April 17, 2023

Supreme Court Temporarily Reinstates FDA Abortion Pill Approval

On April 14, one day after the Fifth Circuit Court of Appeals upheld part of a decision suspending the FDA's approval of the abortion pill mifepristone, the US Supreme Court issued an order temporarily reinstating the pill while they consider the case.

The ongoing court battle in Alliance for Hippocratic Medicine v. Food and Drug Administration concerns a group of pro-life groups and physicians who argue that the FDA unlawfully fast-tracked the approval of mifepristone through a process intended for the treatment of life-threatening illnesses. Further, the group argues that the FDA loosened mifepristone regulations improperly by ending a requirement for the abortion industry to report non-fatal adverse events. Afterward, the FDA used the resulting lack of data to claim that mifepristone is safe.

The Fifth Circuit ruled 2-1 that the FDA could maintain its approval of mifepristone, but its decision reverted changes made in 2016, 2021, and 2023 to loosen its regulation. The Fifth Circuit's decision would have left in place the original requirements that the pill only be used up to the seventh week of pregnancy, that pill methods of abortion take place over three doctors visits, that the drug only be dispensed in-person by doctors, and that abortion providers must report non-fatal adverse events.

Justice Samuel Alito granted the Biden administration's request for an emergency stay against the Fifth Circuit's ruling until April 19. He requested an additional briefing by April 18.

Erin Hawley, senior counsel at Alliance Defending Freedom (which is representing the pro-life groups), told CNA that the temporary ruling was expected. Hawley said,
“The entry of a brief administrative stay is standard operating procedure whenever the Supreme Court is asked to consider an emergency request like this one. It gives the court sufficient time to consider the parties’ arguments before ruling. We look forward to explaining why the FDA has not met its heavy burden to pause the parts of the district court’s decision that restore the critical safeguards for women and girls that were unlawfully removed by the FDA.”
While the Supreme Court's order persists, the Biden FDA can continue its lax regulatory standards regarding mifepristone. These allow mifepristone to be prescribed up to the tenth week of pregnancy, prescribed without a doctor's visit, and distributed via mail order.