Case 2:22-cv-00223-Z Document 55-1 Filed 02/10/23 Page 1 of 26 PageID 2747

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF TEXAS
AMARILLO DIVISION

ALLIANCE FOR HIPPOCRATIC

MEDICINE, et al.,

Plaintiffs,

v. Case No. 2:22-cv-00223-Z

U.S. FOOD AND DRUG

ADMINISTRATION, et al.,

Defendants.

AMICUS CURIAE BRIEF OF MISSISSIPPI, ALABAMA, ALASKA,

ARKANSAS, FLORIDA, GEORGIA, IDAHO, INDIANA, IOWA, KANSAS,
KENTUCKY, LOUISIANA, MONTANA, NEBRASKA, OHIO, OKLAHOMA,
SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, AND
WYOMING IN SUPPORT OF PLAINTIFFS’ MOTION
FOR PRELIMINARY INJUNCTION
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TABLE OF CONTENTS

Page
TABLE OF AUTHORITIES .......................................................................................... ii
INTRODUCTION, INTEREST OF AMICI CURIAE,
AND SUMMARY OF ARGUMENT .............................................................................. 1
BACKGROUND ............................................................................................................. 4
ARGUMENT .................................................................................................................. 7
The Public Interest And Equities Support Injunctive Relief Against The FDA’s
Actions On Mifepristone ........................................................................................ 7
A. The Public Interest And Equities Weigh Strongly Against The FDA’s Actions
Because Those Actions Defy Federal Law....................................................... 8
B. The FDA’s Actions Undermine The Public-Interest Determinations That
States—Not Federal Agencies—Are Entitled To Make ................................ 11
C. The FDA’s Actions Harm The Public Interest By Undermining States’ Ability
To Protect Their Citizens And Forcing States To Divert Scarce Resources To
Investigating And Prosecuting Violations Of Their Laws ............................ 14
CONCLUSION............................................................................................................. 18

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TABLE OF AUTHORITIES

Page(s)
Cases

Dobbs v. Jackson Women’s Health Organization,

142 S. Ct. 2228 (2022) ............................................................ 1, 2, 11, 12, 13, 14, 17

Gonzales v. Oregon,
546 U.S. 243 (2006) ................................................................................................ 12

Hillsborough Cnty., Fla. v. Automated Med. Laboratories, Inc.,

471 U.S. 707 (1985) ................................................................................................ 12

Maine v. Taylor,
477 U.S. 131 (1986) ................................................................................................ 16

Metro. Life Ins. Co. v. Massachusetts,

471 U.S. 724 (1985) .......................................................................................... 12, 15

Rice v. Santa Fe Elevator Corp.,

331 U.S. 218 (1947) ................................................................................................ 15

Solid Waste Agency of N. Cook Cnty. v. U.S. Army Corps of Engineers,

531 U.S. 159 (2001) ................................................................................................ 15

Texas v. Biden,
10 F.4th 538 (5th Cir. 2021) ............................................................................... 8, 11

Texas v. United States,

787 F.3d 733 (5th Cir. 2015) ............................................................................. 16-17

Valley v. Rapides Parish Sch. Bd.,

118 F.3d 1047 (5th Cir. 1997) ............................................................................ 8, 11

Wages & White Lion Invs., LLC v. FDA,

16 F.4th 1130 (5th Cir. 2021) ................................................................................... 8

Constitutional Provision

U.S. Const. amend. X ................................................................................................... 14

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Statutes

18 U.S.C. § 1461 ............................................................................................... 10, 11, 14

18 U.S.C. § 1462 ..................................................................................................... 10, 11

21 U.S.C. § 321 ............................................................................................................... 4

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

21 U.S.C. § 355-1............................................................................................................ 5

21 U.S.C. § 393 ............................................................................................................... 4

Food and Drug Administration Amendments Act,

Pub. L. No. 110-85, 121 Stat. 823 (2007) ............................................................. 5, 9

Ind. Code Ann. § 16-34-2-1 .......................................................................................... 13

La. Stat. Ann. § 40:1061.11 ......................................................................................... 13

Miss. Code Ann. § 41-41-45 ................................................................................... 12, 13

Miss. Code Ann. § 41-41-103 ....................................................................................... 13

Miss. Code Ann. § 41-41-107 ....................................................................................... 13

Okla. Stat. Ann. tit. 63, § 1-729.1 ............................................................................... 13

Pub. L. No. 91-662, 84 Stat. 1973 (1971) .................................................................... 10

Tex. Health & Safety Code Ann. § 171.063 ................................................................ 13

Executive Order

Protecting Access to Reproductive Healthcare Services,

Exec. Order No. 14076,
87 Fed. Reg. 42053 (2022) .................................................................................. 2, 11

Regulations

21 C.F.R. § 314.2 ..................................................................................................... 13-14

21 C.F.R. § 314.500 ............................................................................... 4, 8, 9, 10, 13-14

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21 C.F.R. § 314.520 ........................................................................................................ 4

21 C.F.R. §§ 314.500-314.560 ........................................................................................ 5

Rulemaking

New Drug, Antibiotic, and Biological Drug Product Regulations;

Accelerated Approval,
57 Fed. Reg. 58942 (Dec. 11, 1992) .......................................................................... 9

Other Authorities

Abortion Pills Can Now Be Offered at Retail Pharmacies, F.D.A. Says,

N.Y. Times (Jan. 3, 2023) ....................................................................................... 16

Fact Sheet: President Biden Announces Actions In Light of

Today’s Supreme Court Decision on Dobbs v. Jackson
Women’s Health Organization,
The White House (June 24, 2022)............................................................................ 2

Fact Sheet: President Biden to Sign Presidential Memorandum

on Ensuring Safe Access to Medication Abortion,
The White House (Jan. 22, 2023)............................................................................. 2

H.R. 13959, 95th Cong. (1978) .................................................................................... 10

H.R. Rep. No. 29 (1979) ............................................................................................... 10

Memorandum on Further Efforts to Protect Access to

Reproductive Healthcare Services,
The White House (Jan. 22, 2023)................................................................. 2, 15, 17

NIH, Nat’l Library of Medicine ..................................................................................... 4

Remarks of President Joe Biden—State of the Union Address

as Prepared for Delivery,
The White House (Feb. 7, 2023)............................................................................. 17

Retail Pharmacies Can Now Offer Abortion Pill, FDA Says,

Politico (Jan. 3, 2023) ............................................................................................. 16

U.S. Food & Drug Admin.,

Information about Mifepristone for Medical Termination of
Pregnancy Through Ten Weeks Gestation ........................................................... 6-7

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U.S. Food & Drug Admin.,

Risk Evaluation and Mitigation Strategies............................................................. 5

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INTRODUCTION, INTEREST OF AMICI CURIAE,

AND SUMMARY OF ARGUMENT

Last year, the Supreme Court held that abortion is a matter that is entrusted

to “the people and their elected representatives” to address. Dobbs v. Jackson

Women’s Health Organization, 142 S. Ct. 2228, 2284 (2022). Overruling precedent

that took that authority away from the people, the Court returned the issue of

“regulating or prohibiting abortion” to “the citizens of each State.” Ibid. States may

thus pursue their “legitimate interests” in protecting unborn life, women’s health,

and the medical profession’s integrity by regulating or restricting abortion. Ibid.

Amici curiae are the States of Mississippi, Alabama, Alaska, Arkansas,

Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Montana,

Nebraska, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah,

and Wyoming. Like other States, amici have, consistent with the Constitution and

the Supreme Court’s decision in Dobbs, adopted laws regulating abortion—including

chemical abortion. Those laws strike a balance among the competing interests, are

the results of hard-fought democratic processes, and embody the considered

judgments of “the people and their elected representatives.” Ibid. Some States have

chosen to adopt or maintain tighter restrictions and more thorough regulations on

abortion after Dobbs. Other States have continued or embraced more permissive

regimes. All States have provisions in their abortion laws to protect a woman’s life

and commonly include exceptions in other circumstances. These choices reflect the

approach the Constitution envisions for addressing complex issues that require

“legislative bodies” to “draw lines that accommodate competing interests.” Id. at 2268.

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Rather than respect the Constitution, the Supreme Court, and the democratic

process, the Biden Administration has attacked and worked to undermine the

considered judgments of the elected representatives of States like amici. The

Administration’s actions on abortion drugs typify that effort. The day Dobbs was

decided, President Biden directed his Administration to ensure that abortion drugs

are “as widely accessible as possible,” including “through telehealth and sent by

mail.” Fact Sheet: President Biden Announces Actions In Light of Today’s Supreme

Court Decision on Dobbs v. Jackson Women’s Health Organization, The White House

(June 24, 2022), http://bit.ly/3DqTmwd. The President soon signed an executive order

lamenting States’ regulation of abortion and directing federal agencies to “expand

access to abortion care, including medication abortion.” Protecting Access to

Reproductive Healthcare Services, Exec. Order No. 14076, 87 Fed. Reg. 42053, 42053

(2022). Just weeks ago, President Biden signed a memorandum spotlighting his

Administration’s efforts to “evaluat[e] and monitor[ ]” state laws “that threaten to

infringe” on purported “Federal legal protections [for abortion].” Memorandum on

Further Efforts to Protect Access to Reproductive Healthcare Services, The White

House (Jan. 22, 2023), http://bit.ly/3kEZrPl. He also expressed his intent to promote

access to abortion drugs for patients and providers “no matter where they live.” Fact

Sheet: President Biden to Sign Presidential Memorandum on Ensuring Safe Access

to Medication Abortion, The White House (Jan. 22, 2023), http://bit.ly/3I160Vn.

Although the Biden Administration has, following Dobbs, doubled down on its

efforts to impose on the country an elective-abortion policy that it could never achieve

through the democratic process, that goal is not new—especially with abortion drugs.

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For two decades, the U.S. Food and Drug Administration has acted to establish a

nationwide regime of on-demand abortion by licensing sweeping access to chemical

abortion drugs—in defiance of federal and state laws protecting life, health, and

safety. See Pls.’ Mot. 2-6, Dkt. 7. In 2000, the FDA purported to approve the drug

mifepristone for chemically induced abortions through 49 days of pregnancy. That

approval had basic legal problems of its own, but it did include safety measures to

account for mifepristone’s serious risks to life and health. Yet over time the FDA has

cast even those measures aside. In 2016, the FDA rolled back many safety

requirements—allowing mifepristone to be prescribed later in pregnancy, by non-

doctors, and with only one in-person visit. In 2021, the agency halted the remaining

in-person dispensing requirements during the COVID-19 pandemic and later

abandoned the requirements altogether. After decades of such efforts, the FDA now

broadly condones a wide-ranging mail-order abortion-drug regime. Plaintiffs here

have moved to preliminarily enjoin and set aside the FDA’s actions.

This brief explains why the public interest and equities strongly support relief

against the FDA’s actions. First, the FDA’s actions contravene federal law and so

disserve the public interest. Second, the FDA’s actions defy the public-interest

determinations made by the amici States, which are entrusted with balancing the

policy and equitable considerations in this area. Last, the FDA’s actions threaten to

undermine the amici States’ enforcement of duly enacted laws and thus undercut the

public interest that those laws promote. For these reasons, injunctive relief against

the FDA’s actions would promote the public interest.

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BACKGROUND

The Federal Food, Drug, and Cosmetic Act directs the U.S. Food and Drug

Administration to “protect the public health by ensuring that ... human and

veterinary drugs are safe and effective.” 21 U.S.C. § 393(b)(2)(B). Under the Act, the

FDA is responsible for approving any “new drug” before it is marketed and distributed

to the public. Id. § 321(p)(1). The Act bars anyone from “introduc[ing] or deliver[ing]

for introduction into interstate commerce any new drug” without FDA “approval.” Id.

§ 355(a). To obtain FDA approval, a new drug must undergo an extensive process

with rigorous testing. The FDA’s conclusion that a drug is safe and effective must be

based on “substantial evidence” of expert consensus. Id. § 355(d).

In 2000, the FDA approved the marketing and distribution of mifepristone for

“the medical termination of intrauterine pregnancy through 49 days’ pregnancy.”

App.518, Dkt. 8. Mifepristone is a synthetic steroid that causes “menstrual bleeding,

disruption of the endometrium [or uterine lining], and then termination” of a

pregnancy. Mifepristone, NIH, Nat’l Library of Medicine, http://bit.ly/403EjSN.

Mifepristone is generally followed by a dose of misoprostol, which causes the pregnant

woman’s uterus to contract and expel the detached embryo. Id., Misoprostol,

http://bit.ly/3DgTpKZ.

The FDA approved mifepristone under Subpart H of the agency’s regulations,

which implement the agency’s general authority to approve new drugs that “have

been studied for their safety and effectiveness in treating serious or life-threatening

illnesses,” 21 C.F.R. § 314.500, and “can be safely used only if distribution or use is

restricted,” id. § 314.520. To satisfy Subpart H, the FDA needed to—and did—deem

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pregnancy a “serious or life-threatening illness[ ]” (even in the absence of

complications) and conclude that mifepristone was “safe[ ]” and “provide[d]

meaningful therapeutic benefit.” App.523 (citing 21 C.F.R. §§ 314.500-314.560).

Despite approving mifepristone, the FDA recognized the serious risk of “urgent

adverse event[s] associated with” the drug—including incomplete abortions or severe

bleeding requiring surgery. App.522. These risks increase later in pregnancy and in

cases of ectopic pregnancy. App.518-25, 607-09. The approval thus included

requirements that the drug be provided only “by or under the supervision of a

physician” with the ability to “assess the duration of pregnancy accurately,” “diagnose

ectopic pregnancies,” “provide [or arrange for] surgical intervention in cases of

incomplete abortion or severe bleeding,” and “assure patient access to medical

facilities equipped to provide blood transfusions and resuscitation.” App.523.

In 2007, Congress enacted the Food and Drug Administration Amendments

Act, Pub. L. No. 110-85, 121 Stat. 823 (2007). That law affected FDA approvals under

Subpart H. It directed the agency to adopt a Risk Evaluation and Mitigation Strategy

(REMS) for a new drug when “necessary to ensure that the benefits of the drug

outweigh the risks.” 21 U.S.C. § 355-1(a)(1)-(2). A REMS operates as a “drug safety

program” for medications that present “serious safety concerns.” U.S. Food & Drug

Admin., Risk Evaluation and Mitigation Strategies, http://bit.ly/3wKOwGp; see ibid.

(“While all medications have labeling that informs health care stakeholders about

medication risks, only a few medications require a REMS.”). Because of the serious

safety concerns involved, the FDA established a REMS program for mifepristone in

2011 with various “elements to assure safe use,” including a requirement that the

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drug be dispensed only in certain healthcare settings—clinics, medical offices, and

hospitals—under the supervision of a certified prescriber. App.731-32.

Despite the risks that the FDA itself recognized, over the next decade and

beyond, the Obama and Biden Administrations expanded mifepristone’s use and

dropped the safety measures erected around it. In 2016, the FDA extended the

approved use of mifepristone through 70 days (10 weeks) of pregnancy, allowed a

broader set of persons to prescribe the drug, and reduced the number of required in-

person patient visits from three to one. App.625-52, 732. But the agency maintained

the requirement for at least one in-person visit so that the drug could be dispensed

only in clinics, medical offices, and hospitals under the supervision of a certified

healthcare provider. App.733.

In April 2021, however, the FDA stopped enforcing the in-person-dispensing

requirements. The FDA attributed that decision to “COVID-related risks” of in-

person dispensing. App.715. The agency added that it would “exercise enforcement

discretion during the COVID-19 [public-health emergency] with respect to the

dispensing of mifepristone through the mail.” Ibid.

In December 2021, the FDA abandoned the in-person dispensing requirement

altogether. App.735. It made this decision independent of any COVID-related risks

and despite recognizing that “certain elements of the Mifepristone REMS Program”—

including “healthcare provider certification and dispensing of mifepristone to

patients with evidence or other documentation of safe use conditions”—“remain

necessary to assure the safe use of mifepristone” and “ensure the benefits of

mifepristone outweigh the risks.” Ibid. On January 3, 2023, the FDA modified the

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mifepristone REMS program to make clear the agency’s position that the drug can

now be dispensed by certified prescribers or retail pharmacies “in-person or by mail.”

U.S. Food & Drug Admin., Information about Mifepristone for Medical Termination

of Pregnancy Through Ten Weeks Gestation, http://bit.ly/3kHmh8Q.

While the FDA is authorized to evaluate new drugs for safety and effectiveness,

States are primarily responsible for protecting the health and welfare of their

citizens. Many States, including several amici here, have thus enacted laws to

regulate abortion-inducing drugs and account for their dangers. Such laws can

include in-person examination and dispensing requirements, qualification

requirements for prescribers, mandates for informed consent, bans on distribution by

mailing, or some combination of these and other safety limitations. See infra.

The lawsuit here seeks to enjoin the panoply of agency actions through which

the FDA has approved mifepristone, made it widely accessible, and discarded

measures to manage the risks that it presents.

ARGUMENT
The Public Interest And Equities Support Injunctive Relief Against
The FDA’s Actions On Mifepristone.

The FDA’s challenged actions on mifepristone are deeply flawed. They defy

federal law, flout the public-interest determinations that States have properly made,

and undermine the public interest in the enforcement of validly enacted state laws.

These features strongly support injunctive relief against the agency’s actions.

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A. The Public Interest And Equities Weigh Strongly Against The

FDA’s Actions Because Those Actions Defy Federal Law.

Plaintiffs have demonstrated that the FDA’s actions on mifepristone violate

the Federal Food, Drug, and Cosmetic Act and related FDA regulations. See Pls.’ Mot.

14-23. Amici emphasize that the FDA’s actions defy both the agency’s regulations and

also federal laws restricting the mailing of abortion drugs. The public interest and

equities thus favor injunctive relief against the FDA’s actions.

An agency action defies the public interest if it is unlawful. “There is generally

no public interest in the perpetuation of unlawful agency action.” Texas v. Biden,

10 F.4th 538, 560 (5th Cir. 2021) (brackets omitted); see also Wages & White Lion

Invs., LLC v. FDA, 16 F.4th 1130, 1143 (5th Cir. 2021). Allowing illegal actions by

government agencies to stand “undermine[s]” the public interest. Valley v. Rapides

Parish Sch. Bd., 118 F.3d 1047, 1056 (5th Cir. 1997). And there is a strong public

interest “in having governmental agencies abide by the federal laws that govern their

existence and operations.” Biden, 10 F.4th at 559.

The FDA’s actions here have two basic legal flaws.

First, the FDA’s approval of mifepristone defies the agency’s own regulations.

As noted, the agency relied on Subpart H of its regulations when it first approved

mifepristone in 2000. Subpart H permits the FDA to approve “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 (emphasis added). That

regulation doubly forecloses the FDA’s approval. Pregnancy is not an “illness[ ].” It is

a natural state essential to perpetuating human life. And typical early-stage

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pregnancy without complications is not a condition that is “serious or life-

threatening” or that requires the “treatment” mifepristone provides.

The FDA admits that pregnancy is not an illness but claims that its

rulemaking “explained that Subpart H was available for serious or life-threatening

‘conditions,’ whether or not they were understood colloquially to be ‘illnesses.’” Opp.

26, Dkt. 28 (quoting New Drug, Antibiotic, and Biological Drug Product Regulations;

Accelerated Approval, 57 Fed. Reg. 58942, 58946 (Dec. 11, 1992)). But an

unambiguous regulation—not the agency’s aspirational gloss on it—controls. As

explained, that clear regulatory text defeats the FDA’s view and thus its approval of

mifepristone. At most, the FDA’s argument suggests that it could have approved

mifepristone under Subpart H for cases in which a pregnant woman’s life or health

is seriously in danger. That is not what it did—and the FDA still would have been

stuck with the reality that pregnancy is not an “illness[ ].” 21 C.F.R. § 314.500.

Subpart H does not permit the agency to greenlight elective abortions on a wide scale.

The FDA also claims that “any hypothetical error in the initial reliance on

Subpart H” has “been overtaken by congressional action.” Opp. 25, 26. This is not the

argument of an agency that is confident in the legality of its actions. And the

argument fails. When Congress established the REMS framework in 2007, it

temporarily “deemed to have in effect an approved risk evaluation and mitigation

strategy” any “drug that was [previously] approved” under Subpart H with “elements

to assure safe use,” Pub. L. No. 110-85, § 909(b)(1), 121 Stat. at 950, and required the

sponsors of such drugs to “submit to the [FDA] a proposed risk evaluation and

mitigation strategy” within 180 days, id. § 909(b)(3), 121 Stat. at 951. This means

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that Congress “deemed” preexisting safety requirements to be sufficient REMS

programs under the new 2007 law until a new strategy was approved. That law did

not affect whether a drug was properly authorized under Subpart H in the first place

to treat “serious or life-threatening illnesses.” 21 C.F.R. § 314.500. Congressional

action did not blot out the FDA’s defiance of its own regulation.

Second, the FDA’s actions defy federal criminal law. Longstanding federal law

provides that “[e]very article or thing designed, adapted, or intended for producing

abortion ... [i]s declared to be nonmailable matter and shall not be conveyed in the

mails or delivered from any post office or by any letter carrier.” 18 U.S.C. § 1461. A

related statute makes it a federal crime to “knowingly use[ ] any express company or

other common carrier” to ship “in interstate or foreign commerce ... any drug,

medicine, article, or thing designed, adapted, or intended for producing abortion.” Id.

§ 1462. Violations of either statute are punishable by five or more years of

imprisonment. Id. §§ 1461, 1462. These statutes prohibit using the mail to send or

receive abortion-inducing drugs such as mifepristone. The statutes’ restrictions on

abortion have remained in place—even as Congress has repealed other parts of these

laws. See Pub. L. No. 91-662, 84 Stat. 1973 (1971) (repealing certain restrictions on

contraceptives from what is now section 1461). Congress has also considered

narrowing those statutes with a targeted intent requirement. See H.R. 13959, 95th

Cong. §§ 6701(a)(1)(2), 6702(1)(C)(i) (1978); see also H.R. Rep. No. 29, pt. 3, at 42

(1979) (explaining how bill would have “change[d] current law”). Those efforts failed.

A late-breaking memo from the Biden Justice Department, see Application of the

Comstock Act to the Mailing of Prescription Drugs That Can Be Used for Abortions,

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46 Op. OLC __ (Dec. 23, 2022), reads into sections 1461 and 1462 the very intent

requirement that Congress refused to enact. But that memo cannot paper over clear

statutory language or the historical reality that Congress has not altered the relevant

text.

The FDA’s challenged actions on mifepristone thus defy the agency’s

regulatory authority and longstanding federal criminal law. Because those actions

are at war with the law, the FDA cannot claim any public interest in enforcing them.

Indeed, enjoining the FDA to “abide by” federal law would promote the public

interest, Biden, 10 F.4th at 559—and not issuing injunctive relief would “undermine”

the public interest, Valley, 118 F.3d at 1056.

B. The FDA’s Actions Undermine The Public-Interest

Determinations That States—Not Federal Agencies—Are
Entitled To Make.

The FDA was not responding to changed circumstances on the safety of

mifepristone when it cast aside the longstanding requirements for in-person

dispensing. Nor was the agency following any legislative mandate from Congress

when promoting a new mail-order abortion regime. Rather, the agency was acting at

the behest of the Biden Administration and its allies who demanded political action

after Dobbs. After that decision the Administration swiftly declared that duly enacted

state laws on abortion will have “devastating implications” for “public health” and

that the federal government would act to “expand access to abortion care, including

medication abortion,” Protecting Access to Reproductive Healthcare Services, Exec.

Order No. 14076, 87 Fed. Reg. 42053, 42053 (2022)—despite considered judgments

by elected representatives on how to address the health interests at stake. But, as

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the Supreme Court recognized, it is the responsibility of elected representatives in

States—not unelected bureaucrats in federal agencies—to strike the balance between

“competing interests” on abortion. Dobbs, 142 S. Ct. at 2268. The FDA’s actions seek

to override the balance properly struck by States. If allowed to stand, those actions

will harm the public interest.

Under our Constitution, States have the primary authority to legislate to

protect the health, safety, and welfare of their citizens. Hillsborough Cnty., Fla. v.

Automated Med. Laboratories, Inc., 471 U.S. 707, 719 (1985) (“[T]he regulation of

health and safety matters is primarily, and historically, a matter of local concern.”);

Metro. Life Ins. Co. v. Massachusetts, 471 U.S. 724, 756 (1985) (“The States

traditionally have had great latitude under their police powers to legislate as to the

protection of the lives, limbs, health, comfort, and quiet of all persons.”) (internal

quotation marks omitted). This power includes regulating the medical profession and

setting standards of care. Gonzales v. Oregon, 546 U.S. 243, 270 (2006) (“[A]

functioning medical profession [is] regulated under the States’ police powers.”).

Using this authority, States have adopted varying approaches to abortion that

reflect the policy decisions of their constituent citizens. State laws restricting abortion

ubiquitously include provisions to protect a woman’s life. E.g., Miss. Code Ann. § 41-

41-45(2). They commonly include exceptions in other circumstances too. E.g., ibid.

(abortion permitted “where the pregnancy was caused by rape”). Many States have

passed laws that address the particular risks presented by chemical abortions. Such

laws recognize, for example, that “abortion-inducing drugs” “present[ ] significant

medical risks to women” such as “uterine hemorrhage, viral infections, pelvic

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inflammatory disease, severe bacterial infection and death,” id. § 41-41-103(a); “are

associated with an increased risk of complications relative to surgical abortion” that

heightens “with increasing gestational age,” id. § 41-41-103(b); and “are

contraindicated in ectopic pregnancies,” id. § 41-41-107(2). Given those risks, States

have used their regulatory authority to direct (for example) that only physicians may

provide such drugs, that a physician may do so only after “physically examin[ing] the

woman and document[ing] ... the gestational age and intrauterine location of the

pregnancy,” and that abortion drugs “must be administered in the same room and in

the physical presence of the physician,” ensuring that the pregnant woman is

informed of risks and monitored for complications. Id. §§ 41-41-107(2), (3); see, e.g.,

Ind. Code Ann. § 16-34-2-1 (requiring in-person exam and dispensing); La. Stat. Ann.

§ 40:1061.11 (requiring in-person dispensing); Okla. Stat. Ann. tit. 63, § 1-729.1

(requiring in-person dispensing); Tex. Health & Safety Code Ann. § 171.063(b-1)

(prohibiting shipment of abortion-inducing drugs “by courier, delivery, or mail

service”). Last, like all methods of elective abortion, elective chemical abortion is

generally unlawful in numerous States. E.g., Miss. Code. Ann. § 41-41-45(2) (abortion

unlawful except “where necessary for the preservation of the mother’s life or where

the pregnancy was caused by rape”).

In the actions at issue here, the FDA has sought to impose a federal mail-order

abortion regime that disregards the protections for life, health, and safety adopted by

numerous States’ elected representatives. But the authority to “regulat[e] or

prohibit[ ] abortion” belongs to “the citizens of each State.” Dobbs, 142 S. Ct. at 2284.

The FDA may determine only whether mifepristone is “safe and effective” for its

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intended use. 21 C.F.R. §§ 314.2, 314.500. The agency has no authority to make broad

policy judgments balancing the people’s interests in “prenatal life at all stages of

development,” “maternal health and safety,” and “the integrity of the medical

profession.” Dobbs, 142 S. Ct. at 2284. Legislatures have that authority, and state

legislatures have balanced these interests and others in laws that reflect the views of

constituent citizens. Insofar as the federal legislature has weighed in at all in this

area, it has been to condemn what the FDA has done. Congress has expressly declared

that drugs “designed, adapted, or intended for producing abortion ... shall not be

conveyed in the mails.” 18 U.S.C. § 1461.

State laws on chemical abortion thus account for the public interests at issue—

and they do so with the benefit of democratic legitimacy (and legal authority). The

FDA’s actions can make no such claim. By obstructing the judgments of elected

representatives, the agency has undermined the public interest. Given the absence of

authority for the FDA to establish a mail-order abortion regime—and States’ retained

authority to act, U.S. Const. amend. X—the public interest strongly weighs against

the FDA’s effort to override duly enacted state laws.

C. The FDA’s Actions Harm The Public Interest By Undermining

States’ Ability To Protect Their Citizens And Forcing States To
Divert Scarce Resources To Investigating And Prosecuting
Violations Of Their Laws.

Even if the FDA’s approval of mifepristone harmonized with the agency’s own

regulations and federal criminal law, those actions would not simply displace state

laws regulating abortion. The amici States are entitled to enforce their duly enacted

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laws regulating chemical abortion in the interests of life, health, and safety. Yet the

FDA’s actions will undercut those efforts and thus harm the public interest.

The Biden Administration claims that it has the power to broadly make

abortion drugs accessible despite contrary determinations by States and despite

regulations that States may have enacted to protect life, health, and safety in the use

of those drugs. See Memorandum on Further Efforts to Protect Access to Reproductive

Healthcare Services, The White House (Jan. 22, 2023), http://bit.ly/3kEZrPl (Biden

Memorandum). That claim is wrong. No federal law manifests Congress’s “clear and

manifest purpose” to displace state law in this context. Rice v. Santa Fe Elevator

Corp., 331 U.S. 218, 230 (1947); see also ibid. (Courts should “start with the

assumption that the historic police powers of the States [are] not to be superseded ...

unless that was the clear and manifest purpose of Congress.”). The need for a clear

statement from Congress “is heightened” where, as here, an “administrative

interpretation alters the federal-state framework by permitting federal

encroachment upon a traditional state power.” Solid Waste Agency of N. Cook Cnty.

v. U.S. Army Corps of Engineers, 531 U.S. 159, 173 (2001); see also Metro. Life, 471

U.S. at 740 (Courts “must presume that Congress did not intend to pre-empt areas of

traditional state regulation.”). As discussed above, the relevant federal statutes

criminalize sending or receiving abortion drugs by mail and thus affirmatively

condemn the FDA’s actions. Supra Part B. States are thus entitled to enforce their

laws—protecting life, health, and safety—against persons and businesses involved in

distributing or receiving abortion drugs by mail.

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Yet the FDA’s actions will undermine States’ laws, undercut their efforts to

enforce them, and—as a result—harm the public interest.

First, the FDA’s actions will undermine States’ ability to protect their citizens.

Those actions will lead to the widespread shipment and use of abortion-inducing

drugs. See Abortion Pills Can Now Be Offered at Retail Pharmacies, F.D.A. Says,

N.Y. Times (Jan. 3, 2023), http://bit.ly/3WFFxB0. That widespread use will often

occur in defiance of state laws that protect life, health, and safety. See Retail

Pharmacies Can Now Offer Abortion Pill, FDA Says, Politico (Jan. 3, 2023),

http://bit.ly/3wCPl3V (“Telemedicine and mail delivery of the pills has allowed

patients to circumvent state bans.”). Indeed, the whole point of the Administration’s

recent actions is to encourage and achieve evasion of those state laws. Such evasion—

particularly when coupled with the FDA’s abandonment of key protections on

mifepristone’s use—will harm the citizens of the amici States. That harm defies the

public interest.

Second, the FDA’s actions will force States to devote scarce resources to

investigating and prosecuting violations of their laws. As the FDA continues a

campaign that will harm amici’s citizens, amici will not sit by. Amici will enforce their

laws to protect their citizens. But the FDA’s actions will make that task hard. The

FDA—and the broader Administration—is encouraging lawbreaking on a mass scale.

The new regime will require States to divert scarce resources to investigate and

prosecute violations of their laws to vindicate the public interests that those laws

represent. Cf. Maine v. Taylor, 477 U.S. 131, 137 (1986) (“[A] State clearly has a

legitimate interest in the continued enforceability of its own statutes.”); Texas v.

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United States, 787 F.3d 733, 749 (5th Cir. 2015) (“[S]tates have a sovereign interest

in the power to create and enforce a legal code.”) (internal quotation marks omitted).

Such enforcement will be especially hard in these circumstances, given the

Administration’s position that it will not enforce existing federal restrictions on

abortion drugs, will treat state laws as “barriers” to be avoided, and can be expected

to stymie and defy States’ efforts to enforce their own laws. Biden Memorandum; cf.

Remarks of President Joe Biden—State of the Union Address as Prepared for

Delivery, The White House (Feb. 7, 2023), http://bit.ly/3RHeAfn (reaffirming

opposition to States that are protecting life and health after Dobbs). All of this

subverts the public interest and the equities represented by validly enacted state

laws. It strongly supports injunctive relief.

* * *

The serious nature of the FDA’s unlawful actions, and the agency’s decision to

invite lawbreaking by private parties and government actors across the country,

favors broad relief. The FDA and the Administration as a whole have no intention to

respect the Constitution, the Supreme Court, or the democratic process when it comes

to abortion. This Court’s decisive action is warranted.

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CONCLUSION

The public interest and equities support relief against the FDA’s actions.

Dated: February 10, 2023

Respectfully submitted,

LYNN FITCH
Attorney General

/s/ Justin L. Matheny

SCOTT G. STEWART (MS Bar No. 106359)
Solicitor General
JUSTIN L. MATHENY (MS Bar No.
100754)
Deputy Solicitor General
MISSISSIPPI ATTORNEY
GENERAL’S OFFICE
P.O. Box 220
Jackson, MS 39205-0220
Telephone: (601) 359-3680
Fax: (601) 359-2003
justin.matheny@ago.ms.gov
Counsel for Amici Curiae

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On behalf of:

Steve Marshall Treg Taylor

Attorney General Attorney General
State of Alabama State of Alaska

Tim Griffin Ashley Moody

Attorney General Attorney General
State of Arkansas State of Florida

Christopher M. Carr Raúl R. Labrador

Attorney General Attorney General
State of Georgia State of Idaho

Theodore E. Rokita Brenna Bird

Attorney General Attorney General
State of Indiana State of Iowa

Kris W. Kobach Daniel Cameron

Attorney General Attorney General
State of Kansas Commonwealth of Kentucky

Jeff Landry Austin Knudsen

Attorney General Attorney General
State of Louisiana State of Montana

Michael T. Hilgers Dave Yost

Attorney General Attorney General
State of Nebraska State of Ohio

Gentner F. Drummond Alan Wilson

Attorney General Attorney General
State of Oklahoma State of South Carolina

Marty J. Jackley Jonathan Skrmetti

Attorney General Attorney General
State of South Dakota State of Tennessee

Ken Paxton Sean D. Reyes

Attorney General Attorney General
State of Texas State of Utah

Bridget Hill
Attorney General
State of Wyoming

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CERTIFICATE OF SERVICE

I hereby certify that the foregoing brief has been served on all counsel of record

by ECF.

Dated: February 10, 2023

/s/ Justin L. Matheny
Justin L. Matheny
Counsel for Amici Curiae

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