Amicus Curiae Brief — Food and Drug Administration, et al., Petitioners v. Alliance for Hippocratic Medicine, et al.

Nos. 23-235 and 23-236

IN THE

Supreme Court of the United States

————

FOOD AND DRUG ADMINISTRATION, ET AL.,

Petitioners,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

DANCO LABORATORIES, L.L.C.,

Petitioner,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

On Writs of Certiorari to the United States

Court of Appeals for the Fifth Circuit

BRIEF FOR THE STATE OF MISSISSIPPI

AND 21 OTHER STATES AS AMICI CURIAE

IN SUPPORT OF RESPONDENTS

LYNN FITCH

Attorney General

WHITNEY H. LIPSCOMB

Deputy Attorney General

SCOTT G. STEWART

Solicitor General

Counsel of Record

JUSTIN L. MATHENY

ANTHONY M. SHULTS

Deputy Solicitors General

MISSISSIPPI ATTORNEY

GENERAL’S OFFICE

P.O. Box 220

Jackson, MS 39205-0220

scott.stewart@ago.ms.gov

(601) 359-3680

Counsel for Amici Curiae

TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES ..................................... iii

INTRODUCTION AND INTEREST OF AMICI

CURIAE .......................................................................1

SUMMARY OF ARGUMENT.....................................3

ARGUMENT ...............................................................4

I.

When Agency Action Pushes Constitutional

Boundaries, Judicial Review Of That Action Is

Searching—Not Deferential ...............................4

A. The Constitution Establishes A Limited

Federal Government And Leaves Power

With—And Accountable To—The People .....4

B. Federal Agencies Present Special Dangers To

The Constitutional Design ............................6

C. Because Agencies Present Special Dangers,

This Court Has Been Searching—Not

Deferential—In Reviewing Agency Action

That Pushes Constitutional Boundaries ......9

II.

The FDA’s Actions Push Constitutional

Boundaries And Thus Warrant Searching

Judicial Review .................................................12

A. The FDA’s Actions Undercut The Separation

Of Powers .....................................................12

B. The FDA’s Actions Erode Federalism .........14

ii

C. The FDA’s Actions Rob From The People

Decisions Of Great Importance ...................17

CONCLUSION ..........................................................19

iii

TABLE OF AUTHORITIES

Page(s)

Cases

Alabama Ass’n of Realtors v. HHS,

141 S. Ct. 2485 (2021) (per curiam)

.......................................................... 7, 8, 10, 11, 17

Bond v. United States,

564 U.S. 211 (2011) ................................................5

Bowsher v. Synar,

478 U.S. 714 (1986) ........................................4, 5, 8

Dobbs v. Jackson Women’s Health Organization,

142 S. Ct. 2228 (2022)........................ 13, 15, 17, 19

FDA v. Brown & Williamson Tobacco Corp.,

529 U.S. 120 (2000) ..............................................10

Free Enterprise Fund v. PCAOB,

537 F.3d 667 (D.C. Cir. 2008) ................................7

Free Enterprise Fund v. PCAOB,

561 U.S. 477 (2010) ...................................... 6-9, 18

Freytag v. Commissioner,

501 U.S. 868 (1991) ................................................6

Gonzales v. Oregon,

546 U.S. 243 (2006) .................. 8, 11, 12, 14, 17, 18

Gregory v. Ashcroft,

501 U.S. 452 (1991) ............................ 5, 6, 8, 11, 16

Hillsborough County v.

Automated Medical Laboratories, Inc.,

471 U.S. 707 (1985) ..............................................14

INS v. Chadha,

462 U.S. 919 (1983) ...................................... 4-7, 14

iv

New York v. United States,

505 U.S. 144 (1992) .................................... 5, 6, 8, 9

NFIB v. OSHA,

142 S. Ct. 661 (2022) (per curiam) ...... 9, 10, 11, 14

Planned Parenthood of Southeastern

Pennsylvania v. Casey,

505 U.S. 833 (1992) ..............................................13

Roe v. Wade,

410 U.S. 113 (1973) ..............................................18

Solid Waste Agency of Northern Cook County v.

U.S. Army Corps of Engineers,

531 U.S. 159 (2001) ..............................................11

Utility Air Regulatory Group v. EPA,

573 U.S. 302 (2014) ..............................................10

West Virginia v. EPA,

142 S. Ct. 2587 (2022).......................... 9, 10, 12, 14

Youngstown Sheet & Tube Co. v. Sawyer,

343 U.S. 579 (1952) ................................................5

Constitutional Provisions

U.S. Const. art. I, § 7...................................................6

U.S. Const. amend. X ..................................................6

Statutes

18 U.S.C. § 1461 ........................................................13

18 U.S.C. § 1462 ........................................................14

18 U.S.C. § 1531 ........................................................13

136 Stat. 49 (2022) ....................................................13

Ind. Code Ann. § 16-34-2-1 .......................................15

v

Miss. Code Ann. § 41-41-45 ................................15, 16

Miss. Code Ann. § 41-41-103 ....................................15

Miss. Code Ann. § 41-41-107 ....................................15

Okla. Stat. Ann. tit. 63, § 1-729.1 .............................15

Tex. Health & Safety Code Ann. § 171.063..............15

Other Authorities

Abortion Justice Act of 2023,

H.R. 4303, 118th Cong. (2023) ...........................13

Alice Miranda Ollstein & Lauren Gardner,

Retail Pharmacies Can Now Offer

Abortion Pill, FDA Says,

Politico (Jan. 3, 2023) ..........................................16

Caroline Kitchener,

Blue-State Doctors Launch Abortion Pill

Pipeline Into States With Bans,

Wash. Post (July 19, 2023) ..................................16

John Hart Ely,

Democracy and Distrust (1980).............................8

Jonathan H. Adler & Christopher J. Walker,

Delegation and Time,

105 Iowa L. Rev. 1931 (2020) ................................7

Pam Belluck,

More Women Who Are Not Pregnant Are

Ordering Abortion Pills Just in Case,

N.Y. Times (Jan. 2, 2024) ....................................16

Ronald A. Cass,

Rulemaking Then and Now:

From Management to Lawmaking,

28 Geo. Mason L. Rev. 683 (2021) .........................7

vi

States Choose Life Act of 2023,

H.R. 4414, 118th Cong. (2023) ............................13

The Federalist No. 47

(James Madison) ................................................ 4-5

Women’s Health Protection Act of 2023,

S. 701, 118th Cong. (2023)...................................13

Women’s Public Health and Safety Act,

S. 471, 118th Cong. (2023)...................................13

INTRODUCTION AND INTEREST

OF AMICI CURIAE

This case challenges the U.S. Food and Drug

Administration’s actions adopting an electiveabortion policy that Congress could never pass, that

States have rejected, and in which the American

people had no say. The FDA claims that this Court

“owe[s] significant deference” to those actions and

should review them “deferential[ly].” FDA Br. 34, 44.

The FDA is wrong. This Court gives agencies

deference on matters of special agency competence, on

granular questions requiring technical expertise, and

on issues over which an agency enjoys clear authority.

But this Court does not defer when an agency tests

constitutional boundaries.

That is because federal agencies present special

risks to the constitutional design. Our Constitution

establishes a limited federal government and leaves

power over important issues with the people.

Agencies imperil that design. Where the Constitution

separates the national government’s powers, agencies

seek to concentrate power. The Constitution vests

lawmaking authority—the power to make national

policy—in a vigorous Congress. But federal executive

agencies now routinely exert broad lawmaking power

and impose major national policies. The Constitution

also divides power between the national government

and state governments. Federalism prevents the

national government from wielding so much power

that it can trample liberty and keeps most power with

state governments that the people can better hold

accountable. Federal agencies undercut this

framework. They regularly adopt policies that thwart

state laws—without the public accountability that

2

comes with state lawmaking—causing federal power

to swell and liberty to shrink. And agencies imperil

what may be the Constitution’s core feature: that the

people decide the hardest, most important issues. As

agencies engulf more of American life, the people lose

control over those issues.

The FDA actions challenged here present these

risks to the constitutional design. Start with the

separation of powers. The FDA has adopted a

nationwide elective-abortion regime. It has extended

that regime deeper into pregnancy, with ever fewer

guardrails, and despite abortion’s unique challenges.

Congress has never enacted—and could not now

enact—any such policy. Yet the FDA does not just

claim power to impose such a policy. It demands

“significant deference” to its actions imposing that

policy. This extraordinary claim of lawmaking

authority tests the separation of powers.

Now take federalism. Under the Constitution,

States have the primary authority to protect health,

safety, and welfare. Using that power, many States

have regulated and restricted abortion—including

chemical abortion. Yet the FDA has greenlighted a

permissive elective-abortion policy—undercutting

States’ laws, thwarting States’ ability to enforce

them, and hobbling the interests that those laws

serve. This intrusion on state authority exerts serious

pressure on the federal-state balance of power.

Last, consider how this all affects the American

people. Few issues are as important and controversial

as abortion. Federal lawmaking on abortion has thus

long proceeded incrementally: sweeping action has

not gained the consensus needed to become federal

3

law. And because questions on abortion are so

important, it is critical that the people decide them.

Yet the FDA’s actions rob the people of power to

decide central questions—whether chemical abortion

should be lawful, in what circumstances, and under

what conditions—on this vital issue. That state of

affairs departs from our constitutional order, which

leaves the most important matters to the people.

These tests to the constitutional design—and what

they mean for resolving this case—are of great

importance to amici curiae, the States of Mississippi,

Alabama, Alaska, Arkansas, Florida, Georgia,

Indiana, Iowa, Kentucky, Louisiana, Montana,

Nebraska, North Dakota, Ohio, Oklahoma, South

Carolina, South Dakota, Tennessee, Texas, Utah,

West Virginia, and Wyoming. In adopting the

Constitution, the people reserved most power to

themselves and to States that would protect liberty.

Because of their duty to protect liberty, amici have a

strong interest in rigorous enforcement of

constitutional limits—including searching judicial

review of federal agency actions that press

constitutional boundaries. The FDA’s actions press

those boundaries and this Court should subject those

actions to searching review.

SUMMARY OF ARGUMENT

Our Constitution establishes a limited federal

government that leaves most power with—and

accountable to—the people. Federal agencies present

special risks to that design. So when agency action

pushes constitutional bounds, this Court’s review of

that action is searching—not deferential. The FDA’s

actions here push constitutional bounds. Those

4

actions test the separation of powers, sap federalism,

and take important decisions from the people. This

Court should therefore exercise searching review of

those actions and reject the FDA’s plea for deference.

ARGUMENT

I. When Agency Action Pushes Constitutional

Boundaries, Judicial Review Of That Action

Is Searching—Not Deferential.

This Court often decides challenges to agency

action. At times this Court reviews such action

deferentially. But that is not so when agency action

bristles against the constitutional design. When that

happens, this Court’s review is searching.

A. The Constitution Establishes A Limited

Federal Government And Leaves Power

With—And Accountable To—The People.

The Constitution protects liberty by limiting

government power. It does this mainly through

“structural protections.” Bowsher v. Synar, 478 U.S.

714, 730 (1986). It divides power at the national level,

further divides power between the national and state

governments, and otherwise reinforces that power

remains with and is accountable to the people—

particularly on what is most important.

Start at the national level, with the separation of

powers. The Constitution “divide[s] the ... powers of

the ... Federal Government into three defined

categories, Legislative, Executive, and Judicial.” INS

v. Chadha, 462 U.S. 919, 951 (1983). The Framers

understood that “unit[ing]” different powers in the

“same person or body” destroys “liberty.” The

Federalist No. 47 (James Madison) (quoting

5

Montesquieu). By “diffus[ing] power,” then, the

Constitution aims to “better ... secure liberty.”

Youngstown Sheet & Tube Co. v. Sawyer, 343 U.S.

579, 635 (1952) (Jackson, J., concurring). All the

Constitution’s divisions of national power are critical.

But the division most important to national

policymaking is the one between the legislative and

executive branches. The Constitution establishes “a

vigorous Legislative Branch and a separate and

wholly independent Executive Branch, with each

branch responsible ultimately to the people.”

Bowsher, 478 U.S. at 722. Each of those branches

must “confine itself to its assigned responsibility” and

not “exceed” constitutional limits by exercising power

assigned to the other branch. Chadha, 462 U.S. at

951.

Next, take the division between the national and

state governments: federalism. The Constitution

embraces a system of “dual sovereignty,” in which

“States possess sovereignty concurrent with that of

the Federal Government.” Gregory v. Ashcroft, 501

U.S. 452, 457 (1991). By striking a proper “balance of

power between the States and the Federal

Government,”

federalism

complements

the

separation of powers by “secur[ing] to citizens the

liberties that derive from the diffusion of sovereign

power.” New York v. United States, 505 U.S. 144, 181

(1992). And instead of forcing the people “to rely solely

upon the political processes that control a remote

central power,” the federal structure lets States take

different approaches that respond “to the diverse

needs of a heterogeneous society.” Bond v. United

States, 564 U.S. 211, 221 (2011). By leaving most

power with the States, the Constitution makes those

who most wield power over everyday life accountable

6

to the people as a distant national government can

never be. See Gregory, 501 U.S. at 458.

Last, take the core aim of the Constitution:

protecting liberty by leaving power with—and

making power accountable to—the people. See U.S.

Const. amend. X. “Our Constitution was adopted to

enable the people to govern themselves, through their

elected leaders.” Free Enterprise Fund v. PCAOB, 561

U.S. 477, 499 (2010). The constitutional design

ensures that the officials who wield government

power remain “accountable to political force and the

will of the people,” Freytag v. Commissioner, 501 U.S.

868, 884 (1991), and face “electoral ramifications”

when they use power poorly, New York, 505 U.S. at

169. The separation of powers and federalism of

course serve this aim. And the Constitution reinforces

those protections by limiting federal power—

particularly national lawmaking power. The

Constitution makes that power hard to exercise. A

policy can become federal law only by majority vote of

two differently composed houses of Congress and

approval by the President. U.S. Const. art. I, § 7. This

process is deliberately challenging. See Chadha, 462

U.S. at 944, 949, 959. Requiring hard work and buyin from a wide cross-section of the people’s elected

representatives ensures that “dependence on the

people” remains the “primary contro[l] on the

government.” Free Enterprise Fund, 561 U.S. at 501.

B. Federal

Agencies

Present

Special

Dangers To The Constitutional Design.

Against the constitutional design stand federal

agencies. Agencies pose many risks to that design, but

three are especially acute.

7

First, agencies erode the separation of powers.

Agencies are housed in the executive branch yet often

assert legislative power over matters of “vast

economic and political significance.” Alabama Ass’n of

Realtors v. HHS, 141 S. Ct. 2485, 2489 (2021) (per

curiam) (internal quotation marks omitted). Agencies

have adopted many national policies—on heated,

important issues—that operate as federal law even

though those policies would never have been enacted

by Congress. See infra Part I-C (giving examples).

That is especially so in the modern day, when “the

vast majority” of federal “lawmaking” no longer

“take[s] place in Congress, but within the hundreds of

federal agencies spread across the modern regulatory

state.” Jonathan H. Adler & Christopher J. Walker,

Delegation and Time, 105 Iowa L. Rev. 1931, 1975

(2020); see Ronald A. Cass, Rulemaking Then and

Now: From Management to Lawmaking, 28 Geo.

Mason L. Rev. 683, 694 (2021) (Congress passes 200400 laws each year; federal agencies adopt some 30005000 final rules each year). Agencies have thus

overtaken

much

of

Congress’s

“assigned

responsibility.” Chadha, 462 U.S. at 951.

Second, federal agencies imperil federalism. Just

as there is “hydraulic pressure inherent within each

of the separate [federal] Branches to exceed the outer

limits of its power,” Chadha, 462 U.S. at 951, there is

inherent pressure for the federal government to

exceed its authority by invading the domain of States.

Cf. Free Enterprise Fund v. PCAOB, 537 F.3d 667, 694

n.4 (D.C. Cir. 2008) (Kavanaugh, J., dissenting)

(“Power abhors a vacuum.”), aff’d in part, rev’d in

part, and remanded, 561 U.S. 477 (2010). As federal

power expands, it does so at the expense of state

power. That expense is costly indeed: the people can

8

far better channel power and hold officials

accountable at the state level. Disrupting the

traditional federal-state balance is thus an

“extraordinary power” that Congress “does not

exercise lightly.” Gregory, 501 U.S. at 460. Yet federal

agencies now routinely “intrude[ ] into” the “domain

of state law.” Alabama Ass’n, 141 S. Ct. at 2489. And

they often do so using stale, vague, or inapt

delegations of power that do not reflect Congress’s

“clear and manifest” “intent to intrude on state

governmental functions.” Gregory, 501 U.S. at 461,

470. “[T]he background principles of our federal

system ... belie the notion that Congress would use”

“obscure grant[s] of authority to regulate areas

traditionally supervised by the States’ police power.”

Gonzales v. Oregon, 546 U.S. 243, 274 (2006). Yet

agencies plow ahead, claiming more for themselves—

and less for States.

Third, agencies seize power from the people. Only

a “vigorous” Congress—“responsible ultimately to the

people”

through

elections—enjoys

national

lawmaking authority. Bowsher, 478 U.S. at 722.

When elected representatives in Congress “make[ ] ...

decision[s] in full view of the public,” those officials

“suffer the consequences if” a decision “turns out to be

detrimental or unpopular.” New York, 505 U.S. at

168. And the challenges of the federal-lawmaking

process ensure that “the people” retain ultimate

policymaking control. Free Enterprise Fund, 561 U.S.

at 501. But agencies operate outside these

constraints. They are staffed by faceless functionaries

who are “neither elected nor reelected” and are

“controlled only spasmodically by officials who are.”

John Hart Ely, Democracy and Distrust 131 (1980);

see Free Enterprise Fund, 561 U.S. at 499 (“The

9

growth of the Executive Branch, which now wields

vast power and touches almost every aspect of daily

life, heightens the concern that it may slip from the

Executive’s control, and thus from that of the

people.”). This “insulat[ion]” from “electoral

ramifications” “diminishe[s]” the “[a]ccountability”

the Constitution envisions. New York, 505 U.S. at

169. As a result, agencies often adopt policies, on

major issues, that the people as a whole do not want.

Cf. West Virginia v. EPA, 142 S. Ct. 2587, 2608-09

(2022) (describing cases where agencies adopted

policies that would likely have failed legislatively).

C. Because

Agencies

Present

Special

Dangers,

This

Court

Has

Been

Searching—Not

Deferential—In

Reviewing Agency Action That Pushes

Constitutional Boundaries.

Given the risks that agencies pose to the

constitutional design, this Court has been vigilant in

policing agency actions that test constitutional limits.

First, this Court has safeguarded the separation of

powers by blocking agency actions that arrogate

legislative power from Congress. In West Virginia v.

EPA, for example, this Court rejected the EPA’s claim

of authority to “restructure the American energy

market” by “forc[ing] a nationwide transition” to

renewable energy sources. 142 S. Ct. at 2610, 2616.

“A decision of such magnitude and consequence,” the

Court ruled, “rests with Congress itself”—or at least

with “an agency acting pursuant to a clear delegation

from that representative body.” Id. at 2616. Similarly,

in NFIB v. OSHA, 142 S. Ct. 661 (2022) (per curiam),

this Court rejected the Occupational Safety and

Health Administration’s attempt to impose a

10

nationwide vaccine mandate on “roughly 84 million

workers.” Id. at 662. The “responsibility” for

“weigh[ing] [the] tradeoffs” of such “a significant

encroachment” on the American public, the Court

stressed, belongs to “those chosen by the people

through democratic processes.” Id. at 665, 666.

This Court has rejected many other agency actions

that intruded on Congress’s legislative authority.

E.g., Alabama Ass’n, 141 S. Ct. at 2486, 2490

(“Congress, not the CDC,” is responsible for deciding

“whether the public interest merits” a “nationwide

moratorium on evictions” during a pandemic); Utility

Air Regulatory Group v. EPA, 573 U.S. 302, 324

(2014) (rejecting view of Clean Air Act that would

have

“br[ought]

about

an

enormous

and

transformative expansion in EPA’s regulatory

authority without clear congressional authorization”);

FDA v. Brown & Williamson Tobacco Corp., 529 U.S.

120, 125-26 (2000) (rejecting FDA’s claim that its

power over “drugs” and “devices” includes power to

regulate or ban tobacco products). In doing so, this

Court has applied a “presum[ption]” that “Congress

intends to make major policy decisions itself”—

through legislation—and “not leave those decisions to

agencies.” West Virginia, 142 S. Ct. at 2609. This

Court thus looks skeptically—not deferentially—

when agencies make broad uses of legislative power.

Second, this Court has halted agency actions that

erode federalism. The Court has been especially wary

of actions that “intrude[ ] into an area that is the

particular domain of state law.” Alabama Ass’n, 141

S. Ct. at 2489. Thus in Alabama Association of

Realtors, this Court rejected the CDC’s claimed

authority to impose a nationwide eviction moratorium

in part because that action “intrude[d]” on “landlord-

11

tenant relationship[s]” traditionally regulated by

States. Ibid. And in Gonzales v. Oregon, this Court

refused to read the federal Controlled Substances Act

to give the Attorney General power “to prohibit

doctors from prescribing regulated drugs for use in

physician-assisted suicide.” 546 U.S. at 248-49. This

Court rejected the claimed power of “a single

executive officer” “to effect a radical shift of authority

from the States to the Federal Government to define

general standards of medical practice in every

locality.” Id. at 275. Similarly, in Solid Waste Agency

of Northern Cook County v. U.S. Army Corps of

Engineers, 531 U.S. 159 (2001), this Court refused to

read the Clean Water Act to give a federal agency

control over certain lands traditionally regulated by

States. Id. at 162. A contrary view would have

“result[ed] in a significant impingement of the States’

traditional and primary power over land and water

use.” Id. at 174. In these cases this Court scrutinized

agency action not deferentially but vigilantly—in a

way that honored federalism and preserved the

“proper balance between the States and the Federal

Government.” Gregory, 501 U.S. at 459.

Third, this Court has closely examined agency

actions that take major issues away from the people.

A prominent recent example is the Court’s rejection of

a workplace-safety agency’s effort to mandate

vaccination for much of the U.S. workforce. See NFIB,

142 S. Ct. at 664-66. Such a consequential, debated

issue was for the people’s elected representatives, not

unelected federal functionaries. This Court’s careful

scrutiny was particularly apt because the agency’s

actions set a national policy that cut off an “earnest

and profound debate” “across the country” on a matter

of great importance. Gonzales, 546 U.S. at 267. The

12

Constitution largely leaves such “political and moral

debate[s],” id. at 249, to the people, to resolve through

persuasion and voting. This respect for the people “is

vital because” (as “the framers believed”) “a

republic—a thing of the people—[is] more likely to

enact just laws than a regime administered by a

ruling class of largely unaccountable ‘ministers.’”

West Virginia, 142 S. Ct. at 2617 (Gorsuch, J.,

concurring). So when unaccountable ministers test

our constitutional design, this Court subjects their

work to searching review.

II. The FDA’s Actions Push Constitutional

Boundaries And Thus Warrant Searching

Judicial Review.

This case challenges the FDA’s actions on the

chemical-abortion drug mifepristone. Those actions

test constitutional boundaries. This Court should

therefore reject the FDA’s plea for “significant

deference” (FDA Br. 34; see id. at 34-44) and subject

the FDA’s actions to searching review.

A. The FDA’s Actions

Separation Of Powers.

Undercut

The

The FDA’s actions impose a nationwide electiveabortion regime. This raises serious separation-ofpowers problems.

First consider the landscape under the FDA’s

actions. In 2000, the FDA approved mifepristone for

chemical abortions. J.A. 225. Whatever else could be

said of that approval, it at least included measures

addressing mifepristone’s risks. The approval

extended only through 49 days of pregnancy; allowed

mifepristone to be dispensed only in clinics, medical

13

offices, or hospitals (all under a qualified physician’s

supervision); mandated three in-person office visits;

and required providers to report serious adverse

events from the drug. J.A. 225-32, 296. Yet in 2016,

the FDA rolled back safety requirements—allowing

mifepristone to be prescribed through 70 days of

pregnancy, by non-doctors, with only one in-person

visit—and stopped requiring prescribers to report

non-fatal adverse events. J.A. 293-320. In 2021, the

FDA dropped the in-person-dispensing requirement.

J.A. 364-65, 371. Through these actions, the FDA has

imposed a nationwide elective-abortion regime.

Adopting a nationwide elective-abortion regime

would be a breathtaking feat of federal legislation.

Abortion

is

“unique”

and

“fraught

with

consequences,” Planned Parenthood of Southeastern

Pennsylvania v. Casey, 505 U.S. 833, 852 (1992)—

after all, it “presents an irreconcilable conflict

between the interests of a pregnant woman who seeks

an abortion and the interests in protecting fetal life,”

Dobbs v. Jackson Women’s Health Organization, 142

S. Ct. 2228, 2304 (2022) (Kavanaugh, J., concurring).

Many federal legislative proposals have sought to

address abortion. E.g., States Choose Life Act of 2023,

H.R. 4414, 118th Cong. (2023); Abortion Justice Act

of 2023, H.R. 4303, 118th Cong. (2023); Women’s

Public Health and Safety Act, S. 471, 118th Cong.

(2023); Women’s Health Protection Act of 2023,

S. 701, 118th Cong. (2023). Yet few have gained the

consensus needed to become federal law. The rare

successes have been targeted laws that, far from

endorsing abortion, restrict or discourage it. E.g., 136

Stat. 49, 496 (2022) (Hyde Amendment, restricting

use of federal funds for certain abortions); 18 U.S.C.

§ 1531 (Partial-Birth Abortion Ban Act); id. §§ 1461,

14

1462 (criminal laws making abortion drugs

nonmailable and nonshippable by common carrier).

This all points up the obvious: Congress has never

enacted (and could not now enact) a nationwide

elective-abortion regime. Yet the FDA here claims the

power to itself impose such a policy—and, incredibly,

demands that this Court defer to its actions imposing

that policy. But by claiming the power to make a

“decision of such magnitude and consequence,” West

Virginia, 142 S. Ct. at 2616, the FDA has invaded

Congress’s “assigned responsibility” and eviscerated

the Constitution’s checkpoints for democratic

accountability. INS v. Chadha, 462 U.S. 919, 951

(1983); see id. at 946-51. Under our constitutional

design, the “responsibility” for “weigh[ing] [the]

tradeoffs” of a widescale elective-abortion regime is

with elected officials “chosen by the people through

democratic processes.” NFIB, 142 S. Ct. at 666. The

FDA’s actions undermine this design and thus

warrant this Court’s close scrutiny.

B. The FDA’s Actions Erode Federalism.

The FDA’s broad endorsement

abortion is also hostile to federalism.

of

chemical

Under the Constitution, States have “primar[y]”

authority over health and safety. Hillsborough

County v. Automated Medical Laboratories, Inc., 471

U.S. 707, 719 (1985). “[T]he structure and limitations

of federalism” “allow the States great latitude” to

enact laws protecting “the lives, limbs, health,

comfort, and quiet of all persons.” Gonzales, 546 U.S.

at 270 (internal quotation marks omitted). This

authority includes overseeing the medical profession,

ibid., setting standards of care, see ibid., and

15

regulating or restricting abortion to protect life and

health, Dobbs, 142 S. Ct. at 2284.

Using their retained constitutional authority,

States take varying approaches to abortion. Some

States have adopted permissive regimes. Other

States impose tighter regulations or restrictions.

Abortion laws in those latter States ubiquitously

protect a woman’s life, e.g., Miss. Code Ann. § 41-4145(2), and commonly include other exceptions, e.g.,

ibid. (exception for rape). Many state laws address the

risks of chemical abortions. Such laws recognize, for

example, that “abortion-inducing drugs”: “present[ ]

significant medical risks to women,” such as “uterine

hemorrhage, viral infections, pelvic inflammatory

disease, severe bacterial infection and death,” id.

§ 41-41-103(1)(a); “are associated with an increased

risk of complications relative to surgical abortion”

that surge “with increasing gestational age,” id. § 4141-103(1)(b); and “are contraindicated in ectopic

pregnancies,” id. § 41-41-107(2). States combat those

risks by, among other things, requiring that only

physicians may provide such drugs, that a physician

may do so only after “physically examin[ing] the

woman and document[ing] ... the gestational age and

intrauterine location of the pregnancy,” and that

these drugs “must be administered in the same room

and in the physical presence of the physician.” Id.

§ 41-41-107(1)-(3); see, e.g., Ind. Code Ann. § 16-34-21 (requiring in-person exam and dispensing); Okla.

Stat. Ann. tit. 63, § 1-729.1 (requiring in-person

dispensing); Tex. Health & Safety Code Ann.

§ 171.063(b-1) (prohibiting shipment of abortion

drugs “by courier, delivery, or mail service”). And, like

all elective abortions, elective chemical abortions are

generally unlawful in several States. E.g., Miss. Code

16

Ann. § 41-41-45(2) (abortion unlawful except “where

necessary for the preservation of the mother’s life or

where the pregnancy was caused by rape”).

The FDA’s actions undermine these laws,

undercut States’ efforts to enforce them, and thus

erode the federalism the Constitution deems vital.

Those actions have led to the widespread shipment of

abortion drugs. See Pam Belluck, More Women Who

Are Not Pregnant Are Ordering Abortion Pills Just in

Case, N.Y. Times (Jan. 2, 2024), nyti.ms/3SVJLWy

(tens of thousands of abortion pills have been

provided by telehealth in recent years, including in

States that restrict abortion); Caroline Kitchener,

Blue-State Doctors Launch Abortion Pill Pipeline Into

States With Bans, Wash. Post (July 19, 2023),

wapo.st/3M29JUq (detailing “new pipeline of legally

prescribed abortion pills flowing into states with

abortion bans”); Alice Miranda Ollstein & Lauren

Gardner, Retail Pharmacies Can Now Offer Abortion

Pill, FDA Says, Politico (Jan. 3, 2023), bit.ly/3wCPl3V

(“[t]elemedicine and mail delivery ... has allowed

patients to circumvent state bans”). The FDA has

thus facilitated violations of many States’ laws. The

FDA’s actions force States to divert resources to

investigate and address the harms that this

lawbreaking will inflict on women, children, and the

public interest. See Blue-State Doctors (one “small

group” of providers has mailed abortion pills into

more-restrictive States on a pace that will “facilitate

at least 42,000 abortions” over the next year).

The FDA’s actions thus “intrude on state

governmental functions,” Gregory v. Ashcroft, 501

U.S. 452, 470 (1991), and hobble States’ efforts to

protect health and safety. Without any federal law

expressing Congress’s “exceedingly clear” wish “to

17

significantly alter the balance between federal and

state power,” Alabama Ass’n of Realtors v. HHS, 141

S. Ct. 2485, 2489 (2021) (per curiam), the FDA has

“effect[ed] a radical shift of authority from the States

to the Federal Government” on abortion. Gonzales,

546 U.S. at 275; see Dobbs, 142 S. Ct. at 2284 (the

“authority” to “regulat[e] or prohibit[ ] abortion”

belongs to “the citizens of each State.”). Given these

harms to federalism, this Court should view the

FDA’s actions with skepticism.

C. The FDA’s Actions Rob From The People

Decisions Of Great Importance.

Finally, the FDA’s actions depart from the central

tenet of our Constitution: that power—particularly

over important, hard, controversial issues—resides

with and must be accountable to the people.

Few issues are as important, hard, and

controversial as abortion. Supra pp. 13-14. The

Constitution thus leaves the task of regulating and

restricting abortion to “the people and their elected

representatives.” Dobbs, 142 S. Ct. at 2284. Yet the

FDA’s actions rob from the people important decisions

on this vital issue.

To start, the FDA approved mifepristone for

elective abortions—despite strong opposition across

the country. E.g., J.A. 201-23, 238-70. It did so based

on problematic, contested grounds, including its

determination that an “unwanted pregnancy” is an

“illness[ ]” in need of the “therapeutic benefit” that

mifepristone provides. J.A. 230. Next, the FDA

expanded mifepristone’s use. In 2016, it extended

mifepristone’s approved use from 49 days of

pregnancy to 70 days of pregnancy. E.g., J.A. 295, 299,

18

302. The FDA made this decision even though the risk

of complications increases with gestational age. E.g.,

J.A. 165, 171, 197, 209-12. And it did so even though

abortion becomes increasingly problematic as

pregnancy progresses. Cf. Roe v. Wade, 410 U.S. 113,

162-63 (1973) (interests in protecting “the health of

the pregnant woman” and “the potentiality of human

life” “grow[ ] in substantiality” as pregnancy

progresses). Last, the FDA cast aside safety

measures. When the FDA approved mifepristone, it

recognized the drug’s risks and imposed measures to

mitigate those risks. J.A. 225-32. But the FDA has

dispensed with many of those measures. It now

condones use of mifepristone without a physician

prescriber, without assessing gestational age, without

reporting of non-fatal adverse events, and without

any in-person visits to a doctor—the “primary tool for

ensuring the safe distribution and use of

mifepristone.” FDA Pet. App. 229a. At every turn—in

approving mifepristone, expanding its use, and

dropping safeguards around it—the FDA acted

without buy-in from, or accountability to, the people.

For decades, then, the FDA has seized control over

one of the most important, contested issues of our

time. The agency has denied the people a say,

“through their elected leaders,” on fraught and

consequential questions of policy. Free Enterprise

Fund v. PCAOB, 561 U.S. 477, 499 (2010). Its actions

have short-circuited “an earnest and profound

debate” on the “morality, legality, and practicality” of

chemical abortion—including whether to allow it and

how to regulate it. Gonzales, 546 U.S. at 249. And

those actions have undermined state laws on abortion

that strike a balance among the competing interests,

are the results of hard-fought democratic processes,

19

and embody the considered judgments of “the people

and their elected representatives.” Dobbs, 142 S. Ct.

at 2284. Far from meriting “significant deference,”

FDA Br. 34, the FDA’s actions on mifepristone should

for this reason—and those given above—face this

Court’s searching review.

CONCLUSION

The Court should exercise searching—not

deferential—review over the FDA’s actions, hold that

those actions are unlawful, and affirm the judgment

below.

Respectfully submitted.

LYNN FITCH

Attorney General

WHITNEY H. LIPSCOMB

Deputy Attorney General

SCOTT G. STEWART

Solicitor General

Counsel of Record

JUSTIN L. MATHENY

ANTHONY M. SHULTS

Deputy Solicitors General

MISSISSIPPI ATTORNEY

GENERAL’S OFFICE

P.O. Box 220

Jackson, MS 39205-0220

scott.stewart@ago.ms.gov

(601) 359-3680

Counsel for Amici Curiae

February 29, 2024

20

Counsel for Additional Amici States

STEVE MARSHALL

Attorney General

State of Alabama

LIZ MURRILL

Attorney General

State of Louisiana

TREG TAYLOR

Attorney General

State of Alaska

AUSTIN KNUDSEN

Attorney General

State of Montana

TIM GRIFFIN

Attorney General

State of Arkansas

MICHAEL T. HILGERS

Attorney General

State of Nebraska

ASHLEY MOODY

Attorney General

State of Florida

DREW H. WRIGLEY

Attorney General

State of North Dakota

CHRISTOPHER M. CARR

Attorney General

State of Georgia

DAVE YOST

Attorney General

State of Ohio

THEODORE E. ROKITA

Attorney General

State of Indiana

GENTNER F. DRUMMOND

Attorney General

State of Oklahoma

BRENNA BIRD

Attorney General

State of Iowa

ALAN WILSON

Attorney General

State of South Carolina

RUSSELL COLEMAN

Attorney General

Commonwealth of

Kentucky

MARTY J. JACKLEY

Attorney General

State of South Dakota

21

JONATHAN SKRMETTI

Attorney General

State of Tennessee

KEN PAXTON

Attorney General

State of Texas

SEAN D. REYES

Attorney General

State of Utah

PATRICK MORRISEY

Attorney General

State of West Virginia

BRIDGET HILL

Attorney General

State of Wyoming