Wednesday, December 13, 2023

Supreme Court Grants Review of FDA's Rules on Prescribing and Distributing Abortion Pill

The U.S. Supreme Court today granted certiorari in two related cases, FDA v. Alliance for Hippocratic Medicine, (Docket No. 23-235, cert. granted 12/13/2023) and Danco Laboratories, LLC v. Alliance for Hippocratic Medicine, (Docket No. 23-236, cert. granted, 12/13/2023). (Order List.) (SCOTUSblog case pages 23-235, 23-236) In the single opinion applying to both cases, the U.S. 5th Circuit Court of Appeals upheld portions of a Texas federal district court's orders that stayed actions taken by the FDA in 2016 and 2021 regarding the administration and distribution of the abortion pill mifepristone. The 2016 action increased the gestational age when the drug can be used and lightened certain other dosage and prescribing restrictions. In 2021, in connection with the Covid epidemic, the FDA removed the in-person prescribing requirement for mifepristone, allowing it to be sent by mail. The court found that doctors have standing to challenge these actions, among other things citing conscience injuries to objecting doctors.  Challenges to two other FDA actions on mifepristone were rejected on standing and statute of limitations grounds. (See prior posting.) 

The Supreme Court denied review in Alliance for Hippocratic Medicine v. FDA, (Docket No. 23-395, cert. denied, 12/13/2023) which sought review of the FDA's original approval of mifepristone in 2000. (SCOTUSblog case page.)

The district court's orders are not currently in effect because in April, the U.S. Supreme Court stayed the orders while appeals work their way through the courts. (See prior posting.) 

SCOTUSblog reports on the Supreme Court's grants of review.