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Remote Reproductive Rights
Published online by Cambridge University Press: 30 January 2023
Abstract
In July 2020, a federal district court lifted the U.S. Food & Drug Administration’s (“FDA”) restriction requiring patients to pick up the first drug of a medication abortion—mifepristone—at a healthcare facility. Soon after, an ongoing experiment with remote care for abortion expanded, as telemedicine did in other areas, and virtual clinics began offering no-touch abortions. Growth of virtual care stalled in January 2021 when the Supreme Court stayed a district court’s order pending the appeals process. But in April 2022, persuaded by the evidence of remote abortion’s safety and efficacy, the FDA suspended enforcement of the in-person rule for the course of the pandemic. On December 16, 2021, the FDA lifted the requirement that patients pick up mifepristone at a healthcare facility, clearing the way for supervised mail delivery and pharmacy dispensation.
The expansion of virtual clinics, however, is not without significant limitations. First, questions remain about how to implement the new FDA regulation, specifically regarding certified pharmacies, and several FDA restrictions on mifepristone remain in place. Second, about half the country prohibits telehealth for abortion by either banning all abortion or by requiring the physical presence of a healthcare professional. Third, participation in telemedicine depends on various forms of privilege. Patients must have a stable internet connection or smartphone as well as an uncomplicated pregnancy, which, in part because of U.S. health disparities, is more likely for wealthier and white people. Even with the expansion of remote care, the need for clinical spaces will not disappear; in fact, it will come under increasing pressure.
This Article maps the emergence of virtual abortion care and analyzes the potential trajectory of medication abortion access, given that the Supreme Court has overturned constitutional protections for abortion. It considers the limits of telehealth for abortion—who telehealth can reach and who it cannot. Those living in states that permit abortion will have new options for ending early pregnancies. Those residing in states hostile to abortion will have to seek cross-border care, carry pregnancies to term, or find other avenues to end pregnancies. But the portability of abortion pills, when mailed by prescribers or dispensed by certified pharmacies, will test how closely states officials (or anyone else) can police or impede access to medication abortion.
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References
1 See infra Parts II.B, C.
2 Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228 (2022).
3 See infra Part II.A.
4 Am. Coll. of Obstetricians & Gynecologists v. U.S. Food & Drug Admin., No. TDC-20-1320, 2020 WL 8167535, at *1 (D. Md. Aug. 19, 2020).
5 See infra Part III.
6 See 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, 46-48 (2021); see infra Parts II.C, III.
7 Thirteen states ban abortion throughout pregnancy and Georgia bans abortion after six weeks of pregnancy. Arizona and Florida ban abortion after fifteen weeks, and Utah after eighteen weeks. Tracking States Where Abortion is Now Banned, N.Y. Times (Oct. 13, 2022), https://www.nytimes.com/interactive/2022/us/abortion-laws-roe-v-wade.html [https://perma.cc/M7MG-FDVK ].
8 See infra Part IV.A. Whether states can restrict mifepristone beyond FDA requirements presents a question of federal preemption and was at the heart of a lawsuit withdrawn by the petitioner, the generic drug manufacturer of mifepristone. Brief of Plaintiffs GenBioPro at 27, GenBioPro Inc. v. Dobbs, No. 3:20-cv-00652-HTW-LGI, (S.D. Miss. Oct. 9, 2020). On FDA preemption of state medication abortion bans, see David Cohen, Greer Donley, & Rachel Rebouché, The New Abortion Battleground, 123 Colum. L. Rev. __, Part III.A (forthcoming 2023).
9 See infra Part IV.A.
10 As this Article notes, providers have set up mobile clinics that park on borders between states that permit and prohibit abortion, serving patients in the permissive state. And self-managed medication abortion is available through a website operated by the non-profit organization, AidAccess.
11 Gynuity, a research non-profit organization that conducted an investigational drug study, noted in Part III, used the term “TelAbortion.” See Gynuity’s TelAbortion Study Has Completed Enrollment, Gynuity Health Projects, https://telabortion.org/ [https://perma.cc/R7Y7-SJ9T].
12 Mifeprex (mifepristone) Information, U.S. Food & Drug Admin. (Dec. 16, 2021), https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information [https://perma.cc/Y83U-YSK8].
13 Almost all medication abortions are completed through a mifepristone-misoprostol regimen. Rachel K. Jones & Jenna Jerman, Abortion Incidence and Service Availability in the United States, 2014, 49 Persp. Sexual & Reprod. Health 17, 22 (2017).
14 Mifeprex (mifepristone) Information, supra note 13.
15 NDA 20-687 Mifeprex (mifepristone) Tablets, 200mg: Risk Evaluation & Mitigation Strategy (REMS), U.S. Food & Drug Admin., https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2011-06-08_Full.pdf [https://perma.cc/UXS9-Z37Q]. Mifepristone and misoprostol are delivered together even though the same FDA restrictions do not apply to misoprostol. Maya Manian, The Consequences of Abortion Restrictions for Women’s Healthcare, 71 Wash. Lee L. Rev. 1317, 1331 (2014).
16 21 U.S.C. § 355-1.
17 Id. § 355-1(a)(1).
18 Id. § 355- 1(f)(3).
19 Questions and Answers on Mifeprex, U.S. Food & Drug Admin. (Apr. 2019), https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex [https://perma.cc/AGQ5-AALM].
20 Government Accountability Off., Food & Drug Admin.: Information on Mifeprex Labeling Changes and Ongoing Monitoring Efforts, 7-8 (2018); Alexandra Thompson et al., The Disproportionate Burdens of the Mifepristone REMS, 20 Contraception 1, 2 (2021). After the district court’s opinion in ACOG v. FDA, patients were permitted to electronically sign the Patient Agreement form during a telehealth appointment and return the form electronically or by mail; alternatively, a patient could give verbal consent to the terms of the form during a telehealth session. Order Clarifying July 13 Memorandum Op., Am. Coll. of Obstetricians & Gynecologists v. U.S. Food & Drug Admin., No. TDC-20-1320, 2020 WL 8167535 (D. Md. Aug. 19, 2020).
21 The non-profit organization, Plan C, argued that in-person collection was not required because the FDA REMS did not specify how mifepristone should be dispensed. Abortion Pill FAQ, Plan C, https://www.plancpills.org/guide-how-to-get-abortion-pills#faq [https://perma.cc/444W-VG8R].
22 The FDA first approved mifepristone (or, as known then, RU-486) in 2000. Before and after its approval, FDA decision-making has been embroiled in controversy. Greer Donley shows that the FDA decisions around mifepristone often have been motivated by partisan politics and are distinct as compared to drugs with similar risk profiles. Greer Donley, Medication Abortion Exceptionalism, 107 Cornell L. Rev. 627, 667 (2021).
23 Mifeprex (mifepristone) Information, supra note 13.
24 Of the 17 drugs with the same ETASU, only mifepristone could be taken at home but must have been picked up at a healthcare facility. Am. Coll. of Obstetricians & Gynecologists v. U.S. Food & Drug Admin., No. TDC-20-1320, 2020 WL 8167535, at *1-2 (D. Md. Aug. 19, 2020).
25 The other plaintiffs were the Council of University Chairs of Obstetrics and Gynecology, the New York State Academy of Family Physicians, SisterSong Women of Color Reproductive Justice Collective, and Dr. Honor Macnaughton. See id.
26 Between 2000 and 2017, over 3 million people terminated pregnancies with medication abortion and only 4,200 adverse events occurred; of those, only 0.01% – 0.7% required hospitalization. Government Accountability Off., supra note 21.
27 Plaintiffs’ Amended and Corrected Memorandum of Law in Support of Motion for Preliminary Injunction at 4-10, Am. Coll. of Obstetricians & Gynecologists v. FDA, 506 F. Supp. 3d 328 (D. Md. 2020) (No. 20-1320), 2020 WL 5700818.
28 The district court detailed the FDA’s pandemic-based approach on remote drug delivery. Am. Coll. of Obstetricians & Gynecologists v. FDA, 472 F. Supp. 3d 183, 194 (D. Md. 2020); see also Dept. Health & Hum. Servs., Secretary Azar Announces Historic Expansion of Telehealth Access to Combat COVID–19 (Mar. 17, 2020).
29 Am. Coll. of Obstetricians & Gynecologists v. Food & Drug Admin., 472 F. Supp. 3d 183, 210-11 (D. Md. 2020).
30 Id.
31 Id. at 214.
32 Id. at 214-15.
33 Id. at 215.
34 Id.
35 Id.
36 Food & Drug Admin. v. Am. Coll. of Obstetricians & Gynecologists, 141 S. Ct. 578, 578 (2021). Justice Sotomayor’s dissent called the Court’s reinstatement of the FDA rule “callous” given the lived effects of the restriction: “patients’ health vulnerabilities, public transportation risks, susceptible older family members at home, and clinic closures and reduced services pose substantial, sometimes insurmountable, obstacles for women seeking medication abortions during the COVID-19 pandemic.” Id. at 579, 583 (Sotomayor, J., dissenting).
37 The FDA indicated that it would rely on “information submitted by the sponsors of the new drug application and the abbreviated new drug application, as well as information from other sources, including published literature.” Joint Motion to Stay Case Pending Agency Review at 2, Chelius v. Wright, No. 17-cv-493 (D. Haw. May 7, 2021), ECF No. 148.
38 21 U.S.C. §§ 355-1 (2007).
39 Risk Evaluation and Mitigation Strategies: Modifications and Revisions, Guidance for Industry, Food & Drug Admin. 12 (June 2020).
40 See Food & Drug Admin., Ctr. For Drug Evaluation & Research., Application No.: 020687Orig1s020, Risk Assessment and Risk Mitigation Review(s) 30 (Mar. 29, 2016), https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020RiskR.pdf [https://perma.cc/8A2D-FJ5C].
41 Food & Drug Admin., Mifepristone U.S. Post-Marketing Adverse Events Summary through 12/31/2018, https://www.fda.gov/media/112118/download [https://perma.cc/A9ZG-V533] (last visited April 13, 2022).
42 Questions and Answers on Mifeprex, Food & Drug Admin. (Apr. 12, 2019), https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex [https://perma.cc/3H8T-GGSQ].
43 See Hillary Bracken et al., Alternatives to Routine Ultrasound for Eligibility Assessment Prior to Early Termination of Pregnancy with Mifepristone-Misoprostol, 118 BJOG 17, 21-22 (2011). No-touch protocols have a 98% accuracy in identifying patients within the eligible gestational limits for medication abortion. Ushma D. Upadhyay & Daniel Grossman, Telemedicine for Medication Abortion, 100 Contraception 351, 352 (2019).
44 Elizabeth Raymond et al., TelAbortion: Evaluation of a Direct to Patient Telemedicine Abortion Service in the United States, 100 Contraception 173, 174-76 (2019).
45 Abigail Aiken et al., Effectiveness, Safety and Acceptability of No-Test Medical Abortion (Termination of Pregnancy) Provided via Telemedicine: A National Cohort Study, 128 BJOG 1464, 1471 (2021).
46 Id.
47 See generally Donley, supra note 23 (detailing the exceptional treatment by the FDA of reproductive health issues that primarily affect women).
48 Per the FDCA, the FDA must consider, and accept or reject, possible ETASU, one of which includes the requirement that pharmacies are specially certified. See 21 U.S.C. § 355-1(f)(3)(B) (2007).
49 “In April 2022, the manufacturers will submit proposed protocols to the FDA. After the FDA accepts the submissions, it has 180 days to review or modify the proposed protocols. Pharmacies may be able to sign up for certification to dispense mifepristone by late 2022.” Laurie Sobel et al., The Intersection of State and Federal Policies on Access to Medication Abortion via Telehealth, KFF Women’s Health Pol’y (Feb. 7, 2022), https://www.kff.org/womens-health-policy/issue-brief/the-intersection-of-state-and-federal-policies-on-access-to-medication-abortion-via-telehealth/ [https://perma.cc/2DN2-JPSQ].
50 Medicines like Pomalyst that can cause birth defects are subject to pharmacy certification under a REMS, and those requirements vary in what additional dispensation and administrative restrictions they impose. Food & Drug Admin., REMS Dispenser Certification Requirements (June 1, 2013), https://www.fda.gov/files/about%20fda/published/REMS-Dispenser-Certification-Requirements.pdf [https://perma.cc/7BPM-XNGM].
51 David Cohen, Greer Donley, & Rachel Rebouché, Abortion Pills (Sept. 20, 2022) (on file with the author).
52 Donley, supra note 23, at 643-47 (showing how certification could disincentive physicians from providing medication abortions).
53 Gynuity’s TelAbortion project completed enrollment on September 30, 2021 after five years of study. See Gynuity’s TelAbortion Study Has Completed Enrollment, supra note 11. Note that the Gynuity project is not the first telehealth abortion project: “The first telemedicine abortion program began in Iowa in 2008 … The patient took the first pill, mifepristone, in front of the provider via videoconference, and the second pill at home. Within two weeks, the patient returned to the clinic for a follow-up to ensure the abortion was complete.” Evaluation of Telemedicine in Iowa, Advancing Standards in Reproductive Health, U.C.S.F., https://www.ansirh.org/research/ongoing/evaluation-telemedicine-iowa [https://perma.cc/HQG2-XA6Z] (last visited April 8. 2022).
54 Raymond et al., supra note 45, at 174.
55 Id.
56 Id.
57 See Chong et al., supra note 6 at 44.
58 The Gynuity study offered teleabortion services in 13 states and Washington, D.C. Those states were Colorado, D.C., Georgia, Hawaii, Illinois, Iowa, Maine, Maryland, Minnesota, Montana, New Mexico, New York, Oregon, and Washington. Id. at 44. Gynuity partnered with carafem, which operates a telehealth program for abortion as well as health centers in several states. carafem, Annual Report 3 (2020), https://carafem.org/wp-content/uploads/2020/08/2020-Annual-Report.pdf [https://perma.cc/ZS4G-Z85E].
59 See Carrie N. Baker, How Telemedicine Startups are Revolutionizing Abortion Health Care in the U.S., Ms. Mag. (Nov. 16, 2020), https://msmagazine.com/2020/11/16/just-the-pill-choix-carafem-honeybee-health-how-telemedicine-startups-are-revolutionizing-abortion-health-care-in-the-u-s/ [https://perma.cc/C3E2-KQ2N].
60 This example also is offered in Greer Donley & Rachel Rebouché, The Promise of Telehealth for Abortion, in Digital Health Care Outside of Traditional Clinical Settings: Ethical, Legal and Regulatory Challenges and Opportunities (I. Glenn Cohen et al. eds., forthcoming 2023).
61 Choix imposes age thresholds in compliance with parental involvement laws. Medication Abortion (Abortion Pills), Choix, https://www.mychoix.co/abortion-care [https://perma.cc/D2HF-WYQ7].
62 Carrie N. Baker, Online Abortion Providers Cindy Adam and Lauren Dubey of Choix: “We’re Really Excited about the Future of Abortion Care,” Ms. Mag. (Jan. 14, 2022), https://msmagazine.com/2022/01/14/abortion-pills-california-colorado-illinois-online-abortion-cindy-adam-lauren-dubey-choix/ [https://perma.cc/9VMM-XK7C].
63 Id.
64 Id.
65 Id.
66 Id.
67 Abortion on Demand, for example, offers telehealth services in 22 states. Abortion on Demand, Abortion on Demand, https://abortionondemand.org/ [https://perma.cc/Z3D5-SYL7]; Carrie N. Baker, People are Getting Creative Obtaining Abortion Pills Online, Ms. Mag. (Feb. 7, 2022), https://msmagazine.com/2022/02/07/how-to-get-abortion-pills-online-telemedicine-abortion/ [https://perma.cc/258C-RZZU]; see also Rachel Rebouché, The Public Health Turn in Reproductive Rights, 78 Wash. & Lee L. Rev. 1355, 1416-28 (2021) (describing states that have telehealth services for abortion as of 2021).
68 Baker, supra note 6.
69 Id.; Abortion Pill FAQ, supra note 22.
70 Id. AidAccess offers U.S.-based telehealth services in Alaska, California, Colorado, Connecticut, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New York, New Jersey, New Hampshire, New Mexico, Nevada, Oregon, Rhode Island, Vermont, Virginia and Washington. Shipping takes two to five days and the cost for U.S.-based services is $150. AidAccess, Consultation, https://aidaccess.org/en/i-need-an-abortion.
71 See Rachel Rebouché & Ushma Upadhyay, Online Clinics Show Abortion Access Can Survive State Restrictions and Roe v. Wade Threat, USA Today, Apr. 12, 2021, https://www.usatoday.com/story/opinion/2021/04/12/medication-abortion-rights-protected-online-clinics-column/7106777002/ [https://perma.cc/6YLX-YBHG].
72 Daniel Grossman & Kate Grindlay, Safety of Medical Abortion Through Telemedicine Compared with In Person, 130 Obstetrics & Gynecology 778, 778 (2017).
73 Jareb A. Gleckel & Sheryl L. Wulkan, Abortion and Telemedicine: Looking Beyond COVID-19 and the Shadow Docket, 54 U.C. Davis L. Rev. Online 105, 112 (2021); Katherine Fang & Rachel Perler, Abortion in the Time of COVID-19: Telemedicine Restrictions and the Undue Burden Test, 32 Yale J.L. & Feminism 134, 135 (2021).
74 Food & Drug Admin. v. Am. Coll. of Obstetricians & Gynecologists, 141 S.Ct. 578, 580 (2021).
75 Medication Abortion Requirement, Pol’y Surveillance Program (Dec. 2021), http://lawatlas.org/datasets/medication-abortion-requirements [https://perma.cc/Y46L-XT7V].
76 See Planned Parenthood of the Heartland v. Iowa Bd. of Med., 865 N.W.2d 252, 269 (Iowa 2015); Carrie N. Baker, Advocates Cheer FDA Review of Abortion Pill Restrictions, Ms. Mag. (May 11, 2021), https://msmagazine.com/2021/05/11/fda-review-abortion-pill-restrictions-mifepristone-biden/ [https://perma.cc/35RV-C3PY] (describing the Ohio law and state court injunction); Iris Samuels, Montana Governor Signs Three Bills Restricting Abortion Access, Associated Press, Apr. 26, 2021; Dan Whitcomb, Judge Issues Last-minute Delay to Montana Abortion Laws Hours after Taking Case, Reuters (Oct. 1, 2021), https://www.reuters.com/world/us/judge-issues-last-minute-delay-montana-abortion-laws-hours-after-taking-case-2021-10-01/ [https://perma.cc/9W8C-DQ5N].
77 State Legislation Tracker, Guttmacher Inst. (Dec. 15, 2021), https://www.guttmacher.org/state-policy [https://perma.cc/3BVV-EKNG].
78 The states with teleabortion bans or bans on mailing medication abortion, before Dobbs, included Arizona, Arkansas, Iowa, Alabama, Montana, Ohio, Oklahoma, South Dakota, Wyoming, and West Virginia.
79 Alice Miranda Ollstein, New Attention on Abortion Pill Dispensing Amid Challenge to Roe v. Wade, Politico (May 31, 2021) https://www.politico.com/news/2021/05/31/supreme-court-abortion-fda-491375 [https://perma.cc/FCS7-KAB7].
80 Sobel et al., supra note 52, at 5.
81 Courts in Oklahoma, Iowa, South Dakota, Ohio, and Montana have blocked telemedicine bans. Id. These decisions may be moot in places like Oklahoma and South Dakota where almost all abortion is banned after Dobbs.
82 Greer Donley, Rachel Rebouché & David Cohen, Existing Federal Laws Could Protect Abortion Rights Even if Roe Is Overturned, TIME (Jan. 24, 2022), https://time.com/6141517/abortion-federal-law-preemption-roe-v-wade/ [https://perma.cc/2XXR-M5FN].
83 Cason D. Schmit et al., Telehealth in the COVID-19 Pandemic, in Assessing Legal Responses to COVID-19 123, 123 (Scott Burris et al. eds., 2020), https://debeaumont.org/wp-content/uploads/2020/08/Assessing-Legal-Responses-to-COVID-19-APHA-de-Beaumont.pdf [https://perma.cc/KE4Z-NKNQ].
84 See Betsy Lawton, COVID-19 Illustrates Need to Close the Digital Divide, in Assessing Legal Responses to COVID-19 222 (Scott Burris et al. eds., 2020).
85 Thompson et al., supra note 21, at 17. Non-English speakers have additional barriers for navigating telehealth services, and people with cognitive impairment also may have trouble interacting with video. Jorge A. Rodriguez et al., Disparities in Telehealth Use Among California Patients with Limited English Proficiency, 40 Health Affairs 487, 487 (2021), https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.00823 [https://perma.cc/A39B-SP6B].
86 Rachel K. Jones et al., Medication Abortion Now Accounts for More Than Half of All US Abortions, Guttmacher Inst. (Feb. 2022), https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions (reporting that 54 percent of the nation’s abortions in 2017 were medication abortions).
87 AOD contributes 60 percent of all profits to the Save Our Clinics fund of the Abortion Care Network. Carrie N. Baker, Abortion on Demand Offers Telemedicine Abortion in 20+ States and Counting: “I Didn’t Know I Could Do This!”, Ms. Mag. (June 7, 2021), https://msmagazine.com/2021/06/07/abortion-on-demand-telemedicine-abortion-fda-rems-abortion-at-home/ [https://perma.cc/WSK6-PUEX].
88 Michelle L. McGowan et al., Care Churn—Why Keeping Clinic Doors Open Isn’t Enough to Ensure Access to Abortion, 383 New Eng. J. Med. 508, 509 (2020).
89 See Ruqaiijah Yearby, Breaking the Cycle of “Unequal Treatment” with Health Care Reform: Acknowledging and Addressing the Continuation of Racial Bias, 44 Conn. L. Rev. 1281, 1305-06 (2012).
90 Chloe Murtagh et al., Exploring the Feasibility of Obtaining Mifepristone and Misoprostol from the Internet, 97 Contraception 287, 289 (2018).
91 Having done this for some time, Plan C, a non-profit organization disseminating information about medication abortion, has been a hub for information about virtual clinics as well as self-managed care. Patrick Adams, Amid Covid-19, a Call for M.D.s to Mail the Abortion Pill, N.Y. Times (May 12, 2020), https://www.nytimes.com/2020/05/12/opinion/covid-abortion-pill.html [https://perma.cc/7THA-T4J3].
92 Gleckel & Wulkan, supra note 76, at 120.
93 Frequently Asked Questions, Abortion on Demand, https://abortionondemand.org/faq/ [https://perma.cc/V259-R8K3] (“Our software will confirm you are physically in the state you selected at the time of your scheduled video appointment. This state needs to match the state selected for your medication abortion packet sent in the mail. We cannot provide care outside of the specific states we are licensed to practice. We cannot ship to P.O. boxes, UPS boxes or FedEx shipment centers.”) (last visited Mar. 29, 2022).
94 Id.
95 See Cohen, Donley, & Rebouché, The New Abortion Battleground, supra note 8.