Amicus Curiae Brief — Food and Drug Administration, et al., Petitioners v. Alliance for Hippocratic Medicine, et al.
Supreme Court briefJan 30, 2024
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Nos. 23-235 & 23-236
IN THE
Supreme Court of the United States
̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴̴
FOOD AND DRUG ADMINISTRATION, ET AL.,
Petitioners,
v.
ALLIANCE FOR HIPPOCRATIC MEDICINE ET AL.,
Respondents.
_____________
DANCO LABORATORIES, L.L.C.,
v.
Petitioner,
ALLIANCE FOR HIPPOCRATIC MEDICINE ET AL.,
Respondents.
_____________
On Writs of Certiorari to the United States Court of
Appeals for the Fifth Circuit
_______________________
BRIEF OF AMERICAN COLLEGE OF OBSTETRICIANS AND
GYNECOLOGISTS, AMERICAN MEDICAL ASSOCIATION,
AND OTHER MEDICAL SOCIETIES AS AMICI CURIAE IN
SUPPORT OF PETITIONERS
________________________
MOLLY MEEGAN
JESSICA MORRIS
AMERICAN COLLEGE OF
OBSTETRICIANS
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 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
i
TABLE OF CONTENTS
Page
TABLE OF AUTHORITIES........................................ii
INTEREST OF AMICI CURIAE ................................ 1
SUMMARY OF THE ARGUMENT ............................ 8
ARGUMENT ............................................................. 11
I.
Mifepristone Is an Essential Component
of Reproductive Care. ..................................... 11
II.
Mifepristone Has Been Thoroughly
Studied and Is Conclusively Safe................... 13
III.
There Is No Credible Scientific Basis for
Rewinding the Clock on Evidence-Based
Medical Practice to 2015. ............................... 19
IV.
Restricting the Use of Mifepristone Will
Harm Pregnant Patients and Have
Severe Negative Impacts on the Broader
Health Care System. ...................................... 26
CONCLUSION .......................................................... 32
ii
TABLE OF AUTHORITIES
Cases
All. for Hippocratic Med. v. FDA, 78
F.4th 210 (5th Cir. 2023) ............................... 15, 21
June Med. Servs. LLC v. Russo, 140 S.
Ct. 2103 (2020) ....................................................... 6
Okla. Call for Reprod. Just. v.
Drummond, 526 P.3d 1123 (Okla.
2023) ....................................................................... 6
Planned Parenthood S. Atl. v. State, 882
S.E.2d 770 (S.C. 2023) .......................................... 6
Stenberg v. Carhart, 530 U.S. 914
(2000) ...................................................................... 6
Whole Woman’s Health v. Hellerstedt,
579 U.S. 582 (2016) ................................................ 6
Whole Woman’s Health v. Paxton, 978
F.3d 896 (5th Cir. 2000) ......................................... 6
Other Authorities
2000 FDA Approval Memorandum,
2:22-CV-00223-Z (Nov. 18, 2022),
ECF No. 1-25 ........................................................ 23
ACOG Clinical Consensus No. 1,
Pharmacologic Stepwise Multimodal
Approach for Postpartum Pain
Management (Sept. 2021) .................................... 27
iii
ACOG, Code of Professional Ethics
(Dec. 2018) .............................................................. 9
ACOG Committee Opinion No. 815,
Increasing Access to Abortion (Dec.
2020) ..................................................................... 28
ACOG Obstetric Care Consensus No. 7,
Placenta Accreta Spectrum (Dec.
2018) ..................................................................... 27
ACOG Practice Bulletin No. 183,
Postpartum Hemorrhage (Oct. 2017) .................. 27
ACOG Practice Bulletin No. 200, Early
Pregnancy Loss (Nov. 2018, reaff’d
2021) ............................................. 11, 12, 13, 30, 31
ACOG Practice Bulletin No. 222,
Gestational
Hypertension
and
Preeclampsia (June 2020) .................................... 27
ACOG Practice Bulletin No. 225,
Medication Abortion Up to 70 Days
of Gestation (Oct. 2020, reaff’d 2023) ...... 11, 12, 20
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) ..................... 20
AMA, AMA Principles of Medical Ethics
(2001) ................................................................ 9, 10
iv
Angela M. Mills & Elizabeth M. Danter,
Pregnancy-Related
Complications,
PEDIATRIC EMERGENCY MEDICINE
676 (2008) ............................................................. 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) .............................................................. 14, 15
ANSIRH, U.S. Studies on Medication
Abortion
Without
In-Person
Clinician Dispensing of Mifepristone,
UNIV. OF CAL., S.F. (2021) .................................... 15
ASGE Standards of Practice Comm.,
Complications of Colonoscopy, 74
AM. SOC’Y FOR GASTRO. ENDOSCOPY
745 (2011) ............................................................. 16
Beverly Winikoff et al., Extending
Outpatient
Medical
Abortion
Services Through 70 Days of
Gestational Age, 120 OBSTET. &
GYNECOL. 1070 (2012) .......................................... 20
Brenda Major et al., Abortion and
Mental Health: Evaluating the
Evidence, 64 AM. PSYCH. 863 (2009) .................... 18
Carla Dugas & Valori H. Slane,
Miscarriage, NAT’L LIBR. MED. (June
27, 2022) ......................................................... 12, 31
v
Centers for Disease Control and
Prevention, U.S. Pregnancy Rates
Drop During Last Decade (Apr. 12,
2023) ..................................................................... 12
Christine Dehlendorf & Tracy Weitz,
Access to Abortion Services:
A
Neglected Health Disparity, 22 J.
HEALTH
CARE
FOR
POOR
&
UNDERSERVED 415 (2011) .................................... 28
Christopher M. Wittich et al., Ten
Common Questions (and Their
Answers) About Off-Label Drug Use,
87 MAYO CLINIC PROC. 982 (2012) ....................... 30
Corrine H. Rocca et al., Decision
Rightness and Emotional Responses
to Abortion in the United States: A
Longitudinal Study, 10 PLOS ONE 1
(2015) .................................................................... 18
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) ............................................... 30
Dina Abbas et al., Outpatient Medical
Abortion is Safe and Effective
Through 70 Days Gestation, 92
CONTRACEPT. 197 (2015) ...................................... 20
vi
Donna L. Hoyert, Maternal Mortality
Rates in the United States, 2021,
CENTERS FOR DISEASE CONTROL AND
PREVENTION (last reviewed Mar. 16,
2023) ..................................................................... 27
Elizabeth G. Raymond & David A.
Grimes, The Comparative Safety of
Legal
Induced
Abortion
and
Childbirth in the United States, 119
OBSTET. & GYNECOL. 215 (2012) .......................... 27
Elizabeth G. Raymond & Hillary
Bracken, Early Medical Abortion
Without Prior Ultrasound, 92
CONTRACEPT. 212 (2015) ................................ 15, 23
FDA Ctr. For Drug Eval. & Rsch.,
Medical Review Application No.
020687Orig1s020 (Mar. 29, 2016) ........... 14, 20, 21
Honor MacNaughton et al., Mifepristone
and Misoprostol for Early Pregnancy
Loss and Medication Abortion, 103
AM. FAM. PHYSICIAN 473 (2021) ........................... 30
Jessica Beaman et al., Medication to
Manage Abortion and Miscarriage,
35 J. GEN. INTERNAL MED. 2398
(2020) .................................................................... 31
Katherine Kortsmit et al., Abortion
Surveillance—United States, 2021,
72 CDC MORBIDITY & MORTALITY
WKLY. REP. 1 (2023) ....................................... 15, 27
vii
Katherine A. Rafferty & Tessa
Longbons, #AbortionChangesYou: A
Case Study to Understand the
Communicative Tensions in Women’s
Medication Abortion Narratives, 36
HEALTH COMMC’N. 1485 (2021) ............................ 17
Kathi Aultman et al., Deaths and Severe
Adverse Events after the use of
Mifepristone as an Abortifacient from
September 2000 to February 2019, 36
ISSUES LAW & MED. 3–26 (2021) .......................... 15
Latoya Hill et al, Racial Disparities in
Maternal and Infant Health: Current
Statuts and Efforts to Address Them,
KFF (Nov. 2022) ................................................... 28
Laura Schummers et al., Abortion
Safety and Use with Normally
Prescribed Mifepristone in Canada,
386 NEW ENG. J. MED. 57 (2022) ......................... 14
Lauren Weber et al., Unpacking the
Flawed Science Cited in the Texas
Abortion Pill Ruling, WASH. POST
(Apr. 13, 2023) ...................................................... 18
Leah R. Koenig et al., Patient
Acceptability
of
Telehealth
Medication Abortion Care in the
United States, 2021࣓2022: A Cohort
Study, AM. J. PUB. HEALTH (2024) ....................... 25
viii
Leah R. Koenig et al., The Role of
Telehealth in Promoting Equitable
Abortion Access in the United States:
Spatial Analysis, JMIR PUB. HEALTH
& SURVEILLANCE (2023) ....................................... 29
Lyndsey S. Benson et al., Early
Pregnancy Loss in the Emergency
Department, 2006–2016, 2 J. AM.
COLL. EMERGENCY PHYSICIANS OPEN
e12549 (2021) ....................................................... 28
M. Antonia Biggs et al., Understanding
Why Women Seek Abortions in the
US, 13 BMC WOMEN’S HEALTH 1
(2013) .................................................................... 19
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 J.
AM. MED. ASS’N PSYCH. 169 (2017) ...................... 18
Mara Gordon & Sarah McCammon, A
Drug that Eases Miscarriages is
Difficult for Women to Get, NPR
(Jan. 10, 2019) ...................................................... 30
Mario Tristan et al., Mifepristone for
Uterine
Fibroids,
COCHRANE
DATABASE SYSTEMATIC REVS. (2012).................... 31
Mike Mitka, Some Men Who Take
Viagra Die—Why?, 283 J. AM. MED.
ASS’N 590 (2000) ................................................... 16
ix
Miscarriage, MARCH OF DIMES (Feb.
2023) ..................................................................... 12
Nadine El-Bawab et al., In post-Roe
America, Women Detail Agony of
Being Forced to Carry Nonviable
Pregnancies to Term (Dec. 14, 2023) ................... 29
NAT’L ACADS. OF SCI., ENG’G & MED., The
Safety and Quality of Abortion Care
in the United States (2018) ...................... 16, 18, 27
Office of Minority Health, Advancing
Rural Maternal Health Equity, CTRS.
FOR MEDICARE & MEDICAID SERVS.
(2022) .................................................................... 28
Position Statement on Abortion and
Women’s Reproductive Health Care
Rights, AM. PSYCH. ASS’N (2020).......................... 18
R. Morgan Griffin, Making the Decision
on NSAIDs, WEBMD (Oct. 17, 2005) ................... 16
Rachel K. Jones et al., COVID-19
Abortion
Bans
and
Their
Implications for Public Health, 52
PERSPS. SEXUAL & REPROD. HEALTH
65 (2020) ............................................................... 28
SAGE Journals, Expression of Concern:
A Longitudinal Cohort Study of
Emergency
Room
Utilization
Following Mifepristone Chemical
and Surgical Abortions (July 25,
2023) ..................................................................... 18
x
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 (2014) ......................................................... 29
U.S. GOV’T ACCOUNTABILITY OFF., GAOAND
DRUG
18-292,
FOOD
ADMINISTRATION: INFORMATION ON
MIFEPREX LABELING CHANGES AND
ONGOING MONITORING EFFORTS 15
(2018) .................................................................... 21
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) .................................................................... 26
Ushma
D.
Upadhyay
et
al.,
Effectiveness
and
Safety
of
Telehealth Medication Abortion in
the United States, NATURE MED.
(forthcoming 2024) ............................................... 23
Ushma D. Upadhyay et al., Incidence of
Emergency Department Visits and
Complications After Abortion, 125
OBSTET. & GYNECOL. 175 (2015) .......................... 14
xi
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 (2022)................................... 23
Vignetta E. Charles et al., Abortion and
Long-Term Mental Health Outcomes:
A Systematic Review of the Evidence,
78 CONTRACEPT. 436 (2008) ................................. 18
Walgreens, Walgreens and Mifepristone:
The Facts (Jan. 26, 2024) ..................................... 24
Y. X. Zhang, Effect of Mifepristone in the
Different
Treatments
of
Endometriosis, 43 CLINICAL &
EXPERIMENTAL OBSTET. & GYNECOL.
350 (2016) ............................................................. 31
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) ........................................................... 31
Young-Kyun Kim, Malpractice and
Complications, 43 J. KOREAN ASS’N
ORAL & MAXILLOFACIAL SURGEONS 1
(2017) .................................................................... 13
1
INTEREST OF AMICI CURIAE1
Amici curiae are 16 leading medical societies
representing hundreds of thousands of clinicians who
serve patients nationwide. They include:
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
obstetriciangynecologists dedicated to providing access to highquality, 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.
The American Medical Association (“AMA”).
AMA is 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.
Pursuant to Rule 37.6, counsel for amici 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.
1
2
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.
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 7,000 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.
American Academy of Family Physicians
(“AAFP”). Founded in 1947, AAFP is one of the
largest national medical organizations, representing
129,600 family physicians and medical students
nationwide. AAFP seeks to improve the health of
patients, families, and communities by advocating
for the health of the public and by supporting its
members in providing continuous comprehensive
health care to all.
American Academy of Pediatrics (“AAP”).
AAP was founded in 1930 and is a national, not-forprofit professional organization dedicated to
furthering the interests of child and adolescent
health. Since AAP’s inception, its membership has
grown from 60 physicians to over 67,000 primary
care pediatricians, pediatric medical subspecialists,
and pediatric surgical specialists. Over the past 90
years, AAP has become a powerful voice for child and
adolescent health through education, research,
3
advocacy, and the provision of expert advice. Among
other things, AAP has worked with the federal and
state governments, health care providers, and
parents on behalf of America’s adolescents to ensure
the availability of effective reproductive health care.
American College of Physicians (“ACP”).
ACP is the largest medical specialty organization
and the second largest physician membership society
in the United States. ACP members include 161,000
internal medicine physicians, related subspecialists,
and medical students. Internal medicine physicians
are specialists who apply scientific knowledge,
clinical expertise, and compassion to the preventive,
diagnostic, and therapeutic care of adults across the
spectrum—from health to complex illness.
American College of Preventative Medicine
(“ACPM”). ACPM is a professional medical society
representing approximately 2,000 physicians,
dedicated to the practice of preventive medicine and
improving the health and quality of life of
individuals, families, and communities through
disease prevention and health promotion. ACPM
supports the peer-reviewed, evidence-based practice
of medical care and comprehensive reproductive
health services.
American Gynecological and Obstetrical
Society (“AGOS”).
AGOS is composed of
individuals attaining national prominence in
scholarship and leadership in the discipline of
Obstetrics, Gynecology and Women’s Health.
AGOS's mission is to promote excellence in women’s
health care through advocacy for research and
clinical training and the development of academic
leaders in obstetrics and gynecology. AGOS is
committed to enhancing diversity and inclusion
across the organization.
4
American
Society
for
Reproductive
Medicine (“ASRM”). ASRM is dedicated to the
advancement of science and the practice of
reproductive medicine.
Its members include
approximately 8,000 medical professionals.
American Thoracic Society (“ATS”). ATS is
the world’s leading medical society dedicated to
accelerating the advancement of global respiratory
health through multidisciplinary collaboration,
education, and advocacy. Core activities of the
Society’s more than 16,000 members are focused on
leading scientific discoveries, advancing professional
development,
impacting
global
health,
and
transforming patient care.
North American Society for Pediatric
Adolescent Gynecology (“NASPAG”). NASPAG
is a voluntary, non-profit organization devoted to
conducting, encouraging, and supporting programs of
medical education and professional training in the
field of pediatric and adolescent gynecology (“PAG”).
NASPAG members reside in all 50 states and in
countries abroad. Its focus is to serve and be
recognized as the lead provider in PAG education,
research, and clinical care; conduct and encourage
multidisciplinary and inter-professional programs of
medical education and research in the field of PAG;
and advocate for the reproductive well-being of
children and adolescents and the provision of
unrestricted, unbiased, and evidence-based practice
of PAG.
Society for Adolescent Health and Medicine
(“SAHM”).
Founded in 1968, SAHM is a
multidisciplinary organization committed to the
promotion of optimal health and well-being for all
adolescents and young adults by supporting
adolescent health and medicine professionals
5
through the advancement of clinical practice, care
delivery, research, advocacy, and professional
development.
Society of General Internal Medicine
(“SGIM”).
SGIM is a member-based internal
medical association of over 3,300 of the world’s
leading general internists, who are dedicated to
improving access to care for all populations,
eliminating healthcare disparities, and enhancing
medical education. SGIM’s mission is to cultivate
innovative educators, researchers, and clinicians in
general internal medicine, leading the way to better
health for everyone. SGIM members advance the
practice of medicine through their commitment to
providing comprehensive, coordinated, and costeffective care to adults, educating the next
generation of outstanding physicians, and conducting
cutting-edge research to improve quality of care and
clinical outcomes of all patients.
Society of Gynecologic Oncology (“SGO”).
SGO is the premier medical specialty society for
health
care
professionals
trained
in
the
comprehensive management of gynecologic cancers.
SGO contributes to the advancement of women’s
cancer care by encouraging research, providing
education, raising standards of practice, advocating
for patients and members and collaborating with
other domestic and international organizations.
Society of OB/GYN Hospitalists (“SOGH”).
SOGH is a rapidly growing group of physicians,
midwives, nurses, physician assistants, and other
individuals in the health care field who support the
OB/GYN Hospitalist model. SOGH is dedicated to
improving outcomes for hospitalized women and
supporting those who share this mission. SOGH’s
vision is to shape the future of OB/GYN by
6
establishing the Hospitalist model as the care
standard. SOGH values excellence, collaboration,
leadership, quality, and community.
Society for Academic Specialists in General
Obstetrics
and
Gynecology
(“SASGOG”).
SASGOG seeks to support academic generalist
physicians of all backgrounds throughout the
lifespan of their careers by providing education,
fostering excellence in scholarship and research, and
promoting inclusive leadership opportunities.
***
These organizations collectively represent
hundreds of thousands of medical practitioners
across the country, with deep expertise in 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 evidencebased 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 the current Food and Drug
Administration (“FDA”) regulations for the
prescription and use of mifepristone align with the
overwhelming weight of medical evidence and allow
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); Stenberg v. Carhart, 530 U.S. 914, 928
(2000); Whole Woman’s Health v. Paxton, 978 F.3d 896, 910 (5th
Cir. 2000); Planned Parenthood S. Atl. v. State, 882 S.E.2d 770,
787–88 (S.C. 2023); Okla. Call for Reprod. Just. v. Drummond,
526 P.3d 1123, 1152 n.10 (Okla. 2023).
2
7
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 can
require access to mifepristone, which has undergone
rigorous testing and review and has been safely used
by amici’s members 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.
8
SUMMARY OF THE ARGUMENT
At issue in this case are FDA regulations that
allow clinicians to prescribe, and patients to access,
one of the two drugs used in the standard protocol for
medication abortion and miscarriage management,
known in its generic form as mifepristone.
Mifepristone is extremely safe. Over more than two
decades, hundreds of medical studies and vast
amounts of data have confirmed its safety and
efficacy as part of this two-drug regimen. The
scientific evidence is overwhelming: major adverse
events occur in less than 0.32% of patients. The
risk of death is almost non-existent. Few drugs have
been so extensively studied after their approval by
FDA and can boast such a clear and compelling
record of safe use. Access to mifepristone under
current FDA protocols is supported by the safety
profile of the medication and enables practitioners to
provide safe, medically-appropriate, evidence-based,
and effective care.
Amici are the nation’s leading medical
organizations, representing hundreds of thousands of
members, including those most familiar with the use
of mifepristone in reproductive health care. Their
members are the obstetricians, gynecologists, family
physicians, emergency room doctors, maternal-fetal
subspecialists,
midwives,
nurses,
physician
assistants, and many other providers who care for
pregnant patients.
Many of amici’s members
regularly prescribe mifepristone and have extensive
experience in their own practices with the risks and
benefits for the many patients who rely on it.
Respondents, who represent a group of clinicians
opposed to abortion, make inaccurate and disproven
assertions about mifepristone’s effects and the
9
experiences of clinicians who prescribe and patients
who use the drug. The Fifth Circuit accepted these
assertions with no evidentiary hearing, while
simultaneously discounting the overwhelming
evidence that mifepristone is a safe and essential
component of reproductive health care. The decision
is disconnected from the science and effectively
sanctions Respondents’ misuse of the drug regulatory
system to create barriers to care. By seeking to limit
access to a safe and effective drug in every state in
the country, regardless of that state’s laws related to
abortion and the fact that mifepristone is also used
for miscarriage management and other purposes,
Respondents attempt an end run around this Court’s
commitment in Dobbs to leave it to the states and
the elective process to address the question of
abortion.
Respondents purport to be concerned that
treating pregnancy loss induced by mifepristone will
be psychologically damaging to them as providers.
They urge nationwide restrictions on access to an
essential medication to alleviate that fear. But
Respondents’ prospective personal concerns should
not be a basis to deny medically-appropriate care to
patients.
All patients are entitled to prompt,
complete health care that is firmly rooted in science,
and all members of the medical profession are
obligated by their codes of ethics to put patients’
welfare above their own self-interests and to provide
medically-necessary and appropriate care.3 And
See, e.g., ACOG, Code of Professional Ethics, at 1–2 (Dec.
2018) (“The respect for the right of individual patients to make
their own choices about their health care (autonomy) is
fundamental,” and “the welfare of the patient must form the
basis of all medical judgments.”); AMA, AMA Principles of
3
10
inevitably, all clinicians who treat patients
experiencing the end of a pregnancy must be able to
address excessive bleeding—including patients who
may need a subsequent procedure—because that is a
potential complication when the uterus is emptied,
whether from a spontaneous abortion, an induced
abortion, or any other reason.4
Turning back the clock to reimpose unnecessary
restrictions on mifepristone will exacerbate existing
inequities in maternal health for women of color,
low-income women, and those living in rural areas.
Restricting access to mifepristone will not only
jeopardize health, but worsen racial and economic
inequities and deprive women of the choices that are
at the very core of individual autonomy and wellbeing.
Amici urge this Court not to let the
speculative fears of a handful of doctors deprive
patients throughout the country of an essential
medication that FDA has deemed safe for use. For
all of these reasons, amici join Petitioners in asking
this Court to reverse.
Medical Ethics (2001) (“A physician shall, while caring for a
patient, regard responsibility to the patient as paramount.”).
4
While the term “abortion” is most often associated with
induced abortion, the majority of pregnancies that do not end in
a live birth are an “abortion” in medical terms. Angela M. Mills
& Elizabeth M. Danter, Pregnancy-Related Complications, in
PEDIATRIC EMERGENCY MEDICINE 676, 676-677 (Jill M. Baren et
al., eds., 2008).
11
ARGUMENT
I.
Mifepristone Is an Essential Component
of Reproductive Care.
The medically relevant facts, derived from
decades of reliable research, should inform the
Court’s decision—as they did FDA’s determination to
revise previously imposed restrictions. Amici believe
it is important for the Court to understand how
mifepristone is prescribed and used in practice, as
well as its safety profile and relative advantages for
patients. It is an essential medication used in
reproductive care, with vanishingly small risk and
material benefits to countless patients.
Mifepristone is used in combination with
misoprostol to provide a safe and effective way to end
a pregnancy or manage a miscarriage. The preferred
protocol for medical management of early pregnancy
loss (including spontaneous abortions, missed
abortions, incomplete abortions, and inevitable
abortions) provides that mifepristone is administered
approximately 24 hours before misoprostol to empty
the contents of the uterus.5 This medication protocol
has exceptionally low rates of major adverse events.
Although a misoprostol-only regimen can be used,
the two-drug regimens are the preferred therapy for
medication abortion and miscarriage management
because they are “more effective than misoprostolonly regimens.”6
Mifepristone increases the
protocol’s overall efficacy and mitigates the risk that
ACOG Practice Bulletin No. 200, Early Pregnancy Loss
(Nov. 2018, reaff’d 2021).
6
ACOG Practice Bulletin No. 225, Medication Abortion Up
to 70 Days of Gestation (Oct. 2020, reaff’d 2023).
5
12
subsequent procedural intervention will be needed.7
When used in combination with misoprostol,
mifepristone allows for the termination of pregnancy
within a few days, at home. 8 This helps ensure
access to potentially life-saving care for individuals
who live in maternity care deserts or cannot travel
long distances without significant hardship. Timing
matters: ending a pregnancy at home, within a
discrete period of time, can meaningfully improve
patient well-being. By allowing greater access to
mifepristone, FDA’s current approach improves the
quality of health care and outcomes for patients.
Focus on the use of mifepristone for induced
abortion disregards how similarly essential it is to
the safe and effective treatment of miscarriage or
early pregnancy loss. Miscarriage is common. Of the
roughly 5.5 million pregnancies estimated to occur in
the United States each year, between 10% and 26%
end in miscarriage.9 For the million or more patients
who experience early pregnancy loss annually,
mifepristone is often a critical component of care.
Respondents submit that abortion induced by
mifepristone results in “bleeding and cramping,”
which they characterize as a “complication” that they
may be called upon to treat, and believe warrants
imposing heightened restrictions on the medication.
Amici object to this characterization. Medically
Id.
Id.
9
See ACOG Practice Bulletin No. 200, supra n.5; Centers for
Disease Control and Prevention, U.S. Pregnancy Rates Drop
During Last Decade (Apr. 12, 2023); Carla Dugas & Valori H.
Slane, Miscarriage, NAT’L LIBR. MED. (June 27, 2022) (“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).
7
8
13
speaking, bleeding and cramping are not a
“complication”—that is how the body expels the
uterine lining and contents, and it is what happens
when the uterus is emptied.10 It is a process familiar
to practitioners from menstruation and miscarriage,
as well as medication abortion using the two-drug
protocol, including mifepristone. Mifepristone is not
unique in inducing bleeding and cramping; if
anything, mifepristone eases that process of
emptying the uterus and reduces the risks that it
will be prolonged or incomplete—which is one of the
reasons it is so frequently prescribed off-label 11 for
miscarriage management.12
II.
Mifepristone Has Been Thoroughly
Studied and Is Conclusively Safe.
The overwhelming weight of scientific evidence
and two decades of medical practice show that
mifepristone is safe and effective.
To date,
mifepristone has been discussed in more than 780
medical reviews and used in more than 630
“Common terms used interchangeably to refer to problems
arising from medical . . . treatments include ‘complication’[]
[and] ‘side effect’. . . . Complications refer to other diseases or
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).
11
“Off-label” use of a drug—for new indications or under a
regimen that deviates from FDA-approved labeling—is
widespread and permitted in all areas of medicine. It allows
clinicians to practice evidence-based medicine in accordance to
the latest scientific advances so that patients consistently
receive the best available treatment.
12
ACOG Practice Bulletin No. 200, supra n.5.
10
14
published clinical trials—of which more than 420
were randomized controlled studies, the gold
standard in research design.13
Over decades of research and hundreds of
studies, the findings are stark and consistent:
mifepristone is exceptionally safe and it is rare for
patients to experience even minor complications from
medication abortion. 14 When used in medication
abortion, major adverse events—significant infection,
excessive blood loss, or hospitalization—occur in less
than 0.32% of patients, according to a highly
regarded study with more than 50,000 patients. 15
Serious infection is exceptionally rare, occurring in
only 0.015% to 0.07% of patients.16 The risk of death
is almost non-existent. 17 A 2021 analysis of FDA
Based on a review of PubMed, the National Institute of
Health’s sponsored database of research studies.
14
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]; Laura
Schummers et al., Abortion Safety and Use with Normally
Prescribed Mifepristone in Canada, 386 NEW ENG. J. MED. 57,
57 (2022) (concluding that after restrictions on mifepristone
were eliminated in Canada, the rates of “adverse events and
complications remained stable,” even though “the proportion of
abortions provided by medication increased rapidly”).
15
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).
16
FDA Ctr. For Drug Eval. & Rsch., Medical Review
Application No. 020687Orig1s020, at 53–54 (Mar. 29, 2016)
[hereinafter 2016 FDA Medical Review].
17
A 2021 analysis of FDA data examining potential
mifepristone-related deaths over an 18-year period by the
University of San Francisco Medical Center, for example, found
13
15
data examining potential mifepristone-related
deaths over a more than 20-year period found that
only 13 deaths were possibly or probably related to
medication abortion, yielding an approximate
mortality rate of 0.00027%.18 These strikingly low
rates of adverse outcomes are observed regardless of
the indication for its use. The District Court’s
conclusion that FDA’s loosening of restrictions
“resulted in many deaths” is simply not true.19 The
statistics on which the District Court relied, and the
Fifth Circuit impliedly endorsed, are taken entirely
out of context, at best, and plainly wrong, at worst.
an approximate mortality rate of just 0.00035%. ANSIRH,
Adverse Events 2021, supra n.14; see also Katherine Kortsmit et
al., Abortion Surveillance—United States, 2021, 72 CDC
MORBIDITY & MORTALITY WKLY. REP. 1 (2023).
18
See ANSIRH, Adverse Events 2021, supra n.14, at 1–2; see
also id. at 3 (“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, U.S. Studies on Medication Abortion
Without In-Person 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 n.15.
19
All. for Hippocratic Med. v. FDA, 2:22-CV-00223-Z,
Memorandum Opinion and Order, Apr. 7, 2023, ECF No. 137,
at 57–58 [hereinafter “District Court Opinion”]. For instance,
the Court cited one study that observed “20 deaths” out of more
than 3,000 patients who had taken mifepristone. But that
study did not conclude that those deaths were possibly or
probably related to the use of mifepristone. Indeed, the study
recognized that, of the 20 deaths observed, at least three were
due to homicide, one was attributable to suicide, and four were
overdose-related. Kathi Aultman et al., Deaths and Severe
Adverse Events after the use of Mifepristone as an Abortifacient
from September 2000 to February 2019, 36 ISSUES LAW & MED.
3–26 (2021).
16
To the extent the lower courts suggest that any
adverse-event rate above zero is too much—amici
submit that such a result is neither possible nor
expected in the practice of medicine or the
administration of any drug.
Mifepristone is not just safe—it is far safer than
countless other medications and among the safest
medications or devices approved by FDA and being
used in medical practice. Mifepristone has a safety
profile comparable to that of ibuprofen, which more
than 30 million Americans take in any given day.20
Using Viagra is more dangerous than using
mifepristone; Viagra has a rate of 4.9 deaths for
every 100,000 prescriptions. 21 Colonoscopies are a
routine procedure, widely used in preventive care—
yet death occurs in about 0.03% of colonoscopy
cases.22 Medication abortion involving mifepristone
is among the safest medical interventions in any
category, pregnancy-related or not.
Amici are deeply concerned at the flawed and
selective studies used by Respondents and the lower
courts to stoke fears about mifepristone that are not
supported by credible data. These studies are far
outside the medical consensus and starkly
inconsistent with the overwhelming weight of
credible, peer-reviewed, evidence-based work.
See NAT’L ACADS. OF SCI., ENG’G & MED., The Safety and
Quality of Abortion Care in the United States (2018); see also R.
Morgan Griffin, Making the Decision on NSAIDs, WebMD (Oct.
17, 2005),
https://www.webmd.com/arthritis/features/making-decision-onnsaids.
21
See Mike Mitka, Some Men Who Take Viagra Die—Why?,
283 J. AM. MED. ASS’N 590, 591 (2000).
22
ASGE, Standards of Practice Comm., Complications of
Colonoscopy, 74 AM. SOC’Y FOR GASTROINTESTINAL ENDOSCOPY
745, 747 (2011).
20
17
Providing a court’s imprimatur on unreliable data
and studies designed to serve an ideological end does
not serve patients or further the health of our
medical systems.
The District Court’s conclusion that “adverse
events from chemical abortion drugs can overwhelm
the medical system” is unfounded. 23 As described
above, complications from medication abortion
requiring emergency care are exceedingly rare, and
there is no evidence to suggest, nor have amici
observed, any increase in such events since FDA
loosened restrictions.
Much of Respondents’
“evidence” to the contrary comes from studies that
have been widely critiqued by researchers and
scholars for their serious methodological flaws. For
example, for its inaccurate conclusion that a majority
of women regretted having a medication abortion,
the District Court relied on statistics from a review
of 98 anonymous blog posts from the anti-abortion
advocacy website “abortionchangesyou.com,” which
has none of the indicia of reliability of an evidencebased randomized and controlled study.24
The
publications’ own authors admitted that it was a
“qualitative
case
study”
and
“lack[ed]
[]
25
generalizability.” Furthermore, the District Court’s
reliance on a “study” published by James Studnicki
District Court Opinion, at 7. The District Court’s use of
the term “chemical abortion” itself is an indicator of its
approach to the case. FDA-approved drugs are not referred to
as “chemicals” when prescribed for conditions unrelated to
abortion, and the term should not be used here.
24
See District Court Opinion at 46 nn.40–41.
25
Katherine
A.
Rafferty
&
Tessa
Longbons,
#AbortionChangesYou: A Case Study to Understand the
Communicative Tensions in Women’s Medication Abortion
Narratives, 36 HEALTH COMMC’N. 1485 (2021).
23
18
for the proposition that mifepristone unduly burdens
our emergency-medical system has been widely and
publicly criticized.26
Amici—the
nation’s
leading
medical
organizations comprised of hundreds of thousands of
members—urge this Court to correct inaccurate
statements and recognize that the vast majority of
women who seek abortion care, including medication
abortion, report that they do not regret their
decision. They do not suffer from emotional distress
or negative mental-health outcomes. In fact, women
who seek and are able to obtain abortion care
experience better long-term outcomes than those who
seek abortion care but are denied it.27 Women seek
abortion care for a variety of reasons, including
socioeconomic and social factors—all of which must
be recognized as critical to a patient’s mental and
See, e.g., SAGE Journals, Expression of Concern: A
Longitudinal Cohort Study of Emergency Room Utilization
Following Mifepristone Chemical and Surgical Abortions (July
25,
2023),
https://journals.sagepub.com/doi/full/10.1177/233339282311894
00; Lauren Weber et al., Unpacking the Flawed Science Cited in
the Texas Abortion Pill Ruling, WASH. POST (Apr. 13, 2023, 6:00
PM).
27 See, e.g., Brenda Major et al., Abortion and Mental Health:
Evaluating the Evidence, 64 AM. PSYCH. 863 (2009); NAT’L
ACADS. OF SCI., ENG’G & MED., supra n.20; Vignetta E. Charles
et al., Abortion and Long-Term Mental Health Outcomes: A
Systematic Review of the Evidence, 78 CONTRACEPT. 436 (2008);
Position Statement on Abortion and Women’s Reproductive
Health Care Rights, AM. PSYCH. ASS’N (2020); 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 J. AM. MED. ASS’N PSYCH. 169,
177 (2017); 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).
26
19
physical well-being. Many women who seek abortion
care are already mothers and cite the “need to focus
on other children” as a key component of their
decision-making.28
Women also frequently cite
partner-related
and/or
financial
reasons
as
important factors.29 These facts matter. The ability
to choose when, whether, with whom, and under
what circumstances to raise children is at the very
core of individual autonomy and crucial to overall
well-being. Study after study confirms that those
who receive abortion care do not experience the
regrets Respondents hypothesize, but go on to thrive,
and experience direct measurable benefits from
having been able to access this safe and essential
form of reproductive care.30
III.
There Is No Credible Scientific Basis for
Rewinding the Clock on Evidence-Based
Medical Practice to 2015.
Amici have been successfully providing
reproductive care to millions of patients under the
2016 and 2021 FDA guidelines, and urge this Court
to permit them to continue to provide care under
that demonstrably safe regime. In removing certain
prior restrictions on mifepristone when the
overwhelming evidence confirmed they were not
needed, FDA enhanced the quality and availability of
essential reproductive care. It moved forward—as
M. Antonia Biggs et al., Understanding Why Women Seek
Abortions in the US, 13 BMC WOMEN’S HEALTH 1 (2013).
29
Id. at 1 (40% of patients cited financial reasons as
contributing to their decision, 31% cited partner-related reasons
as contributing to their decision, and 64% reported multiple
reasons for seeking an abortion).
30
Supra n.27.
28
20
medicine and science aspire to do—to ensure greater
access to safer care for more patients and their
providers. This Court should not turn back the clock
to deprive patients of safe and effective modern
medicine.
The FDA decisions at issue are well supported by
credible studies and are consistent with amici’s
experience in years of practice involving millions of
patients. In 2016, FDA’s safety analysis relied on 11
independent clinical studies conducted between 2005
and 2015, covering well “over 30,000 patients;” 31
randomized
controlled
trials32 and
several
prospective,
retrospective,
and
observational
studies,33 which demonstrated the safety and
effectiveness of mifepristone up to the 10-week
gestational period indicated on the current label. 34
This is an enormous and highly reliable data set—
and those studies conclusively demonstrated that
“[s]erious adverse events . . . are rarely reported . . .
with rates generally far below 1.0%.”35 A number
2016 FDA Medical Review, supra n.16, at 49–50.
See id. at 23.
33
See id. at 19.
34
See id. at 6; 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 n.6.
35
2016 FDA Medical Review, supra n.16, at 56 (emphasis
added).
31
32
21
of the studies on which FDA relied assessed the
effect of multiple departures from the previous
conditions of use and closely resembled the proposed
new conditions.36 Based on this sound scientific
evidence, FDA 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.37
These adjustments better serve patients,
including the many patients that are currently facing
critical shortages of health care providers in large
portions of the country or experiencing the
unacceptably high rates of maternal morbidity and
mortality in the United States due in part to
limitations on access to care. Before these first
adjustments were made in 2016, FDA’s complicated
requirements made care unnecessarily difficult to
access. As the data shows, there is no medical
reason to expect a patient who has taken
mifepristone to make two follow-up visits to a health
center afterwards. 38 It provides no benefit to the
See, e.g., Appellants Addendum to Emergency Motion for a
Stay Pending Appeal, All. for Hippocratic Med., v. FDA, No. 2310362 (5th Cir.), Doc. 27, at Add. 782 (citing Claudia Diaz
Olavarrieta, et al., Nurse versus physician-provision of early
medical abortion in Mexico: a randomized controlled noninferiority trial, 93 BULL. WORLD HEALTH ORG. 249, 249–58
(2015) (study conditions included a 70-day gestational age limit,
200 mg oral mifepristone and 800 mcg buccal misoprostol, athome administration, and non-physician prescription)).
37
As Petitioners describe and as set forth above, FDA
adjusted both the “Conditions of Use” printed on the
medication’s label and eliminated certain REMS. See 2016
FDA Medical Review, supra n.16, at 7–8.
38
See, e.g., U.S. GOV’T ACCOUNTABILITY OFF., GAO-18-292,
FOOD AND DRUG ADMINISTRATION: INFORMATION ON MIFEPREX
36
22
patient and can be burdensome, disruptive, and
costly, rendering access to an essential medical
protocol inaccessible to many patients. To the extent
after-care is needed or requested by a patient,
comprehensive telehealth protocols adopted by
clinics 39 make it easy for patients to communicate
with their providers and discuss questions or medical
concerns that arise after use of mifepristone—
without mandating multiple in-person visits that
may be difficult or impossible for patients to
accomplish given their personal circumstances or the
required distance they must travel. And, of course,
alleviating the requirement for follow-up visits in no
way prevents patients who prefer in-person
consultation from doing that instead.
FDA’s subsequent decision in 2021, formalized in
2023, to eliminate the in-person dispensing
requirement and to permit distribution of
mifepristone by mail similarly improved patient
outcomes, using telehealth combined with mail
distribution to improve patient access. And in any
case where there is a need or concern, patients can
be and are seen in person by a clinician.
The growth of telehealth, which is now widely
utilized across many areas of practice including
reproductive care, is another (and perhaps one of the
most important) means to alleviate barriers to care
and improve health outcomes in the United States.
Many health care clinics—including brick-andmortar locations—offer comprehensive telehealth
services, and reproductive care providers are no
different.
LABELING CHANGES AND ONGOING MONITORING EFFORTS 15
(2018) (summarizing studies).
39
See infra p.23.
23
The latest data, collected from more than 6,000
patients in 20 states, shows that “[t]elehealth
medication abortion is effective, safe, and
comparable to published rates of in-person
medication abortion care.” 40 Reproductive health
clinics and providers 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, all of which enable the provision
of care with fewer in-person visits. For prescription
of mifepristone for use in medication abortion or
early pregnancy loss, telehealth protocols offer the
same protections as in-person dispensing and
provide an equivalent level of care. 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
medical eligibility—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.41
Ushma D. Upadhyay et al., Effectiveness and Safety of
Telehealth Medication Abortion in the United States, NATURE
MED. (forthcoming 2024).
41
See Raymond & Bracken, supra n.18; 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
“mifepristone can be dispensed safely either in person or by
mail” and suggesting “the mifepristone label could be revised to
explicitly state that ultrasonography or clinical examination is
not required if pregnancy duration can be reasonably estimated
by history and if no symptoms or risk factors for ectopic
pregnancy are present”); 2000 FDA Approval Memorandum,
2:22-CV-00223-Z, Nov. 18, 2022, Compl. Ex. 24, ECF No. 1-25,
40
24
FDA continues to require involvement of a
specially trained practitioner for telehealth visits,
but allows that provider to prescribe mifepristone,
and the patient to use it, without in-person
dispensing. Under FDA’s current approach, instead
of being required to physically retrieve the
medication from a doctor’s office or certified
pharmacy,42 the patient can have it delivered to her
home after being evaluated by a clinician (via
telehealth or in person) and counseled regarding the
medication, including its administration and side
effects. Then, instead of being expected to return to
the provider’s office to confirm she is no longer
pregnant, the patient can answer a series of
questions asked by the provider, take an at-home
pregnancy or blood test and communicate the results
to her provider via telehealth.
Amici do not believe their patients would be
better served by returning to an era that mandated
repeated, wholly unnecessary office visits for the
prescription and use of an exceedingly safe
medication, and are aware of no medical basis to
exclude those in need of reproductive care from
accessing it through telemedicine. Although some
patients will continue to prefer in-person care,
telehealth provides an important alternative and
offers substantial benefits for patients who choose it.
In a study of 1,600 patients who received abortion
at 6 (“In practice, dating pregnancies occurs through using
other clinical methods, as well as through using ultrasound.”).
42
As of January 2024, no major national retail pharmacy has
received certification, though some had applied. See, e.g.,
Walgreens, Walgreens and Mifepristone: The Facts (last visited
Jan.
26,
2024),
https://www.walgreensbootsalliance.com/walgreens-andmifepristone-facts.
25
care through telemedicine, “nearly all participants
were very satisfied with telehealth abortion”—96% of
those surveyed felt it was the right decision—and
patients reported that choosing telehealth not only
made care more accessible, but allowed them to
receive care quickly, privately, at lower cost, and in
the comfort of their own home.43
The position advanced by Respondents that
telehealth should not be available to patients in need
of reproductive care who live in areas without access
to in-person providers—healthcare deserts—because
they fear patients in those areas will not have access
to “emergency care” is both misguided and
inconsistent with the facts. Access to a demonstrably
safe medication that can be taken at home is not
adding risk to these geographies. The fact that a
patient lacks a local provider is not a basis to deny
them ibuprofen; it should not be a basis to deny them
another medication that is just as safe because it is
used for reproductive care.
Speculation that removing the in-person
dispensing requirement from mifepristone labeling
increases risk to patients smacks of fearmongering,
not facts.
Study after study—and years of
experience—confirm this is demonstrably false.
Mifepristone has been available by mail since FDA’s
2021 determination, and in those three-plus years,
amici’s members have observed no change
whatsoever in the incidence of adverse events from
mifepristone and have no reason to expect that to
change if FDA’s determination remains in effect.
See Leah R. Koenig et al., Patient Acceptability of
Telehealth Medication Abortion Care in the United States,
2021࣓2022: A Cohort Study, AM. J. PUB. HEALTH (2024),
published
online
ahead
of
print,
https://doi.org/10.2105/AJPH.2023.307437.
43
26
The percentage of patients that ever visit an
emergency room for abortion-related complications
remains exceedingly small,44 and the underlying
manner in which the medication is prescribed does
not alter its safety profile.
The drug itself is
exceptionally safe, and that remains true regardless
of whether it is handed to a patient in person or
shipped by mail.
IV.
Restricting the Use of Mifepristone Will
Harm Pregnant Patients and Have
Severe Negative Impacts on the Broader
Health Care System.
Amici are concerned that if the Fifth Circuit’s
decision is allowed to stand, it will impair access to
mifepristone nationwide—even for miscarriage
management and even in states where abortion
remains legal—and endanger pregnant patients.
Fundamentally, mifepristone is one of the most
safe and effective medications used to provide
abortion care or treat early pregnancy loss. Without
it, pregnancy will be even more dangerous than it
already is. To date, the empirical evidence shows
that women are at least 14 times more likely to die
during childbirth than during any abortion
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).
44
27
procedure 45 and are at an increased risk of
experiencing hemorrhage, infection, and injury to
other organs during pregnancy and childbirth.46
Even under the best of circumstances, pregnancy and
childbirth impose significant physiological changes
that can exacerbate underlying conditions and
severely
compromise
health,
sometimes
permanently.47
Pregnancy, particularly when
coupled with preexisting conditions, can quickly
See Elizabeth G. Raymond & David A. Grimes, The
Comparative Safety of Legal Induced Abortion and Childhood
in the Unites States, 119 OBSTET. & GYNECOL. 215, 216 tbl.1
(2012). The U.S. mortality rate associated with live births from
1998 to 2005 was 8.8 deaths per 100,000 live births. Id. Rates
have sharply increased since then, and the average U.S.
maternal mortality rate associated with live births from 2018 to
2021 was 23.6. See Donna L. Hoyert, Maternal Mortality Rates
in the United States, 2021, CENTERS FOR DISEASE CONTROL AND
PREVENTION (last reviewed Mar. 16, 2023). By contrast, the
mortality rate associated with abortions performed from 2013
to 2020 was 0.45 deaths per 100,000 legal procedures. See
Katherine Kortsmit et al., Abortion Surveillance—United
States, 2021, 72 CDC MORBIDITY & MORTALITY WKLY. REP. 1
(2023). A committee of the National Academies in a 2018 peerreviewed, 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 n.20, at 74.
46
See Raymond & Grimes, supra n.45, at 216–17 fig.1.
47
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. 183, Postpartum
Hemorrhage (Oct. 2017).
45
28
evolve into a life-threatening situation necessitating
critical care.
The dangers of pregnancy in the U.S. are far
greater for women of color, low-income women, and
those living in rural areas.48 These populations are
most likely to experience severe maternal morbidity,
more likely to die from pregnancy-related
complications, and are disproportionately harmed by
restrictions on abortion care. 49 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.”50 Pregnant
people of color are also more likely to experience
early pregnancy loss or miscarriage, the treatment
for which can include mifepristone.51
Reimposing
unnecessary
restrictions
on
mifepristone will exacerbate these existing inequities
and pose the greatest danger to those who are
already the most poorly served by our maternal
health system. These patients are among those who
have benefitted most from increased access to care
See Latoya Hill et al., Racial Disparities in Maternal and
Infant Health: Current Status and Efforts to Address Them,
KFF (Nov. 2022); Office of Minority Health, Advancing Rural
Maternal Health Equity, CTRS. FOR MEDICARE & MEDICAID
SERVS., at 1 (2022).
49
See Rachel K. Jones et al., COVID-19 Abortion Bans and
Their Implications for Public Health, 52 PERSPS. ON 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 POOR & UNDERSERVED 415,
416-17 (2011); ACOG Committee Opinion No. 815, Increasing
Access to Abortion (Dec. 2020).
50
Id.
51
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).
48
29
through telemedicine and who will suffer most from
its loss. For example, one recent study found that for
patients who are low-income, rural, or persons of
color, and were able to obtain timely abortion care,
approximately half were able to do so specifically
because of telehealth.52
If this Court is to consider whether patient care
is improved or undermined by FDA’s actions, it
ought to consider the substantial evidence
demonstrating that denial of abortion care causes
harm. Patients who are denied requested abortion
care are more likely to experience intimate partner
violence compared with patients who were able to
access this care. 53 Forced pregnancy undermines
maternal and fetal health and exacerbates the risks
inherent in pregnancy itself.54
Studies have
repeatedly shown that being denied an abortion not
only leads to worse health outcomes, but exacerbates
patients’ economic hardships, revealing “large and
statistically
significant
differences
in
the
socioeconomic trajectories of women who were denied
See Leah R. Koenig et al., The Role of Telehealth in
Promoting Equitable Abortion Access in the United States:
Spatial Analysis, JMIR PUB. HEALTH & SURVEILLANCE (2023)
(finding, in part, that “telehealth made it possible to obtain
timely abortion care . . . [for] patient populations who are
known to face the most structural barriers to abortion care,
such as younger people, those experiencing food insecurity,
those residing in rural areas, and those who resided far from an
abortion facility”).
53
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).
54
See Nadine El-Bawab et al., In post-Roe America, Women
Detail Agony of Being Forced to Carry Nonviable Pregnancies to
Term (Dec. 14, 2023), https://abcnews.go.com/US/post-roeamerica-women-detail-agony-forced-carry/story?id=105563349.
52
30
requested abortions compared with women who
received abortions—with women denied abortions
facing more economic hardships.”55 These effects are
not isolated; many patients seeking abortion have
children already, and the dangers to them—
physically, emotionally, and economically—ripple
outwards within each family and community. As
medical providers throughout the country, amici are
seriously concerned that making it more difficult to
obtain mifepristone will make it more difficult to
provide medication abortion care to those who need
or seek it, consistent with the current standard of
care. This alone endangers patients.
Restricting access to mifepristone endangers
anyone who is pregnant—because its use in the
practice of medicine goes far beyond abortion care.
Mifepristone has critical off-label uses in maternal
care beyond abortion,56 and, as mentioned, is widely
prescribed for management and treatment of
miscarriages,
including
spontaneous,
missed,
57
inevitable, and incomplete abortions.
Nearly one
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).
56
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).
57
See ACOG Practice Bulletin No. 200, supra n.5; see also
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),
https://www.npr.org/sections/healthshots/2019/01/10/666957368/a-drug-that-eases-miscarriages-isdifficult-for-women-to-get.
55
31
out of every five women who becomes pregnant will
experience a miscarriage at some point in her life—
more than a million patients each year.58 Untreated,
miscarriage can occur over two to eight weeks,
exacerbating the emotional strain of pregnancy
loss. 59
Amici’s members frequently prescribe
mifepristone when a patient is experiencing early
pregnancy loss because it can ease the process and
lead to better health outcomes. 60 Patients already
enduring miscarriage should not be forced to suffer
through limited access to a safe and effective
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).61 Mifepristone
is also used off-label to reduce the duration of
bleeding or hemorrhaging during certain serious
pregnancy complications. 62 Restricting access to
See supra n.9.
See Carla Dugas & Valori H. Slane, supra n.9 (stating that
“[a]pproximately 80% of women achieve complete passage of
intrauterine contents within 8 weeks”).
60
See, e.g., ACOG Practice Bulletin No. 200, supra n.5;
Jessica Beaman et al., Medication to Manage Abortion and
Miscarriage, 35 J. GEN. INTERNAL MED. 2398, 2400 (2020).
61
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).
62
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).
58
59
32
mifepristone will prevent patients from receiving
much-needed treatment for these conditions as well.
In short, Respondents should not be permitted to
undermine the nation’s longstanding drug approval
system or deny patients and providers access to a
safe and effective medication used to promote
maternal health based on their opposition to
abortion.
CONCLUSION
For the reasons set forth above, amici urge this
Court to reverse the Fifth’s Circuit’s decision.
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
33
MOLLY MEEGAN
JESSICA MORRIS
NAEMA MALLICK
AMERICAN COLLEGE OF OBSTETRICIANS
AND GYNECOLOGISTS
409 12th Street, SW
Washington, DC 20024
(202) 638-5577
mmeegan@acog.org
jmorris@acog.org
nmallick@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.