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

Supreme Court briefFeb 29, 2024

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Nos. 23-235 and 23-236

In the

Supreme Court of the United States

FOOD AND DRUG ADMINISTRATION, ET AL.,

PETITIONERS,

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

RESPONDENTS.

DANCO LABORATORIES, L.L.C.,

PETITIONER,

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

RESPONDENTS.

ON WRITS OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR THE

FIFTH CIRCUIT

BRIEF OF AMICI CURIAE SUSAN B. ANTHONY

PRO-LIFE AMERICA AND UNITED STATES

CONFERENCE OF CATHOLIC BISHOPS, ET AL.,

IN SUPPORT OF RESPONDENTS

HEATHER GEBELIN HACKER

Counsel of Record

HACKER STEPHENS LLP

108 Wild Basin Rd., Suite 250

Austin, Texas 78746

heather@hackerstephens.com

(512) 399-3022

Counsel for Amici Curiae

TABLE OF CONTENTS

Page

Table of authorities ....................................................... III

Interest of amici curiae .................................................. 1

Summary of argument ..................................................... 5

Argument.......................................................................... 7

I. Informed Consent Is a Cornerstone of

Modern Bioethics and Is Especially Critical in

the Context of Abortion. ..................................... 7

A. Informed consent is fundamental to bodily

autonomy and is firmly rooted in American

law. ................................................................... 7

B. Federal courts have long recognized that

informed consent is particularly important

for abortion.................................................... 10

II. Under FDA’s Current Mifepristone Regime,

Prescribers Cannot Adequately Inform

Patients of Potential Risk. ............................... 11

A. Clinical trials relied on for mifepristone’s

initial approval provided more protection for

women than has ever been required by

mifepristone’s label or REMS. .................... 11

B. The studies relied upon in FDA’s decision

to remove safety measures from

mifepristone’s approved conditions of use

did not establish the safety of mifepristone

use under the reduced requirements. ......... 12

C. FDA’s post-2016 REMS changes fail to

allow for adequate post-marketing

surveillance of mifepristone’s safety. .......... 13

III. Without Providing In-Person Visits,

Mifepristone Prescribers Cannot

Adequately Inform a Patient of Her

Personal Risks................................................... 20

IV. Without Providing In-Person Visits,

Mifepristone Prescribers Cannot

Adequately Screen for Coercion. ..................... 27

Conclusion ...................................................................... 31

III

TABLE OF AUTHORITIES

Page(s)

Cases

All. for Hippocratic Med. v. Food & Drug

Admin.,

No. 23-10362, 2023 WL 2913725 (5th Cir. Apr.

12, 2023) ................................................... 12, 13, 15, 19

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

Admin.,

78 F.4th 210 (5th Cir. 2023) ..................................... 13

Canterbury v. Spence,

464 F.2d 772 (D.C. 1972) ..................................... 8, 27

Cruzan v. Dir., Mo. Dep’t of Health,

497 U.S. 261 (1990) ............................................. 7, 8, 9

Dobbs v. Jackson Women’s Health Org.,

142 S. Ct. 2228 (2022) ............................................... 10

Gonzales v. Carhart,

550 U.S. 124 (2007) ................................................... 11

Harris v. McRae,

448 U.S. 297 (1980) ................................................... 10

Jandre v. Physicians Ins. Co. of Wis.,

792 N.W.2d 558 (Wis. Ct. App. 2010) ................. 9, 22

Mohr v. Williams,

104 N.W. 12 (Minn. 1905) .......................................... 8

Planned Parenthood of Cent. Mo. v. Danforth,

428 U.S. 52 (1976)................................................ 10-11

Planned Parenthood of Se. Pa. v. Casey,

505 U.S. 833 (1992) ................................................... 10

Pratt v. Davis,

79 N.E. 562 (Ill. 1906) ................................................ 8

Schloendorff v. Soc’y of N.Y. Hosp.,

105 N.E. 92 (N.Y. 1914) ............................................. 8

Susan B. Anthony List v. Driehaus,

573 U.S. 149 (2014) ..................................................... 1

Statutes

21 U.S.C. § 355 ............................................................... 5

21 U.S.C. § 355(d) ........................................................ 11

21 U.S.C. § 355-1 ............................................................ 6

Regulations

21 C.F.R. § 201.57(e) ................................................... 19

21 C.F.R. § 314.70 ........................................................ 12

21 C.F.R. § 314.80(a) ................................................... 14

21 C.F.R. § 314.80(c) .................................................... 14

Other Authorities

2016 Patient Agreement Form,

Mifepristone ............................................ 16, 17, 21, 22

AAPLOG, Committee Op. No. 9: Dangers of

Relaxed Restrictions on Mifepristone (Oct.

2021) .............................................................. 18, 23, 29

ACOG Committee Op. No. 554, Reproductive

and Sexual Coercion (February 2013;

Reaffirmed 2019) ..................................................... 28

ACOG Committee Op. No. 700, Methods for

Estimating the Due Date, 129 Obstet. &

Gynecol. 1, 3 (2017) .................................................. 23

ACOG, FAQ: Ectopic Pregnancy ............................... 23

ACOG, Practice Bulletin No. 181: Prevention of

Rh D Alloimmunization, 130 Obstet. &

Gyncol. E57 (2017) ................................................... 26

ACOG, The RH Factor: How it Can Affect Your

Pregnancy .......................................................... 25, 26

Aid Access, How do you know if you have

complications, and what should you do? .............. 17

Alys Harte and Rachel Stonehouse,

Reproductive coercion: ‘I wasn’t allowed to

take my pill,’ BBC News (Mar. 13, 2022) .............. 30

AMA Code of Medical Ethics, Ch. 2 “Consent,

Communication & Decision Making,”

(2016)............................................................. 5, 8, 9, 10

Atrash H.K., et al., Ectopic pregnancy

concurrent with induced abortion: Incidence

and mortality, Am. J. of Obstet. & Gynecol.

726, 727 (1990) .......................................................... 24

Aultman K, 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

(2021)................................................................... 15, 18

Bryan Murray, Informed Consent: What Must a

Physician Disclose to a Patient?, 14 Am.

Med. Asso. J. of Ethics 563 (2012) ........................ 8, 9

Cirucci, CA, et al., Mifepristone Adverse Events

Identified by Planned Parenthood in 2009

and 2010 Compared to Those in the FDA

Adverse Event Reporting System and Those

Obtained Through the Freedom of

Information Act, 8 Health Servs. Res. and

Managerial Epidemiology 1, 5 (2021) ............... 18, 19

Citizen petition submitted by the American

Association of Pro-Life Obstetricians and

Gynecologists and the American College of

Pediatricians on Mar. 29, 2019, Docket No.

FDA-2019-P-1534 .................................................... 26

Citizen petition submitted by the American

Association of Pro-Life Obstetricians and

Gynecologists, the Christian Medical

Association, and the Concerned Women for

America on Aug. 2, 2002, Docket No. FDA2002-P-0364-0001 ............................................... 11, 12

David C. Reardon and Tessa Longbons, Effects

of Pressure to Abort on Women’s Emotional

Responses and Mental Health, Cureus 15(1)

(Jan. 31, 2023). .................................................... 29, 30

Ellertson C., et al., Accuracy of assessment of

pregnancy duration by women seeking early

abortions, 355 Lancet 877, 879 (2000) .................... 23

FDA, Postmarketing Surveillance Programs,

https://www.fda.gov/drugs/

surveillance/postmarketing-surveillanceprograms (last visited Apr. 27, 2023) ............... 13, 14

FDA, Questions and Answers on Mifepristone

for Termination of Pregnancy Through 10

Weeks Gestation .................................................. 6, 27

FDA’s citizen petition response dated Dec. 16,

2021, to the citizen petition submitted by the

American Association of Pro-Life

Obstetricians and Gynecologists and the

American College of Pediatricians on Mar. 29,

2019, Docket No. FDA-2019-P-1534....................... 22

Guttmacher Inst., Medication Abortion ................... 27

Guttmacher Inst., Parental Involvement in

Minors’ Abortions ..................................................... 9

Hannah Howard, Medical and Social Risks

Associated with Unmitigated Distribution of

Mifepristone: A Primer, On Point, Issue 51,

Charlotte Lozier Inst. (Oct. 1, 2020) ...................... 29

VII

Highlights of Prescribing Information ...................... 25

John A. Robertson, Precommitment Issues in

Bioethics, 81 Tex. L. Rev. 1849 (2003) ..................... 7

MedWatch, FDA Safety Information and

Adverse Event Reporting Program ....................... 16

Memorandum from FDA to NDA 20-687

MIFEPREX (mifepristone) Population

Council (Sept. 28, 2000) ........................................... 14

Mifeprex 2000 label, Day 14: Post-Treatment

Examination ............................................................. 26

Mifepristone Shared System REMS (updated

2023) .......................................................................... 15

Mifepristone Tablets, 200 mg Risk Evaluation

and Mitigation Strategy (REMS) Single

Shared System for Mifepristone 200 mg, 2

(most recent modification 2023) .............................. 20

Mifepristone U.S. Post-Marketing Adverse

Events Summary through 06/30/2021, RCM #

2007-525, NDA 020687, ANDA 091178 .................. 24

Mifepristone U.S. Post-Marketing Adverse

Events Summary through 12/31/2018 .................... 23

Nat’l Comm’n for the Protection of Human

Subjects of Biomedical and Behavioral

Research, The Belmont Report: Ethical

Principles and Guidelines for the Protection

of Human Subjects of Research (1979) .................... 8

O. Carter Snead, The (Surprising) Truth About

Schiavo: A Defeat for the Cause of Autonomy,

22 Const. Comment. 383 (2005) ................................ 7

Planned Parenthood, How does the abortion pill

work? ........................................................................ 24

Prescriber Agreement Form, Mifepristone

(updated Jan. 2023) ...................................... 21, 22, 23

VIII

Reproductive Coercion Poll – BBC Radio 4 – 8

March 2022, Savanta ComRes (Aug. 3, 2022).. 30, 31

Shirley Murphy and Rosemary Roberts, “Black

box 101: How the Food and Drug

Administration evaluates, communicates,

and manages drug benefit/risk, 117 J. Allergy

& Clinical Immunol. 34 (2006) ........................... 16, 19

U.S. Gov’t Accountability Office, GAO-08-751,

Food and Drug Administration: Approval and

Oversight of the Drug Mifeprex Appendices

II and III (2008) ....................................................... 14

U.S. Gov’t Accountability Office, GAO-18-292,

Food and Drug Administration: Information

on Mifeprex Labeling Changes and Ongoing

Monitoring Efforts (2018) ....................................... 15

INTEREST OF AMICI CURIAE

Amici curiae1 are a preeminent group of organizations devoted to addressing important social and ethical

issues—including healthcare decisions involving moral

and bioethical concerns—and represent knowledge and

experience across various disciplines:

Susan B. Anthony Pro-Life America is a “pro-life

advocacy organization” 2 dedicated to ending abortion,

while protecting the lives of mothers and their babies, including through advancement of pro-life laws and healthsaving regulatory measures for women, girls, and the unborn through direct lobbying and grassroots campaigns.

United States Conference of Catholic Bishops is a

nonprofit corporation, the members of which are the active Catholic Bishops in the United States. The Conference advocates and promotes the pastoral teachings of

the U.S. Catholic Bishops in such diverse areas of the nation’s life as the free expression of ideas, fair employment and equal opportunity for the underprivileged, the

importance of education, and the sanctity of human life.

Catholic Health Care Leadership Alliance is an alliance of Catholic organizations supporting the rights of

patients and professionals to receive and provide

healthcare in accordance with the moral, ethical, and social teachings of Jesus Christ and His Church.

Pursuant to S. Ct. Rule 37.6, undersigned counsel affirms that

no counsel for any party authored this brief in whole or in part and

that no person or entity other than amici or their counsel made a

monetary contribution intended to fund the preparation and submission of this brief.

Susan B. Anthony List v. Driehaus, 573 U.S. 149, 153 (2014)

(internal quotation marks omitted).

National Catholic Bioethics Center is a nonprofit

research and educational institute committed to applying

the principles of natural and moral law, consistent with

many traditions including the teachings of the Catholic

Church, to ethical issues arising in healthcare and the life

sciences.

Catholic Bar Association is a community of legal

professionals that educates, organizes, and inspires its

members to faithfully uphold and bear witness to the

Catholic faith in the study and practice of law.

Coalition for Jewish Values (CJV) is the largest

Rabbinic public policy organization in America, representing over 2,000 traditional, Orthodox rabbis. The CJV

Healthcare Council was formed by Torah-observant

medical professionals under the auspices of the CJV

Rabbinic Board to promote medical practices consonant

with Jewish values and to preserve conscience rights for

healthcare professionals.

Catholic Benefits Association is a nonprofit limited

cooperative association committed to assisting its Catholic employer members in providing health coverage to

their employees consistent with Catholic values, including protection of members’ legal and conscience rights.

Christ Medicus Foundation is an organization that

defends religious freedom by educating religious and lay

leaders on the intersection of healthcare, the exercise of

faith and religious freedom, and the right to life.

Texas Conference of Catholic Bishops is an unincorporated association consisting of the Bishops of the 15

Catholic dioceses in Texas and the Ordinariate of the

Chair of St. Peter. Through this association, the various

Bishops speak with one voice on issues facing the

Catholic Church in Texas. The Church in Texas has a

long history of ministering to the needs of pregnant

women and their unborn children through various health

care and social service ministries. The Bishops regularly

advocate for both conscience protection of health care

providers and the protection of the life and health of

mothers and their unborn children in Texas.

National Catholic Partnership on Disability

(NCPD) was established to implement the 1978 Pastoral

Statement of U.S. Catholic Bishops on Persons with Disabilities. NCPD serves hundreds of thousands of persons with disabilities, and those who minister to them,

fostering inclusion in Church and society. They know intimately the challenges, and risks related to bias toward

persons with disabilities. Such biases become even more

evident when a pregnant mother has a disability or is

from a family with a disability, especially if of genetic

origin, and there are efforts to discourage the mother

from continuing her pregnancy. True informed consent,

with protections against coercion are essential. The bias

is not only against the mother but also against her unborn child, especially if there is evidence of a congenital

disability. Furthermore, the medical risks to any mother

by the FDA-approved protocol for prescribing and dispensing mifepristone, described herein, are significantly

heightened for a mother with a disability, for example accessing emergency care for hemorrhage or infection in a

timely manner. NCPD continues to advocate for policies

that protect all persons with disabilities, including mothers and their unborn children.

National Association of Catholic Nurses, USA is

the national professional organization for Catholic

nurses in the United States. A nonprofit group of

hundreds of nurses of different backgrounds, the

NACN-USA focuses on promoting moral principles of

patient advocacy, human dignity, and professional and

spiritual development in the integration of faith and

health within the Catholic context in nursing. Its members are critically concerned for the wellbeing of women

and their unborn children threatened by the FDA-approved protocol for prescribing and dispensing mifepristone, described herein.

* * *

The current FDA protocol for mifepristone use has

profoundly negative legal and ethical consequences, including because it lacks safeguards necessary to ensure

informed consent. Amici are well-suited to discuss how

the FDA’s failure harms women who may take mifepristone to cause an abortion.

SUMMARY OF ARGUMENT

The requirement that a healthcare provider obtain a

patient’s freely given informed consent before medical

treatment is firmly established in law and is a cornerstone of modern bioethics.3 The patient’s decision must

be based on adequate disclosure of the diagnosis, the

proposed treatment, its benefits, risks, and alternatives,

and the patient must have capacity and freedom from coercion. These fundamental principles, which protect both

patients and medical professionals, cannot be met when

healthcare providers prescribe mifepristone under

FDA’s current protocol. 4

Because of the risks posed by taking mifepristone to

cause an abortion, its availability is limited by an FDAimposed Risk Evaluation and Mitigation Strategy

(REMS) with post-marketing “elements to assure safe

use” (ETASU).5 But to the detriment of women, FDA’s

AMA Code of Medical Ethics, Ch. 2 “Consent, Communication

& Decision Making,” Op. 2.1.1 (2016), https://www.amaassn.org/system/files/2019-06/code-of-medical-ethics-chapter-2.pdf

(“Informed consent to medical treatment is fundamental in both

ethics and law.”).

Unless otherwise stated, references to mifepristone apply to

both Mifeprex and its generic, which have shared a REMS since

2019. Mifeprex and generic mifepristone are sponsored and manufactured by Intervenor Danco Laboratories and GenBioPro, respectively. Unless otherwise stated, any reference to the mifepristone

REMS applies to the REMS shared by Mifeprex and the generic.

Before approval, an applicant (the drug’s sponsor and/or manufacturer) must demonstrate the drug’s safety and efficacy “for use

under the conditions prescribed, recommended, or suggested in the

proposed labeling.” 21 U.S.C. § 355. When FDA determines that

protocols are “necessary to ensure that the benefits of the drug outweigh the risks,” FDA may require a REMS. If the drug can only

approval was based on studies containing safeguards not

used when actually prescribing the drugs post-approval.

This prevents prescribers from being able to accurately

convey the true risks of the drug to patients. FDA then

eroded those post-marketing requirements in 2016, 2021

and 2023. FDA’s newer post-marketing restrictions do

not require reporting of non-fatal adverse events to the

drug’s sponsors, which is critical to ensuring drugs’

safety. FDA also no longer requires in-person appointments to prescribe mifepristone.6 But in-person visits

are critical. Without it, physicians are unable to adequately diagnose ectopic pregnancy, verify Rh status, or

detect other contraindications. Physicians thus cannot

adequately inform a woman of her personal risks related

to mifepristone. And without in-person visits, prescribers also cannot adequately determine whether patients

are giving consent without coercion. Women can only

benefit from more information and more protection, especially when considering whether to take a drug that

FDA acknowledges is dangerous and that has permanent consequences. Affirming the district court’s ruling

would help prevent further harm to women from the lack

of informed consent.

be approved with specific safeguards, the REMS includes ETASU.

21 U.S.C. § 355-1. REMS with ETASU may be weakened, strengthened, or removed following the submission of a proposal from the

drug manufacturer or on the initiative of the Secretary of HHS. Id.

See FDA, Questions and Answers on Mifepristone for Termination of Pregnancy Through 10 Weeks Gestation,

https://www.fda.gov/drugs/postmarket-drug-safety-informationpatients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation.

ARGUMENT

I. Informed Consent Is a Cornerstone of Modern

Bioethics and Is Especially Critical in the

Context of Abortion.

A. Informed consent is fundamental to bodily

autonomy and is firmly rooted in American

law.

The principle of respect for autonomy and self-determination “predominates in modern bioethics: ‘Because of

the intimate and intrusive nature of biomedical decisions,

a central focus of bioethics has been to respect and protect an individual’s autonomy in making those decisions.’” O. Carter Snead, The (Surprising) Truth About

Schiavo: A Defeat for the Cause of Autonomy, 22 Const.

Comment. 383, 387 (2005) (quoting John A. Robertson,

Precommitment Issues in Bioethics, 81 Tex. L. Rev.

1849, 1849 (2003)). “The principle of informed consent—

the cornerstone of modern biomedical ethics—is in large

measure an extension of this general concept of personal

autonomy.” Id. at 388. According to this principle, “no

medical intervention may be undertaken without the intelligent and voluntary consent of the patient.” Id. (footnote omitted) (emphasis added).

The requirement that a healthcare provider obtain a

patient’s informed consent before treatment is also

firmly established in law. The right to consent to or refuse medical treatment was originally established in

common law, and “this notion of bodily integrity has been

embodied in the requirement that informed consent is

generally required for medical treatment.” Cruzan v.

Dir., Mo. Dep’t of Health, 497 U.S. 261, 269 (1990). Before the early 1900s, treatment was often left to the

discretion of physicians with little patient involvement.

Eventually, courts recognized that a patient should be

able to assess a procedure’s risks and consequences, and

that failing to obtain a patient’s consent for a medical

procedure should result in legal liability. E.g., Schloendorff v. Soc’y of N.Y. Hosp., 105 N.E. 92, 93 (N.Y. 1914)

(Cardozo, J.); Pratt v. Davis, 79 N.E. 562 (Ill. 1906);

Mohr v. Williams, 104 N.W. 12 (Minn. 1905). “The informed consent doctrine has become firmly entrenched

in American tort law.” Cruzan, 497 U.S. at 269. And this

Court has recognized that the principle is so fundamental that it has constitutional dimensions. See id. at 278–

79.

According to both accepted ethical principles and the

law, informed consent requires three elements: information, comprehension, and voluntariness. 7 To satisfy

the first element, a physician must give a patient accurate information about the nature of the procedure,

risks, benefits, and alternatives to the proposed procedure or treatment, and allow the patient to ask questions.8 That includes the risks to the particular patient

given her own circumstances and conditions. 9 It also includes informing a patient of the availability of diagnostic

Part C.1, Nat’l Comm’n for the Protection of Human Subjects

of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979), available at https://www.hhs.gov/

ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf.

Id.; see also Canterbury v. Spence, 464 F.2d 772, 787–88 (D.C.

1972); AMA Code of Medical Ethics, supra n. 3.

Bryan Murray, Informed Consent: What Must a Physician

Disclose to a Patient?, 14 Am. Med. Asso. J. of Ethics 563, 564-65

(2012), available at https://journalofethics.ama-assn.org/sites/journalofethics.ama-assn.org/files/2018-05/hlaw1-1207.pdf.

tests that may rule out a possible condition that would

influence the patient’s treatment decision. 10

The patient must also have capacity to make, and

must in fact make, the decision freely and without coercion. Cruzan, 497 U.S. at 280 (“An incompetent person is

not able to make an informed and voluntary choice to

exercise a hypothetical right to refuse treatment or any

other right.” (emphasis added)). Generally, minors lack

legal capacity to provide consent to medical treatment or

procedures and consent must instead be obtained from

the minor’s parent or legal guardian.11 In the context of

abortion, most states require parental notice or consent

before a minor may obtain an abortion. 12

Aside from the obvious benefits to the patient, the

doctrine of informed consent also benefits the medical

profession. At minimum, it reduces the likelihood of potential legal liability.13 Informed consent also helps physicians provide quality patient care, promotes trust and

See id.; see also, e.g., Jandre v. Physicians Ins. Co. of Wis.,

792 N.W.2d 558, 568 (Wis. Ct. App. 2010) (noting that informed consent under Wisconsin law requires physicians to inform patients of

“a test to rule out a condition [the patient] was possibly suffering

from, and which [the physician] did not rule out.”).

AMA Code of Medical Ethics, supra n. 3, at Op. 2.2.1 (noting

“parents’ authority as decision makers” in treatment decisions for

minor children).

See, e.g., Guttmacher Inst., Parental Involvement in Minors’

Abortions, https://www.guttmacher.org/state-policy/explore/parental-involvement-minors-abortions (last visited Apr. 17, 2023) (summarizing state laws; 36 states require parental involvement).

See, e.g., Murray, supra n. 9.

confidence, and encourages better interactions between

patient and physician.14

B. Federal courts have long recognized that

informed consent is particularly important

for abortion.

The fundamental importance of informed consent is

underscored in the abortion context. This Court

acknowledges that “[a]bortion is inherently different

from other medical procedures, because no other procedure involves the purposeful termination of a potential

life.” Harris v. McRae, 448 U.S. 297, 325 (1980); accord

Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228,

2243 (2022) (“[A]bortion is fundamentally different, as

both Roe and Casey acknowledged, because it destroys

what those decisions called ‘fetal life’ and what the law

now before us describes as an ‘unborn human being.’”);

Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833,

852 (1992), overruled by Dobbs, 142 S. Ct. at 2242 (“Abortion is a unique act. It is an act fraught with consequences for others: for the woman who must live with the

implications of her decision . . . and, depending on one’s

beliefs, for the life or potential life that is aborted.”).

Thus, this Court has also repeatedly recognized the

unique gravity of the abortion decision and the importance of ensuring it is fully informed: “The decision to

abort, indeed, is an important, and often a stressful one,

and it is desirable and imperative that it be made with

full knowledge of its nature and consequences.” Planned

Parenthood of Cent. Mo. v. Danforth, 428 U.S. 52, 67

Id.; see also AMA Code of Medical Ethics, supra n. 3, at Op.

2.1.3 (“Truthful and open communication between physician and patient is essential for trust in the relationship and for respect for autonomy.”).

(1976). “Whether to have an abortion requires a difficult

and painful moral decision. . . . The State has an interest

in ensuring so grave a choice is well informed.” Gonzales

v. Carhart, 550 U.S. 124, 159 (2007) (citation omitted).

II. Under FDA’s Current Mifepristone Regime,

Prescribers Cannot Adequately Inform Patients

of Potential Risk.

A. Clinical trials relied on for mifepristone’s

initial approval provided more protection

for women than has ever been required by

mifepristone’s label or REMS.

For a healthcare provider to adequately inform patients about risks of a treatment or procedure, those

risks must be reasonably known. Applicants seeking approval for a drug must conduct “investigations, reports

of which are required to be submitted to the Secretary

[which] include adequate tests by all methods reasonably

applicable to show whether or not such drug is safe for

use under the conditions prescribed, recommended, or

suggested in the proposed labeling thereof.” 21 U.S.C.

§ 355(d) (emphasis added). But the “conditions” in the

U.S. trial for mifepristone afforded protections to women

that are not required by the drug’s label or REMS.

In the U.S. clinical trial, transvaginal ultrasonography, menstrual history, and pelvic examination were

used to confirm the gestational age of each pregnancy

and exclude women with ectopic pregnancies. 15 The prescribers were physicians with experience in performing

See Citizen petition submitted by the American Association of

Pro-Life Obstetricians and Gynecologists, the Christian Medical

Association, and the Concerned Women for America on Aug. 2, 2002,

Docket No. FDA-2002-P-0364-0001 at 75-76.

surgical abortions, training in the administration of the

mifepristone-misoprostol procedure, and admitting privileges at medical facilities that could provide emergency

treatment.16 And all patients were required to be within

one hour of emergency facilities or the facilities of the

principal investigator, and women were monitored for

four hours for adverse events after taking misoprostol. 17

None of these conditions have ever been included in the

REMS since mifepristone’s approval in 2000. Clinical trials used to justify mifepristone’s approval that include

extra safeguards cannot provide a basis to assess accurately the drug’s risks without those safeguards. Cf. All.

for Hippocratic Med. v. Food & Drug Admin., No. 2310362, 2023 WL 2913725, at *17 (5th Cir. Apr. 12, 2023)

(AHM II). And a woman cannot give truly informed consent if her physician cannot inform her as to the true

risks of medication abortion.

B. The studies relied upon in FDA’s decision to

remove safety measures from mifepristone’s

approved conditions of use did not establish

the safety of mifepristone use under the

reduced requirements.

Likewise, FDA is tasked with reviewing scientific evidence to support any proposed changes to a REMS. 21

C.F.R. § 314.70. However, the studies FDA relied upon

in 2016, 2021, and 2023 when removing safety requirements from the mifepristone REMS did not evaluate the

safety of mifepristone when used in the newly approved

conditions of use, rendering the findings in those studies

useless for informed consent. As the stay panel observed,

Id.

See id.

in 2016, “FDA eliminated REMS safeguards based on

studies that included those very safeguards.” AHM II,

2023 WL 2913725, at *17. The Fifth Circuit panel, in affirming in part the district court’s stay, similarly addressed defects in the 2021 Non-Enforcement Decision

regarding the REMS in-person dispensing requirements:

In the face of concededly limited data, and lacking

more probative information from prescribers,

FDA fell back on studies that were merely ‘not inconsistent’ with its intended conclusion. It did not

refer to any literature that affirmatively supported the notion that mifepristone would remain

safe and effective even without the in-person dispensing requirement.

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

78 F.4th 210, 251 (5th Cir. 2023) (AHM III). Without

such studies, an abortion provider cannot fully inform his

patient about the risks posed by obtaining mifepristone

without in-person dispensing.

C. FDA’s post-2016 REMS changes fail to allow

for adequate post-marketing surveillance of

mifepristone’s safety.

If a drug is approved for use, physicians can also rely

on post-marketing safety data to assess the risks when

informing their patients. And from the FDA’s perspective, post-marketing surveillance of adverse effects is

“essential” for ensuring a drug’s safety.18 Because all

possible side effects of a drug cannot be anticipated

FDA,

Postmarketing

Surveillance

Programs,

https://www.fda.gov/drugs/surveillance/postmarketing-surveillance-programs (last visited Apr. 27, 2023).

based on preapproval studies involving small numbers of

patients, FDA maintains a system of post-marketing

surveillance and risk assessment programs to identify

adverse events that did not appear during the drug-approval process.19 Federal regulations require sponsors to

report all adverse drug experiences to the FDA Adverse

Event Reporting System (FAERS). 21 C.F.R.

§ 314.80(c). “Adverse drug experiences” are defined

broadly and include even adverse events that occur while

using the drug “whether or not considered drug related.”

Id.20

As a condition of mifepristone’s approval in 2000,

FDA required certified prescribers to report any serious

adverse event associated with mifepristone to the sponsor.21 But in 2016, FDA modified the mifepristone REMS

with ETASU and eliminated the reporting requirement

Id.

According to 21 C.F.R. § 314.80(a), an “adverse drug experience” is “[a]ny adverse event associated with the use of a drug in

humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug

product in professional practice; an adverse event occurring from

drug overdose whether accidental or intentional; an adverse event

occurring from drug abuse; an adverse event occurring from drug

withdrawal; and any failure of expected pharmacological action.”

Memorandum from FDA to NDA 20-687 MIFEPREX (mifepristone) Population Council (Sept. 28, 2000), http://wayback.archive-it.org/7993/20161024033545/http:/www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111366.pdf; U.S. Gov’t Accountability

Office, GAO-08-751, Food and Drug Administration: Approval and

Oversight of the Drug Mifeprex Appendices II and III (2008),

https://www.gao.gov/products/gao-08-751.

for non-fatal adverse events.22 As a result, the sponsors

may not receive reports of non-fatal adverse events, even

if they are serious. The removal of the requirement to

report non-fatal adverse events causes vastly undercounted adverse event reports (AERs), skewing the

safety profile of mifepristone. As the stay panel pointed

out, “[i]t’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.” AHM II,

2023 WL 2913725, at *17.

There are other limitations on the safety data that

make FDA’s choice even more concerning. For example,

emergency-room doctors or other non-prescribing providers handle most hemorrhages from drug-induced

abortion. An analysis of AERs for mifepristone submitted to FDA from 2000 to 2019 showed that fewer than

40% of surgeries to remove retained tissue after druginduced abortion are done by abortion providers themselves. Yet the information in the AERs is “almost exclusively obtained from abortion providers, rather than the

physician treating the complication.” 23 Sponsors likely do

See U.S. Gov’t Accountability Office, GAO-18-292, Food and

Drug Administration: Information on Mifeprex Labeling Changes

and Ongoing Monitoring Efforts (2018), https://www.gao.gov/products/gao-18-292; Mifepristone Shared System REMS (updated

2023),

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristonemedical-termination-pregnancy-through-ten-weeks-gestation.

Aultman K, 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 (2021), https://issuesinlawandmedicine.com/wp-content/uploads/2021/01/Deaths-and-Severe-Adverse-Events-after-the-use-of-Mifepristone-as-an-Abortifacient-from-September-2000-to-February-2019-copy5.pdf.

not know about (or report to FAERS) most hemorrhages

because non-prescribing doctors are not required to report them. This problem is exacerbated by the limitedto-nonexistent follow-up performed by abortion providers after chemical abortion; follow-up is now merely advised, no longer required, by the REMS. Patients and

non-prescribing providers may choose to report adverse

events to FDA through the MedWatch website. 24 But

this reporting is entirely voluntary and thus incomplete.25

Further decreasing the likelihood that AERs are reliably reported, some prescribers encourage their patients to hide consumption of abortion-inducing drugs if

treated by other healthcare providers for complications.

Before FDA changed the mifepristone prescribing information and Patient Agreement Form in 2023, the label

instructed prescribers to “[a]dvise the patient to take the

Medication Guide with her if she visits an emergency

room or a healthcare provider who did not prescribe Mifeprex, so that the provider knows that she is undergoing

a medical abortion.” The REMS-required form also

MedWatch is the FDA’s medical product safety reporting program for health professionals, patients and consumers. Information

submitted through MedWatch is reflected in the FAERS database.

See https://www.fda.gov/safety/medwatch-fda-safety-informationand-adverse-event-reporting-program.

For instance, in a study involving a similar system in Germany, 75-85% of providers had never voluntarily reported an adverse event and 20% did not even know about the voluntary reporting system. Shirley Murphy and Rosemary Roberts, Black box 101:

How the Food and Drug Administration evaluates, communicates,

and manages drug benefit/risk, 117 J. Allergy & Clinical Immunol.

34,

(2006);

https://www.jacionline.org/action/showPdf?

pii=S0091-6749%2805%2902325-0.

stated: “I have the MEDICATION GUIDE for mifepristone. I will take it with me if I visit an emergency room

or a healthcare provider who did not give me mifepristone so that they will understand that I am having a medical abortion with mifepristone.”26 Yet, some prescribers,

such as Aid Access, instruct their patients to lie to emergency medical personnel about having taken mifepristone.27

Tragically, FDA’s 2023 changes further enable this

deception. Prescribers are no longer directed to instruct

patients to take the medication guide with them when

seeking emergency treatment, and patients are no

longer directed to do so in the Patient Agreement Form.

This change undermines emergency healthcare providers’ ability to care for patients because they will be missing critical information. It also decreases the likelihood

that adverse events will be reported.

Ample evidence shows that adverse events are significantly underreported. In October 2021, plaintiff American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) warned:

The FDA estimates that 3.7 million medication

abortions occurred between 2000 and 2018. If the

rate of serious adverse events such as emergency

room visits is posited to be a conservative 2%, then

approximately 74,000 complications would be

2016 Patient Agreement Form, https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2021_05_14

_Patient_Agreement_Form.pdf.

See, e.g., Aid Access, How do you know if you have complications,

and

what

should

you

do?,

https://aidaccess.org/en/page/459/how-do-you-know-if-you-have-complicationsand-what-should-you-do.

documented. Two analyses examined the [AERs]

between 2000 to 2019 and documented 607 and

3,197 events. This total of 3,804 AERs suggests

that the FDA received only 5% of an estimated

74,000 serious adverse events. 28

Further, in a study of nearly 20 years of AERs submitted

to FDA, researchers concluded:

[FAERS] is woefully inadequate to determine the

post-marketing safety of mifepristone due to its

inability to adequately assess the frequency or severity of adverse events. The reliance solely on interested parties to report, the large percentage of

uncodable events, the redaction of critical clinical

information unrelated to personally identifiable

information, and the inadequacy of the reports

highlight the need to overhaul the current AER

system.29

Another study compared 2009 and 2010 AERs reported

through FAERS, those provided by FDA via Freedom

of Information Act request, and those identified by other

researchers as having occurred at Planned Parenthood. 30

While Planned Parenthood performs 37% of U.S. abortions, the study identified 1,530 mifepristone cases with

AAPLOG, Committee Op. No. 9: Dangers of Relaxed Restrictions on Mifepristone (Oct. 2021), https://aaplog.org/wp-content/uploads/2021/11/CO-9-Mifepristone-Restrictions-1.pdf.

Aultman, supra n. 23.

Cirucci, CA, et al., Mifepristone Adverse Events Identified by

Planned Parenthood in 2009 and 2010 Compared to Those in the

FDA Adverse Event Reporting System and Those Obtained

Through the Freedom of Information Act, 8 Health Servs. Res. and

Managerial Epidemiology 1, 5 (2021), https://journals.sagepub.com/

doi/full/10.1177/23333928211068919.

AERs at Planned Parenthood alone, while FAERS only

identified 664 from all providers and FDA released only

330 AERs through FOIA.31 These discrepancies show

that the AER reporting system is unreliable.

AERs are FDA’s only objective means to obtain data

on the full range of effects of the FDA-approved regimen

on women. Responsible reporting is a fundamental

safety mechanism that should not be sacrificed in the interest of increasing the availability of an elective drug.

Yet the FDA has done just that by reducing reporting

requirements and overlooking limitations with the data

that is reported. As the stay panel pointed out, “[t]his ostrich’s-head-in-the-sand approach is deeply troubling—

especially on a record that, according to [FDA’s] own

documents, necessitates a REMS program, a ‘Patient

Agreement Form,’ and a ‘Black Box’ warning.” AHM II,

2023 WL 2913725, at *17.32 These agency actions are

“well ‘outside the zone of reasonableness.’” Id. (citation

omitted). Because FDA’s REMS does not require comprehensive reporting of adverse events, it is impossible

for FDA to provide accurate and complete information to

prescribers. In turn, prescribers cannot fully inform

their patients of the risks caused by or associated with

mifepristone, robbing women of their right to make wellinformed decisions.

Id.

A “Black Box” warning means that there is “reasonable evidence of an association of a serious hazard with the drug” and “the

adverse reaction may lead to death or serious injury.” Murphy &

Roberts, supra n. 25, at 36-39; accord 21 C.F.R. § 201.57(e).

III. Without

Providing

In-Person

Visits,

Mifepristone Prescribers Cannot Adequately

Inform a Patient of Her Personal Risks.

To obtain genuine informed consent, a physician

must inform the patient of the medical condition requiring the proposed treatment, and must explain any risks,

including contraindications that increase the patient’s

risk. But FDA’s post-approval changes to the mifepristone label and REMS do not require certified prescribers of mifepristone to adequately screen their patients

for potential risks. A prescriber who merely consults

with a patient through video, phone, or email—which is

now explicitly permitted by FDA—cannot accurately assess the duration of a patient’s pregnancy or diagnose

ectopic pregnancy.

The existing REMS acknowledges the importance of

a healthcare provider’s ability to identify increased

risks, like the presence of an ectopic pregnancy, because

it requires sponsors to ensure that “healthcare providers

who prescribe their mifepristone are specially certified

in accordance with the requirements described [in the

REMS] and de-certify healthcare providers who do not

maintain compliance with certification requirements.” 33

In turn, the REMS requires healthcare providers who

wish to be certified to sign a Prescriber Agreement

Mifepristone Tablets, 200 mg Risk Evaluation and Mitigation

Strategy (REMS) Single Shared System for Mifepristone 200 mg, 2

(most

recent

modification

2023),

https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone

_2023_03_23_REMS_Full.pdf.

Form stating that “you agree that you meet the qualifications [] and will follow the guidelines for use.” 34

The qualifications of prescribers and guidelines for use

are also listed on the form:

Mifepristone must be provided by or under the

supervision of a certified prescriber who meets

the following qualifications:

•

Ability to assess the duration of pregnancy

accurately.

•

Ability to diagnose ectopic pregnancies.

•

Ability to provide surgical intervention in

cases of incomplete abortion or severe

bleeding, or have made plans to provide

such care through others, and be able to assure patient access to medical facilities

equipped to provide blood transfusions and

resuscitation, if necessary. . . .

In addition to meeting these qualifications, you

also agree to follow these guidelines for use:

•

Ensure that the Patient Agreement Form

is reviewed with the patient and the risks

of the mifepristone treatment regimen are

fully explained. Ensure any questions the

patient may have prior to receiving mifepristone are answered.

Prescriber Agreement Form (updated Jan. 2023),

https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_Prescriber_Agreement_Form_for_GenBioPro

_Inc..pdf.

•

Ensure that the healthcare provider and

patient sign the Patient Agreement Form.

•

Ensure that the patient is provided with a

copy of the Patient Agreement Form and

the Medication Guide. . . . 35

But the prescriber qualification requirements and

guidelines regarding a provider’s abilities in the REMS

are meaningless if a prescriber does not actually use

these skills in caring for a patient. What good is a

healthcare provider’s ability to diagnose an ectopic pregnancy, for example, if the provider does not perform the

diagnostic tests to determine whether the patient has an

ectopic pregnancy? A prescriber cannot obtain true informed consent without adequately screening the patient

for contraindications. See, e.g., Jandre, 792 N.W.2d at

568.

FDA claims that it is inappropriate to mandate how

providers assess women for gestational age or ectopic

pregnancy, and that certified prescribers do not have to

be physically present with the patient. 36 These assertions

ignore the best practices necessary to protect women’s

health and ensure informed consent. The REMS requires that certified prescribers be qualified to “assess”

the duration of pregnancy and “diagnose” ectopic pregnancy—not simply confirm a patient’s opinion, or the

opinion of another provider, that the patient’s pregnancy

is 10 weeks or less and that it is an intrauterine

Id.

FDA’s citizen petition response dated Dec. 16, 2021, to the

citizen petition submitted by the American Association of Pro-Life

Obstetricians and Gynecologists and the American College of Pediatricians on Mar. 29, 2019, Docket No. FDA-2019-P-1534 at 25.

pregnancy.37 In a joint Committee Opinion, the American

College of Obstetricians and Gynecologists (ACOG), the

American Institute of Ultrasound in Medicine, and the

Society for Maternal-Fetal Medicine agree that “[u]ltrasound measurement of the embryo or fetus in the first

trimester . . . is the most accurate method to establish or

confirm gestational age.”38 Women often underestimate

gestational age.39 And mifepristone’s failures (requiring

surgery) and complications indisputably increase as gestational age advances, which is why mifepristone is only

approved for use in early pregnancy.40

The possibility that women receiving remote “care”

may take mifepristone with an ectopic or extrauterine

pregnancy is extremely troubling. An ectopic pregnancy

can rupture the fallopian tube as the pregnancy progresses, causing major internal bleeding, severe pain,

and possibly death if emergency surgical intervention is

unavailable.41 Half of women who experience ectopic

Prescriber Agreement Form, supra n. 34.

ACOG Committee Op. No. 700, Methods for Estimating the

Due Date, 129 Obstet. & Gynecol. 1, 3 (2017), https://www.acog.org//media/project/acog/acogorg/clinical/files/committee-opinion/articles/2017/05/methods-for-estimating-the-due-date.pdf.

See, e.g., Ellertson C., et al., Accuracy of assessment of pregnancy duration by women seeking early abortions, 355 Lancet 877,

879

(2000),

abstract

available

https://pubmed.ncbi.nlm.nih.gov/10752703/ (finding that almost 15% of Atlanta

women were in error by more than two weeks when calculating gestation based on LMP).

See AAPLOG Committee Op. No. 9, supra n. 28 (citing Mifepristone U.S. Post-Marketing Adverse Events Summary through

12/31/2018, https://www.fda.gov/media/112118/download).

“What is ectopic pregnancy?,” ACOG, FAQ: Ectopic Pregnancy,

https://www.acog.org/womens-health/faqs/ectopic-pregnancy.

pregnancy do not have any risk factors. 42 As noted above,

ectopic pregnancies can only be reliably diagnosed

through an ultrasound evaluation and confirmation of the

location of the pregnancy. If a woman with an extrauterine pregnancy is given mifepristone, she may believe her

symptoms are simply the effects of drug-induced abortion because they are similar, and may delay obtaining

immediate medical care at great risk to her safety. 43 As

of June 30, 2021, at least 97 women with ectopic pregnancies in the United States had been given mifepristone. 44

At least two of these women bled to death from an undiagnosed ectopic pregnancy.45 They likely did not recognize that their abdominal pain and bleeding were indications of a life-threatening ectopic pregnancy, not expected effects of a chemical abortion. A woman is 30%

more likely to die from an ectopic pregnancy while undergoing an abortion than if she had an ectopic pregnancy but had not sought an abortion. 46

Id. at “What are the risk factors for ectopic pregnancy?”

Compare id. at “What are the symptoms of ectopic pregnancy?” (symptoms include vaginal bleeding, abdominal pain, dizziness, weakness, and fainting) with Planned Parenthood, How does

the abortion pill work?, https://www.plannedparenthood.org/

learn/abortion/the-abortion-pill/how-does-the-abortion-pill-work

(last accessed May 9, 2022) (symptoms related to a medication abortion include heavy vaginal bleeding, abdominal pain, dizziness, vomiting, and weakness).

Mifepristone U.S. Post-Marketing Adverse Events Summary

through 06/30/2021, RCM # 2007-525, NDA 020687, ANDA 091178,

https://www.fda.gov/media/154941/download.

Id.

Atrash H.K., et al., Ectopic pregnancy concurrent with induced abortion: Incidence and mortality, 162 Am. J. of Obstet. &

Gynecol. 726, 727 (1990), abstract available at https://pubmed.ncbi.nlm.nih.gov/2316578/.

There are other contraindications that must also be

investigated before administering mifepristone: presence of an intrauterine device (IUD), undiagnosed adnexal mass, chronic adrenal failure, concurrent longterm corticosteroid therapy, history of allergy to mifepristone, misoprostol, or other prostaglandins, hemorrhagic disorders or concurrent anticoagulant therapy

(risk of heavy bleeding), or inherited porphyrias. 47

Along with the danger of contraindications, a patient’s Rh status is another concern not adequately addressed by FDA’s current REMS, despite its importance

in protecting a patient’s future fertility. The Rh factor is

a protein found on the surface of red blood cells.48 If a

mother’s cells have this protein, she is Rh-positive.49 But

if a mother is Rh-negative and her unborn child is Rhpositive, when the baby’s blood gets into the mother’s

bloodstream, her body will recognize that the Rh-positive blood is not hers and produce anti-Rh antibodies.

These antibodies can cross the placenta in future pregnancies and lead to serious health problems, or even

death, for the unborn child or newborn. 50 A woman’s body

can still produce these antibodies even if the first pregnancy is not carried to term because of abortion. 51 Thus,

Rh-negative patients who have been pregnant before

See Highlights of Prescribing Information 4-5, https://www.

accessdata.fda.gov/drugsatfdadocs/label/2016/020687s020lbl.pdf

(mifepristone prescribing information approved by FDA for Danco).

ACOG, The RH Factor: How it Can Affect Your Pregnancy,

https://www.acog.org/womens-health/faqs/the-rh-factor-how-itcan-affect-your-pregnancy#:~:text=The%20Rh%20factor%20is

%20a,refers%20to%20your%20Rh%20status.

Id.

must be administered Rhogam to avoid miscarriage or

severe injury to their future unborn children. 52 But Rhnegative women who are not tested before a chemical

abortion may not know that they need treatment.

FDA’s elimination of follow-up visits also increases

risks of post-abortion complications. The 2000 regimen’s

requirement that women return fourteen days after ingesting mifepristone and misoprostol is necessary to ensure that the unborn child and all pregnancy tissue have

been expelled from the woman’s body. 53 Retained tissue

can lead to continued bleeding and serious intrauterine

infections.54 A return visit permits the healthcare provider to ensure that the patient is not experiencing complications and to administer Rhogam to Rh-negative

women.55 FDA’s current framework does not require this

visit, which means women may not recognize complications until they become more severe, resulting in greater

harm.

The inadequacy of telemedicine is buttressed by the

fact that twenty-nine states permit only physicians to

prescribe mifepristone, with eighteen states requiring

the provider to be physically present with the patient—

Id.; see also ACOG, Practice Bulletin No. 181: Prevention of

Rh D Alloimmunization, 130 Obstet. & Gyncol. E57 (2017),

https://journals.lww.com/greenjournal/Fulltext/2017/08000/Practice_Bulletin_No__181__Prevention_of_Rh_D.54.aspx.

Mifeprex 2000 label, Day 14: Post-Treatment Examination,

https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/

20687lbl.htm.

Citizen petition submitted by the American Association of

Pro-Life Obstetricians and Gynecologists and the American College

of Pediatricians on Mar. 29, 2019, Docket No. FDA-2019-P-1534 at

10.

Id.

and for good reason.56 A call to a hotline or remote prescriber will not help a hemorrhaging woman reach an

emergency room quickly. It is nonsensical for FDA to

acknowledge that the dangers posed to women from mifepristone require ETASU57 yet also refuse to require

prescribers to perform the most accurate assessments of

women who wish to use the drug. Without these patientspecific determinations, certified prescribers cannot obtain truly informed consent. See Canterbury, 464 F.2d at

787. A woman cannot properly consent to a chemical

abortion without knowing the specific risks that mifepristone poses to her life, health, and fertility.

IV. Without

Providing

In-Person

Visits,

Mifepristone Prescribers Cannot Adequately

Screen for Coercion.

Voluntariness is essential to informed consent. Coerced consent is no consent at all, and there is an increased risk of coercion and abuse in the context of abortion drugs if the prescriber does not thoroughly screen

the patient. Abortion-inducing drugs are inherently different from other prescription drugs in that they are prescribed with the purpose of ending a developing life,

which increases both the probability and the magnitude

of the risk that someone may force a pregnant patient to

take the drugs against her will. This danger is increased

by FDA’s removal of the in-person dispensing requirement—an important safeguard to ensure that physicians

can directly see and evaluate the voluntariness of the patient’s consent. FDA’s post-marketing restrictions thus

See

Guttmacher

Inst.,

Medication

Abortion,

https://www.guttmacher.org/state-policy/explore/medication-abortion (last updated Apr. 13, 2023).

See Questions and Answers on Mifepristone, supra n. 6.

fail to protect women from coercive partners and predators.

ACOG recognizes that “reproductive coercion,”

which “involves behavior intended to maintain power and

control in a relationship related to reproductive health

by someone who is, was, or wishes to be involved in an

intimate or dating relationship with an adult or adolescent,” includes “pregnancy pressure.” 58 Pregnancy pressure includes “forcing a female partner to terminate a

pregnancy when she does not want to [] or injuring a female partner in a way that may cause a miscarriage.” 59

ACOG advises that because violence is often linked to reproductive coercion, “providers should screen women

and adolescent girls for . . . reproductive [] coercion at

periodic intervals such as annual examinations, new patient visits, and during obstetric care (at the first prenatal visit, at least once per trimester, and at the postpartum checkup).”60 In 2007, the prevalence of intimate partner violence was nearly three times greater for women

seeking abortions than for women who continued their

pregnancies.61

With no in-person contact, prescribers lose the ability

to ensure that abusers are not just out of the frame of a

video conference pressuring their victims into requesting abortion-inducing drugs or ordering the drugs

ACOG Committee Op. No. 554, Reproductive and Sexual Coercion (February 2013; Reaffirmed 2019), https://www.acog.org/

clinical/clinical-guidance/committee-opinion/articles/2013/02/reproductive-and-sexual-coercion.

Id.

themselves to lace their victims’ food or beverages. AAPLOG writes:

Intimate partner violence is associated with abortion and with repeat abortions, and this is particularly true of adolescents and women being trafficked for sex. . . . Interaction with the health care

system is an opportunity for these women to be

identified and helped, but availability of medication abortion to abusers removes this opportunity.62

This concern is not hypothetical; abusers have been prosecuted for drugging pregnant women with abortion-inducing drugs without their consent.63 Tragically, the vast

majority of these cases are unlikely to be detected, reported, and prosecuted.

A 2023 peer-reviewed survey demonstrated the prevalence of coercion in women’s abortion decisions that will

undoubtably grow with the removal of the in-person dispensing requirement for mifepristone. A survey of more

than 1,000 American women between the ages of 41 and

45 included over 200 who acknowledged having had abortions.64 Of the women who had abortions, close to 70

AAPLOG Committee Op. No. 9, supra n. 28.

Hannah Howard, Medical and Social Risks Associated with

Unmitigated Distribution of Mifepristone: A Primer, On Point, Issue 51, Charlotte Lozier Institute (Oct. 1, 2020), https://lozierinstitute.org/medical-and-social-risks-associated-with-unmitigated-distribution-of-mifepristone-a-primer/.

David C. Reardon and Tessa Longbons, Effects of Pressure to

Abort on Women’s Emotional Responses and Mental Health, Cureus 15(1) (Jan. 31, 2023), available at https://www.

cureus.com/articles/124269-effects-of-pressure-to-abort-on-womens-emotional-responses-and-mental-health#!/.

percent “described them as coerced, pressured, or inconsistent with their own values and preferences.” 65 Further, “a majority experienced pressure from other people in their lives – belying the dangerous assumption that

abortion is strictly a matter of ‘a woman’s choice.’” 66

This coerced “consent” had real consequences in

these women’s lives: “perceived pressure to abortion was

significantly associated with more negative emotions;

more disruption of daily life, work, or relationships; more

frequent thoughts, dreams, or flashbacks to the abortion;

more frequent feelings of loss, grief or sadness about the

abortion; more moral and maternal conflict over the

abortion decision; a decline in overall mental health that

they attribute to their abortions; more desire or need for

help to cope with negative feelings about the abortion.”67

The BBC also commissioned a survey of one thousand

women aged 18-44 to determine how common sexual coercion is, and found that half said they had experienced

at least one type of reproductive coercion. 68 Fifteen percent of women surveyed said that they had experienced

pressure to terminate a pregnancy against their will. 69

Tessa Longbons and David C. Reardon, Ph.D., Study: Many

Women Who Had Abortions Felt Pressured by Others, Charlotte

Lozier Institute (May 25, 2023), https://lozierinstitute.org/studymany-women-who-had-abortions-felt-pressured-by-others/.

Id.

Reardon and Longbons, supra n. 64.

Alys Harte and Rachel Stonehouse, Reproductive coercion: ‘I

wasn’t allowed to take my pill,’ BBC News (Mar. 13, 2022),

https://www.bbc.com/news/newsbeat-60646285; Reproductive Coercion Poll – BBC Radio 4 – 8 March 2022, Savanta ComRes (Aug. 3,

2022), https://savanta.com/knowledge-centre/poll/reproductive-coercion-poll-bbc-radio-4-8-march-2022/.

Reproductive Coercion Poll, supra n. 68.

Three percent were given a substance to cause an abortion without their knowledge or consent. 70 Five percent

experienced physical violence with the intention to end

their pregnancies.71

Tragically, most instances of coerced abortion are

never publicly known, and there is no justice for the victims. In-person dispensing requirements provided a line

of defense—though an imperfect one—against coerced

abortion. By ceasing to require in-person contact between prescribers and patients, FDA’s post-marketing

restrictions cannot ensure that women and girls are protected from coercive partners and predators—further

eroding the ability of women to make independent, voluntary decisions to use mifepristone.

CONCLUSION

The Court should affirm the Fifth Circuit’s order and

remand for further proceedings.

Respectfully submitted.