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

Supreme Court briefJan 30, 2024

Ask Donna

What actually matters in this document.

Text

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 AMICUS CURIAE

HONEYBEE HEALTH, INC.

IN SUPPORT OF PETITIONERS

---------------------------------♦--------------------------------STEPHANIE L. GUTWEIN

LIBBY L. BANEY

Counsel of Record

FAEGRE DRINKER BIDDLE

A. SCOTT CHINN

& REATH LLP

MATTHEW K. GIFFIN

1500 K Street NW,

ELIZABETH A. CHARLES

Suite 1100

Washington, D.C. 20005

FAEGRE DRINKER BIDDLE

& REATH LLP

(202) 842-8800

300 N. Meridian Street, Suite 2500 libby.baney@

Indianapolis, IN 46204

faegredrinker.com

(317) 237-0300

stephanie.gutwein@faegredrinker.com

scott.chinn@faegredrinker.com

matt.giffin@faegredrinker.com

elizabeth.charles@faegredrinker.com

================================================================================================================

COCKLE LEGAL BRIEFS (800) 225-6964

WWW.COCKLELEGALBRIEFS.COM

TABLE OF CONTENTS

Page

Interest of Amicus Curiae....................................

Summary of Argument ........................................

Argument .............................................................

Access to telemedicine and mail-order

pharmacies advances individual liberties

while preserving states’ rights ..................

II.

Use of abortion medication at home is safe

and effective............................................... 14

III.

Prohibition of mail-order distribution of

mifepristone will inflict serious harm on

the public, patients, and businesses like

Honeybee ................................................... 22

A. The public interest and public policy

weigh against enjoining the availability of mail-order mifepristone ......... 23

B. Data show that eliminating access to

mail-order mifepristone will inflict

harm on many patients ....................... 24

C. Prohibiting mail-order delivery of

mifepristone would inflict serious

harm on Honeybee and other online

pharmacies .......................................... 29

Conclusion............................................................ 30

TABLE OF AUTHORITIES

Page

CASES

All. for Hippocratic Medicine v. U.S.

Food & Drug Admin.,

No. 2:22-cv-00223

(N.D. Tex. Jan. 13, 2023), appeal docketed,

No. 23-10362 (5th Cir. Apr. 10, 2023)......................27

Amoco Prod. Co. v. Vill. of Gambell, Alaska,

480 U.S. 531 (1987) .................................................23

Atwood Turnkey Drilling, Inc. v. Petroleo

Brasileiro, S.A.,

875 F.2d 1174 (5th Cir. 1989) ..................................29

Barsky v. Bd. of Regents of Univ.,

347 U.S. 442 (1954) .................................................11

Fulgenzi v. PLIVA, Inc.,

711 F.3d 578 (6th Cir. 2013) ....................................23

Maryland v. King,

567 U.S. 1301 (2012)................................................23

Mutual Pharm. Co., Inc. v. Barrett,

570 U.S. 472 (2013) .................................................23

Nat’l Ass’n of Farmworkers’ Orgs. v. Marshall,

628 F.2d 604 (D.C. Cir. 1980) ..................................24

Nat’l Propane Gas Ass’n v. U.S. Dep’t of

Homeland Sec.,

534 F. Supp. 2d 16 (D.D.C. 2008) ............................23

Nken v. Holder,

556 U.S. 418 (2009) .................................................23

Pegram v. Herdrich,

530 U.S. 211 (2000) .................................................11

iii

TABLE OF AUTHORITIES—Continued

Page

Pharmacia Corp. v. Alcon Labs., Inc.,

201 F. Supp. 2d 335 (D.N.J. 2002) ...........................28

Reedco, Inc. v. Hoffman-La Roche, Inc.,

667 F. Supp. 1072 (D.N.J. 1987) ..............................28

ViroPharma, Inc. v. Hamburg,

898 F. Supp. 2d 1 (D.D.C. 2012) ..............................29

Watson v. Maryland,

218 U.S. 173 (1910) .................................................11

Weinberger v. Romero-Barcelo,

456 U.S. 305 (1982) .................................................23

STATUTES, RULES, & REGULATIONS

21 C.F.R. § 1304.40 .....................................................10

OTHER AUTHORITIES

Abu-Farha, R., et al., Public Perceptions About

Home Delivery of Medication Service and

Factors Associated with the Utilization of This

Service, Patient Preference and Adherence

(Aug. 22, 2022), available at: https://www.

tandfonline.com/doi/abs/10.2147/PPA.S377558........10

Aiken, A.R.A., et al., Effectiveness, safety and

acceptability of no-test medical abortion

(termination of pregnancy) provided via

telemedicine: a national cohort study, BJOG

2021 (Mar. 24, 2021), available at: https://

obgyn.onlinelibrary.wiley.com/doi/epdf/10.1111/

1471-0528.16668 ........................................... 9, 15, 19

TABLE OF AUTHORITIES—Continued

Page

Autry, B.M., et al., Mifepristone, StatPearls (last

updated May 8, 2022), available at: https://

www.ncbi.nlm.nih.gov/books/NBK557612/ ............28

Chong, E., et al., Expansion of a direct-to-patient

telemedicine abortion service in the United

States and experience during the COVID-19

pandemic, Contraception (Mar. 27, 2021),

available at: https://pubmed.ncbi.nlm.nih.gov/

33781762/ .......................................................... 16, 21

Creanga, A., et al., Racial and Ethnic Disparities

in Severe Maternal Morbidity: A Multi-State

Analysis, 2008-2010, Am. J. Obstet. Gynecol.,

2014 May (Dec. 1, 2013), available at:

https://pubmed.ncbi.nlm.nih.gov/24295922/ ..........26

Dandy, K., et al., The Case for Telemedicine How

Telehealth Solutions Can Reduce Legal Risk

While Improving Patient Access and Lowering

Health Care Costs, N.Y. St. B.J., Nov./Dec.

2018 ...........................................................................6

Daniel, S., et al., Obstetrician-gynecologist

willingness to provide medication abortion

with removal of the in-person dispensing

requirement for mifepristone, Contraception

(Mar. 31, 2021), available at: https://www.

contraceptionjournal.org/article/S0010-7824(21)

00098-6/fulltext .......................................................15

TABLE OF AUTHORITIES—Continued

Page

Diamant, J., et al., What the data says about

abortion in the U.S., Pew Research Center

(Jan. 11, 2023), available at: https://www.pew

research.org/short-reads/2023/01/11/what-thedata-says-about-abortion-in-the-u-s-2/...................14

Disability Impacts All of Us Infographic, CDC,

available at: https://www.cdc.gov/ncbddd/

disabilityandhealth/infographic-disabilityimpacts-all.html (last visited Jan. 23, 2024) ............9

Divya, J., et al., The Provision of Medication

Abortion Care via Telehealth, Women’s Health

Issues, Jacobs Institute of Women’s Health

(June 8, 2023), available at: https://www.whi

journal.com/article/S1049-3867(23)00099-3/

fulltext#articleInformation .....................................15

Duy, D., et al., Trends in Mail-Order Prescription

Use among U.S. Adults from 1996 to 2018: A

Nationally Representative Repeated CrossSectional Study, medRxiv (Sept. 23, 2020),

available at: https://www.medrxiv.org/content/

10.1101/2020.09.22.20199505v2 ...............................4

Endler M., et al., Telemedicine for medical

abortion: a systematic review, BJOG 2019

(Apr. 25, 2019), available at: https://pubmed.ncbi.

nlm.nih.gov/30869829/ ........................................ 3, 25

TABLE OF AUTHORITIES—Continued

Page

Gaffney, A.W., et al., Health Needs and

Functional Disability Among Mail-Order

Pharmacy Users in the US, JAMA Intern.

Med. (Dec. 14, 2020), available at: https://jama

network.com/journals/jamainternalmedicine/full

article/2774124?utm_campaign=articlePDF&

utm_medium=articlePDFlink&utm_source=

articlePDF&utm_content=jamainternmed.2020.

7254 ................................................................... 3, 4, 8

Gajarawala, S., Telehealth Benefits and Barriers,

J. Nurse Pract., 2021 Feb. (Oct. 21, 2020),

available at: https://www.ncbi.nlm.nih.gov/

pmc/articles/PMC7577680/#bib6 .......................... 6, 9

Grossman, D., et al., Mail-order pharmacy

dispensing of mifepristone for medication

abortion after in-person clinical assessment,

Contraception (Sept. 20, 2021), available at:

https://www.contraceptionjournal.org/article/

S0010-7824(21)00384-X/fulltext ........... 17, 20, 21, 27

Honeybee Health Trustpilot, available at: https://

www.trustpilot.com/review/honeybeehealth.com

(last visited Jan. 26, 2024) ........................................1

Hyder, Maryam, et al., Telemedicine in the

United States: An Introduction for Students

and Residents, J. Med. Internet Res. (Nov. 24,

2020), available at: https://www.ncbi.nlm.nih.

gov/pmc/articles/PMC7690251/ ................................6

vii

TABLE OF AUTHORITIES—Continued

Page

Kerestes, C., et al., Provision of medication

abortion in Hawai’i during COVID-19: Practical experience with multiple care delivery

models, Contraception (Mar. 28, 2021), available at: https://www.contraceptionjournal.org/

article/S0010-7824(21)00097-4/fulltext ..............18

Kheyfets, A., et al., The Impact of Hostile Abortion Legislation on the United States Maternal

Mortality Crisis: A Call for Increased Abortion

Education, Front. Pub. Health (Dec. 5, 2023),

available at: https://www.ncbi.nlm.nih.gov/pmc/

articles/PMC10728320/#ref14 ................................26

Koenig, L., et al., Mailing abortion pills does not

delay care: A cohort study comparing mailed

to in-person dispensing of abortion medications in the United States, Contraception (Feb.

1, 2023), available at: https://www.contraception journal.org/article/S0010-7824(23)00015X/fulltext#secsect0005 ...................................... 20, 21

Lawson, N., et al., Disability and telehealth since

the COVID-19 pandemic, Center for Health &

Research Transformation (Aug. 29, 2022),

available at: https://disabilityhealth.medicine.

umich.edu/sites/default/files/downloads/RRTC

%20Telehealth_final2.pdf ............................... 6, 9, 10

Locate a State-Licensed Online Pharmacy, FDA,

available at: https://www.fda.gov/drugs/besaferxyour-source-online-pharmacy-information/

locate-state-licensed-online-pharmacy (last

visited Jan. 23, 2024) ..............................................10

viii

TABLE OF AUTHORITIES—Continued

Page

Ma, J., et al., Characteristics of Mail-Order

Pharmacy Users: Results From the Medical

Expenditures Panel Survey, J. of Pharm. Practice (Oct. 2, 2018), available at: https://journals.

sagepub.com/doi/10.1177/0897190018800188 .... 4, 7, 9

Medication Abortion, Honeybee Health, Inc.,

available at: https://honeybeehealth.com/

conditions/=medication-abortion (last visited

Jan. 23, 2024) ..........................................................13

Meet the Pharmacist Expanding Access to Abortion

Pills Across the U.S., Time Magazine (June 13,

2022), available at: https://time.com/6183395/

abortion-pills-honeybee-health-online-pharmacy/.... 2, 15

Mifeprex REMS Study Group, Sixteen Years of

Overregulation: Time to Unburden Mifeprex,

N. Engl. J. Med., Vol. 376 (Feb. 23, 2017), available at: https://www.nejm.org/doi/10.1056/

NEJMsb1612526.....................................................25

Mifepristone (Mifeprex), Nat’l Library of Medicine (last revised Mar. 15, 2023), available

at: https://medlineplus.gov/druginfo/meds/

a600042.html#how ..................................................28

Muellers, K., Telemedicine decision-making in

primary care during the COVID-19 pandemic:

Balancing patient agency and provider expertise, Health Policy and Tech. (Jan. 9, 2024),

available at: https://www.sciencedirect.com/

science/article/abs/pii/S2211883724000029 .............7

TABLE OF AUTHORITIES—Continued

Page

Neil, W., et al., Mail order pharmacy use and adherence to secondary prevention drugs among

stroke patients, J. Neurological Sci., Vol. 390

(Apr. 6, 2018), available at: https://www.jnsjournal.com/article/S0022-510X(18)30170-9/

fulltext#secst0005 ............................................... 8, 10

Ngo, N., et al., Reproductive Health Policy Saga,

Restrictive Abortion Laws in Low- and Middle-Income Countries (LMICs), Unnecessary

Cause of Maternal Mortality, Health Care for

Women Int’l, Vol. 45 (Nov. 2, 2021), available

at: https://www.tandfonline.com/doi/full/10.

1080/07399332.2021.1994971.................................26

Rafie S., et al., Pharmacist dispensing of mifepristone: An opinion of the Women’s Health

Practice and Research Network of the American College of Clinical Pharmacy, J. Am. Coll.

Clin. Pharm. 2024 (Dec. 13, 2023), available

at: https://accpjournals.onlinelibrary.wiley.com/

doi/full/10.1002/jac5.1909 .......................................15

Raymond, E., et al., TelAbortion: evaluation of a

direct to patient telemedicine abortion service

in the United States, Contraception (June 3,

2019), available at: https://www.contraception

journal.org/article/S0010-7824(19)30176-3/

fulltext .....................................................................21

Recent Guidance: FDA Lifts In-Person Dispensing Requirement for Mifepristone Abortion

Pill, 135 Harv. L. Rev. 2235 (June 2022) ................27

TABLE OF AUTHORITIES—Continued

Page

The Safety and Quality of Current Abortion

Methods, The Safety and Quality of Abortion

Care in the United States, Washington, D.C.,

Nat’l Academies of Sci., Engineering, and Med.,

The Nat’l Academies Press (2018), available at:

https://doi.org/10.17226/24950.............. 17, 20, 21, 25

Schmittdiel, J.A., et al., Opportunities to encourage mail order pharmacy delivery service use

for diabetes prescriptions: a qualitative study,

BMC Health Serv. Res. (June 25, 2019),

available at: https://bmchealthservres.biomed

central.com/articles/10.1186/s12913-019-42507#Abs1 ................................................................... 7, 9

Schmittdiel, J., et al., The Safety and Effectiveness of Mail Order Pharmacy Use in Diabetes

Patients, Am. J. Manag. Care (Nov. 2013),

available at: https://www.ncbi.nlm.nih.gov/pmc/

articles/PMC4278640/pdf/nihms621271.pdf...........8

Schreiber, C., et al., Mifepristone Pretreatment

for the Medical Management of Early Pregnancy Loss, N. Eng. J. Med. Vol. 378 (June 7,

2018), available at: https://www.nejm.org/doi/

full/10.1056/NEJMoa1715726 ................................28

Schummers, L., et al., Abortion Safety and Use

with Normally Prescribed Mifepristone in

Canada, N. Engl. J. Med. 2022 (Jan. 6, 2022)

available at: https://www.nejm.org/doi/full/10.

1056/NEJMsa2109779 ............................................18

TABLE OF AUTHORITIES—Continued

Page

Shaver, J., The State of Telehealth Before and After the COVID-19 Pandemic, Prim. Care (Apr.

25, 2022), available at: https://www.ncbi.nlm.

nih.gov/pmc/articles/PMC9035352/ ..........................6

Stevenson, A., The Pregnancy-Related Mortality

Impact of a Total Abortion Ban in the United

States: A Research Note on Increased Deaths

Due to Remaining Pregnant, Demography (Dec.

1, 2021), available at: https://read.dukeupress.

edu/demography/article/58/6/2019/265968/ThePregnancy-Related-Mortality-Impact-of-a-Total .......26

Swica, Y., et al., Acceptability of home use of mifepristone for medical abortion, Contraception

(Nov. 21, 2012), available at: https://pubmed.

ncbi.nlm.nih.gov/23177917/ ......................................20

Telehealth Emerges as Preferred Channel for

Routine Care While Increasing Access to Mental Health Treatment, J.D. Power Finds, J.D.

Power (Sept. 29, 2022), available at: https://

www.jdpower.com/business/press-releases/

2022-us-telehealth-satisfaction-study ......................2

Telehealth privacy for patients, HHS, available

at: https://telehealth.hhs.gov/patients/telehealthprivacy-for-patients (last visited Jan. 15,

2024) ..........................................................................6

xii

TABLE OF AUTHORITIES—Continued

Page

The U.S. Generic and Biosimilar Medicines Savings Report (Sept. 2023), available at: https://

accessiblemeds.org/sites/default/files/2023-09/

AAM-2023-Generic-Biosimilar-MedicinesSavings-Report-web.pdf ..........................................24

Upadhyay, U.D., et al., Outcomes and Safety of

History-Based Screening for Medication

Abortion: A Retrospective Multicenter Cohort

Study, JAMA Intern. Med. (Mar. 21, 2022),

available at: https://jamanetwork.com/journals/

jamainternalmedicine/fullarticle/2790319 .............17

Upadhyay, U.D., et al., Safety and Efficacy of

Telehealth Medication Abortions in the US

During the COVID-19 Pandemic, JAMA Netw.

Open (Aug. 24, 2021), available at: https://www.

ncbi.nlm.nih.gov/pmc/articles/PMC8385590/ .... 16, 25

Vaduganathan, M., et al., Prescription Filling

Patterns of Evidence-Based Medical Therapies

for Heart Failure During the COVID-19 Pandemic in the United States, J. of Cardiac Failure, Vol. 27, Issue 11 (Nov. 2021), available at:

https://www.sciencedirect.com/science/article/

pii/S1071916421002608 ..........................................10

INTEREST OF AMICUS CURIAE1

Honeybee Health, Inc. (“Honeybee”) is a mailorder pharmacy run by board-certified pharmacists

with more than 40 years’ combined experience. Honeybee has been using technology and transparency since

2018 to safely and effectively deliver medications approved by the federal Food and Drug Administration

(“FDA”) to patients in the United States at costs almost always less than the patients’ local brick-andmortar pharmacies. Honeybee patients obtain their

medications directly from Honeybee, without having to

work through insurance companies. Patients go online

and have their medicine dispensed quickly and affordably via the mail. And they can and do connect in realtime with pharmacists who counsel them through

questions or concerns with the FDA-approved medicine. Thousands of reviews confirm that patients who

have counted on Honeybee to reliably deliver medications directly to them are overwhelmingly satisfied

with their experiences.2

Forty-nine states and Washington D.C. have licensed Honeybee to ship to their residents prescribed

medications; Honeybee also ships over-the-counter

medications to patients across the country, where

No counsel for any party authored this brief in whole or in

part and no entity or person, other than amicus curiae, its members, or its counsel, made any monetary contribution intended to

fund the preparation or submission of this brief.

See Honeybee Health Trustpilot, available at: https://www.

trustpilot.com/review/honeybeehealth.com (last visited Jan. 26,

2024).

lawful to do so. Honeybee was one of the first, and is

the largest, mail-order pharmacy in the United States

to deliver mifepristone to patients—which it delivers

in generic form, almost uniformly in conjunction with

those patients’ receiving telehealth services.3 It also

was the first pharmacy to distribute mifepristone on

behalf of providers. And like the demand for telehealth

services in the United States generally,4 demand for

Honeybee’s services, and for mifepristone specifically,

has only increased since Honeybee’s founding. Currently, Honeybee ships mifepristone to 24 states and

the District of Columbia, all jurisdictions that permit

Honeybee to lawfully deliver this vital medication to

patients by mail. To date, Honeybee has dispensed

more than 150,000 orders for mifepristone.

Honeybee submits this amicus brief to provide the

Court the benefit of its experience in and knowledge of

the market for mail-order medicine. In so doing, Honeybee explains the critical role telemedicine and mailorder pharmacies play in supporting patients’ individual freedom to access quality healthcare through the

means most appropriate to them, while preserving

states’ rights to ensure the healthcare their citizens

Meet the Pharmacist Expanding Access to Abortion Pills

Across the U.S., Time Magazine (June 13, 2022), available at:

https://time.com/6183395/abortion-pills-honeybee-health-onlinepharmacy/.

Telehealth Emerges as Preferred Channel for Routine Care

While Increasing Access to Mental Health Treatment, J.D. Power

Finds, J.D. Power (Sept. 29, 2022), available at: https://www.jd

power.com/business/press-releases/2022-us-telehealth-satisfactionstudy.

receive is safe and effective. Honeybee emphasizes the

wealth of clear and credible information demonstrating the safety and efficacy of mail-order pharmacies

and the use of those pharmacies to obtain mifepristone

for purposes of inducing abortions at home. And it offers additional considerations on the concrete harms

the Court of Appeals’ decision will inflict should it take

effect.

---------------------------------♦---------------------------------

SUMMARY OF ARGUMENT

The role of telemedicine, and mail-order pharmacies in particular, in ensuring that all patients have access to safe and effective healthcare cannot be

overstated.5 Mail carriers, including the United States

Postal Service, have been delivering medications to patients for more than 100 years.6 Between 1990 and

2000, mail-order pharmacies’ market-share of the outpatient prescription drug market nearly doubled, and

use of mail-order pharmacies has continued to increase

“Telemedicine (TM) is the remote assessment and treatment of patients by means of telecommunications technology.”

Endler M., et al., Telemedicine for medical abortion: a systematic

review, BJOG 2019;126:1094-1102 (Apr. 25, 2019), available at:

https://pubmed.ncbi.nlm.nih.gov/30869829/.

Gaffney, A.W., et al., Health Needs and Functional Disability Among Mail-Order Pharmacy Users in the US, JAMA

Intern. Med., 2021;181(4):554-56 (Dec. 14, 2020), available at:

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/

2774124?utm_campaign=articlePDF&utm_medium=articlePDF

link&utm_source=articlePDF&utm_content=jamainternmed.2020.

7254.

since.7 As of 2020, researchers estimate more than

200,000,000 prescriptions are delivered through the

mail annually.8

The ability to use online telemedicine to provide

abortion medications, including mifepristone, has

steadily increased access to safe, effective, and essential reproductive healthcare.9 And, time and again,

studies have shown that, much like other aspects of

healthcare delivered through telemedicine, at-home

medication abortion obtained through telemedicine in

the United States is effective, acceptable to users, and

has a very low rate of serious adverse outcomes.10

Honeybee, which was among the first and is the

largest mail-order pharmacy in the United States to

deliver mifepristone directly to patients for use in athome abortions, offers this brief to reiterate the integral role that telemedicine and mail-order pharmacies

play in ensuring that patients have access to safe, effective, and necessary abortion healthcare services by

mail, and to further articulate the direct and, in some

cases, irreversible harms that restrictions on these

See, e.g., Ma, J., et al., Characteristics of Mail-Order Pharmacy Users: Results From the Medical Expenditures Panel Survey,

J. of Pharm. Practice, 2020;33(3):293-98 (Oct. 2, 2018), available

at: https://journals.sagepub.com/doi/10.1177/0897190018800188;

Duy, D., et al., Trends in Mail-Order Prescription Use among U.S.

Adults from 1996 to 2018: A Nationally Representative Repeated

Cross-Sectional Study, medRxiv (Sept. 23, 2020), available at:

https://www.medrxiv.org/content/10.1101/2020.09.22.20199505v2.

Gaffney, supra note 6.

See infra, § I.

See infra, § II.

services will cause patients, pharmacies, and FDAregulated industries more generally in the United

States.

---------------------------------♦---------------------------------

ARGUMENT

Telemedicine, and mail-order pharmacies specifically, represent a growing healthcare sector on which

patients across the United States increasingly rely to

meet their individual medical needs. Access to mail-order pharmacies promotes individual patients’ freedom

to obtain healthcare in the manner most appropriate

for them, while preserving states’ role in ensuring the

care those patients receive is safe and effective. A

wealth of scientific data confirms that, where legal to

do so, using mail-order pharmacies to obtain mifepristone to induce an abortion at home, outside the presence of a provider, is a safe, effective, and necessary

component of robust patient care in the United States.

Yet, if permitted to stand, the Court of Appeals’ decision, which eliminates access to this vital healthcare

service, will immediately and irreparably harm the

public interest, users of mail-order mifepristone in particular, and companies like Honeybee, whose business

depends on distributing mail-order mifepristone. The

lower court’s order granting relief to the Respondents

should be reversed.

Access to telemedicine and mail-order

pharmacies advances individual liberties

while preserving states’ rights.

Telemedicine—the delivery of medical care and

provision of general health service from a distance—

has a decades-long history in the United States and is

now widely used.11 Recent studies show that 76% of

U.S. hospitals connect with patients using some form

of telemedicine.12 This history has demonstrated that

telemedicine is safe, effective, and can provide patients

benefits over in-person healthcare, including, but not

limited to cost-savings, increased access, and a level of

privacy unachievable through in-person treatment.13

The availability of a telemedicine option also promotes

Hyder, Maryam, et al., Telemedicine in the United States:

An Introduction for Students and Residents, J. Med. Internet Res.

(Nov. 24, 2020), available at: https://www.ncbi.nlm.nih.gov/pmc/

articles/PMC7690251/.

Id.; see also, e.g., Shaver, J., The State of Telehealth Before and

After the COVID-19 Pandemic, Prim. Care, 2022;Dec;49(4):51730 (Apr. 25, 2022), available at: https://www.ncbi.nlm.nih.gov/

pmc/articles/PMC9035352/.

Dandy, K., et al., The Case for Telemedicine How Telehealth

Solutions Can Reduce Legal Risk While Improving Patient Access

and Lowering Health Care Costs, N.Y. St. B.J., Nov./Dec. 2018, at 39,

40; Lawson, N., et al., Disability and telehealth since the COVID19 pandemic, Center for Health & Research Transformation (Aug.

29, 2022), available at: https://disabilityhealth.medicine.umich.

edu/sites/default/files/downloads/RRTC%20Telehealth_final2.pdf;

Gajarawala, S., Telehealth Benefits and Barriers, J. Nurse Pract.,

2021 Feb. (Oct. 21, 2020), available at: https://www.ncbi.nlm.

nih.gov/pmc/articles/PMC7577680/#bib6; Telehealth privacy for

patients, HHS, available at: https://telehealth.hhs.gov/patients/

telehealth-privacy-for-patients (last visited Jan. 15, 2024).

patients’ autonomy to decide the best format for their

medical care based on their own individual needs.14 A

promising body of evidence shows that telemedicine

services increase patient knowledge and adherence to

healthy behaviors.15

Mail-order pharmacies play an integral role in the

larger telemedicine ecosystem. Recent research estimates that perhaps as many as one-quarter of pharmacy sales in the United States occur through use of

mail-order pharmacies.16

Substantial scientific evidence also confirms the

safety, efficacy, and benefits of mail-order pharmacies

for patients across the United States.17 For example,

nearly ten years ago, researchers demonstrated that

patients’ use of mail-order pharmacies “was not negatively associated with patient safety outcomes overall,

suggesting mail order use [is not] a barrier to receiving

primary and preventative care services for most patients.”18 Other research shows that patients who

Muellers, K., Telemedicine decision-making in primary

care during the COVID-19 pandemic: Balancing patient agency

and provider expertise, Health Policy and Tech. (Jan. 9, 2024),

available at: https://www.sciencedirect.com/science/article/abs/

pii/S2211883724000029.

Id.

Schmittdiel, J.A., et al., Opportunities to encourage mail order pharmacy delivery service use for diabetes prescriptions: a

qualitative study, BMC Health Serv. Res. 19, 422 (June 25, 2019),

available at: https://bmchealthservres.biomedcentral.com/articles/

10.1186/s12913-019-4250-7#Abs1.

See, e.g., Ma, supra note 7.

Schmittdiel, supra note 16.

receive medications by mail often demonstrate better

medication adherence, and thus increase their odds of

better health outcomes, than patients who receive

their prescriptions through brick-and-mortar pharmacies.19 For example, research published in 2018 showed

that stroke patients who had been prescribed a new

anticoagulant, antiplatelet, anti-glycemic, antihypertensive, and/or lipid-lowering medication between January 1, 2007 and June 30, 2015 were more likely to

adhere to their medications if they used mail-order

pharmacies to receive them, as compared to those who

used brick-and-mortar pharmacies.20 And still other

data confirms that use of mail-order pharmacies, like

use of telemedicine more generally, also result in lower

health-care costs overall: among other reasons for this

See, e.g., Gaffney, supra note 6; Ma, supra note 7 (“Studies

show that using mail-order pharmacies results in higher medication adherence rate compared to retail pharmacies. Studies have

consistently demonstrated that better medication adherence

leads to better health outcomes; thus, the use of mail-order pharmacies may improve health[.]” (citations omitted)); Schmittdiel,

J., et al., The Safety and Effectiveness of Mail Order Pharmacy Use

in Diabetes Patients, Am. J. Manag. Care, 19(11):882-87 (Nov.

2013), available at: https://www.ncbi.nlm.nih.gov/pmc/articles/

PMC4278640/pdf/nihms621271.pdf (explaining that “[p]revious

studies have shown mail order use is associated with greater medication adherence,” and “suggest mail order pharmacy services

may improve [patient] outcomes” (emphasis added)).

Neil, W., et al., Mail order pharmacy use and adherence to

secondary prevention drugs among stroke patients, J. Neurological

Sci., Vol. 390, 117-20 (Apr. 6, 2018), available at: https://www.jnsjournal.com/article/S0022-510X(18)30170-9/fulltext#secst0005.

cost-savings, mail-order pharmacies often coincide

with lower in- and out-patient and medication costs.21

The benefits of mail-order pharmacies, and telemedicine generally, disproportionately abound to

those with fewer advantages in our society. Telemedicine and mail-order pharmacies provide patients in

remote areas and with disabilities increased access to

healthcare.22 The CDC reports that up to one in four

adults in the United States have some type of disability.23 One in four adults with disabilities aged 18-44

years old do not have a regular healthcare provider.24

Yet, adults with disabilities are six times more likely

to have ten or more physician visits and five times

more likely to be admitted to a hospital compared to

people without disabilities.25 Telemedicine, including

See Ma, supra note 7; Aiken, A.R.A., et al., Effectiveness,

safety and acceptability of no-test medical abortion (termination

of pregnancy) provided via telemedicine: a national cohort

study, BJOG 2021, 128: 1464-74 (Mar. 24, 2021), available at:

https://obgyn.onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.

16668; see also Schmittdiel, supra note 16 (“[M]ail order pharmacy use is correlated with better medication adherence . . . [and]

is also associated with better health care outcomes and decreased

health care utilization and costs.”).

Gajarawala, supra note 13 (reporting benefits of telemedicine for persons with disability including lower cost of care, lower

transportation costs, and decreased need for paid personal assistance services).

Disability Impacts All of Us Infographic, CDC, available

at: https://www.cdc.gov/ncbddd/disabilityandhealth/infographicdisability-impacts-all.html (last visited Jan. 23, 2024).

Id.

Lawson, supra note 13.

mail-order pharmacies, helps to mitigate some of the

disparities in care through improved access over inperson treatment.26

And, just like brick-and-mortar pharmacies, mailorder pharmacies are subject to licensing requirements in each of the states in which they dispense

medications, in addition to regulation by the FDA.27

Pursuant to regulatory requirements, mail-order pharmacies may dispense a wide variety of essential therapeutics, including, for example, therapies for patients

recovering from strokes, suffering from heart failure,

and managing diabetes.28 So while telemedicine, and

mail-order pharmacies specifically, may offer individuals greater freedom to choose the mode of healthcare

best for them, states continue to play an integral regulatory role.

More than a century of precedent confirms states’

authority to regulate aspects of healthcare, including,

Id.

See, e.g., 21 C.F.R. § 1304.40; Locate a State-Licensed Online

Pharmacy, FDA, available at: https://www.fda.gov/drugs/besaferxyour-source-online-pharmacy-information/locate-state-licensedonline-pharmacy (last visited Jan. 23, 2024).

Vaduganathan, M., et al., Prescription Filling Patterns of

Evidence-Based Medical Therapies for Heart Failure During the

COVID-19 Pandemic in the United States, J. of Cardiac Failure,

Vol. 27, Issue 11, 1280-84 (Nov. 2021), available at: https://www.

sciencedirect.com/science/article/pii/S1071916421002608; Neil,

supra note 20; Abu-Farha, R., et al., Public Perceptions About

Home Delivery of Medication Service and Factors Associated

with the Utilization of This Service, Patient Preference and

Adherence, 16, 2259-69 (Aug. 22, 2022), available at:

https://www.tandfonline.com/doi/abs/10.2147/PPA.S377558.

for example, by expanding delivery options and licensing professionals, to enhance health and well-being of

their citizens. See, e.g., Watson v. Maryland, 218 U.S.

173, 176 (1910) (“It is too well settled to require discussion at this day that the police power of the states extends to the regulation of certain trades and callings,

particularly those which closely concern the public

health. There is perhaps no profession more properly

open to such regulation than that which embraces the

practitioners of medicine.”); Barsky v. Bd. of Regents of

Univ., 347 U.S. 442, 449 (1954) (“It is elemental that a

state has broad power to establish and enforce the

standards of conduct within its borders relative to the

health of everyone there.”); Pegram v. Herdrich, 530

U.S. 211, 237 (2000) (recognizing that “the field of

health care” is “a subject of traditional state regulation”). Mail-order pharmacies that operate in compliance with each state’s laws and licensing requirements

thus preserve states’ traditional role in regulating the

provision of healthcare while promoting patients’ individual freedom to access the lawfully available

healthcare of their choice.

The Court need look no further than Honeybee’s

model to see these characteristics of telemedicine playing out in real time. Honeybee provides safe and legal

access to myriad medications approved by the FDA, including but not limited to mifepristone. Its process for

supporting patients’ healthcare needs ensures that patients realize all of the benefits telemedicine, and mailorder pharmacies in particular, have to offer, including

increased privacy, cost-savings, greater access to

quality healthcare, and continuous support throughout a patient’s healthcare journey.

Honeybee’s rigorous processes promote safety and

efficacy. Patients may utilize Honeybee’s services only

after they have consulted with a provider, and Honeybee offers patients resources to help them identify an

appropriate provider, if they have not yet done so. And

Honeybee assigns all its providers and organizations

with which it partners an account manager to assist

with onboarding and ongoing day-to-day operations.

Once a provider has evaluated a patient and prescribed medication, the provider sends the patient’s

prescription to Honeybee electronically, and Honeybee

creates an order for the patient in its system and notifies the patient that it has received the prescription.

Acting as a bridge between the patient and the provider, Honeybee’s dashboard permits the provider to

view, cancel, and change the patient’s prescription order and to update the patient’s information as necessary.

Honeybee’s pharmacists and technicians comply

with all applicable laws when filling patients’ prescriptions. Thus, when filling a mifepristone prescription,

the Honeybee team adheres to the risk evaluation and

mitigation strategy (REMS) requirements, including

by confirming Honeybee has the requisite Prescriber

Agreement with the prescribing provider on file, recording the lot number for the medication, which it

also shares on the patient’s dashboard, and ensuring

each patient timely receives their mifepristone

prescription.29 When it mails the medication (along

with included supplies, supplemental materials from

the patient’s provider, a GenBioPro treatment guide,

and a postcard with Honeybee’s information) to the patient’s provided address, it provides the patient and

the provider the tracking number, and then additionally notifies the patient once the shipping carrier has

marked the order as delivered. And if a shipment is delayed, the Honeybee team works with the patient’s provider to ensure the patient receives a prescription

within the timeframe regulations require.

Throughout the entirety of the process, Honeybee’s pharmacists and support team are available to

answer questions and provide consultations via phone,

email, and live chat. Honeybee also offers medicationabortion specific information to patients and providers

on its website.30 And always, Honeybee operates lawfully. Besides complying with federal law, Honeybee is

licensed by every board of pharmacy in each state to

which it sends medication, it monitors state laws surrounding the drugs it dispenses, including those related to its dispensation of mifepristone, and it ships

mifepristone to only those states where it is legal to do

so.

Through its relationship with GenBioPro, Honeybee also

completes annual audit questionnaires to ensure REMS compliance.

See Medication Abortion, Honeybee Health, Inc., available

at: https://honeybeehealth.com/conditions/medication-abortion

(last visited Jan. 23, 2024).

Honeybee’s model represents the best that telemedicine, and mail-order pharmacies specifically, can

be—for patients and states. Honeybee’s technology and

fulfillment process ensure that the patients and their

providers remain informed and connected, all while

its virtual services give patients the opportunity to realize greater access and privacy in receiving quality

healthcare. Honeybee’s dispensation of generic, rather

than brand-name, drugs, including mifepristone, is

just one example of the cost-savings Honeybee routinely helps patients realize. And Honeybee’s continuous efforts to comply with all applicable laws, and stay

informed as to any changes to them, secures states’

place, alongside the federal government, in ensuring

the healthcare Honeybee provides patients remains

safe and effective.

II.

Use of abortion medication at home is safe

and effective.

Honeybee plays a vital role in allowing pregnant

patients safe and effective mail-order access to medication abortion, with all the attendant benefits discussed above. Since the FDA approved mifepristone in

2000, the number of abortions in the United States has

decreased.31 But, within that figure, the incidence of

medication abortions has continued to increase, now

constituting over half of the legal abortions being

See, e.g., Diamant, J., et al., What the data says about abortion in the U.S., Pew Research Center (Jan. 11, 2023), available at:

https://www.pewresearch.org/short-reads/2023/01/11/what-thedata-says-about-abortion-in-the-u-s-2/.

performed in the United States.32 Honeybee plays a

central role in this growing healthcare service as the

largest mail-order pharmacy in the United States to

deliver mifepristone to patients.33

And study after study after study demonstrates

that dispensation of abortion medication to patients by

mail, and medication, rather than procedural, abortions via this mechanism, are safe, effective, and almost always result in positive patient outcomes.34 For

example:

See, e.g., Divya, J., et al., The Provision of Medication Abortion Care via Telehealth, Women’s Health Issues, 33-4, 333-36, Jacobs Institute of Women’s Health (June 8, 2023), available at:

https://www.whijournal.com/article/S1049-3867(23)00099-3/fulltext

#articleInformation; Daniel, S., et al., Obstetrician-gynecologist

willingness to provide medication abortion with removal of

the in-person dispensing requirement for mifepristone, Contraception, 2021Jul;104(1):73-76 (Mar. 31, 2021), available at:

https://www.contraceptionjournal.org/article/S0010-7824(21)

00098-6/fulltext.

Meet the Pharmacist, supra note 3.

“Medical” or “medication” abortions are defined as the use

of medicines, rather than surgical procedures, to terminate a

pregnancy. See, e.g., Aiken, supra note 21; Rafie S., et al., Pharmacist dispensing of mifepristone: An opinion of the Women’s Health

Practice and Research Network of the American College of Clinical

Pharmacy, J. Am. Coll. Clin. Pharm. 2024; 1-9 (Dec. 13, 2023),

available at: https://accpjournals.onlinelibrary.wiley.com/doi/full/

10.1002/jac5.1909 (“Medication abortion remains safe and effective when dispensed by pharmacists, including in mail-order

pharmacies. Likewise, medication abortion provided through telemedicine has also been shown to be as safe as in-person care.

Using telemedicine was effective and acceptable when compared

with face-to-face visits, with similar overall satisfaction.” (citations omitted)).

• Researchers in 2021 confirmed that out of

more than 1,100 packages containing mifepristone and

misoprostol delivered to patients by mail, in a study

conducted between May 2016 and September 2020,

95% of patients completed the abortion without any

further intervention.35

• A separate study of among over 100 patients

who relied on telehealth services to obtain a medication-abortion regimen by mail between October 2020

and January 2021 found 95% successfully completed

their abortions without the need for follow-up care, and

none reported any major adverse events.36 This efficacy

rate of medication abortion procedures through telehealth and mail-order means “is similar to in-person

provision” and aligns with international studies on use

of telehealth for medication abortions.37

• Researchers analyzing 224 patients who underwent medication abortions at home between January 2020 and April 2021 found that nearly 97% had a

complete abortion with medications alone, and the

Chong, E., et al., Expansion of a direct-to-patient telemedicine abortion service in the United States and experience during

the COVID-19 pandemic, Contraception, 2021Jul;104(1):43-48

(Mar. 27, 2021) available at: htt ps://pubmed. ncbi.nih.gov/

33781762/.

Upadhyay, U.D., et al., Safety and Efficacy of Telehealth

Medication Abortions in the US During the COVID-19 Pandemic,

JAMA Netw. Open, 2021Aug2;4(8):e2122320 (Aug. 24, 2021),

available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC

8385590/.

Id.

overwhelming majority reported being satisfied with

receiving their medications by mail.38

Research specifically aimed at comparing the outcomes of in-person administration of mifepristone with

a provider versus self-administration of the medication obtained by mail after use of telehealth services is

no less compelling.

• A recent retrospective, multicenter cohort

study that analyzed data for nearly 4,000 diverse patients concluded that there was no statistically significant difference in the safety or efficacy of a patient’s

medication abortion when the patient received the

medications by mail, rather than in person.39

• Scientific analysis of abortion outcomes in

Canada after mifepristone became available via “normal prescription dispensed by pharmacists and taken

at user discretion” showed that the change caused no

material increase in the number of abortions or

Grossman, D., et al., Mail-order pharmacy dispensing

of mifepristone for medication abortion after in-person clinical

assessment, Contraception (Sept. 20, 2021), available at:

https://www.contraceptionjournal.org/article/S0010-7824(21)00384X/fulltext; see also, e.g., The Safety and Quality of Current Abortion Methods, The Safety and Quality of Abortion Care in the

United States, Washington, D.C., Nat’l Academies of Sci., Engineering, and Med., The Nat’l Academies Press, 57-58 (2018), available at: https://doi.org/10.17226/24950.

Upadhyay, U.D., et al., Outcomes and Safety of HistoryBased Screening for Medication Abortion: A Retrospective Multicenter Cohort Study, JAMA Intern. Med., 2022;182(5):482-91

(Mar. 21, 2022), available at: https://jamanetwork.com/journals/

jamainternalmedicine/fullarticle/2790319.

abortion-related adverse events, even while “the frequency of medical abortion rose substantially.”40

• Research comparing outcomes of pregnant patients who underwent medication abortions in Hawaii

between April and November 2020 after receiving the

medications either in-person or through mail found

that the “[r]ates of abortion success [were] similar for

all methods of dispensing mifepristone and misoprostol” and that the success rate for completion of the

abortion, greater than 93% across all forms of medication dispensation, also did not depend on whether the

patient underwent an ultrasound before the abortion

procedure.41

• Perhaps the largest study to date, analyzing

over 52,000 medication abortions performed between

January and June 2020, representing nearly 85% of

all medication abortions performed in England and

Wales during that time, found that medication abortions performed at home with no prefatory in-person

treatment or dispensation requirement were at least

as safe and effective as, and in some instances,

Schummers, L., et al., Abortion Safety and Use with Normally Prescribed Mifepristone in Canada, N. Engl. J. Med. 2022;

386:57-67 (Jan. 6, 2022), available at: https://www.nejm.org/

doi/full/10.1056/NEJMsa2109779.

Kerestes, C., et al., Provision of medication abortion in Hawai’i during COVID-19: Practical experience with multiple care

delivery models, Contraception, 2021Jul;104(1):49-53 (Mar. 28,

2021), available at: https://www.contraceptionjournal.org/article/

S0010-7824(21)00097-4/fulltext.

superior to, in-person medical abortion treatments.42

The pregnant patients who accessed medical abortion

care through telehealth and mail-order services

waited, on average, four fewer days for treatment and

accessed the medical abortion services at an earlier

gestation stage, than patients who received in-person

treatment—two data points that support a decreased

risk associated with medication abortions at home, rather than in a clinic setting.43 Pregnant patients who

obtained a medication abortion through telemedicine

and mail-order services also successfully terminated

their pregnancies 98.8% of the time, a rate akin to, but

slightly higher than, those pregnant patients who received their medical services in person.44 No data indicated that pregnant patients who accessed their care

through telehealth and mail-order means experienced

greater incidence of significant adverse events than

those who accessed care in-person.45

Still other research underscores the efficacy of

telehealth in ensuring patients have access to abortion-related care. For example, studies confirm that

mailing of medications for patients’ use in at-home

abortions “[does] not significantly prolong [the] time

from patients’ first contact with the clinic to mifepristone ingestion or increase pregnancy duration at

Aiken, supra note 21.

Id.

Id. (disclosing that the rate of successful medication abortions for in-person patients in the study was 98.2%).

Id.

mifepristone ingestion,”46 and pregnant persons who

take mifepristone at home are no more likely to call a

provider’s office or make an unplanned visit than those

who opt for in-office administration.47

This parity between patients’ experiences accessing abortion medication at home and in-person is unsurprising. As the National Academy of Sciences

previously observed, even when pregnant persons in

the United States obtain a medication abortion within

the presence of a provider, they almost always “return

home after taking mifepristone and take the misoprostol 28 to 48 hours later.”48 As a result, nearly all of

those medication abortions, like those patients selfadminister after receipt of the prescribed medication

by mail, “occur largely in nonclinical settings.”49

The overwhelming evidence of the safety and efficacy of mail-order pharmacies for the provision of

Koenig, L., et al., Mailing abortion pills does not delay care:

A cohort study comparing mailed to in-person dispensing of abortion medications in the United States, Contraception (Feb. 1,

2023), available at: https://www.contraceptionjournal.org/article/

S0010-7824(23)00015-X/fulltext#secsect0005.

Swica, Y., et al., Acceptability of home use of mifepristone

for medical abortion, Contraception, 2013;Jul;88(1):122-27 (Nov.

21, 2012), available at: https://pubmed.ncbi.nlm.nih.gov/23177917/;

see also, e.g., Grossman, supra note 38 (finding that of the few adverse events reported during study by patients who had undergone medication abortion at home, “none . . . would have been

avoided by dispensing medications in person rather than with the

mail-order pharmacy”).

The Safety and Quality of Current Abortion Methods, supra note 38, at 56.

Id.

mifepristone to pregnant patients for abortions at

home allows favorable comparison to other contexts.

Specifically, the extremely low risk profile associated

with self-administered medication abortions is comparable to “the reported risks of serious adverse effects

of commonly used prescription and over-the-counter

medications,” such as NSAIDs and common antibiotics, which further supports that “no facility-specific factors are needed to ensure the safety of medication

abortion, as there is no perceived need for facility-specific factors to ensure the safety of these other common

pharmaceuticals.”50 In other words, “there is no medical reason for mifepristone to be dispensed in clinics.”51

Id. at 58.

Chong, supra note 35; see also, e.g., Koenig, supra note 46

(explaining that several recent studies have demonstrated that

abortion care through telehealth and mail-order services “is safe,

effective, and highly satisfactory to patients”); Grossman, supra

note 38 (“Preliminary findings from this study suggest that medication abortion with mail-order pharmacy dispensing of mifepristone was effective, feasible, and acceptable to patients seeking

early abortion.”); Raymond, E., et al., TelAbortion: evaluation of a

direct to patient telemedicine abortion service in the United States,

Contraception, 2019Sep;100(3):173-77 (June 3, 2019), available

at: https://www.contraceptionjournal.org/article/S0010-7824(19)

30176-3/fulltext (“This direct-to-patient telemedicine abortion

service was safe, effective, efficient, and satisfactory.”).

III. Prohibition of mail-order distribution of

mifepristone will inflict serious harm on

the public, patients, and businesses like

Honeybee

If the Court of Appeals’ ruling is allowed to stand,

neither brand-name nor generic mifepristone will be

available to patients by mail. No mere inconvenience,

such a result would deny some pregnant patients seeking to end pregnancies—and patients with other medical needs—access to a safe, effective medication

altogether. Any consideration of the balance of hardships must account for the grave, irreparable harm

that would befall the public interest, users of mailorder mifepristone in particular, and companies like

Honeybee, whose business depends on distributing

mail-order mifepristone.

As Danco and the FDA have demonstrated, the

Respondents’ theory of harm is speculative and attenuated. Mifepristone has been available to patients

through telemedicine and mail-order pharmacies since

the height of the COVID-19 pandemic, with no significant issues reported in the literature. By contrast, the

harm that will befall pharmacies like Honeybee, patients, and the public interest should the Court of

Appeals’ decision be allowed to stand is certain, immediate, and irreparable. Even if the Respondents had

standing and a reasonable prospect of success on the

merits, equity does not favor the relief they seek.

A. The public interest and public policy

weigh against enjoining the availability of mail-order mifepristone.

Courts must take “particular regard for the public

consequences in employing the extraordinary remedy

of injunction.” Weinberger v. Romero-Barcelo, 456 U.S.

305, 312 (1982). When “the Government is the opposing party,” the assessment of “harm to the opposing

party” and “the public interest” merge. Nken v. Holder,

556 U.S. 418, 435 (2009). And as courts have often recognized, a federal agency suffers inherent harm when

prevented from implementing regulations that Congress has entrusted it with the authority to promulgate in the public interest. See, e.g., Nat’l Propane Gas

Ass’n v. U.S. Dep’t of Homeland Sec., 534 F. Supp. 2d

16, 20 (D.D.C. 2008). See also Maryland v. King, 567

U.S. 1301, 1303 (2012) (“[A]ny time a State is enjoined

by a court from effectuating statutes enacted by representatives of its people, it suffers a form of irreparable

injury.”). Here, the public interest weighs strongly

against overriding the FDA’s judgment as to the drug’s

safety and effectiveness.

Public interest analysis also accounts for the particular policy interests embodied in statute. See, e.g.,

Amoco Prod. Co. v. Vill. of Gambell, Alaska, 480 U.S.

531, 545-46 (1987). The 1984 amendments to the federal Food, Drug, and Cosmetic Act evinced a federal

policy aim of reducing the cost of drugs and promoting

the availability of generics, without compromising

safety. See Mutual Pharm. Co., Inc. v. Barrett, 570 U.S.

472, 476-77 (2013); Fulgenzi v. PLIVA, Inc., 711 F.3d

578, 585 (6th Cir. 2013).52 Among its other impacts, implementation of the Fifth Circuit’s decision would deprive patients of an affordable, efficient way to obtain

a generic medication that has been proven safe—a step

backward from the policy Congress has charged the

FDA with effectuating.

B. Data show that eliminating access to

mail-order mifepristone will inflict

harm on many patients.

Weighing the public interest means considering

not only policy, but also the tangible consequences injunctive relief will have for other individuals or classes

of non-parties. See, e.g., Nat’l Ass’n of Farmworkers’

Orgs. v. Marshall, 628 F.2d 604, 616 (D.C. Cir. 1980).

The Fifth Circuit acknowledged the voices of several

amici on this score, but it assigned little weight to the

harm that would befall patients if the injunction were

allowed to stand. The danger that “eliminating access

to mifepristone, even temporarily, may pose health

risks to certain women” was less material, it reasoned,

because patients’ interest in access to the drug relates

“primarily (if not wholly) to the challenge to the 2000

Approval,” rather than the 2016 REMS and the 2021

Wider availability of generic medications does, in fact,

lower drug costs. The Association for Accessible Medicines estimates that generic drugs saved the U.S. Healthcare system approximately $408 billion in 2022, and a total of $2.9 trillion over

the last ten years. See The U.S. Generic and Biosimilar Medicines

Savings Report (Sept. 2023), available at: https://accessible

meds.org/sites/default/files/2023-09/AAM-2023-Generic-BiosimilarMedicines-Savings-Report-web.pdf (last visited Jan. 18, 2024).

non-enforcement decision. Pet. App. 68a.53 But the

Fifth Circuit made no mention of the distinct interest

of patients who rely on the mail-order mifepristone

that has become available under those FDA actions—

an interest that will suffer severe, immediate injury if

its decision is affirmed. A thorough balancing of the interests at stake requires that the jeopardy to these patients be taken into account.

Medication abortion carries far less risk for American women than childbirth. An analysis by the New

England Journal of Medicine in 2017 demonstrated

that the mortality rate for mothers in live births in

the United States was some 14 times higher than that

associated with medication abortions using mifepristone.54 Because, as discussed supra Section II, accessing

mifepristone through a combination of telemedicine

and mail-order pharmacies is safe and effective,55 still

more recent data establish that the 2016 and 2021

FDA policy changes have not altered this striking mortality disparity.56

We also know that the inverse is true: denying access to abortion threatens women’s lives. Multiple

“Pet. App.” refers to the FDA’s petition appendix in No. 23-

235.

Mifeprex REMS Study Group, Sixteen Years of Overregulation: Time to Unburden Mifeprex, N. Engl. J. Med., Vol. 376,

at 790-94 (Feb. 23, 2017), available at: https://www.nejm.org/

doi/10.1056/NEJMsb1612526; see also The Safety and Quality of

Current Abortion Methods, supra note 38.

Endler, supra note 5.

Upadhyay, supra note 36.

studies, conducted in the United States57 and globally58 have demonstrated a strong correlation between

restrictions on abortion and maternal mortality. Diminished access to abortion exacerbates underlying

disparities in health outcomes for pregnant women

across racial and income lines; due to structural inequalities, Black Americans, for instance, are more

likely to seek abortions than white Americans, are thus

more likely to be denied access to abortion where its

availability is legally curtailed, and face far higher

rates of serious complications or death in bringing a

pregnancy to term.59 And to the extent that enjoining

mail-order mifepristone causes some patients to lose

access to abortion altogether, who absent the injunction could access it legally via mail, the Fifth Circuit’s

Stevenson, A., The Pregnancy-Related Mortality Impact of

a Total Abortion Ban in the United States: A Research Note on Increased Deaths Due to Remaining Pregnant, Demography 58 (6):

2019-28 (Dec. 1, 2021), available at: https://read.dukeupress.

edu/demography/article/58/6/2019/265968/The-Pregnancy-RelatedMortality-Impact-of-a-Total.

Ngo, N., et al., Reproductive Health Policy Saga, Restrictive

Abortion Laws in Low- and Middle-Income Countries (LMICs),

Unnecessary Cause of Maternal Mortality, Health Care for Women

Int’l, Vol. 45 at 5-23 (Nov. 2, 2021), available at: https://www.

tandfonline.com/doi/full/10.1080/07399332.2021.1994971.

See Creanga, A., et al., Racial and Ethnic Disparities in

Severe Maternal Morbidity: A Multi-State Analysis, 2008-2010,

Am. J. Obstet. Gynecol., 2014 May (Dec. 1, 2013), available at:

https://pubmed.ncbi.nlm.nih.gov/24295922/; Kheyfets, A., et al.,

The Impact of Hostile Abortion Legislation on the United States

Maternal Mortality Crisis: A Call for Increased Abortion Education, Front. Pub. Health (Dec. 5, 2023), available at: https://

www.ncbi.nlm.nih.gov/pmc/articles/PMC10728320/#ref14.

ruling could cause them to seek alternatives, some of

which may be unsafe.

Moreover, as with access to a range of medicines

and health treatments, for some who live in isolated

rural areas, who have disabilities, or who have limited

or no access to transportation, an in-person dispensing

requirement may be an insuperable obstacle—or

enough of a disincentive that many ultimately will not

obtain abortion care.60 And as amici before the Fifth

Circuit explained and the district court record

showed, survivors of sexual violence or other trauma

may need the greater privacy and autonomy provided

by obtaining medication abortion through telehealth

and mail-order pharmacies.61 For these patients, or

others for whom the marginal differences in cost, time,

and convenience mean the difference between obtaining care and forgoing it, countermanding the FDA’s

judgment and reinstating the in-person prescription

Grossman, supra note 38 (noting that many patients access mail-order pharmacies because they “live far away from a local pharmacy or have difficulty making the trip”).

See Decl. of Katherine B. Glaser, M.D., Ex. 7, at 6, All. for

Hippocratic Medicine v. U.S. Food & Drug Admin., No. 2:22-cv00223 (N.D. Tex. Jan. 13, 2023), appeal docketed, No. 23-10362

(5th Cir. Apr. 10, 2023), ECF No. 28; see also Recent Guidance:

FDA Lifts In-Person Dispensing Requirement for Mifepristone

Abortion Pill, 135 Harv. L. Rev. 2235, 2240-41 (June 2022) (noting

that the REMS in effect for mifepristone, including the in-person

prescription requirement, “disproportionately affect the most

marginalized pregnant people seeking abortions,” and that

“[r]acially marginalized, trans, and nonbinary pregnant individuals face prohibitive challenges,” including but not limited to travel

to sites where in-person prescriptions can be obtained (asterisk

omitted)).

requirement will curtail access to legal abortion care.

This will inflict a cognizable harm on the women who

are thereby denied a lawful means of medication abortion. See, e.g., Pharmacia Corp. v. Alcon Labs., Inc., 201

F. Supp. 2d 335, 385 (D.N.J. 2002) (explaining that

where an injunction would deprive the public of an

FDA-approved medication, the public interest is paramount); Reedco, Inc. v. Hoffman-La Roche, Inc., 667

F. Supp. 1072, 1080 (D.N.J. 1987) (finding that harm to

patients from a three-month interruption in supply of

a prescription drug weighed against issuance of an injunction).

And vital uses of mifepristone extend beyond abortion. Mifepristone has been shown to be an effective

treatment for miscarriage management, reducing the

incidence of serious complications from pregnancy

loss.62 Scientific studies also reflect that mifepristone

may be used for other non-abortion-related medical

reasons, including managing and treating uterine leiomyomas,63 at least one type of brain tumor, and endometriosis.64 Depriving patients of mail-order access

to mifepristone for these uses constitutes a harm

Schreiber, C., et al., Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss, N. Eng. J. Med. Vol. 378,

at 2161-70 (June 7, 2018), available at: https://www.nejm.org/

doi/full/10.1056/NEJMoa1715726.

See Autry, B.M., et al., Mifepristone, StatPearls (last updated

May 8, 2022), available at: https://www.ncbi.nlm.nih.gov/books/

NBK557612/.

See Mifepristone (Mifeprex), Nat’l Library of Medicine

(last revised Mar. 15, 2023), available at: https://medlineplus.gov/

druginfo/meds/a600042.html#how.

independent of the evolving legal and policy landscape

surrounding abortion.

C. Prohibiting mail-order delivery of mifepristone would inflict serious harm on

Honeybee and other online pharmacies.

To the harms to patients must be added the injury

that members of the pharmaceutical community, including Honeybee, will suffer if the injunction is allowed to go into effect. See, e.g., ViroPharma, Inc. v.

Hamburg, 898 F. Supp. 2d 1, 28-29 (D.D.C. 2012) (concluding that business harm to producers of a generic

drug should its distribution be enjoined weighed

against injunctive relief ). While some forms of economic harm are discounted in the balancing of interests, the threat of existential harm to a company’s

business merits considerable weight. Atwood Turnkey

Drilling, Inc. v. Petroleo Brasileiro, S.A., 875 F.2d 1174,

1179 (5th Cir. 1989).

Here, Honeybee’s business, like that of many providers and pharmacies, depends on the FDA because,

pursuant to the state Board of Pharmacy licenses necessary to operate its business, it may dispense only

FDA-approved medications. Specifically with respect

to mifepristone, Honeybee has relied heavily on the

FDA’s determination that dispensation of the drug

through mail to facilitate medication abortions, is safe

and effective. As noted above, under the regulatory regime the FDA has created, Honeybee has delivered

thousands of doses of mifepristone to patients by mail

at costs lower than those patients could realize at their

local brick-and-mortar providers, and it has served

some patients who may not otherwise be able to access

the medication easily or at all.

Honeybee has done so based on its appreciation for

the robust scientific data demonstrating the soundness

of the FDA’s decision and its well-founded reliance on

the congressionally mandated legal framework which

designates the FDA as the federal government’s foremost scientific expert on evaluating drugs’ safety and

efficacy. Honeybee’s business model—and the service it

provides to these patients—would be hamstrung if this

Court overrides the FDA’s assessment of the ample scientific evidence supporting the safety, effectiveness,

and convenience of mail-order mifepristone.

---------------------------------♦---------------------------------

CONCLUSION

Mail-order pharmacies like Honeybee that operate

in compliance with all applicable laws play an integral

role in the growing telemedicine healthcare sector.

They support patients’ individual freedom to access

the healthcare most appropriate for them, while preserving states’ place to ensure, via regulation, that the

healthcare all patients receive is both safe and effective. And the overwhelming evidence is that abortion

through medication obtained by mail is not only safe

and effective, but also often the only means by which a

pregnant person in need of an abortion may be able to

obtain that life-changing care. The theoretical harms

the Respondents have advanced do not outweigh the

real, data-supported harm prohibiting this vital

healthcare access will cause these patients and the

businesses like Honeybee who support them. The

Court of Appeals’ order should be reversed to the extent it granted relief to the Respondents.

Respectfully submitted,

STEPHANIE L. GUTWEIN

Counsel of Record

A. SCOTT CHINN

MATTHEW K. GIFFIN

ELIZABETH A. CHARLES

FAEGRE DRINKER BIDDLE & REATH LLP

300 N. Meridian Street, Suite 2500

Indianapolis, IN 46204

(317) 237-0300

stephanie.gutwein@faegredrinker.com

scott.chinn@faegredrinker.com

matt.giffin@faegredrinker.com

elizabeth.charles@faegredrinker.com

LIBBY L. BANEY

FAEGRE DRINKER BIDDLE & REATH LLP

1500 K Street NW, Suite 1100

Washington, D.C. 20005

(202) 842-8800

libby.baney@faegredrinker.com

Counsel for Amicus Curiae

Honeybee Health, Inc.

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.