Amicus Curiae Brief — GenBioPro, Inc., Applicant v. Louisiana, et al.
Supreme Court briefMay 7, 2026
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Text
Nos. 25A1207, 25A1208
In the
Supreme Court of the United States
DANCO LABORATORIES, LLC,
Applicant,
v.
LOUISIANA, et al.,
Respondents.
GENBIOPRO, INC.,
Applicant,
v.
LOUISIANA, et al.,
Respondents.
On A pplications to Stay the Judgment of the
United States Court of A ppeals for the Fifth Circuit
BRIEF OF AMICUS CURIAE HONEYBEE HEALTH, INC.
IN SUPPORT OF APPLICATIONS BY DANCO AND
GENBIOPRO TO STAY OR VACATE THE
FIFTH CIRCUIT’S STAY PENDING APPEAL
Eugene M. Gelernter
Counsel of Record
Hilarie M. Meyers
Hadiya Williams
Jillian F. Horowitz
Patterson Belknap Webb & T yler LLP
1133 Avenue of the Americas
New York, NY 10036
(212) 336-2000
emgelernter@pbwt.com
Counsel for Amicus Curiae Honeybee Health, Inc.
392650
A
(800) 274-3321 • (800) 359-6859
TABLE OF CONTENTS
Page
INTEREST OF AMICUS CURIAE .................................................................... 1
SUMMARY OF ARGUMENT............................................................................. 1
ARGUMENT ....................................................................................................... 3
I.
Mail-Order Pharmacies Benefit Patients’ Health and Autonomy. ........ 3
II.
Obtaining Mifepristone by Telehealth and Mail-Order Pharmacies Is
Safe and Effective. .................................................................................... 7
III.
The In-Person Dispensing Requirement for Mifepristone Seriously
Harms Patients and Mail-Order Pharmacies. ...................................... 12
A.
Eliminating access to mifepristone by mail harms
patients. ....................................................................................... 12
B.
Prohibiting mail-order dispensing of mifepristone inflicts
serious harm on mail-order pharmacies. .................................... 17
CONCLUSION .................................................................................................. 20
i
TABLE OF AUTHORITIES
Page(s)
Cases
Atwood Turnkey Drilling, Inc. v. Petroleo Brasileiro, S.A.,
875 F.2d 1174 (5th Cir. 1989), cert. denied, 493 U.S. 1075 (1990) ....................... 17
Doran v. Salem Inn, Inc.,
422 U.S. 922 (1975) ................................................................................................ 17
hiQ Labs, Inc. v. LinkedIn Corp.,
31 F.4th 1180 (9th Cir. 2022) ................................................................................. 17
John B. Hull, Inc. v. Waterbury Petrol.,
588 F.2d 24 (2nd Cir. 1978), cert. denied, 440 U.S. 960 (1979) ............................ 17
Stormans, Inc. v. Selecky,
586 F.3d 1109 (9th Cir. 2009) ................................................................................ 13
Statutes
21 U.S.C. § 355-1 ..................................................................................................... 8, 13
Regulations
21 C.F.R. § 1304.40 ........................................................................................................ 4
Other Authorities
Abigail Adams, Meet the Pharmacist Expanding Access to Abortion
Pills Across the U.S., TIME (June 13, 2022),
https://time.com/6183395/pills-honeybee-health-online-pharmacy/ ....................... 7
Adam W. Gaffney et al., Health Needs and Functional Disability
Among Mail-Order Pharmacy Users in the US, 181 JAMA Internal
Med. 554 (2021) ........................................................................................................ 4
Alison Gemmill et al., US Abortion Bans and Infant Mortality, 333
JAMA 1315 (2025) .................................................................................................. 15
Am. Coll. Obstetricians & Gynecologists, Medication Abortion Up to 70
Days of Gestation, Practice Bulletin No. 225 (Oct. 2020, reaff’d
2023), https://www.acog.org/clinical/clinical-guidance/practicebulletin/articles/2020/10/medication-abortion-up-to-70-days-ofgestation.................................................................................................................... 8
ii
Amanda Cleeve et al., The use of telemedicine services for medical
abortion, 6 Cochrane Database of Systematic Revs. CD013764
(2025), https://pmc.ncbi.nlm.nih.gov/articles/PMC12135146/ .............................. 11
Amanda Jean Stevenson, The Pregnancy-Related Mortality Impact of a
Total Abortion Ban in the United States: A Research Note on
Increased Deaths Due to Remaining Pregnant, 58 Demography 2019
(2021) ...................................................................................................................... 15
Andreea A. Creanga et al., Racial and Ethnic Disparities in Severe
Maternal Morbidity: A Multi-State Analysis, 2008-2010, 210 Am. J.
Obstet. Gynecol. 435.e1 (2014),
https://doi.org/10.1016/j.ajog.2013.11.039 ............................................................. 16
Anna Kheyfets et al., The Impact of Hostile Abortion Legislation on the
United States Maternal Mortality Crisis: A Call for Increased
Abortion Education, 11 Frontiers Pub. Health 1291668 (2023),
https://doi.org/10.3389/fpubh.2023.1291668.......................................................... 16
The Availability and Use of Medication Abortion, KFF (Mar. 20, 2024),
https://www.kff.org/womens-health-policy/the-availability-and-useof-medication-abortion/ ............................................................................................ 8
Bharathi Ramachandran et al., A Randomized Encouragement Trial to
Increase Mail Order Pharmacy Use and Medication Adherence in
Patients with Diabetes, 36 J. Gen. Internal Med. 154 (2020) ................................. 5
Blake M. Autry & Roopma Wadhwa, Mifepristone, StatPearls (Feb. 28,
2024), https://www.ncbi.nlm.nih.gov/books/NBK557612 ...................................... 16
Carly McCord et al., Comparison of in-person vs. telebehavioral health
outcomes from rural populations across America, 22 BMC
Psychiatry 778 (2022) ............................................................................................... 3
Christopher M. Jones et al., Receipt of Telehealth Services, Receipt and
Retention of Medications for Opioid Use Disorder, and Medically
Treated Overdose Among Medicare Beneficiaries Before and During
the COVID-19 Pandemic, 79 JAMA Psychiatry 981 (2022) .................................... 4
Courtney Schreiber et al., Mifepristone Pretreatment for the Medical
Management of Early Pregnancy Loss, 378 N. Eng. J. Med. 2161
(2018) ...................................................................................................................... 16
iii
Daniel Grossman & Sarah Raifman, Analysis of Medication Abortion
Risk and the FDA Report “Mifepristone US Post-Marketing Adverse
Events Summary Through 12/31/2024”, Advancing New Standards
in Reprod. Health (May 15, 2025),
https://www.ansirh.org/sites/default/files/202505/Issue%20Brief%20MAB%20SAEs-May2025%20Final_0.pdf .......................... 14
Daniel Grossman et al., Mail-order pharmacy dispensing of
mifepristone for medication abortion after in-person clinical
assessment, 107 Contraception 36 (2021) .......................................................... 4, 11
Derek J. Baughman et al., Comparison of Quality Performance
Measures for Patients Receiving In-Person vs Telemedicine Primary
Care in a Large Integrated Health System, 5 JAMA Network Open
e223367 (2022), https://pubmed.ncbi.nlm.nih.gov/36156147/................................. 3
Dovile Vilda et al., State Abortion Policies and Maternal Death in the
United States, 2015-2018, 111 Am. J. Pub. Health. 1696 (2021) ......................... 15
Duy Do & Pascal Geldsetzer, Trends in Mail-Order Pharmacy Use in
the U.S. From 1996 to 2018: An Analysis of the Medical Expenditure
Panel Survey, 61 Am. J. Preventative Med. e63 (2021),
https://pmc.ncbi.nlm.nih.gov/articles/PMC8319048/ .............................................. 4
Elizabeth C. Romanis et al., Safeguarding and Teleconsultation For
Abortion, 398 Lancet 555 (2021) ............................................................................ 13
Emily M. Godfrey et al., Patient Perspectives Regarding Clinician
Communication During Telemedicine Compared With In-Clinic
Abortion, 141 Obstetrics & Gynecology 1139 (2023) ............................................. 13
Erica Chong et al., Expansion of a direct-to-patient telemedicine
abortion service in the United States and experience during the
COVID-19 pandemic, 104 Contraception 43 (2021) .............................................. 12
Grace Sparks et al., Americans’ Challenges with Health Care Costs,
KFF (Apr. 30, 2026), https://www.kff.org/health-costs/americanschallenges-with-health-care-costs/........................................................................... 6
Isaac Maddow-Zimet et al., Abortion in the United States, Guttmacher
Inst. (Mar. 2026), https://www.guttmacher.org/fact-sheet/inducedabortion-united-states .............................................................................................. 7
Jill Barr-Walker et al., Experiences Of Women Who Travel for Abortion:
A Mixed Methods Systematic Review, 14 PLoS ONE.e0209991
(2019), https://doi.org/10.1371/journal.pone.0209991 ........................................... 13
iv
Joan M. Neuner et al., Medication delivery factors and adjuvant
endocrine therapy adherence in breast cancer, 197 Breast Cancer
Rsch. Treatment 223 (2023) ..................................................................................... 5
Joseph Ford & Markus Reuber, Comparisons of Communication in
Medical Face-To-Face and Teleconsultations: A Systemic Review
and Narrative Synthesis, 39 Health Commc’n 1012 (2023) .................................... 3
Julie A. Schmittdiel et al., Opportunities to encourage mail order
pharmacy delivery service use for diabetes prescriptions: a
qualitative study, 19 BMC Health Serv. Rsch. 422 (2019),
https://doi.org/10.1186/s12913-019-4250-7 .............................................................. 5
Julie A. Schmittdiel et al., The Safety and Effectiveness of Mail Order
Pharmacy Use in Diabetes Patients, 19 Am. J. Managed Care 882
(2013) .................................................................................................................... 4, 5
Junyi Ma & Li Wang, Characteristics of Mail-Order Pharmacy Users:
Results from the Medical Expenditures Panel Survey, 33 J.
Pharmacy Prac. 293 (2018) ........................................................................ 4, 5, 6, 13
Latoya Hill et al., What are the Implications of the Dobbs Ruling for
Racial Disparities?, KFF (Apr. 24, 2024),
https://www.kff.org/womens-health-policy/what-are-theimplications-of-the-dobbs-ruling-for-racial-disparities ......................................... 15
Lauren J. Ralph et al., Comparison of No-Test Telehealth and InPerson Medication Abortion, 332 JAMA 898 (2024) ............................................. 10
Leah R. Koenig 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, 121 Contraception 109962 (2023),
https://doi.org/10.1016/j.contraception.2023.109962 ............................................. 11
Leah R. Koenig et al., Patient Acceptability of Telehealth Medication
Abortion Care in the United States, 2021-2022: A Cohort Study, 114
Am. J. Pub. Health 241 (2024) ..................................................................... 7, 10, 13
Leah R. Koenig et al., The Role of Telehealth in Promoting Equitable
Abortion Access in the United States: Spatial Analysis, 9 JMIR Pub.
Health Surveillance e45671 (2023),
https://pmc.ncbi.nlm.nih.gov/articles/PMC10664017/ .......................................... 13
v
Leonardo Cely-Andrade et al., Telemedicine for the provision of
medication abortion to pregnant people at up to twelve weeks of
pregnancy: a systematic literature review and meta-analysis, 21
Reprod. Health 136 (2024) ............................................................................... 10, 11
Lisa Wu et al., ExPAND Mifepristone: Medical Management of
Miscarriage and Abortion in FQHCs, 21 Annals Fam. Med. 468
(2023) ...................................................................................................................... 16
Locate a State-Licensed Online Pharmacy, U.S. Food & Drug Admin.,
https://www.fda.gov/drugs/besaferx-your-source-online-pharmacyinformation/locate-state-licensed-online-pharmacy (last visited May
2, 2026) ...................................................................................................................... 4
Memorandum on Further Efforts To Protect Access to Reproductive
Healthcare Services, 88 Fed. Reg. 4895 (Jan. 22, 2023) ......................................... 8
Mifeprex REMS Study Grp., Sixteen Years of Overregulation: Time to
Unburden Mifeprex, 376 N. Engl. J. Med. 790 (2017)........................................... 14
Mifepristone (Mifeprex), Nat’l Libr. Med. (Feb. 15, 2026),
https://medlineplus.gov/druginfo/meds/a600042.html#ho .................................... 16
Nat’l Acads. of Sci., Eng’g & Med., The Safety and Quality of Abortion
Care in the United States (2018) ................................................................ 12, 13, 14
Natalie Lawson et al., Disability and telehealth since the COVID-19
pandemic, Ctr. Health & Rsch. Transformation (Aug. 29, 2022),
https://chrt.org/wp-content/uploads/2022/08/RRTC-Telehealth-Aug2022-1.pdf ................................................................................................................. 7
Ngo Valery Ngo et al., Reproductive Health Policy Saga, Restrictive
Abortion Laws in Low- and Middle-Income Countries (LMICs),
Unnecessary Cause of Maternal Mortality, 45 Health Care for
Women Int’l 5 (2021) .............................................................................................. 15
Pankajkumar A. Anawade et al., A Comprehensive Review on
Exploring the Impact of Telemedicine on Healthcare Accessibility, 16
Cureus e55996 (2024),
https://pmc.ncbi.nlm.nih.gov/articles/PMC11009553/ ............................................ 7
Parvati Singh & Maria F. Gallo, National Trends in Infant Mortality in
the US After Dobbs, 178 JAMA Pediatrics 1364 (2024) ........................................ 15
vi
Phil Schwab et al., A Retrospective Database Study Comparing
Diabetes-Related Medication Adherence and Health Outcomes for
Mail-Order Versus Community Pharmacy, 25 J. Managed Care &
Specialty Pharm. 332 (2019) ................................................................................ 4, 5
Questions and Answers on Mifepristone for Medical Termination of
Pregnancy Through Ten Weeks Gestation, U.S. Food & Drug Admin.
(Apr. 8, 2026), https://www.fda.gov/drugs/postmarket-drug-safetyinformation-patients-and-providers/questions-and-answersmifepristone-medical-termination-pregnancy-through-ten-weeksgestation#TheMifepristoneREMSProgram ........................................................... 18
Roman Pabayo et al., Laws Restricting Access to Abortion Services and
Infant Mortality Risk in the United States, 17 Int’l J. Env’t Rsch.
Pub. Health 3773 (2020) ........................................................................................ 15
Scott Devine et al., A comparison of diabetes medication adherence and
healthcare costs in patients using mail order pharmacy and retail
pharmacy, 13 J. Med. Econ. 203 (2010) ................................................................... 5
Shilpa N. Gajarawala & Jessica N. Pelkowski, Telehealth Benefits and
Barriers, 17 J. Nurse Prac. 218 (2021) .................................................................... 3
Silpa Srinivasulu et al., Telehealth Medication Abortion in Primary
Care: A Comparison to Uusual in-Clinic Care, 37 J. Am. Bd. Fam.
Med. 295 (2024) ...................................................................................................... 11
U.S. Food & Drug Admin., Ctr. for Drug Evaluation & Research,
Application No. 020687Orig1s020 Summary Review (Jan. 3, 2023) ..................... 8
U.S. Food & Drug Admin., Ctr. for Drug Evaluation & Research,
REMS Modification Rationale Review (Dec. 16, 2021) ........................................... 8
Ushma D. Upadhyay et al., Effectiveness and safety of telehealth
medication abortion in the USA, 30 Nature Med. 1191 (2024) ........................ 9, 14
Ushma D. Upadhyay et al., Outcomes and Safety of History-Based
Screening for Medication Abortion: A Retrospective Multi-center
Cohort Study, 182 JAMA Internal Med. 482 (2022) ............................................... 9
Victor C. Ezeamii et al., Revolutionizing Healthcare: How Telemedicine
Is Improving Patient Outcomes and Expanding Access to Care, 16
Cureus e63881 (2024),
https://pmc.ncbi.nlm.nih.gov/articles/PMC11298029/ ........................................ 3, 7
vii
William P. Neil et al., Mail order pharmacy use and adherence to
secondary prevention drugs among stroke patients, 390 J.
Neurological Scis. 117 (2018) ................................................................................... 5
Yael Swica et al., Acceptability of home use of mifepristone for medical
abortion, 88 Contraception 122 (2012) .................................................................. 11
Yam B. Limbu & Bruce A. Huhmann, What influences consumers’
online medication purchase intentions and behavior? A scoping
review, 15 Frontiers in Pharmacology 1356059 (2024),
https://doi.org/10.3389/fphar.2024.1356059 ............................................................ 7
viii
INTEREST OF AMICUS CURIAE1
Amicus curiae Honeybee Health, Inc. (“Honeybee”) is a mail-order pharmacy
run by a board-certified pharmacist with more than twenty years of experience.
Honeybee was the first mail-order pharmacy in the United States to dispense
mifepristone by mail after the U.S. Food and Drug Administration (“FDA”) lifted the
in-person dispensing requirement for mifepristone. Honeybee dispenses the highest
volume of mifepristone by mail of any U.S. mail-order pharmacy. Honeybee only
dispenses mifepristone by mail in jurisdictions whose laws permit it to do so
(currently thirty-one states and the District of Columbia) and does not ship
mifepristone to Louisiana. It has safely dispensed hundreds of thousands of orders of
mifepristone to date.
Honeybee submits this brief to highlight: (1) the role that telehealth and mailorder pharmacies play in providing patients with access to high-quality and low-cost
healthcare and medications; (2) the many studies showing the safety and efficacy of
using medication, including mifepristone, dispensed by mail-order pharmacies; and
(3) the harms that the in-person dispensing requirement will impose on patients and
mail-order pharmacies.
SUMMARY OF ARGUMENT
Telehealth and mail-order pharmacies play a vital role in ensuring that
patients have access to safe and effective healthcare and medication. Medications
1 No
counsel for any party authored this brief in whole or in part or made any
monetary contribution to its preparation and submission.
1
have been delivered to patients by mail for more than 100 years, and in recent years,
use of mail-order pharmacies in the United States has increased dramatically.
Research has shown that the use of telehealth and mail-order pharmacies is safe and
effective and benefits patients by improving health outcomes, providing cost savings,
and promoting patient privacy and autonomy.
Access to mail-order pharmacies promotes individual patients’ ability to obtain
high-quality and affordable healthcare in the manner that is most appropriate for
them. That is true for mifepristone, which is an essential part of the recommended
and most commonly used medication abortion regimen in the United States.
Numerous studies have shown that prescribing mifepristone by telehealth and using
mail-order pharmacies to dispense it is safe and effective, with an extraordinarily low
rate of serious adverse outcomes. Research also underscores that this model is a safe
and effective way of providing patients with timely access to abortion care. Thus,
substantial scientific evidence supports the FDA’s decision to lift the in-person
dispensing requirement for mifepristone. The Fifth Circuit’s decision disregards this
scientific evidence.
Reinstating the in-person dispensing requirement eliminates access to
mifepristone by mail even in states where abortion is legal. This imposes severe harm
on patients who rely on mail-order pharmacies to obtain this medication. This harm
falls hardest on patients who face difficulties accessing in-person healthcare and
brick-and-mortar pharmacies. The in-person dispensing requirement also seriously
harms mail-order pharmacies, like Honeybee, that have relied on the FDA’s
2
determination that dispensing mifepristone by mail is safe and effective. The inperson dispensing requirement eliminates a significant portion of Honeybee’s
business and jeopardizes the viability of mail-order pharmacies more broadly.
ARGUMENT
I.
Mail-Order Pharmacies Benefit Patients’ Health and Autonomy.
Telehealth, telemedicine, and mail-order pharmacies play a vital role in
ensuring that patients have access to safe and effective healthcare and medication,
including mifepristone.2 Decades of experience have shown that telemedicine is safe
and effective, and provides patients with important benefits, including cost-savings
and increased healthcare access.3 Research has also demonstrated that telehealth
and telemedicine is as effective as in-person care,4 and may be more effective in some
circumstances.5
2 Although the terms “telehealth” and “telemedicine” are often used interchangeably,
“telehealth” refers broadly to “the use of telecommunications technology in health
care delivery, information, and education,” including pharmacy services, whereas
“telemedicine” “refers specifically to clinical services.” Shilpa N. Gajarawala &
Jessica N. Pelkowski, Telehealth Benefits and Barriers, 17 J. Nurse Prac. 218, 218
(2021).
3 Victor C. Ezeamii et al., Revolutionizing Healthcare: How Telemedicine Is Improving
Patient Outcomes and Expanding Access to Care, 16 Cureus e63881 (2024),
https://pmc.ncbi.nlm.nih.gov/articles/PMC11298029/.
E.g., Carly McCord et al., Comparison of in-person vs. telebehavioral health
outcomes from rural populations across America, 22 BMC Psychiatry 778 (2022);
Joseph Ford & Markus Reuber, Comparisons of Communication in Medical Face-ToFace and Teleconsultations: A Systemic Review and Narrative Synthesis, 39 Health
Commc’n 1012, 1012, 1017 (2023).
4
5 E.g., Derek J. Baughman et al., Comparison of Quality Performance Measures for
Patients Receiving In-Person vs Telemedicine Primary Care in a Large Integrated
Health
System,
5
JAMA
Network
Open
e223367
(2022),
3
Mail-order pharmacies like Honeybee play an integral role in the telehealth
ecosystem. Between 1996 and 2018, use of mail-order pharmacies in the United
States increased by approximately fifty percent.6 An estimated 200,000,000
prescriptions are delivered by mail annually.7 Like brick-and-mortar pharmacies,
mail-order pharmacies are subject to regulation by state pharmacy boards and must
comply with FDA regulations as to the medications that they dispense.8
Substantial scientific evidence confirms the safety, efficacy, and benefits of
using mail-order pharmacies.9 For example, research has shown that patients who
use mail-order pharmacies often exhibit better adherence to their medication
https://pubmed.ncbi.nlm.nih.gov/36156147/; Christopher M. Jones et al., Receipt of
Telehealth Services, Receipt and Retention of Medications for Opioid Use Disorder,
and Medically Treated Overdose Among Medicare Beneficiaries Before and During
the COVID-19 Pandemic, 79 JAMA Psychiatry 981, 981, 991 (2022).
6 Duy Do & Pascal Geldsetzer, Trends in Mail-Order Pharmacy Use in the U.S. From
1996 to 2018: An Analysis of the Medical Expenditure Panel Survey, 61 Am. J.
Preventative
Med.
e63,
e69
(2021),
https://pmc.ncbi.nlm.nih.gov/articles/PMC8319048/.
7 Adam W. Gaffney et al., Health Needs and Functional Disability Among Mail-Order
Pharmacy Users in the US, 181 JAMA Internal Med. 554, 555 (2021).
8 See, e.g., 21 C.F.R. § 1304.40; Locate a State-Licensed Online Pharmacy, U.S. Food
& Drug Admin., https://www.fda.gov/drugs/besaferx-your-source-online-pharmacyinformation/locate-state-licensed-online-pharmacy (last visited May 2, 2026).
9 E.g., Junyi Ma & Li Wang, Characteristics of Mail-Order Pharmacy Users: Results
from the Medical Expenditures Panel Survey, 33 J. Pharm. Prac. 293, 293 (2018); Phil
Schwab et al., A Retrospective Database Study Comparing Diabetes-Related
Medication Adherence and Health Outcomes for Mail-Order Versus Community
Pharmacy, 25 J. Managed Care & Specialty Pharm. 332, 332, 337–39 (2019); Daniel
Grossman et al., Mail-order pharmacy dispensing of mifepristone for medication
abortion after in-person clinical assessment, 107 Contraception 36, 36 (2021). See also
Julie A. Schmittdiel et al., The Safety and Effectiveness of Mail Order Pharmacy Use
in Diabetes Patients, 19 Am. J. Managed Care 882, 884, 886 (2013) (finding that use
of mail-order pharmacies “may be associated with improved health outcomes”).
4
regimens, which in turn can lead to better health outcomes.10 For example, a 2018
study showed that stroke patients who had been prescribed anticoagulant,
antiplatelet, anti-glycemic, antihypertensive, and/or lipid-lowering medications were
more likely to adhere to their medication regimen if they used a mail-order pharmacy,
rather than a brick-and-mortar pharmacy.11 Similarly, a 2019 study found greater
medication adherence among patients with type 2 diabetes mellitus who used mailorder pharmacies.12
Additionally, data show that using mail-order pharmacies provides significant
cost savings.13 For example, a study published in 2010 found that patients with
diabetes who switched from retail pharmacies to mail-order pharmacies “trended
toward lower total and diabetes-related medical costs over time.”14 And a 2020 study
found that “overall health-care costs including medication costs, inpatient costs, and
10 E.g., Ma & Wang, supra note 9, at 293; Schmittdiel et al., supra note 9, at 882, 885.
William P. Neil et al., Mail order pharmacy use and adherence to secondary
prevention drugs among stroke patients, 390 J. Neurological Scis. 117, 118–19 (2018).
11
12 Schwab et al., supra note 9, at 332, 339; see also Bharathi Ramachandran et al., A
Randomized Encouragement Trial to Increase Mail Order Pharmacy Use and
Medication Adherence in Patients with Diabetes, 36 J. Gen. Internal Med. 154, 154,
158–60 (2020) (finding that mail-order pharmacy use improved adherence to a key
class of diabetes medications); Joan M. Neuner et al., Medication delivery factors and
adjuvant endocrine therapy adherence in breast cancer, 197 Breast Cancer Rsch.
Treatment 223, 223 (2023) (“Mail order users had higher adherence in both
commercial and Medicare-insured cohorts [of breast cancer patients].”)
13 See Ma & Wang, supra note 9, at 293; see also Julie A. Schmittdiel et al.,
Opportunities to encourage mail order pharmacy delivery service use for diabetes
prescriptions: a qualitative study, 19 BMC Health Serv. Rsch. 422 (2019).
14 Scott Devine et al., A comparison of diabetes medication adherence and healthcare
costs in patients using mail order pharmacy and retail pharmacy, 13 J. Med. Econ.
203, 203 (2010).
5
outpatients costs, are . . . lower for mail-order pharmacy users.”15 These cost savings
are particularly important at a time when many patients find that healthcare costs
are spiraling out of control.16
Telehealth and mail-order pharmacies also increase the availability of
healthcare for many patients, particularly those who live in remote areas, lack access
to transportation, or have disabilities that make travel difficult. For these patients,
mail-order pharmacies make it possible to obtain medication that otherwise would be
15 Ma & Wang, supra note 9, at 293.
16 Recent polling shows that “[j]ust under half of U.S. adults say it is difficult to afford
health care costs,” with one-third saying “they have skipped or postponed getting
health care they needed because of cost” in the past 12 months and one in four saying
they “have not filled a prescription . . . because of the cost.” Grace Sparks et al.,
Americans’ Challenges with Health Care Costs, KFF (Apr. 30, 2026),
https://www.kff.org/health-costs/americans-challenges-with-health-care-costs/.
Moreover, “[h]ealth care costs remain at the top of the list of people’s financial
worries, with nearly two-thirds (64%) saying they are at least somewhat worried
about affording the cost of health care.” Id.
6
difficult, if not impossible, to obtain.17 And patients who use telehealth and mailorder pharmacies cite increased privacy as a further benefit.18
II.
Obtaining Mifepristone by Telehealth and Mail-Order Pharmacies Is
Safe and Effective.
Mail-order pharmacies like Honeybee play a vital role in providing patients
with safe and effective access to mifepristone by mail.19 Medication abortions now
account for nearly two-thirds of abortions provided nationwide.20 Mifepristone is an
17 See Ezeamii et al., supra note 3 (“Telemedicine can eliminate the need for long-
distance travel for patients in rural or underserved areas, reducing the time and costs
associated with accessing healthcare.”); Natalie Lawson et al., Disability and
telehealth since the COVID-19 pandemic, Ctr. Health & Rsch. Transformation (Aug.
29, 2022), https://chrt.org/wp-content/uploads/2022/08/RRTC-Telehealth-Aug-20221.pdf (explaining that telehealth can benefit people with disabilities by, inter alia,
lessening the need to coordinate transportation, increasing access to specialists, and
supporting independence); Pankajkumar A. Anawade et al., A Comprehensive Review
on Exploring the Impact of Telemedicine on Healthcare Accessibility, 16 Cureus
e55996 (2024), https://pmc.ncbi.nlm.nih.gov/articles/PMC11009553/ (“[T]elemedicine
extends healthcare reach to remote and underserved areas while enhancing temporal
accessibility with round-the-clock availability.”)
18 E.g., Leah R. Koenig et al., Patient Acceptability of Telehealth Medication Abortion
Care in the United States, 2021-2022: A Cohort Study, 114 Am. J. Pub. Health 241,
246 (2024) (reporting that 76% of patients who obtained abortion care through
telehealth cited increased privacy as a benefit); see also Yam B. Limbu & Bruce A.
Huhmann, What influences consumers’ online medication purchase intentions and
behavior? A scoping review, 15 Frontiers in Pharmacology 1356059 (2024),
https://doi.org/10.3389/fphar.2024.1356059 (“[C]onsumers’ perceptions of privacy can
influence their decision to buy some prescription medicines online . . . .”).
19 See, e.g., Abigail Adams, Meet the Pharmacist Expanding Access to Abortion Pills
Across the U.S., TIME (June 13, 2022), https://time.com/6183395/abortion-pillshoneybee-health-online-pharmacy/.
20 See Isaac Maddow-Zimet et al., Abortion in the United States, Guttmacher Inst.
(Mar. 2026), https://www.guttmacher.org/fact-sheet/induced-abortion-united-states.
7
essential part of the recommended21 and most commonly used22 medication abortion
regimen.
In evaluating Plaintiffs’ likelihood of success on the merits, the Fifth Circuit
failed to consider the abundance of scientific evidence demonstrating that dispensing
mifepristone by mail is safe, effective, and beneficial to patients. During the COVID19 crisis, the FDA determined that mifepristone can safely be dispensed by mail-order
pharmacies in order to minimize burdens on patients, without jeopardizing patients’
health.23 As Applicants Danco Laboratories, LLC, and GenBioPro, Inc. explain in
detail in their applications to this Court, that initial nonenforcement determination
was supported by robust scientific evidence, and even more compelling evidence
supported the FDA’s December 2021 decision to lift the in-person dispensing
requirement24 and its 2023 formalization of that decision.25 Thus, mifepristone has
21 Am. Coll. Obstetricians & Gynecologists, Medication Abortion Up to 70 Days of
Gestation,
Practice
Bulletin
No.
225
(Oct.
2020,
reaff’d
https://www.acog.org/clinical/clinical-guidance/practicebulletin/articles/2020/10/medication-abortion-up-to-70-days-of-gestation.
2023),
The Availability and Use of Medication Abortion, KFF (Mar. 20, 2024),
https://www.kff.org/womens-health-policy/the-availability-and-use-of-medicationabortion/ (“The most common medication abortion regimen in the United States
involves . . . mifepristone.”).
22
23 In implementing risk evaluation and mitigation strategies with respect to drugs
like mifepristone, the FDA is required to “minimize the burden on the health care
delivery system” and ensure that access to the drug is not “unduly burdensome on
patient access to the drug.” 21 U.S.C. § 355-1(f)(2)(C)– (D).
See U.S. Food & Drug Admin., Ctr. for Drug Evaluation & Research, REMS
Modification Rationale Review, at 4 (Dec. 16, 2021).
24
25 See U.S. Food & Drug Admin., Ctr. for Drug Evaluation & Research, Application
No. 020687Orig1s020 Summary Review (Jan. 3, 2023); see also Memorandum on
8
been available to patients through telehealth and mail-order pharmacies since the
height of the COVID-19 pandemic.
Research from before and after the FDA’s decision confirms the safety, efficacy,
and benefits of dispensing mifepristone by mail. For example:
•
A 2024 study reviewing over 4,500 medication abortions prescribed via
telehealth and obtained by mail-order pharmacy found that 97.7% of
patients completed the abortion without further intervention, with a
serious adverse event rate of only 0.25%.26 This study looked at both
synchronous and asynchronous models of telehealth care and found no
difference in safety or effectiveness.27
•
A study analyzing data for nearly 4,000 patients who visited either inperson or telehealth clinics and obtained abortion medication through
either in-person or mail-order dispensing concluded that there was no
statistically significant difference in the safety or efficacy of medication
abortion when the patient received the medications by mail, rather than in
person.28
Further Efforts To Protect Access to Reproductive Healthcare Services, 88 Fed. Reg.
4895 (Jan. 22, 2023).
Ushma D. Upadhyay et al., Effectiveness and safety of telehealth medication
abortion in the USA, 30 Nature Med. 1191, 1191 (2024).
26
27 Id. at 1192.
28 See Ushma D. Upadhyay et al., Outcomes and Safety of History-Based Screening
for Medication Abortion: A Retrospective Multicenter Cohort Study, 182 JAMA
Internal Med. 482, 487 (2022).
9
•
In a study of over 500 patients who obtained telehealth abortion care and
abortion medication dispensed by mail, telehealth abortion care and
abortion medication dispensed in person, or in-person care, researchers
concluded that medication abortion through telehealth and mail-order
dispensing has similar efficacy rates to in-person care, with “low rates of
[adverse events] overall.”29
•
A 2024 study of 1600 patients who obtained abortion care by telehealth and
obtained abortion medication from a mail-order pharmacy found that
“nearly all [patients] were very satisfied with telehealth abortion,”
including because this model ensures more privacy and is less expensive
and faster than traveling to a clinic.30
•
A meta-analysis of 21 studies published between 2011 and 2022 determined
that there are no differences in the safety, effectiveness, and patient
satisfaction between telemedicine medication abortion and in-person
abortion care.31 The study also found that the wait time to receive abortion
medication was around 4.2 days shorter for those who used telemedicine as
opposed to those who received in-person care.32
29 Lauren J. Ralph et al., Comparison of No-Test Telehealth and In-Person Medication
Abortion, 332 JAMA 898, 901, 903 (2024).
30 Koenig et al., supra note 18, at 248.
31 Leonardo Cely-Andrade et al., Telemedicine for the provision of medication abortion
to pregnant people at up to twelve weeks of pregnancy: a systematic literature review
and meta-analysis, 21 Reprod. Health 136 (2024).
32 Id. at 18.
10
Other research underscores that telehealth is a safe and effective way for
patients to obtain timely access to abortion care. For example, studies confirm that
telehealth medication abortion “[is] as effective, timelier, and potentially more
accessible than in-clinic care,” with telehealth patients “receiv[ing] care more quickly”
and seeking care earlier in pregnancy than patients who receive in-clinic care.33
Researchers have also found that mailing mifepristone for patients’ in-home use
“[does] not significantly prolong [the] time from patients’ first contact with the clinic
to mifepristone ingestion or increase pregnancy duration at mifepristone ingestion.”34
Moreover, pregnant persons who take mifepristone at home are no more likely than
patients who take mifepristone at a health clinic to call a provider’s office or make an
unplanned medical visit than those who receive in-person care.35
Even when patients obtain mifepristone and misoprostol in person at a clinic,
they complete the two-drug regimen at home. Thus, even before the FDA lifted the
in-person dispensing requirement, nearly all medication abortions “occur[red] largely
Silpa Srinivasulu et al., Telehealth Medication Abortion in Primary Care: A
Comparison to Uusual in-Clinic Care, 37 J. Am. Bd. Fam. Med. 295, 299 (2024). See
also, e.g., Cely-Andrade et al., supra note 31; Amanda Cleeve et al., The use of
telemedicine services for medical abortion, 6 Cochrane Database of Systematic Revs.
CD013764 (2025), https://pmc.ncbi.nlm.nih.gov/articles/PMC12135146/.
33
34 Leah R. Koenig 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,
121
Contraception
109962
(2023),
https://doi.org/10.1016/
j.contraception.2023.109962.
35 Yael Swica et al., Acceptability of home use of mifepristone for medical abortion, 88
Contraception 122 (2012); see also, e.g., Grossman et al., supra note 9, at 39 (finding
that of the few adverse events reported by patients who had under-gone medication
abortion at home, “none . . . would have been avoided by dispensing medications in
person rather than with the mail-order pharmacy”).
11
in nonclinical settings.”36 In other words, “there is no medical reason for mifepristone
to be dispensed in clinics.”37
III.
The In-Person Dispensing Requirement for Mifepristone Seriously
Harms Patients and Mail-Order Pharmacies.
The in-person dispensing requirement for mifepristone seriously harms
patients and mail-order pharmacies like Honeybee. If mifepristone is unavailable to
patients by mail, it will effectively deny some pregnant persons access to this safe
and effective abortion medication altogether, even in states where abortion is legal
and protected by the state constitution. It also prevents mail-order pharmacies like
Honeybee from dispensing this important medication in accordance with FDA
regulations in states where it is permissible to do so under applicable state law. The
Fifth Circuit’s Order failed to take these harms into account.
A.
Eliminating access to mifepristone by mail harms patients.
Eliminating access to mifepristone by mail imposes severe harm on patients
who rely on mail-order pharmacies for access to this medication, like the patients
Honeybee serves.
The harms of restricted access to mifepristone fall hardest on patients who face
barriers to accessing in-person healthcare and brick-and-mortar pharmacies, such as
those who live in rural areas, are unable to travel, or have limited financial
36 Nat’l Acads. of Sci., Eng’g & Med., The Safety and Quality of Abortion Care in the
United States 56 (2018).
37 Erica Chong et al., Expansion of a direct-to-patient telemedicine abortion service in
the United States and experience during the COVID-19 pandemic, 104 Contraception
43, 43 (2021).
12
resources.38 Requiring mifepristone to be dispensed in person also harms survivors of
sexual violence or other trauma who may need the greater privacy and autonomy that
mail-order pharmacies provide.39 For all these patients, being able to obtain
mifepristone from a mail-order pharmacy can mean the difference between obtaining
desired medical care and having to forgo it. See, e.g., Stormans, Inc. v. Selecky, 586
F.3d 1109, 1139 (9th Cir. 2009) (“There is a general public interest in ensuring that
all citizens have timely access to lawfully prescribed medications.”); see also 21 U.S.C.
§ 355-1(f)(2)(C) (requiring REMS elements to “not be unduly burdensome on patient
access to the drug”).
38 See, e.g., Ma & Wang, supra note 9, at 293 (noting that many patients use mail-
order pharmacies because they “live far away from a local pharmacy or have difficulty
making the trip”); Leah R. Koenig et al., The Role of Telehealth in Promoting
Equitable Abortion Access in the United States: Spatial Analysis, 9 JMIR Pub. Health
Surveillance e45671 (2023), https://pmc.ncbi.nlm.nih.gov/articles/PMC10664017/
(finding that telehealth reduced travel barriers and made it possible to obtain timely
abortion care, particularly among patients who already face barriers to care); Nat’l
Acads. of Sci., Eng’g & Med., supra note 36, at 58, 78 (“Financial burdens and
difficulty obtaining insurance are frequently cited by women as reasons for delay in
obtaining an abortion.”); Jill Barr-Walker et al., Experiences Of Women Who Travel
for Abortion: A Mixed Methods Systematic Review, 14 PLoS ONE. e0209991 (2019),
https://doi.org/10.1371/journal.pone.0209991 (explaining that studies find burdens
related to travel can negatively impact reproductive choices).
39 See Elizabeth C. Romanis et al., Safeguarding and Teleconsultation For Abortion,
398 Lancet 555, 556 (2021) (“Many women in situations of intimate partner or family
violence are prevented from attending a clinic in the first place.”); see also Koenig et
al., supra note 18, at 248 (“Most patients also reported choosing telehealth for greater
privacy[.]”); Emily M. Godfrey et al., Patient Perspectives Regarding Clinician
Communication During Telemedicine Compared With In-Clinic Abortion, 141
Obstetrics & Gynecology 1139, 1143 (2023) (noting that telemedicine allowed patients
to “talk more freely and openly”).
13
Limiting access to abortion has dire consequences for maternal and infant
health. As discussed supra in Section II, accessing mifepristone through telehealth
and mail-order pharmacies is safe and effective. Indeed, medication abortion carries
far less risk for American women than childbirth. In 2017, the New England Journal
of Medicine published an expert commentary observing that the maternal mortality
rate for women having live births in the United States was 14 times higher than the
associated fatality rate for medication abortions using mifepristone.40 More recent
data establish that lifting the in-person dispensing requirement has not altered the
safety of the mifepristone regimen, which remains significantly safer than continued
pregnancy and birth; indeed, deaths among mifepristone users are virtually nonexistent.41 We also know that denying access to abortion threatens women’s lives.
40 Mifeprex REMS Study Grp., Sixteen Years of Overregulation: Time to Unburden
Mifeprex, 376 N. Engl. J. Med. 790, 791 (2017); see also Nat’l Acads. of Sci., Eng’g &
Med., supra note 36, at 74–76.
41 Daniel Grossman & Sarah Raifman, Analysis of Medication Abortion Risk and the
FDA Report “Mifepristone US Post-Marketing Adverse Events Summary Through
12/31/2024”, Advancing New Standards in Reprod. Health (May 15, 2025),
https://www.ansirh.org/sites/default/files/2025-05/Issue%20Brief%20MAB%20SAEsMay2025%20Final_0.pdf; see also Upadhyay et al., supra note 26, at 1191; Nat’l
Acads. of Sci., Eng’g & Med., supra note 36, at 74–76. See generally supra Section II
(discussing safety of dispensing mifepristone by mail).
14
Studies conducted both in the United States42 and abroad43 have demonstrated a
strong correlation between abortion restrictions and maternal mortality. Additional
studies demonstrate that abortion restrictions are correlated with increased infant
mortality rates.44
Furthermore, restricting access to mifepristone will exacerbate health
disparities across racial and income lines. Due to structural inequalities, Black
Americans, for instance, are more likely to seek abortions than white Americans, and
are more likely to be denied access to abortion due to restrictions and bans.45 Black
Americans also face higher incidences of maternal mortality and pregnancy
complications, creating greater risk of experiencing adverse health outcomes when
42 E.g., Amanda Jean Stevenson, The Pregnancy-Related Mortality Impact of a Total
Abortion Ban in the United States: A Research Note on Increased Deaths Due to
Remaining Pregnant, 58 Demography 2019, 2019, 2023 (2021) (“Overall, estimated
pregnancy-related deaths would increase for the total population by 7% in the first
year of a [total abortion] ban and by 21% in subsequent years.”); Dovile Vilda et al.,
State Abortion Policies and Maternal Death in the United States, 2015‒2018, 111 Am.
J. Pub. Health 1696, 1699 (2021) (finding maternal mortality rates “were significantly
higher . . . in states with the largest number of abortion restrictions”).
43 E.g., Ngo Valery Ngo et al., Reproductive Health Policy Saga: Restrictive Abortion
Laws in Low- and Middle-Income Countries (LMICs), Unnecessary Cause of Maternal
Mortality, 45 Health Care for Women Int’l 5 (2021).
44 E.g., Alison Gemmill et al., US Abortion Bans and Infant Mortality, 333 JAMA
1315 (2025); Parvati Singh & Maria F. Gallo, National Trends in Infant Mortality in
the US After Dobbs, 178 JAMA Pediatrics 1364 (2024); Roman Pabayo et al., Laws
Restricting Access to Abortion Services and Infant Mortality Risk in the United States,
17 Int’l J. Env’t Rsch. Pub. Health 3773 (2020).
Latoya Hill et al., What are the Implications of the Dobbs Ruling for Racial
Disparities?, KFF (Apr. 24, 2024), https://www.kff.org/womens-health-policy/whatare-the-implications-of-the-dobbs-ruling-for-racial-disparities.
45
15
access to abortion care is denied.46 In short, the harms of restricting access to
mifepristone will fall hardest on vulnerable communities who already face significant
barriers to accessing healthcare.
Moreover, mifepristone has important medical uses in addition to its FDAapproved use as a part of a medication abortion regimen. For example, mifepristone
has been effectively used for medical resolution of miscarriage, with a significantly
higher success rate than other regimens.47 Scientific studies also demonstrate that
mifepristone is effective for managing and treating uterine leiomyomas,48 for treating
one type of brain tumor, and for treating endometriosis.49 Depriving patients of access
to mifepristone dispensed by mail will also harm patients who need mifepristone for
reasons unrelated to abortion care.
46 E.g., Andreea A. Creanga et al., Racial and Ethnic Disparities in Severe Maternal
Morbidity: A Multi-State Analysis, 2008-2010, 210 Am. J. Obstetrics & Gynecology
435.e1 (2014), https://doi.org/10.1016/j.ajog.2013.11.039; Anna Kheyfets et al., The
Impact of Hostile Abortion Legislation on the United States Maternal Mortality Crisis:
A Call for Increased Abortion Education, 11 Frontiers Pub. Health 1291668 (2023),
https://doi.org/10.3389/fpubh.2023.1291668.
47 Courtney Schreiber et al., Mifepristone Pretreatment for the Medical Management
of Early Pregnancy Loss, 378 N. Eng. J. Med. 2161, 2161, 2167–69 (2018); Lisa Wu et
al., ExPAND Mifepristone: Medical Management of Miscarriage and Abortion in
FQHCs, 21 Annals Fam. Med. 468 (2023).
48 See Blake M. Autry & Roopma Wadhwa, Mifepristone, StatPearls (Feb. 28, 2024),
https://www.ncbi.nlm.nih.gov/books/NBK557612.
See Mifepristone (Mifeprex), Nat’l Libr. Med.
https://medlineplus.gov/druginfo/meds/a600042.html#ho.
49
16
(Feb.
15,
2026),
B.
Prohibiting mail-order dispensing of mifepristone inflicts
serious harm on mail-order pharmacies.
The Court should also consider the injury that reinstating the in-person
dispensing requirement imposes on mail-order pharmacies such as Honeybee.
Honeybee has relied heavily on the FDA’s determination that dispensing
mifepristone by mail is safe and effective. Reinstating the in-person dispensing
requirement causes significant and irreparable harm to Honeybee’s and other mailorder pharmacies’ business. The threat of existential harm to a company’s business
merits considerable weight. See, e.g., Doran v. Salem Inn, Inc., 422 U.S. 922, 932
(1975); hiQ Labs, Inc. v. LinkedIn Corp., 31 F.4th 1180, 1188 (9th Cir. 2022); Atwood
Turnkey Drilling, Inc. v. Petroleo Brasileiro, S.A., 875 F.2d 1174, 1179 (5th Cir. 1989),
cert. denied, 493 U.S. 1075 (1990); John B. Hull, Inc. v. Waterbury Petrol., 588 F.2d
24, 28–29 (2nd Cir. 1978), cert. denied, 440 U.S. 960 (1979).
Dispensing mifepristone by mail accounts for about a quarter of Honeybee’s
overall business. Thus, Honeybee’s business depends on its ability to dispense
mifepristone to patients by mail in accordance with the FDA’s evidence-based
regulations that permit it to do so. Under the regulatory regime the FDA has created,
Honeybee has dispensed hundreds of thousands of mifepristone prescriptions by mail
to patients in jurisdictions that permit it to do so.50 Honeybee has been able to
50 Honeybee is licensed by every board of pharmacy in each state to which it sends
medication and only ships mifepristone to states that permit it to do so. Honeybee
has implemented a system whereby specific medications have “Shipping Rules,”
which define the states in which those medications are permitted to be shipped. In
Honeybee’s system, mifepristone is only shipped to states that have permitted the
use of such medication via applicable state laws and regulations.
17
dispense mifepristone at lower costs than other pharmacies, and it has serves some
patients who may not otherwise be able to access the medication easily or at all. For
example, Honeybee often serves patients who do not live near clinics or cannot afford
the costs of in-person care and associated travel. Reinstating the in-person dispensing
requirement for mifepristone eliminates a substantial portion of Honeybee’s business
and prevents it from providing a safe, essential, and effective medication to patients.
Honeybee has invested substantial time and resources to ensure that its
dispensing of mifepristone complies with state and federal laws. Patients may utilize
Honeybee’s services only after they have received a prescription for mifepristone from
a healthcare provider. And when filling prescriptions for mifepristone, the Honeybee
team adheres to the FDA’s REMS requirements,51 e.g., by: completing a Pharmacy
Agreement Form; confirming that Honeybee has the requisite Prescriber Agreement
with the prescribing provider on file; recording the lot number for the medication,
and sharing that information on the patient’s dashboard; and ensuring each patient
receives their mifepristone prescription within four days.52 When Honeybee mails the
medication, it provides the tracking number to the patient and the patient’s
healthcare provider, and notifies the patient once the shipping carrier has marked
51 See Questions and Answers on Mifepristone for Medical Termination of Pregnancy
Through Ten Weeks Gestation, U.S. Food & Drug Admin. (Apr. 8, 2026),
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-andproviders/questions-and-answers-mifepristone-medical-termination-pregnancythrough-ten-weeks-gestation#TheMifepristoneREMSProgram.
52 Through its relationship with GenBioPro, Honeybee also completes annual audit
questionnaires to ensure REMS compliance.
18
the order as delivered. If a shipment is delayed, the Honeybee team works with the
patient’s healthcare provider to ensure the patient receives the medication within the
timeframe required by applicable regulations. Thus, Honeybee has devoted
significant resources to developing systems and processes that comply with the FDA’s
evidence-based regulations, and reinstating the in-person dispensing requirement
would cause Honeybee substantial harm.
Critically, reinstating the in-person dispensing requirement creates instability
and uncertainty for mail-order pharmacies even outside the context of mifepristone.
As set forth above, mail-order pharmacies invest substantial time and resources and
develop considerable business interests based on the FDA’s evidence-based
determination to eliminate a restriction on mail-order dispensing. The Fifth Circuit’s
Order opens the door to similar challenges to countless other medications that mailorder pharmacies dispense, thereby threatening to destabilize other aspects of mailorder pharmacies’ business. When the FDA makes an evidence-based determination
regarding the safety and efficacy of dispensing a particular medication by mail, mailorder pharmacies need to be able to rely on the stability of that determination absent
credible scientific evidence to the contrary. The Fifth Circuit’s Order creates
uncertainty that undermines the business model of mail-order pharmacies writ large.
It also undermines the legitimacy of the mail-order dispensing model overall, despite
ample research that mail-order dispensing is safe, effective, and beneficial to
patients.53
53 See supra Sections I, II.
19
Like other mail-order pharmacies, Honeybee’s business depends on its ability
to dispense safe and effective medications, such as mifepristone, by mail in
compliance with applicable federal and state laws. And Honeybee’s practices present
a paradigm for what mail-order pharmacies can offer: its technology and fulfillment
processes ensure that the patients and their providers remain informed and
connected, while its virtual services give patients the opportunity to realize greater
privacy in receiving quality healthcare at a lower cost. Reinstating the in-person
dispensing requirement for mifepristone seriously jeopardizes the viability of mailorder pharmacies like Honeybee and the benefits that they provide to patients.
CONCLUSION
For the foregoing reasons, Honeybee respectfully asks that this Court stay or
vacate the Fifth Circuit’s ruling.
Dated: May 7, 2026
Respectfully submitted,
EUGUENE GELERNTER
Counsel of Record
HILARIE M. MEYERS
HADIYA WILLIAMS
JILLIAN F. HOROWITZ
PATTERSON BELKNAP WEBB &
TYLER LLP
1133 Avenue of the Americas
New York, New York 10036
(212) 336-2000
emgelernter@pbwt.com
Counsel for Amicus Curiae
Honeybee Health, Inc.
20
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.