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US could take action including fines against Hims after brief Wegovy copy launch
Reuters· 2026-02-13 11:05
Core Viewpoint - The Trump administration may take legal action against Hims for attempting to sell a compounded version of Novo Nordisk's Wegovy weight-loss pill, following the FDA's referral to the DOJ for potential violations of federal law [1]. Group 1: Legal Actions and Implications - Hims initially planned to offer a $49 version of Wegovy but backed off after the FDA's warning [1]. - The DOJ could pursue an injunction or fines against Hims for marketing an unapproved drug, as indicated by legal experts [1]. - The FDA's actions aim to protect pharmaceutical investments and ensure product safety, highlighting concerns over compounded drugs that have not undergone rigorous testing [1]. Group 2: Industry Context and Reactions - Weight-loss drug manufacturers, including Novo Nordisk and Eli Lilly, are struggling to meet the increasing demand for their products [1]. - Compounded pharmaceuticals are legal under specific conditions, but the FDA can enforce actions against those that bypass the federal approval process [1]. - Hims claims its products are legal due to patient personalization, but the legality of this claim is under scrutiny [1]. Group 3: Future Considerations - The FDA may inspect Hims' records to assess compliance with prescription documentation [1]. - Hims' withdrawal from offering the compounded weight-loss pill may influence the DOJ's decision on whether to take action [1]. - The administration could focus on Hims' compounded injectable weight-loss drugs, which present a more complex legal case [1].