Hims & Hers Faces FDA Heat As Commissioner Martin Makary Calls Out Super Bowl Ad For Hiding Drug Risks - Hims & Hers Health (NYSE:HIMS), Novo Nordisk (NYSE:NVO)

Core Viewpoint - Hims & Hers Health Inc. is accused of violating federal law with its Super Bowl advertisement promoting weight-loss drugs, as it failed to adequately disclose potential side effects of the drugs [1][2]. Regulatory Compliance - The FDA states that the advertisement did not present a balanced view of the benefits and risks associated with the prescription medication, which is a requirement for such ads [2]. - The FDA plans to increase enforcement actions against misleading pharmaceutical advertisements, including sending out approximately 100 cease-and-desist orders and thousands of warning letters [4]. Company Response - A spokesperson for Hims & Hers defended the advertisement, claiming it aimed to raise awareness about the obesity crisis rather than promote a specific treatment [3]. - The advertisement featured compounded versions of Novo Nordisk A/S's Wegovy during a period of nationwide supply shortages [3]. Historical Context - FDA enforcement has significantly declined, with only one warning letter issued in 2023 compared to hundreds in the late 1990s [5]. - The Hims & Hers advertisement has been labeled by the FDA Commissioner as "the most overt breach" of advertising regulations [5]. Stock Performance - Following the controversy, Hims & Hers Health stock closed at $55.50, reflecting an increase of $3.74 on the day of the announcement [5].