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

No. 23-235, 23-236

IN THE

Supreme Court of the United States

__________

U.S. FOOD AND DRUG ADMINISTRATION, ET AL.,

Petitioners,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

___________

Respondents.

On Writs of Certiorari to the United States Court of

Appeals for the Fifth Circuit

___________

MOTION FOR LEAVE TO FILE BRIEF OUT OF

TIME AND BRIEF OF AMERICAN BAR

ASSOCIATION AS AMICUS CURIAE

IN SUPPORT OF PETITIONERS

___________

MARY SMITH

Counsel of Record

AMERICAN BAR ASSOCIATION

PRESIDENT

321 N. Clark St.

Chicago, IL 60654

(312) 988-5000

amicusbriefs@americanbar.org

CAROLYN E. SHAPIRO

SCHNAPPER-CASTERAS PLLC

200 E. Randolph St.

Suite 5100

Chicago, IL 60601

(202) 630-3644

cshapiro@schnappercasteras.com

JOHN PAUL SCHNAPPER-CASTERAS

RACHAEL R. YOCUM

SCHNAPPER-CASTERAS PLLC

1717 K Street NW, Suite 900

Washington, D.C. 20006

(202) 630-3644

jpsc@schnappercasteras.com

Counsel for Amicus Curiae

No. 23-235, 23-236

IN THE

Supreme Court of the United States

__________

U.S. FOOD AND DRUG ADMINISTRATION, ET AL.,

Petitioners,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

___________

Respondents.

On Writs of Certiorari to the United States Court of

Appeals for the Fifth Circuit

___________

MOTION FOR LEAVE TO FILE AMICUS

CURIAE BRIEF OUT OF TIME

___________

Pursuant to Supreme Court Rules 21.1 and 37.2, the

American Bar Association (“ABA”) respectfully seeks

leave to file a brief as amicus curiae in support of

Petitioners after the deadline for filing such briefs. The

ABA has notified all parties of its intent to file this

motion and amicus brief. Petitioner Danco

Laboratories, L.L.C. consents; Petitioner the FDA has

not yet responded; Respondent Alliance for

Hippocratic Medicine has not yet responded.

For the foregoing reasons, this motion should be

granted.

The Petition was granted in this case on December

13, 2023, and consolidated with case 23-236. According

to the original schedule, Petitioners’ merits briefs were

2

due to be filed January 29, 2024 (pursuant to Supreme

Court Rule 25.1, since January 27 fell on a Saturday)

and, assuming filing on that date, any amicus brief in

support of Petitioners would be due February 5, 2024

(pursuant to Supreme Court Rule 37.3).

The ABA has a rigorous and extensive process for

authorizing and filing amicus briefs, see ABA Policy

and Procedures Handbook, 2023-2024, pp. 61-64, that

is designed to ensure that any such brief is consistent

with the ABA’s official positions. Typically, pro bono

counsel submits a detailed application to file an

amicus brief to the Standing Committee on Amicus

Curiae Briefs (the “Amicus Committee”). Id. at p. 62.

If the application is accepted, the Amicus Committee

works with the drafters in preparing the proposed

brief. Id. Once approved by the Amicus Committee, the

Executive Committee of the Board of Governors must

review and authorize the amicus brief. Id. at p. 61

(citing section 25.2 of the ABA Bylaws). The Board of

Governors meets at four scheduled meetings each

year. Id. at p. 10.

In this case, on the same day this Court granted the

Petition, December 13, 2023, an ABA section

committee immediately recruited pro bono counsel,

who by the next day began the process of writing the

requisite application to the ABA Amicus Committee as

well as developing and drafting a brief. Counsel, in

consultation with the Amicus Committee and ABA

staff, established a number of fixed internal deadlines

consistent with the expected filing date of February 5,

2024. Final approval by the Amicus Committee was

set in time for presentation to and consideration by the

Executive Committee at its prescheduled ABA

Midyear Meeting on February 1, 2024. The Executive

3

Committee put consideration of the proposed amicus

brief on its agenda for that meeting.

Once it became apparent that Petitioners filed their

brief before the January 29, 2024 due date, and that

amicus briefs supporting Petitioners were due on

January 30, 2024, the ABA explored emergency

measures to try to approve and file its brief that day,

but was unable to accelerate its internal process. Final

approval thus required the ABA to wait for Executive

Committee review at its February 1, 2024 meeting.

The ABA filed this motion immediately after the

Executive Committee formally approved the brief.

As discussed in more detail in the accompanying

brief, this case presents an issue of significant

importance to the ABA, the largest professional

association in the world—namely, advancing and

preserving the rule of law. Judicial review of agency

action serves as a cornerstone of the rule of law by

guarding against arbitrary or unlawful actions and

promoting predictability and stability. However, to

play that role, courts must conduct judicial review

consistent with this Court’s longstanding precedent.

When courts depart from those principles—whether by

affording too much or too little deference (as the courts

below did in this case) to an agency’s adjudicative

judgments—it can result not only in an erroneous

outcome in the particular case but also in broader

deleterious consequences for public confidence in the

objectivity of the judicial system and the predictability

that is necessary for the rule of law.

4

In light of the accelerated filing schedule in this case,

the ABA’s rigorous internal review process, and the

importance of this issue, the ABA respectfully requests

this Court grant its motion to file this brief out of time.

Respectfully submitted,

MARY SMITH

Counsel of Record

AMERICAN BAR ASSOCIATION

PRESIDENT

321 N. Clark St.

Chicago, IL 60654

(312) 988-5000

amicusbriefs@americanbar.org

February 2, 2024

CAROLYN E. SHAPIRO

SCHNAPPER-CASTERAS PLLC

200 E. Randolph St.

Suite 5100

Chicago, IL 60601

(202) 630-3644

cshapiro@schnappercasteras.com

JOHN PAUL SCHNAPPER-CASTERAS

RACHAEL R. YOCUM

SCHNAPPER-CASTERAS PLLC

1717 K Street NW, Suite 900

Washington, D.C. 20006

(202) 630-3644

jpsc@schnappercasteras.com

i

TABLE OF CONTENTS

Interest of Amicus Curiae .......................................... 1

Summary of Argument ................................................ 2

Argument ..................................................................... 5

I. TO ADVANCE THE RULE OF LAW, JUDICIAL

REVIEW OF ADMINISTRATIVE AGENCY

DECISIONS MUST ADHERE TO SETTLED

PRINCIPLES. .............................................................. 5

II. BY DEFYING CONGRESS’S DELEGATION OF

SCIENTIFIC JUDGMENTS TO THE EXPERT

AGENCY AND THE DEFERENTIAL STANDARD

OF REVIEW THIS COURT HAS MANDATED, THE

FIFTH CIRCUIT UNDERMINED THE RULE OF

LAW AND THE PREDICTABILITY IT FOSTERS. 10

1. The Decision Below Defied Congress’s

Decision to Authorize the FDA, Not the Federal

Courts, to Make Scientific Judgments Regarding

Drug Safety and Efficacy ................................... 10

2. The Decision Below Defied this Court’s

Precedent Establishing the Arbitrary-andCapricious Standard ........................................... 15

Conclusion .................................................................. 18

ii

TABLE OF AUTHORITIES

CASES

Biden v. Missouri et al.,

595 U.S. 87 (2022) .................................................... 6

CIBA Corp. v. Weinberger,

412 U.S. 640 (1973) ................................................ 11

Citizens United v. FEC,

558 U.S. 310 (2010) .................................................. 7

Cytori Therapeutics, Inc. v. FDA,

715 F.3d 722 (D.C. Cir. 2013) .......................... 12, 13

Far East Conference v. United States,

342 U.S. 570 (1952) ................................................ 11

FCC v. Fox Television Stations, Inc.,

556 U.S. 502 (2009) ............................................ 7, 16

FCC v. Prometheus Radio Project,

592 U.S. 414 (2021) ............................................ 6, 15

FDA v. American Coll. Of Obstetricians and

Gynecologists, 141 S. Ct. 10 (2020)........................ 13

FDA v. American Coll. Of Obstetricians and

Gynecologists, 141 S. Ct. 578 (2021)...................... 13

FERC v. Electric Power Supply Ass’n.,

577 U.S. 260 (2016) ............................................ 7, 15

Gundy v. United States,

139 S. Ct. 2116 (2019) .............................................. 5

Mallory v. Norfolk S. Ry. Co.,

600 U.S. 122 (2023) .................................................. 8

Marbury v. Madison,

5 U.S. (1 Cranch) 137 (1803) ................................... 4

iii

Motor Vehicles Mfrs. Ass’n of United States, Inc. v.

State Farm Mut. Auto. Ins. Co.,

463 U.S 29 (1983) ............................................... 6, 14

National Ass’n of Home Builders v. Defenders of

Wildlife, 551 U.S. 644 (2007) ................................... 6

New York State Bd. of Elections v. Lopez Torres,

552 U.S. 196 (2008) .................................................. 4

Pharm. Mfg. Rsch. Serv. v. FDA,

957 F.3d 254 (D.C. Cir. 2020) ................................ 13

Premo Pharmaceutical Labs., Inc., v. United States,

629 F.2d 795 (2d Cir. 1980) ................................... 13

Ramos v. Louisiana,

140 S. Ct. 1390 (2020) .............................................. 7

Rodriguez de Quijas v. Shearson/American

Express, Inc., 490 U.S. 477 (1989) ........................... 8

Serono Labs, Inc. v. FDA,

715 F.3d 722 (D.C. Cir. 1998) ................................ 13

United States v. Nixon,

418 U.S. 683 (1974) .................................................. 4

Wayman v. Southard,

23 U.S. (10 Wheat.) 1 (1825) .................................... 5

Weinberger v. Bentex Pharmaceuticals, Inc.,

412 U.S. 645 (1973) .......................................... 11, 12

Weinberger v. Hynson, Westcott & Dunning, Inc.,

412 U.S. 609 (1973) .......................................... 10, 11

STATUTES

21 U.S.C. § 355 ........................................................... 10

21 U.S.C. § 393 ............................................................. 9

5 U.S.C. § 706 ......................................................... 6, 11

iv

5 U.S.C. Ch. 7 ............................................................. 10

OTHER AUTHORITIES

ABA Goal IV,

ABA Resolution 08A121 (adopted 2008) ................. 2

ABA Resolution 06M111 (adopted 2006) .................... 2

American Bar Association, What is the rule of law.... 4

Antonin Scalia, The Rule of Law is the Law of Rules,

56 U. Chi. L. Rev. 1175 (1989) ................................. 5

Br. of Amicus Curiae American Bar Association in

Support of Respondents, No. 20-303,

2022 WL 16552943, Moore v. Harper,

600 U.S. 1 (Sept. 7, 2021) ........................................ 2

Congressional Research Service, Organizing

Executive Branch Agencies: Who Makes the Call?

(June 27, 2018) ......................................................... 5

FDA, Development & Approval Process |

Drugs (Aug. 8, 2022) .............................................. 10

FDA, FDA STEM Outreach, Education and

Engagement (June 8, 2022) ................................... 10

FDA, Laws, Regulations, Policies and Procedures

for Drug Applications (Dec. 4, 2014) ..................... 10

Justice Sandra Day O’Connor, Remarks at the

Inaugural Sandra Day O’Connor Distinguished

Lecture Series, 41 Tex. Tech L. Rev. 1169 (2009) ... 4

Kevin M. Stack, An Administrative Jurisprudence:

The Rule of Law in the Administrative State,

115 Colum. L. Rev. 1985 (2015)............................... 6

Kurt T. Lash, Originalism, Popular Sreignty,

and Reverse Stare Decisis,

93 Va. L. Rev. 1437 (2007) ....................................... 8

v

Report to ABA Resolution 23A509

(adopted Aug. 2023) ................................................. 2

Scott D. Gerber, The Political Theory of an

Independent Judiciary,

116 Yale L.J. Pocket Part 223 (2007) ...................... 4

Stanford Encyclopedia of Philosophy, The Rule of

Law (June 22, 2016) ................................................. 7

Stephen Breyer, Making Our Democracy Work: A

Judge’s View (2010) .................................................. 4

Thomas W. Merrill, The Essential Meaning of the

Rule of Law, 17 J. L. Econ. & Pol’y 673 (2022) ....... 5

1

INTEREST OF AMICUS CURIAE 1

The American Bar Association (“ABA”) is the largest

voluntary professional association in the world,

spanning all fifty states and the full spectrum of legal

professionals.2

Founded in 1878, the ABA has long been committed

to advancing the rule of law in America and abroad.

Domestically, the ABA aims to increase public

understanding of and respect for the rule of law and

the legal process – including by providing educational

content, resources for legal professionals, law school

accreditation, and model ethics codes. Internationally,

the ABA promotes its mission through the Rule of Law

Initiative, which was established in 1990 after the fall

of the Berlin Wall.

In furtherance of its mission to advance the rule of

law, in 2006, the ABA adopted a Statement of Core

Principles underscoring that the “ABA has adopted a

wide range of policies supporting fundamental

principles associated with the Rule of Law” and

“strongly supporting the efforts of bar associations

Pursuant to Supreme Court Rule 37.6, counsel for amicus

curiae states that no counsel for a party authored this brief in

whole or in part. No counsel or party made a monetary

contribution intended to fund the preparation or submission of

this brief, and no person other than amicus or its counsel made

such a contribution.

1

2 Neither this brief nor the decision to file it should be

interpreted as reflecting the views of any judicial member. No

member of the ABA Judicial Division Council participated in this

brief’s preparation or in the adoption or endorsement of its

positions.

2

worldwide to promote the Rule of Law. . . .”3 See also

ABA Goal IV, ABA Resolution 08A121 (adopted 2008)

(setting forth objectives to advance the rule of law).

The ABA has also submitted several amicus briefs in

this Court and others urging faithful application of

rule-of-law principles to preserve the integrity of, and

public confidence in, our judicial system. See, e.g., Br.

of Amicus Curiae American Bar Association in

Support of Respondents, No. 20-303, 2022 WL

16552943, Moore v. Harper, 600 U.S. 1 (Sept. 7, 2021).

The ABA respectfully offers its perspective on the

rule of law in this case, see Report to ABA Resolution

23A509 at 2 (adopted Aug. 2023), particularly as this

Court considers the second question presented by the

petition of the United States.

SUMMARY OF ARGUMENT

The ABA seldom takes a position about particular

instances of judicial review of administrative action,

whether in the Supreme Court or the courts of appeals.

Nor does the ABA normally get involved as amicus in

litigation about the Food and Drug Administration’s

(“FDA’s”) approval or reconsideration of any particular

pharmaceutical drug. But in this case, the court of

appeals departed markedly from settled principles of

judicial review enshrined in both the Administrative

Procedure Act (“APA”) and in this Court’s precedent.

Judicial review of agency action serves as a

cornerstone of the rule of law by guarding against

arbitrary or unlawful actions and promoting

predictability and stability. But to play that role,

courts must conduct judicial review consistent with

3 ABA Resolution 06M111 (adopted 2006), available at

https://www.americanbar.org/content/dam/aba/directories/policy/

midyear-2006/2006_my_111.pdf.

3

the well-settled standard of “arbitrary and capricious”

review required by the APA and this Court’s

longstanding precedent. In some cases, when courts

depart from those principles—whether by affording

too much or too little deference to an agency’s

adjudicative judgments—it can result not only in an

erroneous outcome in the particular case but also in

broader deleterious consequences for public confidence

in the objectivity of the judicial system and the

predictability that is necessary for the rule of law.

This is one such case. Unlike most cases in which

courts invalidate agency action, a court’s substitution

of its own judgment for that of the FDA on the specific

question of drug safety can raise broader rule-of-law

implications. Congress exercised its prerogative to

delegate authority over those decisions to the FDA, not

to the courts, and, unlike the FDA, courts have none of

the scientific or medical expertise needed to make

those judgments. For these reasons, this Court has

repeatedly called for heightened deference to the

“complex

chemical

and

pharmacological

considerations” that are “within the peculiar

expertise” of the FDA. Weinberger v. Bentex

Pharmaceuticals, Inc., 412 U.S. 645, 654 (1973). In

that specific context of drug-safety determinations,

those considerations pose a unique concern that a

court decision disagreeing with the FDA’s scientific

judgment will not carry the appearance or reality that

the court is “doing law.”

The Fifth Circuit’s decision illustrates these

dangers. As the Petitioners have demonstrated, the

court of appeals rested its decision on criticisms of the

FDA’s scientific judgments and methodology—secondguessing the agency’s determinations as to the type

and quantum of evidence necessary before a drug can

be deemed safe or a prior safety decision should be

4

reevaluated. That approach overrode Congress’s

decision to assign responsibility for scientific

judgments regarding drug safety to the FDA, which is

staffed by thousands of doctors and scientists who

pored over decades of data and dozens of medical

studies in approving mifepristone. By comparison, “[a]

court is ill-equipped to second-guess that kind of

agency scientific judgment under the guise of the

APA’s arbitrary and capricious standard.” Cytori

Therapeutics, Inc. v. FDA, 715 F.3d 722, 727 (D.C. Cir.

2013) (Kavanaugh, J.).

In rejecting the FDA’s scientific judgment about

mifepristone, the Fifth Circuit also failed to properly

and faithfully apply the APA and this Court’s

precedents about “arbitrary and capricious” review,

particularly in the context of FDA drug approvals. The

Fifth Circuit did not even attempt to apply the

traditional factors that this Court has set out. Instead,

it fixated on precise types of evidence that it would

have preferred the FDA to consider in approving

mifepristone. By taking on for itself the role of making

a fundamentally scientific judgment that a court is so

ill-equipped to make, the Fifth Circuit’s approach

threatens to erode the appearance of objectivity and

the predictability and stability that are critical — not

only for Americans choosing what drugs to consume

and pharmaceutical companies deciding what to

research and where to invest — but also to the rule of

law and public confidence in our system of judicial

review.

5

ARGUMENT

I.

TO ADVANCE THE RULE OF LAW,

JUDICIAL

REVIEW

OF

ADMINISTRATIVE

AGENCY

DECISIONS

MUST

ADHERE

TO

SETTLED PRINCIPLES.

Judicial review is a basic pillar of the rule of law.4

Judicial review of government actions advances the

rule of law by ensuring fidelity to constitutional and

statutory commands and precluding arbitrariness or

abuse. See, e.g., Marbury v. Madison, 5 U.S. (1 Cranch)

137, 180 (1803).5 Such judicial review preserves the

predictability that the rule of law requires, including

when administrative agencies act. See Antonin Scalia,

The Rule of Law is the Law of Rules, 56 U. Chi. L. Rev.

1175, 1179 (1989) (“Predictability . . . is a needful

See, e.g., Justice Sandra Day O’Connor, Remarks at the

Inaugural Sandra Day O’Connor Distinguished Lecture Series, 41

Tex. Tech L. Rev. 1169, 1170 (2009); Stephen Breyer, Making Our

Democracy Work: A Judge’s View 3-12 (2010); Administrative

Office of the U.S. Courts, Overview – Rule of Law, available at

www.uscourts.gov/educational-resources/educational-activities/

overview-rule-law (last visited Jan. 10, 2024); American Bar

Association, What is the rule of law, available at

www.americanbar.org/advocacy/rule_of_law/what-is-the-rule-oflaw/ (last visited Jan. 10, 2024).

4

5 See also United States v. Nixon, 418 U.S. 683, 705 (1974) (“it

is the province and duty of this Court ‘to say what the law is’” and

“[a]ny other conclusion would be contrary to the basic concept of

separation of powers and [] checks and balances”) (citing Marbury

and The Federalist No. 47); New York State Bd. of Elections v.

Lopez Torres, 552 U.S. 196, 212 (2008) (Kennedy, J., concurring

in the judgment) ("The rule of law, which is a foundation of

freedom, presupposes a functioning judiciary respected for its

independence, its professional attainments, and the absolute

probity of its judges.”); Scott D. Gerber, The Political Theory of an

Independent Judiciary, 116 Yale L.J. Pocket Part 223, 225 (2007).

6

characteristic of any law worthy of the name.”).6 But

judicial review can play that critical role in advancing

the rule of law only if courts conduct their review of

agency action in a manner consistent with settled,

objective principles, including this Court’s precedent

establishing the proper standards of review.

These key principles of judicial review and their role

in supporting the rule of law are firmly embedded in

American law. First, it is beyond question that when

“Congress makes the policy decisions, it may authorize

another branch to ‘fill up the details’” in determining

how to apply statutory commands. Gundy v. United

States, 139 S. Ct. 2116, 2136 (2019) (Gorsuch, J.,

dissenting) (quoting Wayman v. Southard, 23 U.S. (10

Wheat.) 1, 43 (1825) (Marshall, C.J.)).7 But as

Congress itself recognized in enacting the

Administrative Procedure Act (APA), courts can and

should provide a check against “arbitrary and

capricious” exercises of such delegated authority. 5

U.S.C. § 706(2)(A).

6 See, also, e.g., Thomas W. Merrill, The Essential Meaning of

the Rule of Law, 17 J. L. Econ. & Pol’y 673, 700 (2022) (“[A] broad

right of judicial review of executive action is critical in creating

and sustaining the rule of law. If the ultimate purpose of the rule

of law is to make the use of coercive force by the executive

predictable, and if the judiciary’s penchant for enforcing settled

law is the lynchpin in creating such a condition, then the

executive must be answerable to the courts.”).

7 See also, e.g., Congressional Research Service, Organizing

Executive Branch Agencies: Who Makes the Call? (June 27, 2018)

(“Congress may act pursuant to its specific, enumerated

authorities to establish [executive branch] agencies” and their

“power to establish agencies may be enhanced by the Necessary

and Proper Clause . . . .”), available at https://crsreports.

congress.gov/product/pdf/LSB/LSB10158.

7

Faithful application of this arbitrary-and-capricious

standard promotes the rule of law by respecting

Congress’s decision to empower agencies, on the one

hand, while requiring rational decision-making and

reason-giving on the other. See Kevin M. Stack, An

Administrative Jurisprudence: The Rule of Law in the

Administrative State, 115 Colum. L. Rev. 1985, 2010

(2015). As this Court has explained, “[r]eview under

the arbitrary and capricious standard is deferential.”

National Ass’n of Home Builders v. Defenders of

Wildlife, 551 U.S. 644, 658 (2007). A court “will not

vacate an agency’s decision unless it ‘has relied on

factors which Congress had not intended it to consider,

entirely failed to consider an important aspect of the

problem, offered an explanation for its decision that

runs counter to the evidence before the agency, or is so

implausible that it could not be ascribed to a difference

in view or the product of agency expertise.’” Id.

(quoting Motor Vehicles Mfrs. Ass’n of United States,

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

(1983)).

This Court has directed that arbitrary-andcapricious review limits a court’s consideration to

whether “the agency has acted within a zone of

reasonableness and, in particular, has reasonably

considered the relevant issues and reasonably

explained the decision.” FCC v. Prometheus Radio

Project, 592 U.S. 414, 423 (2021).8 See also Biden v.

Missouri et al., 595 U.S. 87, 96 (2022) (per curiam)

(holding it was not was not arbitrary and capricious

8

See generally Congressional Research Service, An

Introduction to Judicial Review of Federal Agency Action, R44699

at 18-21 (Dec. 7, 2016) (summarizing Motor Vehicle

Manufacturers Association v. State Farm Auto Mutual Insurance

Co., 463 U.S. 29, 43 (1983) and other case law about the arbitraryand-capricious standard).

8

for Secretary of Health and Human Services to issue

an interim rule requiring COVID-19 vaccination in

facilities participating in Medicare and Medicaid);

FERC v. Electric Power Supply Ass’n., 577 U.S. 260,

292-295 (2016) (holding it was not arbitrary and

capricious for FERC to issue a rule compensating

electricity users at the same rate as electricity

generators, provided that users commit to reduce their

electricity use during peak periods and pass a netbenefits test); FCC v. Fox Television Stations, Inc., 556

U.S. 502, 513-14 (2009) (holding it was not arbitrary

and capricious for the FCC to change its previous

policy regarding enforcement of its indecency ban).

And in the specific context of “complex chemical and

pharmacological considerations” that are “within the

peculiar expertise” of the FDA, this Court has

emphasized that judges exercise only “‘limited

functions of review.’” Bentex, 412 U.S. at 654 (quoting

Far East Conference v. United States, 342 U.S. 570,

574 (1952)).

Consistent adherence to this Court’s precedents

governing arbitrary-and-capricious review likewise

advances the stability and predictability that is

necessary to the rule of law. The “greatest purpose” of

stare decisis “is to serve a constitutional ideal—the

rule of law.” Citizens United v. FEC, 558 U.S. 310, 378

(2010) (Roberts, C.J., concurring)); see also Stanford

Encyclopedia of Philosophy, The Rule of Law (June 22,

2016) (“The Rule of Law envisages law operating as a

relatively stable set of norms available as public

knowledge.”).9 While this Court, of course, has

discretion to revisit its own precedent when

appropriate, the rule of law requires that the lower

9 Available at https://plato.stanford.edu/entries/rule-of-law/

#RuleLawRuleLaw (last visited Jan. 16, 2024).

9

federal courts practice absolute fidelity to this Court’s

precedents. “[V]ertical stare decisis”—that is, the

lower courts’ obligation to faithfully follow the

precedents of this Court—is “absolute, as it must be in

a hierarchical system with ‘one supreme Court.’”

Ramos v. Louisiana, 140 S. Ct. 1390, 1416 n.5 (2020)

(Kavanaugh, J., concurring in part) (quoting U.S.

Const., Art III, § 1); see also Mallory v. Norfolk S. Ry.

Co., 600 U.S. 122, 136 (2023) (reiterating that “‘[i]f a

precedent of this Court has direct application to a

case,’ . . . a lower court ‘should follow the case which

directly controls . . . .”) (quoting Rodriguez de Quijas v.

Shearson/American Express, Inc., 490 U.S. 477, 484

(1989)); Kurt T. Lash, Originalism, Popular

Sovereignty, and Reverse Stare Decisis, 93 Va. L. Rev.

1437, 1454 (2007) (noting that “vertical stare decisis .

. . provides maximal rule of law benefits”).

All of these elements—predictability, respect for

appropriate congressional delegations to expert

agencies, adherence to this Court’s articulated

standards of judicial review of agency action, and stare

decisis—form the rule-of-law framework of American

administrative law. And together they balance rule-oflaw considerations that can point in different

directions: If judicial review is hamstrung, then

executive actions can be prone to excess or even

lawlessness. But if judicial review becomes so

aggressive that it appears arbitrary or rooted in

personal or political preference, then it too can

undermine public confidence in the judicial system

and the predictability on which Congress, the

Executive Branch, and the people appropriately rely.

10

II.

BY

DEFYING

CONGRESS’S

DELEGATION

OF

SCIENTIFIC

JUDGMENTS

TO

THE

EXPERT

AGENCY AND THE DEFERENTIAL

STANDARD OF REVIEW THIS COURT

HAS

MANDATED,

THE

FIFTH

CIRCUIT UNDERMINED THE RULE

OF LAW AND THE PREDICTABILITY

IT FOSTERS.

The ABA rarely takes a position regarding specific

instances of judicial review of administrative action,

whether in the courts of appeals or this Court. Nor

does the ABA typically weigh in as amicus in litigation

about the FDA’s approval or review of any given drug

applications. But in this case, the courts below

departed substantially from settled principles of

judicial review to substitute their own judgment for

that of the FDA on the specific question of drug safety

and efficacy. In doing so, those decisions implicate

broader rule-of-law concerns by eroding public

confidence in the judicial system and the predictability

and stability of the law. In particular, the Fifth

Circuit: (1) overrode Congress’s decision to delegate

scientific judgments to the FDA and (2) failed to

properly and faithfully apply this Court’s precedent

establishing the deferential standard of review for the

FDA’s decisions.

1.

The Decision Below Defied

Congress’s Decision to Authorize the

FDA, Not the Federal Courts, to

Make Scientific Judgments

Regarding Drug Safety and Efficacy

Congress created the FDA to implement its policy

that Americans should have access to pharmaceutical

drugs that are safe and effective for their intended

uses. See 21 U.S.C. § 393. In doing so, Congress made

11

a considered decision—to which the courts owe

deference—to “grant . . . primary jurisdiction” over the

scientific and medical judgments necessary to ensure

drug safety and effectiveness to an “expert agency.”

Weinberger v. Hynson, Westcott & Dunning, Inc., 412

U.S. 609, 627 (1973). The FDA is staffed by over 12,000

scientists,

including

“biologists,

chemists,

epidemiologists, nurses, pharmacists, [] physicians[,]

social and behavioral scientists, statisticians,

veterinarians, and engineers.” FDA, FDA STEM

Outreach, Education and Engagement (June 8,

2022).10 It implements well-established and rigorous

criteria and procedures for approving drugs,

determining conditions for the prescription and

dispensing of drugs, and removing drugs from the

market if they are later shown not to be safe and

effective. See generally FDA, Development & Approval

Process | Drugs (Aug. 8, 2022).11 The statute creating

the FDA and authorizing its work is explicit that the

FDA make its decisions based on scientific expertise

and evidence. See, e.g., 21 U.S.C. § 355; FDA, Laws,

Regulations, Policies and Procedures for Drug

Applications (Dec. 4, 2014).12

Consistent with the rule of law, Congress also

provided for judicial review of agency decisions, like

those of the FDA. See generally 5 U.S.C. Ch. 7

(establishing judicial review under the Administrative

Procedure Act); infra p. 5-7. Moreover, Congress

10 Available at https://www.fda.gov/science-research/fda-stemoutreach-education-and-engagement (last visited Jan. 22, 2024).

Available at https://www.fda.gov/drugs/developmentapproval-process-drugs (last visited Jan. 16, 2024).

11

12

Available at https://www.fda.gov/drugs/developmentapproval-process-drugs/laws-regulations-policies-andprocedures-drug-applications (last visited Jan. 16, 2024).

12

determined that FDA decisions to approve drugs

should be evaluated under the arbitrary-andcapricious standard of review. 5 U.S.C. § 706(2)(A). As

this Court has explained, that review respects

Congress’s reliance on the FDA’s expertise in

evaluating medical and scientific evidence, precludes

irrational decisions, and promises a stable regulatory

framework.13 In one of the earliest cases involving the

FDA’s authority, for example, this Court recognized

that “[t]he determination whether a drug is generally

recognized as safe and effective . . . necessarily

implicates complex chemical and pharmacological

considerations” that are “within the peculiar

expertise” of the FDA, and over which courts exercise

only “‘limited functions of review.’” Bentex, 412 U.S. at

654 (quoting Far East Conference, 342 U.S. at 574).

After all, as then-Judge Kavanaugh explained, “[a]

court is ill-equipped to second-guess that kind of

agency scientific judgment under the guise of the

APA’s arbitrary and capricious standard.”Cytori

13

See Hynson, 412 U.S. at 624 (“FDA is indeed the

administrative agency selected by Congress to administer the

[Federal Food, Drug, and Cosmetic] Act”); id. at 627 (“The heart

of the new procedures designed by Congress is the grant of

primary jurisdiction to FDA, the expert agency it created”); CIBA

Corp. v. Weinberger, 412 U.S. 640, 643-44 (1973) (where the

question “involves a determination of technical and scientific

questions by experts . . . the agency is therefore appropriately the

arm of Government to make the . . . determination”); id. at 644

(“the Act does not create a dual system of control – one

administrative, and the other judicial”); Bentex, 412 U.S. at 652

(the statutory drug approval provisions “strongly suggest that

Congress desired that the administrative agency make” all drug

regulatory determinations); id. at 653 (“Evaluation of conflicting

reports as to the reputation of drugs among experts in the field is

not a matter well left to a court without chemical or medical

background”).

13

Therapeutics, Inc. v. FDA, 715 F.3d 722, 727 (D.C. Cir.

2013) (Kavanaugh, J.).

In this case, however, the Fifth Circuit did not

follow Congress’s direction. First, contrary to

congressional design, the Fifth Circuit substituted its

judgment for the FDA’s expertise when it rejected

conclusions the FDA drew from scientific evidence. For

example, the Fifth Circuit claimed that because the

FDA “failed to seek data on the cumulative effect” of

several changes it made to the mifepristone risk

evaluation and mitigation strategy (REMS) in 2016,

its decision to allow those changes was arbitrary and

capricious, Pet. 53a. Similarly, the Fifth Circuit held

that the FDA did not have adequate evidence to

support its decisions in 2020 and 2021 to allow remote

prescription of mifepristone. Pet. 59a-63a. But in both

instances, the FDA had substantial amounts of

evidence, “including dozens of scientific studies and

decades of safe use of mifepristone by millions of

women in the United States and around the world,”

Pet. 12, from which it drew its conclusions.

The Fifth Circuit’s second-guessing of the FDA’s

conclusions undermines Congress’s decision to rely on

the FDA’s expertise and this Court’s insistence on

respecting that decision. This Court has long

instructed that because the judiciary typically lacks

scientific expertise, courts reviewing FDA decisions to

approve drugs must respect the FDA’s scientific

determinations. See, e.g., Bentex, 412 U.S. at 464. To

this day, members of this Court continue to insist on

judicial deference to the FDA’s expertise. For example,

Justices Alito and Thomas, in a previous mifepristone

case, criticized a district court judge “[who] took it

upon himself to overrule the FDA on a question of drug

safety . . . [d]isregarding the Chief Justice’s

admonition against judicial second-guessing of

14

officials with public health responsibilities.” FDA v.

American Coll. Of Obstetricians and Gynecologists,

141 S. Ct. 10, 12 (2020) (Alito and Thomas, JJ.,

dissenting). See FDA v. American Coll. Of

Obstetricians and Gynecologists, 141 S. Ct. 578, 579

(2021) (Roberts, C.J., concurring) (reiterating, in a

case involving mifepristone, his previous admonition

that “courts owe significant deference to the politically

accountable entities with the background, competence,

and expertise to assess public health”).

Unlike the Fifth Circuit in this case, other lower

courts have consistently heeded Congress’s and this

Court’s mandate of judicial deference to the FDA’s

medical and scientific expertise. See, e.g., Pharm. Mfg.

Rsch. Serv. v. FDA, 957 F.3d 254, 265 (D.C. Cir. 2020)

(Rao, J.) (“Meaningful review of the agency’s actions

does not require us to step into the FDA’s shoes and

reassess

its

scientific

judgments”);

Cytori

Therapeutics, 715 F.3d at 727; Serono Labs, Inc. v.

FDA, 715 F.3d 722, 727 (D.C. Cir. 1998) (“Neither we,

nor the district judge, are scientists independently

capable of assessing the validity of the agency

determination – beyond holding it to the standards of

rationality required by the Administrative Procedure

Act”); Premo Pharmaceutical Labs., Inc., v. United

States, 629 F.2d 795, 803 (2d Cir. 1980) (“[W]hether

the product . . . is in fact safe and effective . . . is to be

determined by the FDA which, as distinguished from

a court, possesses superior expertise, usually of a

complex scientific nature, for resolving the issue”).

In contrast, in this case, the Fifth Circuit secondguessed the FDA’s scientific findings and imposed its

own conclusions instead of properly examining the

extensive record before the FDA and applying the

arbitrary-and-capricious standard as it applies to the

drug approval context.

15

2.

The Decision Below Defied this

Court’s Precedent Establishing the

Arbitrary-and-Capricious Standard

The Fifth Circuit’s decision also contravenes this

Court’s precedent as to the proper application of

arbitrary-and-capricious review. As outlined above,

infra p. 7-8, the term “arbitrary and capricious” has an

established legal meaning that is distinct from de novo

or reasonableness review.

Here, the Fifth Circuit did not even try to reason

that the FDA “relied on factors which Congress had

not intended it to consider, . . . offered an explanation

for its decision that runs counter to the evidence before

the agency, or is so implausible that it could not be

ascribed to a difference in view or the product of

agency expertise,” Motor Vehicles Mfrs. Ass’n, 463 U.S

at 43. Instead, the Fifth Circuit took the view that the

FDA did not consider the cumulative effects of

loosening restrictions on mifepristone in 2016, Pet.

53a, wrongly changed its collection of non-fatal

adverse events, Pet. 54a-56a, and failed to gather

evidence about the risks of remote prescription, Pet.

63a, 74a-75a.

This is problematic in at least three ways:

First, the Fifth Circuit effectively converted its

inexpert, judicial conclusions that the FDA’s evidence

was inadequate into a claim that the FDA “entirely

failed to consider an important aspect of the problem.”

463 U.S at 43. While the Fifth Circuit might prefer

additional or more precise types of data, that does not

transform its judicial preferences into a legal

conclusion that the FDA “entirely failed to consider”

relevant factors in making a uniquely scientific

judgment. The factual record indicates the contrary.

16

Second, the Fifth Circuit flouted this Court’s

frequent admonition that arbitrary-and-capricious

review is not de novo review of the expert agency’s

conclusions and inferences. Rather, as this Court has

explained, the question for the reviewing court is

whether “the agency has acted within a zone of

reasonableness and, in particular, has reasonably

considered the relevant issues and reasonably

explained the decision.” Prometheus Radio Project, 592

U.S. at 423. The Fifth Circuit’s final published opinion

identified no aspect of the FDA’s determination or

record

that

was

outside

this

“zone

of

reasonableness.”14

Third, the Fifth Circuit’s approach would erode

precedent by allowing a reviewing court to require

highly specific evidence of the court’s choosing rather

than deferring to the FDA’s more informed judgment

as to what evidence is required and the agency’s

reasonable inferences and conclusions informed by the

agency’s scientific expertise. This Court has rejected

such a demanding approach to arbitrary-andcapricious review. For example, in upholding the

Federal Communications Commission’s decision to

tighten restrictions on profanity in broadcasts as part

of its enforcement of Congress’s “determination that

indecency is harmful to children,” the Court explained

14 See also FERC v. Electric Power Supply Ass’n., 577 U.S. 260,

292 (2016) (“In reviewing [the agency’s] decision, we may not

substitute our own judgment for that of the Commission” because

a “court is not to ask whether a regulatory decision is the best one

possible or even whether it is better than the alternatives.

Rather, the court must uphold a rule if the agency has

‘examine[d] the relevant [considerations] and articulate[d] a

satisfactory explanation for the action[,] including a rational

connection between the facts found and the choice made.’”)

(citations omitted).

17

that empirical studies on precisely how much and

what kind of profanity caused harm were unnecessary.

Fox, 556 U.S. at 519. “[I]t suffices to know that

children mimic the behavior they observe—or at least

the behavior that is presented to them as normal and

appropriate.” Id. Neither the Administrative

Procedure Act nor this Court’s precedent on arbitraryand-capricious review empowers the lower courts to

demand that the FDA (or any other expert agency on

which Congress relies to implement its policies)

conduct any particular meta-analysis or collect

particular data on medical risks.

*

*

*

While scientific research and agency decisions can

evolve over time, courts must exercise a careful and

steady hand, especially in the context of revisiting

longstanding drug approvals. The rule of law is served

when the judiciary properly reviews the decisions of a

federal agency. The Administrative Procedure Act

plays an important role in our governmental structure,

and when appropriate, judicial invalidation of

administrative rulings can serve as a valuable check

on agency arbitrariness or overreach. Rule-of-law

principles can be undermined, however, when a court

that lacks any scientific expertise deploys the

Administrative Procedure Act to selectively secondguess the FDA’s exercise of scientific judgment

without any valid basis. For all these reasons, the ABA

respectfully urges the Court to give effect to Congress’s

decision to delegate scientific assessment of drug

safety to the FDA and adhere to the proper standard

of review established in this Court’s precedent.

18

CONCLUSION

For the foregoing reasons, this Court should reverse.

Respectfully submitted,

MARY SMITH

Counsel of Record

AMERICAN BAR ASSOCIATION

PRESIDENT

321 N. Clark St.

Chicago, IL 60654

(312) 988-5000

amicusbriefs@americanbar.org

CAROLYN E. SHAPIRO

SCHNAPPER-CASTERAS PLLC

200 E. Randolph St.

Suite 5100

Chicago, IL 60601

(202) 630-3644

cshapiro@schnappercasteras.com

JOHN PAUL SCHNAPPERCASTERAS

RACHAEL R. YOCUM

SCHNAPPER-CASTERAS PLLC

1717 K Street NW, Suite 900

Washington, D.C. 20006

(202) 630-3644

jpsc@schnappercasteras.com

Counsel for Amicus Curiae

February 2, 2024