Hims & Hers has abandoned plans to sell a compounded version of Novo Nordisk’s weight loss pill following backlash from U.S. regulators and the threat of a federal investigation.
In a short statement posted on the social media platform X Saturday, Hims said that, after “constructive conversations with stakeholders across the industry,” it “decided to stop offering access” to the treatment. “We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.”
The sudden turn quickly ends, for now, plans by the telehealth company to launch a copycat form of Novo’s “Wegovy” pill. Hims had announced those plans on Thursday and, in doing so, quickly drew legal threats from Novo as well as swift action from the Food and Drug Administration.
Hims is one of many compounding pharmacy companies that have recently used legal loopholes to capitalize on the demand for GLP-1 weight loss drugs. These compounding firms started making lower-cost, knockoff versions of Novo’s injectable Wegovy and Eli Lilly’s rival Zepbound when those medicines were in short supply. But despite lawsuits and warnings from the FDA, those efforts have continued even after the end of those shortages, as compounders have used methods of personalizing treatment regimens to try to comply with federal laws.
Hims stepped up those plans last week, when it revealed plans to launch a compounded version of the pill form of Wegovy. The FDA approved Novo’s drug in December, making it the first pill of its kind available for obesity. And since then, early prescription totals suggest it’s gotten off to a very fast start. That progress is important for Novo, which has seen its market share eroded by compounders, pricing pressure and competition from Lilly.
Hims attempted to quickly undercut Novo by selling a knockoff at a lower price. In doing so, Hims claimed that its copycat of oral semaglutide — the active ingredient in Wegovy — was formulated differently and involves a different delivery method to protect it during digestion. Some Wall Street analysts expressed skepticism about those claims, as Novo uses a specialized technology to ensure the effectiveness of its pill, which is a complex “peptide” drug instead of a standard small molecule.
Novo immediately threatened legal action and accused Hims of “illegal mass compounding and deceptive advertising.” Federal regulators stepped in shortly afterwards. In a social media post Thursday, FDA commissioner Martin Makary threatened “swift action” against companies mass-marketing illegal copycat drugs.
A day later, the FDA announced it would “take decisive steps” to restrict active pharmaceutical ingredients compounders are using to mass-market knockoff GLP-1 drugs as “similar alternatives” to FDA-approved medications. The Department for Health and Human Services then referred Hims to the Department of Justice to investigate potential violations of the Federal Food, Drug and Cosmetic Act.
