Compounders sue US FDA over semaglutide ruling

A group representing compounding pharmacies has filed a lawsuit against the US Food and Drug Administration, arguing that the agency acted unlawfully when it removed Novo Nordisk’s (NOV: N) semaglutide-based drugs Ozempic (semaglutide) and Wegovy (semaglutide) from the official shortage list. 

The lawsuit, filed in a federal court in Texas, challenges the decision, which means compounders must halt production of cheaper alternatives in the coming months. The ruling is alleged to have been made “without notice-and-comment rulemaking,” depriving patients of a vital treatment option and limiting competition.

The complaint, brought by the Outsourcing Facilities Association and Texas-based FarmaKeio Superior Custom Compounding, claims the US regulator dismissed evidence that shortages persist and failed to follow the legally required process before making the change.