The FDA’s telehealth safety net for abortion only stretches so far
Though the Supreme Court has dominated the conversation about abortion rights the past few weeks, the Food and Drug Administration recently proved that abortion access relies on more than the court’s rulings. On Thursday, the FDA permanently removed its requirement to dispense medication abortion in-person, making early abortion more accessible than ever before in many states — a ruling that does not rely on the constitutional right to abortion and will therefore stand even if Roe is overturned later this year.
Medication abortion allows the termination of a pregnancy at or before 10 weeks by taking two drugs (mifepristone and misoprostol) 24-48 hours apart. The first drug, mifepristone, has historically been subject to a special safety protocol that only allowed certified providers to prescribe it and required patients to pick it up in-person at a healthcare facility.
In the past decade, evidence has mounted demonstrating that mifepristone is exceedingly safe and that the FDA’s additional safety protocols were unnecessary. As a result, there was wide medical consensus that the FDA’s restrictions did not actually “ensure that the benefits of the drug outweigh the risks of the drug,” as federal law requires.
Rather, the restrictions on mifepristone had only one effect: encumbering abortion access by requiring in-person pick up, limiting the number of providers who can prescribe the drug and prohibiting pharmacies from selling it. The harmful effect of these rules became clear during the pandemic.
In July 2020, a federal district court suspended the in-person dispensing requirement to allow patients to receive medication abortions through telehealth, and after the Supreme Court stayed that decision, the Biden administration used its enforcement discretion to temporarily suspend the requirement while it reconsidered its position long term.
These decisions changed the nature of abortion care almost overnight. A future that had seemed distant two years ago — abortion care from the safety and comfort of one’s home — arrived. Abortion providers established clinics to counsel patients online, deliver medication abortions through supervised mail-order services and monitor patients through smartphone apps and 24-hour helplines. One of these virtual abortion clinics, Abortion on Demand, now offers services in over 20 states and plans to expand to others.
Fortunately, these changes haven’t occurred in the dark — researchers have been studying their safety and efficacy, showing that patient satisfaction is high and the incidence of adverse effects is very low. The increase in access has shown no negative consequences for safety.
The FDA’s decision to remove the in-person dispensing requirement will allow virtual clinics to remain in operation and, by all present signs, thrive. Abortion will be earlier and cheaper, as most virtual clinics charge hundreds of dollars less than brick-and-mortar clinics. Patients can avoid the cost and logistical burden of traveling to an abortion clinic, where protestors often congregate to shame women for accessing healthcare. And abortion care will be portable: Picking up the two-drug regimen at a pharmacy or receiving it in the mail opens up any number of possibilities for cross-border care.
That is all to say, the FDA’s decision can make a critical difference to abortion access, one that is independent of the constitutional right.
But the benefits of this decision are not for everyone. For patients too far along to use medication to terminate their pregnancy, who would prefer a procedural abortion, or who want the counseling and care that in-person clinics can offer, the FDA’s announcement does not change the barriers to care they will face. Moreover, 19 states have their own laws that prevent telemedicine for abortion provision, and the FDA’s decision will not immediately disrupt them.
If the Supreme Court overrules Roe v Wade in its Dobbs v Jackson Women’s Health Organization ruling — as many commentators and legal scholars fear is likely — much of the country will not only be missing out on this expansion of abortion access but will see legal abortion disappear. The result: the disparity in abortion access across state lines will grow exponentially. Abortion will become more accessible than ever in some states, while women in other states will lose access altogether.
Still, removing the medically unnecessary barriers to medication abortion may nevertheless help women in conservative states. In a post-Roe world, self-managed abortion — self-administered medication abortion outside of the traditional healthcare system — will become common, legal or not. The FDA’s pronouncement that medication abortion can be safely and effectively provided without in-person care could help pave the way for providers in states where abortion is legal to help women in states where it isn’t.
Though the FDA’s decision is important, obstacles to broader access remain. There are barriers to telehealth, including that it works best for people with internet connectivity, smartphones, digital literacy and other resources that are often marked by racial, income and geographic disparities. And we can expect challenges to come down the pike — namely, that conservative states will pass laws specifically designed to punish those who provide, assist, or obtain abortion care across state lines. The FDA could also be sued under the Administrative Procedure Act, although it will be very difficult for plaintiffs to prove that the agency acted arbitrarily by relying on the best scientific evidence.
Expect to see a battle of experts, only some of whom will have science on their side, play out in the courts. But our hope is to highlight a small reason for optimism at a time when abortion rights supporters are inundated with depressing headlines.
Rachel Rebouché is the interim dean of Temple University’s Beasley School of Law and the James E. Beasley professor of Law. Greer Donley is an assistant professor of law at the University of Pittsburgh Law School. David S. Cohen is a professor of law at the Thomas R. Kline School of Law at Drexel University (firstname.lastname@example.org.)