Amicus Curiae Brief — Alliance for Hippocratic Medicine, et al., Petitioners v. Food and Drug Administration, et al.
Supreme Court briefNov 15, 2023
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No. 23-395
In the Supreme Court of the United States
__________
ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,
Petitioners,
v.
FOOD AND DRUG ADMINISTRATION, ET AL.,
Respondents.
__________
ON CONDITIONAL CROSS-PETITION FOR A
WRIT OF CERTIORARI TO THE UNITED STATES
COURT OF APPEALS FOR THE FIFTH CIRCUIT
__________
BRIEF AMICI CURIAE OF 109 MEMBERS
OF CONGRESS IN SUPPORT OF
CROSS-PETITIONERS AND CONDITIONAL
CROSS-PETITION
__________
STEVEN H. ADEN
Counsel of Record
CAROLYN MCDONNELL
DANIELLE PIMENTEL
AMERICANS UNITED FOR LIFE
1150 Connecticut Ave., N.W.,
Suite 500
Washington, D.C. 20036
Steven.Aden@aul.org
Tel: (202) 741-4917
Counsel for Amici Curiae
i
TABLE OF CONTENTS
TABLE OF CONTENTS ............................................. i
TABLE OF AUTHORITIES ..................................... iii
STATEMENT OF INTEREST OF AMICI
CURIAE ................................................................ 1
SUMMARY OF ARGUMENT.................................... 2
ARGUMENT .............................................................. 4
I. The FDA Exceeded its Subpart H Authority
by Approving Mifepristone.............................. 4
A. The FDA Misclassified Pregnancy as a
“Life-Threatening Illness” ......................... 6
B. Chemical Abortions Do Not Provide a
“Meaningful Therapeutic Benefit” Over
Surgical Abortions ................................... 10
II. The FDA’s Approval of Mifepristone
Subverted Patient Health and Safety
Safeguards Within Federal Laws ................. 13
A. The FDA’s Failure to Adhere to the
FDCA’s Drug Approval Process Has
Created Significant Health and Safety
Risks to Women and Girls ....................... 15
B. The
FDA
Endangers
Pregnant
Adolescents Seeking Chemical Abortion
ii
Drugs by Subverting the Pediatric Study
Requirement ............................................. 21
CONCLUSION ......................................................... 27
APPENDIX TABLE OF CONTENTS ...................... ia
LIST OF AMICI CURIAE ........................................ 1a
U.S. Senate.......................................................... 1a
U.S. House of Representatives ........................... 2a
iii
TABLE OF AUTHORITIES
Cases
All. for Hippocratic Med. v. U.S. Food & Drug
Admin.,
78 F.4th 210 (5th Cir. 2023) ...........3, 5, 6, 7, 10
All. for Hippocratic Med. v. U.S. Food & Drug
Admin.,
No. 2:22-CV-223-Z (N.D. Tex. Apr. 7,
2023)......................................................... 21, 22
Burlington Truck Lines, Inc. v. United States,
371 U.S. 156 (1962) ....................................... 14
Dep’t of Homeland Sec. v. Regents of the Univ.
of Cal.,
140 S. Ct. 1891 (2020) ................................... 14
Dobbs v. Jackson Women’s Health Org.,
142 S. Ct. 2228 (2022) ............................. 10, 23
H.L. v. Matheson,
450 U.S. 398 (1981) ....................................... 23
Heckler v. Chaney,
470 U.S. 821 (1985) ....................................... 21
Mistretta v. United States,
488 U.S. 361 (1989) ......................................... 1
Motor Vehicle Mfrs. Ass’n of the U.S., Inc. v.
State Farm Mut. Auto. Ins. Co.,
463 U.S. 29 (1983) ............................. 14, 19, 22
iv
Skinner v. Mid-America Pipeline Co.,
490 U.S. 212 (1989) ......................................... 1
Wisconsin v. Yoder,
406 U.S. 205 (1972) ....................................... 23
Statutes
21 U.S.C. § 355.......................................... 3, 15, 16
21 U.S.C. § 355-1 .................................................. 5
21 U.S.C. § 355c ........................................ 3, 21, 26
21 U.S.C. § 393...................................................... 1
5 U.S.C. § 706.............................................. 1, 3, 15
Regulations
21 C.F.R. § 314.500 ................................. 2, 4, 6, 10
21 C.F.R. § 314.520 ............................................... 4
Investigational New Drug, Antibiotic, and
Biological Drug Product Regulations;
Procedures for Drugs Intended to Treat
Life-Threatening and Severely Debilitating
Illnesses, 53 Fed. Reg. 41,516 (Oct. 21,
1988) (to be codified at 21 C.F.R. pts. 312,
314)................................................................... 9
Investigational New Drug, Antibiotic, and
Biological Drug Product Regulations;
Treatment Use and Sale, 52 Fed. Reg.
v
19,466 (May 22, 1987) (to be codified at 21
C.F.R. pt. 312).................................................. 8
New Drug, Antibiotic, and Biological Drug
Product Regulations; Accelerated Approval,
57 Fed. Reg. 58,942 (Dec. 11, 1992) (to be
codified at 21 C.F.R. pts. 314, 601) ................. 8
Legislation and Legislative History
Agriculture, Rural Development, Food and
Drug Administration, and Related Agencies
Appropriations for 2001: Part 2 of Hearings
Before the Subcomm. of the Comm. on
Appropriations, 106th Cong. (2000).............. 19
Child Interstate Abortion Notification Act:
Hearing on H.R. 2299 Before the Subcomm.
on the Const. of the H. Comm. on the
Judiciary, 112th Cong. (2012) ................ 23, 24
Staff of Subcomm. on Crim. Just., Drug Pol’y &
Hum. Res. of the H. Comm. on Gov’t
Reform, 109th Cong., The FDA and RU-486:
Lowering the Standard for Women’s Health
(Subcomm.
2006)...................... 2, 6, 7, 11, 12, 15, 16, 25, 26
The Assault on Reproductive Rights in a PostDobbs America: Hearing before the S.
Comm. on the Jud., 118th Cong. (2023)
(written testimony of Monique Chireau
Wubbenhorst, Senior Rsch. Assoc., de
Nicola Ctr. for Ethics & Culture).................. 12
vi
Other Authorities
AAPLOG Statement: Clarification of Abortion
Restrictions, Am. Ass’n of Pro-Life
Obstetricians & Gynecologists (July 14,
2022), https://aaplog.org/aaplog-statementclarification-of-abortion-restrictions/ .............. 9
Ams. United for Life, Unsafe: America’s
Abortion Industry Endangers Women (2021
ed.) .................................................................. 12
Aviva L. Katz et al., Informed Consent in
Decision-Making in Pediatric Practice,
Pediatrics, Aug. 2016, at e1 .......................... 23
Christina A. Circucci et al., Mifepristone
Adverse Events Identified by Planned
Parenthood in 2009 and 2010 Compared to
Those in the FDA Adverse Event Reporting
System and Those Obtained Through the
Freedom of Information Act, Health Servs.
Rsch. & Managerial Epidemiology, Dec. 21,
2021, at 1 ....................................................... 17
Clarke D. Forsythe & Donna Harrison, State
Regulation of Chemical Abortion After
Dobbs, 16 Liberty U. L. Rev. 377 (2022)2, 25,
26
David C. Reardon & Christopher Craver,
Effects of Pregnancy Loss on Subsequent
Postpartum Mental Health: A Prospective
vii
Longitudinal Cohort Study, Int’l J. Env’t
Rsch. & Pub. Health, Feb. 23, 2021, at 1 ..... 20
F.
Gary Cunningham et al., Williams
Obstetrics (18th ed. 1989)................................ 7
Illness, Merriam-Webster’s Med. Dictionary
https://unabridged.merriamwebster.com/medical/illness (last visited
Nov. 6, 2023) .................................................... 6
James Studnicki et al., A Longitudinal Cohort
Study of Emergency Room Utilization
Following Mifepristone Chemical and
Surgical Abortions, 1999–2015, Health
Servs. Rsch. & Managerial Epidemiology,
Nov. 9, 2021, at 1 ........................................... 18
Kathryn R. Grauerholz et al., Uncovering
Prolonged Grief Reactions Subsequent to a
Reproductive Loss: Implications for the
Primary Care Provider, Frontiers Psych.,
May 12, 2021, at 1 ......................................... 20
Lars Noah, A Miscarriage in the Drug Approval
Process?: Mifepristone Embroils the FDA in
Abortion Politics, 36 Wake Forest L. Rev.
571 (2001) .................................................... 5, 9
Letter from Cindy Hyde-Smith, Senator, U.S.
Cong., et al., to Robert Califf, Comm’r, U.S.
Food & Drug Admin. (Jan. 26, 2023),
https://www.hydesmith.senate.gov/sites/def
ault/files/2023-
viii
01/012623%20Bicameral%20Letter%20to%
20FDA%20re%20Abortion%20Drugs.pdf ..... 14
Letter from James Lankford, Senator, U.S.
Cong., et al., to Merrick B. Garland, Att’y
Gen., U.S. Dep’t of Just. (Jan. 25, 2023),
https://www.lankford.senate.gov/imo/media
/doc/dojletterabortionmail.pdf ....................... 13
Louis Jacob et al., Association Between Induced
Abortion, Spontaneous Abortion, and
Infertility Respectively and the Risk of
Psychiatric Disorders in 57,770 Women
Followed in Gynecological Practices in
Germany, 251 J. Affective Disorders 107
(2019) ............................................................. 20
Maarit J. Mentula et al., Immediate Adverse
Events After Second Trimester Medical
Termination of Pregnancy: Results of a
Nationwide Registry Study, 26 Hum.
Reprod. 927 (2011)......................................... 13
Maarit
Niinimaki
et
al.,
Immediate
Complications After Medical Compared
with Surgical Termination of Pregnancy,
114 Obstetrics & Gynecology 795
(2009) ............................................................ 12
Mifepristone U.S. Post-Marketing Adverse
Events Summary Through 12/31/2022,
U.S. Food & Drug Admin. 1 (Dec. 31, 2022),
https://www.fda.gov/media/164331/downloa
d...................................................................... 17
ix
Nadia Akseer et al., Characteristics and Birth
Outcomes
of
Pregnant
Adolescents
Compared to Older Women: An Analysis of
Individual Level Data from 140,000
Mothers from 20 RCTs, eClinicalMed., Feb.
26, 2022, at 1 ................................................. 24
Nathalie Fleming et al., Adolescent Pregnancy
Guidelines, 37 J. Obstetrics & Gynaecology
Can. 740 (2015)........................................ 24, 25
Pregnancy,
Merriam-Webster’s
Med.
Dictionary,
https://unabridged.merriamwebster.com/medical/pregnancy
(last
visited Nov. 6, 2023) ........................................ 6
Pregnancy,
Taber’s
Med.
Dictionary,
https://www.tabers.com/tabersonline/view/
TabersDictionary/756370/all/pregnancy?q=pregna
ncy (last visited Nov. 6, 2023) ......................... 7
Pregnant, Merriam-Webster’s Med. Dictionary,
https://unabridged.merriamwebster.com/medical/pregnant (last visited
Nov. 6, 2023) .................................................... 7
Pro. Ethics Comm., Am. Ass’n of Pro-Life
Obstetricians & Gynecologists, Hippocratic
Objection to Killing Human Beings in
Medical Practice, Comm. Op. No. 1, at 8
(May 8, 2017) ................................................. 10
x
Questions and Answers on Mifepristone for
Medical Termination of Pregnancy Through
Ten Weeks Gestation, U.S. Food & Drug
Admin.
(Sept.
1,
2023),
https://www.fda.gov/drugs/postmarketdrug-safety-information-patients-andproviders/questions-and-answersmifepristone-medical-terminationpregnancy-through-ten-weeks-gestation ........ 2
Ralph
P.
Miech,
Pathophysiology
of
Mifepristone-Induced Septic Shock Due to
Clostridium
Sordellii,
39
Annals
Pharmacotherapy 1483 (2005) ...................... 26
Rsch. Comm., Am. Ass’n of Pro-Life
Obstetricians & Gynecologists, Concluding
Pregnancy Ethically, Prac. Guideline No. 10
(Aug. 2022) ..................................................... 10
Rsch. Comm., Am. Ass’n Pro-Life Obstetricians
& Gynecologists, Medication Abortion, Prac.
Guideline No. 8 (Feb. 2020) .................... 16, 17
1
STATEMENT OF INTEREST OF
AMICI CURIAE 1
Amici are 109 Members of the United States
Congress, 17 Senators and 92 Members of the House
of Representatives, representing 32 States. A
complete list of Amici is found in the Appendix to this
brief. Congress authorizes power to the U.S. Food and
Drug Administration (“FDA”) to approve drugs and
regulate their safety and efficacy. 21 U.S.C. § 393.
Congress directs administrative agencies to act
within the scope of their authorized powers. 5 U.S.C.
§ 706; see Skinner v. Mid-America Pipeline Co., 490
U.S. 212, 218 (1989) (citing Mistretta v. United States,
488 U.S. 361, 379 (1989)) (There is a “longstanding
principle that so long as Congress provides an
administrative agency with standards guiding its
actions such that a court could ‘ascertain whether the
will of Congress has been obeyed,’ no delegation of
legislative authority trenching on the principle of
separation of powers has occurred.”).
As pro-life elected representatives, Amici are
committed to protecting women and girls from the
harms of the abortion industry. By approving and
then deregulating chemical abortion drugs, the FDA
contravened its own regulations, and failed to follow
Congress’ statutorily prescribed drug approval
1 No party’s counsel authored any part of this brief. No person
other than Amici Curiae and their counsel contributed any
money intended to fund the preparation or submission of this
brief. Cross-Petitioners and Cross-Respondents received timely
notice to the filing of this brief.
2
process to the detriment of patient welfare. The FDA’s
lawless actions ultimately have endangered women
and girls seeking chemical abortions.
SUMMARY OF ARGUMENT
The FDA approved mifepristone, an abortioninducing drug, in 2000. The “chemical abortion pill”
(also known as a “medical abortion”) is a regimen of
two
drugs,
mifepristone
and
misoprostol. 2
“[M]ifepristone (brand name, Mifeprex), is an
antiprogesterone, which starves the pregnancy. The
second, misoprostol (brand name, Cytotec), a
prostaglandin, causes the uterus to contract, which
mechanically expels the fetus and placenta.” Clarke
D. Forsythe & Donna Harrison, State Regulation of
Chemical Abortion After Dobbs, 16 Liberty U. L. Rev.
377, 377 (2022).
There were “approval irregularities” in the FDA’s
consideration of mifepristone. Staff of Subcomm. on
Crim. Just., Drug Pol’y & Hum. Res. of the H. Comm.
on Gov’t Reform, 109th Cong., The FDA and RU-486:
Lowering the Standard for Women’s Health 15
(Subcomm. Print 2006). Relying improperly upon its
Subpart H authority, the FDA misclassified
pregnancy as a “life-threatening illness.” See 21
C.F.R. § 314.500. Pregnancy is not an illness, let alone
Questions and Answers on Mifepristone for Medical
Termination of Pregnancy Through Ten Weeks Gestation, U.S.
Food
&
Drug
Admin.
(Sept.
1,
2023),
https://www.fda.gov/drugs/postmarket-drug-safety-informationpatients-and-providers/questions-and-answers-mifepristonemedical-termination-pregnancy-through-ten-weeks-gestation.
2
3
a life-threatening one. Likewise, chemical abortions
do not provide a “meaningful therapeutic benefit”
over surgical abortions, especially considering
chemical abortions pose greater health risks than
surgical abortions. In approving mifepristone, the
FDA also acted arbitrarily and capriciously in
violation of the Administrative Procedure Act
(“APA”). See 5 U.S.C. § 706(2)(A). The FDA subverted
its obligations under the Food, Drug, and Cosmetic
Act (“FDCA”) to ensure new drugs are safe and
effective, see 21 U.S.C. § 355, and failed to assess the
safety and effectiveness of the drugs for pediatric use,
as well as the proper dosing and administration for
these young patients under the Pediatric Research
Equity Act (“PREA”). See 21 U.S.C. § 355c.
The Fifth Circuit held it was untimely for the
Cross-Petitioners to challenge the FDA’s 2000
approval of mifepristone and did not have standing to
challenge the 2019 generic drug approval, but
correctly upheld a stay of the FDA’s 2016 and 2021
actions that deregulated mifepristone. All. for
Hippocratic Med. v. U.S. Food & Drug Admin., 78
F.4th 210, 222–223 (5th Cir. 2023). Amici support the
Fifth Circuit’s reinstatement of common-sense
patient safeguards, which include in-person
dispensing of mifepristone as well as an in-person
follow-up examination to ensure a woman has not
suffered complications or retained fetal tissue.
Accordingly, Amici support Cross-Petitioners’
opposition to the FDA and Danco’s petitions for a writ
of certiorari, which have asked this Court to
4
reconsider patient safeguards that protect women
and girls seeking chemical abortion drugs.
Amici agree with Cross-Petitioners that they have
a timely challenge to the FDA’s unlawful approval of
mifepristone in this case. See Conditional Cross-Pet.
Writ Cert. 16–23. Amici write separately to contribute
a federal policy perspective as to why the FDA, in
approving mifepristone, (I) went beyond the scope of
its Subpart H authority, and (II) acted in violation of
the APA, FDCA, and PREA. Since the FDA’s lawless
approval of mifepristone subverts patient safeguards
and contravenes federal laws, Amici urge the Court to
grant Alliance for Hippocratic Medicine’s conditional
cross-petition if the Court grants the Food & Drug
Administration and/or Danco’s petitions for a writ of
certiorari.
ARGUMENT
I. The FDA Exceeded its Subpart H Authority by
Approving Mifepristone.
The FDA may apply Subpart H’s accelerated
approval process “to certain new drug products that
have been studied for their safety and effectiveness in
treating serious or life-threatening illnesses and that
provide meaningful therapeutic benefit to patients
over existing treatments.” 21 C.F.R. § 314.500. In
certain circumstances for drugs approved under
Subpart H, the “FDA will require such postmarketing
restrictions as are needed to assure safe use of the
drug product.” 21 C.F.R. § 314.520. Congress codified
5
Subpart H’s post-marketing restrictions into the
FDCA in 2007 as Risk Evaluation and Mitigation
Strategies (“REMS”). 21 U.S.C. § 355-1(a)(1)–(2).
The FDA used Subpart H to accelerate the
approval process for the chemical abortion drug. As
Professor Lars Noah detailed:
The Clinton administration went to great
lengths to bring mifepristone into the United
States. From pressuring the hesitant
manufacturer to apply for approval, and
utilizing a specialized review procedure
normally reserved for life-saving drugs, to
imposing unusual restrictions on distribution,
and promising to keep the identity of the
manufacturer a secret, the FDA’s approval
process deviated from the norm in several
respects.
Lars Noah, A Miscarriage in the Drug Approval
Process?: Mifepristone Embroils the FDA in Abortion
Politics, 36 Wake Forest L. Rev. 571, 576 (2001). The
FDA indicated in its approval letter to the Population
Council in 2000 that the “FDA has determined that
the termination of an unwanted pregnancy is a
serious condition within the scope of Subpart H. The
meaningful therapeutic benefit over existing surgical
abortion is the avoidance of a surgical procedure.” All.
for Hippocratic Med., 78 F.4th at 224. Yet, the FDA
exceeded the scope of Subpart H’s authority with this
reasoning. Amici highlight that (A) pregnancy is not
an “illness,” nor “life-threatening” in normal
6
circumstances; and (B) chemical abortions do not
provide meaningful therapeutic benefit over surgical
abortions.
A. The FDA Misclassified Pregnancy as a “LifeThreatening Illness.”
Subpart H applies to drugs the FDA has “studied
for their safety and effectiveness in treating serious
or life-threatening illnesses.” 21 C.F.R. § 314.500. Yet,
in efforts to approve mifepristone, the FDA rewrote
this language, indicating the “termination of an
unwanted pregnancy is a serious condition within the
scope of Subpart H.” All. for Hippocratic Med., 78
F.4th at 224 (emphasis added). Even with these
“[l]inguistic
gymnastics . . . pregnancy
or
the
termination of pregnancy is not a ‘serious or lifethreatening illness,’ and therefore does not fall within
the defined reach of subpart H; the term ‘serious
condition’ is not found in the Subpart H rule.” Staff of
Subcomm. on Crim. Just., supra, at 20.
Fundamentally, “pregnancy itself is not an
illness.” Id. An illness is “an unhealthy condition of
body or mind.” Illness, Merriam-Webster’s Med.
Dictionary
https://unabridged.merriamwebster.com/medical/illness (last visited Nov. 6,
2023). Pregnancy is “the condition of being
pregnant,” 3 which, in turn, means “[a body] contain[s]
a developing embryo, fetus, or unborn offspring.”
Pregnancy,
Merriam-Webster’s
Med.
Dictionary,
https://unabridged.merriam-webster.com/medical/pregnancy
(last visited Nov. 6, 2023).
3
7
Pregnant, Merriam-Webster’s Med. Dictionary,
https://unabridged.merriamwebster.com/medical/pregnant (last visited Nov. 6,
2023); see also Pregnancy, Taber’s Med. Dictionary,
https://www.tabers.com/tabersonline/view/TabersDictionary/756370/all/pregnancy?q=pregnancy (last
visited Nov. 6, 2023) (defining pregnancy as “[t]he
condition of having a developing embryo or fetus in
the body after successful conception”).“Pregnancy is
not a bad or unhealthy condition of the body—it’s a
natural consequence of a healthy and functioning
reproductive system.” All. for Hippocratic Med., 78
F.4th at 263 (Ho, J., concurring in part and dissenting
in part). Indeed, as the field of obstetrics recognizes,
“ordinarily pregnancy is a normal physiological
state . . . .” F. Gary Cunningham et al., Williams
Obstetrics 12 (18th ed. 1989).
Pregnancy is not an illness, let alone a “lifethreatening illness,” which is what Subpart H
requires. Although “[t]here are situations in which
serious or life-threatening complications may
arise, . . . these are atypical events.” Staff of
Subcomm. on Crim. Just., supra, at 20. The
“pregnancy can sometimes result in illness. But that
does not make the pregnancy itself an illness.” All. for
Hippocratic Med., 78 F.4th at 263 (Ho., J., concurring
in part and dissenting in part) (emphasis in original)
(citation omitted).
When the FDA initially promulgated Subpart H, it
indicated the agency “discussed the meaning of the
terms ‘serious’ and ‘life-threatening’ in its final rules
8
on
‘treatment
IND’s
[investigational
new
drugs]’ . . . and ‘subpart E’ procedures . . . . The use of
these terms in this rule is the same as FDA defined
and used the terms in those rulemakings.” New Drug,
Antibiotic, and Biological Drug Product Regulations;
Accelerated Approval, 57 Fed. Reg. 58,942, 58,945
(Dec. 11, 1992) (to be codified at 21 C.F.R. pts. 314,
601). In turn, the treatment INDs rule “defined an
immediately life-threatening disease in the
regulation as being a stage of a disease in which there
is a reasonable likelihood that death will occur within
a matter of months or in which premature death is
likely without early treatment.” Investigational New
Drug, Antibiotic, and Biological Drug Product
Regulations; Treatment Use and Sale, 52 Fed. Reg.
19,466, 19,467 (May 22, 1987) (to be codified at 21
C.F.R. pt. 312). The INDs rule listed examples, such
as “[a]dvanced cases of AIDs . . . [a]dvanced
congestive heart failure . . . [and m]ost advanced
metastatic refractory cancers.” Id. For its part, the
Subpart E rule indicated:
A “life-threatening” disease is defined as one in
which the likelihood of death is high unless the
course of the disease is interrupted (e.g.,
progression from asymptomatic HIV infection
to symptomatic HIV infection, or further
progression to a later stage of AIDS; metastatic
cancer; amyotrophic lateral sclerosis). This use
of the term “life-threatening” plainly includes
any disease whose progression is likely to lead
to death, especially in a short period of time
(e.g., 6 months to 1 year).
9
Investigational New Drug, Antibiotic, and Biological
Drug Product Regulations; Procedures for Drugs
Intended to Treat Life-Threatening and Severely
Debilitating Illnesses, 53 Fed. Reg. 41,516, 41,518–
41,519 (Oct. 21, 1988) (to be codified at 21 C.F.R. pts.
312, 314). Pregnancy, which is a normal and healthy
physiological condition, cannot plausibly be compared
to such life-threatening diseases.
Drugs used to treat these life-threatening illnesses
contrast with mifepristone, which is intended for
elective abortions. In the words of “William Hubbard,
who served as the FDA’s Associate Commissioner for
Policy
throughout
the
Clinton
administration, . . . [who] remark[ed] shortly before
joining the agency: ‘RU-486 is intended for
convenien[t] use by healthy young women rather than
as a therapy for an incapacitating or life-threatening
disease.’” Noah, supra, at 582. This means the FDA
approved mifepristone for elective abortion. An
“elective abortion is defined as those drugs or
procedures used with the primary intent to end the
life of the human being in the womb.” AAPLOG
Statement: Clarification of Abortion Restrictions, Am.
Ass’n of Pro-Life Obstetricians & Gynecologists (July
14,
2022),
https://aaplog.org/aaplog-statementclarification-of-abortion-restrictions/. It is not
medically required. “‘Elective’ . . . refers to inductions
done in the absence of some condition of the mother
or the fetus which requires separation of the two to
protect the life of one or the other (or both).” Rsch.
Comm., Am. Ass’n of Pro-Life Obstetricians &
Gynecologists, Concluding Pregnancy Ethically, Prac.
10
Guideline No. 10, at 5 (Aug. 2022). This means that
“by definition, there is no medical indication for
elective induced abortion, since it cures no medical
disease. . . . Pregnancy is not a disease, and the
killing of human beings in utero is not medical care.”
Pro. Ethics Comm., Am. Ass’n of Pro-Life
Obstetricians & Gynecologists, Hippocratic Objection
to Killing Human Beings in Medical Practice, Comm.
Op. No. 1, at 8 (May 8, 2017) (emphasis omitted). In
other words, medical professionals perform elective
induced abortions for non-medical reasons, which
does not meet Subpart H’s requirement that the drug
treat “life-threatening illnesses.” Accordingly, the
FDA exceeded its Subpart H authority in approving
mifepristone.
B. Chemical Abortions Do Not Provide a
“Meaningful Therapeutic Benefit” Over
Surgical Abortions.
For the FDA to approve a drug under Subpart H,
the drug must “provide meaningful therapeutic
benefit to patients over existing treatments.” 21
C.F.R. § 314.500. Here, the FDA contends “[t]he
meaningful therapeutic benefit over existing surgical
abortion is the avoidance of a surgical procedure.” All.
for Hippocratic Med., 78 F.4th at 224. “Clearly, this
mistakes a definition for a syllogism” by saying a
chemical abortion is better than a surgical abortion
because, by definition, it does not involve surgery.
Dobbs v. Jackson Women’s Health Org., 142 S. Ct.
2228, 2268 (2022) (cleaned up). “[E]ven though some
women may prefer [mifepristone] abortions over
11
surgical abortions, that fact does not establish the
existence of a therapeutic benefit in and of itself.”
Staff of Subcomm. on Crim. Just., supra, at 22.
Regardless of this logical fallacy, the FDA failed to
demonstrate—contrary to its Subpart H obligations—
that chemical abortion provides a meaningful
therapeutic benefit over existing treatments.
As Cross-Petitioners highlight, “[m]ifepristone is
not ‘therapeutic.’” Conditional Cross-Pet. Writ Cert.
27. The U.S. House Committee on Government
Reform (now known as the Committee on Oversight
and Accountability)’s Subcommittee on Criminal
Justice, Drug Policy and Human Resources
recognized, “[mifepristone] was not approved for a
medical indication intended for only the treatment of
patients who were intolerant of surgical abortion. It
was approved to treat the general population of
women seeking first-trimester abortions.” Staff of
Subcomm. on Crim. Just., supra, at 22.
The FDA likewise failed to satisfy its Subpart H
obligation because “it appears that no concurrentlycontrolled trials comparing medical and surgical
abortion were required by FDA, because the Agency
already knew that medical abortion—i.e., abortion by
[mifepristone]—is unambiguously inferior to surgical
abortion with respect to safety and effectiveness.” Id.
Comparatively, chemical abortions have greater risks
12
than surgical abortions. 4 In a study of 42,619 Finnish
women receiving chemical abortions up to nine weeks
gestational age, for example, the overall adverse
events were almost fourfold higher in chemical
(20.0%) versus surgical abortions (5.6%). Maarit
Niinimaki et al., Immediate Complications After
Medical Compared with Surgical Termination of
Pregnancy, 114 Obstetrics & Gynecology 795, 795
(2009). Women hemorrhaged more commonly after
chemical abortion (15.6% compared with 2.1%). Id.
They also had incomplete abortions more often in
chemical abortions (6.7% versus 1.6%). Id. The rate of
surgical (re)evacuation was higher after chemical
abortions (5.9%) than surgical abortions (1.8%). Id.
Likewise, “surgery is an integral part of the
[mifepristone] abortion process, because a substantial
proportion of women require [dilation and curettage
abortions] after beginning the mifepristone regimen.
Therefore, women who have [mifepristone] abortions
must be able to tolerate the surgical procedure.” Staff
of Subcomm. on Crim. Just., supra, at 22. A study
examining first and second trimester chemical
abortions of 18,248 Finnish women highlighted
4 To be clear, whether chemical or surgical, abortion poses grave
safety concerns. “Abortion not only poses risks to the mother, it
is always lethal to an unborn child.” The Assault on Reproductive
Rights in a Post-Dobbs America: Hearing before the S. Comm. on
the Jud., 118th Cong. 2 (2023) (written testimony of Monique
Chireau Wubbenhorst, Senior Rsch. Assoc., de Nicola Ctr. for
Ethics & Culture). The abortion industry’s pervasive failure to
adhere to health and safety standards only exacerbates these
risks to women’s health. See Ams. United for Life, Unsafe:
America’s Abortion Industry Endangers Women (2021 ed.).
13
medical professionals may use surgery to complete a
failed chemical abortion. Maarit J. Mentula et al.,
Immediate Adverse Events After Second Trimester
Medical Termination of Pregnancy: Results of a
Nationwide Registry Study, 26 Hum. Reprod. 927, 927
(2011). Women undergoing first and second trimester
chemical abortions needed surgical evacuation in
9.9% of cases. Id. at 929. Women specifically
undergoing second trimester chemical abortions
needed surgical evacuation in 39% of cases. Id. at 931.
In sum, chemical abortions do not provide
“meaningful therapeutic benefits” to women and girls
over surgical abortions, and in fact pose higher health
and safety risks. The FDA improperly used its
Subpart H authority to approve chemical abortion
drugs.
II. The FDA’s Approval of Mifepristone Subverted
Patient Health and Safety Safeguards Within
Federal Laws.
Amici agree with Cross-Petitioners that the FDA’s
actions have contravened the APA and FDCA.
Conditional Cross-Pet. Writ Cert. 28–31. 5 Amici add
5 Amici also note the FDA’s 2021 actions, which eliminated inperson dispensing of chemical abortion drugs, contradicted the
“plain text and clear meaning of the [Comstock Act].” Letter from
James Lankford, Senator, U.S. Cong., et al., to Merrick B.
Garland, Att’y Gen., U.S. Dep’t of Just. 1 (Jan. 25, 2023),
https://www.lankford.senate.gov/imo/media/doc/dojletterabortio
nmail.pdf. Members of Congress recently expressed their
opposition to the FDA’s 2021 actions, recognizing the dangers
14
that the FDA’s actions also have subverted PREA,
discussed below. “‘[A]n agency literally has no power
to act . . . unless and until Congress confers power
upon it.’ When an agency exercises power beyond the
bounds of its authority, it acts unlawfully.” Dep’t of
Homeland Sec. v. Regents of the Univ. of Cal., 140 S.
Ct. 1891, 1921 (2020) (Thomas, J., concurring in the
judgment in part and dissenting in part) (alterations
in original) (citations omitted). The FDA must adhere
to the APA’s “arbitrary and capricious” standard,
which means “the agency must examine the relevant
data and articulate a satisfactory explanation for its
action including a ‘rational connection between the
facts found and the choice made.’” Motor Vehicle Mfrs.
Ass’n of the U.S., Inc. v. State Farm Mut. Auto. Ins.
Co., 463 U.S. 29, 43 (1983) (citing Burlington Truck
Lines, Inc. v. United States, 371 U.S. 156, 168 (1962)).
The FDA acted arbitrarily and capriciously in
approving mifepristone. As the U.S. House
Committee on Government Reform’s Subcommittee
on Criminal Justice, Drug Policy and Human
Resources recognized:
The integrity of the FDA in the approval and
monitoring of RU-486 has been substandard
and necessitates the withdrawal of this
mail-order chemical abortions pose to women and girls. Letter
from Cindy Hyde-Smith, Senator, U.S. Cong., et al., to Robert
Califf, Comm’r, U.S. Food & Drug Admin. (Jan. 26, 2023),
https://www.hydesmith.senate.gov/sites/default/files/202301/012623%20Bicameral%20Letter%20to%20FDA%20re%20Ab
ortion%20Drugs.pdf.
15
dangerous and fatal product before more
women suffer the known and anticipated
consequences or fatalities. RU-486 is a
hazardous drug for women, its unusual
approval demonstrates a lower standard of
care for women, and its withdrawal from the
market is justified and necessary to protect the
public’s health.
Staff of Subcomm. on Crim. Just., supra, at 40. In
approving mifepristone, the FDA did not act “in
accordance” with patient safeguards within the FDCA
and PREA, and approved mifepristone in excess of its
statutory authority. See 5 U.S.C. § 706(2)(A).
A. The FDA’s Failure to Adhere to the FDCA’s
Drug Approval
Process Has Created
Significant Health and Safety Risks to Women
and Girls.
Congress places safeguards within the FDCA to
ensure new drugs are safe and efficacious for patients.
21 U.S.C. § 355. As Cross-Petitioners note, the FDA
failed to include critical patient safeguards in its
approval of chemical abortion drugs, even though the
FDA approved mifepristone by relying upon studies
that used those safeguards. Conditional Cross-Pet.
Writ Cert. 30. Namely, the clinical trials required
medical professionals to perform “an ultrasound to
confirm gestational age and to exclude an ectopic
pregnancy,” as well as monitor the woman for a period
of three to five hours after she took misoprostol. Id.
Removing these conditions of use, even after relying
16
upon them in the approval of mifepristone, is contrary
to the FDCA’s requirements. See 21 U.S.C. § 355(d).
By subverting these patient safeguards, the
ultimate victims of the FDA’s lawless actions have
been women and girls seeking these drugs.
Unfortunately, “the medical community knew what
American women would soon learn by experience,”
that chemical abortion drugs pose significant risks.
Staff of Subcomm. on Crim. Just., supra, at 13.
“[M]ifepristone interferes with the body’s immune
response . . . is more inconvenient than surgical
abortion . . . is more painful . . . is less effective . . . is
associated with more adverse events . . . [and] causes
more frequent and more severe hemorrhage than its
surgical counterpart.” Id. at 13–14.
Fundamentally, chemical abortion drugs pose
serious health and safety risks to women and girls.
There is an “assumption that [a chemical abortion] is
more natural, private and safer than a surgical
procedure, but physicians and patients alike may be
unaware that it takes much longer, involves far more
bleeding and pain, and complications occur four times
more frequently from medical as compared to surgical
abortions.” Rsch. Comm., Am. Ass’n Pro-Life
Obstetricians & Gynecologists, Medication Abortion,
Prac. Guideline No. 8, at 3 (Feb. 2020). After taking
chemical abortion drugs, [t]he average woman bleeds
for 9–16 days and eight percent will bleed longer than
a month.” Id. Unfortunately, “[t]he side effects of
cramping, vaginal bleeding, hemorrhage, nausea,
weakness, fever/chills, vomiting, headache, diarrhea,
17
and dizziness occur in almost all women.” Id. As the
gestational age increases, so too will the complication
rates for women taking chemical abortion drugs. Id.
Since 2016, the FDA has only required adverse
events reporting for deaths resulting from chemical
abortion drugs; reporting is otherwise voluntary. 6
Even so, the FDA has received FAERS Mifeprex
reports through December 31, 2022 documenting 32
deaths (regardless of causality), 4,218 adverse events,
1,049 hospitalizations (excluding deaths), 604 blood
loss incidents requiring transfusions, 418 infections,
and 75 severe infections. Mifepristone U.S. PostMarketing Adverse Events Summary Through
12/31/2022, U.S. Food & Drug Admin. 1, 1–2 (Dec.
31,
2022),
https://www.fda.gov/media/164331/download.
A 2021 peer-reviewed study showed alarming
results: chemical-abortion related emergency room
visits (i.e., visits medically coded as chemical abortion
complications) per 1,000 abortions “went from 8.5 to
51.7, an increase of 507%” over thirteen years. James
Studnicki et al., A Longitudinal Cohort Study of
Emergency Room Utilization Following Mifepristone
As one study concludes, “FAERS [the FDA Adverse Event
Reporting System] is inadequate to evaluate the safety of
mifepristone” due to reporting discrepancies, and the fact that
the FDA no longer mandates reporting of non-lethal adverse
events. Christina A. Circucci et al., Mifepristone Adverse Events
Identified by Planned Parenthood in 2009 and 2010 Compared
to Those in the FDA Adverse Event Reporting System and Those
Obtained Through the Freedom of Information Act, Health
Servs. Rsch. & Managerial Epidemiology, Dec. 21, 2021, at 1, 4.
6
18
Chemical and Surgical Abortions, 1999–2015, Health
Servs. Rsch. & Managerial Epidemiology, Nov. 9,
2021, at 1, 5. By 2015, the rate of emergency room
visits within 30 days for any cause (i.e., any
emergency room visit regardless of how it was
medically coded) per 1000 chemical abortions was
354.8. Id. at 4–5. This means 35.48% of women ended
up in the emergency room within thirty days of taking
chemical abortion drugs. Id. The study found that
“[emergency room] visits following mifepristone
abortion grew from 3.6% of all postabortion visits in
2002 to 33.9% of all postabortion visits in 2015.” Id. at
8. During the same period, chemical abortions
“increased from 4.4% of total abortions in 2002 to
34.1% in 2015.” Id.
The actual number of adverse events is likely
much higher due to emergency room miscoding. As
compared to miscoding of surgical abortion-related
treatment, 2015 data showed emergency rooms were
four times as likely to miscode chemical abortionrelated treatment as miscarriage-related treatment.
Id. at 3. Between 2013 and 2015, emergency rooms
miscoded up to 60.9% of chemical abortion-related
visits as miscarriage-related visits. Id. at 4. This
means that U.S. data are severely incomplete, and
studies have understated the risks chemical abortion
drugs pose to women and girls, which include
hemorrhaging and infection due to retained
pregnancy tissue.
One concerning aspect of the initial drug approval
is that the FDA “entirely failed to consider an
19
important aspect of the problem,” State Farm, 463
U.S. at 43, namely, the evidence of the drugs’
psychological or long-term physical effects. As FDA
Commissioner Jane Henney testified before Congress
in February 2000 regarding the FDA’s review of
chemical abortion drugs:
The primary clinical trials conducted by the
sponsor to support the safety and efficacy of
mifepristone—RU-486—were discussed before
the Reproductive Health Advisory Committee
in July 1996. These clinical studies did not
include an evaluation of the psychological
effects of the drug in women or an evaluation of
the long-term medical consequences of the drug
in women. FDA is unaware of any published
studies on the psychological effects or the longterm medical consequences of mifepristone in
women. 7
Abortion poses mental health risks for women and
girls. “Pregnancy loss (natural or induced) is
associated with an increased risk of mental health
problems.” David C. Reardon & Christopher Craver,
Effects of Pregnancy Loss on Subsequent Postpartum
Mental Health: A Prospective Longitudinal Cohort
Study, Int’l J. Env’t Rsch. & Pub. Health, Feb. 23,
Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies Appropriations for 2001:
Part 2 of Hearings Before the Subcomm. of the Comm. on
Appropriations, 106th Cong. (2000) (emphasis added). The
testimony
is
available
at
https://www.govinfo.gov/content/pkg/CHRG106hhrg63888/html/CHRG-106hhrg63888.htm.
7
20
2021, at 1, 1. “Research on mental health subsequent
to early pregnancy loss as a result of elective induced
abortions has historically been polarized, but recent
research indicates an increased correlation to the
genesis or exacerbation of substance abuse and
affective disorders including suicidal ideation.”
Kathryn R. Grauerholz et al., Uncovering Prolonged
Grief Reactions Subsequent to a Reproductive Loss:
Implications for the Primary Care Provider, Frontiers
Psych., May 12, 2021, at 1, 2. Scholarship shows “that
the emotional reaction or grief experience related to
miscarriage and abortion can be prolonged, afflict
mental health, and/or impact intimate or parental
relationships.” Id. Similarly, “[s]everal recent
international studies have demonstrated that
repetitive early pregnancy loss, including both
miscarriage and induced abortions, is associated with
increased levels of distress, depression, anxiety, and
reduced quality of life scores in social and mental
health categories.” Id.; see, e.g., Louis Jacob et al.,
Association Between Induced Abortion, Spontaneous
Abortion, and Infertility Respectively and the Risk of
Psychiatric Disorders in 57,770 Women Followed in
Gynecological Practices in Germany, 251 J. Affective
Disorders 107, 111 (2019) (finding “a positive
relationship between induced abortion . . . and
psychiatric disorders in gynecological practices in
Germany”).
In sum, the FDA failed to follow FDCA patient
safety requirements, which is to the detriment of the
health and safety of women and girls seeking
chemical abortion drugs.
21
B. The FDA Endangers Pregnant Adolescents
Seeking Chemical Abortion Drugs by
Subverting the Pediatric Study Requirement.
Under PREA, assessments of new drugs must
include studies showing the safety and effectiveness
of the drug for pediatric use, as well as the proper
dosing and administration for adolescent patients. 21
U.S.C. § 355c(a)(2)(A). 8 The FDA can waive the
pediatric study “[i]f the course of the disease and the
effects of the drug are sufficiently similar in adults
and pediatric patients . . . .” Id. at § 355c(a)(2)(B)(i).
Again,
Congress did not set agencies free to disregard
legislative direction in the statutory scheme
that the agency administers. Congress may
limit an agency’s exercise of enforcement power
if it wishes, either by setting substantive
priorities, or by otherwise circumscribing an
agency’s power to discriminate among issues or
cases it will pursue.
Heckler v. Chaney, 470 U.S. 821, 833 (1985).
Accordingly, the FDA must adhere to PREA before
approving or deregulating drugs for adolescent
patients because they face unique challenges when
experiencing pregnancy.
For background on the FDA’s pediatric rule and Congress’
codification of the regulation into PREA, see All. for Hippocratic
Med. v. U.S. Food & Drug Admin., No. 2:22-CV-223-Z, slip op. at
51 n.49 (N.D. Tex. Apr. 7, 2023); Compl. ¶¶ 8996, Dist. Ct. ECF
No. 1 at 26–28.
8
22
The FDA subverted PREA and exceeded the scope
of its authorized power. In the initial drug approval of
chemical abortion drugs in 2000, the FDA waived the
pediatric study, incorrectly stating “there is no
biological reason to expect menstruating females
under age 18 to have a different physiological outcome
with the regimen.” Compl. Ex. 24, Dist. Ct. ECF No.
1-25 at 8; All. for Hippocratic Med. v. U.S. Food &
Drug Admin., No. 2:22-CV-223-Z, slip op. at 51 (N.D.
Tex. Apr. 7, 2023) (during the 2000 approval, “[n]or
was the drug tested for under-18 girls undergoing
reproductive development”). 9 This contention “is so
implausible that it could not be ascribed to a
difference in view or the product of agency expertise,”
State Farm, 463 U.S. at 43, and endangers girls
seeking chemical abortion drugs. 10
Adolescent patients seeking chemical abortions
face unique challenges that place them in dissimilar
conditions to adult women. Thus, it is imperative that
the FDA fulfills its statutory duty to ensure the drugs,
dosages, and administration are safe and effective for
girls seeking chemical abortion drugs.
Adolescents do not have fully developed decisionmaking capabilities. As the Supreme Court
acknowledged in H.L. v. Matheson, “[t]he medical,
9 References to “Dist. Ct. ECF” are to the District Court docket,
No. 2:22-cv-223-Z (N.D. Tex.). All ECF page numbers reference
the blue ECF headers.
10 The FDA likewise failed to meet its PREA obligations during
the 2016 Major REMS changes. See Compl. ¶¶ 206–216, Dist. Ct.
ECF No. 1 at 57–60.
23
emotional, and psychological consequences of an
abortion are serious and can be lasting; this is
particularly so when the patient is immature.” 450
U.S. 398, 411 (1981) overruled on other grounds by
Dobbs, 142 S. Ct. 2228. Generally, “[a]ppropriate
decisional capacity and legal empowerment are the
determinants of decision-making authority in
medicine.” Aviva L. Katz et al., Informed Consent in
Decision-Making in Pediatric Practice, Pediatrics,
Aug. 2016, at e1, e2. Nevertheless, “[a] reliance on
individual liberties and autonomy in the pediatric
patient is not realistic or legally accepted, so parents
or other surrogates provide ‘informed permission’ for
diagnosis and treatment, with the assent of the child
as developmentally appropriate.” Id. Consequently,
parental guidance is instrumental for an adolescent
patient’s informed consent. 11 Parental involvement
helps an adolescent patient select a competent
healthcare professional who prioritizes her health.
Child Interstate Abortion Notification Act: Hearing on
H.R. 2299 Before the Subcomm. on the Const. of the H.
Comm. on the Judiciary, 112th Cong. 19 (2012)
(statement of Teresa Stanton Collett, Professor of
Law, University of St. Thomas School of Law).
Parents may “provide additional medical history and
The FDA’s approval and deregulation of chemical abortion
drugs also blatantly ignores parents’ constitutional rights to the
care and upbringing of their minor pregnant daughters. See
Wisconsin v. Yoder, 406 U.S. 205, 232 (1972) (“The history and
culture of Western civilization reflect a strong tradition of
parental concern for the nurture and upbringing of their
children. This primary role of the parents in the upbringing of
their children is now established beyond debate as an enduring
American tradition.”).
11
24
information [regarding their minor daughter] to
abortion providers prior to [the] performance of the
abortion,” safeguard that an adolescent girl
understands the medical risks of the procedure, and
give her advice during the informed consent process.
Id. at 26–27. Moreover, parental involvement
“ensures that the parents have the ability to monitor
for post-abortion complications.” Id. at 19.
Adolescents have high risk pregnancies and often
delay prenatal care. “Adolescence is a critical period
marking phenomenal changes including rapid
physical, psychosocial, sexual and cognitive
maturation, and nutrient needs of adolescents are
higher than at any other stage in the lifecycle.” Nadia
Akseer et al., Characteristics and Birth Outcomes of
Pregnant Adolescents Compared to Older Women: An
Analysis of Individual Level Data from 140,000
Mothers from 20 RCTs, eClinicalMed., Feb. 26, 2022,
at 1, 3. During pregnancy, “adolescent girls are a
particularly vulnerable group since the demands of
regular growth and development are augmented by
the heightened nutritional requirements of
supporting a fetus.” Id. Due to adolescent patients’
developing bodies, they have a “biological
predisposition for high-risk pregnancies.” Id. at 12.
The high-risk nature of adolescent pregnancy is
compounded by the fact that pregnant adolescent
patients often delay care. Nathalie Fleming et al.,
Adolescent Pregnancy Guidelines, 37 J. Obstetrics &
Gynaecology Can. 740, 743 (2015). There are multiple
reasons adolescent patients delay care, including:
25
lack of knowledge about the importance of
prenatal care and lack of understanding of the
consequences of its absence; history as a victim
of violence, desire to hide pregnancy, fear of
potential
apprehension
of
the
baby,
contemplation of abortion services; concerns
about lack of privacy or judgemental attitudes
from health care providers or adults; and
financial barriers.
Id. Unfortunately, “[l]ack of, or delayed, adolescent
prenatal care is associated with adverse maternal,
obstetrical, and neonatal outcomes.” Id.
The FDA approved and deregulated chemical
abortion drugs without knowing the drugs’ impact on
adolescent development, especially their effects on
girls’ immune systems. See Staff of Subcomm. on
Crim. Just., supra, at 12 (recognizing medical
concerns about mifepristone’s immune system
inhibition); Compl. ¶ 216, Dist. Ct. ECF No. 1 at 60
(During the 2016 Major REMS changes, “[t]he FDA
did not require any studies on the long-term effects of
chemical abortion drugs in pediatric populations with
developing reproductive systems.”). Mifepristone, an
anti-progestin, interferes with the immune system
“by binding with a woman’s progesterone receptors on
the nuclear membranes of cells in the uterus, ovary,
brain, breast, and immune system.” Forsythe, supra,
at 388. Since mifepristone has blocked uterine
progesterone receptors, “the mother’s cells in the
placenta stop functioning, which eventually leads to
the death of the embryo through, in essence,
26
starvation,” and at a certain point, the mother loses
her unborn child. Id. at 388–389. However,
mifepristone has another effect upon the body: “the
blockade of glucocorticoid receptors also induces an
unexpected immune blockade, suppressing the
immune system, which can result in increased
susceptibility to overwhelming infection” throughout
the body. Id. at 389; see also Ralph P. Miech,
Pathophysiology of Mifepristone-Induced Septic
Shock Due to Clostridium Sordellii, 39 Annals
Pharmacotherapy 1483, 1483 (2005) (“[I]t appears
that the mechanisms of mifepristone action favor the
development of infection that leads to septic shock
and intensifies the actions of multiple inflammatory
cytokines, resulting in fulminant, lethal septic
shock.”).
Thus, adolescent patients seeking chemical
abortion drugs face unique challenges compared to
their adult counterparts. The FDA had no authority
to waive the pediatric study in the initial 2000 drug
approval, and did not ensure the chemical abortion
drugs, dosages, and administration are safe and
effective for adolescent patients. See 21 U.S.C. § 355c.
Accordingly, the FDA acted outside the scope of its
authorized power under PREA and risked the health
and safety of adolescent patients.
In sum, “the political motivations for bringing
[mifepristone] to the U.S. market overwhelmed
considerations of women’s health and safety.” Staff of
Subcomm. on Crim. Just., supra, at 9. The FDA
27
subverted patient safeguards when it violated the
APA, FDCA, and PREA’s requirements.
CONCLUSION
If the Court grants the FDA and/or Danco’s
petitions for a writ of certiorari, then Amici urge the
Court to grant Alliance for Hippocratic Medicine’s
conditional cross-petition. The FDA unlawfully
approved mifepristone as a “life-threatening illness”
under Subpart H, and subverted patient safeguards
within federal laws. The FDA’s actions have
endangered women and girls seeking these dangerous
drugs.
Respectfully submitted,
STEVEN H. ADEN
Counsel of Record
CAROLYN MCDONNELL
DANIELLE PIMENTEL
AMERICANS UNITED FOR LIFE
1150 Connecticut Ave., N.W.
Suite 500
Washington, DC 20036
Steven.Aden@aul.org
Telephone: (202) 741-4917
Counsel for Amici Curiae
November 15, 2023
APPENDIX
ia
APPENDIX TABLE OF CONTENTS
APPENDIX TABLE OF CONTENTS ...................... ia
LIST OF AMICI CURIAE ........................................ 1a
U.S. Senate.......................................................... 1a
U.S. House of Representatives ........................... 2a
1a
LIST OF AMICI CURIAE
U.S. Senate
Lead Senator: Cindy Hyde-Smith (MS)
John Barrasso (WY)
John Hoeven (ND)
Mike Braun (IN)
James Lankford (OK)
Katie Britt (AL)
Roger Marshall (KS)
Ted Budd (NC)
Markwayne Mullin (OK)
Bill Cassidy (LA)
James Risch (ID)
Kevin Cramer (ND)
Marco Rubio (FL)
Mike Crapo (ID)
Rick Scott (FL)
Steve Daines (MT)
Roger Wicker (MS)
2a
U.S. House of Representatives
Lead Representative: August Pfluger (TX–11)
Robert Aderholt (AL–04)
Mark Alford (MO–04)
Rick Allen (GA–12)
Jodey Arrington (TX–19)
Brian Babin (TX–36)
Michael Burgess, M.D.
(TX–26)
Eric Burlison (MO–07)
Kat Cammack (FL–03)
Jerry Carl (AL–01)
Don Bacon (NE–02)
Earl L. “Buddy” Carter
(GA–01)
James Baird (IN–04)
Ben Cline (VA–06)
Troy Balderson (OH–12)
Michael Cloud (TX–27)
Jim Banks (IN–03)
Andrew S. Clyde (GA–09)
Aaron Bean (FL–04)
Mike Collins (GA–10)
Cliff Bentz (OR–02)
Dan Crenshaw (TX–02)
Andy Biggs (AZ–05)
Warren Davidson
(OH–08)
Gus Bilirakis (FL–12)
Lauren Boebert (CO–03)
Mike Bost (IL–12)
Josh Brecheen (OK–02)
Tim Burchett (TN–02)
Jeff Duncan (SC–03)
Dr. Neal Dunn (FL–02)
Jake Ellzey (TX–06)
Ron Estes (KS–04)
3a
Mike Ezell (MS–04)
Ashley Hinson (IA–02)
Scott Fitzgerald (WI–05)
Erin Houchin (IN–09)
Virginia Foxx (NC–05)
Richard Hudson (NC–09)
Russ Fulcher (ID–01)
Bill Johnson (OH–06)
Bob Good (VA–05)
Jim Jordan (OH–04)
Lance Gooden (TX–05)
Mike Kelly (PA–16)
Paul A. Gosar, D.D.S.
(AZ–09)
Trent Kelly (MS–01)
Garrett Graves (LA–06)
Mark Green (TN–07)
Marjorie Taylor Greene
(GA–14)
Michael Guest (MS–03)
Harriet Hageman (WY)
Andy Harris, M.D.
(MD–01)
Doug Lamborn (CO–05)
Jake LaTurner (KS–02)
Debbie Lesko (AZ–08)
Barry Loudermilk
(GA–11)
Lisa McClain (MI–09)
Dr. Richard McCormick
(GA–06)
Carol Miller (WV–01)
Diana Harshbarger
(TN–01)
Mary Miller (IL–15)
Kevin Hern (OK–01)
John Moolenaar (MI–02)
Clay Higgins (LA–03)
Alex X. Mooney (WV–02)
4a
Barry Moore (AL–02)
Nathaniel Moran (TX–01)
Ralph Norman (SC–05)
Andrew Ogles (TN–05)
Gary Palmer (AL–06)
Bill Posey (FL–08)
Mike Rogers (AL–03)
John Rose (TN–06)
Christopher H. Smith
(NJ–04)
Claudia Tenney (NY–24)
Glenn “GT” Thompson
(PA–15)
William Timmons, IV
(SC–04)
Beth Van Duyne (TX–24)
Tim Walberg (MI–05)
David Rouzer (NC–07)
Randy Weber, Sr.
(TX–14)
John H. Rutherford
(FL–05)
Daniel Webster (FL–11)
Austin Scott (GA–08)
Brad R. Wenstrup,
D.P.M. (OH–02)
Keith Self (TX–03)
Pete Sessions (TX–17)
Adrian Smith (NE–03)
Roger Williams (TX–25)
Joe Wilson (SC–02)
Rudy Yakym (IN–02)
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.