Amicus Curiae Brief — Danco Laboratories, L.L.C., Petitioner v. Alliance for Hippocratic Medicine, et al.

Supreme Court briefOct 12, 2023

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Text

Nos. 23-235, 23-236

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In The

Supreme Court of the United States

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

Petitioners,

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

---------------------------------♦--------------------------------DANCO LABORATORIES, L.L.C.,

Petitioner,

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

---------------------------------♦--------------------------------On Petitions For Writs Of Certiorari

To The United States Court Of Appeals

For The Fifth Circuit

---------------------------------♦--------------------------------BRIEF OF AMICI CURIAE

NATIONAL ASSOCIATION OF NURSE

PRACTITIONERS IN WOMEN’S HEALTH,

AMERICAN COLLEGE OF NURSE-MIDWIVES,

AMERICAN ACADEMY OF PHYSICIAN ASSOCIATES,

AND ASSOCIATION OF PHYSICIAN ASSOCIATES

IN OBSTETRICS AND GYNECOLOGY

IN SUPPORT OF PETITIONERS’

PETITIONS FOR WRITS OF CERTIORARI

---------------------------------♦--------------------------------425 Lexington Avenue

JONATHAN K. YOUNGWOOD

New York, NY 10017

Counsel of Record

JYoungwood@stblaw.com

SIMONA G. STRAUSS

SStrauss@stblaw.com

CLAIRE E. CAHOON

Claire.Cahoon@stblaw.com

ISABEL R. MATTSON

Isabel.Mattson@stblaw.com

SIMPSON THACHER &

(212) 455-2000

BARTLETT LLP

================================================================================================================

COCKLE LEGAL BRIEFS (800) 225-6964

WWW.COCKLELEGALBRIEFS.COM

TABLE OF CONTENTS

Page

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

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

ARGUMENT ........................................................

II.

ADVANCED PRACTICE CLINICIANS

MUST SATISFY RIGOROUS EDUCATION AND CERTIFICATION REQUIREMENTS TO PROVIDE THE BROAD

SCOPE OF HEALTH CARE THEY ROUTINELY PROVIDE ....................................

ADVANCED PRACTICE CLINICIANS

PROVIDE SAFE AND EFFECTIVE

ABORTION CARE ..................................... 10

A. Advanced Practice Clinicians Achieve

the Same, or Better, Health Outcomes

as Physicians When Providing Medication Abortion .......................................... 11

B. Advanced Practice Clinicians Regularly

and Safely Provide Aspiration Abortions, Just as Physicians Do .................. 14

C. The Ability of Advanced Practice Clinicians to Prescribe Mifepristone Improves

Already Exceedingly Safe Abortion

Care ........................................................ 17

III.

ADVANCED PRACTICE CLINICIANS

REGULARLY PROVIDE HEALTH CARE,

INCLUDING CHILDBIRTH CARE, THAT

IS EQUALLY OR MORE COMPLEX THAN

MEDICATION ABORTION ........................ 19

TABLE OF CONTENTS – Continued

Page

A. Medication Abortion Is More Straightforward Than Much of the Health Care

Provided by APCs .................................. 20

B. Advanced Practice Clinicians Provide

Prenatal and Labor Care That Is As

Safe and Effective, If Not More So, As

the Care Provided by Physicians ........ 22

IV.

MAINSTREAM MEDICAL AND PUBLIC

HEALTH GROUPS OVERWHELMINGLY

SUPPORT THE PROVISION OF MEDICATION ABORTION CARE BY APCS ..... 24

CONCLUSION..................................................... 29

iii

TABLE OF AUTHORITIES

Page

OTHER AUTHORITIES

Defs.’ Opp. to Pls.’ Mot. for Prelim. Inj., ECF No.

28-1, Alliance for Hippocratic Medicine v. U.S.

Food and Drug Administration (N.D. Tex. No.

2:22-cv-99223-Z) (“Defs.’ Opp.”) ..............................10

Adv. Pract. Educ. Ass’n, How Should Nurse Practitioners List Their Credentials, https://www.

apea.com/blog/How-Should-Nurse-PractitionersList-Their-Credentials-26/ ........................................6

Aimee C. Holland et al., Preparing for Intrauterine Device Consults and Procedures, Women’s

Healthcare (2020)....................................................21

Am. Acad. PAs, 2023-2024 Policy Manual 97

(2023), https://www.aapa.org/download/116915/

?tmstv=1690405277 ................................................27

Am. Acad. PAs, PA Prescribing (2020), https://

www.aapa.org/download/61323/?tmstv=1696

531381 ................................................................. 5, 21

Am. Acad. PAs, PA Scope of Practice (2019),

https://www.aapa.org/download/61319/?tmstv

=1696532297 ....................................................... 9, 10

Am. Acad. PAs, PAs in Obstetrics and Gynecology

(2021), https://www.aapa.org/download/19515/ .... 9, 27

Am. Ass’n Nurse Pract., Discussion Paper: Scope

of Practice for Nurse Practitioners (2022), https://

storage.aanp.org/www/documents/advocacy/

position-papers/Scope-of-Practice.pdf ......................5

TABLE OF AUTHORITIES – Continued

Page

Am. Ass’n Nurse Pract., State Practice Environment, https://www.aanp.org/advocacy/state/

state-practice-environment ......................................6

Am. Coll. Nurse-Midwives, Definition of Midwifery and Scope of Practice of Certified

Nurse-Midwives and Certified Midwives

(2021), https://www.midwife.org/acnm/files/acnm

librarydata/uploadfilename/000000000266/

Definition%20Midwifery%20Scope%20of%20

Practice_2021.pdf .................................................. 7, 8

Am. Coll. Nurse-Midwives, Midwives as Abortion

Providers (2019), http://www.midwife.org/acnm/

files/acnmlibrarydata/uploadfilename/000000

000314/PS-Midwives-as-Abortion-ProvidersFINAL-August-2019.pdf .........................................27

Am. Coll. Obstetricians & Gynecologists, Medication Abortion Up to 70 Days of Gestation

Practice Bulletin (2020), https://www.acog.org/

clinical/clinical-guidance/practice-bulletin/

articles/2020/10/medication-abortion-up-to70-days-of-gestation ................................................15

Am. Coll. of Obstetricians & Gynecologists, Abortion Training and Education, Committee Opinion No. 612 (2022), https://www.acog.org/ClinicalGuidance-and-Publications/Committee-Opinions/

Committee-on-Health-Care-for-UnderservedWomen/Abortion-Training-and-Education ...... 25, 26

TABLE OF AUTHORITIES – Continued

Page

Am. Coll. of Obstetricians & Gynecologists, Early

Pregnancy Loss Practice Bulletin (2018),

https://www.acog.org/clinical/clinical-guidance/

practice-bulletin/articles/2018/11/early-pregnancyloss ...........................................................................20

Am. Med. Ass’n, State Law Chart: Nurse Practitioner Prescriptive Authority (2017), https://

www.ama-assn.org/sites/ama-assn.org/files/

corp/media-browser/specialty%20group/arc/

ama-chart-np-prescriptive-authority.pdf .................5

Am. Med. Women’s Ass’n, Position Paper on Principals of Abortion & Access to Comprehensive

Reproductive Health Services, https://www.am

wa-doc.org/wp-content/uploads/2018/05/Abortionand-Access-to-Comprehensive-ReproductiveHealth-Services.pdf .................................................26

Am. Pub. Health Ass’n, Provision of Abortion Care

by Advanced Practice Nurses and Physician

Assistants (2011), https://www.apha.org/policiesand-advocacy/public-health-policy-statements/

policy-database/ 2014/07/28/16/00/provisionof-abortion-care-by-advanced-practice-nursesand-physician-assistants .................................. 21, 25

Amy J. Levi & Tara Cardinal, Early Pregnancy

Loss Management for Nurse Practitioners and

Midwives, Women’s Healthcare: A Clinical

Journey for NPs (2016) ..................................... 15, 20

TABLE OF AUTHORITIES – Continued

Page

Amy Levi et al., Training in aspiration abortion

care: An observational cohort study of achieving procedural competence, 88 Int’l J. Nursing

Studies 55 (2018).....................................................16

Anand Tamang et al., Comparative satisfaction

of receiving medical abortion service from

nurses and auxiliary nurse-midwives or doctors in Nepal: results of a randomized trial, 14

Reproductive Health 1 (2017) ........................... 13, 14

Andrea Carson et al., Nurse practitioners on ‘the

leading edge’ of medication abortion care: A

feminist qualitative approach, 79 J. Adv. Nursing 686 (2023) ..........................................................14

Candice Chen et al., Who is providing contraception care in the United States? An observational

study of the contraceptive workforce, 226 Am.

J. Obstetrics & Gynecology E1 (2021) ....................19

Carole Joffe & Susan Yanow, Advanced Practice

Clinicians as Abortion Providers: Current Developments in the United States, 12 Reproductive Health Matters Supp. 198 (2004) ....................17

Courtney B. Jackson, Expanding the Pool of

Abortion Providers: Nurse-Midwives, Nurse

Practitioners, and Physician Assistants,

Women’s Health Issues (2011)................................21

D. Taylor et al., Advanced practice clinicians as

abortion providers: preliminary findings from

the California primary care initiative, 80 Contraception 199 (2009) ..............................................18

vii

TABLE OF AUTHORITIES – Continued

Page

David I. Auerbach et al., Growing Ranks of Advanced Practice Clinicians – Implications for

the Physician Workforce, 378 N. Engl. J. Med.

2358 (2018) ..............................................................18

Dorothy Brooten et al., A Randomized Trial of

Nurse Specialist Home Care for Women with

High-Risk Pregnancies: Outcomes and Costs,

7 Am. J. Managed Care 793 (2008) ................... 23, 24

Dr. IK Warriner et al., Can midlevel health-care

providers administer early medical abortion

as safely and effectively as doctors? A randomised controlled equivalence trial in Nepal, 377

Lancet 1155 (2011) ..................................................13

Eva Patil & Blair Darney et al., Aspiration Abortion with Immediate Intrauterine Device Insertion: Comparing Outcomes of Advanced

Practice Clinicians and Physicians, 61 J. Midwifery & Women’s Health 325 (2016) .....................16

Grant R. Martsolf et al., Employment of Advance

Practice Clinicians in Physician Practice, 178

JAMA Intern. Med. (2018), https://www.ncbi.

nlm.nih.gov/pmc/articles/PMC6126674/ ................22

H. Kopp Kallner et al., The Efficacy, Safety and

Acceptability of Medical Termination of Pregnancy Provided by Standard Care by Doctors

or by Nurse-midwives: A Randomised Controlled Equivalence Trial, 122 BJOG: Int’l J.

Obstetrics & Gynecology 510 (2014) ................ 12, 13

viii

TABLE OF AUTHORITIES – Continued

Page

Hyungjung Lee et al., Determinants of rural-urban

differences in health care provider visits among

women of reproductive age in the United

States, 15 PLoS ONE, e0240700 (2020) .................19

Int’l Confed. Midwives, Position Statement: Midwives’ Provision of Abortion-Related Services

(2014), https://www.internationalmidwives.org/

assets/files/statement-files/2018/04/midwivesprovision-of-abortion-related-services-eng.pdf ........28

Kate Coleman-Minahan et al., Interest in Medication and Aspiration Abortion Training

Among Colorado Nurse Practitioners, Nurse

Midwives, and Physician Assistants, Women’s

Health Issues (2020) ...............................................15

Katy Backes Kozhimannil et al., Recent trends

in clinicians providing care to pregnant

women in the United States, 57 J. Midwifery

Womens Health 433 (2012) .....................................18

L. Porsch et al., Advanced practice clinicians

and medication abortion safety: A 10-year Retrospective Review, 101 Contraception 357

(2020) .......................................................................12

Mary Anne Freedman et al., Comparison of Complication Rates in First Trimester Abortions

Performed by Physician Assistants and Physicians, 76 Am. J. Public Health 550 (1986) ..............17

Mary Huynh, Provider Type and Preterm Birth

in New York City Births, 2009-2010, 25 J.

Health Care for the Poor and Underserved,

1520 (2014) ..............................................................23

TABLE OF AUTHORITIES – Continued

Page

Nat. Acad. Sci., Eng’g Med., The Safety and

Quality of Abortion Care in the United

States (2018), https://nap.nationalacademies.

org/catalog/24950/the-safety-and-quality-ofabortion-care-in-the-united-states .........................11

Nat’l Governors Ass’n, The Role of Nurse Practitioners in Meeting Increasing Demand for

Primary Care (2012) ............................................. 5, 6

NPWH, Reproductive Rights Policy Summary

(2022), https://cdn.ymaws.com/npwh.org/resource/

resmgr/positionstatement/npwh_reproductive_

rights_pol.pdf ..........................................................27

NPWH, Women’s Health Nurse Practitioner:

Guidelines for Practice and Education (8th

ed. 2022) .............................................................. 7, 27

Roderick S. Hooker et al., Forecasting the physician assistant/associate workforce: 2020-2035,

9 Future Healthcare J. 57 (2022) ...........................18

Sharmani Barnard et al., Doctors or mid-level

providers for abortion, Cochrane Database

Sys. R. (2015) ...........................................................11

Tim Dall et al., The Complexities of Physician

Supply and Demand: Projections from 2018 to

2030 (2021) ..............................................................18

Tracy A. Weitz et al., Safety of Aspiration Abortion

Performed by Nurse Practitioners, Certified

Nurse Midwives, and Physician Assistants

Under a California Legal Waiver, 103 Am. J.

Pub. Health 454 (2013) ..................................... 16, 20

TABLE OF AUTHORITIES – Continued

Page

U.S. Dep’t of Justice, Diversion Control Division,

Mid-Level Practitioners Authorized by State,

https://www.deadiversion.usdoj.gov/drugreg/

practioners/index.html (last visited Oct. 7,

2023) ........................................................................21

Vivienne Souter et al., Comparison of Midwifery

and Obstetric Care in Low-Risk Hospital

Births, 134 Obstetrics & Gynecology 1056

(2019) .......................................................................23

Washington, DC, National Abortion Federation,

Symposium Report: Strategies for Expanding

Abortion Access: The Role of Physician Assistants, Nurse Practitioners, and Nurse-Midwives in Providing Abortions (1997) ......................26

World Health Organization, Abortion Care Guideline (2022), https://www.who.int/publications/

i/item/9789240039483 .............................................28

Y. Tony Yang et al., State Scope of Practice Laws,

Nurse-Midwifery Workforce, and Childbirth

Procedures and Outcomes, 26 Women’s Health

Issues 262 (2016).....................................................22

Yiska Lowenberg Weisband et al., Birth Outcomes

of Women Using a Midwife versus Women Using a Physician for Prenatal Care, 63 J. Midwifery & Women’s Health 399 (2018) .....................23

RECORD

Pet. U.S. Food and Drug Administration App’x at

17a ...........................................................................15

INTEREST OF AMICI CURIAE1

Amicus curiae National Association of Nurse

Practitioners in Women’s Health (“NPWH”) is the

national professional association for women’s health

nurse practitioners and advanced practice registered

nurses who provide women’s and gender-related

healthcare. NPWH sets a standard of excellence by

translating and promoting the latest women’s

healthcare research and evidence-based clinical

guidance, providing high quality continuing education,

and advocating for patients, providers, and the

women’s health nurse practitioner profession. NPWH’s

mission includes protecting and promoting women’s

and all individuals’ rights to make their own choices

regarding their health and well-being within the

context of their lived experience and their personal,

religious, cultural, and family beliefs.

Amicus curiae American College of NurseMidwives (“ACNM”) is the professional association

that represents certified nurse-midwives and certified

midwives in the United States. ACNM sets the

standard for excellence in midwifery education and

practice in the United States and strengthens the

capacity of midwives in developing countries.

Pursuant to Rule 37.6 of the Supreme Court of the United

States, counsel for Amici certify that no party’s counsel authored

this brief in whole or in part; no party or party’s counsel made a

monetary contribution intended to fund the preparation or

submission of this brief; and no person or entity other than Amici

or their counsel made such a monetary contribution. Pursuant to

Rule 37.2, counsel of record for the parties received timely notice

of Amici’s intent to file this brief.

Members of ACNM are primary care providers for

women throughout their lifespans, with a special

emphasis on pregnancy, childbirth, and gynecologic

and reproductive health. ACNM’s mission is to

support midwives, advance the practice of midwifery,

and achieve optimal, equitable health outcomes for

the people and communities midwives serve through

inclusion, advocacy, education, leadership development,

and research.

Amicus curiae American Academy of Physician

Associates (“AAPA”) is the national professional

association for physician associates/physician assistants

(“PAs”). AAPA advocates and educates on behalf of

the profession and the patients and communities

PAs serve. Its mission includes enhancing PAs’

ability to improve the quality, accessibility, and

cost-effectiveness of patient-centered healthcare, as

well as ensuring the professional growth, personal

excellence, and recognition of PAs.

Amicus curiae Association of Physician Associates

in Obstetrics and Gynecology (“APAOG”) is the

professional association representing Obstetrics and

Gynecologic Physician Associates in the United States.

APAOG supports PAs practicing obstetrics, gynecology,

and all of its subspecialties by advancing the role of

PAs to serve patients throughout their lifespan.

APAOG’s mission is to promote equitable patient care

through education, research, advocacy, inclusivity, and

leadership.

Amici are interested in this matter because they

care deeply about not only the advanced practice

clinicians (“APCs”) and qualified practitioners they

represent, but also the well-being of the women served

by APCs. Amici have extensive experience providing

reproductive healthcare, including aspiration and

medication abortion, which they have been doing for

many years. Amici highlight the overwhelmingly

positive outcomes for the hundreds of thousands of

women treated by APCs in reproductive health each

year. Amici have an interest in dispelling the

misinformed assumption, seemingly shared by

Respondents and the Fifth Circuit, that women

have better health outcomes when any medication

abortion care they may receive is provided by

physicians rather than APCs.

---------------------------------♦---------------------------------

SUMMARY OF ARGUMENT

Mifepristone is an essential component of the

safe and effective provision of reproductive healthcare

and has been used regularly nationwide for more

than two decades. Advanced practice clinicians

have safely prescribed mifepristone under physician

supervision since 2000 and, since the Food & Drug

Administration’s (“FDA”) 2016 changes to mifepristone’s

approved conditions of use, have routinely prescribed

the medication independently where permitted to do

so by state law.

Despite the overwhelming evidence that APCs

have been independently, effectively, and safely

prescribing mifepristone for years, the opinion issued

by the Fifth Circuit would prohibit APCs from

prescribing this medication as part of their scope of

practice.

This ruling ignores that APCs are crucial providers

of reproductive healthcare and are as qualified to

provide and as successful in providing medication

abortion as physicians, if not more so. In addition to

regularly providing medication abortion and aspiration

abortion care, APCs provide care and perform

procedures that are far more complex than medication

abortion. Moreover, depriving women of medication

abortion care by APCs would result in many women

being unable to receive the healthcare they require. It

is in part for these reasons that mainstream medical

and public health groups overwhelmingly support the

provision of medication abortion by APCs.

The petitions for writs of certiorari should be

granted.

---------------------------------♦---------------------------------

ARGUMENT

ADVANCED PRACTICE CLINICIANS MUST

SATISFY

RIGOROUS

EDUCATION

AND

CERTIFICATION

REQUIREMENTS

PROVIDE

THE

BROAD

SCOPE

HEALTHCARE THEY ROUTINELY PROVIDE.

APCs, which include certified women’s health

nurse practitioners, certified nurse-midwives, and

physician associates, are vital participants in the U.S.

healthcare system. They are licensed to provide a

broad range of health services consistent with their

heightened educational standards and rigorous

certification and continuing education requirements.

APCs have prescriptive authority in every state,

including for controlled substances.2 They are key

providers of primary, gynecological, maternity, acute,

and chronic care across the country, including for

low-income patients and those living in rural and

medically underserved areas.

NPs provide an extensive range of health services,

including diagnosing and treating acute and chronic

illnesses, prescribing and managing medications and

other therapies, providing immunizations, performing

procedures, ordering and interpreting lab tests and

x-rays, coordinating patient care, and providing health

education.3 NPs dispense these essential health

services in a wide variety of practice areas, including

family medicine, pediatrics, geriatrics, and women’s

health, among others.4

See Am. Med. Ass’n, State Law Chart: Nurse Practitioner

Prescriptive Authority (2017), https://www.ama-assn.org/sites/

ama-assn.org/files/corp/media-browser/specialty%20group/arc/

ama-chart-np-prescriptive-authority.pdf; Am. Acad. PAs, PA

Prescribing (2020), https://www.aapa.org/download/61323/?tmstv

=1696531381.

Am. Ass’n Nurse Pract., Discussion Paper: Scope of Practice

for Nurse Practitioners (2022), https://storage.aanp.org/www/

documents/advocacy/position-papers/Scope-of-Practice.pdf.

See Nat’l Governors Ass’n, The Role of Nurse Practitioners

in Meeting Increasing Demand for Primary Care 4 (2012).

NPs must satisfy rigorous educational and

certification requirements. First, NPs must obtain a

registered nurse license and complete several years of

graduate education at the masters, post-masters, or

doctoral level.5 NPs must pass a national certification

exam to receive the designation of Board-certified NP

(NP-BC) which is required for practice in a vast

majority of states.6 Certification testing assesses

the “applicant’s knowledge and skill in diagnosing,

determining treatments, and prescribing for their

patient population of focus.”7

The women’s health nurse practitioner (“WHNP”)

is prepared at the master’s or doctoral level to

provide holistic, client-centered primary care for

women from puberty through the adult lifespan,

with a focus on common and complex gynecologic,

sexual, reproductive, menopause-transition, and postmenopause healthcare; uncomplicated and highrisk antepartum and postpartum care; and sexual

and reproductive healthcare for men. The education,

certification, and practice of the WHNP are congruent

Id. at 8.

Id.; Adv. Pract. Educ. Ass’n, How Should Nurse

Practitioners List Their Credentials, https://www.apea.com/

blog/How-Should-Nurse-Practitioners-List-Their-Credentials-26/.

In forty-seven states, NPs must receive a certification from a

nationally recognized certified body; in the remaining three

states (California, Kansas, and New York), NPs must complete a

board-approved master’s degree with similar course requirements to

those accepted by one of the national certifying bodies. Am. Ass’n

Nurse Pract., State Practice Environment, https://www.aanp.org/

advocacy/state/state-practice-environment (last visited Oct. 7, 2023).

Nat’l Governors Ass’n, supra, at 8.

with the NP role and the women’s health population

focus. As a licensed healthcare provider, the WHNP

functions within the scope of practice rules and

regulations established by and pursuant to the nurse

practice act in the state(s) in which the WHNP is

licensed and works. The WHNP provides care in

outpatient, inpatient, community, and other settings,

both independently and collaboratively as a healthcare

team member. The role of the WHNP includes

providing consultation services to other healthcare

providers regarding the unique healthcare needs of

women. The WHNP provides leadership to improve

women’s healthcare and health outcomes in practice

settings, healthcare systems, and communities.8

WHNPs maintain certification and recertify every

three years through the National Certification Board

and are required to meet continuing education

requirements.

Like NPs, certified nurse-midwives (“CNMs”)

offer a wide array of health services: they provide

comprehensive assessment, diagnosis, and treatment

care; prescribe medications, including controlled

substances; admit, manage, and discharge patients;

order and interpret laboratory and diagnostic tests;

and provide wellness education and counseling.9

NPWH, Women’s Health Nurse Practitioner: Guidelines for

Practice and Education 2-3 (8th ed. 2022).

See Am. Coll. Nurse-Midwives, Definition of Midwifery and

Scope of Practice of Certified Nurse-Midwives and Certified

Midwives (2021), https://www.midwife.org/acnm/files/acnmlibrarydata/

uploadfilename/000000000266/Definition%20Midwifery%20

Scope%20of%20Practice_2021.pdf.

CNMs principally focus on the provision of patient care

during pregnancy, childbirth, and the postpartum period;

sexual and reproductive health; gynecologic health;

and family planning services, including preconception

care.10 CNMs also provide primary care for all ages.11

Education and certification requirements for CNMs

are exacting. Following completion of a bachelor’s

degree and a graduate midwifery education program,

CNMs must pass a national certification exam to

receive the designation of CNM (a title conferred on

those who have active RN credentials when they pass

the certification exam).12 CNMs must continuously

demonstrate that they meet the Core Competencies for

Basic Midwifery Practice of Amicus ACNM and are

required to practice in accordance with the ACNM

Standards for the Practice of Midwifery.13 The ACNM

competencies and standards are consistent with or

exceed the International Confederation of Midwives’

global midwifery competencies and standards.14 CNMs

must be recertified every five years through the

American Midwifery Certification Board and are

required to meet continuing education requirements.15

Similarly, PAs’ generalist clinical practice

includes taking medical histories, performing

physical examinations, ordering and interpreting

Id.

laboratory tests, diagnosing illness, developing and

managing treatment plans, prescribing medication,

including controlled substances, and assisting in

surgery.16 PAs play an integral role in a broad array of

clinical settings, including obstetrics and gynecology,

in both outpatient and in-hospital settings, providing

a wide range of care from the diagnosis and treatment

of acute and chronic gynecological conditions to

independently performing critical clinical procedures

such as vaginal deliveries, amniotomies, inseminations,

endometrial and vulvar biopsies, and loop excision

electrocoagulation procedures, and assisting in

surgeries.17

In order to become certified and licensed to

practice, PAs must first graduate from an accredited

master’s degree program, which spans three academic

years and employs a rigorous curriculum modeled on

the medical school program.18 Students take more than

75 hours in pharmacology, 175 hours in behavioral

sciences, 400 or more hours in basic sciences, and

nearly 580 hours of clinical medicine, and complete

over 2,000 hours of supervised clinical practice.19 PAs

must then pass the Physician Assistant National

Certifying Exam, become state-licensed, and, in order

to maintain national certification, must complete 100

Am. Acad. PAs, PA Scope of Practice (2019), https://www.

aapa.org/download/61319/?tmstv=1696532297.

See Am. Acad. PAs, PAs in Obstetrics and Gynecology

(2021), https://www.aapa.org/download/19515/.

Id.; PA Scope of Practice, supra.

PAs in Obstetrics and Gynecology, supra.

hours of continuing medical education every two years

and take a recertification exam every ten years.20

The rigorous education and certification

requirements for NPs, CNMs, and PAs belie any

notion that these groups of accomplished health

professionals are in any way unqualified to provide

medication abortion.

II.

ADVANCED PRACTICE CLINICIANS PROVIDE

SAFE AND EFFECTIVE ABORTION CARE.

In 2016, when the FDA approved a supplemental

new drug application from mifepristone’s sponsor that

changed the drug’s conditions for use and the FDA

Risk Evaluation and Mitigation Strategy (“REMs”) to

allow licensed healthcare providers (i.e., APCs) to

prescribe and dispense mifepristone, it considered

“data from over 3200 women in randomized controlled

trials and data on 596 women in prospective cohorts

comparing medical abortion care by” APCs with

that provided by physicians, all of which “clearly

demonstrate[d] that efficacy is the same,” if not better,

with APCs compared to physicians. Defs.’ Opp. to Pls.’

Mot. for Prelim. Inj., ECF No. 28-1 at 48-49, Alliance

for Hippocratic Medicine v. U.S. Food and Drug

Administration (N.D. Tex. No. 2:22-cv-99223-Z) (“Defs.’

Opp.”). And, like physicians, APCs also regularly provide

safe and effective aspiration abortions, including,

if necessary, as follow-up care after a medication

PA Scope of Practice, supra.

abortion. Additionally, APCs enable people to access

abortion care earlier in a pregnancy, when such care is

even more safe and effective. Given the overwhelming

body of scientific evidence before it, the FDA

unsurprisingly removed conditions restricting APCs’

ability to be certified prescribers of mifepristone.

A. Advanced Practice Clinicians Achieve the Same,

or Better, Health Outcomes as Physicians

When Providing Medication Abortion.

Peer-reviewed studies have long established

that APCs provide medication abortions as safely

and effectively as physicians, if not more so. Indeed,

after a comprehensive review of medical literature on

the safety of abortion, the National Academies of

Science, Engineering, and Medicine, the non-partisan,

non-governmental institution set up to advise the

nation on issues related to those disciplines, concluded

that “[b]oth trained physicians (OB/GYNs, family

medicine physicians, and other physicians) and APCs

(physician assistants, certified nurse-midwives, and

nurse practitioners) can provide medication and

aspiration abortions safely and effectively.”21 A tenyear retrospective review of patients who initiated

Nat. Acad. Sci., Eng’g Med., The Safety and Quality of

Abortion Care in the United States 14 (2018), https://nap.national

academies.org/catalog/24950/the-safety-and-quality-of-abortioncare-in-the-united-states; see also Sharmani Barnard et al.,

Doctors or mid-level providers for abortion, Cochrane Database

Sys. R. (2015) (concluding that there was no statistically

significant difference in risk of failure for medication abortions

performed by APCs compared with physicians in comparative

review of studies assessing medication abortion outcomes).

medication abortion from 2009 to 2018 further

supports the safe and effective outcomes of

medication abortion provided by APCs.22 The

researchers concluded that these outcomes were

well within the published benchmarks for medication

abortion effectiveness and safety for medication

abortion provided by physicians.23

In fact, some research shows that APCs may

provide medication abortions with greater efficacy and

patient acceptability than physicians. For example,

one of the studies cited by the FDA in connection with

the 2016 REMS review was a randomized study of

1180 women who received medication abortions

that concluded that nurse-midwives’ provision of

medication abortion had “superior efficacy” over that

provided by physicians.24 The study found that 99% of

the 481 women treated by nurse-midwives did not

require further intervention (i.e., follow-up aspiration

or surgery to complete the abortion), and 95.8%

experienced no complications following the medication

abortion (compared to 97.4% and 93.5%, respectively,

See L. Porsch et al., Advanced practice clinicians and

medication abortion safety: A 10-year Retrospective Review, 101

Contraception 357, 357 (2020).

Id.

See H. Kopp Kallner et al., The Efficacy, Safety and

Acceptability of Medical Termination of Pregnancy Provided by

Standard Care by Doctors or by Nurse-midwives: A Randomised

Controlled Equivalence Trial, 122 BJOG: Int’l J. Obstetrics &

Gynecology 510, 515 (2015).

for women treated by physicians).25 Moreover, women

who met with nurse-midwives were significantly more

likely to express a preference for nurse-midwives if

they ever required another medication abortion in the

future.26

Similarly, another FDA-cited randomized study

of 1295 women who received medication abortions

found that abortions provided by government-trained,

certified nurses and auxiliary nurse midwives did not

pose any higher risk of failure or incomplete abortions

compared to those provided by physicians.27 In fact,

97.3% of the medication abortions provided by certified

nurses or auxiliary nurse midwives were completed

without further intervention, as compared to 96.1% of

those provided by physicians.28 A later review of data

collected in that same study found that of the women

who received care from certified nurses and auxiliary

nurse midwives, 38% reported being highly satisfied

with their care and 62% reported being satisfied,

reflecting a 100% satisfaction rate, compared to 35%,

64%, and 99% for physicians, respectively.29

Id. at 514. None of the 1180 women participating in the

study experienced any serious complications, across provider

groups. Id. at 513.

Id.

Dr. IK Warriner et al., Can midlevel health-care providers

administer early medical abortion as safely and effectively as

doctors? A randomised controlled equivalence trial in Nepal, 377

Lancet, 1155, 1155-61 (2011).

Id.

Anand Tamang et al., Comparative satisfaction of receiving

medical abortion service from nurses and auxiliary nurse-midwives

Further, APCs working with physicians often take

on leadership roles, educating the physicians about

medication abortion or being asked to take the lead on

patients who are under a physician’s care. A 2022

qualitative study of NPs who provide medication

abortion in Canada found that NPs commonly “educat[ed]

physician colleagues about mifepristone.”30 One NP

who participated in the study explained that she provided

a number of physician-attended information sessions

and held one-on-ones to answer physician questions,

and that she understood “that [her] role was to try to

teach [the physicians]” about medication abortion.31

“There’s a lack of [provider] knowledge [about

medication abortion],” she explained, but it has “been

a lot better since I’ve been able to inform them” and

“orient them toward the best treatment for the patient.”32

B. Advanced Practice Clinicians Regularly

and Safely Provide Aspiration Abortions,

Just as Physicians Do.

APCs also safely and effectively provide aspiration

abortions. Aspiration abortion involves the dilation of

or doctors in Nepal: results of a randomized trial, 14 Reproductive

Health 1, 1 (2017). Significantly, there is a conspicuous but telling

absence of studies or empirical data suggesting that medication

abortion in states that prohibit APCs from providing this care is

any more safe or effective than in states that allow APCs to do so.

Andrea Carson et al., Nurse practitioners on ‘the leading

edge’ of medication abortion care: A feminist qualitative approach,

79 J. Adv. Nursing 686, 690 (2023).

Id. at 690-91.

Id. (alteration in original).

the cervix and the use of a curette to remove the

uterine contents through gentle suction; the identical

procedure is used to evacuate a patient’s uterus in the

event of an incomplete miscarriage.33 Aspiration

abortion may be performed to terminate a pregnancy

or as follow-up care in the rare instance of a failed

medication abortion.34

The Fifth Circuit suggested that emergency room

physicians would be responsible for providing aspiration

abortions in the unlikely event such care is needed

following a medication abortion. See Pet. U.S. Food &

Drug Administration App’x at 17a. In so doing, it

incorrectly assumed that APCs cannot safely and

effectively perform this procedure for abortion and/or

miscarriage care. That is demonstrably wrong, and

evidence confirms that APCs provide aspiration abortion

with the same safety and efficacy as physicians.

For example, in one study, researchers compared

5,812 aspiration procedures performed by physicians

with 5,675 aspiration procedures performed by APCs

See Kate Coleman-Minahan et al., Interest in Medication

and Aspiration Abortion Training Among Colorado Nurse

Practitioners, Nurse Midwives, and Physician Assistants,

Women’s Health Issues 167, 169 (2020); Amy J. Levi & Tara

Cardinal, Early Pregnancy Loss Management for Nurse

Practitioners and Midwives, Women’s Healthcare: A Clinical

Journey for NPs 43, 44 (2016).

Am. Coll. Obstetricians & Gynecologists, Medication

Abortion Up to 70 Days of Gestation Practice Bulletin (2020),

https://www.acog.org/clinical/clinical-guidance/practice-bulletin/

articles/2020/10/medication-abortion-up-to-70-days-of-gestation.

over a span of four years.35 The study concluded

that abortion “care provided by newly trained NPs,

CNMs, and PAs was not inferior to that provided

by experienced physicians.”36 With regard to major

complications, the study found that there was no

significant difference in terms of risk between provider

groups.37 The results “confirm[ed] existing evidence

from smaller studies that the provision of abortion[s]

by [NPs, CNMs, and PAs] is safe and from larger

international and national reviews that have found

these clinicians to be safe and qualified health care

providers.”38

See Tracy A. Weitz et al., Safety of Aspiration Abortion

Performed by Nurse Practitioners, Certified Nurse Midwives, and

Physician Assistants Under a California Legal Waiver, 103 Am. J.

Pub. Health 454, 457 (2013).

Id. at 458.

Id. at 459.

Id.; see also Eva Patil & Blair Darney et al., Aspiration

Abortion with Immediate Intrauterine Device Insertion: Comparing

Outcomes of Advanced Practice Clinicians and Physicians, 61 J.

Midwifery & Women’s Health 325, 329 (2016) (finding no

clinically significant differences between aspiration abortions

followed by IUD insertions performed by physicians or by APCs);

Amy Levi et al., Training in aspiration abortion care: An

observational cohort study of achieving procedural competence, 88

Int’l J. Nursing Studies 55, 57 (2018) (concluding that

“complication rates did not differ significantly between

[aspiration abortion] procedures performed by [APC trainees] and

physician residents” and there was “no difference between the

complications experienced in training and those found when the

clinicians worked without direct supervision” following a study of

a competency-based training model teaching NPs, CNMs, and PAs

to perform vacuum aspiration abortion care).

Further buttressing these studies, PAs have a

long history of successfully providing aspiration

abortions, and performed surgical abortions in states

such as Vermont and Montana as early as 1973.39

An early study analyzing the outcomes of firsttrimester surgical abortions performed in a Vermont

clinic found that of 2,458 first trimester abortions,

those performed by physician assistants presented

a 2.74% complication rate as compared with a

3.08% complication rate for abortions performed by

physicians.40

C. The Ability of Advanced Practice Clinicians

to Prescribe Mifepristone Improves Already

Exceedingly Safe Abortion Care.

Although abortion is safe at any stage of

pregnancy, safety increases the earlier the care is

provided. See Defs.’ Opp., ECF No. 28-2, at 21. It

is no surprise, then, that participation by trained

APCs in abortion care improves both patient safety

and overall outcomes, as it allows early diagnosis

and management of unintended pregnancies and

Carole Joffe & Susan Yanow, Advanced Practice Clinicians

as Abortion Providers: Current Developments in the United States,

12 Reproductive Health Matters Supp. 198, 199 (2004).

Mary Anne Freedman et al., Comparison of Complication

Rates in First Trimester Abortions Performed by Physician

Assistants and Physicians, 76 Am. J. Public Health 550, 550

(1986).

integrated abortion and early pregnancy care, thereby

reducing delays and unnecessary referrals.41

APCs are, and will likely continue to be, easier to

access than physicians for healthcare as a general

matter. Demand for healthcare is projected to continue

to outpace supply. Significantly, the number of

physicians is expected to increase annually by only

1.1% from 2016 to 2030, while the number of APCs is

expected to increase more rapidly, with a predicted

6.8% increase in NPs annually during that same

period and a predicted 35% increase of clinically active

PAs from 2020 to 2035.42

With respect to reproductive healthcare specifically,

from 2000 to 2009 alone, the percentage of women

who reported receiving maternity care from a

midwife, NP, or PA increased 4% annually, indicating

a cumulative increase of 48% over the decade.43 APCs

also are “important contraception providers” in the

D. Taylor et al., Advanced practice clinicians as abortion

providers: preliminary findings from the California primary care

initiative, 80 Contraception 199, 199 (2009).

David I. Auerbach et al., Growing Ranks of Advanced

Practice Clinicians – Implications for the Physician Workforce,

378 N. Engl. J. Med. 2358, 2359 (2018); Tim Dall et al., The

Complexities of Physician Supply and Demand: Projections from

2018 to 2030 (2021), https://www.aamc.org/media/54681/download;

Roderick S. Hooker et al., Forecasting the physician assistant/

associate workforce: 2020-2035, 9 Future Healthcare J. 57, 57

(2022).

Katy Backes Kozhimannil et al., Recent trends in

clinicians providing care to pregnant women in the United States,

57 J. Midwifery Womens Health 433, 433 (2012).

reproductive healthcare landscape.44 The increased

role of APCs in providing reproductive healthcare is

especially pronounced in rural areas, where lower

OB-GYN availability means patients rely on NPs and

PAs at higher rates for their reproductive healthcare

needs.45 The relative availability of APCs as compared

to physicians means that patients seeking medication

abortion can access professional healthcare earlier,

thereby lowering already low complication rates.

III.

ADVANCED

PRACTICE

CLINICIANS

REGULARLY

PROVIDE

HEALTHCARE,

INCLUDING CHILDBIRTH CARE, THAT IS

EQUALLY OR MORE COMPLEX THAN

MEDICATION ABORTION.

As part of their everyday practice, APCs routinely

provide healthcare services that are comparable to

or more complex than medication abortion. These

services include reproductive health-related care,

including aspiration abortions and miscarriage

management, and non-reproductive health-related

See Candice Chen et al., Who is providing contraception

care in the United States? An observational study of the

contraceptive workforce, 226 Am. J. Obstetrics & Gynecology E1,

E5 (2021).

See Hyungjung Lee et al., Determinants of rural-urban

differences in health care provider visits among women of

reproductive age in the United States, 15 PLoS ONE, e0240700

(2020); see also Chen et al., supra, at E5 (suggesting that

“advanced practice nurses,” i.e., NPs and CNMs, are “especially”

important for provision of contraceptive care in rural areas).

procedures. APCs also regularly prescribe controlled

substances and assist in complicated surgeries and

medical procedures. Moreover, studies have demonstrated

that APC-provided obstetrical care (including labor

and delivery) results in better outcomes than that

provided by physicians despite the inherent, serious

risks associated with such care, underscoring APCs’

excellent provision of complex care to patients.

A. Medication Abortion Is More Straightforward

Than Much of the Healthcare Provided by

APCs.

APCs routinely provide reproductive healthrelated care that is akin to medication abortion. APCs

provide miscarriage treatment, for example, which

frequently calls for the use of the same course of

medication used in medication abortion (mifepristone

followed by misoprostol).46 Further, as discussed above,

APCs perform aspiration procedures both for abortion

and for miscarriage management.47

As a routine part of their everyday practice,

APCs also provide reproductive and non-reproductive

healthcare services that are far more complex than

medication abortion. For example, APCs insert and

remove intrauterine contraceptive devices (“IUDs”)

See Am. Coll. Obstetricians & Gynecologists, Early Pregnancy

Loss Practice Bulletin (2018), https://www.acog.org/clinical/clinicalguidance/practice-bulletin/articles/2018/11/early-pregnancy-loss.

See, e.g., Weitz et al., supra, at 457-58; Levi & Cardinal,

supra, at 44.

and other contraceptive implants and perform

endometrial biopsies.48 Inserting and removing an

IUD involves placing an instrument through the

cervix, and complicated removals may necessitate

cervical dilation.49 These procedures exceed the

complexity involved in medication abortion.

Non-reproductive healthcare services provided by

APCs that are far more complex than medication

abortion include but are not limited to neuraxial

anesthesia, central line insertions, arterial line

insertions, intubations, chest tube insertions, surgical

first assistance, colonoscopies, and endoscopies. All

PAs, as well as other APCs with Drug Enforcement

Administration registrations, can prescribe controlled

substances, which are potentially dangerous and

addictive and thus carry greater risk than the

medications used in medical abortions.50 They also

Courtney B. Jackson, Expanding the Pool of Abortion

Providers: Nurse-Midwives, Nurse Practitioners, and Physician

Assistants, Women’s Health Issues S42, S42 (2011); see also Am.

Pub. Health Ass’n, Provision of Abortion Care by Advanced Practice

Nurses and Physician Assistants (2011), https://www.apha.org/

policies-and-advocacy/public-health-policy-statements/policy-database/

2014/07/28/16/00/provision-of-abortion-care-by-advanced-practicenurses-and-physician-assistants (noting the same).

See Aimee C. Holland et al., Preparing for Intrauterine

Device Consults and Procedures, Women’s Healthcare 37, 39 (2020).

See U.S. Dep’t of Justice, Diversion Control Division, MidLevel Practitioners Authorized by State, https://www.deadiversion.

usdoj.gov/drugreg/practioners/index.html (last visited Oct. 7, 2023);

see also PA Prescribing, supra (“PAs are authorized to prescribe

medications in all jurisdictions where they are licensed. Where

PAs have prescriptive authority, that authority includes controlled

medications.”).

provide vital assistance in complex specialist procedures,

including orthopedic surgeries, cardiology procedures,

and plastic surgery.51

In light of the complexity of the healthcare

provided by APCs, there is no principled basis for

disallowing APCs from continuing to prescribe

mifepristone where permitted by state law, as they

have successfully done since 2016.

B. Advanced Practice Clinicians Provide

Prenatal and Labor Care That Is As Safe

and Effective, If Not More So, As the Care

Provided by Physicians.

Childbirth is far more dangerous to women than

abortion, and APCs routinely attend and manage

deliveries. Significantly, studies comparing the outcomes

of prenatal and labor care provided by APCs and

physicians demonstrate that care provided by APCs is

often more effective than care provided by physicians.52

For example, one study comparing the outcomes

of midwife- and obstetrician-provided care in low-risk

See Grant R. Martsolf et al., Employment of Advance

Practice Clinicians in Physician Practice, 178 JAMA Intern. Med.

(2018), https://www.ncbi.nlm.nih.gov/pmc/articles/MC6126674/.

See, e.g., Y. Tony Yang et al., State Scope of Practice

Laws, Nurse-Midwifery Workforce, and Childbirth Procedures

and Outcomes, 26 Women’s Health Issues 262, 262 (2016) (finding

that women in states with autonomous practice laws for nursemidwives have lower rates of cesarean delivery, preterm births,

and low birth weight, as compared to women in states without

such laws).

pregnancies found that midwife care resulted in “less

intervention in labor, higher rates of physiologic birth,

and similar hospital length of stay” as compared to

physician-provided care.53 The study found that care

provided by midwives lowered the risk of caesarian

delivery in patients who had no prior births by 30%

and in patients who had had at least one prior birth by

40%.54 Another similar study found that women

receiving maternal and neonatal care from a midwife

were at a lower risk of cesarean and preterm birth and

did not have any increased odds of neonatal intensive

care admissions, neonatal deaths, or severe maternal

morbidity.55

With respect to NPs, one study of women at high

risk of delivering low-birth-weight infants found

notably better outcomes and rates of satisfaction for

those receiving prenatal care from NPs at home than

from physicians at hospital clinics.56 The study found a

Vivienne Souter et al., Comparison of Midwifery and

Obstetric Care in Low-Risk Hospital Births, 134 Obstetrics &

Gynecology 1056, 1057 (2019).

Id.

Yiska Lowenberg Weisband et al., Birth Outcomes of

Women Using a Midwife versus Women Using a Physician for

Prenatal Care, 63 J. Midwifery & Women’s Health 399, 399 (2018);

see also Mary Huynh, Provider Type and Preterm Birth in New

York City Births, 2009-2010, 25 J. Health Care for the Poor and

Underserved, 1520, 1520 (2014) (“Preterm birth was significantly

lower for women who received care from a midwife led model than

for those with a physician led model (2.8% vs 4.6%, p<.0001).”).

Dorothy Brooten et al., A Randomized Trial of Nurse

Specialist Home Care for Women with High-Risk Pregnancies:

Outcomes and Costs, 7 Am. J. Managed Care 793, 798-99 (2008).

2% infant mortality rate and 31% preterm delivery

rate where care was provided by NPs, as compared

with 9% and 41%, respectively, where care was provided

by physicians.57 As with abortion care, physicians

themselves recognize the significant benefits of APCs

providing women’s healthcare. Physicians in the NP

study comparing outcomes for women at high risk of

delivering low-birth-weight infants actually “approached

the APNs [advanced practice nurses] with a patient

they believed needed the [APN-led care] program and

the APN expertise; the APNs had to remind them that

this was a randomized controlled trial.”58

IV.

MAINSTREAM MEDICAL AND PUBLIC HEALTH

GROUPS OVERWHELMINGLY SUPPORT THE

PROVISION OF MEDICATION ABORTION

CARE BY APCS.

Major medical and public health groups support

the provision of medication abortions by APCs as

a means of providing greater access to qualified

healthcare providers.

The American Public Health Association

(“APHA”) is the largest organization of public health

professionals dedicated to addressing public health

issues and public health policies backed by science. For

[more than] a decade, APHA has recommended that

appropriately trained and competent NPs, CNMs, and

Id. at 797.

Id. at 802.

PAs be permitted to provide medication and aspiration

abortion.59 APHA notes that the Institute of Medicine

Committee on the Future of Primary Care and the

Patient Protection and Affordable Care Act and the

Health Care and Education Reconciliation Act

(known together as the Affordable Care Act of 2010)

has defined NPs, CNMs, and PAs as “primary care

clinicians.”60 APHA also cites evidence to conclude

that “these clinicians are well positioned within the

healthcare system to address women’s needs for

comprehensive primary care and preventive reproductive

health services that include abortion care.”61

The American College of Obstetricians and

Gynecologists (“ACOG”) is the leading professional

organization of physicians specializing in obstetrics

and gynecology. ACOG recommends “support[ing] . . .

clinical training for residents and advanced practice

clinicians in abortion care in order to increase the

availability of trained abortion providers.”62 ACOG also

has called for the cease and repeal of “requirements

See Am. Pub. Health Ass’n, Provision of Abortion Care by

Advanced Practice Nurses and Physician Assistants (2011),

https://www.apha.org/policies-and-advocacy/public-health-policystatements/policy-database/2014/07/28/16/00/provision-of-abortioncare-by-advanced-practice-nurses-and-physician-assistants.

Id.

Am. Coll. Obstetricians & Gynecologists, Abortion Training

and Education, Committee Opinion No. 612 (2022), https://www.

acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/

Committee-on-Health-Care-for-Underserved-Women/AbortionTraining-and-Education.

that only physicians or obstetrician-gynecologists may

provide abortion care. . . .”63

The American Medical Women’s Association

(“AMWA”) is an organization that functions at the

local, national, and international level to advance

women in medicine and improve women’s health,

by providing and developing leadership, advocacy,

education, expertise, mentoring, and strategic alliances.

AMWA has pledged to “work to increase the number of

abortion providers by supporting initiatives to improve

and increase training for medical students, residents

and physicians in the full range of abortion procedures,

and to add adequately trained Nurse-Midwives, Nurse

Practitioners and Physician Assistants to the pool of

potential abortion providers.”64

The positions of these leading medical and

public health organizations reflect and support the

recommendations that organizations representing

APCs have long asserted in terms of APCs’ ability

to provide abortion care. Since 1991, Amicus NPWH

has maintained that abortion care is within women’s

health nurse practitioners’ scope of practice.65 This

Id.

Am. Med. Women’s Ass’n, Position Paper on Principals of

Abortion & Access to Comprehensive Reproductive Health Services,

https://www.amwa-doc.org/wp-content/uploads/2018/05/Abortionand-Access-to-Comprehensive-Reproductive-Health-Services.pdf.

Washington, DC, National Abortion Federation, Symposium

Report: Strategies for Expanding Abortion Access: The Role of

Physician Assistants, Nurse Practitioners, and Nurse-Midwives

in Providing Abortions 22 (1997).

policy has been reaffirmed to the present day, with

NPWH stating in its guidelines that “[t]he breadth

and depth of a WHNP program curriculum in these

areas prepares the [NP] with distinct competencies

to provide advanced assessment, diagnosis, and

management,” including the ability to “[p]rovide

medication abortion.”66 Similarly, in 2019, Amicus

ACNM updated and approved a position statement on

“Midwives as Abortion Providers” that affirmed that

“medication abortion may be safely provided by

trained advance practice clinicians (APCs), including

midwives.”67 Amicus AAPA has also affirmed PAs’

ability to provide abortion care, stating that “the PA

profession is a natural fit for team-oriented obstetrics

and gynecology (OBGYN) practice. PAs increase patient

access and contribute to improved quality by providing

medical care and care coordination.”68

NPWH, Guidelines for Practice and Education, supra, at

13-14; see also NPWH, Reproductive Rights Policy Summary (2022),

https://cdn.ymaws.com/npwh.org/resource/resmgr/positionstatement/

npwh_reproductive_rights_pol.pdf (NPWH supports “the full

spectrum of reproductive health” including “abortion services”).

Am. Coll. Nurse-Midwives, Midwives as Abortion Providers

(2019), http://www.midwife.org/acnm/files/acnmlibrarydata/upload

filename/000000000314/PS-Midwives-as-Abortion-Providers-FINALAugust-2019.pdf.

PAs in Obstetrics and Gynecology, supra; see also Am. Acad.

PAs, 2023-2024 Policy Manual 97 (2023), https://www.aapa.org/

download/116915/?tmstv=1690405277 (“AAPA believes all PAs

should advocate for and promote equitable and confidential

access to comprehensive, evidence-based, developmentally

appropriate, and culturally sensitive sexual and reproductive

health information and services.”).

The views of the professional medical, health, and

nursing organizations above are shared by global

health organizations. Since at least 2012, the World

Health Organization, an agency of the United

Nations tasked with promoting the health of people

internationally, has emphasized the importance of

having APCs provide abortion care. In a wellresearched policy guidance paper, the WHO noted

that “[s]ince the advent of vacuum aspiration and

medical abortion, [ ] abortion can be safely provided

by a wide range of health workers in diverse

settings” and recommended that APCs be permitted

to deliver medication abortion using mifepristone plus

misoprostol, or misoprostol alone, at up to 12 weeks

gestational age.69

Additionally, the International Confederation

of Midwives (“ICM”), a multinational organization

representing 150 midwives’ associations in over

100 countries, has consistently endorsed midwives

providing abortion care. ICM expressly stated in a

positpion paper that “ICM affirms that a woman

who seeks or requires abortion-related services is

entitled to be provided with such services by

midwives.”70

The message of these mainstream professional

and public health organizations is clear: the provision

World Health Org., Abortion Care Guideline 59 (2022),

https://iris.who.int/bitstream/handle/10665/349316/97892400394

83-eng.pdf ?sequence=1.

Int’l Confed. Midwives, Position Statement: Midwives’

Provision of Abortion-Related Services 1 (2014), https://www.

internationalmidwives.org/assets/files/statement-files/2018/04/

midwives-provision-of-abortion-related-services-eng.pdf.

of medication abortion involving mifepristone falls

well within APCs’ scope of practice. Promoting women’s

health, which Amici aim to do, is best achieved by

allowing APCs to provide medication abortion as they

have been doing for many years. The FDA reached

this conclusion in 2016 when it approved changes

to mifepristone’s conditions of use to allow APCs

to prescribe and dispense mifepristone. There is no

reason to disturb that conclusion now.

---------------------------------♦---------------------------------

CONCLUSION

The petitions for a writ of certiorari should be

granted.

October 12, 2023

Respectfully submitted,

JONATHAN K. YOUNGWOOD

Counsel of Record

SIMONA G. STRAUSS

CLAIRE E. CAHOON

ISABEL R. MATTSON

SIMPSON THACHER & BARTLETT LLP

425 Lexington Avenue

New York, NY 10017

JYoungwood@stblaw.com

SStrauss@stblaw.com

Claire.Cahoon@stblaw.com

Isabel.Mattson@stblaw.com

(212) 455-2000

Counsel for Amici Curiae National Association of

Nurse Practitioners in Women’s Health, American

College of Nurse-Midwives, American Academy of

Physician Associates, and Association of Physician

Associates in Obstetrics and Gynecology

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.