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

Supreme Court briefOct 12, 2023

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Nos. 23-235 & 23-236

IN THE

Supreme Court of the United States

FOOD AND DRUG ADMINISTRATION, et al.,

Petitioners,

ALLIANCE FOR HIPPOCRATIC MEDICINE, et al.,

Respondents.

DANCO LABORATORIES, L.L.C.,

Petitioner,

ALLIANCE FOR HIPPOCRATIC MEDICINE, et al.,

Respondents.

On Petitions for Writ of Certiorari

to the United States Court of Appeals

for the Fifth Circuit

BRIEF OF AMERICAN COLLEGE OF

OBSTETRICIANS AND GYNECOLOGISTS,

AMERICAN MEDICAL ASSOCIATION,

SOCIETY FOR MATERNAL-FETAL

MEDICINE, AND OTHER MEDICAL AND

PUBLIC HEALTH SOCIETIES AS AMICI

CURIAE IN SUPPORT OF PETITIONERS

SHANNON ROSE SELDEN

Counsel of Record

ADAM AUKLAND-PECK

DEBEVOISE & PLIMPTON LLP

66 Hudson Boulevard

New York, NY 10001

(202) 909-6000

srselden@debevoise.com

aauklandpeck@debevoise.com

MOLLY MEEGAN

JESSICA MORRIS

NAEMA MALLICK

AMERICAN COLLEGE OF

OBSTETRICIANS AND

GYNECOLOGISTS

409 12th Street, SW

Washington, D.C. 20024

(202) 638-5577

mmeegan@acog.org

jmorris@acog.org

nmallick@acog.org

MEGAN MCGUIGGAN

DEBEVOISE & PLIMPTON LLP

801 Pennsylvania Avenue, NW

Washington, D.C. 20004

(202) 383-8000

mmcguiggan@debevoise.com

TABLE OF CONTENTS

Page

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

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

SUMMARY OF THE ARGUMENT ............................ 4

ARGUMENT ............................................................... 7

Mifepristone Has Been Thoroughly

Studied and Is Conclusively Safe..................... 7

II.

There Is No Scientific Basis for

Rewinding the Clock on Evidence-Based

Medical Practice to 2015. ............................... 11

III.

Restricting the Use of Mifepristone Will

Harm Pregnant Patients and Have

Severe Negative Impacts on the Broader

Health Care System. ...................................... 17

CONCLUSION .......................................................... 24

TABLE OF AUTHORITIES

Cases

All. for Hippocratic Med. v. U.S. Food &

Drug Admin., 78 F.4th 210 (5th Cir.

2023) ....................................................................... 5

June Med. Servs. LLC v. Russo, 140 S.

Ct. 2103 (2020) ....................................................... 2

Planned Parenthood Ctr. for Choice v.

Abbott, No. A-20-CV-323-LY, 2020

WL 1815587 (W.D. Tex. Apr. 9,

2020) ....................................................................... 2

Stenberg v. Carhart, 530 U.S. 914

(2000) ...................................................................... 2

Whole Woman’s Health v. Hellerstedt,

579 U.S. 582 (2016) ................................................ 2

Whole Woman’s Health v. Paxton, 978

F.3d 896 (5th Cir. 2000) ......................................... 2

Other Authorities

2000 FDA Approval Memorandum,

2:22-CV-00223-Z (Nov. 18, 2022),

ECF No. 1-25 ........................................................ 15

ACOG Clinical Consensus No. 1,

Pharmacologic Stepwise Multimodal

Approach for Postpartum Pain

Management (Sept. 2021) .................................... 19

iii

ACOG Committee Opinion No. 815,

Increasing Access to Abortion (Dec.

2020) ................................................................. 8, 20

ACOG Obstetric Care Consensus No. 7,

Placenta Accreta Spectrum (Dec.

2018) ..................................................................... 19

ACOG Practice Bulletin No. 183,

Postpartum Hemorrhage (Oct. 2017) .................. 19

ACOG Practice Bulletin No. 190,

Gestational Diabetes Mellitus (Feb.

2018) ..................................................................... 19

ACOG Practice Bulletin No. 198,

Prevention and Management of

Obstetric Lacerations at Vaginal

Delivery (Sept. 2018) ............................................ 19

ACOG Practice Bulletin No. 200, Early

Pregnancy Loss (Nov. 2018, reaff’d

2021) ................................................................. 8, 22

ACOG Practice Bulletin No. 222,

Gestational

Hypertension

and

Preeclampsia (June 2020) .................................... 19

ACOG Practice Bulletin No. 225,

Medication Abortion Up to 70 Days

of Gestation (Oct. 2020, reaff’d 2023) .............. 8, 12

Adriana A. Boersma et al., Mifepristone

Followed by Home Administration of

Buccal Misoprostol for Medical

Abortion Up to 70 Days of

Amenorrhoea in a General Practice

in Curacao, 16 EUR. J. CONTRACEPT.

& REPROD. HEALTH CARE 61 (2011) ..................... 12

ANSIRH, Analysis of Medication

Abortion Risk and the FDA Report

“Mifepristone US Post-Marketing

Adverse Events Summary Through

12/31/2018,” UNIV. OF CAL., S.F.

(2019) .................................................................... 10

ANSIRH, Analysis of Medication

Abortion Risk and the FDA Report

“Mifepristone US Post-Marketing

Adverse Events Summary Through

6/30/2021,” UNIV. OF CAL., S.F.

(2022) ................................................................ 9, 10

ANSIRH, U.S. Studies on Medication

Abortion

Without

In-Person

Clinician Dispensing of Mifepristone,

UNIV. OF CAL., S.F. (2021) .................................... 10

ASGE Standards of Practice Comm.,

Complications of Colonoscopy, 74

AM. SOC’Y FOR GASTRO. ENDOSCOPY

745 (2011) ............................................................. 10

Beverly Winikoff et al., Extending

Outpatient

Medical

Abortion

Services Through 70 Days of

Gestational Age, 120 OBSTET. &

GYNECOL. 1070 (2012) .......................................... 12

Carla Dugas & Valori H. Slane,

Miscarriage,

NAT’L

CTR.

FOR

BIOTECH. INFO. (2022) ............................................ 8

Christine Dehlendorf & Tracy Weitz,

Access to Abortion Services:

Neglected Health Disparity, 22 J.

HEALTH CARE FOR THE POOR &

UNDERSERVED 415 (2011) .................................... 19

Christopher M. Wittich et al., Ten

Common Questions (and Their

Answers) About Off-Label Drug Use,

87 MAYO CLINIC PROC. 982 (2012) ....................... 21

David Boulware, Recent Increases in the

U.S. Maternal Mortality Rate:

Disentangling

Trends

from

Measurement Issues, 129 OBSTET. &

GYNECOL. 385 (2017) ............................................ 18

Diana

Greene

Foster

al.,

Socioeconomic Outcomes of Women

Who Receive and Women Who Are

Denied Wanted Abortions in the

United States, 108 AM. J. PUB.

HEALTH 407 (2018) ............................................... 21

Dina Abbas et al., Outpatient Medical

Abortion is Safe and Effective

Through 70 Days Gestation, 92

CONTRACEPT. 197 (2015) ...................................... 12

Elizabeth G. Raymond & David A.

Grimes, The Comparative Safety of

Legal

Induced

Abortion

and

Childbirth in the United States, 119

OBSTET. & GYNECOL. 215 (2012) .............. 11, 18, 19

Elizabeth G. Raymond & Hillary

Bracken, Early Medical Abortion

Without Prior Ultrasound, 92

CONTRACEPT. 212 (2015) ................................ 10, 15

FDA Ctr. For Drug Eval. & Rsch.,

Medical Review, Application No.

020687Orig1s020 (Mar. 29, 2016) ............. 9, 12, 13

Honor MacNaughton et al., Mifepristone

and Misoprostol for Early Pregnancy

Loss and Medication Abortion, 103

AM. FAM. PHYSICIAN 473 (2021) ........................... 21

Jenna Jerman et al., Characteristics of

U.S. Abortion Patients in 2014 and

Changes Since 2008, GUTTMACHER

INST. (2016) ........................................................... 19

Jessica Beaman, Medication to Manage

Abortion and Miscarriage, 35 J. GEN.

INTERNAL MED. 2398 (2020)................................. 22

vii

Juanita Chinn et al., Health Equity

Among Black Women in the United

States, 30 J. WOMEN’S HEALTH 212,

(2021) .................................................................... 20

Kanan Yelikar et al., Safety and

Efficacy of Oral Mifepristone in PreInduction Cervical Ripening and

Induction of Labour in Prolonged

Pregnancy, 65 J. OBSTET. &

GYNAECOL. INDIA 221 (2015) ................................ 22

Katherine Kortsmit et al., Abortion

Surveillance—United States, 2019,

70 CDC MORBIDITY & MORTALITY

WKLY. REP. 1 (2021) ............................................... 9

Lyndsey S. Benson et al., Early

Pregnancy Loss in the Emergency

Department, 2006–2016, 2 J. AM.

COLL. EMERGENCY PHYSICIANS OPEN

e12549 (2021) ....................................................... 20

Mara Gordon & Sarah McCammon, A

Drug that Eases Miscarriages is

Difficult for Women to Get, NPR

(Jan. 10, 2019) ...................................................... 21

Mario Tristan et al., Mifepristone for

Uterine

Fibroids,

COCHRANE

DATABASE SYSTEMATIC REVS. (2012).................... 22

Maternity Care Desert, MARCH OF DIMES

(Oct. 2022) ............................................................ 16

viii

Mifeprex Highlights of Prescribing

Information, FDA (Mar. 2016) ............................ 11

Mike Mitka, Some Men Who Take

Viagra Die—Why?, 283 J. AM. MED.

ASS’N 590 (2000) ................................................... 10

Miscarriage, MARCH OF DIMES (Feb.

2023) ....................................................................... 8

NAT’L ACADS. OF SCI., ENG’G & MED.,

THE SAFETY AND QUALITY OF

ABORTION CARE IN THE UNITED

STATES (2018) ................................................. 10, 18

Office of Minority Health, Advancing

Rural Maternal Health Equity, CTRS.

FOR MEDICARE & MEDICAID SERVS.

(2022) .............................................................. 16, 20

Press

Release,

Endocrine

Soc’y,

Endocrine Society Alarmed by Texas

Court Ruling Banning Mifepristone

(Apr. 10, 2023) ..................................................... 22

Press Release, Walgreens, Walgreens

and Mifepristone: The Facts, (July

11, 2023) .............................................................. 15

R. Morgan Griffin, Making the Decision

on NSAIDs, WEBMD (Oct. 17, 2005) ................... 10

Rachel K. Jones et al., COVID-19

Abortion

Bans

and

Their

Implications for Public Health, 52

PERSPS. SEXUAL & REPROD. HEALTH

65 (2020) ............................................................... 19

Rural Health Council, CMS Rural

Health

Strategy,

CTRS.

FOR

MEDICARE & MEDICAID SERVS. (2018) ................. 19

Ushma D. Upadhyay et al., AbortionRelated

Emergency

Department

Visits in the United States: An

Analysis of a National Emergency

Department Sample, 16 BMC MED. 1

(2018) .................................................................... 17

Ushma D. Upadhyay et al., Incidence of

Emergency Department Visits and

Complications After Abortion, 125

OBSTET. & GYNECOL. 175 (2015) ............................ 9

Ushma D. Upadhyay et al., Outcomes

and

Safety

History-Based

Screening for Medication Abortion: A

Retrospective Multicenter Cohort

Study, 182 J. AM. MED. ASS’N

INTERNAL MED. 482 (2022)................................... 15

Y. X. Zhang, Effect of Mifepristone in the

Different

Treatments

Endometriosis, 43 CLINICAL &

EXPERIMENTAL OBSTET. & GYNECOL.

350 (2016) ............................................................. 22

Yanxia Cao et al., Efficacy of

Misoprostol

Combined

with

Mifepristone

Postpartum

Hemorrhage and Its Effects on

Coagulation Function, 13 INT’L. J.

CLINICAL & EXPERIMENTAL MED.

2234 (2020) ........................................................... 22

Young-Kyun Kim, Malpractice and

Complications, 43 J. KOREAN ASS’N

ORAL & MAXILLOFACIAL SURGEONS 1

(2017) ...................................................................... 5

INTEREST OF AMICI CURIAE1

Amici curiae are leading medical and publichealth societies representing physicians, clinicians,

and public-health professionals who serve patients in

Texas and nationwide. They include: (1) The

American College of Obstetricians and Gynecologists

(“ACOG”). Representing more than 90% of boardcertified OB/GYNs in the United States, ACOG is the

nation’s

premier

professional

membership

organization for obstetrician-gynecologists dedicated

to access to high-quality, safe, and equitable

obstetric and gynecologic care. ACOG maintains the

highest standards of clinical practice and continuing

education of its members, promotes patient

education, and increases awareness among its

members and the public of the changing issues facing

women’s health care.

ACOG is committed to

ensuring access for all people to the full spectrum of

evidence-based quality reproductive health care,

including abortion care, and is a leader in the effort

to confront the maternal mortality crisis in the

United States; (2) The American Medical Association

(“AMA”), the largest professional association of

physicians, residents, and medical students in the

country.

Through state and specialty medical

societies and other physician groups seated in its

House of Delegates, substantially all physicians,

residents, and medical students in the United States

Pursuant to Rule 37.6, counsel for amici curiae authored

this brief in whole; no party’s counsel authored, in whole or in

part, this brief; and no person or entity other than amici and its

counsel contributed monetarily to preparing or submitting this

brief. Pursuant to Rule 37.2, counsel for amici curiae timely

notified the counsel of record of their intent to file this brief.

are represented in the AMA’s policy-making process.

The AMA was founded in 1847 to promote the art

and science of medicine and the betterment of public

health, and these remain its core purposes; (3) The

Society for Maternal-Fetal Medicine (“SMFM”).

Founded in 1977, SMFM is the medical professional

society for maternal-fetal medicine subspecialists,

who are obstetricians with additional training in

high-risk pregnancies. SMFM represents more than

5,500 members who care for high-risk pregnant

people and provides education, promotes research,

and engages in advocacy to advance optimal and

equitable perinatal outcomes for all people who

desire and experience pregnancy. SMFM and its

members are dedicated to ensuring that all medically

appropriate treatment options are available for

individuals experiencing a high-risk pregnancy; and

(4) Nine other organizations whose members’ work is

impacted by the matter before this Court and who

can offer a unique perspective not otherwise provided

by the parties.

These organizations collectively represent

hundreds of thousands of medical practitioners

across the country, with deep expertise in both

medical research and the treatment of patients in

real-world settings. Courts frequently rely on

amici’s medical and scientific expertise in cases

involving pregnancy. 2 Ensuring robust access to

evidence-based health care and promoting health

See, e.g., June Med. Servs. LLC v. Russo, 140 S. Ct. 2103,

2131 (2020); Whole Woman’s Health v. Hellerstedt, 579 U.S.

582, 612–13 (2016); Whole Woman’s Health v. Paxton, 978 F.3d

896, 910 (5th Cir. 2000); Stenberg v. Carhart, 530 U.S. 914, 928

(2000); Planned Parenthood Ctr. for Choice v. Abbott, No. A-20CV-323-LY, 2020 WL 1815587, at *4–5 (W.D. Tex. Apr. 9,

2020).

care policy that improves patient health are central

to amici’s missions. Amici believe that all patients

are entitled to prompt, complete, and unbiased

health care that is medically and scientifically

sound. Amici submit this brief to explain that the

current Food and Drug Administration-endorsed

(“FDA”) protocol for the prescription and use of

mifepristone aligns with the overwhelming weight of

medical evidence and allows amici to safely

administer the drug in a manner consistent with

medical ethics and medically appropriate standards

of care.

Amici’s ability to effectively care for patients

often requires access to mifepristone, which has

undergone rigorous testing and review and has been

approved for use in the United States for more than

20 years. Accordingly, amici have a strong interest

in preserving that access and ensuring that the

science surrounding mifepristone’s safety, efficacy,

and administration is correctly understood.

Amici are the following organizations: ACOG;

AMA; SMFM; American Academy of Family

Physicians; American Academy of Pediatrics;

American Gynecological and Obstetrical Society;

American Society for Reproductive Medicine; Council

of University Chairs of Obstetrics and Gynecology;

North American Society for Pediatric Adolescent

Gynecology; Society for Academic Specialists in

General Obstetrics and Gynecology; Society of

Family Planning; and Society of OB/GYN

Hospitalists.

SUMMARY OF THE ARGUMENT

This Court should not allow the speculative fears

of a handful of doctors to deprive patients throughout

the country of an essential medication that is proven

safe for use in early pregnancy. All patients are

entitled to prompt, complete, and unbiased health

care. No patient should be denied treatment for

miscarriage or other early pregnancy loss because of

Respondents’ hypothetical fears or personal beliefs.

Patients in states where abortion remains legal and

protected should not be denied the ability to safely

and privately seek to exercise that right through safe

and effective medication abortion.

Certainly,

patients should not be forced to carry pregnancies to

term or be denied appropriate medical treatment for

complications that happen regularly during

pregnancy or pregnancy loss simply because

Respondents at the margins of medical practice fear

they may encounter a patient in the vanishingly

small percentage of those who suffer complications

requiring treatment after a medication abortion.

Respondents claim that they will suffer legal

injury if they are asked to provide medical care—as

their professional ethics and positions require—to

patients who may be among the very few who seek

treatment after taking mifepristone to end a

pregnancy. This claim of injury is unsupported for

the myriad legal reasons set forth by Petitioners.

But it is also untenable as a matter of maternal

medicine. The issues Respondents fear are for the

most part not “complications” at all as that term is

used in the practice of medicine.3 Bleeding and

“Common terms used interchangeably to refer to problems

arising from medical . . . treatments include ‘complication[]’

[and] ‘side effect’. . . . Complications refer to other diseases or

cramping are known and expected side effects of

using mifepristone, as the Mifeprex label states, but

they certainly are not unique to the use of

mifepristone. Bleeding and cramping happen when

a pregnancy ends, whether through miscarriage,

medication abortion, or procedural abortion (and

these effects have a real impact on patients). In

describing these as “complications” of medication

abortion, Respondents are disregarding the medical

reality to create unwarranted fears of injury. If

Respondents are concerned by treating patients

presenting with bleeding and cramping that may

require subsequent intervention, that risk arises

with any form of pregnancy loss. These are not

“complications” and they are not unique to the use of

mifepristone.4

Respondents ask the courts to place their

individual concerns about speculative and unlikely

injuries of conscience above the very real and

immediate life-threatening and life-altering concerns

of hundreds of thousands of pregnant patients. But

that is not consistent with medical ethics or practice.

Amici represent legions of practitioners who have

come to rely on the FDA’s current regulatory

approach to mifepristone and whose patients deserve

the most current and medically appropriate standard

symptoms that occur in relation to a given disease. Side effects

refer to undesirable effects that occur concomitantly with the

originally intended outcome.” Young-Kyun Kim, Malpractice

and Complications, 43 J. KOREAN ASS’N ORAL & MAXILLOFACIAL

SURGEONS 1, 1 (2017).

All. for Hippocratic Med. v. U.S. Food & Drug Admin., 78

F.4th 210, 230–31 (5th Cir. 2023) (citing Respondent Medical

Organizations’ member declarations discussing instances in

which patients require procedural intervention following an

incomplete abortion).

of care. Neither patients nor physicians are served

by rolling the clock back by nearly a decade to the

pre-2016 regulatory regime.

Restricting access to mifepristone—the safety of

which is proven by decades of rigorous scientific

study and millions of uses—in ways that are not

medically necessary or scientifically sound would

seriously increase risk for hundreds of thousands of

patients, while protecting none.

For already

vulnerable populations (particularly those living in

areas with limited access to OB/GYN care) the rollback approved by the Fifth Circuit promises to be

especially devastating and to further perpetuate

racial and socioeconomic inequalities.

These

concerns are not speculative. The risk of harm is

concrete and rooted in the reality that mifepristone

is an essential component of reproductive care,

including miscarriage and abortion, without which a

vast number of patients will suffer.

Respondents seek to undermine decades of

approved, safe, and effective use of mifepristone to

the detriment of patients. Amici are the nation’s

leading medical organizations, whose policies and

guidance represent the considered judgment of

hundreds of thousands of physicians and clinicians

in this country. Amici write in full support of

Petitioners to alert the Court to the many ways that

Respondents’ view and the Fifth Circuit’s

endorsement of the same undermine the principles of

patient care, compromise patient safety and wellbeing, impede the provision of quality health care

services, and threaten the effective functioning of

health care institutions and the practice of medicine.

Amici urge this Court not to return doctors, patients,

and the medical profession to an outdated regulatory

regime that imposes restrictions the FDA has

already set aside as unnecessary and unjustified. It

should grant the Petitions for Writ of Certiorari

(“Petitions”) and reverse the decisions below.

ARGUMENT

Amici urge this Court to grant the Petitions to

preserve access to mifepristone under the conditions

deemed appropriate by the FDA. The decision to reimpose the Risk Evaluation and Mitigation

Strategies (“REMS”) restrictions and Conditions of

Use5 the FDA previously eliminated as unnecessary

in 2016 and 2021 is not supported by scientific

evidence and not consistent with best medical

practices.

It would impede patient care and

endanger individual patients who rely on the

availability of mifepristone for safe, effective

treatment consistent with the current standard of

care.

Mifepristone Has Been Thoroughly

Studied and Is Conclusively Safe.

Amici are the nation’s leading medical

organizations, whose members are committed to

providing ethical, evidence-based, scientifically

sound care to patients throughout the country.

Unlike Respondents, many of amici’s members

As a preliminary matter, the Fifth Circuit’s decision

conflates the Conditions of Use printed on the medication’s

label and the applicable REMS, treating both categories as

though they are one in the same. They are not, and these

different groups carry very different implications for providers.

For this reason alone, the Court should grant review in this

case to address the Fifth Circuit’s failure to carefully consider

the evidence proving the safety of mifepristone or appreciate

the distinction between REMS and labeling protocol.

regularly prescribe mifepristone in early pregnancy

and are in fact familiar with the medical needs of

and risks and benefits for the many patients who

rely on mifepristone.

Amici and their patients rely on the continued

availability of mifepristone to provide, in

combination with misoprostol, a safe and effective

way to end an early pregnancy. This medication

protocol combines to empty the contents of the uterus

and has exceptionally low rates of major adverse

events. 6 This treatment protocol may be used to

induce abortion 7 and is used regularly in the

effective treatment of miscarriage or early pregnancy

loss8 (including spontaneous abortions, missed

abortions, incomplete abortions, and inevitable

abortions). Early pregnancy loss, like pregnancy

itself, is not rare but can be life-threatening. Ready

access to mifepristone provides a safe treatment for

the millions of patients—an estimated 10–26% of all

pregnant patients—who experience it each year.9

The overwhelming weight of scientific evidence

and two decades of medical practice show that

mifepristone is safe and effective and that it is not

Combined mifepristone-misoprostol regimens are the

preferred therapy for medication abortion because they are

“more effective than misoprostol-only regimens.”

ACOG

Practice Bulletin No. 225, Medication Abortion Up to 70 Days of

Gestation (Oct. 2020, reaff’d 2023).

See ACOG Committee Opinion No. 815, Increasing Access

to Abortion (Dec. 2020).

See ACOG Practice Bulletin No. 200, Early Pregnancy Loss

(Nov. 2018, reaff’d 2021).

See id.; Carla Dugas & Valori H. Slane, Miscarriage, NAT’L

CTR. FOR BIOTECH. INFO. (2022) (“It is estimated that as many

as 26% of all pregnancies end in miscarriage and up to 10% of

clinically recognized pregnancies.”); see also Miscarriage,

MARCH OF DIMES (Feb. 2023).

medically necessary to impose additional restrictions

around its use.

Mifepristone has been (and

continues to be) one of the most studied medications

prescribed in the United States.

To date,

mifepristone has been discussed in more than 780

medical reviews and used in more than 630

published clinical trials—of which more than 420

were randomized controlled studies, the gold

standard in research design. 10 These studies have

consistently concluded that it is exceedingly rare for

patients to experience even minor complications from

medication abortion. 11 When used in medication

abortion, major adverse events—significant infection,

excessive blood loss, or hospitalization—occur in less

than 0.32% of patients.12 Serious infection is

exceptionally rare, occurring in only 0.015% to 0.07%

of patients.13 The risk of death is almost nonexistent.14 Indeed, mifepristone has a safety profile

Based on a review of PubMed, the National Institute of

Health’s sponsored database of research studies.

See, e.g., ANSIRH, Analysis of Medication Abortion Risk

and the FDA Report “Mifepristone US Post-Marketing Adverse

Events Summary Through 6/30/2021,” UNIV. OF CAL., S.F. 2

(2022) [hereinafter ANSIRH, Adverse Events 2021].

See Ushma D. Upadhyay et al., Incidence of Emergency

Department Visits and Complications After Abortion, 125

OBSTET. & GYNECOL. 175, 175 (2015) (a study of nearly 55,000

abortions found a major complications rate of 0.31% for

medication abortion).

FDA Ctr. For Drug Eval. & Rsch., Medical Review,

Application No. 020687Orig1s020, at 53–54 (Mar. 29, 2016)

[hereinafter 2016 FDA Medical Review].

See Katherine Kortsmit et al., Abortion Surveillance—

United States, 2019, 70 CDC MORBIDITY & MORTALITY WKLY.

REP. 1, 29, tbl.15 (2021). A 2019 analysis of FDA data

examining potential mifepristone-related deaths over an 18year period by the University of San Francisco Medical Center,

for example, found an approximate mortality rate of just

comparable to that of ibuprofen, which more than 30

million Americans take in any given day. 15 These

strikingly low rates of adverse outcomes are observed

regardless of the indication for its use.

Mifepristone is not just safe—it is far safer than

countless other medications and among the safest

medications or devices approved by the FDA and

being used in medical practice. 16 Again, its safety

profile is similar to that of ibuprofen.17 Using Viagra

is more dangerous than using mifepristone, with a

rate of 4.9 deaths for every 100,000 Viagra

prescriptions.18

Colonoscopies are a routine

procedure, widely used in preventive care—yet death

occurs in about 0.03% of colonoscopy cases.19 Those

0.00035%. ANSIRH, Analysis of Medication Abortion Risk and

the FDA Report “Mifepristone US Post-Marketing Adverse

Events Summary Through 12/31/2018,” UNIV. OF CAL., S.F. 1–

2 (2019) [hereinafter ANSIRH, Adverse Events 2018].

See NAT’L ACADS. OF SCI., ENG’G & MED., THE SAFETY AND

QUALITY OF ABORTION CARE IN THE UNITED STATES 79 (2018);

see also R. Morgan Griffin, Making the Decision on NSAIDs,

WEBMD (Oct. 17, 2005).

See ANSIRH, Adverse Events 2018, supra note 14, at 2

(“The safety profile [of medication abortion with mifepristone

and misoprostol] is similar to that of vacuum aspiration

abortion, and medication abortion is safer than continuing a

pregnancy to term or using other common medications.”);

ANSIRH, Adverse Events 2021, supra note 11, at 3 (same); see

also ANSIRH, U.S. Studies on Medication Abortion Without InPerson Clinician Dispensing of Mifepristone, UNIV. OF CAL., S.F.

(2021); Elizabeth Raymond & Hillary Bracken, Early Medical

Abortion Without Prior Ultrasound, 92 CONTRACEPT. 212

(2015); Upadhyay et al., supra note 12.

See sources cited supra note 15.

See Mike Mitka, Some Men Who Take Viagra Die—Why?,

283 J. AM. MED. ASS’N 590, 591 (2000).

ASGE Standards of Practice Comm., Complications of

Colonoscopy, 74 AM. SOC’Y FOR GASTRO. ENDOSCOPY 745, 747

(2011).

risks of death associated with childbirth are

exponentially higher than the risk of death in a

medication abortion involving mifepristone. 20 In

light of the evidence, the FDA was and can continue

to be confident in its judgment that “[n]o causal

relationship between the use of MIFEPREX and

misoprostol and [fatal infections and bleeding] has

been established.” 21 Medication abortion involving

mifepristone is among the safest medical

interventions in any category, pregnancy-related or

not.

II.

There Is No Scientific Basis for

Rewinding the Clock on Evidence-Based

Medical Practice to 2015.

The FDA revisited its guidance on mifepristone

use in 2016 and 2021 and reached the reasoned

conclusion that, based on the overwhelming evidence

of mifepristone’s efficacy and safety gathered before

and after FDA’s initial approval, certain of its prior

restrictions were not necessary and could be

removed. That removal has meaningfully improved

access to care for patients throughout the country.

Reinstating the restrictions on access to

mifepristone that Respondents request will do

nothing to make patients safer or improve their

Elizabeth G. Raymond & David A. Grimes, The

Comparative Safety of Legal Induced Abortion and Childbirth

in the United States, 119 OBSTET. & GYNECOL. 215, 215, 217

(2012) (showing that “[t]he risk of death associated with

childbirth is approximately 14 times higher than that with

abortion,” that the mortality rate associated with mifepristone

is “0.7 per 100,00 users”).

Mifeprex Highlights of Prescribing Information, FDA, at 2,

5 (Mar. 2016) https://www.accessdata.fda.gov/drugsatfda_docs/

label/2016/020687s020lbl.pdf.

health. They would reimpose extensive burdens on a

drug that was singled out for heightened regulation

because of its use in medication abortion, not

because of its safety profile.22 The FDA revisions to

which Respondents object—and the Fifth Circuit

would reverse—merely aligned the FDA’s regulation

protocols more closely with an objective, evidencebased assessment of mifepristone’s safety profile. In

2016, the FDA’s safety analysis relied on 11

independent clinical studies conducted between 2005

and 2015, covering well “over 30,000 patients”; 23

randomized controlled trials; 24 and several

prospective,

retrospective,

and

observational

studies,25 which demonstrated the safety and

effectiveness of mifepristone up to the 10-week

gestational period.26 Those studies conclusively

demonstrated that “serious adverse events . . . are

rarely reported . . . with rates generally far below

See American College of Obstetricians and Gynecologists et

al., FDA Citizen Petition, at 9–10 (Oct. 4, 2022).

2016 FDA Medical Review, supra note 13, at 47–48, 50,

61–62.

See id. at 50.

See id.

See id. at 47; Adriana A. Boersma et al., Mifepristone

Followed by Home Administration of Buccal Misoprostol for

Medical Abortion Up to 70 Days of Amenorrhoea in a General

Practice in Curacao, 16 EUR. J. CONTRACEPT. & REPROD. HEALTH

CARE 61 (2011); Beverly Winikoff et al., Extending Outpatient

Medical Abortion Services Through 70 Days of Gestational Age,

120 OBSTET. & GYNECOL. 1070 (2012); see also Dina Abbas et

al., Outpatient Medical Abortion is Safe and Effective Through

70 Days Gestation, 92 CONTRACEPT. 197 (2015). More recent

studies have again confirmed these results. For example, a

2020 evidence review recognized that medication abortion can

safely and effectively be used up to at least 70 days of gestation.

See ACOG Practice Bulletin No. 225, supra note 6.

1.0%.”27 Based on this sound scientific evidence, the

FDA correctly determined that it was appropriate to

adjust the heavy restrictions on mifepristone’s use

and

begin

unwinding

previously

mandated

requirements and other barriers to access.

These adjustments better serve patients and

their providers. For instance, the FDA’s decision,

based on the evidence and sound medical science, to

eliminate the labeling condition that patients return

for two in-person visits following their use of

mifepristone removed a clearly unnecessary and

burdensome element of the protocol on the label.

The data was and remains clear: there is no medical

basis for forcing patients who have taken

mifepristone to make two visits to a health center

afterwards. 29

Requiring two follow-up visits—

regardless of the patient’s circumstances—for a drug

as safe as ibuprofen is burdensome and disruptive,

can be costly, and is medically unnecessary. Indeed,

comprehensive telehealth protocols adopted by

clinics30 ensure that patients can easily communicate

with their providers and discuss any questions or

2016 FDA Medical Review, supra note 13, at 56 (emphasis

added).

As Petitioners describe and as set forth above, the FDA

adjusted both the “Conditions of Use” printed on the

medication’s label and eliminated certain REMS—including inperson follow-up appointments at 14 days after Mifeprex (a pre2016 Condition of Use) and an “adverse reporting” requirement

for mifepristone prescribers (a pre-2016 REMS restriction). See

2016 FDA Medical Review, supra note 13, at 7–8.

See, e.g., U.S. GOV’T ACCOUNTABILITY OFF., GAO-18-292,

FOOD AND DRUG ADMINISTRATION: INFORMATION ON MIFEPREX

LABELING CHANGES AND ONGOING MONITORING EFFORTS 15

(2018) (summarizing studies).

See infra pp. 14–17.

medical concerns that come up after use of

mifepristone.

Amici also fully endorse the FDA’s subsequent

decision in 2021, formalized in 2023, to eliminate the

in-person dispensing requirement and to permit

distribution of medication abortion pills by mail.

That decision was again based on the overwhelming

and substantial scientific evidence showing that

mifepristone is safe and that requiring patients to

take a pill in the presence of a physician does

nothing to improve patient health or safety.

Telehealth protocols ensure involvement of a

specially trained practitioner (which the FDA still

requires) and allow for the safe prescription and use

of mifepristone without the need for in-person

dispensing. Many health care clinics—including

brick-and-mortar locations—offer comprehensive

telehealth services to meet with patients before and

after procedures, and reproductive health clinics that

use telehealth have developed specific protocols and

technologies to ensure adequate patient contact and

monitoring,

including

health

questionnaires;

specialized patient platforms (e.g., a patient

“portal”), messaging and chat functions; and phone

or video calls.

Telehealth protocols offer all the same steps and

protections—and therefore provide an equivalent

level of care—as in-person dispensing. Patients are

still evaluated by a qualified health care provider—

just as they would be in person. They are asked

about their symptoms and about facts needed to

determine gestational age—just as they would be in

person. They are counseled on their options and on

the risks and benefits of each one—just as they

would be in person. For example, although an

ultrasound can help determine gestational age and

can identify an ectopic pregnancy, studies have

shown that both of these goals can be accomplished

just as effectively by discussing the patient’s medical

history—even via a telemedicine appointment.31

Telehealth protocols ensure involvement of a

specially trained practitioner (which the FDA still

requires) and allow for the safe prescription and use

of mifepristone without the need for in-person

dispensing. The FDA’s current approach means that

instead of requiring a patient to physically retrieve

the medication from a doctor’s office or specially

certified pharmacy,32 the medication can be

conveniently delivered to the patient’s home—

without any additional risk, because the patient

would have already been evaluated by the clinician

(via telehealth or in person) and counseled with

respect to the medication, as well as its

administration and side effects. Likewise, rather

than requiring a patient to return to the provider’s

office to obtain (and pay for) an ultrasound to

confirm she is no longer pregnant after taking

See Raymond & Bracken, supra note 16; Ushma D.

Upadhyay et al., Outcomes and Safety of History-Based

Screening for Medication Abortion: A Retrospective Multicenter

Cohort Study, 182 J. AM. MED. ASS’N INTERNAL MED. 482, 489

(2022) (finding that “mifepristone can be dispensed safely either

in person or by mail” and “pregnancy duration can be

reasonably estimated by history and if no symptoms or risk

factors for ectopic pregnancy are present”); cf. Compl. Ex. 24,

2000 FDA Approval Memorandum, 2:22-CV-00223-Z (Nov. 18,

2022), ECF No. 1-25, at 6 (“In practice, dating pregnancies

occurs through using other clinical methods, as well as through

using ultrasound.”).

At least as of July 2023, no major national retail pharmacy

had received certification, though some had applied. See Press

Release, Walgreens, Walgreens and Mifepristone: The Facts,

(July 11, 2023).

mifepristone, the patient can simply take an at-home

pregnancy or blood test and communicate the results

to her provider via telehealth. The importance of

this option is essential, since requiring in-person

visits has a clear disparate impact on individuals

that come from historically marginalized populations

or that live in the increasing number of places in our

country where appropriate medical providers are not

easily available.33 Should the provider have any

concerns based on a patient’s reported symptoms or

test results, an in-person appointment would be

scheduled if appropriate—but would not be

unnecessarily required without any regard to the

patient’s individual circumstances. Notably, if a

patient preferred to receive follow-up in-person care

even if it were not medically required, she could do

so. The choice is up to her and her provider, whereas

Respondents would mandate in-person medical

appointments regardless of the circumstances—an

approach that intrudes on the physician-patient

relationship, renders care unavailable to many

patients, and undermines the trained, independent

medical judgment of physicians as to what follow-up

care is and is not needed in a particular situation.

With these protections in place, the FDA’s

current approach of allowing patients to take

mifepristone outside the physical presence of a

physician has not had any detrimental effect on

patient care, nor has it resulted in any increased

burden on emergency rooms. The percentage of

Indeed, 6.9 million women of childbearing age live in areas

of the United States where maternity care is limited or

nonexistent. See Maternity Care Desert, MARCH OF DIMES (Oct.

2022); see also Office of Minority Health, Advancing Rural

Maternal Health Equity, CTRS. FOR MEDICARE & MEDICAID

SERVS. at 1 (2022).

patients that ever visit an emergency room for

abortion-related complications remains exceedingly

small.34 Respondents point to no data suggesting

that significantly more patients have experienced

serious harm or life-threatening injury as the result

of telehealth protocols, which is consistent with the

experience of our clinicians. Given these facts and

the dearth of accessible in-person health care in

large portions of this country, there is no medical or

scientific reason to implement barriers to medical

care and place burdens on patients with no medical

benefit.

III.

Restricting the Use of Mifepristone Will

Harm Pregnant Patients and Have

Severe Negative Impacts on the Broader

Health Care System.

The Fifth Circuit’s decision will unnecessarily

restrict mifepristone nationwide—even in states

where abortion remains legal—and impose a severe

cost on pregnant patients without any discernible

benefit.

Because mifepristone is an essential

component of medication abortion care and of

treatment for miscarriage or early pregnancy loss,

even temporary lack of access to mifepristone caused

by reimposing the previously removed REMS will

That patients sometimes seek emergency care for reasons

other than the severity of their symptoms is consistent with

prior studies. A 2018 study concluded that only 0.01% of

emergency department visits among women aged 15–49 were

abortion-related and that many could have been “managed at a

less costly level of care.” Ushma D. Upadhyay et al., AbortionRelated Emergency Department Visits in the United States: An

Analysis of a National Emergency Department Sample, 16 BMC

MED. 1, 10 (2018).

cause patients to suffer physical and psychological

harm. Restricting access to mifepristone endangers

patients and jeopardizes their lives and health by

forcing those who seek abortion to use more

medically onerous means with greater side effects

and by depriving patients suffering miscarriage of an

essential and safe form of care. Amici are concerned

that the Fifth Circuit’s failure to meaningfully

address the overwhelming body of evidence reflecting

the safety of medication abortion, or the primacy in

medical practice of ethical commitments and

evidence-based care, has allowed Respondents’ fear

of remote and implausible psychological injury to

trump the very real, very serious consequences for

patients.

Empirical evidence shows that women are at

least 14 times more likely to die during childbirth

than during any abortion procedure35 and are at an

increased risk of experiencing hemorrhage, infection,

and injury to other organs during pregnancy and

See Raymond & Grimes, supra note 20, at 216–17, fig.1.

The U.S. mortality rate associated with live births from 1998 to

2005 was 8.8 deaths per 100,000 live births. Id. at 216 tbl.1.

Rates have sharply increased since then. David Boulware,

Recent Increases in the U.S. Maternal Mortality Rate:

Disentangling Trends from Measurement Issues, 129 OBSTET. &

GYNECOL. 385, 385–86 (2017). By contrast, the mortality rate

associated with abortions performed from 1998 to 2005 was 0.6

deaths per 100,000 procedures. See Raymond & Grimes, supra

note 20, at 216 tbl.1. A committee of the National Academies in

a 2018 peer-reviewed, evidence-based report similarly

concluded that abortion is safer than pregnancy; specifically,

“the risk of death subsequent to a legal abortion (0.7 [deaths]

per 100,000 [patients]) is a small fraction of that for childbirth

(8.8 [deaths] per 100,000 [patients]).” NAT’L ACADS. OF SCI.,

ENG’G & MED., supra note 14, at 74.

childbirth as well.36

Even under the best of

circumstances, pregnancy and childbirth impose

significant physiological changes that can exacerbate

underlying conditions and severely compromise

health, sometimes permanently.37

Pregnancy,

particularly when coupled with preexisting

conditions, can quickly evolve into a life-threatening

situation necessitating critical care, including

abortion.

These dangers are far greater for women of color,

low-income women, and those living in rural areas.

Low-income patients and patients of color38 are most

likely to experience severe maternal morbidity and

more likely to die from pregnancy-related

See Raymond & Grimes, supra note 20 at 215, 216–17 fig.1.

See, e.g., ACOG Clinical Consensus No. 1, Pharmacologic

Stepwise Multimodal Approach for Postpartum Pain

Management (Sept. 2021); ACOG Practice Bulletin No. 222,

Gestational Hypertension and Preeclampsia (June 2020); ACOG

Obstetric Care Consensus No. 7, Placenta Accreta Spectrum

(Dec. 2018); ACOG Practice Bulletin No. 198, Prevention and

Management of Obstetric Lacerations at Vaginal Delivery (Sept.

2018); ACOG Practice Bulletin No. 190, Gestational Diabetes

Mellitus (Feb. 2018); ACOG Practice Bulletin No. 183,

Postpartum Hemorrhage (Oct. 2017).

See Rachel K. Jones et al., COVID-19 Abortion Bans and

Their Implications for Public Health, 52 PERSPS. SEXUAL &

REPROD. HEALTH 65, 66 (2020); see also Christine Dehlendorf &

Tracy Weitz, Access to Abortion Services: A Neglected Health

Disparity, 22 J. HEALTH CARE FOR THE POOR & UNDERSERVED

415, 416-17 (2011); Jenna Jerman et al., Characteristics of U.S.

Abortion Patients in 2014 and Changes Since 2008,

GUTTMACHER INST. (2016), at 11–12; see also Rural Health

Council, CMS Rural Health Strategy, CTRS. FOR MEDICARE &

MEDICAID SERVS. at 2 (2018).

complications,39 and those in rural areas are

disproportionately harmed by restrictions on

abortion care. 40 The majority of abortion patients

identify as people of color, and “75% of those seeking

abortion [care] are living at or below 200% of the

federal poverty level.”41 Pregnant people of color are

also more likely to experience early pregnancy loss or

miscarriage, the treatment for which can include

procedural or medication abortion.42 Restricting the

use of mifepristone without medical justification will

harm these patients by making it more difficult to

obtain a relatively accessible and entirely safe

treatment—which in some cases may result in the

complete denial of medical care.

Reimposing

unnecessary

restrictions

mifepristone will exacerbate these inequities and

have the most severe consequences for those who are

already most poorly served by our maternal health

system. Substantial evidence demonstrates that the

denial of abortion care causes harm. Patients who

are denied requested abortions are more likely to

experience intimate partner violence compared with

patients who were able to have an abortion.43

Studies have repeatedly shown that being denied an

abortion also exacerbated patients’ economic

hardships, revealing “large and statistically

See Office of Minority Health, supra note 33, at 1; see also

Juanita Chinn et al., Health Equity Among Black Women in the

United States, 30 J. WOMEN’S HEALTH 212, 215 (2021).

See ACOG Committee Opinion No. 815, supra note 7.

Id.

See Lyndsey S. Benson et al., Early Pregnancy Loss in the

Emergency Department, 2006–2016, 2 J. AM. COLL. EMERGENCY

PHYSICIANS OPEN e12549 at 6–7 (2021).

See Sarah C.M. Roberts et al., Risk of Violence from the

Man Involved in the Pregnancy After Receiving or Being Denied

an Abortion, 12 BMC MED. 1, 6 (2014).

significant differences in the socioeconomic

trajectories of women who were denied requested

abortions compared with women who received

abortions—with women denied abortions facing more

economic hardships.” 44 Making it more difficult to

obtain mifepristone will make it more difficult to

obtain medication abortion care consistent with the

current standard of care. This alone endangers

patients.

But anyone who is pregnant will be at greater

risk if they and their providers have more limited

access to mifepristone. That is because, as with

many medications, mifepristone has critical off-label

uses in maternal care beyond abortion.45

Mifepristone is already widely prescribed for

management and treatment of miscarriages,

including spontaneous, missed, inevitable, and

incomplete abortions.46 Miscarriage is sadly common

in this country, occurring with unfortunate frequency

and affecting around one out of every five women.47

When a patient is miscarrying or experiencing early

pregnancy loss, mifepristone can ease the process,

reduce the risk of infection and pain experienced,

Diana Greene Foster et al., Socioeconomic Outcomes of

Women Who Receive and Women Who Are Denied Wanted

Abortions in the United States, 108 AM. J. PUB. HEALTH 407,

412 (2018).

See Christopher M. Wittich et al., Ten Common Questions

(and Their Answers) About Off-Label Drug Use, 87 MAYO

CLINIC PROC. 982, 982–85 (2012).

See Honor MacNaughton et al., Mifepristone and

Misoprostol for Early Pregnancy Loss and Medication Abortion,

103 AM. FAM. PHYSICIAN 473, 475 (2021); Mara Gordon & Sarah

McCammon, A Drug that Eases Miscarriages is Difficult for

Women to Get, NPR (Jan. 10, 2019).

See sources cited supra note 9.

and lead to better health outcomes.48 Patients

already enduring miscarriage should not be forced to

suffer through limited access to critical medication.

Studies have also examined mifepristone for a

range of other maternal-health purposes, including

treatment of uterine fibroids (tumorous growths of

uterine muscle) and treatment of endometriosis

(abnormal tissue growth outside the uterus, which

can cause severe pain and infertility).49 Mifepristone

is also used off-label to reduce the duration of

bleeding or hemorrhaging during certain serious

pregnancy complications, and it may have beneficial

effects on the cervix in full-term pregnancies, which

in turn may affect the likelihood of successful labor.50

Patients who may benefit from these and other

treatments for reasons unrelated to abortion will also

face additional hurdles to receiving this medication—

again, with no medical justification.51

See, e.g., ACOG Practice Bulletin No. 200, supra note 8;

Jessica Beaman, Medication to Manage Abortion and

Miscarriage, 35 J. GEN. INTERNAL MED. 2398, 2400 (2020).

See Y. X. Zhang, Effect of Mifepristone in the Different

Treatments of Endometriosis, 43 CLINICAL & EXPERIMENTAL

OBSTET. & GYNECOL. 350 (2016); Mario Tristan et al.,

Mifepristone for Uterine Fibroids, COCHRANE DATABASE

SYSTEMATIC REVS. (2012).

See Yanxia Cao et al., Efficacy of Misoprostol Combined

with Mifepristone on Postpartum Hemorrhage and Its Effects on

Coagulation Function, 13 INT’L. J. CLINICAL & EXPERIMENTAL

MED. 2234 (2020); Kanan Yelikar et al., Safety and Efficacy of

Oral Mifepristone in Pre-Induction Cervical Ripening and

Induction of Labour in Prolonged Pregnancy, 65 J. OBSTET. &

GYNAECOL. INDIA 221 (2015).

See, e.g., Press Release, Endocrine Soc’y, Endocrine Society

Alarmed by Texas Court Ruling Banning Mifepristone (Apr. 10,

2023) (recognizing that “mifepristone is [also] used to treat

people with Cushing’s syndrome and diabetes or high blood

sugar who are not surgical candidates or have failed surgery”

Again, these harms are concrete, certain, and

will affect hundreds of thousands of patients and

their providers. Amici fear for the patients they

treat if the decision below is allowed to stand.

and that the District Court’s decision could restrict access to

such treatment).

CONCLUSION

For the reasons set forth above, the Petitions for

Writ of Certiorari should be granted.

Respectfully submitted,

SHANNON ROSE SELDEN

Counsel of Record

ADAM AUKLAND-PECK

DEBEVOISE & PLIMPTON LLP

66 Hudson Boulevard

New York, NY 10001

(212) 909-6000

srselden@debevoise.com

aauklandpeck@debevoise.com

MEGAN MCGUIGGAN

DEBEVOISE & PLIMPTON LLP

801 Pennsylvania Ave. N.W.

Washington, D.C. 20004

(202) 383-8000

mmcguiggan@debevoise.com

MOLLY MEEGAN

JESSICA MORRIS

AMERICAN COLLEGE OF OBSTETRICIANS

AND GYNECOLOGISTS

409 12th Street, SW

Washington, DC 20024

(202) 638-5577

mmeegan@acog.org

jmorris@acog.org

Counsel for Amici Curiae

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