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

Supreme Court briefApr 14, 2023

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No. 22A902

IN THE

Supreme Court of the United States

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

Applicants,

ALLIANCE FOR HIPPOCRATIC MEDICINE ET AL.,

Respondents.

APPLICATION TO STAY THE ORDER ENTERED BY THE UNITED STATES

DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS AND FOR AN

ADMINISTRATIVE STAY

BRIEF OF MEDICAL AND PUBLIC HEALTH SOCIETIES AS AMICI CURIAE IN SUPPORT OF

APPLICANTS

MOLLY MEEGAN

JESSICA MORRIS

AMERICAN COLLEGE OF OBSTETRICIANS

AND GYNECOLOGISTS

409 12th Street, SW

Washington, D.C. 20024

(202) 638-5577

mmeegan@acog.org

jmorris@acog.org

SHANNON ROSE SELDEN

Counsel of Record

ADAM AUKLAND-PECK

DEBEVOISE & PLIMPTON LLP

66 Hudson Blvd.

New York, NY 10001

(212) 909-6000

srselden@debevoise.com

MEGAN MCGUIGGAN

DEBEVOISE & PLIMPTON LLP

801 Penn. Ave, NW

Washington, D.C. 20004

(202) 383-8000

TABLE OF CONTENTS

Page

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

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

ARGUMENT .................................................................................................................. 8

Mifepristone Has Been Thoroughly Studied and Is Conclusively Safe. ...... 9

II.

REMS Restrictions Are Not Necessary to Ensure Patients’ Safety. ......... 15

III.

Limiting Access to Mifepristone Will Harm Pregnant Patients and Have

Severe Negative Impacts on the Broader Health Care System................. 18

Expanding the REMS Will Harm Patients. .......................................... 19

Physicians and the Health Care System Will Be Harmed by Expanded

REMS. ..................................................................................................... 22

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

TABLE OF AUTHORITIES

Page

CASES

June Med. Servs. LLC v. Russo, 140 S. Ct. 2103 (2020).................................................... 2

Planned Parenthood Ctr. for Choice v. Abbott, No. A-20-CV-323, 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

STATUTES & RULES

21 CFR § 314.80 ................................................................................................................. 16

OTHER AUTHORITIES

A.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) ..... 15

ACOG Clinical Consensus No. 1, Pharmacologic Stepwise Multimodal Approach for

Postpartum Pain Management (Sept. 2021) .............................................................. 21

ACOG, Code of Professional Ethics (Dec. 2018) ............................................................... 23

ACOG Committee Opinion No. 815, Increasing Access to Abortion (Dec. 2020) ........... 19

ACOG Obstetric Care Consensus No. 7, Placenta Accreta Spectrum (July 2012, reaff’d

2021) ............................................................................................................................. 21

ACOG Practice Bulletin No. 183, Postpartum Hemorrhage (Oct. 2017) ......................... 21

ACOG Practice Bulletin No. 190, Gestational Diabetes Mellitus (Feb. 2018) ................ 21

ACOG Practice Bulletin No. 198, Prevention and Management of Obstetric Lacerations

at Vaginal Delivery (Sept. 2018) ................................................................................. 21

ACOG Practice Bulletin No. 200, Early Pregnancy Loss (Nov. 2018, reaff’d 2021) ...... 6, 8

ACOG Practice Bulletin No. 222, Gestational Hypertension and Preeclampsia (June

2020) ............................................................................................................................. 21

ACOG Practice Bulletin No. 225, Medication Abortion Up to 70 Days of Gestation (Oct.

2020, reaff’d 2023).............................................................................................. 8, 15, 17

Alexander Janke, An Emergency in U.S. Emergency Care: Two Studies Show Rising

Strain, U. MICH. INST. OF HEALTHCARE POL’Y & INNOVATION (Oct. 7, 2022) ............. 22

AMA, Code of Medical Ethics Opinion 1.1.1 ..................................................................... 23

ANSIRH, Analysis of Medication Abortion Risk and the FDA Report: Mifepristone U.S.

Post-Marketing Adverse Events Summary through 12/31/2018, UNIV. OF CAL., S.F.

(April 2019) .................................................................................................................. 11

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.

(Nov. 2022) ............................................................................................................. 11, 12

ANSIRH, Safety of Abortion in the United States, UNIV. OF CAL., S.F. (Dec. 1,

2014) ...................................................................................................................... 11, 12

ANSIRH, U.S. Studies on Medication Abortion without In-Person Clinician

Dispensing of Mifepristone, UNIV. OF CAL., S.F. (Oct. 2021) ...................................... 12

ASGE Standards of Practice Comm., Complications of Colonoscopy, 74 AM. SOC’Y

FOR GASTROINTESTINAL ENDOSCOPY 745 (2011) .................................................... 12, 13

Beverly Winikoff, et al., Extending Outpatient Medical Abortion Services Through

70 Days of Gestational Age, 120 OBSTET. & GYNECOL. 1070 (2012) .......................... 15

iii

Brenda Major, et al., Abortion and Mental Health: Evaluating the Evidence, 64

AM. PSYCH. 863 (2009) (update to APA Task Force Report 2008) ............................. 14

Christine Dehlendorf & Tracy Weitz, Access to Abortion Services: A Neglected Health

Disparity, 22 J. HEALTH CARE FOR THE POOR & UNDERSERVED 415 (May 2011) ....... 19

Corrine H. Rocca et al., Decision Rightness and Emotional Responses to Abortion in the

United States: A Longitudinal Study, 10 PLOS ONE 1 (2015) .................................. 14

Ctrs. for Medicare & Medicaid Servs., Advancing Rural Maternal Health Equity (May

2022) ............................................................................................................................. 20

Ctrs. for Medicare & Medicaid Servs., CMS Rural Health Strategy (2018) .................... 19

David Boulware, Recent Increases in the U.S. Maternal Mortality Rate: Disentangling

Trends from Measurement Issues, 129(2) OBSTET. & GYNECOL. 385 (Feb 2016) ...... 19

David C. Reardon et al., Deaths Associated with Pregnancy Outcome: A Record Linkage

Study of Low Income Women, 95 S. MED. J. 834 (2002) ........................................... 14

Development & Approval Process: Drugs, FDA (Aug. 08, 2008)...................................... 10

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 (2018) ...................................................................................................... 20

Dina Abbas et al., Outpatient Medical Abortion is Safe and Effective Through 70 Days

Gestation, 92 CONTRACEPT. 197 (2015) ....................................................................... 16

E.V. Gouk, Medical Termination of Pregnancy at 63 to 83 Days Gestation, 106 BR. J.

OBSTET. GYNAECOL. 535 (1999) .................................................................................... 16

Elizabeth G. Raymond & David A. Grimes, The Comparative Safety of Legal

Induced Abortion and Childbirth in the United States, 119 OBSTET. &

GYNECOL. 215 (2012) .............................................................................................. 13, 21

Elizabeth Raymond & Hillary Bracken, Early Medical Abortion Without Prior

Ultrasound, 92 CONTRACEPTION 212 (2015) ........................................................ 12, 17

FDA Ctr. For Drug Eval. & Research, Medical Review, Application No.

020687Orig1s020 (Mar. 29, 2016) ................................................................... 11, 15, 16

Frederick M. Grazer & Rudolph H. de Jong, Fatal Outcomes from Liposuction: Census

Survey of Cosmetic Surgeons, 105 Plastic & Reconstruct. Surgery 436 (2000) .......... 3

Jenna Jerman et al., Characteristics of U.S. Abortion Patients in

2014 and Changes Since 2008, GUTTMACHER INST. 1 (May 2016) ............................ 19

Juanita Chinn, et al., Health Equity Among Black Women in the United States, 30 J.

WOMEN’S HEALTH 212 (2021) ....................................................................................... 20

Katherine Kortsmit, et al., Abortion Surveillance – United States, 2019, 70 CDC

MORBIDITY & MORTALITY WKLY. REP. 1 (Nov. 26, 2021)............................................. 12

Lyndsey S. Benson et al., Early Pregnancy Loss in the Emergency Department, 2006–

2016, 2 J. AM. C. EMERGENCY PHYSICIANS OPEN e12549 (2021) ................................. 20

M. Antonia Biggs et al., Women’s Mental Health and Well-being 5 Years After

Receiving or Being Denied an Abortion: A Prospective, Longitudinal Cohort Study,

74 JAMA Psychiatry 169 (2017).................................................................................. 14

M. Antonia Biggs, et al., Mental Health Diagnoses after Receiving or Being Denied an

Abortion in the US, 105(12) AM. J. OF PUB. HEALTH 2557(Dec. 2015) ....................... 15

Mara Gordon & Sarah McCammon, A Drug that Eases Miscarriages is Difficult for

Women to Get, NPR (Jan. 10, 2019) ........................................................................... 22

Mario Tristan et al., Mifepristone for Uterine Fibroids, COCHRANE

DATABASE SYST. REV. (Aug. 2012) ............................................................................... 22

Mike Mitka, Some Men Who Take Viagra Die—Why?, 283 JAMA, 590 (Feb. 2,

2000)…………………………………………………………………………………………….13

Nat’l Acads. of Sci., Eng’g. & Med., The Safety and Quality of Abortion Care in the

United States, NAT’L ACADS. PRESS 45 (2018) ............................................... 10, 11, 21

PPGNHAIK Statement on Incorrect Indiana Data, PLANNED PARENTHOOD, April 11,

2023 .............................................................................................................................. 12

Priscilla K. Coleman, Abortion and Mental Health: Quantitative Synthesis and

Analysis of Research Published 1995–2009, 199 BRITISH J. PSYCHIATRY 180

(2011) ............................................................................................................................ 14

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(2) PERSPECTIVES ON SEXUAL AND REPROD. HEALTH 65 (May 14, 2020)... 19

Sarah Roberts et al., Risk of Violence from the Man Involved in the Pregnancy After

Receiving or Being Denied an Abortion, 12 BMC MEDICINE 1 (2014) ....................... 20

U.S. GOV'T ACCOUNTABILITY OFF., GAO-08-751, Report to Congressional Requestors:

Food and Drug Administration Approval and Oversight of the Drug Mifeprex (Aug.

2008) ............................................................................................................................ 10

Ushma D. Upadhyay, et al., Incidence of Emergency Department Visits and

Complications after Abortion, 125 OBSTET. & GYNECOL. 175 (Jan. 2015) ................. 11

Ushma D. Upadhyay, et al., Outcomes and Safety of History-Based Screening for

Medication Abortion; A retrospective Multicenter Cohort Study, 182 JAMA

INTERNAL MED. 175 (Jan. 2015) .................................................................................. 17

Vignetta E Charles, et al., Abortion and Long-term Mental Health Outcomes: A

Systematic Review of the Evidence, 78(6) CONTRACEPTION 436 (2008)..................... 15

Wittich et al., Ten Common Questions (and Their Answers) About Off-label Drug Use,

87 MAYO CLINIC PROC. 982 (Oct. 2012)........................................................................ 22

Y. X. Zhang, Effect of Mifepristone in the Different Treatments of Endometriosis, CLIN.

AND EXP. OBSTET. & GYNECOL. 350 (2016) .................................................................. 22

Yanxia Cao et al., Efficacy of Misoprostol Combined with Mifepristone on Postpartum

Hemorrhage and its Effects on Coagulation Function, 13 INT. J. CLIN. EXP. MED.

2234 (Apr. 30, 2020) ..................................................................................................... 22

vii

INTEREST OF AMICI CURIAE1

Amici curiae are leading medical and public-health 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 board-certified 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 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

1 Pursuant to United States Supreme Court 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 their counsel contributed monetarily to preparing or submitting this brief.

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) 13 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 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 mifepristone is exceedingly

safe and effective and that the Food and Drug Administration’s (“FDA”) decision to

2 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-20-CV-323-LY, 2020 WL 1815587, at *4–5 (W.D. Tex. Apr. 9, 2020).

eliminate certain restrictions on mifepristone was and continues to be based on

sound medical science.

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 twenty years. Accordingly, amici have a

strong interest in preserving that access and ensuring that the science surrounding

mifepristone’s safety and efficacy is correctly understood.

Amici are the following organizations: ACOG; SMFM; AMA; American Academy

of Family Physicians; American Academy of Nursing; American Academy of Pediatrics; American College of Nurse-Midwives; American Gynecological and Obstetrical

Society; American Society for Reproductive Medicine; Council of University Chairs

of Obstetrics and Gynecology; National Association of Nurse Practitioners in Women’s Health; Society for Academic Specialists in General Obstetrics and Gynecology;

Society of Family Planning; Society of General Internal Medicine; Society of Gynecologic Oncology; and Society of OB/GYN Hospitalists.

SUMMARY OF THE ARGUMENT

On behalf of the nation’s leading medical organizations and the patients they

serve, Amici urge this Court to preserve access to mifepristone under the conditions

of use established by the FDA. Those conditions—set aside without proper basis by

the decisions of the two courts below—are scientifically sound and supported by

decades of evidence, and ensure access to an exceedingly safe and commonly used

medication that is necessary to preserve the life and health of countless patients.

The Fifth Circuit’s decision to reimpose restrictions deemed unnecessary by the

FDA will significantly limit access to mifepristone and have dramatic, harmful consequences for amici and their patients.

Without any form of evidentiary hearing and completely disregarding the

overwhelming body of evidence proving that mifepristone is safe, the District

Court’s order (the “Order”) purported to suspend the use of a treatment essential to

amici’s patients, in order to further its own agenda and that of Respondents. The

decision is rife with medically inappropriate assumptions and terminology. It disregards decades of unambiguous analysis supporting the use of mifepristone in miscarriage and abortion care.

It relies on pseudoscience and on speculation, and

adopts wholesale and without appropriate judicial inquiry the assertions of a small

group of declarants who are ideologically opposed to abortion care and at odds with

the overwhelming majority of the medical community and the FDA.

The Fifth Circuit agreed to temporarily stay the Order as to the FDA’s initial

2000 approval, but embraced the same flawed and unscientific logic as the District

Court: (i) that the FDA’s decision to begin alleviating the Risk Evaluation and Miti4

gation Strategies (“REMS”) for mifepristone in 2016 was arbitrary and capricious,

and (ii) that reinstating those unnecessarily harsh restrictions would help patients,

not hurt them. On the contrary, the decisions below endanger amici’s patients by

depriving them of medically appropriate, safe access to an effective and important

medicine. This Court should not uphold or ignore a decision that is so demonstrably

at odds with the facts and so hostile to amici’s patients.

Each amici organization and its members adhere to a standard of ethics and

practice centered on patient care, and on the bedrock principal to “do no harm.” The

erroneous decision to reintroduce unnecessary restrictions on the prescription and

use of mifepristone threatens the very core of amici’s medical practice by preventing

the provision of appropriate, safe, and standard care for their patients.

Amici urge this Court to uphold science and the rule of law. Mifepristone is

extremely safe and effective. Hundreds of medical studies and vast amounts of data

amassed over the course of more than two decades have confirmed it. When mifepristone is used in medication abortion, as part of a two-step, two-drug regimen

with misoprostol, serious side effects are exceedingly rare compared to many commonly used medications, occurring in less than 1% of patients.

Major adverse

events—significant infection, blood loss, or hospitalization—occur in less than 0.3%

of patients. The risk of death is almost non-existent.

Mifepristone is not just used for medication abortion—it has become an essential medicine for the treatment of miscarriage as well. Miscarriage3 is common.

It can be dangerous, even life-threatening. The District Court’s order purporting to

prevent the use of mifepristone harms these patients too. Limiting patients’ access

to standard, safe care that will protect their lives, health, and ability to carry future

pregnancies to term is an extraordinary departure from the provision of evidencebased medicine and the patient-centered approach that amici and their members

advocate and practice.

The Fifth Circuit took issue with the FDA’s scientific judgment that certain

previous restrictions on the use of mifepristone are not actually necessary. REMS

programs do not apply by default and should be deployed only where necessary to

keep patients safe—circumstances that do not exist here. The REMS at issue do

nothing to protect patients given mifepristone’s demonstrated safety, and instead

act only as a barrier to access. Science proves that. The hundreds of studies conducted prior to 2016 were more than sufficient to justify the FDA’s decision to begin

lifting restrictions. And studies conducted since 2016 have shown no increase in

adverse events.

In concluding otherwise, the Fifth Circuit has supplanted the

FDA’s judgment with its own—a dangerous precedent that will lead to uncertainty

and destabilize the drug approval process in the United States.

3 See ACOG Practice Bulletin No. 200, Early Pregnancy Loss (Nov. 2018, reaff’d 2021) (“Early preg-

nancy loss is defined as a nonviable, intrauterine pregnancy with either an empty gestational sac or

a gestational sac containing an embryo or fetus without fetal heart activity within the first 12 6/7

weeks of gestation. In the first trimester, the terms miscarriage, spontaneous abortion, and early

pregnancy loss are used interchangeably[.]”).

Limiting access to mifepristone will not make patients safer—it will actively

jeopardize their health. Pregnancy can be dangerous. The risks of maternal mortality in the U.S. are alarmingly high, and drastically higher for Black women, poor

women, and all those whose access to reproductive care has been historically and

geographically limited. Pregnancy can cause hemorrhaging, infection, dangerously

high blood pressure, and many other critical physiological conditions. These dangers directly impair the health and well-being of pregnant patients, often in material ways. Abortion, including medication abortion involving a regimen of mifepristone and misoprostol, is an essential component of reproductive care that is

protected in many states. Despite the harrowing stories coming out of states that

are banning or severely restricting abortion, it is essential that miscarriage management remain available and accessible in all states. Limiting access to mifepristone simply endangers patients, regardless of whether they are seeking abortion or

miscarriage care.

The Fifth Circuit’s assumption that broad access to mifepristone increases

the burden on our health care system is also incorrect. Removing the in-person dispensing requirement actively reduces any burden, as patients in need of abortion

care are able to take mifepristone at home following consultation with their health

care provider. And because mifepristone is an effective treatment for miscarriage as

well as a range of other pregnancy-related conditions, reducing access to mifepristone will increase the burden on patients, clinicians, and the health care system as

a whole by depriving countless patients of an established and effective form of care.

Failing to stay the Order in full will cause profound and irreparable harm to

patients across the country. These impacts will be most severe for people of color as

well as low-income and rural patients, who are more likely to die or develop serious

complications from pregnancy, and more likely to have limited access to alternative

procedures (i.e., procedural abortion) or lack the ability to travel long distances for

health care. The FDA’s decision to remove certain restrictions on the use of mifepristone—just like its initial approval—is supported by law and the overwhelming

weight of medical evidence. This Court should grant Applicants’ request to stay the

Order.

ARGUMENT

The most common method of medication abortion in the U.S. is a two-drug

regimen in which mifepristone is used in conjunction with misoprostol to end an

early pregnancy by emptying the contents of the uterus.4 Mifepristone followed by

misoprostol is used both to induce abortion,5 and in the treatment of miscarriage or

early pregnancy loss (which can be life threatening),6 a term which includes spontaneous abortion, missed abortion, incomplete abortion, or inevitable abortion.

The overwhelming weight of the scientific evidence supports the FDA’s finding that mifepristone is safe and effective and that the restrictions on its use that

4 A combined mifepristone-misoprostol regimen is the preferred therapy for medication abortion be-

cause it is more effective than a misoprostol-only regimen. See ACOG Practice Bulletin No. 225,

Medication Abortion Up to 70 Days of Gestation, 1, 4 (Oct. 2020, reaff’d 2023).

5 Id.

6 See ACOG Practice Bulletin No. 200, Early Pregnancy Loss (Nov. 2018, reaff’d 2021).

were imposed in 2000 and codified in the REMS are no longer necessary. Mifepristone is one of the most studied medications prescribed in the U.S. and has a safety

profile comparable to ibuprofen. Hundreds of studies and more than two decades of

medical practice show that: (1) mifepristone is safe and effective; (2) special restrictions on its use are not necessary to keep patients safe; and (3) imposing unnecessary restrictions will limit access to mifepristone and have serious consequences for patients across the country—for those seeking abortions and for those

experiencing pregnancy loss.

Respondents provide no scientific evidence supporting their position. They

rely instead on anecdotes, speculation, and theories untested by cross-examination.

The so-called studies on which the District Court relied are not scientifically tested

or sound; they are produced by anti-abortion advocacy groups or contain serious

(and often well-documented) methodological flaws—or both. If the District Court

and Fifth Circuit are going to disregard the well-supported and expert judgment of

an executive agency and rule to upend the status quo, they should not be permitted

to do so based on untested claims outside the realm of mainstream, modern medical

practice. If the District Court’s decision is not stayed in full, it will impair access to

safe and effective medical care for millions of women—whether seeking miscarriage

or abortion care. This decision endangers the health and well-being of amici’s patients, and disrupts the sound, evidence-based practice of medicine that is at the

very core of amici’s missions.

I. Mifepristone Has Been Thoroughly Studied and Is Conclusively Safe.

Decades of evidence demonstrate that medication abortion is safe and effective, with exceptionally low rates of major adverse events. Mifepristone’s safety

profile is on par with common painkillers like ibuprofen, which more than 30 million Americans take in any given day.7 The District Court was wrong to conclude

otherwise—and the Fifth Circuit was wrong to supplant the FDA’s judgment with

its own opinion. REMS are simply not necessary to maintain that safety profile.8

The FDA first approved the use of mifepristone in 2000, basing its decision on

multiple, extensive clinical trials and sound research.9 The FDA’s analysis included

an independent and unbiased review of the manufacturer’s preclinical research and

clinical test results to ensure that mifepristone was safe and effective, and that the

health benefits outweighed the known risks.10 It considered trials conducted for

more than a decade and involving thousands of women.

7 See Nat’l Acads. of Sci.,

Eng’g. & Med., The Safety and Quality of Abortion Care in the United

States, NAT’L ACADS. PRESS 45, 79 (2018); see also R. Morgan Griffin, Making the Decision on

NSAIDs, WEBMD (Oct. 17, 2005), https://www.webmd.com/arthritis/features/making-decision-onnsaids.

8 Memorandum Opinion and Order, 2:22-CV-00223, Apr. 7, 2023, ECF No. 137, at 47 [hereinafter

Mem]. Again, the District Court adopts Plaintiff-Respondents’ assertions at its own, including

statements that are purposefully inflammatory, are not based on the reality of a medication abortion

in accordance with FDA’s approved labeling, and are made without so much as a factual inquiry or

an evidentiary hearing.

9 See

U.S. Gov't Accountability Off., GAO-08-751, Report to Congressional Requestors: Food and

Drug Administration Approval and Oversight of the Drug Mifeprex, 1, 15–16 (Aug. 2008); 2000 FDA

Approval Memorandum, Compl. Ex. 24, ECF No. 1-25.

See

Development

Approval

Process:

Drugs,

FDA

(Aug.

08,

2008),

https://www.fda.gov/drugs/development-approval-process-drugs. In contrast, five other drugs were

approved under restrictive Subpart H with clinical sample sizes of “several hundred patients or less.”

U.S. Gov't Accountability Off., supra note 9, at 26.

In the two decades since mifepristone’s approval, and the many years since

the FDA’s 2016 review, hundreds of additional studies have reaffirmed that medication abortion is safe for patients—safer than pregnancy and safer than countless

other medical procedures. 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).11 These studies have repeatedly concluded that even minor complications

arising from medication abortion are rare.12

Major adverse events—which include hospitalization and serious infection or

bleeding—are “exceedingly rare,” occurring in approximately 0.3% of cases.13 Studies have shown an even smaller number, finding between 0.015% and 0.07% of patients experience serious infection.14 The FDA has made clear that the same complications can be observed following a miscarriage, procedural abortion, or

medication abortion—i.e., any time the pregnant uterus is emptied—and that “[n]o

11 Based on a review of PubMed, the National Institutes of Health’s sponsored database of research

studies.

12 See, e.g., Advancing New Standards in Reproductive Health (“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. at 2 (Nov. 2022) [hereinafter “ANSIRH, Adverse Events

2021”]; ANSIRH, Analysis of Medication Abortion Risk and the FDA Report: Mifepristone U.S. PostMarketing Adverse Events Summary through 12/31/2018, UNIV. OF CAL., S.F. (April 2019) [hereinafter “ANSIRH, Adverse Events 2018”]; ANSIRH, Safety of Abortion in the United States, UNIV. OF

CAL., S.F. (Dec. 1, 2014) [hereinafter “ANSIRH, Abortion Safety” ]; Nat’l Acads. of Sci., Eng’g. &

Med., supra note 7.

For Drug Eval. & Research, Medical Review, Application No. 020687Orig1s020 at 56

(Mar. 29, 2016) [hereinafter “2016 FDA Medical Review”]; Ushma D. Upadhyay, et al., Incidence of

Emergency Department Visits and Complications After Abortion, 125 OBSTET. & GYNECOL. 175, 175

(2015).

13 FDA Ctr.

14 2016 FDA Medical Review, supra note 13, at 53–54.

causal relationship between the use of MIFEPREX and misoprostol and [infections

and bleeding] has been established.”15

The risk of death from medication abortion is near zero.16 A 2019 analysis of

FDA data examining potentially mifepristone-related deaths over an 18-year period

by the University of San Francisco Medical Center found that only 13 deaths were

possibly or probably related to medication abortion, yielding an approximate mortality rate of 0.00027%.17 Even when considering deaths that followed a medication

abortion but did not appear to be related to mifepristone use, that number rises to

only 0.00053%.18 While the District Court claims that “at least two women” died

from medication abortion last year, this is demonstrably false—and underscores the

danger of limiting access to mifepristone before a hearing on the merits.19

The mifepristone safety profile is similar to that of procedural abortion—and

both are comparatively low compared to other common medications and procedures.20 There is a greater risk of complications or mortality from procedures like

Mifeprex

Prescribing

Information,

FDA

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf.

(Mar.

2016)

16 See Katherine Kortsmit, et al., Abortion Surveillance – United States, 2019, 70 CDC MORBIDITY &

MORTALITY WKLY. REP. at 29, tbl. 15 (2021).

17 ANSIRH, Adverse Events 2021, supra note 12, at 1–2.

18 Id.

19 Mem. at 53, 61; PPGNHAIK Statement on Incorrect Indiana Data, PLANNED PARENTHOOD (April

11, 2023), https://www.plannedparenthood.org/planned-parenthood-great-northwest-hawaii-alaskaindiana-kentuck/press/ppgnhaik-statement-on-incorrect-indiana-data.

20 ANSIRH, Adverse Events 2021, supra note 12, at 2 (“[t]he 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”); see also

ANSIRH, U.S. Studies on Medication Abortion without In-Person Clinician Dispensing of Mifepristone, UNIV. OF CAL., S.F. (Oct. 2021); Elizabeth Raymond & Hillary Bracken, Early Medical Abortion

Without Prior Ultrasound, 92 CONTRACEPT. 212 (2015); Upadhyay, et al. (2015), supra note 13.

wisdom-tooth removals, tonsillectomies, colonoscopies, and plastic surgeries, than

by any abortion method (medication or procedural).21 Using Viagra is more dangerous than using mifepristone. Studies have shown Viagra to be associated with 4.9

deaths per 100,000 prescriptions,22 death by colonoscopy occurs in about 0.03% of

cases,23 and the “risk of death associated with childbirth [is] approximately 14 times

higher” than the risk associated with an abortion.24 Every drug has side effects,

and every procedure has risks—but medication abortion is among the safest medical interventions in any category, pregnancy-related or not.25

The District Court did not consider these facts. Instead, it selectively relied

on a narrow minority of biased and flawed studies in an attempt to set aside decades of safe, FDA-approved use. For example, it recites statistics on emergency

room visits from a study whose author is an employee of an anti-abortion organiza-

21 Compare ANSIRH, Abortion Safety, supra note 12 (complication rate for wisdom-tooth extraction

is approximately 3.5x higher than abortions; complication rate for tonsillectomies is approximately

4x higher than abortions) with ASGE Standards of Practice Comm., Complications of Colonoscopy,

74 AM. PLASTIC & RECONSTR. SURGERY 745, 745 (2011) (up to 33% of colonoscopies result in minor

complications); Frederick M. Grazer & Rudolph H. de Jong, Fatal Outcomes from Liposuction: Census Survey of Cosmetic Surgeons, 105 PLASTIC & RECONSTR. SURGERY 436, 441 (2000) (mortality rate

from liposuction was 20 deaths per 100,000 patients).

22 See Mike Mitka, Some Men Who Take Viagra Die—Why?, 283 JAMA, 590, 590–93 (Feb. 2, 2000).

23 ASGE Standards of Practice Comm., supra note 21, at 747.

24 Elizabeth G. Raymond & David A. Grimes, The Comparative Safety of Legal Induced Abortion and

Childbirth in the United States, 119 OBSTET. & GYNECOL. 215, 215 (2012).

25 Respondents also inaccurately claim that mifepristone acts as an “endocrine-disruptor” in adoles-

cents. See Compl. ¶¶ 54, 60. Nothing suggests that medication abortion has any effect on adolescent

development.

tion.26 Amici strongly disagree with the District Court’s approach and conclusions,

and the Fifth Circuit’s partial approval of that decision.

The District Court’s unquestioning endorsement of Respondents’ view that

medication abortion causes emotional and physical harm is again unsupported by

scientific fact. Studies show that patients who seek an abortion, including medication abortion, do not suffer from emotional distress or negative mental-health outcomes, and experience better long-term outcomes than those who seek abortion care

but are denied it.27 For example, participants who received abortion care confirmed

in one study that they believed it had been the “right decision for them” in the years

that followed.28

The District Court chose to rely on studies that served an agenda, including

one cited “study” authored by an anti-abortion research group that was based on

blog posts made on an anti-abortion website,29 and on studies that have been widely

critiqued by researchers and scholars for their serious methodological flaws.30 The

26 See, e.g., Mem. at

47 n.44-45. Study authors James Studnicki and Kathi Aultman are listed on

the website of the Charlotte Lozier Institute as the Director of Analytics and as an Associate Scholar,

respectively. The Charlotte Lozier Institute describes itself as the “research and education institute

of Susan B. Anthony Pro-Life America.” Charlotte Lozier Institute, About Us,

https://lozierinstitute.org/about/, see Charlotte Lozier Institute, Leadership and Staff,

https://lozierinstitute.org/leadership-and-staff.

27 M. Antonia Biggs et al., Women’s Mental Health and Well-being 5 Years After Receiving or Being

Denied an Abortion: A Prospective, Longitudinal Cohort Study, 74 JAMA PSYCHIATRY 169, 177

(2017).

28 Corrine H. Rocca et al., Decision Rightness and Emotional Responses to Abortion in the United

States: A Longitudinal Study, 10 PLOS ONE, 1, 7 (2015).

29 See Mem. at 46 n. 40-41.

30 Id. at 11 (citing David C. Reardon et al., Deaths Associated with Pregnancy Outcome: A Record

Linkage Study of Low Income Women, 95 S. MED. J. 834 (2002); Priscilla K. Coleman, Abortion and

Mental Health: Quantitative Synthesis and Analysis of Research Published 1995–2009, 199 BRIT. J.

PSYCHIATRY 180 (2011)).

District Court’s selective reliance on pseudoscience endangers amici’s patients and

their ability to provide safe, effective reproductive care. It purports to suspend the

use of a common and safe medicine based on studies that are directly contradicted

by the vast majority of research—research that demonstrates overwhelmingly and

conclusively that there is no association between medication abortion and adverse

physical or psychological outcomes.31 This Court should not endorse that dangerous

result.

II. REMS Restrictions Are Not Necessary to Ensure Patients’ Safety.

When it revisited its guidance on mifepristone use in 2016, the FDA had exceptionally broad and strong confirmation of mifepristone’s safety and efficacy. It

therefore concluded that it could revisit certain aspects of the REMS put in place

sixteen years prior. Each change to the REMS since 2016 has been fully supported

by scientific evidence and has not changed mifepristone’s safety profile.

The FDA’s safety analysis relied on 11 independent clinical studies conducted

between 2005 and 2015, covering “well over 30,000 patients,”32 a randomized control

trial,33 and several observational studies,34 all of which demonstrated the safety and

31 See, e.g., Brenda Major et al., Abortion and Mental Health: Evaluating the Evidence, 64(9) AM.

PSYCH. 863 (2009); M. Antonia Biggs, et al., Mental Health Diagnoses After Receiving or Being Denied an Abortion in the United States 105(12) AM. J. OF PUB. HEALTH 2557 (2015); Vignetta E. Charles, et al., Abortion and Long-term Mental Health Outcomes: A Systematic Review of the Evidence,

78(6) CONTRACEPT. 436 (2008).

32 2016 FDA Medical Review, supra note 13, at 50.

33 See id. at 79.

34 See, e.g., id. at 18, 35–38.

effectiveness of mifepristone up to the ten-week gestational period.35 Those studies

conclusively demonstrated that “serious adverse events . . . are rarely reported . . .

with rates generally far below 1.0%.”36 This medicine is safer than countless other

drugs on the market. Based on this sound, scientific evidence, the FDA determined

that it was appropriate to adjust the heavy restrictions on mifepristone’s use, and

began unwinding previously mandated ultrasound requirements and other unnecessary barriers.

The agency concluded that mifepristone’s safety profile was “wellcharacterized” and it could therefore remove the adverse reporting requirement imposed on Danco Labs from the REMS.37 Contrary to what the District Court believes, this does not “ensur[e] that almost all new adverse events [will] go unreported or underreported.”38 As the FDA recognized in its 2016 Medical Review, Danco is

still bound by 21 CFR § 314.80 to report serious, unexpected adverse events within

15 days, and all others on an annual basis.39 The suggestion that recent safety data

is somehow tainted by this decision or materially different from the data gathered

35 See, e.g., Dina Abbas et al., Outpatient Medical Abortion is Safe and Effective Through 70 Days

Gestation, 92 CONTRACEPT. 197 (2015); A.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); E.V. Gouk,

Medical Termination of Pregnancy at 63 to 83 Days Gestation, 106 BR. J. OBSTET. GYNAECOL. 535

(1999); Beverly Winikoff et al., Extending Outpatient Medical Abortion Services Through 70 Days of

Gestational Age, 120 OBSTET. & GYNECOL. 1070 (2012). 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,

Medication Abortion Up to 70 Days of Gestation at 1, 4 (Oct. 2020, reaff’d 2023).

36 2016 FDA Medical Review, supra note 13, at 56 (emphasis added).

37 Id. at 8.

38 Mem. at 59.

See 2016 FDA Medical Review, supra note 13, at 8.

between 2000 and 2016 is simply incorrect. Adverse events are still being reported

and mifepristone continues to be used safely and effectively.

The Fifth Circuit’s conclusion that mifepristone’s safety must have been a re-

sult of the REMS fundamentally misunderstands the science, and shows exactly

why these decisions are best left to agency experts. For example, the ultrasound

requirement was removed because, although an ultrasound can help determine gestational age and identify ectopic pregnancies, these goals can be accomplished just

as effectively by discussing the patient’s medical history—and that holds true even

if the medical history is collected via telemedicine rather than in person.40 The decision of which method to use should be left to the provider’s reasonable judgment,

based on the facts before them.

The District Court’s purported concern that the FDA was abdicating its responsibilities and “assum[ing] physicians will ascertain gestational age” 41 fundamentally misunderstands the practice of medicine—which is not predicated solely

on FDA medication approvals. To ensure the safety and wellbeing of their patients,

physicians, and other practitioners follow clinical guidance and use their years of

Compl. Ex. 24, ECF No. 1-25 at 6 (“In practice, dating pregnancies occurs through using other clinical methods, as well as through using ultrasound.”); Raymond & Bracken, supra note 20, at 214

(noting that gestational dating using last monthly period rather than ultrasound may be reasonable

for selected patients before medication abortion); see also Ushma D. Upadhyay et al., Outcomes and

Safety of History-Based Screening for Medication Abortion: A Retrospective Multicenter Cohort

Study, 182 JAMA INTERNAL MED. 482, 489 (2022) (finding that mifepristone labels could be revised

to state that “if pregnancy duration can be reasonably estimated by history and if no symptoms or

risk factors for ectopic pregnancy are present,” ultrasonography should not be required); Holly Anger

et al., Clinical and Service Delivery Implications of Omitting Ultrasound before Medication Abortion

Provided via Direct-to-Patient Telemedicine and Mail in the U.S., 104 CONTRACEPT. 659 (2021).

41 Mem. at 51.

training, expertise, and experience to treat patients, which before prescribing mifepristone, require them to determine gestational age.42

Similarly, mifepristone’s in-person dispensing requirement was removed in

2021 based on scientific evidence that doing so would not pose any additional harm

to patients. In response to the COVID-19 pandemic, the FDA initially exercised its

enforcement discretion to suspend the in-person dispensing requirement—but only

after determining that the science “[did] not appear to show” that doing so would

result in any “increases in serious safety concerns (such as hemorrhage, ectopic

pregnancy, or surgical interventions).”43 Months later, the FDA denied a Citizens

Petition by anti-abortion organizations seeking to reinstate that constraint 44 —

having confirmed that eliminating the in-person requirement had no effect on mifepristone’s safety profile based on a comparison of adverse events data from before

and during the suspension of this requirement, which revealed no significant

change in safety profile.45

Given these facts and the dearth of accessible in-person health care in large

portions of this country, there is no logical reason to declare the FDA’s reasoned

judgment arbitrary and capricious, or to create a precedent allowing a court to sub42 ACOG Practice Bulletin No. 225, Medication Abortion Up to 70 Days of Gestation at 1, 4 (Oct.

2020, reaff’d 2023).

43 Letter from Janet Woodcock, Acting Comm’r, FDA, to Maureen G. Phipps, Chief Exec. Officer, Am.

Coll. of Obstetricians and Gynecologists, and William Grobman, President, Soc’y for Maternal-Fetal

Med. at 2 (Apr. 12, 2021), https://www.aclu.org/wp-content/uploads/legal-documents/fda_acting_

commissioner_letter_to_acog_april_12_2021.pdf.

44 See Response Letter from FDA Ctr. For Drug Evaluation & Rsch. Amer. Ass’n of Pro-Life Obstetri-

cians and Gynecologists and Amer. Coll. of Pediatricians, Docket No. FDA-2019-P-1534 (Dec. 16,

2021), https://www.regulations.gov/document/FDA-2019-P-1534-0016.

45 Id. at 26–27.

stitute its judgment and reinstate requirements that have been shown, time and

again, to provide no meaningful health benefits to patients.

III.

Limiting Access to Mifepristone Will Harm Pregnant Patients and Have

Severe Negative Impacts on the Broader Health Care System.

The Fifth Circuit’s judicial expansion of the REMS will impose a severe cost

on pregnant patients, their providers, and the health care system as a whole.

A. Expanding the REMS Will Harm Patients.

Even temporary lack of access to mifepristone—caused by a medically unnecessary expansion of the current REMS program—will cause patients to suffer serious physical harm, and even death. And because mifepristone has many uses outside of medication abortion, limiting access, even temporarily will also cause

irreparable harm to patients who depend on this drug for miscarriage management

and other conditions.

Abortion care can be lifesaving, especially for people suffering from serious

health conditions or experiencing early pregnancy loss. Medication abortion’s relative availability makes it more accessible to patients with limited access to medical

care, including low-income patients and patients of color46—the very people who are

most likely to experience severe maternal morbidity and more likely to die from

46 See Christine Dehlendorf & Tracy Weitz, Access to Abortion Services: A Neglected Health Dispari-

ty, 22 J. HEALTH CARE FOR THE POOR & UNDERSERVED 415, 416 (2011); Jenna Jerman et al., Characteristics of U.S. Abortion Patients in 2014 and Changes Since 2008, GUTTMACHER INST. at 11 (May

2016); Rachel K. Jones et al., COVID-19 Abortion Bans and Their Implications for Public Health, 52

PERSPECTIVES ON SEXUAL & REPROD. HEALTH 65–67 (2020); see also Ctrs. for Medicare & Medicaid

Servs., CMS Rural Health Strategy at 2 (2018), https://www.cms.gov/About-CMS/AgencyInformation/OMH/Downloads/Rural-Strategy-2018.pdf.

pregnancy-related complications.47 Indeed, 75% of those seeking abortion care are

living at or below 200% of the federal poverty level, a majority of whom identify as

people of color.48 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.49 Restricting the use of mifepristone would only harm these

patients by making an entirely safe treatment less available in the marketplace—

resulting in the denial of medical care to many.

Substantial evidence demonstrates that the denial of abortion care alone

causes harm. Patients who are denied abortions are more likely to experience intimate partner violence compared with patients who were able to have an abortion.50

Studies have shown that being denied an abortion also exacerbated patients’ economic hardships, revealing “large and statistically significant differences in the socioeconomic trajectories of women who were denied wanted abortions compared

with women who received abortions—with women denied abortions facing more

economic hardships.”51

47 See Ctrs. for Medicare & Medicaid Servs., Advancing Rural Maternal Health Equity at 1 (May

2022), https://www.cms.gov/files/document/maternal-health-may-2022.pdf; see also Juanita Chinn, et

al., Health Equity Among Black Women in the United States, 30 J. WOMEN’S HEALTH 212, 215

(2021).

48 ACOG Committee Opinion No. 815, Increasing Access to Abortion (Dec. 2020).

49 See Lyndsey S. Benson et al., Early Pregnancy Loss in the Emergency Department, 2006–2016, 2

J. AM. COLL. EMERGENCY PHYSICIANS OPEN e12549 at 2 (2021).

50 See Sarah Roberts et al., Risk of Violence from the Man Involved in the Pregnancy After Receiving

or Being Denied an Abortion, 12 BMC MEDICINE 1, 6 (2014).

51 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).

Respondents’ claim that continuing a pregnancy is a safer alternative—

specifically, that “[p]regnancy rarely leads to complications that threaten the life of

the mother or the child”52—is not based on science. Empirical evidence shows that

women are at least 14 times more likely to die during childbirth than during any

abortion procedure53 and are at an increased risk of experiencing hemorrhage, infection, and injury to other organs during pregnancy and childbirth as well.54 Even

under the best of circumstances, pregnancy and childbirth impose significant physiological changes that can exacerbate underlying conditions and can severely compromise health, sometimes permanently.55 Pregnancy, particularly when coupled

with preexisting conditions, can quickly evolve into a life-threatening situation necessitating critical care, including abortion.

Reverting to medically unnecessary

restrictions will do nothing to alleviate those risks.

52 See Compl. ¶ 51.

53 See Raymond & Grimes, supra note 24, 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. Rates have sharply

increased since then. See, e.g., David Boulware, Recent Increases in the U.S. Maternal Mortality

Rate: Disentangling Trends from Measurement Issues, 128 OBSTET. & GYNECOL. 447 (2016). By

contrast, the mortality rate associated with legal abortions performed from 1998 to 2005 was 0.6

deaths per 100,000 procedures. See Raymond & Grimes, supra note 24, at 216. 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 7, at 7.

54 Raymond & Grimes, supra note 24, at 215, 216–17, fig.1.

55 See, e.g., ACOG Practice Bulletin No. 190, Gestational Diabetes Mellitus (Feb. 2018); ACOG Prac-

tice Bulletin No. 222, Gestational Hypertension and Preeclampsia (June 2020); ACOG Practice Bulletin No. 183, Postpartum Hemorrhage (Oct. 2017); ACOG Obstetric Care Consensus No. 7, Placenta

Accreta Spectrum (July 2012, reaff’d 2021); ACOG Practice Bulletin No. 198, Prevention and Management of Obstetric Lacerations at Vaginal Delivery (Sept. 2018); ACOG Clinical Consensus No. 1,

Pharmacologic Stepwise Multimodal Approach for Postpartum Pain Management (Sept. 2021).

Patients experiencing early pregnancy loss, miscarriage, and other maternalhealth issues will also suffer. As with many medications, mifepristone also has

many critical off-label uses beyond abortion.56 Mifepristone is already widely prescribed for management and treatment of miscarriages, including spontaneous,

missed, inevitable, and incomplete abortions.57 Studies have also examined its use

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). 58 Mifepristone is also used off-label to reduce the duration of bleeding or

hemorrhaging during certain serious pregnancy complications, and may have beneficial effects on the cervix in full-term pregnancies, which in turn may affect the

likelihood of successful labor.59 Restricting the use of mifepristone will harm patients seeking a prescription for reasons unrelated to abortion.

B. Physicians and the Health Care System Will Be Harmed by Expanded REMS.

Limiting access to mifepristone through restrictions the FDA has previously

deemed unnecessary will harm physicians, and, at a macro level, increase the bur-

56 See Christopher M. Wittich et al., Ten Common Questions (and Their Answers) About Off-Label

Drug Use, 87 MAYO CLINIC PROC. 982 (2012).

57 See Mara Gordon & Sarah McCammon, A Drug that Eases Miscarriages is Difficult for Women to

Get, NPR (Jan. 10, 2019), https://www.npr.org/sections/health-shots/2019/01/10/666957368/a-drugthat-eases-miscarriages-is-difficult-for-women-to-get.

58 See

Mario Tristan et al., Mifepristone for Uterine Fibroids, COCHRANE DATABASE SYST. REV.

(2012); Y. X. Zhang, Effect of Mifepristone in the Different Treatments of Endometriosis, CLIN. AND

EXP. OBSTET. & GYNECOL. 350 (2016).

59 See Yanxia Cao et al., Efficacy of Misoprostol Combined with Mifepristone on Postpartum Hemor-

rhage and its Effects on Coagulation Function, 13 INT. J. CLIN. EXP. MED. 2234 (Apr. 30, 2020).

den on the nation’s health care system, particularly women’s health and OBGYN

care. Medical facilities will experience an increased strain on already-limited resources.60 Medication abortion allows patients to ingest their prescriptions safely at

home after consultation with their health care providers, freeing clinicians and inpatient resources to focus on providing other needed care. The FDA’s lifting of the

REMS in 2016 had the same effect—which previously required physicians to dispense the medication to patients in person and required patients to travel for medically unnecessary follow-up appointments. Reinstating those restrictions without

compelling justification—and against the FDA’s sound scientific judgment—will not

only harm individual patients, but unnecessarily strain practitioners and health

care system as a whole.

Imposing medically unnecessary REMS also raises serious medical ethics

concerns for providers. Physicians are required to ensure their patients have access

to demonstrably safe and effective drugs, like mifepristone—particularly when that

medication serves as a safe and effective alternative to other more invasive treatments. At their core, medical ethics require that “the welfare of the patient . . . form

the basis of all medical judgments.”61 Revisiting the REMS the FDA has already

determined, based on a wide range of medical studies and years of data, are no

60 Cf. Alexander Janke, An Emergency in U.S. Emergency Care: Two Studies Show Rising Strain, U.

MICH. INST. OF HEALTHCARE POL’Y & INNOVATION (Oct. 7, 2022), https://ihpi.umich.edu/news/

emergency-us-emergency-care-two-studies-show-rising-strain.

61 ACOG, Code of Professional Ethics at 2 (Dec. 2018); AMA, Code of Medical Ethics Opinion 1.1.1

(“The relationship between a patient and a physician is based on trust, which gives rise to physicians’ ethical responsibility to place patients’ welfare above the physician’s own self-interest or obligations to others, to use sound medical judgment on patients’ behalf, and to advocate for their patients’ welfare.”).

longer beneficial to patients, undermines this principle, improperly inserts the

courts in the doctor–patient relationship, and allows a court to supplant the FDA

and a clinician’s scientific and medical judgments regarding what is in the patients’

best interests with a court’s non-expert decision regarding whether and when physicians may provide routine, safe, and essential healthcare.

CONCLUSION

For the reasons explained above and outlined more fully in the Applicants’ submissions, Amici respectfully urge the Court to grant Applicants’ requested relief.

Respectfully submitted,

MOLLY MEEGAN

JESSICA MORRIS

AMERICAN COLLEGE OF OBSTETRICIANS

AND GYNECOLOGISTS

409 12th Street, SW

Washington D.C. 20024

(617) 373-8921

mmeegan@acog.org

jmorris@acog.org

/S/ SHANNON ROSE SELDEN

SHANNON ROSE SELDEN

Counsel of Record

ADAM AUKLAND-PECK

DEBEVOISE & PLIMPTON LLP

66 Hudson Blvd.

New York, NY 10001

(212) 909-6000

srselden@debevoise.com

MEGAN MCGUIGGAN

DEBEVOISE & PLIMPTON LLP

801 Penn. Ave, NW

Washington, D.C. 20004

(202) 383-8000

Counsel to Amici Curiae

April 14, 2023

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.