Shares of Hims & Hers (NYSE:HIMS) moved lower in premarket trading on Monday, following comments from U.S. Food and Drug Administration (FDA) Commissioner Martin Makary, who said the company’s Super Bowl advertisement broke federal rules by promoting weight-loss treatments without mentioning potential risks.
By 06:55 ET (10:55 GMT), the stock was down 2.8%.
In an article published in the medical journal JAMA, Makary emphasized that U.S. law requires prescription drug advertisements to provide a “fair balance” between highlighting benefits and outlining possible side effects.
He also drew attention to a steep drop in FDA enforcement, noting that while the agency sent out hundreds of warning letters annually in the late 1990s, it issued just one in 2023 and none last year.
Responding to the criticism, a spokesperson for Hims & Hers argued that the company’s “Super Bowl ad did not advertise any one treatment or solution. Rather, it aimed to raise awareness to a critical issue – the obesity public health crisis – by showcasing the impact of obesity and the realities of the lack of access to life-saving holistic weight loss care.”
The pushback arrives as the Biden administration signals a tougher line on pharmaceutical advertising. On Tuesday, President Donald Trump signed a memorandum directing regulators to step up enforcement of consumer-facing drug marketing rules.
That same day, the FDA announced it would be sending about 100 cease-and-desist orders along with thousands of warning letters to drugmakers, underscoring that firms are required to comply with advertising standards.
Hims & Hers aired its Super Bowl spot in February, highlighting compounded alternatives to Novo Nordisk’s Wegovy. Under U.S. law, compounding pharmacies can manufacture copies of branded medicines during shortages, and Wegovy experienced significant supply disruptions in 2024.
As a result, many consumers who were either unable to afford or access Wegovy turned to lower-cost compounded versions offered by pharmacies and telehealth firms such as Hims & Hers and WeightWatchers.
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