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

Supreme Court briefJan 23, 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 FOR DANCO LABORATORIES, LLC

PHILIP KATZ

LYNN W. MEHLER

HOGAN LOVELLS US LLP

555 13th Street, N.W.

Washington, D.C. 20004

EVA M. SCHIFINI

HOGAN LOVELLS US LLP

1999 Avenue of the Stars

Suite 1400

Los Angeles, CA 90067

JESSICA L. ELLSWORTH

Counsel of Record

CATHERINE E. STETSON

JO-ANN TAMILA SAGAR

DANIELLE DESAULNIERS STEMPEL

MARLAN GOLDEN

DANA A. RAPHAEL

HOGAN LOVELLS US LLP

555 13th Street, N.W.

Washington, D.C. 20004

(202) 637-5600

jessica.ellsworth@hoganlovells.com

Counsel for Danco Laboratories, LLC

QUESTIONS PRESENTED

In 2000, the Food and Drug Administration (FDA)

approved Danco’s drug Mifeprex for termination of

early pregnancy based on the agency’s expert

judgment that clinical data showed the drug to be safe

and effective. The agency later modified certain

conditions of use for mifepristone in 2016 and 2021,

again relying on clinical data and the agency’s expert

judgment that the drug would remain safe and

effective under the modified conditions of use. In

2022, associations of doctors who have never

prescribed Mifeprex sued FDA, arguing that FDA’s

actions modifying the drug’s conditions of use in 2016

and 2021 violated the Administrative Procedure Act.

The questions presented are:

1. Whether an association can demonstrate Article

III standing to enjoin a government action by arguing

that some unspecified member may be injured at some

future time by the challenged action; and

2. Whether the Fifth Circuit erred in upholding the

preliminary injunction of FDA’s 2016 and 2021

actions based on the court’s review of an incomplete

administrative record.

(i)

PARTIES TO THE PROCEEDING

Petitioners in this Court are Danco Laboratories,

LLC, which was an intervenor-appellant below, and

the U.S. FDA; Robert M. Califf, M.D., in his official

capacity as Commissioner of Food and Drugs; Janet

Woodcock, M.D., in her official capacity as Deputy

Commissioner of Food and Drugs; Patrizia Cavazzoni,

M.D., in her official capacity as Director of FDA’s

Center for Drug Evaluation and Research; the U.S.

Department of Health and Human Services (HHS);

and Xavier Becerra, in his official capacity as

Secretary of HHS, which were defendants-appellants

below.

Respondents were plaintiffs-appellees below.

They are Alliance for Hippocratic Medicine; American

Association of Pro-Life Obstetricians & Gynecologists;

American College of Pediatricians; Christian Medical

& Dental Associations; Shaun Jester, D.O.; Regina

Frost-Clark, M.D.; Tyler Johnson, D.O.; and George

Delgado, M.D.

iii

CORPORATE DISCLOSURE STATEMENT

Pursuant to Supreme Court Rule 29.6, Danco

Laboratories, LLC hereby states that it is a whollyowned subsidiary of Danco Investors Group, LP. No

publicly held corporation owns 10% or more of the

stock of either entity.

RELATED PROCEEDINGS

Supreme Court of the United States (U.S.):



Danco Laboratories, LLC v. Alliance for

Hippocratic Medicine, et al., No. 22A901 (Apr. 21,

2023) (granting application for stay)



Food & Drug Administration, et al. v. Alliance for

Hippocratic Medicine, et al., No. 22A902 (Apr. 21,

2023) (granting application for stay)



Alliance for Hippocratic Medicine, et al. v. Food

& Drug Administration, et al., No. 23-395 (Dec.

13, 2023) (denying conditional cross-petition for

certiorari)

United States Court of Appeals (5th Cir.):



Alliance for Hippocratic Medicine, et al. v. U.S.

Food & Drug Administration et al., No. 23-10362

(Aug. 16, 2023) (partially affirming grant of

preliminary injunction)



Alliance for Hippocratic Medicine, et al. v. U.S.

Food & Drug Administration et al., No. 23-10362

(Apr. 12, 2023) (partially granting and partially

denying stay pending appeal)

United States District Court (N.D. Tex.):



Alliance for Hippocratic Medicine, et al. v. U.S.

Food & Drug Administration et al., No. 2:22-cv223 (Apr. 7, 2023) (granting preliminary

injunction)

TABLE OF CONTENTS

Page

QUESTIONS PRESENTED ....................................... i

PARTIES TO THE PROCEEDING ........................... ii

CORPORATE DISCLOSURE STATEMENT .......... iii

RELATED PROCEEDINGS ..................................... iv

TABLE OF AUTHORITIES.................................... viii

INTRODUCTION ....................................................... 1

OPINIONS BELOW ................................................... 4

JURISDICTION ......................................................... 4

STATUTORY PROVISIONS INVOLVED ................ 4

STATEMENT OF THE CASE ................................... 4

A. Statutory And Regulatory Background .......... 4

B. Factual Background ........................................ 6

1. 2016 sNDA Approval And Labeling

Changes ......................................................... 6

i. Prescribing information: dosing

and gestational age .................................. 6

ii. Number of in-person clinical visits

and prescribing providers........................ 8

iii. Adverse-event reporting ......................... 10

2. 2021 Non-Enforcement Decisions

And 2023 REMS .......................................... 11

C. Procedural History ........................................ 12

SUMMARY OF ARGUMENT ................................... 15

ARGUMENT ............................................................. 19

I. RESPONDENTS LACK STANDING.................. 19

TABLE OF CONTENTS—Continued

Page

A. No Association Member Faces Certainly

Impending Injury From FDA’s 2016 Or

2021 Actions................................................... 19

1. Respondents Rely On Statistics Rather

Than Identifying An Association Member

Facing Actual, Imminent Injury ................ 20

2. Respondents’ Speculative Claims Of

Future Injury Depend On Attenuated

Chains Of Third Parties’ Choices ............... 24

3. Respondents Offer No Facts Showing

Their Asserted Injuries Ever Occurred ...... 27

B. Respondents’ Alleged Injuries Are Not

Traceable To FDA’s 2016 Or 2021 Actions

Or Redressable By This Court ...................... 29

C. Ruling For Respondents Would Require

Fundamentally Rewriting Standing

Doctrine .......................................................... 33

II. RESPONDENTS’ MERITS ARGUMENTS

FAIL ..................................................................... 35

A. Respondents Cannot Obtain Relief

Without The Administrative Record............. 36

B. The Existing Record Shows FDA’s 2016

And 2021 Actions Were Reasonable And

Reasonably Explained, As Required By

The APA ......................................................... 38

1. FDA Carefully Analyzed And

Reasonably Explained Its Approval Of

Changes To Mifeprex’s Labeling ................ 39

2. FDA Lawfully Changed The AdverseEvent Reporting Requirements In 2016 .... 45

vii

TABLE OF CONTENTS—Continued

Page

3. FDA’s Actions In 2021 Were Not

Arbitrary And Capricious ........................... 48

C. The Equities Favor Danco ............................. 52

CONCLUSION ......................................................... 54

viii

TABLE OF AUTHORITIES

Page(s)

CASES:

A.L. Pharma, Inc. v. Shalala,

62 F.3d 1484 (D.C. Cir. 1995) .............................. 39

Am. Bankers Ass’n v. Nat’l Credit Union

Admin.,

271 F.3d 262 (D.C. Cir. 2001) .............................. 38

Am. Bioscience, Inc. v. Thompson,

243 F.3d 579 (D.C. Cir. 2001) .............................. 38

Apache Corp. v. FERC,

627 F.3d 1220 (D.C. Cir. 2010) ............................ 39

Bennett v. Spear,

520 U.S. 154 (1997) ........................................ 30, 31

Bowman Transp., Inc. v. Ark.–Best Freight

Sys., Inc.,

419 U.S. 281 (1974) .............................................. 48

Bristol-Myers Squibb Co. v. Shalala,

91 F.3d 1493 (D.C. Cir. 1996) .............................. 35

California v. Texas,

141 S. Ct. 2104 (2021) .................................... 30, 32

Citizens to Pres. Overton Park, Inc. v. Volpe,

401 U.S. 402 (1971) .................................. 17, 36, 38

City of Los Angeles v. Lyons,

461 U.S. 95 (1983) .......................................... 16, 19

Clapper v. Amnesty Int’l USA,

568 U.S. 398 (2013) ................ 16, 17, 19, 27, 30, 31

Coal. for Mercury-Free Drugs v. Sebelius,

671 F.3d 1275 (D.C. Cir. 2012) ............................ 35

Cytori Therapeutics, Inc. v. FDA,

715 F.3d 922 (D.C. Cir. 2013) .............................. 39

TABLE OF AUTHORITIES—Continued

Page(s)

Dep’t of Com. v. New York,

139 S. Ct. 2551 (2019) .......................................... 31

Dobbs v. Jackson Women’s Health Org.,

597 U.S. 215 (2022) .............................................. 23

FCC v. Prometheus Radio Project,

592 U.S. 414 (2021) .......... 17, 36, 39, 40, 43, 48, 51

FDA v. Brown & Williamson Tobacco Corp.,

529 U.S. 120 (2000) .............................................. 35

Friedman v. FAA,

890 F.3d 1092 (D.C. Cir. 2018) ............................ 43

Gonzales v. O Centro Espirita Beneficente

Uniao do Vegetal,

546 U.S. 418 (2006) .............................................. 38

Hunt v. Wash. State Apple Advert. Comm’n,

432 U.S. 333 (1977) ........................................ 19, 20

In re Polar Bear ESA Listing & Section 4(d)

Rule Litig.--MDL No. 1993,

709 F.3d 1 (D.C. Cir. 2013) .................................. 52

In re United States,

583 U.S. 29 (2017) ................................................ 38

Lewis v. Casey,

518 U.S. 343 (1996) .............................................. 32

Lujan v. Defs. of Wildlife,

504 U.S. 555 (1992) .......... 17, 19, 21, 29, 30, 33, 35

Marsh v. Or. Nat. Res. Council,

490 U.S. 360 (1989) .................................. 46, 47, 50

Merck Sharp & Dohme Corp. v. Albrecht,

139 S. Ct. 1668 (2019) .......................................... 35

TABLE OF AUTHORITIES—Continued

Page(s)

Monsanto Co. v. Geertson Seed Farms,

561 U.S. 139 (2010) .............................................. 35

Motor Vehicle Mfrs. Ass’n v. State Farm

Mut. Auto. Ins. Co.,

463 U.S. 29 (1983) .......................................... 35, 43

Mut. Pharm. Co. v. Bartlett,

570 U.S. 472 (2013) ................................................ 4

Simon v. E. Ky. Welfare Rts. Org.,

426 U.S. 26 (1976) ................................................ 33

Steel Co. v. Citizens for a Better Env’t,

523 U.S. 83 (1998) ................................................ 33

Summers v. Earth Island Instit.,

555 U.S. 488 (2009) ................ 16, 20, 21, 22, 23, 29

Transp. Div. of Int’l Ass’n of Sheet Metal,

Air, Rail v. Fed. R.R. Admin.,

40 F.4th 646 (D.C. Cir. 2022) .............................. 48

TransUnion LLC v. Ramirez,

594 U.S. 413 (2021) ........................................ 32, 34

United States v. Rutherford,

442 U.S. 544 (1979) ................................................ 5

United States v. Texas,

599 U.S. 670 (2023) .............................................. 34

Vt. Yankee Nuclear Power Corp. v. NRDC,

435 U.S. 519 (1978) ........................................ 36, 44

Winter v. Nat. Res. Def. Council, Inc.,

555 U.S. 7 (2008) .................................................. 29

STATUTES AND REGULATIONS:

5 U.S.C. § 706 ........................................................ 2, 36

TABLE OF AUTHORITIES—Continued

Page(s)

21 U.S.C. § 331(d) ........................................................ 4

21 U.S.C. § 355(a) .................................................. 4, 53

21 U.S.C. § 355(d) .......................... 5, 41, 42, 43, 44, 54

21 U.S.C. § 355(d)(5) ................................................. 39

21 U.S.C. § 355-1(a)................................................... 45

21 U.S.C. § 355-1(a)(1) ............................................ 3, 5

21 U.S.C. § 355-1(d)................................................... 46

21 U.S.C. § 355-1(f) ................................................... 45

21 U.S.C. § 355-1(f)(1) ......................................... 48, 49

21 U.S.C. § 355-1(f)(2) ............................................... 52

21 U.S.C. § 355-1(f)(3) ................................................. 5

21 U.S.C. § 355-1(g) ................................................... 42

21 U.S.C. § 355-1(g)(2)(B) ......................................... 46

21 U.S.C. § 355-1(g)(2)(C) ......................................... 46

21 U.S.C. § 355-1(g)(4) ........................ 5, 41, 43, 44, 52

21 U.S.C. § 355-1(g)(4)(A) ................................... 39, 42

21 U.S.C. § 355-1(g)(4)(B) ......................................... 49

21 U.S.C. § 356a .............................................. 5, 42, 53

21 U.S.C. § 356a(b) .............................................. 41, 42

28 U.S.C. § 1254(1) ...................................................... 4

42 U.S.C. § 238n ........................................................ 28

42 U.S.C. § 300a-7(c) ................................................. 28

42 U.S.C. § 300a-7(d)................................................. 28

Consolidated Appropriations Act, Pub. L.

No. 117-103, Div. H, Tit. V, § 506 (2022) ............ 28

Ga. Code § 16-12-141(b) (2019) ................................. 23

xii

TABLE OF AUTHORITIES—Continued

Page(s)

Ga. Code § 31-9A-3 (2020)......................................... 23

Ind. Code § 16-34-2-1 (2021) ..................................... 23

Ind. Code § 16-34-2-1.1(a)(5) (2022) ......................... 23

Ind. Code § 25-1-9.5-0.5 (2021) ................................. 23

Tex. Health & Safety Code § 171.204 (2021) ........... 23

Tex. Health & Safety Code § 171.063 (2021) ........... 23

21 C.F.R. § 314.70 ....................................................... 5

21 C.F.R. § 314.70(b) ................................................. 53

21 C.F.R. § 314.80 ............................................... 11, 46

21 C.F.R. § 314.81 ............................................... 11, 46

21 C.F.R. § 314.105(c) ................................................. 5

73 Fed. Reg. 16,313 (Mar. 27, 2008) ........................... 6

OTHER AUTHORITIES:

AAPLOG, Join AAPLOG Today!,

https://aaplog.org/become-a-member/

(last visited Jan. 23, 2024)................................... 26

Ctr. for Drug Evaluation & Rsch., Approval

Package for: Application Number

020687Orig1s025 (Jan. 3, 2023),

https://www.accessdata.fda.gov/drugsatf

da_docs/nda/2023/020687Orig1s025.pdf ............. 12

FDA, Approved Risk Evaluation and Mitigation

Strategies (REMS),

https://www.accessdata.fda.gov/scripts/cder/re

ms/index.cfm (last visited Jan. 23, 2024) ............ 46

xiii

TABLE OF AUTHORITIES—Continued

Page(s)

FDA, FDA’s Drug Review Process:

Continued (2015),

https://www.fda.gov/drugs/informationconsumers-and-patients-drugs/fdasdrug-review-process-continued.............................. 4

FDA, Lotronex sNDA Approval (Sept. 8, 2023),

https://www.accessdata.fda.gov/drugsatfda_

docs/appletter/2023/021107Orig1s030ltr.pdf ...... 51

FDA, MedWatch Online Voluntary

Reporting Form,

https://www.accessdata.fda.gov/scripts/

medwatch/ (last visited Jan. 23, 2024) ................ 10

FDA, Mifeprex Prescriber Agreement Form

(Mar. 2023),

https://www.accessdata.fda.gov/drugsatfda_

docs/rems/Mifepristone_2023_03_23_Prescr

iber_Agreement_Form_for_Danco_Laborato

ries_LLC.pdf ......................................................... 25

FDA, Mifeprex Prescribing Information

(Jan. 2023),

https://www.accessdata.fda.gov/drugsatfda

_docs/label/2023/020687Orig1s025Lbl.pdf .......... 10

FDA, REMS Single Shared System for

Mifepristone 200 mg (Mar. 2023),

https://www.accessdata.fda.gov/drugsatfda_

docs/rems/Mifepristone_2023_03_23_REMS

_Full.pdf ................................................................. 11

Nadia N. Sawicki, Protections from Civil

Liability in State Abortion Conscience

Laws, 322 J. Am. Med. Ass’n 1918 (2019)........... 28

IN THE

Supreme Court of the United States

Nos. 23-235, 23-236

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 FOR DANCO LABORATORIES, LLC

INTRODUCTION

Millions of women have safely and effectively used

mifepristone in the nearly two and a half decades

since FDA approved it for the termination of early

pregnancy. Respondents are doctors and associations

of doctors who do not prescribe mifepristone. They are

opposed to all forms of abortion and would prefer if

mifepristone were not available for other healthcare

providers to prescribe. At their request, the Fifth

Circuit upheld a preliminary injunction upending—

years after the fact—FDA’s 2016 and 2021 actions

(1)

relating to mifepristone’s approved labeling and

conditions of use. This injunction is unprecedented.

The questions presented are not hard under

existing precedent. They do not ask the Court to wade

into a politically charged debate around abortion. The

same rules govern here that govern any challenge to

agency action by any plaintiff.

This Court’s

precedents therefore make short work of this case.

First, Respondents lack standing. The court of

appeals

held

that

Respondents

established

associational standing by showing that other

healthcare providers prescribe mifepristone to women

who might someday seek care in an emergency room

where some member of a Respondent association

might be asked to provide some sort of postmedication-abortion care. Respondents’ speculative

claims of injury to unknown association members

based on attenuated chains of unknown third parties’

actions and circumstances satisfy none of the Article

III standing requirements.

Second, Respondents presented no valid basis to

enjoin FDA’s reasonable and reasonably explained

decision to modify requirements related to

mifepristone’s use in 2016 and 2021. Although a

court’s deferential review of agency action requires

evaluating “the whole record,” 5 U.S.C. § 706, the

Fifth Circuit rushed to enjoin FDA’s actions without

the entirety of the documents on which FDA based its

decisions. Yet, even the subset of administrativerecord documents before the court contained

hundreds of pages of careful assessment of the

scientific and data-driven basis for each of FDA’s

conclusions. Neither Respondents’ disagreement with

those conclusions, nor the lower courts’ picayune

quarrels with FDA’s exercise of predictive judgment,

support entry of this unprecedented injunction.

The Fifth Circuit ran roughshod over this Court’s

precedents. Those errors have serious consequences.

The court’s standing analysis would give medical

organizations standing to challenge virtually every

government regulation that touches on health or

safety.

And its merits analysis threatens to

destabilize the pharmaceutical industry, which relies

both on FDA’s ability to make predictive judgments

and on courts not second-guessing those scientific

judgments. PhRMA Cert. Br. 19-21; Pharm. Cos.

Cert. Br. 20-22.

This Court should now reverse. These same

analytical

shortcomings

and

industry-wide

repercussions were before the Court at the emergency

stay stage, and this Court granted emergency stay

relief. The Fifth Circuit merits panel then doubled

down on the same injunction this Court had already

stayed. Reversal will not foreclose FDA’s continued

real-world evaluation of the use restrictions

“necessary to ensure that the benefits of the drug

outweigh the risks of the drug,” 21 U.S.C.

§ 355-1(a)(1)—the same standard FDA applies to

every drug with use restrictions. Nor will it pass

judgment on the validity of any individual State’s

laws addressing access to abortion care. It will simply

ensure that the claims brought by these would-be

litigants are assessed under the same standards this

Court has consistently said govern federal jurisdiction

and questions of administrative law. And under those

standards, this case is straightforward to resolve in

favor of Danco and the government.

OPINIONS BELOW

The Fifth Circuit’s opinion is reported at 78 F.4th

210 (5th Cir. 2023). Pet. App. 1a-110a.1 The District

Court’s memorandum opinion and order is reported at

___ F. Supp. 3d ___, and available at 2023 WL

2825871 (N.D. Tex. Apr. 7, 2023). Pet. App. 111a195a.

JURISDICTION

The Fifth Circuit entered judgment on August 16,

2023. This Court has jurisdiction under 28 U.S.C.

§ 1254(1).

STATUTORY PROVISIONS INVOLVED

Pertinent provisions are set out in FDA’s Petition

Appendix. See Pet. App. 249a-254a.

STATEMENT OF THE CASE

A. Statutory And Regulatory Background

The Food, Drug, and Cosmetic Act (FDCA)

prohibits the “marketing [of] any drug in interstate

commerce” absent FDA approval. Mut. Pharm. Co. v.

Bartlett, 570 U.S. 472, 476 (2013) (citation omitted);

see 21 U.S.C. §§ 355(a), 331(d). Once a new drug

application (NDA) is filed, a team of “medical doctors,

chemists,

statisticians,

microbiologists,

pharmacologists, and other experts * * * evaluates

whether the studies the sponsor submitted show that

the drug is safe and effective for its proposed use.”

FDA, FDA’s Drug Review Process: Continued (2015).2

Because “[f]ew if any drugs are completely safe in

the sense that they may be taken by all persons in all

For consistency, citations are to FDA’s Petition Appendix.

https://www.fda.gov/drugs/information-consumers-andpatients-drugs/fdas-drug-review-process-continued.

circumstances without risk,” in this context, “safe”

means that “the expected therapeutic gain justifies

the risk entailed by its use.” United States v.

Rutherford, 442 U.S. 544, 555 (1979); see 21 U.S.C.

§ 355(d). If FDA determines “upon the basis of the

information submitted” or otherwise “before” the

agency that the drug is “safe for use” and there is

“substantial evidence that the drug will have the

effect it purports or is represented to have,” FDA

“shall” approve the drug. 21 U.S.C. § 355(d); see 21

C.F.R. § 314.105(c).

Once a drug is approved, a pharmaceutical

manufacturer wishing to make dosing or other

changes to the drug’s labeling must typically submit a

supplemental new drug application (sNDA) and

obtain FDA’s approval. 21 U.S.C. §§ 355(d), 356a; see

21 C.F.R. § 314.70. Applications proposing a new

indication or change to the dosing regimen undergo

the same rigorous review process as NDAs. See FDA

Scholars Cert. Br. 3-4.

FDA may also impose certain use restrictions on

drugs through its Risk Evaluation and Mitigation

Strategy (REMS) authority if “necessary to ensure

that the benefits of the drug outweigh” its risks. 21

U.S.C. § 355-1(a)(1). Under its REMS authority, FDA

may (among other things) require prescribers,

pharmacies, or health care settings that dispense the

drug to be certified.

Id. § 355-1(f)(3).

Those

restrictions can later be “modified” or “removed” if

FDA determines they are no longer necessary to

ensure the drug’s benefits outweigh any risks. Id.

§ 355-1(g)(4).

B. Factual Background

Danco, a small pharmaceutical company

incorporated in Delaware, holds the NDA for Mifeprex

(mifepristone) Tablets for use in a regimen with

misoprostol for the medical termination of

intrauterine pregnancy.

FDA first approved Mifeprex in 2000. FDA

imposed certain use restrictions with that approval,

including that the drug be dispensed by a doctor inperson and that patients have an in-person follow-up

appointment. Those use restrictions were deemed a

REMS by the 2007 amendments to the FDCA. See 73

Fed. Reg. 16,313 (Mar. 27, 2008). The statute also

required Danco to submit an sNDA for its REMS,

which Danco did and which FDA approved in 2011.

ROA 672-675.3

1. 2016 sNDA

Changes

Approval

And

Labeling

In 2015, Danco submitted an sNDA to modify

certain aspects of Mifeprex’s prescribing information

and REMS. FDA approved these changes after

considering dozens of studies reporting the outcomes

for tens of thousands of women under various

combinations of the proposed changes and 15 years of

data reflecting the drug’s safety profile.

Prescribing information:

gestational age

dosing

and

FDA approved lowering the mifepristone dose from

600 to 200 milligrams (mg) and increasing the

misoprostol dose from 400 to 800 micrograms (mcg),

changing the misoprostol route of administration from

References to “ROA” are to the Record on Appeal in the Fifth

Circuit.

oral to buccal (in the cheek pouch), changing the

dosing time interval between Mifeprex and

misoprostol from 48 hours to 24-48 hours, and

extending the approved gestational age from 49 to 70

days. FDA considered 22 studies of over 35,000

women supporting this new dosing regimen, J.A. 446450, and seven studies of 934 women supporting

increasing the gestational-age cutoff, many of which

also used the proposed dosing regimen, J.A. 455-456.

FDA summarized these studies in the following

tables, reflecting that "97.4% (US) and 96.1% (nonUS)" of the patients required no further intervention.

J.A. 449. These data showed "that the proposed new

dosing regimen is considerably more effective for all

gestations through 70 days"—meaning fewer women

needed additional intervention such as a surgical

abortion—as compared to the data supporting the

initial approval through 49 days. J.A. 451.

Table 3: Efficacy- Mifepristone 200 mg with Buccal Misoprostol 800 mcg 24-48

Hours Later - US Studies

Study &Year

Design,

Location

Gestation

(maximum

days)

M-M Interval

(hrs)

Evaluable

Subjects (N)

Success • no

Intervention (%)

Middleton 2005'

Prospective

24-48

216

94.9

Winikoff 2008"

Prospective

24-36

421

96.2

Fjerstad 2009'

Retrospective

24-48

1,349

98.3

Grossman 201136

US - Clinic Mife v.

Tele-med

Prospective

24-48

449

Winikoff 2012"

Getter 201573

Chong 2015"

TOTALS

Clinic: 96.9%

Telemed: 98.7%

Prospective

57-70

24-48

629

93.2

Retrospective

24-48

13,373

97.7

Prospective

7 Studies

24-48

357

96.7

56-70 days

24-48 hr

16,794

97.4

Source: Modified from Table 3, page 14 15, Chen-Cre nin 2015 Review and submitted articles. All

subjects had 200 mg oral mifepristone followed by 800 mcg buccal misoprostol.

Success percentages calculated by clinical reviewer.

Table 4: Efficacy- Mifepristone 200 mg with Buccal Misoprostol 800 mcg 24-48

Hours Later- Non- US Studies

Study &YearlCountry

Design,

Location

Alam 201337

Bangladesh

Prospective

Gestation

(maximum)

M-M Interval

(hre)

Evaluable

Subjects (N)

Success - no

intervention (%)

629

92.7

Blum 2012T0

Prospective

210

92.9

Boerema 201122

Curacao

Prospective

24-48

307

97,7

Chal 2013" Hong Kong

Prospective

95.6

Dahiya 2012" India

Prospective

Chong 2012°

Georgia, Vietnam

Prospective

36-48

560

96.4

Girl 2011"

Prospective

93.6

Goldstone 2012"

Australia

Retrospective

24-48

11,155

96.5

Louie 2014"

Azerbaijan

Prospective

24-48

863

97.3

Nepal

Ngo 201242

China

Retrospective

36-48

167

91.0

Ngoc 201143

Vietnam

Prospective

201

96.5

Ngoc 201416

Vietnam

Prospective

24-48

1,371

94.7

Olavartette 201566

Mexico

Prospective

884

98.2

Pena 201444

Prospective

24-4-8

971

97.3

Prospective

24-48

896

93.3

15 Studies

56-70 days

24-48 his

15,425

96.1%

Mexico

Sanhueza 2015i6

Mexico

TOTALS

Source: Modified from Table 3, page 14 15, Chen-C re n in 2015 Review and submitted articles. All

subjects had 200 mg oral mlfepristone followed by 800 mcg buccal misoprostol.

Success percentages calculated by clinical reviewer.

J.A. 447-449 (emphases added).

FDA also analyzed the data and literature

concerning serious adverse events for the proposed

new dosing regimen and concluded it was "safe to

approve through 70 days gestation." J.A. 475; see

J.A. 469-475. The data showed that "[s]erious adverse

events" were "exceedingly rare," "generally far below

1.0% for any individual [serious] adverse event."

J.A. 474.

ii.

Number of in-person clinical visits and

prescribing providers

Before 2016, FDA required three in-person clinical

visits: one to receive Mifeprex; one to receive

misoprostol two days later; and one to follow up. After

analyzing numerous studies involving tens of

thousands of women, FDA determined there was no

safety or efficacy reason to mandate that the latter

two visits be conducted in person.

In considering the change to allow at-home

administration of misoprostol, FDA reviewed 11

studies involving 30,763 women who took misoprostol

at home. J.A. 458. “The two largest studies * * *

showed 97% success using the new proposed dosing

regimen with home use of buccal misoprostol.”

J.A. 459. These studies also showed comparable

results through 63 and 70 days gestation. J.A. 458.

Based on this data, FDA concluded that at-home use

of misoprostol is effective, J.A. 459, and “safe to

approve,” J.A. 479-481.

FDA also found that several studies, including one

of over 45,000 women, supported allowing multiple

methods of follow-up. J.A. 462. FDA explained that

“[f]ollow-up after taking Mifeprex and misoprostol is

necessary,” but that “[t]he exact timing and method

[of follow-up] should be flexible and determined

jointly by the healthcare provider and the individual

woman being treated.” Id. FDA noted that there were

several advantages to allowing alternative follow-up

methods and that “no single option is superior to the

others.” Id.

FDA also approved changing the terminology on

Mifeprex’s labeling from “doctor” to “healthcare

provider” so that healthcare providers licensed to

prescribe drugs under state law could prescribe

mifepristone. FDA reviewed data including four

studies of 3,200 women prescribed mifepristone by

nurses and certified nurse midwives; none showed a

statistical difference in outcomes from physician-

prescribed mifepristone. J.A. 461. FDA concluded

that this “clearly demonstrates that efficacy is the

same with non-physician providers,” id., and that “it

is safe for [such] providers to administer medical

abortion,” J.A. 497; see J.A. 495-498.

iii. Adverse-event reporting

FDA analyzed the data and literature for

information about adverse events in support of its

decision to modify a requirement that Mifeprex

prescribers report all serious adverse events. Based

on its analysis of 15 years of such reporting, FDA

concluded that “the safety profile of Mifeprex is wellcharacterized, that no new safety concerns have

arisen in recent years, and that the known serious

risks occur rarely.” J.A. 426. Of the more than 2.5

million women who had taken mifepristone as of 2015,

fewer than one-tenth of one percent experienced any

adverse event, and only 0.035% had been hospitalized.

J.A. 500-502. The numbers of other serious adverse

events are rarer still. Id.

Based on this data, FDA found it “appropriate to

modify the current adverse-event reporting

requirements” for prescribers. J.A. 466. Even after

the 2016 changes, anyone can report an adverse event

for Mifeprex by calling a 1-800 number on the labeling

or submitting a form on FDA’s website. See FDA,

Mifeprex Prescribing Information 1 (Jan. 2023);4 FDA,

MedWatch Online Voluntary Reporting Form. 5 And

like every NDA holder, Danco is required to report to

https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/

020687Orig1s025Lbl.pdf.

https://www.accessdata.fda.gov/scripts/medwatch/ (last

visited Jan. 23, 2024).

FDA all adverse events that it learns of from any

source.

21 C.F.R. §§ 314.80, 314.81.

Mifeprex

prescribers remain obligated to report to Danco—and

Danco to FDA—any patient deaths, “whether or not

considered drug-related.” FDA, REMS Single Shared

System for Mifepristone 200 mg 5 (Mar. 2023).6

2. 2021 Non-Enforcement Decisions And

2023 REMS

During the COVID-19 public health emergency,

the American College of Obstetricians and

Gynecologists (ACOG) urged FDA to suspend

enforcement of the in-person dispensing requirement

for mifepristone because it unnecessarily put patients

and providers at risk of COVID-19, delayed timesensitive healthcare, and served “as a barrier to

accessing this safe, effective medication.” ROA 783.

FDA evaluated that issue, including by analyzing

medical literature, post-marketing adverse-event

reporting from earlier in the pandemic, and

information about deviations or noncompliance events

associated with the REMS. J.A. 364-365. FDA found

no indication that noncompliance or modification of

the in-person dispensing requirement had increased

adverse events. J.A. 365. FDA’s April 2021 response

letter to ACOG therefore stated the agency would

exercise enforcement discretion as to that

requirement. Id.

FDA reiterated this analysis and reasoning in its

December 2021 response to Respondents’ 2019 citizen

petition challenging certain of the 2016 changes.

Based on the evidence, FDA concluded that

https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifep

ristone_2023_03_23_REMS_Full.pdf.

“mifepristone may be safely used without in person

dispensing,” J.A. 399, and that in-person dispensing

was “no longer necessary to ensure that the benefits

of the drug outweigh the risks,” J.A. 397. FDA relied

on safety data from the non-enforcement period,

which showed “no indication” that suspending the inperson

dispensing

requirement

“contributed

to” adverse events. J.A. 397-398. FDA also pointed to

three studies permitting pharmacy dispensing by mail

and five studies allowing clinic dispensing by mail, all

of which supported the conclusion that mifepristone

remains safe and effective without mandatory inperson dispensing. J.A. 402-406.

Based on its analysis, FDA directed Danco to

submit an sNDA proposing modifications to the

REMS “to remove the in-person dispensing

requirement.” J.A. 407; see J.A. 378-379. Danco

complied, and FDA approved Danco’s sNDA in

January 2023. See Ctr. for Drug Evaluation & Rsch.,

Approval

Package

for:

Application

Number

020687Orig1s025 (Jan. 3, 2023).7

C. Procedural History

1. In November 2022, Respondents brought an

APA suit challenging FDA’s 2000 approval of

Mifeprex, FDA’s 2016 changes to the labeling, and

FDA’s 2021 non-enforcement decisions, and asked the

District Court to preliminarily enjoin those FDA

actions.8 Danco intervened.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/0

20687Orig1s025.pdf.

Respondents never amended their complaint to challenge the

2023 REMS modifications. The documents on which FDA based

the 2021 statements of enforcement discretion and the 2023

REMS modification are not in the record.

All parties agreed to defer Respondents’

preliminary-injunction request until after the

administrative record was produced. ROA 3240-3252;

ROA 3588-3595; ROA 3801-3811. The District Court,

however, declined to wait for the record, ROA 4192,

and instead entered a ruling purporting to “stay” the

long-passed effective dates of each challenged FDA

action, Pet. App. 193a-195a (citing 5 U.S.C. § 705).

The court found that Respondents had standing,

Pet. App. 118a-133a, and that FDA likely acted

arbitrarily and capriciously in 2000, 2016, and 2021,

id. at 159a, 184a-186a. The court also concluded that

FDA’s 2021 decision to remove the in-person

dispensing requirement likely violated the Comstock

Act, id. at 151a-159a, and that the remaining

preliminary-injunction factors favored Respondents,

id. at 187a-193a.

2. Danco and the Government appealed and

sought an emergency stay. The Fifth Circuit left in

place the District Court’s order as to FDA’s 2016 and

2021 actions. Id. at 244a.

Danco and the Government submitted emergency

stay applications to this Court, which stayed the

preliminary injunction in full through the disposition

of its review. Id. at 245a.

3. The Fifth Circuit merits panel affirmed the

District Court’s decision to enjoin FDA’s 2016 and

2021 actions.

The panel found that Respondents had established

associational standing. On injury-in-fact, the panel

inferred that, “given the millions of women who take

mifepristone, the number of women who experience

complications from taking the drug, and the high

number of the Organizations’ members who treat such

women,” “it is highly likely that one or more of their

members will be required to provide emergency care

to a mifepristone patient in the near future,” and in

the course of providing care could be injured through

wasted resources, liability costs, and conscience

violations.

Id. at 17a, 23a-26a, 31a-32a.

traceability, the panel concluded that these purported

injuries are traceable to the 2016 changes and 2021

non-enforcement decisions based on an “increased

risk” that more complications and more follow-up care

might occur as a result of FDA’s actions. Id. at 36a38a.

On redressability, the panel offered no

reasoning.

On the merits—and although it, too, lacked the

administrative record—the panel found that FDA

failed to fully consider its decisions, rendering the

agency’s 2016 and 2021 actions likely arbitrary and

capricious.

As to the 2016 changes, the panel concluded that

FDA had not sufficiently addressed whether there

was a potential “cumulative effect” of the 2016

changes, id. at 53a, even though the limited record

shows that FDA extensively considered data involving

various combinations of the changes, none of which

showed any impact on the drug’s safety and efficacy

profile. The panel also concluded that FDA likely

acted arbitrarily and capriciously in continuing

mandatory prescriber adverse-event reporting only

for fatalities, even though, like with all drugs,

prescribers or anyone else can still voluntarily report

any adverse event. As the panel saw it, FDA did not

sufficiently consider whether “the 2016 Amendments

might alter the risk profile.” Id. at 54a-56a.

As to FDA’s 2021 decisions to exercise enforcement

discretion on in-person dispensing, the panel

concluded that Respondents’ challenge was not

mooted by the unchallenged 2023 removal of the inperson dispensing requirement. Id. at 57a-59a.

Based on the panel’s view that FDA acted arbitrarily

and capriciously in 2016 by narrowing prescribers’

mandatory-adverse-event reporting, the panel

asserted that FDA could not rely on data in any

adverse-event reports as a basis for exercising

enforcement discretion. Id. at 59a-61a. The panel

also faulted FDA for describing medical literature as

“not inconsistent with” the agency’s conclusion, rather

than saying the literature “affirmatively supported”

its conclusion. Id. at 61a-63a.

The panel also affirmed the District Court’s

conclusion that Respondents were likely to suffer

irreparable harm absent relief, and that the equities

favored Respondents. Id. at 63a-69a.

The panel rejected remand-without-vacatur

because, in its view, and even without knowing what

else was in the agency records, FDA would be unable

to remedy these purported errors. Id. at 72a.

Judge Ho concurred in part and dissented in part.

Pet. App. 76a-110a. He agreed with the majority’s

analysis of FDA’s 2016 and 2021 actions but would

have also invalidated the 2000 approval and held that

FDA’s 2021 non-enforcement decisions violated the

Comstock Act. Id.

SUMMARY OF ARGUMENT

The Firth Circuit erred in affirming the District

Court’s order preliminarily enjoining FDA’s 2016 and

2021 actions.

Respondents lack Article III standing to

challenge these actions. The court of appeals held

that Respondents have standing because some

member of a Respondent association may one day

treat a woman who is seeking care in the emergency

room after she was prescribed mifepristone by a

different healthcare provider.

That theory of injury flunks Article III for reasons

articulated in multiple decisions of this Court. It rests

on claims of having provided past emergency-room

care in a few handfuls of isolated situations over the

decades in which many millions of women have taken

mifepristone, paired with speculation that these

isolated instances will recur—none of which adds up

to an Article III injury.

Clapper v. Amnesty

International USA held that “[a]llegations of possible

future injury” are insufficient, 568 U.S. 398, 409

(2013) (citation omitted); City of Los Angeles v. Lyons

held that claims of past injury “do not amount to that

real and immediate threat of injury necessary to make

out a case or controversy,” 461 U.S. 95, 103 (1983);

and Summers v. Earth Island Institute held that these

rules govern even when claims of past harm are

coupled with “a statistical probability that some

[plaintiffs] are threatened with concrete injury,” 555

U.S. 488, 495, 497 (2009).

Respondents have also failed to show that any

claimed injuries are traceable to the 2016 or 2021

actions they challenge, or would be alleviated by the

injunction they seek. Respondents are not themselves

“the object of the government action or inaction [they]

challenge[ ],” and their injuries turn on the

independent decisions of multiple third parties—both

healthcare providers exercising medical judgment

and women choosing to have a medication abortion—

in circumstances that do not involve and are unknown

to Respondents. Lujan v. Defs. of Wildlife, 504 U.S.

555, 562 (1992).

Respondents are left offering

“speculation about ‘the unfettered choices made by

independent actors not before the court,’ ” Clapper,

568 U.S. at 414 n.5 (quoting Lujan, 504 U.S. at 562),

which defeats traceability and redressability.

II. On the merits, the Fifth Circuit erred in

enjoining FDA’s 2016 and 2021 actions. Before

enjoining agency action as arbitrary and capricious for

failure to consider some aspect of a problem, a court

must know what is included in “the full

administrative record that was before the [agency] at

the time [it] made [its] decision.” Citizens to Pres.

Overton Park, Inc. v. Volpe, 401 U.S. 402, 420 (1971),

abrogated on other grounds, Califano v. Sanders, 430

U.S. 99 (1977). Otherwise, the court is simply

speculating about what the agency considered. There

is no debate that the record here is incomplete.

Even the limited record that was before the lower

courts, however, demonstrates that FDA’s 2016 and

2021 actions were “reasonable and reasonably

explained.” FCC v. Prometheus Radio Project, 592

U.S. 414, 423 (2021). The available record contains no

basis to overturn FDA’s considered scientific

judgment. The Fifth Circuit questioned whether FDA

had sufficiently considered the potential “cumulative

effect” of the 2016 changes, even though FDA’s

reasoned scientific judgment was that the available

evidence demonstrated zero additional safety or

efficacy concerns from the modifications. The court

questioned FDA’s 2016 decision that some of the

mandatory prescriber adverse-event reporting was no

longer necessary, even though the evidence showed it

was no longer warranted in the face of Mifeprex’s

established safety profile. And the court disagreed

that FDA had enough evidence to warrant exercising

enforcement discretion as to in-person dispensing in

2021, even though FDA comprehensively explained

why both real-world data and scientific literature

supported that conclusion.

The Fifth Circuit’s decision to enjoin drug labeling

that had been in place for years was entirely

unprecedented.

It was destabilizing to the

pharmaceutical industry, which relies on courts

applying narrow, deferential review to FDA’s

scientific assessments. It posed serious risk to women

and teenage girls, including pushing them to laterstage, more invasive surgical abortions, and to

resource-constrained public healthcare systems,

including by reimposing requirements of multiple inperson physician visits that do not improve outcomes.

It also directly injured Danco, whose only product is

Mifeprex, as Danco outlined in its emergency stay

application. Stay App., No. 22A901, Long Decl. ¶¶ 34, 11-28.

Given all of these serious harms, coupled with the

lack of impending injury and federal and state

conscience statutes that—when invoked—protect

Respondents and their members, the unprecedented

act of enjoining FDA’s determination of a drug’s

required conditions of use was improper. Even if

there was anything to the Fifth Circuit’s purported

concerns (and there was not), the court should have

obtained the entire record and provided FDA an

opportunity to address those concerns before acting to

effectively remove a long-used drug from the market

for an unknown length of time and requiring a return

to outdated labeling for patients and providers.

Reversal is warranted.

ARGUMENT

I. RESPONDENTS LACK STANDING.

Respondents claim to have associational standing

to challenge FDA’s 2016 and 2021 actions. As

relevant here, an association has standing on behalf

of its members when “its members would otherwise

have standing to sue in their own right.” Hunt v.

Wash. State Apple Advert. Comm’n, 432 U.S. 333, 343

(1977). To satisfy that requirement, Respondents

must show that at least one of their members

“suffered an injury in fact”; the injury is “fairly

traceable” to FDA’s actions; and it is “ ‘likely,’ as

opposed to merely ‘speculative,’ that the injury will be

‘redressed by a favorable decision.’ ” Lujan, 504 U.S.

at 555, 560-561 (citation and alterations omitted).

Respondents cannot show even one of these, much less

all three.

A. No Association Member Faces Certainly

Impending Injury From FDA’s 2016 Or

2021 Actions.

To have standing to seek injunctive relief, a

plaintiff must establish facts showing an injury that

is “certainly impending,” which requires something

more than an “objectively reasonable likelihood.”

Clapper, 568 U.S. at 410 (citation omitted). A plaintiff

cannot rest on “[a]llegations of possible future injury,”

id. at 409 (citation omitted), or “past wrongs,” because

such assertions do not “amount to that real and

immediate threat of injury necessary to make out a

case or controversy,” Lyons, 461 U.S. at 103. Nor can

a plaintiff bolster claims of past harm with “a

statistical probability” of injury to some association

member; to hold otherwise “would make a mockery of

[this Court’s] prior cases.” Summers, 555 U.S. at 495,

497-498.

Respondents failed to offer facts

demonstrating an association member faces such

certainly impending injury.

1. Respondents Rely On Statistics Rather

Than

Identifying

Association

Member Facing Actual, Imminent

Injury.

Asserting a statistical possibility of injury is

categorically insufficient to establish associational

standing. An injury-in-fact must be “actual and

imminent, not conjectural or hypothetical.” Summers,

555 U.S. at 493, 497. For that reason, although an

organization can sue on behalf of its members “[e]ven

in the absence of injury to itself,” Hunt, 432 U.S. at

342 (citation omitted), an association cannot merely

rely on the size of its membership to prove that it has

standing, Summers, 555 U.S. at 497-498.

Instead, this Court has consistently “required

plaintiff-organizations to make specific allegations

establishing that at least one identified member had

suffered or would suffer harm.” Summers, 555 U.S. at

498. Summers, for instance, held that organizations

lacked associational standing to challenge a Forest

Service regulation even though they had “thousands

of members” who “use[d] and enjoy[ed]” areas affected

by the regulation and there was “a statistical

probability that some of those members [were]

threatened with concrete injury.” Id. at 497-498

(citation omitted).

Likewise, Lujan held that

organizations lacked associational standing to

challenge a rule concerning wildlife funding because

they had not shown “that one or more of [their]

members would thereby be directly affected apart

from their special interest in th[e] subject.” 504 U.S.

at 563 (citation and quotation marks omitted).

Here, Respondents’ affidavits do not support the

conclusion that any particular member faces certainly

impending injury from FDA’s 2016 or 2021 actions.

Some declarants speculate about what “may,” “could,”

or “might” occur if they happen to be working in an

emergency room when an unknown future patient

needs unknown future care. E.g., J.A. 166-167. None

assert that they have a regular practice of providing

follow-up care to women who chose to have a

medication abortion using mifepristone prescribed by

another provider. The court of appeals plainly erred

in holding that assertions of possible future harm to

unidentified members in uncertain circumstances

meets Article III’s injury-in-fact requirement.

The Fifth Circuit wrongly described its decision as

consistent with Summers. According to the court,

because certain doctors stated they had previously

treated a woman who experienced complications from

mifepristone, these “prior instances” of care in

combination

with

“mifepristone’s

continued

availability” showed that Respondents’ “members are

reasonably likely to be injured again.” Pet. App. 28a.

That reasoning is precisely the sort of probabilistic

inquiry Summers expressly denounced.

In Summers, the majority specifically rejected the

suggestion that the “requirement of imminent harm”

could be “replace[d]” with “a realistic threat” that

proven, past conduct would “recur[ ] * * * in the

reasonably near future.” Summers, 555 U.S. at 499-

500 (quotation marks and emphasis omitted) (quoting

id. at 505 (Breyer, J., dissenting)). A statement by a

Respondent-association member that she (or a

colleague) previously treated a woman for

complications related to a medication abortion cannot

excuse Respondents’ failure to identify a member

facing an imminent risk of future harm from FDA’s

2016 or 2021 actions. Mifeprex has been approved for

medication abortion since 2000. Pointing to a handful

of past incidents over 20+ years, as the court of

appeals did, is no substitute for concrete, impending

future injury from the specific 2016 or 2021 usecondition changes that is personal to an individual

association member. See id. at 495-496 (no standing

where affiant engaged in conduct hundreds or

thousands of times in the past).

Respondents are in a worse position than even the

Summers plaintiffs because their claims of past injury

primarily refer to care some other doctor provided,

point to undated experiences that may predate or be

unrelated to the use-condition changes made in 2016

or 2021, and lack facts showing that any woman

treated in the emergency room had been prescribed

FDA-approved mifepristone. For example, although

Dr. Skop claims that during her decades of practice,

she has “cared for at least a dozen women who have

required surgery,” the statement is carefully phrased

in the passive voice; Dr. Skop never specifies whether

she performed these surgeries herself, whether

another physician could have stepped in if she

preferred not to, in what year this care occurred, and

whether the patient had been validly prescribed FDAapproved mifepristone by another provider. J.A. 163;

see also, e.g., J.A. 154 (declarant’s “partner” provided

“critical care”); J.A. 163 (declarant’s “group practice

admitted three women”); J.A. 153 (patient took

unapproved drug “from India”).

Moreover, because the legal landscape has recently

changed dramatically, past instances are less

relevant. At most, Respondents’ declarants assert

they know about one to two patients a year who

presented to an emergency room with a “chemical

abortion” related complaint. And that was before the

States in which most declarants practice restricted

medication abortion after Dobbs v. Jackson Women’s

Health Organization, 597 U.S. 215 (2022). The

limitations on, or complete unavailability of,

medication abortion under state law where declarants

work further shrinks the already tiny fraction of

hypothetical women any declarant could potentially

encounter in an emergency room.9

Ultimately, Respondents’ associational standing

theory fails to pinpoint any specific member facing

concrete, non-speculative, imminent harm by FDA’s

2016 or 2021 actions. The Fifth Circuit’s decision

accepting it makes the same “mockery of [this Court’s]

prior cases” that Summers condemned. 555 U.S. at

498.

See, e.g., Tex. Health & Safety Code § 171.204 (2021)

(banning abortion after detection of fetal heartbeat); id.

§ 171.063 (2021) (where not already prohibited, restricting

medication abortion to physician-only prescribing; requiring inperson dispensing; prohibiting mailing); Ind. Code §§ 16-34-2-1

(2021), 16-18-2-327.9 (2022) (banning most abortions); id. §§ 251-9.5-0.5 (2021), 16-34-2-1.1(a)(5) (2022) (where not already

prohibited, prohibiting telehealth abortion care; requiring

waiting period and ultrasound); Ga. Code § 16-12-141(b) (2019)

(banning abortion after detection of fetal heartbeat); id. § 31-9A3 (2020) (where not already prohibited, restricting medication

abortion to physician-only prescribing).

2. Respondents’ Speculative Claims Of

Future Injury Depend On Attenuated

Chains Of Third Parties’ Choices.

The Fifth Circuit’s bad math does not add up to

non-speculative injury to a Respondent-association

member. The court’s future-injury analysis was based

on (a) the fact that “millions of women” have taken

mifepristone since its 2000 approval; (b) an

(unsupportable) assertion that “a definite percentage

of women who take mifepristone will require

emergency-room care”; and (c) supposed “testi[mony]

that hundreds of [Respondents’] members are

OB/Gyns and emergency-room doctors who care for

women in these circumstances.” Pet. App. 26a. The

panel reasoned that this combination made it “highly

likely that one or more of [Respondents’] members will

be required to provide emergency care to a

mifepristone patient in the near future.” Id. at 17a,

23a-24a. Every step of that analysis was wrong.

First, there are no record facts showing the

number of women who were prescribed mifepristone

after the 2016 or 2021 actions and would not

otherwise have been prescribed the drug. But only

that incremental group of women is relevant to

whether an association member faces injury from the

use-condition changes made in 2016 or 2021. The

Fifth Circuit’s analysis was wrong from the start

because its “millions of women” who have taken

mifepristone premise counts all women who have

taken the drug since its 2000 approval. The actual

starting point for any statistical calculation would

have to be the number of additional women who have

taken or will take Mifeprex as a result of the specific

changes in 2016 or 2021. That number is not in the

record.

Second, there is no factual basis in the record for

the statement that a “definite percentage” of women

will seek emergency-room care as a result of FDA’s

2016 or 2021 actions. The extensive study data that

FDA relied on in 2016 showed that, on average, 97.4%

of women (US studies) and 96.1% of women (non-US

studies) need no intervention of any kind. See supra

pp. 7-8. Since Mifeprex’s 2000 approval, serious

adverse events of any kind have been “exceedingly

rare,” J.A. 465, including a rate of post-use

hospitalization well below 1%, see supra p. 10. And

when some sort of additional intervention is needed,

it can (and often does) occur through further follow-up

with the original prescriber or at a location the

original prescriber has directed the patient to go,

which may be any number of locations other than an

emergency room where a Respondent-association

member is working. J.A. 309-310; see also FDA,

Mifeprex Prescriber Agreement Form 1 (Mar. 2023)10

(directing that prescribers either have the “[a]bility to

provide surgical intervention” or “ma[k]e plans to

provide such care through others”).11

No facts in the record show any women—let alone

a “definite percent”—who will certainly seek

emergency-room care.

But any valid statistical

https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mife

pristone_2023_03_23_Prescriber_Agreement_Form_for_Danco_

Laboratories_LLC.pdf.

A second dose of misoprostol results in the avoidance of any

surgical follow-up for 90% of the small percentage of women for

whom the initial mifepristone-misoprostol regimen does not

result in a complete treatment. J.A. 461.

analysis of future injury would require knowing the

fraction of women who will need further care as a

result of the 2016 or 2021 actions, and the even

smaller fraction who will seek such care at an

emergency room. That number is not in the record.

Third, there are no facts in the record showing how

often a Respondent-member will be working in an

emergency room and obligated to provide care to a

woman who took mifepristone because of the 2016 or

2021 actions. The record does not even show the total

number of individual emergency-room doctors among

the associations’ memberships, let alone where or how

often they work. But when trying to establish a

probability of harm to an association member, these

facts matter—one association describes itself as for

pediatricians; another for dentists; a third welcomes

retired, foreign, and non-practicing doctors of many

specialties; and the fourth association is comprised of

the other three. J.A. 9-11; see AAPLOG, Join

AAPLOG Today! 12

Even knowing how many

individual, practicing emergency-room doctors are

among these membership rolls would not speak to any

statistical likelihood of one of them being obligated to

treat a particular woman; that would turn on a whole

other array of facts like what percentage of time the

member is the only doctor available, which in turn

would require knowing, among other things, where

and how often those members practice, how many

doctors make up the staff in those locations, and what

alternative facilities or practitioners could provide

emergency care to any given individual when she

needs it. Again, none of that is in the record.

https://aaplog.org/become-a-member/ (last visited Jan. 23,

2024).

The bottom line:

Respondents’ claims of

threatened injury “rel[y] on a highly attenuated chain

of possibilities,” including “speculation about the

decisions of independent actors”—both healthcare

providers and women choosing to have a medication

abortion. Clapper, 568 U.S. at 410-414. This Court

already rejected that approach as “necessarily

conjectural.”

Id. at 412.

Whatever “certainly

impending” means, it is more than a percentage of a

fraction of a portion of a possibility.

3. Respondents Offer No Facts Showing

Their Asserted Injuries Ever Occurred.

The Fifth Circuit described three possible injuries

that it said could occur if a woman sought care in an

emergency

room

after

taking

mifepristone:

Respondents’ members (1) could be forced to “choose

between following their conscience and providing

care,” causing “mental and emotional stress,”

Pet. App. 32a, 34a-35a; (2) might have to “divert time

and resources away from their regular patients,” id.

at 31a; and (3) might face a risk of “greater liability

and increased insurance costs,” id.

Respondents’ declarations fail to substantiate that

a member was or could be unable to raise a conscience

objection to providing care, or that any member’s

liability or insurance costs are any different for

treating a patient after a medication abortion than for

any other patients. And the mix of patients an

emergency-room doctor treats on a given shift is not a

cognizable Article III injury, nor was a diversion-ofcare injury factually demonstrated here. Emergencyroom doctors, after all, lack “regular patients”; their

job is to provide care to whomever needs it.

The declarants also obliquely reference past

objections of other healthcare providers (who they do

not allege are Respondent-association members) or

care that the declarants apparently provided without

objection. 13 For example, Dr. Francis describes an

incident in which her “partner felt * * * forced to

participate in something that she did not want to be a

part of,” but never states this partner is a Respondentassociation member or raised a conscience objection.

Pet. App. 32a (quoting J.A. 154) (emphasis added); see

also id. (citing dental-association member and nonphysician declarations expressing future “concerns”

about unspecified other members, again without

addressing statutory conscience rights, J.A. 142-143;

J.A. 120-121). And although Dr. Skop states that she

has “cared for at least a dozen women who have

required surgery,” she does not allege that she herself

had to perform the surgery or provide other care, let

alone that she raised a conscience objection that was

denied. Id. (quoting J.A. 163). Similarly, Dr. Wozniak

states that she once treated a woman who had

previously been “advised” that medication abortion

was “contraindicated” for her, without ever asserting

the treatment violated Dr. Wozniak’s conscience or

that she raised a conscience objection. J.A. 173.

There are similar gaps in the allegations

concerning economic and resource injuries.

declarants describe accusations of malpractice or

See 42 U.S.C. §§ 238n, 300a-7(c), (d) (federal conscience

protections); Consolidated Appropriations Act, Pub. L. No. 117103, Div. H, Tit. V, §§ 506-507 (2022) (similar); Nadia N. Sawicki,

Protections from Civil Liability in State Abortion Conscience

Laws, 322 J. Am. Med. Ass’n 1918, 1918 (2019) (“State conscience

laws typically provide additional protections that supplement

those established by federal antidiscrimination law.”).

increased insurance costs in the 20 years mifepristone

has been available, nor have they (or can they) tie any

such claims to the 2016 or 2021 actions. See J.A. 292;

e.g., J.A. 142. Nor do the declarants describe any

“regular patients” or offer facts showing that an

emergency room lacked resources to care for other

patients as a result of women prescribed mifepristone

under FDA’s 2016 or 2021 actions—even assuming it

would be Article III cognizable injury for an

emergency-room doctor to have to triage among

individuals seeking care. The only reference to a socalled resource diversion does not link that diversion

to any injury. See Pet. App. 25a (explaining that

because Dr. Francis “spent several hours” with one

patient she had to “call in an additional physician to

help cover” other patients in the labor and delivery

unit).

Because each element of standing must “be

supported in the same way as any other matter on

which the plaintiff bears the burden of proof,” Lujan,

504 U.S. at 561, at the preliminary-injunction stage,

a movant must make a “clear showing” of its

entitlement to such relief, Winter v. Nat. Res. Def.

Council, Inc., 555 U.S. 7, 22 (2008); see also Summers,

555 U.S. at 499 (parties must make “a factual showing

of perceptible harm” (citation omitted)). Respondents

failed to do so.

B. Respondents’ Alleged Injuries Are Not

Traceable To FDA’s 2016 Or 2021 Actions

Or Redressable By This Court.

Standing also requires that Respondents’ asserted

injuries be attributable to the specific agency action

challenged and alleviated by the judicial ruling they

seek. Lujan, 504 U.S. at 560. Respondents fail in both

respects.

1. An injury suffices for Article III standing only if

it is “fairly traceable to the challenged action of the

defendant, and not the result of the independent

action of some third party not before the court.” Id.

(citation, brackets, and ellipses omitted). Although

that principle “does not exclude” any non-regulated

party from ever demonstrating traceability, Bennett v.

Spear, 520 U.S. 154, 169 (1997), it does mean that

standing is “substantially more difficult to establish”

when a party is not regulated by the challenged

action, Lujan, 504 U.S. at 562 (citation and quotation

marks omitted). That is because a plaintiff cannot

establish standing simply by showing that the

defendant’s conduct creates the possibility of injury.

Clapper, 568 U.S. at 417.

Yet mere possibility is all that ties Respondents to

FDA’s 2016 and 2021 actions. Respondents’ theory of

standing depends on the independent decisions of

healthcare providers and their patients—neither of

whom are coerced by FDA to behave in a particular

way. Id. at 412. Because Respondents cannot predict

the medical judgment of third-party healthcare

providers who choose to prescribe mifepristone, or the

discretionary actions of third-party patients who

choose to have a medication abortion, Respondents’

evidence “does not adequately trace the necessary

connection” between FDA’s 2016 and 2021 actions and

any purported injury. California v. Texas, 141 S. Ct.

2104, 2118-19 (2021).

The Court has consistently looked for that

predictability to bridge the gap created by third-party

decisionmaking. In Bennett, for example, the Court

found that the plaintiffs had standing to challenge a

Fish and Wildlife Service opinion even though the

Bureau

Reclamation

retained

ultimate

responsibility for determining whether the project

would go forward. 520 U.S. at 158-160, 168-169. The

Court found standing because the Bureau would risk

civil and criminal penalties if it disregarded the

Service’s opinion, making the opinion “virtually

determinative.” Id. at 169-170. By contrast, in

Clapper, the Court held the plaintiffs lacked standing

to challenge a federal surveillance statute that “at

most authorizes—but does not mandate or direct—the

surveillance that [plaintiffs] fear.” 568 U.S. at 411412. Clapper’s holding maps directly onto this case:

The challenged 2016 and 2021 actions permit but do

not require a particular action by healthcare

providers who prescribe mifepristone and by patients

who choose to take it, defeating traceability. Id. at

412.

That makes this case unlike Department of

Commerce v. New York, where this Court found States

had standing to challenge a citizenship-based census

question even though the States’ financial injuries

depended on people not responding if the census

included the question. 139 S. Ct. 2551, 2565-66

(2019).

The multi-thousand-page administrative

record showed that the challenged question

historically resulted in significant undercounting and

would continue to do so at a predictable rate. Id. at

2564-65. Respondents here do not use historical data

to predict a specific rate of emergency-room visits for

a declarant’s hospital based on FDA’s 2016 and 2021

actions. They offer no facts demonstrating that the

rate of emergency-room visits to that hospital will

necessarily affect any declarant, or require that

declarant to provide any specific care. They likewise

cannot accurately predict how third-party doctors or

those doctors’ patients would act in the future.

2. Respondents also must “demonstrate standing

for each claim that they press and for each form of

relief that they seek.” TransUnion LLC v. Ramirez,

594 U.S. 413, 431 (2021). Respondents have never

attempted to separate injuries allegedly traceable to

FDA’s 2016 or 2021 actions from those that would

have occurred anyway based on mifepristone’s

original approval. That leaves Respondents unable to

demonstrate traceability.

“[H]arm from one

particular inadequacy in government administration”

does not create standing to challenge “all

inadequacies in that administration.” Lewis v. Casey,

518 U.S. 343, 357 (1996); see, e.g., California, 141 S.

Ct. at 2119-20 (no standing to challenge minimumessential-coverage provision of the Affordable Care

Act where injuries were caused by other statutory

provisions).

Respondents have not and cannot identify the

doctors, patients, hospitals, times, or circumstances

that would lead a member to treat a patient for harm

resulting from FDA’s 2016 or 2021 decisions, which

would not have occurred under the 2000 approval.

The Fifth Circuit’s simple solution was to say that

FDA’s 2016 and 2021 actions “will increase the

number of women who suffer complications as a result

of taking mifepristone.” Pet. App. 36a. But even if

that (factually wrong) assertion somehow amounted

to a certainly impending injury for a Respondentassociation member, it does not solve this separate

standing problem: Traceability speaks to the “causal

connection between the injury and the conduct

complained of,” not the risk that the injury will occur.

Lujan, 504 U.S. at 560.

3. Respondents also bear the burden of showing

that they will “benefit in a tangible way from the

court’s intervention.” Steel Co. v. Citizens for a Better

Env’t, 523 U.S. 83, 103 n.5 (1998) (citation omitted).

The Fifth Circuit did not address redressability,

despite acknowledging the “rigorous evidence”

necessary to prove it. Pet. App. 36a. Respondents’

redressability arguments fail for all the same reasons

that their injury and traceability arguments fail. Cf.,

e.g., Simon v. E. Ky. Welfare Rts. Org., 426 U.S. 26, 28,

42-43 & n.23 (1976) (plaintiffs lacked standing where

it was “purely speculative” whether a decision

“allowing favorable tax treatment” to hospitals that

limited services for indigents would result in hospitals

providing less indigent care). But there are other

reasons, too. Principal among them: Because FDA’s

actions made Mifeprex more effective and further

reduced adverse events, Respondents’ requested

relief—returning to the pre-2016 labeling—would

make it more, not less, likely that women who are

prescribed mifepristone will need additional

intervention.

Compare J.A. 450 (92% need no

intervention under original labeling) with supra

pp. 7-8 (96.1% and 97.4% of women need no

intervention under 2016 changes).

C. Ruling For Respondents Would Require

Fundamentally

Rewriting

Standing

Doctrine.

The decisions that the court of appeals pushed past

to find standing for these Respondents to assert these

claims—Clapper,

Summers,

Lujan,

and

TransUnion—all police the boundaries of standing for

issue-oriented advocacy groups.

The Court has

repeatedly emphasized that relaxing Article III

standing requirements would amount to an expansion

of judicial power vis-a-vis the other branches of

government. E.g., TransUnion, 594 U.S. at 422-423;

United States v. Texas, 599 U.S. 670, 675-676 (2023).

This Court should not create special standing rules for

medical associations.

All drugs have side effects and complication risks,

so the Fifth Circuit’s reasoning would bless any suit

by an association of healthcare providers challenging

any agency decision that might affect a potential

patient. Some anti-depressants can increase risks of

suicidal thoughts; some drugs to treat one form of

cancer can increase the risk of another; some drugs

cause birth defects; the list goes on. And FDA is not

the only agency whose actions affect health and

safety. Some doctors dislike recommended vaccines;

others dislike lifting mask mandates. Pediatricians

might dislike easing air pollution regulations, which

might cause more children to need treatment for

severe asthma, taking time away from other patients.

Emergency-room doctors might dislike easing gun

restrictions,

laws

eliminating

workplace

protections like mandatory water breaks on hot days,

or the way a car seat recall is being handled—all of

which could result in a patient seeking care in an

emergency room someday.

There is no way to limit such sweeping changes to

standing doctrine to medical professionals. Teacher

associations could challenge regulations they believe

affect students in a way that disrupts the classroom;

associations of firefighters could challenge regulations

of products they say present fire risks. And so on.

This Court’s standing precedents—unlike the decision

below—ensure

that

an unregulated party’s

disagreement with governmental policy is not a

sufficient basis to challenge that policy.

Respondents are outside the limited types of

plaintiffs with Article III standing to challenge

regulatory decisions concerning someone else’s

product. They are not consumers of Danco’s product.14

They do not sell or advertise it. 15 They do not

manufacture a competing product.16 And they are not

the “object of the action * * * at issue”: Respondents’

members do not prescribe mifepristone for abortion,

or seek to treat patients who have taken mifepristone

in an elective abortion. Lujan, 504 U.S. at 561. Nor

are they required to do so by any FDA action

challenged in this case. Mercury-Free Drugs, 671 F.3d

at 1280-81. In short, Respondents are unaffected in

an Article III sense by FDA’s labeling of mifepristone.

II. RESPONDENTS’

FAIL.

MERITS

ARGUMENTS

Arbitrary-and-capricious review is “narrow,”

Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto.

Ins. Co., 463 U.S. 29, 43 (1983), and “deferential,”

Cf., e.g., Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct.

1668, 1675 (2019); see also Coal. for Mercury-Free Drugs v.

Sebelius, 671 F.3d 1275, 1281 (D.C. Cir. 2012) (collecting cases

“permitt[ing] consumers of a product to challenge agency action

that prevented the consumers from purchasing a desired

product”).

Cf., e.g., FDA v. Brown & Williamson Tobacco Corp., 529

U.S. 120, 129 (2000).

Cf., e.g., Monsanto Co. v. Geertson Seed Farms, 561 U.S. 139,

154-155 (2010); Bristol-Myers Squibb Co. v. Shalala, 91 F.3d

1493, 1497-99 (D.C. Cir. 1996).

Prometheus, 592 U.S. at 427. “[A] court may not

substitute its own policy judgment for that of the

agency.” Prometheus, 592 U.S. at 423. After “review

[of] the whole record,” 5 U.S.C. § 706, the court’s role

is “simply” to determine whether the agency “acted

within a zone of reasonableness,” Prometheus, 592

U.S. at 423.

The Fifth Circuit erred in holding FDA’s 2016 and

2021 actions likely arbitrary and capricious based on

the agency’s supposed failure to consider all aspects of

the problem before it, when the court itself did not

have all aspects of the problem before it. The court

faulted FDA without reviewing the whole record, but

even the limited preliminary-injunction record shows

that FDA appropriately exercised its predictive

judgment based on the evidence before it and

reasonably explained its decisions.

A. Respondents

Cannot

Obtain

Relief

Without The Administrative Record.

Judicial review of agency action must be “based on

the full administrative record that was before the

[agency] at the time [it] made [its] decision.” Overton

Park, 401 U.S. at 420 (emphasis added). That rule is

dictated by the APA and common sense: The statute

provides that “the court shall review the whole record”

in assessing the legality of agency action, 5 U.S.C.

§ 706, and under arbitrary-and-capricious review, the

agency’s “decision ha[s] to be judged by the

information then available to it,” and “the validity of

that action must ‘stand or fall * * * on the

administrative record made,’ ” Vt. Yankee Nuclear

Power Corp. v. NRDC, 435 U.S. 519, 549, 553 (1978).

The documents before the Fifth Circuit constituted

a fraction of the administrative record. For the 2016

changes, the documents available to the court were

FDA’s final letter approving the changes;

Respondents’ citizen petition and FDA’s denial; and a

few of FDA’s internal documents. J.A. 284-291;

J.A. 322-347; J.A. 373-412; J.A. 293-320; J.A. 418525; ROA 2251-2337. For the 2021 decision, the court

considered only the correspondence with ACOG and

the December 2021 citizen petition denial—no

internal FDA documents. ROA 783-785; J.A. 364-365;

J.A. 371; J.A. 373-412.

That is why all the parties had agreed the District

Court should defer ruling on Respondents’

preliminary-injunction request until FDA produced

the record. See ROA 3240-3252; ROA 3588-3595;

ROA 3801-3811.

Although one panel member

expressed concern about ruling on Respondents’

claims without the full record, see 5th Cir. Oral Arg.

22:23-24:43 (May 17, 2023), the Fifth Circuit

ultimately faulted FDA for failing to consider

important aspects of the problem without even

knowing the full scope of the agency’s consideration.

The Fifth Circuit described its review as

“searching and careful,” Pet. App. 52a (quotation

marks omitted), but a searching and careful review of

a few chapters of a book doesn’t mean you’ve reviewed

the book. The court never considered whether there

might be other review documents, including

statistical reviews, clinical reviews, risk assessment

and mitigation analysis, REMS assessments, or

correspondence with Danco, that might bear on the

reasonableness of the agency’s decisions.

The procedural posture of this case does not cure

the Fifth Circuit’s rush to judgment. To be sure, a

partial record may sometimes suffice to resolve an

APA challenge—like in cases asking whether the

agency failed to act within statutory or regulatory

constraints, see, e.g., Am. Bankers Ass’n v. Nat’l Credit

Union Admin., 271 F.3d 262, 266 (D.C. Cir. 2001), or

cases presenting justiciability problems, In re United

States, 583 U.S. 29, 32 (2017) (per curiam)—but a

request for a preliminary injunction does not permit a

court to set the APA aside. “[T]he burdens at the

preliminary injunction stage track the burdens at

trial,” Gonzales v. O Centro Espirita Beneficente

Uniao do Vegetal, 546 U.S. 418, 429 (2006), and

Respondents’ complaints about the reasonableness of

FDA’s decisionmaking process and thoroughness of its

explanation are precisely the sort of claims requiring

review of “the full administrative record,” Overton

Park, 401 U.S. at 420. Thus, just like at the merits

stage, proceeding without the complete record on a

preliminary injunction means the court is “merely

speculating” as to the “basis” for “the agency action

the plaintiff seeks to enjoin.” Am. Bioscience, Inc. v.

Thompson, 243 F.3d 579, 580-582 (D.C. Cir. 2001).

B. The Existing Record Shows FDA’s 2016

And 2021 Actions Were Reasonable And

Reasonably Explained, As Required By

The APA.

Even on the limited preliminary-injunction record,

however, FDA’s 2016 and 2021 actions satisfy the

narrow arbitrary-and-capricious standard.

FDA

comprehensively detailed the evidence supporting

each decision, made reasonable predictive judgments

based on the data, and explained why the evidence

supported labeling changes. In holding Respondents

were likely to succeed in showing otherwise, the Fifth

Circuit did exactly what this Court’s precedents

prohibit:

It “second-guess[ed]” FDA’s “scientific

judgment,” Cytori Therapeutics, Inc. v. FDA, 715 F.3d

922, 927 (D.C. Cir. 2013) (Kavanaugh, J.), and

“substitute[d] its own policy judgment for that of the

agency,” Prometheus, 592 U.S. at 423. Its decision

should be overturned.

Even if there was anything to the Fifth Circuit’s

purported concerns (and there was not), the court

should have remanded without vacatur to allow FDA

an opportunity to address these purported

shortcomings in the first instance—particularly given

the disruptive effects of effectively removing a longused drug from the market for an unknown length of

time and requiring a return to outdated labeling for

patients and providers. See, e.g., Apache Corp. v.

FERC, 627 F.3d 1220, 1221 (D.C. Cir. 2010)

(Kavanaugh, J.) (remand without vacatur appropriate

where “there is ‘a serious possibility that the [agency]

will be able to substantiate its decision on remand’ ”

(quoting Allied-Signal, Inc. v. U.S. Nuclear Regul.

Comm’n, 988 F.2d 146, 151 (D.C. Cir. 1993))); A.L.

Pharma, Inc. v. Shalala, 62 F.3d 1484, 1492 (D.C. Cir.

1995) (remanding without vacatur to determine

whether FDA approval was justifiable because

vacatur would “prove disruptive” to sponsor, “which

ha[d] relied on” drug approval “in good faith for over

thirteen years”); see also infra pp. 52-54.

1. FDA

Carefully

Analyzed

And

Reasonably Explained Its Approval Of

Changes To Mifeprex’s Labeling.

In 2016, FDA approved several changes to

Mifeprex’s labeling. FDA approved changing the

dosing regimen and updating the gestational age

cutoff. Supra pp. 6-8; see 21 U.S.C. § 355(d)(5). FDA

also approved modifications to the REMS: reducing

the number of in-person clinical visits and allowing

other healthcare providers qualified under state law

to prescribe Mifeprex. Supra pp. 8-10; see 21 U.S.C.

§ 355-1(g)(4)(A).

Based on the evidence before it, FDA’s decision to

approve these changes was “reasonable and

reasonably explained.” Prometheus, 592 U.S. at 423.17

FDA’s determination was rooted in an exhaustive

review of more than 20 years of clinical and real-world

data. J.A. 435. Across hundreds of pages, a team of

experts carefully analyzed over 90 sources, J.A. 509516, including over 50 unique studies covering tens of

thousands of women, many of which specifically

addressed each change FDA was considering:

● twenty-two studies including over 35,000

women supporting the conclusion that the new

dosing regimen remained safe and effective,

J.A. 446-450; J.A. 478-479;

● seven studies including 934 women supporting

the conclusion that the new drug regimen was

safe and effective up to 70 days gestation, J.A.

455-456; J.A. 478-479;

● seven studies including 4,018 women

supporting finding a repeat dose of misoprostol

was safe and effective, J.A. 460-461; J.A. 481482;

● eleven studies including 30,763 women

supporting finding home administration of

Respondents abandoned any challenge to individual

changes; they argued below only that the 2016 changes violated

the APA because FDA could not point to a study evaluating those

changes “as a whole.” Appellees Br. 52-55 (5th Cir. May 8, 2023).

misoprostol was comparably effective and safe

as compared to in-office administration,

J.A. 458-459; J.A. 479-481;

● four studies including 3,200 women supporting

the conclusion that allowing non-physician

prescribing of Mifeprex would be safe and

comparably effective to results from physician

prescribers, J.A. 461-462; J.A. 497-498; and

● one study involving over 45,000 women

supporting increased flexibility for follow-ups,

showing this was “safe to approve,” J.A. 485;

J.A. 462; J.A. 482-485.

After carefully reviewing these studies, alongside

15 years of real-world data showing Mifeprex’s safe

use under various conditions, J.A. 478-479; J.A. 506,

FDA determined that adopting all the proposed

changes would not alter Mifeprex’s safety and efficacy

profile, J.A. 424-425; 21 U.S.C. §§ 355(d), 356a(b),

355-1(g)(4). As FDA explained, “[t]he submitted

efficacy and safety information supported approval of

the proposed dosing regimen through 70 days

gestation, and other changes.” J.A. 317; accord

ROA 2280-2281. FDA further concluded that “the

benefit-risk profile for Mifeprex continues to be

favorable and with the agreed-to labeling changes and

REMS modifications, the Mifeprex REMS program

will continue to assure safe use.” J.A. 319; accord

ROA 2280-2281.

In short, FDA evaluated the

evidence, explained its conclusions, and reasonably

determined that Mifeprex would remain safe and

effective under the approved labeling.

The Fifth Circuit reached a contrary conclusion for

one reason: According to the court, FDA was required

to “consider the cumulative effect” of the 2016 changes

and did not do so. Pet. App. 53a. That argument fails

several times over.

First, even the limited record shows that FDA

addressed whether Mifeprex would remain safe and

effective if the agency approved the interrelated set of

changes. 21 U.S.C. §§ 355(d), 356a(b), 355-1(g). FDA

relied on many studies of proposed changes in

combination. FDA said as much: “As these major

changes are interrelated, in some cases data from a

given study were relied on to provide evidence to

support multiple changes.” J.A. 298; see J.A. 442. For

example, “[f]our studies” including almost 3,000

women “and one systemic review evaluated the exact

proposed dosing regimen through 70 days gestation.”

ROA 2260; ROA 2278. Four studies concerned the athome administration of misoprostol through 70 days

gestation, under both the current and proposed new

misoprostol dosing regimen. J.A. 458; see ROA 22642266. And FDA reviewed three studies evaluating

“the safety and efficacy of medical abortion when

performed by non-physician healthcare providers”

under “the proposed dosing regimen,” in which

“[a]lmost 1,500 women (over 700 of whom had nonphysician care) had gestations through 70 days or

more.” ROA 2268.

After analyzing this evidence, multiple separate

FDA reviewers unanimously recommended approving

all the proposed changes. Each reviewer identified all

the changes to Mifeprex’s labeling that Danco sought;

detailed the many studies that addressed various

combinations of the changes; explained why those

studies supported a safety and efficacy finding; and

“recommend[ed] an approval action.”

J.A. 423;

ROA 2254; J.A. 317-319. That is all the APA requires.

In approving labeling changes, FDA is tasked with

“evaluat[ing],” based on the information “before” it,

whether the drug is safe and effective “under the

conditions of use prescribed, recommended, or

suggested in the labeling.” 21 U.S.C. § 355(d); see id.

§ 355-1(g)(4)(A). FDA satisfied that obligation when

it concluded that each of Danco’s requested

“interrelated” changes posed zero additional safety

concerns. J.A. 298. Reviewing courts “may not set

aside an agency [action] that is * * * based on

consideration of the relevant factors and within the

scope of the authority delegated to the agency by the

statute.” State Farm, 463 U.S. at 42. And FDA was

“not required to author an essay for the disposition of

[Danco’s] application”; rather, “[i]t suffices” that “the

why and wherefore” can be discerned. Friedman v.

FAA, 890 F.3d 1092, 1099 (D.C. Cir. 2018) (citation

omitted).

Respondents and the Fifth Circuit pointed to no

evidence before FDA that suggested approving the

interrelated changes altered Mifeprex’s safety profile.

They likewise offered no reason to believe that adding

zero plus zero plus zero additional safety concerns

would equal anything other than zero “cumulative”

safety concerns, and thus no basis to question FDA’s

predictive judgment that Mifeprex was safe and

effective under the revised labeling. See Prometheus,

592 U.S. at 425-427 (finding agency’s predictive

judgment reasonable based “on the data it had (and

the absence of any countervailing evidence)”).

Agencies are not required to have “perfect empirical

or statistical data” before acting. Id. at 427. And

nothing in the FDCA requires FDA to “conduct its own

empirical or statistical studies before exercising its

discretion.” Id.; see 21 U.S.C. §§ 355(d), 355-1(g)(4).

The contrary:

If FDA concludes based on the

“information submitted” in an sNDA that the drug is

safe and effective under its proposed labeling, FDA

“shall issue an order approving the application.” 21

U.S.C. § 355(d) (emphasis added).

Second, the court of appeals faulted FDA for not

including a lengthier discussion of “cumulative

changes,” Pet. App. 53a-54a, but Respondents’ citizen

petition never made any such argument. Plaintiffs

cannot “fail[ ] * * * to bring the matter to the agency’s

attention,” and then “seek[ ] to have that agency

determination vacated on the ground that the agency

failed to consider [those] matters.” Vt. Yankee, 435

U.S. at 553-554 (citation omitted). FDA’s detailed

response addressed each argument Respondents did

make and each study they cited. J.A. 379-393.

Third, the Fifth Circuit effectively faulted FDA for

not meeting the so-called “study-match” requirement

that Respondents argued exists in the FDCA. Under

this theory, having multiple clinical trials that study

a drug’s safety and efficacy under varying protocols is

insufficient to allow for scientific decisionmaking

about proposed labeling; there must be one clinical

trial conducted under the exact “labeled conditions of

use” before FDA can find the drug safe and effective.

Br. in Opp’n 43. The notion that FDA is required to

point to a single study “examin[ing] the effect of

implementing” every labeling change “together” defies

the statutory text. See Pet. App. 53a. The FDCA

requires only that FDA determine whether “adequate

tests” show a drug is safe under its proposed labeling

and that the benefits of the drug outweigh its risks.

21 U.S.C. § 355(d); see id. § 355-1(g)(4). And virtually

no drug would be approved today if such a studymatch requirement existed. Pharm. Cos. Cert. Br. 20.

2. FDA Lawfully Changed The AdverseEvent Reporting Requirements In 2016.

FDA also reasonably explained its conclusion that

the pre-2016 mandatory serious-adverse-event

reporting for Mifeprex prescribers was no longer

necessary in light of the drug’s established safety

profile and Danco’s continuing reporting obligations.

J.A. 506; 21 U.S.C. § 355-1(a), (f), (g)(4).

From 2000 to 2016, Mifeprex was subject to the

most demanding form of mandatory-adverse-event

reporting—something no current REMS requires.

Under that regime, Mifeprex prescribers had to report

all serious adverse events. J.A. 230. By 2016, FDA

had amassed 15 years of data demonstrating

Mifeprex’s track record as a safe product. J.A. 392;

J.A. 500. Of the more than 2.5 million women in the

United States who had taken mifepristone by then,

more than 99.9% did not experience a serious adverse

event. J.A. 501-502. For instance, only 878 women

out of the more than 2.5 million who had taken

mifepristone—0.035%—were hospitalized. Id.

Based on this “well-characterized safety profile,”

developed over 15 years and millions of patients, FDA

decided that mifepristone should be subject to the

same adverse-event reporting requirements applied

to other drugs, with one heightened requirement

remaining. J.A. 392. Under the 2016 decision,

prescribers must still report any fatality for any

reason, even if unrelated to mifepristone. Supra

pp. 10-11. Adverse-event reporting for mifepristone

thus remains more stringent than for the vast

majority of drugs with a REMS; only seven of the 67

REMS mandate adverse-event reporting of deaths.

See FDA, Approved Risk Evaluation and Mitigation

Strategies (REMS).18 As with other drugs, prescribers,

patients, and others can (and do) voluntarily report

non-fatal adverse events, such as hospitalizations and

blood transfusions, either to Danco directly, or to

FDA. Supra pp. 10-11. And like all NDA-holders,

Danco must share with FDA any adverse events that

Danco learns about. See J.A. 506; J.A. 392; 21 C.F.R.

§§ 314.80, 314.81. Moreover, adverse-event reports

are not FDA’s only monitoring tool; the agency can

also examine scientific literature documenting the

drug’s safety, e.g., J.A. 299-300, and REMS

“assessments,” which the drug’s sponsor must provide

to FDA at regular intervals, 21 U.S.C. § 355-1(d),

(g)(2)(B)-(C).

The Fifth Circuit erred in holding that FDA acted

arbitrarily and capriciously by modifying the adverseevent reporting requirements for Mifeprex prescribers

in 2016. According to the Fifth Circuit, the agency

should have kept prescribers’ heightened mandatory

serious-adverse-event reporting in place just in case

the 2016 changes altered the drug’s safety profile,

Pet. App. 55a-56a, even though FDA had just decided

based on extensive evidence that they would not.

The court’s decision is contrary to the statute,

which mandates that these types of REMS

requirements be “necessary to assure safe use of the

drug.” 21 U.S.C. § 355-1(f)(1) (emphasis added). The

court’s decision also re-weighs the scientific evidence,

which is improper under arbitrary-and-capricious

review. Marsh v. Or. Nat. Res. Council, 490 U.S. 360,

https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

(last visited Jan. 23, 2024).

377 (1989) (“When examining this kind of scientific

determination a reviewing court must generally be at

its most deferential” (citation and ellipses omitted)).

In 2016, FDA determined, based on the available

evidence, that serious adverse events under the 2000

approval were exceedingly rare and that the modified

labeling would not change the safety profile. Supra

pp. 6-11. FDA specifically “evaluated the adverse

event information” associated with each proposed

change. J.A. 308-309. For example, FDA concluded

that “data for the proposed regimen,” including the

revised gestational-age cutoff, “do not suggest a safety

profile that deviates from that of the originally

approved regimen.” J.A. 310; see J.A. 304. FDA also

found that at-home administration of misoprostol “is

associated with exceedingly low rates of serious

adverse events, and [comparable] rates of common

adverse events” to the 2000 approval. J.A. 308; see

also J.A. 310 (finding “the evidence demonstrated

acceptable safety for each * * * proposed change[ ]”).

FDA thus concluded that (1) Mifeprex’s safety

profile was established and “essentially unchanged”

across 15 years of data; (2) Mifeprex’s safety profile

would not change as a result of the 2016 changes; and

(3) continued mandatory reporting by prescribers of

non-fatal serious adverse events was therefore

unnecessary. In other words, FDA predicted there

would be a comparable number of serious adverse

events reported under both the 2000 and 2016

labeling, and given the exceedingly rare number of

serious adverse events reported under the 2000

labeling, continued mandatory prescriber-reporting of

non-fatal serious adverse events was unnecessary.

FDA was well within its right to make this sort of

“predictive judgment” “based on the evidence it had.”

Prometheus, 592 U.S. at 427. And FDA’s path is

reasonably discernable. E.g., Bowman Transp., Inc.

v. Ark.–Best Freight Sys., Inc., 419 U.S. 281, 286

(1974); Transp. Div. of Int’l Ass’n of Sheet Metal, Air,

Rail v. Fed. R.R. Admin., 40 F.4th 646, 657 (D.C. Cir.

2022) (agency reasonably predicted that “fewer

occasions” for situations that can result in injury

“would lead to fewer injuries”). The Fifth Circuit

erred in holding otherwise.

3. FDA’s Actions In 2021

Arbitrary And Capricious.

Were

Not

The Fifth Circuit should not have even reached

Respondents’ challenge to FDA’s December 2021 nonenforcement decision because that decision is moot.

In 2023, FDA superseded its non-enforcement

decisions by modifying the REMS to remove the inperson dispensing requirement. Supra pp. 11-12.

Respondents did not amend their complaint or

otherwise raise a challenge to the 2023 REMS. And

before the Fifth Circuit, Respondents did not dispute

Danco’s and FDA’s contention that this claim was

moot, thereby forfeiting any such argument.

Regardless of whether “FDA’s policy remains

unchanged,” Pet. App. 59a, FDA’s reasoning for

temporarily exercising enforcement discretion no

longer matters, because in-person dispensing is no

longer a REMS requirement. There is thus no “live

dispute” about whether FDA’s December 2021

reasoning was deficient. Contra id. at 57a.

In any event, FDA’s December 2021 decision to

suspend the in-person dispensing requirement was

reasonable. FDA comprehensively reviewed the data

and cogently explained why in-person dispensing was

unnecessary. J.A. 378; J.A. 394; J.A. 407; 21 U.S.C.

§ 355-1(f)(1), (g)(4)(B). Even the limited record proves

that decision “was the result of a thorough scientific

review by experts within [FDA] who evaluated

relevant information, including available clinical

outcomes data and adverse event reports.” J.A. 377.

FDA’s decision relied on post-marketing data from

adverse-event reports.

FDA compared postmarketing data from nearly nine months when inperson dispensing was enforced against data from

eleven months when in-person dispensing was not

enforced.19 J.A. 398. “Based on FDA’s review of this

data, [the agency] concluded that there does not

appear to be a difference in adverse events when inperson dispensing was and was not enforced.” J.A.

399. All of this confirmed to FDA’s satisfaction “that

mifepristone may be safely used without in-person

dispensing,” J.A. 399, and that in-person dispensing

thus was not necessary to ensure safe use, J.A. 378;

see 21 U.S.C. § 355-1(f)(1), (g)(4)(B).

FDA also looked to study data. As part of its

“extensive review of the published literature,”

J.A. 399, FDA examined three studies permitting

pharmacy dispensing through the mail, one of which

showed a mere 0.9% of women experienced an adverse

event after taking mifepristone, J.A. 402. These

studies also supported finding “that efficacy of

medical abortion is maintained with mail order

pharmacy dispensing.” J.A. 403. FDA also examined

In-person dispensing was suspended twice before: once in

response to a court order, from July 2020 to January 2021, and

again by FDA in response to the COVID-19 pandemic, in April

2021. J.A. 398. FDA’s December 2021 response to Respondents’

citizen petition explained that FDA would continue to exercise

enforcement discretion with respect to this requirement.

J.A. 378.

five studies allowing clinic dispensing by mail,

explaining that “these studies overall support that

dispensing by mail from clinic is safe and effective.”

J.A. 403-406.

The Fifth Circuit erred in second-guessing FDA’s

scientific judgment. The Fifth Circuit offered two

purported reasons for its decision. Neither holds up.

First, the Fifth Circuit faulted FDA for relying on

adverse-event data.

The data showed that a

vanishingly small number of women who take

mifepristone experience an adverse event, but the

court found supposed “limitations” in that data.

Pet. App. 59a. The Fifth Circuit criticized FDA for

supposedly

“eliminat[ing]”

the

adverse-event

reporting requirement in 2016 and then relying on the

absence of adverse-event reports in 2021. Id. But, as

explained, FDA did not eliminate adverse-event

reporting; prescribers still must report fatalities, and

anyone can still report any other adverse events to

FDA or to Danco. Supra pp. 10-11. FDA was thus

entitled to rely on the adverse-event data relating to

mifepristone in 2021, just as FDA relies on that data

for other drugs. Marsh, 490 U.S. at 377 (deference

especially warranted to agency action involving “a

high level of technical expertise”).

The Fifth Circuit also found FDA’s data

“insufficient to draw general conclusions about

adverse events” because some “adverse events will go

unreported” due to the voluntary nature of this

system. Pet. App. 59a-60a. But that is true for every

FDA-approved drug. Indeed, for the vast majority of

drugs, prescribers are not even required to report

fatalities. Supra pp. 45-46. Yet FDA routinely relies

on adverse-event data to relax or discontinue a REMS

as prescribers become more familiar with a drug’s

safety profile. See FDA Scholars Cert. Br. 21-22 &

n.18; see also, e.g., FDA, Lotronex sNDA Approval 2

(Sept. 8, 2023)20 (eliminating REMS where “[a]dverse

event reporting * * * has been stable, and an increase

in severe outcomes has not been observed”). It “is not

unusual in day-to-day agency decisionmaking” for

agencies to rely on imperfect data. Prometheus, 592

U.S. at 427. Indeed, if FDA were permitted to modify

a REMS only when it has reporting about all adverse

events, FDA would never be able to modify a REMS.

See FDA Scholars Cert. Br. 13.

Second, the Fifth Circuit faulted FDA for stating

that scientific literature was “not inconsistent with”

FDA’s conclusion, which it interpreted to mean “the

studies neither confirmed nor rejected” the proposed

change. Pet. App. 62a (quoting J.A. 400). Wrong

again.

FDA made the exact statement the Fifth Circuit

was looking for: FDA explicitly said its conclusion was

“supported by our review of the published literature.”

J.A. 397. The Fifth Circuit’s conclusion also rests on

a flawed premise. An agency decision that relies on

the absence of data will be upheld, provided the

agency makes a “reasonable predictive judgment.”

Prometheus, 592 U.S. at 427. That is what happened

here. FDA reviewed the data, and based on the lack

of real-world adverse events and several supporting

studies, reasonably predicted that the in-person

dispensing requirement could be “modified to reduce

the burden on the health care delivery system without

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/

2023/021107Orig1s030ltr.pdf.

compromising patient safety.” J.A. 394; see J.A. 371;

21 U.S.C. § 355-1(f)(2), (g)(4).

Finally, the Fifth Circuit criticized FDA for relying

on studies despite “recogniz[ing]” their limitations.

Pet. App. 62a. But agency action that candidly

acknowledges the “limitations” of its data and

“carefully explain[s] why its limited reliance on [that

data] was justified” is not arbitrary and capricious. In

re Polar Bear ESA Listing & Section 4(d) Rule Litig.-MDL No. 1993, 709 F.3d 1, 14 (D.C. Cir. 2013). FDA

reasonably identified shortcomings in certain studies

and detailed why those studies it did rely on, coupled

with all the other evidence the agency examined,

supported its conclusion that in-person dispensing

was not necessary.

C. The Equities Favor Danco.

The Fifth Circuit also erred in analyzing the

remaining preliminary-injunction factors. Both the

equities and risk of irreparable harm to Danco and the

public overwhelmingly favored denying preliminary

relief.

The panel’s order will cause tremendous harm,

including pushing women to later and more invasive

surgical abortions or unapproved regimens with more

complications, and impeding access to miscarriage

management. E.g., Doctors for Am. Cert. Br. 8-11

(“mifepristone means improved access to care” in

rural areas); id. at 11-16 (“restricting mifepristone

would undermine * * * safe and effective management

of early pregnancy loss”); ACOG Cert. Br. 5-7, 17-23

(decisions below “compromise patient safety and

wellbeing, impede the provision of quality health care

services, and threaten the effective functioning of

health care institutions and the practice of medicine”);

States Cert. Br. 1-3, 8-20 (detailing investments by 23

States and D.C. in medication abortion access); Local

Gov’ts Cert. Br. 2, 18-20 (burdens on understaffed and

underfunded hospitals); Dr. Goldberg Decl. ¶¶ 9-15

(5th Cir. Apr. 10, 2023), ECF No. 29 (patients “choose

medication abortions over surgical ones for many

reasons”; limiting access to medication abortion

means “patients will carry undesired, high-risk

pregnancies forward at great risk to themselves”); Dr.

Schreiber Decl. ¶¶ 17-23 (5th Cir. Apr. 10, 2023), ECF

No. 29 (medication abortion is often “safer and/or

preferable for some patients given their individual

circumstances”).

The court did not consider the consequences of

ordering a less-effective dosing regimen, which would

prescribe three times the current recommended

amount of mifepristone. And the court did not give

any weight to the inevitable gap in access between the

effective date of a court order requiring Danco to

return to the pre-2016 regime, and the date Danco

could begin distributing Mifeprex with “drug labels

and documentation that comply with the mifepristone

REMS as of 2011.” Pet. App. 66a-67a.

The Fifth Circuit’s decision also has serious

consequences for Danco. The changes required by the

injunction are not ones Danco can make quickly or

unilaterally—they are major changes that would

require Danco to submit an sNDA and for FDA to

approve it, even though Danco would be seeking

approval for outdated prescribing information and

with use conditions that studies repeatedly show are

unnecessary. 21 U.S.C. §§ 355(a), (d), 356a; 21 C.F.R.

§ 314.70(b). The Fifth Circuit never explained how

FDA could approve a sort of hypothetical sNDA

effective only upon a decision of this Court to uphold

the preliminary injunction, or how FDA could ignore

its statutory mandates on safety, efficacy, and the

weight of benefits and risk and instead grant a courtordered sNDA based on that court’s concerns. See 21

U.S.C. § 355(d). Nor did it address a competing court

injunction prohibiting FDA from approving any

changes to the 2023 REMS in 17 States and D.C.

Order Granting in Part Pls.’ Mot. for Prelim. Inj. at

30, Washington v. FDA, No. 1:23-cv-03026 (E.D.

Wash. Apr. 7, 2023), ECF No. 80.

The pharmaceutical industry has offered

additional reasons why an injunction here is contrary

to the public interest: It would severely destabilize

the industry, stifle innovation in drug development,

and prevent patients from accessing a drug with a

long record of safe and effective use. See PhRMA Cert.

Br. 19-21; Pharm. Cos. Cert. Br. 12-22. The Fifth

Circuit’s ruling “represents a destabilizing threat to

the investment-backed expectations that make drug

innovation possible.” PhRMA Cert. Br. 21. And it

“threatens a seismic shift in the clinical development

and drug approval processes—erecting unnecessary

and unscientific barriers to the approval of lifesaving

medicines, chilling drug development and investment,

threatening patient access, and destabilizing FDA’s

rigorous, well-established, and longstanding drug

approval process.” Pharm. Cos. Cert. Br. 22.

CONCLUSION

The judgment of the Fifth Circuit should be

reversed and the case remanded with instructions to

dismiss for lack of standing. In the alternative, it

should be reversed on the merits.

Respectfully submitted,

PHILIP KATZ

LYNN W. MEHLER

HOGAN LOVELLS US LLP

555 13th Street, N.W.

Washington, D.C. 20004

EVA M. SCHIFINI

HOGAN LOVELLS US LLP

1999 Avenue of the Stars

Suite 1400

Los Angeles, CA 90067

JESSICA L. ELLSWORTH

Counsel of Record

CATHERINE E. STETSON

JO-ANN TAMILA SAGAR

DANIELLE DESAULNIERS STEMPEL

MARLAN GOLDEN

DANA A. RAPHAEL

HOGAN LOVELLS US LLP

555 13th Street, N.W.

Washington, D.C. 20004

(202) 637-5600

jessica.ellsworth@hoganlovells.com

Counsel for Danco Laboratories, LLC

JANUARY 2024

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.