Lawyers for the American College of Obstetricians and Gynecologists urged the Supreme Court on Tuesday to leave in place a lower-court order that allows patients, during the coronavirus pandemic, to avoid a requirement that they visit a medical office in order to obtain a pill used to induce abortion in the early stages of pregnancy. The Food and Drug Administration has asked the justices to freeze that order and reinstate the federal requirement that the drug be picked up in person from a health care provider. The dispute is the latest battle in which the justices have been asked to intervene on an emergency basis in an issue arising from the pandemic.

The drug at the center of the dispute is Mifeprex, the brand name for mifepristone, which the FDA has approved to end pregnancies through the first 10 weeks. Under the FDA’s regulations, the drug can be distributed only by a health care provider in a medical setting, and only after the patient signs a form acknowledging that she is aware of the risks associated with the drug. After picking up the drug from a hospital or clinic, patients are permitted to self-administer it by taking the pill at home. But the regulations do not allow patients to receive the pill in the mail.

ACOG, the main professional organization for OB-GYNs, and other medical groups asked the FDA this spring to suspend those requirements because of the pandemic. When the FDA did not respond, the groups sued in federal court in Maryland, arguing that requiring the in-person visits during the pandemic violates the Constitution by creating a substantial obstacle in the path of patients seeking abortions. The district court agreed, and in July it issued an order that temporarily barred the FDA from enforcing the in-person requirements anywhere in the United States. The U.S. Court of Appeals for the 4th Circuit declined to put that order on hold while the FDA appeals.

Represented by Acting Solicitor General Jeffrey Wall, the FDA went to the Supreme Court last month, asking the justices to block the district court’s order and permit it to continue enforcing the in-person requirements while the litigation proceeds. Because patients can still obtain surgical abortions, the FDA stressed, enforcing the Mifeprex regulations during the early stages of pregnancy “does not constitute a substantial obstacle to abortion access” even if the pandemic has made it “somewhat riskier” to obtain an abortion in person. More broadly, the FDA added, although the Supreme Court “has made clear that judges are not to second-guess how officials address public-health concerns in areas of uncertainty,” the district judge in this case “dismissed the FDA’s expert judgment in favor of its own view that the safety requirements are medically unnecessary.”

In a response filed on Tuesday, ACOG and the other groups pushed back, framing the question before the justices as whether the FDA can force patients and their health care providers “to unnecessarily risk exposure to a life-threatening disease by mandating that patients travel to a health center for the sole purpose of picking up a pill and signing a form.” The district court’s conclusion that the regulations place a substantial obstacle in the path of patients seeking abortions was based, ACOG argued, on “unrebutted evidence” that “the transportation, childcare, and other interpersonal contact necessitated by an in-person trip to a health center pose serious exposure risks.” ACOG also stressed that abortion patients as a group are especially vulnerable to COVID-19, both because they are pregnant and because most patients seeking abortions are people of color, who are at heightened risk for serious illness or death from the virus. For some patients, ACOG emphasized, the regulations require patients to choose between postponing or even canceling an abortion or risking COVID-19 for themselves and their families – even though Mifeprex is the only FDA-approved drug that must be picked up in person but can be self-administered. The risk would be avoided, ACOG said, if physicians were allowed to prescribe the drug via telemedicine and send it to patients by mail – as commonly occurs with other medications, particularly as the use of telemedicine has expanded during the pandemic.

The FDA is likely to file a reply to ACOG’s brief. Once it does, the court could rule on the agency’s request at any time.

This post was originally published at Howe on the Court.

Posted in Food and Drug Administration v. American College of Obstetricians and Gynecologists, Featured, Emergency appeals and applications

Recommended Citation: Amy Howe, Physicians tell justices not to disturb lower-court ruling that eased access to abortion pill during pandemic, SCOTUSblog (Sep. 8, 2020, 5:50 PM), https://www.scotusblog.com/2020/09/physicians-tell-justices-not-to-disturb-lower-court-ruling-that-eased-access-to-abortion-pill-during-pandemic/