FDA Commissioner Marty Makary pledged swift enforcement against companies mass‑marketing unapproved copycat drugs after telehealth firm Hims announced a compounded semaglutide pill claimed to mirror Novo Nordisk’s Wegovy. Makary said the FDA cannot verify the safety or effectiveness of non‑approved drugs and warned companies would face action for unlawful mass compounding. Novo Nordisk filed suit against Hims alleging Wegovy patent infringement and warned the Hims product uses an untested delivery mechanism versus Wegovy’s SNAC technology. Regulators’ statements and Novo’s legal move underline intensifying enforcement and IP litigation risks as GLP‑1 demand draws alternative suppliers and compounding services.