By Evie Liu
Hims & Hers Health said Saturday that it would no longer offer a compounded version of the popular weight-loss medicine Wegovy, following increased scrutiny from federal regulators.
Hims announced on Thursday the offering of its copycat drug of Wegovy, which is sold by Danish drugmaker Novo Nordisk, at a sharply discounted price -- starting at $49 per month, compared to Wegovy at $149.
Unlike Wegovy, the Hims product has not been reviewed or approved by the FDA for safety or effectiveness. While U.S. law allows compounded drugs under limited circumstances, regulators have warned that they run the risk of misleading advertising if the marketing implies that they have similar effects as FDA-approved drugs.
"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," Hims said in a statement to Barron's. "We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care."
The news comes after Mike Stuart, general counsel for the Department of Health and Human Services, wrote in a post on X Friday afternoon that the agency had referred Hims to the Department of Justice for investigation.
Stuart said the referral was for investigation of potential violations by Hims of the Federal Food, Drug, and Cosmetic Act -- the main U.S. drug law enforced by the Food and Drug Administration -- and applicable Title 18 provisions, which covers federal crimes. Stuart's post on Friday did not explicitly name Hims' copycat drug.
"Hims & Hers has always operated with a deep commitment to the safety and best interests of consumers and in compliance with applicable law. We have a long history of successfully working with regulators, and look forward to continuing to engage with the FDA to ensure safe access to affordable healthcare," Hims said in a Friday statement to Barron's, before it decided to pull back the drug.
Hims stock dropped 2% on Friday during the regular session, while Novo shares rallied 10%. Shares of Hims tumbled more than 12% on Friday in after-hours trading, while Novo shares jumped 4.2%.
Novo Nordisk said in a statement on Thursday that Hims' product is "illegal" and "poses a significant risk to patient safety."
Hims said in a post on X on Thursday, "This is not the first time (nor will it be the last time) a big pharma company has suggested taking an accessible, customer-first approach to healthcare is dangerous, illegal, or bad for the marketplace."
On Thursday, FDA's commissioner Dr. Marty Makary said in a post on X that the agency would "take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products." Makary didn't refer to Novo or Hims by name.
George Glover contributed to this article.
Write to Evie Liu at evie.liu@barrons.com
This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.
(END) Dow Jones Newswires
February 07, 2026 15:42 ET (20:42 GMT)
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