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

Supreme Court briefFeb 29, 2024

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Nos. 23-235, 23-236

IN THE

Supreme Court of the United States

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

Petitioners,

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

DANCO LABORATORIES, L.L.C.,

Petitioner,

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

ON WRITS OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT

BRIEF OF AMICI CURIAE SOUTHEASTERN LEGAL

FOUNDATION AND TEXAS PUBLIC POLICY

FOUNDATION IN SUPPORT OF RESPONDENTS

Braden H. Boucek

SOUTHEASTERN LEGAL FOUNDATION

560 W. Crossville Rd., Ste. 104

Roswell, GA 30075

(770) 977-2131

Robert Henneke

TEXAS PUBLIC POLICY FOUNDATION

901 Congress Avenue

Austin, Texas 78701

(512) 472-2700

Thomas R. McCarthy

Counsel of Record

Tiffany H. Bates

ANTONIN SCALIA LAW SCHOOL

ADMINISTRATIVE LAW CLINIC

CONSOVOY MCCARTHY PLLC

1600 Wilson Boulevard

Suite 700

Arlington, VA 22209

(703) 243-9423

tom@consovoymccarthy.com

February 29, 2024

Counsel for Amici Curiae

TABLE OF CONTENTS

TABLE OF AUTHORITIES ....................................... ii

INTEREST OF AMICI CURIAE................................ 1

INTRODUCTION AND SUMMARY OF

THE ARGUMENT ...................................................... 2

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

Staying the effective date of FDA’s unlawful

actions under section 705 of the APA was an

appropriate remedy. ............................................. 4

A. Section 705 allows courts to stay alreadyeffective agency actions and courts routinely do so. .................................................... 4

B. Because the Alliance ultimately seeks vacatur, a stay was an appropriate remedy. .... 8

CONCLUSION ......................................................... 10

TABLE OF AUTHORITIES

Cases

Action on Smoking & Health v. Civil Aeronautics

Bd., 713 F.2d 795 (D.C. Cir. 1983) ........................ 10

Advocs. for Highway & Auto Safety v. Fed. Motor

Carrier Safety Admin.,

429 F.3d 1136 (D.C. Cir. 2005) ................................ 9

BST Holdings, L.L.C. v. OSHA,

17 F.4th 604 (5th Cir. 2021) ................................ 1, 2

Cath. Legal Immigr. Network, Inc. v. Exec. Office

for Immigr. Rev., No. 21-00094, 2021 WL

3609986 (D.D.C. Apr. 4, 2021) ................................. 7

Clean Air Council v. Pruitt,

862 F.3d 1 (D.C. Cir. 2017) ...................................... 7

Ctr. for Biological Diversity v. Regan,

597 F. Supp. 3d 173 (D.D.C. 2022 ........... 3, 4, 6, 7, 8

Holland v. Florida,

560 U.S. 631 (2010) .................................................. 8

In re GTE Serv. Corp.,

762 F.2d 1024 (D.C. Cir. 1985) ................................ 6

Kisor v. Wilkie,

139 S. Ct. 2400 (2019) .............................................. 1

iii

Meeker v. Lehigh Valley R. Co.,

236 U.S. 412 (1915) .................................................. 6

Mexichem Specialty Resins, Inc. v. EPA,

787 F.3d 544 (D.C. Cir. 2015) .................................. 6

Monsanto Co. v. Geertson Seed Farms,

561 U.S. 139 (2010) ............................................ 4, 10

Nat’l Ass’n of Mfrs. v. Dep’t of Def.,

138 S. Ct. 617 (2018) ................................................ 1

Nat’l Fed’n of Indep. Bus. v. OSHA,

142 S. Ct. 661 (2022) ................................................ 7

Nken v. Holder,

556 U.S. 418 (2009) .............................................. 7, 9

Sampson v. Murray,

415 U.S. 61 (1974) .................................................... 5

Scripps-Howard Radio, Inc. v. FCC,

316 U.S. 4 (1942) .................................................. 4, 5

Texas v. Biden,

646 F. Supp. 3d 753 (N.D. Tex. 2022),

appeal dismissed, No. 23-10143, 2023

WL 5198783 (5th Cir. May 25, 2023) .................. 7, 8

Texas v. EPA,

829 F.3d 405 (5th Cir. 2016) .................................... 7

U.S. Dep’t of Energy v. Ohio,

503 U.S. 607 (1992) .................................................. 8

United Steel v. Mine Safety & Health Admin.,

925 F.3d 1279 (D.C. Cir. 2019) ................................ 9

Util. Air Regulatory Grp. v. EPA,

573 U.S. 302 (2014) .................................................. 1

Wages & White Lion Invs., L.L.C. v. FDA,

16 F.4th 1130 (5th Cir. 2021) .................................. 7

West Virginia v. EPA,

577 U.S. 1126 (2016) ................................................ 7

Statutes

5 U.S.C. §705 ........................................... 3, 4, 5, 6, 7, 8

28 U.S.C. §1651(a) ....................................................... 8

Regulations

21 C.F.R. §10.30(e)(2) .................................................. 2

21 C.F.R. §314.500 ....................................................... 2

Other Authorities

1 H. Joyce, A Treatise on the Law Relating to

Inunctions §1 (1909)................................................. 9

Black’s Law Dictionary (6th ed. 1990) ........................ 9

Frank Chang, The Administrative Procedure

Act’s Stay Provision: Bypassing Scylla and

Charybdis of Preliminary Injunctions, 85 Geo.

Wash. L. Rev. 1529 (2017) ................................... 4, 9

Tom C. Clark, Att’y Gen’s Manual on the

Administra-tive Procedure Act 105 (1947) .......... 5, 6

Mila Sohoni, The Power to Vacate a Rule,

88 Geo. Wash. L. Rev. 1121 (2020) .................... 9, 10

INTEREST OF AMICI CURIAE1

Southeastern Legal Foundation, founded in 1976,

is a national, nonprofit legal organization dedicated to

defending liberty and rebuilding the American Republic. For nearly 50 years, SLF has advocated, both in

and out of the courtroom, to protect individual rights

and the framework set forth to protect such rights in

the Constitution. This aspect of its advocacy is reflected in the regular representation of those challenging government overreach and other actions in violation of the constitutional framework. See, e.g., Util. Air

Regulatory Grp. v. EPA, 573 U.S. 302 (2014), and Nat’l

Ass’n of Mfrs. v. Dep’t of Def., 138 S. Ct. 617 (2018).

SLF also regularly files amicus curiae briefs with this

Court about issues of agency overreach and deference.

See, e.g., Kisor v. Wilkie, 139 S. Ct. 2400 (2019).

The Texas Public Policy Foundation is a nonprofit,

nonpartisan research foundation dedicated to promoting and defending liberty, personal responsibility, and

free enterprise throughout Texas and the nation. For

decades, TPPF has worked to advance these goals

through research, policy advocacy, and impact litigation. In pursuit of its broad mission, TPPF has advocated against unconstitutional judicial deference to

unelected bureaucrats through its litigation, in cases

such as BST Holdings, L.L.C. v. OSHA, 17 F.4th 604

1 Pursuant to this Court’s Rule 37.6, counsel for amici curiae

certify that this brief was not authored in whole or in part by

counsel for any party and that no person or entity other than

amici curiae or its counsel has made a monetary contribution to

the preparation or submission of this brief.

(5th Cir. 2021); its public advocacy, both in Texas and

across the country; and amicus briefs such as this one.

INTRODUCTION AND SUMMARY

OF THE ARGUMENT

In 1996, the Population Council—a nonprofit

founded to combat alleged “overpopulation”—filed a

new drug application with the Food and Drug Administration for mifepristone as “part of a two-drug regimen designed to cause abortion.” Pet. App. 6a. In

2000, FDA approved mifepristone under Subpart H,

which allows expedited approval of drugs treating “serious or life-threatening illnesses.” 21 C.F.R. 314.500.

Because of the accelerated approval process, FDA imposed certain post-approval restrictions. Among other

things, these restrictions capped the maximum gestation age for drug administration at seven weeks, required three in-office visits to administer the drugs

and monitor for complications, and required prescribers to report adverse events.

In 2002, the Alliance for Hippocratic Medicine

filed a petition with FDA challenging the 2000 mifepristone approval. The law required FDA to respond

to that petition within “180 days of receipt.” 21 C.F.R.

§10.30(e)(2). But not until 2016—nearly fourteen

years later—did it reject the petition. On the same day

as that rejection, FDA also loosened many of the original restrictions it had imposed on the chemical abortion regimen.

In March 2019, the Alliance filed a new petition

challenging the 2016 loosening of the safety restrictions. Two years later, FDA announced that it

would allow mifepristone to be dispensed through the

mail during the COVID pandemic. And later that

year, FDA finally denied most of the Alliance’s 2019

petition. The Alliance then filed suit seeking to set

aside the FDA’s actions.

Ruling for the Alliance, the district court stayed

the effective dates of FDA’s 2000 approval of mifepristone and all subsequent challenged actions related to

that approval under section 5 of the APA. 5 U.S.C.

§705; Pet. App. 194a-95a. The Fifth Circuit affirmed

that relief in part. App. 43a-44a.

Staying the effective date of FDA’s unlawful actions under section 705 of the APA was an appropriate

remedy. Section 705 expressly authorizes courts to

“postpone the effective date of an agency action.” 5

U.S.C. §705. It separately authorizes the agency to do

the same. Id. FDA reads section 705 to “require[] that

any postponement be contemporaneous with or predate the effective date of the challenged agency action.” FDA Br. at 45. But FDA’s myopic focus on the

word “postpone” is unpersuasive. Only agencies themselves may not stay already effective agency actions

under section 705. For good reason: if agencies could

stay already-effective actions, they could evade the notice-and-comment process that would otherwise be required to modify or suspend a regulatory action that is

already in force. Unlike agencies, however, courts may

and do stay already-effective agency action.

Yet even if this Court accepts FDA’s reading of

“postpone,” it should give effect to section 705’s full

text. Section 705 “confers a broader authority on reviewing courts” than on agencies. Ctr. for Biological

Diversity v. Regan, 597 F. Supp. 3d 173, 205 (D.D.C.

2022). It empowers courts “to postpone the effective

date ... or to preserve status or rights pending conclusion of the review proceedings.” Id. And, unlike an

agency, a court may “issue all necessary and appropriate process” to do so. 5 U.S.C. §705. A stay of an agency

action already in effect fits comfortably within that

power.

Finally, a stay is the correct remedy because the

Alliance ultimately seeks to set aside or vacate the

FDA’s actions. Just as a district court has authority to

enter a preliminary injunction as “the temporary form

of a permanent injunction,” it may also enter a stay as

“the temporary form of vacatur.” Pet. App. 70a. Because vacatur is a “less drastic remedy” than an injunction, the lower courts were well within their power

to choose it. Pet. App. 70a (quoting Monsanto Co. v.

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

ARGUMENT

Staying the effective date of FDA’s unlawful

actions under section 705 of the APA was an

appropriate remedy.

A. Section 705 allows courts to stay alreadyeffective agency actions and courts routinely do so.

The “[c]onventional wisdom is that §705 authorizes a stay.” Frank Chang, The Administrative Procedure Act’s Stay Provision: Bypassing Scylla and Charybdis of Preliminary Injunctions, 85 Geo. Wash. L.

Rev. 1529, 1546 (2017). Before the APA, this Court

recognized stays of agency action as “part of” the federal courts’ “traditional equipment for the administration of justice.” Scripps-Howard Radio, Inc. v. FCC,

316 U.S. 4, 9-11 (1942). The APA then codified the existing equitable powers of federal courts to stay agency

actions. See Sampson v. Murray, 415 U.S. 61, 68 &

n.15 (1974) (explaining section 705 “was primarily intended to reflect existing law”); Tom C. Clark, Att’y

Gen’s Manual on the Administrative Procedure Act 105

(1947) (noting “the function” of section 705 was “to

make judicial review effective”).

Section 705 comprises two sentences, each discussing the types of interim relief a specified actor

may grant while a challenge to an agency action is

pending. The first sentence provides an agency itself

with the power to grant interim relief pending judicial

review by postponing the effective date of an agency

action. See 5 U.S.C. §705 (“When an agency finds that

justice so requires, it may postpone the effective date

of action taken by it, pending judicial review.”).

The second sentence describes the powers of “the

reviewing court” to similarly “postpone the effective

date of an agency action.” Id. But it also provides

courts the additional power to “issue all necessary and

appropriate process” “to preserve status or rights

pending conclusion of the review proceedings.” Id.

(“On such conditions as may be required and to the extent necessary to prevent irreparable injury, the reviewing court, including the court to which a case may

be taken on appeal from or on application for certiorari

or other writ to a reviewing court, may issue all necessary and appropriate process to postpone the effective

date of an agency action or to preserve status or rights

pending conclusion of the review proceedings.”).

As the district court concluded, this language

“plainly authorizes” a court to stay an agency action—

even after the effective date. Pet. App. 194a. It “confers upon every ‘reviewing court’ discretionary authority to stay agency action pending judicial review ‘to the

extent necessary to prevent irreparable injury.’”

Clark, supra, 105; see also In re GTE Serv. Corp., 762

F.2d 1024, 1026 (D.C. Cir. 1985) (section 705 provides

“statutory authority to stay agency orders pending review”); Mexichem Specialty Resins, Inc. v. EPA, 787

F.3d 544, 562 (D.C. Cir. 2015) (Kavanaugh, J., dissenting in part) (“Section 705 of the APA authorizes courts

to stay agency rules pending judicial review without

any time limit on the duration of the stay.”).

Yet FDA argues a stay is the wrong remedy. It contends that a court cannot “postpone” the “effective

date of actions that became effective years before the

litigation began.” FDA Br. at 45. In the government’s

view, section 705 “requires that any postponement be

contemporaneous with or predate the effective date of

the challenged agency action; otherwise there would

be no way for a court to postpone that effective date.”

Id. But FDA’s myopic focus on the word “postpone” is

unpersuasive. See, e.g., Meeker v. Lehigh Valley R. Co.,

236 U.S. 412, 424-425 (1915) (describing how Congress “postponed” the effective date of a statute after

that date had passed). Only agencies themselves may

not stay already-effective agency actions under section

705. “[O]nce a rule has taken effect, the agency can no

longer ‘put off’ the effective date; it can only rescind or

modify it.” Ctr. for Biological Diversity, 597 F. Supp.

3d at 205 (emphasis added).

That the APA gives courts—but not agencies—the

power to stay already-effective agency actions makes

sense. First, this “greater limitation on agencies exists

because ‘agencies are creatures of statute’” and “‘possess only the authority that Congress has provided.’”

Texas v. Biden, 646 F. Supp. 3d 753, 770 (N.D. Tex.

2022), appeal dismissed, No. 23-10143, 2023 WL

5198783 (5th Cir. May 25, 2023) (quoting Nat’l Fed’n

of Indep. Bus. v. OSHA, 142 S. Ct. 661, 665 (2022)).

Second, if agencies could stay already-effective actions, they could evade the notice-and-comment process that would otherwise be required to make

changes to an extant rule or policy. See, e.g., Ctr. for

Biological Diversity, 597 F. Supp. 3d. at 204 (“[I]t is

one thing to permit an agency to stay an administrative decision pending judicial review in order to maintain the status quo, but something altogether different

to alter the status quo without providing an opportunity for notice and comment.”). Indeed, an agency

order “delaying [a] rule’s effective date … [is] tantamount to amending or revoking a rule[,]” which must

go through notice and comment. Clean Air Council v.

Pruitt, 862 F.3d 1, 6 (D.C. Cir. 2017).

Unlike agencies, courts may—and routinely do—

stay already-effective agency actions. See, e.g., West

Virginia v. EPA, 577 U.S. 1126 (2016) (staying EPA’s

Clean Power Plan after 29 states moved for a stay under section 705); Wages & White Lion Invs., L.L.C. v.

FDA, 16 F.4th 1130, 1135 (5th Cir. 2021); Texas v.

EPA, 829 F.3d 405, 410-11 (5th Cir. 2016); Texas v.

Biden, 646 F. Supp. 3d at 771; Cath. Legal Immigr.

Network, Inc. v. Exec. Office for Immigr. Rev., No. 2100094, 2021 WL 3609986 at *4 (D.D.C. Apr. 4, 2021).

And even when courts do not explicitly cite section

705, they may use their equitable powers to issue a

stay. See Nken v. Holder, 556 U.S. 418, 421 (2009); see

also Holland v. Florida, 560 U.S. 631, 646 (2010) (noting courts do “not construe a statute to displace courts’

traditional equitable authority absent the clearest

command.”) (cleaned up). Indeed, the All Writs Act

“‘preserves’ courts’ authority to issue such stays.”

Texas, 646 F. Supp. 3d at 771; 28 U.S.C. §1651(a).

Even if this Court accepts FDA’s reading of “postpone,” it should give effect to section 705’s full text. See

U.S. Dep’t of Energy v. Ohio, 503 U.S. 607, 630 (1992)

(White, J., concurring in part) (“It is axiomatic that a

statute should be read as a whole.”). Section 705 “confers a broader authority on reviewing courts” than on

agencies. Ctr. for Biological Diversity, 597 F. Supp. 3d

at 205. It empowers courts “to postpone the effective

date ... or to preserve status or rights pending conclusion of the review proceedings.” Id. And, unlike an

agency, a court may “issue all necessary and appropriate process” to do so. 5 U.S.C. §705. Because “Congress

use[d] different language in the very same section” of

the statute to give courts broader powers, this Court

“should assume that it intended that difference to

have some meaning.” Ctr. for Biological Diversity, 597

F. Supp. 3d at 205. A stay of an agency action already

in effect fits comfortably within that power.

B. Because the Alliance ultimately seeks vacatur, a stay was an appropriate remedy.

A stay is the correct remedy because the Alliance

ultimately seeks to set aside or vacate the FDA’s actions. Just as a district court has authority to enter a

preliminary injunction as “the temporary form of a

permanent injunction,” it may also enter a stay as “the

temporary form of vacatur.” Pet. App. 70a.

Stays and preliminary injunctions are not “one

and the same.” Nken, 556 U.S. at 434. Indeed, they

differ in a crucial way: “stays act on the proceeding”

while “preliminary injunctions act on the person.”

Chang, supra, at 1546; see also Nken, 556 U.S. at 428

(“[A]n injunction is a judicial process or mandate operating in personam” (quoting 1 H. Joyce, A Treatise

on the Law Relating to Inunctions §1 (1909)); Nken,

556 U.S. at 428 (an injunction “tells someone what to

do or not to do … [,] directs the conduct of a party, and

does so with the backing of [the court’s] full coercive

powers”); id. at 428 (a stay “halt[s] or postpone[s] some

portion of the proceeding” or “temporarily divest[s] an

order of enforceability” (citing Stay, Black’s Law Dictionary 1413 (6th ed. 1990)). So while both an injunction and a stay can prevent “some action before the legality of that action has been conclusively determined[,]” an injunction “direct[s] an actor’s conduct”

but a stay “temporarily suspend[s] the source of authority to act.” Nken, 556 U.S. at 428-29.

Suspending FDA’s authority to act is the Alliance’s goal here. “[U]nsupported agency action normally warrants vacatur.” Advocs. for Highway & Auto

Safety v. Fed. Motor Carrier Safety Admin., 429 F.3d

1136, 1151 (D.C. Cir. 2005). And the “ordinary practice” is to “vacate unlawful agency action.” United

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

1287 (D.C. Cir. 2019). Vacatur “does not order the defendant to do anything; it only removes the source of

the defendant’s authority.” Pet. App. 70a (citing Nken,

556 U.S. at 428-29). Indeed, “[w]hen a court holds on

the merits that a rule is unlawful and should be ‘set

aside,’ the rule is vacated, and thereafter cannot be

applied to anyone.” Mila Sohoni, The Power to Vacate

a Rule, 88 Geo. Wash. L. Rev. 1121, 1131 (2020) (citing

Action on Smoking & Health v. Civil Aeronautics Bd.,

713 F.2d 795, 797 (D.C. Cir. 1983) (“To ‘vacate,’ as the

parties should well know, means ‘to annul; to cancel or

rescind; to declare, to make, or to render, void; to defeat; to deprive of force; to make of no authority or validity; to set aside.’”)). Because vacatur is a “less drastic remedy” than an injunction, the lower courts were

well within their power to choose it. Pet. App. 70a

(quoting Monsanto Co., 561 U.S. 139 at 165 (2010)).

CONCLUSION

For these reasons, the Court should affirm the decision below.

Respectfully submitted,