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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 elective-
abortion 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 buy-
in 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 200-
400 laws each year; federal agencies adopt some 3000-
5000 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 Undercut The


Separation Of Powers.
The FDA’s actions impose a nationwide elective-
abortion regime. This raises serious separation-of-
powers 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 of chemical
abortion is also hostile to federalism.
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. § 41-41-
45(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. § 41-
41-103(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. § 16-34-2-
1 (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 LIZ MURRILL
Attorney General Attorney General
State of Alabama State of Louisiana

TREG TAYLOR AUSTIN KNUDSEN


Attorney General Attorney General
State of Alaska State of Montana

TIM GRIFFIN MICHAEL T. HILGERS


Attorney General Attorney General
State of Arkansas State of Nebraska

ASHLEY MOODY DREW H. WRIGLEY


Attorney General Attorney General
State of Florida State of North Dakota

CHRISTOPHER M. CARR DAVE YOST


Attorney General Attorney General
State of Georgia State of Ohio

THEODORE E. ROKITA GENTNER F. DRUMMOND


Attorney General Attorney General
State of Indiana State of Oklahoma

BRENNA BIRD ALAN WILSON


Attorney General Attorney General
State of Iowa State of South Carolina

RUSSELL COLEMAN MARTY J. JACKLEY


Attorney General Attorney General
Commonwealth of State of South Dakota
Kentucky
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

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