Will the FDA Permanently Remove In-Person Dispensing Requirements for Medication-Induced Abortions?

By Kelly Folkers (Aug. 10, 2021)

As the COVID-19 pandemic continues, increasing numbers of patients are seeking care through telemedicine, allowing them to communicate with their doctors and be prescribed medicines without leaving home. Access to abortion medication is a part of this trend, with more pregnant people seeking to terminate early pregnancies by requesting access to medication they can self-administer at home. Despite the FDA’s decision earlier this year not to enforce a previous requirement that abortion medications be administered in person, access to medication-induced abortion remains vastly inequitable as conservative state legislatures target the practice.

Current Food and Drug Administration (FDA) regulations on abortion medication officially require that the first dose be administered in a healthcare setting or under the supervision of a provider specifically certified to prescribe the medication. In 2020, the ACLU filed a lawsuit on behalf of the American College of Obstetricians and Gynecologists (ACOG) challenging the in-person dispensing requirement, which resulted in a nationwide injunction preventing the FDA from enforcing the rule. But the Supreme Court lifted the injunction in January 2021 and held, in a 6-3 decision, that the district court should have deferred to the FDA’s expertise, avoiding the question of whether the rule imposed an undue burden on the constitutional right to abortion. After President Biden took office, the FDA announced in April 2021 that it would not enforce the in-person dispensing requirement for the duration of the COVID-19 pandemic.

The agency is now considering permanently removing the in-person dispensing requirement. But as access to abortion hangs in a precarious balance as the Supreme Court prepares to hear a direct challenge to Roe v. Wade later this year, have passed laws in 2021 targeting medication-induced abortions.

There are two types of abortion: surgical and medication. While a surgical abortion is a medical procedure that must be performed in a clinic or medical office, the procedure for most medication-induced abortions requires that patients take two medicines, mifepristone and misoprostol, at least 24 hours apart, respectively. ACOG has stated in its most recent guidance on medication-induced abortions, that patients can safely and effectively take abortion medications at home. But the FDA issued a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone when it was approved in 2000, requiring that the medication be ordered, prescribed, and dispensed under the supervision of a health care provider who is specifically certified to administer it. The agency issues REMS to “reinforce medication use behaviors and actions that support safe use of that medication.” While there have been some reported adverse events, including a handful of deaths, associated with use of mifepristone, the medication is widely considered to be safe and effective, with over 3.7 million patients having been prescribed the drug since its approval.

Though the FDA announced that it would not be enforcing the REMS on mifepristone during the pandemic, even before the pandemic, the restriction had long frustrated abortion rights advocates, who believe it is too restrictive and politically motivated. In 2019, former FDA Commissioner Dr. Jane Henney argued in the New England Journal of Medicine that the restrictions on distribution of mifepristone made at its approval in 2000, before the drug was widely used and in the United States and additional safety and efficacy data collected, may no longer be appropriate.

Despite ACOG’s assertion that the in-person dispensing requirement has no medical benefit for patients, conservative state legislatures have used the Supreme Court’s decision to target medication-induced abortions. Montana has effectively banned telehealth for abortion. Ohio has a similar law in effect, which is being challenged by Planned Parenthood and other advocacy groups in court. Indiana not only required that the first dose of medication be administered in the presence of a healthcare professional, patients must be advised that their abortions can be reversed with progesterone, which is not scientifically supported. The law has since been blocked by a federal judge. At least 20 states prevent telemedicine appointments for abortion pill prescriptions, and more than 30 require that physicians must write the prescriptions, rather than nurse practitioners or physician assistants who are otherwise able to prescribe medication.

Though laws limiting access to medication-induced abortion continue to threaten reproductive rights, there is hope that under the new Democratic Administration, the FDA will end the restrictive in-person dispensing requirement.