Telehealth firm Hims & Hers announced it will stop offering a compounded version of Novo Nordisk’s Wegovy after escalating legal and regulatory pressure. The company moved to halt distribution following warnings from federal regulators about selling an unapproved form of a marketed GLP‑1 product. Separately, U.S. authorities have signaled interest in a Department of Justice probe into the matter. Hims’ withdrawal follows direct challenges from Novo Nordisk and public regulatory pushback that centered on product approval status and intellectual‑property and safety concerns. The episode underscores heightened enforcement scrutiny of compounding businesses seeking to replicate high‑demand, branded weight‑loss drugs without agency approval. The actions highlight the tension between patient access claims by telehealth vendors and regulators' mandate to protect market exclusivity and patient safety. Companies and investors in digital therapeutics, telehealth prescribing, and compounded biologic analogs will watch whether this prompts broader DOJ or FDA enforcement across the sector.
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