Hims to stop offering GLP-1 pill after FDA warned of crackdown

By Anusha Shah and Amina Niasse Feb 7 (Reuters) – Online telehealth company Hims & Hers on Saturday reversed course on its launch of a $49 compounded version of Novo Nordisk's Wegovy weight-loss pill after the U.S. Food and Drug Administration said it would take action against it. "Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment," the telehealth firm said. The FDA said on Friday that it plans to restrict GLP-1 ingredients used in compounded drugs that companies such as Hims and online pharmacies have marketed, citing concerns over quality, safety and potential violations of federal law. The Department of Health and Human Services said on Friday it would refer the company to the Department of Justice but did not make clear whether it could quickly halt the sale of the Hims' product, the cheapest GLP-1 therapy on the U.S. market. Reuters reported on Thursday that Hims would begin offering copies of Novo Nordisk's new Wegovy pill at an introductory price of $49 per month, about $100 less than the brand name. NOVO, LILLY SHARES SOLD OFF The news caused a selloff in shares of Novo and rival Eli Lilly, whose own pill is expected to launch in April. The shares recovered some of the losses on Friday after FDA Commissioner Dr. Marty Makary tweeted his concern after the market's close on Thursday while Hims' shares fell. Compounding, in which pharmacies mix ingredients for specialized medicines or to copy a drug but at different dosages, has flourished as Americans chase cheaper prices for drugs. The practice is legal under the Federal Food, Drug and Cosmetic Act in certain circumstances. Novo on Thursday responded to Hims' launch by threatening legal action against the company while Lilly, which has battled compounded copies of its injectable drug Zepbound, said that patients deserved better than copies with no clinical evidence. Hims' compounded drug is not FDA-approved and has not gone through clinical trials to prove efficacy. Novo and Lilly did not immediately respond to a Reuters request for comment on Saturday. Hims & Hers did not respond to a Reuters query about whether it would continue selling compounded semaglutide injections on its website. The company, alongside Novo and Lilly, is spending millions during Sunday's Super Bowl to promote its offerings. NOVO IN MARKET SHARE FIGHT Novo has been losing share in the weight-loss market to rival Lilly and telehealth firms like Hims. Novo and Hims had a partnership in 2025 allowing Hims to sell injectable Wegovy, but the two companies walked away with Novo saying Hims had wrongfully marketed copycats of Wegovy. Hims' CEO Andrew Dudum accused Novo of attempting to control how clinicians at Hims make decisions. Makary said in a statement on Friday that the agency will "use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns." HHS, which oversees the FDA, was not immediately available for comment. (Reporting by Anusha Shah and Amina Niasse; Editing by Caroline Humer and Andrea Ricci)

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