Following over a 13% gain in the prior session, Hims & Hers (HIMS) traded lower after the U.S. FDA sent a new batch of warning letters to telehealth firms that illegally market low-cost compounded versions of GLP-1s, the popular class of weight-loss drugs marketed by Novo (NVO) and Lilly (LLY).
In a press release, the agency said that it sent 30 such letters to telehealth firms for using “false and misleading claims” to sell compounded GLP-1 products on their platforms.
Hims & Hers (HIMS) was forced to pull a compounded version of Novo’s (NVO) newly launched oral GLP-1 therapy, the Wegovy pill, last month after the product, offered at a sharp discount to the brand-name version, drew intense regulatory scrutiny.
“It’s a new era of enforcement. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action,” said FDA Commissioner Marty Makary.
The warnings are part of a crackdown the FDA launched in September, when it sent nearly 100 letters to companies making deceptive claims in direct-to-consumer advertisements of pharmaceutical products.
Hims & Hers (HIMS) was also among the recipients of the first set of warning letters as the FDA targeted its marketing practices related to compounded versions of semaglutide, the active ingredient of Wegovy.