HIMS Faces DOJ Investigation Over Unapproved Wegovy Copy Plan

U.S. regulators could pursue an injunction or civil/criminal fines against HIMS (HIMS.NYS) following its brief plan to market an unapproved compounded version of Novo Nordisk’s Wegovy. The FDA referred HIMS to the Department of Justice after it temporarily launched a $49 alternative, citing potential violations of the Food, Drug and Cosmetic Act. HIMS retreated from the offering, and enforcement hinges on whether the prescriptions meet the personalized-compounding criteria under federal law. The FDA lacks independent litigation authority and will likely collaborate with the Justice Department, which typically leads enforcement actions. HIMS has also faced prior warnings over misleading advertising, including a Feb 5 notice to Novo regarding promotional claims about Wegovy. The administration’s next steps remain contingent on HIMS’ current policy position and a potential inspection of its records.