Outsourcing Facilities v. FDA

Summary

The court affirmed summary judgment for the FDA and Eli Lilly concerning the FDA’s removal of tirzepatide products from the drug shortage list. Assuming without deciding that the FDA should have used notice-and-comment procedures, the court held that any procedural error was harmless because the compounders had actual notice, participated extensively, and identified no additional information that would have changed the result. The court also held that the FDA’s determination that supply met or exceeded projected demand was reasoned and not arbitrary or capricious.