Amicus Curiae Brief — Danco Laboratories, LLC, Applicant v. Louisiana, et al.

Nos. 25A1207, 25A1208

IN THE

Supreme Court of the United States

DANCO LABORATORIES, L.L.C., et al.

Applicant,

v.

STATE OF LOUISIANA, et al.,

Respondents.

GENBIOPRO, INC., et al.

Applicant,

v.

STATE OF LOUISIANA, et al.,

Respondents.

BRIEF FOR 259 MEMBERS OF CONGRESS AS AMICI CURIAE IN

SUPPORT OF APPLICATIONS BY DANCO AND GENBIOPRO TO STAY OR

VACATE THE FIFTH CIRCUIT’S STAY PENDING APPEAL

ABBY F. RUDZIN

Counsel of Record

CAMILA TUCKER

O’MELVENY & MYERS

LLP

1301 Avenue of the

Americas

New York, NY 10019

202-326-2061

arudzin@omm.com

NANCY L. SCHROEDER

O’MELVENY & MYERS

LLP

400 S. Hope Street

Los Angeles, CA 90071

213-430-6000

nschroeder@omm.com

SAMANTHA GALVÁN

O’MELVENY & MYERS

LLP

1625 Eye Street, NW

Washington, D.C. 20006

202-383-5300

sgalvan@omm.com

MICHAEL MCMILLIN

HARMUKH SINGH

O’MELVENY & MYERS

LLP

401 West 4th Street

Austin, TX 78701

737-261-8600

mmcmillin@omm.com

KEITH OSENTOSKI

O’MELVENY & MYERS

LLP

1999 Avenue of the Stars

Los Angeles, CA 900767

310-553-6700

kosentoski@omm.com

Counsel for Lead Amici Curiae

A complete list of the 47 United States Senators and the 212 Members

of the United States House of Representatives participating as amici

curiae is provided as an appendix. The Lead Amici Curiae are:

Sen. Charles E. Schumer

Sen. Patty Murray

Sen. Richard J. Durbin

Sen. Ron Wyden

Rep. Hakeem Jeffries

Rep. Katherine Clark

Rep. Frank Pallone, Jr.

Rep. Jamie Raskin

Rep. Diana DeGette

Rep. Ayanna Pressley

TABLE OF CONTENTS

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

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

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

I.

II.

III.

FDA’S DECISION TO ELIMINATE THE IN-PERSON

DISPENSING REQUIREMENT WAS BASED ON THE HIGHQUALITY SCIENTIFIC EVIDENCE THE ACT REQUIRES. .............. 4

A.

Through the Act, Congress directed that FDA’s decisions

be science- and evidence-based. .................................................... 4

B.

FDA’s repeated determination that mifepristone is safe is

supported by peer-reviewed research and years of real

patient experience. ........................................................................ 7

C.

FDA’s decision to eliminate the in-person dispensing

requirement is supported by substantial evidence that

mifepristone remains safe when dispensed by mail or

pharmacy. ...................................................................................... 9

THE ACT REQUIRES THAT A REMS NOT UNDULY

BURDEN PATIENT ACCESS. .............................................................. 13

A.

In removing the in-person dispensing requirement, FDA

complied with its congressional mandate not to unduly

burden patient access. ................................................................. 13

B.

The in-person dispensing requirement unduly burdens

patient access to mifepristone. .................................................... 14

C.

This Court should not permit Louisiana to unduly burden

nationwide patient access to medication. ................................... 18

LOUISIANA’S CRITICISM OF FDA’S DECISION TO

ELIMINATE THE IN-PERSON DISPENSING REQUIREMENT

LACKS SCIENTIFIC MERIT AND IS THEREFORE

FORECLOSED BY THE ACT. .............................................................. 20

A.

The Act requires FDA to make decisions based on science,

not flawed, ideological publications. ........................................... 20

B.

FDA’s use of FAERS data was appropriate under the Act. ....... 21

C.

One state should not be able to hijack the science-based

REMS system Congress designed to force its policy

choices onto others. ...................................................................... 23

CONCLUSION............................................................................................................. 25

APPENDIX: List of Amici Curiae .............................................................................. 1a

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TABLE OF CITED AUTHORITIES

Cases

Am. Acad. of Pediatrics v. Kennedy,

2026 WL 733828 (D. Mass. Mar. 16, 2026) ............................................................. 13

Am. Coll. of Obstetricians & Gynecologists v. FDA,

472 F. Supp. 3d 183 (D. Md. 2020), order clarified sub nom.,

2020 WL 8167535 (D. Md. Aug. 19, 2020)................................................................. 9

Benisek v. Lamone,

585 U.S. 155 (2018) .................................................................................................. 19

Dobbs v. Jackson Women’s Health Org.,

597 U.S. 215 (2022) .............................................................................................. 3, 24

Farmland Dairies v. Barber,

65 N.Y.2d 51 (1985) .................................................................................................. 25

FCC v. Prometheus Radio Project,

592 U.S. 414 (2021) .................................................................................................. 22

Purcell v. Kennedy,

2025 WL 3101785 (D. Haw. Oct. 30, 2025) ....................................................... 13, 15

S. Bay United Pentecostal Church v. Newsom,

590 U.S. 965 (2020) .................................................................................................. 20

Washington v. FDA,

108 F.4th 1163 (9th Cir. 2024) .......................................................................... 13, 14

Statutes

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

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

21 U.S.C. § 355(d) .................................................................................................. 5, 6, 8

21 U.S.C. § 355-1(a) ................................................................................................. 6, 24

21 U.S.C. § 355-1(b) ....................................................................................................... 6

21 U.S.C. § 355-1(f)(1).................................................................................................... 6

21 U.S.C. § 355-1(f)(2).......................................................................... 14, 15, 16, 17, 20

21 U.S.C. § 355-1(f)(5).................................................................................................. 14

21 U.S.C. § 355-1(g)(2) ................................................................................................... 7

21 U.S.C. § 355-1(g)(3) ................................................................................................... 7

21 U.S.C. § 355-1(g)(4) ............................................................................................. 7, 11

21 U.S.C. § 393(b) .......................................................................................................... 5

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Regulations

21 C.F.R. § 314.105 ........................................................................................................ 5

21 C.F.R. § 314.50 .......................................................................................................... 5

21 C.F.R. § 314.520 ........................................................................................................ 8

21 C.F.R. § 314.80 ........................................................................................................ 22

21 C.F.R. § 314.81 ........................................................................................................ 22

Other Authorities

2011 REMS for NDA 020687 Mifeprex (mifepristone) Tablets, 200 mg,

(June 2011) ................................................................................................................. 8

Alexa Delbosc & Rahman Shafi, What Do We Know About Immigrants’ Travel

Behaviour? A Systematic Literature Review and Proposed Conceptual

Framework, 43 Transport Revs. 914 (2023) ............................................................ 16

Am. College of Obstetricians and Gynecologists, Medication Abortion Up to 70

Days of Gestation, Practice Bulletin No. 225 (Oct. 2020) ....................................... 18

Analysis of Medication Abortion Risk and the FDA Report “Mifepristone US

Post-Marketing Adverse Events Summary Through 12/31/2024”,

Advancing New Standards in Reproductive Health (May 15, 2025) ....................... 9

Andrés Argüello & Andrea Ducas, The Big, ‘Beautiful’ Bill’s Health Care Cuts

Would Drive Up Uncompensated Care and Threaten Vulnerable Hospitals,

Center for American Progress, https://www.americanprogress.org/article/

the-big-beautiful-bills-health-care-cuts-would-drive-up-uncompensatedcare-and-threaten-vulnerable-hospitals/................................................................. 18

Ann P. Bartel et al., Racial and Ethnic Disparities in Access to and Use of

Paid Family and Medical Leave: Evidence from Four Nationally

Representative Datasets, U.S. Bureau of Labor Statistics (Jan. 2019) .................. 17

Caitlin Myers et al., Abortion Access Dashboard,

https://experience.arcgis.com/experience/6e360741bfd84db79d5db774a1147

815 (last updated Mar. 16, 2026)............................................................................. 15

Citizen Petition from American College of Obstetricians and Gynecologists,

https://www.regulations.gov/document/FDA-2025-P-0377-0001 ............................. 9

Development & Approval Process: Drugs, FDA (Aug. 8, 2022),

https://www.fda.gov/drugs/development-approval-process-drugs ........................ 5, 7

FDA Adverse Event Monitoring System (AEMS), FDA (Mar. 11, 2026),

https://www.fda.gov/drugs/surveillance/fda-adverse-event-monitoringsystem-aems ............................................................................................................. 21

FDA Ctr. For Drug Eval. & Rsch., Application No. 020687Orig1s020

Summary Review (Jan. 3, 2023) .............................................................................. 11

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FDA Letter re: In-Person Dispensing Requirement in Mifepristone REMS

Program During the COVID-19 Public Health Emergency Reference:

NDA # 020687 (Apr. 12, 2021) ................................................................................. 10

FDA Letter regarding Citizen Petition Denial (Mar. 29, 2016) ................................. 11

FDA REMS Modification Rationale Review, NDA No. 020687 & ANDA

No. 91178 (Dec. 16, 2021) .................................................................................. 10, 11

FDA REMS Modification Review, NDA No. 020687/S-020 (Mar. 29, 2016) ........... 8, 9

Jason M. Lindo et al., How Far Is Too Far? New Evidence on Abortion Clinic

Closures, Access, and Abortions, 55 J. Human Resources 1137 (2020) ................. 15

Jillian McKoy, Travel Times to Abortion Facilities Have Increased Drastically

in Post-Roe Era, Bos. Univ. Sch. of Pub. Health (Nov. 23, 2022) ........................... 16

Laura Schummers et al., Abortion Safety and Use with Normally Prescribed

Mifepristone in Canada, 386 New Eng. J. Med. 57 (2022) ....................................... 9

Lauren J. Ralph et al., Comparison of No-Test Telehealth and In-Person

Medication Abortion, 332 JAMA 898 (2024) ........................................................... 12

Lauren Van Schilfgaarde et al., Tribal Nations and Abortion Access: A Path

Forward, 46 Harv. J.L. & Gender 1 (2023) ............................................................. 16

Leonardo Cely-Andrade et al., Telemedicine for the Provision of Medication

Abortion to Pregnant People at Up to Twelve Weeks of Pregnancy: A

Systematic Literature Review And Meta-Analysis, 21 Reproductive Health

136 (2024) ................................................................................................................. 12

Letter from Dr. Graham Chelius of The Society of Family Planning to FDA,

(Sept. 29, 2021) ......................................................................................................... 16

Liza Fuentes & Jenna Jerman, Distance Traveled for Abortion in the United

States and Reasons for Clinic Choice, 28 J. Women’s Health 1623 (2019) ............ 16

M. Antonia Biggs et al., Access to Reproductive Health Services Among People

with Disabilities, JAMA Network Open, Vol. 6, No. 11 (Nov. 29, 2023) ................ 15

Margot Sanger-Katz, et al., Who Gets Abortions in America?, New York Times

(Dec. 14, 2021), https://www.nytimes.com/interactive/2021/12/14/

upshot/who-gets-abortions-in-america.html ........................................................... 17

Mifepristone U.S. Post-Marketing Adverse Events Summary through

12/31/2024, FDA (2025), https://fda.gov/media/185245/download ................... 9, 11

Nat’l P’ship for Women & Families, Paid Sick Days Enhance Women’s

Abortion Access and Economic Security 3 (May 2019) ........................................... 17

New Drug Application (NDA), FDA (Jan. 21, 2022),

https://www.fda.gov/drugs/types-applications/new-drug-application-nda............... 5

- iv -

Office Memorandum to Population Council (Sept. 28, 2000), FDA,

https://wayback.archive-it.org/7993/20161024033545/http://www.fda.gov/

downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatient

sandProviders/ucm111366.pdf................................................................................... 8

Questions and Answers on Mifepristone for Medical Termination of Pregnancy

Through Ten Weeks Gestation, FDA (Feb. 8, 2026), https://www.fda.gov/

drugs/postmarket-drug-safety-information-patients-andproviders/questions-and-answers-mifepristone-medical-terminationpregnancy-through-ten-weeks-gestation................................................................... 8

Reproductive Health Researches Comment Letter to FDA, UCLA Law (Aug.

27, 2025), https://law.ucla.edu/reproductive-health-researchers-commentletter-fda ................................................................................................................... 20

Risk Evaluation and Mitigation Strategy (REMS) Single Shared System for

Mifepristone 200 mg, FDA (Jan. 2023), https://www.accessdata.fda.gov/

drugsatfda_docs/rems/Mifepristone_2023_01_03_REMS_Full.pdf ........................ 11

Selena Simmons-Duffin & Shelly Cheng, How Many Miles Do You Have to

Travel to Get Abortion Care? One Professor Maps It, NPR (June 21, 2023) .......... 15

U.S. Gov’t Accountability Off., GAO-08-751, FDA Approval and Oversight of

the Drug Mifeprex (2008)....................................................................................... 7, 8

Ushma D. Upadhay, et al., Outcomes and Safety of History-Based Screening

for Medication Abortion A Retrospective Multicenter Cohort Study, 182

JAMA 482 (2022)........................................................................................................ 9

Ushma D. Upadhyay et al., Effectiveness and Safety of Telehealth Medication

Abortion in the United States, 30 Nature Med. 1191 (2024) .................................. 12

What is a Serious Adverse Event?, FDA (May 18, 2023),

https://www.fda.gov/safety/reporting-serious-problems-fda/what-seriousadverse-event ........................................................................................................... 22

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INTEREST OF AMICI CURIAE

Amici curiae are 259 Members of Congress—47 United States Senators and

212 Members of the United States House of Representatives. 1 Amici have a special

interest in both upholding the Constitution’s separation of powers—including by

ensuring that federal administrative agencies faithfully exercise the authorities

Congress delegated to them in accordance with statutory limits—and protecting the

physical health and safety of their constituents.

Amici believe that this Court should grant an emergency stay of or vacate the

Fifth Circuit’s Order, which requires the nationwide reinstatement of the in-person

dispensing requirement for mifepristone that has not been enforced in more than five

years. The Fifth Circuit’s Order should be stayed because the relief it granted has no

basis in law, threatens the congressionally-mandated evidence-based process for

drug-regulatory decisions, and poses a serious health risk to pregnant individuals.

Mifepristone, which patients have used for more than 25 years as part of the most

common and recommended regimen for medication abortion, should not be made

more difficult to access across the entire country. The Fifth Circuit’s decision to do

so now—before the merits have even been litigated—is particularly egregious.

Accordingly, Amici respectfully urge this Court to grant an emergency stay of

or vacate the Fifth Circuit’s erroneous order.

1 The complete list of amici is located in the Appendix. Under 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 amicus curiae, their members, or their counsel contributed money that

was intended to finance the preparation or submission of this brief.

-1-

SUMMARY OF ARGUMENT

The regulatory scheme Congress designed aims to ensure patient access to safe

and effective medications in the United States by requiring expert-led, evidencebased regulatory decisions. In 1938, Congress enacted the Federal Food, Drug, and

Cosmetic Act (the “Act”), which established the standards for the modern regulation

of our drug supply and designated the U.S. Food and Drug Administration (“FDA”)

as the expert federal agency responsible for regulating access to new drugs. While

Congress permitted judicial review of FDA’s approval decisions, it did not invite

federal courts to short-circuit the statutorily mandated expert process, weigh

scientific evidence in the first instance, or impose sweeping burdens on access to FDAapproved medications, as the Fifth Circuit’s Order does.

FDA’s decision to eliminate the in-person dispensing requirement for

mifepristone complied with Congress’s mandate that any restrictions FDA imposes

on access to an approved medication must (a) be rooted in sound scientific evidence

and (b) not unduly burden patient access. For more than a quarter century, FDA has

repeatedly and consistently affirmed that mifepristone is safe. Over seven million

patients in the U.S. have safely used mifepristone. And as with other drugs, FDA

continues to monitor the post-marketing safety data on mifepristone—data

confirming that mifepristone is safe without regard to how it is dispensed.

FDA’s decision to lift the in-person dispensing requirement was an evidencebased exercise of its congressionally-mandated responsibility to avoid unnecessary

burdens on patient access to safe and effective drugs. Louisiana’s assertion that FDA

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was motivated by a desire to undermine state abortion restrictions after Dobbs v.

Jackson Women’s Health Organization, 597 U.S. 215 (2022), is baseless and belied by

the timeline: The in-person dispensing requirement was first suspended by court

order in 2020 in the context of the COVID-19 pandemic. In April 2021, based on realworld evidence of mifepristone’s continued safe use during the injunction period, as

well as scientific literature further confirming the medication’s safety when

dispensed by mail, FDA suspended the in-person requirement for the duration of the

COVID-19 Public Health Emergency. In December 2021, based on its continued

monitoring of mifepristone’s safety under the COVID-19 nonenforcement policy, and

consistent with additional peer-reviewed studies, FDA determined that it would

permanently lift this unnecessary and burdensome requirement.

All of these

regulatory decisions occurred well before Dobbs came down—and were grounded in

the new body of evidence confirming mifepristone’s safety when dispensed by mail

that arose during the pandemic. Louisiana’s chronological error cannot justify its

attempt to reimpose an unnecessary burden on all of America, even in sovereign

states that protect abortion.

Decades after FDA’s initial approval of mifepristone and years after the inperson dispensing requirement was eliminated, the Fifth Circuit on an “emergency”

basis ordered FDA to re-impose this onerous nationwide restriction on all Americans.

Allowing that decision to remain in place undermines the science-based statutory

framework Congress commands and threatens patient access to reproductive health

care. As has been well publicized, many U.S. residents in states where abortion is

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legal live far from any reproductive health care provider. Reinstating an in-person

dispensing requirement for mifepristone exacerbates an already significant

reproductive health crisis by limiting access to the most common method of early

abortion.

Preserving evidence-based access to mifepristone, including when dispensed

by mail or retail pharmacy, is necessary to mitigate the imminent harm facing

members of the public. Women deserve access to mifepristone for reproductive health

care, and all Americans deserve integrity in the congressionally-mandated, evidencebased process for FDA’s drug regulatory decisions. Congress commanded that FDA’s

drug regulatory decisions be rooted in sound scientific evidence and prioritize patient

access to essential medications, and Amici call on this Court to give due weight to

Congress’s mandate.

ARGUMENT

I.

FDA’S DECISION TO ELIMINATE THE IN-PERSON DISPENSING

REQUIREMENT WAS BASED ON THE HIGH-QUALITY SCIENTIFIC

EVIDENCE THE ACT REQUIRES.

A.

Through the Act, Congress directed that FDA’s decisions be

science- and evidence-based.

Congress required FDA to review new drugs and regulate existing drugs in

accordance with established scientific principles. The centrality of sound science is

evident throughout the Act, including in FDA’s mission statement: To “promote the

public health by promptly and efficiently reviewing clinical research and taking

appropriate action on the marketing of regulated products” and ensuring that “drugs

-4-

are safe and effective.” 2 The Act directs FDA to carry out this mission by “consult[ing]

with experts in science, medicine, and public health” and collaborating with “sciencebased Federal agencies.” 3 In short, Congress designed the Act to ensure that drug

regulatory decisions are based on robust evidence.

The Act makes clear that science- and evidence-based determinations are

requisite elements of FDA’s complex drug approval and regulation processes. An

approval of a New Drug Application, for example, requires a team of FDA experts

with specialized scientific expertise—including physicians, statisticians, chemists,

pharmacologists, and other scientists—to review “full reports of investigations” and

determine that there is “substantial evidence” of safety and efficacy. 4 And Congress

defined “substantial evidence” 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.” 5 When

science-based standards provide substantial evidence of a drug’s safety and efficacy,

2 21 U.S.C. §§ 393(b)(1)-(2).

3 21 U.S.C. §§ 393(b)(4), (c).

4 21 U.S.C. § 355(d); see also 21 C.F.R. §§ 314.50, 314.105(c); Development & Approval Process:

Drugs, FDA (Aug. 8, 2022), https://www.fda.gov/drugs/development-approval-process-drugs; New

Drug Application (NDA), FDA (Jan. 21, 2022), https://www.fda.gov/drugs/types-applications/newdrug-application-nda; 21 U.S.C. § 355(b)(5)(A) (noting that all individuals who review new drug

applications should have “technical excellence, lack of bias and conflict of interest, and knowledge of

regulatory and scientific standards”).

5 21 U.S.C. § 355(d).

-5-

and none of the limited other grounds under the statute exist to refuse approval, FDA

“shall” approve it. 6

Congress requires that any decision by FDA to impose a Risk Evaluation and

Mitigation Strategy (“REMS”) must also follow the science. Congress authorized FDA

to impose REMS restrictions only after a determination that such restrictions are

“necessary to ensure that the benefits of the drug outweigh the risks of the drug,”

considering specified, evidence-based factors including the seriousness of the

condition to be treated, the expected benefit of the drug, and the seriousness of any

known or potential adverse events related to the drug. 7 A post-approval REMS is

authorized only if there is “new safety information” or a “signal of a serious risk,”

established by “scientific data,” such as “information derived from a clinical trial,” or

“peer-reviewed biomedical literature.” 8 And Congress limited FDA’s authority to

impose “elements to assure safe use,” the most onerous kind of REMS—such as the

in-person dispensing requirement (“IPDR”) at issue here—to only those drugs for

which it is so necessary that the drug’s approval must otherwise be “withdrawn.” 9

Even after a REMS has been imposed, FDA may—and in some circumstances

must—continually assess the REMS strategies and goals and modify the REMS if

The statute provides only seven narrow grounds for refusing approval: five focus on lack

of sufficient safety or efficacy evidence, one concerns patent information, and one concerns misleading

labeling.

6 See id.

7 21 U.S.C. § 355-1(a)(1) (describing initial approval REMS); 21 U.S.C. § 355-1(a)(2) (describing

post-approval REMS).

8 21 U.S.C. § 355-1(b)(3) (defining “new safety information”); 21 U.S.C. § 355-1(b)(6) (defining

what evidence is permissible to show a “signal of a serious risk”).

9 21 U.S.C. 355-1(f)(1)(A).

-6-

necessary. 10 The statutory requirements include that, in assessing a REMS, FDA

must evaluate whether each REMS and each REMS element continues to meet its

goals. 11

The Act also specifically contemplates modification of a drug’s REMS,

including removal of specific elements such as an IPDR, in order to, among other

things, “minimize the burden on the health care delivery system of complying with

the strategy.” 12

In short, Congress has mandated a rigorous, science-based system for drug

approvals and regulation. Neither FDA nor the federal courts have authority to

impose restrictions that are not grounded in sound scientific evidence.

B.

FDA’s repeated determination that mifepristone is safe is

supported by peer-reviewed research and years of real patient

experience.

Substantial evidence establishes that mifepristone is a safe and effective drug.

FDA first approved mifepristone in September 2000, based on peer-reviewed research

and extensive clinical trials showing that mifepristone is safe and effective and that

its health benefits outweighed its risks. 13 That approval came after a four-year

review process with three separate clinical trials involving more than 4,000 patients

and a unanimous advisory committee vote in favor of approval. 14 As FDA put it, its

10 21 U.S.C. § 355-1(g)(2).

11 21 U.S.C. § 355-1(g)(3).

12 21 U.S.C. § 355-1(g)(4).

13 See 2000 FDA Approval Letter, Compl. Ex. 24, ECF No. 1-24; see also Development & Approval

Process: Drugs, FDA (Aug. 8, 2022), https://www.fda.gov/drugs/development-approval-process-drugs;

U.S. Gov’t Accountability Off., GAO-08-751, FDA Approval and Oversight of the Drug Mifeprex at 15–

16, 26 (2008) [hereinafter, “GAO-08-751”].

14 See Office Memorandum to Population Council (Sept. 28, 2000), FDA, https://wayback.archive-

it.org/7993/20161024033545/http://www.fda.gov/downloads/Drugs/DrugSafety/

-7-

initial approval of mifepristone was “based on a thorough and comprehensive review

of the scientific evidence presented” that found mifepristone was “safe and effective

for its indicated use.” 15 FDA was required to approve it. 16

FDA initially approved mifepristone with certain restrictions. 17 After fifteen

years of data from millions of patient uses showing that serious adverse events are

“extremely

rare”

and additional

scientific evidence

further demonstrating

mifepristone’s safety, FDA began, consistent with the Act’s requirements, to

eliminate some unnecessary REMS restrictions. Specifically, in 2016, FDA modified

the REMS to permit qualified non-physician practitioners to become certified

prescribers and to remove a REMS requirement that prescribers report non-fatal

adverse events potentially associated with mifepristone. 18

In making these modifications, FDA’s scientific and medical reviewers

examined numerous articles “published widely in peer-reviewed medical journals,”

independent clinical studies on “well over 30,000 patients,” and adverse event

reporting across more than 2.5 million patient uses in the U.S. between 2000 and

PostmarketDrugSafetyInformationforPatientsandProviders/ucm111366.pdf; see also GAO-08-751 at

15–16, 26.

15 Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten

Weeks Gestation, FDA (Feb. 8, 2026), https://www.fda.gov/drugs/postmarket-drug-safety-informationpatients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancythrough-ten-weeks-gestation.

16 See 21 U.S.C. §§ 355(d) and 355(c)(1) (in the absence of a specified ground for denial, FDA

“shall” approve a drug application).

These restrictions, original adopted under Subpart H (21 C.F.R. § 314.520), were later

incorporated into FDA’s 2011 REMS. See 2011 REMS for NDA 020687 Mifeprex (mifepristone)

Tablets, 200 mg, (June 2011).

17

18 FDA REMS Modification Review, NDA No. 020687/S-020, at 6, 8, 88 (Mar. 29, 2016).

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2016. 19

FDA relied on mifepristone’s stable risk profile over fifteen years of

mandatory serious-adverse-event prescriber reporting to conclude that such

reporting was no longer necessary.

FDA explained that “the safety profile of

[mifepristone] is well-characterized,” “no new safety concerns” had arisen in recent

years, and “the known serious risks occur rarely.” 20 That decision was supported by

the weight of scientific evidence, as the Act requires. 21

C.

FDA’s decision to eliminate the in-person dispensing

requirement is supported by substantial evidence that

mifepristone remains safe when dispensed by mail or pharmacy.

The volumes of high-quality research and real-world data amassed over the

past 25 years establish that mifepristone is a safe treatment whether it is dispensed

in person or not. 22 Decades of reliable science and data confirming mifepristone’s

safety and efficacy supported FDA’s 2021 and 2023 decisions to first suspend and

then permanently eliminate the IPDR.

A federal court suspended enforcement of the IPDR from July 2020 through

19 Id. at 13, 62, 84.

20 Id. at 8.

See Citizen Petition from American College of Obstetricians and Gynecologists,

https://www.regulations.gov/document/FDA-2025-P-0377-0001 (explaining evidence demonstrating

safety of mifepristone).

21

22 See, e.g., NDA No. 020687 & ANDA No. 091178, Mifepristone U.S. Post-Marketing Adverse

Events Summary through 12/31/2024, FDA (2025), https://fda.gov/media/185245/download; Laura

Schummers et al., Abortion Safety and Use with Normally Prescribed Mifepristone in Canada, 386

New Eng. J. Med. 57, 57 (2022); Analysis of Medication Abortion Risk and the FDA Report

“Mifepristone US Post-Marketing Adverse Events Summary Through 12/31/2024”, Advancing New

Standards in Reproductive Health (May 15, 2025); Ushma D. Upadhay, et al., Outcomes and Safety of

History-Based Screening for Medication Abortion A Retrospective Multicenter Cohort Study, 182 JAMA

482, 487 (2022).

-9-

January 2021, due to the COVID-19 pandemic. 23 In April 2021, based in part on realworld experience of mifepristone’s continued safety while that injunction was in

place, and consistent with FDA’s obligation under the Act to consider burdens on

patient access, FDA announced that it would suspend enforcement of mifepristone’s

IPDR for the duration of the pandemic. 24 This decision was based on substantial

evidence, including adverse-event and clinical outcome data showing that

mifepristone remained safe without the IPDR. 25

In December 2021, after reviewing additional published literature, safety

information, and adverse-event data, FDA announced that it would permanently

remove the IPDR. 26

Consistent with the Act, this decision was based on large

amounts of high-quality scientific data, including REMS assessment data; data from

the FDA Adverse Event Reporting System (“FAERS”) during the non-enforcement

period, which showed no increase in adverse events; and numerous published studies

encompassing tens of thousands of patients that assessed safety outcomes with

23 Am. Coll. of Obstetricians & Gynecologists v. FDA, 472 F. Supp. 3d 183, 218 (D. Md. 2020), order

clarified sub nom., 2020 WL 8167535 (D. Md. Aug. 19, 2020) (relying on, inter alia, a “comprehensive

report on the safety of abortion by the National Academies of Sciences, Engineering, and Medicine, an

independent, nonpartisan group, which found that there is no evidence that the dispensing or taking

of [medication abortion pills] requires the physical presence of a clinician.”) (internal quotation marks

omitted).

24 FDA Letter re: In-Person Dispensing Requirement in Mifepristone REMS Program During the

COVID-19 Public Health Emergency Reference: NDA # 020687 (Apr. 12, 2021), Ex. 1 to Brief of Former

and Acting Commissioners of the U.S. Food and Drug Admin. as Amici Curiae Opposing Plaintiffs’

Motion For Preliminary Injunction, ECF No. 208-1.

25 Id.

26 See FDA REMS Modification Rationale Review, NDA No. 020687 & ANDA No. 91178, at 4 (Dec.

16, 2021) (noting that FDA would remove the IPDR following FDA’s “comprehensive review” of

scientific data, including published literature, safety information collected during pandemic, one-year

REMS assessment report of the Mifepristone REMS Program, adverse event data, and information

provided by advocacy groups, individuals, and applicants).

- 10 -

different mifepristone distribution systems, including at pharmacies and by mail. 27

This body of scientific data “generally support[ed] a conclusion that dispensing by

mail is safe” and that “mifepristone will remain safe, and efficacy will be maintained

if the [IPDR] is removed.” 28

In January 2023, FDA amended the mifepristone REMS to formally remove

the IPDR and add a new pharmacy certification requirement. 29 Decades of data

continue to confirm mifepristone’s safety and the rarity of serious complications. A

recent FDA summary report, for example, found that among the patients who used

mifepristone in the United States between 2000 and 2024, only 0.008% experienced

blood loss requiring transfusions, 0.006% experienced an infection, and 0.001%

experienced a severe infection. 30

That same report shows that mifepristone-

associated deaths are incredibly low (0.00048%), and FDA has repeatedly made clear

that there is no evidence showing that mifepristone caused any of these deaths. 31

27 Id. at 10.

28 Id. at 23, 39.

29 FDA Ctr. For Drug Eval. & Rsch., Application No. 020687Orig1s020 Summary Review (Jan. 3,

2023), Compl. Ex. 50, ECF No. 1-50; see also Risk Evaluation and Mitigation Strategy (REMS) Single

Shared System for Mifepristone 200 mg, FDA (Jan. 2023), https://www.accessdata.fda.gov/

drugsatfda_docs/rems/Mifepristone_2023_01_03_REMS_Full.pdf.

The January 2023 REMS

modifications followed additional statutorily-required consultation with the drug sponsors. See 21

U.S.C. § 355-1(g)(4)(B).

30 Mifepristone U.S. Post-Marketing Adverse Events Summary, supra n.22.

It is important to note

that this report does not purport to establish a causal link between the recorded deaths and

mifepristone, explaining that fatalities were included in the summary report “regardless of causal

attribution to mifepristone.” Id.

31 See, e.g., FDA Letter Regarding Citizen Petition Denial, at 25-26 n.69 (Mar. 29, 2016),

https://www.regulations.gov/document/FDA-2002-P-0364-0002 (FDA concluding that the “critical risk

factor” for certain rare serious infections after mifepristone use “[wa]s pregnancy itself,” not

mifepristone); Mifepristone 2023 Labeling and Medication Guide, at 1, 14, 16 (mifepristone label

noting that “serious and sometimes fatal infections or bleeding” can arise whenever the pregnant

uterus is evacuated, whether by “miscarriage, surgical abortion, medical abortion, or childbirth”).

- 11 -

Indeed, “[n]o causal relationship between [mifepristone] and misoprostol use and an

increased risk of infection or death has been established.” 32

Nor is there any evidence that serious adverse events have increased since

FDA eliminated the IPDR.

To the contrary, research published since the 2023

decision continues to demonstrate that mifepristone is safe and effective without the

IPDR, including when it is prescribed via telemedicine and dispensed by mail or

pharmacy. 33 One study demonstrated that the rate of serious adverse events for

patients who obtained mifepristone by mail after a telemedicine visit, rather than in

person, is comparable and, for either method of dispensing, extremely low. 34

Numerous other studies on telemedicine medication abortions have confirmed that

safety and effectiveness rates are similar whether mifepristone was dispensed in

person or by mail. 35

Evidence of mifepristone’s safety and efficacy is so well established that a

federal court recently found in Purcell v. Kennedy that FDA acted arbitrarily and

32 Mifepristone 2023 Labeling and Medication Guide, at 2, 5.

33 Ushma D. Upadhyay et al., Effectiveness and Safety of Telehealth Medication Abortion in the

United States, 30 Nature Med. 1191, 1191 (2024) (“[M]edication abortion [delivered through

telemedicine care] is effective, safe, and comparable to published rates of in-person medication

abortion care.”).

34 See, e.g., Lauren J. Ralph et al., Comparison of No-Test Telehealth and In-Person Medication

Abortion, 332 JAMA 898, 902 (2024) (finding that the rate of serious adverse events for patients who

used telehealth and were sent mifepristone by mail was 1.5%, compared to 1.4% for the group with inperson pickup).

35 Upadhay, supra n.22 at 482-91 (finding “similarly high effectiveness and safety rates comparing

patients who received medications in-person vs by mail” and concluding that “mifepristone can be

dispensed safely either in person or by mail”); Leonardo Cely-Andrade et al., Telemedicine for the

Provision of Medication Abortion to Pregnant People at Up to Twelve Weeks of Pregnancy: A Systematic

Literature Review And Meta-Analysis, 21 Reproductive Health 136, at 18 (2024) (analyzing nearly two

dozen published articles and concluding that there are no significant safety differences between

telehealth and in-person abortion care).

- 12 -

capriciously in deciding to maintain other REMS requirements for mifepristone in

2023, even after lifting the IPDR.

In other words, the court found that FDA

continues to subject mifepristone today to more stringent REMS restrictions

than are justified by the scientific evidence. 36 The court recognized that a wealth of

high-quality evidence demonstrates that mifepristone remains extremely safe when

regulated as other prescription drugs are (i.e., without special REMS restrictions).

The court highlighted “statements from preeminent medical societies urging

elimination of the mifepristone REMS” and “a Canadian study examining the effects

of [Canada’s] removal of REMS-like restrictions on mifepristone,” which found that

adverse events and complications did not increase when Canada eliminated its

special restrictions on mifepristone altogether. 37

II.

THE ACT REQUIRES THAT A REMS NOT UNDULY BURDEN

PATIENT ACCESS.

A.

In removing the in-person dispensing requirement, FDA

complied with its congressional mandate not to unduly burden

patient access.

Through the Act, Congress commanded that FDA cannot impose the most

burdensome restrictions (such as an IPDR requirement) unless that restriction is

“commensurate with the specific serious risk and [does] not unduly burden patient

36 Purcell v. Kennedy, 2025 WL 3101785, at *23–27 (D. Haw. Oct. 30, 2025).

Notably, another

federal court has also recently recognized that the Department of Health and Human Services must

adhere to evidence-based science in public health decision-making. See Am. Acad. of Pediatrics v.

Kennedy, 2026 WL 733828, at *1–2 (D. Mass. Mar. 16, 2026) (staying revisions to childhood

immunization schedule because the decision-maker had disregarded scientific methods).

37 Purcell, 2025 WL 3101785, at *23 (internal quotation marks omitted).

- 13 -

access.” 38

FDA must “consider[] in particular . . . patients who have difficulty

accessing health care (such as patients in rural or medically underserved areas); and

patients with functional limitations.” 39 Patient access is paramount: if FDA imposes

such restrictions, it must “periodically reevaluate them to ensure the restrictions are

well calibrated to balance safety, access, and the burden on the health care delivery

system.” 40

FDA’s consideration of patient burden when eliminating the IPDR was thus

mandatory, not discretionary. FDA would have violated its statutory obligation if it

had failed to consider the burdens the IPDR imposes on patient access and to modify

the REMS accordingly. Its decision to do so was appropriate.

B.

The in-person dispensing requirement unduly burdens patient

access to mifepristone.

Requiring a patient to obtain a medication at a hospital or medical office rather

than by mail or at a pharmacy significantly burdens access to that medication. The

Act therefore prohibits FDA from demanding it without substantial justification, and

here no such justification exists. The Fifth Circuit’s Order is untethered to any

legitimate safety concern and would impose onerous burdens on pregnant women

nationwide—the exact opposite of what Congress commands FDA to do.

Even within one’s own state, traveling to and from a provider to obtain

mifepristone requires time and imposes costs, such as gas or transportation fares,

38 Washington v. FDA, 108 F.4th 1163, 1169 (9th Cir. 2024) (internal quotation marks omitted);

21 U.S.C. § 355-1(f)(2).

39 21 U.S.C. § 355-1(f)(2)(C)(ii)-(iii).

40 Washington, 108 F.4th at 1169 (internal quotation marks omitted); 21 U.S.C. § 355-1(f)(5)(B).

- 14 -

childcare, and lost wages. This reality is true regardless of where the patient lives,

but the burden grows with distance—potentially requiring more expensive travel,

such as airfare or lodging to stay overnight.

Distance from an in-person provider is a significant barrier to accessing

abortion care. 41

Research shows that even moderate increases in distance to a

provider negatively impacts abortion access—e.g., traveling just 50-100 miles

decreases abortion rates by 16%, and rates declined further with greater distances

(28% at 100-150 miles, 38% at 150-200 miles, and 44% beyond 200 miles). 42 And as

of April 2023, one study had found that “the average American is 86 miles from a

provider.” 43 Another study found that 50.7% of people with disabilities experienced

logistical

barriers

to

accessing

reproductive

health

care,

which

included

transportation burdens, compared to 29.7% of people without disabilities. 44

Eliminating the IPDR minimizes serious burdens in accessing mifepristone and is

thus consistent with the Act’s statutory command that FDA consider “in

particular . . . patients who have difficulty accessing health care (such as patients in

rural or medically underserved areas)” and “patients with functional limitations.” 45,46

41 See Caitlin Myers et al., Abortion Access Dashboard, https://experience.arcgis.com/experience/

6e360741bfd84db79d5db774a1147815 (last updated Mar. 16, 2026).

42 Jason M. Lindo et al., How Far Is Too Far? New Evidence on Abortion Clinic Closures, Access,

and Abortions, 55 J. Human Resources 1137, 1152–53 (2020).

Selena Simmons-Duffin & Shelly Cheng, How Many Miles Do You Have to Travel to Get

Abortion Care? One Professor Maps It, NPR (June 21, 2023).

43

44 M. Antonia Biggs et al., Access to Reproductive Health Services Among People with Disabilities,

JAMA Network Open, Vol. 6, No. 11 at 6–7 (Nov. 29, 2023).

45 21 U.S.C. § 355-1(f)(2)(C)(ii)–(iii).

46 See Purcell, 2025 WL 3101785, at *18-19 (discussing need to address burdens of in-person

dispensing and related requirements).

- 15 -

Indeed, studies show that patients in rural areas are eight times more likely than

patients living in urban areas to have to travel more than 100 miles to access abortion

care (36% to 4%). 47 The Fifth Circuit’s nationwide order—a federal requirement that

every mifepristone patient in the country travel to a hospital or medical office just to

be handed a pill—imposes exactly the kind of burden on patients that Congress

prohibited, particularly for patients in rural or medically underserved areas. 48

Patients suffer from these financial burdens, but so does the health care

delivery system, which Congress also mandates FDA to consider in its burden

analysis. 49 The IPDR reduces the quantity of mifepristone providers, making it even

harder to find and reach one. This is because the IPDR imposes an “extremely

unusual” burden on providers “to serve as, in effect, both prescribers and

pharmacists” by stocking and dispensing mifepristone onsite at their health center,

rather than issuing a prescription to be filled at a pharmacy. 50 As FDA recognized,

these burdens significantly decreased the number of qualified providers offering

mifepristone, with evidence showing that provider volume would “potentially

doubl[e]” with elimination of the IPDR. 51 The IPDR also “burdens the health care

47 Liza Fuentes & Jenna Jerman, Distance Traveled for Abortion in the United States and Reasons

for Clinic Choice, 28 J. Women’s Health 1623, 1627 (2019).

48 See, e.g., Lauren Van Schilfgaarde et al., Tribal Nations and Abortion Access: A Path Forward,

46 Harv. J.L. & Gender 1 (2023); Jillian McKoy, Travel Times to Abortion Facilities Have Increased

Drastically in Post-Roe Era, Bos. Univ. Sch. of Pub. Health (Nov. 23, 2022); Alexa Delbosc & Rahman

Shafi, What Do We Know About Immigrants’ Travel Behaviour? A Systematic Literature Review and

Proposed Conceptual Framework, 43 Transport Revs. 914 (2023); Fuentes, supra n.47.

49 21 U.S.C. § 355-1(f)(2)(D).

50 Letter from Dr. Graham Chelius of The Society of Family Planning to FDA, at 4 (Sept. 29, 2021).

51 See id. (noting that “the proportion of medication abortion providers would likely double if

clinicians were permitted to prescribe mifepristone through a pharmacy”).

- 16 -

delivery system and severely reduces patient access because of the challenges of

obtaining institutional approval to dispense mifepristone onsite, and the complicated

logistics necessary to do so.” 52 Eliminating the IPDR is thus consistent with the Act’s

statutory command that FDA “minimize the burden on the health care delivery

system” and ensure that a REMS “not be unduly burdensome on patient access.” 53

The IPDR also imposes other real-world economic burdens. A majority of

women seeking abortion care already have children, meaning the IPDR forces them

to incur additional child care and family accommodation costs while traveling to

access mifepristone. 54 Additionally, many people seeking abortion care lack paid time

off, meaning the IPDR forces them to lose wages and employment opportunities to

access this care. 55 And the unduly burdensome consequences of the Fifth Circuit’s

Order will disproportionately burden people of color and low-income Americans.

Black and Hispanic employees, for example, are less likely to have paid parental leave

and paid sick leave benefits than white employees. 56 For people residing in states

that permit telemedicine abortion care, ensuring access to this safe, effective, and

52 Id. (noting that “fewer than 0.1% of FDA-approved drugs must be dispensed in a hospital,

medical office, or clinic”).

53 21 U.S.C. § 355-1(f)(2)(C)-(D).

54 Margot Sanger-Katz, et al., Who Gets Abortions in America?, New York Times (Dec. 14, 2021),

https://www.nytimes.com/interactive/2021/12/14/upshot/who-gets-abortions-in-america.html.

55 See Nat’l P’ship for Women & Families, Paid Sick Days Enhance Women’s Abortion Access and

Economic Security 3, 5 (May 2019) (finding that “people without paid sick days are three times more

likely than people with paid sick days to delay or go without medical care for themselves” and that

women lacking paid sick days face “lost wages and possibly job loss”).

56 See Ann P. Bartel et al., Racial and Ethnic Disparities in Access to and Use of Paid Family and

Medical Leave: Evidence from Four Nationally Representative Datasets, U.S. Bureau of Labor

Statistics (Jan. 2019).

- 17 -

legal medication without requiring in-office dispensing alleviates these burdens.

These burdens are not just economic—they can make the difference in whether

a patient can access an abortion at all. Navigating travel-related costs and logistical

barriers can delay patients past the point in pregnancy when medication abortion is

available.

This might force them into a more invasive, resource-intensive, and

expensive procedure, which may itself only be available at a greater distance. 57 This

has dramatic consequences on the lives of everyday Americans seeking to make

important reproductive health care decisions for their families and dire consequences

on health care systems nationwide—both of which are already strained. 58

C.

This Court should not permit Louisiana to unduly burden

nationwide patient access to medication.

Reinstating the IPDR would needlessly force patients to travel farther and

spend more time and money to access a safe medication in person where telemedicine

abortion care is legally protected by state law. FDA carefully evaluated extensive

real-world evidence and determined that in-person dispensing of mifepristone does

not enhance patient safety, while removing the requirement reduces burdens on

patients and the health care system. This Court should stay the Fifth Circuit’s Order

57 See, e.g., Am. College of Obstetricians and Gynecologists, Medication Abortion Up to 70 Days of

Gestation, Practice Bulletin No. 225 (Oct. 2020).

58 See Andrés Argüello & Andrea Ducas, The Big, ‘Beautiful’ Bill’s Health Care Cuts Would Drive

Up Uncompensated Care and Threaten Vulnerable Hospitals, Center for American Progress,

https://www.americanprogress.org/article/the-big-beautiful-bills-health-care-cuts-would-drive-upuncompensated-care-and-threaten-vulnerable-hospitals/ (estimating that recent Republican policy

will result in 13.7 million Americans losing health insurance and providers to face an estimated $31

billion in uncompensated care costs).

- 18 -

because it undermines Congress’s mandate and unduly burdens patient access to this

medication all across America.

Reinstating the IPDR severely limits access to mifepristone and denies

medically appropriate care to patients far beyond Louisiana’s borders, exacerbating

existing inequities in maternal health for patients of color, patients with low income,

patients with disabilities, and patients living in rural areas—the populations most

likely to rely on telemedicine care. 59 Indeed, more than half of U.S. counties do not

have a hospital that provides obstetric care; 35% do not even have a single birthing

facility or obstetric clinician. 60

Mifepristone has been used as part of the most common and recommended

regimen for medication abortion for more than 25 years and has been available

without FDA’s IPDR for more than five years. Health care delivery systems have

adapted and created new infrastructure in reliance on that evidence-based decision.

Allowing Louisiana to force a nationwide rollback of this status quo would have a

“needlessly chaotic and disruptive effect.” 61 The impact would be acute in states with

legal protections for abortion under state law. Such an injunction would further

burden already taxed health care systems, harm residents of those States, and

undermine their sovereign policy choices. Many states and private providers have

59 See generally Ashely Stoneburner, et al., Nowhere to Go: Maternity Care Deserts Across the US,

March of Dimes (2024).

60 Id. at 8 (noting that approximately 6 in 10 of these counties are rural, less populated areas).

61 Benisek v. Lamone, 585 U.S. 155, 161 (2018) (internal quotation marks omitted).

- 19 -

invested in infrastructure to deliver medication abortion via telemedicine—

investments that would be undermined by the reinstatement of in-person dispensing.

FDA’s decision to eliminate the IPDR complied with the Congressionallymandated requirement to minimize burdens, and Louisiana’s request would force

FDA to reimpose restrictions that violate the statute.

III.

LOUISIANA’S CRITICISM OF FDA’S DECISION TO ELIMINATE THE

IN-PERSON DISPENSING REQUIREMENT LACKS SCIENTIFIC

MERIT AND IS THEREFORE FORECLOSED BY THE ACT.

A.

The Act requires FDA to make decisions based on science, not

flawed, ideological publications.

Congress created FDA to ensure that subject-matter experts review the safety

of drugs and medical devices, relying on scientifically sound evidence. 62 As detailed

above, FDA eliminated the IPDR because the evidence showed that patient health

and safety will be protected while “assur[ing] access and minimiz[ing] burden” on “the

health care delivery system,” thus complying with Congress’s requirements. 63

Unlike the sound scientific evidence supporting FDA’s decision to remove the

IPDR, Respondents’ attacks on mifepristone’s safety are based on so-called studies

that lack scientific rigor and appear driven by a political agenda rather than science,

as has been amply explained by numerous expert researchers. 64

Congress tasked FDA with making evidence-based decisions about drug safety

62 S. Bay United Pentecostal Church v. Newsom, 590 U.S. 965, 967 (2020) (Roberts, C.J.,

concurring).

63 21 U.S.C. § 355-1(f)(2).

64 See Reproductive Health Researches Comment Letter to FDA at 7-19, UCLA Law (Aug. 27,

2025), https://law.ucla.edu/reproductive-health-researchers-comment-letter-fda.

- 20 -

and ensuring that any restrictions, including limits on how drugs can be prescribed

and dispensed, are justified by the science and account for patients’ ability to access

necessary care. Decades of data confirming mifepristone’s safety supported FDA’s

decision to eliminate the IPDR. This Court should reject Respondents’ invitation to

use self-serving and flawed publications as an excuse to override sound, sciencebacked conclusions.

B.

FDA’s use of FAERS data was appropriate under the Act.

FDA appropriately considered FAERS data in making its determination to

eliminate the IPDR. Respondents’ claims otherwise are baseless and ignore that

FDA’s reliance on FAERS data is standard practice for FDA’s post-marketing

surveillance of all approved drugs. 65

When FDA was reviewing whether it could safely remove the IPDR for

mifepristone, it analyzed FAERS data for the period January 27, 2020, through

September 30, 2021; for more than half of that period, the IPDR was not enforced. 66

Over that nearly-two-year period, there were only eight adverse events reported in

FAERS for patients who had taken mifepristone, with no difference in safety outcome

See, e.g., FDA Adverse Event Monitoring System (AEMS), FDA (Mar. 11, 2026),

https://www.fda.gov/drugs/surveillance/fda-adverse-event-monitoring-system-aems (“The [FAERS]

database is designed to support the FDA’s post-marketing safety surveillance program for drug and

therapeutic biologic products.”); see also FDA Adverse Event Reporting System (FAERS) Public

Dashboard FAQs, FDA, https://fis.fda.gov/extensions/FPD-FAQ/FPD-FAQ.html#_Toc514144622

(“FAERS is a useful tool for FDA for activities such as looking for new safety concerns that might be

related to a marketed product, evaluating a manufacturer’s compliance to reporting regulations and

responding to outside requests for information.”).

65

66 FDA Letter to Am. Ass’n of Pro-Life Obstetricians & Gynecologist (Dec. 16, 2021), Compl. Ex.

10, ECF No. 1-10 at 27 [hereinafter “ECF No. 1-10”].

- 21 -

based on where the medication was dispensed. 67 The FAERS data provided strong

support for FDA’s conclusion that there had not been an uptick in the rate of adverse

events or other emerging safety trends when the IPDR was not being enforced. 68

Respondents have suggested that the FAERS data supporting removal of the

IPDR was unreliable because FDA does not require prescribing clinicians to report

all potentially associated adverse events in patients taking mifepristone. But again,

that is the case for nearly every drug—as a general practice, FDA requires

manufacturers, not individual physicians, to report any serious adverse events,

though prescribing physicians can still voluntarily report adverse events. 69 And

unlike nearly every other drug it regulates, FDA still requires prescribers to report

fatalities when a patient takes mifepristone—without any evidence of causation.

Respondents have also latched onto FDA’s previous acknowledgements that

FAERS data is not comprehensive or perfect to argue that such data cannot be used

to support safety determinations for regulated drugs. But FAERS data does not have

to be perfect to have value. 70 And while it is true that FAERS is not designed to

FDA defines “adverse event” as “any untoward medical occurrence associated with the use

of a drug in humans, whether or not considered drug related.” 21 C.F.R. § 312.32(a). That definition

makes clear that an adverse event need not necessarily be caused by the drug, but simply that the

event occurred. Id.

67 Id.

68 ECF No. 1-10 at 28.

69 See, e.g., 21 C.F.R. §§ 314.80 and 314.81 (requiring drug manufacturers collect and report to

FDA information about adverse drug experiences). An adverse event is considered serious if it results

in death, a substantial risk of death, a prolonged hospital stay, a congenital anomaly or birth defect,

or permanent impairment or damage, or requires medical intervention to prevent such damage. See

What is a Serious Adverse Event?, FDA (May 18, 2023), https://www.fda.gov/safety/reporting-seriousproblems-fda/what-serious-adverse-event.

70 See, e.g., FCC v. Prometheus Radio Project, 592 U.S. 414, 427 (2021) (explaining that agency

need not have perfect data to support its decisions).

- 22 -

capture every adverse event related to a drug, FDA takes that fact into account when

reviewing the data. Here, FDA corroborated the FAERS data by cross-referencing it

with adverse event summaries that were submitted by mifepristone’s manufacturers,

which included the same eight events that were reflected in FAERS. 71 FDA then

conducted a review of published medical literature to search for additional adverse

event reports across the relevant period and found none, confirming the

reasonableness of relying on the FAERS data. 72 This information, combined with

decades of data showing that mifepristone is a safe medication and that adverse

events are very rare, was sufficient to support FDA’s decision to remove the IPDR.

A finding that it is arbitrary and capricious for FDA to rely on FAERS data

would have far-reaching consequences on the agency’s practices for monitoring drug

safety beyond just mifepristone. FDA uses FAERS as the primary source of adverse

event reporting for virtually all drugs that it regulates. FDA has determined that

manufacturer-reporting generates sufficient data to keep the agency informed about

whether there have been changes to a drug’s safety profile. This Court should not

allow litigants to exploit alleged limitations of FAERS data as a path to challenging

FDA decisions and undermine the system Congress and FDA established.

C.

Louisiana should not be able to hijack the science-based REMS

system Congress designed to force its policy choices onto others.

The obvious flaws in Respondents’ criticism of the 2023 REMS reflect a larger

problem with its case: Louisiana sought—and the Fifth Circuit granted—an order

71 ECF No. 1-10 at 28.

72 Id. at 27.

- 23 -

that contradicts congressional mandates, overrides FDA’s well-reasoned, databacked decision to remove the IPDR, and imposes unnecessary barriers to essential

care—nationwide. But that is not up to Louisiana. The efforts of other states to

protect and expand access to abortion generally, and to medication abortion

specifically, within their borders are a result of the “constitutional processes of

democratic self-government.” 73 The Fifth Circuit’s Order would undermine those

processes by forcing FDA to reinstate—against scientific evidence and statutory

requirements—the IPDR for mifepristone.

Louisiana relies on Dobbs v. Jackson Women’s Health Organization to argue

that FDA’s regulations cannot override state-level prohibitions on abortion. That

reliance is misplaced for several reasons. First, FDA’s REMS authority is limited to

assessing whether a restriction “is necessary to ensure that the benefits of the drug

outweigh the risks of the drug.” 74 FDA does not—and under the system Congress

designed, is not authorized to—consider the regulatory or enforcement priorities of

individual States when assessing whether to impose or modify a REMS.

Second, the timeline demonstrates that FDA did not remove the IPDR to

frustrate state abortion prohibitions. The requirement was first suspended by court

order in 2020 during the pandemic and then was subject to an April 2021 nonenforcement determination—both occurring well before Dobbs was handed down.

FDA likewise initiated its 2021 review of mifepristone’s REMS, and reached its

73 Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215, 346 (2022)

concurring).

74 21 U.S.C. § 355-1(a)(1).

- 24 -

(Kavanaugh, J.,

evidence-based decision to permanently remove the IPDR, well before Dobbs was

decided. There is simply no evidence supporting Louisiana’s claims that the agency’s

scientific evaluation of the IPDR was motivated by state abortion bans.

Third, FDA’s decision to eliminate the IPDR does not prevent Louisiana or

similarly situated States from enforcing their own laws restricting abortion (though

the undersigned disagree with those laws). Respondents’ principal objection is that

other States have made different policy choices than Louisiana.

But “each

sovereignty is free to determine what conduct shall be proscribed within its

jurisdiction,” and the “wrong committed by violating such proscription” does not

automatically cross state lines. 75

This Court should not permit Louisiana to

weaponize its policy disagreements with sister States to force FDA to violate its

statutory obligation not to unduly burden patient access to medication nationwide.

CONCLUSION

For the foregoing reasons, Amici Members of Congress respectfully request

that this Court grant an emergency stay of the Fifth Circuit’s erroneous Order.

Dated: May 4, 2026

Respectfully submitted,

ABBY F. RUDZIN,

Counsel of Record

O’MELVENY & MYERS LLP

1301 Avenue of the Americas

New York, NY 10019

arudzin@omm.com

Counsel for Lead Amici

75 Farmland Dairies v. Barber, 65 N.Y.2d 51, 56-57 (1985); see also Dobbs, 597 U.S. at 346

(Kavanaugh J. concurring).

- 25 -

APPENDIX

TABLE OF CONTENTS

List of Amici Curiae ..................................................................................................... 1a

-i-

LIST OF AMICI CURIAE 259 MEMBERS OF CONGRESS

47 United States Senators

Majority Leader Charles E. Schumer

Sen. Patty Murray

Sen. Richard J. Durbin

Sen. Ron Wyden

Sen. Angela D. Alsobrooks

Sen. Tammy Baldwin

Sen. Michael F. Bennet

Sen. Richard Blumenthal

Sen. Lisa Blunt Rochester

Sen. Cory A. Booker

Sen. Maria Cantwell

Sen. Christopher A. Coons

Sen. Catherine Cortez Masto

Sen. Tammy Duckworth

Sen. John Fetterman

Sen. Ruben Gallego

Sen. Kirsten Gillibrand

Sen. Margaret Wood Hassan

Sen. Martin Heinrich

Sen. John W. Hickenlooper

Sen. Mazie K. Hirono

- 1a -

Sen. Tim Kaine

Sen. Mark Kelly

Sen. Andy Kim

Sen. Angus S. King, Jr.

Sen. Amy Klobuchar

Sen. Ben Ray Luján

Sen. Edward J. Markey

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. Bernard Sanders

Sen. Brian Schatz

Sen. Adam B. Schiff

Sen. Jeanne Shaheen

Sen. Elissa Slotkin

Sen. Tina Smith

Sen. Chris Van Hollen

Sen. Mark Warner

- 2a -

Sen. Raphael Warnock

Sen. Elizabeth Warren

Sen. Peter Welch

Sen. Sheldon Whitehouse

- 3a -

212 Members of the United States House of Representatives

Minority Leader Hakeem Jeffries

Rep. Katherine Clark

Rep. Frank Pallone, Jr.

Rep. Jamie Raskin

Rep. Diana DeGette

Rep. Ayanna Pressley

Rep. Alma S. Adams

Rep. Pete Aguilar

Rep. Gabe Amo

Rep. Yassamin Ansari

Rep. Jake Auchincloss

Rep. Becca Balint

Rep. Nanette Barragán

Rep. Joyce Beatty

Rep. Wesley Bell

Rep. Ami Bera, M.D.

Rep. Donald S. Beyer Jr.

Rep. Sanford D. Bishop, Jr.

Rep. Suzanne Bonamici

Rep. Brendan F. Boyle

Rep. Shontel Brown

Rep. Julia Brownley

Rep. Nikki Budzinski

- 4a -

Rep. Janelle S. Bynum

Rep. Salud Carbajal

Rep. André Carson

Rep. Troy A. Carter Sr.

Rep. Greg Casar

Rep. Ed Case

Rep. Sean Casten

Rep. Kathy Castor

Rep. Joaquin Castro

Rep. Judy Chu

Rep. Gilbert R. Cisneros, Jr.

Rep. Yvette D. Clarke

Rep. Emanuel Cleaver, II

Rep. James E. Clyburn

Rep. Steve Cohen

Rep. Dr. Herb Conaway

Rep. J. Luis Correa

Rep. Jim Costa

Rep. Joe Courtney

Rep. Angie Craig

Rep. Jasmine Crockett

Rep. Jason Crow

Rep. Sharice L. Davids

Rep. Danny K. Davis

- 5a -

Rep. Donald G. Davis

Rep. Madeleine Dean

Rep. Rosa L. DeLauro

Rep. Suzan K. DelBene

Rep. Chris Deluzio

Rep. Mark DeSaulnier

Rep. Dr. Maxine Dexter

Rep. Debbie Dingell

Rep. Lloyd Doggett

Rep. Sarah Elfreth

Rep. Veronica Escobar

Rep. Adriano Espaillat

Rep. Dwight Evans

Rep. Cleo Fields

Rep. Shomari C. Figures

Rep. Lizzie Fletcher

Rep. Bill Foster

Rep. Valerie P. Foushee

Rep. Lois Frankel

Rep. Laura Friedman

Rep. Maxwell Alejandro Frost

Rep. John Garamendi

Rep. Sylvia R. Garcia

Rep. Robert Garcia

- 6a -

Rep. Jesús “Chuy” García

Rep. Laura Gillen

Rep. Marie Gluesenkamp Perez

Rep. Jared Golden

Rep. Dan Goldman

Rep. Jimmy Gomez

Rep. Maggie Goodlander

Rep. Josh Gottheimer

Rep. Adam Gray

Rep. Al Green

Rep. Adelita S. Grijalva

Rep. Josh Harder

Rep. Jahana Hayes

Rep. Jim Himes

Rep. Eleanor Holmes Norton

Rep. Steven A. Horsford

Rep. Chrissy Houlahan

Rep. Steny H. Hoyer

Rep. Val Hoyle

Rep. Jared Huffman

Rep. Glenn F. Ivey

Rep. Jonathan L. Jackson

Rep. Sara Jacobs

Rep. Pramila Jayapal

- 7a -

Rep. Julie E. Johnson

Rep. Henry C. (“Hank”) Johnson, Jr.

Rep. Sydney Kamlager-Dove

Rep. Marcy Kaptur

Rep. William R. Keating

Rep. Robin L. Kelly

Rep. Timothy M. Kennedy

Rep. Ro Khanna

Rep. Raja Krishnamoorthi

Rep. Greg Landsman

Rep. Rick Larsen

Rep. John B. Larson

Rep. George Latimer

Rep. Summer L. Lee

Rep. Susie Lee

Rep. Teresa Leger Fernández

Rep. Mike Levin

Rep. Sam T. Liccardo

Rep. Ted W. Lieu

Rep. Zoe Lofgren

Rep. Stephen F. Lynch

Rep. Seth Magaziner

Rep. John Mannion

Rep. Doris Matsui

- 8a -

Rep. Lucy McBath

Rep. Sarah McBride

Rep. April McClain Delaney

Rep. Jennifer McClellan

Rep. Betty McCollum

Rep. Kristen McDonald Rivet

Rep. Morgan McGarvey

Rep. James P. McGovern

Rep. LaMonica McIver

Rep. Gregory W. Meeks

Rep. Analilia Mejia

Rep. Christian Menefee

Rep. Rob Menendez

Rep. Grace Meng

Rep. Kweisi Mfume

Rep. Dave Min

Rep. Gwen Moore

Rep. Joseph D. Morelle

Rep. Kelly Morrison

Rep. Jared Moskowitz

Rep. Seth Moulton

Rep. Frank J. Mrvan

Rep. Kevin Mullin

Rep. Jerrold Nadler

- 9a -

Rep. Richard E. Neal

Rep. Joe Neguse

Rep. Donald Norcross

Rep. Alexandria Ocasio-Cortez

Rep. Johnny Olszewski

Rep. Ilhan Omar

Rep. Jimmy Panetta

Rep. Chris Pappas

Rep. Nancy Pelosi

Rep. Scott H. Peters

Rep. Brittany Pettersen

Rep. Chellie Pingree

Rep. Stacey E. Plaskett

Rep. Mark Pocan

Rep. Nellie Pou

Rep. Mike Quigley

Rep. Delia C. Ramirez

Rep. Emily Randall

Rep. Josh Riley

Rep. Luz Rivas

Rep. Deborah K. Ross

Rep. Raul Ruiz

Rep. Patrick Ryan

Rep. Andrea Salinas

- 10a -

Rep. Linda T. Sanchez

Rep. Mary Gay Scanlon

Rep. Jan Schakowsky

Rep. Bradley Scott Schneider

Rep. Hillary Scholten

Rep. Kim Schrier, M.D.

Rep. Robert C. “Bobby” Scott

Rep. Terri A. Sewell

Rep. Brad Sherman

Rep. Lateefah Simon

Rep. Adam Smith

Rep. Eric Sorensen

Rep. Darren Soto

Rep. Melanie Stansbury

Rep. Greg Stanton

Rep. Haley Stevens

Rep. Marilyn Strickland

Rep. Suhas Subramanyam

Rep. Thomas R. Suozzi

Rep. Emilia Sykes

Rep. Mark Takano

Rep. Shri Thanedar

Rep. Mike Thompson

Rep. Bennie G. Thompson

- 11a -

Rep. Dina Titus

Rep. Rashida Tlaib

Rep. Jill N. Tokuda

Rep. Paul Tonko

Rep. Norma J. Torres

Rep. Ritchie Torres

Rep. Lori Trahan

Rep. Derek Tran

Rep. Lauren Underwood

Rep. Juan Vargas

Rep. Gabe Vasquez

Rep. Marc A. Veasey

Rep. Nydia M. Velázquez

Rep. Eugene Simon Vindman

Rep. James R. Walkinshaw

Rep. Debbie Wasserman Schultz

Rep. Maxine Waters

Rep. Bonnie Watson Coleman

Rep. George Whitesides

Rep. Nikema Williams

Rep. Frederica S. Wilson

- 12a -