The U.S. Food and Drug Administration (FDA) has announced that it is halting the sale of Hims & Hers Health's generic weight-loss drug. The San Francisco-based telehealth company had been permitted to sell a generic version of a popular diabetes and weight loss drug while it was deemed to be in short supply. However, the FDA has now declared that the shortage of the GLP-1 injectable has been resolved, allowing pharmaceutical companies like Novo Nordisk and Eli Lilly to regain control of the market.
Hims & Hers Health had capitalized on the drug shortage by developing copycat compounded versions of the medications, as permitted by the FDA. However, the FDA determined that the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. This means that drugs like Eli Lilly’s Mounjaro, used to treat diabetes, and Zepbound, used for weight loss, can now keep up with current demand. The removal from the shortage list could effectively bar the commercial production of knock-off tirzepatide products, according to Yahoo Finance.
However, Hims’ weight-loss injection does not use tirzepatide. Its injection is a compounded form of semaglutide, the medicine sold by Novo Nordisk as Ozempic and Wegovy, which remains on the FDA’s shortage list. Thus, Hims & Hers contends that the FDA’s move doesn’t affect it at all and doesn’t preclude the compounding of GLP-1 drugs.
The news of the FDA's decision led to a nearly 10% drop in Hims & Hers' stock in pre-market trading.