Hims is in the crosshairs. What does it mean for compounding?
In January, Novo Nordisk started selling a pill form of Wegovy, its previously injection-only weight loss medication. But for many Americans, it was old hat. They’d already been able to access semaglutide as a pill — and mints, and gummies, and even something that looks like a dissolvable breath strip — from compounding pharmacies and telehealth companies for more than a year.
And yet, when Hims & Hers — one of the largest telehealth platforms offering semaglutide — announced it would offer its own compounded version of the pill last week, the hammer came down swiftly.
By Friday, the Food and Drug Administration said it would take “decisive steps” to restrict compounded GLP-1s from being mass marketed as similar to FDA-approved drugs, naming Hims specifically. The Department of Health and Human Services asked the Department of Justice to investigate the company for potential violations of the Food, Drug, and Cosmetic Act (FDCA). Over the weekend, Hims backed down, saying it would stop selling the pill, only to have Novo Nordisk file a patent infringement lawsuit on Monday. Hims stock has fallen 35% since Thursday.
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