Introduction
In December 2021, the FDA permanently lifted the requirement that patients collect mifepristone, the first drug in a medication abortion, at a health care facility.Footnote 1 Moving forward, certified providers can prescribe medication abortion after an online consultation, then mail pills to patients, as they had been permitted to do for most of the COVID-19 pandemic. In addition, certified pharmacies will be able to dispense medication abortion pills in the near future. Though the process of certification for pharmacies is not yet clear, the FDA’s decision could make a critical difference to people’s ability to gain access to medication abortion. In June 2022, the Supreme Court issued its ruling in Dobbs v. Jackson Women’s Health Organization, overturning Roe v. Wade and clearing the way for states to enact abortion bans from the earliest stages of pregnancy.Footnote 2
A medication abortion involves taking two types of drugs within twenty-four to forty-eight hours to end pregnancies, as approved by the FDA, through ten weeks of gestation. The first drug, mifepristone, is subject to a safety protocol that the FDA applies to medicines deemed risky and in need of monitoring.Footnote 3 However, the consensus, even at the FDA, is that mifepristone is not risky and is in fact exceedingly safe. Among various requirements, the FDA, until recently, mandated that patients pick up the drug at a health care facility. The effect of this rule was to prohibit dispensation of mifepristone through the mail or at a pharmacy. The burdens this restriction imposed on patients became clear during the COVID-19 pandemic. In July 2020, a federal district court suspended the in-person collection requirement to allow patients to receive medication abortion services through telehealth.Footnote 4 As was true across many healthcare sectors, telehealth became a means by which patients could minimize provider and clinic contact and receive online oversight of their care.
Telehealth for medication abortion has proved to be an effective and safe means to end a pregnancy. After the federal district court enjoined the in-person collection requirement, virtual clinics launched to counsel patients online, deliver medication abortions through a mail order service, and monitor patient health through text, smartphone apps, and helplines.Footnote 5 Research on “no-touch” abortions revealed that patient satisfaction with remote care is high and the incidence of adverse effects is very low.Footnote 6
Virtual abortion care is cheaper, costing hundreds of dollars less than brick-and-mortar procedures, and less cumbersome for many: picking up the two-drug regimen at a pharmacy or receiving it in the mail reduces the costs and delay of travel.
Telehealth for abortion, however, faces significant limitations. At the time of writing, fourteen states ban abortion from the early stages of pregnancy.Footnote 7 In addition to these states, eight states have statutes that require the in-person delivery of care, effectively banning an entirely virtual process for abortion.Footnote 8 Patients in these places will need to travel to states with permissive policies or find other means of gaining access to abortion pills.
Moreover, telehealth only works for people with internet connectivity, smartphones, digital literacy, and other resources that are often marked by racial, income, and geographic disparities. The expansion of telemedicine could consequentially fail to reach many low-income people who compromise three-fourths of abortion patients.Footnote 9 And only patients who have uncomplicated pregnancies, such as those with a low risk of an ectopic pregnancy, are candidates for teleabortion. Finally, medication abortion cannot serve those needing care after the first trimester or those who cannot gain access to telehealth for whatever reason; people will continue to need services at brick-and-mortar clinics.
The barriers to telehealth for abortion should not be understated, but they are not insurmountable. Providers, researchers, advocates, and lawyers who made the case for changing federal restrictions on medication abortion have introduced new ways of reaching medication abortion care.Footnote 10
This Article proceeds in three parts. Part II describes the federal restrictions on medication abortion that have curtailed introduction of remote care before turning to the litigation and policy developments that have ushered in telehealth for abortion. Specifically, this Part explains the court decision that suspended FDA regulations during the pandemic and the review of those regulations by the FDA. Part III maps where telehealth for abortion is available and the process for obtaining care through virtual clinics. Part IV assesses the limitations of teleabortion: state bans, disparities in who can gain access to telehealth, and consequences for brick-and-mortar clinics. This Article concludes by briefly assessing the road ahead for mailed medication abortion.
Telehealth for medication abortion
Although there had been investigations of telehealth for medication abortion over the last decade, the onset of the pandemic was the catalyst for the expansion of “teleabortion” as well as several other applications of telemedicine.Footnote 11 The wider introduction of remote abortion care, however, is a result of a court decision suspending the FDA rule governing how the drug regimen is collected by patients—a restriction the FDA subsequently lifted. This Part reviews the FDA’s regulation of mifepristone and the litigation over and changes to that policy.
FDA regulation of medication abortion
A medication abortion is accomplished by taking two drugs. Mifepristone is the first drug ingested and it blocks the hormone progesterone, which is necessary for a pregnancy to continue.Footnote 12 The second drug, misoprostol, is taken twenty-four to forty-eight hours after mifepristone and causes uterine contractions that expel the pregnancy.Footnote 13 The FDA approves medication abortion through ten weeks of gestation.Footnote 14
A drug safety program—a Risk Evaluation and Mitigation Strategy (“REMS”)—applies to mifepristone (and not to misoprostol).Footnote 15 In 2007, the Food and Drug Administration Amendments Act created the REMS program for drugs with “serious safety concerns.”Footnote 16 The FDA issues a REMS if it is “necessary to ensure that the benefits of the drug outweigh the risks of the drug.”Footnote 17 As part of a REMS, the FDA can adopt “elements to assure safe use” (“ETASU”), which can limit distribution and set the terms of who can prescribe a drug and under what conditions.Footnote 18
There are several parts to mifepristone’s ETASU. Providers must be certified to dispense the drug. Certification entails submitting a form to the drug sponsor attesting to abilities to “assess the duration of pregnancy accurately,” “diagnose ectopic pregnancies,” and “provide surgical intervention” or “plans to provide such care through others.”Footnote 19 Patients must receive a Medication Guide and sign a Patient Agreement Form; providers agree to report any adverse events.Footnote 20 And, as noted, patients were required to pick up mifepristone at a healthcare facility—a hospital, clinic, or medical office—precluding dispensation through the mail or by a pharmacy.Footnote 21
In 2016, the FDA reviewed and revised some of the restrictions on mifepristone.Footnote 22 For example, the FDA approved use of mifepristone from up to forty-nine days to up to seventy days from the first day of the last menstrual period, lowered the dose regimen, permitted non-physician providers to apply for certification to prescribe mifepristone, and allowed patients to take mifepristone outside a healthcare facility.Footnote 23 The FDA did not revise the in-person dispensation requirement (or other aspects of the REMS). At the time, mifepristone was the only FDA-regulated drug that had to be collected at a healthcare facility but could be taken anywhere without healthcare provider supervision.Footnote 24
REMS litigation
In 2020, the American College of Obstetricians and Gynecologists (“ACOG”) brought suit with four other parties to enjoin the in-person dispensation ETASU during the pandemic.Footnote 25 ACOG argued that applying the in-person requirement contradicted substantial evidence of the drug’s safety and was ineffectual in protecting patients. Any adverse event, which is very rare, would occur where the patient takes the medicine, which is typically the patient’s home.Footnote 26 Further, requiring patients to come to a healthcare facility heightened the risk of COVID-19 contraction,Footnote 27 which was the reason the FDA had suspended the in-person ETASU for far riskier drugs, like certain opioids, during the pandemic.Footnote 28
In July 2020, the U.S. District Court for the District of Maryland enjoined the in-person requirement for the course of the public health emergency.Footnote 29 The district court held that the relevant part of the ETASU imposed an undue burden on the right to an abortion because requiring collection at a healthcare facility for a medicine that need not be taken there offers no medical benefit. Any possible benefit was outweighed by the burdens that the ETASU imposed.Footnote 30 The district court found that the practical and economic strains of the pandemic caused clinics to scale back operating hours or close altogether, creating long wait lists to collect medication abortion.Footnote 31 The court asserted that “abortion patients generally face more significant health risks arising from traveling to a medical facility during the pandemic … 60 percent of women who have abortions are people of color, and 75 percent are poor or low-income,” and those populations are more likely to have preexisting medical conditions.Footnote 32 Such populations also are less likely to have access to medical care, which would have left a significant number of abortion patients at higher risk of illness and death if infected with COVID-19.Footnote 33
In addition to health risks, the pandemic made arranging childcare, housing, transport, and time off work all the more difficult. The district court’s decision highlighted how people seeking abortions—again, primarily low-income patients and people of color—shoulder these hardships disproportionately under the FDA’s rules.Footnote 34 Taking the example of travel, the court cited providers’ testimony that many patients do not own a car or cannot afford private transportation. The resulting logistical hurdles can delay individuals from obtaining a medication abortion, “which can either increase the health risk to them or, in light of the ten-week limit, prevent them from receiving a medication abortion at all.”Footnote 35
The district court’s order was in effect for six months until the Supreme Court granted the FDA’s petition to stay the district court’s order in January 2021.Footnote 36 The litigation became moot in April 2021 because the FDA suspended enforcement of the in-person REMS for the duration of the pandemic and, soon after, announced that it would reconsider aspects of the REMS based on existing evidence.Footnote 37 The FDA could have decided to keep the restrictions in place, drop them altogether, or waive some existing rules while maintaining others. The FDA took the third road. The next Section assesses the FDA’s decision and what may lie ahead for the FDA’s regulation of medication abortion.
Reviewing remote care
The FDA’s REMS review adheres to the process authorized by Congress as part of the Federal Food, Drug and Cosmetic Act. Under that Act, the FDA must balance the risks and benefits of a drug, based on the most current evidence, without overly burdening health care delivery.Footnote 38 Evidence submitted by drug sponsors must establish an “adequate rationale” for modification, including the reasons why modification is necessary.Footnote 39
Much like the changes made to the REMS and labeling in 2016, the FDA considered “safety data” and “information about current clinical practice” in its review.Footnote 40 The FDA’s website noted the safety of mifepristone: “[a]s of December 31, 2018, there were reports of 24 deaths of women associated with Mifeprex since the product was approved in September 2000” compared to 3.7 million women who had taken the drug.Footnote 41 Even those “adverse events cannot with certainty be causally attributed to mifepristone.”Footnote 42
Since then, numerous studies have demonstrated not only the safety of mifepristone but also the efficacy of the drug when taken without in-person oversight.Footnote 43 Research resulting from an investigational drug study of “TelAbortion,” for example, demonstrated that of over 1300 patients, only two participants reported serious adverse events, and “neither event would have been averted had the abortion medications been provided in person.”Footnote 44 U.S.-based research has been supported by experimentation with telehealth for medication abortion abroad. A U.K. study of teleabortion during the pandemic, for instance, saw no increase in complications from medication abortions as compared to before COVID-19 when a physician’s office visit was required.Footnote 45 Of almost 30,000 at-home abortions between January and June of 2020, seven people needed hospitalization, as compared to eight people (in a comparison group) who picked up pills from a physician.Footnote 46
In sum, substantial evidence suggests that in-person dispensation of medication abortion does not protect patient health and “no-touch” abortions are safe. But it took years for the FDA to reach that conclusion, and mifepristone remains one of the safest yet most restricted drugs on the market.Footnote 47 In lifting in-person dispensation but keeping the other restrictions, the FDA maintains the pattern of treating medication abortion differently than other drugs with similar safety profiles.
An additional avenue to retrieve medication abortion, however, will soon be available—dispensation by a certified pharmacy.Footnote 48 The FDA will define pharmacy certification after reviewing the suggested protocols put forward by mifepristone’s manufacturers.Footnote 49 In comparing pharmacy certification requirements for other drugs, a range of possibilities emerge for how the FDA could proceed.Footnote 50 Pharmacies may have to attest to compliance with safety standards by submitting a Pharmacy Enrollment Form to the drug sponsors, the FDA, or both. But the new REMS also could require a pharmacy, to be certified, to utilize an authorization number that marks the prescription valid for a period of time—that is, requiring dispensation within twenty-four or forty-eight hours, for example.
The FDA can mandate that certified pharmacies maintain a system that documents compliance with FDA rules and engage in ongoing education and training for pharmacists as well as counseling for patients. Education or training might entail materials on the risks and benefits of the drug. Counseling for patients could include information about the drug’s risks, in addition to instructions on administration, as well as a warning not to share mifepristone with anyone else. Certification is a crucial component of mifepristone’s broader distribution: the certification will either incentivize or disincentive larger pharmacies to dispense medication abortion pills.Footnote 51
In addition to the future of pharmacy certification, it bears repeating that other aspects of the mifepristone REMS have not changed. The FDA still mandates that only certified providers, who must register with the drug manufacturer, may prescribe the drug, which is an unnecessary administrative burden.Footnote 52 The Patient Agreement Form, an additional informed consent requirement that patients sign before a medication abortion, remains a requirement despite repeating what providers communicate to patients.
The removal in-person dispensation of mifepristone, however, may not result in distribution at your neighborhood pharmacy or through your primary care provider, though both scenarios are more likely than ever before. In the wake of events described in this Part, abortion providers have refashioned and reimagined their practices to serve patients online. The rise of telehealth for abortion has revealed what is possible for early abortion care.
Telehealth and the virtual clinic
As court decisions and new policies changed the regulation of mifepristone, providers changed their practices. Healthcare providers formed to provide medication abortion virtually in 2020. But well before then, an on-going national study of “TelAbortion” demonstrated the effectiveness and safety of remote care.Footnote 53
In 2016, Gynuity Health Projects (“Gynuity”) received an Investigational New Drug Approval to deliver medication abortion without the in-person collection requirement.Footnote 54 Providers counseled patients through videoconferencing and patients confirmed gestational age with blood tests and ultrasounds at a location of their choosing.Footnote 55 Potentially because of the ultrasound requirement, which kept the project from being entirely virtual, only a few hundred people participated the first few years of the study.Footnote 56 During the pandemic, however, study participants who were at low risk of complications did not have to undergo an ultrasound or have a blood test; rather, gestational age was assessed by home pregnancy tests and questions about the date of the patient’s last menstrual period.Footnote 57 Gynuity mailed the medication abortion regimen directly to the patient and requested to meet the patient online seven to fourteen days after. Other REMS requirements, such as receipt of a Medication Guide, also occurred virtually.Footnote 58
Following in Gynuity’s footsteps, virtual clinics have worked with online pharmacies to mail medication abortion as prescribed by certified providers.Footnote 59 Take the example of Choix, which operates in California, Colorado, Maine, New Mexico, and Illinois.Footnote 60 Two nurse practitioners, partnered with a physician certified in family medicine and with a practice at a family health clinic, launched a virtual clinic in the summer of 2020, shortly after the district court’s ruling in ACOG. Choix prescribes medication abortion up through eleven weeks of pregnancy.Footnote 61
Clear advantages of virtual care are its speed and affordability. The founders describe how Choix’s asynchronous telehealth platform works:
Patients first sign up on our website and fill out an initial questionnaire, then we review their history and follow up via text with any questions. Once patients are approved to proceed, they’re able to complete the consent online. We send our video and educational handouts electronically and make them available via our patient portal. We’re always accessible via phone for patients.Footnote 62
The asynchronous intake is completed within one business day, and Choix partners with an online pharmacy, which mails pills to patients one to four business days after the intake process.Footnote 63 Patients have check-in visits via text once the first drug is ingested and then a 72-hour follow-up, also by text, after the second drug (misoprostol) is taken.Footnote 64 The cost is $289, with a consultation fee of $20 applied toward the total, which is around $300 less than medication abortions offered by a clinic.Footnote 65 From October 2020 to January 2022, Choix served over 2,200 people.Footnote 66
A constellation of clinics, some with physical spaces and some without, offer telehealth services in twenty-four states and Washington, DC.Footnote 67 Providers offering remote care operate in states that have not banned abortion or in states that do not require in-person dispensation of the pills.Footnote 68
Plan C is a non-profit organization that endeavors to open access to medication abortion for people across the country, even in the states that ban abortion. Carrie Baker reports:
Many people are getting abortion pills from outside of the U.S. by ordering them directly from online pharmacies. Researchers at Plan C have vetted many of these online pharmacies by ordering abortion pills from them and testing the pills for quality. On their website, Plan C lists websites that send quality medication, along with cost and shipping time, …[from] pharmacies that do not require a prescription to obtain abortion pills.Footnote 69
Another organization, AidAccess, works with European-based physicians, who review the consultation forms and prescribe the pills for patients in states with abortion bans, which are delivered by an India-based pharmacy within one to three weeks for $105.Footnote 70
In addition to state prohibitions, on-the-ground realities about how telemedicine is delivered obstruct gaining access to remote care. The next section covers legislative barriers to medication abortion, the limited reach of telehealth for certain populations, and the continued need for brick-and-mortar clinics before concluding with thoughts about the future of remote abortion access.
The limits and future of remote care
The landscape of abortion provision—early terminations without a visit to a physical clinic—has shifted in ways that many thought unimaginable ten years before.Footnote 71 And patient satisfaction surveys suggest that the value of remote abortion care is what one could have predicted: effective care with privacy, convenience, and reduced delay and cost.Footnote 72 However, many states have banned or erected roadblocks to teleabortion.Footnote 73 At the same time, barriers to telemedicine, generally, and the continuing need for clinical spaces may shorten the reach of teleabortion.
The limits of telehealth
Laws in about half of the country limit, explicitly or indirectly, telehealth for abortion.Footnote 74 As noted, fourteen states ban almost all abortion within their borders, and an additional eight states require a physician to be present upon delivery of medication abortion.Footnote 75 State legislation that requires in-person visits for counseling or ultrasounds also influences whether telehealth for abortion is feasible.Footnote 76
Some state legislation has targeted telehealth for abortion. Before Dobbs, for example, Indiana passed a law requiring in-person provision of medication abortion and banning the use of telehealth.Footnote 77 In addition to states that ban all abortion, bans on teleabortion have passed in Arizona, Iowa, Ohio,Footnote 78 and legislators in Maryland and Minnesota are considering similar restrictions.Footnote 79 A Montana law, temporarily enjoined by a state court, bans distribution of “abortion-inducing medication by mail;” it is one of six similar laws passed last year.Footnote 80 As in Montana, some courts (federal and state) have enjoined these legislative efforts.Footnote 81 And now that the FDA expressly permits mailed and pharmacy-dispensed medication abortion, state laws contradicting FDA rules could be subject to preemption.Footnote 82
State law, however, is not the only obstacle to remote care: there is also the unequal access to telehealth, mirroring broader health disparities.Footnote 83 Patients often need access to a telehealth-capable device, high-speed data transmission, and digital literacy. Consider, for instance, the availability of broadband internet service.Footnote 84 The “digital divide” disproportionately affects the marginalized populations that live in places that lack the infrastructure necessary for telehealth delivery.Footnote 85
Finally, remote care cannot assist those who need or want in-person care, which currently accounts for forty-six percent of the country’s abortions—a percentage that may decrease as teleabortion expands.Footnote 86 As the use of medication abortion increases, particularly as an online service at lower cost, financial sustainability of brick-and-mortar clinics will be under threat.Footnote 87 Many facilities operate at a loss, due in no small part to the costs of complying with state restrictions.Footnote 88 As clinics shut down, either because of abortion bans or because of the costs of staying in business, patients who need abortions past ten weeks of gestation or patients who are not candidates for medication abortion—patients with health complications, for example—will have limited options.Footnote 89 As smaller providers are driven out of business, only large clinical centers will exist in states with permissive abortion laws. Future access to abortion clinics will require travel, sometimes extensive or cost-prohibitive travel, meaning that those with resources will be able to reach care while those without may self-manage their abortions or carry pregnancies to term.
In the light of these obstacles, the next section asks what the future of abortion access looks like in a country where many people will travel or pursue terminations in defiance of state law.
Remote reproductive rights
With increased regional disparities for abortion law and care, workarounds to state laws will emerge, as they have already. In states where abortion services are non-existent or scarce, studies demonstrate that people self-manage their abortions by ordering medications online.Footnote 90
The portability of medication abortion opens avenues that test the bounds of legality and networks of advocates for abortion care have mobilized to make pills available to people across the country.Footnote 91 One can envision various means for obtaining mailed abortion pills:
For practical purposes … it is not clear how (or why) an abortion clinic would ensure that patients attend their telemedicine appointments from the state in which they purport to be. Then, as long as a patient has friends or family (or someone they could pay) in a state where abortion is legal, the clinic could mail the pills to that address. At that point, the patient could drive to pick up the pills at her convenience, such as over a weekend when she does not have to work. Alternatively, friends or family could drive the pills to a half-way point, deliver them on a visit, or even risk mailing the pills.Footnote 92
Providers of virtual services, however, warn against trying to circumvent state laws through virtual private networks or mail forwarding.Footnote 93 Abortion on Demand, for example, tracks IP addresses to confirm location at patient intake.Footnote 94 Extralegal strategies could have serious consequences and costs, particularly for those already vulnerable to state surveillance and punishment. And attempts to bypass state laws might backfire for providers, who are subject to professional, civil, and criminal penalties, as well as those who assist providers and patients.
That said, there are a number of measures that could expand telehealth for abortion. First, the federal government can play a role in improving access to telehealth for abortion.Footnote 95 The FDA could remove the remaining elements of the mifepristone REMS, such as requiring that only certified providers prescribe the medication. And the agency could ensure that the yet-to-be-determined pharmacy certification process reflects mifepristone’s excellent safety record and imposes minimal requirements. Second, state policy in jurisdictions supportive of abortion rights can invest in telehealth generally to reduce disparities and continue to loosen restrictions on telehealth (such as permitting telephonic appointments), which many states have done in response to the pandemic. Third, practical solutions to the legal barriers to teleabortion are already underway. Providers are setting up mobile clinics with telehealth stations at state borders with restrictive laws and advocates are increasing logistical and funding support for interstate travel.
These potential strategies for protecting medication abortion access will no doubt result in litigation and carry their own risks. What will undoubtedly remain in the midst of legal and practical uncertainty is the problem of resources. How will advocates, researchers and lawyers work together to redistribute resources to enable low-income people in hostile states to access abortion care? Answering that question depends on political mobilization, money, and state as well as federal commitment to protecting abortion rights in different ways.
Conclusion
An uncertain future is in store for reproductive rights. On the one hand, the Supreme Court reversed constitutional protection for abortion, allowing states to ban abortion early in pregnancy. On the other hand, the federal government, through the FDA, has taken steps to make medication abortion more accessible. What seems clear, in a moment in which there is much change, is that abortion access does not solely depend on courts’ articulation of abortion rights. Rather, executive action, agency decisions, and protective state legislation are legal inventions that will shape abortion’s availability in a post-Dobbs country.
