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

————

U.S. FOOD & 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 OVER 300 REPRODUCTIVE

HEALTH RESEARCHERS AS AMICI CURIAE

IN SUPPORT OF PETITIONERS

————

MELISSA GOODMAN

Counsel of Record

AMANDA BARROW

CATHREN COHEN

JACLYN SERPICO

CENTER ON REPRODUCTIVE

HEALTH, LAW, AND POLICY

UCLA SCHOOL OF LAW

1060 Veteran Avenue

Los Angeles, CA 90095

(310) 267-4382

goodmanm@law.ucla.edu

Counsel for Amici Curiae

CLAUDIA HAMMERMAN

AARON DELANEY

PAUL, WEISS, RIFKIND,

WHARTON & GARRISON LLP

1285 Avenue of the Americas

New York, NY 10019

(212) 373-3000

chammerman@paulweiss.com

January 30, 2024

WILSON-EPES PRINTING CO., INC. – (202) 789-0096 – WASHINGTON, D.C. 20002

TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES ................................

iii

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

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

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

I. FDA’s

2016

Decision,

Modifying

Mifepristone’s REMS and Labeling, Was

Supported by Ample Scientific Evidence .

A. Extensive Scientific Evidence Supported

Permitting Prescribing Healthcare

Providers to Be Certified Prescribers

of Mifepristone .....................................

B. Extensive Scientific Evidence Supported

the Safety and Effectiveness of the

Amended Dosing Regimen Indicated

on the Label .........................................

C. Extensive Scientific Evidence Supported

the Safety and Effectiveness of

Increasing the Gestational Limit

Indicated on the Label.........................

D. Extensive Scientific Evidence Supported

the Safety and Effectiveness of Reducing

the Number of In-Person Clinical Visits

Indicated on the Label.........................

E. FDA’s Judgment that the Individual

Changes in 2016 Were Collectively Safe

and Effective Was Supported by a

Robust Record of Scientific Evidence ....

(i)

TABLE OF CONTENTS—Continued

Page

F. Modification of the Adverse Event

Reporting Requirement Was Supported

by More Than Adequate Rationale .....

II. FDA’s 2021 Decision Removing the InPerson Dispensing Requirement from the

REMS, Formalized in 2023, Was

Supported by Ample Scientific Evidence .

A. FDA Relied upon Ample Scientific

Evidence Supporting the Safety and

Effectiveness of Removing the InPerson Dispensing Requirement ........

1. The April 2021 Nonenforcement

Decision Was Supported by Ample

Scientific Evidence .........................

2. Additional Studies Before FDA in

2021 and Relied on in its December

2021 Analyses Supported the

removal of the In-Person Dispensing

Requirement ...................................

B. Additional Evidence Supports the Safety

and Effectiveness of Removing the InPerson Dispensing Requirement ........

CONCLUSION ....................................................

APPENDIX

iii

TABLE OF AUTHORITIES

STATUTES

Page(s)

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

3, 4

21 U.S.C. § 355-1(f)(2) ..................................

21 U.S.C. § 355-1(f)(2)(C) .............................

21 U.S.C. § 355-1(g) ......................................

21 U.S.C. § 355-1(g)(4)(a) .............................

21 U.S.C. § 505(b) .........................................

COURT FILINGS

Brief of Amici Food and Drug Law Scholars

as Amicus Curiae in Support of Petitions

for Writ of Certiorari, FDA v. Alliance for

Hippocratic Medicine (Oct. 12, 2023) .......

OTHER AUTHORITIES

Aiken et al., Effectiveness, safety and

acceptability of no-test medical abortion

(termination of pregnancy) provided via

telemedicine: a national cohort study, 128

BJOG 1464 (2021) ..................................... 25, 26

Anger et al., Clinical and service delivery

implications of omitting ultrasound

before medication abortion provided via

direct-to-patient telemedicine and mail in

the US, 104 CONTRACEPTION 659 (2021) ..

TABLE OF AUTHORITIES—Continued

Page(s)

Boersma et al., Mifepristone followed by

home administration of buccal misoprostol

for medical abortion up to 70 days of

amenorrhoea in a general practice in

Curaçao, 16 EUR. J. CONTRACEPT.

REPROD. HEALTH CARE 61 (2011) .............

Cameron et al. Can women determine the

success of early medical termination of

pregnancy themselves? 91 CONTRACEPTION

6 (2015) ......................................................

Chen et al., Mifepristone with buccal

misoprostol for medical abortion, a

systematic review, 126 OBSTET. GYNECOL.

12 (2015) ...................................... 8, 9, 12, 18, 24

Chong et al., A randomized controlled trial

of different buccal misoprostol doses in

mifepristone medical abortion, 86

CONTRACEPTION 251 (2012) ......................

Chong et al., Expansion of direct-to-patient

telemedicine abortion service in the

United States and experience during the

COVID-19 pandemic, 104 CONTRACEPTION 43 (2021) ..................................... 24, 26, 27

Diaz Olavarrieta et al., Nurse versus

physician-provision of early medical

abortion in Mexico: a randomized

controlled non-inferiority trial, 93 BULL.

WORLD HEALTH ORG. 249 (2015) .............. 7, 17

TABLE OF AUTHORITIES—Continued

Page(s)

Fjerstad et al., Effectiveness of medical

abortion with mifepristone and buccal

misoprostol though 59 gestational days,

80 CONTRACEPTION 282 (2009) .................

Gallo et al., A systematic review of more

than one dose of misoprostol after

mifepristone for abortion up to 10 weeks

of gestation, 74 CONTRACEPTION 36

(2006) .........................................................

Gatter et al., Efficacy and safety of medical

abortion using mifepristone and buccal

misoprostol though 63 days, 91

CONTRACEPTION 269 (2015) ......................

Grossman et al., Alternatives to ultrasound

for follow-up after medication abortion: a

systematic review, 83 CONTRACEPTION

504 (2011) ..................................................

Grossman et al., Effectiveness and acceptability of medical abortion provided through

telemedicine, 118 OBSTET. GYNECOL. 296

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

Grossman et al., Mail-order pharmacy

dispensing of mifepristone for medication

abortion after in-person clinical assessment,

107 CONTRACEPTION 36 (2022) ................. 27, 28

Grossman et al., Medication abortion with

pharmacist dispensing of mifepristone,

137 OBSTET. GYNECOL. 613 (2021) ...........

TABLE OF AUTHORITIES—Continued

Page(s)

Kaplan et al., Review of evidence supporting

2022 US Food and Drug Administration

drug approvals, 6 JAMA Network Open

e2327650 (2023) ........................................

3, 4

Kerestes et al., Provision of medication

abortion in Hawaii during COVID-19:

practical experience with multiple care

delivery models, 104 CONTRACEPTION 49

(2021) ......................................................... 25, 27

Koenig et al., The role of telehealth in

promoting equitable abortion access in

the United States: a spatial analysis, 9

JMIR PUB. HEALTH & SURVEILLANCE

e45671 (2023) ............................................

Koenig et al., Mailing abortion pills does

not delay care: A cohort study comparing

mailed in-person dispensing of abortion

medications in the United States, 121

CONTRACEPTION 109962 (2023) ................

Kopp Kallner et al., The efficacy, safety and

acceptability of medical termination of

pregnancy provided by standard care by

doctors or by nurse-midwives:

randomized controlled equivalence trial,

122 BJOG 510 (2015) ................................ 6, 18

Ngo et al., Comparative effectiveness, safety

and acceptability of medical abortion at

home and in a clinic: a systematic review,

89 BULL. WORLD HEALTH ORG. 360

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

vii

TABLE OF AUTHORITIES—Continued

Page(s)

Pena et al., Telemedicine for medical

abortion service provision in Mexico: a

safety, feasibility, and acceptability

study, 114 CONTRACEPTION 67 (2022) ......

Puri et al., The role of auxiliary nursemidwives and community health volunteers

in expanding access to medical abortion

in rural Nepal, 22 REPROD. HEALTH

MATTERS 94 (2015) ....................................

Raymond et al., First-trimester medical

abortion with mifepristone 200 mg and

misoprostol: a systematic review, 87

CONTRACEPTION 26 (2013) ........................ 13-15

Raymond et al., TelAbortion: evaluation of

a direct to patient telemedicine abortion

service in the United States, 100

CONTRACEPTION 173 (2019) ......................

Reynolds-Wright et al., Telemedicine medical

abortion at home under 12 weeks’

gestation: a prospective observational

cohort study during the COVID-19

pandemic, 47 BMJ SEX REPROD. HEALTH

246 (2021) ..................................................

Rocca et al., Effectiveness and safety of early

medication abortion provided in pharmacies by auxiliary nurse-midwives: A noninferiority study in Nepal, PLOS ONE

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

viii

TABLE OF AUTHORITIES—Continued

Page(s)

Sanhueza Smith et al., Safety, efficacy and

acceptability of outpatient mifepristonemisoprostol medical abortion through 70

days since last menstrual period in public

sector facilities in Mexico City, 22

REPROD. HEALTH MATTERS 75 (2015) ....... 12, 17

Schummers et al., Abortion safety and use

with normally prescribed mifepristone in

Canada, 386 N. ENG. J. MED. 57 (2022) ...

Swica et al., Acceptability of home use of

mifepristone for medical abortion, 88

CONTRACEPTION 122 (2013) ......................

Upadhyay et al., Comparison of outcomes

before and after Ohio’s law mandating

use of the FDA-approved protocol for

medication abortion: a retrospective

cohort study. PLOS MED. (2016) ...............

Upadhyay et al., Effectiveness and safety of

telehealth medication abortion in the

United States, NATURE MED. (2024) .........

Upadhyay et al., Incidence of emergency

department visits and complications after

abortion, 125 OBSTET. GYNECOL. 175

(2015) .........................................................

Upadhyay et al., Outcomes and safety of

history-based screening for medication

abortion: a retrospective multicenter

cohort study, 182 JAMA INTERNAL MED.

482 (2022) ..................................................

TABLE OF AUTHORITIES—Continued

Page(s)

Upadhyay et al., Safety and efficacy of

telehealth medication abortion in the US

during the COVID-19 pandemic, 4 JAMA

NETWORK OPEN e2122320 (2021) ............. 20, 28

Warriner et al., Can midlevel health-care

providers administer early medical abortion

as safely and effectively as doctors? A

randomised controlled equivalence trial

in Nepal, 377 THE LANCET 1155 (2011) ....

Winikoff et al., Extending outpatient

medical abortion services through 70

days of gestational age, 120 OBSTET.

GYNECOL. 1070 (2012)............................... 11, 17

Winikoff et al., Two distinct oral routes of

misoprostol in mifepristone medical

abortion, 112 OBSTET. GYNECOL. 1303

(2008) .........................................................

INTEREST OF THE AMICI CURIAE1

Amici curiae are leading reproductive health

researchers in the United States and worldwide.

Amici are trained and experienced in conducting or

evaluating clinical and social science studies on

reproductive health issues, including studies on the

safety and effectiveness of mifepristone. Amici share

a significant interest in evidence-based reproductive

health care, and submit this brief to explain the ample

scientific evidence of mifepristone’s safety and effectiveness supporting the Food and Drug Administration’s

2016 and 2021 decisions.

SUMMARY OF ARGUMENT

This Court should not allow the politics of abortion

to obscure the clear, abundant, and plainly sufficient

scientific record supporting FDA’s decision-making in

this case. In approving certain modifications to mifepristone’s Risk Evaluation and Mitigation Strategy

(“REMS”) and labeling in 2016 and 2021, FDA

reviewed and relied on extensive scientific evidence

conclusively showing the safety and effectiveness of

the changes.

In 2016, FDA modified the mifepristone REMS to

permit healthcare providers with prescriptive authority

under state law (such as nurse practitioners and

physician assistants) to become certified prescribers of

mifepristone, and updated the dosing regimen, gestational limit, and number of required in-clinic visits

included in mifepristone’s labeling. In evaluating the

No counsel for a party authored this brief in whole or in part,

and no party or counsel for a party made a monetary contribution

intended to fund its preparation or submission. No person other

than amici or amici’s counsel made a monetary contribution to

the preparation or submission of this brief.

safety and effectiveness of these changes, FDA reviewed

58 scientific studies, which together analyzed tens of

thousands of patient experiences. These studies were

conducted by qualified experts and adhered to rigorous

standards of reliability and validity, as demonstrated

by their selection for publication in reputable scientific

journals, subject to the rigorous academic peer-review

process. The record makes clear that FDA extensively

studied each individual change and that, contrary to

the Fifth Circuit’s conclusion, FDA also analyzed the

individual changes as “interrelated,” including reviewing many studies containing all or almost all the

changes in combination. Without exception, these

studies demonstrated that the modifications to the

REMS and the labeling continued to ensure that

mifepristone remained extremely safe—with rates of

serious adverse events generally far below 1.0%—and

extremely effective—generally resulting in complete

pregnancy termination without procedural intervention in over 96% of cases. These rates are comparable

or superior to those observed in studies assessing

safety and effectiveness of medication abortion care

under the prior, more restrictive REMS and labeling.

FDA’s decision to eliminate the in-person dispensing

requirement from the REMS in 2021, formalized in

2023, was also supported by ample scientific evidence.

FDA’s multiple analyses of this REMS requirement

during 2021 encompassed 25 high quality scientific

studies, which together covered more than 50,000

patient experiences. These studies confirmed conclusively that mifepristone remains extremely safe and

effective without the requirement that the medication

be dispensed only at a hospital, clinic, or medical office.

Other studies considered by FDA also demonstrated

that the in-person dispensing requirement reduced

access to mifepristone. Given this evidence, FDA

properly determined that the in-person dispensing

requirement was inconsistent with the statutory

requirements for maintaining REMS elements to

assure safe use, and appropriately removed it. See 21

U.S.C. § 355-1(f)(2) (elements to assure safe use within

a REMS must be “commensurate with [a] specific

serious risk listed in the labeling of the drug,” and

cannot be “unduly burdensome on patient access to the

drug, considering in particular . . . patients who have

difficulty accessing health care (such as patients in

rural or medically underserved areas)”).

It is clear that the evidentiary support for FDA’s

2016 and 2021 decisions far exceeded the statutory

requirements. See 21 U.S.C. 355(d) (“[D]ata from one

adequate and well-controlled clinical investigation and

confirmatory evidence” may be sufficient) (emphasis

added); 21 U.S.C. § 355-1(g) (modification of a REMS

need only be supported by an assessment and an

“adequate rationale”). Pursuant to the statutory requirements, FDA regularly approves drugs supported by

only one clinical study.2 In this case, the record supporting the 2016 and 2021 changes to mifepristone’s

REMS and labeling demonstrates that FDA not only

met its statutory requirements, but also went well

beyond them.

Amici submit this brief to explain the vast scientific

evidence supporting each component and the totality

of FDA’s 2016 and 2021 Decisions. The studies leave

no doubt as to the safety and effectiveness of mifepristone’s modified REMS and labeling. Consistent with

See Kaplan et al., Review of evidence supporting 2022 US Food

and Drug Administration drug approvals, 6 JAMA NETWORK OPEN

e2327650 (2023) (finding that 65% percent of approved novel

drugs in 2022 were supported by one clinical study).

this overwhelming evidence, this Court should reverse

the Fifth Circuit’s decision.

ARGUMENT

I. FDA’s

2016

Decision,

Modifying

Mifepristone’s REMS and Labeling, Was

Supported by Ample Scientific Evidence.

Extensive data from many rigorous scientific studies

supported FDA’s 2016 Decision to modify its regulation of mifepristone. Indeed, FDA reviewed robust

evidence far exceeding the statutory requirements for

modifications of the REMS3 and for changes to a label’s

conditions of use.4 The data clearly demonstrated that

medication abortion using mifepristone and misoprostol

is both extremely effective—defined as resulting in a

complete abortion without need for procedural

FDA has wide discretion in determining the information

needed to support modifying a REMS; modifications to a REMS

need only be supported by “adequate rationale.” 21 U.S.C. § 3551(g)(4)(a).

A supplemental application seeking changes to conditions of

use must be supported by sufficient evidence of safety and

substantial evidence of effectiveness. 21 U.S.C. § 505(b); 21 U.S.C.

355(d). “Substantial evidence” is defined as “evidence consisting

of adequate and well-controlled investigations, including clinical

investigations, by experts qualified by scientific training and

experience to evaluate the effectiveness of the drug involved, on

the basis of which it could fairly and responsibly be concluded by

such experts that the drug will have the effect it purports or is

represented to have under the conditions of use prescribed,

recommended, or suggested in the labeling or proposed labeling

thereof.” 21 U.S.C. 355(d). “[D]ata from one adequate and wellcontrolled clinical investigation and confirmatory evidence (obtained

prior to or after such investigation) . . . [may] constitute

substantial evidence.” Id. (emphasis added). Pursuant to the

statutory requirements, FDA regularly approves drugs supported

by only one clinical study. See supra note 2.

intervention—and extremely safe—defined as the

absence of serious adverse events such as hospital

admission, major surgery, or blood transfusion.

To be clear, the Fifth Circuit did not conclude—and

could not conclude, consistent with the record—that

there was insufficient evidence supporting each individual

2016 change. See App. 53a-56a.5 Rather, the Fifth

Circuit concluded that the 2016 Decision was likely

arbitrary and capricious because FDA failed to evaluate

the individual changes in combination. Id. The record

plainly refutes that conclusion. As set forth below,

FDA reviewed and relied on numerous studies conclusively demonstrating that the changes were safe and

effective both individually and in combination.6

A. Extensive Scientific Evidence Supported

Permitting Prescribing Healthcare

Providers to Be Certified Prescribers of

Mifepristone.

The Fifth Circuit did not conclude, and could not

conclude based on the record, that there was insufficient evidence of the safety and efficacy supporting

FDA’s 2016 determination to permit healthcare providers

with prescriptive authority under state law to become

certified prescribers of mifepristone. See App. 53a-56a.

In evaluating whether these providers could safely

and effectively prescribe and dispense mifepristone,

“App.” refers to the Appendix to the Petition for a Writ of

Certiorari filed by Petitioners U.S. Food and Drug Administration,

et al.

Although Sections I.A-D focus on the evidence supporting

each individual 2016 change, many of the studies discussed in

those Sections contained more than one relevant change. Section

I.E discusses the many studies evaluating all or almost all the

2016 changes in combination.

FDA relied primarily on three randomized controlled

trials with a combined 3,200 participants and one

cohort study with 596 participants. J.A. 302, 461-62,

495-98. Those studies found no differences in effectiveness or safety between patients who received

mifepristone from physicians compared to those who

were prescribed and dispensed mifepristone by other

healthcare professionals. J.A. 316.7

Two FDA-reviewed randomized controlled trials

designed to test for equivalence between nurses and

physicians both found that nurses could provide

equivalent care. The first evaluated outcomes of 938

patients and found equivalent safety and efficacy

between nurse-midwives and physicians.8 Indeed, the

nurse-midwife group actually demonstrated higher

efficacy at 99.0% vs. 97.4% among the physician

group.9 The second, with 1,077 participants, also found

that nurses and auxiliary nurse-midwives provided

medication abortion with statistically equivalent efficacy

to physicians, reporting complete abortion rates of

97.3% compared to 96.1% for physicians.10

Another FDA-reviewed randomized controlled trial

designed to test for non-inferiority between nurses and

physicians included 884 participants and determined

“J.A.” refers to the Joint Appendix filed by Petitioners U.S.

Food and Drug Administration, et al. on January 23, 2024.

Kopp Kallner et al., The efficacy, safety and acceptability of

medical termination of pregnancy provided by standard care by

doctors or by nurse-midwives: a randomized controlled equivalence

trial, 122 BJOG 510 (2015).

Id.

Warriner et al., Can midlevel health-care providers administer

early medical abortion as safely and effectively as doctors? A

randomised controlled equivalence trial in Nepal, 377 THE

LANCET 1155 (2011).

that nurse provision of medication abortion was not

inferior to physician provision, with complete abortion

rates of 97.9% in the nurse group compared to 98.4%

in the physician group.11 Only one serious adverse

event (bleeding) was reported in the trial, by a patient

who had been seen by a physician.12

Further research has continued to confirm that

healthcare providers with prescriptive authority can

safely and effectively provide medication abortion

care. For example, a 2018 study of 605 patients found

that nurse-midwives could provide effective medication

abortion care at both health facilities (97.4% efficacy)

and pharmacies (98.7% efficacy), without any serious

adverse events.13

There was ample evidence supporting the REMS

modification, and evidence gathered since the 2016

Decision has only affirmed the safety and effectiveness

of provision by these healthcare providers.

B. Extensive Scientific Evidence Supported

the Safety and Effectiveness of the

Amended Dosing Regimen Indicated on

the Label.

The Fifth Circuit did not conclude, and could not

conclude based on the record, that there was insufficient evidence supporting the safety and effectiveness

of the amended dosing regimen indicated on the

Diaz Olavarrieta et al., Nurse versus physician-provision of

early medical abortion in Mexico: a randomized controlled noninferiority trial, 93 BULL. WORLD HEALTH ORG. 249 (2015).

Id.

Rocca et al., Effectiveness and safety of early medication

abortion provided in pharmacies by auxiliary nurse-midwives: A

non-inferiority study in Nepal, PLOS ONE (2018).

label. See App. 53a-56a. Indeed, FDA reviewed and

relied upon at least 24 studies conclusively demonstrating the safety and effectiveness of the amended

dosing regimen, which decreased the oral dose of

mifepristone from 600 mg to 200 mg, changed the

misoprostol dose from 400 mcg administered orally 48

hours after administration of mifepristone to 800 mcg

administered buccally 24-48 hours after administration of mifepristone, and allowed for a repeat dose of

misoprostol to ensure completion. J.A. 299-301, 44250, 459-61, 478-79, 481-82.

FDA relied upon a systematic review of clinical

outcomes from twenty studies, including a total of

33,846 individuals, using 200 mg oral mifepristone

followed by 800 mcg buccal misoprostol.15 Of the

twenty studies using the amended dose and routes of

administration, fifteen studies used a 24-48 hour

dosing interval, and four studies allowed for repeat

dosing of misoprostol to ensure completion.16 The

review found that the effectiveness of the amended

dosing regimen was 96.7%, notably higher than the

92.1% efficacy rate of the regimen FDA approved in

2000.17 The review also demonstrated the overwhelming safety of the dosing regimen: across the 20 studies,

As relevant here, the “dosing regimen” consists of the “dose”

(the quantity of medication), the “route of administration” (how

the medication is taken), and the “dosing interval” (the time

between taking each medication).

Chen et al., Mifepristone with buccal misoprostol for medical

abortion, a systematic review, 126 OBSTET. GYNECOL. 12 (2015).

Id.

serious adverse events were extremely rare, ranging

between 0.01%-0.9%.18

In addition to the systematic review, FDA evaluated

many other studies providing conclusive evidence that

the amended dosing regimen was safe and effective. In

one such study, 1,349 individuals used the amended

dosing regimen resulting in a 98.3% effectiveness rate.19

Another FDA-reviewed study demonstrated through a

randomized controlled trial that buccal administration

of 800 mcg misoprostol after 200 mg mifepristone was

96.2% effective.20

Other FDA-reviewed studies similarly showed safety

and effectiveness of the amended dosing regimen, and

a higher effectiveness rate than the dosing regimen

included in the FDA labeling at the time. One study

showed that a dosing regimen of 200 mg oral mifepristone followed by either 400 mcg or 800 mcg buccal

misoprostol resulted in 96.4% effectiveness.21 Another

study using the amended dosing regimen found 98.7%

effectiveness rates for site-to-site telemedicine patients22

and 96.9% for face-to-face patients, with low rates of

serious adverse events among both groups of patients,

Id.

Fjerstad et al., Effectiveness of medical abortion with

mifepristone and buccal misoprostol though 59 gestational days,

80 CONTRACEPTION 282 (2009).

Winikoff et al., Two distinct oral routes of misoprostol in

mifepristone medical abortion, 112 OBSTET. GYNECOL. 1303

(2008).

Chong et al., A randomized controlled trial of different

buccal misoprostol doses in mifepristone medical abortion, 86

CONTRACEPTION 251 (2012).

This study used a site-to-site telemedicine model, in which

patients visit a health center to meet remotely with a clinician

located in another health center.

including zero deaths and zero hospitalizations out of

578 participants.23

Incomplete abortions are extremely rare when using

the amended dosing regimen, and FDA’s decision to

allow for an additional dose of misoprostol in cases of

incomplete abortion was also well supported. In

making this decision, FDA relied on several studies

totaling over 4,000 patients; of these, only 3.4% had an

incomplete abortion and took a second dose, which

resulted in complete abortion in 90% of those cases.

J.A. 460.24 In other words, among the small portion of

patients who experience incomplete abortion, the overwhelming majority can avert a procedural intervention

and complete their termination by taking an additional

dose of misoprostol. Indeed, FDA acknowledged in its

review that offering this additional dose was already

“standard protocol in many US clinics,” underscoring

that the change brought the label into alignment with

existing, evidence-based clinical practice. J.A. 461.

In sum, the evidence of the safety and effectiveness

of the amended dosing regimen indicated on the label

far exceeded the necessary showing to support a

change to the conditions of use.

Grossman et al., Effectiveness and acceptability of medical

abortion provided through telemedicine, 118 OBSTET. GYNECOL.

296 (2011).

See also Gallo et al., A systematic review of more than one

dose of misoprostol after mifepristone for abortion up to 10 weeks

of gestation, 74 CONTRACEPTION 36 (2006) (systematic review of

studies of additional dose of misoprostol, including three randomized controlled trials finding no differences in effectiveness and

no serious adverse events).

C. Extensive Scientific Evidence Supported

the Safety and Effectiveness of Increasing

the Gestational Limit Indicated on the

Label.

The Fifth Circuit did not, and could not based on the

record, conclude that there was insufficient evidence

supporting the safety and efficacy of increasing the

gestational limit listed in the mifepristone labeling

from 49 to 70 days. See App. 53a-56a. FDA reviewed

a number of studies providing strong support for

extending the gestational limit past 49 days, including

studies evaluating medication abortion safety and efficacy

at multiple gestational durations up through 70 days.

J.A. 299, 450-56, 478-79. Of critical importance were

several primary studies and the above-discussed systematic review, which together evaluated over 30,000

patients using the exact proposed dosing regimen

through 70 days’ gestation. Based on this extensive

evidence, FDA concluded that mifepristone’s efficacy

at 50-70 days was comparable to that of the initial

2000 approval for up to 49 days gestation. Furthermore,

FDA found “no association between adverse outcomes

and increasing gestational age.” J.A. 310.

A study using data from 629 patients across the

United States specifically compared outcomes of medication abortion patients between 57-63 days gestation

to those at 64-70 days and found that rates of complete

abortion were statistically equivalent at both gestational ranges.25 The study also found no significant

difference in serious adverse events based on gestation.26

Winikoff et al., Extending outpatient medical abortion

services through 70 days of gestational age, 120 OBSTET.

GYNECOL. 1070 (2012).

Id.

Another study reviewed by FDA also found equivalent

efficacy at 64-70 days compared to earlier gestations,

with data from 307 individuals using the 2016 dosing

regimen offered up to 70 days gestation, which was

effective in 97.7% of cases.27

FDA also evaluated a study including 960 patients

who received medication abortion up to 70 days

gestation, finding high effectiveness at all gestational

ranges, with an average of 93.3%, which is within the

range of other studies with similar protocols.28 Finally,

the systematic review, which evaluated the results of

20 studies for a combined total of 33,846 individuals,

found high effectiveness for medication abortion

through 64-70 days gestation (93.1%).29

The evidence before FDA in 2016 was more than

sufficient to support extending the gestational limit

indicated on the label, through 70 days.

D. Extensive Scientific Evidence Supported

the Safety and Effectiveness of

Reducing the Number of In-Person

Clinical Visits Indicated on the Label.

The Fifth Circuit did not conclude, and could not

conclude based on the record, that there was insufficient

evidence supporting FDA’s determination to reduce

Boersma et al., Mifepristone followed by home administration of buccal misoprostol for medical abortion up to 70 days of

amenorrhoea in a general practice in Curaçao, 16 EUR. J.

CONTRACEPT. REPROD. HEALTH CARE 61 (2011).

Sanhueza Smith et al., Safety, efficacy and acceptability of

outpatient mifepristone-misoprostol medical abortion through 70

days since last menstrual period in public sector facilities in

Mexico City, 22 REPROD. HEALTH MATTERS 75 (2015).

Chen et al., supra note 15.

the number of in-person clinical visits listed in the

mifepristone labeling. See App. 53a-56a. Prior to the

2016 changes, the approved dosing regimen involved

three in-person appointments: (1) administration of

mifepristone on the first day, (2) administration of

misoprostol on the third day, and (3) follow-up on the

fourteenth day to confirm pregnancy termination. The

evidence before FDA in 2016 strongly supported

reducing the number of in-person clinical visits

indicated in the labeling, given the well-documented

safety of patients taking misoprostol at home and

following up with their provider remotely.30 J.A. 300302, 456-59, 462, 479-85.

In evaluating whether to retain the language

indicating that misoprostol be administered in clinic,

FDA relied on nearly a dozen studies involving large

numbers of participants, all of which showed that it

is extremely effective and extremely safe for people

to complete the two-drug protocol at home, with

“exceedingly low” rates of serious adverse events. J.A.

308. This evidence included a systematic review which

analyzed 87 studies covering over 45,000 patients

using a range of mifepristone and misoprostol treatment regimens, about half of which involved home

administration of misoprostol.31

Efficacy of the

regimens was found to be similar whether or not

misoprostol was taken in clinic and there was “no

For discussion of the evidence before FDA in 2021 to remove

the first in-person clinical visit, see infra Section II.

Raymond et al., First-trimester medical abortion with

mifepristone 200 mg and misoprostol: a systematic review, 87

CONTRACEPTION 26 (2013).

evidence” that allowing home administration of

misoprostol increased rates of adverse events.32

FDA also considered individual studies, including

four U.S.-based studies totaling over 14,700 patients

and seven international studies totaling over 16,000

patients. These studies showed that medication abortion

with misoprostol administered at home is highly

effective, with rates of complete abortion ranging

between 91.9-97.7%. J.A. 458. In particular, the

largest U.S.-based study collected data on 13,373

patients over five years, using the dosing regimen

approved in 2016 with misoprostol taken at home.33

The regimen was effective in 97.7% of cases; only six

people over the entire study period developed a serious

adverse event requiring hospitalization, with incidence

of hospitalization less than or equal to 0.18% at all

gestations,34 which is consistent with research showing

similarly low prevalence of adverse events among

patients who take misoprostol at home and in clinic.35

Furthermore, the evidence available to FDA in 2016

supported home administration not only of misoprostol,

but also of mifepristone. In one study, 301 patients

were given the choice to take mifepristone at home or

in their physician’s office—46% chose to take mifepris-

Id. at 32.

Gatter et al., Efficacy and safety of medical abortion using

mifepristone and buccal misoprostol though 63 days, 91

CONTRACEPTION 269 (2015).

Id.

See, e.g., Ngo et al., Comparative effectiveness, safety and

acceptability of medical abortion at home and in a clinic: a

systematic review, 89 BULL. WORLD HEALTH ORG. 360 (2011).

tone at home, and all took misoprostol at home.36 The

authors found no differences in effectiveness or serious

adverse events between groups.37

Ample evidence also supported flexibility with

regards to timing and method of follow-up assessment.

In particular, FDA relied on the 2013 systematic

review of over 45,000 medication abortions, which

found no association between efficacy and timing of

follow-up.38 FDA also relied on a systematic review of

studies examining alternatives to in-person ultrasound

follow-up, which identified eight studies that together

enrolled almost 2,400 participants and evaluated a

variety of follow-up methods, including remote methods

such as phone screening, standardized questionnaires,

and at-home pregnancy tests.39 The studies analyzed

in the review identified remote methods that were

suitable alternatives to ultrasound follow-up (serum

human chorionic gonadotropin (hCG) measurement,

urine pregnancy test plus standardized self-assessment,

and standardized telephone consultation with a provider);

these methods identified over 90% of patients with

continuing pregnancy and produced fewer than 1%

false positives.40 Overall, FDA noted that the proportion of patients unable to be reached for follow-up in

these studies “do[es] not appear to exceed those

associated with a planned in-clinic follow-up.” J.A.

Swica et al., Acceptability of home use of mifepristone for

medical abortion, 88 CONTRACEPTION 122 (2013).

Id.

Raymond, supra note 31.

Grossman et al., Alternatives to ultrasound for follow-up after

medication abortion: a systematic review, 83 CONTRACEPTION 504

(2011).

Id.

484-85. In addition to these systematic reviews, FDA

also considered multiple individual studies permitting

remote follow-up; for example, one study of over 1700

patients who chose self-assessment follow-up, finding

no more delays in care than would be expected for inclinic follow-up.41

These extensive data, demonstrating the safety and

efficacy of home administration of misoprostol and

flexibility in follow-up assessments, were more than

sufficient to support FDA’s labeling change.

E. FDA’s Judgment that the Individual

Changes in 2016 Were Collectively Safe

and Effective Was Supported by a

Robust Record of Scientific Evidence.

Despite the vast data supporting each individual

change, the Fifth Circuit held that FDA’s 2016 decision

was likely arbitrary and capricious because FDA failed

to consider the effect of those changes “as a whole.”

App. 53a. Yet, the record makes clear that FDA relied

on many studies evaluating combined aspects of the

2016 changes and analyzed the individual changes as

“interrelated.” J.A. 298 (reasoning that “in some cases

data from a given study were relied on to provide

evidence to support multiple changes”); J.A. 299, 44649, 461.

For example, FDA reviewed and relied upon a

randomized controlled trial with over 800 participants

which supported the safety and effectiveness of provision by healthcare providers with prescriptive authority

and mirrored the other aspects of the 2016 changes:

Cameron et al. Can women determine the success of early

medical termination of pregnancy themselves? 91 CONTRACEPTION

6 (2015).

nurses provided the medication abortion, and participants had pregnancies of up to 70 days, used a dosing

regimen of 200 mg oral mifepristone and 800 mcg

buccal misoprostol with an additional misoprostol dose

if needed, and administered the misoprostol at home

24 hours after taking the mifepristone.42 These conditions, in combination, resulted in no serious adverse

events and a 97.9% efficacy rate, which is higher than

the 92.1% efficacy rate of the U.S. trial relied upon for

FDA’s approval of the regimen in 2000.43

Additionally, FDA reviewed and relied upon several

large studies that closely matched the 2016 label

changes by demonstrating the safety and effectiveness

of at-home administration of misoprostol through 70

days, while also utilizing the same dosing regimen as

the 2016 changes (200 mg oral mifepristone and 800

mcg misoprostol administered buccally 24-48 hours

later, with an additional dose of misoprostol if needed).

One such study found 92.8%-93.5% effectiveness and

extremely rare occurrence of serious adverse events

(between 0.41% and 0.69%).44 Another such study

found 93.3% effectiveness among 960 individuals

using the amended dosing regimen, with at-home

administration of misoprostol, through 70 days.45

FDA also considered studies showing the safety and

effectiveness of provision by healthcare providers with

prescriptive authority using the exact amended dosing

regimen included in the updated labeling. In one such

study of 938 individuals using 200 mg mifepristone

and 800 mcg misoprostol and the option of at-home

Diaz Olavarrieta, supra note 11.

Id.; J.A. 225.

Winikoff, supra note 25.

Sanhueza Smith, supra note 28.

misoprostol administration, 99% of patients treated by

nurse-midwives had complete abortions and 95.8% did

not need any unscheduled treatment—these numbers

were high both as an absolute matter and as relative

to physician prescription (97.4% effectiveness and 93.5%

without need for additional treatment).46 Moreover,

many of the studies FDA considered in evaluating the

amended dosing regimen also involved the provision of

mifepristone up to 70 days.47 As FDA observed in its

review, the 2016 changes brought the regimen in line

with World Health Organization guidelines. J.A. 445-46.

The foregoing evidence clearly demonstrates that

the record before FDA in 2016 was more than sufficient to conclude that the proposed changes would be

safe and effective in combination. Evidence gathered

contemporaneously and since has only further confirmed

that conclusion. Respondents assert that the 2016

changes created less safe conditions resulting in more

required follow-up care, when in fact the opposite is true.

In all areas of medicine, “off-label” use of medications

to reflect evolutions in evidence-based practice is

permissible, common, and necessary to ensure that

clinical care is not undermined by scientifically outdated

labeling. Thus, even before FDA updated the mifepristone

Kopp Kallner, supra note 8; see also Puri et al., The role of

auxiliary nurse-midwives and community health volunteers in

expanding access to medical abortion in rural Nepal, 22 REPROD.

HEALTH MATTERS 94 (2015) (study of nurse-midwife provision of

the same dosing regimen of 200 mg mifepristone and 800 mcg

misoprostol, with 82.3% self-administering misoprostol at home,

and no reported serious adverse events).

See, e.g., Chen, supra note 15 (review summarizing clinical

outcomes from 20 studies, including a total of 33,846 individuals,

finding high effectiveness rates (96.7%) and extremely low rates

of serious adverse events (0.01-0.9%).

labeling, prescribers were providing evidence-based

care consistent with the studies described above—

FDA’s 2016 updates brought the labeling in line with

that evidence-based clinical practice. But in 2011,

Ohio passed a law mandating fidelity with the outdated

conditions of use listed in the 2000 mifepristone

labeling. Researchers then examined the medical

records of 2,783 patients who obtained medication

abortion before and after the law took effect.48 The

studied protocol from the period before the Ohio law

took effect was very similar to the updated regimen

FDA would adopt in 2016 and included 200 mg

mifepristone and 800 mcg of misoprostol, with

misoprostol allowed to be taken at home, flexibility in

timing of follow-up (5-14 days), and a gestational limit

beyond 49 days (63 days).49 The research showed that

this updated protocol was safer and more effective

than the conditions of use in the original 2000 label

that were still in effect when Ohio enacted this law.

After the law mandating reversion to the outdated

2000 regimen, the proportion of patients requiring at

least one additional clinical intervention increased

from 4.9% to 14.3%; in other words, the odds of needing

an additional intervention were three times higher

under the pre-2016 regime.50 The rate of adverse

events (defined in this study as acute hemorrhage,

infection, continuing pregnancy or incomplete abortion)

increased from 2% to 5%.51 In short, the pre-2016

labeling Respondents prefer would recommend a

protocol that is actually less safe and would require

Upadhyay et al., Comparison of outcomes before and after

Ohio’s law mandating use of the FDA-approved protocol for

medication abortion: a retrospective cohort study. PLOS MED. (2016).

Id.

more clinical follow-up care—exactly what Respondents

profess to wish to avoid.

Additional studies conducted after the 2016 decision

contained all of the changes made in 2016 and further

support the safety and effectiveness of the changes in

combination. For example, a 2021 study of 110

patients using the same dosing regimen, a 70-day

gestational limit, provision by nurse practitioners, athome administration of misoprostol (and mifepristone),

and remote follow-up resulted in a 95% effectiveness

rate with no serious adverse events.52

In sum, the record clearly shows that FDA did

consider many studies examining the effect of multiple

proposed modifications prior to its 2016 decision, even

though as the Fifth Circuit acknowledged, “FDA is not

required to conduct a study that perfectly mirrors the

conditions under which the drug will be used.” App.

53a-54a. Indeed, FDA routinely approves drugs with

conditions of use that differ from clinical trial protocols,

as many clinical trial designs are more restrictive than

recommended in post-approval clinical use, with additional caution exercised until the safety and efficacy of

the product is demonstrated. In addition to the

evidence affirmatively showing the changes were safe

and effective in combination, there was also no

evidence—at the time of the 2016 decision or since—

suggesting that combining the proposed changes would

lead to unsafe or ineffective outcomes.

Upadhyay et al., Safety and efficacy of telehealth medication

abortion in the US during the COVID-19 pandemic, 4 JAMA

NETWORK OPEN e2122320 (2021); see also infra Section II (discussing studies assessing the removal of the in-person dispensing

requirement, many of which contained all of the 2016 changes in

combination).

F. Modification of the Adverse Event

Reporting Requirement Was Supported

by More Than Adequate Rationale.

Based on the extensive and rigorous scientific

evidence, FDA reasonably concluded that the 2016

changes would not alter the safety profile of the

original regimen approved in 2000. J.A. 310. Indeed,

the rates of serious adverse events in the studies

evaluating the proposed 2016 changes were “generally

far below 1.0%.” J.A. 474. And, FDA had already

received 15 years of reporting on serious adverse events

associated with mifepristone, which conclusively demonstrated that major adverse events such as excessive

blood loss, hospitalization, or surgery are exceedingly

rare.53 As a result, FDA reasonably concluded that

reporting on events other than deaths could be

collected in periodic safety updates. FDA’s modification of the adverse event reporting requirement was

reasonable at the time the decision was made, J.A. 506,

and confirmed by review of adverse reports submitted

in the FAERS database since 2016. J.A. 398.

See, e.g., Upadhyay et al., Incidence of emergency department

visits and complications after abortion, 125 OBSTET. GYNECOL.

175 (2015) (finding only a 0.31% serious adverse event rate

among the 11,319 patients who had medication abortions).

II. FDA’s 2021 Decision Removing the InPerson Dispensing Requirement from the

REMS, Formalized in 2023, Was Supported

by Ample Scientific Evidence.

A. FDA Relied upon Ample Scientific

Evidence Supporting the Safety and

Effectiveness of Removing the InPerson Dispensing Requirement.

The Fifth Circuit held that FDA’s 2021 nonenforcement decision was likely arbitrary and capricious

because the literature FDA relied upon “did not

affirmatively support its position.”54

App. 61a.

However, this conclusion conflicts with the record FDA

considered and relied upon while evaluating the inperson dispensing requirement. FDA’s decision not to

enforce and ultimately to remove the in-person dispensing requirement from the REMS was supported

by a thorough scientific review. In addition to reviewing the in-person dispensing requirement in support of

In addition, the Fifth Circuit found that FDA’s decision was

likely arbitrary and capricious because the Agency relied upon

adverse event report data that no longer had data from

prescribers because reporting requirements had been modified by

the 2016 Amendments. App. 59a. However, FDA had ample

evidence to support this change given over 15 years of adverse

event reporting indicating that risks occurred rarely. J.A. 319.

Further, even after the 2016 change, more extensive reporting of

adverse events is required for mifepristone than the vast majority

of other medications. See Brief of Amici Food and Drug Law

Scholars as Amicus Curiae in Support of Petitions for Writ of

Certiorari, FDA v. Alliance for Hippocratic Medicine at 15 (Oct.

12, 2023). The Fifth Circuit’s reasoning, which disregards data

from such rigorous reporting requirements would have disruptive

effects throughout the regulatory landscape, and prevent FDA

from relying on adverse events data derived from anything less

than the most stringent reporting requirements.

the April 2021 nonenforcement decision, FDA further

analyzed the requirement in December 2021—as

described both in a REMS modification rationale

review directing manufacturers to apply for a modified

REMS, and in a denial of a citizen petition seeking to

roll back multiple REMS changes—before formally

removing the in-person dispensing requirement in

January 2023. FDA considered and cited scientific

studies each time that supported the Agency’s determination that the in-person dispensing requirement

was not necessary to ensure the safety and effectiveness of mifepristone for medication abortion. Indeed,

the FDA-reviewed studies far exceeded the statutory

requirements.

1. The April 2021 Nonenforcement

Decision Was Supported by Ample

Scientific Evidence.

As the basis for its April 2021 nonenforcement

decision, FDA relied on studies that included clinical

outcome data for over 50,000 instances of medication

abortion provision. J.A. 364. These studies reviewed

safety and effectiveness of care delivered in person, via

telemedicine, and through hybrid options in which

some but not all stages of care were provided in person

(i.e., screening took place via telemedicine but pills

were picked up in person, or patients visited a clinic of

their choice to receive an ultrasound prior to pills

being sent by mail). Id. The studies also compared

outcomes before and after the COVID-19 public health

emergency, which permitted the use of telemedicine for

mifepristone and provided a natural experiment for

assessing the safety of telemedicine abortion provision. Id. FDA concluded that the “overall findings

from these studies do not appear to show increases in

safety concerns” in the absence of an in-person

dispensing requirement. J.A. 365. Each study FDA

relied upon found high effectiveness and high safety

rates for medication abortion provision via telemedicine, with patient outcomes consistent with in-person

dispensing of mifepristone. Id. FDA thus had ample

evidence to find that the in-person dispensing requirement was not necessary to ensure the safety and

effectiveness of mifepristone.

One such study was an assessment of the

TelAbortion Project, a pilot program which was the

first in the United States through which patients could

obtain an abortion legally without an in-person visit.55

The study found 95% effectiveness across 1157 patients

receiving medication abortion, of which almost all did

not have in-person dispensing.56 This effectiveness

rate is comparable to effectiveness for in-person care

demonstrated by prior research.57 Only 0.9% of

patients experienced serious adverse events, which is

also consistent with serious adverse event rates when

mifepristone is delivered in-person.58 The authors

concluded that their “data disprove[d] the notion that

medication abortion must be dispensed in-person[.]”59

In addition, FDA relied upon a study that directly

compared rates of success and safety for 334 patients

receiving medication abortion via three methods:

telemedicine consultation with pills sent by mail,

telemedicine consultation with in-person medication

Chong et al., Expansion of direct-to-patient telemedicine

abortion service in the United States and experience during the

COVID-19 pandemic, 104 CONTRACEPTION 43 (2021).

Id.

Id. (citing Chen, supra note 15).

Id.

Id. at 48.

pick-up, and in-person care provision.60 The study

found similar rates of completion for each method,

with entirely remote care having the highest effectiveness (97.1% for mailed pills, 95.8% for in-person pill

pick-up, and 93.6% for in-clinic care).61 The study

found that all three provision methods had similarly

low rates of serious adverse events, and the study

authors concluded that the data “does not support that

the REMS [requiring an in-person visit] increases the

safety of medication abortion.”62

Further, FDA considered two international studies,

one of which included data from a total of 52,142

patients, including 85% of medication abortions taking

place in England and Wales during the two months

before and two months after COVID-19-related guidelines lifted in-person ultrasound requirements and

shifted medication abortion care to telemedicine.63

This study compared outcomes from 22,158 traditional

clinic-based abortions with 29,984 telemedicine abortions.

The authors found successful abortions for 98.8% of

telemedicine patients compared to 98.2% success rates

for in-clinic care, and extremely low rates of serious

adverse events for both groups (.02% telemedicine

compared to .04% in-clinic).64 The study also found

that telemedicine increased access to care with

Kerestes et al., Provision of medication abortion in Hawaii

during COVID-19: practical experience with multiple care delivery

models, 104 CONTRACEPTION 49 (2021).

Id.

Id. at 53.

Aiken et al., Effectiveness, safety and acceptability of no-test

medical abortion (termination of pregnancy) provided via

telemedicine: a national cohort study, 128 BJOG 1464 (2021).

Id.

significant reductions in waiting times and gestation

at the time of abortion.65

A Scotland-based study of 663 patients found 98%

completion rates for patients receiving medication

abortion following a telephone consultation.66 All

patients took mifepristone at home, and 78.7% of

patients determined gestation using last menstrual

period, i.e. they did not have an in-person visit prior to

obtaining the medication.67 Low rates of serious

adverse events were reported, with only 2 patients

(0.3%) being admitted to the hospital.68

Based on this extensive data, FDA appropriately

determined that waiving and ultimately removing the

in-person dispensing requirement would not affect the

safety and effectiveness of mifepristone used for

medication abortion.

2. Additional Studies Before FDA

in 2021 and Relied on in its

December 2021 Analyses Supported

the Removal of the In-Person

Dispensing Requirement.

Additional studies FDA considered in 2021 supported

the removal of the in-person dispensing requirement.

In analyses issued by FDA in December 2021, the

Agency relied on a set of studies which included over

3,000 patients. Two of these studies (Chong et al. and

Id.

Reynolds-Wright et al., Telemedicine medical abortion at

home under 12 weeks’ gestation: a prospective observational

cohort study during the COVID-19 pandemic, 47 BMJ SEX

REPROD. HEALTH 246 (2021).

Id.

Kerestes et al.) had also been considered by FDA in

April 2021 and are described above. Two other studies

discussed by FDA were additional assessments of the

TelAbortion Project, which, like Chong et al., found

very low rates of serious adverse events and high rates

of completion without follow-up care.69 One found a

94% completion rate with only two serious adverse

events among 217 patients (1%).70 The other found a

95.6% completion rate and only three serious adverse

events among 412 patients (0.7%).71 The Anger et al.

study also compared groups of patients who had a

pretreatment ultrasound or pelvic exam to patients

who did not and found no statistically significant

differences in serious adverse events.72

Additional studies analyzed by FDA provided further

evidence of the safety and effectiveness of the provision

of mifepristone without in-person dispensing. One

such study included outcome data for 227 patients who

were evaluated for eligibility during a clinic visit and

received the medication through a mail-order pharmacy

rather than at the clinic visit.73 The study found a

Raymond et al., TelAbortion: evaluation of a direct to patient

telemedicine abortion service in the United States, 100

CONTRACEPTION 173 (2019); Anger et al., Clinical and service

delivery implications of omitting ultrasound before medication

abortion provided via direct-to-patient telemedicine and mail in

the US, 104 CONTRACEPTION 659 (2021). Many of the participants

in these two studies were also in the Chong study. See supra note

55.

Raymond et al., supra note 69.

Anger et al., supra note 69.

Id.

Grossman et al., Mail-order pharmacy dispensing of

mifepristone for medication abortion after in-person clinical

assessment, 107 CONTRACEPTION 36 (2022).

96.9% completion rate with only two (0.9%) serious

adverse events, which is comparable to wholly in-clinic

care.74 Another study involved 141 patients receiving

medication abortion delivered by a mail-order pharmacy

after being evaluated through an online form that

collected information on pregnancy and medical history.75

The study found 95% of participants experienced

complete abortion without the need for follow-up care,

and no serious adverse events were reported.76 An

additional study evaluated the provision of mifepristone through retail pharmacies, including outcomes

of 243 patients who received mifepristone in a retail

pharmacy following in-clinic evaluation.77 The study

found a 93.5% effectiveness rate, with no serious

adverse events.78

Based on the record of scientific evidence considered,

FDA reasonably concluded that removing the inperson dispensing requirement would not reduce the

safety or effectiveness of mifepristone for medication

abortion. FDA’s decision to remove the requirement

was well-supported by the medical evidence, both at

the time the decision was made in April 2021 and at

later moments of consideration in December 2021.

Id.

Upadhyay (2021), supra note 52.

Id.

Grossman et al., Medication abortion with pharmacist

dispensing of mifepristone, 137 OBSTET. GYNECOL. 613 (2021).

Id.

B. Additional Evidence Supports the

Safety and Effectiveness of Removing

the In-Person Dispensing Requirement.

While FDA announced its intention to remove the

in-person dispensing requirement in 2021, this decision

was formalized in 2023. In the interim, additional

studies were published that supported the removal of

the in-person dispensing requirement. These studies

documented how patients’ real-life experiences with

medication abortion via telemedicine have continued

to be safe and effective, with high effectiveness and low

rates of serious adverse events that are very similar to

in-clinic dispensing.

One such study examined a cohort of nearly 4,000

patients living across 24 states receiving medication

abortion in different settings and found similar rates

of effectiveness when medications were dispensed by

mail (93.3%) compared to in-person (95.4%); serious

adverse events occurred rarely whether medications

were dispensed in-person or mailed.79 A study currently

in press assessing the experiences of 6,034 patients

across 20 states evaluated the effectiveness and safety

of asynchronous telemedicine for medication abortion,

finding 97.7% effectiveness with only 0.3% of patients

experiencing serious adverse events, with no significant differences between synchronous or asynchronous

models of care.80 Yet another study evaluating 330

patients found a 93% success rate with only one

Upadhyay et al., Outcomes and safety of history-based

screening for medication abortion: a retrospective multicenter

cohort study, 182 JAMA INTERNAL MED. 482 (2022).

Upadhyay et al., Effectiveness and safety of telehealth

medication abortion in the United States, NATURE MED. (2024).

serious adverse event (0.3%).81 Further, a study

reviewing the safety and effectiveness of medication

abortion before and after Canada eliminated its

REMS-like restrictions on mifepristone and made it

available with a normal prescription included outcome

data for nearly 280,000 abortions, and found there

were no material changes in the incidence of serious

adverse events.82

In addition, recent studies demonstrate that

removal of the in-person dispensing requirement is

consistent with the statutory requirements for REMS,

which must “not be unduly burdensome on patient

access to the drug, considering in particular . . .

patients who have difficulty accessing health care

(such as patients in rural or medically underserved

areas) . . . and . . . patients with functional limitations.”

21 U.S.C. §§ 355-1(f)(2)(C). For example, a geospatial

analysis of over 6,000 patients living in 31 states and

Washington D.C. found that patients who obtained

abortion care via telemedicine averted significant travel

time by not needing to visit a clinic; virtual care was

particularly beneficial for patients who used public

transit, who saved a median of 1 hour and 25 minutes

of travel time.83 Given this evidence, the in-person

Pena et al., Telemedicine for medical abortion service

provision in Mexico: a safety, feasibility, and acceptability study,

114 CONTRACEPTION 67 (2022).

Schummers et al., Abortion safety and use with normally

prescribed mifepristone in Canada, 386 N. ENG. J. MED. 57 (2022).

Koenig et al., The role of telehealth in promoting equitable

abortion access in the United States: a spatial analysis, 9 JMIR

PUB. HEALTH & SURVEILLANCE e45671 (2023). Additionally, a

retrospective study of medication abortion patients found that

dispensing mifepristone by mail did not significantly prolong time

from patients’ first contact with the clinic to the time of

mifepristone ingestion or increase pregnancy duration at

dispensing requirement was inconsistent with the

statutory requirements for imposing the REMS elements

and was appropriately removed.

These recent studies demonstrating continued

safety of telemedicine abortion care further show that

FDA’s decision to remove the in-person dispensing

requirement was reasonable and supported by extensive evidence, consistent with statutory requirements.

CONCLUSION

The Court should grant the relief requested by

Petitioners.

Respectfully submitted,

CLAUDIA HAMMERMAN

AARON DELANEY

PAUL, WEISS, RIFKIND,

WHARTON & GARRISON LLP

1285 Avenue of the Americas

New York, NY 10019

(212) 373-3000

chammerman@paulweiss.com

MELISSA GOODMAN

Counsel of Record

AMANDA BARROW

CATHREN COHEN

JACLYN SERPICO

CENTER ON REPRODUCTIVE

HEALTH, LAW, AND POLICY

UCLA SCHOOL OF LAW

1060 Veteran Avenue

Los Angeles, CA 90095

(310) 267-4382

goodmanm@law.ucla.edu

Counsel for Amici Curiae

January 30, 2024

ingestion. Koenig et al., Mailing abortion pills does not delay

care: A cohort study comparing mailed in-person dispensing of

abortion medications in the United States, 121 CONTRACEPTION

109962 (2023).

APPENDIX

APPENDIX TABLE OF CONTENTS

Page

APPENDIX: List of Amici Reproductive Health

Researchers ......................................................

APPENDIX

List of Amici

Reproductive Health Researchers1

Alice M. Abernathy, MD, MSHP, Assistant

Professor, University of Pennsylvania

Chris E. Adkins, PhD, Associate Professor of

Pharmaceutical Sciences, South University School

of Pharmacy

Abigail R.A. Aiken, MD, MPH, PhD, Associate

Professor, University of Texas at Austin

Clayton A. Alfonso, MD, Assistant Professor,

Duke University

Amy E. Alspaugh, PhD, MSN, Assistant

Professor, University of Tennessee

Amy E. Alterman, PhD, MPH, Research

Associate, University of California, Los Angeles

Stephanie I. Amaya, MD, Fellow, Stanford

University

Miranda Aragón, MD, Assistant Professor,

Associate Residency Program Director, University

of New Mexico School of Medicine

Andrea Arena, MD, Associate Professor, Brown

University

Whitney Arey, PhD, Postdoctoral Trainee,

Maternal and Child Health, University of North

Carolina at Chapel Hill

The listed institutions are the current places of employment

of the amici. The institution is listed for identification purposes

only and the views expressed in this brief do not necessarily

reflect the views of amici’s affiliated institutions.

Ifeyinwa Asiodu, PhD, MS, RN, Associate

Professor, University of California, San Francisco

Samantha L. Auerbach, PhD, WHNP-BC,

Postdoctoral Fellow, University of California, San

Francisco

Amy Autry, MD, Professor, Interim Chief

Obstetrics and Gynecology, University of

California, San Francisco, Fresno

Sarah Averbach, MD, MAS, Associate Professor,

Researcher, Clinician, University of California, San

Diego

C. Finley Baba, MPH, Senior Project Manager,

Advancing New Standards in Reproductive Health,

University of California, San Francisco

Lela Bachrach, MD, MS, Health Sciences

Clinical Professor, University of California, San

Francisco

Carrie N. Baker, MA, JD, PhD, Professor, Smith

College

Maureen K. Baldwin, MD, MPH, Associate

Professor of Obstetrics and Gynecology, Oregon

Health & Science University

Aleta Baldwin, MPH, PhD, Associate Professor,

California

State

University

Sacramento,

Department of Public Health

Jill Barr-Walker, MPH, MS, Clinical Librarian,

University of California, San Francisco

Maya Bass, MD, MA FAAFP, Program Director,

Cooper University Hospital

Molly Frances Battistelli, MPH, Director of

Policy and Administration, Advancing New

Standards in Reproductive Health, University of

California, San Francisco

Sarah E. Baum, MPH, Senior Research Scientist,

Ibis Reproductive Health

Lisa Bayer, MD, MPH, Associate Professor,

Oregon Health & Science University

Jonathan Marc Bearak, PhD, Senior Research

Scientist, Guttmacher Institute

Andrea Becker, PhD, MA, Postdoctoral Fellow,

Advancing New Standards in Reproductive Health,

University of California, San Francisco

Suzanne O. Bell, PhD, MPH, Assistant Professor,

Johns Hopkins Bloomberg School of Public Health

April J. Bell, PhD, MPH, Assistant Professor,

University of California, San Francisco

Ian Bennett, MD, PhD, Professor, University of

Washington

Ariana H. Bennett, DrPH, MPH, Postdoctoral

Scholar, University of California, Berkeley

Lyndsey S. Benson, MD, MS, Assistant Professor,

University of Washington

Nancy F. Berglas, DrPH, Public Health Social

Scientist, University of California, San Francisco

Caitlin Bernard, MD, MSCI, FACOG, Assistant

Professor, Indiana University School of Medicine

Erin Berry, MD, MPH, Medical Director and

Director of Research, Planned Parenthood

Danielle Bessett, MA, PhD,

Sociology, University of Cincinnati

Professor

M. Antonia Biggs, PhD, Associate Professor,

Advancing New Standards in Reproductive Health,

University of California, San Francisco

Natalie D. Bingham, MD, MPH, FACOG,

Associate Clinical Professor, Prisma Health

Kelly Blanchard, MSc, President, Ibis Reproductive Health

Paul D. Blumenthal, MD, MPH, Professor of

Obstetrics and Gynecology, Emeritus, Stanford

University

Christy Boraas, MD, MPH, Associate Professor,

University of Minnesota

Lynn Borgatta, MD, MPH, Board Member,

Institutional Review Boards

Sonya Borrero, MD, MS, Professor, University of

Pittsburgh

Elizabeth Heger Boyle, PhD, JD, Professor,

University of Minnesota, Twin Cities

Kari Braaten, MD, MPH, Physician, Brigham

and Women’s Hospital

Caila Brander, MSc, Research Manager, Ibis

Reproductive Health

Sofia Braunstein, MPH, Research Manager, Ibis

Reproductive Health

Claire D. Brindis, DrPH, MPH, Distinguished

Professor, University of California, San Francisco

Kathleen Broussard, PhD, Assistant Professor,

University of South Carolina

Katherine Brown, MD, MAS, Assistant

Professor, University of California, San Francisco

Benjamin Patterson Brown, MD, MS, Mimi

Pichey Assistant Professor of Obstetrics and

Gynecology, The Warren Alpert Medical School of

Brown University

Mara Buchbinder, PhD, Professor, University of

North Carolina at Chapel Hill

Alice F. Cartwright, PhD, MPH,

Research Scientist, Guttmacher Institute

Senior

Diana Carvajal, MD, MPH, Associate Professor

and Attending Physician, University of Maryland

School of Medicine

Philicia W. Castillo, MPH, Researcher

Aaron Caughey, MD, MPP, MPH, PhD,

Professor and Chair, Oregon Health & Science

University

Shawna Chan, MD, Resident Physician, University of California, Los Angeles

Wendy Chavkin, MD, MPH, Professor Emerita,

Columbia University Mailman School of Public

Health and College of Physicians and Surgeons

Beatrice Chen, MD, MPH, Associate Professor,

University of Pittsburgh

Shibani Chettri, MPH, Researcher and PhD

Student, The Ohio State University

Erica Chong, MPH, Executive

Montefiore Medical Center, RHEDI

Director,

Cynthia Chuang, MD, MSc, Professor of

Medicine and Public Health Sciences, Penn State

College of Medicine

Kathryn Church, MA, MSc, PhD, Honorary

Assistant Professor in Sexual and Reproductive

Health, London School of Hygiene & Tropical

Medicine

Damian Clarke, DPhil, Associate Professor,

Universidad de Chile

Kelly Cleland, MPA, MPH, Executive Director,

American Society for Emergency Contraception

Francine M. Coeytaux, MPH, Co-Founder,

Plan C

Kate Coleman-Minahan, PhD, RN, FNP-BC,

Assistant Professor, University of Colorado College

of Nursing

Alyssa Covelli Colwill, MD, MCR, Assistant

Professor, Oregon Health & Science University

Sarah K. Cowan, PhD, MA, Associate Professor,

New York University

Allison Cowett, MD, MPH, Health Systems

Clinician, Northwestern University Feinberg

School of Medicine

Chris Creatura, MD, Clinical Assistant Professor

of Obstetrics and Gynecology, Weill-Cornell

Medical College

Mitchell D. Creinin, MD, Professor of Obstetrics

and Gynecology, University of California, Davis

Halley P. Crissman, MD, MPH, Adjunct

Assistant Clinical Professor, University of

Michigan

Kelly R. Culwell, MD, MPH, Assistant Professor,

University of California, San Diego

Sara Daniel, MPH, Doctoral Candidate, Johns

Hopkins Bloomberg School of Public Health

Chelsea Daniels, MD, Staff Physician, Planned

Parenthood of South, East and North Florida

Cynthia R. Daniels, PhD, Professor and Project

Director, The Informed Consent Project, Rutgers

University

Philip Dempsey Darney, MD, MSc, Distinguished Research Professor Emeritus, University

of California, San Francisco

Blair G. Darney, PhD, MPH, Associate Professor,

Oregon Health & Science University

Camelia Davtyan, MD, Professor, University of

California, Los Angeles

Christine Dehlendorf, MD, MAS, Professor,

University of California, San Francisco

Amanda Dennis, DrPH, MBE,

Director, Society of Family Planning

Executive

Teresa DePiñeres, MD, MPH, FACOG, Coach

and Reproductive Health Consultant

Sheila Desai, DrPH, MPH, Research Director,

Coalition to Expand Contraceptive Access

Divya

Dethier,

Permanente

MD,

Shokoufeh Dianat,

Dandelion Health

DO,

Physician,

MAS,

Kaiser

Physician,

Claudia Diaz Olavarrieta, MA, PhD, Professor

and Researcher, National Autonomous University

of Mexico, School of Medicine

Samuel L. Dickman, MD, Chief Medical Officer,

Planned Parenthood of Montana

Justin T. Diedrich, MD, MSCI, FACOG,

Physician, Planned Parenthood

Alesha E. Doan, MA, PhD, Professor, University

of Kansas

Monica V. Dragoman, MD, MPH, System

Director, Complex Family Planning Division, Icahn

School of Medicine at Mount Sinai

Eleanor Drey, MD, EdM, Professor, University of

California, San Francisco

Nicole I. Economou, MD, MPH, Assistant

Clinical Professor, University of California, Davis

Alison Edelman, MD, MPH, Professor of Obstetrics and Gynecology, Oregon Health & Science

University

Katherine Ehrenreich, MSc, Senior Project

Manager, Advancing New Standards in Reproductive Health, University of California, San Francisco

David L. Eisenberg, MD, MPH, Professor,

Washington University in St. Louis School of

Medicine

Gretchen E. Ely, PhD, Professor, University of

Tennessee

Margit Endler, MD, PhD, Associate Professor,

Karolinska Institutet

Anna Fiastro, PhD, MPH, MEM, Research

Scientist, University of Washington

Alecia Fields, DO, OBGYN Generalist, Complex

Family Planning Specialist, Cumberland Family

Medical Center

Jason Fletcher, PhD, Professor, University of

Wisconsin

Catherine S. Forest, MD, MOH, Clinical

Associate Professor of Medicine, University of

California, San Francisco Natividad Family

Medicine Residency

Angel M. Foster, DPhil, MD, AM, Professor,

University of Ottawa

Diana Greene Foster, PhD, Professor, University

of California, San Francisco

Dov Fox, LLM, JD, DPhil, Herzog Research

Professor of Law, University Professor, and

Director, Center for Health Law Policy & Bioethics,

University of San Diego School of Law

Linda S. Franck, RN, PhD, Professor, University

of California, San Francisco

Valerie French, MD, MAS, Associate Professor,

University of Kansas

Juliana Friend, PhD, MPhil, Philip R. Lee

Postdoctoral Fellow in Health Policy, University of

California, San Francisco

Lori Frohwirth, BA, Researcher

Laura J. Frye, MPH, Researcher

Liza Fuentes, DPH, MPH, Director of Research,

Health Equity, Boston Medical Center

Maria F. Gallo, PhD, Professor and Associate

Dean of Research, College of Public Health, The

Ohio State University

Aileen Gariepy, MD, MPH, MHS, Associate

Professor, Director of Complex Family Planning,

Weill Cornell Medicine

Kristina

Professor,

Gemzell-Danielsson, MD, PhD,

Senior Consultant, and Head of

10a

Department, Karolinska Institutet, Department of

Women’s and Children’s Health

Caitlin Elisabeth Gerdts, PhD, MHS, Vice

President for Research, Ibis Reproductive Health

Adrienne R. Ghorashi, JD, Lead Law and Policy

Analyst, Center for Public Health Law Research

Jessica D. Gipson, MPH, PhD, Professor and

Director, University of California, Los Angeles

Bixby Center to Advance Sexual and Reproductive

Health Equity, University of California, Los

Angeles Fielding School of Public Health

Natalie Gladstein, MD,

Northland Family Planning

MSc,

Physician,

Emily M. Godfrey, MD,

University of Washington

MPH,

Professor,

Marji Gold, MD, Professor, Teaching and

Research Faculty, Albert Einstein College of

Medicine

Alisa B. Goldberg, MD, MPH, Director, Division

of Family Planning, Brigham and Women’s

Hospital

Bethany Golden, RN, MSN, PhD(c), PreDoctoral Fellow, ACTIONS, School of Nursing,

University of California, San Francisco

Anu Manchikanti Gomez, PhD, MSc, Associate

Professor, University of California, Berkeley

Rebecca Gomperts, MD, MPP, PhD, Director,

Aid Access

Joel R. Gonzalez, MPH, MPP, University of

California, Merced

11a

Suzan Goodman, MD, MPH, Clinical Professor

and Training Director, University of California,

San Francisco

Heather Gould, MPH, Research Project Director,

University of California, San Francisco

Wendy Terese Grace, MD, MS, MA, Medical

Doctor

Melissa S. Grant, BA, Chief Operations Officer,

Carafem

Daniel Grossman, MD, Professor, Advancing

New Standards in Reproductive Health, University

of California, San Francisco

Sofia Gruskin, JD, MIA, Professor and Director,

Institute on Inequalities in Global Health,

University of Southern California

Kelli Stidham Hall, PhD,

Professor, Columbia University

MS, Associate

Cynthia Harper, PhD, Professor, Obstetrics,

Gynecology & Reproductive Sciences, University of

California, San Francisco

Elizabeth K. Harrington, MD, MPH, Assistant

Professor, University of Washington

Maria Harvey, MPH, DrPH, Distinguished

Professor of Public Health, Associate Dean for

Research, Oregon State University

Lee Hasselbacher, JD, Research Assistant

Professor, The University of Chicago

Jennifer Hastings, MAT, MD, Clinical Professor,

University

California,

San

Francisco

Department of Family and Community Medicine

12a

Jillian T. Henderson, PhD, MPH, Senior

Investigator, Kaiser Permanente Center for Health

Research

Andrea Henkel, MD, MS, Clinical Assistant

Professor, Stanford University

Jenny A. Higgins, PhD, MPH, Professor,

University of Wisconsin – Madison

Stephanie Ho, MD, MPH, Physician, Alameda

Health System

Kelsey Holt, ScD, MA, Associate Professor,

University of California, San Francisco

Sarah Horvath, MD, MSHP, Assistant Professor,

Penn State Hershey Medical Center

Safiyah Hosein, MD, Assistant Professor, Brown

University Women and Infants Hospital

Melody Y. Hou, MD, MPH, Professor in Clinical

Obstetrics and Gynecology, University of

California, Davis

Michele Hugin, MD, MS, Clinical Assistant

Professor, Stanford University

Sara L. Imershein, MD, MPH, Clinical Professor,

George Washington University School of Medicine

& Health Sciences

Luu Ireland, MD, MPH, Assistant Professor,

UMass Memorial Health

Andrea V. Jackson, MD, MAS, Professor,

University of California San Francisco

Laura E. Jacobson, MPH, PhD(c), PhD

Candidate, OHSU-PSU School of Public Health

13a

Marian Jarlenski, PhD, MPH,

Professor, University of Pittsburgh

Associate

Ruvani Jayaweera, MPH, PhD, Research

Scientist, Ibis Reproductive Health

Carole Joffe, PhD, Professor, University of

California, San Francisco

Nicole E. Johns, MPH, Research Data Analyst,

University of California, San Diego

Dana M. Johnson, PhD, Senior Associate

Research Scientist, Ibis Reproductive Health

Heidi E. Jones, PhD, MPH, Associate Professor,

City University of New York School of Public

Health

Rachel K. Jones, PhD, Principal Research

Scientist, Guttmacher Institute

Rebecca B. Joseph, MD, MPH, Physician,

Greater Lawrence Family Health Center

Shelly Kaller, MPH, Project Director, Advancing

New Standards of Reproductive Health, University

of California, San Francisco

Bliss Kaneshiro,

University of Hawaii

MD,

MPH,

Professor,

Nathalie Kapp, MD, MPH, Chief Medical

Advisor, International Planned Parenthood

Federation

Jennifer Karlin, MD, PhD, Assistant Professor,

University of California, Davis

Megan L. Kavanaugh, DrPH, Principal Research

Scientist, Guttmacher Institute

14a

Kimberly Kelly, PhD, MA, MA, BA, Professor of

Sociology, Mississippi State University

Katherine Key, MPH, Associate

Scientist, Ibis Reproductive Health

Research

Katrina Kimport, PhD, Professor, University of

California, San Francisco

Elizabeth Kinsey, MD, Fellow, Complex Family

Planning, University of California, San Francisco

Gail Kligman, PhD, Distinguished Professor of

Sociology, University of California, Los Angeles

Jennifer Ko, BS, MLIS, Project

University of California, San Francisco

Director,

Leah R. Koenig, MSPH, PhD Candidate,

Research Analyst, Advancing New Standards in

Reproductive Health, University of California, San

Francisco

Helena Kopp Kallner, MD, PhD, Associate

Professor, Karolinska Institutet

Kathryn Kost, PhD, Director of Domestic

Research, Guttmacher Institute

Stephanie Lambert, MD, MPH, Assistant

Professor, Penn State Hershey Medical Center

Uta Landy, PhD, Senior Advisor, University of

California, San Francisco

Kathryn J. LaRoche, PhD, MSc, Assistant

Professor, Purdue University

Klaira Lerma, MPH, Research

University of Wisconsin – Madison

Amy Levi, PhD, MSN, Project Director

Director,

15a

Laura Lindberg, PhD, MA, Professor, Rutgers

School of Public Health

Kelsey Loeliger, MD, PhD, Complex Family

Planning Fellow, University of California, San

Diego

Patricia A. Lohr, MD, MPH, Medical Director

and Director, Centre for Reproductive Research &

Communication, British Pregnancy Advisory

Service

Melanie MacLennan, MD, MPH, MFA, Director,

Elmhurst Hospital New York City

Isaac Maddow-Zimet,

Guttmacher Institute

MS,

Data

Scientist,

Jennifer Manegold, MD, MS, Fellow, University

of California, Los Angeles Semel Institute

Alice Mark, MD, MSc,

Independent Consultant

Medical

Advisor,

Megan M. Masten, MD, Fellow, University of

Colorado

Namrata Mastey, MD, Associate Medical

Director, Planned Parenthood Mar Monte

Michelle L. McGowan, PhD, Professor of

Biomedical Ethics, Mayo Clinic

Monica R. McLemore, PhD,

Professor, University of Washington

MPH,

RN,

Colleen P. McNicholas, DO, MSCI, Chief

Medical Officer, Planned Parenthood

Karen R. Meckstroth, MD, MPH, Professor,

University of California, San Francisco

16a

Annie Menzel, PhD, Associate

University of Wisconsin – Madison

Professor,

Rebecca J. Mercier, MD, MPH, Associate

Professor, Thomas Jefferson University

Tamer Middleton, MD, Medical Director, Atlanta

Comprehensive Wellness Clinic

Hayley Miller, MD, Fellow, Stanford University

Ghazaleh Moayedi, DO, MPH, President,

Founder, Pegasus Health Justice Center

Sepideh Modrek, MA, PhD, Professor, San

Francisco State University

Sheila Mody, MD, MPH, Professor, University of

California, San Diego

Melissa Montoya, MD, MA, Fellow, University of

Pennsylvania

Caroline Moreau, MD, MPH, PhD, Associate

Professor, Bloomberg School of Public Health,

Johns Hopkins University

Natalie Morris, MPH, Project Manager,

Advancing New Standards of Reproductive Health,

University of California, San Francisco

Joann Elizabeth Moschella, DO, MA, Associate

Professor, Family and Community Medicine

Residency, University of California, San Francisco,

San Francisco General Hospital

Heidi Moseson, PhD, MPH, Senior Research

Scientist, Ibis Reproductive Health

Elizabeth A. Mosley, PhD, MSN, Assistant

Professor, University of Pittsburgh

17a

Isabel Muñoz, MPH, Research Manager and PhD

Student, University of California, San Francisco

Sarah Munro, PhD, MA, Assistant Professor,

University of Washington

Pamela M. Murnane, PhD, MPH, Assistant

Professor, University of California San Francisco

Caitlin Myers, PhD, John G. McCullough

Professor of Economics, Middlebury College

Subasri Narasimhan, PhD, MPH, Assistant

Professor, Emory University

Ashley Navarro, MD, MPH, Clinical Faculty,

Mountain Area Health Education Center & PPSAT

Monika Nayak, PhD Candidate, University of

California, Los Angeles

Rachel Neal, MD, Staff Physician, Endeavor

Health

Anita Lorraine Nelson, MD, Professor Emeritus,

Obstetrics and Gynecology, David Geffen School of

Medicine at University of California, Los Angeles

Alison Norris, MD, PhD, Professor, The Ohio

State University

Jenny O’Donnell, ScD, MS, Senior Director of

Research and Evaluation, Society of Family

Planning

Harika Pal, MD, Physician, Parsley Health

Amy E. Paris, MD, MS, Assistant Professor of

Obstetrics and Gynecology, The Geisel School of

Medicine at Dartmouth

Marit Pearlman Shapiro, MD, MPH, Assistant

Professor, University of Southern California

18a

Beth Phillips, MPH, Project Director, University

of California, San Francisco

Mayra Pineda-Torres, PhD, Georgia Institute of

Technology

Michael S. Policar, MD, MPH, Professor

Emeritus

Obstetrics, Gynecology,

and

Reproductive Sciences, University of California,

San Francisco, and Senior Medical Advisor,

California Prevention Training Center

Amy M. Potter, MD, Physician,

Parenthood of Greater Ohio

Planned

Joseph E. Potter, PhD, MPA, Professor

Emeritus, University of Texas at Austin

Allison Power, MPH, Senior Fellow, CDC

Sarah Ward Prager, MD, MAS, Professor,

University of Washington

Kimala Price, PhD, Professor and Chair, San

Diego State University

Sally Rafie, PharmD, Pharmacist Specialist,

University of California San Diego Health

Shandhini Raidoo, MD, MPH,

Professor, University of Hawaii

Associate

Sarah E. Raifman, MSc, Project Director,

Advancing New Standards in Reproductive Health,

University of California, San Francisco

Tina Raine-Bennett, MD, MPH, Physician

Medical Staff, University of California, San

Francisco

Lauren J. Ralph, PhD, MPH, Associate Professor

of Obstetrics, Gynecology, and Reproductive

Sciences, University of California, San Francisco

19a

Jessika Ralph, MD, MSCI, Assistant Professor of

Obstetrics and Gynecology, University of

Minnesota

Ana Maria Ramirez, MPH, Project Director, Ibis

Reproductive Health

Stephanie Rand, MAS, MD, Director of Family

Planning, Harlem Hospital

Elizabeth Gray

Researcher, Gynuity

Raymond,

MD,

MPH,

Na’amah Razon, MD, PhD, Assistant Professor,

University of California, Davis

Sara K. Redd, PhD, MSPH, Assistant Professor,

Emory University

Whitney S. Rice, DrPH, MPH, Rollins Assistant

Professor and Director, Emory University

JaNelle M. Ricks, DrPH, MPA, Assistant

Professor, The Ohio State University College of

Public Health

Sarah CM Roberts, DrPH, Professor, University

of California, San Francisco

Corinne Rocca, PhD, MPH, Professor,

University of California, San Francisco

Roger Rochat, MD, Emeritus Professor, Emory

University

Andrea H. Roe, MD, MPH, Assistant Professor,

University of Pennsylvania School of Medicine

Susan E. Rubin, MD, MPH, Reproductive Health

Research Director, The Institute for Family Health

Jessica Rubino, MD, Physician

20a

Samantha Ruggiero, MA, Project Manager, Ibis

Reproductive Health

Jennefer Russo, MD, MPH, Chief Medical

Officer, DuPont Clinic

Jessica Sanders, PhD, MSPH, Assistant

Professor and Director of Research, University of

Utah

John Santelli, MD, MPH, Professor, Columbia

University

Raffaela Schiavon, MD, Researcher and Doctor

of Medicine, Former Country Director of Ipas

Mexico and Former Deputy General Director of

Sexual and Reproductive Health at the Federal

Ministry of Health, Mexico

Robyn Schickler, MD, MSc, Chief Medical

Officer, Planned Parenthood of Southwest and

Central Florida

Courtney A. Schreiber, MD MPH, University of

Pennsylvania

Hayley Schultz, MD, Resident, University of

California, San Diego

Julie Schultz, MD, MPH, Faculty Attending

Physician, MedStar Franklin Square

Laura Schummers, ScD, Assistant Professor,

University of British Columbia

Eleanor Bimla Schwarz, MD, MS, Professor,

Chief Division of General Internal Medicine,

University of California, San Francisco

Susan Seibold-Simpson, PhD, MPH, RN, FNP,

Nurse Practitioner, Southern Tier Women’s Health

Services, LLC

21a

Dominika Seidman, MD, MAS, Associate

Professor, University of California, San Francisco

Leigh G. Senderowicz, ScD, MPH, Assistant

Professor, University of Wisconsin – Madison

Leslie G. Serrano, MPH, Research Data Analyst,

University of California, Los Angeles

Jane W. Seymour, PhD, MPH, Research

Scientist, University of Wisconsin – Madison

Collaborative for Reproductive Equity

Meera Shah, MD, MPH, MS, Chief Medical

Officer, Planned Parenthood Hudson Peconic

Tara Shochet, PhD, MPH, Director of Programs

and Grants, Family Planning Council of Iowa

Hannah Simons, DrPH, National Director,

Research & Evaluation, Planned Parenthood

Federation of America

Gretchen Sisson, PhD, Researcher, Advancing

New Standards in Reproductive Health, University

of California, San Francisco

Mikaela Smith, PhD, Research Scientist, The

Ohio State University

Mindy Sobota, MD, MS, MPhil, Associate

Professor of Medicine, Alpert Medical School of

Brown University

Reni Soon, MD, MPH, Professor, University of

Hawaii

Silpa Srinivasulu, MPH, Director, Reproductive

Health Access Project

Jody Steinauer, MD, PhD, Professor, University

of California, San Francisco

22a

Julia R. Steinberg, PhD, Associate Professor,

Department of Family Science, School of Public

Health, University of Maryland, College Park

Rachel Steward, MD, MSc, Medical Director,

FPA Women’s Health

Julia Strasser, DrPH, MPH, Director, Jacobs

Institute of Women’s Health; Assistant Research

Professor, Health Policy & Management, George

Washington University

Debra Stulberg, MD, MA, Professor and Chair of

Family Medicine, University of Chicago

Siri Suh, PhD, MPH, Associate Professor of

Sociology, Brandeis University

Renee Sullender, MD, MPH, Resident Physician,

University of California, San Diego

Elizabeth Sully, MA, PhD, Principal Research

Scientist, Guttmacher Institute

Jonas Swartz, MD, MPH, Assistant Professor,

Duke University Medical Center

Jennifer H. Tang, MD, MSCR,

Professor, University of North Carolina

FACOG,

Julia Tasset, MD, MPH, Fellow, Oregon Health &

Science University

Paula Tavrow, PhD, Adjunct Professor,

University of California, Los Angeles Fielding

School of Public Health

Stephanie Teal, MD, MPH, Professor and Chair,

Obstetrics and Gynecology and Reproductive

Biology, Case Western Reserve University School of

Medicine

23a

Terri-Ann M. Thompson, PhD, Senior Research

Scientist, Ibis Reproductive Health

Olivia Thornton, MD, MPH, Complex Family

Planning Fellow, Brigham & Women’s Hospital

Mary S. Tschann, PhD, MPH, Complex Family

Planning Scientist, The Queen’s Medical Center

Janet M. Turan, PhD, MPH,

University of Alabama at Birmingham

Professor,

Jema K. Turk, PhD, MA, MPA, Director of

Evaluation, University of California, San Francisco

David Turok, MD, MPH, Professor, University of

Utah

Erinma Ukoha, MD, MPH, Clinical Fellow,

Columbia University Irving Medical Center

Ushma Upadhyay, PhD, MPH, Professor,

University of California, San Francisco

Ena Suseth Valladares, MPH, MSN Student,

Charles R. Drew University of Medicine and

Science

Suzanne Veldhuis, MD, MSc, PhD(c), PhD

Candidate, El Colegio de la Frontera Sur

(ECOSUR)

Robin Wallace, MD, MAS, Physician Director,

Medical Services, Planned Parenthood Federation

of America

Lin-Fan Wang, MD, MPH, Assistant Professor

Carol S. Weisman, PhD, Distinguished Professor

Emerita of Public Health Sciences, Pennsylvania

State University College of Medicine

24a

Tracy A. Weitz, PhD, MPA, Professor of Sociology

and Director of the Center on Health, Risk, and

Society, American University

Elisa S. Wells, MPH, Co-Founder, Co-Director,

Plan C

Carolyn L. Westhoff, MD, Professor, Columbia

University

Libby Wetterer, MD, Assistant Professor,

University of Pennsylvania, Philadelphia

Sara Whetstone, MD, MHS, Associate Professor,

University of California, San Francisco

Kari White, PhD, MPH, Executive and Scientific

Director, Resound Research for Reproductive

Health

Caitlin R. Williams, MSPH, PhD(c), Research

Consultant and PhD Candidate, Gillings School of

Global Public Health, University of North Carolina

at Chapel Hill

Erin Wingo, MSPH, Project Director, University

of California, San Francisco

Beverly Winikoff, MD, MPH, President, Gynuity

Health Projects

Diana Wohler, MD, Assistant Clinical Professor,

Warren Alpert Medical School at Brown University

Alexandra Wollum, PhD, MPH,

Scientist, Ibis Reproductive Health

Research

Melissa L. Wong, MD, Professor, Montefiore

Medical Center

Emily T. Wood, MD, PhD, Clinical Assistant

Professor, Charles R. Drew University

25a

Katie Woodruff, DrPH, Researcher, University of

California, San Francisco

Tricia E. Wright, MD, MS, Professor, University

of California, San Francisco

Diana Wu, MD, Physician Staff, Asian Health

Services

Gail Elizabeth Wyatt, PhD, Professor, University

of California, Los Angeles

Carmela Zuniga, MA, Associate

Scientist, Ibis Reproductive Health

Research

Enav Zusman, PharmD, MSc, Pharmacist,

Graduate Researcher, The University of British

Columbia

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