Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine

Questions presented

SCOTUS records, cert granted 13 Dec 2023

1. In 2000, the Food and Drug Administration (FDA) approved Danco's drug Mifeprex for termination of early pregnancy based on the agency's expert judgment that clinical data showed the drug to be safe and effective. The agency later modified certain conditions of use for mifepristone in 2016 and 2021, again relying on clinical data and the agency's expert judgment that the drug would remain safe and effective under the modified conditions of use. In 2022, associations of doctors who have never prescribed Mifeprex sued FDA, arguing that FDA's actions modifying the drug's conditions of use in 2016 and 2021 violated the Administrative Procedure Act. The questions presented are:
2. Whether an association can demonstrate Article III standing to enjoin a government action by arguing that some unspecified member may be injured at some future time by the challenged action; and
3. Whether the Fifth Circuit erred in upholding the preliminary injunction of FDA's 2016 and 2021 actions based on the court's review of an incomplete administrative record.

Opinion summary

Etalia.ai summary of the majority opinion

The case involves Danco Laboratories, L.L.C., a pharmaceutical company that produces mifepristone, and the Alliance for Hippocratic Medicine, which challenged the FDA's approval of this medication used in medical abortions. The central issue was whether the FDA followed proper procedures when approving mifepristone and if its decision should be overturned due to alleged safety concerns raised by the plaintiffs. The Supreme Court ruled in favor of Danco Laboratories, upholding the FDA’s authority and discretion in drug approvals unless there is clear evidence of procedural violations or significant health risks not considered during approval. This decision reinforced judicial deference to federal agencies' expertise on technical matters like drug safety evaluations.