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

Supreme Court briefFeb 29, 2024

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Nos. 23-235, 23-236

In the

Supreme Court of the United States

U.S. FOOD AND DRUG ADMINISTRATION, ET AL.,

Petitioners,

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

DANCO LABORATORIES, L.L.C.,

Petitioner,

ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.,

Respondents.

ON WRITS OF CERTIORARI TO THE UNITED STATES COURT

OF APPEALS FOR THE FIFTH CIRCUIT

BRIEF OF AMICI CURIAE GIANINA CAZANLONDON MD, MELISSA HALVORSON MD,

AND WAGNER FAITH & FREEDOM CENTER

IN SUPPORT OF RESPONDENTS

William Wagner

Counsel of Record

GREAT LAKES JUSTICE CENTER

5600 W. Mount Hope Hwy.

Lansing, MI 48917

(517) 643-1765

Prof.WWJD@gmail.org

February 29, 2024

Counsel for Amici Curiae

Becker Gallagher · Cincinnati, OH · Washington, D.C. · 800.890.5001

QUESTIONS PRESENTED

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.

This amici curiae brief primarily addresses the

second issue.

TABLE OF CONTENTS

QUESTIONS PRESENTED........................................ i

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

STATEMENT OF IDENTITY AND INTERESTS

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

SUMMARY OF THE ARGUMENT ............................3

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

THE FDA ARBITRARILY AND CAPRICOUSLY

AUTHORIZED THE DISPENSING OF A

DANGEROUS DRUG DESIGNED WITH THE

SINGULAR PURPOSE OF KILLING AN

INNOCENT HUMAN LIFE ...................................4

CONCLUSION ..........................................................19

iii

TABLE OF AUTHORITIES

CASES

FCC v. Fox Television Stations, Inc.,

556 U.S. 502 (2009) ............................................. 4, 5

FCC v. WNCN Listeners Guild,

450 U.S. 582 (1981) ................................................. 5

FCC v. Prometheus Radio Project,

592 U.S. 414 (2021) ................................................. 4

Motor Vehicle Mfrs. Assn. of United States, Inc. v.

State Farm Mut. Automobile Ins. Co.,

463 U.S. 29 (1983) ................................................... 5

STATUTES

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

21 U.S.C. § 355(d) ........................................................ 4

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

21 U.S.C. § 909(b)(1) .................................................... 5

Food and Drug Administration Amendments Act of

2007, Pub.L. No. 110-85, tit. IX § 909(b)(1), 121

Stat. 823............................................................... 5, 6

REGULATIONS

21 C.F.R. 314.71 .......................................................... 4

OTHER AUTHORITIES

Appl. For. Stay, FDA v. ACOG, No. 20A34 (U.S.

Aug. 26, 2020) ..........................................................7

Francis J. Beckwith, Defending Life: A Moral and

Legal Case Against Abortion Choice (2007) .........13

Brief of the American Medical Assn., American

Nurses Assn., American Psychiatric Assn., et

al., as Amicus Curiae in Support of Petitioners,

Glucksberg (No. 96-110), available in 1996 WL

656263......................................................................8

Genesis 1:26 (NIV) .......................................................7

Hippocratic Oath,

https://biotech.law.lsu.edu/cases/research

/hippocratic-oath.htm ..............................................8

Hollowell, K. J., Defining a Person Under the

Fourteenth Amendment: A Constitutionally and

Scientifically Based Analysis, 14 Regent UL

Rev. 67 (2001) ........................................................15

https://www.aafp.org/pubs/afp/issues/2020/

0515/p599.html ........................................................9

https://www.accessdata.fda.gov/scripts/cder

/rems/index.cfm .......................................................6

https://www.ehd.org/gallery/436/Hiding-theFace#content ...................................................17, 18

https://www.ehd.org/movies/231/Responds-toTouch .....................................................................17

https://www.ehd.org/your-life-before-birthvideo/ ................................................................16, 17

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4

616906/...................................................................18

https://www.nhs.uk/pregnancy/week-by-week/28to-40-plus/37-weeks/ ..............................................15

Dianne N. Irving, When do human beings begin?

Scientific

myths

and

scientific

facts,

International Journal of Sociology and Social

Policy,

Vol.

No.

3/4

(1999),

https://doi.org/10.1108/ 01443339910788730 .......13

Ben Johnson, “Supreme Court Allows Abortionists

to Violate FDA Guidelines When Using RU486,” LifeSiteNews.com, December 15, 2014,

https://www.lifesitenews.com/news/supremecourt-allows-abortionists-to-violate-fdaguidelines-when-using-ru-4/ .................................11

Scott Klusendorf, The Case for Life (2009) .........13, 16

Charles I. Lugosi, Conforming to the Rule of Law:

When Person and Human Being Finally Mean

the Same Thing in Fourteenth Amendment

Jurisprudence, 4 GEOJLPP 361 (2006) ...............13

Mifeprex Medication Guide, U.S. Food and Drug

Administration,

https://www.accessdata.fda.gov/scripts/cder/daf

/index.cfm................................................. 7, 9, 10, 12

Lennart

Nilsson,

Foetus

weeks,

http://100photos.time.com/photos/lennartnilsson-fetus ..........................................................16

Carole Novielli, “Increasing Number of Abortion

Pill Expansion Schemes Flout FDA Safety

Regulations,” Live Action News, November 7,

2021,

https://www.liveaction.org/news/increasingabo

rtion-pill-expansion-flout-fda/ ...............................10

Bonnie Rochman, A 21-Week-Old Baby Survives

and Doctors Ask, How Young is Too Young to

Save? Time Magazine (May 27, 2011),

https://healthland.time.com/2011/05/27/babyborn-at-21-weeks-survives-how-young-is-tooyoung-to-save/ ........................................................15

STATEMENT OF IDENTITYAND

INTERESTS OF AMICI CURIAE

Pursuant to Supreme Court Rule 37, amici curiae,

obstetricians-gynecologists Gianina Cazan-London

MD and Melissa Halvorson MD, and the Wagner

Faith & Freedom Center at Spring Arbor University

submit this brief. 1

Obstetricians-gynecologists

Gianina

CazanLondon MD (Maternal Fetal Medicine/ObGyn) and

Melissa Halvorson MD, (ObGyn) are physicians who

believe every human being holds the inalienable right

to life from conception until natural death. They

endeavor to ensure that pregnant women receive the

highest quality medical care and are fully informed of

the effects of abortion, including the potential longterm consequences of abortion on women’s health.

They hold special expertise and understanding of fetal

development and abortion-related health risks helpful

to this Court. Finally, these physicians educate the

public truthfully about human development and the

immense advancements made in their field over the

last several years.

Amici Curiae physicians have special knowledge

and insight that can assist this Court concerning

chemical abortions.

1 Amici Curiae state that no counsel for any party authored this

brief in whole or in part, and no counsel or party made a

monetary contribution intended to fund the preparation or

submission of this brief. No person or entity, other than amici

curiae, its members, or its counsel, made a monetary contribution

to the preparation or submission of this brief.

Housed on the campus of Spring Arbor University,

the Wagner Faith & Freedom Center serves as a

national academic voice for faith, family, freedom, and

the sanctity of human life. Working daily to secure the

future for freedom of thought, conscience, and religion,

the WFFC equips the next generation to be a voice for

the lives of unborn children.

In public forums throughout the world the WFFC

speaks on behalf of the persecuted and most

vulnerable, including most especially, the unborn

child.

The WFFC champions the cause of the

defenseless and oppressed, standing for faith,

freedom, and the sanctity of life all around the world.

The WFFC holds special knowledge helpful to this

Court, having a significant interest in preserving

constitutional good governance under the rule of law,

and is a leading voice in this area.

It is through this brief that Amici Curiae present

to this Court the life and death ethical context

underlying the good governance issues before it, and

especially the question of whether FDA’s 2016 and

2021 actions were arbitrary and capricious.

SUMMARY OF THE ARGUMENT

The Government action at issue before this Court

authorizes the telephonic dispensing of a dangerous

abortion drug. Throughout its exercise of government

power, the FDA acted far outside any “zone of

reasonableness” and never “considered the relevant

issues” or “reasonably explained” its decisions.

Not once did the FDA acknowledge that it was

providing government authorization for the

dispensing of a drug designed with the singular

purpose of killing an innocent human life. Not once

did it acknowledge the humanity of the pre-born child.

And not once, in the name of political expediency, was

it not willing to diminish the health and safety of

pregnant mothers and the integrity of the medical

profession. Whether radically weakening health and

safety protections by changing the conditions of the

drug’s use in 2016 sans adequate study, or relying on

deficient analysis to remove even the vital in-person

doctor visit in 2021, the FDA placed itself and a

progressive abortion agenda above the law.

Good governance, the rule of law, and humanity

require more than the arbitrary and capricious

exercise of power.

ARGUMENT

THE FDA ARBITRARILY AND

CAPRICOUSLY AUTHORIZED THE

DISPENSING OF A DANGEROUS DRUG

DESIGNED WITH THE SINGULAR

PURPOSE OF KILLING AN INNOCENT

HUMAN LIFE

Good governance under the rule of law requires

that the Food and Drug Administration (FDA) act

within the scope of the rule of law. Here that legal

authority is the Food, Drug, and Cosmetic Act (FDCA)

Title 21 U.S.C. § 355(d), and its implementing

regulation 21 C.F.R. 314.71, which mandate that the

FDA ensure that the drugs it approves under its

purview are “safe and effective.” 21 U.S.C. § 355.

Under this congressional mandate the FDA cannot

give initial approval or modify a drug approval

without a “sufficient” showing that the drug is safe for

use as labeled.

The Government action at issue before this Court

authorizes the telephonic dispensing of a dangerous

drug designed with the singular purpose of killing an

innocent human life. It is that government action with

which we begin.

Ultimately, this Court must decide whether the

FDA’s 2016 and 2021 actions were arbitrary and

capricious. In Federal Communications Commission

v. Prometheus Radio Project, 592 U.S. 414, 423 (2021)

this Court held that the Administrative Procedure

Act’s “arbitrary-and-capricious standard requires that

agency action be reasonable and reasonably

explained” citing, FCC v. Fox Television Stations, Inc.,

556 U.S. 502, 513–514 (2009); Motor Vehicle Mfrs.

Assn. of United States, Inc. v. State Farm Mut.

Automobile Ins. Co., 463 U.S. 29, 43 (1983) and FCC

v. WNCN Listeners Guild, 450 U.S. 582, 596 (1981).

Under this standard the FDA was required to act

“within a zone of reasonableness.” Id. Specifically, the

FDA was required to “reasonably” consider the

relevant issues and “reasonably” explain its decisions.

Id. The FDA failed miserably.

In 2000, the U.S. Food and Drug Administration

(FDA) approved the abortion drug RU486 (brand

name Mifeprex, also known as mifepristone). J.A. 18,

39. Although promoted as a private way to abort a

child up to 7 weeks gestation, J.A. 234, the FDA

understood that without extra precautions use of the

drug was not safe. J.A.230. The regulation, therefore,

required physicians prescribing the drug to: 1) be

licensed; 2) be capable of correctly determining

gestational age; and 3) be capable of diagnosing

ectopic pregnancies. Id. Additionally, to protect the

health and safety of the mother from the danger posed

by the drug, the FDA mandated treating physicians

provide continuing in-person physician-patient care.

J.A. 226-27, 230.

A 2007 act of Congress mandated a “Risk

Evaluation and Mitigation Strategy” (REMS) by the

FDA because of its “potential harmfulness” and

connection with a “serious adverse drug experience.”

Food and Drug Administration Amendments Act of

2007, Pub.L. No. 110-85, tit. IX § 909(b)(1), 121 Stat.

823, 950. Because, with added safety considerations,

the FDA had previously approved the dangerous

abortion drug, the new congressional mandate here

considered the drug to provisionally hold an approved

REMS. 21 U.S.C. § 355-1(f)(1); Pub. L. No. 110-85 at

§ 909(b)(1).

Thereafter, FDA approval of a REMS for RU-486

occurred in 2011. ROA 671-75; JA 296. At this time

the FDA reaffirmed the necessity of the in-person

physician-patient meetings, (i.e., physical exam,

counselling, etc), and reiterated the health and safety

concern of gestational age determinations and ectopic

pregnancies dangers. J.A. 276; 296. Only 62 drugs

with such potentially serious side effects require a

REMS— and the drug at issue before this Court is one

of them. https://www.accessdata.fda.gov/scripts/cder

/rems/index.cfm.

The FDA, in 2016, profoundly changed the

conditions of the drug’s use, radically diminishing

previous safety standards such as lengthening

permissible use of the drug for up to 10 weeks

gestation, J.A. 295, and removing any requirement to

report serious adverse events to the FDA. J.A. 318.

The government in doing so neither conducted any

analysis that examined the changes made as

considered all together, nor did it describe why it

declared cumulative studies unnecessary here. See

e.g., J.A. 549

Then, in 2021, the FDA relied on untrustworthy

information and deficient analysis to modify its

approval by additionally removing even the vital inperson doctor visit originally required by the rule.

J.A.365; 378; Pet. App. 59a; 61a. This was so even

though two national physician associations had

previously warned the FDA of the extreme danger in

doing so. J.S. 321-47. This was so even though the

FDA in 2020 represented to this Court that an inperson physician-patient meeting was “necessary” to

for the safety of the women and girls taking the drug.

Appl. For. Stay, FDA v. ACOG, No. 20A34 (U.S. Aug.

26, 2020).

Again, it is important to understand what the

government authorized here: The dispensing of a

drug designed with the singular purpose of killing an

innocent human life. The chemical killing regimen

here includes two steps:

1) depriving the unborn human baby

of necessary nutrients to survive and

weakening the connection between the

mother and baby - (via an initial dose of

RU-486 which blocks the vital pregnancy

hormone progesterone); and

2) expelling the baby after it is killed

-(via the ulcer medicine misoprostol

taken 24 to 48 hours later, causing the

uterus to contract)

Mifeprex Medication Guide, U.S. Food and Drug

Administration, accessed December 28, 2021,

https://www.accessdata.fda.gov/scripts/cder/daf/index

.cfm

Amici curiae believe that human life is made in the

image of God, and that therefore every human life

holds positive value worthy of protection and dignity.

Genesis 1:26 (NIV). Underlying the government’s

action here is a rejection of this inviolable standard

present in the natural law, divine law, and positive

law, in favor of an arbitrary and capricious morally

relative standard where a government regime

authorizes absent doctors to decide when and whether

a human life has positive value.

Ultimately, allowing the telephonic dispensing of

federally controlled drugs to kill an innocent unborn

child proceeds from the fundamentally erroneous

premise that human life in certain conditions has no

positive value. That premise has incalculably grave

implications for all of us. When we abandon medical

moral absolutes today, it becomes easy tomorrow to

choose death in other ways, for other people, in other

situations, since the positive value of life has become

an immorally relative individual choice.

The Hippocratic Oath written during the fifth to

fourth centuries B.C. declares, “… I will not give to a

woman an abortive remedy. In purity and holiness I

will guard my life and my art.” Hippocratic Oath,

available at https://biotech.law.lsu.edu/cases/research

/hippocratic-oath.htm (last visited February 26, 2024).

For most of world history this standard was a

cornerstone of medical ethics.

Physicians treating a pregnant mother have two

patients, the mother and the unborn child. In the

context of chemical abortion, a treating doctor cannot

help one patient without endangering the other. And,

absent an in-person physical examination, could

endanger both the mother and child. Abortion of preborn children is, and always has been, fundamentally

incompatible with the physician’s role as healer. Cf.

Brief of the American Medical Assn., American Nurses

Assn., American Psychiatric Assn., et al., as Amicus

Curiae in Support of Petitioners at 5, Glucksberg (No.

96-110), available in 1996 WL 656263.

The government’s conduct in the case at bar rejects

this position and the fundamental inviolable standard

which serves as its foundation. Underlying its action

instead is a morally relative medical foundation,

where politically driven regimes and doctors choose

when and whether a human life has positive value,

completely ignoring the health and safety of the

physician’s patients.

For example, it is undisputed that the presence

of an ectopic pregnancy affects the health and safety

of pregnant women. Ectopic pregnancies occur in 1-2%

of all pregnancies and cause 2.7% of pregnancy related

deaths. https://www.aafp.org/pubs/afp/ issues/2020/

0515/p599.html (last visited February 26, 2024)

Undiagnosed ectopic pregnancies are particularly

dangerous; the side effects of Mifepristone are similar

to symptoms of a potentially fatal ruptured ectopic

pregnancy. Even the FDA acknowledges that doctors

should not prescribe Mifepristone to “patients with a

confirmed or suspected ectopic pregnancy” and that an

ectopic pregnancy cannot be diagnosed without a

physical examination. 2

2 The FDA medication guide for Mifepristone provides that

MIFEPREX is contraindicated in patients with a

confirmed or suspected ectopic pregnancy because

MIFEPREX is not effective for terminating ectopic

pregnancies [see Contraindications (4)]. Healthcare

providers should remain alert to the possibility that a

patient who is undergoing a medical abortion could

have an undiagnosed ectopic pregnancy because some

of the expected symptoms experienced with a medical

abortion (abdominal pain, uterine bleeding) may be

similar to those of a ruptured ectopic pregnancy. The

The FDA’s actions in the case at bar nonetheless

enabled the dispensing of Mifepristone via the U.S.

mail without a physician conducting a physical

examination. Instead, a physician merely has an

electronic “patient consultation” (e.g., via phone or

video). The physician dispenses the death drug

through the mail without any follow-up medical care.

The FDA promulgated this policy knowing

abortionists had previously violated FDA guidelines

by using telemedicine procedures to bypass the initial

in-person distribution safety requirement. Carole

Novielli, “Increasing Number of Abortion Pill

Expansion Schemes Flout FDA Safety Regulations,”

Live

Action

News,

November

2021,

https://www.liveaction.org/news/increasingabortionpill-expansion-flout-fda/. Moreover, the FDA enacted

this change notwithstanding the very real-life

scenario where a despicable third person could trick or

coerce a pregnant mother with an undiagnosed ectopic

pregnancy into taking the death drug at issue here with no physical exam by a physician to save her.

presence of an ectopic pregnancy may have been missed

even if the patient underwent ultrasonography prior to

being prescribed MIFEPREX. Patients who became

pregnant with an IUD in place should be assessed for

ectopic pregnancy.

Mifeprex medication guide, U.S. Food and Drug Administration,

5.4 Ectopic Pregnancy, accessed December 28, 2021,

https://www.accessdata.fda.gov/scripts/cder/daf/ index.cfm

https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/0206

87Orig1s025Lbl.pdf

Likewise, correct gestational age affects the health

and safety of pregnant women. The FDA’s action

nonetheless enabled the dispensing of chemical

abortion drugs via the U.S. mail without a physician

conducting a physical examination to determine

gestational age. This is so even though abortion

providers continually violated the FDA guidelines by

prescribing RU-486 to women beyond the permitted

gestation time. Ben Johnson, “Supreme Court Allows

Abortionists to Violate FDA Guidelines When Using

RU-486,” LifeSiteNews.com, December 15, 2014,

https://www.lifesitenews.com/news/supreme-courtallows-abortionists-to-violate-fda-guidelines-whenusing-ru-4/ (last accessed February 26, 2024)

Moreover, the FDA’s action endangers the mother’s

health and safety in additional ways. A review of the

FDA’s own data shows that 85% of women report at

least one or more of the following adverse reactions

after taking the death drug regimen:

•

bleeding

•

nausea

•

weakness

•

fever/chills

•

vomiting

•

headache

•

diarrhea

•

dizziness

Women bled or spotted for an average of 9 to 16

days. Between 2% and 7% of the abortions failed,

meaning women needed follow-up surgical abortions.

Moreover, the FDA received reports of the deaths of

women associated with RU-486. Mifeprex Medication

Guide, U.S. Food and Drug Administration, accessed

December 28, 2021, https://www.accessdata.fda.gov/

scripts/cder/daf/index.cfm. Even today the FDA

acknowledges that up to 4.6 percent of pregnant

mothers who use the prescription will go to an

emergency room afterwards. J.A. 533

The grave implications for our nation of a

government authorizing doctors to dispense poison

designed with the sole purpose of efficiently killing an

innocent human life should cause pause, especially

given the historical proficiency with which other

governments, like the Third Reich, arbitrarily and

capriciously authorized doctors to dispense poison

designed with the sole purpose of efficiently killing

“unworthy” innocent human life. Foundations do

matter. Every human life holds inherent value as a

moral absolute, and is worthy, therefore, of being

treated with dignity and respect. No government

regime and no doctor should hold the power to decide

that someone else’s life is not worthy. Innocent

human life must be protected and promoted by the law

if order and liberty are to flourish. There is no state

or medical interest greater than the protection of

human life. And there is no life more in need of state

and medical protection than those most vulnerable,

such as a pre-born child.

Human life holds inherent value and merits

protection when it is human, and every human life

begins at conception. 3 As Professor Francis Beckwith

cogently explains:

Only artifacts, such as clocks and

spaceships, come into existence part by

part. Living beings come into existence

all at once and then gradually unfold to

themselves and to the world what they

already are, but only incipiently are.

Because one can only develop certain

functions by nature (i.e., a result of basic,

intrinsic capacities) a human being at

every stage of development is never a

potential person, she is always a person

with potential even if that potential is

never actualized due to premature death

or the result of the absence or deformity

of a physical state necessary to actualize

that potential. 4

3 See, e.g., Scott Klusendorf, The Case for Life (2009) at 36, 44

(citing numerous embryological experts and texts and noting that

even rabid abortion advocates such as Peter Singer admit an

embryo is a human being at conception); Dianne N. Irving, When

do human beings begin? Scientific myths and scientific facts,

International Journal of Sociology and Social Policy, Vol. 19 No.

3/4 (1999) at 22-46, available at https://doi.org/10.1108/

01443339910788730 (last visited 7/24/21); Charles I.

Lugosi, Conforming to the Rule of Law: When Person and Human

Being Finally Mean the Same Thing in Fourteenth Amendment

Jurisprudence, 4 GEOJLPP 361, 362, n.2 (2006) (citing a variety

of authoritative sources).

4 Francis J. Beckwith, Defending Life: A Moral and Legal Case

Against Abortion Choice (2007) at 34 (emphasis in original;

internal citation omitted).

Again, what this means as practical matter is that

all human life has dignity and is worthy of protection.

Significantly, scientists no longer disagree on when

human life begins. The consensus among scientists is

that it begins at conception. 5

Any

decision

involving

the

government

authorization of chemical abortion presupposes a

decision about when one becomes a person, because a

person cannot be killed lawfully——except in cases of

self-defense or a state-administered sentence after a

fair trial and exhaustion of all appeals -- but not by a

mail order death drug pursuant to a progressive

abortion agenda.

If a government decides a baby at a certain stage

of development can, in ordinary circumstances, be

killed, it has decided that that baby is not a person. If

it decides that baby cannot be killed, it has decided

that that baby is a person. What a government

purports to be doing when it makes those decisions is

immaterial; it is unquestionably defining our

humanity. The only question is how it will do so.

Conceived by a human father and a human mother,

are we to be recognized as human beings, whole and

equal by nature?

Why, exactly, does the state have an interest in the

lives of pre-born human beings? It is because they are

human beings – not only as a matter of morality, but

of biological science as well. If the state has an

interest in preserving human life (which it does), then

5 See fn. 3, supra.

it has an interest in human life; and that interest

begins when human life begins.

Our humanity is a constant. It does not vary over

time under different circumstances. It is our nature,

not a feature of our environment or our

accomplishment. It does not vacillate based on the

state of our technology, including even the technology

that lets a baby live outside the mother’s womb. Just

a few centuries ago, a child typically couldn’t live

outside the womb before it reached near full gestation,

which is thirty-seven to forty weeks. You and your

baby at 37 weeks pregnant, available at

https://www.nhs.uk/pregnancy/week-by-week/28-to40-plus/37-weeks/ (last visited February 26, 2024).

When Roe was decided, just fifty years ago, viability—

and hence personhood in the Roe Court’s eyes—was

gained at about twenty-eight weeks. 6 Now in the postDobbs era, it is about twenty-three weeks. 7 One can

imagine a time when our technology advances to the

point that an embryo at conception could be placed

into a technological or bionic “mother” of some sort and

be viable. Any conception of our humanity as a

technologically determined variables is utterly

dehumanizing.

Hollowell, K. J., Defining a Person Under the Fourteenth

Amendment: A Constitutionally and Scientifically Based

Analysis, 14 Regent UL Rev. 67, 83-86 (2001); see also Bonnie

Rochman, A 21-Week-Old Baby Survives and Doctors Ask, How

Young is Too Young to Save? Time Magazine (May 27, 2011),

available at https://healthland.time.com/2011/05/27/baby-bornat-21-weeks-survives-how-young-is-too-young-to-save/

(last

visited July 27, 2021).

7 Id. at 84.

Advances in science now reveal the remarkable

development of a pre-born child from the moment of

fertilization. Gone are the days when society can

question whether such a pre-born child is merely a

“clump of cells.” 8 Actual video of children in the womb

reveals the completeness of development of a fetus.

See https://www.ehd.org/your-life-before-birth-video/

(last visited February 26, 2024) (displaying pieces of

actual video footage of a child’s development in utero).

At twenty-two days, the child’s heart begins to

beat.

https://www.ehd.org/your-life-before-birthvideo/ (last visited July 15, 2020).

At six weeks, the child begins moving. Id.

See Klusendorf, supra, at 38-39 (dispelling “clump of cells”

argument).

9 Photograph of a human fetus at eighteen weeks of gestational

development.

Lennart Nilsson, Foetus 18

http://100photos.time.com/photos/lennart-nilsson-fetus

visited July 14, 2020).

weeks,

(last

At seven weeks, scientists can detect a child’s

brainwaves, and the child can move his or her own

head and hands. Id. The child also displays leg

movements and the startle response by that time. Id.

At eight weeks, the child’s brain exhibits complex

development. Id. The child also then begins breathing

movements and shows preference for either his or her

left or right hand. Id. At nine weeks, the child sucks

his or her thumb, swallows, and responds to light

touch. Id.

At ten weeks, the child’s unique fingerprints are

formed on his or her fingers. Id.

At twelve weeks, the child opens and closes his or

her mouth and moves his or her tongue. Id. The

child’s fingers and hands are also fully formed by

twelve weeks’ gestation. Id.

https://www.ehd.org/movies/231/Responds-to-Touch

(last visited February 26, 2024) (displaying video of

baby at fifteen weeks responding to touch).

By sixteen weeks, the child’s gender is easily

detectable, and the child looks undeniably human:

https://www.ehd.org/gallery/436/Hiding-theFace#content (last visited February 26, 2024)

(showing

photographic still

of sixteen-week

ultrasound video of a male fetus hiding his head away

from the touch of the ultrasound transducer).

By nineteen weeks, the child hears and responds to

noises, even making different facial expressions when

listening to music. See, e.g., https://www.ncbi.nlm.nih

.gov/pmc/articles/PMC4616906/ (last visited February

26, 2024) (finding that neural pathways participating

in the auditory–motor system may be developed as

early as the gestational age of sixteen weeks).

The humanity of the pre-born child is even more

apparent today than ever before.

Throughout its exercise of government power, the

FDA acted far outside any “zone of reasonableness”

and never “considered the relevant issues” or

“reasonably explained” its decisions. Not once did the

FDA acknowledge that it was providing government

authorization for the dispensing of a drug designed

with the singular purpose of killing an innocent

human life. Not once did it acknowledge the humanity

of the pre-born child. And not once, in the name of

political expediency, was it not willing to diminish the

health and safety of pregnant mothers and the

integrity of the medical profession. Whether radically

weakening health and safety protections by changing

the conditions of the drug’s use in 2016 sans adequate

study, or relying on deficient analysis to remove even

the necessary in-person doctor visit in 2021, the FDA

placed itself and its progressive abortion agenda above

the law.

Good governance, the rule of law, and humanity

require more than the arbitrary and capricious

exercise of power.

CONCLUSION

For the foregoing reasons, Amici Curiae urge this

Court to affirm the Fifth Circuit’s order and remand

for further proceedings.

Respectfully submitted,