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

Nos. 23-235, 23-236

In the

Supreme Court of the United States

FOOD AND DRUG ADMINISTRATION, et al.,

Petitioners,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, et al.,

Respondents.

DANCO LABORATORIES, L.L.C.,

Petitioner,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, et al.,

Respondents.

On Writs of Certiorari to the

United States Court of A ppeals for the Fifth Circuit

BRIEF FOR 263 MEMBERS OF CONGRESS AS

AMICI CURIAE IN SUPPORT OF PETITIONERS

William A. McConagha

Jennifer L. Bragg

Keyawna Griffith

Skadden, A rps, Slate,

Meagher & Flom LLP

1440 New York Avenue NW

Washington, DC 20005

Boris Bershteyn

Counsel of Record

Eryn M. Hughes

Yunyi Chen

Skadden, A rps, Slate,

Meagher & Flom LLP

One Manhattan West

New York, New York 10001

(212) 735-3000

boris.bershteyn@skadden.com

Counsel for Amici Curiae

327058

A

(800) 274-3321 • (800) 359-6859

A complete list of the 50 U.S. Senators and the

213 Members of the U.S. House of Representatives

participating as amici curiae is provided as

an appendix to the brief. Among them are:

Sen. Charles E. Schumer

Sen. Patty Murray

Sen. Bernard Sanders

Sen. Richard J. Durbin

Sen. Richard Blumenthal

Rep. Hakeem Jeffries

Rep. Katherine Clark

Rep. Frank Pallone, Jr.

Rep. Jerrold Nadler

Rep. Diana DeGette

Rep. Barbara Lee

i

TABLE OF CONTENTS

Page

TABLE OF CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . . . i

TABLE OF APPENDICES . . . . . . . . . . . . . . . . . . . . . . iii

TABLE OF CITED AUTHORITIES . . . . . . . . . . . . . . . iv

INTEREST OF AMICI CURIAE . . . . . . . . . . . . . . . . . . 1

SUMMARY OF ARGUMENT . . . . . . . . . . . . . . . . . . . . 2

ARGUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

I.

CONGRESS CHARGED EXPERTS AT

FDA WITH EVALUATING THE SAFETY

AND EFFECTIVENESS OF DRUGS—

SUBJECT ONLY TO CIRCUMSCRIBED

JUDICIAL REVIEW . . . . . . . . . . . . . . . . . . . . . 4

II. F DA’ S DET ER M I NAT ION T H AT

M I F EPR I S T ON E I S S A F E A N D

EFFECTIVE FOLLOWED A THOROUGH

AND COMPREHENSIVE PROCESS

PR E S CR I BED A N D OV ER S EEN

BY THE LEGISLATIVE BRANCH . . . . . . . . . 8

ii

Table of Contents

Page

III. A J U D I C I A L S T A Y O F F D A’ S

CURRENT A PPROACH TO

R E GU L A T I NG M I F E P R I S T ON E

WOULD PROFOUNDLY DISRUPT THE

SCIENCE-BASED, EXPERT-DRIVEN

PROCESS THAT CONGRESS DESIGNED

FOR DETERMINING WHETHER DRUGS

ARE SAFE AND EFFECTIVE . . . . . . . . . . . 11

IV. IN VA LIDATING FDA’S CURRENT

A PPROACH T O REGU L AT ING

MIFEPRISTONE

WOULD

REDUCE ACCESS TO A BORTION,

E X ACER BAT I NG A N A LR E A DY

SIGN I F ICA N T R EPR ODUC T I V E

HEALTH CRISIS . . . . . . . . . . . . . . . . . . . . . . . . 12

CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

iii

TABLE OF APPENDICES

Page

APPENDIX A — LIST OF AMICI CURIAE . . . . . . . 1a

iv

TABLE OF CITED AUTHORITIES

Page

CASES

Baltimore Gas & Electric Co. v. Natural

Resources Defense Council, Inc.,

462 U.S. 87 (1983) . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Dobbs v. Jackson Women’s Health Organization,

597 U.S. 215 (2022) . . . . . . . . . . . . . . 1, 2, 12, 15, 16, 20

MKB Management Corp. v. Burdick,

855 N.W.2d 31 (N.D. 2014) . . . . . . . . . . . . . . . . . . . . . . 7

National Mining Ass’n v.

Secretary, U.S. Department of Labor,

812 F.3d 843 (11th Cir. 2016) . . . . . . . . . . . . . . . . . 6, 12

Planned Parenthood of Southwest &

Central Florida v. State,

No. 2022 CA 912, 2022 WL 2436704

(Fla. Cir. Ct. July 5, 2022), rev’d on other grounds,

344 So. 3d 637 (Fla. Dist. Ct. App. 2022),

review granted, No. SC22-1050,

2023 WL 356196 (Fla. Jan. 23, 2023) . . . . . . . . . . . . . 7

Sabine River Authority v.

U.S. Department of Interior,

951 F.2d 669 (5th Cir. 1992) . . . . . . . . . . . . . . . . . . . . . 7

Schering Corp. v. FDA,

51 F.3d 390 (3d Cir. 1995) . . . . . . . . . . . . . . . . . . . . . . . 5

v

Cited Authorities

Page

STATUTES

5 U.S.C. § 706(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

21 U.S.C. § 321(p) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2, 4

21 U.S.C. § 355 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

21 U.S.C. § 355(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2, 4

21 U.S.C. § 355(b)(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

21 U.S.C. § 355(b)(1)(A)(i) . . . . . . . . . . . . . . . . . . . . . . . . . 8

21 U.S.C. § 355(c)(1)(A) . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

21 U.S.C. § 355(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5, 8

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

21 U.S.C. § 355(h) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

21 U.S.C. § 355-1(g)(4)(B) . . . . . . . . . . . . . . . . . . . . . . . . 10

21 U.S.C. § 371(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

21 U.S.C. § 393(b)(2)(B) . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Feder a l Food, D r ug, a nd Cosmet ic Ac t ,

21 U.S.C. §§ 301 to 399i . . . . . . . . . . . . . . . . . . . . . . . . 2

vi

Cited Authorities

Page

OTHER AUTHORITIES

Affidavit of Dr. Sharon Liner in Support of Plaintiffs’

Motion, Preterm-Cleveland v. Yost, No. A2203203

(Ohio Ct. Com. Pl. filed Sept. 2, 2022) . . . . . . . . . . . 14

After Roe Fell: Abortion Laws by State, Ctr.

for Reprod. Rts., https://reproductiverights.

org /maps /abor t ion-law s -by- st at e /

(last visited Jan. 22, 2024) . . . . . . . . . . . . . . . . . . . . . 13

Appendix to the Petition for a Writ of Certiorari, U.S.

Food & Drug Administration, et al. v. Alliance for

Hippocratic Med., et al. (Sept. 8, 2023) . . . . . . . . . . . 6

Jessica Beaman et al., Medication to Manage

Abortion and Miscarriage, 35 J. Gen. Intern.

Med. 2398 (2020) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Chantel Boyens et al., Access to Paid Leave Is

Lowest Among Workers with the Greatest

Needs, Urban Inst. (July 2022), https://

www.urban.org/sites/default/files/2022-07/

Access%2 0 t o%2 0Pa id%2 0Leave%2 0

Is%20Lowest%20among%20Workers%20

with%20the%20Greatest%20Needs.pdf . . . . . . . . . . 18

vii

Cited Authorities

Page

Brief of Amicus Curiae Doctors for America,

Alliance for Hippocratic Medicine v. U.S. Food

& Drug Administration, No. 2:22-cv-00223-Z

(N. D. Tex. Feb. 13, 2023), ECF No. 99 . . . . . . . 15, 16

Compla i nt , Zur awski v. Texa s, No. D -1GN - 2 3 - 0 0 0 9 6 8 ( T e x . D i s t . C t . f i l e d

Mar. 6, 2023) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14, 15

Cong. Budget Off., Research and Development

in the Pharmaceutical Industry (Apr. 2021),

https://w w w.cbo.gov/system/files/2021-04/

57025-Rx-RnD.pdf . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Eugene Declercq et al., The U.S. Maternal Health

Divide: The Limited Maternal Health Services

and Worse Outcomes of States Proposing

New Abortion Restrictions, Commonwealth

F u n d ( D e c . 14 , 2 0 2 2) , h t t p s : // w w w.

commonwealthfund.org/publications/issuebriefs/2022/dec/us-maternal-health-dividelimited-services-worse-outcomes . . . . . . . . . 18, 19, 20

Ioannis T. Farmakis et al., Maternal Mortality

Related to Pulmonary Embolism in the

Uni t e d St a t e s , 2 0 0 3 - 2 0 2 0 , 5 A . M . J.

Obst et r ics & Gy necolog y Mat er na lFetal Med. 100754 (2023) . . . . . . . . . . . . . . . . . . . . . . 15

Food & Drug Administration; Delegation of Authority,

86 Fed. Reg. 49,337 (Sept. 2, 2021). . . . . . . . . . . . . . . . 5

viii

Cited Authorities

Page

Kimya Forouzan & Isabel Guarnieri, State

Policy Trends 2023: In the First Full Year

Since Roe Fell , a Tumultuous Year for

Abortion and Other Reproductive Health

Care, Guttmacher Inst. (Dec. 19, 2023),

https://www.guttmacher.org/2023/12/statepolicy-trends-2023-first-full-year-roe-felltumultuous-year-abortion-and-other . . . . . . . . . . . . 13

Kimya Forouzan et al., The High Toll of US

Abortion Bans: Nearly One in Five Patients

Now Traveling Out of State for Abortion

Care, Guttmacher Inst. (Dec. 7, 2023), https://

www.guttmacher.org/2023/12/high-toll-usabortion-bans-nearly-one-five-patients-nowtraveling-out-state-abortion-care . . . . . . . . . . . . . . . 14

Diana Greene Foster, The Turnaway Study:

Ten Years, a Thousand Women, and the

C o n s e q u e n c e s o f Ha v i n g — o r B e i n g

Denied—an Abortion (2021) . . . . . . . . . . . . . . . . . . . 19

Diana Greene Foster et al., Socioeconomic Outcomes

of Women Who Receive and Women Who Are

Denied Wanted Abortions in the United States,

108 Am. J. Pub. Health 407 (2018) . . . . . . . . . . . . . . 19

K a ren Brooks Ha r per, Wealth Will No w

Largely Deter mine Which Texans Can

Access Abortion, Tex. Trib. (June 24, 2022),

https://w w w.texastribune.org/2022/06/24/

texas-abortion-costs/ . . . . . . . . . . . . . . . . . . . . . . . . . 18

ix

Cited Authorities

Page

Donna L. Hoyert, Maternal Mortality Rates in the

United States, 2020, Ctrs. for Disease Control

& Prevention (Feb. 23, 2022), https://www.cdc.

gov/nchs/data/hestat/maternal-mortality/2020/

maternal-mortality-rates-2020.htm . . . . . . . . . . . . . 19

Donna L. Hoyert, Maternal Mortality Rates in the

United States, 2021, Ctrs. for Disease Control

& Prevention (Mar. 16, 2023), https://www.cdc.

gov/nchs/data/hestat/maternal-mortality/2021/

maternal-mortality-rates-2021.htm . . . . . . . . . . . . . 19

Information about Mifepristone for Medical

Termination of Pregnancy Through Ten

Weeks Gestation, U.S. Food & Drug Admin.

(Mar. 23, 2023), https://www.fda.gov/drugs/

p o s t m a rk e t - d r u g - s a fe t y- i n fo r m a t i o n pat ient s - a nd-prov ider s / i n for mat ionabout-mifepristone-medical-terminationpregnancy-through-ten-weeks-gestation . . . . . . . . . . 8

Joint Appendix, U.S. Food & Drug Administration,

et al. v. Alliance for Hippocratic Med., et al.

Nos. 23-235 & 23-236 (Jan. 23, 2024) . . . . . 8, 9, 10, 17

Rachel K. Jones et al., Medication Abortion

Now Accounts for More Than Half of All US

Abortions, Guttmacher Inst. (Feb. 24, 2022),

https://www.guttmacher.org/article/2022/02/

medication-abortion-now-accounts-morehalf-all-us-abortions . . . . . . . . . . . . . . . . . . . . . . . . . . 17

x

Cited Authorities

Page

Marielle Kirstein et al., 100 Days Post-Roe:

At Least 66 Clinics Across 15 US States

Have Stopped Of fer ing Abor tion Care,

Guttmacher Inst. (Oct. 6, 2022), https://www.

g uttmacher.org / 2 0 2 2 /10/10 0 - days-post roe-least- 66 -clinics-across-15 -us-stateshave-stopped-offering-abortion-care . . . . . . . . . 13, 14

Jennifer Ko, What the FDA Can Teach Us About

Regulatory Excellence, Regulatory Rev. (Jan. 16,

2018), https://www.theregreview.org/2018/01/16/

fda-teach-regulatory-excellence/ . . . . . . . . . . . . . . . . 4

M ichel le Mea dow s , Pr o m otin g Safe an d

Effective Drugs for 100 Years, FDA Consumer

(Jan.-Feb. 2006), https://www.fda.gov/files/

Promoting-Safe-and-Effective-Drugs-for100-Years-%28download%29.pdf . . . . . . . . . . . . . . . . . 4

Mifepristone U.S. Post-Marketing Adverse

Events Summary through 12/31/2022 U.S.

Food & Drug Admin. (Dec. 31, 2022), https://

www.fda.gov/media/164331/download . . . . . . . . . 10-11

Nat’l Acads. of Scis., Eng’g & Med., The Safety and

Quality of Abortion Care in the United States

(2018), http://nap.edu/24950 . . . . . . . . . . . . . . . . . . . . . 7

xi

Cited Authorities

Page

Benjamin Rader et al., Estimated Travel Time and

Spatial Access to Abortion Facilities in the US

Before and After the Dobbs v Jackson Women’s

Health Decision, JAMA Network (Nov. 1,

2022), https://jamanetwork.com/journals/

jama/fullarticle/2798215. . . . . . . . . . . . . . . . . . . . . . . 14

Rosalyn Schroeder et al., Trends in Abortion Care

in the United States, 2017-2021, Advancing New

Standards in Reprod. Health, U.C.S.F. (2022) . . . . 18

Frances Stead Sellers & Fenit Nirappil, Confusion

Post-Roe Spurs Delays, Denials for Some

Lifesaving Pregnancy Care, Wash. Post

(July 16, 2022), https://www.washingtonpost.

com/health/2022/07/16/abortion-miscarriageectopic-pregnancy-care/ . . . . . . . . . . . . . . . . . . . . . . . 14

The State of Reproductive Health in the United

States: The End of Roe and the Perilous Road

Ahead for Women in the Dobbs Era , Gender

Equity Pol’y Inst. (Jan. 19, 2023), https://

thegepi.org /wp-content/uploads/2023/06/

GEPI-State-of-Repro-Health-Report-US.pdf . . . . . 20

U.S. Dep’t of Health & Hum. Servs., Approved

Drug Products with Therapeutic Equivalence

Ev a lu a ti o n s (4 3 r d e d . 2 0 2 3), ht t p s: //

www.fda.gov/media/71474/download . . . . . . . . . . . . 12

xii

Cited Authorities

Page

U. S . G ov ’t Accou nt abi l it y Of f., GAO - 0 8 751, Food & Drug Admin., Approval and

Oversight of the Drug Mifeprex (2008), https://

www.gao.gov/assets/gao-08-751.pdf . . . . . . . . . . . . 8-9

U.S. Gov’t Accountability Off., GAO-18-292, Food &

Drug Admin., Information on Mifeprex Labeling

Changes and Ongoing Monitoring Efforts (2018),

https://www.gao.gov/assets/gao-18-292.pdf . . . . . . . . 9

Jessica Va lent i, I Wr it e Abo ut Post-Roe

America Every Day. It’s Worse Than You

Think, N.Y. Times (Nov. 5, 2022), https://

w w w. ny t i me s .c om / 2 0 2 2 / 11 / 0 5 /opi n ion /

election-abortion-roe-women.html . . . . . . . . . . . . . . 15

Rosemary Westwood, Bleeding and in Pain, She

Couldn’t Get 2 Louisiana ERs to Answer:

Is It a Miscarriage?, WGCU (Dec. 29, 2022),

https://news.wgcu.org/2022-12-29/bleedingand-in-pain-she-couldnt-get-2-louisiana-ersto-answer-is-it-a-miscarriage . . . . . . . . . . . . . . . 16, 17

W h a t Ar e th e Ri sk s of Pr eecl amps i a &

Eclampsia to the Mother?, Nat’l Insts. of

Health, https://www.nichd.nih.gov/health/to

pics/‌preeclampsia/‌conditioninfo/risk-mother

(last updated Jan. 22, 2024) . . . . . . . . . . . . . . . . . . . . 15

xiii

Cited Authorities

Page

Katharine O’Connell White, POV: Overturning Roe

v. Wade Will Worsen Health Inequities in All

Reproductive Care, BU Today (June 24, 2022),

https://www.bu.edu/articles/2022/overturningroe-v-wade-will-worsen-health-inequities/ . . . . . 17-18

1

INTEREST OF AMICI CURIAE1

Amici curiae are 263 Members of Congress—50

Senators and 213 Members of the House of Representatives.

(See Appendix for List of Amici.) Amici have a special

interest in both upholding the Constitution’s separation

of powers—among other things, by ensuring that federal

administrative agencies are able to faithfully exercise the

authorities Congress delegated to them by statute without

undue judicial interference—and protecting the physical

health and safety of their constituents.

Amici believe that the United States Court of Appeals

for the Fifth Circuit incorrectly affirmed the district court’s

stay of the U.S. Food and Drug Administration’s 2016 and

2021 actions with respect to mifepristone’s approved

conditions of use. The Fifth Circuit’s decision threatens

the congressionally mandated drug approval process and

poses a serious health risk to pregnant individuals by

making abortion more difficult to access—when access has

already been seriously eroded in the aftermath of Dobbs

v. Jackson Women’s Health Organization, 597 U.S. 215

(2022). Accordingly, Amici respectfully urge this Court

to reverse the Fifth Circuit’s affirmance of the district

court’s stay of the U.S. Food and Drug Administration’s

2016 and 2021 actions.

1. Pursuant to Rule 37.6 of the Rules of this Court, amici state

that no counsel for a party wrote this brief in whole or in part. No

party, party’s counsel or any person other than the amici curiae,

their members, or their counsel contributed money that was intended

to finance the preparation or submission of this brief.

2

SUMMARY OF ARGUMENT

For the last century, a statutory scheme designed

by Congress has assured the safety and effectiveness

of the drugs available in the United States. At its core

resides the application of scientific standards by agency

experts. In 1938, Congress enacted the Federal Food,

Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 to

399i, which established the foundations for the modern

regulation of our drug supply. See 21 U.S.C. §§ 321(p),

355(a). Congress designated the U.S. Food and Drug

Administration (“FDA”) as the expert federal agency

with authority to review and approve drug applications,

including subsequent changes to those applications.

While Congress permitted some judicial review of FDA’s

approval decisions, it did not invite federal courts to

substitute their judgment for the expert conclusions of

FDA’s scientists.

Here, FDA’s determination that mifepristone is safe

and effective is based on a thorough and comprehensive

review process prescribed and overseen by the legislative

branch. Since mifepristone’s initial approval in 2000,

FDA has repeatedly and consistently affirmed that the

medication is safe and effective for its approved conditions

of use. FDA’s process and conclusions have been validated

by both Congress and the Government Accountability

Office—and by the lived experience of over 5 million

patients who have used the drug in the United States.

And, as with all drugs, FDA continued to closely monitor

the post-marketing safety data on mifepristone.

By maintaining the district court’s stay of mifepristone’s

current, FDA-approved conditions of use, the Fifth Circuit

3

has disrupted the longstanding statutory framework and

erroneously countenanced an extraordinary remedy.

Decades after FDA’s initial approval—yet somehow in

an emergency posture—the district court and the Fifth

Circuit intruded into FDA’s drug approval process, casting

a shadow of uncertainty over its decisions. The perils of

this unwarranted judicial intervention into science-based

determinations can hardly be overstated. Researchers,

health care providers, and patients suffering from a range

of medical conditions rely on the integrity and stability

of the rigorous science-based drug approval process.

The specter of precipitous judicial meddling therefore

threatens access to life-improving and lifesaving drugs.

More immediately, the misguided stay of mifepristone’s

current FDA-approved conditions of use will reduce

access to abortion, exacerbating an already significant

reproductive health crisis. Although the district court

styled its relief as “less drastic” than a mandatory

injunction, it is not apparent that its consequences are less

disruptive. Since this Court’s decision in Dobbs v. Jackson

Women’s Health Organization, abortion has become

inaccessible in much of the United States. The resulting

delays and denials of care have already had baleful effects

on the health of pregnant individuals, for some of whom

pregnancy is a life-threatening condition, regardless

of their desire to carry their fetus to term. The Fifth

Circuit’s order would exacerbate these adverse health

outcomes by limiting access to the most common method

of early abortion—a two drug regimen of mifepristone

and misoprostol.

Therefore, this Court’s reversal of the Fifth Circuit’s

order with respect to FDA’s 2016 and 2021 actions is

4

necessary to mitigate the imminent harm facing members

of the public, many of whom rely on the availability of

mifepristone for reproductive care—and many more of

whom rely on the integrity of FDA’s drug approval process

for continued access to life-improving and lifesaving

drugs. Congress intended to—and did—vest authority

in FDA to evaluate and ensure the safety and efficacy of

drugs in the United States, and Amici call on this Court

to give due weight to that intent.

ARGUMENT

I.

CONGRESS CHARGED EXPERTS AT FDA

W I T H EVA LUATI NG T H E SA FET Y A N D

EFFECTIVENESS OF DRUGS—SUBJECT ONLY

TO CIRCUMSCRIBED JUDICIAL REVIEW

Congress has designed a system for assuring the

safety and effectiveness of the drugs available in the

United States—a system that became the envy of the

world. 2 At the core of that system is the expert application

of scientific standards. In 1938, Congress enacted a

landmark statute, the FDCA, which established the

foundations for the modern regulation of our drug supply.

See 21 U.S.C. §§ 321(p), 355(a). Since 1962, Congress has

required that drugs be shown to be safe and effective for

their intended use before they can be sold in the United

States. See 21 U.S.C. § 355; see also id. § 393(b)(2)(B).

2. See Jennifer Ko, What the FDA Can Teach Us About

Regulatory Excellence, Regulatory Rev. (Jan. 16, 2018), https://

www.theregreview.org/2018/01/16/fda-teach-regulatory-excellence/;

see also Michelle Meadows, Promoting Safe and Effective Drugs

for 100 Years, FDA Consumer (Jan.-Feb. 2006), https://www.fda.

gov/files/Promoting-Safe-and-Effective-Drugs-for-100-Years%28download%29.pdf.

5

FDA is the expert agency charged by Congress

with reviewing and approving drug applications and any

subsequent changes to those applications. 3 In accordance

w ith cong ressional design, a team of physicians,

statisticians, chemists, pharmacologists, and other

scientific experts reviews each New Drug Application

(“NDA”) submitted to the agency and assesses all relevant

data in light of the proposed labeling and intended use

of the drug.4 The agency must approve an application if,

among other requirements, it has concluded that the drug

is safe and effective under the conditions of use prescribed,

recommended or suggested in the proposed labeling. 5

FDCA’s review provisions do not invite the courts

to substitute their judgment for the expert assessment

of FDA scientists, but to treat their “finding[s] . . . as

to the facts, if supported by substantial evidence,” as

“conclusive.” 21 U.S.C. § 355(h); see also Schering Corp.

v. FDA, 51 F.3d 390, 399 (3d Cir. 1995) (“[J]udgments as

to what is required to ascertain the safety and efficacy of

drugs fall squarely within the ambit of the FDA’s expertise

and merit deference from us.”); 5 U.S.C. § 706(2) (limiting

scope of review to certain circumscribed grounds); Balt.

3. See 21 U.S.C. § 371(a) (“The authority to promulgate

regulations for the efficient enforcement of this chapter [21 U.S.

Code ch. 9 (the FDCA)] . . . is vested in the Secretary [of Health and

Human Services].”). The Secretary of Health and Human Services

(“the Secretary”) has in turn delegated all functions vested in the

Secretary under the FDCA to the FDA Commissioner of Food and

Drugs. See Food & Drug Administration; Delegation of Authority,

86 Fed. Reg. 49,337 (Sept. 2, 2021).

4. See 21 U.S.C. § 355(b)(1).

5. See 21 U.S.C. § 355(d).

6

Gas & Elec. Co. v. Nat. Res. Def. Council, Inc., 462 U.S.

87, 103 (1983) (“When examining [an expert agency’s]

scientific determination, as opposed to simple findings

of fact, a reviewing court must generally be at its most

deferential.”); Nat’l Mining Ass’n v. Sec’y, U.S. Dep’t of

Lab., 812 F.3d 843, 866 (11th Cir. 2016) (stating that it

is appropriate for reviewing courts to “give an extreme

degree of deference to the agency when it is evaluating

scientific data within its technical expertise”; “[t]o do

otherwise puts [a] court in the unenviable—and legally

untenable—position of making for itself judgments

entrusted by Congress to [the expert agency]” (citation

omitted)). Indeed, the district court’s order—now upheld

in material part by the Fifth Circuit—appears to be the

very first time in FDA’s history that a court has stayed

the conditions of approval of a widely marketed drug over

the agency’s objection.

Here, rather than affording due deference to FDA,

the district court’s order (affirmed in part by the Fifth

Circuit) appears to have second-guessed FDA’s expert

determinations with cherry-picked anecdotes and studies,

and on that basis, imposed a remedy that will significantly

upend the status quo. See, e.g., Appendix to the Petition

for a Writ of Certiorari at 166a-167a, U.S. Food & Drug

Administration, et al. v. Alliance for Hippocratic Med.,

et al. No. 23-235 (Sept. 12, 2023) [hereinafter Pet. App.]

(asserting that “chemical abortion drugs do not provide a

meaningful therapeutic benefit over surgical abortion”);

Pet. App. at 171a (claiming that surgical abortion is a far

safer procedure); Pet. App. at 177a (relying on “myriad

stories and studies brought to the Court’s attention”);

Pet. App. at 183a-184a (admitting the court does not

have exact numbers and is relying on compounding

7

assumptions). The National Academies of Sciences,

Engineering and Medicine have concluded that much of

the published literature on the supposed negative effects

of abortion (such as that relied upon by the district court)

“fails to meet scientific standards for rigorous, unbiased

research.”6 Numerous courts have rejected the expert

testimony of the physicians whose submissions the district

court accepted at face value.7 Even when “conflicting

evidence is before the agency”—which was not the case

here—“the agency and not the reviewing court has the

discretion to accept or reject from the several sources of

evidence.” Sabine River Auth. v. U.S. Dep’t of Interior,

951 F.2d 669, 678 (5th Cir. 1992).

For decades, the federal judiciary has respected

Congress’s delegation of the drug approval process to

FDA’s scientists and experts. While courts have, on

occasion, held against FDA on issues related to the

market exclusivity that is afforded to a drug sponsor by

the statute, it is an extraordinary and unprecedented step

for a court to invalidate on substantive grounds—and

over FDA’s objection—approval for a drug with a history

of safe and effective use or the drug’s conditions of use.

6. Nat’l Acads. of Scis., Eng’g & Med., The Safety and Quality of

Abortion Care in the United States 152 (2018), http://nap.edu/24950.

7. See, e.g., MKB Mgmt. Corp. v. Burdick, 855 N.W.2d 31, 68

(N.D. 2014) (per curiam) (rejecting testimony of Dr. Harrison as

lacking “scientific support”); Planned Parenthood of Sw. & Cent.

Fla. v. State, No. 2022 CA 912, 2022 WL 2436704, at *13 (Fla. Cir.

Ct. July 5, 2022) (rejecting testimony of Dr. Skop, who “provided no

credible scientific basis for her disagreement with recognized highlevel medical organizations in the United States”), rev’d on other

grounds, 344 So. 3d 637 (Fla. Dist. Ct. App. 2022), review granted,

No. SC22-1050, 2023 WL 356196 (Fla. Jan. 23, 2023).

8

II. FDA’S DETERMINATION THAT MIFEPRISTONE

IS SAFE AND EFFECTIVE FOLLOWED A

THOROUGH AND COMPREHENSIVE PROCESS

PRESCRIBED A N D OV ERSEEN BY THE

LEGISLATIVE BRANCH

More than t wenty yea rs ago, FDA approved

mifepristone, determining that it is safe and effective for

the medical termination of intrauterine pregnancy under

the conditions set forth in the FDA-approved prescribing

information. See Joint Appendix at 224, U.S. Food & Drug

Administration, et al. v. Alliance for Hippocratic Med.,

et al. Nos. 23-235 & 23-236 (Jan. 23, 2024) [hereinafter

Joint App.] (Approval of NDA for mifepristone, Sept. 28,

2000); see also 21 U.S.C. § 355(b)(1)(A)(i), (c)(1)(A), (d).

Since then, FDA has repeatedly and consistently affirmed

that mifepristone is safe and effective for its approved

conditions of use. 8

The integ r ity of FDA’s approval process for

mifepristone, including actions after the 2000 approval,

has been examined before—and found to be sound. In

2008, the U.S. Government Accountability Office (GAO),

an independent, non-partisan agency, conducted an

extensive audit of mifepristone’s 2000 approval, concluding

it was “generally consistent with the approval processes

for the other . . . Subpart H restricted drugs.” 9 The GAO

8 . See Info r m atio n abo ut Mifep r isto ne fo r Medical

Termination of Pregnancy Through Ten Weeks Gestation, U.S.

Food & Drug Admin. (Mar. 23, 2023), https://www.fda.gov/drugs/

postmarket-drug-safety-information-patients-and-providers/

information-about-mifepristone-medical-termination-pregnancythrough-ten-weeks-gestation.

9. U.S. Gov’t Accountability Off., GAO- 08-751, Food &

Drug Admin., Approval and Oversight of the Drug Mifeprex, at 6

9

also noted that, when it came to post-market oversight of

mifepristone, “FDA has routinely reviewed the available

information on reported adverse events” from a range of

sources and then, “working with the drug’s sponsor, has

taken a variety of steps . . . . to address safety concerns.”10

Notably, in conducting its study, the GAO “interviewed

FDA officials and external stakeholders who had access

to technical information or had conducted analyses”

concerning the drug.11 The GAO report considered many

of the same concerns raised by plaintiffs in this case

fifteen years later.

In 2016, after approving risk evaluation and mitigation

strategies (“REMS”) for mifepristone, FDA approved a

supplemental NDA. See Joint App. at 283-291. In 2018,

the GAO reviewed this 2016 approval, and after evaluating

62 studies and articles that supported the efficacy of the

proposed labeling changes as well as safety information and

adverse event data, concluded FDA “followed its standard

review process when it approved the [2016 supplemental new

drug application] and revised labeling.”12 The report further

found that “FDA has conducted a variety of monitoring

activities and these have not identified significant concerns

(2008), https://www.gao.gov/assets/gao-08-751.pdf. The report was

prepared at the request of three Republican members of Congress

during the Bush administration: Senator Enzi, Senator DeMint and

Representative Bartlett.

10. Id. at 38, 41.

11. Id. at 4.

12. U.S. Gov’t Accountability Off., GAO-18-292, Food & Drug

Admin., Information on Mifeprex Labeling Changes and Ongoing

Monitoring Efforts, cover pg. (2018), https://www.gao.gov/assets/

gao-18-292.pdf; see also id. at 11-16.

10

with the safety and use of [mifepristone], in accordance with

its approved REMS.”13

FDA’s 2021 actions were likewise grounded in careful

review of safety data and scientific literature. In April 2021,

in light of COVID-19-related risks, FDA announced its

intent to exercise enforcement discretion as to the in-person

dispensing requirement, explaining that its decision was

“the result of a thorough scientific review by experts” who

evaluated “available clinical outcomes data and adverse

event reports.” Joint App. at 377. In December 2021, FDA

further determined that “mifepristone will remain safe and

effective for medical abortion if the in-person dispensing

requirement is removed” and directed mifepristone’s

sponsors to initiate the process to modify the REMS

accordingly. Id. at 378, see also id. at 373, 379; 21 U.S.C.

§ 355-1(g)(4)(B). FDA explained that its determination came

after seeking out information from the drug’s sponsors,

see Joint App. at 399, evaluating “routinely monitor[ed]

postmarketing safety data,” id. at 398, and conducting an

“extensive review of the published literature.” Id. at 399.

See generally id. at 397-408 (discussing review of available

data and scientific literature).

Thus, FDA has repeatedly demonstrated that its

approval of mifepristone and its conditions of use is based on

a rigorous review of scientific data and literature supporting

the safety and efficacy of the drug, which has been validated

by the decades of experience of many Americans who, in

consultation with their health care providers, have chosen

to use mifepristone for a medication abortion.14

13. Id. at cover pg.

14. See Mifepristone U.S. Post-Marketing Adverse Events

Summary through 12/31/2022 at 1, U.S. Food & Drug Admin.

11

III. A J U DICI A L STAY OF FDA’ S CU RREN T

APPROACH TO REGULATING MIFEPRISTONE

WOULD PROFOUNDLY DISRUPT THE SCIENCEBASED, EXPERT-DRIVEN PROCESS THAT

CONGRESS DESIGNED FOR DETERMINING

WHETHER DRUGS ARE SAFE AND EFFECTIVE

The consequences of the Fifth Circuit’s decision

could extend far beyond mifepristone, for it undermines

the science-based, expert-driven process that Congress

designed for determining whether drugs are safe and

effective. By disrupting FDA’s current regulation of

mifepristone, the Fifth Circuit has countenanced judicial

interference that erroneously substitutes a court’s

judgment for FDA’s scientific determination.

As a result, the Fifth Circuit’s order undermines the

well-established statutory and regulatory framework

for the approval and regulation of new drugs and the

due process generally accorded to drug marketing

application holders by statute.15 Its perilous consequences

reach far beyond mifepristone. Providers and patients

rely on the availability of thousands of FDA-approved

drugs to treat or manage a range of medical conditions,

including asthma, HIV, infertility, heart disease, diabetes,

(Dec. 31, 2022), https://www.fda.gov/media/164331/download (“The

estimated number of women who have used mifepristone in the U.S.

for medical termination of pregnancy through the end of December

2022 is approximately 5.9 million women.”).

15. Section 505(e) of the FDCA allows for withdrawal of

approval of an application with respect to any drug under the section

only “after due notice and opportunity for hearing to the applicant.”

21 U.S.C. § 355(e).

12

and more.16 Moreover, the prospect of courts secondguessing FDA’s rigorous drug safety and effectiveness

determinations will disrupt industry expectations and

could chill pharmaceutical research and development.

“Developing new drugs is a costly and uncertain process,”

and only about 12 percent of drugs entering clinical

trials are approved by FDA.17 Were each court to take

the “legally untenable . . . position of making for itself

judgments entrusted by Congress to” FDA, Nat’l Mining

Ass’n, 812 F.3d at 866, the unpredictability of piecemeal

judicial intervention would upend industry expectations,

dampening incentives for companies to incur the research

and development costs necessary to develop new drugs.

Consequently, patient access to life-improving and

potentially lifesaving new drugs will suffer, while public

interest strongly favors preserving the integrity of FDA’s

drug-approval and review process.

IV. INVALIDATING FDA’S CURRENT APPROACH

TO REGU LATING MIFEPRISTONE

WOULD REDUCE ACCESS TO ABORTION,

EXACERBATING AN ALREADY SIGNIFICANT

REPRODUCTIVE HEALTH CRISIS

In the aftermath of this Court’s decision in Dobbs

v. Jackson Women’s Health Organization, abortion

has become inaccessible in much of the United States.

Abortion is banned, with extremely limited exceptions

for life-endangerment, in 14 states, and access is severely

16. See generally U.S. Dep’t of Health & Hum. Servs., Approved

Drug Products with Therapeutic Equivalence Evaluations (43rd

ed. 2023), https://www.fda.gov/media/71474/download.

17. Cong. Budget Off., Research and Development in the

Pharmaceutical Industry 2 (Apr. 2021), https://www.cbo.gov/system/

files/2021-04/57025-Rx-RnD.pdf.

13

restricted in an additional 10 states.18 As of October 2022,

approximately 22 million women of childbearing age,

representing almost one third of the total population of

women ages 15 to 49—in addition to other people who

may not identify as women but are capable of becoming

pregnant and may need an abortion—now live “in states

where abortion is [entirely] unavailable or severely

restricted.”19 At least 66 clinics across 15 states have

stopped offering abortion care. 20 (Prior to June 24, 2022,

those same 15 states had a total of 79 clinics that offered

abortion care; as of October 2022, there were only 13

such clinics, all located in Georgia. 21) As of December

2023, “almost 18 million women of reproductive age, in

addition to transgender and nonbinary people who may

need an abortion, no longer have access to abortion care

in their state of residence.” 22 Travel time and wait time to

obtain abortion care have increased significantly across

18. See After Roe Fell: Abortion Laws by State, Ctr. for Reprod.

Rts., https://reproductiverights.org/maps/abortion-laws-by-state/

(last visited Jan. 22, 2024).

19. Marielle Kirstein et al., 100 Days Post-Roe: At Least

66 Clinics Across 15 US States Have Stopped Offering Abortion

Care, Guttmacher Inst. (Oct. 6, 2022), https://www.guttmacher.

org/2022/10/100-days-post-roe-least-66-clinics-across-15-us-stateshave-stopped-offering-abortion-care.

20. See id.

21. See id.

22. Kimya Forouzan & Isabel Guarnieri, State Policy Trends

2023: In the First Full Year Since Roe Fell, a Tumultuous Year for

Abortion and Other Reproductive Health Care, Guttmacher Inst.

(Dec. 19, 2023), https://www.guttmacher.org/2023/12/state-policytrends-2023-first-full-year-roe-fell-tumultuous-year-abortion-andother.

14

the United States. 23 In the first half of 2023, nearly one in

five patients who obtained abortion care traveled to other

states. 24 The shortage of providers has also stretched the

capacity of clinics in states where abortion remains legal. 25

The resulting delays and denials of care have already

dangerously affected health outcomes for pregnant

individuals. Some individuals report being forced to

forgo cancer treatment, 26 while others report developing

sepsis, 27 being left bleeding for days after an incomplete

miscarriage, 28 enduring the risk of rupture due to

23. See Kirstein et al., supra note 19; see also Benjamin Rader et

al., Estimated Travel Time and Spatial Access to Abortion Facilities

in the US Before and After the Dobbs v Jackson Women’s Health

Decision, JAMA Network (Nov. 1, 2022), https://jamanetwork.com/

journals/jama/fullarticle/2798215.

24. See Kimya Forouzan et al., The High Toll of US Abortion

Bans: Nearly One in Five Patients Now Traveling Out of State

for Abortion Care, Guttmacher Inst. (Dec. 7, 2023), https://www.

guttmacher.org/2023/12/high-toll-us-abortion-bans-nearly-one-fivepatients-now-traveling-out-state-abortion-care.

25. See Kirstein et al., supra note 19.

26. Affidavit of Dr. Sharon Liner in Support of Plaintiffs’

Motion at 4-5, Preterm-Cleveland v. Yost, No. A2203203 (Ohio Ct.

Com. Pl. filed Sept. 2, 2022).

27. Complaint ¶¶ 17-25, Zurawski v. Texas, No. D -1GN-23-000968 (Tex. Dist. Ct. filed Mar. 6, 2023); see also id. at

1 (plaintiffs were denied necessary and potentially lifesaving

obstetrical care because medical professionals throughout the state

feared liability under Texas’s abortion bans).

28. See Frances Stead Sellers & Fenit Nirappil, Confusion

Post-Roe Spurs Delays, Denials for Some Lifesaving Pregnancy

Care, Wash. Post (July 16, 2022), https://www.washingtonpost.com/

health/2022/07/16/abortion-miscarriage-ectopic-pregnancy-care/.

15

ectopic pregnancy or being forced to continue carrying

a fetus diagnosed with a lethal fetal anomaly such as

anencephaly. 29 For some individuals, pregnancy is a lifethreatening condition, regardless of their desire to carry

their fetus to term. 30 Since Dobbs, numerous individuals

have been left struggling to access the essential health

care they need. 31 Reports from doctors and journalists

highlight the increasing importance of mifepristone for

reproductive health care in Dobbs’ wake:

• One doctor who had “to stop providing

abortion care to patients in Wisconsin for

the past six months” observes “further

difficulties for patients in rural settings.”

Rural patients “are now being forced to

birth, so the risks of bleeding and poor fetal

and maternal outcomes have significantly

risen. Mifepristone is vital to providing safe

care for early pregnancy loss.” 32

29. See Complaint ¶¶ 82-94, Zurawski, supra note 27.

30. See, e.g., Ioannis T. Farmakis et al., Maternal Mortality

Related to Pulmonary Embolism in the United States, 2003-2020,

5 A.M. J. Obstetrics & Gynecology Maternal-Fetal Med. 100754 (2023);

What Are the Risks of Preeclampsia & Eclampsia to the Mother?,

Nat’l Insts. of Health, https://www.nichd.nih.gov/health/topics/

preeclampsia/‌conditioninfo/risk-mother (last updated Jan. 22, 2024).

31. See Jessica Valenti, I Write About Post-Roe America Every

Day. It’s Worse Than You Think, N.Y. Times (Nov. 5, 2022), https://www.

nytimes.com/2022/11/05/opinion/election-abortion-roe-women.html.

32. Brief of Amicus Curiae Doctors for America at 6-7, All. for

Hippocratic Med. v. U.S. Food & Drug Admin., No. 2:22-cv-00223-Z

(N.D. Tex. Feb. 13, 2023), ECF No. 99.

16

• Another doctor recounts a patient who was

raped when she was actively planning for

pregnancy. The soonest a paternity test

could be conducted was at 7 weeks gestation,

while Texas, where the patient lived, had

banned abortion after 6 weeks. The patient

could not afford to travel out of state for

termination, and had to seek a medication

abortion before her sixth week. 33

• A woman residing in Louisiana, where all

abortion (including in cases of rape and

incest) has been banned after Dobbs, was

refused treatment for her miscarriage

when she was between 10 and 11 weeks

pregnant. When asked whether treatment

was available to alleviate her pain and speed

up the process, the doctor replied: “We’re

not doing that now.” 34 Mifepristone is part

of standard treatment to manage early

pregnancy loss. 35

These examples bespeak a broader public health crisis

aggravated by providers denying care for fear that their

33. Id. at 9-10.

34. Rosemary Westwood, Bleeding and in Pain, She Couldn’t

Get 2 Louisiana ERs to Answer: Is It a Miscarriage?, WGCU (Dec.

29, 2022), https://news.wgcu.org/2022-12-29/bleeding-and-in-painshe-couldnt-get-2-louisiana-ers-to-answer-is-it-a-miscarriage.

35. See Jessica Beaman et al., Medication to Manage Abortion

and Miscarriage, 35 J. Gen. Intern. Med. 2398, 2398 (2020) (“Thus,

for both medication abortion and medical management of early

miscarriage, the standard of care is to provide oral mifepristone

followed by misoprostol tablets.”).

17

treatment will contravene state criminal law and lead to

prosecution. 36 No other practice of medicine bears witness

to these types of denials of care based on state restrictions

and ideological interference.

The Fifth Circuit’s order will exacerbate these

adverse health outcomes by limiting access to the most

common method of early abortion. 37 It will also create

additional confusion on top of the post-Dobbs uncertainty

surrounding the legality of different forms of reproductive

health care. As a result, childbearing individuals may have

to turn to procedural abortion, which is more invasive, may

require extensive travel to obtain, has longer wait times,

and is often much more expensive. Alternatively, affected

individuals would have to seek methods of medication

abortion that do not involve mifepristone or to travel

to find a distributing physician, even though FDA has

concluded that mifepristone remains safe and effective

with the in-person dispensing requirement removed. See

Joint App. at 378, 407.

These health risks, as well as financial and logistical

challenges, would disproportionately affect individuals

already facing systemic barriers to health care, who could

be forced to choose amongst a more costly procedural

abortion, costly travel and an unwanted pregnancy. 38

36. See, e.g., Westwood, supra note 34.

37. See Rachel K. Jones et al., Medication Abortion Now

Accounts for More Than Half of All US Abortions, Guttmacher

Inst. (Feb. 24, 2022), https://www.guttmacher.org/article/2022/02/

medication-abortion-now-accounts-more-half-all-us-abortions.

38. See Katharine O’Connell White, POV: Overturning Roe

v. Wade Will Worsen Health Inequities in All Reproductive Care,

18

These particularly vulnerable groups may include lowincome individuals, people of color, young people and

those residing in rural areas. 39 Medication abortion

using mifepristone is an important means for vulnerable

groups to access medical care without having to bear the

cost of long-distance travel to find access to procedural

abortion and the difficulties associated with getting time

off or finding child care.40 By curtailing access to the

most common method of medication abortion, the Fifth

Circuit’s order erects additional barriers to health care

for vulnerable populations.

Reduced abortion access is also associated with higher

rates of poverty, and lower educational attainment for both

BU Today (June 24, 2022), https://w w w.bu.edu/articles/2022/

overturning-roe-v-wade-will-worsen-health-inequities/.

39. See generally Eugene Declercq et al., The U.S. Maternal

Health Divide: The Limited Maternal Health Services and

Worse Outcomes of States Proposing New Abortion Restrictions,

Commonwealth Fund (Dec. 14, 2022), https://www.commonwealthfund.

org/publications/issue-briefs/2022/dec/us-maternal-health-dividelimited-services-worse-outcomes; see also Rosalyn Schroeder et al.,

Trends in Abortion Care in the United States, 2017-2021, Advancing

New Standards in Reprod. Health, U.C.S.F. (2022).

40. See Karen Brooks Harper, Wealth Will Now Largely

Determine Which Texans Can Access Abortion, Tex. Trib. (June

24, 2022), https://www.texastribune.org/2022/06/24/texas-abortioncosts/ (“About 73% of the people who call Fund Texas Choice for help

with travel expenses are Black, Indigenous, Hispanic and Asian.”);

id. (“[T]hose working in wage-based jobs with no paid time off.”); see

also Chantel Boyens et al., Access to Paid Leave Is Lowest Among

Workers with the Greatest Needs 2, Urban Inst. (July 2022), https://

www.urban.org/sites/default/files/2022-07/Access%20to%20Paid%20

Leave%20Is%20Lowest%20among%20Workers%20with%20the%20

Greatest%20Needs.pdf.

19

children and parents.41 The Turnaway Study conducted

at the University of California, San Francisco found that

being denied an abortion was associated with increased

economic insecurity and household poverty for both the

mother and children born as a result of abortion denial.42

The limited availability of mifepristone will have an

especially acute impact on Black maternal health. In 2021,

the overall maternal mortality rate shot up by nearly

40 percent,43 and the maternal mortality rate for Black

women was especially high, at 69.9 deaths per 100,000 live

births—1.3 times higher than it was in 2020, and 2.6 times

higher than the rate for white women.44 In 2020, maternal

death rates were 62 percent higher in abortion-restriction

states than in abortion-access states.45 From 2018 to 2020,

the maternal mortality rate increased nearly twice as fast

in states with abortion restrictions than in states without

41. Diana Greene Foster et al., Socioeconomic Outcomes of

Women Who Receive and Women Who Are Denied Wanted Abortions

in the United States, 108 Am. J. Pub. Health 407, 412 (2018).

42. See Diana Greene Foster, The Turnaway Study: Ten Years,

a Thousand Women, and the Consequences of Having—or Being

Denied—an Abortion (2020).

43. See Donna L. Hoyert, Maternal Mortality Rates in

the United States, 2021, Ctrs. for Disease Control & Prevention

(Mar. 16, 2023), https://www.cdc.gov/nchs/data/hestat/maternalmortality/2021/maternal-mortality-rates-2021.htm.

44. See id.; see also Donna L. Hoyert, Maternal Mortality

Rates in the United States, 2020, Ctrs. for Disease Control &

Prevention (Feb. 23, 2022), https://www.cdc.gov/nchs/data/hestat/

maternal-mortality/2020/maternal-mortality-rates-2020.htm.

45. See Declercq et al., supra note 39, at Exhibit 4.

20

them.46 In 2021, the maternal mortality rate in states which

restricted abortion and later banned abortion after Dobbs

was 2.4 times that in states with a supportive environment

for access to abortion care.47 Additional restrictions on

access to medication abortion threaten to further increase

the maternal mortality rate—an issue disproportionately

affecting Black women—and exacerbate an already grave

Black maternal health crisis.48

The Fifth Circuit’s decision will further restrict

abortion access, exacerbating the harmful effects of

existing limitations. Just as Dobbs upended abortion

access and led to chaos following the decision, a disruption

of mifepristone’s current conditions of use will further

narrow options for care.

46. See id.

47. See The State of Reproductive Health in the United States:

The End of Roe and the Perilous Road Ahead for Women in the

Dobbs Era 7, 15 n.9, Gender Equity Pol’y Inst. (Jan. 19, 2023), https://

thegepi.org/wp-content/uploads/2023/06/GEPI-State-of-ReproHealth-Report-US.pdf.

48. See id. at 9-10 (Conclusion).

21

CONCLUSION

For the foregoing reasons, Amici Members of

Congress respectfully request that this Court reverse

the Fifth Circuit’s affirmance of the district court’s stay

of FDA’s 2016 and 2021 actions.

Respectfully submitted,

William A. McConagha

Boris Bershteyn

Jennifer L. Bragg

Counsel of Record

Keyawna Griffith

Eryn M. Hughes

Skadden, A rps, Slate,

Yunyi Chen

Meagher & Flom LLP Skadden, A rps, Slate,

1440 New York Avenue NW Meagher & Flom LLP

Washington, DC 20005

One Manhattan West

New York, New York 10001

(212) 735-3000

boris.bershteyn@skadden.com

Counsel for Amici Curiae

January 30, 2024

APPENDIX

i

TABLE OF APPENDICES

Page

APPENDIX A — LIST OF AMICI CURIAE . . . . . . . 1a

1a

Appendix A —Appendix

List ofAAmici Curiae

MEMBERS OF CONGRESS

50 United States Senators

Majority Leader Charles E. Schumer

Sen. Patty Murray

Sen. Bernard Sanders

Sen. Richard J. Durbin

Sen. Richard Blumenthal

Sen. Tammy Baldwin

Sen. Michael F. Bennet

Sen. Cory A. Booker

Sen. Sherrod Brown

Sen. Laphonza Butler

Sen. Maria Cantwell

Sen. Benjamin L. Cardin

Sen. Thomas R. Carper

Sen. Robert P. Casey, Jr.

2a

Appendix A

Sen. Christopher A. Coons

Sen. Catherine Cortez Masto

Sen. Tammy Duckworth

Sen. John Fetterman

Sen. Kirsten Gillibrand

Sen. Margaret Wood Hassan

Sen. Martin Heinrich

Sen. John W. Hickenlooper

Sen. Mazie K. Hirono

Sen. Tim Kaine

Sen. Mark Kelly

Sen. Angus S. King, Jr.

Sen. Amy Klobuchar

Sen. Ben Ray Luján

Sen. Edward J. Markey

Sen. Robert Menendez

3a

Appendix A

Sen. Jeffrey A. Merkley

Sen. Christopher S. Murphy

Sen. Jon Ossoff

Sen. Alex Padilla

Sen. Gary C. Peters

Sen. Jack Reed

Sen. Jacky Rosen

Sen. Brian Schatz

Sen. Jeanne Shaheen

Sen. Kyrsten Sinema

Sen. Tina Smith

Sen. Debbie Stabenow

Sen. Jon Tester

Sen. Chris Van Hollen

Sen. Mark Warner

Sen. Raphael Warnock

4a

Appendix A

Sen. Elizabeth Warren

Sen. Peter Welch

Sen. Sheldon Whitehouse

Sen. Ron Wyden

5a

Appendix A

213 Members of the

United States House of Representatives

Minority Leader Hakeem Jeffries

Rep. Katherine Clark

Rep. Frank Pallone, Jr.

Rep. Jerrold Nadler

Rep. Diana DeGette

Rep. Barbara Lee

Rep. Alma S. Adams, Ph.D.

Rep. Pete Aguilar

Rep. Colin Allred

Rep. Game Amo

Rep. Jake Auchincloss

Rep. Becca Balint

Rep. Nanette Diaz Barragán

Rep. Joyce Beatty

Rep. Ami Bera, M.D.

6a

Appendix A

Rep. Donald S. Beyer Jr.

Rep. Sanford Bishop

Rep. Earl Blumenauer

Rep. Lisa Blunt Rochester

Rep. Suzanne Bonamici

Rep. Jamaal Bowman, Ed.D.

Rep. Brendan Boyle

Rep. Shontel Brown

Rep. Julia Brownley

Rep. Nikki Budzinski

Rep. Cori Bush

Rep. Yadira Caraveo, M.D.

Rep. Salud Carbajal

Rep. Tony Cárdenas

Rep. André Carson

Rep. Troy A. Carter, Sr.

7a

Appendix A

Rep. Matt Cartwright

Rep. Greg Casar

Rep. Ed Case

Rep. Sean Casten

Rep. Kathy Castor

Rep. Joaquin Castro

Rep. Sheila Cherfilus-McCormick

Rep. Judy Chu

Rep. Yvette D. Clarke

Rep. Emanuel Cleaver

Rep. James E. Clyburn

Rep. Steve Cohen

Rep. Gerald E. Connolly

Rep. J. Luis Correa

Rep. Jim Costa

Rep. Joe Courtney

8a

Appendix A

Rep. Angie Craig

Rep. Jasmine Crockett

Rep. Jason Crow

Rep. Sharice L. Davids

Rep. Danny K. Davis

Rep. Donald G. Davis

Rep. Madeleine Dean

Rep. Rosa L. DeLauro

Rep. Suzan K. DelBene

Rep. Chris Deluzio

Rep. Mark DeSaulnier

Rep. Debbie Dingell

Rep. Lloyd Doggett

Rep. Veronica Escobar

Rep. Anna G. Eshoo

Rep. Adriano Espaillat

9a

Appendix A

Rep. Dwight Evans

Rep. Lizzie Fletcher

Rep. Bill Foster

Rep. Valerie Foushee

Rep. Lois Frankel

Rep. Maxwell Alejandro Frost

Rep. Ruben Gallego

Rep. John Garamendi

Rep. Jesús G. “Chuy” García

Rep. Robert Garcia

Rep. Sylvia Garcia

Rep. Marie Gluesenkamp Perez

Rep. Jared F. Golden

Rep. Dan Goldman

Rep. Jimmy Gomez

Rep. Josh Gottheimer

10a

Appendix A

Rep. Al Green

Rep. Raúl M. Grijalva

Rep. Josh Harder

Rep. Jahana Hayes

Rep. Brian Higgins

Rep. Jim Himes

Del. Eleanor Holmes Norton

Rep. Steven Horsford

Rep. Chrissy Houlahan

Rep. Steny H. Hoyer

Rep. Val Hoyle

Rep. Jared Huffman

Rep. Glenn Ivey

Rep. Sheila Jackson Lee

Rep. Sara Jacobs

Rep. Jeff Jackson

11a

Appendix A

Rep. Jonathan L. Jackson

Rep. Pramila Jayapal

Rep. Henry C. “Hank” Johnson, Jr.

Rep. Sydney Kamlager-Dove

Rep. Marcy Kaptur

Rep. William R. Keating

Rep. Robin L. Kelly

Rep. Ro Khanna

Rep. Daniel T. Kildee

Rep. Derek Kilmer

Rep. Andy Kim

Rep. Raja Krishnamoorthi

Rep. Ann McLane Kuster

Rep. Greg Landsman

Rep. John B. Larson

Rep. Susie Lee

12a

Appendix A

Rep. Summer Lee

Rep. Teresa Leger Fernandez

Rep. Mike Levin

Rep. Ted Lieu

Rep. Zoe Lofgren

Rep. Stephen Lynch

Rep. Seth Magaziner

Rep. Kathy Manning

Rep. Doris Matsui

Rep. Lucy McBath

Rep. Jennifer McClellan

Rep. Betty McCollum

Rep. Morgan McGarvey

Rep. James P. McGovern

Rep. Gregory Meeks

Rep. Robert Menendez

13a

Appendix A

Rep. Grace Meng

Rep. Kweisi Mfume

Rep. Gwen Moore

Rep. Joseph Morelle

Rep. Jared Moskowitz

Rep. Seth Moulton

Rep. Frank Mrvan

Rep. Kevin Mullin

Rep. Grace F. Napolitano

Rep. Richard E. Neal

Rep. Joe Neguse

Rep. Wiley Nickel

Rep. Donald Norcross

Rep. Alexandria Ocasio-Cortez

Rep. Ilhan Omar

Rep. Jimmy Panetta

14a

Appendix A

Rep. Chris Pappas

Rep. Bill Pascrell

Rep. Donald M. Payne Jr.

Rep. Nancy Pelosi

Rep. Mary Peltola

Rep. Scott Peters

Rep. Brittany Pettersen

Rep. Dean Phillips

Rep. Chellie Pingree

Del. Stacey E. Plaskett

Rep. Mark Pocan

Rep. Katie Porter

Rep. Ayanna Pressley

Rep. Mike Quigley

Rep. Delia Ramirez

Rep. Jamie Raskin

15a

Appendix A

Rep. Deborah K. Ross

Rep. Raul Ruiz, M.D.

Rep. C.A. Dutch Ruppersberger

Rep. Patrick Ryan

Del. Gregorio Kilili Camacho Sablan

Rep. Andrea Salinas

Rep. Linda T. Sánchez

Rep. John P. Sarbanes

Rep. Mary Gay Scanlon

Rep. Jan Schakowsky

Rep. Adam Schiff

Rep. Bradley S. Schneider

Rep. Hillary Scholten

Rep. Kim Schrier, M.D.

Rep. David Scott

Rep. Robert C. “Bobby” Scott

16a

Appendix A

Rep. Terri A. Sewell

Rep. Brad Sherman

Rep. Mikie Sherrill

Rep. Elissa Slotkin

Rep. Adam Smith

Rep. Eric Sorensen

Rep. Darren Soto

Rep. Abigail Spanberger

Rep. Melanie Stansbury

Rep. Greg Stanton

Rep. Haley Stevens

Rep. Marilyn Strickland

Rep. Eric Swalwell

Rep. Emilia Sykes

Rep. Mark Takano

Rep. Shri Thanedar

17a

Appendix A

Rep. Bennie Thompson

Rep. Mike Thompson

Rep. Dina Titus

Rep. Rashida Tlaib

Rep. Jill Tokuda

Rep. Paul Tonko

Rep. Ritchie Torres

Rep. Norma J. Torres

Rep. Lori Trahan

Rep. David Trone

Rep. Lauren Underwood

Rep. Juan Vargas

Rep. Gabe Vasquez

Rep. Marc A. Veasey

Rep. Nydia M. Velázquez

Rep. Debbie Wasserman Schultz

18a

Appendix A

Rep. Maxine Waters

Rep. Bonnie Watson Coleman

Rep. Jennifer Wexton

Rep. Susan Wild

Rep. Nikema Williams

Rep. Frederica S. Wilson