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Investing.com -- Shares in Hims & Hers slipped in premarket trading on Monday, days after the U.S. Food and Drug Administration (FDA) Commissioner Martin Makary said the telehealth firm’s Super Bowl commercial violated federal rules by promoting weight-loss drugs without disclosing possible risks.
The stock was down 2.8% as of 06:55 ET (10:55 GMT).
Makary, writing in the medical journal JAMA, noted that federal law requires prescription drug ads to provide a “fair balance” of both benefits and side effects.
He also pointed to a sharp decline in FDA oversight, saying the agency once issued hundreds of warning letters annually in the late 1990s but sent only one in 2023 and none in 2024.
A spokesperson for Hims & Hers pushed back, saying 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 criticism comes as the Biden administration signals tougher scrutiny of drug advertising. On Tuesday, President Donald Trump signed a memorandum instructing regulators to ramp up enforcement of direct-to-consumer pharmaceutical marketing standards.
That same day, the FDA announced plans to send roughly 100 cease-and-desist notices and thousands of warning letters to drugmakers, underscoring that companies must comply with advertising rules.