- A pair of bipartisan senators, as well as an industry group, are asking the FDA to review a Super Bowl ad for weight loss medication from a popular telehealth platform. The senators are concerned that the FDA did not approve the products.
- In a letter, Partnership for Safe Medicines said that the ad is “blatantly misleading.” They say it poses a “substantial risk” to consumers.
- Hims and Hers, the telehealth company behind the ad, said it’s being stifled. The company says their marketing highlights flaws in the healthcare system.
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Two senators and an industry group are calling for a U.S. Food and Drug Administration (FDA) review of a Super Bowl ad by the telehealth platform Hims and Hers, which promotes compounded GLP-1 weight loss medications. The senators expressed concern that the FDA did not approve the advertised products. They also say the medications do not list potential side effects.
In a letter, Sens. Dick Durbin, D-Ill., and Roger Marshall, R-Kan., urged the FDA to ensure the advertisement complies with federal regulations governing prescription drug advertising. They said FDA-approved labels and advertisements for brand-name GLP-1 medications include information about side effects. Those include nausea, vomiting, diarrhea, constipation and abdominal pain.
The Partnership for Safe Medicines, a pharmaceutical industry group, said in a separate letter to the FDA that the ad is “blatantly misleading.” They say it poses a “substantial risk” to consumers.
The organization pointed out that the FDA has approved GLP-1 medications such as Wegovy and Ozempic for weight loss. However, they say compounded versions of the drugs may not meet the same safety and quality standards.
In response, Hims and Hers defended its advertisement, emphasizing that the company is not a drug manufacturer but a telehealth platform that connects customers with licensed healthcare providers. According to the company, the ad accurately represents its services. They note they include the option for healthcare providers who can prescribe compounded medications when appropriate.
“We follow all applicable laws and regulations when it comes to advertising access to treatments available through our platform,” the company stated in a response. “We always include clear language that compounded products are not FDA-approved or evaluated by the FDA for safety, efficacy, or quality.”
Hims and Hers said the pushback is an attempt to stifle the advertisement. The company says it highlights flaws in the 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 to SAN. “The system is broken, and this is just another example of how they don’t want Americans to know they have options.”
The FDA had not yet commented on whether it will review the advertisement or take further action.
