Scholars consider how the authorization of telehealth can expand access to medication abortion.
Before the pandemic, patients seeking abortions faced the complicated and often expensive process of finding freestanding abortion clinics. Now, telehealth abortion enables quick and simple access to medication abortion in the privacy of the home. But experts say that the Dobbs v. Jackson Women’s Health Organization decision has created legal gray areas that may disrupt future access to medication abortion care.
Telehealth abortions consist of a two-drug combination of mifepristone and misoprostol, commonly known as mifepristone. In 2000, the U.S. Food and Drug Administration (FDA) approved pills with these drugs as safe and effective means of ending pregnancies up to ten weeks. By 2020, medication-based abortions accounted for over half of abortions in the United States. Despite widespread use of mifepristone, FDA approved a risk evaluation and mitigation strategy (REMS) for abortion medication which included an in-person dispensing requirement and limited prescribing to certified providers, making it difficult for those who lacked access to doctors’ offices to access the drug.
The COVID-19 pandemic had the unintended consequence of paving the way for more accessible telehealth abortions. During the pandemic, some states relaxed the in-person dispensing requirement for medication abortions. In response to medical professionals’ advocacy, and during a time when reproductive rights seemed increasingly vulnerable, FDA conducted a review of the mifepristone REMS program. In 2021, FDA removed the in-person dispensing requirement, formally allowing medication abortion by mail in 31 states.
Nonetheless, 19 states still have their own legislative mandates that require prescribing physicians to be in the physical presence of patients to prescribe abortion medication. In addition to worrying about how these state laws limit abortion access, experts and reproductive health advocates worry that a different federal administration in the future could reverse FDA’s action and revert to enforcing the agency’s in-person dispensing requirement.
According to the Dobbs decision, the U.S. Constitution does not prohibit states from regulating abortion, including medication abortion. But this does not necessarily preclude federal statutes or regulations from preempting states’ ability to limit access to medication abortion. Although the Biden Administration argues that FDA’s approval preempts states’ from restricting telehealth access to medication abortion, ongoing litigation currently creates uncertainty about how the question of federal preemption will ultimately be settled.
The ensuing battle for regulatory control over medication abortion holds implications not only for those seeking abortion care via telehealth, but also for future federal-state regulatory conflicts. In this week’s Saturday Seminar, experts analyze current telehealth regulatory barriers and explore policy options related to medication abortion care.
- In an article published by Frontiers in Global Women’s Health, Terri-Ann Thompson of Ibis Reproductive Health, Dana Northcraft of Kisaco Research, and Fabiola Carrión of National Health Law Program argue that the regulation of telehealth services and abortion medication distribution perpetuates inequity in the health care system, especially for Black and impoverished communities. FDA’s removal of its in-person dispensing requirement improves the viability of telehealth services for many of the populations who may benefit from it most, Thompson, Northcraft, and Carrión explain. They argue, however, that patient and provider certifications lacking quantifiable safety mechanisms should also be removed.
- In a report published by the Congressional Research Service, Jennifer A. Staman and Jon O. Shimabukuro evaluate the interaction between FDA’s regulation of abortion medication under the Federal Food, Drug, and Cosmetic Act and new state efforts to regulate abortion following the Supreme Court’s decision in Although FDA’s current policies allow for abortion medications to be prescribed via telehealth and mailed to patients, some state legislatures have moved to ban medication abortion drugs alongside surgical abortions, explain Staman and Shimabukuro in their report. They anticipate that the relationship between a state’s power to regulate the protection of public health and FDA’s role in determining the safety of prescription drugs will prompt the passage of federal legislation clarifying the extent to which federal regulations related to medication abortions preempt state measures.
- In an article in the Cornell Law Review, Greer Donley of the University of Pittsburgh School of Law argues that the negligible benefits of the mifepristone REMS are outweighed by its detrimental impacts on access to abortion and other aspects of reproductive health care. Outlining what Donley and others describe as FDA’s history of devaluing women’s health, Donley compares FDA’s regulation of mifepristone to that of Plan B, female sex drugs, and drug labeling for use in pregnancy. Donley advocates removing the mifepristone REMS entirely. She urges reproductive health scholars to demonstrate that the remaining requirements are unnecessary and encourages lawyers to continue challenging FDA’s statutory basis for imposing a mifepristone REMS.
- Although states have broader latitude to regulate the practice of medicine directly, they cannot impose policies that conflict with FDA requirements, according to Patricia J. Zettler of the Ohio State University Moritz College of Law and Ameet Sarpatwari of Harvard Medical School Center for Bioethics in an article published in The New England Journal of Medicine. Despite this limitation, states have long attempted to restrict medication abortion access. Zettler and Sarpatwari argue that such state laws encroach on FDA’s purview and that courts may therefore strike them down to promote public health. Although some fear that preemption challenges to state medication abortion restrictions risk undermining other important state and local regulations, Zettler and Sarpatwari highlight that state litigation efforts can complement FDA oversight and preserve the future viability of public health federalism.
- In an article published in the Guttmacher Policy Review, Megan K. Donovan, formerly of the Guttmacher Institute, argues that the politicized nature of abortion hinders advancements in telehealth. According to Donovan, policymakers must develop multistate solutions that adequately account for the complex variety of state laws restricting reproductive care resources. Certain state policies, for example, require in-person exams or specific relationships between providers and patients. Furthermore, some states distinguish abortion from other health services to limit avenues of public funding. To address this discrepancy, policymakers must ensure that abortion providers are included in telehealth-related grants, Donovan argues.
- In an article published in Contraception, Ushma D. Upadhyay and Daniel Grossman of the University of California, San Francisco, and Alice F. Cartwright of the University of North Carolina at Chapel Hill, examine the relationship between self-managed abortion—defined as terminating a pregnancy without medical supervision—and access to reproductive health resources. Upadhyay, Grossman, and Cartwright note that the deciding factors in study participants’ choice to self-manage their abortions included travel, finances, secrecy, and fear. When telehealth was unavailable, participants took herbs and supplements, ordered abortion pills online, or even sought potentially harmful physical methods to terminate their pregnancies. Upadhyay, Grossman, and Cartwright argue that states should repeal laws banning telehealth-based abortion care and that FDA should allow pharmacy access to abortion pills to reduce the potential harms of self-managed abortions.
The Saturday Seminar is a weekly feature that aims to put into written form the kind of content that would be conveyed in a live seminar involving regulatory experts. Each week, The Regulatory Review publishes a brief overview of a selected regulatory topic and then distills recent research and scholarly writing on that topic.