Supreme Court Agrees to Hear Case Over Access to Abortion Pill

The U.S. Supreme Court recently agreed to take on another controversial abortion dispute. The consolidated cases before the justices this time around involve access to a drug used in medical abortions. The decision will be closely watched given the Court’s decision in Dobbs v. Jackson Women’s Health Organization, which abolished the constitutional right to an abortion.

Facts of the Case

The case concerns mifepristone, a drug that the U.S. Food and Drug Administration (FDA) approved in 2000 as safe and effective for terminating early pregnancies. Upon approval, theFDA imposed a number of conditions designed to prevent the drug from causing serious medical side effects.

In 2016, the FDA amended those conditions, extending the gestational age from 7 weeks to 10 weeks and otherwise limiting restrictions. It subsequently approved a generic version in 2019. Two years later, the FDA announced that it would not enforce an agency regulation requiring mifepristone to be prescribed and dispensed in person. It ultimately removed that requirement from mifepristone’s conditions for use.

The Alliance for Hippocratic Medicine-an association of doctors who research, teach, and advocate for ethical medical practices-several similar organizations, and several individual doctors filed suit. They contend that the FDA violated the Administrative Procedure Act (APA) in overlooking important safety risks in approving mifepristone and amending its restrictions. The doctors further maintain that when they treat women who are experiencing complications after taking mifepristone, they are required to perform or complete an abortion, or otherwise required to participate in a process that facilitates abortion. They maintain that personally conducting those procedures violates their sincerely held moral beliefs.

The Fifth Circuit Court of Appeals held that the associations and doctors have Article III standing to challenge FDA’s 2016 and 2021 actions with respect to mifepristone’s approved conditions of use. It further held that the FDA’s actions were likely arbitrary and capricious.

Issues Before the Supreme Court

The FDA appealed to the U.S. Supreme Court. The agency argues that the respondents lack Article III standing because while theyoppose abortion on religious and moral grounds, they do not prescribe mifepristone, and FDA’s approval of the drug does not require them to do or refrain from doing anything.

The FDA further maintains that the Fifth Circuit’s decision seeks to compel the FDA to return to a pre-2016 regulatory regime that imposes restrictions on distribution that FDA has found to be unnecessary and unjustified. “If the portions of that order affirmed by the Fifth Circuit are now allowed to take effect, it would up-end the regulatory regime for mifepristone, with damaging consequences for women seeking lawful abortions and a healthcare system that relies on the availability of the drug under the current conditions of use,” the FDA argued in its petition for certiorari. “And the logic of the Fifth Circuit’s unprecedented decision would threaten to severely disrupt the pharmaceutical industry and prevent FDA from fulfilling its statutory responsibilities according to its scientific judgment.”

The Supreme Court granted review and consolidated it with another case, Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, which largely involves the same issues.

In Food and Drug Administration v. Alliance for Hippocratic Medicine, the Court agreed to consider the following questions:1. Whether respondents have Article III standing to challenge FDA’s 2016 and 2021 actions. 2. Whether FDA’s 2016 and 2021 actions were arbitrary and capricious. 3. Whether the district court properly granted preliminary relief.

In Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, the justices will decide two questions: 1. Whether an association can demonstrate Article III standing to enjoin a government action by arguing that some unspecified member may be injured at some future time by the challenged action; and 2. whether the U.S. Court of Appeals for the 5th Circuit erred in upholding the preliminary injunction of the Food and Drug Administration’s 2016 and 2021 actions with respect to mifepristone’s approved conditions of use based on the court’s review of an incomplete administrative record.

Oral arguments have not yet been scheduled. A decision is expected before the term ends in June 2024.