Hims & Hers retreats from compounded GLP-1 pill
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Hims & Hers has backed off plans to sell a cheaper copycat version of Novo Nordisk's Wegovy pill after the Department of Health and Human Services asked for an investigation of whether the telehealth brand violated federal law.
Why it matters: The developments underscored continued tension over compounded GLP-1 weight loss drugs and when companies can make customized versions tailored to patients' needs.
- Hims & Hers has relied on sales of compounded versions of GLP-1 injections to fuel its growth. But in September, the Food and Drug Administration warned the company about what regulators said were misleading claims implying its products are the same as FDA-approved drugs.
Driving the news: Last week, Hims & Hers advertised a version of the Wegovy pill for $49 for the first month and $99 a month thereafter — an introductory price roughly $100 less than Novo Nordisk's.
- HHS general counsel Mike Stuart wrote on X Friday that the company had been referred to DOJ for potential violations of the Food, Drug and Cosmetic Act following a review.
- FDA commissioner Marty Makary also warned his agency would take "decisive steps" to restrict GLP-1 active ingredients intended for use in non-FDA-approved compounded drugs that are mass-marketed by companies including Hims & Hers.
- Hims & Hers said in a statement on Saturday that it decided to stop offering access to the treatment after "constructive conversations with stakeholders across the industry."
Novo Nordisk on Monday said it sued Hims & Hers for patent infringement, asking the U.S. District Court in Delaware to permanently ban the sale of unapproved compounded drugs that infringe on its patents and seeking damages.
Editor's note: The story has been updated with details of Novo Nordisk's lawsuit.
