Two U.S. senators, along with a pharmaceutical industry group, are calling on the U.S. Food and Drug Administration (FDA) to investigate a Super Bowl advertisement for weight-loss drugs promoted by the telehealth platform Hims and Hers. The ad, which highlights compounded GLP-1 medications, has sparked controversy due to concerns over its accuracy and the lack of FDA approval for the products featured.
In a joint letter, Senators Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.) expressed their concerns that the advertisement may be misleading consumers. The senators pointed out that while FDA-approved GLP-1 medications, such as Wegovy and Ozempic, include critical safety information, the ad did not disclose potential side effects commonly associated with these drugs—such as nausea, vomiting, and abdominal pain.
The Partnership for Safe Medicines, an industry coalition, also weighed in, accusing Hims and Hers of promoting a “blatantly misleading” ad that poses a significant risk to public health. The group emphasized that while FDA-approved versions of GLP-1 medications have undergone rigorous testing, compounded versions, such as those offered by the company, may not meet the same safety and quality standards.
In its defense, Hims and Hers asserted that the ad accurately reflects the company’s role as a telehealth platform connecting patients with licensed healthcare providers. The company clarified that it does not manufacture the drugs but provides prescriptions for compounded medications when deemed appropriate by medical professionals. Hims and Hers also emphasized that it includes clear disclaimers in its advertising stating that the compounded products are not FDA-approved or evaluated for safety and efficacy.
The company further argued that the criticism of the ad is part of a broader attempt to stifle its marketing, which it claims sheds light on deficiencies within the U.S. healthcare system. “This is a clear attempt by industry groups to cancel an advertisement that directly calls out how they are part of a system that fails to prioritize the health of Americans,” the company said in a statement.
As of now, the FDA has not commented on whether it will review the advertisement or take any further action. The ongoing debate highlights the tensions between innovative healthcare marketing and the need for consumer protection in an increasingly complex pharmaceutical landscape.
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