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

NOS. 23-235, 23-236

IN THE

Supreme Court of the United States

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

Petitioners,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

and

DANCO LABORATORIES, L.L.C.,

Petitioner,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

On Writs of Certiorari to the

United States Court of Appeals for the Fifth Circuit

BRIEF FOR THE RESPONDENTS

JAMES A. CAMPBELL

ERIK C. BAPTIST

CODY S. BARNETT

GABRIELLA MCINTYRE

ALLIANCE DEFENDING

FREEDOM

44180 Riverside Pkwy

Lansdowne, VA 20176

(571) 707-4655

ERIN M. HAWLEY

Counsel of Record

JOHN J. BURSCH

MATTHEW S. BOWMAN

ALLIANCE DEFENDING FREEDOM

440 First Street NW, Suite 600

Washington, DC 20001

(202) 393-8690

ehawley@ADFlegal.org

Counsel for Respondents

i

QUESTIONS PRESENTED

In 2000, the Food and Drug Administration (FDA)

approved the high-risk abortion drug mifepristone

and imposed critical safety requirements on its use.

Yet in 2016, FDA stripped away most of those standards without any study evaluating the changes under

the new conditions of use and without a reasonable

explanation. Then, in 2021, FDA allowed prescribers

to give these drugs to women without an initial inperson visit. It did so based on adverse event data that

it elsewhere recognizes as unreliable and studies that

it considered inadequate. The questions presented

are:

1. Whether doctors and medical associations have

Article III standing to challenge FDA’s removal of

drug-safety standards where (1) the doctors are

OB/GYN hospitalists, on-call OB/GYNs, and

emergency-room physicians who have suffered

repeated injuries, (2) FDA admits 2.9 to 4.6 percent of

women who take abortion drugs end up in the

emergency room, (3) FDA directed women harmed by

abortion drugs to emergency rooms, and (4) FDA’s

2021 and 2016 actions have increased the substantial

risk of harm to these doctors and their patients.

2. Whether FDA violated the APA by (1) relying

on admittedly unreliable information and inadequate

studies to remove the initial in-person visit in 2021,

(2) failing to evaluate the safety of the 2016 changes

as a whole under the conditions of use in the proposed

labeling, and (3) failing to reasonably explain its 2021

and 2016 actions.

3. Whether the lower courts properly granted

preliminary relief.

ii

CORPORATE DISCLOSURE SATEMENT

Petitioner organizations—Alliance for Hippocratic

Medicine, American Association of Pro-Life Obstetricians & Gynecologists, American College of Pediatricians, and Christian Medical & Dental Associations—

have no parent corporations, and no publicly held

corporation owns 10 percent or more of the stock of

any of them.

iii

TABLE OF CONTENTS

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

CORPORATE DISCLOSURE SATEMENT.............. ii

TABLE OF AUTHORITIES ..................................... vi

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

STATEMENT OF THE CASE ................................... 2

A. FDA’s approval of mifepristone with

safeguards ........................................................ 2

B. Challenges and changes to FDA’s 2000

approval ........................................................... 4

C. FDA’s 2016 changes ........................................ 6

D. Challenges and modifications to FDA’s

2016 changes ................................................... 7

E. FDA’s 2021 actions .......................................... 8

1. Adverse event reports ................................ 9

2. Published literature ................................. 10

F. Mifepristone’s current labeling ..................... 12

G. Proceedings below ......................................... 12

SUMMARY OF THE ARGUMENT ......................... 14

ARGUMENT ............................................................ 17

I. Respondents have standing to challenge the

2021 and 2016 actions. ....................................... 17

A. Respondents have individual and

associational standing. .................................. 17

1. Respondent doctors face concrete harms

from FDA’s actions. .................................. 18

iv

2. Respondents face a substantial risk of

harm anticipated by FDA, supported by

data, and confirmed by testimony. .......... 24

3. Respondents’ injuries are traceable to

FDA’s 2021 and 2016 removal of safety

standards. ................................................. 33

a. The 2021 action increased the risk of

harm to Respondents. ......................... 35

b. The 2016 changes increased the risk

of harm to Respondents. ..................... 39

4. Respondents’ harms are redressable....... 41

B. Plaintiffs have organizational standing. ...... 42

C. Plaintiffs have third-party standing............. 45

II. FDA’s removal of safeguards for abortion

drugs was arbitrary, capricious, an abuse of

discretion, and otherwise unlawful. ................... 47

A. FDA’s 2021 removal of the initial in-person

office visit was arbitrary, capricious, and

unlawful. ........................................................ 48

1. FDA’s 2021 removal of the initial inperson office visit was arbitrary and

capricious. ................................................. 49

a. It was arbitrary for FDA to conclude

that adverse event reports

supported its 2021 action. .................. 50

b. It was arbitrary for FDA to conclude

that scientific literature supported

its 2021 action. .................................... 52

v

2. FDA’s 2021 removal of the initial office

visit also violates the Comstock Act. ....... 56

B. FDA’s 2016 elimination of two of three inperson visits while increasing gestational

age and eliminating the reporting

requirement was arbitrary and capricious. .. 58

1. FDA failed to consider an important

aspect of the problem. .............................. 59

2. FDA failed to provide a satisfactory

explanation. .............................................. 62

3. FDA’s elimination of the reporting

requirement for all serious adverse

events was arbitrary and capricious. ...... 63

4. A full administrative record is not

necessary at this stage. ............................ 63

III.The remedy issued is appropriate. ..................... 65

CONCLUSION ......................................................... 70

vi

TABLE OF AUTHORITIES

Cases

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

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

Abington School District v. Schempp,

374 U.S. 203 (1963) .............................................. 31

Alabama Association of Realtors v. Department

of Health & Human Services,

141 S. Ct. 2485 (2021) .......................................... 65

American Bioscience, Inc. v. Thompson,

243 F.3d 579 (D.C. Cir. 2001) .............................. 64

Armstrong v. Exceptional Child Center, Inc.,

575 U.S. 320 (2015) .............................................. 57

Babbitt v. United Farm Workers National Union,

442 U.S. 289 (1979) .............................................. 30

Bank of America Corp. v. City of Miami,

581 U.S. 189 (2017) .............................................. 42

Bours v. United States,

229 F. 960 (7th Cir. 1915).................................... 57

Burlington Truck Lines v. United States,

371 U.S. 156 (1962) ................................................ 1

Burwell v. Hobby Lobby Stores, Inc.,

573 U.S. 682 (2014) .............................................. 19

Califano v. Yamasaki,

442 U.S. 682 (1979) .............................................. 67

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

401 U.S. 402 (1971) .............................................. 64

vii

City of Arlington v. FCC,

569 U.S. 290 (2013) ................................................ 1

City of Los Angeles v. Lyons,

461 U.S. 95 (1983) ................................................ 27

Clapper v. Amnesty International USA,

568 U.S. 398 (2013) .................................. 18, 24, 29

Crawford v. Marion County Election Board,

472 F.3d 949 (7th Cir. 2007)................................ 44

Darby v. Cisneros,

509 U.S. 137 (1993) .............................................. 61

Davis v. FEC,

554 U.S. 724 (2008) .............................................. 34

Department of Commerce v. New York,

139 S. Ct. 2551 (2019) .................................... 33, 34

Department of Education v. Brown,

600 U.S. 551 (2023) .............................................. 30

Department of Homeland Security v. Regents of

the University of California,

140 S. Ct. 1891 (2020) ............. 17, 59, 60, 62, 69, 70

Dobbs v. Jackson Women’s Health Organization,

597 U.S. 215 (2022) .............................................. 46

Duke Power Company v. Carolina Environmental

Study Group, Inc.,

438 U.S. 59 (1978) ................................................ 41

Encino Motorcars, LLC v. Navarro,

579 U.S. 211 (2016) .................................. 48, 50, 62

FCC v. Fox Television Stations, Inc.,

556 U.S. 502 (2009) ........................................ 48, 56

viii

FCC v. Prometheus Radio Project,

592 U.S. 414 (2021) .................................. 16, 53, 55

FDA v. American College of Obstetricians &

Gynecologists,

141 S. Ct. 578 (2021) .............................................. 8

FDA v. Brown & Williamson Tobacco Corp.,

529 U.S. 120 (2000) .............................................. 59

Havens Realty Corp. v. Coleman,

455 U.S. 363 (1982) ........................................ 42, 43

Hunt v. Washington State Apple Advertising

Commission,

432 U.S. 333 (1977) .............................................. 18

June Medical Services LLC v. Russo,

140 S. Ct. 2103 (2020) .......................................... 46

Khodara Environmental, Inc. v. Blakey,

376 F.3d 187 (3d Cir. 2004) ................................. 33

Kisor v. Wilkie,

139 S. Ct. 2400 (2019) .......................................... 55

Kolender v. Lawson,

461 U.S. 352 (1983) .............................................. 30

Larson v. Valente,

456 U.S. 228 (1982) .............................................. 41

Little Sisters of the Poor v. Pennsylvania,

140 S. Ct. 2367 (2020) .......................................... 31

Losch v. Nationstar Mortgage LLC,

995 F.3d 937 (11th Cir. 2021)........................ 21, 22

Lujan v. Defenders of Wildlife,

504 U.S. 555 (1992) .............................................. 23

ix

Massachusetts v. EPA,

549 U.S. 497 (2007) .............................................. 29

Monsanto Company v. Geertson Seed Farms,

561 U.S. 139 (2010) .............................................. 33

Motor Vehicle Manufacturers Association of

United States, Inc. v. State Farm Mutual

Automobile Insurance Company,

463 U.S. 29 (1983) ............. 27, 48, 49, 56, 59, 60, 62

Nasir v. Morgan,

350 F.3d 366 (3d Cir. 2003) ................................. 46

National Treasury Employees Union v. Campbell,

589 F.2d 669 (D.C. Cir. 1978) .............................. 47

New York v. FERC,

535 U.S. 1 (2002) ............................................ 48, 62

Nken v. Holder,

556 U.S. 418 (2009) ........................................ 65, 66

Nnebe v. Daus,

644 F.3d 147 (2d Cir. 2011) ................................. 44

Northeastern Florida Chapter of Associated

General Contractors of America v. City of

Jacksonville,

508 U.S. 656 (1993) .............................................. 58

O’Shea v. Littleton,

414 U.S. 488 (1974) .............................................. 27

OCA-Greater Houston v. Texas,

867 F.3d 604 (5th Cir. 2017)................................ 44

Pacific Legal Foundation v. Goyan,

664 F.2d 1221 (4th Cir. 1981).............................. 45

x

Perez v. McCreary, Veselka, Bragg & Allen, P.C.,

45 F.4th 816 (5th Cir. 2022) ................................ 22

Powers v. Ohio,

499 U.S. 400 (1991) .............................................. 46

Rydholm v. Equifax Information Services LLC,

44 F.4th 1105 (8th Cir. 2022) .............................. 22

Sierra Club v. Morton,

405 U.S. 727 (1972) ........................................ 22, 43

Singleton v. Wulff,

428 U.S. 106 (1976) .............................................. 46

Spann v. Colonial Village, Inc.,

899 F.2d 24 (D.C. Cir. 1990) ................................ 43

Summers v. Earth Island Institute,

555 U.S. 488 (2009) ........................................ 23, 30

Susan B. Anthony List v. Driehaus,

573 U.S. 149 (2014) .......................15, 17, 21, 24, 29

Texas Department of Housing & Community

Affairs v. Inclusive Communities Project, Inc.,

576 U.S. 519 (2015) .............................................. 57

TransUnion LLC v. Ramirez,

594 U.S. 413 (2021) .................................. 18, 22, 23

United Steel v. Mine Safety & Health

Administration,

925 F.3d 1279 (D.C. Cir. 2019) ............................ 70

University of Texas v. Camenisch,

451 U.S. 390 (1981) .............................................. 63

Uzuegbunam v. Preczewski,

141 S. Ct. 792 (2021) ............................................ 41

xi

Valley Forge Christian College v. Americans

United for Separation of Church & State,

454 U.S. 464 (1982) .............................................. 31

Washington Association for Television & Children

v. FCC,

712 F.2d 677 (D.C. Cir. 1983) .............................. 61

Statutes

18 U.S.C. 1461 .......................................................... 56

18 U.S.C. 1462 .......................................................... 56

21 U.S.C. 355 ............... 2, 34, 47, 49, 52, 54, 55, 59, 62

21 U.S.C. 355-1....................................................... 5, 7

47 U.S.C. 303 ............................................................ 55

47 U.S.C. 309 ............................................................ 55

5 U.S.C. 705 .................................................. 13, 66, 67

5 U.S.C. 706 ........................................................ 63, 64

Drug Amendments Act of 1962, Pub. L. No. 87781, 76 Stat. 780 .................................................. 54

Food and Drug Administration Amendments Act

of 2007, Pub. L. No. 110-85, tit. IX § 909(b)(1),

121 Stat. 823 ...................................................... 4, 5

Regulations

21 C.F.R. 10.45 ................................................... 45, 67

21 C.F.R. 314.3 ......................................................... 47

21 C.F.R. 314.71 ......................................................... 2

40 Fed. Reg. 40682 (Sept. 3, 1975) .......................... 45

42 Fed. Reg. 4680 (Jan. 25, 1977).............................. 1

xii

Other Authorities

Charles Alan Wright & Arthur R. Miller, Fed.

Prac. & Proc. (3d ed. 2023) ............................ 44, 46

2000 Mifeprex Label ............................................ 3, 60

ACOG Practice Bulletin 193 (Mar. 2018)................ 37

Danco Letter (Nov. 12, 2004) ............................... 4, 25

Dilation and Curettage, Johns Hopkins Medicine .. 20

FDA 2023 Approval Letter (Jan. 3, 2023) ............... 68

FDA 2023 Summary Review ................................... 58

H.R. 13959, 95th Cong. §§ 6701(a)(2), 6702(1)(C)(i)

(1978) .................................................................... 57

H.R. Rep. No. 1980 (1946)........................................ 66

Lynn Borgatta et al., Surgical Techniques for

First-Trimester Abortion, The Alliance for

Global Women’s Medicine (May 2012) ................ 20

Medication Abortion up to 70 days of Gestation,

Am. Coll. of Obstetrics & Gynecology Clinical

Practice Bulletin (Oct. 2020) ................... 32, 39, 60

Melissa J. Chen & Mitchell D. Creinin,

Mifepristone With Buccal Misoprostol for

Medical Abortion: A Systematic Review,

U.C. Davis (July 2015) ............................. 32, 39, 60

Michael Krupka, Exasperated But Not Exhausted:

Unlocking the Trap Set by the Exhaustion

Doctrine on the FDA’s REMS Petitioners, Vand.

L. Rev. (Forthcoming) .......................................... 61

News Release, Guttmacher Institute, Number of

Abortions in the United States Likely to Be

Higher in 2023 than in 2020 (Jan. 17, 2024) ...... 26

xiii

Rachel K. Jones et al., Abortion incidence and

service availability in the United States 2020,

Guttmacher Institute (Nov. 2022)................. 26, 34

Rep. of the Subcomm. on Crim. Just. on

Recodification of Fed. Crim. L., H.R. Rep. No.

95-29, pt. 3 (1978) ................................................ 57

1

INTRODUCTION

No agency is above the law. Congress gave federal

courts the authority—and obligation—to review the

actions of agencies that regulate nearly “every nook

and cranny of daily life.” City of Arlington v. FCC, 569

U.S. 290, 315 (2013) (Roberts, C.J., dissenting). FDA’s

insistence that this Court cannot check its work runs

counter to the Administrative Procedure Act (APA).

Judicial review ensures that an agency doesn’t

“become a monster which rules with no practical

limits.” Burlington Truck Lines v. United States, 371

U.S. 156, 167 (1962) (cleaned up). Giving such

unfettered power to FDA—an agency whose actions

“affect every citizen,” 42 Fed. Reg. 4680, 4680 (Jan.

25, 1977)—is particularly problematic. Turning a

blind eye to FDA’s patently unreasonable actions

here, which jeopardize women’s health throughout

the nation, would be unprecedented.

Petitioners spend the bulk of their briefs erecting

procedural roadblocks. None are persuasive. Respondent doctors and medical associations have standing.

In removing crucial safeguards for the use of abortion

drugs, FDA expressly counted on OB/GYN hospitalists and emergency-room doctors—like Respondents—to manage abortion-drug complications. When

faced with these emergencies, Respondents have no

choice but to provide immediate treatment, even

though this kind of participation in an elective

abortion harms their consciences and injures them in

other ways. Had FDA retained the safeguards that it

called “necessary” and “minimally burdensome” just a

few years ago, it could have prevented many of these

emergency events. It instead shifted the burden to

OB/GYN hospitalists, emergency-room doctors, and

on-call OB/GYNs. This is no ordinary agency action.

2

Petitioners barely defend the merits of FDA’s

2021 and 2016 actions. For good reason. In 2021, FDA

withdrew the initial in-person office visit—the

opportunity to screen for ectopic pregnancies and

other dangerous conditions—based on data and

studies that the agency acknowledged were insufficient and inadequate. And in 2016, the agency

removed numerous interrelated safeguards without

studies examining the changes as a whole or

explaining why cumulative studies were unnecessary.

These arbitrary and unreasonably explained agency

actions fall far short of what the APA requires. This

Court should affirm.

STATEMENT OF THE CASE

Since the introduction of abortion drugs into the

United States, FDA has conscripted OB/GYNs,

OB/GYN hospitalists, and emergency-room doctors

into addressing serious complications caused by these

drugs. FDA’s removal of safety standards that the

agency once deemed essential increases the likelihood

of women needing emergency medical treatment.

A. FDA’s approval of mifepristone with

safeguards

The Food, Drug, and Cosmetic Act (FDCA)

requires FDA to ensure that approved drugs are “safe

and effective.” 21 U.S.C. 355. Under the FDCA, the

agency must reject an application or modification for

a drug unless “adequate tests,” test “results,” and

“[ ]sufficient information” demonstrate the drug safe

for use “under the conditions … in the proposed

labeling.” 21 U.S.C. 355(d) (initial approval); 21

C.F.R. 314.71 (modification).

3

In 2000, FDA approved a two-drug abortion

regimen: mifepristone—also known as “RU-486” and

“Mifeprex”—and misoprostol. J.A. 18, 39. Mifepristone blocks nutrition to the developing baby. J.A. 18.

And misoprostol induces contractions to expel the

unborn child from the mother’s womb. Ibid. Respondents refer to this abortion regimen as chemical

abortion.

FDA concluded that mifepristone could not be

“safely used” without special measures. J.A. 230. FDA

limited the drug’s approved use to seven weeks’

gestation or less. J.A. 234. Prescribers needed to be

licensed doctors able to diagnose ectopic pregnancies

and accurately determine gestational age. J.A. 230.

And doctors were required to provide ongoing inperson care: (1) the Day 1 in-person administration of

mifepristone; (2) the Day 3 in-person administration

of misoprostol; and (3) the Day 14 visit to check for

complications. J.A. 226–27, 230. FDA emphasized

that the Day 3 visit ensured the doctor would “provide

ongoing care,” J.A. 227; and the Day 14 visit was

“very important to confirm by clinical examination or

ultrasonographic scan” that the abortion was

complete,

2000

Mifeprex

Label

15,

https://perma.cc/3V7C-SU6Q.

FDA acknowledged that “the percentage of

women who considered any particular adverse event

as severe ranged from 2 to 35%.” Id. at 12. FDA also

included a Black Box warning to alert women that

“surgical intervention may be necessary” and inform

them of “what to do in the event of an emergency.”

J.A. 226.

Given the potential for serious adverse events,

FDA recognized that “access to … emergency services

4

is critical for the safe and effective use of the drug.”

J.A. 227 (emphasis added). FDA required doctors “to

assure patient access to medical facilities equipped to

provide blood transfusions and resuscitation, if

necessary.” J.A. 230. The drug was “contraindicated”

where “access to emergency services” was

“[in]adequate.” J.A. 229. And FDA required prescribing physicians without the ability to perform

emergency services to “direct” women “to a hospital

for emergency services.” Ibid.

B. Challenges and changes to FDA’s 2000

approval

In 2002, Respondents American Association of

Pro-Life Obstetricians & Gynecologists (AAPLOG)

and Christian Medical & Dental Associations

(CMDA) submitted a citizen petition asking FDA to

rescind the 2000 approval (2002 Citizen Petition).

J.A. 44–49.

Before the agency responded, FDA and Danco

agreed that Danco would issue a “Dear Emergency

Room Director” letter to “assist [ER Directors] in taking care of patients who may present in an emergency

room setting” after taking abortion drugs. Danco

Letter 1 (Nov. 12, 2004), https://perma.cc/734R-LLSQ.

The letter warned that “there may be some women

who present to an emergency room with serious and

sometimes fatal infections and bleeding” or ruptured

ectopic pregnancies. Ibid.

In 2007, Congress enacted the Food and Drug

Administration Amendments Act (FDAAA). Food and

Drug Administration Amendments Act of 2007, Pub.

L. No. 110-85, tit. IX § 909(b)(1), 121 Stat. 823, 950.

The FDAAA requires a risk evaluation and mitigation

5

strategy (REMS) whenever FDA determines it “necessary to assure safe use of the drug, because of its …

potential harmfulness” and association “with a serious adverse drug experience.” 21 U.S.C. 355-1(f)(1).

Drugs like mifepristone previously approved with

added safeguards were temporarily “deemed to have

in effect an approved [REMS].” Pub. L. No. 110-85 at

§ 909(b)(1).

In 2011, FDA approved a REMS for mifepristone.

ROA 671–75. The REMS and accompanying materials “incorporated the restrictions under which the

drug was originally approved.” J.A. 296. FDA found

that three in-person visits remained necessary. J.A.

276. The agency explained that a woman should take

mifepristone only after receiving in-person counseling

and “getting a physical exam” to diagnose ectopic

pregnancies and gestational age at the Day 1 office

visit. Ibid. FDA also required women to “return to

[their] provider on Day 3 and about Day 14.” J.A. 277.

The 2011 REMS materials warned that women

should not take mifepristone if they “cannot easily get

emergency medical help [for] 2 weeks” after taking

the drug. J.A. 276. The REMS required prescribers “to

assure patient access to appropriate medical facilities,” J.A. 272, “equipped to provide blood transfusions and resuscitation, if necessary,” J.A. 278.

Women were required to acknowledge they understood what to do if they “need emergency care due to

the treatment.” J.A. 280. And the agency instructed

women to take the medication guide with them

“[w]hen [they] visit an emergency room.” J.A. 275.

In 2016, FDA rejected the 2002 Citizen Petition,

14 years after it was submitted. J.A. 238. In its denial,

FDA said it would continue to rely on emergency

6

rooms as a backstop to “ensure that women have

access to medical facilities for emergency care” to

manage the expected complications. J.A. 258.

C. FDA’s 2016 changes

On the same day FDA denied the 2002 Citizen

Petition, the agency approved Danco’s request to

make “interrelated,” “major changes” to mifepristone’s conditions of use. J.A. 283–98. Among other

things, FDA (1) eliminated the Day 3 visit for

misoprostol administration, (2) removed the Day 14

visit to check for complications, and (3) increased the

maximum gestational age from seven to ten weeks.

J.A. 295. FDA also eliminated the requirements that

prescribers be physicians and report serious non-fatal

adverse events to the agency. J.A. 318–19.

Meanwhile, the agency retained the requirements

that providers “assure patient access to medical

facilities equipped to provide blood transfusions and

resuscitation” and that women have “access to

appropriate emergency medical care.” J.A. 391.

In making the 2016 changes, FDA did not rely on

any study that evaluated the changes as a whole, J.A.

549, or explain why an analysis of the cumulative

effects was unnecessary. FDA’s piecemeal analysis

relied on studies that included safety measures

omitted under the labeled conditions of use. J.A. 548.

Consider one study FDA cited. J.A. 299, 301, 304

(discussing the Winikoff study). The researchers (1)

confirmed gestational age (and presumably screened

for ectopic pregnancies) “based on routine ultrasound

practices,” (2) required the participants to return for

a follow-up visit and ultrasound, and (3) “intervened

surgically” if necessary or requested. ROA 727–28.

But the 2016 changes did not require (1) ultrasounds

7

to confirm gestational age or screen for ectopic

pregnancies, (2) in-person follow-up exams, let alone

using ultrasonography, or (3) provider ability to

perform surgical intervention. J.A. 292–320. FDA did

not explain how it could determine that the new

protocol was safe based on studies containing

safeguards omitted from the protocol.

D. Challenges and modifications to FDA’s

2016 changes

In 2019, Respondents AAPLOG and American

College of Pediatricians (ACPeds) filed a citizen

petition asking FDA to restore and strengthen the

previous safeguards for mifepristone (2019 Citizen

Petition). The petition described how the 2016

changes impacted each other and mifepristone’s

overall safety. J.A. 328. It also asked FDA to retain

the in-person dispensing requirement. J.A. 321–47.

Respondents explained that remote providers “cannot

adequately evaluate patients for contraindications to

the drugs,” and that “[t]elemedicine abortion further

distances women from the practitioners responsible

for caring for them.” J.A. 339–41. It is “extremely

dangerous,” the petition added, for women and young

girls in rural areas to take mifepristone because “they

will have little recourse if they face known and

predictable emergency complications.” J.A. 340.

One month later, FDA approved GenBioPro, Inc.’s

abbreviated new drug application for generic mifepristone. J.A. 348–54. The approval explained that a

generic drug “and the listed drug it references must

use a single, shared system for elements to assure

safe use (ETASU)” under 21 U.S.C. 355-1(i). J.A. 349.

FDA thus established a single, shared system REMS

8

for Mifeprex and GenBioPro’s generic version “called

the Mifepristone REMS Program.” J.A. 357.

In August 2020, FDA asked this Court to stay a

lower court order enjoining the in-person dispensing

and counseling requirement. Appl. for Stay, FDA v.

ACOG, No. 20A34 (U.S. Aug. 26, 2020) (2020 FDA

Stay Appl.). In that filing, the agency affirmed that

the initial and only remaining in-person office visit

was both “minimally burdensome” and “necessary” to

preserve the safety of the women and girls who take

abortion drugs. Id. at 4, 13. FDA also explained that

it had reviewed “thousands of adverse events

resulting from the use of Mifeprex,” determined that

abortion drugs continue to cause “serious risks for up

to seven percent of patients,” and concluded that an

in-office visit was “necessary to mitigate [those]

serious risks.” Id. at 4, 7, 21. This Court granted the

requested stay. FDA v. Am. Coll. of Obstetricians &

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

E. FDA’s 2021 actions

In April 2021, FDA said it would “exercise

enforcement discretion” and allow “dispensing of

mifepristone through the mail” during the COVID-19

pandemic. J.A. 365. Then, in December 2021, FDA

denied the 2019 Citizen Petition, J.A. 374, concluded

the initial in-person visit was “no longer necessary,”

and permanently removed it, J.A. 378.

In its petition denial, FDA continued to identify

emergency medical care as the backstop for abortiondrug complications. For instance, prescribers were

required to “ensure that mifepristone is prescribed

[only] to women for whom emergency care is

available.” J.A. 411. And prescribers were not

9

themselves required to be able to treat lifethreatening complications, just “assure patient access

to medical facilities equipped to provide blood

transfusions and resuscitation.” J.A. 381. Recognizing

that this emergency care would frequently come from

OB/GYN hospitalists and emergency-room doctors,

FDA observed that “[i]t is common practice for

healthcare providers to provide emergency care

coverage for other healthcare providers’ patients, and

in many places, hospitals employ ‘hospitalists’ to

provide care to all hospitalized patients.” J.A. 384.

FDA based its decision to remove the initial inperson visit on (1) adverse event reports and (2) published literature that the agency conceded was not

adequate. J.A. 397.

1. Adverse event reports

FDA relied on its Adverse Event Reporting

System (FAERS) database from parts of 2020 and

2021 to “conclud[e] that there d[id] not appear to be a

difference” in adverse events when the in-person

requirement had not been enforced. J.A. 398–99. But

the agency’s official position is that “the FAERS data

by themselves are not an indicator of the safety profile

of the drug.” J.A. 417 (emphasis added). Indeed, FDA

cautions that “[t]he number of suspected reactions in

FAERS should not be used to determine the likelihood

of a side effect occurring.” Ibid. (emphasis added).

And because “FDA does not receive reports for every

adverse event … that occurs with a product,” FAERS

data “cannot be used to estimate the incidence

(occurrence rates) of the reactions reported.” Ibid.

What’s more, FDA did not acknowledge its 2016

decision to eliminate the requirement that prescribers

10

report all serious adverse events. J.A. 398–99. The

agency,

instead,

noted

that

abortion-drug

manufacturers “report adverse events, including

serious adverse events, to FDA.” J.A. 399. But FDA

did not explain how these far-removed manufacturers

would learn about adverse events from OB/GYNs,

hospitalists, and emergency-room doctors who are

under no obligation to report. Ibid.; accord J.A. 128.

2. Published literature

FDA also claimed support from published literature evaluating mail-order dispensing by pharmacies

and clinics. J.A. 399. Yet the agency conceded that it

was unable to “generalize” the results to the United

States population, and that “the usefulness of the

studies is limited in some instances by small sample

sizes and lack of follow-up information on outcomes.”

J.A. 400. FDA thus acknowledged that “the studies

[it] reviewed are not adequate on their own to establish the safety of the model of dispensing mifepristone by mail.” J.A. 407 (emphasis added). Instead,

the studies were merely “not inconsistent with” FDA’s

conclusion that removing the initial in-person visit

would be safe. J.A. 400 (emphasis added).

FDA reviewed three studies for “mail order pharmacy dispensing.” J.A. 402. One (Hyland) alarmingly

reported that 3 percent of the participants needed to

be hospitalized—a 330 percent increase over the rate

on the approved label. J.A. 403. FDA disregarded this

dramatic increase, saying it could not make any

“conclusions on [that study’s] safety findings.” Ibid.

Another study (Upadhyay) had certain “deviations”

from abortion practices in the United States, “limited

follow-up information, and small sample size”—all of

which “limit[ed] [its] usefulness.” Ibid. And the third

11

study, an “interim analysis” (Grossman), was largely

irrelevant because it evaluated outcomes for “dispens[ing] by mail-order pharmacy after in-person clinical

assessment.” J.A. 402 (emphasis added).

FDA also cited five studies that “evaluated clinic

dispensing by mail.” J.A. 403. In one (Raymond), “7

percent of participants had clinical encounters in

[emergency department (ED)]/urgent care centers.”

J.A. 404. In another (Chong), “6 percent of participants had unplanned clinical encounters in ED/urgent care,” and “[s]urgical interventions were required in 4.1 percent to complete abortion.” Ibid. A

third study (Anger) revealed that “12.5 percent had

an unplanned clinical encounter.” J.A. 404–05. In the

fourth study (Kerestes), 5.8 percent in the “telemedicine plus mail group” had “ED visits,” which was

almost three times higher than “the in-person group.”

J.A. 405. And the final study (Aiken) had “significant

limitations” because “investigators were unable to

verify the outcomes” and “the study’s design did not

capture all serious safety outcomes.” J.A. 406.

After reviewing these studies, FDA conceded that

“the literature suggests there may be more frequent

ED/urgent care visits related to the use of mifepristone when dispensed by mail from the clinic.” J.A.

407; accord J.A. 405–06. The agency similarly

acknowledged that the Anger study “suggests a preabortion examination may decrease the occurrence of

procedural intervention and decrease the number of

unplanned visits for postabortion care.” J.A. 405

(emphasis added). Nevertheless, FDA concluded that

“these studies overall support that dispensing by mail

from the clinic is safe.” J.A. 406.

12

F. Mifepristone’s current labeling

FDA’s current label for mifepristone continues to

require a Black Box warning because the drug can

cause “[s]erious and sometimes fatal infections and

bleeding.” J.A. 526. It also directs women to emergency rooms if one of many adverse complications

arise. J.A. 527.

On that label, FDA estimates that 2.9 to 4.6

percent of women will visit the emergency room after

taking mifepristone. J.A. 533. And FDA’s medication

guide acknowledges that as many as 7 percent of

women will need surgery after taking mifepristone “to

stop bleeding” or to complete the abortion. J.A. 542.

The label also warns that a prescriber must

“[e]xclude [ectopic pregnancy] before treatment,” J.A.

526, “because some of the expected symptoms experienced with a medical abortion (abdominal pain,

uterine bleeding) may be similar to those of a ruptured ectopic pregnancy,” J.A. 531.

G. Proceedings below

In November 2022, Respondents filed this lawsuit

challenging, among other things, FDA’s 2021 and

2016 actions. Pet. App. 202a. 1 Respondents are four

medical associations—the Alliance for Hippocratic

Medicine (AHM), AAPLOG, CMDA, and ACPeds—

their doctor members, and four individual doctors.

J.A. 9–10. 2 These medical professionals include

OB/GYN hospitalists, OB/GYNs, and emergency1 All citations to “Pet. App.” are to Case No. 23-235.

2 References to “Respondent doctors” include both the named

plaintiff doctors and the associations’ physician members.

13

room physicians. J.A. 120, 152, 161, 172, 178, 184,

195–96. OB/GYN hospitalists “manage both high- and

low-risk pregnancies and deliveries, obstetric critical

care, gynecological emergencies presenting to [the]

Emergency Department, and inpatient obstetric and

gynecologic consultations.” J.A. 152–54, 161–62.

OB/GYNs similarly deliver babies, perform hysterectomies, and provide other women’s health treatments,

including treating complications from abortion drugs.

J.A. 196.

Respondents moved for a preliminary injunction,

and Danco intervened. Pet. App. 117a. The district

court concluded that FDA’s 2021 and 2016 actions

were likely unlawful, so it stayed their effective dates

under 5 U.S.C. 705, and in the alternative, imposed a

preliminary injunction. Pet. App. 111a, 159a, 172a–

74a, 193a–95a.

Petitioners appealed and moved to stay. A Fifth

Circuit motions panel upheld the district court’s

ruling on the 2021 and 2016 actions. Pet. App. 196a.

The panel found that “the individual plaintiffs and

doctors in plaintiff associations have standing.” Pet.

App. 207a. It also concluded that FDA’s 2021 and

2016 changes were likely arbitrary and capricious.

Pet. App. 236a. Petitioners then sought, and this

Court granted, a stay. Pet. App. 245a.

After full briefing and argument, the Fifth Circuit

held that Respondent doctors and associations have

standing. The doctors suffer harm because they have

no choice but to violate “their conscience” by

completing elective abortions in emergency situations

and “divert[ing] time and resources away” from their

regular obstetrics practice when women present with

abortion-drug complications. Pet. App. 31a–32a.

14

“FDA’s [own] data and the Doctors’ testimony”

establish that Respondents face a “substantial risk” of

these injuries, Pet. App. 26a–27a, and FDA’s 2021

and 2016 actions increase that risk, Pet. App. 36a–

41a.

Exercising well-established principles of judicial

review over agency actions, the court of appeals then

held that the 2021 and 2016 actions likely violated the

APA. Pet. App. 51a–56a, 56a–63a. For 2021, the Fifth

Circuit criticized FDA for (1) “g[iving] dispositive

weight to adverse event data in FAERS—despite the

uncontested limitations of doing so,” Pet. App. 59a,

and (2) “rel[ying] on various literature relating to

remote prescription of mifepristone—despite [its]

admission that the literature did not affirmatively

support its position,” Pet. App. 61a. And for 2016,

FDA failed to consider a major aspect of the problem:

“the cumulative effect” of the interrelated changes.

Pet. App. 53a.

This Court granted certiorari.

SUMMARY OF THE ARGUMENT

That OB/GYNs, OB/GYN hospitalists, and

emergency-room physicians will often be called upon

to treat abortion-drug complications is not a bug in

FDA’s abortion-drug plan but part of its very design.

When the agency eliminated crucial safeguards in

2021 and 2016—safeguards like the ongoing care of

healthcare providers—FDA justified their removal

based on the availability of emergency-care coverage.

Respondent doctors have standing to challenge

FDA’s actions. For starters, they are facing multiple

concrete injuries. As to conscience harms, Respondents object not only to taking the life of an unborn

15

child but also to complicity in the process of an

elective abortion. That FDA does not view such

participation as morally objectionable is irrelevant. In

addition, the emergency situations expressly and

repeatedly contemplated by FDA cause Respondents

to divert time and resources away from their labor

and delivery practices and increase their malpractice

risks.

Respondent doctors face a substantial risk of

these harms occurring. Petitioners’ position that

Respondents’ harms are too speculative blinks

reality. FDA has long recognized that emergency care

is essential to handle abortion-drug complications;

the agency’s own numbers say that roughly one in 25

women who take mifepristone will end up in the

emergency room; and Respondent doctors have testified to routinely treating women suffering abortiondrug harm. Factor in that hundreds of thousands of

women take abortion drugs each year in the United

States, and that FDA’s own data indicates that tens

of thousands of them go to the emergency room, and

Respondents easily establish a “substantial risk” that

these harms “will occur” again. Susan B. Anthony List

v. Driehaus, 573 U.S. 149, 158 (2014) (“SBA List”)

(cleaned up).

Traceability also exists. FDA’s 2021 removal of

the initial in-person visit strips away the best opportunity to diagnose dangerous ectopic pregnancies and

accurately assess gestational age. It’s no wonder,

then, that FDA cited data indicating the need for

emergency care will increase without the initial inperson visit. Likewise, the 2016 changes—which

increased the gestational-age limit (thereby raising

the rates of failed abortions and surgical intervention)

and removed the Day 3 and 14 follow-up visits—

16

heighten the risk that Respondent doctors must

participate in elective abortions. It is no answer to

say, as Petitioners do, that a woman’s decision to take

the drug absolves the agency of responsibility to

ensure the drug’s safety.

On the merits, FDA failed to engage in the

reasoned decision-making the APA requires. It is

hornbook law that when an agency acts, it must

“reasonably consider[ ] the relevant issues and

reasonably explain[ ]” its actions. FCC v. Prometheus

Radio Project, 592 U.S. 414, 423 (2021). FDA did

neither here.

FDA’s 2021 decision to remove the initial inperson visit was arbitrary and capricious. First, FDA

relied on adverse event data from FAERS. But FDA

concedes elsewhere that FAERS data cannot be used

to estimate the incidence of adverse events or indicate

the safety profile of a drug. Equally problematic, FDA

did not recognize that it had years before abandoned

the requirement that mifepristone prescribers report

nonfatal adverse events. As the Fifth Circuit stay

panel concluded, “[t]his ostrich’s-head-in-the-sand

approach is deeply troubling” and “unreasonable.”

Pet. App. 236a. Second, FDA claimed that a small set

of studies supported its decision to remove the initial

in-person visit. Yet the agency admitted the studies

were “not adequate” for that purpose. Indeed, the best

FDA could say about them was that they were “not

inconsistent” with its (apparently preordained)

conclusion. The 2021 action cannot stand because two

admittedly insufficient rationales do not a reasoned

decision make.

FDA’s 2016 action fares no better. Those changes

removed two of three office visits, increased the

17

gestational-age limit, allowed non-doctors to prescribe the drugs, and ended the requirement for

prescribers to report all serious adverse events. Yet

FDA failed to consider the cumulative impact of

removing all these interrelated safeguards at once.

And the agency failed to explain why it could extrapolate safety conclusions for its omnibus changes

from studies that did not evaluate the changes as a

whole. Also troubling is the agency’s reliance on

studies that included safety measures like ultrasound

screenings and follow-up visits, even though those

safeguards were not included in the approved

regimen. This is not the reasoned decision-making

that the APA requires.

FDA unlawfully and without adequate explanation removed safeguards it had once deemed necessary to protect women who use abortion drugs. With

so much at stake, “the Government should turn

square corners in dealing with the people.” Dep’t of

Homeland Sec. v. Regents of the Univ. of Cal., 140 S.

Ct. 1891, 1909 (2020) (citation omitted).

ARGUMENT

I.

Respondents have standing to challenge the

2021 and 2016 actions.

A. Respondents have individual

associational standing.

and

Standing requires “(1) an injury in fact, (2) a

sufficient causal connection,” and “(3) a likelihood

that the injury will be redressed.” SBA List, 573 U.S.

at 157–58 (cleaned up). The Fifth Circuit correctly

held that Respondent doctors and associations have

standing. See Hunt v. Wash. State Apple Advert.

Comm’n, 432 U.S. 333, 343 (1977) (associational

18

standing exists where an identified member has

standing). After discussing at length the harm

suffered by Respondent doctors, the Fifth Circuit

“conclude[d] that [they] have made a ‘clear showing’

that [they] face injury with sufficient likelihood to

support entering a preliminary injunction.” Pet. App.

16a.

1. Respondents face concrete

from FDA’s actions.

harms

Article III requires an injury in fact that is “concrete.” Clapper v. Amnesty Int’l USA, 568 U.S. 398,

409 (2013). “Central to assessing concreteness is

whether the asserted harm has a close relationship to

a harm traditionally recognized as providing a basis

for a lawsuit in American courts.” TransUnion LLC v.

Ramirez, 594 U.S. 413, 417 (2021) (cleaned up). FDA’s

2021 and 2016 actions create a substantial risk that

Respondent doctors will see more women suffering

emergency complications from abortion drugs, which

threaten to inflict several concrete harms.

Conscience harms. FDA does not contest that Respondents’ conscience harms are concrete. FDA Br. 20–

21; accord Pet. App. 32a. Nor could it. “[I]ntangible

harms” “traditionally recognized … in American

courts” undoubtedly include conscience injuries.

TransUnion, 594 U.S. at 425 (referencing claims

based on religious exercise).

FDA instead denigrates Respondent doctors by

suggesting that they object to treating “patients in

need of care.” FDA Br. 17. That’s outrageous. Respondents object not to caring for patients but to

participating in an elective abortion they find morally

and ethically objectionable.

19

FDA attempts to minimize Respondents’ conscience injuries, limiting them to situations where the

doctor herself “terminate[s] an ongoing pregnancy.”

FDA Br. 24. But some Respondent doctors—including

many AAPLOG and CMDA members—consider any

participation in an elective abortion objectionable,

including removing fetal parts and placental tissue.

Doing so causes them “moral distress” by making

them “feel complicit” in a procedure that

unnecessarily ends a life. J.A. 142–43; see also J.A.

87. Dr. Francis, for example, has been forced to “finish

evacuating [a patient’s] uterus of the remaining

pregnancy tissue.” J.A. 153. She and other AAPLOG

and CMDA members consider the “completion of an

elective chemical abortion,” including the removal of

fetal remains and placental materials, to be ethically

objectionable. J.A. 155. These sincerely held

conscience-based objections are like others this Court

has upheld. E.g., Burwell v. Hobby Lobby Stores, Inc.,

573 U.S. 682, 701 (2014) (ruling for litigants who

could not in good conscience provide insurance for

abortion-inducing drugs).

To be sure, Respondent doctors also suffer a

conscience harm when treating women “suffering

complications from chemical abortion while [they are]

still carrying a living fetus.” J.A. 136. As Dr. Skop

explains: “My moral and ethical obligation to my

patients is to promote human life and health. But the

FDA’s actions may force me to end the life of a human

being in the womb for no medical reason.” J.A. 167.

It’s not hard to see why doctors who consider

abortion objectionable are harmed when they must

complete a chemical abortion—even if the child is no

longer alive. J.A. 152–54. During a dilation and

curettage surgery, J.A. 136, doctors must scrape out a

20

patient’s uterine lining with a spoon-shaped instrument to remove the unborn baby and pregnancy

tissues, Dilation and Curettage, Johns Hopkins Medicine, https://perma.cc/M3CR-HUZZ. And for suction

aspiration procedures, J.A. 163, doctors use a

machine or syringe to suck the baby and pregnancy

tissue into a cannister before examining its contents,

Lynn Borgatta et al., Surgical Techniques for FirstTrimester Abortion, The Alliance for Global Women’s

Medicine (May 2012), https://perma.cc/FLR7-RJG3.

FDA insists that nothing forces Respondent doctors to perform the procedures they deem objectionable. FDA Br. 21–23. But this ignores that FDA

expressly relies on doctors like Respondents to treat

emergent and life-threatening complications from

abortion drugs, J.A. 384, and that Respondents facing

these emergency situations must act immediately.

E.g., J.A. 172–73 (“emergency situations”); J.A. 180

(“life-threatening situations”); J.A. 142 (“life-threatening circumstances”); J.A. 120 (“emergency treatment” for heavy bleeding and sepsis); J.A. 166–67

(emergency surgery).

Respondents have treated an “unconscious”

woman with “heavy bleeding” in need of a “blood

transfusion,” J.A. 179, women presenting with

“torrential” or “extremely heavy” bleeding, J.A. 172,

180, and a woman so ill that her Uber driver took her

directly from Planned Parenthood to the emergency

room, J.A. 173. One doctor has treated “at least a

dozen cases of life-threatening complications,”

J.A. 179; another has treated at least a dozen women

“suffering significant bleeding,” J.A. 184; and a third

described the many “near misses” where women face

“potentially deadly situations,” J.A. 174. These emergency situations leave Respondent doctors no choice

21

but to participate in a process that violates their

conscience.

Diverted time and resources. “[T]here is no

question that [diverting one’s] time is a concrete

harm.” Losch v. Nationstar Mortg. LLC, 995 F.3d 937,

943 (11th Cir. 2021); cf. SBA List, 573 U.S. at 165–66

(noting the hardship when litigants are “forced to

divert significant time and resources” without

deciding whether that hardship “gives rise to an

Article III injury”). Respondent doctors have suffered

this harm because FDA’s 2021 and 2016 actions have

forced them “to divert time and resources away from

their regular [labor and delivery] patients”—yet

another “quintessential Article III injury.” Pet. App.

31a.

Respondents are pro-life OB/GYNs “committed to

the care and well-being of … pregnant women and

their unborn children” by assisting with their labor

and delivery. J.A. 126, 152. FDA’s challenged actions

have redirected these doctors away from that critical

labor and delivery work, compelling them to devote

time and resources to facilitating elective abortions.

While Respondent doctors entered their professions to

bring unborn babies into the world, FDA’s recklessness has caused them to reallocate their resources to

facilitating processes that bring about those babies’

demise.

The record is replete with examples of

Respondent doctors experiencing this harm. Dr.

Francis testified to being pulled away from her

“primary patient responsibilities in the labor and

delivery unit” and required to spend “several hours”

addressing abortion-drug complications. J.A. 153–54.

Dr. Skop said that when she “must perform surgery

22

to deal with complications from chemical abortions,

this takes attention away from … multiple laboring

patients” preparing to give birth. J.A. 166–67. And

Dr. Wozniak testified that when she “spent a significant amount of time” with a woman “working to save

her life from … [abortion] complications,” her “time

and attention was taken away from [her labor and

delivery] patients, who also need[ed] [her] care.” J.A.

174. All this constitutes concrete harm.

FDA minimizes the significance of these injuries

by contending that they are part of “[e]mergency

medicine.” FDA Br. 27. Yet FDA misunderstands who

Respondent doctors are. Most of them practice as

OB/GYNs or OB/GYN hospitalists who are at times

pulled into emergency situations. J.A. 152–54, 161–

62, 170–74, 184, 196, 198. They normally deliver

babies and perform “other women’s health treatments.” J.A. 152, 161, 166–67, 196. They do not spend

most of their time in the emergency room “triaging.”

Contra FDA Br. 27. Only one named Respondent—

Dr. Johnson—works full-time in the emergency room.

J.A. 178.

Mental, emotional, and spiritual distress.

Litigants have “a cognizable interest” in avoiding

harm to their “well-being” and “quality of life.” Sierra

Club v. Morton, 405 U.S. 727, 734–35 (1972). The

common law has historically protected these interests

by recognizing “infliction of emotional distress” as a

concrete injury. TransUnion, 594 U.S. at 436 n.7;

accord Rydholm v. Equifax Info. Servs. LLC, 44 F.4th

1105, 1108 (8th Cir. 2022); Perez v. McCreary,

Veselka, Bragg & Allen, P.C., 45 F.4th 816, 824 (5th

Cir. 2022); Losch, 995 F.3d at 943.

23

FDA’s actions have forced Respondent doctors to

witness and participate in the grisly process of

treating abortion-drug complications—retained fetal

parts, heavy bleeding, severe infections—causing the

doctors mental, emotional, and spiritual distress. J.A.

87. Dr. Skop called it “heartbreaking” to watch the

“suffer[ing]” caused by “[u]nsupervised chemical

abortion.” J.A. 167. Dr. Jester testified that these are

“high-pressure … situation[s].” J.A. 198–99. And Dr.

Wozniak affirmed that treating abortion-drug

complications “places enormous stress and pressure

on physicians and OB/Gyns who work in hospitals.”

J.A. 172.

If plaintiffs have an “undeniably … cognizable

interest” in avoiding the distress of losing “an animal

species,” Lujan v. Defs. of Wildlife, 504 U.S. 555, 562–

63 (1992), or even the chance to “view[ ] the flora and

fauna,” Summers v. Earth Island Inst., 555 U.S. 488,

494 (2009), then Respondent doctors have a concrete

interest in avoiding heartbreaking emergency

situations that require them to be complicit in a

process that ends an unborn life. Pet. App. 80a–83a

(Ho, J., concurring and dissenting in part)

(Respondents’ “aesthetic injury from the destruction

of unborn life” is “cognizable”). The emotional harm

Respondents suffer “suffice[s] for Article III

standing.” TransUnion, 594 U.S. at 440.

Increased liability and insurance costs. FDA’s

illegal actions also expose Respondent doctors to

greater liability risks and increased insurance costs.

Forcing the doctors to shift more time to “emergency

situations ... increases [their] exposure to claims of

malpractice and liability.” J.A. 180. These emergent

and life-threatening circumstances put Respondents

24

“in increasingly higher risk situations,” J.A. 180, and

“at increased risk of liability,” J.A. 121, 142, 186.

Ongoing lawsuits demonstrate that this liability

risk is not mere speculation. E.g., Compl., Dixon v.

Dignity Health d/b/a Dignity Health Emerus – Blue

Diamond, No: A-23-877731-C (Clark County, Nev.,

Sept. 13, 2023) (malpractice suit against hospital and

healthcare professionals over abortion drug death).

And the increased risk of liability, in turn, drives up

Respondents’ “insurance costs.” J.A. 92, 142. The

Fifth Circuit correctly held that these increased risks

and costs qualify as concrete harms. Pet. App. 31a–

32a.

2. Respondents face a substantial risk of

harm anticipated by FDA, supported

by data, and confirmed by testimony.

Plaintiffs who allege future injuries satisfy Article

III if there is a “‘substantial risk that the harm will

occur.’” SBA List, 573 U.S. at 158 (quoting Clapper,

568 U.S. at 414 n.5). As discussed above, Respondents

endure various concrete injuries when women experiencing abortion-drug complications seek emergency

services from them. Petitioners’ primary response is

that this harm is too speculative. FDA Br. 22; Danco

Br. 24. That argument conflicts with (1) FDA’s

repeated acknowledgement that OB/GYN hospitalists

and emergency-room doctors are the backstop for

abortion-drug complications, (2) FDA’s data confirming the frequency of those emergency-room visits, and

(3) Respondent doctors’ testimony that they have

treated many women suffering from abortion-drug

complications.

25

FDA’s statements. From the initial drug approval

in 2000 to the removal of the initial in-person visit in

2021, FDA has repeatedly confirmed that emergencyroom visits are part of its solution to abortion-drug

complications. FDA’s 2000 approval memorandum

acknowledged that “access to … emergency services is

critical for the safe and effective use of the drug.” J.A.

227 (emphasis added). This was so important that the

labeling had “a contraindication if there [was] no

access to medical facilities for emergency services.”

Ibid. And in determining that prescribing physicians

need not have surgical skills, FDA depended on the

“medical practice” of “referr[ing] patients who need

surgery … to a physician possessing the skills,”

including “[r]eferral to a hospital for emergency

services.” J.A. 229. In fact, FDA required abortion

providers unable to perform surgeries to “direct

patients to hospitals” for “emergency services.” Ibid.

To aid those emergency services, Danco issued a

2004 “Dear Emergency Room Director” warning that

women may “present to an emergency room with

serious and sometimes fatal infections and bleeding”

or ruptured ectopic pregnancies. Danco Letter 1 (Nov.

12, 2004), https://perma.cc/734R-LLSQ. And in 2016,

the agency reiterated the importance of “access to

medical facilities for emergency care” to manage the

expected abortion-drug complications. J.A. 258.

In 2021, when FDA permanently removed the

initial in-person visit, the agency again relied on the

“common practice for healthcare providers to provide

emergency care coverage for other healthcare providers’ patients.” J.A. 384. FDA justified eliminating

that initial visit because hospitals “employ ‘hospitalists’ to provide care” for other physicians’ patients.

Ibid. The agency even admitted “there may be more

26

frequent ED/urgent care visits related to the use of

mifepristone when dispensed by mail.” J.A. 407.

In sum, FDA counted on OB/GYN hospitalists and

emergency-room doctors like Respondents to treat

women harmed by abortion drugs. The harm caused

Respondents by abortion-drug complications is not

just predictable; it is embedded in FDA’s plan.

The data. Of the approximately one million women who obtained an abortion in the United States in

2023, over half used abortion drugs. News Release,

Guttmacher Institute, Number of Abortions in the

United States Likely to Be Higher in 2023 than in

2020 (Jan. 17, 2024), https://perma.cc/2UMR-MJAR;

Rachel K. Jones et al., Abortion incidence and service

availability in the United States 2020, Guttmacher

Institute (Nov. 2022), https://perma.cc/RK5L-ENUX

(Guttmacher 2022 Report). According to mifepristone’s current medication guide, between 2.9 and

4.6 percent of women who use the drug go to the

emergency room. J.A. 533. Some experience especially

severe conditions, such as sepsis, hospitalization, or a

blood transfusion because of heavy bleeding. Ibid.

Additionally, the current mifepristone medication

guide discloses that “[a]bout 2 to 7 out of 100 women”

taking abortion drugs “will need a surgical procedure”

to “stop bleeding” or complete the abortion. J.A. 542.

All this data led the Fifth Circuit to conclude that the

need for emergency-room treatment is both “predictable and consistent.” Pet. App. 27a (cleaned up).

Doctor testimony. Many Respondent doctors “have

already been required to treat patients experiencing

complications due to mifepristone.” Pet. App. 27a.

(citing City of Los Angeles v. Lyons, 461 U.S. 95, 102

(1983)). Drs. Johnson, Frost-Clark, and Skop each

27

testified to treating emergency medical conditions

caused by mifepristone a dozen times or more. J.A.

161–66, 179, 184. Dr. Skop has been required to

perform surgery to remove embryos, fetuses, or

pregnancy tissue in at least a dozen different cases.

J.A. 163.

“[P]ast wrongs” like these “are evidence bearing

on whether there is a real and immediate threat of

repeated injury.” O’Shea v. Littleton, 414 U.S. 488,

496 (1974). The Fifth Circuit correctly held that the

record “amply supports” standing because Respondent doctors “are reasonably likely to be injured

again.” Pet. App. 28a. In short, FDA’s statements, its

“data[,] and the [d]octors’ testimony show that women

will continue to present to the emergency room after

taking mifepristone, requiring urgent treatment.”

Pet. App. 27a.

One of this Court’s seminal APA decisions involved a challenge to the National Highway Traffic

Safety Administration’s (NHTSA) removal of carsafety standards. Motor Vehicle Mfrs. Ass’n of U.S.,

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

(1983). Because automobile manufacturers benefited

from the safeguard’s removal, they brought no

challenge. But this Court allowed suit by the insurers

who had to backstop the injuries caused by the

change. Id. at 39. Article III standing is even stronger

here where FDA planned that OB/GYN hospitalists

and emergency-room doctors would treat abortiondrug complications. J.A. 229, 384.

Petitioners’ flawed arguments. FDA says Respondent doctors’ harms are “speculat[ive]” because Respondents do not prescribe abortion drugs. FDA Br. 27–

28. But prescribing the drugs isn’t what increases

28

Respondents’ exposure. That harm results from

FDA’s removal of the safeguards. FDA’s unlawful

actions have left Respondent doctors “to deal with

preventable emergent and life-threatening situations.” J.A. 180.

Petitioners also suggest that affirming Respondent doctors’ standing would open the floodgates.

FDA Br. 26–27; Danco Br. 34–35. But Petitioners’

parade of horribles does not march. Petitioners fail to

identify any other situation where an agency

acknowledged that a specific group of doctors are

“critical” to managing complications caused by the

removal of safety measures. J.A. 327. And none of

Petitioners’ hypothetical situations involve an agency

action so directly traceable to a conscience injury like

the forced facilitation of an abortion. Pet. App. 35a.

Danco argues that fewer than one-tenth of one

percent of women who take abortion drugs experienced any adverse events. Danco Br. 10. But Danco

arrives at this number using FAERS data that FDA

warns “cannot be used to estimate the incidence

(occurrence rates) of the reactions reported.” J.A. 417.

That argument echoes FDA’s reckless suggestion that

abortion drugs are as safe as ibuprofen. FDA CA5

Mot. for Stay 1. These rose-colored views of mifepristone’s safety cannot be squared with FDA’s own

documents. As FDA told this Court a few years ago,

mifepristone exposes as many as 7 percent of women

to serious risks. 2020 FDA Stay Appl. 7. And the

current label and medication guide say that 2.9 to 4.6

percent of women will need emergency care, and 2 to

7 percent will need surgical intervention. J.A. 533,

542. That doesn’t happen with ibuprofen.

29

Petitioners next compare Respondents’ injuries to

the speculative allegations in Clapper. FDA Br. 21–

22. That case is nothing like this one. Respondents’

harms are based not on “a highly attenuated chain of

possibilities,” 568 U.S. at 410, but on a medical reality

FDA repeatedly and expressly anticipated—that

OB/GYN hospitalists and emergency-room doctors

would manage abortion-drug complications. J.A. 384.

And unlike Clapper, the government directly

imposes the injury here. As Danco notes, the surveillance statute in Clapper “at most authorize[d]—but

[did] not mandate or direct—the surveillance that

[plaintiffs] fear[ed].” Danco Br. 31 (quoting 568 U.S.

at 411–12). Here, however, FDA has repeatedly

directed women suffering complications from abortion

drugs to emergency rooms. J.A. 227, 229, 258, 275–

76, 278, 280, 411.

Petitioners fixate on the phrase “certainly

impending” and, in so doing, distort the standard for

establishing standing through future injuries. FDA

Br. 21. As the Court has emphasized, litigants may

establish standing through a “future injury” if “the

threatened injury is ‘certainly impending,’ or there is

a ‘substantial risk that the harm will occur.’” SBA

List, 573 U.S. at 158 (quoting Clapper, 568 U.S. at 414

& n.5). This standard does not require that the

threatened injury be “literally certain.” Pet. App. 15a

(citing Clapper, 568 U.S. at 414 n.5). Otherwise,

forward-looking relief would seldom be possible. But

this Court regularly allows plaintiffs to seek such

relief. E.g., Massachusetts v. EPA, 549 U.S. 497, 525

n.23 (2007) (“Even a small probability of injury is

sufficient … provided of course that the relief sought

would, if granted, reduce the probability.”); Kolender

v. Lawson, 461 U.S. 352, 355 n.3 (1983) (requiring a

30

“credible threat”); Babbitt v. United Farm Workers

Nat’l Union, 442 U.S. 289, 298 (1979) (requiring “a

realistic danger of sustaining a direct injury”).

Petitioners’ reliance on Summers is even further

afield. Unlike the Summers plaintiffs, Respondents

here assert “specific allegations establishing that at

least one identified [associational] member” will

suffer harm. Summers, 555 U.S. at 498. In Summers,

the government conceded that standing would exist

where an associational member alleged injury to

“interests in viewing the flora and fauna,” affirmed

that he “had repeatedly visited [a certain park],” and

expected “to do so again.” Id. at 494. Yet “no plaintiff

in Summers had standing because none had alleged

specific plans to observe nature in one of the areas at

issue.” Dep’t of Educ. v. Brown, 600 U.S. 551, 566 n.3

(2023). While it might be doubtful whether a plaintiff

will “stumble across” a small forest tract among the

19 million acres of United States forestland,

Summers, 555 U.S. at 496, it is not speculative that

women suffering abortion-drug complications will

follow FDA’s decades-long directive to seek

emergency care. Nor is there any question that

Respondent doctors—many of whom have treated

such complications more than a dozen times—will be

again placed in positions where they must address

abortion-drug complications. J.A. 161–66, 178, 184.

Petitioners’ flawed conscience arguments. Petitioners take special aim at the likelihood of Respondent doctors’ conscience harms. FDA Br. 20–25.

Those shots all miss the mark.

FDA argues that Respondents’ conscience harms

are unlikely because they can “refer the patient to

another[ ] non-objecting doctor.” FDA Br. 24. Not so.

31

First, as discussed above, abortion-drug complications often present as emergency situations. See

supra at 20–21. Respondents don’t have the luxury of

seeking out a non-objecting colleague. Second, a nonobjecting doctor will not always be onsite and

available, particularly in “healthcare deserts where

there are no OB/Gyn’s.” J.A. 155. Third, referral itself

is a conscience harm for Respondent doctors who

object to any participation in an elective abortion. See

Little Sisters of the Poor v. Pennsylvania, 140 S. Ct.

2367, 2376 (2020) (alleging that self-certification

accommodation burdened plaintiffs’ religious exercise). FDA may not force Respondents “to assume

special burdens to avoid” what harms their conscience. Valley Forge Christian Coll. v. Ams. United

for Separation of Church & State, 454 U.S. 464, 486

n.22 (1982) (characterizing Abington Sch. Dist. v.

Schempp, 374 U.S. 203 (1963)).

FDA alternatively contends that Respondent

doctors’ conscience harm is unlikely because they can

“invoke federal conscience protections.” FDA Br. 21.

But when a woman enters the emergency room with

severe complications from abortion drugs, the doctor

hardly has time to invoke her federal rights. In addition, the nature and scope of federal conscience

protections are far from clear. Even the government

can’t get its story straight. Discussing the Emergency

Medical Treatment and Labor Act (EMTALA), FDA

here says that the statute “imposes obligations on

covered hospitals, not individual doctors.” FDA Br. 23

n.3 (cleaned up). But the government told this Court

a few months ago that “treating physicians who

violate EMTALA face civil penalties and exclusion

from Medicare.” Resp. to Appls. for Stay 5, Idaho v.

United States, No. 23A470 (U.S. Nov. 30, 2023)

32

(emphasis added). And the government previously

argued that EMTALA trumps federal conscience

protections. Defs.’ Br. in Supp. Mot. to Dismiss at 27,

Texas v. Becerra, No. 5:22-cv-185-H (N.D. Tex. Aug.

15, 2022), ECF No. 40. Given all this, FDA’s present

attempt to hide behind federal conscience protections

rings hollow.

FDA not only ignores that some Respondent

doctors object to any participation in an elective

abortion, but also overlooks that even doctors who

object only to taking the unborn baby’s life are at an

increased risk of harm because of FDA’s actions.

That’s because abortion drugs taken at ten weeks’

gestation—the high end of the currently approved

range—fail in roughly 7 percent of cases. J.A. 538;

Medication Abortion up to 70 days of Gestation, Am.

Coll. of Obstetrics & Gynecology Clinical Practice

Bulletin (Oct. 2020), https://perma.cc/52KQ-HYF9

(ACOG Gestation Bulletin); Melissa J. Chen &

Mitchell D. Creinin, Mifepristone With Buccal

Misoprostol for Medical Abortion: A Systematic

Review,

U.C.

Davis

(July

2015),

https://perma.cc/ZB7C-UNGE. And many of those

women—nearly half—will need a surgical procedure

to end the pregnancy. J.A. 538. Dr. Francis testified

that one of her colleagues “had no choice but to perform an emergency [surgery]” to end the life of a

“preborn baby [who] still had a heartbeat.” J.A. 154.

Other Respondent doctors are at substantial risk of

that happening to them.

*****

In sum, FDA has spent decades directing women

harmed by abortion drugs to emergency rooms. J.A.

229. Many of them have sought treatment from

33

Respondent doctors. Now that FDA is called to

account for the harm caused, the agency cannot insist

that the very treatment option it directed is somehow

speculative. See Monsanto Co. v. Geertson Seed

Farms, 561 U.S. 139, 153–54 (2010) (finding standing

based on a “reasonable probability” and “substantial

risk” that an agency’s deregulatory action would

impact non-regulated parties). To hold otherwise

would create a hole in standing jurisprudence

allowing agencies to conscript third parties into fixing

problems caused by their regulatory actions without

affording those parties judicial recourse.

3. Respondents’ injuries are traceable to

FDA’s 2021 and 2016 removal of safety

standards.

The Fifth Circuit correctly determined that FDA’s

2021 and 2016 actions—which include increasing

approved gestational age and removing all three of

the in-person office visits—have directly contributed

to the substantial risk of harm Respondent doctors

face. Pet. App. 36a–41a.

“Article III requires no more than de facto causality.” Dep’t of Com. v. New York, 139 S. Ct. 2551, 2566

(2019) (cleaned up). “[T]raceability is satisfied” when

third-party action contributing to the plaintiffs’ harm

is “likely attributable at least in part” to the

challenged action. Ibid. See also Khodara Env’t, Inc.

v. Blakey, 376 F.3d 187, 195 (3d Cir. 2004) (traceability does not demand but-for causation) (Alito, J.).

Petitioners suggest Respondents’ harms are not

traceable to FDA’s removal of abortion-drug safeguards because women make independent decisions

to take the drugs. FDA Br. 22; Danco Br. 27. But FDA

34

is charged with protecting public health by ensuring

that drugs on the market are “safe for use under the

conditions prescribed, recommended, or suggested in

the proposed labeling.” 21 U.S.C. 355(d). It would be

absurd to insulate an agency’s deregulation of a highrisk drug because women reasonably rely on those

actions. That’s like denying standing to the insurers

in State Farm because passengers ultimately made

the decision to ride in a car without airbags.

Further, the independent actions of third parties

do not defeat standing where they are “the predictable

effect of Government action.” Dep’t of Com., 139 S. Ct.

at 2566. In Department of Commerce, the evidence

“established a sufficient likelihood that the reinstatement of a citizenship question would result in noncitizen households responding to the census at lower

rates than other groups, which in turn would … lead

to many of [plaintiff states’] asserted injuries.” Id. at

2565. Traceability was satisfied—despite independent third-party actions—because plaintiff states

showed that “third parties will likely react in

predictable ways” that harm plaintiffs. Id. at 2566.

Accord Davis v. FEC, 554 U.S. 724, 734–35 (2008)

(standing to challenge asymmetrical funding mechanism despite harm depending on decision of third

party).

So too here. FDA’s data shows the predictable

effect of its actions on third parties. Roughly 500,000

women per year take abortion drugs in the United

States. See Guttmacher 2022 Report, supra. FDA’s

recognition that 2.9 to 4.6 percent of mifepristone

users go to the emergency room, J.A. 533, means that

tens of thousands of women will end up there each

year, and many of them will receive treatment from

Respondent doctors. As the stay panel concluded, it is

35

reasonably certain “that women will continue needing

[Respondents’] ‘emergency care.’” Pet. App. 216a.

Danco next claims that traceability analysis may

only consider the number of “additional women” who

would not have been prescribed abortion drugs but for

the 2021 and 2016 removal of safeguards. Danco Br.

24–25. That is wrong. As FDA recognizes, the

question is whether the removal of safeguards

increased the risk of harm from abortion drugs writ

large. FDA Br. 29–30. Danco’s cramped traceability

analysis ignores that FDA’s 2021 and 2016 actions

make every chemical abortion more likely to result in

complications necessitating emergency care. As the

Fifth Circuit stay panel explained, FDA’s “virtual

elimination of controls” has led to “an increasing

number of women coming to the emergency room with

complications from chemical abortions.” Pet. App.

215a; accord J.A. 171.

a. The 2021 action increased the risk

of harm to Respondents.

Respondents face a substantial threat of future

injury due to the increased risk caused by FDA’s 2021

action. That action removed the initial in-office visit,

thereby “enabl[ing] women to (1) get the drug without

ever talking to a physician, (2) take the drug without

ever having a physical exam to [confirm] gestational

age [and rule out] an ectopic pregnancy, and (3) attempt to complete the chemical abortion regimen at

home.” Pet. App. 215a.

Traceability is satisfied for the 2021 action

because studies on which FDA relied showed “more

frequent ED/urgent care visits related to the use of

mifepristone when dispensed by mail.” J.A. 407.

36

According to the agency, the continued safe use of

abortion drugs after removing that visit depended on

the “common practice” of OB/GYN hospitalists and

emergency-room doctors like Respondents “provid[ing] emergency care coverage for other healthcare

providers’ patients.” J.A. 384. FDA knew that

eliminating the initial in-office visit—the only

opportunity to physically screen for ectopic pregnancy

and other contraindications—would result in more

women going to emergency rooms when the inevitable

complications arose.

The studies in FDA’s 2021 decisional document

make Respondents’ case for increased harm. Almost

every study FDA considered on the safety of mailing

abortion drugs from a clinic raised significant

concerns. The Raymond study reported that 7 percent

of women will need emergency or urgent care; Chong

found 6 percent will; and Kerestes said the rate of

women needing emergency care was 5.8 percent. J.A.

403–06. In addition, Anger found that 12.5 percent of

the women (1 out of every 8) who used these drugs

without an initial in-person visit sought unplanned

medical intervention. J.A. 405. According to FDA,

Anger’s data suggested that an in-person examination might “decrease the occurrence of procedural

intervention.” Ibid. If that weren’t enough, the

Kerestes study compared outcomes of women mailed

abortion drugs with and without an in-person

examination and found that the rate of emergencyroom visits increased almost threefold when the inperson examination was omitted. Ibid.

It’s not surprising that eliminating the initial inperson visit increases emergency-room visits. The

removal of this safeguard heightens the risk for

37

women—and the harm to Respondent doctors—in two

ways.

First, FDA requires that an ectopic pregnancy be

ruled out before taking abortion drugs. J.A. 526. It is

undisputed that an ultrasound is the best way to do

that. J.A. 212–13; ACOG Practice Bulletin 193 at 2

(Mar. 2018), https://perma.cc/3AA3-CNQX (“The

minimum diagnostic evaluation of a suspected ectopic

pregnancy is a transvaginal ultrasound evaluation

and confirmation of pregnancy.”). Ectopic pregnancies

occur in about one of every 50 pregnancies and are “a

significant cause of pregnancy-related mortality.”

ACOG Practice Bulletin 193 at 1. Because the

“symptoms” of a chemical abortion and a “ruptured

ectopic pregnancy” are similar, taking abortion

drugs—which are “not effective for terminating

ectopic pregnancies”—may cause women to miss “an

undiagnosed ectopic pregnancy” and delay critical

life-saving care. J.A. 531. Delivering mifepristone

through the mail to women who have never been

physically examined for contraindications “will cause

some women to remain undiagnosed [for ectopic

pregnancies] and at high risk for these adverse

outcomes.” Pet. App. 23a.

FDA tries to minimize this risk, arguing that

ectopic pregnancy occurs rarely in women who use

mifepristone. FDA Br. 32 n.6. But that’s because

ectopic pregnancies are contraindicated for abortion

drugs; women with ectopic pregnancies aren’t

supposed to take them. J.A. 542. By eliminating the

initial in-person visit, FDA denies women the best

opportunity to have ectopic pregnancies diagnosed,

increasing the likelihood that more women with

ectopic pregnancies will take mifepristone.

38

Second, because FDA eliminated the requirement

for an initial in-person visit, “many women are now

being prescribed mifepristone … without a sonogram

to verify the gestational age of the unborn child.” J.A.

172. FDA acknowledges that abortion “failure rate”

and thus the need for surgical intervention steadily

“increase[ ] with … gestational age.” J.A. 381, 538.

Without an initial in-person visit, women may

underestimate gestational age and take the drugs

past the approved ten-week limit. J.A. 165, 196–97.

Women beyond ten weeks’ gestation have higher

“chances of complications due to the increased

amount of tissue, leading to hemorrhage, infection[,]

and/or the need for surgeries or other emergency

care.” J.A. 165. In addition, as FDA told this Court

just a few years ago, “in-person dispensing avoids the

possibility of delay” in taking mifepristone and the

increased “risks of serious complications” caused by

such delay. 2020 FDA Stay Appl. 6.

Respondent doctors’ unrebutted testimony corroborates that the 2021 action will contribute to their

harm. One doctor testified that “[t]he increasing

number of chemical abortions through mail-order or

telemedicine methods means that more women will

suffer complications from unsupervised use of mifepristone and misoprostol.” J.A. 171. And another

affirmed that “FDA’s suspension of the in-person

dispensing requirement … harms women and doctors

because it has resulted in an increase in complications.” J.A. 185.

For all these reasons, Respondents’ harms are

traceable to FDA’s elimination of what it once viewed

as necessary: the initial in-person visit.

39

b. The 2016 changes increased the

risk of harm to Respondents.

FDA’s 2016 changes also eliminated critical safeguards and increased the risk that more women

taking abortion drugs will need emergency care. It did

so in three ways.

First, those changes increased the gestational-age

limit from seven to ten weeks. As noted, FDA

concedes that “the failure rate” of abortion drugs and

thus the need for surgical intervention consistently

“increase[ ] with … gestational age.” J.A. 381, 538.

When moving from seven to ten weeks’ gestation, the

“failure rate” climbs from roughly 2 to 7 percent, as

confirmed by FDA’s label, see J.A. 538, ACOG documents, see ACOG Gestation Bulletin, supra, and a

systematic review that FDA relied on in 2016, see J.A.

447–49 (citing Chen & Creinin, supra). This higher

failure rate, as FDA’s label indicates, increases

tenfold the rate of “[s]urgical intervention.” J.A. 538.

FDA thus recognizes that up to 7 percent of “women

taking Mifeprex will need a surgical procedure” to end

the pregnancy, remove retained fetal parts or tissue,

or “stop bleeding.” J.A. 542; see also ROA 469 (study

finding gestational age increases need for surgical

intervention).

FDA cites its 2016 summary review to say that

increased gestational age does not increase serious

adverse events. FDA Br. 31. But the review omitted

incomplete or failed abortions from the definition of

adverse events. J.A. 468. Yet it is undisputed, as just

discussed, that failure rates increase with gestational

age and that failed or incomplete abortions often

require surgical intervention. J.A. 381, 538, 542.

40

Second, FDA’s removal of the Day 14 in-person

follow-up visit puts Respondent doctors at an “increased risk” of treating women experiencing abortiondrug complications. Pet. App. 37a. A routine follow-up

examination can uncover complications—such as

retained pregnancy tissue—before they become more

serious. J.A. 199–200. Removing the requirement for

those visits naturally results in more women

“report[ing] to the emergency room.” Pet. App. 37a.

Respondent doctors have experienced this

avoidable harm dozens of times, performing

emergency surgeries to remove embryos, fetuses, or

pregnancy tissue. J.A. 163, 179, 184. As Dr. Jester

testified when discussing one woman he treated for

abortion-drug complications, the “situation could have

been avoided before requiring overnight hospitalization

and [his patient] being at risk for developing sepsis” if

“she had a routine follow-up visit, as required by past

REMS.” J.A. 200.

Third, the 2016 changes ended the requirement

that licensed doctors prescribe and provide ongoing

care to women using abortion drugs. As FDA has

acknowledged, many abortion providers cannot

provide life-saving surgeries and interventions. Pet.

App. 217a; see also ROA 2476, 2482–83. When such

emergencies occur—and FDA concedes they will—it

is OB/GYNs, OB/GYN hospitalists, and emergencyroom doctors like Respondents “who must manage the

aftermath.” Pet. App. 217a.

Given the myriad ways FDA’s 2016 removal of

safeguards increases the risk of and need for emergency care, Respondents’ injuries are traceable to

those changes.

41

4. Respondents’ harms are redressable.

Respondents’ claims are also redressable. To

satisfy this requirement, plaintiffs “need not show

that a favorable decision will relieve [their] every

injury.” Larson v. Valente, 456 U.S. 228, 243 n.15

(1982). A “substantial likelihood,” Duke Power Co. v.

Carolina Env’t Study Grp., Inc., 438 U.S. 59, 74–75

(1978), that a favorable ruling will “effectuate a

partial remedy” is enough, Uzuegbunam v. Preczewski, 141 S. Ct. 792, 801 (2021). Restoring the crucial

safety standards that once protected women who use

abortion drugs will relieve Respondent doctors of at

least some of the injuries caused by FDA’s 2021 and

2016 actions.

For the 2021 action, FDA discussed studies

indicating that removing the initial in-person office

visit would send more women to the emergency room.

See supra at 10–11, 35–36. The agency also conceded

that keeping this visit might “decrease the occurrence

of procedural intervention.” J.A. 405. That is the

definition of redressability. And with respect to the

2016 changes, raising the gestational age increases

failure and intervention rates, J.A. 381, 538, while

removing the follow-up visits leads to increased

complications, J.A. 200. This, too, establishes redressability.

Danco (but not FDA) makes the counterintuitive

argument that Respondents’ injuries are not

redressable because FDA’s elimination of safeguards

somehow made the drugs safer. Danco Br. 33

(claiming “reduced adverse events”). This argument

ignores that, as FDA acknowledges, Respondents do

not challenge the dosing, timing, or route of administration changes made by FDA in 2016. FDA Br. 5 n.2,

42

41 n.8. The regimen that includes those changes will

remain available. Id. at 41 n.8. And in fact, providers

have been using that regimen since 2001, long before

the 2016 changes. J.A. 443, 446, 465.

Petitioners may suggest that Respondents’ harms

are not redressable because the 2019 approval of

GenBioPro’s generic mifepristone is not before this

Court. But because the generic is “bioequivalent” to

Danco’s Mifeprex, the drugs “use a single, shared

system for [the ETASU].” J.A. 349. So any REMS

change necessarily applies to both drugs, as

GenBioPro concedes. GenBioPro Am. Br. 24.

B. Respondents have organizational standing.

Respondent medical associations also have

organizational standing. Under Havens Realty Corp.

v. Coleman, 455 U.S. 363, 379 (1982), organizational

standing exists where, as here, an organization has

diverted resources in response to unlawful action.

Accord Bank of Am. Corp. v. City of Miami, 581 U.S.

189, 198 (2017) (recognizing that Havens confers

standing to “a nonprofit organization that spent

money to combat [unlawful action]”). To hold otherwise would require overruling Havens—something

Petitioners have not requested.

In Havens, this Court found standing where the

plaintiff organization “had to devote significant

resources to identify and counteract the defendant’s

racially discriminatory steering practices.” 455 U.S.

at 379 (quoting complaint, cleaned up). The unlawful

practices “impaired” the organization’s “ability to provide counseling and referral services.” Ibid. “[T]here

can be no question,” this Court held, “that the organi-

43

zation ha[d] suffered injury in fact” because “[s]uch

concrete and demonstrable injury to the organization’s activities—with the consequent drain on the

organization’s resources—constitute[d] far more than

simply a setback to the organization’s abstract social

interests.” Ibid. (citing Sierra Club, 405 U.S. at 739).

“That the alleged injury result[ed] from the organization’s noneconomic interest in encouraging open

housing d[id] not [a]ffect the nature of the injury

suffered, and accordingly d[id] not deprive the

organization of standing.” Id. at 379 n.20 (citation

omitted).

So too here. FDA’s 2021 and 2016 actions have

impaired Respondent organizations’ ability to provide

services and achieve their organizational missions.

Removing the crucial safety standards and prescriber

adverse event reporting requirements—while insisting that abortion drugs are no riskier than ibuprofen,

FDA CA5 Mot. for Stay 1—downplays the potential

dangers of those drugs. This “frustrates and

complicates” the organizations’ missions to support

women’s health and educate the public, their

members, and their members’ patients about the

potential risks of abortion drugs. J.A. 119, 122–23,

133–34, 141–42, 148–49, 156–58.

FDA’s actions have caused Respondent organizations to “divert limited time, energy, and resources” to

“conduct[ ] their own studies and analyses of the

available data” about abortion drugs. J.A. 134, 157.

FDA’s removal of crucial safeguards has created a

false “public impression” of drug safety. Spann v.

Colonial Village, Inc., 899 F.2d 24, 30 (D.C. Cir. 1990).

The same is true for the removal of the prescriber

reporting requirements. Without a better reporting

obligation, Respondent doctors cannot “accurately

44

advise their patients and the public about these

risks.” J.A. 89, 133–34, 141, 166, 172, 181.

FDA’s actions have also forced Respondent organizations to expend “considerable time, energy, and

resources to draft the 26-page [2019 Citizen Petition],

in addition to compiling and analyzing supporting

sources and studies.” J.A. 149, 157. And the groups

continue to spend considerable resources on their

public advocacy and educational activities exposing

the risks of FDA’s 2021 and 2016 actions to women

and girls. J.A. 135, 149, 158. This reallocation of

resources comes at the expense of other organizational efforts, including exposing “the dangers of

surgical abortion” and affirming “the sanctity of life

at all stages.” J.A. 135, 157.

As in Havens, there is “no question” Respondent

organizations have suffered injuries in fact. The

diversion of their resources in response to FDA’s

actions has undermined their ability to advance their

mission. See 13A Charles Alan Wright & Arthur R.

Miller, Fed. Prac. & Proc. § 3531.9.5 (3d ed. 2023)

(standing exists where “organization has devoted

specific effort and expense to combat the challenged

activity”). This harm fits squarely within lower court

caselaw. E.g., OCA-Greater Houston v. Texas, 867

F.3d 604, 610–12 (5th Cir. 2017) (organization had

standing because it “went out of its way” and “spen[t]

extra time and money educating its members” about

the challenged law and its alleged “negative effects”);

Nnebe v. Daus, 644 F.3d 147, 156–57 (2d Cir. 2011)

(taxi drivers’ alliance could sue agency for expenditure of resources in counseling and assisting drivers

threatened with summary suspension); Crawford v.

Marion Cnty. Election Bd., 472 F.3d 949, 951 (7th Cir.

2007) (political party had standing to challenge voting

45

law because it caused party “to devote resources” to

getting supporters to the polls); Pac. Legal Found. v.

Goyan, 664 F.2d 1221, 1224 (4th Cir. 1981)

(organization had standing to sue FDA when the

agency caused it to “expend more time and funds” to

monitor and comment on agency actions).

FDA takes issue with organizational standing

writ large, complaining that any party filing a citizen

petition “could bootstrap its way into standing” using

that doctrine. FDA Br. 33. But it is FDA that requires

citizen petitions to challenge its actions, 21 C.F.R.

10.45(b), with the promise that it will consider parties

who file petitions to have “standing to obtain judicial

review,” 21 C.F.R. 10.45(d)(1)(ii); accord 40 Fed. Reg.

40682, 40689 (Sept. 3, 1975) (adopting this position on

standing and acknowledging that FDA’s actions

“vitally and directly affect the interests of every

citizen”). FDA cannot now reasonably object to Respondent organizations following the prescribed process. FDA’s real beef is with Havens.

C. Respondents have third-party standing.

Respondent doctors also have standing to sue on

behalf of their patients. Those patients include the

women harmed by FDA’s removal of the abortiondrug safeguards and the labor and delivery patients

who lose access to their doctors when those doctors

are pulled away to manage emergency complications

caused by abortion drugs. J.A. 75–79, 120–21.

Standing to assert a third party’s interest requires (1) the plaintiff to have a “close relation[ship]”

with the third party and (2) the third party to face

“some hindrance” to protecting her own interests.

46

Powers v. Ohio, 499 U.S. 400, 410–11 (1991). Both

prongs are satisfied here.

First, the doctor-patient relationship is an inherently close one. Singleton v. Wulff, 428 U.S. 106, 115

(1976). Many Respondent doctors have a close and

often years-long relationship with their labor and

delivery patients. And they routinely spend hours

treating patients harmed by FDA’s removal of

safeguards. J.A. 153–54.

Second, Respondents’ patients are hindered from

bringing their own lawsuit. Many of them “desire to

protect the very privacy of [their] decision from the

publicity of a court suit.” Singleton, 428 U.S. at 117.

And not knowing the finer points of FDA’s regulatory

actions—much less the safety precautions FDA has

stripped away—women often lack awareness of what

caused their injuries. Nasir v. Morgan, 350 F.3d 366,

376 (3d Cir. 2003).

Allowing third-party standing here is consistent

with precedent “permitt[ing] abortion providers to

invoke the rights of their actual or potential patients

in challenges to abortion-related regulations.” June

Med. Servs. LLC v. Russo, 140 S. Ct. 2103, 2118

(2020), abrogated on other grounds by Dobbs v.

Jackson Women’s Health Org., 597 U.S. 215 (2022);

see also Wright & Miller, supra, at § 3531.9.3

(“Doctors regularly achieve standing to protect the

rights of patients.”). Given that doctors “can invoke

the right of a third party for the purpose of attacking

legislation enacted to protect the third party,” June

Med. Servs., 140 S. Ct. at 2153 (Alito, J., dissenting),

Respondents must be able to sue on behalf of their

injured patients to challenge government action that

harms them.

47

II. FDA’s removal of safeguards for abortion

drugs was arbitrary, capricious, an abuse of

discretion, and otherwise unlawful.

FDA’s merits defense boils down to one word:

deference. In its haste to consign the federal courts to

obeisance, the agency ignores its statutory obligations

and overlooks basic APA requirements. But FDA has

no discretion to disregard congressional mandates.

The lower courts did not second-guess FDA’s scientific

determinations; they held the agency to well-settled

statutory requirements that govern FDA decisions to

remove safety measures from high-risk drugs.

The FDCA authorizes drug approvals and

modifications only where the drug sponsor proves the

drug sufficiently safe. 21 U.S.C. 355(d); 21 C.F.R.

314.3 (defining application to include amendments

and supplements). The statute requires adequate

tests, test results, and sufficient information to

establish the safety of a drug “for use under the

conditions prescribed … in the proposed labeling.” 21

U.S.C. 355(d). FDA must refuse to modify a REMS

where the information submitted by a drug sponsor

(1) does “not include adequate tests … to show

whether or not [the] drug is safe for use under the

conditions prescribed,” 21 U.S.C. 355(d)(1); (2) “the

results of such tests … do not show that such drug is

safe for use under such conditions,” 21 U.S.C.

355(d)(2); or (3) FDA “has insufficient information to

determine whether such drug is safe for use under

such conditions,” 21 U.S.C. 355(d)(4). FDA’s

“discretion … is bounded by [Section 355(d)]; and it is

to the courts that the task of policing the boundary

falls.” Nat’l Treasury Emps. Union v. Campbell, 589

F.2d 669, 678 (D.C. Cir. 1978).

48

For its part, the APA requires an agency to

“cogently explain why it has exercised its discretion in

a given manner.” New York v. FERC, 535 U.S. 1, 36

(2002) (quotation omitted). The agency “must

examine the relevant data and articulate a satisfactory explanation for its action including a rational

connection between the facts found and the choice

made.” State Farm, 463 U.S. at 43 (cleaned up). A

court must assess “whether the decision was based on

a consideration of the relevant factors and whether

there has been a clear error of judgment.” Ibid.

(cleaned up).

Where an agency changes its longstanding position, it must adequately explain itself and “show that

there are good reasons for the new policy.” Encino

Motorcars, LLC v. Navarro, 579 U.S. 211, 221 (2016).

A “reasoned explanation is needed for disregarding

facts and circumstances that underlay or were

engendered by the prior policy.” Id. at 222 (quoting

FCC v. Fox Television Stations, Inc., 556 U.S. 502,

515–16 (2009)).

FDA’s removal of long-existing and commonsense

safety standards like the ongoing care of a doctor was

arbitrary and capricious.

A. FDA’s 2021 removal of the initial inperson office visit was arbitrary, capricious, and unlawful.

In August 2020, FDA told this Court that the

initial and only remaining in-person office visit was

“minimally burdensome” and “necessary” to preserve

safety. 2020 FDA Stay Appl. 4, 13. FDA reaffirmed

the need for this visit in three separate agency actions

over two decades. Id. at 6 (citing 2011, 2013, and 2016

49

regulatory decisions). After reviewing “thousands of

adverse events resulting from the use of Mifeprex,”

FDA explained that it “has made, and continuously

adhered to, the judgment that [the initial office visit]

mitigate[s] serious health risks associated with the

drug, which can increase if the patient delays taking

the drug or fails to receive proper counseling about

possible complications.” Id. at 2, 21.

What a difference a few months make. FDA’s

2021 decision to remove the initial in-person visit

paved the way for mail-order and unsupervised

abortions. FDA’s precipitous decision to remove its

“longstanding, minimally burdensome” in-office visit,

id. at 13, was a textbook violation of the APA.

1. FDA’s 2021 removal of the initial inperson office visit was arbitrary and

capricious.

Section 355(d) of the FDCA is not one of those

open-ended statutes that grants unfettered discretion

to the agency. It requires substantial evidence,

adequate testing, supportive test results, and

sufficient information to find a drug safe. FDA must

refuse to modify a REMS where the information

submitted by a drug sponsor does “not include

adequate tests,” test “results,” or “[ ]sufficient

information to determine” whether the drug “is safe

for use under the conditions prescribed.” 21 U.S.C.

355(d)(1)–(4).

But FDA failed to give a “satisfactory explanation” for its decision to remove the initial in-person

visit. State Farm, 463 U.S. at 43. That decision rested

on (1) adverse event reports from FAERS and the

drug sponsors and (2) a review of the scientific

50

literature. J.A. 397. FDA conceded that neither of

these sources independently supported its decision,

but nevertheless said that zero plus zero equals one.

Cobbling together two insufficient rationales to

support a conclusion is not “reasoned decisionmaking.” This is especially true where, as here, the

agency changes its longstanding position. Encino

Motorcars, 579 U.S. at 221–22.

a. It was arbitrary for FDA to

conclude that adverse event

reports supported its 2021 action.

FDA first erred by giving dispositive weight to

adverse event data in FAERS. J.A. 397. Petitioners

accuse the lower court of second-guessing FDA. But

FDA’s own public statements repeatedly acknowledge

that FAERS data cannot be used to indicate drug

safety. FDA cautions that “[r]ates of occurrence [for

an adverse event] cannot be established with

[FAERS] reports.” J.A. 417. Because reporting is

voluntary, “FDA does not receive reports for every

adverse event … that occurs.” Ibid. Indeed, FDA’s

website warns: (1) “[t]he number of suspected reactions in FAERS should not be used to determine the

likelihood of a side effect occurring,” ibid. (emphasis

added); and (2) “FAERS data cannot be used to

calculate the incidence of an adverse event or medication error in the U.S. population,” J.A. 415 (emphasis added). Summarizing the utility of the data, FDA

says that “the FAERS data by themselves are not an

indicator of the safety profile of the drug.” J.A. 417

(emphasis added).

Yet FDA used mifepristone FAERS data for those

prohibited purposes. The agency said that it “analyzed the FAERS data” from parts of 2020 and 2021 “to

51

determine if there was a difference in adverse events

when in-person dispensing was and was not

enforced.” J.A. 399. It was arbitrary for FDA to use

data that admittedly “cannot be used to calculate the

incidence of an adverse event,” J.A. 415, to determine

the incidence of mifepristone’s adverse events.

And of course, FDA is responsible for the paucity

of FAERS data during 2020 and 2021. In 2016, the

agency removed the requirement that abortion drug

providers report serious adverse events other than

death to FDA. “It’s unreasonable for an agency to

eliminate a reporting requirement for a thing and

then use the resulting absence of data to support its

decision.” Pet. App. 236a. “This ostrich’s-head-in-thesand approach is deeply troubling—especially” for a

high-risk drug that “necessitates a REMS program …

and a ‘Black Box’ warning.” Ibid.

FDA additionally considered adverse event data

submitted by Danco and GenBioPro. But that data

contained the identical adverse events found in

FAERS, suffered from the same flaws, and provided

no independent justification for removing the initial

in-person visit. J.A. 397–99, 402. FDA even admitted

that the sponsor information “included the same cases

identified in FAERS.” J.A. 399. This was not

surprising given that abortion providers need not

submit non-fatal adverse event reports to the drug

sponsors. J.A. 392 (acknowledging some events may

not be reported because reporting is voluntary). All

FDA could say for the drug-sponsor data was that it

did not cause the agency to “change [its] conclusion.”

J.A. 399. That is hardly a ringing endorsement of

safety.

52

b. It was arbitrary for FDA to conclude that scientific literature

supported its 2021 action.

FDA’s conclusion that the scientific literature

“supported” its decision to remove the initial office

visit was also arbitrary and capricious. J.A. 397. FDA

conceded the studies were “not adequate on their own

to establish the safety of … dispensing mifepristone

by mail.” J.A. 407 (emphasis added). Cf. 21 U.S.C.

355(d)(1) (directing FDA to reject drug applications

that “do not include adequate tests”). The best FDA

could say was that the studies were “not inconsistent

with [its] conclusion” that removing the last remaining in-person visit was safe. J.A. 400 (emphasis

added). In other words, the literature did not disprove

FDA’s apparently predetermined view that eliminating the initial office visit was safe. That’s cold

comfort to women taking high-risk drugs without the

safeguards FDA once declared crucial.

It’s not hard to see why FDA carefully qualified

its statements regarding the literature. The studies it

relied on were deeply problematic. FDA conceded that

the study results could not be “generalize[d]” to the

United States population because small sample sizes,

lack of information about safety outcomes, and the

inclusion of pre-abortion safeguards like in-person

examinations and ultrasounds limited the studies’

usefulness. J.A. 400.

FDA’s reliance on the literature was also

arbitrary because—to the extent the studies showed

anything—it was increased risk. FDA admitted that

“the literature suggests there may be more frequent

ED/urgent care visits related to the use of

mifepristone when dispensed by mail from the clinic.”

53

J.A. 407. In fact, the studies assessing the safety of

mailing abortion drugs from a clinic showed troubling

rates of emergency-room visits, urgent-care trips, and

unplanned medical encounters. Raymond reported

that 7 percent of women sought ER/urgent care

attention, Chong said 6 percent did, Kerestes noted

that 5.8 percent went to the emergency room, and

Anger told of 12.5 percent requiring unplanned

medical encounters. J.A. 403–05. These studies

showed that as many as 1 in 8 women would need

unplanned medical care if the in-person dispensing

requirement was eliminated. Ibid.

FDA’s only explanation for ignoring these

alarming figures was its nonanswer that “there are no

apparent increases in other significant adverse events

related to mifepristone use.” J.A. 407 (emphasis

added). The agency never explained why the high

rates of emergency-room visits wasn’t itself a red flag.

Nor did it identify what other serious adverse events

it had in mind. That is well “outside the zone of

reasonableness.” Prometheus, 592 U.S. at 428.

It was also unreasonable for FDA to say there

were no “apparent” increases in “other serious

adverse” outcomes, J.A. 406, when one of the three

pharmacy studies found that hospitalization rates

increased by 330 percent, J.A. 403. The Hyland study

saw hospitalization rates soar beyond the less than 1

percent figure on the label to reach 3 percent of

women mailed abortion drugs (not including seven

patients hospitalized without follow-up information).

Ibid. That the reasons for the hospitalizations were

unknown is hardly a reason to disregard them—but

that’s the only rationale FDA gave. FDA’s “conclusion[ ]” that “safety findings cannot be made in the

absence of information about the reasons for hospital-

54

ization,” ibid., gets the agency’s burden backwards. A

sponsor must prove a drug safe, a standard that has

been clear since the 1962 amendments to the FDCA.

Drug Amendments Act of 1962, Pub. L. No. 87-781, 76

Stat. 780. It was unreasonable for FDA to brush away

these safety concerns.

Further, FDA conceded that the Anger study

“suggests a pre-abortion examination may decrease

the occurrence of procedural intervention and decrease the number of unplanned visits for postabortion care.” J.A. 405 (emphasis added). That’s because the study “found that those without an

examination or ultrasound prior to medical abortion

were more likely to require procedural interventions

and had more unplanned clinical encounters.” Ibid.

FDA also noted Kerestes’s finding that 5.8 percent in

the “telemedicine plus mail group” had “ED visits”—

a rate exceeding the range on the label (2.9 to 4.6 percent) and almost three times higher than its 2.1

percent comparator figure for women who had an “inperson” visit. J.A. 405, 533. It was capricious for FDA

to blow past these warning signs.

FDA argues that the APA does not obligate it to

commission or conduct scientific studies. FDA Br. 37.

Of course not. But it does require agencies adequately

to explain their decisions and comply with their

authorizing legislation. The FDCA demands that an

application include adequate testing, test results, and

sufficient information to show a drug safe under the

proposed labeling. 21 U.S.C. 355(d). But FDA pointed

to no testing or information satisfying that burden.

Petitioners also claim this Court’s decision in

Prometheus entitles FDA to rely on its “reasonable

predictive judgment” based on the evidence before it.

55

Danco Br. 51 (quoting Prometheus, 592 U.S. at 427).

But that case involved the Federal Telecommunications Act’s grant of vast discretion to the agency

to regulate “as public convenience, interest, or necessity requires.” 47 U.S.C. 303; see also 47 U.S.C.

309(a). It is one of those statutes that “employ[s]

broad and open-ended terms” that “afford agencies

broad policy discretion.” Kisor v. Wilkie, 139 S. Ct.

2400, 2448–49 (2019) (Kavanaugh, J., concurring).

Not so the FDCA. It requires FDA to reject a

REMS modification if the evidence before it fails to

show that the “drug is safe for use under the

conditions” in the proposed labeling. 21 U.S.C. 355(d).

Likewise, where tests are not “adequate” or

information is “insufficient” to establish safety, FDA

must decline to modify a drug’s safeguards. Ibid.

While the FCC might be authorized to make educated

guesses about which ownership rules best serve the

public interest, FDA is not allowed to engage in

conjecture about the safety profile of high-risk drugs.

At a minimum, it must reasonably explain its decision

to remove long-standing safeguards.

In sum, FDA relied on FAERS data it conceded

may not be used to calculate the incidence of an

adverse event and scientific literature that it

admitted was inadequate. The 2021 elimination of the

initial in-person visit does not reflect the careful

deliberation that must precede a change of this

magnitude.

The arbitrariness of FDA’s decision is heightened

because it conflicts with decades of agency findings.

While an agency may change its mind, it must

adequately explain its reasons for doing so. State

Farm, 463 U.S. at 56. FDA failed to do so here. It did

56

not address the agency’s prior repeated concern—

expressed as recently as 2020—that removing the

initial office visit creates the potential for a woman to

delay taking the drugs. 2020 FDA Stay Appl. 6. FDA’s

utter silence on these risks of delay (not to mention

the benefits of in-person counseling) does not constitute the “reasoned explanation … needed for

disregarding facts and circumstances that underlay

or were engendered by the prior policy.” Fox

Television Stations, 556 U.S. at 515–16.

2. FDA’s 2021 removal of the initial inperson office visit also violates the

Comstock Act.

FDA’s 2021 action also violates the Comstock Act,

as Respondents argued below. That statute prohibits

using “the mails” to send any “drug … advertised or

described in a manner calculated to lead another to

use or apply it for producing abortion.” 18 U.S.C.

1461. It also forbids using a “common carrier or

interactive computer service” to ship “any drug ...

designed, adapted, or intended for producing

abortion.” 18 U.S.C. 1462.

FDA’s 2021 action authorizes the widespread

mailing and shipping of abortion drugs. Yet as Judge

Ho explained below, mailing drugs that cause

abortion is “precisely what the Comstock Act

prohibits.” Pet. App. 100a.

Petitioners made an assortment of contrary-totext arguments below. Each fails. FDA’s primary

argument was that Comstock applies only to

“unlawful abortions.” FDA CA5 Br. 57–60. But the

text contains no such limitation, and Congress in

1978 considered—and rejected—an amendment

57

limiting the law to “illegal abortions.” H.R. 13959,

95th Cong. §§ 6701(a)(2), 6702(1)(C)(i) (1978); accord

Rep. of the Subcomm. on Crim. Just. on Recodification

of Fed. Crim. L., H.R. Rep. No. 95-29, pt. 3, at 42

(1978) (explaining the amendment would “change[ ]

current law by requiring proof … to produce an illegal

abortion”).

Nor does the prior-construction canon help Petitioners. That rule applies only when “judicial interpretations have settled the meaning,” Armstrong v.

Exceptional Child Ctr., Inc., 575 U.S. 320, 330 (2015)

(emphasis added, citation omitted), through “a uniform interpretation by inferior courts,” Tex. Dep’t of

Hous. & Cmty. Affs. v. Inclusive Cmtys. Project, Inc.,

576 U.S. 519, 536 (2015) (emphasis added, citation

omitted). No such uniformity exists here. Petitioners

support their theory with old dicta from a smattering

of circuits, most of which construed since-repealed

language covering contraception. See ROA 4174–78

(Ethics and Public Policy Center Am. Br.). And at

least one circuit rejected Petitioners’ reading, explaining that Comstock “indicates a national policy of discountenancing abortion” regardless of “what the local

statutory definition of abortion is, what acts of

abortion are included, or what excluded.” Bours v.

United States, 229 F. 960, 964 (7th Cir. 1915).

Danco (but not FDA) argues that Respondents’

challenge to FDA’s December 2021 action is moot

because FDA’s 2023 REMS supposedly “superseded

its [2021] non-enforcement decisions.” Danco Br. 48

(emphasis added). This argument fails factually

because FDA’s December 2021 action was not a

nonenforcement decision but rather permanently

removed the in-person dispensing requirement. J.A.

58

378 (finding in-person dispensing “no longer necessary”).

Danco’s argument also fails legally because when

new government action is “sufficiently similar” to

prior action, “the challenged conduct continues,” and

the controversy remains. Ne. Fla. Chapter of Associated Gen. Contractors of Am. v. City of Jacksonville,

508 U.S. 656, 662 & n.3 (1993). The 2023 REMS

merely effectuated FDA’s 2021 decision. See FDA

2023 Summary Review 6, https://perma.cc/W4U3L38P (noting that FDA “determined” on “12/16/2021”

that “the REMS must be modified to remove the inperson dispensing requirement”). So “FDA’s formalization of the policy it announced in 2021 does not

render this claim moot.” Pet. App. 58a. Otherwise,

agencies could always escape review by promulgating

subsequent action after suit is filed.

B. FDA’s 2016 elimination of two of three inperson visits while increasing gestational age and eliminating the reporting

requirement was arbitrary and capricious.

FDA announced sweeping changes to abortiondrug safeguards in 2016. It increased the maximum

gestational age from seven to ten weeks, eliminated

the Day 3 and Day 14 in-person doctors’ visits,

allowed healthcare providers other than doctors to

prescribe and administer chemical abortions, and

eliminated the requirement that abortion providers

report all serious adverse events. These changes

violate the APA for three reasons.

59

1. FDA failed to consider an important

aspect of the problem.

FDA violated the APA when it “failed to consider

an important aspect of the problem” by not assessing

the 2016 changes as a whole. State Farm, 463 U.S. at

43. “The cumulative effect of [those changes] is unquestionably an important aspect of the problem.”

Pet. App. 53a. FDA admitted as much when it

acknowledged that the 2016 changes were not just

“major” but “interrelated.” J.A. 298. And as explained,

the FDCA requires adequate tests, test results, and

sufficient information to show mifepristone safe

“under the conditions of use … in the proposed

labeling.” 21 U.S.C. 355(d); accord FDA v. Brown &

Williamson Tobacco Corp., 529 U.S. 120, 140 (2000)

(FDA must determine safety “as used by consumers”).

Yet FDA concedes that every study it relied on to

make the 2016 changes included safeguards missing

from the new labeling. J.A. 548–62. And FDA treated

studies on the safety of removing one or two of the

safeguards in isolation as “sufficient to rescind [all

interrelated conditions at once] without explanation.”

Regents, 140 S. Ct. at 1912. FDA’s changes are akin

to an agency no longer requiring seatbelts and airbags

based on studies that evaluated the risk of removing

just one of those protections. “That was obviously

arbitrary and capricious in State Farm.” Pet. App.

235a. And it is arbitrary here.

In State Farm, NHTSA required that motor

vehicles be equipped with a passive restraint—either

airbags or automatic seatbelts. 463 U.S. at 37–38, 46.

Based on its conclusion that automatic seatbelts

would not provide effective protection, the agency

rescinded the passive restraint requirement in full.

60

Id. at 38. The total recission of the requirement was

arbitrary and capricious because NHTSA’s justification supported only “disallow[ing] compliance by

means of” automatic seatbelts. Id. at 47. The agency

erred by treating a rationale that applied to only part

of a policy as sufficient to rescind the entire policy.

Regents, 140 S. Ct. at 1912 (citing State Farm, 463

U.S. at 51). FDA’s 2016 changes suffer the same flaw.

Further, the interrelated nature of the changes

matters. To take one example: FDA increased the

maximum gestational age by three full weeks, which

indisputably increases rates of abortion failures,

surgical interventions, and complications. See J.A.

538, 542; ACOG Gestation Bulletin, supra; Chen &

Creinin, supra. Simultaneously, the agency removed

in-person follow-up visits that afford the opportunity

to diagnose and treat complications before they result

in an emergency. One mistake compounds the other,

which is why it’s essential for the agency to assess

these changes as a whole.

FDA says that three studies “closely mirrored”

the 2016 changes. FDA Br. 38–39. But all of them

included in-person, post-abortion follow-up visits—

one of the safeguards the agency removed despite

previously calling it “very important.” 2000 Mifeprex

Label 15, https://perma.cc/3V7C-SU6Q. It was arbitrary and capricious for the agency to eliminate

multiple interrelated safeguards based on studies

that addressed the safety of removing only some of

them. See State Farm, 463 U.S. at 43. Likewise,

Danco’s reference to “dozens of studies” that addressed various combinations of the 2016 changes,

Danco Br. 6, fails because none of those studies

evaluated the 2016 changes as a whole or under the

labeled conditions of use.

61

FDA next contends that it relied on evidence

about the use of mifepristone since 2000. FDA Br. 37.

Yet that past information cannot carry FDA’s burden

to show that the 2016 changes met the strict safety

requirements of the FDCA and complied with the

APA. Put differently, the past performance of a drug

with safety standards A, B, C, and D is insufficient to

establish that the drug will be safe with only safety

standard A.

FDA is wrong to suggest this challenge to the

2016 changes was unexhausted. FDA Br. 38. First,

Respondents’ 2019 Citizen Petition raised objections

to the interrelated changes. J.A. 328. Second, the APA

requires exhaustion of administrative remedies only

when required by statute or when an agency rule

“provides that the [agency] action … is inoperative”

during appeal. 5 U.S.C. 704; accord Darby v. Cisneros,

509 U.S. 137, 154 (1993) (exhaustion required “when

an agency rule requires appeal before review and the

administrative action is made inoperative pending

that review”). No such statute or FDA rule exists

here. See Michael Krupka, Exasperated But Not

Exhausted: Unlocking the Trap Set by the Exhaustion

Doctrine on the FDA’s REMS Petitioners, Vand. L.

Rev. (Forthcoming), https://perma.cc/4A3M-7C4H.

Third, the equitable doctrine of exhaustion does not

apply when, as here, it would have been clearly

useless for the plaintiff to raise the argument to an

entrenched agency. Wash. Ass’n for Television &

Child. v. FCC, 712 F.2d 677, 682 (D.C. Cir. 1983)

(cleaned up).

62

2. FDA failed to provide a satisfactory

explanation.

FDA’s 2016 action also violated the APA because

it gave no “satisfactory explanation for” its decision to

ignore the cumulative effect of the changes. Pet. App.

52a; State Farm, 463 U.S. at 43. The FDCA directs

the agency to evaluate a drug’s safety “under the

conditions of use in the proposed labeling.” 21 U.S.C.

355(d). At a minimum, the APA requires the agency

to explain why it could rely on piecemeal studies to

find safe the interrelated changes in the proposed

labeling. Yet FDA nowhere provided that explanation.

FDA insists it was not required to consider the

changes together. FDA Br. 37–38. But “that there

may be a valid reason” not to consider the changes as

a whole “does not establish that [FDA] considered

that option or that such consideration was unnecessary.” Regents, 140 S. Ct. at 1913. Under the APA,

FDA “must cogently explain why it has exercised its

discretion in a given manner, and that explanation

must be sufficient to enable [the Court] to conclude

that the [agency’s action] was the product of reasoned

decisionmaking.” A.L. Pharma, Inc. v. Shalala, 62

F.3d 1484, 1491 (D.C. Cir. 1995) (quotations omitted).

FDA’s failure to explain why it could rely on studies

examining some of the 2016 changes as sufficient to

justify all of them “prevents [this Court] from evaluating whether or not the agency engaged in reasoned

decisionmaking.” New York, 535 U.S. at 36 (Thomas,

J., concurring in part). This is particularly true here,

where FDA’s changes represent a major deviation

from its prior requirements. Encino Motorcars, 579

U.S. at 221–22.

63

3. FDA’s elimination of the reporting

requirement for all serious adverse

events was arbitrary and capricious.

FDA’s decision to eliminate the requirement that

abortion providers report all serious adverse events

was also arbitrary and capricious. J.A. 319. FDA

justified this decision by asserting that “after 15 years

of reporting serious adverse events, the safety profile

of Mifeprex is essentially unchanged.” Ibid. That

backward-looking rationale says nothing about mifepristone’s safety profile going forward without the

removed safeguards.

Petitioners respond that the two drug sponsors

remain obligated to report adverse events, FDA Br.

43, Danco Br. 46. But the sponsors lack any meaningful ability to track the problems on the ground.

Nowhere near America’s emergency rooms, these

companies rely entirely on the voluntary reporting of

busy doctors. It is unreasonable for the agency to rely

on voluntary reporting to assess the ongoing safety of

these high-risk drugs.

C. A full administrative record is not

necessary at this stage.

Danco (but not FDA) argues that this Court

should adopt a new rule prohibiting a lower court

from providing preliminary relief without a full

administrative record. Danco Br. 36. But the APA

expressly allows a court to grant relief based on “the

whole record or those parts of it cited by a party.” 5

U.S.C. 706 (emphasis added); see Univ. of Tex. v.

Camenisch, 451 U.S. 390, 395–96 (1981) (noting that

a party seeking a preliminary injunction need neither

“present” nor “prove his case in full”). Were Danco

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correct, federal agencies would have a potent weapon

to marshal against preliminary relief. Case in point:

FDA told the Fifth Circuit that the administrative

record in this case still remains in “cold storage.” Oral

Arg. at 24:30 (5th Cir. May 17, 2023).

None of Danco’s cases are remotely like this one.

In Citizens to Pres. Overton Park, Inc. v. Volpe, 401

U.S. 402, 406 (1971), which was decided on summary

judgment, the district court had no “part[ ] of” the

administrative record before it but only affidavits

created during litigation. Id. at 409. Similarly, the

D.C. Circuit in American Bioscience, Inc. v. Thompson, 243 F.3d 579, 582 (D.C. Cir. 2001), found that it

was “not sufficient” for the district court “to have

relied on the parties’ written or oral representations

to discern the basis on which the FDA acted.” Here, in

contrast, the agency’s decisional documents are

“part[ ] of [the record] cited by” the parties. 5 U.S.C.

706. And Petitioners were free to submit to the

district court any agency document that they believe

would have advanced their case.

In any event, Danco waived this argument. Before

the district court, Danco didn’t argue that the lack of

a full administrative record deprived the court of

authority to grant preliminary relief. ROA 2002–35;

ROA 2086–137. Rather, Danco acknowledged that

only a “ruling beyond the preliminary injunction

motion would be premature,” and that a “preliminary

injunction record is necessarily incomplete” in APA

cases. ROA 3589–90; see also ROA 3802 (FDA recognizing that “preliminary proceedings typically are

‘granted on the basis of procedures that are less

formal and evidence that is less complete than in a

trial on the merits’”) (citation omitted).

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III. The remedy issued is appropriate.

FDA concedes that “the traditional four-factor

test for a preliminary injunction” applied by the lower

courts is the “correct[ ]” standard. FDA Br. 46

(quoting Pet. App. 44a). As those courts held, the

factors favor Respondents. Pet. App. 63a–69a, 150a–

193a.

First, Respondents are likely to succeed on the

merits. Second, Respondents’ harms are irreparable

because “[n]o legal remedy can adequately redress”

their “conscience,” “mental-distress,” “economic,” and

other injuries. Pet. App. 64a. Notably, Petitioners

nowhere deny that Respondents’ injuries, if

established, are irreparable. And Petitioners overlook

that Respondents represent the interests of the

women they treat who are harmed by FDA actions.

Exposing women to frantic emergency-room visits

because of FDA’s recklessness qualifies as irreparable

harm.

The equities and public interest—the remaining

two factors, which “merge when the Government is

the [defendant],” Nken v. Holder, 556 U.S. 418, 435

(2009)—also favor Respondents. Pet. App. 63a–69a.

Only modest relief is at stake—the restoration of

safety standards that FDA required for 16 years and

under which millions of women took mifepristone.

FDA faces no harm because it lacks any interest in

enforcing unlawful agency action. See Ala. Ass’n of

Realtors v. Dep’t of Health & Hum. Servs., 141 S. Ct.

2485, 2490 (2021) (per curiam) (“our system does not

permit agencies to act unlawfully”). Any effect on

Danco is negligible because it will still be able to sell

and profit from mifepristone. And the public—including women using mifepristone—will benefit from

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FDA restoring key safeguards that once protected

women’s health. Indeed, “the public interest is

disserved by a drug that does not afford adequate

protections to its users.” Pet. App. 69a. Respondents

satisfy the standard for preliminary relief.

FDA’s Section 705 argument. FDA (but not Danco)

argues the district court cannot use 5 U.S.C. 705 to

stay “agency actions that ha[ve] been in effect for

years.” FDA Br. 15. Yet the broad statutory text

contains no such limitation. It allows courts to “issue

all necessary and appropriate process to postpone the

effective date of an agency action or to preserve status

or rights pending conclusion of the review

proceedings.” 5 U.S.C. 705 (emphasis added).

FDA’s myopic focus on the word “postpone,” FDA

Br. 45, ignores the statutory disjunctive. The

authority to enter “all necessary and appropriate”

relief to “preserve … rights” pending judicial review

includes the authority to stay unlawful agency action

that has already gone into effect. 5 U.S.C. 705

(emphasis added). Indeed, “[t]he authority granted

[by Section 705] is equitable and should be used by …

courts to prevent irreparable injury or afford parties

an adequate judicial remedy.” H.R. Rep. No. 1980, at

277 (1946). And of course, stays are less drastic

remedies than injunctions because they don’t order

defendants to act. Nken, 556 U.S. at 428–29.

FDA acknowledges courts may enter stays that

are “contemporaneous with or predate” an action’s

“effective date,” conceding the power to postpone

recently passed effective dates. FDA Br. 45 (emphasis

added). But no statutory text supports FDA’s distinction between recently past effective dates and older

effective dates.

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The implications of FDA’s cramped construction

of Section 705 are untenable. It would prevent courts

from ever staying FDA drug approvals or modifications given the agency’s demand that challengers

first file citizen petitions, 21 C.F.R. 10.45(b), and its

practice of delaying responses for many years, Pet.

App. 112a, sometimes for more than a decade.

At day’s end, whether Section 705 authorizes a

stay of the effective dates here is an academic question. The district court said that “it alternatively would

have ordered” FDA to pause its 2021 and 2016 actions

pending final judgment. Pet. App. 195a. That alternative injunction fits squarely within Section 705’s

equitable authority to issue “all necessary and

appropriate” interim relief to “prevent irreparable

injury” and “preserve … rights.” 5 U.S.C. 705. As

discussed, every one of the preliminary-injunction

factors favor pausing FDA’s actions. And such relief

is “necessary to provide complete relief” to Respondents. Califano v. Yamasaki, 442 U.S. 682, 702

(1979). Members of Respondent associations are

located throughout the country, as are the women

they serve and whose interests they represent. E.g.,

J.A. 119, 126, 146–47. And even Respondent doctors

located in jurisdictions that limit abortion are affected

by women who receive the drugs from other states

and seek treatment from Respondents. J.A. 126, 179,

198; Mississippi Multi-State Am. Br. Part II.

Anything less than a pause on the challenged actions

is insufficient to protect Respondents.

Petitioners’ equity arguments. Petitioners’ equity

arguments also fall flat. Petitioners claim hardship

from updating mifepristone’s “labeling.” FDA Br. 46;

Danco Br. 53. But the Fifth Circuit’s ruling merely

requires FDA and Danco to restore standards

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previously in effect—not craft new ones. And Petitioners have had more than six months since the Fifth

Circuit’s ruling to prepare—and will have several

more before this Court rules.

Danco (but not FDA) complains that it might have

to submit a supplemental drug application and that

FDA might not approve it. Danco Br. 53–54. Talk

about speculative. FDA has never expressed any

safety or efficacy concerns with the prior protocols.

J.A. 302, 502. There’s no reason to think they’d do so

now.

Petitioners’ concerns about “access” to abortion

are groundless. FDA Br. 46–47; Danco Br. 52–53.

Millions of women had abortions under the prior

safety standards—they just did so with the oversight

and ongoing care of a healthcare provider. Moreover,

Petitioners’ “access” arguments disregard women’s

safety by overlooking the studies that FDA discussed

in 2021 indicating that the absence of an in-person

visit causes more trips to emergency rooms and

urgent care. J.A. 403–07. And Petitioners’ focus on

women in rural settings, Danco Br. 52, ignores FDA’s

recognition that women living “significant distances

from their providers … have been associated with

higher use of [emergency departments]” following

chemical abortion. FDA 2023 Approval Letter (Jan. 3,

2023), https://bit.ly/49mvzeL (page 121 of full PDF).

Despite Danco’s claim, relief for Respondents does

not require FDA to revert to the prior “dosing

regimen.” Danco Br. 53. As FDA recognizes, Respondents have not challenged the 2016 dosing change.

FDA Br. 41 n.8. And FDA’s own records show that

abortion providers were using the dosing regimen

Danco prefers since 2001, long before FDA’s 2016

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action. J.A. 443, 446, 465. A ruling for Respondents

won’t change that.

Petitioners also minimize Respondents’ injuries,

claiming they are unlikely to occur. FDA Br. 47. This

adds nothing new but simply rehashes Petitioners’

flawed standing arguments. It also ignores that

Respondents represent the interests of women they

treat who are harmed by FDA’s actions. Those

women—who rely on FDA to protect them—have

strong interests in FDA restoring the unreasonably

removed safeguards. Respondents’ labor and delivery

patients likewise have their own interests in preserving access to Respondents’ care.

Staying FDA’s 2021 and 2016 actions will not

“destabilize” the “pharmaceutical industry.” Contra

Danco Br. 54. To the contrary, restoring safety

standards for abortion drugs removed through FDA’s

unlawful actions fortifies the public’s trust in the

pharmaceutical-approval process. Nowhere in their

hyperbole do Petitioners cite a single specific drug

approval that will be jeopardized. And given that

FDA’s actions here are especially egregious, pausing

them leaves other drug approvals untouched.

No remand for agency reconsideration. Petitioners’ final plea is that FDA’s actions should not be

paused but only remanded for “further [agency]

consider[ation].” FDA Br. 48. Yet this Court has not

hesitated to vacate other arbitrary and unreasonably

explained agency action. E.g., Regents, 140 S. Ct. at

1901, 1916 (“vacat[ing]” agency action when the

agency failed to “provide a reasoned explanation”).

FDA thinks it can better explain itself if given

another chance and allowed to invoke its “years of

experience” with abortion drugs since 2016. FDA Br.

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48–49. But the APA prohibits “post hoc rationalization,” so any further elaboration would be confined to

the original administrative record and “the determinative reason[s] for [each] action.” Regents, 140 S. Ct.

at 1908. In 2021, for example, the record and rationale consisted of only concededly unreliable FAERS

data and inadequate studies. No amount of elaboration on that record will “justify [FDA’s] decision on

remand.” United Steel v. Mine Safety & Health

Admin., 925 F.3d 1279, 1287 (D.C. Cir. 2019). It is

revealing that despite over a year of litigation, FDA

has never provided a reasonable explanation. Nothing

suggests it could do so now.

CONCLUSION

The Court should affirm the Fifth Circuit’s order

and remand for further proceedings.

Respectfully submitted,

JAMES A. CAMPBELL

ERIK C. BAPTIST

CODY S. BARNETT

GABRIELLA MCINTYRE

ALLIANCE DEFENDING

FREEDOM

44180 Riverside Pkwy

Lansdowne, VA 20176

(571) 707-4655

FEBRUARY 2024

ERIN M. HAWLEY

Counsel of Record

JOHN J. BURSCH

MATTHEW S. BOWMAN

ALLIANCE DEFENDING

FREEDOM

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Suite 600

Washington, DC 20001

(202) 393-8690

ehawley@ADFlegal.org