Court hears oral arguments in next stage of mifepristone abortion pill legal challenge

Parties to the federal case seeking to overturn FDA approval of the abortion drug mifepristone presented oral arguments to a panel of three judges in the 5th U.S. Circuit Court of Appeals on Wednesday.

As Healio previously reported, on April 7, a U.S. District Court judge in Texas ruled in Alliance for Hippocratic Medicine vs. U.S. Food and Drug Administration that the FDA must suspended its approval of mifepristone granted in 2000. On April 12, a different panel of judges from the 5th U.S. Circuit Court of Appeals granted a stay of the district court decision: Mifepristone would remain approved. However, the appeals court let stand parts of the original ruling that would reverse regulations adopted since 2016 that allow telehealth prescribing and mail-order distribution of the drug and its use up to 10 weeks’ gestation, among others.

On April 21, the U.S. Supreme Court issued an order to maintain the status quo until the 5th circuit judges could hear oral arguments — the arguments presented on May 17 — and rule in the case. Whatever decision the circuit court reaches, the case is likely to ultimately head to the Supreme Court.

Oral arguments focused on whether the plaintiffs are harmed by availability of mifepristone and have the legal right to challenge the FDA approval.

In addition, the judges had questions for the appellant attorneys about the safety of mifepristone use over telehealth or with mail-order dispensing. Questions for the plaintiff attorneys centered on details of the FDA approval process when dispensing requirements were loosened after 2016.

References:

• Danco Laboratories, LLC v. Alliance for Hippocratic Medicine, et al, No. 22A901, Food and Drug Administration, et al, v. Alliance for Hippocratic Medicine, et al, No. 22A902 (U.S. Supreme Court 2023). Available at: www.supremecourt.gov/opinions/22pdf/22a901_3d9g.pdf. Filed April 22, 2023. Accessed April 22, 2023.