Published August 16, 2023
In a ruling today in Alliance for Hippocratic Medicine v. FDA, a Fifth Circuit panel majority affirmed in part and vacated in part the district-court order from April that ruled against the FDA’s approval of the abortion drug mifepristone.
The ruling is a significant victory for the plaintiffs in two respects: It would invalidate the FDA’s 2016 amendments that relaxed the restrictions that accompanied its approval of mifepristone. It would also invalidate the FDA’s decision in 2021 that effectively allowed mifepristone to be prescribed remotely and sent via mail. But these invalidations will not become effective unless and until the Supreme Court agrees with the Fifth Circuit or denies the FDA’s petition for certiorari.
The ruling is a significant loss for the plaintiffs on their claims challenging the FDA’s approval of mifepristone in 2000 and of its approval of a generic version in 2019. (Those issues could of course also be revisited by the Supreme Court.)
This matter is procedurally complicated, so let me try to present things clearly.
1. The plaintiffs challenge the lawfulness under the Administrative Procedures Act of four separate actions by the FDA regarding mifepristone: the FDA’s initial approval in 2000; its amendments in 2016 that lightened the protections accompanying the approval; its 2019 approval of a generic version of mifepristone; and its announcement in 2021 that it would not enforce a regulation requiring that mifepristone be prescribed and dispensed in person.
2. In April, federal district judge Matthew Kacsmaryk ruled in favor of plaintiffs and entered an order that stayed the effective date of the FDA’s approval of mifepristone. On the FDA’s application for emergency relief, the Supreme Court blocked Judge Kacsmaryk’s ruling from taking effect until the Court itself has completed its review of the matter.
What the Court’s April order means, as the Fifth Circuit panel emphasizes, is that the Fifth Circuit’s ruling today does not alter the status quo. In other words, those portions of the district-court order that the panel affirms do not go into effect.
3. The Fifth Circuit panel majority, in an opinion by Judge Jennifer Walker Elrod that Judge Cory Wilson joined, ruled:
a. Plaintiffs’ claim challenging the 2000 approval is likely barred by the statute of limitations.
b. Plaintiffs have not shown that they are likely to be injured by the 2019 approval of the generic version.
c. Plaintiffs are likely to succeed on their claim that the FDA adopted the 2016 amendments in violation of governing administrative-law principles. The FDA did not consider the cumulative effect of the 2016 amendments. It also failed to consider whether it needed to continue to collect data of non-fatal adverse events in light of the major changes to the mifepristone REMS (risk evaluation and mitigation strategy). (Slip op. at 43-47.)
d. Plaintiffs are likely to succeed on their claim that the FDA’s non-enforcement announcement in 2021 was arbitrary and capricious. The FDA wrongly gave dispositive weight to dubious adverse-event data, and it relied on literature regarding remote prescription of mifepristone that it admitted does not support its position. (Slip op. at 49-53.)
4. In partial dissent, Judge James Ho would affirm the district court in its entirety. (See opinion beginning on p. 64.) Judge Ho also concludes that the FDA’s 2021 revisions violate the Comstock Act. (Slip op. at 82-88.)
Disclosure: On behalf of the Ethics and Public Policy Center, I submitted an amicus brief in support of plaintiffs on the Comstock Act. (Judge Ho cites our amicus brief with approval.)
Ed Whelan holds the Antonin Scalia Chair in Constitutional Studies at the Ethics and Public Policy Center.