FDA v. Alliance for Hippocratic Medicine

(Slip Opinion) OCTOBER TERM, 2023 1

Syllabus

NOTE: Where it is feasible, a syllabus (headnote) will be released, as is

being done in connection with this case, at the time the opinion is issued.

The syllabus constitutes no part of the opinion of the Court but has been

prepared by the Reporter of Decisions for the convenience of the reader.

See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.

SUPREME COURT OF THE UNITED STATES

Syllabus

FOOD AND DRUG ADMINISTRATION ET AL. v.

ALLIANCE FOR HIPPOCRATIC MEDICINE ET AL.

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR

THE FIFTH CIRCUIT

No. 23–235. Argued March 26, 2024—Decided June 13, 2024*

In 2000, the Food and Drug Administration approved a new drug

application for mifepristone tablets marketed under the brand name

Mifeprex for use in terminating pregnancies up to seven weeks. To

help ensure that Mifeprex would be used safely and effectively, FDA

placed additional restrictions on the drug’s use and distribution, for

example requiring doctors to prescribe or to supervise prescription of

Mifeprex, and requiring patients to have three in-person visits with

the doctor to receive the drug. In 2016, FDA relaxed some of these

restrictions: deeming Mifeprex safe to terminate pregnancies up to 10

weeks; allowing healthcare providers, such as nurse practitioners, to

prescribe Mifeprex; and approving a dosing regimen that required just

one in-person visit to receive the drug. In 2019, FDA approved an

application for generic mifepristone. In 2021, FDA announced that it

would no longer enforce the initial in-person visit requirement. Four

pro-life medical associations and several individual doctors moved for

a preliminary injunction that would require FDA either to rescind

approval of mifepristone or to rescind FDA’s 2016 and 2021 regulatory

actions. Danco Laboratories, which sponsors Mifeprex, intervened to

defend FDA’s actions.

The District Court agreed with the plaintiffs and in effect enjoined

FDA’s approval of mifepristone, thereby ordering mifepristone off the

market. FDA and Danco appealed and moved to stay the District

Court’s order pending appeal. As relevant here, this Court ultimately

——————

*Together with No. 23–236, Danco Laboratories, L.L.C. v. Alliance for

Hippocratic Medicine, also on certiorari to the United States Court of

Appeals for the Fifth Circuit.

2 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Syllabus

stayed the District Court’s order pending the disposition of

proceedings in the Fifth Circuit and this Court. On the merits, the

Fifth Circuit held that plaintiffs had standing. It concluded that

plaintiffs were unlikely to succeed on their challenge to FDA’s 2000

and 2019 drug approvals, but were likely to succeed in showing that

FDA’s 2016 and 2021 actions were unlawful. This Court granted

certiorari with respect to the 2016 and 2021 FDA actions.

Held: Plaintiffs lack Article III standing to challenge FDA’s actions

regarding the regulation of mifepristone. Pp. 5–25.

(a) Article III standing is a “bedrock constitutional requirement that

this Court has applied to all manner of important disputes.” United

States v. Texas, 599 U. S. 670, 675. Standing is “built on a single basic

idea—the idea of separation of powers.” Ibid. Article III confines the

jurisdiction of federal courts to “Cases” and “Controversies.” Federal

courts do not operate as an open forum for citizens “to press general

complaints about the way in which government goes about its

business.” Allen v. Wright, 468 U. S. 737, 760. To obtain a judicial

determination of what the governing law is, a plaintiff must have a

“personal stake” in the dispute. TransUnion LLC v. Ramirez, 594

U. S. 413, 423.

To establish standing, a plaintiff must demonstrate (i) that she has

suffered or likely will suffer an injury in fact, (ii) that the injury likely

was caused or will be caused by the defendant, and (iii) that the injury

likely would be redressed by the requested judicial relief. See

Summers v. Earth Island Institute, 555 U. S. 488, 493. The two key

questions in most standing disputes are injury in fact and causation.

By requiring the plaintiff to show an injury in fact, Article III standing

screens out plaintiffs who might have only a general legal, moral,

ideological, or policy objection to a particular government action.

Causation requires the plaintiff to establish that the plaintiff ’s injury

likely was caused or likely will be caused by the defendant’s conduct.

Causation is “ordinarily substantially more difficult to establish” when

(as here) a plaintiff challenges the government’s “unlawful regulation

(or lack of regulation) of someone else.” Lujan v. Defenders of Wildlife,

504 U. S. 555, 560–561. That is because unregulated parties often may

have more difficulty linking their asserted injuries to the government’s

regulation (or lack of regulation) of someone else. Pp. 5–12.

(b) Plaintiffs are pro-life, oppose elective abortion, and have sincere

legal, moral, ideological, and policy objections to mifepristone being

prescribed and used by others. Because plaintiffs do not prescribe or

use mifepristone, plaintiffs are unregulated parties who seek to

challenge FDA’s regulation of others. Plaintiffs advance several

complicated causation theories to connect FDA’s actions to the

plaintiffs’ alleged injuries in fact. None of these theories suffices to

Cite as: 602 U. S. ____ (2024) 3

Syllabus

establish Article III standing. Pp. 13–24.

(1) Plaintiffs first contend that FDA’s relaxed regulation of

mifepristone may cause downstream conscience injuries to the

individual doctors. Even assuming that FDA’s 2016 and 2021 changes

to mifepristone’s conditions of use cause more pregnant women to

require emergency abortions and that some women would likely seek

treatment from these plaintiff doctors, the plaintiff doctors have not

shown that they could be forced to participate in an abortion or provide

abortion-related medical treatment over their conscience objections.

Federal conscience laws definitively protect doctors from being

required to perform abortions or to provide other treatment that

violates their consciences. Federal law protects doctors from

repercussions when they have “refused” to participate in an abortion.

§300a–7(c)(1). The plaintiffs have not identified any instances where

a doctor was required, notwithstanding conscience objections, to

perform an abortion or to provide other abortion-related treatment

that violated the doctor’s conscience since mifepristone’s 2000

approval. Further, the Emergency Medical Treatment and Labor Act

(or EMTALA) neither overrides federal conscience laws nor requires

individual emergency room doctors to participate in emergency

abortions. Thus, there is a break in any chain of causation between

FDA’s relaxed regulation of mifepristone and any asserted conscience

injuries to the doctors. Pp. 14–17.

(2) Plaintiffs next assert they have standing because FDA’s

relaxed regulation of mifepristone may cause downstream economic

injuries to the doctors. The doctors cite various monetary and related

injuries that they will allegedly suffer as a result of FDA’s actions—in

particular, diverting resources and time from other patients to treat

patients with mifepristone complications; increasing risk of liability

suits from treating those patients; and potentially increasing

insurance costs. But the causal link between FDA’s regulatory actions

in 2016 and 2021 and those alleged injuries is too speculative, lacks

support in the record, and is otherwise too attenuated to establish

standing. Moreover, the law has never permitted doctors to challenge

the government’s loosening of general public safety requirements

simply because more individuals might then show up at emergency

rooms or in doctors’ offices with follow-on injuries. Citizens and

doctors who object to what the law allows others to do may always take

their concerns to the Executive and Legislative Branches and seek

greater regulatory or legislative restrictions. Pp. 18–21.

(3) Plaintiff medical associations assert their own organizational

standing. Under the Court’s precedents, organizations may have

standing “to sue on their own behalf for injuries they have sustained,”

Havens Realty Corp. v. Coleman, 455 U. S. 363, 379, n. 19, but

4 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Syllabus

organizations must satisfy the usual standards for injury in fact,

causation, and redressability that apply to individuals, id., at 378–379.

According to the medical associations, FDA has “impaired” their

“ability to provide services and achieve their organizational missions.”

Brief for Respondents 43. That argument does not work to

demonstrate standing. Like an individual, an organization may not

establish standing simply based on the “intensity of the litigant’s

interest” or because of strong opposition to the government’s conduct,

Valley Forge Christian College v. Americans United for Separation of

Church and State, Inc., 454 U. S. 464, 486. The plaintiff associations

therefore cannot establish standing simply because they object to

FDA’s actions. The medical associations claim to have standing based

on their incurring costs to oppose FDA’s actions. They say that FDA

has “caused” the associations to conduct their own studies on

mifepristone so that the associations can better inform their members

and the public about mifepristone’s risks. Brief for Respondents 43.

They contend that FDA has “forced” the associations to “expend

considerable time, energy, and resources” drafting citizen petitions to

FDA, as well as engaging in public advocacy and public education, all

to the detriment of other spending priorities. Id., at 44. But an

organization that has not suffered a concrete injury caused by a

defendant’s action cannot spend its way into standing simply by

expending money to gather information and advocate against the

defendant’s action. Contrary to what the medical associations

contend, the Court’s decision in Havens Realty Corp. v. Coleman does

not stand for the expansive theory that standing exists when an

organization diverts its resources in response to a defendant’s actions.

Havens was an unusual case, and this Court has been careful not to

extend the Havens holding beyond its context. So too here.

Finally, it was suggested that plaintiffs must have standing because

otherwise it may be that no one would have standing to challenge

FDA’s 2016 and 2021 actions. That suggestion fails because the Court

has long rejected that kind of argument as a basis for standing. The

“assumption” that if these plaintiffs lack “standing to sue, no one

would have standing, is not a reason to find standing.” Schlesinger v.

Reservists Comm. to Stop the War, 418 U. S. 208, 227. Rather, some

issues may be left to the political and democratic processes. Pp. 21–

24.

78 F. 4th 210, reversed and remanded.

KAVANAUGH, J., delivered the opinion for a unanimous Court. THOMAS,

J., filed a concurring opinion.

Cite as: 602 U. S. ____ (2024) 1

Opinion of the Court

NOTICE: This opinion is subject to formal revision before publication in the

United States Reports. Readers are requested to notify the Reporter of

Decisions, Supreme Court of the United States, Washington, D. C. 20543,

pio@supremecourt.gov, of any typographical or other formal errors.

SUPREME COURT OF THE UNITED STATES

_________________

Nos. 23–235 and 23–236

_________________

FOOD AND DRUG ADMINISTRATION, ET AL.,

PETITIONERS

23–235 v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.

DANCO LABORATORIES, L.L.C., PETITIONER

23–236 v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.

ON WRITS OF CERTIORARI TO THE UNITED STATES COURT OF

APPEALS FOR THE FIFTH CIRCUIT

[June 13, 2024]

JUSTICE KAVANAUGH delivered the opinion of the Court.

In 2016 and 2021, the Food and Drug Administration

relaxed its regulatory requirements for mifepristone, an

abortion drug. Those changes made it easier for doctors to

prescribe and pregnant women to obtain mifepristone.

Several pro-life doctors and associations sued FDA, arguing

that FDA’s actions violated the Administrative Procedure

Act. But the plaintiffs do not prescribe or use mifepristone.

And FDA is not requiring them to do or refrain from doing

anything. Rather, the plaintiffs want FDA to make

mifepristone more difficult for other doctors to prescribe

and for pregnant women to obtain. Under Article III of the

Constitution, a plaintiff ’s desire to make a drug less

available for others does not establish standing to sue. Nor

do the plaintiffs’ other standing theories suffice. Therefore,

the plaintiffs lack standing to challenge FDA’s actions.

2 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Opinion of the Court

I

A

Under federal law, the U. S. Food and Drug

Administration, an agency within the Executive Branch,

ensures that drugs on the market are safe and effective.

For FDA to approve a new drug, the drug sponsor (usually

the drug’s manufacturer or potential marketer) must

submit an application demonstrating that the drug is safe

and effective when used as directed. 21 U. S. C. §355(d).

The sponsor’s application must generally include proposed

labeling that specifies the drug’s dosage, how to take the

drug, and the specific conditions that the drug may treat.

21 CFR §§201.5, 314.50 (2022).

If FDA determines that additional safety requirements

are necessary, FDA may impose extra requirements on

prescription and use of the drug. 21 U. S. C. §355–1(f )(3).

For example, FDA may require that prescribers undergo

specialized training; mandate that the drug be dispensed

only in certain settings like hospitals; or direct that doctors

monitor patients taking the drug. Ibid.

In 2000, FDA approved a new drug application for

mifepristone tablets marketed under the brand name

Mifeprex. FDA approved Mifeprex for use to terminate

pregnancies, but only up to seven weeks of pregnancy. To

help ensure that Mifeprex would be used safely and

effectively, FDA placed further restrictions on the drug’s

use and distribution. For example, only doctors could

prescribe or supervise prescription of Mifeprex. Doctors

and patients also had to follow a strict regimen requiring

the patient to appear for three in-person visits with the

doctor. And FDA directed prescribing doctors to report

incidents of hospitalizations, blood transfusions, or other

serious adverse events to the drug sponsor (who, in turn,

was required to report the events to FDA).

In 2015, Mifeprex’s distributor Danco Laboratories

submitted a supplemental new drug application seeking to

Cite as: 602 U. S. ____ (2024) 3

Opinion of the Court

amend Mifeprex’s labeling and to relax some of the

restrictions that FDA had imposed. In 2016, FDA approved

the proposed changes. FDA deemed Mifeprex safe to

terminate pregnancies up to 10 weeks rather than 7 weeks.

FDA allowed healthcare providers such as nurse

practitioners to prescribe Mifeprex. And FDA approved a

dosing regimen that reduced the number of required in-

person visits from three to one—a single visit to receive

Mifeprex. In addition, FDA changed prescribers’ adverse

event reporting obligations to require prescribers to report

only fatalities—a reporting requirement that was still more

stringent than the requirements for most other drugs.

In 2019, FDA approved an application for generic

mifepristone. FDA established the same conditions of use

for generic mifepristone as for Mifeprex.

In 2021, FDA again relaxed the requirements for

Mifeprex and generic mifepristone. Relying on experience

gained during the COVID–19 pandemic about pregnant

women using mifepristone without an in-person visit to a

healthcare provider, FDA announced that it would no

longer enforce the initial in-person visit requirement.

B

Because mifepristone is used to terminate pregnancies,

FDA’s approval and regulation of mifepristone have

generated substantial controversy from the start. In 2002,

three pro-life associations submitted a joint citizen petition

asking FDA to rescind its approval of Mifeprex. FDA

denied their petition.

In 2019, two pro-life medical associations filed another

petition, this time asking FDA to withdraw its 2016

modifications to mifepristone’s conditions of use. FDA

denied that petition as well.

This case began in 2022. Four pro-life medical

associations, as well as several individual doctors, sued

FDA in the U. S. District Court for the Northern District of

4 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Opinion of the Court

Texas. Plaintiffs brought claims under the Administrative

Procedure Act. They challenged the lawfulness of FDA’s

2000 approval of Mifeprex; FDA’s 2019 approval of generic

mifepristone; and FDA’s 2016 and 2021 actions modifying

mifepristone’s conditions of use. Danco Laboratories, which

sponsors Mifeprex, intervened to defend FDA’s actions.

The plaintiffs moved for a preliminary injunction that

would require FDA to rescind approval of mifepristone or,

at the very least, to rescind FDA’s 2016 and 2021 actions.

The District Court agreed with the plaintiffs and in effect

enjoined FDA’s approval of mifepristone, thereby ordering

mifepristone off the market. 668 F. Supp. 3d 507 (ND Tex.

2023). The court first held that the plaintiffs possessed

Article III standing. It then determined that the plaintiffs

were likely to succeed on the merits of each of their claims.

Finally, the court concluded that the plaintiffs would suffer

irreparable harm from FDA’s continued approval of

mifepristone and that an injunction would serve the public

interest.

FDA and Danco promptly appealed and moved to stay the

District Court’s order pending appeal. The U. S. Court of

Appeals for the Fifth Circuit granted the stay motion in

part and temporarily reinstated FDA’s approval of

Mifeprex. 2023 WL 2913725, *21 (Apr. 12, 2023). But the

Court of Appeals declined to stay the rest of the District

Court’s order. The Court of Appeals’ partial stay would

have left Mifeprex (though not generic mifepristone) on the

market, but only under the more stringent requirements

imposed when FDA first approved Mifeprex in 2000—

available only up to seven weeks of pregnancy, only when

prescribed by doctors, and only with three in-person visits,

among other requirements.

FDA and Danco then sought a full stay in this Court.

This Court stayed the District Court’s order in its entirety

pending the disposition of FDA’s and Danco’s appeals in the

Court of Appeals and ultimate resolution by this Court. 598

Cite as: 602 U. S. ____ (2024) 5

Opinion of the Court

U. S. ___ (2023). As a result of this Court’s stay, Mifeprex

and generic mifepristone have remained available as

allowed by FDA’s relaxed 2016 and 2021 requirements.

A few months later, the Court of Appeals issued its

decision on the merits of the District Court’s order,

affirming in part and vacating in part. 78 F. 4th 210, 222–

223 (CA5 2023). The Court of Appeals first concluded that

the individual doctors and the pro-life medical associations

had standing. The Court of Appeals next concluded that

plaintiffs were not likely to succeed on their challenge to

FDA’s 2000 approval of Mifeprex and 2019 approval of

generic mifepristone. So the Court of Appeals vacated the

District Court’s order as to those agency actions. But the

Court of Appeals agreed with the District Court that

plaintiffs were likely to succeed in showing that FDA’s 2016

and 2021 actions were unlawful.

The Court of Appeals’ merits decision did not alter this

Court’s stay of the District Court’s order pending this

Court’s review. This Court then granted certiorari with

respect to the 2016 and 2021 FDA actions held unlawful by

the Court of Appeals. 601 U. S. ___ (2023).

II

The threshold question is whether the plaintiffs have

standing to sue under Article III of the Constitution.

Article III standing is a “bedrock constitutional

requirement that this Court has applied to all manner of

important disputes.” United States v. Texas, 599 U. S. 670,

675 (2023). Standing is “built on a single basic idea—the

idea of separation of powers.” Ibid. (quotation marks

omitted). Importantly, separation of powers “was not

simply an abstract generalization in the minds of the

Framers: it was woven into the document that they drafted

in Philadelphia in the summer of 1787.” TransUnion LLC

v. Ramirez, 594 U. S. 413, 422–423 (2021) (quotation marks

omitted). Therefore, we begin as always with the precise

6 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Opinion of the Court

text of the Constitution.

Article III of the Constitution confines the jurisdiction of

federal courts to “Cases” and “Controversies.” The case or

controversy requirement limits the role of the Federal

Judiciary in our system of separated powers. As this Court

explained to President George Washington in 1793 in

response to his request for a legal opinion, federal courts do

not issue advisory opinions about the law—even when

requested by the President. 13 Papers of George

Washington: Presidential Series 392 (C. Patrick ed. 2007).

Nor do federal courts operate as an open forum for citizens

“to press general complaints about the way in which

government goes about its business.” Allen v. Wright, 468

U. S. 737, 760 (1984) (quotation marks omitted); see

California v. Texas, 593 U. S. 659, 673 (2021); Valley Forge

Christian College v. Americans United for Separation of

Church and State, Inc., 454 U. S. 464, 487 (1982); United

States v. Richardson, 418 U. S. 166, 175 (1974); Ex parte

Levitt, 302 U. S. 633, 634 (1937) (per curiam);

Massachusetts v. Mellon, 262 U. S. 447, 487–488 (1923);

Fairchild v. Hughes, 258 U. S. 126, 129–130 (1922).

As Justice Scalia memorably said, Article III requires a

plaintiff to first answer a basic question: “ ‘What’s it to

you?’ ” A. Scalia, The Doctrine of Standing as an Essential

Element of the Separation of Powers, 17 Suffolk U. L. Rev.

881, 882 (1983). For a plaintiff to get in the federal

courthouse door and obtain a judicial determination of what

the governing law is, the plaintiff cannot be a mere

bystander, but instead must have a “personal stake” in the

dispute. TransUnion, 594 U. S., at 423. The requirement

that the plaintiff possess a personal stake helps ensure that

courts decide litigants’ legal rights in specific cases, as

Article III requires, and that courts do not opine on legal

issues in response to citizens who might “roam the country

in search of governmental wrongdoing.” Valley Forge, 454

U. S., at 487; see, e.g., Schlesinger v. Reservists Comm. to

Cite as: 602 U. S. ____ (2024) 7

Opinion of the Court

Stop the War, 418 U. S. 208, 227 (1974); Richardson, 418

U. S., at 175; Tyler v. Judges of Court of Registration, 179

U. S. 405, 406 (1900). Standing also “tends to assure that

the legal questions presented to the court will be resolved,

not in the rarified atmosphere of a debating society, but in

a concrete factual context conducive to a realistic

appreciation of the consequences of judicial action.” Valley

Forge, 454 U. S., at 472. Moreover, the standing doctrine

serves to protect the “autonomy” of those who are most

directly affected so that they can decide whether and how

to challenge the defendant’s action. Id., at 473.

By limiting who can sue, the standing requirement

implements “the Framers’ concept of the proper—and

properly limited—role of the courts in a democratic society.”

J. Roberts, Article III Limits on Statutory Standing, 42

Duke L. J. 1219, 1220 (1993) (quotation marks omitted). In

particular, the standing requirement means that the

federal courts decide some contested legal questions later

rather than sooner, thereby allowing issues to percolate and

potentially be resolved by the political branches in the

democratic process. See Raines v. Byrd, 521 U. S. 811, 829–

830 (1997); cf. Clapper v. Amnesty Int’l USA, 568 U. S. 398,

420–422 (2013). And the standing requirement means that

the federal courts may never need to decide some contested

legal questions: “Our system of government leaves many

crucial decisions to the political processes,” where

democratic debate can occur and a wide variety of interests

and views can be weighed. Schlesinger, 418 U. S., at 227;

see Campbell v. Clinton, 203 F. 3d 19, 23 (CADC 2000).

A

The fundamentals of standing are well-known and firmly

rooted in American constitutional law. To establish

standing, as this Court has often stated, a plaintiff must

demonstrate (i) that she has suffered or likely will suffer an

injury in fact, (ii) that the injury likely was caused or will

8 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Opinion of the Court

be caused by the defendant, and (iii) that the injury likely

would be redressed by the requested judicial relief. See

Summers v. Earth Island Institute, 555 U. S. 488, 493

(2009); Lujan v. Defenders of Wildlife, 504 U. S. 555, 560–

561 (1992). Those specific standing requirements

constitute “an essential and unchanging part of the case-or-

controversy requirement of Article III.” Id., at 560.

The second and third standing requirements—causation

and redressability—are often “flip sides of the same coin.”

Sprint Communications Co. v. APCC Services, Inc., 554

U. S. 269, 288 (2008). If a defendant’s action causes an

injury, enjoining the action or awarding damages for the

action will typically redress that injury. So the two key

questions in most standing disputes are injury in fact and

causation.1

First is injury in fact. An injury in fact must be

“concrete,” meaning that it must be real and not abstract.

See TransUnion, 594 U. S., at 424. The injury also must be

particularized; the injury must affect “the plaintiff in a

personal and individual way” and not be a generalized

grievance. Lujan, 504 U. S., at 560, n. 1. An injury in fact

can be a physical injury, a monetary injury, an injury to

one’s property, or an injury to one’s constitutional rights, to

take just a few common examples. Moreover, the injury

must be actual or imminent, not speculative—meaning that

the injury must have already occurred or be likely to occur

soon. Clapper, 568 U. S., at 409. And when a plaintiff seeks

prospective relief such as an injunction, the plaintiff must

establish a sufficient likelihood of future injury. Id., at 401.

By requiring the plaintiff to show an injury in fact, Article

——————

1 Redressability can still pose an independent bar in some cases. For

example, a plaintiff who suffers injuries caused by the government still

may not be able to sue because the case may not be of the kind

“traditionally redressable in federal court.” United States v. Texas, 599

U. S. 670, 676 (2023); cf. California v. Texas, 593 U. S. 659, 671–672

(2021).

Cite as: 602 U. S. ____ (2024) 9

Opinion of the Court

III standing screens out plaintiffs who might have only a

general legal, moral, ideological, or policy objection to a

particular government action. For example, a citizen does

not have standing to challenge a government regulation

simply because the plaintiff believes that the government

is acting illegally. See Valley Forge, 454 U. S., at 473, 487.

A citizen may not sue based only on an “asserted right to

have the Government act in accordance with law.” Allen,

468 U. S., at 754; Schlesinger, 418 U. S., at 225–227. Nor

may citizens sue merely because their legal objection is

accompanied by a strong moral, ideological, or policy

objection to a government action. See Valley Forge, 454

U. S., at 473.

The injury in fact requirement prevents the federal

courts from becoming a “vehicle for the vindication of the

value interests of concerned bystanders.” Allen, 468 U. S.,

at 756 (quotation marks omitted). An Article III court is

not a legislative assembly, a town square, or a faculty

lounge. Article III does not contemplate a system where

330 million citizens can come to federal court whenever

they believe that the government is acting contrary to the

Constitution or other federal law. See id., at 754.

Vindicating “the public interest (including the public

interest in Government observance of the Constitution and

laws) is the function of Congress and the Chief Executive.”

Lujan, 504 U. S., at 576.

In sum, to sue in federal court, a plaintiff must show that

he or she has suffered or likely will suffer an injury in fact.

Second is causation. The plaintiff must also establish

that the plaintiff ’s injury likely was caused or likely will be

caused by the defendant’s conduct.

Government regulations that require or forbid some

action by the plaintiff almost invariably satisfy both the

injury in fact and causation requirements. So in those

cases, standing is usually easy to establish. See Lujan, 504

U. S., at 561–562; see, e.g., Susan B. Anthony List v.

10 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Opinion of the Court

Driehaus, 573 U. S. 149, 162–163 (2014).

By contrast, when (as here) a plaintiff challenges the

government’s “unlawful regulation (or lack of regulation) of

someone else,” “standing is not precluded, but it is ordinarily

substantially more difficult to establish.” Lujan, 504 U. S.,

at 562 (quotation marks omitted); see Summers, 555 U. S.,

at 493. That is often because unregulated parties may have

more difficulty establishing causation—that is, linking

their asserted injuries to the government’s regulation (or

lack of regulation) of someone else. See Clapper, 568 U. S.,

at 413–414; Lujan, 504 U. S., at 562; Duke Power Co. v.

Carolina Environmental Study Group, Inc., 438 U. S. 59, 74

(1978); Simon v. Eastern Ky. Welfare Rights Organization,

426 U. S. 26, 41–46 (1976); Warth v. Seldin, 422 U. S. 490,

504–508 (1975).

When the plaintiff is an unregulated party, causation

“ordinarily hinge[s] on the response of the regulated (or

regulable) third party to the government action or

inaction—and perhaps on the response of others as well.”

Lujan, 504 U. S., at 562. Yet the Court has said that

plaintiffs attempting to show causation generally cannot

“rely on speculation about the unfettered choices made by

independent actors not before the courts.” Clapper, 568

U. S., at 415, n. 5 (quotation marks omitted); see also

Bennett v. Spear, 520 U. S. 154, 168–169 (1997). Therefore,

to thread the causation needle in those circumstances, the

plaintiff must show that the “ ‘third parties will likely react

in predictable ways’ ” that in turn will likely injure the

plaintiffs. California, 593 U. S., at 675 (quoting

Department of Commerce v. New York, 588 U. S. 752, 768

(2019)).

As this Court has explained, the “line of causation

between the illegal conduct and injury”—the “links in the

chain of causation,” Allen, 468 U. S., at 752, 759—must not

be too speculative or too attenuated, Clapper, 568 U. S., at

410–411. The causation requirement precludes speculative

Cite as: 602 U. S. ____ (2024) 11

Opinion of the Court

links—that is, where it is not sufficiently predictable how

third parties would react to government action or cause

downstream injury to plaintiffs. See Allen, 468 U. S., at

757–759; Simon, 426 U. S., at 41–46. The causation

requirement also rules out attenuated links—that is, where

the government action is so far removed from its distant

(even if predictable) ripple effects that the plaintiffs cannot

establish Article III standing. See Allen, 468 U. S., at 757–

759; cf. Department of Commerce, 588 U. S., at 768.

The causation requirement is central to Article III

standing. Like the injury in fact requirement, the causation

requirement screens out plaintiffs who were not injured by

the defendant’s action. Without the causation requirement,

courts would be “virtually continuing monitors of the

wisdom and soundness” of government action. Allen, 468

U. S., at 760 (quotation marks omitted).

Determining causation in cases involving suits by

unregulated parties against the government is admittedly

not a “mechanical exercise.” Id., at 751. That is because

the causation inquiry can be heavily fact-dependent and a

“question of degree,” as private petitioner’s counsel aptly

described it here. Tr. of Oral Arg. 50. Unfortunately,

applying the law of standing cannot be made easy, and that

is particularly true for causation. Just as causation in tort

law can pose line-drawing difficulties, so too can causation

in standing law when determining whether an unregulated

party has standing.

That said, the “absence of precise definitions” has not left

courts entirely “at sea in applying the law of standing.”

Allen, 468 U. S., at 751. Like “most legal notions, the

standing concepts have gained considerable definition from

developing case law.” Ibid. As the Court has explained, in

“many cases the standing question can be answered chiefly

by comparing the allegations of the particular complaint to

those made in prior standing cases.” Id., at 751–752.

Stated otherwise, assessing standing “in a particular case

12 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Opinion of the Court

may be facilitated by clarifying principles or even clear

rules developed in prior cases.” Id., at 752.

Consistent with that understanding of how standing

principles can develop and solidify, the Court has identified

a variety of familiar circumstances where government

regulation of a third-party individual or business may be

likely to cause injury in fact to an unregulated plaintiff. For

example, when the government regulates (or under-

regulates) a business, the regulation (or lack thereof ) may

cause downstream or upstream economic injuries to others

in the chain, such as certain manufacturers, retailers,

suppliers, competitors, or customers. E.g., National Credit

Union Admin. v. First Nat. Bank & Trust Co., 522 U. S. 479,

488, n. 4 (1998); General Motors Corp. v. Tracy, 519 U. S.

278, 286–287 (1997); Barlow v. Collins, 397 U. S. 159, 162–

164 (1970); Association of Data Processing Service

Organizations, Inc. v. Camp, 397 U. S. 150, 152 (1970).

When the government regulates parks, national forests, or

bodies of water, for example, the regulation may cause

harm to individual users. E.g., Summers, 555 U. S., at 494.

When the government regulates one property, it may

reduce the value of adjacent property. The list goes on. See,

e.g., Department of Commerce, 588 U. S., at 766–768.

As those cases illustrate, to establish causation, the

plaintiff must show a predictable chain of events leading

from the government action to the asserted injury—in other

words, that the government action has caused or likely will

cause injury in fact to the plaintiff.2

——————

2 In cases of alleged future injuries to unregulated parties from

government regulation, the causation requirement and the imminence

element of the injury in fact requirement can overlap. Both target the

same issue: Is it likely that the government’s regulation or lack of

regulation of someone else will cause a concrete and particularized injury

in fact to the unregulated plaintiff?

Cite as: 602 U. S. ____ (2024) 13

Opinion of the Court

B

Here, the plaintiff doctors and medical associations are

unregulated parties who seek to challenge FDA’s regulation

of others. Specifically, FDA’s regulations apply to doctors

prescribing mifepristone and to pregnant women taking

mifepristone. But the plaintiff doctors and medical

associations do not prescribe or use mifepristone. And FDA

has not required the plaintiffs to do anything or to refrain

from doing anything.

The plaintiffs do not allege the kinds of injuries described

above that unregulated parties sometimes can assert to

demonstrate causation. Because the plaintiffs do not

prescribe, manufacture, sell, or advertise mifepristone or

sponsor a competing drug, the plaintiffs suffer no direct

monetary injuries from FDA’s actions relaxing regulation of

mifepristone. Nor do they suffer injuries to their property,

or to the value of their property, from FDA’s actions.

Because the plaintiffs do not use mifepristone, they

obviously can suffer no physical injuries from FDA’s actions

relaxing regulation of mifepristone.

Rather, the plaintiffs say that they are pro-life, oppose

elective abortion, and have sincere legal, moral, ideological,

and policy objections to mifepristone being prescribed and

used by others. The plaintiffs appear to recognize that those

general legal, moral, ideological, and policy concerns do not

suffice on their own to confer Article III standing to sue in

federal court. So to try to establish standing, the plaintiffs

advance several complicated causation theories to connect

FDA’s actions to the plaintiffs’ alleged injuries in fact.

The first set of causation theories contends that FDA’s

relaxed regulation of mifepristone may cause downstream

conscience injuries to the individual doctor plaintiffs and

the specified members of the plaintiff medical associations,

who are also doctors. (We will refer to them collectively as

“the doctors.”) The second set of causation theories asserts

that FDA’s relaxed regulation of mifepristone may cause

14 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Opinion of the Court

downstream economic injuries to the doctors. The third set

of causation theories maintains that FDA’s relaxed

regulation of mifepristone causes injuries to the medical

associations themselves, who assert their own

organizational standing. As we will explain, none of the

theories suffices to establish Article III standing.

1

We first address the plaintiffs’ claim that FDA’s relaxed

regulation of mifepristone causes conscience injuries to the

doctors.

The doctors contend that FDA’s 2016 and 2021 actions

will cause more pregnant women to suffer complications

from mifepristone, and those women in turn will need more

emergency abortions by doctors. The plaintiff doctors say

that they therefore may be required—against their

consciences—to render emergency treatment completing

the abortions or providing other abortion-related

treatment.

The Government correctly acknowledges that a

conscience injury of that kind constitutes a concrete injury

in fact for purposes of Article III. See Tr. of Oral Arg. 11–

12; TransUnion, 594 U. S., at 425; see, e.g., Holt v. Hobbs,

574 U. S. 352 (2015). So doctors would have standing to

challenge a government action that likely would cause them

to provide medical treatment against their consciences.

But in this case—even assuming for the sake of argument

that FDA’s 2016 and 2021 changes to mifepristone’s

conditions of use cause more pregnant women to require

emergency abortions and that some women would likely

seek treatment from these plaintiff doctors—the plaintiff

doctors have not shown that they could be forced to

participate in an abortion or provide abortion-related

medical treatment over their conscience objections.

That is because, as the Government explains, federal

conscience laws definitively protect doctors from being

Cite as: 602 U. S. ____ (2024) 15

Opinion of the Court

required to perform abortions or to provide other treatment

that violates their consciences. See 42 U. S. C. §300a–

7(c)(1); see also H. R. 4366, 118th Cong., 2d Sess., Div. C,

Title II, §203 (2024). The Church Amendments, for

instance, speak clearly. They allow doctors and other

healthcare personnel to “refus[e] to perform or assist” an

abortion without punishment or discrimination from their

employers. 42 U. S. C. §300a–7(c)(1). And the Church

Amendments more broadly provide that doctors shall not be

required to provide treatment or assistance that would

violate the doctors’ religious beliefs or moral convictions.

§300a–7(d). Most if not all States have conscience laws to

the same effect. See N. Sawicki, Protections From Civil

Liability in State Abortion Conscience Laws, 322 JAMA

1918 (2019); see, e.g., Tex. Occ. Code Ann. §103.001 (West

2022).

Moreover, as the Government notes, federal conscience

protections encompass “the doctor’s beliefs rather than

particular procedures,” meaning that doctors cannot be

required to treat mifepristone complications in any way

that would violate the doctors’ consciences. Tr. of Oral Arg.

37; see §300a–7(c)(1). As the Government points out, that

strong protection for conscience remains true even in a so-

called healthcare desert, where other doctors are not

readily available. Tr. of Oral Arg. 18.

Not only as a matter of law but also as a matter of fact,

the federal conscience laws have protected pro-life doctors

ever since FDA approved mifepristone in 2000. The

plaintiffs have not identified any instances where a doctor

was required, notwithstanding conscience objections, to

perform an abortion or to provide other abortion-related

treatment that violated the doctor’s conscience. Nor is

there any evidence in the record here of hospitals overriding

or failing to accommodate doctors’ conscience objections.

In other words, none of the doctors’ declarations says

anything like the following: “Here is the treatment I

16 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Opinion of the Court

provided, here is how it violated my conscience, and here is

why the conscience protections were unavailable to me.” Cf.

App. 153–154 (Dr. Francis saw a patient suffering

complications from an abortion drug obtained from India;

no allegation that Dr. Francis helped perform an abortion);

id., at 154 (Dr. Francis witnessed another doctor perform

an abortion; no allegation that the other doctor raised

conscience objections or tried not to participate); id., at 163–

164 (doctor’s hospital treated women suffering

complications from abortion drugs; no allegation that the

doctors treating the patients had or raised conscience

objections to the treatment they provided); id., at 173–174

(doctor treated a patient suffering from mifepristone

complications; no description of what that treatment

involved and no statement that the doctor raised a

conscience objection to providing that treatment).

In response to all of that, the doctors still express fear

that another federal law, the Emergency Medical

Treatment and Labor Act or EMTALA, might be

interpreted to override those federal conscience laws and to

require individual emergency room doctors to participate in

emergency abortions in some circumstances. See 42

U. S. C. §1395dd. But the Government has disclaimed that

reading of EMTALA. And we agree with the Government’s

view of EMTALA on that point. EMTALA does not require

doctors to perform abortions or provide abortion-related

medical treatment over their conscience objections because

EMTALA does not impose obligations on individual doctors.

See Brief for United States 23, n. 3. As the Solicitor

General succinctly and correctly stated, EMTALA does not

“override an individual doctor’s conscience objections.” Tr.

of Oral Arg. 18; see also Tr. of Oral Arg. in Moyle v. United

States, O. T. 2023, No. 23–726 etc., pp. 88–91 (Moyle Tr.).

We agree with the Solicitor General’s representation that

federal conscience protections provide “broad coverage” and

will “shield a doctor who doesn’t want to provide care in

Cite as: 602 U. S. ____ (2024) 17

Opinion of the Court

violation of those protections.” Tr. of Oral Arg. 18, 36.

The doctors say, however, that emergency room doctors

summoned to provide emergency treatment may not have

time to invoke federal conscience protections. But as the

Government correctly explained, doctors need not follow a

time-intensive procedure to invoke federal conscience

protections. Reply Brief for United States 5. A doctor may

simply refuse; federal law protects doctors from

repercussions when they have “refused” to participate in an

abortion. §300a–7(c)(1); Reply Brief for United States 5.

And as the Government states, “[h]ospitals must

accommodate doctors in emergency rooms no less than in

other contexts.” Ibid. For that reason, hospitals and

doctors typically try to plan ahead for how to deal with a

doctor’s absence due to conscience objections. Tr. of Oral

Arg. 18; Moyle Tr. 89–90. And again, nothing in the record

since 2000 supports plaintiffs’ speculation that doctors will

be unable to successfully invoke federal conscience

protections in emergency circumstances.

In short, given the broad and comprehensive conscience

protections guaranteed by federal law, the plaintiffs have

not shown—and cannot show—that FDA’s actions will

cause them to suffer any conscience injury. Federal law

fully protects doctors against being required to provide

abortions or other medical treatment against their

consciences—and therefore breaks any chain of causation

between FDA’s relaxed regulation of mifepristone and any

asserted conscience injuries to the doctors.3

——————

3 The doctors also suggest that they are distressed by others’ use of

mifepristone and by emergency abortions. It is not clear that this alleged

injury is distinct from the alleged conscience injury. But even if it is, this

Court has long made clear that distress at or disagreement with the

activities of others is not a basis under Article III for a plaintiff to bring

a federal lawsuit challenging the legality of a government regulation

allowing those activities. See, e.g., Valley Forge Christian College v.

Americans United for Separation of Church and State, Inc., 454 U. S.

464, 473, 485–486 (1982); United States v. Richardson, 418 U. S. 166,

18 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Opinion of the Court

2

In addition to alleging conscience injuries, the doctors cite

various monetary and related injuries that they allegedly

will suffer as a result of FDA’s actions—in particular,

diverting resources and time from other patients to treat

patients with mifepristone complications; increasing risk of

liability suits from treating those patients; and potentially

increasing insurance costs.

Those standing allegations suffer from the same

problem—a lack of causation. The causal link between

FDA’s regulatory actions and those alleged injuries is too

speculative or otherwise too attenuated to establish

standing.

To begin with, the claim that the doctors will incur those

injuries as a result of FDA’s 2016 and 2021 relaxed

regulations lacks record support and is highly speculative.

The doctors have not offered evidence tending to suggest

that FDA’s deregulatory actions have both caused an

increase in the number of pregnant women seeking

treatment from the plaintiff doctors and caused a resulting

diversion of the doctors’ time and resources from other

patients. Moreover, the doctors have not identified any

instances in the past where they have been sued or required

to pay higher insurance costs because they have treated

pregnant women suffering mifepristone complications. Nor

have the plaintiffs offered any persuasive evidence or

reason to believe that the future will be different.

In any event, and perhaps more to the point, the law has

never permitted doctors to challenge the government’s

loosening of general public safety requirements simply

because more individuals might then show up at emergency

rooms or in doctors’ offices with follow-on injuries. Stated

otherwise, there is no Article III doctrine of “doctor

standing” that allows doctors to challenge general

——————

175 (1974); Sierra Club v. Morton, 405 U. S. 727, 739 (1972).

Cite as: 602 U. S. ____ (2024) 19

Opinion of the Court

government safety regulations. Nor will this Court now

create such a novel standing doctrine out of whole cloth.

Consider some examples. EPA rolls back emissions

standards for power plants—does a doctor have standing to

sue because she may need to spend more time treating

asthma patients? A local school district starts a middle

school football league—does a pediatrician have standing to

challenge its constitutionality because she might need to

spend more time treating concussions? A federal agency

increases a speed limit from 65 to 80 miles per hour—does

an emergency room doctor have standing to sue because he

may have to treat more car accident victims? The

government repeals certain restrictions on guns—does a

surgeon have standing to sue because he might have to

operate on more gunshot victims?

The answer is no: The chain of causation is simply too

attenuated. Allowing doctors or other healthcare providers

to challenge general safety regulations as unlawfully lax

would be an unprecedented and limitless approach and

would allow doctors to sue in federal court to challenge

almost any policy affecting public health.4

And in the FDA drug-approval context, virtually all drugs

come with complications, risks, and side effects. Some

drugs increase the risk of heart attack, some may cause

cancer, some may cause birth defects, and some heighten

the possibility of stroke. Approval of a new drug may

therefore yield more visits to doctors to treat complications

or side effects. So the plaintiffs’ loose approach to causation

would also essentially allow any doctor or healthcare

provider to challenge any FDA decision approving a new

drug. But doctors have never had standing to challenge

FDA’s drug approvals simply on the theory that use of the

——————

4 A safety law regulating hospitals or the doctors’ medical practices

obviously would present a different issue—either such a law would

directly regulate doctors, or the causal link at least would be

substantially less attenuated.

20 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Opinion of the Court

drugs by others may cause more visits to doctors.

And if we were now to invent a new doctrine of doctor

standing, there would be no principled way to cabin such a

sweeping doctrinal change to doctors or other healthcare

providers. Firefighters could sue to object to relaxed

building codes that increase fire risks. Police officers could

sue to challenge a government decision to legalize certain

activities that are associated with increased crime.

Teachers in border states could sue to challenge allegedly

lax immigration policies that lead to overcrowded

classrooms.

We decline to start the Federal Judiciary down that

uncharted path. That path would seemingly not end until

virtually every citizen had standing to challenge virtually

every government action that they do not like—an approach

to standing that this Court has consistently rejected as

flatly inconsistent with Article III.

We recognize that many citizens, including the plaintiff

doctors here, have sincere concerns about and objections to

others using mifepristone and obtaining abortions. But

citizens and doctors do not have standing to sue simply

because others are allowed to engage in certain activities—

at least without the plaintiffs demonstrating how they

would be injured by the government’s alleged under-

regulation of others. See Coalition for Mercury-Free Drugs

v. Sebelius, 671 F. 3d 1275, 1277 (CADC 2012). Citizens

and doctors who object to what the law allows others to do

may always take their concerns to the Executive and

Legislative Branches and seek greater regulatory or

legislative restrictions on certain activities.

In sum, the doctors in this case have failed to establish

Article III standing. The doctors have not shown that

FDA’s actions likely will cause them any injury in fact. The

asserted causal link is simply too speculative or too

Cite as: 602 U. S. ____ (2024) 21

Opinion of the Court

attenuated to support Article III standing.5

3

That leaves the medical associations’ argument that the

associations themselves have organizational standing.

Under this Court’s precedents, organizations may have

standing “to sue on their own behalf for injuries they have

sustained.” Havens Realty Corp. v. Coleman, 455 U. S. 363,

379, n. 19 (1982). In doing so, however, organizations must

satisfy the usual standards for injury in fact, causation, and

redressability that apply to individuals. Id., at 378–379.

According to the medical associations, FDA has

“impaired” their “ability to provide services and achieve

their organizational missions.” Brief for Respondents 43.

That argument does not work to demonstrate standing.

Like an individual, an organization may not establish

standing simply based on the “intensity of the litigant’s

interest” or because of strong opposition to the

government’s conduct, Valley Forge, 454 U. S., at 486, “no

matter how longstanding the interest and no matter how

qualified the organization,” Sierra Club v. Morton, 405

U. S. 727, 739 (1972). A plaintiff must show “far more than

simply a setback to the organization’s abstract social

interests.” Havens, 455 U. S., at 379. The plaintiff

——————

5 The doctors also suggest that they can sue in a representative

capacity to vindicate their patients’ injuries or potential future injuries,

even if the doctors have not suffered and would not suffer an injury

themselves. This Court has repeatedly rejected such arguments. Under

this Court’s precedents, third-party standing, as some have called it,

allows a narrow class of litigants to assert the legal rights of others. See

Hollingsworth v. Perry, 570 U. S. 693, 708 (2013). But “even when we

have allowed litigants to assert the interests of others, the litigants

themselves still must have suffered an injury in fact, thus giving them a

sufficiently concrete interest in the outcome of the issue in dispute.” Ibid.

(quotation marks and alterations omitted). The third-party standing

doctrine does not allow doctors to shoehorn themselves into Article III

standing simply by showing that their patients have suffered injuries or

may suffer future injuries.

22 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Opinion of the Court

associations therefore cannot assert standing simply

because they object to FDA’s actions.

The medical associations say that they have

demonstrated something more here. They claim to have

standing not based on their mere disagreement with FDA’s

policies, but based on their incurring costs to oppose FDA’s

actions. They say that FDA has “caused” the associations

to conduct their own studies on mifepristone so that the

associations can better inform their members and the

public about mifepristone’s risks. Brief for Respondents 43.

They contend that FDA has “forced” the associations to

“expend considerable time, energy, and resources” drafting

citizen petitions to FDA, as well as engaging in public

advocacy and public education. Id., at 44 (quotation marks

omitted). And all of that has caused the associations to

spend “considerable resources” to the detriment of other

spending priorities. Ibid.

But an organization that has not suffered a concrete

injury caused by a defendant’s action cannot spend its way

into standing simply by expending money to gather

information and advocate against the defendant’s action.

An organization cannot manufacture its own standing in

that way.

The medical associations respond that under Havens

Realty Corp. v. Coleman, standing exists when an

organization diverts its resources in response to a

defendant’s actions. 455 U. S. 363. That is incorrect.

Indeed, that theory would mean that all the organizations

in America would have standing to challenge almost every

federal policy that they dislike, provided they spend a single

dollar opposing those policies. Havens does not support

such an expansive theory of standing.

The relevant question in Havens was whether a housing

counseling organization, HOME, had standing to bring a

claim under the Fair Housing Act against Havens Realty,

which owned and operated apartment complexes. Id., at

Cite as: 602 U. S. ____ (2024) 23

Opinion of the Court

368, 378. Havens had provided HOME’s black employees

false information about apartment availability—a practice

known as racial steering. Id., at 366, and n. 1, 368.

Critically, HOME not only was an issue-advocacy

organization, but also operated a housing counseling

service. Id., at 368. And when Havens gave HOME’s

employees false information about apartment availability,

HOME sued Havens because Havens “perceptibly impaired

HOME’s ability to provide counseling and referral services

for low- and moderate-income homeseekers.” Id., at 379. In

other words, Havens’s actions directly affected and

interfered with HOME’s core business activities—not

dissimilar to a retailer who sues a manufacturer for selling

defective goods to the retailer.

That is not the kind of injury that the medical

associations have alleged here. FDA’s actions relaxing

regulation of mifepristone have not imposed any similar

impediment to the medical associations’ advocacy

businesses.

At most, the medical associations suggest that FDA is not

properly collecting and disseminating information about

mifepristone, which the associations say in turn makes it

more difficult for them to inform the public about safety

risks. But the associations have not claimed an

informational injury, and in any event the associations

have not suggested that federal law requires FDA to

disseminate such information upon request by members of

the public. Cf. Federal Election Comm’n v. Akins, 524 U. S.

11 (1998).

Havens was an unusual case, and this Court has been

careful not to extend the Havens holding beyond its context.

So too here.

Finally, it has been suggested that the plaintiffs here

must have standing because if these plaintiffs do not have

standing, then it may be that no one would have standing

to challenge FDA’s 2016 and 2021 actions. For starters, it

24 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

Opinion of the Court

is not clear that no one else would have standing to

challenge FDA’s relaxed regulation of mifepristone. But

even if no one would have standing, this Court has long

rejected that kind of “if not us, who?” argument as a basis

for standing. See Clapper, 568 U. S., at 420–421; Valley

Forge, 454 U. S., at 489; Richardson, 418 U. S., at 179–180.

The “assumption” that if these plaintiffs lack “standing to

sue, no one would have standing, is not a reason to find

standing.” Schlesinger, 418 U. S., at 227. Rather, some

issues may be left to the political and democratic processes:

The Framers of the Constitution did not “set up something

in the nature of an Athenian democracy or a New England

town meeting to oversee the conduct of the National

Government by means of lawsuits in federal courts.”

Richardson, 418 U. S., at 179; see Texas, 599 U. S., at 685.

* * *

The plaintiffs have sincere legal, moral, ideological, and

policy objections to elective abortion and to FDA’s relaxed

regulation of mifepristone. But under Article III of the

Constitution, those kinds of objections alone do not

establish a justiciable case or controversy in federal court.

Here, the plaintiffs have failed to demonstrate that FDA’s

relaxed regulatory requirements likely would cause them to

suffer an injury in fact. For that reason, the federal courts

are the wrong forum for addressing the plaintiffs’ concerns

about FDA’s actions. The plaintiffs may present their

concerns and objections to the President and FDA in the

regulatory process, or to Congress and the President in the

legislative process. And they may also express their views

about abortion and mifepristone to fellow citizens,

including in the political and electoral processes.

“No principle is more fundamental to the judiciary’s

proper role in our system of government than the

constitutional limitation of federal-court jurisdiction to

actual cases or controversies.” Simon, 426 U. S., at 37. We

reverse the judgment of the U. S. Court of Appeals for the

Cite as: 602 U. S. ____ (2024) 25

Opinion of the Court

Fifth Circuit and remand the case for further proceedings

consistent with this opinion.

It is so ordered.

Cite as: 602 U. S. ____ (2024) 1

THOMAS, J., concurring

SUPREME COURT OF THE UNITED STATES

_________________

Nos. 23–235 and 23–236

_________________

FOOD AND DRUG ADMINISTRATION, ET AL.,

PETITIONER

23–235 v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.

DANCO LABORATORIES, L.L.C., PETITIONER

23–236 v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.

ON WRITS OF CERTIORARI TO THE UNITED STATES COURT OF

APPEALS FOR THE FIFTH CIRCUIT

[June 13, 2024]

JUSTICE THOMAS, concurring.

I join the Court’s opinion in full because it correctly ap-

plies our precedents to conclude that the Alliance for Hip-

pocratic Medicine and other plaintiffs lack standing. Our

precedents require a plaintiff to demonstrate that the de-

fendant’s challenged actions caused his asserted injuries.

And, the Court aptly explains why plaintiffs have failed to

establish that the Food and Drug Administration’s changes

to the regulation of mifepristone injured them. Ante, at 13–

24.

The Court also rejects the plaintiff doctors’ theory that

they have third-party standing to assert the rights of their

patients. Ante, at 21, n. 5. Our third-party standing prec-

edents allow a plaintiff to assert the rights of another per-

son when the plaintiff has a “close relationship with the

person who possesses the right” and “there is a hindrance

to the possessor’s ability to protect his own interests.” Kow-

2 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

THOMAS, J., concurring

alski v. Tesmer, 543 U. S. 125, 130 (2004) (internal quota-

tion marks omitted). Applying these precedents, the Court

explains that the doctors cannot establish third-party

standing to sue for violations of their patients’ rights with-

out showing an injury of their own. Ante, at 21, n. 5. But,

there is a far simpler reason to reject this theory: Our third-

party standing doctrine is mistaken. As I have previously

explained, a plaintiff cannot establish an Article III case or

controversy by asserting another person’s rights.1 See June

Medical Services L. L. C. v. Russo, 591 U. S. 299, 366 (2020)

(THOMAS, J., dissenting); Kowalski, 543 U. S., at 135

(THOMAS, J., concurring). So, just as abortionists lack

standing to assert the rights of their clients, doctors who

oppose abortion cannot vicariously assert the rights of their

patients.

I write separately to highlight what appear to be similar

problems with another theory of standing asserted in this

suit. The Alliance and other plaintiff associations claim

that they have associational standing to sue for their mem-

bers’ injuries.2 Under the Court’s precedents, “an associa-

tion has standing to bring suit on behalf of its members

when: (a) its members would otherwise have standing to

sue in their own right; (b) the interests it seeks to protect

are germane to the organization’s purpose; and (c) neither

the claim asserted nor the relief requested requires the par-

ticipation of individual members in the lawsuit.” Hunt v.

Washington State Apple Advertising Comm’n, 432 U. S.

——————

1 Certain forms of standing that may be representational in a general

sense, such as next friend standing, are “not inconsistent with this

point.” June Medical Services, L. L. C. v. Russo, 591 U. S. 299, 365, n. 2

(2020) (THOMAS, J., dissenting).

2 By “associational standing,” I do not refer to standing premised upon

an association’s own alleged injuries. Instead, I refer to the doctrine that

permits a plaintiff association to assert the rights of its members. See

Warth v. Seldin, 422 U. S. 490, 511 (1975).

Cite as: 602 U. S. ____ (2024) 3

THOMAS, J., concurring

333, 343 (1977). If an association can satisfy these require-

ments, we allow the association to pursue its members’

claims, without joining those members as parties to the

suit.

Associational standing, however, is simply another form

of third-party standing. And, the Court has never ex-

plained or justified either doctrine’s expansion of Article III

standing. In an appropriate case, we should explain just

how the Constitution permits associational standing.

I

Associational standing raises constitutional concerns by

relaxing both the injury and redressability requirements

for Article III standing. It also upsets other legal doctrines.

First, associational standing conflicts with Article III by

permitting an association to assert its members’ injuries in-

stead of its own. The “judicial power” conferred by Article

III “is limited to cases and controversies of the sort tradi-

tionally amenable to, and resolved by, the judicial process.”

See June Medical, 591 U. S., at 364 (opinion of THOMAS, J.)

(internal quotation marks omitted). “[T]o ascertain the

scope of Article III’s case-or-controversy requirement,”

courts therefore “refer directly to the traditional, funda-

mental limitations upon the powers of common-law courts.”

Ibid. (internal quotation marks omitted). Traditionally, a

plaintiff had to show a violation of his own rights to have

his claim considered by a common-law court. See id., at

364–366. So, “private parties could not bring suit to vindi-

cate the constitutional [or other legal] rights of individuals

who are not before the Court.” Id., at 359. “After all, ‘[t]he

province of the court is, solely, to decide on the rights of in-

dividuals,’ ” not to answer legal debates in the abstract.

Acheson Hotels, LLC v. Laufer, 601 U. S. 1, 10 (2023)

(THOMAS, J., concurring in judgment) (quoting Marbury v.

Madison, 1 Cranch 137, 170 (1803)); see also ante, at 5–7.

Associational standing seems to run roughshod over this

4 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

THOMAS, J., concurring

traditional understanding of the judicial power. Our doc-

trine permits an association to have standing based purely

upon a member’s injury, not its own. If a single member of

an association has suffered an injury, our doctrine permits

that association to seek relief for its entire membership—

even if the association has tens of millions of other, non-

injured members. See Brief for Professor F. Andrew

Hessick as Amicus Curiae 28 (explaining that, among other

associations, the American Association of Retired People’s

“potential standing is staggering” because our doctrine per-

mits it to “sue to redress” the injury of a single member out

of its “almost thirty-eight million members”). As I have al-

ready explained in the context of third-party standing, Ar-

ticle III does not allow a plaintiff to seek to vindicate some-

one else’s injuries. See June Medical, 591 U. S., at 364–366

(opinion of THOMAS, J.); Kowalski, 543 U. S., at 135 (opin-

ion of THOMAS, J.). It is difficult to see why that logic

should not apply with equal force to an association as to any

other plaintiff. I thus have serious doubts that an associa-

tion can have standing to vicariously assert a member’s in-

jury.

The Alliance’s attempted use of our associational-stand-

ing doctrine illustrates how far we have strayed from the

traditional rule that plaintiffs must assert only their own

injuries. The Alliance is an association whose members are

other associations. See 1 App. 9–10. None of its members

are doctors. Instead, the Alliance seeks to have associa-

tional standing based on injuries to the doctors who are

members of its member associations. Thus, the allegedly

injured parties—the doctors—are two degrees removed

from the party before us pursuing those injuries.

Second, our associational-standing doctrine does not ap-

pear to comport with the requirement that the plaintiff pre-

sent an injury that the court can redress. For a plaintiff to

have standing, a court must be able to “provid[e] a remedy

that can redress the plaintiff ’s injury.” Uzuegbunam v.

Cite as: 602 U. S. ____ (2024) 5

THOMAS, J., concurring

Preczewski, 592 U. S. 279, 291 (2021) (emphasis added).

But, as explained, associational standing creates a mis-

match: Although the association is the plaintiff in the suit,

it has no injury to redress. The party who needs the rem-

edy—the injured member—is not before the court. Without

such members as parties to the suit, it is questionable

whether “relief to these nonparties . . . exceed[s] constitu-

tional bounds.” Association of American Physicians & Sur-

geons v. FDA, 13 F. 4th 531, 540 (CA6 2021); see also De-

partment of Homeland Security v. New York, 589 U. S. ___,

___ (2020) (GORSUCH, J., concurring in grant of stay) (ex-

plaining that remedies “are meant to redress the injuries

sustained by a particular plaintiff in a particular lawsuit”);

Brief for Professor F. Andrew Hessick as Amicus Curiae 18

(“A bedrock principle of the Anglo-American legal system

was that the right to a remedy for an injury was personal”).

Consider the remedial problem when an association

seeks an injunction, as the Alliance did here. See 1 App.

113. “We have long held” that our equity jurisdiction is lim-

ited to “the jurisdiction in equity exercised by the High

Court of Chancery in England at the time of the adoption of

the Constitution.” Grupo Mexicano de Desarrollo, S. A. v.

Alliance Bond Fund, Inc., 527 U. S. 308, 318 (1999). And,

“as a general rule, American courts of equity did not provide

relief beyond the parties to the case.” Trump v. Hawaii, 585

U. S. 667, 717 (2018) (THOMAS, J., concurring). For associ-

ations, that principle would mean that the relief could not

extend beyond the association. But, if a court entered “[a]n

injunction that bars a defendant from enforcing a law or

regulation against the specific party before the court—the

associational plaintiff—[it would] not satisfy Article III be-

cause it w[ould] not redress an injury.” Association of Amer-

6 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

THOMAS, J., concurring

ican Physicians & Surgeons, 13 F. 4th, at 540 (internal quo-

tation marks omitted).3

Our precedents have provided a workaround for this ob-

vious remedial problem through the invention of the so-

called “universal injunction.” Universal injunctions typi-

cally “prohibit the Government from enforcing a policy with

respect to anyone.” Trump, 585 U. S., at 713, n. 1

(THOMAS, J., concurring). By providing relief beyond the

parties to the case, this remedy is “legally and historically

dubious.” Id., at 721; see also Labrador v. Poe, 601 U. S.

___, ___–___ (2024) (slip op., at 4–5) (GORSUCH, J., concur-

ring in grant of stay). It seems no coincidence that associa-

tional standing’s “emergence in the 1960s overlaps with the

emergence of [this] remedial phenomenon” of a similarly

questionable nature. Association of American Physicians &

Surgeons, 13 F. 4th, at 541. Because no party should be

permitted to obtain an injunction in favor of nonparties, I

have difficulty seeing why an association should be permit-

ted to do so for its members. Associational standing thus

seems to distort our traditional understanding of the judi-

cial power.

In addition to these Article III concerns, there is tension

between associational standing and other areas of law.

First, the availability of associational standing subverts the

class-action mechanism. A class action allows a named

plaintiff to represent others with similar injuries, but it is

subject to the many requirements of Federal Rule of Civil

Procedure 23. Associational standing achieves that same

——————

3 This also raises the question of who should pick the remedy. Associ-

ations “may have very different interests from the individuals whose

rights they are raising.” Kowalski v. Tesmer, 543 U. S. 125, 135 (2004)

(THOMAS, J., concurring). For example, an association might prefer an

injunction preventing the enforcement of a law that harms its members,

while an injured member may instead want damages to compensate him

for his injuries. Or perhaps a member would wish to settle the litigation,

whereas an association might want to continue the fight. Our associa-

tional-standing doctrine ignores these obvious concerns.

Cite as: 602 U. S. ____ (2024) 7

THOMAS, J., concurring

end goal: One lawsuit can provide relief to a large group of

people. “As compared to a class action,” however, associa-

tional standing seems to require “show[ing] an injury to

only a single member,” and the association “need not show

that litigation by representation is superior to individual

litigation.” 13A C. Wright, A. Miller, & E. Cooper, Federal

Practice and Procedure §3531.9.5, pp. 879–880 (3d ed.,

Supp. 2023); see also Fed. Rule Civ. Proc. 23(a). Associa-

tional standing thus allows a party to effectively bring a

class action without satisfying any of the ordinary require-

ments. Second, associational standing creates the possibil-

ity of asymmetrical preclusion. The basic idea behind pre-

clusion is that a party gets only one bite at the apple. If a

party litigates and loses an issue or claim, it can be barred

from reasserting that same issue or claim in another suit.

In general, preclusion prevents the relitigation of claims or

issues only by a party to a previous action, and we have

been careful to limit the exceptions to that rule. See Taylor

v. Sturgell, 553 U. S. 880, 892–893 (2008). In the context of

associational standing, the general rule would mean that

preclusion applies only to the association, even though the

purpose of the association’s suit is to assert the injuries of

its members. See id., at 893–896. But, if the association

loses, it is not clear whether the adverse judgment would

bind the members. See Automobile Workers v. Brock, 477

U. S. 274, 290 (1986) (suggesting that, if an association fails

to adequately represent its members, “a judgment won

against it might not preclude subsequent claims by the as-

sociation’s members without offending due process princi-

ples”). Associational standing might allow a member two

bites at the apple—after an association’s claims are re-

jected, the underlying members might be able to assert the

exact same issues or claims in a suit in their own names.

In short, our associational-standing doctrine appears to

create serious problems, both constitutional and otherwise.

8 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

THOMAS, J., concurring

II

I am particularly doubtful of associational-standing doc-

trine because the Court has never attempted to reconcile it

with the traditional understanding of the judicial power.

Instead, the Court departed from that traditional under-

standing without explanation, seemingly by accident. To

date, the Court has provided only practical reasons for its

doctrine.

For over a century and a half, the Court did not have a

separate standing doctrine for associations. As far as I can

tell, the Court did not expressly contemplate such a doc-

trine until the late 1950s. In NAACP v. Alabama ex rel.

Patterson, 357 U. S. 449 (1958), the Court permitted an as-

sociation to assert the constitutional rights of its members

to prevent the disclosure of its membership lists. While the

Court allowed the NAACP to raise a challenge on behalf of

its members, it also acknowledged that the NAACP had ar-

guably faced an injury of its own. Id., at 459–460. The

Court, however, soon discarded any notion that an associa-

tion needed to have its own injury, creating our modern as-

sociational-standing doctrine. In National Motor Freight

Traffic Assn., Inc. v. United States, 372 U. S. 246 (1963) (per

curiam), the Court suggested that an uninjured industry

group had standing to challenge a tariff schedule on behalf

of its members. Id., at 247. The Court offered no explana-

tion for how that theory of standing comported with the tra-

ditional understanding of the judicial power. In fact, the

Court’s entire analysis consisted of a one-paragraph order

denying rehearing. Since then, however, the Court has par-

roted that “[e]ven in the absence of injury to itself, an asso-

ciation may have standing solely as the representative of its

members.” Warth v. Seldin, 422 U. S. 490, 511 (1975) (em-

phasis added; citing National Motor Freight Traffic Assn.,

372 U. S. 246); see also, e.g., Automobile Workers, 477 U. S.,

at 281. The Court has gone so far as to hold that a state

Cite as: 602 U. S. ____ (2024) 9

THOMAS, J., concurring

agency—not a membership organization at all—had associ-

ational standing to “asser[t] the claims of the Washington

apple growers and dealers who form its constituency.”

Hunt, 432 U. S., at 344.

Despite its continued reliance on associational standing,

the Court has yet to explain how the doctrine comports with

Article III. When once asked to “reconsider and reject the

principles of associational standing” in favor of the class-

action mechanism, the Court justified the doctrine solely by

reference to its “special features, advantageous both to the

individuals represented and to the judicial system as a

whole.” Automobile Workers, 477 U. S., at 288–289. Those

“special features” included an association’s “pre-existing

reservoir of expertise and capital,” and the fact that people

often join an association “to create an effective vehicle for

vindicating interests that they share with others.” Id., at

289–290. But, considerations of practical judicial policy

cannot overcome the Constitution’s mandates. The lack of

any identifiable justification further suggests that the

Court should reconsider its associational-standing doctrine.

* * *

No party challenges our associational-standing doctrine

today. That is understandable; the Court consistently ap-

plies the doctrine, discussing only the finer points of its op-

eration. See, e.g., Students for Fair Admissions, Inc. v.

President and Fellows of Harvard College, 600 U. S. 181,

199–201 (2023). In this suit, rejecting our associational-

standing doctrine is not necessary to conclude that the

plaintiffs lack standing. In an appropriate case, however,

the Court should address whether associational standing

can be squared with Article III’s requirement that courts

respect the bounds of their judicial power.