U.S. Supreme Court Hears Arguments Related to Legality of Medication Abortion.

On March 26, 2024, the Supreme Court heard the case of Alliance for Hippocratic Medicine, et al v FDA (5th Circuit Court ruling, stayed and awaiting final adjudication from the U.S. Supreme Court), involving challenges to the FDA’s September 2000 approval of mifepristone for medication abortion, as well as subsequent COVID-era rules from 2020-2021 expanding mifepristone’s access by permitting mifepristone to be prescribed via telehealth and dispensed from mail-order pharmacies, where not otherwise prohibited by law.

Mifepristone is a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue. Mifepristone, when used together with another medicine called misoprostol, is used to end a pregnancy up through ten weeks of gestation (70 days or fewer since the first day of the last menstrual period).

Employer Action Items

Employers should be mindful that while the Supreme Court’s review of mifepristone’s FDA approval process and its COVID-era access expansions arise relative to a single abortion-related legal controversy, several additional active legal controversies exist. Currently, multiple reproductive rights related cases are winding their way through the state and federal courts. It is vital for employers and plan sponsors to make strategic use of this intervening time. To be sure, a speedy and comprehensive course of action may be required for those employers hoping to prosper through this current and rather seismic evolution of abortion-related public policy in the United States, as well as its complex and interrelated regulatory enforcement mechanisms.

Summary

On March 26, 2024, the Supreme Court heard the case of Alliance for Hippocratic Medicine v FDA (5th Circuit Court ruling, stayed and currently awaiting final adjudication), involved challenges to the FDA’s September 2000 approval of mifepristone for medication abortion, as well as subsequent COVID-era rules from 2020-2021 expanding mifepristone’s access by permitting mifepristone to be prescribed via telehealth, and also dispensed from mail-order pharmacies (where not otherwise prohibited by law). The Supreme Court heard arguments in the case after a Texas district court elected to revoke the Food and Drug Administration’s (FDA) 23-year-old approval of mifepristone and unilaterally installed a nationwide injunction upon mifepristone’s FSA approval, severely impeding the prescribing of mifepristone, as well as the shipping of the medication across state lines.

The restrictions, if allowed to remain into effect, include cutting off access to the pill through the mail, barring telemedicine prescriptions for mifepristone, and reinstating a seven-week gestation period limitation for use of the medication, even in states where abortion remains legal. Upon agreeing to hear arguments in the case, the Supreme Court placed the district court’s injunction on hold, pending the outcome of the case, so at this time, prescribing of mifepristone remains unobscured.

In the case, the FDA argues that the in-person prescribing requirement is not necessary to ensure the safe and effective use of the medication, which is subject to the FDA’s Risk Evaluation and Mitigation Strategy (“REMS”) program, a regulatory mechanism for drugs that have serious safety concerns. The FDA contends that the lower court abused its discretion by issuing a nationwide injunction that overrides the FDA’s scientific judgment and interferes with its authority to regulate drugs during a public health emergency. The FDA also claims that the plaintiffs lack standing to challenge the in-person prescribing requirement because they have not shown that they have suffered, or will in fact suffer, any cognizable injury because of the mifepristone’s prescriptive requirements.

Plaintiffs counter that the in-person requirement does not impose an undue burden on the right to abortion. They argue that the requirement does not expose patients and providers to a heightened risk of contracting COVID-19 and that the FDA has failed to show any medical benefit from the requirement that outweighs the harm. They also assert that they have standing to challenge the requirement because it directly affects their ability to provide and obtain medical treatments.

The outcome of the case will have far-reaching implications for reproductive healthcare access and the legal landscape surrounding abortion rights in the U.S. Medication abortion has become an increasingly common and safe method for terminating pregnancies, with more than five million women in the U.S. utilizing mifepristone for medication abortion since the mifepristone’s FDA approval in 2000. Today, six (6) in ten (10) annual abortions are performed via medication abortion, up from around 53% in 2020, based upon research reported by the Guttmacher Institute.

The specific legal issues the Supreme Court is considering in this matter include the following:

• Whether the district court acted within its discretion by issuing a preliminary injunction that suspends the FDA’s in-person requirement for abortion pills during the COVID-19 pandemic;
• Whether the plaintiffs have standing to challenge the FDA’s in-person requirement for abortion pills; and
• Whether the FDA’s in-person requirement for abortion pills imposes an undue burden on the right to abortion.

For More Information

• The certiorari petition for the United States Supreme Court.