Outsourcing Facilities Association v. FDA

Summary

The court affirmed summary judgment for the FDA and Novo Nordisk, holding that any possible violation arising from the FDA's failure to use notice-and-comment procedures was harmless. The court also held that the FDA's decision to remove Ozempic and Wegovy from the drug-shortage list was not arbitrary or capricious because the agency considered relevant supply-and-demand data, explained its methodology, and reasonably addressed contrary evidence. The court declined to decide whether the FDA properly characterized or conducted the delisting action as adjudication rather than rulemaking.