Amicus Curiae Brief — Food and Drug Administration, et al., Petitioners v. Alliance for Hippocratic Medicine, et al.
Supreme Court briefJan 30, 2024
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Nos. 23-235, 23-236
In the Supreme Court of the United States
FOOD AND DRUG ADMINISTRATION, ET AL.,
Petitioners,
v.
ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,
Respondents.
DANCO LABORATORIES, L.L.C.,
Petitioner,
v.
ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,
Respondents.
ON WRITS OF CERTIORARI TO THE UNITED STATES
COURT OF APPEALS FOR THE FIFTH CIRCUIT
BRIEF OF MEDICAL STUDENTS FOR CHOICE
AS AMICUS CURIAE
IN SUPPORT OF PETITIONERS
JAYME JONAT
Counsel Of Record
CHARLOTTE BAIGENT
HOLWELL SHUSTER & GOLDBERG LLP
425 Lexington Avenue, 14th Floor
New York, NY 10017
(646) 837-8455
jjonat@hsgllp.com
cbaigent@hsgllp.com
Counsel for Amicus Curiae
i
INTERESTS OF AMICUS CURIAE ..........................1
SUMMARY OF ARGUMENT .....................................1
ARGUMENT ................................................................3
I.
The FDA’s evidence-based regulation of
mifepristone warrants deference .....................3
II.
Medical schools must be permitted to teach
evidence-based medicine ................................10
III.
Clinical and residency programs must be
permitted to provide evidence-based
training............................................................18
CONCLUSION ..........................................................27
ii
TABLE OF AUTHORITIES
CASES
Biden v. Missouri,
595 U.S. 87 (2022) ................................................... 9
Dobbs v. Jackson Women’s Health Org.,
597 U.S. 215 (2022) ............................................... 22
FCC v. Prometheus Radio Project,
592 U.S. 414 (2021) ........................................... 9, 10
FDA v. Am. Coll. Of Obstetricians & Gynecologists,
141 S. Ct. 10 (2021) ................................................. 7
FDA v. Am. Coll. of Obstetricians & Gynecologists,
141 S. Ct. 578 (2021) ............................................... 7
FDA v. Brown & Williamson Tobacco Corp.,
529 U.S. 120 (2000) ................................................. 7
Kisor v. Wilkie,
139 S. Ct. 2400 (2019) ............................................. 9
Little Rock Family Planning Serv. v. Rutledge,
397 F. Supp. 3d (E.D. Ark. 2019) ............................ 8
Planned Parenthood of Greater Iowa, Inc. v. Miller,
30 F. Supp. 2d 1157 (S.D. Iowa 1998) .................... 8
Planned Parenthood of Ind. & Ky., Inc. v. Comm’r,
Ind. State Dep’t of Health, 896 F. 3d (7th Cir.
2018). ....................................................................... 8
Planned Parenthood of Wis., Inc. v. Schimel,
806 F. 3d (7th Cir. 2015) ......................................... 8
South Bay United Pentecostal Church v. Newsom,
140 S. Ct. 1613 (2020) ............................................. 7
iii
Weinberger v. Bentex Pharms., Inc.,
412 U.S. 645 (1973) ............................................... 13
STATUTES
21 U.S.C. § 331 note .................................................... 4
21 U.S.C. § 355(d) .................................................... 2, 4
21 U.S.C. § 355-1 ..................................................... 2, 4
OTHER AUTHORITIES
Accreditation Council for Graduate Med. Educ.,
ACGME Program Requirements for Graduate
Medical
Education
in
Obstetrics
and
Gynecology (Sept. 17, 2022) ..................................21
Anna Popinchalk & Gilda Sedgh, Trends in the
method and gestational age of abortion in highincome countries, 45 BMJ SEX REPROD. HEALTH
95 (2019) ..................................................................3
Ara Aiken et al., Effectiveness, safety and
acceptability of no-test medical abortion
(termination of pregnancy) provided via
telemedicine: a national cohort study, 128 NAT’L
LIBR. MED. 1464 (2021) ...........................................6
Basil Varkey, Principles of Clinical Ethics and
Their Application to Practice, 30 MED.
PRINCIPLES & PRAC. 17 (2021)...............................17
Eve Espey et al., Abortion education in the medical
curriculum: a survey of student attitudes, 77
CONTRACEPTION 205 (2008) ...................................18
Greer
Donley,
Medication
Abortion
Exceptionalism, 107 CORNELL L. REV. 627
(2022) ...................................................................3, 4
iv
Gynuity Health Projects, Mifepristone Approved
List (May 2023)....................................................2, 5
Helena K. Kallner et al., Home self-administration
of vaginal misoprostol for medical abortion at
50–63 days compared with gestation of below 50
days, 25 HUMAN REPROD. 1153 (2010) ....................6
Honor MacNaughton et al., Mifepristone and
Misoprostol for Early Pregnancy Loss and
Medication Abortion, 103 AM. FAM. PHYSICIAN
473 (2021) ................................................................3
Jeff Diamant & Besheer Mohamed, What the data
says about abortion in the U.S., PEW RSCH. CTR.
(Jan. 11, 2023) .........................................................3
Jennifer K. Hsia et al., Medical abortion with
mifepristone and vaginal misoprostol between
64 and 70 days’ gestation, 100 CONTRACEPTION
178 (2019) ................................................................6
Josephine L. Dorsch et al., Impact of an evidencebased medicine curriculum on medical students’
attitudes and skills, 92 J. MED. LIBR. ASS’N 397
(2004) .....................................................................11
Kavita Vinekar et al., Projected Implications of
Overturning Roe v Wade on Abortion Training
in U.S. Obstetrics and Gynecology Residency
Programs, 140 OBSTETRICS & GYNECOLOGY 146
(2022) .....................................................................23
v
Kendal Orgera et al., Training Location
Preferences of U.S. Medical School Graduates
Post Dobbs v. Jackson Women’s Health, AM.
ASS’N AM. MED. COLL. RSCH. ACTION INST. (Apr.
13, 2013) ................................................................23
Laura Menard et al., Integrating evidence-based
medicine skills into a medical school
curriculum:
a
quantitative
outcomes
assessment, 26 BMJ EVIDENCE BASED MED. 249
(2020) .....................................................................11
Laura Schummers et al., Abortion Safety and Use
with Normally Prescribed Mifepristone, 386
New Eng. J. MED. 57 (2022) ....................................6
Liaison Committee on Medical Education,
Functions and Structure of a Medical School
(Nov. 2023)................................................. 11, 12, 15
Lisa S. Lehmann et al., A Survey of Medical Ethics
Education at U.S. and Canadian Medical
Schools, 79 ACAD. MED. 682 (2004).......................15
Luci Hulsman et al., Impact of the Dobbs v.
Jackson Women’s Health Organization decision
on retention of Indiana medical students for
residency, 5 AM. J OBSTETRICS & GYNECOLOGY
101164 (Nov. 2023) ................................................22
Marike Lemmers et al., Medical Treatment for
Early Fetal Death (Less Than 24 Weeks), 6
COCHRANE DATABASE SYST. REV. 1 (2019) ..............3
vi
Med. School Objectives Writing Grp., Learning
Objectives for Medical Student Education—
Guidelines for Medical Schools: Report I of the
Medical School Objectives Project, 74 ACAD.
MED. 13 (1999).......................................................11
Mette Løkeland et al., Implementing Medical
Abortion with Mifepristone and Misoprostol in
Norway 1998–2013, 46 INT’L J. EPIDEMIOLOGY
643 (2017) ................................................................6
Mitchell D. Creinin et al., Medication Abortion Up
to 70 Days of Gestation, AM. COLL.
OBSTETRICIANS & GYNECOLOGISTS PRAC. BULL.
NO. 225 (Oct. 2020), ................................................9
Nick Anderson, A race to teach abortion
procedures, before the bans begin, WASH. POST
(Jun. 20, 2022) .......................................................24
Rachel K. Jones, Medication Abortion Now
Accounts for More Than Half of All US
Abortions, GUTTMACHER INST. (Feb. 24, 2022) .......3
Rachel R. Peachman, Dobbs Decision Threatens
Full Breadth of Ob-Gyn Training, 328 J. AM.
MED. ASS’N 1668 (2022) ...................................18, 23
Sarah McNeilly & Vivian Kim, A Call to
Standardize Abortion Education Across U.S.
Medical Schools, ALBERT EINSTEIN COLL. MED.
(Jul. 7, 2022) ..........................................................22
Steven Tenny & Matthew Varacallo, Evidence
Based Medicine, STATPEARLS PUBL’G (Oct. 24,
2022) ................................................................10, 14
vii
Thomas R. McCormick et al., Principles of
Bioethics, UNIV. WASH. MED. DEP’T BIOETHICS &
HUMAN. (last visited Jan. 24, 2024)......................15
Tom L. Beauchamp & James F. Childress,
Principles of Biomedical Ethics (8th ed. 2019) ....15
Univ. of Cal., S.F., Analysis of Medication
Abortion Risk and the FDA Report: Mifepristone
U.S. Post-Marketing Adverse Events Summary
through 12/31/2018, BIXBY CTR. FOR REPROD.
HEALTH (Apr. 2019) .................................................5
Univ. of Cal., S.F., The Kenneth J. Ryan Residency
Training Program in Abortion & Family
Planning, BIXBY CTR. FOR REPROD. HEALTH
(last visited Jan. 28, 2024) ....................................24
U.S. Food & Drug Admin., Information about
Mifepristone for Medical Termination of
Pregnancy Through Ten Weeks Gestation (Mar.
23, 2023) ..................................................................5
U.S. Food & Drug Admin., Mifepristone U.S. PostMarketing Adverse Events Summary Through
12/31/2022 (Dec. 31, 2022) ....................................5
World Health Org., Medical management of
abortion (2018) ......................................................17
World Health Org., Model List of Essential
Medicines (2019) ......................................................3
viii
Yen Yi Tan et al., Comparing clinical trial
population representativeness to real-world
populations: an external validity analysis
encompassing 43 895 trials and 5 685 738
individuals across 989 unique drugs and 286
conditions in England, 3 LANCET 674 (2022) .......14
1
INTERESTS OF AMICUS CURIAE 1
Medical Students for Choice (“MSFC”) is a nonprofit organization with over 10,000 members at
nearly 300 chapters in over 30 countries, including
185 chapters across the United States. MSFC seeks to
ensure that medical students and trainees have access
to comprehensive, evidence-based education on
reproductive healthcare. MSFC has a strong interest
in protecting evidence-based medical education and
training. Accordingly, MSFC submits this brief to
outline the concerns of the organization’s members
concerning judicial interference with evidence-based
access to mifepristone. 2
SUMMARY OF ARGUMENT
Medical education in the United States should be
among the best in the world. However, judicial
interference with the Food and Drug Administration’s
(“FDA”) evidence-based regulation of mifepristone
risks damaging the quality and reputation of medical
education and training in this country.
Mifepristone is a safe and effective medication
used in nearly 100 countries around the world for
1 Pursuant to Supreme Court Rule 37.6, amicus curiae states that
no counsel for a party authored this brief in whole or in part, and
no person or entity, other than amicus curiae and its counsel,
made a monetary contribution to its preparation or submission.
The statements provided herein express the views of the
speaker as a member of MSFC and should not be attributed to
any other institutions with which such speakers may be
affiliated.
2
2
abortion care and miscarriage management. 3 Doctors
and patients can trust that mifepristone is safe and
effective as distributed, relying on the FDA’s evidencebased and scientifically rigorous review and approval
process. See 21 U.S.C. § 355(d) (mandating for drug
approval “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”); 21 U.S.C. § 3551 (empowering the FDA to implement “risk evaluation
and mitigation strategies” (REMS)). The Fifth
Circuit’s stay of the FDA’s changes to mifepristone’s
label and REMS, after decades of data on its safe and
effective use, cannot be squared with science.
There is a grave risk that if courts can supplant
their views for those of the FDA, against the weight of
scientific evidence and global consensus, then the
quality of medical education and training in the
United States will suffer. Medical schools would be left
to translate policies that are not scientifically
supported to students, contrary to their core function
of providing an evidence-based education. Meanwhile,
clinical and residency programs would be unduly
limited in their ability to train future physicians on a
globally accepted, evidence-based standard of care.
In short, medical schools and residency programs
in the United States cannot provide world-class
teaching and training in a healthcare system in which
evidence-based medicine is overruled by courts.
Gynuity Health Projects, Mifepristone Approved List (May
2023), https://shorturl.at/eDINX.
3
3
ARGUMENT
I.
The FDA’s evidence-based regulation of
mifepristone warrants deference.
Mifepristone is a globally accepted standard of
care, championed by the World Health Organization
as an essential medicine and available in almost 100
countries. 4 After nearly a quarter-century of
mifepristone’s safe and effective use in the United
States, medication abortions now account for more
than half of all abortions in the country. 5 Around the
world, the data similarly shows that medication
abortions account for approximately half of all
abortions in most high-income countries. 6 This Court
should defer to the FDA’s evidence-based regulation of
mifepristone—a drug proven to be safe and effective
for
medication
abortions
and
miscarriage
management. 7
Id.; World Health Org., Model List of Essential Medicines
(2019), at 47, https://rb.gy/j5ouh.
4
See Rachel K. Jones, Medication Abortion Now Accounts for
More Than Half of All US Abortions, GUTTMACHER INST. (Feb. 24,
2022), https://rb.gy/jf9ey; Jeff Diamant & Besheer Mohamed,
What the data says about abortion in the U.S., PEW RSCH. CTR.
(Jan. 11, 2023), https://rb.gy/232rl.
5
6 Anna
Popinchalk & Gilda Sedgh, Trends in the method and
gestational age of abortion in high-income countries, 45 BMJ SEX
REPROD. HEALTH 95 (2019).
7 E.g., Honor MacNaughton et al., Mifepristone and Misoprostol
for Early Pregnancy Loss and Medication Abortion, 103 AM. FAM.
PHYSICIAN 473 (2021); Marike Lemmers et al., Medical
Treatment for Early Fetal Death (Less Than 24 Weeks), 6
COCHRANE DATABASE SYST. REV. 1 (2019); Greer Donley,
4
A. The FDA is the agency entrusted to decide,
based on its scientific expertise, whether mifepristone
is safe and effective for distribution and on what
terms. The FDA cannot approve a drug for
distribution, unless there are “adequate tests by all
methods reasonably applicable to show whether or not
such drug is safe for use.” 21 U.S.C. § 355(d). In 2000,
the FDA determined—after a four-year review—that
mifepristone was safe and effective for use under
specified conditions, including adverse effects
reporting and ongoing studies of patient outcomes.
J.A. 224–231. In 2007, Congress enacted the FDA’s
REMS regime. See U.S.C. § 355-1. Mifepristone was
deemed to have REMS, in accordance with the
restrictions on use set out in the 2000 approval. See 21
U.S.C. § 331 note.
In 2016, after 16 years of reporting and data, the
FDA modified mifepristone’s label to inter alia
increase the gestational age limit from 49 days to 70
days, change the dosing from 600 to 200 mg, and
reduce in-person visits from three to one. JA. 293–300.
The FDA also changed the REMS to permit additional
licensed
healthcare
providers
to
prescribe
mifepristone
and
remove
certain
reporting
requirements, after 16 years of such data. J.A. 309–
310. In 2021, the FDA halted enforcement of the inperson dispensing requirement, J.A. 377, later
permanently removing the requirement based on
decades of “data and information support[ing]
Medication Abortion Exceptionalism, 107 CORNELL L. REV. 627,
651–52 (2022).
5
modification of the REMS to reduce burden on the
health care delivery system.” 8
B. Judicial interference with the FDA’s evidencebased regulation of mifepristone would result in the
United States being out of step with global scientific
consensus. Decades of data on mifepristone establish
that it is safe and effective, and indeed much safer
than commonly prescribed drugs like Viagra or
Tylenol. 9 Nearly six million Americans have safely
used mifepristone to complete an abortion, and nearly
100 countries have approved use of mifepristone,
including the United Kingdom, France, Canada,
Sweden, Germany, Norway, and Switzerland. 10
The FDA’s gradual reduction of restrictions on
mifepristone is in keeping with global scientific
consensus based on decades of data. A study in
Canada—where mifepristone has been accessible like
any other prescription since November 2017—showed
that adverse effects and complications remained
8 U.S. Food & Drug Admin., Information about Mifepristone for
Medical Termination of Pregnancy Through Ten Weeks Gestation
(Mar. 23, 2023), https://t.ly/v3aOV.
9 Univ. of Cal., S.F., Analysis of Medication Abortion Risk and the
FDA Report: Mifepristone U.S. Post-Marketing Adverse Events
Summary through 12/31/2018, BIXBY CTR. FOR REPROD. HEALTH
(Apr. 2019), http://bit.ly/48MBVnu.
10 U.S. Food & Drug Admin., Mifepristone U.S. Post-Marketing
Adverse Events Summary Through 12/31/2022 (Dec. 31, 2022),
https://rb.gy/s3zav; Gynuity Health Projects, supra note 3.
6
stable before and after REMS-like restrictions. 11
Another study of over 50,000 patients in the United
Kingdom showed no material difference in safety or
efficacy using a telemedicine-hybrid model, with
ultrasonography performed only when ectopic
pregnancy is indicated. 12 Numerous additional studies
support the FDA’s changes to mifepristone’s
regulations, including increasing the indicated
gestational age from seven to ten weeks and reducing
the number of required in-person doctor visits. 13
C. It is not the role of courts to second-guess the
FDA’s scientific expertise. Courts, for good reason,
“owe significant deference to the politically
accountable entities [like the FDA] with the
Laura Schummers et al., Abortion Safety and Use with
Normally Prescribed Mifepristone, 386 NEW ENG. J. MED. 57
(2022).
11
12 Ara Aiken et al., Effectiveness, safety and acceptability of no-
test medical abortion (termination of pregnancy) provided via
telemedicine: a national cohort study, 128 NAT’L LIBR. MED. 1464
(2021).
13 E.g., Mette Løkeland et al., Implementing Medical Abortion
with Mifepristone and Misoprostol in Norway 1998–2013, 46
INT’L J. EPIDEMIOLOGY 643 (2017) (Norwegian study of over
200,000 medication abortions up to 12 weeks’ gestation); Jennifer
K. Hsia et al., Medical abortion with mifepristone and vaginal
misoprostol between 64 and 70 days’ gestation, 100
CONTRACEPTION 178 (2019) (English study of medical records
showing mifepristone-misoprostol abortion is safe up to 70 days’
gestation); Helena K. Kallner et al., Home self-administration of
vaginal misoprostol for medical abortion at 50–63 days compared
with gestation of below 50 days, 25 HUMAN REPROD. 1153 (2010)
(Swedish study showing mifepristone-misoprostol regimen is safe
up to 63 days, with partial at-home use).
7
‘background, competence, and expertise to assess
public health.’” FDA v. Am. Coll. of Obstetricians &
Gynecologists, 141 S. Ct. 578, 579 (2021) (quoting
South Bay United Pentecostal Church v. Newsom, 140
S. Ct. 1613, 1614 (2020) (Roberts, C. J., concurring));
FDA v. Brown & Williamson Tobacco Corp., 529 U.S.
120, 142 (2000) (“[T]he FDA must determine that
there is a reasonable assurance that the product’s
therapeutic benefits outweigh the risk of harm.”); FDA
v. Am. Coll. Of Obstetricians & Gynecologists, 141 S.
Ct. 10, 12 (2021) (Alito, J., dissenting, with Thomas, J.
joining) (same).
As Sarah McNeilly, a third-year medical student at
the Albert Einstein College of Medicine, explains:
As a future physician, knowing that
courts may soon intervene with the
evidence-based decisions made by our
regulatory bodies like the FDA is gravely
concerning. The FDA is meant to be
independent, issuing guidance based
solely on clinical and scientific evidence.
When it comes to mifepristone, the
evidence is clear: it is safe and effective.
As physicians, we can and should be able
to rely on the FDA to guide our clinical
practice. If our faith in our regulatory
institutions is eroded, physicians will
suffer. This will, in turn, harm patients,
who are already struggling to navigate
mass medical misinformation. Having
such misinformation endorsed by the
courts would be extremely harmful to
8
patients, public health, and the practice
of medicine.
This case reveals the perils of courts supplanting
their scientific views for those of the FDA. By way of
example, the District Court stayed the FDA’s approval
of mifepristone based on its own review of “myriad
stories and studies brought to the Court’s attention,”
which courts (unlike the FDA) lack the scientific
expertise to apply. Pet. App. 177a. Indeed, the District
Court cited evidence on deaths and severe adverse
events after mifepristone that numerous courts have
rejected, 14 as well as studies on the mental health
consequences of abortion that have been scientifically
discredited. 15
Similarly, the Fifth Circuit cited the testimony of
doctors who treated incomplete medication abortions.
Pet. App. 19a–22a. But many of those doctors describe
14 Compare Pet. App. 170a (citing Aultman study), with Little
Rock Family Planning Serv. v. Rutledge, 397 F. Supp. 3d 1213,
1302–05 (E.D. Ark. 2019) (rejecting Aultman’s evidence on
medication abortions), aff’d 984 F.3d 682 (8th Cir.), vacated, 142
S. Ct. 2894 (2022); Planned Parenthood of Greater Iowa, Inc. v.
Miller, 30 F. Supp. 2d 1157, 1165, n. 9 (S.D. Iowa 1998) (holding
“[Aultman] has not performed an abortion since 1982 and is not
current on the medical aspects of abortion”), aff’d 195 F.3d 386
(8th Cir. 1999).
15 Compare Pet. App. 123a–124a (citing Coleman and Reardon
studies), with Planned Parenthood of Ind. & Ky., Inc. v. Comm’r,
Ind. State Dep’t of Health, 896 F. 3d 809, 826 (7th Cir. 2018)
(describing Coleman study as “controversial and much
maligned”), vacated, 141 S. Ct. 184 (2020); Planned Parenthood
of Wis., Inc. v. Schimel, 806 F. 3d 908, 922 (7th Cir. 2015)
(rejecting Reardon and Coleman study).
9
“adverse effects” such as “very heavy bleeding followed
by significant abdominal pain and a fever”—
symptoms that are to be expected. Pet. App. 20a. A
patient who follows a mifepristone-misoprostol
regimen is expected to experience cramping and
bleeding, much like a patient who experiences a
miscarriage. 16 Some may also require procedural
abortions, as the Fifth Circuit found, but that risk is
exceedingly rare with an occurrence rate of under 0.01
percent. 17 Contrary to the Fifth Circuit’s view, the
FDA’s impugned actions do not increase that risk.
When courts supplant an agency’s scientific
analysis with their own, they step beyond their role
and risk damaging evidence-based medicine in this
country. See FCC v. Prometheus Radio Project, 592
U.S. 414, 423 (2021) (holding a court cannot
“substitute its own policy judgment for that of the
agency”); Kisor v. Wilkie, 139 S. Ct. 2400, 2442 (2019)
(Gorsuch J., concurring, with Thomas and Kavanaugh
JJ. joining) (“[C]ourts should pay close attention to an
expert agency’s views on technical questions in its
field.”). That is why this Court has repeatedly held
that during challenges to an agency’s expert analysis,
“particularly concerning the nature of the data relied
upon, the role of courts in reviewing arbitrary and
capricious challenges is to ‘simply ensur[e] that the
agency has acted within a zone of reasonableness.’”
Biden v. Missouri, 595 U.S. 87, 96 (2022) (quoting
16 Mitchell D. Creinin et al., Medication Abortion Up to 70 Days
of Gestation, AM. COLL. OBSTETRICIANS & GYNECOLOGISTS PRAC.
BULL. NO. 225 (Oct. 2020), https://shorturl.at/dhI12.
17 Id.
10
Prometheus Radio Project, 592 U.S. at 423).
Otherwise, as occurred here, courts risk undermining
the very purpose of empowering agencies to make
decisions based on their subject-matter expertise.
II.
Medical schools must be permitted to
teach evidence-based medicine.
Medical school curricula in the United States are
premised on evidence-based medicine, teaching
students to use the scientific method combined with
clinical experience to arrive at the best medical
decisions for their patients. 18 If courts can upend the
FDA’s evidence-based regulation of medications, the
ability of medical schools in the United States to offer
evidence-based teaching will be impaired.
A. It is essential that medical schools in the United
States offer evidence-based medical curricula. Armed
with a strong scientific foundation, medical students
must be taught to care for patients based on principles
derived from published evidence, national and
international guidelines, medical society consensus,
and clinical experience, all with the goal of improving
medical outcomes based on the highest quality
evidence available. 19
Numerous studies have demonstrated the benefits
of an evidence-based medical education on patient
18 See Steven Tenny & Matthew Varacallo, Evidence Based
Medicine, STATPEARLS PUBL’G (Oct. 24, 2022) (“Evidence-based
medicine (EBM) uses the scientific method to organize and apply
current
data
to
improve
healthcare
decisions.”),
https://rb.gy/3nxyo.
19 Id.
11
care and outcomes. 20 Accordingly, the Association of
American Medical Colleges’ Medical School Objectives
Project concluded that, upon graduation, medical
students “must understand the scientific basis and
evidence of effectiveness for each of the therapeutic
options that are available for patients at different
times in the course of the patients’ conditions, and be
prepared to discuss those options with patients in an
honest and objective fashion.” 21
Teaching evidence-based medicine is not only
valuable; it is mandatory. The Liaison Committee on
Medical Education requires accredited medical
schools to select curricular content that teaches
students how scientific research “is conducted,
evaluated, explained to patients, and applied to
patient care,” and “provides opportunities for medical
students to acquire skills of critical judgment based on
evidence and experience, and develops medical
students’ ability to use those principles and skills
20 See Laura Menard et al., Integrating evidence-based medicine
skills into a medical school curriculum: a quantitative outcomes
assessment, 26 BMJ EVIDENCE BASED MED. 249 (2020); Josephine
L. Dorsch, et al., Impact of an evidence-based medicine
curriculum on medical students’ attitudes and skills, 92 J. MED.
LIBR. ASS’N 397 (2004).
Med. School Objectives Writing Grp., Learning Objectives for
Medical Student Education— Guidelines for Medical Schools:
Report I of the Medical School Objectives Project, 74 ACAD. MED.
13, 16 (1999).
21
12
effectively in
disease.” 22
solving
problems
of
health
and
B. Judicial interference with the FDA’s regulation
of mifepristone—based on rigorous review and
scientific consensus—runs counter to the evidencebased curricula that medical schools in this country
are entrusted to teach.
Hanna Amanuel, a medical student at Harvard
Medical School, fears being restricted in providing
evidence-based care to her patients:
I came to medical school to develop the
skills to support people, especially people
who are least cared for in the US medical
system. At a basic level, this means using
the most safe and effective medications
and treatments available, and scientific
research, to guide healthcare decisions.
Mifepristone is safely used in 96
countries around the world and is safely
taken at home. It troubles me that my
peers and I might be in a position where
we cannot prescribe a medication for use
on terms that we know based on the
evidence to be safe and effective.
If this Court affirms the Fifth Circuit’s decision,
thereby reinstating medically unnecessary and
outdated restrictions on mifepristone, medical schools
Liaison Committee on Medical Education, Functions and
Structure of a Medical School (Nov. 2023), at 10,
http://bit.ly/47LxI29.
22
13
will be left with the impossible task of teaching
students to provide evidence-based care, but to
potentially disregard the current scientific evidence
when doing so is judicially mandated. See Weinberger
v. Bentex Pharms., Inc., 412 U.S. 645, 653–54 (1973)
(holding that evaluating “reports as to the reputation
of drugs among experts in the field is not a matter well
left to a court without chemical or medical
background”).
As Danna Ghafir, a medical student at the
University of Texas McGovern Medical School,
describes:
We are expected to learn comprehensive
reproductive
healthcare,
including
abortion care, which is tested on our
national exams, and most importantly,
applied in practice to achieve the best
possible patient outcomes.
According
to
our
evidence-based
textbooks, which pull from a plethora of
peer-reviewed
clinical
research,
medication abortion is most effective
when mifepristone and misoprostol are
taken in combination. The management
of some miscarriages or early pregnancy
complications also calls for mifepristone
in combination with misoprostol to
maximize patient safety during uterine
evacuation. When abortion care is
restricted, physicians and care teams are
prevented from employing best practices
14
supported by decades of accumulated
scientific evidence.
Medical schools teach students to review clinical
studies under controlled conditions (used by the FDA
prior to the 2000 approval of mifepristone), as well as
data based on real-world use and reporting (used by
the FDA to modify mifepristone’s label and REMS). 23
As one study of over 40,000 clinical trials and 5.6
million real-world health records showed, evidencebased medicine is greatly benefited by real-world data
that more accurately reflects real-world conditions,
combinations of drugs, and demographics including
clinically vulnerable users. 24
The Fifth Circuit’s preferred scientific method—
focused on clinical studies over real-world data—is
incompatible with these core principles of evidencebased medicine. For example, the Fifth Circuit faulted
the FDA for purportedly failing to require clinical
studies of the cumulative effect of the modifications or
consider whether to collect clinical data on non-fatal
adverse events, notwithstanding that the FDA had
collected such data for over a decade from millions of
real users of mifepristone. Pet. App. 53–54a.
Reverting to mifepristone’s regulations as of 2000,
before the FDA had decades of real-world data on the
23 Tenny & Varacallo, supra note 18.
Yen Yi Tan et al., Comparing clinical trial population
representativeness to real-world populations: an external validity
analysis encompassing 43 895 trials and 5 685 738 individuals
across 989 unique drugs and 286 conditions in England, 3
LANCET 674 (2022).
24
15
drug’s safe and effective use, would undermine the
evidence-based curricula that our medical schools are
entrusted and required to teach.
C. Judicial interference with evidence-based
medicine undermines another central tenet of medical
school curricula: to teach medical students to follow
principles of medical ethics in caring for patients. 25
Although the precise content of ethical curricula
varies among medical schools, 26 the four commonly
accepted principles of medical ethics are respect for
autonomy (respecting and supporting autonomous
decisions); nonmaleficence (avoiding causation of
harm); beneficence (relieving, lessening, or preventing
harm, providing benefits, and balancing benefits
against risks and costs); and justice (fairly
distributing benefits, risks, and costs). 27
25 See Liaison Committee on Medical Education, Functions and
Structure of a Medical School, at 11, https://rb.gy/uur42
(requiring accredited medical schools to “ensure that the medical
curriculum includes instruction for medical students in medical
ethics and human values both prior to and during their
participation in patient care activities and require medical
students to behave ethically in caring for patients and in relating
to patients’ families and others involved in patient care”).
26 See Lisa S. Lehmann et al., A Survey of Medical Ethics
Education at U.S. and Canadian Medical Schools, 79 ACAD. MED.
682 (2004).
Tom L. Beauchamp & James F. Childress, Principles of
Biomedical Ethics (8th ed. 2019); Thomas R. McCormick et al.,
Principles of Bioethics, UNIV. OF WASH. MED., DEP’T BIOETHICS &
HUMAN. (last visited Jan. 24, 2024), https://rebrand.ly/zs1l6gb.
27
16
As Rose Al Abosy, M.D., explains:
Restricting the option of mifepristone
would seriously undermine my medical
training. Medical school teaches us to use
rigorously
defined
evidence-based
practice along with compassionate
counseling to decide with our patients
the treatment that works best for them.
If mifepristone is no longer as accessible,
then I can no longer offer some patients
this accepted standard of care, even
though my medical training teaches that
mifepristone is an extremely safe and
effective option, and even though many
patients prefer medical abortions over
procedural abortions. This outcome
would contradict the basic principles of
my medical training.
Similarly, as Ashley Hurd-Jackson, a third-year
medical student in Iowa, describes:
Mifepristone allows patients to have an
effective, safe, and non-invasive option
for abortion and managing miscarriage.
Providing a medication option to patients
increases access to care. More than onethird of Iowa’s counties are considered
rural, where patients face several
barriers to receiving in-person care.
Mifepristone allows mitigation of both
delays and access to care in rural areas
with the option of providing this
treatment via telemedicine.
17
Already, I have encountered several
incredibly difficult decisions that women
have had to make. These are pregnancies
that these women have prayed for,
planned for, cried tears of joy for. I have
handed tissues to a patient that was
recently diagnosed with cervical cancer
who had to decide if she wanted to
continue her pregnancy while receiving
cancer treatment. I helped care for
another patient after she was run over by
a vehicle and sustained injuries that led
to her losing the twins she was pregnant
with. Let us start by referring to abortion
as what it truly is – healthcare.
Imposing medically unnecessary restrictions on a
treatment option that is not only safe and effective,
but also one that some patients prefer, conflicts with
the principles of evidence-based and ethical care that
medical students are taught to uphold. 28
III.
Clinical and residency programs must be
permitted to provide evidence-based
training.
Clinical and residency programs in the United
States must be permitted to train future physicians to
provide evidence-based care. Restricting access to
mifepristone, contrary to the weight of scientific
See Basil Varkey, Principles of Clinical Ethics and Their
Application to Practice, 30 MED. PRINCIPLES & PRAC. 17, 18
(2021); World Health Org., Medical management of abortion
(2018), at 1–2, https://rb.gy/nmino.
28
18
evidence, jeopardizes the quality of evidence-based
training that residents, particularly those in
obstetrics and gynecology (OB/GYN), can receive in
the United States.
A. Imposing medically unnecessary restrictions on
mifepristone hinders the ability of clinical and
residency programs to train future physicians on all
evidence-based standards for abortion care and
miscarriage management. Medical students and
residents across the country have expressed a strong
desire for abortion care training. One study found that
96 percent of medical students indicated that abortion
education was appropriate in the preclinical and
clinical curricula, and 84 percent found it to be
worthwhile or valuable. 29 Numerous studies also show
that residents who receive routine abortion training
are more skilled in miscarriage management. 30
Without comprehensive reproductive healthcare
training, physicians across specialities will be less
equipped to care for their patients.
Rose Al Abosy, M.D., describes the importance of
her medication abortion training at Boston University
School of Medicine as follows:
The first time I learned about
mifepristone was in my pre-clinical
courses, which all medical students take
29 See Eve Espey et al., Abortion education in the medical
curriculum: a survey of student attitudes, 77 CONTRACEPTION
205, 206 (2008).
30 Rachel R. Peachman, Dobbs Decision Threatens Full Breadth
of Ob-Gyn Training, 328 J. AM. MED. ASS’N 1668, 1668 (2022).
19
regardless of the area of medicine they
will specialize in. Specifically, I learned
about mifepristone during a lecture on
abortion options, including both medical
and procedural abortion. I continued to
learn about mifepristone during my
OB/GYN rotation as a third-year medical
student, when I saw it administered to a
number of patients to manage abortion
and miscarriage. Then, as a fourth-year
medical student, I completed a rotation
in family planning and offered
medication and procedural abortion to
patients myself as part of options
counseling.
This training was absolutely helpful for
my practice. Knowing how to talk
through medical and procedural options
for abortion and miscarriage is a critical
skill set, not only for OB/GYN doctors,
but for anyone practicing medicine. If a
patient comes to you for issues unrelated
to reproductive health and has a history
of abortion or miscarriage, having
reproductive
health
training
is
important because your job as a
physician is to care for the patient as a
whole.
B. Amidst declining access to abortion care
training across the country, it is essential that the
clinical and residency programs that do provide this
training be permitted to teach globally accepted
20
standards of care based on the best available, up-todate scientific evidence.
The imposition of medically unnecessary
restrictions on mifepristone—such as reducing the
label’s indicated period of use from ten weeks of
pregnancy to only seven weeks and requiring three inperson doctor visits—would make a safe and effective
drug less accessible. JA. 293–300. In turn, clinical
training opportunities on counseling patients on
mifepristone as an option, as well as providing this
standard of care, would also become less accessible.
As fourth-year medical student at the University of
Texas McGovern Medical School, Danna Ghafir,
explains:
At the time I completed my OB/GYN
clinical rotation at a hospital in Texas,
several restrictions on abortion care were
already in effect in Texas, and access to
mifepristone was restricted despite its
well-established safety profile. We had
patients present to the emergency room
with early pregnancy complications and
inevitable spontaneous abortions, which
we managed with misoprostol alone.
My
textbooks
taught
me
that
mifepristone in combination with
misoprostol has better efficacy in certain
cases than misoprostol alone, so I asked
my attending why we weren’t using
mifepristone as well. The attending
responded that although it would be
21
ideal to give the two medications in
combination, the REMS on mifepristone
influenced the hospital’s decision to stop
carrying mifepristone altogether. Even
though I was taught a mifepristonemisoprostol management protocol, we
were unable to offer that option.
If access to mifepristone is restricted by
the courts, trainees nationwide could
have less access to experiential learning
on the highest quality, evidence-based
management
protocols
involving
mifepristone.
Abortion care training is required for the
accreditation
of
OB/GYNs.
Currently,
the
Accreditation Council for Graduate Medical Education
(“ACGME”) requires OB/GYN residency programs to
provide “clinical experience or access to clinical
experience in the provision of abortions as part of the
planned curriculum,” and if doing so would be
unlawful, to “provide access to this clinical experience
in a different jurisdiction where it is lawful.” 31
Further, the ACGME requires specific training on
medication abortion methods and management of
abortion complications, as well as clinical experience
in spontaneous abortion, pregnancy loss, and uterine
Accreditation Council for Graduate Med. Educ., ACGME
Program Requirements for Graduate Medical Education in
Obstetrics and Gynecology (Sept. 17, 2022), at IV.C.7.a(4),
https://bit.ly/4b9hXoP.
31
22
evacuation in the operating room and outpatient
settings. 32
Already, residency training on abortion care is in
decline. It is predicted that in the aftermath of Dobbs
v. Jackson Women’s Health Org., 597 U.S. 215
(2022)—reversing federal constitutional protection for
the right to abortion—available placements for
abortion care training will be cut roughly in half. 33
Indeed, the data shows that medical students in
abortion-ban states are leaving to study in states
without restrictive abortion laws. 34
As a third-year medical student in Iowa, Alina
Beltrami, describes:
Abortion is healthcare. I am considering
moving to another state where I know
that I will be able to get the training that
I need to provide care to my patients. In
Texas, patients effectively need to be
septic to receive an abortion. In Idaho,
where I completed an OB/GYN clinical
rotation, physicians are very afraid that
if they do not provide abortions their
patients could die or lose their uterus,
32 Id. at IV.C.7–8.
33 Sarah McNeilly & Vivian Kim, A Call to Standardize Abortion
Education Across U.S. Medical Schools, ALBERT EINSTEIN COLL.
MED. (Jul. 7, 2022), https://shorturl.at/quFMX.
See Luci Hulsman et al., Impact of the Dobbs v. Jackson
Women’s Health Organization decision on retention of Indiana
medical students for residency, 5 AM. J OBSTETRICS &
GYNECOLOGY 101164 (Nov. 2023).
34
23
but if they do, they could lose their
license, their ability to pay off their
medical school loans, and their ability to
care for future patients. In Iowa, I would
be very hesitant to stay here for
residency if there is an abortion ban in
place, and I have classmates who will not
apply for residency in any states with
restrictive abortion laws.
As the data shows, states with restrictive abortion
laws have seen the number of residency applications
drop across specialties. Applications for OB/GYN
residency programs, in particular, have dropped by
10.7 percent in states that ban abortion and 7.1
percent in states with gestational limits on abortion. 35
In 2022, approximately 45 percent of all accredited
OB/GYN residency programs across the country were
in states certain or likely to ban abortion. 36 Since
abortion care training is a requirement for OB/GYN
accreditation, residents in abortion-ban states will
have to travel out-of-state for this training. 37 As access
35 See Kendal Orgera et al., Training Location Preferences of U.S.
Medical School Graduates Post Dobbs v. Jackson Women’s
Health, AM. ASS’N AM. MED. COLL. RSCH. ACTION INST. (Apr. 13,
2013), https://rb.gy/0tu9gc.
See Kavita Vinekar et al., Projected Implications of
Overturning Roe v Wade on Abortion Training in U.S. Obstetrics
and Gynecology Residency Programs, 140 OBSTETRICS &
GYNECOLOGY 146 (2022); see also Peachman, supra note 30, at
1668.
36
37 The Ryan Residency Training Program in Abortion & Family
Planning helps meet the ACGME mandate for routine abortion
training in OB/GYN residency programs, including by assisting
24
to abortion care training declines, there simply is “no
guarantee that enough slots would be available to
meet demand.” 38
It is therefore critical that the safe havens for
abortion care training in the United States be able to
offer
comprehensive
evidence-based
training,
including on prescribing mifepristone based on the
scientific evidence.
C. This case presents a significant risk of harming
the reputation of medical training in the United States
by setting a new precedent that the FDA’s evidencebased actions are subject to judicial second-guessing.
Dango Mwambene, a medical student at the
University of Cape Town, describes the following
concerns:
I have considered specialising or
subspecialising
in
obstetrics
and
gynaecology in the United States, but a
ruling restricting mifepristone and that
further federally limits access to abortion
significantly makes me reconsider this
possibility. I’d rather stay in South Africa
and specialise here or go elsewhere
in establishing partnerships between residency programs in
abortion-ban states and out-of-state facilities where their
residents can complete required training. See Univ. of Cal., S.F.,
The Kenneth J. Ryan Residency Training Program in Abortion &
Family Planning, BIXBY CTR. FOR REPROD. HEALTH (last visited
Jan. 28, 2024), https://shorturl.at/nvwD7.
38 See Nick Anderson, A race to teach abortion procedures, before
the bans begin, WASH. POST (Jun. 20, 2022), https://rb.gy/rz3px0.
25
where abortion access is constitutionally
protected.
Similarly, Hadiza Thompson, a recent medical
school graduate completing clinical training at the
University of Nigeria teaching hospital, shared the
following concerns:
The United States is considered a global
leader in providing the basic framework
for evidence-based medical education
and training around the world. I strongly
believe that if the United States no
longer abides by the evidence-based
medicine and ethics that it purports to
teach, then it will tarnish its reputation
and standing in the global medical
community.
I have also seen how restrictive abortion
laws impair medical training. In Nigeria,
abortion is illegal unless the pregnancy
poses an imminent risk of death. The
only reason I have training on
mifepristone is because I completed it in
another country, and I can hardly use my
training. When a patient had a
miscarriage, I had to collect her payment,
go to the pharmacy, pick up mifepristone,
and administer it to her at the hospital.
Those barriers mean very few patients
can access mifepristone, and very few
physicians have experience providing
this basic and even life-saving care.
26
In the United States, medical students and
graduates are grappling with the uncertainty around
their ability to provide evidence-based abortion care in
the future. As Rose Al Abosy, M.D., explains:
Now that the situation around abortion
training and access in this country is
growing increasingly dire, when I think
about my future practice as an OB/GYN,
I think about what it would be like to
practice in a different country. If abortion
options become very limited in the
United States and I am not permitted to
practice medicine here in the way that I
was trained, I would consider my options
for practicing elsewhere.
Medical students seeking to practice in the United
States and to train in this country’s prestigious
medical programs should not need to settle for
incomplete and scientifically inferior training on
reproductive healthcare. As the testimonials of
current and former medical students above illustrate,
judicial interference with the FDA’s regulation of
mifepristone would erode evidence-based medicine in
this country and have a detrimental impact on medical
education and training.
CONCLUSION
It is imperative to the quality and reputation of
medical education in the United States that medical
schools, clinical programs, and residency programs be
permitted to teach evidence-based medicine.
27
This Court should decline to impose medically
unnecessary restrictions on mifepristone, contrary to
the FDA’s scientific expertise, global consensus, and
the evidence-based medicine that our medical schools
and training programs are entrusted to teach.
This Court should reverse.
Respectfully submitted,
JAYME JONAT
Counsel of Record
CHARLOTTE BAIGENT
HOLWELL SHUSTER & GOLDBERG LLP
425 LEXINGTON AVENUE
New York, NY 10017
(646) 837-5120
jjonat@hsgllp.com
cbaigent@hsgllp.com
Counsel for Amicus Curiae
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.