Petitioners Brief — Food and Drug Administration, et al., Petitioners v. Alliance for Hippocratic Medicine, et al.
Supreme Court briefJan 23, 2024
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Nos. 23-235 and 23-236XX-XX
In the Supreme Court of the United States
U.S. FOOD AND DRUG ADMINISTRATION, ET AL.,
PETITIONERS
v.
ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.
DANCO LABORATORIES, L.L.C., PETITIONER
v.
ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.
ON WRITS OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
BRIEF FOR THE FEDERAL PETITIONERS
SAMUEL R. BAGENSTOS
General Counsel
Department of Health
and Human Services
Washington, DC. 20201
MARK RAZA
Chief Counsel
U.S. Food and Drug
Administration
Silver Spring, MD 20993
ELIZABETH B. PRELOGAR
Solicitor General
Counsel of Record
BRIAN M. BOYNTON
Principal Deputy Assistant
Attorney General
BRIAN H. FLETCHER
EDWIN S. KNEEDLER
Deputy Solicitors General
SARAH E. HARRINGTON
Deputy Assistant Attorney
General
ERICA L. ROSS
CHARLES L. MCCLOUD
Assistants to the Solicitor
General
MICHAEL S. RAAB
CYNTHIA A. BARMORE
Attorneys
Department of Justice
Washington, D.C. 20530-0001
SupremeCtBriefs@usdoj.gov
(202) 514-2217
QUESTIONS PRESENTED
This case concerns mifepristone, a drug that the U.S.
Food and Drug Administration (FDA) approved in 2000
as safe and effective for terminating early pregnancies.
The Fifth Circuit held that respondents—doctors and
associations of doctors who oppose abortion—have Article III standing to challenge FDA’s 2016 and 2021 actions with respect to mifepristone’s approved conditions
of use and that those actions were likely arbitrary and
capricious. The court therefore affirmed the district
court’s stay of the relevant agency actions. The questions presented are:
1. Whether respondents have Article III standing to
challenge FDA’s 2016 and 2021 actions.
2. Whether FDA’s 2016 and 2021 actions were arbitrary and capricious.
3. Whether the district court properly granted preliminary relief.
(I)
PARTIES TO THE PROCEEDING
The federal petitioners were defendants-appellants
in the court of appeals. They are the U.S. Food and
Drug Administration (FDA); Robert M. Califf, M.D., in
his official capacity as FDA’s Commissioner of Food
and Drugs; Janet Woodcock, M.D., in her official capacity as Principal Deputy Commissioner of FDA; Patrizia
Cavazzoni, M.D., in her official capacity as Director of
FDA’s Center for Drug Evaluation and Research; the
U.S. Department of Health and Human Services
(HHS); and Xavier Becerra, in his official capacity as
Secretary of HHS.
Respondents were plaintiffs-appellees below. They
are Alliance for Hippocratic Medicine; American Association of Pro-Life Obstetricians & Gynecologists; American College of Pediatricians; Christian Medical &
Dental Associations; Shaun Jester, D.O.; Regina FrostClark, M.D.; Tyler Johnson, D.O.; and George Delgado,
M.D.
Danco Laboratories, L.L.C., petitioner in No. 22236, was an intervenor-appellant below.
(II)
RELATED PROCEEDINGS
United States District Court (N.D. Tex.):
Alliance for Hippocratic Medicine, et al. v. U.S.
Food & Drug Administration, et al., No. 22-cv223 (Apr. 7, 2023)
United States Court of Appeals (5th Cir.):
Alliance for Hippocratic Medicine, et al. v. U.S.
Food & Drug Administration, et al., No. 23-10362
(Aug. 16, 2023)
Supreme Court of the United States:
U.S. Food & Drug Administration, et al. v. Alliance
for Hippocratic Medicine, et al., No. 22A902
(Apr. 21, 2023)
Danco Laboratories, LLC v. Alliance for Hippocratic Medicine, et al., No. 22A901 (Apr. 21, 2023)
(III)
TABLE OF CONTENTS
Page
Opinions below .............................................................................. 1
Jurisdiction .................................................................................... 2
Statutory provisions involved ...................................................... 2
Statement ...................................................................................... 2
A. Statutory background.................................................... 3
B. FDA’s actions addressing mifepristone ...................... 4
C. Respondents’ citizen petitions ...................................... 7
D. Proceedings below ......................................................... 8
Summary of argument ............................................................... 12
Argument:
I. Respondents lack Article III standing ...................... 15
A. Respondents have not established a
cognizable injury .................................................. 16
1. Respondents cannot rely on statistics and
must instead identify at least one
member who satisfies Article III ................. 17
2. Respondents have not identified any
member who faces an imminent
conscience injury ........................................... 20
3. Respondents’ remaining theories of
injury likewise fail ......................................... 25
B. Respondents have not shown that their
asserted injuries are fairly traceable to
FDA’s 2016 and 2021 actions .............................. 28
C. Respondents lack organizational standing ........ 32
II. FDA’s actions were lawful .......................................... 34
A. FDA lawfully changed the conditions of use
in 2016 ................................................................... 34
B. FDA lawfully changed the adverse event
reporting requirements in 2016 .......................... 41
C. FDA lawfully decided to remove the inperson dispensing requirement in 2021 ............. 42
(V)
VI
Table of Contents—Continued:
Page
III.
The district court’s remedy was improper ................ 44
A. The district court erred in relying on
5 U.S.C. 705 ............................................................ 45
B. The balance of the equities and the public
interest do not support preliminary relief .......... 46
Conclusion ................................................................................... 49
Appendix — Statutory provisions ........................................... 1a
TABLE OF AUTHORITIES
Cases:
Allen v. Wright, 468 U.S. 737 (1984) .................................... 28
American Coll. of Obstetricians & Gynecologists
v. FDA, 472 F. Supp. 3d 183 (D. Md. 2020) ...................... 6
Bloomberg L.P. v. SEC,
45 F.4th 462 (D.C. Cir. 2022) ............................................. 48
City of Los Angeles v. Lyons, 461 U.S. 95 (1983) ............... 25
Clapper v. Amnesty Int’l USA,
568 U.S. 398 (2013).................................................. 16, 21, 22
Coalition for Mercury-Free Drugs (CoMeD, Inc.) v.
Sebelius, 671 F.3d 1275 (D.C. Cir. 2012) .......................... 16
Cytori Therapeutics, Inc. v. FDA,
715 F.3d 922 (D.C. Cir. 2013) ............................................. 44
Department of Commerce v. New York,
139 S. Ct. 2551 (2019) ......................................................... 35
FCC v. Prometheus Radio Project,
592 U.S. 414 (2021)............................................ 34, 36, 37, 45
FDA v. American Coll. of Obstetricians &
Gynecologists, 141 S. Ct. 578 (2021) ............................. 6, 35
Garland v. Ming Dai, 593 U.S. 357 (2021).......................... 39
Haaland v. Brackeen, 599 U.S. 255 (2023) ......................... 16
Havens Realty Corp. v. Coleman, 455 U.S. 363 (1982)...... 33
VII
Cases—Continued:
Page
Hunt v. Washington State Apple Adver. Comm’n,
432 U.S. 333 (1977).............................................................. 18
Lujan v. Defenders of Wildlife,
504 U.S. 555 (1992)........................................................ 21, 34
Motor Vehicle Mfrs. Ass’n of the U.S., Inc. v. State
Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) ................. 41
Simon v. Eastern Ky. Welfare Rights Org.,
426 U.S. 26 (1976) ............................................................... 33
Spokeo, Inc. v. Robins, 578 U.S. 330 (2016) ........................ 29
Students for Fair Admissions, Inc., v. President &
Fellows of Harvard Coll., 600 U.S. 181 (2023) ................. 18
Summers v. Earth Island Inst.,
555 U.S. 488 (2009)................................. 12, 16, 18-20, 22, 23
TransUnion LLC v. Ramirez,
594 U.S. 413 (2021)........................................................ 29, 33
United Food & Commercial Workers Union Local
751 v. Brown Grp., Inc., 517 U.S. 544 (1996) ................... 18
United States v. Rutherford, 442 U.S. 544 (1979) .............. 40
United States v. Texas, 599 U.S. 670 (2023) ........... 15, 16, 29
Valley Forge Christian Coll. v. Americans United
for Separation of Church & State, Inc.,
454 U.S. 464 (1982).............................................................. 15
Warth v. Seldin, 422 U.S. 490 (1975) ................................... 18
Weinberger v. Romero-Barcelo,
456 U.S. 305 (1982).............................................................. 48
Winter v. NRDC, Inc., 555 U.S. 7 (2008) ............................ 46
Constitution, statutes, and regulations:
U.S. Const. Art. III ....2, 9, 12, 13, 15-20, 22, 25-27, 33, 34, 47
Administrative Procedure Act,
5 U.S.C. 701 et seq................................................................. 9
5 U.S.C. 705 .................................................9, 11, 15, 45, 1a
VIII
Statutes and regulations—Continued:
Page
Comstock Act, Act of Mar. 3, 1873, ch. 258,
17 Stat. 598 (18 U.S.C. 1461-1462) ...................................... 9
Consolidated Appropriations Act, 2022,
Pub. L. No. 117-103, Div. H, Tit. V,
§§ 506-507, 136 Stat. 496 .................................................... 22
Emergency Medical Treatment and Labor Act,
42 U.S.C. 1395dd ................................................................. 23
42 U.S.C. 1395dd(b)(1) .................................................... 23
Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 301 et seq. .............................................................. 3
21 U.S.C. 321(p) ................................................................. 3
21 U.S.C. 355 ................................................................ 3, 1a
21 U.S.C. 355(d) ..................................................... 3, 40, 1a
21 U.S.C. 355( j).................................................................. 6
21 U.S.C. 355-1 ............................................................ 3, 3a
21 U.S.C. 355-1(f )(3) .......................................................... 3
21 U.S.C. 355-1(g) ........................................................ 3, 5a
21 U.S.C. 355-1(g)(4) ................................................... 4, 5a
21 U.S.C. 355-1(g)(4)(B) .............................................. 7, 6a
21 U.S.C. 355-1(h) .............................................................. 3
21 U.S.C. 393(b)(2)(B) ....................................................... 3
Food and Drug Administration Amendments Act of
2007, Pub. L. No. 110-85, Tit. IX, 121 Stat. 922:
§ 901, 121 Stat. 922 ............................................................ 3
§ 909(b), 121 Stat. 950-951 (21 U.S.C. 331 note) ............. 4
42 U.S.C. 238n ........................................................................ 22
42 U.S.C. 300a-7(c) ................................................................ 22
42 U.S.C. 300a-7(d) ................................................................ 22
21 C.F.R.:
Pt. 10:
Section 10.45(b) ............................................................ 7
IX
Regulations—Continued:
Page
Pt. 314:
Section 314.50 ............................................................... 3
Section 314.80(c)(1)(i) ................................................ 42
Section 314.98 ............................................................. 42
Section 314.105(c) ........................................................ 3
Miscellaneous:
Black’s Law Dictionary (3d ed. 1933) ................................. 45
Claudia Diaz Olavarrieta et al., Nurse versus
physician-provision of early medical abortion in
Mexico a randomized controlled non-inferiority
trial, 93 Bull. World Health Organ. 249 (2015)................ 38
Patricio Sanhueza Smith et al., Safety, efficacy and
acceptability of outpatient mifepristonemisoprostol medical abortion through 70 days
since last menstrual period in public sector
facilities in Mexico City, 22 Reproductive Health
Matters Supp. (44) 75 (Feb. 2015) ..................................... 38
U.S. Food & Drug Admin.:
Center for Drug Evaluation & Research, REMS
Modification Rationale Review (2021),
https://perma.cc/W4U3-L38P................................... 44
Mifepristone U.S. Post-Marketing Adverse
Events Summary through 12/31/2022,
https://perma.cc/LAM4-KVDZ .......................... 30, 39
Risk Evaluation and Mitigation Strategy
(REMS) Single Shared System for
Mifepristone 200 mg (Jan. 2023),
https://perma.cc/MJT5-35LF ..................................... 7
U.S. Gov’t Accountability Office, GAO-08-751,
Food and Drug Administration: Approval
and Oversight of the Drug Mifeprex (2008),
https://perma.cc/JZW33J8N ............................................. 32
X
Miscellaneous—Continued:
Page
Webster’s New International Dictionary of the
English Language (1928)................................................... 45
Beverly Winikoff et al., Extending Outpatient
Medical Abortion Services Through 70 Days of
Gestational Age, 120 Obstet. & Gynecol. 1070
(Nov. 2012) ........................................................................... 38
In the Supreme Court of the United States
No. 23-235
U.S. FOOD AND DRUG ADMINISTRATION, ET AL.,
PETITIONERS
v.
ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.
No. 23-236
DANCO LABORATORIES, L.L.C., PETITIONER
v.
ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.
ON WRITS OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
BRIEF FOR THE FEDERAL PETITIONERS
OPINIONS BELOW
The opinion of the court of appeals (Pet. App. 1a110a) is reported at 78 F.4th 210.1 The opinion and order of the district court (Pet. App. 111a-195a) is not yet
reported but is available at 2023 WL 2825871. This
Court’s order granting a stay (Pet. App. 245a-248a) is
reported at 143 S. Ct. 1075. The court of appeals’ order
granting a stay in part (Pet. App. 196a-244a) is not pubAll references in this brief to “Pet. App.” are to the appendix to
the petition for a writ of certiorari filed in No. 23-235.
1
(1)
2
lished in the Federal Reporter but is available at 2023
WL 2913725.
JURISDICTION
The judgment of the court of appeals was entered on
August 16, 2023. The petition for a writ of certiorari
was filed on September 8, 2023 and granted on December 13, 2023. The jurisdiction of this Court rests on 28
U.S.C. 1254(1).
STATUTORY PROVISIONS INVOLVED
Pertinent statutory provisions are reproduced in the
appendix to this brief. App., infra, 1a-6a.
STATEMENT
In 2000, the U.S. Food and Drug Administration
(FDA) approved mifepristone for termination of early
pregnancy based on the agency’s scientific judgment
that the drug is safe and effective. FDA has maintained
that judgment across five presidential administrations,
and it has modified the original conditions of mifepristone’s approval as decades of experience have further
confirmed the drug’s safety. Today, more than half of
American women who choose to terminate their pregnancies rely on mifepristone to do so. And study after
study has shown that when mifepristone is taken in accordance with its approved conditions of use, serious adverse events are exceedingly rare.
Respondents are doctors and associations of doctors
who oppose abortion on religious and moral grounds.
They do not prescribe mifepristone, and FDA’s approval of the drug does not require them to do or refrain
from doing anything. Yet the lower courts held that respondents have Article III standing to challenge FDA’s
actions. The courts then countermanded FDA’s scientific judgment by suspending FDA’s 2016 changes to
3
mifepristone’s approved conditions of use and FDA’s
2021 decision to eliminate the requirement that the
drug be dispensed in person. And the courts ordered
that sweeping preliminary relief even though it would
upend the regulatory regime for mifepristone, with disruptive consequences for FDA, mifepristone’s sponsors, and women who need access to the drug.
A. Statutory Background
Congress has entrusted FDA with the authority and
responsibility to determine whether a “new drug” is safe
and effective before it is distributed. 21 U.S.C. 321(p),
355; see 21 U.S.C. 393(b)(2)(B). The Federal Food,
Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq.,
directs FDA to approve a new drug if, among other
things, the sponsor’s application demonstrates that the
drug is safe and effective for its intended use. 21 U.S.C.
355(d); see 21 C.F.R. 314.50, 314.105(c).
In 2007, Congress codified and expanded FDA’s prior
regulatory regime by authorizing the agency to require
a “risk evaluation and mitigation strategy” (REMS)
when it determines that such a strategy is necessary
to ensure that the benefits of a drug outweigh the risks.
21 U.S.C. 355-1; see Food and Drug Administration
Amendments Act of 2007 (FDAAA), Pub. L. No. 110-85,
Tit. IX, § 901, 121 Stat. 922. Under the REMS framework, FDA’s approval of a drug may include “elements
to assure safe use,” such as a requirement that a drug’s
prescribers have particular training or that a drug be
dispensed only in certain settings. 21 U.S.C. 355-1(f )(3).
The FDAAA allows either the drug sponsor or the
FDA to initiate the process of modifying an existing
REMS. 21 U.S.C. 355-1(g) and (h). FDA, for example,
may require submission of a proposed modification if it
determines that the modification should be made to en-
4
sure that the benefits of the drug outweigh the risks or
to minimize the burden of complying with the REMS. 21
U.S.C. 355-1(g)(4).
B. FDA’s Actions Addressing Mifepristone
1. In 2000, after a four-year review of the original
sponsor’s application, FDA approved mifepristone under the brand name Mifeprex. J.A. 224-232. Mifepristone is approved for use in a regimen with another drug,
misoprostol, to end an early pregnancy. A patient who
follows the two-drug regimen experiences cramping and
bleeding similar to that associated with a miscarriage.
J.A. 485-487. In approving mifepristone, FDA invoked
regulations known as “Subpart H” to impose requirements to assure the drug’s safe use, including a requirement that mifepristone be dispensed in person by or under the supervision of a doctor with specified qualifications. J.A. 230. The original approved conditions of use
called for women to make three clinical visits: An initial
visit to take mifepristone; a second visit two days later
to take misoprostol; and a follow-up visit two weeks after
the initial visit to confirm the termination of the pregnancy. J.A. 296. FDA concluded based on a review of
clinical trials and other scientific evidence that, under
those conditions, mifepristone was safe and effective to
terminate pregnancy through seven weeks of gestation.
J.A. 225-232.
When Congress adopted the REMS framework in
2007, it deemed each drug with existing Subpart H
restrictions—including mifepristone—to have an approved REMS imposing the same restrictions. FDAAA
§ 909(b), 121 Stat. 950-951 (21 U.S.C. 331 note). In 2011,
FDA approved a REMS for mifepristone providing for
essentially the same requirements that had previously
been imposed under Subpart H. Pet. App. 9a.
5
2. In 2016, FDA approved a supplemental new drug
application from mifepristone’s sponsor, petitioner Danco
Laboratories, L.L.C., that sought to alter the drug’s
conditions of use, including the REMS. J.A. 284-291.
FDA’s approval was based on a comprehensive review
of the safety and efficacy of the proposed changes that
considered “ 20 years of experience with [mifepristone],
guidelines from professional organizations here and
abroad, and clinical trials that have been published in
the peer-reviewed medical literature.” J.A. 435; see J.A.
418-519.
Based on safety and efficacy data from numerous
studies, FDA approved three changes to mifepristone’s
conditions of use that are relevant here: (1) increasing
the gestational age limit from seven to ten weeks, J.A.
283-291, 298-300, 450-456; (2) reducing the number of inperson visits from three to one, J.A. 300-302, 456-457;
and (3) modifying the REMS to allow mifepristone to be
prescribed by non-physician healthcare providers licensed under state law to prescribe drugs, such as nurse
practitioners, J.A. 309-310, 461-462.2
In addition, FDA modified a prior requirement under
the REMS that prescribers of mifepristone agree to report certain adverse events such as hospitalizations and
blood transfusions to the drug’s sponsor. J.A. 319. FDA
determined based on “15 years of reporting” that the
REMS requirement to report non-fatal adverse events
was no longer warranted and that, as with all other approved drugs, information on such events could be “colFDA also altered the approved dosing regimen, including reducing the amount of mifepristone from 600 mg to 200 mg, increasing
the amount of misoprostol, and changing the administration of misoprostol from oral to buccal (dissolved in the cheek pouch). J.A. 424.
Those changes were not challenged in this litigation.
2
6
lected in the periodic safety update reports and annual
reports” submitted by the drug’s sponsor to FDA pursuant to FDA regulations. Ibid.
In approving the 2016 changes, FDA concluded that
the use of mifepristone under the revised conditions
would be “safe,” emphasizing that serious adverse events
“are exceedingly rare.” J.A. 465. Specifically, FDA explained that published studies involving tens of thousands of women who had taken mifepristone found that
hospitalization occurs in between 0% and 0.7% of cases;
that serious infections occur in between 0% and 0.2% of
cases; and that bleeding requiring transfusion occurs in
between 0% and 0.5% of cases. J.A. 303-304. Studies
also show that those rates of adverse events are comparable to the rates of the same adverse events following
surgical abortions. J.A. 410.
3. In 2019, FDA approved an application from another sponsor, GenBioPro, to market a generic version
of mifepristone. J.A. 348-354; see 21 U.S.C. 355( j). The
same REMS covers both versions of the drug. J.A. 349351.
4. In July 2020, during the COVID-19 public health
emergency, a district court enjoined FDA from enforcing the requirement that mifepristone be dispensed in
person. American Coll. of Obstetricians & Gynecologists v. FDA, 472 F. Supp. 3d 183, 233 (D. Md. 2020).
The injunction remained in place until January 2021,
when it was stayed by this Court. FDA v. American
Coll. of Obstetricians & Gynecologists, 141 S. Ct. 578
(2021).
In April 2021, FDA announced that, in light of the
continued risk that dispensing mifepristone in person
would expose patients to COVID-19, the agency intended to exercise enforcement discretion as to the in-
7
person dispensing requirement during the public health
emergency. J.A. 377. FDA explained that its decision
“was the result of a thorough scientific review by [agency]
experts” who evaluated evidence including “clinical outcomes data and adverse event reports.” Ibid.
5. In December 2021, based in part on its experience
during the pandemic, FDA determined that the inperson dispensing requirement was not necessary to assure mifepristone’s safe use. FDA thus directed Danco
and GenBioPro to initiate the process of modifying the
REMS accordingly. J.A. 378-379; see J.A. 397-412; 21
U.S.C. 355-1(g)(4)(B). In 2023, after this suit was filed,
FDA approved the sponsors’ applications to remove the
in-person dispensing requirement from the REMS.
FDA, Risk Evaluation and Mitigation Strategy
(REMS) Single Shared System for Mifepristone 200 mg
(Jan. 2023), https://perma.cc/MJT5-35LF. The REMS
continues to provide that the drug may be dispensed
only on a prescription from a certified prescriber who
has ensured that the patient has reviewed and signed a
patient agreement form providing information on the
drug, including its risks, and instructions on when and
how to seek follow-up care if necessary. Ibid.
C. Respondents’ Citizen Petitions
Before challenging FDA’s decision to take or refrain
from taking action with respect to a drug, a party must
file a citizen petition with the agency. 21 C.F.R. 10.45(b).
Respondents have filed two citizen petitions concerning
mifepristone.
First, in 2002, two respondents filed a petition asking
FDA to withdraw its 2000 approval of mifepristone. J.A.
201-223. FDA denied the petition in March 2016, on the
same day it approved the changes to mifepristone’s conditions of use. J.A. 237-270. In the denial, FDA ex-
8
plained that “well-controlled clinical trials” had “supported the safety” of mifepristone at the time of the 2000
approval, and that “over 15 years of postmarketing data
and many comparative clinical trials in the United
States and elsewhere continue to support [its] safety.”
J.A. 254.
Second, in 2019, two respondents filed a petition challenging FDA’s 2016 changes to mifepristone’s approved
conditions of use and urging the agency to retain the inperson dispensing requirement. J.A. 321-347. In December 2021, FDA denied that petition in relevant part.
J.A. 372-412. FDA determined that respondents’ various criticisms of the 2016 changes were unfounded. J.A.
379-393. The agency also explained that “the in-person
dispensing requirement is no longer necessary to assure
the safe use of mifepristone.” J.A. 378. In addition to
reviewing the available scientific literature, FDA reviewed the available data and found no evidence of “a
difference in adverse events when in-person dispensing
was and was not enforced.” J.A. 399; see J.A. 398-408.
D. Proceedings Below
1. In November 2022, respondents filed this suit
challenging the 2000 approval of Mifeprex; the 2016
changes to the drug’s conditions of use; the 2019 approval of generic mifepristone; the 2021 exercise of enforcement discretion; and the 2016 and 2021 denials of
respondents’ citizen petitions. J.A. 97-112. Respondents sought a preliminary injunction ordering FDA to
suspend those actions. Pet. App. 117a.
2. The district court granted respondents’ motion.
Pet. App. 111a-195a. The court rejected the government’s arguments that respondents lack standing, id. at
118a-133a, and that their challenge to the 2000 approval
of mifepristone was time-barred, id. at 134a-141a. On
9
the merits, the court held that FDA’s actions were arbitrary and capricious under the Administrative Procedure Act (APA), 5 U.S.C. 701 et seq. Pet. App. 171a187a. The court separately held that statutory provisions derived from the 1873 Comstock Act prevented
FDA from removing the in-person dispensing requirement. Id. at 151a-159a; see Act of Mar. 3, 1873, ch. 258,
17 Stat. 598 (18 U.S.C. 1461-1462).
Respondents had styled their motion as seeking a
preliminary injunction. But the district court instead invoked 5 U.S.C. 705 to “stay[]” the effective date of the
relevant FDA actions—even though those actions had
already been in effect for years. Pet. App. 194a (capitalization and emphasis omitted).
3. The government and Danco appealed and sought
a stay pending appeal. The Fifth Circuit granted a stay
as to FDA’s 2000 approval of mifepristone, but otherwise denied relief. Pet. App. 196a-244a. The government and Danco then sought a stay from this Court. The
Court stayed the district court’s order in its entirety. Id.
at 245a.
4. After further briefing and argument, the Fifth
Circuit issued an opinion that largely tracked the stay
panel’s analysis and affirmed the suspension of FDA’s
2016 and 2021 actions. Pet. App. 1a-110a.
a. The Fifth Circuit first held that respondents have
Article III standing to challenge FDA’s decisions with
respect to branded mifepristone. Pet. App. 14a-42a.
Relying on a theory of associational standing, the court
reasoned that “a certain percentage” of women who
take mifepristone will experience adverse events or require surgical abortions, id. at 16a; that some percentage of that percentage will seek emergency care, ibid.;
and that some of respondents’ unidentified members
10
are likely to treat women who experience such adverse
events, id. at 17a; see id. at 26a-28a. The court accepted
respondents’ contention that treating women who take
mifepristone and experience complications constitutes
a cognizable injury because doctors who treat such patients may be required to provide care that violates
their consciences, may be “forced to divert time and resources away from their regular patients,” and may be
“expose[d] * * * to greater liability and increased insurance costs.” Id. at 31a-32a. The court further determined that respondents had demonstrated traceability
by sufficiently establishing that FDA’s 2016 and 2021
actions “cause[] an increased risk of injury.” Id. at 40a.
But the court held that respondents had failed to introduce evidence showing they were injured by the approval of generic mifepristone, and the court therefore
vacated the portion of the district court’s order suspending FDA’s approval of the generic version of the
drug. Id. at 42a-44a.
The Fifth Circuit next held that respondents’ challenge to FDA’s original 2000 approval of mifepristone
was likely untimely. Pet. App. 45a-51a. The court accordingly vacated the portion of the district court’s order staying the 2000 approval. Id. at 51a.
b. Turning to the merits, the Fifth Circuit held that
respondents are likely to succeed on their claims that
FDA’s 2016 and 2021 actions were arbitrary and capricious. Pet. App. 51a-63a. As to the 2016 changes to mifepristone’s conditions of use, the court acknowledged
that FDA had relied on studies establishing the safety
of the relevant changes. But it nonetheless concluded
that FDA acted arbitrarily because “none of the studies
it relied on examined the effect of implementing all of
those changes together.” Id. at 53a. The court further
11
held that FDA acted arbitrarily in changing the
adverse-event reporting requirement in 2016. Id. at
54a-56a. The court stated that, although FDA had determined that the risks associated with mifepristone
were “well known” by 2016, FDA had “failed to account
for” the possibility that the 2016 changes “might alter
the risk profile.” Id. at 54a-55a.
The Fifth Circuit next concluded that FDA’s 2021
decision to eliminate the in-person dispensing requirement was arbitrary and capricious because the agency
had relied in part on adverse-event data that the court
viewed as unreliable due to the 2016 change to the reporting requirement. Pet. App. 59a-63a. Although the
court identified no evidence that contradicted the
agency’s determination that the in-person dispensing
requirement was no longer necessary to assure safe use,
the court faulted FDA for citing studies that were
“merely ‘not inconsistent’ with” FDA’s conclusions, rather than studies that “affirmatively supported” the
change. Id. at 63a.
c. As to remedy, the Fifth Circuit affirmed the district court’s conclusion that respondents would be irreparably harmed absent relief and that the balance of the
equities favored respondents. Pet. App. 63a-69a. The
court also held that the district court properly invoked
5 U.S.C. 705 to “stay” the effective date of FDA’s
already-effective actions. Pet. App. 69a-74a. And the
court concluded that the flaws it perceived in FDA’s explanation for the 2016 and 2021 actions would justify vacatur of those actions rather than a mere direction to
consider the issues further because, in the court’s view,
“ ‘it is far from certain’ that FDA could cure its mistakes
with further consideration.” Id. at 72a (citation omitted).
12
D. Judge Ho concurred in part and dissented in part.
Pet. App. 76a-110a. He agreed with the majority’s analysis of the 2016 and 2021 actions but would have suspended FDA’s 2000 approval of mifepristone as well.
Id. at 83a-97a. He also would have held that removal of
the in-person dispensing requirement violated the Comstock Act, an issue that the majority did not reach. Id.
at 98a-104a; see id. at 63a n.8.
SUMMARY OF ARGUMENT
To the government’s knowledge, this case marks the
first time any court has restricted access to an FDAapproved drug by second-guessing FDA’s expert judgment about the conditions required to assure that
drug’s safe use. The Fifth Circuit reached that unprecedented result through a series of errors that contradict
this Court’s precedents and violate black-letter Article
III and administrative-law principles. The Court should
reverse.
I. Respondents lack Article III standing. They do
not prescribe mifepristone, and FDA’s actions allowing
other providers to prescribe the drug do not require
them to do or refrain from doing anything. The Fifth
Circuit nonetheless held that the respondent associations have standing based on what the court viewed as
a statistical probability that some of their unidentified
members might be called upon to treat women who are
prescribed mifepristone and then suffer exceedingly
rare serious adverse events. But this Court has emphatically rejected that statistical approach to associational standing, explaining that it would “make a mockery” of Article III. Summers v. Earth Island Inst., 555
U.S. 488, 498 (2009).
Even respondents have now abandoned that statistical approach, conceding that they must identify at least
13
one member who faces an imminent, cognizable injury.
But respondents have not come close to carrying that
burden. Their primary theory is that their members
could be required to violate their consciences by completing an abortion for a woman who presents in an
emergency room with an ongoing pregnancy. But that
hypothetical scenario cannot establish an imminent injury because it rests on a long and speculative chain of
contingencies. Indeed, although mifepristone has been
on the market for decades, respondents cannot identify
even a single case where any of their members has been
forced to provide such care. Respondents’ other theories are likewise speculative. And those theories are independently foreclosed because they rest on the untenable premise that emergency-room doctors suffer an
Article III injury whenever they provide emergency
care.
Respondents also lack standing because they have
not shown that their asserted injuries are fairly traceable to FDA’s challenged actions. If those injuries occur
at all, they will be linked to FDA’s actions only by a long
and attenuated causal chain involving independent actions by other providers, patients, and third parties. In
addition, respondents have scarcely even attempted to
show that their asserted injuries are attributable to the
incremental effects of FDA’s 2016 and 2021 changes to
mifepristone’s conditions of use.
Respondents’ attempt to defend the judgment below
on the alternative ground that they have organizational
standing likewise fails. This Court has never accepted
respondents’ suggestion that an organization can manufacture standing to challenge an agency action merely
by expending resources on that challenge.
14
II. FDA’s actions were lawful.
A. FDA’s 2016 changes to mifepristone’s approved
conditions of use were supported by an exhaustive review of a record including dozens of scientific studies
and decades of safe use of mifepristone by millions of
women in the United States and around the world. The
Fifth Circuit did not suggest that FDA overlooked any
material in the record and did not point to any evidence
suggesting that any of the 2016 changes would be unsafe, either alone or in combination. Instead, the court
overturned FDA’s actions solely because it believed
FDA had failed to cite a study examining the combined
effect of all of the relevant changes. But there is no basis for that novel requirement—and in any event, FDA
did cite a study that combined the relevant changes.
B. FDA lawfully changed mifepristone’s adverseevent reporting requirement in 2016, bringing that requirement more in line with the reporting mechanism
that applies to nearly all other FDA-approved drugs.
Based on more than 15 years of experience, the agency
determined that a heightened reporting requirement
previously applicable to mifepristone was no longer
needed because the drug’s safety profile was well-established and serious adverse events were exceedingly
rare.
C. FDA lawfully decided to eliminate the in-person
dispensing requirement in 2021. The agency concluded,
based in part on actual experience during the pandemic,
that the requirement was no longer necessary to ensure
mifepristone’s safe use and thus no longer justified under the FDCA. The Fifth Circuit faulted FDA for relying on available adverse-event data and published studies because it viewed those sources as flawed. But the
APA does not require agencies to act based on perfect
15
data, which seldom exists. Instead, it requires them to
act reasonably based on the information available. That
is what FDA did here.
III. Even if respondents had standing and some likelihood of success on the merits, the Fifth Circuit erred
in affirming sweeping preliminary relief. The district
court’s invocation of 5 U.S.C. 705 to “postpone” agency
actions that had been in effect for years contravenes
that provision’s plain text. And there is no equitable
justification for allowing parties whose asserted injuries are at best attenuated—and whose relevant claims
assert only that FDA failed adequately to explain its
actions—to secure disruptive nationwide relief that
threatens profound harms to the government, the
healthcare system, patients, and the public.
ARGUMENT
I. RESPONDENTS LACK ARTICLE III STANDING
Article III standing is a “bedrock constitutional requirement that this Court has applied to all manner of
important disputes.” United States v. Texas, 599 U.S.
670, 675 (2023). It is “built on a single basic idea—the
idea of separation of powers. ” Ibid. (citation omitted).
The requirement that a plaintiff demonstrate standing
“helps safeguard the Judiciary’s proper—and properly
limited—role in our constitutional system,” ibid., by ensuring that federal courts do not become “forums for
the ventilation of public grievances” more properly resolved through the democratic process, Valley Forge
Christian Coll. v. Americans United for Separation of
Church & State, Inc., 454 U.S. 464, 473 (1982).
To demonstrate Article III standing, a plaintiff must
“show that she has suffered an injury in fact that is
‘fairly traceable to the defendant’s allegedly unlawful
conduct and likely to be redressed by the requested re-
16
lief.’ ” Haaland v. Brackeen, 599 U.S. 255, 291-292
(2023) (citation omitted). The asserted injury must be
“legally and judicially cognizable,” Texas, 599 U.S. at
676 (citation omitted), and “concrete, particularized,
and actual or imminent,” Clapper v. Amnesty Int’l USA,
568 U.S. 398, 409 (2013) (citation omitted). And where,
as here, an association asserts standing to sue on behalf
of its members, it must show that “at least one identified
member ha[s] suffered or would suffer” the requisite injury. Summers v. Earth Island Inst., 555 U.S. 488, 498
(2009).
Those familiar Article III principles resolve this
case. Respondents’ claim of associational standing fails
because they have not shown that any identified member faces any imminent, judicially cognizable injury—
much less an injury fairly traceable to FDA’s 2016 and
2021 actions. And respondents’ alternative assertion of
organizational standing is likewise meritless.
A. Respondents Have Not Established A Cognizable Injury
Respondents oppose abortion and therefore oppose
the use of mifepristone. But respondents “are not required to receive” or prescribe mifepristone, and
“[t]hey do not have standing to challenge FDA’s decision to allow other people to receive” or prescribe the
drug because those actions by third parties do not impose any cognizable harms on respondents. Coalition
for Mercury-Free Drugs v. Sebelius, 671 F.3d 1275,
1277 (D.C. Cir. 2012) (Kavanaugh, J.). “The Constitution therefore requires that [respondents] direct their
objections to the Executive and Legislative Branches,
not to the Judiciary.” Id. at 1283.
In attempting to avoid that straightforward result,
respondents have asserted that the respondent associations have Article III standing to sue on behalf of their
17
members on the theory that other doctors will prescribe
mifepristone to women who choose to take it; that some
fraction of those women will seek emergency care; that
some fraction of that fraction will seek care from respondents’ member-doctors; and that those doctors will
suffer cognizable injuries as a result. The Fifth Circuit
endorsed that theory, reasoning that because many
women take mifepristone and respondents claim that
their members include many doctors, it is statistically
likely that some members will suffer the asserted injuries. But respondents have now abandoned that statistical approach, correctly acknowledging that they must
identify at least one specific member who faces an imminent injury to a legally protected interest.
Respondents have not come close to meeting that
burden. Their primary theory is that their members
could be forced to violate their consciences by completing an abortion for a woman with an ongoing pregnancy,
but that scenario rests on a chain of speculative contingencies. Indeed, although mifepristone has been on the
market for decades, respondents have not identified
even a single case in which any association member has
been required to provide such treatment. Respondents’
other theories of injury are equally unpersuasive.
Among other things, they reduce to the assertion that
doctors suffer Article III injury whenever they are presented with patients in need of care—an unprecedented
and limitless theory that would allow doctors to challenge virtually any policy affecting public health.
1. Respondents cannot rely on statistics and must instead identify at least one member who satisfies Article III
The Fifth Circuit did not purport to identify any particular individual respondent or member of a respond-
18
ent organization who faces actual or imminent injury.
Instead, the court relied on a statistical approach to associational standing: It reasoned that “a definite percentage of women who take mifepristone will require
emergency-room care”; that respondents had “testified
that hundreds of their members are OB/Gyns and
emergency-room doctors”; and that respondents’
members—in the aggregate—thus face what the court
viewed as a “substantial risk” of future injury. Pet.
App. 26a-27a. That statistical approach flatly contradicts this Court’s precedent, and even respondents have
now abandoned it.
a. This Court’s associational-standing precedents
hold that a membership organization can sometimes sue
“as the representative of its members.” Students for
Fair Admissions, Inc., v. President & Fellows of Harvard Coll., 600 U.S. 181, 199 (2023) (citation omitted).
“The possibility of such representational standing, however, does not eliminate or attenuate the constitutional
requirement of a case or controversy.” Warth v. Seldin,
422 U.S. 490, 511 (1975). An organization seeking to
represent its members thus must show that those members “would otherwise have standing to sue in their own
right.” Harvard, 600 U.S. at 199 (quoting Hunt v.
Washington State Apple Adver. Comm’n, 432 U.S. 333,
343 (1977)). Put differently, the organization must identify “at least one member with standing.” United Food
& Commercial Workers Union Local 751 v. Brown
Grp., Inc., 517 U.S. 544, 555 (1996).
The Fifth Circuit’s statistical approach flouts that
requirement. Instead, it mirrors the “novel” approach
this Court emphatically rejected in Summers. 555 U.S.
at 498. There, the Court explained that it “would make
a mockery” of Article III to find standing whenever,
19
based on an “organization’s self-description of the activities of its members, there is a statistical probability
that some of those members are threatened with concrete injury.” Id. at 497-498. Yet that is precisely what
the Fifth Circuit did here in “bas[ing] standing on the
likelihood that some [unidentified] members of a discrete group, but not all, will be injured.” Pet. App. 28a.
The Fifth Circuit purported to distinguish Summers,
asserting that “[t]he problem in that case was not that
plaintiffs’ standing theory was invalid,” but rather “that
the organizational plaintiffs failed to prove that their
members would be injured.” Pet. App. 28a. But an invalid theory of standing was precisely the problem this
Court identified in Summers. After holding that no
identified member had standing, see Summers, 555
U.S. at 495-497, the Court faulted the dissent for
“propos[ing] a hitherto unheard-of test for organizational standing” that relied on statistics to elide the requirement that an organization “make specific allegations establishing that at least one identified member”
will suffer cognizable harm, id. at 497-498. The Court
emphasized that the “requirement of naming the affected members has never been dispensed with in light
of statistical probabilities.” Id. at 498-499. Contrary to
the Fifth Circuit’s assertion, therefore, the Court did
not suggest that a stronger showing of “the facts upon
which such probabilistic standing depends” could somehow satisfy Article III. Id. at 499. Instead, the Court
rejected that probabilistic approach root and branch.
b. Although respondents themselves relied on a statistical theory earlier in this litigation, see, e.g., Pet.
App. 23a-24a, they declined to defend it in opposing certiorari, see Br. in Opp. 26-27. Instead, respondents appeared to concede that they must show that “at least
20
one identified member” satisfies Article III. Summers,
555 U.S. at 498. Below, respondents offered evidence
about just seven specific members who described themselves as practicing doctors who could suffer the kinds
of injuries on which respondents rely. See J.A. 150-200
(declarations of Drs. Francis, Skop, Wozniak, Johnson,
Frost-Clark, Delgado, and Jester).
Respondents’
standing thus depends on showing that at least one of
those seven members faces an imminent Article III injury.
2. Respondents have not identified any member who
faces an imminent conscience injury
Respondents’ primary theory of injury is that the
availability of mifepristone could give rise to circumstances in which their members could be required to
provide treatment that “conflicts with their sincerely
held moral beliefs and violates their rights of conscience.” Pet. App. 17a. But respondents have not
shown that any member faces any imminent threat of
such an injury. To the contrary, respondents’ asserted
conscience injury rests on a long chain of contingencies
so speculative that respondents have not identified even
a single case in which it has materialized during the decades that mifepristone has been available.
a. Just two of respondents’ seven identified members offered any evidence about their religious or moral
beliefs; both stated that they oppose “being forced to
end the life of a human being in the womb” by completing “an incomplete elective chemical abortion.” J.A.
155; see J.A. 167. The declarations from the leaders of
the respondent organizations that discuss conscience
injuries likewise stated that respondents’ members
generally object to being forced to perform or complete
21
an abortion for a patient who presents with an ongoing
pregnancy. J.A. 121, 135-136, 142-143.
For such an injury to come to pass, all of the following contingencies would have to occur: (i) a woman
chooses to take mifepristone after consultation with another provider; (ii) the woman suffers an exceedingly
rare serious adverse event requiring emergency care;
(iii) rather than returning to the prescribing provider,
the woman seeks care from one of respondents’ members or presents in an emergency room where a member is working; (iv) when the woman does so, her pregnancy is still ongoing; (v) it would violate the member’s
conscience to complete an abortion in such urgent circumstances; and (vi) the member is unable to seek assistance from another doctor or invoke federal conscience protections and is instead forced to complete an
abortion.
To state that theory is to refute it. This Court has
“repeatedly reiterated that ‘threatened injury must be
certainly impending to constitute injury in fact,’ and
that ‘allegations of possible future injury’ are not sufficient.” Clapper, 568 U.S. at 409 (brackets and citation
omitted). Time and again, therefore, the Court has rejected theories of standing that rest on a “speculative
chain of possibilities,” id. at 414, especially where, as
here, those possibilities depend on “unfettered choices
made by independent actors,” Lujan v. Defenders of
Wildlife, 504 U.S. 555, 562 (1992) (citation omitted).
In Clapper, for example, the Court reversed a decision finding standing based on “an objectively reasonable likelihood” that plaintiffs would suffer injury from
the challenged policy. 568 U.S. at 410. The Court explained that such an approach is “inconsistent with [the]
requirement that ‘threatened injury must be certainly
22
impending.’ ” Ibid. (citation omitted). Similarly, in
Summers, the Court explained that an organization
member’s assertion that he planned to visit “unnamed”
national forests was insufficient to establish standing to
challenge regulations exempting certain Forest Service
projects from notice, comment, and appeal procedures.
555 U.S. at 495; see id. at 490. The Court explained that
because the theory of standing depended on a chain of
contingencies, it might have demonstrated “a chance”
of injury, but “hardly [the] likelihood” necessary to satisfy Article III. Id. at 495.
So too here. Respondents’ theory relies on a long
chain of contingencies involving independent actions by
third parties, including other providers, patients, and
respondents’ employers. And key links in that chain are
particularly speculative. As the Fifth Circuit acknowledged, for example, mifepristone’s rates of serious adverse events such as hospitalization, blood transfusion,
or serious infection are extremely low. Pet. App. 18a;
see J.A. 303-304. And by definition, the risk that a
woman experiencing such an adverse event would present in an emergency room with an ongoing pregnancy
is even lower.
In addition, even if such a woman happened to present in an emergency room where a respondent doctor
was working, respondents have not explained how or
why the doctor would be compelled to provide an abortion against her conscience. A variety of federal laws
prohibit employers from requiring employees to perform or participate in abortions or other procedures to
which they object. See, e.g., 42 U.S.C. 238n, 300a-7(c)
and (d); Consolidated Appropriations Act, 2022, Pub.
L. No. 117-103, Div. H, Tit. V, §§ 506-507, 136 Stat. 496.
Respondents’ two declarations addressing identified
23
members’ religious or moral objections do not explain
why those protections would not be available to the declarants. See J.A. 155, 167. Indeed, those declarations
do not include any information about employer policies
or other circumstances that could compel the declarants
to provide care to which they object. 3
b. Decades of experience confirm that none of respondents’ member doctors face any realistic threat—
much less a certainly impending threat—of being forced
to complete an abortion for a mifepristone patient.
Standing to seek prospective relief, of course, cannot be
based on mere “past injury”; instead, a plaintiff must
show an “imminent future injury.” Summers, 555 U.S.
at 495. Here, however, the striking absence of any past
conscience injury powerfully underscores that respondents’ theory is speculative.
Mifepristone has been on the market for more than
23 years. During that time, more than five million
American women have relied on the drug to end their
pregnancies. Pet. App. 19a. And respondents claim
The Fifth Circuit stated that federal conscience protections did
not “alleviate the Doctors’ conscience injury” because the court believed the government’s invocation of those protections here is inconsistent with its arguments in other litigation concerning the
Emergency Medical Treatment and Labor Act (EMTALA), 42
U.S.C. 1395dd. Pet. App. 34a; see id. at 33a-34a. The government
has argued that, in some circumstances, the emergency care required by EMTALA may include abortion care; this Court has
granted certiorari to review that question in Moyle v. United States,
cert. granted, No. 23-726 (Jan. 5, 2024). But EMTALA imposes obligations on covered “hospital[s],” not individual doctors. 42 U.S.C.
1395dd(b)(1). And in the separate litigation on which the Fifth Circuit relied, the government specifically disclaimed the suggestion
that “EMTALA would compel individuals to perform abortions contrary to their sincerely held religious or moral beliefs.” Gov’t Reply
Br. at 25, Texas v. Becerra, 89 F.4th 529 (5th Cir. 2024).
3
24
that their members include “thousands of doctors and
hundreds of OB/Gyns and emergency-room doctors.”
Id. at 23a. Yet neither respondents nor the Fifth Circuit have pointed to even a single instance in which a
member of a respondent organization was required to
terminate an ongoing pregnancy.
Instead, the Fifth Circuit primarily relied on Dr.
Francis’s description of the experience of her unidentified “partner.” Pet. App. 19a (quoting J.A. 154); see id.
at 24a; Br. in Opp. 33-34. Notably, nothing in the declaration states that the partner is a member of a respondent organization. Nor does the declaration explain why
the partner chose to provide treatment rather than refer the patient to another, non-objecting doctor or invoke federal conscience protections.
The other declarations on which the Fifth Circuit
and respondents have relied also do not substantiate
their asserted conscience injury. Those declarations recount only that at some point in the more than two decades mifepristone has been on the market, the declarants or other doctors treated patients who experienced
“complications” after using mifepristone to end a pregnancy. Br. in Opp. 21. But none of those declarations
states that the declarant had a religious or moral objection to providing such care.
Respondents focus (Br. in Opp. 21) on the declaration of Dr. Skop, which describes one incident in which
she performed a procedure to remove pregnancy tissue
from a patient’s uterus but does not suggest that the
pregnancy was ongoing at the time. See J.A. 164. The
declaration neither states that Dr. Skop conscientiously
objected to providing such care, nor explains why, if she
did object, she chose to proceed rather than invoking
applicable conscience protections. Dr. Skop’s other spe-
25
cific allegations state that she or someone in her “group
practice” “cared for” patients who required certain
treatments other than the termination of an ongoing
pregnancy, without explaining whether she personally
performed any particular medical procedure or whether
she objected to doing so. J.A. 163. Respondents’ remaining declarations are similarly vague and lacking in
evidence of a conscience injury. 4
Again, even demonstrated instances of past injury
would not necessarily establish standing to seek prospective relief. See City of Los Angeles v. Lyons, 461
U.S. 95, 105-106 (1983). But particularly given the lack
of any showing of such past incidents here, respondents
cannot satisfy Article III with bare speculation that the
availability of mifepristone “could force [them] to have
to surgically finish an incomplete elective chemical
abortion.” Pet. App. 24a (quoting J.A. 167) (emphasis
added).
3. Respondents’ remaining theories of injury likewise
fail
In addition to their asserted conscience injury, respondents contend that providing emergency care to
women who have taken mifepristone will cause the individual respondents or members of respondent organizations “mental and emotional stress”; that it will require them to “divert time and resources away from
their ordinary practice”; and that it will “expose[]
[them] to greater malpractice liability and increased inSee Pet. App. 22a (citing J.A. 173-174) (relying on Dr. Wozniak’s
declaration, which describes one instance in which she treated a patient for “adverse effects,” without suggesting any objection); id. at
28a (citing J.A. 198) (relying on Dr. Jester’s statement that he
treated a woman with a uterine infection, without suggesting any
objection).
4
26
surance costs.” Pet. App. 24a-26a. But like the conscience theory, those theories fail at the outset because
respondents have not identified any doctor who faces an
imminent risk of being forced to treat a mifepristone
patient. And each of respondents’ other theories has
additional flaws.
a. Respondents first assert that treating women
who have taken mifepristone causes them to experience
feelings of “stress and pressure.” Pet. App. 34a (quoting J.A. 172). But even the Fifth Circuit rejected the
suggestion that those feelings are a judicially cognizable injury. Instead, the court found that such “mental
and emotional stress” is “best understood as additional
to the Doctors’ conscience injuries, not independent
from them.” Id. at 34a-35a.
The Fifth Circuit correctly recognized that respondents’ feelings of “stress and pressure” are not themselves Article III injuries. Pet. App. 35a. Respondents’
identified members are doctors who have chosen to provide emergency care in hospital settings. “Stress and
pressure” are inherent in that vocation, and respondents have not cited any authority suggesting that simply
being presented with a person in need of emergency
care qualifies as an Article III injury to a doctor whose
chosen profession is treating patients in an emergent
setting.
Endorsing that novel theory would open the courthouse doors to an endless parade of suits. Doctors could
sue to challenge virtually any policy that allegedly increased the risk that they would be presented with patients whose cases they find distressing—a category
that could include everything from gun regulations to
automobile or workplace safety standards. Nor would
the logic be limited to doctors; lawyers and other pro-
27
fessionals could likewise sue to challenge any policy that
allegedly caused them to be presented with potential
clients whose cases they found stressful. The Fifth Circuit correctly rejected that limitless conception of Article III.5
b. Respondents’ reliance on a “diversion of resources” theory, Pet. App. 25a, is equally limitless and
equally flawed. Emergency medicine necessarily requires triaging patients and thereby diverting resources from some patients to others. If that were sufficient for standing, then emergency-room doctors
could challenge any regulation (or lack thereof ) that
threatened to increase the number of patients with a
particular condition. Nor do respondents provide any
basis for defining one group of patients as their “regular” ones, id. at 31a, and thereby labeling treatment of
those in the disfavored class a source of diversion. And
while respondents have suggested vague harm to their
“business interests,” Br. in Opp. 35 (brackets and citation omitted), they provide no support for the counterintuitive proposition that doctors suffer cognizable economic harm when they are presented with patients requiring care.
c. Finally, respondents and the Fifth Circuit provide no basis for concluding that FDA’s regulatory actions with respect to a drug that respondents’ members
do not prescribe exposes them to malpractice claims or
higher insurance costs. Pet. App. 28a, 31a. They do not
identify any instance in which respondents or any of
The Fifth Circuit stated that respondents’ standing theory was
not “ ‘limitless,’ ” but that was because the court treated the stressrelated injury as “augment[ing]” the conscience-based theory rather than “provid[ing] a separate basis for Article III standing.”
Pet. App. 35a (citation omitted).
5
28
their members have ever been sued, threatened with a
lawsuit, or required to pay increased insurance premiums because they treated women who had taken mifepristone. See id. at 31a-32a (citing J.A. 141-142, which
simply speculates as to this possible chain of events).
Respondents’ unadorned speculation cannot demonstrate an imminent injury in fact.
B. Respondents Have Not Shown That Their Asserted Injuries Are Fairly Traceable To FDA’s 2016 And 2021 Actions
The Fifth Circuit committed two additional, independent errors in holding that respondents’ alleged injuries were fairly traceable to FDA’s actions in 2016 and
2021. Pet. App. 36a-41a.
1. As an initial matter, FDA’s challenged actions
simply authorized Danco and GenBioPro to distribute
mifepristone under specified conditions. FDA did not
require any healthcare provider to prescribe the drug
or any patient to take it. A patient’s decision to take
mifepristone—in consultation with her provider and after being fully advised of the risks—is the product of
independent actions by those third parties. And in the
exceedingly rare cases where the result of those independent actions is a serious adverse event requiring
emergency medical treatment, FDA’s actions neither
require patients to seek treatment from respondents
nor require respondents to provide it. Accordingly,
even if respondents’ asserted future harms were cognizable, they would not be fairly traceable to FDA’s actions because they rest on a “line of causation” that is
“attenuated at best” and that turns on the independent
decisions of multiple third parties who are strangers to
this litigation. Allen v. Wright, 468 U.S. 737, 757 (1984).
29
Nor have respondents suggested that Congress has
attempted to “elevate[]” their asserted injuries “to the
status of legally cognizable injuries redressable by a
federal court,” Texas, 599 U.S. at 681-682, or to “articulate chains of causation that will give rise to a case or
controversy where none existed before,” Spokeo v. Robins, 578 U.S. 330, 341 (2016) (citation omitted). Nothing
in the FDCA confers any rights on respondents or contemplates suits based on incidental and attenuated
harms to doctors who oppose the availability of a drug
and seek to prevent other doctors and patients from
prescribing and using it.
2. The Fifth Circuit’s traceability holding also fails
on its own terms.
a. As the Fifth Circuit acknowledged (Pet. App.
36a), it is axiomatic that “standing is not dispensed in
gross; rather, plaintiffs must demonstrate standing for
each claim that they press and for each form of relief
that they seek.” TransUnion LLC v. Ramirez, 594 U.S.
413, 431 (2021). Here, the Fifth Circuit held that respondents’ challenge to FDA’s original 2000 approval of
mifepristone is likely time barred, and this Court has
declined to grant certiorari on that question. Respondents thus cannot establish traceability by simply asserting that all adverse events associated with mifepristone
“are traceable to FDA because it approved the drug.”
Pet. App. 16a. Instead, respondents must demonstrate
that they face imminent injury due to the incremental
effects of FDA’s 2016 and 2021 actions addressing mifepristone’s conditions of use.
That poses a serious hurdle because respondents’ evidentiary presentation in the district court focused almost entirely on their assertion that they are injured by
the availability of mifepristone in general—an assertion
30
that depended on respondents’ recounting of undated
and sporadic encounters with women who took the drug,
and that made little or no effort to isolate the effects of
FDA’s 2016 and 2021 actions. Pet. App. 129a-131a.
The Fifth Circuit nonetheless held that respondents
made the required traceability showing on the theory
that FDA’s 2016 and 2021 actions “will increase the
number of women who suffer complications as a result
of taking mifepristone.” Pet. App. 36a. But it is implausible that the incremental effects of FDA’s actions
cause enough additional serious adverse events to establish a certainly impending injury to respondents. To
the contrary, the record demonstrates that serious adverse events remain extremely infrequent with the relevant actions in place. See, e.g., J.A. 442-500; see also
FDA, Mifepristone U.S. Post-Marketing Adverse
Events Summary through 12/31/2022 (Adverse Events
Summary).
b. The Fifth Circuit did not cite any studies or other
scientific evidence to support its conclusion that the
2016 Amendments will cause more women to experience
complications from mifepristone. Instead, the court
simply repeated the “three reasons” asserted in respondents’ declarations. Pet. App. 36a. None of those
reasons withstands scrutiny.
First, the court echoed respondents’ assertion that
“the risk of complication increases with gestational age”
and raising the gestational age limit from 49 to 70 days
will thus result in additional complications. Pet. App.
36a. That contention rested on respondents’ own conclusory declarations; respondents have not supported it
with studies or other evidence. And the available scientific evidence demonstrates that mifepristone remains
extremely safe throughout the full 70-day period: As
31
FDA explained in 2016, “[i]ncreased gestational age
was not associated with an increased incidence of [serious adverse events].” J.A. 304.
Second, the court reasoned that the removal of the
second and third in-person visits would result in an “increase” in “the percentage of women who experience
complications that present to [an] emergency room.”
Pet. App. 37a. But again, respondents did not cite any
statistics demonstrating such an increase in the seven
years the 2016 changes had been in effect—much less
an increase sufficient to put any identifiable respondent
or member at imminent risk of being required to treat
a mifepristone patient she would not have had to treat
under the framework that existed prior to 2016.
Third, the Fifth Circuit stated that “the percentage
of women who present to the emergency room will increase because the [2016 changes] allow non-physicians
to prescribe mifepristone,” and the court believed that
patients who receive a prescription from such a practitioner “ ‘cannot possibly go back to their non-doctorprescribers for surgical abortions.’ ” Pet. App. 37a (citation omitted). But the court’s premise was wrong. In
fact, non-physician practitioners who were authorized
to prescribe mifepristone were already providing abortion care, including follow-up surgical care, before the
2016 changes. See, e.g., J.A. 309-310, 497; National Ass’n
of Nurse Practitioners Cert. Amicus Br. 10-11, 14-17.
c. The Fifth Circuit likewise erred in determining
that FDA’s 2021 decision that the in-person dispensing
requirement was no longer warranted “contributes to
[respondents’ alleged] injury.” Pet. App. 38a. Again,
the court relied on respondents’ unsupported allegations that—contrary to FDA’s findings—that decision
would result in “more complications” requiring emer-
32
gency care. Id. at 41a. And again, the court did not attempt to quantify that supposed increase, nor explain
how it would be significant enough to demonstrate that
any particular doctor would imminently be required to
treat a patient suffering such a complication despite the
doctor’s objection. 6
C. Respondents Lack Organizational Standing
The Fifth Circuit relied solely on associational standing and did not decide whether the respondent associations have “organizational standing” to sue on their own
behalf. Pet. App. 41a. Respondents have advanced an
organizational theory as an alternative basis for upholding the Fifth Circuit’s decision (Br. in Opp. 37-39), but
that theory is equally meritless.
The Fifth Circuit repeated respondents’ assertion that the effects of the 2021 decision would be particularly great “in cases of
ectopic pregnancy.” Pet. App. 39a (citing J.A. 165-166). But mifepristone does not exacerbate ectopic pregnancy; it simply is not effective in treating that condition. As FDA recognized, ectopic pregnancies may be diagnosed without an in-person examination. J.A.
255. And as with respondents’ other theories of injury, their reliance on the possibility of undiagnosed ectopic pregnancies attributable to FDA’s 2021 decision rests on a speculative chain of events:
that a woman with an ectopic pregnancy will be prescribed mifepristone by another provider who fails to diagnose that condition; that
the ectopic pregnancy would have been caught during an in-person
visit; that the woman’s ectopic pregnancy will rupture before she
confirms with her provider that she is still pregnant; and that she
will ultimately seek emergency care from a member of a respondent
organization—despite the fact that ectopic pregnancy occurs in just
0.005% of women who use mifepristone. U.S. Gov’t Accountability
Office, GAO-08-751, FDA: Approval and Oversight of the Drug Mifeprex 39 (2008), https://perma.cc/JZW33J8N. Moreover, the risks
associated with ectopic pregnancy provide no support for respondents’ principal theory of injury because no respondent has asserted
any conscience objection to treating an ectopic pregnancy.
6
33
Respondents assert that FDA’s 2016 actions caused
them to “expend[] ‘considerable time, energy and resources’ on their 26-page citizen petition challenging”
those actions. Br. in Opp. 38 (citation omitted). But if
the cost of opposing agency action were sufficient to satisfy Article III, any party could bootstrap its way into
standing to challenge any agency action merely by doing so. That is not the law.
Respondents also assert that FDA’s 2021 decision
regarding the in-person dispensing requirement “ ‘impaired’ ” their “ ‘ability to provide [chemical abortion]
counseling’ to pregnant women.” Br. in Opp. 38 (quoting Havens Realty Corp. v. Coleman, 455 U.S. 363, 379
(1982)) (brackets in original). But FDA’s action in no
way prohibited respondents from providing counseling
to any women willing to receive it. And respondents do
not explain how a change in the way other providers dispense mifepristone to women who decide to seek it has
any effect on respondents’ counseling efforts. 7
* * * * *
“No principle is more fundamental to the judiciary’s
proper role in our system of government than the constitutional limitation of federal-court jurisdiction to actual cases or controversies.” Simon v. Eastern Ky. Welfare Rights Org., 426 U.S. 26, 37 (1976); see TransUnion, 141 S. Ct. at 2203. The lower courts lost sight of
Although the Fifth Circuit did not reach the question (Pet. App.
41a-42a), respondents have briefly suggested (Br. in Opp. 20 n.2)
that they “satisfy the requirements for third-party standing.” But
those requirements are additional showings that must be made
when a party seeks to assert the rights of a third party. Third-party
standing is not a substitute for the “irreducible constitutional minimum of standing,” which requires “the plaintiff” to have “suffered
an ‘injury in fact.’ ” Lujan, 504 U.S. at 560.
7
34
that principle in drawing on the conclusory assertions
in respondents’ declarations to credit their highly speculative and attenuated claims of Article III injury. This
Court should reject respondents’ profoundly flawed
theories and put an end to this case by holding that respondents lack Article III standing.
II. FDA’S ACTIONS WERE LAWFUL
The Fifth Circuit compounded its standing errors by
holding that FDA acted arbitrarily and capriciously in
approving changes to mifepristone’s conditions of use in
2016, in modifying the adverse-event reporting requirements under the REMS at the same time, and in determining in 2021 that the in-person dispensing requirement was no longer necessary. The arbitrary and capricious standard is “deferential.” FCC v. Prometheus
Radio Project, 592 U.S. 414, 423 (2021). A reviewing
court’s only role is to ensure “that the agency has acted
within a zone of reasonableness” and “has reasonably
considered the relevant issues and reasonably explained the decision.” Ibid. And where, as here, the
parties disagree on matters relating to public health,
“courts owe significant deference to the politically accountable entities with the ‘background, competence,
and expertise to assess public health.’ ” FDA v. American Coll. of Obstetricians & Gynecologists, 141 S. Ct.
578, 579 (2021) (Roberts, C.J., concurring in the grant
of application for stay) (citation omitted). The Fifth
Circuit’s decision ignored those foundational principles.
A. FDA Lawfully Changed The Conditions Of Use In 2016
1. In 2016, FDA approved Danco’s application to
change mifepristone’s conditions of use by, as relevant
here, (a) increasing the gestational age limit from seven
to ten weeks; (b) reducing the number of office visits
35
from three to one; and (c) allowing certain licensed nonphysician health care providers to prescribe mifepristone. J.A. 283-291. FDA’s approval of the 2016 changes
was both “reasonable and reasonably explained.” Department of Commerce v. New York, 139 S. Ct. 2551,
2571 (2019). FDA based its decision on an exhaustive
review of “experience and data gained in the last 20 years
from millions of women in the US and abroad,” among
other information. J.A. 451; see J.A. 436-437 (listing 14
“major studies and review articles covering over 45,000
women”); J.A. 509-516 (listing over 70 publications examining safety and efficacy). And FDA carefully explained how that scientific evidence supported its conclusion that the changes would not result in “a safety
profile different from the original approved Mifeprex
dosing regimen.” J.A. 304; see J.A. 292-320; 418-525.
Increase in gestational age. FDA relied on “[f]our
studies” and a “systematic review” including “over
30,000” women, all of which had “evaluated the exact
proposed dosing regimen through 70 days gestation.”
J.A. 299. These publications showed that mifepristone’s
success rate between 49 and 70 days gestation—still
well within the first trimester—was “comparable to
(and in several studies, greater than) the success rates
for medical abortion in the initial 2000 decision for Mifeprex up to 49 days gestation.” J.A. 456. The data also
indicated “that the rates of * * * serious adverse events
are not clinically different from that of other gestational
age ranges.” J.A. 304.
Reduction in office visits. FDA relied on nearly a
dozen studies involving “large numbers of women in the
U.S.” and other countries, all of which showed that completing the two-drug protocol at home was “associated
with exceedingly low rates of serious adverse events,
36
and with rates of common adverse events comparable to
those in the studies of clinic administration of misoprostol that supported the initial approval in 2000.” J.A.
308; see J.A. 458 (citing studies); J.A. 466 (discussing
“studies including well over 30,000 patients”). FDA explained that “there is no medical rationale” for a woman
to return to the clinic to be given misoprostol and that
“it is preferable for the woman to be in a convenient,
safe place”—rather than in transit home from a second
visit—for the onset of the cramping and bleeding that
typically occur shortly after taking misoprostol. J.A.
459. FDA likewise concluded that there is no medical
reason for an in-person follow-up visit to confirm the
termination of the pregnancy and that the method of
follow up should instead be “determined jointly by the
healthcare provider and the individual woman being
treated.” J.A. 462.
Prescriptions by non-physician providers. FDA relied on “four studies with 3,200 women in randomized
controlled clinical trials and 596 women in prospective
cohorts.” J.A. 302. Those studies found “no differences
in efficacy, serious adverse events, ongoing pregnancy
or incomplete abortion” depending on whether a physician prescribed the drug. J.A. 497.
2. The Fifth Circuit’s sole basis for holding that the
2016 changes were arbitrary and capricious was its assertion that FDA purportedly failed to “consider the cumulative effect of the 2016 amendments” because it did
not cite a study that evaluated the effects of those
changes “as a whole.” Pet. App. 53a. That holding was
doubly wrong.
First, the APA requires an agency to review the record, “reasonably consider[] the relevant issues,” and
“reasonably explain[] [its] decision.” Prometheus, 592
37
U.S. at 423. Here, FDA explicitly determined that the
approved conditions of use after the 2016 changes would
“continue to assure safe use” of the drug and that “the
benefit-risk profile for Mifeprex continues to be favorable” with the changes. J.A. 319. FDA grounded its
judgment in a voluminous body of medical evidence
on the widespread use of mifepristone over decades.
And the agency carefully explained why the available
data supported its conclusion that the 2016 changes
would allow the drug to continue to be used safely and
effectively—as in fact it has been since that time. J.A.
307-310, 478-485.
The Fifth Circuit did not conclude that FDA ignored
any study in the administrative record. Nor did it identify any evidence suggesting that any of the changes
would be unsafe, either alone or in combination. Instead, the court faulted FDA for “neither consider[ing]
the effects as a whole”—by which the court meant citing
a study that “examined the effect of implementing all of
[the 2016] changes together”—nor “explain[ing] why it
declined to do so.” Pet. App. 53a. But FDA was not
required to commission or conduct scientific studies.
And as this Court explained in rejecting a similar argument, it was not arbitrary or capricious for FDA to
“rel[y] on the data it had (and the absence of any countervailing evidence) to predict” that changes it had determined were safe individually would also be safe collectively. Prometheus, 592 U.S. at 425.
The Fifth Circuit’s contrary conclusion ignored the
realities of the drug-approval process. As FDA has explained, “[m]any clinical trial designs are more restrictive * * * than will be necessary or recommended in
postapproval clinical use; this additional level of caution
is exercised until safety and efficacy of the product is
38
demonstrated.” J.A. 265. The pharmaceutical industry
has underscored this point, noting that “[t]here are virtually always differences between clinical trial conditions and approved labeling,” in part because studies
typically include extra conditions intended to assure
data quality. Pharm. Cos. Cert. Amici Br. 15. Requiring sponsors to provide a single study exactly matching
all of the approved conditions of use would thus impose
“an impossibly rigid new standard.” Id. at 12 (emphasis
omitted); see PhRMA Cert. Amicus Br. 12-19.
Nor did the Fifth Circuit posit any reason to think
that three changes that were shown to be safe individually would somehow be dangerous in combination. Respondents have not attempted to make such a showing
either. To the contrary, their citizen petition challenging the 2016 changes never suggested that the changes
could be unsafe in combination even if they were safe
individually or that FDA had erred because no study
considered the changes “as a whole.” See J.A. 321-347.
FDA can scarcely be faulted for failing to more explicitly consider an issue that respondents themselves
failed to raise before the agency.
Second, and in any event, the Fifth Circuit’s conclusion that FDA did not rely on studies considering the
cumulative effect of the 2016 changes was wrong on the
record. FDA considered numerous studies that examined the effect of multiple proposed modifications. Indeed, FDA considered at least three studies that closely
mirrored challenged aspects of the 2016 conditions. See,
e.g., Sanhueza Smith et al. 2015 (cited at J.A. 299 n.3)
(up to 70 days gestation, same dose, dosing regimen,
route of administration, and at-home administration of
misoprostol); Winikoff et al. 2012 (cited at J.A. 299 n.1)
(same); Olavarietta 2015 (cited at J.A. 299 n.4) (same,
39
and also evaluating prescribing by nurses versus physicians). FDA explicitly stated that it was relying on data
from those studies, and others, “to support multiple
changes.” J.A. 298. Fairly read, therefore, the record
makes plain FDA’s conclusion that the combined changes
would not affect the well-established safety or effectiveness profile of mifepristone. And neither the APA, the
FDCA, nor any other source of law required FDA to use
the phrase “as a whole” or otherwise “incant ‘magic
words.’ ” Garland v. Ming Dai, 593 U.S. 357, 369 (2021).
3. Respondents and the district court—but not the
Fifth Circuit—also questioned the substance of FDA’s
assessment of the data before the agency. But the deferential arbitrary and capricious standard does not give
litigants or the courts a license to second-guess highly
technical determinations that Congress has assigned to
an expert agency. In any event, respondents’ and the
district court’s objections lack merit.
a. The district court highlighted some reports of
particularly serious events in patients who had taken
mifepristone, including deaths. E.g., Pet. App. 178a.
But the fact that a drug is associated with an adverse
event for reporting purposes does not mean that it actually caused that event. As of December 2022, 32
deaths had been reported among nearly six million
women who have taken mifepristone, and some of those
had obvious alternative causes—including homicide,
drug overdose, and other factors entirely unrelated to
mifepristone. See Adverse Events Summary. In addition, pregnancy itself entails a significantly higher risk
of serious adverse events, including a death rate 14
times higher than that associated with legal abortion.
J.A. 241.
40
Regardless, the FDCA does not limit FDA to approving drugs only when they are without risk—a
standard no drug could satisfy. Instead, FDA must consider whether “the expected therapeutic gain justifies
the risk entailed by [the drug’s] use.” United States v.
Rutherford, 442 U.S. 544, 555 (1979); see 21 U.S.C.
355(d). That is what FDA did here. Although FDA has
acknowledged that serious adverse events can occur
with mifepristone use, it found that they are “exceedingly rare.” J.A. 465. And it concluded that the evidence relating to the proposed changes “d[id] not suggest a safety profile different from the original approved Mifeprex dosing regimen,” J.A. 304, and that
“the benefit-risk profile for Mifeprex continues to be favorable” with the changes, J.A. 319.
b. For their part, respondents have criticized (Br. in
Opp. 43) various features of a handful of the dozens of
studies on which FDA relied. For example, respondents object (ibid.) that FDA’s decision extending mifepristone’s gestational limit from seven to ten weeks was
based on studies involving “ultrasounds and follow-up
visits,” even though FDA did not impose those requirements in the approved 2016 conditions of use. To the
extent respondents suggest that FDA failed to consider
the potential necessity of ultrasound and follow-up, they
are mistaken. FDA addressed both points at length in
its review of Danco’s application and when responding
to respondents’ citizen petitions. See J.A. 254-256, 265,
285-341, 466, 482-485. With respect to ultrasound, FDA
explained that such a requirement was unnecessary because “in clinical practice, pregnancies can also be (and
frequently are) dated using other clinical methods.”
J.A. 255; see J.A. 482-485. And FDA explained that a
requirement of in-clinic follow-up care was unnecessary
41
because “appropriate follow-up * * * may be accomplished in multiple ways and not all require an in-clinic
visit.” J.A. 385-386. These aspects of the record, which
respondents simply ignore, demonstrate that FDA did
not “fail[] to consider an important aspect of the problem.” Motor Vehicle Mfrs. Ass’n of the U.S., Inc. v.
State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). 8
B. FDA Lawfully Changed The Adverse Event Reporting
Requirements In 2016
FDA’s 2016 action also changed the requirement under the REMS that prescribers of mifepristone agree to
report certain adverse events such as hospitalizations
and blood transfusions to the drug’s sponsor—a requirement that created obligations beyond FDA’s
standard reporting requirements for drug sponsors,
which are applicable to all FDA-approved drugs. J.A.
319, 392. FDA determined that “after 15 years of reporting serious adverse events, the safety profile for
Mifeprex is essentially unchanged,” J.A. 319, and that
the continued reporting of non-fatal adverse events by
prescribers under the REMS was “not warranted” because mifepristone’s “known risks occur[] rarely,” J.A.
392. But FDA made clear that mifepristone’s sponsors
In addition, FDA’s 2016 action also changed mifepristone’s approved dosing regimen, including reducing the amount of mifepristone from 600 mg to 200 mg; increasing the amount of misoprostol;
reducing the amount of time between taking mifepristone and misoprostol; and changing the route of administration of the misoprostol.
J.A. 295. FDA explained that those changes would more closely
align with clinical practice. J.A. 443-450. Respondents have not specifically challenged those changes. Accordingly, even if the Court
determines that FDA acted arbitrarily in approving other changes
in 2016, it should make clear that any resulting relief does not require FDA to revert to an outdated dosing regimen.
8
42
remained (and still remain) under an obligation to report all “serious and unexpected” adverse events to
FDA within 15 days, and to report all other adverse
events annually, 21 C.F.R. 314.80(c)(1)(i); see 21 C.F.R.
314.98. J.A. 392.
The Fifth Circuit held that FDA’s change to the reporting requirements was arbitrary and capricious, asserting that FDA failed to acknowledge that the 2016
changes to the conditions of use “might alter the risk
profile” of mifepristone. Pet. App. 55a. As explained
above, however, FDA had already found that the 2016
changes would not affect mifepristone’s safety profile.
The APA did not compel FDA to maintain heightened
reporting requirements it had determined were unnecessary to account for changes in risk that FDA had determined would not occur.
In any event, even if the Fifth Circuit were correct
that FDA acted arbitrarily and capriciously in eliminating the special adverse-event reporting requirement
that previously applied to mifepristone, the only relief
that such an error could justify would be an order requiring FDA to reinstate that requirement or explain
more fully why it is unnecessary. The asserted error
would provide no basis for suspending the changes to
mifepristone’s approved conditions of use.
C. FDA Lawfully Decided To Remove The In-Person
Dispensing Requirement In 2021
The Fifth Circuit likewise erred in concluding that
FDA acted arbitrarily and capriciously by deciding to
remove the in-person dispensing requirement after determining it was no longer needed to assure mifepristone’s safe use—and thus no longer justified under the
FDCA. J.A. 397-408. FDA’s decision “was the result of
a thorough scientific review” by agency experts who
43
evaluated “available clinical outcomes data and adverse
event reports.” J.A. 377.
The Fifth Circuit suggested that because FDA had,
as part of the 2016 changes, eliminated the REMS requirement for prescribers to report certain non-fatal serious adverse events to the sponsor, it was “unreasonable” for FDA to “use the resulting absence of data to
support its decision.” Pet. App. 59a (citation omitted).
But as noted, see pp. 41-42, supra, FDA’s 2016 changes
left undisturbed the reporting requirements governing
mifepristone’s sponsors. And as FDA explained, adverse event reports are contained in the FDA Adverse
Event Reporting System (FAERS) database, which
FDA “routinely monitors.” J.A. 398. FDA’s decision to
remove the in-person dispensing requirement thus incorporated information about all adverse event reports
it had received, including non-fatal adverse events.
Ibid.
The Fifth Circuit stated that FDA’s FAERS database was “insufficient” because some “adverse events
will go unreported.” Pet. App. 59a-60a. By that logic,
FDA acts arbitrarily whenever it relies on the adverseevent data yielded by the reporting regime, which is applicable to all FDA-approved drugs. The Fifth Circuit
did not even attempt to justify that startling conclusion.
Moreover, data from the FAERS system was not the
only evidence FDA considered in 2021. FDA also specifically sought out information from the drug’s sponsors and concluded that the nonenforcement of the inperson dispensing requirement during much of 2020
and 2021 (due to an injunction and, later, enforcement
discretion) did not appear to affect adverse events. J.A.
397-399. FDA also relied on “an extensive review of the
published literature,” including studies that “examined
44
replacing in-person dispensing in certain healthcare
settings” with “dispensing at retail pharmacies” and
“by mail.” J.A. 399-400. FDA’s analysis of those studies
spans nearly ten full pages in the agency’s 2021 petition
response. J.A. 399-408. And FDA further analyzed the
issue in another contemporaneous document explaining
its decision. See FDA, REMS Modification Rationale
Review 19-36, 38-40 (2021), https://perma.cc/W4U3L38P (document beginning on PDF page 41).
The Fifth Circuit focused on FDA’s statement that
the studies were “not adequate on their own to establish
the safety of the model of dispensing mifepristone by
mail.” Pet. App. 63a (quoting J.A. 407). But FDA
acknowledged those limitations and went on to explain
why, “[d]espite the limitations of the studies [it] reviewed,” the available evidence supported its conclusion
that “mifepristone will remain safe and effective if the
in-person dispensing requirement is removed.” J.A.
400, 407. The deferential arbitrary and capricious
standard does not give litigants or the courts a license to
“unduly second-guess” the agency’s “scientific judgments.” Cytori Therapeutics, Inc. v. FDA, 715 F.3d
922, 923 (D.C. Cir. 2013) (Kavanaugh, J.). And this
Court has emphasized that an agency must have the
freedom to make “a reasonable predictive judgment”
based on the available evidence when, as is often the
case, it is operating without “perfect empirical or statistical data.” Prometheus, 592 U.S. at 427. The lower
courts violated this fundamental administrative-law
principle in overriding FDA’s predictive judgments
here.
III. THE DISTRICT COURT’S REMEDY WAS IMPROPER
Even if the Fifth Circuit were correct that respondents have standing and a likelihood of success on the
45
merits, the court erred in affirming the portions of the
district court’s order suspending FDA’s 2016 and 2021
actions. The district court erroneously invoked 5 U.S.C.
705 to “postpone” the effective date of agency actions
that had long been in effect. And especially given the
nature of the errors the lower courts identified, there
was no basis for imposing disruptive preliminary relief
that would harm women, the Nation’s healthcare system, FDA, and mifepristone’s sponsors.
A. The District Court Erred In Relying On 5 U.S.C. 705
Although respondents sought a preliminary injunction requiring FDA to withdraw or suspend the relevant
agency actions, the district court instead invoked
5 U.S.C. 705 to “stay” the effective date of FDA’s challenged actions. Pet. App. 194a. Section 705 provides in
relevant part that, “to the extent necessary to prevent
irreparable injury,” a reviewing court “may issue all
necessary and appropriate process to postpone the effective date of an agency action or to preserve status or
rights pending conclusion of the review proceedings.”
5 U.S.C. 705. But the lower courts never explained how
a court could “postpone” the effective date of actions
that became effective years before the litigation began.
To “postpone” means “to defer to a future or later
time; to put off; delay.” Webster’s New International
Dictionary 1682 (1928) (def. 1); see Black’s Law Dictionary 1389 (3d ed. 1933) (“To put off; defer; delay”).
Section 705 thus requires that any postponement be
contemporaneous with or predate the effective date of
the challenged agency action; otherwise there would be
no way for a court to postpone that effective date. Here,
however, FDA’s challenged decisions with respect to
mifepristone became effective in 2016 and 2021—years
before the district court issued its order. Neither the
46
district court nor the Fifth Circuit made any effort to
reconcile the district court’s order “postpon[ing]”
FDA’s already-effective actions with the text of Section
705.
The lower courts thus erred in interpreting Section
705 to authorize “an interim * * * form of vacatur” and
in treating that relief as the default interim remedy in
suits seeking review of agency action, Pet. App. 194a
(citation omitted)—a theory that departs from background principles requiring party-specific remedies
and would improperly make universal relief the norm.
Instead, courts reviewing agency action must apply the
traditional equitable principles governing the propriety
and scope of any preliminary relief. See, e.g., Winter v.
NRDC, Inc., 555 U.S. 7, 20, 24 (2008).
B. The Balance Of The Equities And The Public Interest
Do Not Support Preliminary Relief
The Fifth Circuit correctly recognized that the availability of any preliminary relief in this case is governed
by “the traditional four-factor test for a preliminary injunction,” including a balancing of the equities and consideration of the public interest. Pet. App. 44a. For at
least three reasons, the Fifth Circuit erred in holding
that those considerations justified affirmance of an order upending a years-long status quo.
First, the portions of the district court’s order affirmed by the Fifth Circuit would impose grave harms
on the government, mifepristone’s sponsors, women
seeking legal medication abortions, and the public. Extant doses of mifepristone would become misbranded
and FDA and the drug’s sponsors would be required to
bring its labeling and other conditions into compliance
with the Fifth Circuit’s decision. Even after FDA made
the required changes, the more restrictive pre-2016
47
conditions of use could unnecessarily impair access to
mifepristone for many women who are seeking to lawfully terminate their pregnancies. The drug would be
approved for a significantly shorter period of time
(through seven, rather than ten, weeks’ gestation), and
the approved conditions would call for women to complete three office visits—even though FDA has found
those conditions to be unnecessary and unjustified.
The loss of access to mifepristone would be damaging for women and healthcare providers around the Nation. For many patients, mifepristone is the best
method to lawfully terminate their early pregnancies.
They may choose mifepristone over surgical abortion
because of medical necessity, a desire for privacy, or
past trauma. C.A. ROA 2468-2470, 2478-2485, 25102511. Surgical abortion is an invasive procedure that
can have greater health risks for some patients, such as
those who are allergic to anesthesia. J.A. 228-230, 242.
Second, respondents’ asserted injuries cannot remotely justify the disruptive alteration of the status quo
that the district court’s preliminary relief would entail.
Respondents’ central contention is that if mifepristone
were available under the pre-2016 conditions rather
than the current conditions, the risk that one or more of
their members would be called upon to treat a serious
adverse event would be reduced to some marginal and
unquantified extent. Even if that attenuated, probabilistic injury could satisfy Article III, it would not justify
destabilizing nationwide preliminary relief. Respondents’ own conduct underscores the point: They delayed
for almost three years before petitioning FDA to reconsider the changes made in 2016; waited nearly a year to
challenge the denial of that 2019 petition; and then disclaimed a need for preliminary relief and instead asked
48
the district court to consolidate their preliminaryinjunction motion with a full trial on the merits, C.A.
ROA 3250. That history belies any need for immediate
relief, or any equitable basis for granting it.
Third, the grounds on which the Fifth Circuit held
that respondents are likely to succeed further underscore the impropriety of preliminary relief. Unlike the
district court, the Fifth Circuit did not conclude that
mifepristone is unsafe. Instead, the court held that
FDA did not adequately explain its 2016 and 2021 actions. Even if that were true, those asserted failures of
explanation would at most have justified a direction to
FDA to further consider the relevant issues, without additional relief that would bar distribution of mifepristone as presently approved. See, e.g., Weinberger v.
Romero-Barcelo, 456 U.S. 305, 312-314, 320 (1982).
Lower courts sometimes order such limited equitable
relief by describing the remedy as a “remand without
vacatur.” Bloomberg L.P. v. SEC, 45 F.4th 462, 466
(D.C. Cir. 2022). Whatever the form, that approach accords with traditional equitable principles by avoiding
“needless[] disrupt[ion]” when an agency can likely cure
a defect through further consideration and explanation.
Id. at 478; see Romero-Barcelo, 456 U.S. at 320.
Here, the Fifth Circuit expressed doubt that “FDA
could cure its mistakes with further consideration.”
Pet. App. 72a. But it offered no meaningful explanation
for that conclusion. As to the 2016 changes, for example, the only flaw the Fifth Circuit identified is that
FDA failed to explicitly state that it had concluded that
three changes that it had exhaustively found to be safe
by themselves would also be safe in combination. And
if FDA considered either the 2016 or the 2021 actions
again now, it would also be able to rely on years of ex-
49
perience with the continued safe and effective use of
mifepristone under the challenged conditions. At a minimum, FDA should have the opportunity to address the
Fifth Circuit’s concerns before the entry of sweeping
preliminary relief that would alter a years-long status
quo and inflict profound harm on women, the medical
system, the agency, and the public.
CONCLUSION
The judgment of the court of appeals should be reversed.
Respectfully submitted.
SAMUEL R. BAGENSTOS
General Counsel
Department of Health
and Human Services
MARK RAZA
Chief Counsel
U.S. Food and Drug
Administration
JANUARY 2024
ELIZABETH B. PRELOGAR
Solicitor General
BRIAN M. BOYNTON
Principal Deputy Assistant
Attorney General
BRIAN H. FLETCHER
EDWIN S. KNEEDLER
Deputy Solicitors General
SARAH E. HARRINGTON
Deputy Assistant Attorney
General
ERICA L. ROSS
CHARLES L. MCCLOUD
Assistants to the Solicitor
General
MICHAEL S. RAAB
CYNTHIA A. BARMORE
Attorneys
APPENDIX
TABLE OF CONTENTS
Page
Appendix —
Statutory provisions:
5 U.S.C. 705....................................... 1a
21 U.S.C. 355 ..................................... 1a
21 U.S.C. 355-1.................................. 3a
APPENDIX
1.
5 U.S.C. 705 provides:
Relief pending review
When an agency finds that justice so requires, it
may postpone the effective date of action taken by it,
pending judicial review. On such conditions as may be
required and to the extent necessary to prevent irreparable injury, the reviewing court, including the court to
which a case may be taken on appeal from or on application for certiorari or other writ to a reviewing court,
may issue all necessary and appropriate process to
postpone the effective date of an agency action or to
preserve status or rights pending conclusion of the review proceedings.
2.
21 U.S.C. 355 provides in relevant part:
New drugs
(a)
Necessity of effective approval of application
No person shall introduce or deliver for introduction
into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b)
or ( j) is effective with respect to such drug.
*
(d)
*
*
*
*
Grounds for refusing application; approval of application; “substantial evidence” defined
If the Secretary finds, after due notice to the applicant in accordance with subsection (c) and giving him an
opportunity for a hearing, in accordance with said sub(1a)
2a
section, that (1) the investigations, reports of which are
required to be submitted to the Secretary pursuant to
subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such
drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling
thereof; (2) the results of such tests show that such drug
is unsafe for use under such conditions or do not show
that such drug is safe for use under such conditions; (3)
the methods used in, and the facilities and controls used
for, the manufacture, processing, and packing of such
drug are inadequate to preserve its identity, strength,
quality, and purity; (4) upon the basis of the information
submitted to him as part of the application, or upon the
basis of any other information before him with respect
to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions; or (5) evaluated on the basis of the information
submitted to him as part of the application and any other
information before him with respect to such drug, there
is a lack of substantial evidence that the drug will have
the effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) the application failed to contain the patent information prescribed by subsection (b); or (7) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall issue an order refusing to approve the application. If, after such notice and
opportunity for hearing, the Secretary finds that clauses
(1) through (6) do not apply, he shall issue an order approving the application. As used in this subsection and
subsection (e), the term “substantial evidence” means
evidence consisting of adequate and well-controlled in-
3a
vestigations, including clinical investigations, by experts
qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis
of which it could fairly and responsibly be concluded by
such experts that the drug will have the effect it purports or is represented to have under the conditions of
use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. If the Secretary determines, based on relevant science, that data from one
adequate and well-controlled clinical investigation and
confirmatory evidence (obtained prior to or after such
investigation) are sufficient to establish effectiveness,
the Secretary may consider such data and evidence to
constitute substantial evidence for purposes of the preceding sentence. The Secretary shall implement a
structured risk-benefit assessment framework in the
new drug approval process to facilitate the balanced
consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and the communication of the benefits and
risks of new drugs. Nothing in the preceding sentence
shall alter the criteria for evaluating an application for
marketing approval of a drug.
3.
21 U.S.C. 355-1 provides in relevant part:
Risk evaluation and mitigation strategies
(a)
Submission of proposed strategy
(1) Initial approval
If the Secretary, in consultation with the office
responsible for reviewing the drug and the office responsible for postapproval safety with respect to the
drug, determines that a risk evaluation and mitiga-
4a
tion strategy is necessary to ensure that the benefits
of the drug outweigh the risks of the drug, and informs the person who submits such application of
such determination, then such person shall submit to
the Secretary as part of such application a proposed
risk evaluation and mitigation strategy. In making
such a determination, the Secretary shall consider
the following factors:
(A) The estimated size of the population
likely to use the drug involved.
(B) The seriousness of the disease or condition that is to be treated with the drug.
(C) The expected benefit of the drug with respect to such disease or condition.
(D) The expected or actual duration of treatment with the drug.
(E) The seriousness of any known or potential adverse events that may be related to the
drug and the background incidence of such
events in the population likely to use the drug.
(F) Whether the drug is a new molecular entity.
(2) Postapproval requirement
(A) In general
If the Secretary has approved a covered application (including an application approved before
the effective date of this section) and did not
when approving the application require a risk
evaluation and mitigation strategy under paragraph (1), the Secretary, in consultation with the
5a
offices described in paragraph (1), may subsequently require such a strategy for the drug involved (including when acting on a supplemental
application seeking approval of a new indication
for use of the drug) if the Secretary becomes
aware of new safety information and makes a determination that such a strategy is necessary to
ensure that the benefits of the drug outweigh the
risks of the drug.
(B) Submission of proposed strategy
Not later than 120 days after the Secretary notifies the holder of an approved covered application that the Secretary has made a determination
under subparagraph (A) with respect to the drug
involved, or within such other reasonable time as
the Secretary requires to protect the public
health, the holder shall submit to the Secretary a
proposed risk evaluation and mitigation strategy.
*
(g)
*
*
*
*
Assessment and modification of approved strategy
(4) Modification
(A) On initiative of responsible person
After the approval of a risk evaluation and mitigation strategy by the Secretary, the responsible
person may, at any time, submit to the Secretary
a proposal to modify the approved strategy.
Such proposal may propose the addition, modification, or removal of any goal or element of the
approved strategy and shall include an adequate
rationale to support such proposed addition, mod-
6a
ification, or removal of any goal or element of the
strategy.
(B) On initiative of Secretary
After the approval of a risk evaluation and mitigation strategy by the Secretary, the Secretary
may, at any time, require a responsible person to
submit a proposed modification to the strategy
within 120 days or within such reasonable time as
the Secretary specifies, if the Secretary, in consultation with the offices described in subsection
(c)(2), determines that 1 or more goals or elements should be added, modified, or removed
from the approved strategy to—
(i) ensure the benefits of the drug outweigh the risks of the drug;
(ii) minimize the burden on the health care
delivery system of complying with the strategy; or
(iii) accommodate different, comparable aspects of the elements to assure safe use for a
drug that is the subject of an application under
section 355( j) of this title, and the applicable
listed drug.
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.