The Court requires in-person visits for patients seeking medication abortion despite the risks of COVID-19.
In January, the U.S. Supreme Court granted a Trump Administration request to reinstate a U.S. Food and Drug Administration (FDA) rule requiring patients seeking a medication abortion to make a medically unnecessary in-person visit to their health care provider to pick up the abortion pill mifepristone.
The Court’s decision in FDA v. American College of Obstetricians and Gynecologists reverses a federal district court ruling from last July that suspended the FDA rule during the pandemic. In that lower court decision, Judge Theodore Chuang ruled that the FDA’s required in-person visit imposed a “substantial obstacle” to abortion health care that is likely unconstitutional. Judge Chuang’s order allowed clinicians to mail mifepristone to patients after a telemedicine consultation. As a result of the judge’s order, clinicians across the country began offering abortion medication by telemedicine, and U.S.-based online pharmacies began to ship mifepristone to patients. In fact, a recent nationwide study in the United Kingdom has shown that no-test telemedicine abortion is just as safe and effective as in-person abortion health care.
Approved by FDA for use during the first ten weeks of gestation, medication abortion uses two types of pills: mifepristone, which interrupts the flow of the hormone progesterone that sustains the pregnancy, and misoprostol, which causes contractions to expel the contents of the uterus. This combination of pills is more than 95 percent effective and is a safe way to end an early pregnancy.
Despite the safety of medication abortion, politically motivated restrictions on mifepristone have blocked easy access to the pill. After years of anti-abortion resistance, FDA approved the drug in 2000 but restricted the drug under the Risk Evaluation and Mitigation Strategy (REMS) drug safety program. Under this restriction, FDA prohibits retail pharmacies from stocking and distributing mifepristone and seeks to “mitigate the risk of serious complications associated with mifepristone” through the following steps: mandating that providers who prescribe mifepristone obtain Mifepristone REMS Program certification; requiring that mifepristone be dispensed only in certain health care facilities through a certified prescriber; and instructing providers to notify patients of the potential serious complications related to mifepristone.
From the start, most clinicians interpreted the REMS to mean that mifepristone had to be handed to the patient in-person, with some clinicians even going so far as to require patients to swallow the medication in their presence. Today, the word “dispensed” is usually interpreted to require patients to make an in-person visit to their clinicians to obtain the pill, which they can then ingest at home.
Following Judge Chuang’s order lifting the in-person facet of the REMS, the Trump Administration appealed to the Supreme Court. Without issuing an opinion explaining their decision, the six conservatives on the Court—Justices John Roberts, Clarence Thomas, Samuel Alito, Neil Gorsuch, Brett Kavanaugh and Amy Coney Barrett—granted the Trump Administration’s request to reimpose the REMS restriction on mifepristone.
In a one-paragraph concurrence, Chief Justice Roberts argued that the question before the Court was not the constitutionality of the REMS, but whether the lower court could order FDA to lift the REMS restriction based on “the court’s own evaluation of the impact of the COVID–19 pandemic.” Chief Justice Roberts said no, noting that “courts owe significant deference to the politically accountable entities with the ‘background, competence, and expertise to assess public health.’”
Whereas Justice Stephen Breyer simply stated that he would deny the application, Justice Sonia Sotomayor wrote a 12-page dissent, joined by Justice Elena Kagan, excoriating the majority for its “callous” decision that forces patients to expose themselves and others to COVID-19 for no medical benefit. “Due to particularly severe health risks, vastly limited clinic options, and the 10-week window for obtaining a medication abortion, FDA’s requirement that women obtain mifepristone in person during the COVID-19 pandemic places an unnecessary and undue burden on their right to abortion,” explained Justice Sotomayor. She noted that the FDA policy particularly endangered minority and low-income populations, who are “more likely to live in intergenerational housing, so patients risk infecting not just themselves, but also elderly parents and grandparents.”
Justice Sotomayor concluded that, “together, 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.”
Lawmakers, medical professionals, and activists are now calling on the Biden Administration to reverse the Trump-era policy and end FDA’s restriction on the abortion pill.
On February 9, members of the House Committee on Oversight and Reform wrote a letter to FDA requesting that it lift the in-person requirement for medication abortion care: “In light of the clear danger that the reinstated requirement poses to people seeking comprehensive reproductive health care at the height of the coronavirus pandemic, we urge you to immediately eliminate the medically unnecessary in-person dispensing requirement for mifepristone.”
The House Committee members emphasized the disproportionate impact of the restriction on vulnerable communities and explained that “imposing this requirement in the midst of a deadly pandemic—one that has disproportionately impacted communities of color across the United States—needlessly places patients and providers in harm’s way, and further entrenches longstanding health inequities.”
Medical professionals also widely condemned the Supreme Court’s ruling. It “puts people’s health and lives at risk,” Daniel Grossman of the University of California San Francisco’s Department of Obstetrics and Gynecology reportedly said. He noted that “there is no reason during a pandemic to require patients seeking medication abortion care to be seen in person when telemedicine is equally safe and effective. There is no benefit to patients receiving the medications in person—especially given the fact that FDA allows them to take the pills at home.”
Kirsten Moore of the Expanding Medication Abortion Access Project, has reportedly agreed, stating that “all eyes now turn to the Biden-Harris Administration. We urge them to direct FDA to follow the science and immediately lift these restrictions during the pandemic and conduct a full review of the REMS. Twenty years of science and experience tell us that it shouldn’t be this hard to get medication abortion care.”
Another approach to the REMS restriction would be to reinterpret it. The advocacy group Plan C disputes the interpretation that the REMS require an in-person visit to a clinician, noting that the language of the REMS does not specify “in-person” dispensing or prohibit clinicians from mailing pills to patients.
According to Plan C co-director and co-founder Elisa Wells, “‘dispensing’ is generally understood to mean identifying the correct medication and dosing, then packaging and labeling it to ensure correct use by the patient. We know that some providers are dispensing the medications in their clinics, as required by the REMS, and then distributing them to their patients by mail. This is a common sense approach not just during a pandemic, but all the time, and research has demonstrated that it is just as safe and effective as handing the meds directly to patients.” Under Wells’s common sense interpretation, health care providers can mail mifepristone to patients after a telemedicine consultation, despite the Supreme Court’s ruling.
Lifting FDA’s restriction would not make telemedicine abortion available in all states. In 19 states, clinicians providing medication abortions are required to administer the medication in person, which eliminates the option to prescribe the abortion pill remotely. Despite this limitation in some states, lifting the FDA’s REMS restriction would significantly increase medication abortion patients’ access to telemedicine and help to ensure their safety during the pandemic.