation activities on certain lowacreage lots without the ordinary notice and comment

procedures. Various environmental organizations

sued on behalf of their members, asserting

recreational injury based on their members’ professed

intent to visit one of the hundreds of parks that might

be affected by the new Service regulation. 555 U.S. at

490–92. Their primary evidence was an affidavit

executed by one member who had visited a park

already subject to fire-remediation activities, and who

intended to visit the park again. The Service conceded

that this plaintiff had standing, but the parties settled

the dispute as to the particular park, and so it was

“not at is-sue” once the case was before the Supreme

Court. Id. at 491 (quoting Earth Island Inst. v.

Pengilly, 376 F. Supp. 2d 994, 999 (E.D. Cal. 2005)).

The plaintiffs attempted to continue their challenge

to the regulation, asserting that their other members

were statistically likely to travel to one of the many

parks that would likely be affected by the regulation.

To be sure, the majority expressed skepticism with

that theory. See id. at 497 (criticizing the dissent’s

“hitherto unheard-of test for organizational standing:

whether. . . there is a statistical probability that some

of [the plaintiffs’] members are threatened with

concrete injury”). But its bigger concern was that

plaintiffs failed to prove their claims: they lacked

evidence of the number of association members who

intended to visit the parks, and when:

A major problem with the dissent’s approach is

that it accepts the organizations’ self-

31a

descriptions of their membership, on the simple

ground that “no one denies” them. But it is well

established that the court has an independent

obligation to assure that standing exists,

regardless of whether it is challenged by any of

the parties.

Id. at 499. A primary reason for the lack of evidence

was the majority’s decision to not consider several

affidavits offered after the district court entered

judgment—affidavits that would have made the

required showing. See id. at 495 n.* (declining to

consider the affidavits); cf. id. at 508–09 (Breyer, J.,

dissenting) (arguing that the Court should consider

them). Without those affidavits, the majority

understood itself as not having evidence of any other

member’s injury:

In part because of the difficulty of verifying the

facts upon which such probabilistic standing

depends, the Court has required plaintiffs

claiming an organizational standing to identify

members who have suffered the requisite

harm—surely not a difficult task here, when so

many thousands are alleged to have been

harmed.

Id. at 499. This understanding of Summers is

reinforced by the Court’s recent decision in

Department of Education v. Brown, 143 S. Ct. 2343

(2023). There, the Court reiterated its view that no

plaintiff had shown that he or she actively planned to

visit the sites at issue. See id. at 2354 n.3 (“[N]o

plaintiff in Summers had standing because none had

alleged specific plans to observe nature in one of the

areas at issue . . . .”).

32a

Summers does not stand for the proposition that

courts must categorically reject standing when a

plaintiff alleges that a defendant’s action puts

hundreds of association members at risk of future

injury. It stands for the proposition that courts must

treat such assertions with caution. The standard for

making this showing is high, but the Medical

Organizations and Doctors have met it. They have

provided multiple examples of organization members

who sustained the exact harm they say will recur.

They have explained that the conditions producing

that harm remain in place. And they have testified to

having hundreds of members who are reasonably

likely to be harmed. At this stage, that is enough.

b. Cognizable Injury

In addition to being sufficiently imminent,

threatened injuries must also be legally cognizable.

TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2204–

07 (2021); Lujan, 504 U.S. at 562. The injuries here

are. To begin, economic harm—like damage to one’s

business interest—is a quintessential Article III

injury. TransUnion, 142 S. Ct. at 2204; see, e.g.,

Greater Phila. Chamber of Com. v. City of

Philadelphia, 949 F.3d 116, 131 (3d Cir. 2020)

(recognizing that businesses had standing to

challenge local ordinance, which would hamper hiring

and salary decisions). The Doctors therefore sustain a

concrete injury when they are forced to divert time

and resources away from their regular patients. Dr.

Skop Declaration ¶ 32; Dr. Francis Declaration ¶ 12;

Dr. Harrison Declaration ¶¶ 27–30; see also All. for

Hippocratic Med., 2023 WL 2913725, at *6–7. And by

the same token, the Doctors sustain a concrete injury

when mifepristone patients expose them to greater

33a

liability and increased insurance costs. Dr. Barrows

Declaration ¶¶ 21–24; Dr. Jester Declaration ¶¶ 20–

21; Dr. Johnson Declaration ¶ 15.

The Medical Organizations and Doctors also face a

concrete injury when they are forced to choose

between following their conscience and providing care

to a woman experiencing complications as a result of

taking mifepristone. As recounted above, evidence

was offered of a doctor who personally gave care in

these circumstances. Dr. Skop Declaration ¶ 17 (“In

my practice, I have cared for at least a dozen women

who have required surgery to remove retained

pregnancy tissue after a chemical abortion.

Sometimes this includes the embryo or fetus, and

sometimes it is placental tissue that has not been

completely expelled.”). Another doctor testified about

her partner, who experienced the same thing. Dr.

Francis Declaration ¶ 13 (“Due to the amount of

bleeding . . . my partner had no choice but to perform

an emergency D&C. . . . And because the preborn baby

still had a heartbeat when the patient presented, my

partner felt as though she was forced to participate in

something that she did not want to be a part of—

completing the abortion.”). And other doctors testified

of fear that they or fellow physicians will be forced into

similar situations. Dr. Barrows Declaration ¶ 26; Dr.

Skop Declaration¶ 34; cf. Dickerson Declaration ¶ 16.

FDA and Danco do not dispute that the Medical

Organizations and Doctors’ conscience injury is

cognizable. But they defend FDA’s actions on the

ground that federal law would allow the Doctors to

refuse care based on a conscientious objection. FDA

Br. at 26; Danco Br. at 21 (citing 42 U.S.C. §§ 238n,

300a-7(c), (d)). The Medical Organizations and

34a

Doctors respond by pointing out that the federal

government has recently taken a contrary position.

That is, in July 2022, the Department of Health and

Human Services issued a guidance document that

interprets the Emergency Medical Treatment and

Active Labor Act to require hospitals to provide care

to, among others, a woman with an “incomplete

medical abortion,” irrespective of objections of

conscience. Reinforcement of EMTALA Obligations

Specific to Patients Who Are Pregnant or Are

Experiencing Pregnancy Loss, at 6, Centers for

Medicare & Medicaid Services (July 11, 2022). A

district court has enjoined that guidance, and an

appeal is proceeding before this court. Texas v.

Becerra, 623 F. Supp. 3d 696 (N.D. Tex. 2022)

(entering preliminary injunction); Texas v. Becerra,

No. 5:22-CV-185, 2023 WL 2467217 (N.D. Tex. Jan.

10, 2023) (final judgment and permanent injunction).

At oral argument, counsel for FDA disputed that

EMTALA binds individual doctors, arguing instead

that the obligation to provide abortion-related care

runs to hospitals. That is, individual doctors may

assert conscience objections so long as one doctor at

the hospital can provide the required care. This raises

the question of what would happen if no other doctor

were available—a situation that seems particularly

likely in smaller clinics. But setting that issue to the

side, counsel’s argument appears to conflict with the

Government’s position on appeal in the Texas case.

See Br. for Appellants at 25, Texas v. Becerra (5th Cir.

May 1, 2023) (No. 23-10246) (“EMTALA requires

doctors to offer abortion care when that care is the

necessary stabilizing treatment for an emergency

medical condition.”) (emphasis added); id. at 27

35a

(“[W]hen pregnant women come to a Medicare-funded

hospital with an emergency medical condition,

EMTALA obligates the treating physician to provide

stabilizing treatment, including abortion care.”)

(quoting United States v. Idaho, 623 F. Supp. 3d 1096,

1109 (D. Idaho 2022)).

We conclude that the federal laws Defendants cite

do not alleviate the Doctors’ conscience injury, at least

for purposes of this preliminary posture. The

inconsistencies between the Government’s position in

Texas v. Becerra and FDA’s position here tend to rebut

the notion that Doctors are free to refuse treatment to

mifepristone patients.

We next address the Doctors’ argument that they

will suffer an independent injury by way of the

“enormous stress and pressure” that is involved with

treating women suffering complications from taking

mifepristone. Dr. Wozniak Declaration ¶ 17. They

maintain that FDA’s actions cause women to present

at the emergency room with complications that

involve a unique level of trauma and distress, due to

the high amount of emotional and physical strain

often associated with the experience. Dr. Delgado

Declaration ¶ 14; Dickerson Declaration ¶ 14; Dr.

Skop Declaration ¶ 33.

It is true that the Supreme Court has interpreted

Article III to recognize injuries that “significantly

affect[]” a plaintiff’s “quality of life.” Sierra Club v.

Morton, 405 U.S. 727, 734–35 (1972). And several of

our sister circuits acknowledge standing that is

predicated on “emotional or psychological harm.”

Maddox v. Bank of N.Y. Mellon Tr. Co., 19 F.4th 58,

65 (2d Cir. 2021) (quoting TransUnion, 141 S. Ct. at

2211 n.7); see also Clemens v. ExecuPharm Inc., 48

36a

F.4th 146, 155 (3d Cir. 2022) (same). However, the

mental and emotional stress shown here is best

understood as additional to the Doctors’ conscience

injuries, not independent from them. The threat of

being forced to violate a sincerely held moral belief is

cognizable at least in part because the event would

involve acute emotional and psychological harm.

Maddox, 19 F.4th at 65; Clemens, 48 F.4th at 155. The

emotional and mental strain of which the Doctors

testify is of the same nature, albeit of an arguably

lesser magnitude. In this way, the “enormous stress

and pressure” that the Medical Organizations and

Doctors cite augment the Doctors’ conscience injuries,

but does not provide a separate basis for Article III

standing.4

Danco argues that the Medical Organizations and

Doctors’ standing argument is “limitless,” and worries

that its logic would allow doctors to challenge firearm

laws based on the stress involved with treating

gunshot victims. Danco Br. at 22–23 (citing E.T. v.

Paxton, 41 F.4th 709, 721 (5th Cir. 2022)). But we see

several limits. Foremost is the rigorous evidence

needed to prove traceability and redressability. The

plaintiffs in Danco’s hypothetical would lack standing

unless they could prove that a particular law caused

there to be more gunshot victims, and that enjoining

enforcement of the law would cause there to be fewer.

That is a tall order, to say the least. Equally

significant is the requirement that a plaintiff be

4

We understand the Doctors’ conscience injuries as being

supported by longstanding precedent of the Supreme Court and

this court. We thus do not discuss our colleague’s thoughtful

comments on other types of injuries that may be cognizable. Post

at 67–70.

37a

threatened with injury akin to being forced to violate

his or her sincerely held conscience beliefs. That sort

of injury will be absent except in the most exceptional

cases. We do not think that our holding will open the

floodgates to the litigation Danco describes.

c. Traceability

Standing to challenge mifepristone’s approval does

not necessarily include standing to challenge FDA’s

subsequent actions. That is so because “standing is

not dispensed in gross; rather, plaintiffs must

demonstrate standing for each claim that they press

and for each form of relief that they seek.”

TransUnion, 141 S. Ct. at 2208. As we have said many

times, standing proceeds claim by claim. E.g., In re

Gee, 941 F.3d 153, 170–71 (5th Cir. 2019); Friends of

St. Frances Xavier v. FEMA, 658 F.3d 460, 466 (5th

Cir. 2011). The Medical Organizations and Doctors

are correct, then, to acknowledge that they must show

“harms to the plaintiff doctors and associations [that]

flow from each of the relevant FDA actions.” Alliance

Br. at 22.

i. 2016 Amendments

The Medical Organizations and Doctors contend

that the 2016 Amendments will increase the number

of women who suffer complications as a result of

taking mifepristone. That is so for three reasons, they

say. First, the risk of complication increases with

gestational age, and the Amendments increase the

maximum permissible age from forty-nine days to

seventy days. See Dr. Skop Declaration ¶ 28 (asserting

that taking mifepristone at later stages of gestation

increases the chance of “complications due to the

increased amount of tissue, leading to hemorrhage,

38a

infection and/or the need for surgeries or other

emergency care”); see also Dr. Barrows Declaration

¶ 22; Dr. Wozniak Declaration ¶ 10.

Second, the percentage of women who experience

complications that present to the emergency room (as

opposed to their mifepristone provider) will increase

because the Amendments remove the requirement for

a second and third in-person visit. One doctor

explained this phenomenon:

Under the current practice by those who

prescribe and dispense chemical abortion drugs

like mifepristone and misoprostol, there is no

follow-up or additional care provided to

patients. Instead, with no established

relationship with a physician, patients are

simply left to report to the emergency room

when they experience adverse events.

Dr. Foley Declaration ¶ 11; see also Dr. Harrison

Declaration ¶ 44 (testifying that eliminating inperson evaluations and follow-up care “places our

member doctors at increased risk of being forced to

violate their conscience rights”); Dr. Frost-Clark

Declaration ¶ 21 (similar).

Third, and relatedly, the percentage of women who

present to the emergency room will increase because

the Amendments allow non-physicians to prescribe

mifepristone. As the motions panel explained, women

who receive the drug from someone other than a

doctor “cannot possibly go back to their non-doctorprescribers for surgical abortions.” All. for Hippocratic

Med., 2023 WL 2913725, at *5. And multiple doctors

testified that they have seen or expect to see more

women with serious complications resulting from

mifepristone. Dr. Harrison Declaration ¶ 26; Dr. Skop

39a

Declaration ¶¶ 20– 21; Dr. Wozniak Declaration

¶¶ 18, 29; Dr. Johnson Declaration ¶ 18; Dr. FrostClark Declaration ¶ 18; Dr. Jester Declaration ¶ 13.

Given the already substantial risk of harm, the

evidence of increased risk is sufficient to confer

standing to challenge the 2016 Amendments. See Nat.

Res. Def. Council, Inc. v. EPA, 464 F.3d 1, 6–7 (D.C.

Cir. 2006) (holding that plaintiffs had standing based

on “increased risk” of developing skin cancer); Sutton

v. St. Jude Med. S.C., Inc., 419 F.3d 568, 570–75 (6th

Cir. 2005) (holding that plaintiffs had standing based

on an “increased risk” of harm from a medical device).

ii. 2021 Non-Enforcement Decision

The Medical Organizations and Doctors have also

shown that the 2021 Non-Enforcement Decision

contributes to their injury. That decision effectively

removes the in-person dispensing requirement,

allowing women to request and take mifepristone

without ever going to the doctor’s office. Evidence was

introduced that this change will cause additional

severe complications. Among other things, several

doctors testified that supervision is necessary to

ensure patients’ safety:

The FDA’s actions harm women, including my

patients, because clinics and physicians

prescribing or dispensing chemical abortion

drugs, or websites that provide these drugs

through mail order delivery without any

physician involvement, often underprepare

women for the severity and risks of chemical

abortion, and they often provide insufficient or

no follow-up care to those women.

Dr. Skop Declaration ¶ 27; see also Dr. Harrison

Declaration ¶ 25 (“Mifepristone and misoprostol are

40a

serious drugs that should not be administered without

medical supervision. The FDA’s actions to eliminate

the necessary supervision of these drugs harms

women and obstetrics professionals . . . .”); cf.

Dickerson Declaration ¶ 12 (“[Mifepristone] can now

be administered and dispensed with no in-person

examination or oversight by a physician.”).

Doctors also testified that, without in-person

examination, the prescriber is less likely to accurately

determine gestational age:

Mifepristone and misoprostol are dangerous

drugs that can potentially harm women.

Relaxing the required medical supervision and

oversight for patients taking these drugs puts

women’s health at risk.

By eliminating the in-person dispensing

requirement and the requirement for a postabortion follow-up, the FDA has exposed

women to a higher likelihood of undetected

serious

complications.

Specifically,

the

expanded use of telemedicine for chemical

abortions means that some women who are

beyond 70 days’ gestation because they are

mistaken or wrong about the gestational age of

their unborn child will take these drugs outside

of the appropriate window.

Dr. Barrows Declaration ¶¶ 16–17; see also Dr. Skop

Declaration ¶ 28 (“Unsupervised chemical abortion

. . . harms women because they may have

underestimated the gestational age of their unborn

child.”). And the Doctors say that the need for inperson supervision is even greater in cases of ectopic

pregnancy. Dr. Skop Declaration ¶¶ 27, 29.

41a

Finally, many doctors offered testimony that, as a

result of the 2021 Non-Enforcement Decision, more

women will suffer serious adverse events. Dr.

Wozniak Declaration ¶ 14 (“The increasing number of

chemical

abortions

through

mail-order

or

telemedicine methods means that more women will

suffer complications from unsupervised use of

mifepristone and misoprostol.”); Dr. Frost-Clark

Declaration ¶ 12 (“The FDA’s suspension of the inperson dispensing requirement of mifepristone and

misoprostol harms women and doctors because it has

resulted in an increase in complications.”); see also Dr.

Skop Declaration ¶¶ 20–21; Dr. Johnson Declaration

¶ 18; Dr. Jester Declaration ¶ 13. One doctor

personally witnessed an increase in complications

after a district court temporarily enjoined the inperson dispensing requirement in the midst of the

COVID-19 pandemic. Dr. Francis Declaration ¶ 11

(“The frequency of these complications has increased

since a federal district court first enjoined and set

aside the FDA’s in-person dispensing requirement of

mifepristone in 2020.”); see generally Am. Coll. of

Obstetricians & Gynecologists v. FDA, 472 F. Supp. 3d

183 (D. Md. 2020) (district court opinion enjoining the

in-person requirements).5

Based on that evidence, the Medical Organizations

and Doctors have made a clear showing that the 2021

Non-Enforcement Decision causes an increased risk of

injury. FDA and Danco resist this conclusion, arguing

5

FDA initially appealed that ruling, but the parties dismissed

the appeal after FDA announced that it would decline to enforce

the in-person dispensing and prescription requirements. See Am.

Coll. of Obstetricians & Gynecologists v. Indiana, No. 20-1784,

2021 WL 3276054 (4th Cir. May 19, 2021).

42a

that any increase to the Medical Organizations and

Doctors injury is speculative because the number of

women who experience ectopic pregnancies is so

small. FDA Reply Br. at 24; Danco Reply Br. at 11–12.

But that understates the bases of the alleged injury.

The Medical Organizations and Doctors argue that

ectopic pregnancy (and the possible failure to

diagnose it) is one of the reasons why removing the inperson dispensing requirement will lead to more

complications—not the only reason. As explained

above, the declarants offer several other grounds for

their contention, including the need for in-person

supervision when a patient takes mifepristone, the

need to accurately assess gestational age, and the

need for in-person follow-up. We conclude that the

Medical Organizations and Doctors have shown a

substantial risk of injury due to the 2021 NonEnforcement Decision. As such, they have

associational standing to challenge this action.

***

Because we hold that the Medical Organizations and

Doctors have associational standing, we need not

consider whether they also have organizational or

third-party standing. See generally ACORN v. Fowler,

178 F.3d 350, 356–57 (5th Cir. 1999); see also All. for

Hippocratic Med., 2023 WL 2913725, at *4 n.4.

However, to the extent that it were necessary to

consider third-party standing, it is likely that

emergency-room doctors have a sufficiently “close

relationship” with mifepristone patients. Kowalski v.

Tesmer, 543 U.S. 125, 130 (2004); cf. June Med. Servs.

LLC v. Russo, 140 S. Ct. 2103, 2118–19 (2020),

overruled on other grounds, Dobbs v. Jackson Women’s

Health Org., 142 S. Ct. 2228 (2022). Indeed, the Court

43a

has “long permitted abortion providers to invoke the

rights of their actual or potential patients.” June Med.

Servs., 140 S. Ct. at 2118. We fail to see how this case

is materially different.

FDA and Danco deny that third-party standing

applies, saying that the Doctors have a “diametrically

opposed” or “antagonistic” relationship with women

experiencing severe complications as a result of

taking mifepristone. FDA Br. at 33; Danco Br. at 32.

That is so, Defendants contend, because the relief the

Doctors seek would reimpose certain conditions of

using mifepristone. That dubious proposition

misunderstands the nature of the would-be

representation. The Doctors pursue third-party

standing to represent their patients’ interest in

avoiding or limiting the dangerous side effects that

sometimes occur when a woman takes mifepristone.

Although we do not fulsomely consider the issue

here, we suspect that the Doctors—who have provided

firsthand care to dozens of mifepristone patients

experiencing acute physical and emotional distress in

an emergency setting—have a relationship with their

patients that is more than adequate to support thirdparty standing. In many respects, such a relationship

may be closer than those previously recognized by the

Supreme Court. June Med. Servs., 140 S. Ct. at 2118–

19; Whole Women’s Health v. Hellerstedt, 136 S. Ct.

2292, 2314 (2016); Gonzales v. Carhart, 550 U.S. 124,

133 (2007).

B. 2019 Generic Approval

Unlike FDA’s other actions, the Medical

Organizations and Doctors did not introduce evidence

showing that they are likely to be injured by the 2019

Generic Approval. They point to the 2000 Approval,

44a

arguing that the two actions impose the same injuries.

Alliance Br. at 23 n.4 (“The generic drug comes with

all the same harms as does the name brand—so the

district court’s harm analysis applies fully to the 2019

ANDA approval.”). That may be true, but the Medical

Organizations and Doctors cannot carry their burden

of proof with legal argument. There is nothing in the

record tending to show that the 2019 Generic

Approval contributes to the risk of harm—no evidence

that the women the Doctors have treated took the

generic version of mifepristone, and no evidence that

the number of women experiencing medical

complications after taking mifepristone has risen as a

result of the generic.

Indeed, the preliminary-injunction exhibits do not

mention generic mifepristone at all. Separate from

associational standing, there is no evidence that the

2019 Generic Approval contributed to any

organizational injury sustained by the Medical

Organizations or any individual injury sustained by a

third-party patient. In short, the Medical

Organizations and Doctors did not prove that the 2019

Generic Approval affects their risk of future harm.

Accordingly, we must vacate the component the

district court’s order staying the effective date of

FDA’s approval of the generic version of mifepristone.

This holding means that generic mifepristone, like

the brand version, will remain available for use under

the conditions provided by the relevant mifepristone

REMS. FDA amended that REMS in 2016 and 2021,

but for the reasons explained below, we affirm the

portion of the district court’s order that stays the

effective dates of those amendments. And so pending

trial on the merits, the current REMS will be the

45a

version that was in effect prior to the 2016

Amendments. Of course, the mifepristone REMS does

not distinguish between branded and generic

mifepristone. FDA Br. at 9 (“The same REMS covers

both versions of mifepristone.”). As such, the generic

version will be available under the same conditions as

Mifeprex.

III. Merits

Having concluded that the Medical Organizations

and Doctors have standing except as to the 2019

Generic Approval, we now turn to the merits of the

district court’s stay order. That inquiry involves the

traditional four-factor test for a preliminary

injunction. To merit relief, a movant must show: (1) a

substantial likelihood of success on the merits, (2) a

substantial threat of irreparable harm, (3) that the

threat of injury outweighs any harm that an

injunction would cause, and (4) that the public

interest is not disserved by an injunction. Garcia v.

Jones, 910 F.3d 188, 190 (5th Cir. 2018).

In reviewing those factors, we review legal

conclusions de novo and findings of fact for clear error.

Jones v. Tex. Dep’t of Crim. Just., 880 F.3d 756, 759

(5th Cir. 2018). The parties agree that these

preliminary-injunction factors apply even though the

district court entered a stay under 5 U.S.C. § 705.

That is so because a stay has the practical effect of an

injunction. 28 U.S.C. § 1292(a); see All. for Hippocratic

Med., 2023 WL 2913725, at *3 n.3; accord Colorado v.

EPA, 989 F.3d 874, 883 (10th Cir. 2021) (“These four

factors also determine when a court should grant a

stay of agency action under section 705 of the APA.”).

The first question is whether the Medical

Organizations and Doctors have shown a substantial

46a

likelihood of success on the merits. At the outset, we

note that “substantial” does not mean “certain.” Byrne

v. Roemer, 847 F.2d 1130, 1133 (5th Cir. 1988)

(explaining that “the movant need not always show a

probability of success on the merits”) (quoting

Celestine v. Butler, 823 F.2d 74, 77 (5th Cir. 1987)); see

Jefferson Cmty. Health Care Ctrs., Inc. v. Jefferson

Parish, 849 F.3d 615, 626 (5th Cir. 2017) (“Though

there is no particular degree of likelihood of success

that is required in every case, the party seeking a

preliminary injunction must establish at least some

likelihood of success on the merits before the court

may proceed to assess the remaining requirements.”).

A plaintiff need not prove “its entitlement to summary

judgment in order to establish a substantial likelihood

of success on the merits.” Byrum v. Landreth, 566 F.3d

442, 446 (5th Cir. 2009) (internal quotation marks

omitted). But at a minimum, it must “present a

substantial case on the merits.” Bryne, 847 F.2d at

1133(quoting Celestine, 823 F.2d at 77).

A. 2000 Approval

As explained above, the Medical Organizations and

Doctors have standing to challenge the 2000

Approval, the 2016 Amendments, and the 2021 NonEnforcement Decision. Before addressing the merits

of the challenge as to the 2000 Approval, we must

consider a threshold issue: whether that claim was

timely asserted.

The Medical Organizations and Doctors admit that

they did not raise a claim as to FDA’s denial of their

2002 citizen petition within six years, as required for

civil actions filed against the United States. 28 U.S.C.

§ 2401. They present two independent arguments for

why their claim as to the 2000 Approval is nonetheless

47a

timely. The motions panel rejected both arguments.

All. for Hippocratic Med., 2023 WL 2913725, at *13–

15. We do the same.

1. Reopening Doctrine

First, the Medical Organizations and Doctors point

to a judge-made exception to the statute of limitations

called the “reopening doctrine.” Essentially, this

doctrine allows a plaintiff to challenge an agency

action past the ordinary timeline if the agency

substantively reconsiders the original action in a

subsequent decision. See Nat’l Biodiesel Bd. v. EPA,

843 F.3d 1010, 1017 (D.C. Cir. 2016); Sierra Club v.

EPA, 551 F.3d 1019, 1024 (D.C. Cir. 2008). The

Medical Organizations and Doctors maintain that the

2016 Amendments and 2021 Petition Denial each

trigger reopening. We disagree.6

a. 2016 Amendments

The Medical Organizations and Doctors point both

to FDA’s denial of their 2002 citizen petition and to

the agency’s approval of the amendments to

mifepristone’s conditions for use. They argue that,

when FDA denied the citizen petition, it denied their

request to rescind approval of mifepristone. And when

FDA approved the 2016 Amendments, it altered the

regime by which mifepristone is prescribed and used.

6

The Supreme Court has cast some doubt on whether the

reopening doctrine is a legitimate exception to a statute of

limitations. See Biden v. Texas, 142 S. Ct. 2528, 2545 n.8 (2022)

(“[T]his Court has never adopted [the reopening doctrine], and

[it] appears to be inapposite to the question of final agency

action.”). But the parties both assume that the doctrine is good

law in this circuit. And in any event, we need not address that

threshold question because we ultimately conclude that the

doctrine does not apply here.

48a

Taken together, they say, these actions show that

FDA substantively reconsidered the 2000 Approval.

To begin, the 2016 petition denial does not inform

the 2016 Amendments. They are plainly different in

nature; the former reaffirms FDA’s conclusion that

the agency properly approved mifepristone for use in

2000 and the latter considers relaxed conditions for

the drug’s use. The Medical Organizations and

Doctors likely could have challenged the 2000

Approval if they had timely filed suit in response to

the petition denial. But they did not. The argument

that the two decisions must be considered in tandem

is really just an end-run around the fact that the

Medical Organizations and Doctors were too late to

challenge FDA’s denial of their citizen petition.

Accordingly, we consider only whether the 2016

Amendments themselves give rise to the reopening

doctrine. They do not. Nothing in FDA’s approval of

the amendments shows that it undertook a “serious,

substantive reconsideration” of the 2000 Approval.

Texas v. Biden, 20 F.4th 928, 951–52 (5th Cir. 2021),

rev’d on other grounds, 142 S. Ct. 2528 (2022).

Actually, the opposite is true. FDA took the

restrictions imposed in 2000 as a given, and

considered only whether the REMS amendments were

safe and effective. As explained by the motions panel:

“FDA’s 2016 decision to relax many of the REMS was

issued in response to Danco’s supplemental

application requesting as much.” All. for Hippocratic

Med., 2023 WL 2913725, at *13.

The Medical Organizations and Doctors respond

that the 2016 Amendments were so significant as to

constitute a change to the “basic regulatory scheme,”

Nat’l Biodiesel Bd., 843 F.3d at 1017, thereby

49a

constructively reopening the 2000 Approval. It is

certainly true that the amendments meaningfully

altered the conditions under which mifepristone is

prescribed and taken. But a regulatory amendment,

even a major one, is insufficient to satisfy the

reopening doctrine. Nat. Res. Def. Council, Inc. v.

EPA, 571 F.3d 1245, 1265–66 (D.C. Cir. 2009); see also

Nat’l Ass’n of Reversionary Prop. Owners v. Surface

Transp. Bd., 158 F.3d 135, 144–46 (D.C. Cir. 1998);

United Transp. Union-Ill. Legis. Bd. v. Surface

Transp. Bd., 132 F.3d 71, 76 (D.C. Cir. 1998)

(Ginsburg, J.). To meet this high bar and trigger the

reopening

doctrine,

the

amendment

must

fundamentally alter the nature of the regulation such

that it “could not have been reasonably anticipated.”

Env’t Def. v. EPA, 467 F.3d 1329, 1334 (D.C. Cir.

2006).

The 2016 Amendments do not clear that bar. They

do not alter FDA’s basic assumption that mifepristone

is safe and effective, subject to certain conditions for

use. To be sure, the amendments put the public on

notice of a significant change in the degree of

mifepristone’s

availability

and

restriction.

Disagreement with that decision would support

challenging the new amendments—and that is exactly

what the Medical Organizations did. But as to

mifepristone’s approval per se, the 2016 Amendments

tell the public nothing they did not already know. As

before, FDA approved a drug that chemically induces

abortion, with the knowledge that the drug causes

medical complications in a definite percentage of

women. We cannot say that the amendments

“significantly alter[ed] the stakes of judicial review” so

as to allow the Medical Organizations and Doctors to

50a

challenge the 2000 Approval sixteen years after the

fact. Sierra Club, 551 F.3d at 1025.

b. 2019 Citizen Petition

The Medical Organizations and Doctors also

contend that FDA reopened the 2000 Approval when

it denied their 2019 citizen petition. They emphasize

the agency’s use of the phrase “full review,” and argue

that FDA actively questioned whether mifepristone

was safe.

The record does not bear out that claim. To start, the

citizen petition did not actually ask FDA to reconsider

its approval of mifepristone; it requested that FDA

“restore” previous restrictions and “retain” others

currently in place. 2019 Citizen Petition at 1, 2. So

FDA had no reason to reevaluate mifepristone from

the ground up. Turning to the denial itself, FDA did

not reexamine its prior approval. It certainly

described its action as “a full review of the

Mifepristone REMS Program,” 2021 Denial Letter at

6, but the letter’s context shows that the agency

reviewed the conditions for use that the citizen

petition had put at issue—not mifepristone’s

underlying approval.

Nor did FDA constructively reopen the 2000

Approval by adopting a significant amendment to the

mifepristone REMS. As with the 2016 Amendments,

removing the in-person dispensing requirement does

not change the basic concept of allowing women to use

mifepristone. Nat’l Biodiesel Bd., 843 F.3d at 1017.

Between an “incremental adjustment[]” to the 2000

Approval and a “substantive reconsideration” of it, the

decision to allow remote prescription and dispensing

of mifepristone looks more like the former. Texas, 20

F.4th at 953, 952 (citations omitted). And so if the

51a

reopening doctrine is a valid exception to the statute

of limitations, and we are not sure that it is, that

doctrine does not apply here because neither the 2016

Amendments nor the 2021 Petition Denial

reevaluated FDA’s decision in 2000 to approve

mifepristone. The reopening doctrine therefore does

not permit the Medical Organizations and Doctors to

challenge the 2000 Approval after the prescribed

limitations period.

2. Equitable Tolling

The Medical Organizations and Doctors also point to

equitable tolling as a justification for considering the

2000 Approval claim even though it is untimely. But

that is a very narrow exception. See Jones v. Lumpkin,

22 F.4th 486, 490 (5th Cir. 2022) (reiterating that

equitable tolling “is warranted in only ‘rare and

exceptional circumstances’”) (quoting Davis v.

Johnson, 158 F.3d 806, 811 (5th Cir. 1998)). It applies

only if the plaintiff satisfies two conditions: “(1) that

he has been pursuing his rights diligently, and (2) that

some extraordinary circumstance stood in his way and

prevented timely filing.” Menominee Indian Tribe of

Wis. v. United States, 577 U.S. 250, 255 (2016)

(citation omitted).

Supposing that the Medical Organizations and

Doctors could meet the first condition, they cannot

meet the second. This court has stressed that

equitable tolling does not apply if the party seeking its

benefit could have complied with the relevant

deadline. Jones, 22 F.4th at 490 (“[A] petitioner’s

failure to satisfy the statute of limitations must result

from external factors beyond his control; delays of the

petitioner’s own making do not qualify.”) (quoting In

re Wilson, 442 F.3d 872, 875 (5th Cir. 2006)). Here, the

52a

Medical Organizations and Doctors offer no reason

why they could not have filed their lawsuit within the

six-year limitations period. See All. for Hippocratic

Med., 2023 WL 2913725, at *15 (explaining that

FDA’s delay in ruling on the 2002 Citizen Petition

“had no impact on the length of the statute-oflimitations period or plaintiffs’ capacity to challenge

the 2016 Petition Denial”). Their failure to do so

forecloses any possibility of relief.

***

For the reasons stated above, we conclude that the

claim as to the 2000 Approval is untimely.

Consequently, the Medical Organizations and Doctors

are not likely to succeed on that claim. And that

means that we must vacate the component of the

district court’s order that stays the 2000 Approval.

Willey v. Harris Cnty. Dist. Att’y, 27 F.4th 1125, 1129

(5th Cir. 2022).

B. 2016 Amendments

In addition to the 2000 Approval claim, which is not

likely to succeed, the Medical Organizations and

Doctors challenge two other actions taken by FDA: the

2016 Amendments to the mifepristone REMS and the

2021 decision to not enforce regulations requiring inperson prescription. The parties agree that the claims

as to the 2016 Amendments and the 2021 NonEnforcement decision are timely, so we proceed to the

merits.

The Medical Organizations and Doctors ground

their claims in the Administrative Procedure Act.

That law requires federal courts to “hold unlawful and

set aside agency action, findings, and conclusions

found to be arbitrary, capricious, an abuse of

53a

discretion, or otherwise not in accordance with the

law.” 5 U.S.C. § 706(2)(A). The Supreme Court has

explained that the “arbitrary-and-capricious standard

requires that agency action be reasonable and

reasonably explained.” FCC v. Prometheus Radio

Project, 141 S. Ct. 1150, 1158 (2021). That standard of

review is “deferential,” id., but “not toothless.” Sw.

Elec. Power Co. v. EPA, 920 F.3d 999, 1013 (5th Cir.

2019).

On the contrary, our review is “searching and

careful.” Univ. of Texas M.D. Anderson Cancer Ctr. v.

U.S. Dep’t of Health and Hum. Servs., 985 F.3d 472,

475 (5th Cir. 2021) (quoting Marsh v. Or. Nat. Res.

Council, 490 U.S. 360, 378 (1989)). Above all, an

agency must “examine the relevant data and

articulate a satisfactory explanation for its action

including a ‘rational connection between the facts

found and the choice made.’” Motor Vehicle Mfrs. Ass’n

v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43

(1983) (quoting Burlington Truck Lines v. United

States, 371 U.S. 156, 168 (1962)). An agency violates

these rules where it “entirely fail[s] to consider an

important aspect of the problem,” or offers “an

explanation for its decision that runs counter to the

evidence before the agency, or is so implausible that it

could not be ascribed to a difference in view or the

product of agency expertise.” Id.; see also Michigan v.

EPA, 576 U.S. 743, 752 (2015); Mexican Gulf Fishing

Co. v. U.S. Dep’t of Com., 60 F.4th 956, 971 (5th Cir.

2023); Sw. Elec. Power Co., 920 F.3d at 1018–19

(explaining that courts must set aside agency action

where there are “shortcomings in the agency’s

explanations”).

54a

With those standards in mind, we first address the

2016 Amendments and hold that the Medical

Organizations and Doctors are substantially likely to

succeed on the merits of that claim. Byrne, 847 F.3d

at 1133. That is so for two instances of the same

defect: failing to consider an important aspect of the

problem. Michigan, 576 U.S. at 752; State Farm, 463

U.S. at 43.

First, FDA did not consider the cumulative effect of

the 2016 Amendments. Those changes include:

increasing the maximum gestational age from fortynine days to seventy days; allowing non-physicians to

prescribe mifepristone; removing the requirement

that the administration of misoprostol and the

subsequent follow-up appointment be conducted in

person; eliminating prescribers’ obligation to report

non-fatal adverse events; switching the method of

administration for misoprostol from oral to buccal;

and changing the dose of mifepristone (600 mg to 200

mg) and misoprostol (400 mcg to 800 mcg). FDA

Summary Review of 2016 Amendments at 2.

FDA admits that none of the studies it relied on

examined the effect of implementing all of those

changes together. It studied the amendments

individually. FDA Medical Review of 2016

Amendments at 32–38 (Mar. 29, 2016) (gestational

age); id. at 38–41 (in-person appointments); id. at 43–

44 (prescription by non-physician). And some clinical

trials considered “multiple changes.” FDA Summary

Review of 2016 Amendments at 5–9. But FDA neither

considered the effects as a whole, nor explained why

it declined to do so. The cumulative effect of the 2016

Amendments is unquestionably an important aspect

of the problem; indeed, that was the whole point of

55a

FDA’s action. Because FDA failed to seek data on the

cumulative effect, and failed to explain why it did not,

its decision to approve the amendments was likely

arbitrary and capricious. Michigan, 576 U.S. at 752;

State Farm, 463 U.S. at 43; Sw. Elec. Power Co., 920

F.3d at 1019.

FDA and Danco defend the 2016 Amendments,

asserting that FDA is not required to conduct a study

that perfectly mirrors the conditions under which the

drug will be used. That is true, so far as it goes.

Indeed, the APA gives agencies discretion “in

determining whether a study is adequate and well

controlled.” FDA Br. at 43 (quoting Weinberger v.

Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 621

n.17 (1973)).

But Defendants attack a rule that is not at issue.

The problem is not that FDA failed to conduct a

clinical trial that included each of the proposed

changes as a control. It is that FDA failed to address

the cumulative effect at all. At a minimum, the agency

needed to acknowledge the question, determine if the

evidence before it adequately satisfied the concern,

and explain its reasoning. See All. for Hippocratic

Med., 2023 WL 2913725, at *17 (“[FDA] relied on zero

studies that evaluated the safety-and-effectiveness

consequences of the 2016 Major REMS Changes as a

whole. This deficiency shows that FDA failed to

consider ‘an important aspect of the problem’ when it

made the 2016 Major REMS Changes.”) (quoting

Michigan, 576 U.S. at 752). FDA did not do those

things, and so likely violated the APA.

The second important aspect that FDA failed to

consider is whether it needed to continue to collect

data of non-fatal adverse events in light of the “major”

56a

changes to the mifepristone REMS. When considering

the data-collection question, FDA reasoned that nonfatal adverse events did not have to be recorded

because the risks associated with mifepristone were

well known. FDA Summary Review of 2016

Amendments at 26 (“[A]fter 15 years of reporting

serious adverse events, the safety profile for Mifeprex

is essentially unchanged.”).

But FDA failed to account for the fact that it was

about to significantly loosen mifepristone’s conditions

for use. At no point during the decision did the agency

acknowledge that the 2016 Amendments might alter

the risk profile. And when FDA addressed this subject

in its response to the 2019 citizen petition, it just

referred back to its statement that the risks were

minimal under the 2011 REMS. See 2021 Denial

Letter at 20. We conclude that FDA ignored “an

important aspect of the problem,” Michigan, 576 U.S.

at 752 (quoting State Farm, 463 U.S. at 43), and that

its explanation of the basis for the change contains

significant “shortcomings.” Sw. Elec. Power Co., 920

F.3d at 1018–19. This also likely violates the APA.

Defendants respond that the change is insignificant

because Danco remains obligated to report serious

adverse events to FDA. See FDA Br. at 53; Danco Br.

47 (citing 21 C.F.R. §§ 314.80, 314.98). True, Danco is

still subject to some reporting requirements, but these

are significantly different than the ones that were

removed. Before, prescribers were required to report

certain adverse events directly to FDA. Given that

prescribers interact with the women taking

mifepristone, they are well placed to know if a patient

actually experiences an adverse event. By contrast,

Danco has no direct relationship with Mifeprex

57a

patients and little ability to track events. Like any

member of the public, Danco can access the FDA

Adverse Event Reporting System (FAERS), a

voluntary reporting website. But prescribers are not

required to log non-fatal adverse events. Indeed, no

one is required to report anything on FAERS. Nor are

prescribers required to report to Danco. The end

result is that the removal of the adverse-event

reporting requirement significantly diminishes FDA’s

ability to collect this data. Danco’s residual reporting

requirements do not cure this APA violation.

C. 2021 Non-Enforcement Decision

We now assess whether the Medical Organizations

and Doctors are likely to succeed on their claim

regarding the 2021 Non-Enforcement Decision. That

decision essentially involves three parts. First, in

April 2021, FDA announced that it would temporarily

suspend enforcement of the in-person dispensing

requirement in light of the COVID-19 pandemic.

Next, in December of that year, FDA stated its intent

to eliminate the requirement permanently. See 2021

Denial Letter at 25 (“[W]e believe that the

Mifepristone REMS Program must be modified to

remove the requirement that mifepristone be

dispensed only in certain healthcare settings . . .

because this requirement is no longer necessary to

ensure that the benefits of the drug outweigh the

risks.”). And then in January 2023, FDA amended

mifepristone’s REMS, for Mifeprex and the generic,

formalizing the change.

FDA supported its decision by pointing to two

sources of information. First, the agency examined

adverse-events data collected during the period of

time when the in-person dispensing requirement was

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enjoined. FDA obtained this data from FAERS—the

voluntary reporting website. 2021 Denial Letter at 26.

Danco also submitted its records of adverse events

during the relevant interval, but its data set was the

same as the one obtained via FAERS. Id. at 27 (“The

information provided by the Applicants included the

same cases identified in FAERS . . . .”). Five events7

were reported during that time, but FDA concluded

that there did not “appear to be a difference in adverse

events when in-person dispensing was and was not

enforced.” Id.

Second, FDA considered published literature

relating to remote prescription of mifepristone. It

determined that those studies were “not inconsistent

with our conclusion that . . . mifepristone will remain

safe and efficacy will be maintained if the in-person

dispensing requirement is removed from the

Mifepristone REMS Program.” Id. at 28. Based on

these sources, FDA concluded that “mifepristone will

remain safe and effective if the in-person dispensing

requirement is removed.” Id. at 35.

1. Mootness

Defendants first raise a threshold question: whether

the Medical Organizations and Doctors’ challenge to

the 2021 non-enforcement policy is moot. They

contend that the 2023 modification of mifepristone’s

REMS supersedes the 2021 policy, and also that the

prior policy was tied to the Government’s COVID-19

public health emergency, which has since expired. For

7

According to FDA, the causes of those events are as follows:

ongoing pregnancy, drug intoxication and death, death

(unknown cause), sepsis and death, and pulmonary embolism.

2021 Denial Letter at 26.

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these reasons, FDA and Danco say, there is no longer

a live dispute as to the 2021 Non-Enforcement

Decision.

Neither reason is availing. First, FDA is incorrect to

say that it tied its December 2021 decision not to

enforce the in-person dispensing requirement to the

COVID-19 pandemic. True, FDA cited the pandemic

as a justification for taking the initial action. FDA

Letter of April 2021 at 2 (“[FDA] intends to exercise

enforcement discretion during the COVID-19

[pandemic] with respect to the in-person dispensing

requirement

of

the

Mifepristone

REMS

Program . . . .”).

But

when

FDA

“directed

mifepristone’s sponsors to submit a proposed REMS

modification,” several months later, it did so without

regard to pandemic conditions. FDA Br. at 11; see

2021 Denial Letter at 6, 25–26. FDA simply did not

tether its action in December of 2021 to the continued

existence of the public health emergency.

Second, FDA’s formalization of the policy it

announced in 2021 does not render this claim moot.

At bottom, the mootness doctrine asks whether the

court faces a live dispute. Freedom from Religion

Found., Inc. v. Abbott, 58 F.4th 824, 831 (5th Cir.

2023). That is, a case is moot if “the parties lack a

legally cognizable interest in the outcome.” Id.

(quoting Already, LLC v. Nike, Inc., 568 U.S. 85, 91,

(2013)).

A live dispute exists as to the 2021 NonEnforcement Decision. The decision that FDA made in

2021—to permanently not enforce in-person

prescription and dispensing requirements—remains

in force. FDA may have formalized that policy by

modifying the mifepristone REMS. But the effect is

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the same, as is FDA’s ultimate judgment that

mifepristone can be safely used without in-person

prescription and dispensing.

Moreover, the Supreme Court has recognized that

the government does not moot a controversy when it

introduces the final form of a previous, identical

policy. Biden v. Texas, 142 S. Ct. 2528, 2544–45 (2022)

(considering a prior agency action even after it was

formalized by a later, similar action); see All. for

Hippocratic Med., 2023 WL 2913725, at *2 n.2. That

type of action is different in kind than the repeal or

modification of a government policy. Freedom from

Religion Found., 58 F.4th at 832. Unlike a repealed

policy, FDA’s policy remains unchanged and on the

books (albeit in a permanent form). We see no

jurisdictional obstacle to reviewing the claim as to the

2021 Non-Enforcement Decision.

2. Merits

Because the 2021 Non-Enforcement claim is not

moot, we must proceed to the question of whether that

action was arbitrary and capricious. For two reasons,

we hold that it likely was. First, FDA gave dispositive

weight to adverse-event data in FAERS—despite the

uncontested limitations of doing so. Recall that,

because of the 2016 Amendments, FDA no longer had

access to perhaps the best source of data: the

prescribers. The agency is responsible for its own

inability to obtain probative data; it cannot then cite

its lack of information as an argument in favor of

removing further safeguards. As the motions panel

aptly put it: “It’s unreasonable for an agency to

eliminate a reporting requirement for a thing and

then use the resulting absence of data to support its

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decision.” All. for Hippocratic Med., 2023 WL

2913725, at *17.

Moreover, considerable evidence shows that FAERS

data is insufficient to draw general conclusions about

adverse events. Indeed, in describing the database,

FDA itself recognizes that “FAERS data cannot be

used to calculate the incidence of an adverse event or

medication error in the U.S. population.” FDA admits

that FAERS reporting is purely voluntary, FDA Br. at

53; consequently, many adverse events will go

unreported.

For example, one doctor testified that she obtained

adverse-event data from one provider (Planned

Parenthood) and compared it to FAERS data for the

same time period. For 2010, the provider reported

1,530 adverse events, whereas FAERS reported only

664 events for all providers nationwide. Dr. Harrison

Declaration ¶ 17; see also id. (“These discrepancies

render FAERS inadequate to evaluate the safety of

mifepristone abortions.”).

In addition, the Doctors introduced evidence that

many physicians do not use FAERS, either because

they are not aware of the system or because they

believe that using the system is difficult, and takes

time away from their ordinary medical practice:

Many doctors likely do not know about the need

to report adverse events related to chemical

abortion to the FDA. Similarly, many doctors

likely do not know how to report adverse

events. . . . I personally know of practitioners

. . . who have tried to report adverse events

related to chemical abortion drugs to the FDA.

The process is complicated, cumbersome, and

time-consuming. The adverse event reporting

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requirements and the FAERS submission

process harm medical practices by taking away

significant time from a doctor to treat and meet

with patients.

Dr. Harrison Declaration ¶¶ 33–34; see also Dr. FrostClark Declaration ¶ 23 (“I have not reported adverse

events that I have witnessed as a result of chemical

abortions because the process is so cumbersome.”).

One doctor testified that it can take hours to report an

adverse event to FAERS:

[T]he process of reporting to [FAERS] is also

cumbersome. The actual form to be filled out is

not easy to find online—requiring several steps

to get it. It once took me two hours to get the

website to accept submission of the form, taking

me away from the care of my other patients.

The minimum amount of time I have spent

reporting a mifepristone complication to the

FAERS is thirty minutes—valuable time that

should be spent in patient care.

Dr. Francis Declaration ¶ 18. FDA’s decision to rely so

heavily on data from FAERS “runs counter to” the

critical limitations associated with that data. State

Farm, 463 U.S. at 43; Sw. Elec. Power Co., 920 F.3d

at 1018–19.

FDA responds that it also considered adverse-event

data submitted by Danco, but Danco’s data was

exactly the same as the data FDA obtained from

FAERS. FDA acknowledged as much in its letter

denying the 2019 citizen petition. 2021 Denial Letter

at 27. (“The information provided by the Applicants

included the same cases identified in FAERS . . . .”). If

anything, the fact that Danco submitted identical

data tends to confirm the assertion that FDA lacked

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sufficient information; it shows that neither FDA nor

Danco had the means to collect data directly from

prescribers.

The second defect in the Non-Enforcement Decision

is that it relied on various literature relating to

remote prescription of mifepristone—despite FDA’s

admission that the literature did not affirmatively

support its position. Danco insists that the studies “all

. . . supported the conclusion that mifepristone would

still be safe and effective even with a relaxed inperson dispensing requirement,” Danco Br. at 48, but

that is not what FDA said in 2021. On the contrary,

FDA candidly acknowledged that the literature was

only “not inconsistent with [its] conclusion.” 2021

Denial Letter at 28. In other words, the studies

neither confirmed nor rejected the idea that

mifepristone would be safe if the in-person dispensing

requirement were removed. In discussing the various

studies, FDA recognized many significant limitations:

We note that the ability to generalize the

results of these studies to the United States

population is hampered by differences between

the studies with regard to pre-abortion care

(e.g., telemedicine versus in-person). In

addition, the usefulness of the studies is limited

in some instances by small sample sizes and

lack of follow-up information on outcomes with

regard to both safety and efficacy.

There are also factors which complicate the

analysis of the dispensing element alone. Some

of these factors are: (1) only a few studies have

evaluated alternatives for in-person dispensing

of mifepristone in isolation (for example, most

studies on mail dispensing of mifepristone also

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include telemedicine consultation); and (2)

because most serious adverse events with

medical abortion are infrequent, further

evaluation of changes in dispensing would

require studies with larger numbers of

participants. We did not find any large clinical

studies that were designed to collect safety

outcomes in healthcare systems similar to the

United States.

Id. Given those limitations, FDA concluded that the

studies were “not adequate on their own to establish

the safety of the model of dispensing mifepristone by

mail.” Id. at 35.

Especially in light of the unreliability of the adverseevent data, it was not reasonable for FDA to depend

on the published literature to support its decision.

Courts must set aside agency action where there are

“shortcomings in the agency’s explanations” or where

“[n]o record evidence affirmatively makes” the

agency’s case. Sw. Elec. Power Co., 920 F.3d at 1018–

19; see also State Farm, 463 U.S. at 56 (“While [an]

agency is entitled to change its view . . . it is obligated

to explain its reasons for doing so.”). That is the case

here.

In the face of concededly limited data, and lacking

more probative information from prescribers, FDA fell

back on studies that were merely “not inconsistent”

with its intended conclusion. It did not refer to any

literature that affirmatively supported the notion that

mifepristone would remain safe and effective even

without the in-person dispensing requirement. We

conclude that the Medical Organizations and Doctors

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are likely to succeed in showing that this action

violated the APA.8

IV. Irreparable Harm and Balance of the

Equities

We now proceed to the remaining steps of the

preliminary-injunction analysis. First, we ask if the

Medical Organizations and Doctors are likely to

sustain irreparable harm absent an injunction.

Garcia, 910 F.3d at 190. If so, we then balance the

equities and consider whether an injunction serves

the public interest. Winter, 555 U.S. at 20. And where

the government appeals an injunction, its interests

“merge” with the public interest. Tex. Democratic

Party v. Abbott, 961 F.3d 389, 412 (5th Cir. 2020)

(quoting Veasey v. Abbott, 870 F.3d 387, 391 (5th Cir.

2017)).

We have already concluded that the Medical

Organizations and Doctors are likely to sustain

injury; now we need only determine whether the

threatened injuries are irreparable. They are. An

irreparable harm is one “for which there is no

adequate remedy at law.” Louisiana v. Biden, 55 F.4th

1017, 1033–34 (5th Cir. 2022) (quoting Daniels Health

Scis., LLC v. Vascular Health Scis., LLC, 710 F.3d

579, 585 (5th Cir. 2013)). No legal remedy can

adequately redress the Doctors’ conscience and

mental-distress injuries. And the economic injuries—

the potential damage to their medical practice,

heightened exposure to malpractice liability, and

increased insurance costs—are irreparable too.

8

Given this holding, we do not consider the Medical

Organizations and Doctors’ independent argument that the 2021

Non-Enforcement Decision violates the Comstock Act of 1873.

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Monetary harm cannot be remedied where, as here,

the defendant is entitled to sovereign immunity. See

Wages & White Lion Invs., LLC v. FDA, 16 F.4th 1130,

1142 (5th Cir. 2021).

This risk of irreparable harm must be weighed

against any injury FDA and Danco would sustain as a

result of the stay order, as well as against the public

interest. Starting with FDA, we recognize that

anytime the Government is enjoined from enforcing

its statutes or regulations, “it suffers a form of

irreparable injury.” Maryland v. King, 567 U.S. 1301,

1303 (2012) (Roberts, C.J., in chambers); accord

Valentine v. Collier, 956 F.3d 797, 803 (5th Cir. 2020).

But on the other hand, neither FDA nor the public has

any interest in enforcing a regulation that violates

federal law. Louisiana, 55 F.4th at 1035 (“There is

generally no public interest in the perpetuation of

unlawful agency action.”) (citations omitted).

In this regard, the government/public-interest

analysis collapses with the merits. See Sierra Club v.

U.S. Army Corps of Eng’rs, 990 F. Supp. 2d 9, 43

(D.D.C. 2013) (Jackson, J.) (explaining that “public

interest arguments” are “derivative of . . . merits

arguments and depend in large part on the vitality of

the latter”) (citing Serono Lab’ys, Inc. v. Shalala, 158

F.3d 1313, 1326 (D.C. Cir. 1998)); see also Louisiana,

55 F.4th at 1035; League of Women Voters of U.S. v.

Newby, 838 F.3d 1, 12 (D.C. Cir. 2016). The Medical

Organizations and Doctors are likely to succeed on

their claims as to the 2016 Amendments and 2021

Non-Enforcement Decision. It follows that FDA and

the public will not be injured by an order staying those

likely unlawful actions.

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FDA also points to the “disruptive practical effects”

of a stay, FDA Br. at 66–67, arguing that it will incur

substantial costs if it complies with the stay order,

only for the order to be reversed later. As a

preliminary matter, this argument is also highly

duplicative of the merits. FDA’s injury only comes into

play if the stay order is vacated—that is, if the

Medical Organizations and Doctors are not likely to

succeed on the merits. After careful consideration, we

have concluded that these claims are likely to succeed.

Accordingly, we do not consider the costs that might

be incurred if the stay order goes into effect and is

later vacated. Moreover, we doubt whether an

agency’s interim compliance costs could outweigh a

threat of irreparable harm. See Al Otro Lado v. Wolf,

952 F.3d 999, 1008 (9th Cir. 2020).

Turning to Danco’s interest, we acknowledge that

the district court’s stay order would impose significant

injury. See Texas v. EPA, 829 F.3d 405, 434 (5th Cir.

2016) (explaining that financial harm may be

irreparable “where the loss threatens the very

existence of the [party’s] business”) (quoting Wis. Gas

Co. v. FERC, 758 F.2d 669, 674 (D.C. Cir. 1985)). That

threat, however, is substantially lessened because we

vacate the component of the stay order that would

pause FDA’s initial approval of mifepristone in 2000.

What remains is any injury that Danco will face as

a result of the stay order as amended. The Medical

Organizations and Doctors point out that Danco

already has drug labels and documentation that

comply with the mifepristone REMS as of 2011. Danco

does not deny this, but responds that “[r]equiring a

return to a prior and outdated REMS and label would

also create months-long loss of access, while FDA and

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Danco work through the sNDA process.” Danco Br. at

61 (citing Declaration of Dr. Janet Woodcock ¶ 14).

But this potential injury is greatly diminished by the

fact that the Supreme Court’s stay of the district

court’s order will remain in effect pending disposition

of any petition for certiorari.

It is a well-established maxim that “equity regards

substance rather than form.” Dobbs, 1 Law of

Remedies 83 (2d ed. 1993). This means, among other

things, that courts exercising equitable power should

account

for

the

real,

boots-on-the-ground

circumstances, not those supposed or theorized by the

parties. As Pomeroy has explained:

Equity always attempts to get at the substance

of things, and to ascertain, uphold, and enforce

rights and duties which spring from the real

relations of parties. It will never suffer the mere

appearance and external form to conceal the

true purposes, objects, and consequences of a

transaction.

Pomeroy, II Equity Jurisprudence § 378 (5th ed.

1941); see, e.g., Freedom from Religion Found., 58

F.4th at 837. Applying this principle, we must take

into consideration the fact that the district court’s stay

order will likely not go into effect for several months,

if not more than a year.

The Supreme Court’s stay alleviates (or at least

greatly reduces) any possible harm to Danco because

it establishes a substantial window to prepare to

comply with the district court’s stay order, as modified

by this court. The soonest the district court’s stay

order could go into effect would be if neither party

filed a petition for certiorari, and the deadline to do so

is ninety days after the entry of this court’s judgment.

69a

Sup. Ct. R. 13. Alternatively, if either of the

Defendants seek certiorari, the stay will remain in

effect at least until the denial of that petition, should

it be denied. But even that would likely require a

minimum of six months for briefing by the parties and

disposition by the Supreme Court. And if the Court

grants the writ, that would extend the stay for

upwards of another year. Either way, Danco will have

“months” of time needed to arrange for mifepristone

to be distributed under the 2011 REMS and prevent

any “loss of access.”

Other

public-interest

considerations

merit

discussion. Various amici assert that eliminating

access to mifepristone, even temporarily, may pose

health risks to certain women, including those who

use the drug to manage miscarriage. Br. of American

College of Obstetricians and Gynecologists et al. at

21–26; Br. of Physicians for Reproductive Health at

18–27; Br. of Over 200 Reproductive Health, Rights,

and Justice Organizations at 14–25; Br. of Doctors for

America et al. at 14–23; Br. of Advocates for Survivors

of Intimate Partner Violence at 18–26. Other amici

argue that “disrupting access to mifepristone” would

burden state and local health-care systems. Br. of

New York et al. at 4; see also Br. of Local Governments

at 24–26; Br. of the City of New York et al. at 8–31;

Br. of Medical Students for Choice at 3–22. And still

other amici say that staying FDA’s approval of

mifepristone would destabilize the pharmaceutical

industry,

especially

research-and-development

sections. Br. of Pharmaceutical Companies,

Executives, and Investors at 3–4; Br. of

Pharmaceutical Research and Manufacturers of

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America et al. at 22–26; Br. of Patient and Provider

Advocacy Organizations at 9–20.

These concerns are not insignificant. But they apply

primarily (if not wholly) to the challenge to the 2000

Approval—a claim that we have concluded is not

likely to succeed. All. for Hippocratic Med., 2023 WL

2913725, at *20 (“[T]hese concerns center on the

district court’s removal of mifepristone from the

market. [Defendants] make no arguments as to why

the 2016 Major REMS Changes, the 2019 Generic

Approval, or the 2021 and 2023 Mail Order Decisions

are similarly critical to the public . . . .”). Insofar as

these concerns translate to the 2016 Amendments and

2021 Non-Enforcement Decision, they are lessened by

the fact that mifepristone would remain available

under the 2011 REMS, as would options for surgical

abortion.

And of course, the public interest is disserved by a

drug that does not afford adequate protections to its

users. See Deerfield Med. Ctr. v. City of Deerfield

Beach, 661 F.2d 328, 338 (5th Cir. 1981); 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.”). To be clear, the evidence does not show that

mifepristone is unsafe in all applications. But on this

record and at this preliminary stage, the Medical

Organizations and Doctors have made a substantial

showing that the 2016 Amendments and 2021 NonEnforcement Decision were taken without sufficient

consideration of the effects those changes would have

on patients.

Weighing all of these considerations, we conclude

that the balance of the equities favors the Medical

71a

Organizations and Doctors. They face a substantial

risk of irreparable harm to their medical practice,

mental and emotional health, and conscience. The

limited relief affirmed by our judgment threatens

neither FDA nor Danco with substantial harm. Nor

does it offend the public interest. The Medical

Organizations and Doctors therefore satisfy the

remaining preliminary-injunction factors. Winter, 555

U.S. at 20.

V. Form of Relief

Finally, FDA and Danco challenge the form of the

relief entered by the district court—a stay of the

actions’ effective dates. FDA argues that the Medical

Organizations and Doctors were required to first seek

an administrative stay, but failed to do so. See 21

C.F.R. § 10.45(c) (“A request that administrative

action be stayed must first be the subject of an

administrative decision based upon a petition for stay

of action . . . before a request is made that a court stay

the action.”). It also contends that § 705 authorizes

only requests made at the same time the challenged

action is enacted. Here, by contrast, the Medical

Organizations and Doctors seek a stay years after the

relevant policies took effect. And Danco maintains

that injunctive relief is categorically unavailable,

reasoning that if the Medical Organizations and

Doctors prevailed, they would only be entitled to

remand without vacatur.

We hold that the district court entered an

appropriate form of relief. To begin, consider the

nature of a “stay” under § 705. In the same way that

a preliminary injunction is the temporary form of a

permanent injunction, a stay is the temporary form of

vacatur. Between vacatur and an injunction, the

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former is the “less drastic remedy.” Monsanto Co. v.

Geertson Seed Farms, 561 U.S. 139, 165 (2010). That

is so because vacatur does not order the defendant to

do anything; it only removes the source of the

defendant’s authority. See Nken v. Holder, 556 U.S.

418, 428–29 (2009) (“[A] stay achieves this result by

temporarily suspending the source of authority to

act—the order or judgment in question—not by

directing an actor’s conduct.”); see also Texas v. United

States, 40 F.4th 205, 220 (5th Cir. 2022) (“Apart from

the constitutional or statutory basis on which the

court invalidated an agency action, vacatur neither

compels nor restrains . . . agency decision-making.”).

Upon a successful APA claim, vacatur effectively

rescinds the unlawful agency action. See Data Mktg.

P’ship, LP v. U.S. Dep’t of Lab., 45 F.4th 846, 859 (5th

Cir. 2022) (“Vacatur . . . retroactively undoes or

expunges a past state action. . . . Unlike an injunction,

which merely blocks enforcement, vacatur unwinds

the challenged agency action.”) (quoting Driftless Area

Land Conservancy v. Valcq, 16 F.4th 508, 522 (7th Cir.

2021)). Keeping with the preliminary-permanent

injunction analogy, a stay temporarily voids the

challenged authority.

Practically speaking, a stay means that—while the

order is in effect—Danco will have legal authority to

market and sell Mifeprex under the conditions that

were in effect before 2016. Likewise, GenBioPro will

have authority to market and sell the generic version

of mifepristone under those same conditions—that is,

those that appeared in the 2011 REMS. The in-person

dispensing requirements, and FDA’s obligation to

enforce them, will continue to apply.

73a

In terms of enforcement, unlike with a preliminary

injunction, a stay does not actively prohibit conduct,

and so does not carry the same threat of contempt.

Plaintiffs could move to enforce the stay in the

unlikely event that FDA or Danco took some action to

violate it. But of course, we have absolutely no reason

to believe that such a motion would be necessary. And

we should reiterate that the Supreme Court’s stay of

the district court’s order will remain in effect pending

disposition of any petition for certiorari.

Turning to Danco’s objection to a stay, we do not

agree that the Medical Organizations and Doctors will

be limited to remand without vacatur if they obtain a

favorable judgment. “[V]acatur of an agency action is

the default rule in this Circuit.” Cargill v. Garland, 57

F.4th 447, 472 (5th Cir. 2023) (en banc) (plurality op.);

Data Mktg. P’ship, 45 F.4th at 859; accord United

Steel v. Mine Safety & Health Admin., 925 F.3d 1279,

1287 (D.C. Cir. 2019) (“The ordinary practice is to

vacate unlawful agency action.”). Given that

presumption, remand without vacatur is appropriate

only if “there is at least a serious possibility that the

agency will be able to substantiate its decision given

an opportunity to do so.” Texas v. United States, 50

F.4th 498, 529 (5th Cir. 2022) (quoting Texas Assn. of

Mfrs. v. U.S. Consumer Prod. Safety Comm’n, 989

F.3d 368, 389–90 (5th Cir. 2021)); accord RadioTelevision News Dirs. Ass’n v. FCC, 184 F.3d 872, 888

(D.C. Cir. 1999).

Remand without vacatur is likely not appropriate

because “it is far from certain” that FDA could cure its

mistakes with further consideration. Env’t Def. Fund

v. FERC, 2 F.4th 953, 976 (D.C. Cir. 2021). FDA erred

by failing to consider the cumulative effects of the

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2016 Amendments on mifepristone’s safety and by

disregarding the lack of recent data on adverse events

when

removing

the

in-person

dispensing

requirement. The record does not tend to show that

FDA would have arrived at the same decision if it had

considered those things. See Oglala Sioux Tribe v.

U.S. Nuclear Regul. Comm’n, 896 F.3d 520, 536 (D.C.

Cir. 2018) (declining to remand without vacatur

because of the “seriousness” of the action’s

“deficiency”); Pollinator Stewardship Council v. EPA,

806 F.3d 520, 532 (9th Cir. 2015) (same); cf. Sierra

Club v. FERC, 68 F.4th 630, 652 (D.C. Cir. 2023)

(remanding without vacatur because it was possible

that FERC could “adequately explain its decision” if

given another opportunity). If the Medical

Organizations and Doctors succeed on the merits, it is

likely that the default remedy—vacatur—will be

appropriate. And the temporary version of vacatur is

a stay.

We are also unpersuaded by FDA’s contentions.

First, FDA argues Medical Organizations and Doctors

cannot seek a stay before the district court because

they failed to seek one from the agency. But the record

shows that FDA would have denied any request for an

administrative stay. See Gulf Restoration Network v.

Salazar, 683 F.3d 158, 176 (5th Cir. 2012). FDA

unequivocally denied the 2019 citizen petition,

rejecting the premise that 2016 Amendments made

mifepristone less safe. It discussed the 2021 NonEnforcement Decision in the same document, and

then formalized the policy in 2023. These

pronouncements show that FDA was committed to

implementing these changes, and foreclose any notion

that the agency would have granted an administrative

75a

stay. Tesoro Refin. & Mktg. Co. v. FERC, 552 F.3d 868,

874 (D.C. Cir. 2009) (explaining that the exhaustion

requirement does not apply “when resort to

administrative remedies [would be] clearly useless”)

(citations omitted). That FDA denied a request to stay

the 2000 Approval further aids this conclusion. See

2016 Denial Letter at 32 (“As described above, we are

denying your Petition. Therefore, your request for a

stay pending final action on your Petition is moot.”).

Second, FDA provides no authority for its assertion

that § 705 of the APA limits stays to contemporaneous

agency actions. The text does not provide such a

limitation. Instead, it empowers a reviewing court to

“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.” 5 U.S.C. § 705. Circuit courts

have interpreted this statute as providing something

akin to the general stay power recognized by Rule 18

of the Federal Rules of Appellate Procedure, see Ohio

v. Nuclear Regul. Comm’n, 812 F.2d 288, 290 (6th Cir.

1987); In re GTE Serv. Corp., 762 F.2d 1024, 1026

(D.C. Cir. 1985), which weighs against construing §

705 as requiring that a stay be issued concurrently

with an agency action. We are disinclined to reach a

definitive answer on this question, given the cursory

treatment by both parties. But we strongly doubt that

§ 705 should be read to impose the limit urged by

FDA. Nothing about this argument persuades us that

the district court abused its discretion by entering this

particular form of relief.

VI. Conclusion

For the foregoing reasons, the stay order entered by

the district court is VACATED in part and

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AFFIRMED in part. We vacate the component of the

order that stayed the effective date of the 2000

Approval and the 2019 Generic Approval. Mifeprex

will remain available under the safety restrictions

that were in effect prior to 2016. Generic mifepristone

will also remain available under those same

restrictions.

We affirm the portions of the stay order regarding

the 2016 Amendments and the 2021 NonEnforcement Decision. In loosening mifepristone’s

safety restrictions, FDA failed to address several

important concerns about whether the drug would be

safe for the women who use it. It failed to consider the

cumulative effect of removing several important

safeguards at the same time. It failed to consider

whether those “major” and “interrelated” changes

might alter the risk profile, such that the agency

should continue to mandate reporting of non-fatal

adverse events. And it failed to gather evidence that

affirmatively showed that mifepristone could be used

safely without being prescribed and dispensed in

person.

At

this

preliminary

stage,

the

Medical

Organizations and Doctors have made a substantial

showing that the 2016 Amendments and the 2021

Non-Enforcement Decision violate the APA.

Accordingly, those actions will be stayed pending final

judgment. But to repeat, all of this relief is subject to

the Supreme Court’s prior order, which stays the

district court’s order until the disposition of any

petition for certiorari.

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JAMES C. HO, Circuit Judge, concurring in part and

dissenting in part:

The Constitution vests “the authority to regulate

abortion” in “the people and their elected

representatives.” Dobbs v. Jackson Women’s Health

Org., 142 S. Ct. 2228, 2279 (2022). Congress has

enacted a number of laws that affect the regulation of

abortion, including the Administrative Procedure Act

and the Comstock Act. Those laws dictate the outcome

in this case.

Congress has conferred significant regulatory power

on administrative agencies such as the FDA. In

exchange, Congress has enacted the APA to ensure

that agency action is subject to meaningful judicial

review. It requires courts to “hold unlawful and set

aside agency action” that we determine to be

“arbitrary, capricious, an abuse of discretion, or

otherwise not in accordance with law.” 5 U.S.C.

§ 706(2)(A).

That’s precisely what occurred here. Plaintiffs

challenge the FDA’s approval of mifepristone in 2000,

as well as its 2016 and 2021 revisions to its

mifepristone regulations. I agree with the panel

majority that the FDA’s 2016 and 2021 revisions to its

mifepristone regulations must be set aside as

arbitrary and capricious under the APA. I would add

that the FDA’s initial approval of mifepristone in 2000

also violates the agency’s own rules and thus must be

set aside under the APA as well.

The FDA approved mifepristone under its Subpart

H regulations. But Subpart H only authorizes the

FDA to approve drugs that “treat[] serious or life-

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threatening illnesses.” 21 C.F.R. § 314.500. And

pregnancy is plainly not an illness. So it was unlawful

for the FDA to approve mifepristone under Subpart H.

To quote the Population Council, the entity that

sought FDA approval of mifepristone in 2000:

“Neither pregnancy nor unwanted pregnancy is an

illness, and Subpart H is therefore inapplicable for

that reason alone.” Population Council Letter to FDA

at 1–2 (Sep. 6, 2000).

Perhaps the FDA could have approved mifepristone

through some other regulatory process. But

established precedent requires us to review the FDA’s

action based on the path it took—not the path it might

have taken. See SEC v. Chenery Corp., 318 U.S. 80, 95

(1943); DHS v. Regents of the Univ. of Cal. 140 S. Ct.

1891, 1909 (2020) (“An agency must defend its actions

based on the reasons it gave when it acted.”).

The FDA’s 2021 revisions also violate the Comstock

Act. That Act makes it a federal crime to mail any

“article or thing designed . . . or intended for producing

abortion,” as well as any “drug, medicine, or thing . . .

advertised . . . in a manner calculated to lead another

to use . . . it for producing abortion.” 18 U.S.C. § 1461.

It also makes it a crime to “use[] . . . [an] express

company” to ship a “drug, medicine, article, or thing

designed . . . or intended for producing abortion.” 18

U.S.C. § 1462.

So I would affirm the district court. Accordingly, I

concur in part and dissent in part.

I.

I agree with the thorough and well-reasoned panel

majority opinion that Plaintiffs have demonstrated

Article III standing to challenge both the FDA’s 2000

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approval of mifepristone and the 2016 and 2021

revisions. I write separately to elaborate on the

historical pedigree of Plaintiffs’ conscience injury, and

to explore how Plaintiffs suffer aesthetic injury as

well.

A.

The Supreme Court has instructed that we look to

“history and tradition” as “a meaningful guide to the

types of cases that Article III empowers federal courts

to consider.” United States v. Texas, 143 S. Ct. 1964,

1970 (2023) (quoting Sprint Communications Co. v.

APCC Services, Inc., 554 U.S. 269, 274 (2008)). We ask

whether the “injury to the plaintiff has a ‘close

relationship’ to a harm ‘traditionally’ recognized as

providing a basis for a lawsuit in American courts.”

TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2204

(2021) (quoting Spokeo, Inc. v. Robins, 578 U.S. 330,

341 (2016)).

By the standards of history and tradition, the harm

to conscience that Plaintiffs suffer is a

paradigmatically cognizable injury. American law has

recognized conscience rights from the start. See, e.g.,

N.H. CONST. of 1784, pt. I, art. IV (“Among the natural

rights, some are in their very nature unalienable,

because no equivalent can be given or received for

them. Of this kind are the RIGHTS OF CONSCIENCE.”);

PA. CONST. of 1790, art. IX, § 3 (“[N]o human authority

can, in any case whatever, control or interfere with

the rights of conscience.”); KY. CONST. of 1792, art.

XII, § 3 (same); OHIO CONST. of 1803, art. VIII, § 3

(same); ALA. CONST. of 1819, art. I, § 4 (“No human

authority ought, in any case whatever, to control or

interfere with the rights of conscience.”); TENN.

CONST. of 1835, art. I, § 3 (“[N]o human authority can,

80a

in any case whatever, control or interfere with the

rights of conscience.”); MO. CONST. of 1820, art. XIII, §

4 (“[N]o human authority can control or interfere with

the rights of conscience.”); ARK. CONST. of 1836, art.

II, § 3 (“[N]o human authority can, in any case

whatever, interfere with the rights of conscience.”);

WIS. CONST. of 1848, art. I, § 18 (“Nor shall any control

of, or interference with the rights of conscience be

permitted.”); MINN. CONST. of 1858, art. I, § 16 (same);

KAN. CONST. of 1859, Bill of Rights, § 7 (same).

Throughout the nineteenth century, American

courts granted relief to parties who challenged

government action as injurious to conscience. See, e.g.,

White v. McBride, 7 Ky. (4 Bibb) 61, 61 (1815) (suit

brought against sheriff by plaintiffs who “entertained

conscientious scruples against bearing arms”); In re

Dorsey, 7 Port. 293, 345, 365–69 (Ala. 1838) (attorney

seeking conscience-based exemption from antidueling oath required for bar admission); State ex rel.

Weiss v. Dist. Bd. of Sch. Dist. No. 8 of City of

Edgerton, 44 N.W. 967, 967–68, 976 (Wis. 1890) (writ

of mandamus requested by public school students who

raised conscience-based objection to curriculum).

And even where parties were not ultimately granted

relief, courts entertained their suits alleging injuries

to conscience and reached the merits of their claims.

See, e.g., Donahoe v. Richards, 38 Me. 379, 413 (1854)

(public school student raised conscience-based

objection to curriculum); Innis v. Bolton, 17 P. 264,

269 (Idaho 1888) (plaintiff brought conscience-based

objection to anti-polygamy oath required for voting).

Here, Plaintiffs have alleged conscience injuries

analogous to those historically recognized at law and

in equity. The FDA’s approval of mifepristone creates

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a substantial risk that Plaintiffs will be forced to

participate in the abortion process. See, e.g., Dr.

Francis Declaration ¶ 14 (“[M]ore physicians with

ethical and medical objections to abortion will be

forced to participate in completing unfinished elective

chemical abortions, just as my partner was.”); Dr.

Skop Declaration ¶ 34 (“The FDA’s expansion of

chemical abortion . . . harms my conscience rights

because it could force me to have to surgically finish

an incomplete elective chemical abortion. I object to

abortion because it ends a human life.”).

The Supreme Court has recognized that intangible

interests in free speech and free exercise are

sufficiently concrete for Article III standing. See

Spokeo, 578 U.S. at 340. So it’s not surprising that

both the FDA and intervenor Danco agree that

conscience injuries can satisfy Article III. I agree with

the panel majority that Plaintiffs have established

Article III standing based on injury to conscience.

B.

In addition to the injuries analyzed by the majority,

Plaintiffs have demonstrated another basis for Article

III standing: the aesthetic injury they experience in

the course of their work. See, e.g., Sierra Club v.

Morton, 405 U.S. 727, 734–35 (1972) (recognizing

aesthetic harm as “injury to a cognizable interest”);

Lujan v. Defs. of Wildlife, 504 U.S. 555, 562–63 (1992)

(“[T]he desire to use or observe an animal species,

even for purely esthetic purposes, is undeniably a

cognizable interest for purpose of standing.”); id. at

566 (“[T]he person who observes or works with a

particular animal threatened by a federal decision is

facing perceptible harm.”).

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It’s well established that, if a plaintiff has “concrete

plans” to visit an animal’s habitat and view that

animal, that plaintiff suffers aesthetic injury when an

agency has approved a project that threatens the

animal. See Lujan, 504 U.S. at 564. See also Humane

Soc’y v. Hodel, 840 F.2d 45, 52 (D.C. Cir. 1988)

(standing where agency expanded approval for

hunting, “depleting the supply of animals . . . that . . .

[plaintiffs] seek to view” and causing plaintiffs to

witness “animal corpses”); Am. Bottom Conservancy v.

Army Corps of Engineers, 650 F.3d 652, 657 (7th Cir.

2011) (standing for birdwatchers to challenge agency

permit that would allow development and thus

“diminish the wildlife population visible to them”);

Ctr. for Biological Diversity v. EPA, 861 F.3d 174, 183

(D.C. Cir. 2017) (standing where agency authorization

to use pesticide created “demonstrable risk” to beetles

and butterflies that plaintiffs intended to view).

Unborn babies are a source of profound joy for those

who view them. Expectant parents eagerly share

ultrasound photos with loved ones. Friends and family

cheer at the sight of an unborn child. Doctors delight

in working with their unborn patients—and

experience an aesthetic injury when they are aborted.

Plaintiffs’ declarations illustrate that they

experience aesthetic injury from the destruction of

unborn life. Dr. Francis testified to working with an

unborn child who was subsequently killed by

mifepristone:

[A] partner of mine and I cared for another

patient who also suffered complications from

chemical abortion. I had taken care of her when

she was hospitalized . . . at 9 weeks 5 days

gestation. She was discharged home in good

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condition after significant improvement with

medications. During that hospital stay, she had

an ultrasound, which showed a healthy

pregnancy with no apparent complications and

a strong fetal heart rate. . . . Approximately one

week after her discharge, the patient presented

back at our emergency room with heavy vaginal

bleeding and unstable vital signs as a result of

taking chemical abortion drugs.

Dr. Francis Declaration ¶ 13.

Dr. Jester put Plaintiffs’ interest in unborn life this

way: “When my patients have chemical abortions, I

lose the opportunity . . . to care for the woman and

child through pregnancy and bring about a successful

delivery of new life.” Dr. Jester Declaration ¶ 19. See

Ctr. for Biological Diversity v. EPA, 937 F.3d 533, 541

(5th Cir. 2019) (recognizing judicially cognizable

injury where plaintiff experiences aesthetic harm at

work).

The Supreme Court has recognized that “the person

who observes or works with a particular animal

threatened by a federal decision is facing perceptible

harm, since the very subject of his interest will no

longer exist.” Lujan, 504 U.S. at 566. Every circuit,

including our own, has concluded that, when a federal

agency authorizes third parties to harm flora or fauna

that a plaintiff intends to view or study, that satisfies

all of the requirements for Article III standing. See,

e.g., Housatonic River Initiative v. EPA, _ F.4th_, 2023

WL 4730222, *9 (1st Cir. July 25, 2023); NRDC v.

FAA, 564 F.3d 549, 555 (2nd Cir. 2009); Sierra Club v.

EPA, 972 F.3d 290, 298–99 (3rd Cir. 2020); Sierra

Club v. Dep’t of the Interior, 899 F.3d 260, 282–85 (4th

Cir. 2018); Gulf Restoration Network v. Salazar, 683

84a

F.3d 158, 166–68 (5th Cir. 2012); Meister v. Dep’t of

Agriculture, 623 F.3d 363, 369–70 (6th Cir. 2010); Am.

Bottom Conservancy, 650 F.3d at 656–60; Sierra Club

v. Army Corps of Engineers, 645 F.3d 978, 985–86 (8th

Cir. 2011); Cottonwood Env’t Law Ctr. v. Forest

Service, 789 F.3d 1075, 1079–83 (9th Cir. 2015);

WildEarth Guardians v. EPA, 759 F.3d 1196, 1206–

07 (10th Cir. 2014); Black Warrior Riverkeeper, Inc. v.

Army Corps of Engineers, 781 F.3d 1271, 1280–83

(11th Cir. 2015); Ctr. for Biological Diversity v. EPA,

56 F.4th 55, 66–69 (D.C. Cir. 2022).

In all of these cases, a federal agency approved some

action—such as developing land or using pesticides—

that threatens to destroy the animal or plant life that

plaintiffs wish to enjoy. This injury is redressable by

a court order holding unlawful and setting aside the

agency approval.

And so too here. The FDA has approved the use of a

drug that threatens to destroy the unborn children in

whom Plaintiffs have an interest. And this injury is

likewise redressable by a court order holding unlawful

and setting aside approval of that abortifacient drug.

I see no basis for allowing Article III standing based

on aesthetic injury when it comes to animals and

plants—but not unborn human life.

II.

I now turn specifically to Plaintiffs’ challenge to the

FDA’s 2000 approval of mifepristone. The FDA

contends that the challenge is untimely. But it

concedes that “the well-established reopening

doctrine” is binding precedent in this circuit. Texas v.

Biden, 20 F.4th 928, 951 (5th Cir. 2021), rev’d on other

grounds, 142 S. Ct. 2528 (2022). And it accepts that,

85a

under that doctrine, the clock for an APA claim

restarts when an agency revises its regulations in a

manner that “significantly alters the stakes of judicial

review.” Sierra Club v. EPA, 551 F.3d 1019, 1025

(D.C. Cir. 2008). See also NRDC v. EPA, 571 F.3d

1245, 1266 (D.C. Cir. 2009) (same).

That standard is easily met here. It seems obvious

that the 2016 and 2021 revisions significantly altered

the regulatory landscape. Indeed, the FDA recently

told the Supreme Court that setting aside those

revisions would “upend the regulatory regime for

mifepristone” and “unleash[] regulatory chaos.”

Application to Stay the Order Entered by the United

States District Court for the Northern District of

Texas and for An Administrative Stay, 2023 WL

3127519, at *2–3, FDA v. Alliance for Hippocratic

Medicine, 143 S. Ct. 1075 (2023). If switching from the

2016/2021 regime to the 2000-era regime significantly

alters the “basic regulatory scheme,” NRDC, 571 F.3d

at 1266, then surely the reverse does, too.

So the district court was correct that “FDA’s 2016

and 2021 Changes . . . significantly departed from the

agency’s original approval of the abortion regimen.

FDA . . . altered its original decision by removing

safeguards and changing the regulatory scheme for

chemical abortion drugs.” Alliance for Hippocratic

Medicine v. FDA, _ F. Supp. 3d _, 2023 WL 2825871,

at *11 (N.D. Tex. Apr. 7, 2023). As a result, the 2016

and 2021 revisions triggered the reopening doctrine.

Plaintiffs’ challenge to the 2000 approval is timely.

A.

Challenges to federal administrative action are

subject to a six-year statute of limitations. See 28

U.S.C. § 2401(a). This six-year clock initially started

86a

ticking in March 2016, when the FDA denied

Plaintiffs’ 2002 petition objecting to the 2000

approval. See 21 C.F.R. § 10.45(d). Absent reopening,

Plaintiffs’ challenge to the 2000 approval would be

barred by this six-year statute of limitations, because

Plaintiffs filed this suit after March 2022.

But under the administrative reopening doctrine,

the agency can restart the clock in two ways: (1) if “the

agency opened the issue up anew, and then

reexamined and reaffirmed its prior decision,” NRDC,

571 F.3d at 1265 (cleaned up), or (2) “if the revision of

accompanying regulations ‘significantly alters the

stakes of judicial review’ as the result of a change that

‘could have not been reasonably anticipated,’” id. at

1266 (quoting Sierra Club v. EPA, 551 F.3d 1019,

1025 (D.C. Cir. 2008)).

This second type of reopening is called “constructive

reopening.” Id. I would hold that constructive

reopening applies here, rendering Plaintiffs’ challenge

to the 2000 approval timely.

“A constructive reopening occurs if the revision of

. . . regulations ‘significantly alters the stakes of

judicial review.’” Sierra Club, 551 F.3d at 1025

(quoting Kennecott Utah Copper Corp. v. Dep’t of the

Interior, 88 F.3d 1191, 1227 (D.C. Cir. 1996)). The

paradigmatic example of this is when the agency

unexpectedly removes “necessary safeguards,” thus

giving “new significance” to the original action. Id. at

1025–26.

In Sierra Club, the EPA’s initial 1994 rule exempted

pollutant-emitting plants from emission limits when

the plants were starting up, shutting down, or

malfunctioning. See id. at 1022. To be eligible for the

exemption, a plant had to show it was doing its

87a

“reasonable best” to stay under the emission limits.

Id.

But in the early 2000s, new EPA rules removed this

“reasonable best” requirement. To qualify for the

exemption, plants no longer had to show they were

doing their best to limit emissions. See id. at 1023.

This elimination of safeguards “significantly altered

the stakes of judicial review” for the environmental

plaintiffs, thereby triggering reopening. Id. at 1025

(cleaned up).

The same is true here. Just as the EPA initially

authorized emissions under certain safeguards to

minimize harm, the FDA initially authorized

mifepristone under certain safeguards to minimize

harm. Remove these safeguards, and you’ve

significantly altered the stakes of judicial review. The

original scheme is now much more “worth

challenging.” Id. at 1026 (quotation omitted).

B.

Plaintiffs’ challenge to the 2000 approval easily

satisfies the reopening doctrine. Both the 2016 and

2021 revisions made significant and unexpected

alterations to the basic regulatory scheme. They took

away key safeguards, significantly raising the stakes

of judicial review for the underlying approval.

When it approved mifepristone in 2000, the FDA

included a number of “necessary safeguards” to

minimize harm from this dangerous drug. Sierra

Club, 551 F.3d at 1025. For example, the FDA

required an in-person follow-up appointment to

protect the woman from sepsis, which occurs if the

child’s remains are not removed from her body after

the abortion. See FDA Approval Memorandum to

88a

Population Council at 3 (Sep. 28, 2000). It also limited

the use of mifepristone to the first seven weeks,

ensuring that the abortion took place early in

pregnancy. See id. at 1. And it required a physician to

supervise the administration of mifepristone, in order

to “date pregnancies and diagnose ectopic

pregnancies.” Id. at 5. See also id. at 6 (same).

The 2016 amendments removed these key

safeguards. By approving the abortifacient for use up

to ten weeks, by allowing non-physicians to prescribe

and administer the drug, and by removing the inperson follow-up requirement, the 2016 revisions

significantly altered the stakes of judicial review.

“These are not mere ‘minor changes.’” Sierra Club,

551 F.3d at 1025. By modifying its original

restrictions, the FDA constructively reopened the

drug’s approval.

The 2016 amendments became final in 2021, when

the FDA denied the 2019 Petition challenging them.

See 21 C.F.R. § 10.45(d). Plaintiffs’ challenge is

therefore timely.

The 2021 Mail-Order Decision worked an even

greater “sea change” to the “basic regulatory scheme.”

NRDC, 571 F.3d at 1266. From the get-go, the FDA’s

approval of mifepristone was explicitly premised on

in-person dispensing. The initial 2000 approval

required “[p]rovision of [the] drug through a direct,

confidential physician distribution system that

ensures only qualified physicians will receive the drug

for patient dispensing.” FDA Approval Memorandum

to Population Council at 6. See also id. at 4 (“[T]he

drug will be distributed directly to physicians. It will

not be available from pharmacies.”). The agency

89a

viewed this as necessary to “address[] the issue of

physical security of the drug.” Id.

So “[t]he in-person dispensing requirement . . . was

critical to FDA’s initial approval of mifepristone in

2000, which relied on the in-person dispensing

requirement to dismiss concerns about provider

qualifications, improper use, illicit distribution, and

detection of adverse events.” Alliance for Hippocratic

Medicine v. FDA, 2023 WL 2913725, at *14 (5th Cir.

Apr. 12, 2023). “[T]he in-person dispensing

requirement was FDA’s primary tool for ensuring the

safe distribution and use of mifepristone.” Id. at *15.

“[T]his change eliminates a major safeguard against

complications and adverse effects arising from

improper mifepristone use.” Id. It “significantly alters

the stakes of judicial review,” triggering reopening.

NRDC, 571 F.3d at 1266 (quoting Sierra Club, 551

F.3d at 1025).

C.

The FDA counters that the 2016 and 2021 revisions

could not have significantly altered the stakes of

judicial review or made the regulatory scheme worth

challenging in a way it wasn’t before. After all, the

FDA says, Plaintiffs already challenged the original

2000 approval in their 2002 petition.

But not all of the Plaintiffs here participated in the

2002 petition. For those Plaintiffs, the FDA’s current

regime is clearly “worth challenging,” even if the

ancien régime of 2000 “may not have been” on its own.

Kennecott Utah Copper Corp., 88 F.3d at 1227.

Indeed, the FDA itself has characterized the switch

from one regime to the other as a “sea change.” NRDC,

571 F.3d at 1266. Under the limited stay issued by a

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previous panel of our court, the FDA was required to

return to the regulatory regime that existed between

2000 and 2016. See Alliance, 2023 WL 2913725, at *1.

The FDA vigorously protested the substitution of the

2016 and 2021 regime with the original 2000

regulations. It urged the Supreme Court to restore the

2016 and 2021 regulations by granting a stay of the

entire district court order. Switching back to the 2000

restrictions, it argued, would “upend the regulatory

regime for mifepristone, with sweeping consequences

for the pharmaceutical industry, women who need

access to the drug, and FDA’s ability to implement its

statutory authority.” FDA Stay Application, 2023 WL

3127519, at *3. It would “unleash[] regulatory chaos”

for “patients, prescribers, and the health care delivery

system.” Id. at *2, *4.

In sum, the FDA insisted that switching from one

regime to the other would “change the basic

regulatory scheme.” NRDC, 571 F.3d at 1266. It

claimed that switching from the 2016/2021 scheme

back to the 2000 scheme counts as a sweeping change

with huge stakes. The same must be true of switching

from 2000 to 2016/2021—that too “upend[ed] the

regulatory regime for mifepristone, with sweeping

consequences.”

Plaintiffs’ challenge to the 2000 approval of

mifepristone is timely.

III.

Turning to the merits, I would hold the 2000

approval unlawful. It’s a longstanding principle that

agencies must follow their own regulations. See

Arizona Grocery Co. v. Atchison, Topeka & Santa Fe

Ry. Co., 284 U.S. 370, 386 (1932) (agency’s legislative

rule “has the force of a statute”); Fort Stewart Schools

91a

v. FLRA, 495 U.S. 641, 654 (1990) (“It is a familiar

rule of administrative law that an agency must abide

by its own regulations.”). The FDA violated that

principle when it approved mifepristone under

Subpart H—as even the drug’s sponsor, the

Population Council, admitted in 2000.

A.

Subpart H authorizes the FDA to approve only those

drugs that treat “serious or life-threatening illnesses.”

21 C.F.R. § 314.500. See also 57 Fed. Reg. 58958 (Dec.

11, 1992) (Accelerated Approval of New Drugs for

Serious or Life-Threatening Illnesses). It “applies to

certain new drug products that have been studied for

their safety and effectiveness in treating serious or

life-threatening illnesses and that provide meaningful

therapeutic benefit to patients over existing

treatments.” 21 C.F.R. § 314.500 (emphasis added).

Pregnancy is not an illness. An “illness” is a “[b]ad

or unhealthy condition of the body.” OXFORD ENGLISH

DICTIONARY (2nd ed. 1989), s.v. illness, sense 3. It’s a

“disease, ailment, sickness, malady.” Id. Pregnancy,

by contrast, is when a woman is “with child.” OXFORD

ENGLISH DICTIONARY, s.v. pregnancy, sense II.3.a.

Pregnancy is not a bad or unhealthy condition of the

body—it’s a natural consequence of a healthy and

functioning reproductive system. See, e.g., Gudenkauf

v. Stauffer Communications, Inc., 922 F. Supp. 465,

473 (D. Kan. 1996) (“Being the natural consequence of

a properly functioning reproductive system,

pregnancy cannot be called an impairment.”); Lacount

v. South Lewis, 2017 WL 319217, at *3 (N.D. Okla.

Jan. 20, 2017) (same); Whitaker v. Bosch Braking Sys.

Div. of Robert Bosch Corp., 180 F. Supp. 2d 922, 928

(W.D. Mich. 2001) (pregnancy is “not a serious health

92a

condition”); Brennan v. National Telephone Directory

Corp., 850 F. Supp. 331, 343 (E.D. Pa. 1994) (“it

cannot be said that [a woman’s] reproductive system

is negatively affected” by pregnancy).

To be sure, pregnancy can sometimes result in

illness. Cf. Spees v. James Marine, Inc., 617 F.3d 380,

397 (6th Cir. 2010) (“Pregnancy-related conditions

have typically been found to be impairments where

they are not part of a ‘normal’ pregnancy.”). But that

does not make the pregnancy itself an illness. See

Whitaker, 180 F. Supp. 2d at 929 (“pregnancy per se

does not constitute a serious health condition”).

The same could be said about old age. Many people

become ill as they grow older. But growing older itself

is obviously not an illness. Like pregnancy, it’s the

“natural consequence” of a healthy and functioning

body. It’s entirely normal to celebrate pregnancies,

just as it’s normal to celebrate birthdays. We don’t

typically celebrate “bad or unhealthy conditions.”

So pregnancy does not qualify as a “serious or lifethreatening illness” within the meaning of 21 C.F.R.

§ 314.500. The FDA implausibly “determined” that it

does. FDA Approval Memorandum to Population

Council at 6. Courts do not defer to agency

interpretations of unambiguous regulations. See Kisor

v. Wilkie, 139 S. Ct. 2400, 2415 (2019). There’s “only

one reasonable construction” of the word “illness”—

and it doesn’t include pregnancy. Id.

There is accordingly no basis for deferring to the

agency. The FDA simply got it wrong. As even the

sponsor of mifepristone, the Population Council,

admitted, “[n]either pregnancy nor unwanted

pregnancy is an illness, and Subpart H is therefore

inapplicable for that reason alone.” Population

93a

Council Letter to FDA at 1–2. “The plain meaning of

these terms does not comprehend normal, everyday

occurrences such as pregnancy and unwanted

pregnancy.” Id. at 2.

B.

The FDA does not even try to argue that pregnancy

is an “illness.” Instead, the FDA, along with

intervenor Danco, points out that the preamble to

Subpart H uses the terms “illness,” “disease,” and

“condition” interchangeably. See, e.g., 57 Fed. Reg.

58942, 58948 (“The drug in question must be for a

serious or life-threatening condition.”). So they argue

that Subpart H allows the FDA to approve drugs that

treat life-threating conditions, as well as lifethreating illnesses. And although pregnancy is plainly

not an “illness,” the argument goes, pregnancy is at

least a “condition.”

There are two problems with this argument. First,

we do not use preambles to expand the meaning of

clear regulatory text. See District of Columbia v.

Heller, 554 U.S. 570, 578 n.3 (2008) (“[I]n America ‘the

settled principle of law is that the preamble cannot

control the enacting part of the statute in cases where

the enacting part is expressed in clear, unambiguous

terms.’”); ANTONIN SCALIA & BRYAN A. GARNER,

READING LAW 218 (2012) (“[T]he prologue cannot give

words and phrases of the dispositive text a meaning

that they cannot bear.”).

Second, this argument—that the preamble broadens

“illness” to include “conditions”—equivocates between

two distinct meanings of the word “condition.” As used

in the preamble, “condition” means a “defective state

of

health.”

MERRIAM-WEBSTER’S

COLLEGIATE

DICTIONARY (11th ed. 2007), s.v. condition, sense 4c.

94a

In this sense, “condition” is a synonym of “illness.” See

MERRIAM-WEBSTER’S COLLEGIATE THESAURUS (1988),

s.v. condition, sense 6 (listing “disease,” “aliment,”

and “sickness” as synonyms of “condition”).

Of course, “condition” can also mean “a state of

being”

more

broadly.

MERRIAM-WEBSTER’S

COLLEGIATE DICTIONARY, s.v., condition, sense 4a.

And pregnancy is certainly a “condition” in this

broader sense.

But the fact that pregnancy is a “condition” in the

broad sense of “state of being” does not make it a

“condition” in the narrow sense of “illness.” And

Subpart H plainly contemplates the narrow sense,

because it uses “condition” interchangeably with

“illness.” A regulation about “cars” doesn’t cover

bicycles just because its preamble sometimes

mentions “vehicles.” Likewise, a regulation about

“illnesses” doesn’t address pregnancy just because its

preamble sometimes mentions “conditions.”1

C.

The agency’s brief proclaims that “FDA Properly

Approved Mifepristone Under Subpart H.” Yet in the

very next paragraph, the FDA turns around and

denies that it used Subpart H to approve

mifepristone—claiming that the approval was “based

1

Danco responds by citing a Government Accountability Office

report, which observes that the FDA has used Subpart H to

approve drugs for treating “breakthrough cancer pain, specific

symptoms of narcolepsy, and severe acne.” GAO, APPROVAL AND

OVERSIGHT OF THE DRUG MIFEPREX at 10 (Aug. 2008). “Severe

recalcitrant nodular acne” may well be a serious illness. Id. at

44. But that has nothing to do with whether pregnancy is a

serious or life-threatening illness.

95a

on FDA’s statutory authority under 21 U.S.C. § 355,

not Subpart H.”

As the panel majority opinion details, Subpart H

encompasses two different paths. The first is entitled

“Approval based on a surrogate endpoint or on an

effect on a clinical endpoint other than survival or

irreversible morbidity.” 21 C.F.R. § 314.510 (emphasis

omitted). The second is entitled “Approval with

restrictions to assure safe use.” 21 C.F.R. § 314.520

(emphasis omitted).

Mifepristone was approved under § 314.520 of

Subpart H—approval with restrictions. But the FDA

now suggests that § 314.520 isn’t really a method of

approval at all—it’s just a method of adding

restrictions on use.

This argument is belied by the regulations. The

header explicitly refers to this second path as a

method of “[a]pproval.” Id. § 314.520. More

importantly, the regulatory text repeatedly refers to

§ 314.520 as a method of drug approval. See id.

§ 314.530(a) (“new drugs approved under . . .

314.520”); id. § 314.530(b) (“an application approved

under . . . § 314.520”); id. § 314.560 (“drug products

approved under § 314.520”).

The FDA’s argument contradicts not only the text,

but also its own statements over the past 23 years. See

Chenery, 318 U.S. at 95; Motor Vehicle Mfrs. Ass’n v.

State Farm, 463 U.S. 29, 50 (1983) (“[C]ourts may not

accept appellate counsel’s post hoc rationalizations for

agency action.”).

In its original 2000 approval memo, the FDA

expressly stated that “[t]his drug is being approved

under Subpart H.” FDA Approval Memorandum to

96a

Population Council at 8. And it has repeatedly

reaffirmed this view in the years since. See FDA

Supplemental Approval Letter to Danco Labs at 1

(June 6, 2011) (application “approved under the

provisions of 21 CFR 314.520 (Subpart H)”); FDA

Letter Denying 2002 Citizen Petition at 2 (Mar. 29,

2016) (“The application was approved under 21 CFR

part 314, subpart H.”); FDA Letter Denying 2019

Citizen Petition at 2 (Dec. 16, 2021) (same).

The GAO report cited by both the FDA and Danco

likewise repeatedly describes mifepristone as having

been “approved” under Subpart H. GAO, APPROVAL

AND OVERSIGHT OF THE DRUG MIFEPREX at 1 (Aug.

2008) (“FDA approved the drug under a provision of

the agency’s Subpart H regulations.”); id. at 5 (“FDA

approved Mifeprex under the restricted distribution

provision of its Subpart H regulations.”); id. at 6 (FDA

“approved the Mifeprex [application] under Subpart

H.”). See also id. at 10, 14–15, 21–24, 32, 44 (same).

The report also notes that the FDA used Subpart H to

“approve” other drugs. See id. at 5 n.13, 25 n.46, 27

n.50, 29 n.53, 36 n.63. And it explicitly refers to §

314.520 as an “approval provision.” Id. at 1 n.2.

The FDA notes that its statutory authority to

approve drugs comes from 21 U.S.C. § 355. But that

doesn’t change the fact that the regulatory path it

chose was Subpart H. Section 355 gives the FDA the

power to approve drugs. And the agency exercised

that power when it promulgated Subpart H. The FDA

did not have to adopt Subpart H in the first place. But

once it did, it was bound to follow it.

D.

As a final defense, the FDA contends that

subsequent events cured any defects in its initial 2000

97a

approval. Specifically, the FDA points to the 2007

Food and Drug Administration Amendments Act and

to the agency’s 2011 Risk Evaluation and Mitigation

Strategy. It claims that both authorities render any

faults with the 2000 approval irrelevant.

First, the FDA argues that the 2007 Act “deemed”

mifepristone to be approved. But the statutory text

contradicts this argument. The Act makes clear that

“[a] drug that was approved before the effective date of

this Act is . . . deemed to have in effect an approved

risk evaluation and mitigation strategy . . . if there are

in effect on the effective date of this Act elements to

assure safe use . . . required under [21 C.F.R. §]

314.520.”

Food

and

Drug

Administration

Amendments Act of 2007, Pub. L. No. 110-85, tit. IX

§ 909(b)(1), 121 Stat. 823, 950 (emphasis added).

So the Act itself did not approve any drugs. It only

approved any risk evaluation and mitigation

strategies for those drugs that the FDA had already

validly approved under § 314.520 of Subpart H. And

as explained above, the FDA’s attempted approval

was invalid because it failed to comply with Subpart

H. The FDA’s reliance on the 2007 Act is entirely

circular—it only works if you assume that the agency

had already validly approved mifepristone in the first

place.

The FDA also points to its 2011 Risk Evaluation and

Mitigation Strategy, arguing that this too re-approved

mifepristone and cured any defects in its 2000

approval. It did not. To the contrary, the 2011 REMS

letter made clear that the agency continued to rely on

Subpart H for its approval of mifepristone—that it “is

approved under the provisions of 21 CFR 314.520

(Subpart H).” FDA Supplemental Approval Letter to

98a

Danco Labs at 1. Moreover, the letter only approved

the Risk Evaluation and Mitigation Strategy proposed

in Danco’s 2008 Supplemental Application— it did not

re-approve the drug apart from Subpart H. In fact, the

letter recognized the need for continued compliance

with the conditions “required by” Subpart H. Id. at 2

(citing 21 C.F.R. § 314.550).

***

For these reasons, I would find that Plaintiffs are

likely to succeed on the merits of their challenge to the

2000 approval. Plaintiffs also satisfy the remaining

factors for equitable relief. The harm to Plaintiffs is

irreparable. No relief at law can adequately address

Plaintiffs’ conscience injuries. See BST Holdings,

L.L.C. v. OSHA, 17 F.4th 604, 618 (5th Cir. 2021). Nor

can money damages remedy the destruction of life. Cf.

Amoco Production Co. v. Village of Gambell, 480 U.S.

531, 545 (1987). The balance of equities and public

interest also favor Plaintiffs. Plaintiffs seek to

vindicate the “national policy of discountenancing

abortion as inimical to the national life,” as reflected

in Congressional enactments including the Comstock

Act. Bours v. United States, 229 F. 960, 964 (7th Cir.

1915). See 18 U.S.C. § 1461; id. § 1462. Cf. 19 U.S.C.

§ 1305(a).

IV.

With respect to the FDA’s 2016 and 2021 revisions,

I agree with the majority’s thoughtful analysis

explaining how the FDA “entirely failed to consider an

important aspect of the problem” in 2016 and “offered

an explanation for its decision that runs counter to the

evidence before the agency” in 2021. State Farm, 463

U.S. at 43. The agency thus acted arbitrarily in

violation of the APA.

99a

I write separately to add that the 2021 revisions

violate the Comstock Act, 18 U.S.C. §§ 1461–62, and

are “not in accordance with law” for that reason as

well. 5 U.S.C. § 706(2)(A).

A.

The text of the Comstock Act prohibits the mailing

of abortifacient drugs:

Every article or thing designed, adapted, or

intended for producing abortion . . . and [e]very

article, instrument, substance, drug, medicine,

or thing which is advertised or described in a

manner calculated to lead another to use or

apply it for producing abortion . . . [i]s declared

to be nonmailable matter and shall not be

conveyed in the mails or delivered from any

post office or by any letter carrier.

Whoever knowingly uses the mails for the

mailing, carriage in the mails, or delivery of

anything declared by this section . . . to be

nonmailable . . . shall

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