Outsourcing Facilities Association v. FDA

Summary

The court affirmed summary judgment for the FDA and Novo Nordisk, holding that any failure to use APA notice-and-comment procedures was harmless because the compounders had actual notice and ample opportunities to submit information but could not show prejudice. 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, addressed contrary evidence, and reasonably concluded that supply met or exceeded demand. The court declined to decide whether the FDA was required to proceed by rulemaking rather than adjudication or whether the FDA abused its discretion in choosing its procedure.