FDA Commissioner Targets telehealth company in Push Against Prescription Drug Advertising. Hims & Hers Health has become the central focus of a new federal crackdown on prescription drug advertising after its controversial Super Bowl commercial promoting weight-loss medications. Food and Drug Administration (FDA) Commissioner Dr. Marty Makary has repeatedly criticized the telehealth company for failing to disclose risks associated with the drugs, calling the omission a clear breach of federal rules.
The scrutiny marks a major challenge for Hims, whose business model relies heavily on aggressive marketing to attract customers for its generic and compounded drug offerings. In 2024, the company reported spending $678.8 million on marketing, about 61% of its total operating expenses.
Ad Sparks Regulatory and Lawmaker Backlash
The dispute began earlier this year when Hims aired a Super Bowl ad portraying its weight-loss products as a consumer-friendly alternative to expensive branded drugs. The ad referenced “life-changing weight-loss medications” and featured Hims-branded vials resembling compounded versions of Novo Nordisk’s Wegovy, but it did not mention potential side effects.
FDA rules require ads making claims about a drug’s benefits to also disclose risks. While companies are not obligated to include disclaimers when no specific product is named, Makary and other critics argue that Hims’ commercial crossed the line by indirectly promoting its compounded GLP-1 treatments.
Several U.S. lawmakers raised concerns with the FDA just before the ad aired, citing its lack of disclosures. The issue intensified last week when Makary authored opinion pieces in national publications and medical journals, accusing Hims of advertising “with only upsides mentioned” and singling out the ad as the “most overt” violation of FDA standards.
A Hims spokesperson defended the campaign, saying it aimed to highlight the public health crisis of obesity rather than market a specific therapy. “The ad was designed to raise awareness of the barriers many face in accessing effective weight-loss care,” the spokesperson said.
Business Model at Stake
The FDA’s renewed focus on drug advertising comes amid broader efforts by federal health regulators to enforce stricter compliance. Makary has said the agency sent about 100 letters to companies over potentially unlawful ads, and Hims was reportedly among the recipients.
For Hims & Hers Health , the timing is particularly sensitive. The company had been selling large volumes of compounded GLP-1 weight-loss drugs during a national shortage of Wegovy but was bracing for that market to narrow once supply stabilized. Its Super Bowl ad appeared to position the firm as aligned with initiatives aimed at lowering drug costs. Instead, the strategy appears to have backfired, leaving the company isolated from regulators it once hoped to win over.
Despite regulatory headwinds, Hims’ stock has not yet shown significant damage. Shares rose more than 15% last week after the company announced plans to expand into testosterone treatments for men. However, the stock dipped 0.6% on Monday following Makary’s latest critique.
Outlook for Telehealth company Advertising
The Hims & Hers Health case underscores the risks facing telehealth company that rely on heavy marketing to drive prescription sales. While digital-first platforms have attracted consumers with convenience and lower costs, federal regulators are signaling a stricter stance on how such firms present their offerings to the public.
If the FDA enforces tighter standards, companies like Hims & Hers Health may be forced to overhaul their advertising strategies, potentially curbing their ability to grow as quickly in the competitive telehealth company marketplace. For now, investors and patients alike are watching closely as the agency decides how far to push its crackdown.
Also Read :- WHO Adds GLP-1 Weight Loss Drugs to Essential Medicines List for First Time
