The FDA is urging Novo Nordisk to correct what it said were “misleading” claims the drugmaker made in a television advertisement for its new Wegovy pill.
The agency sent a letter to Novo Nordisk Feb. 5, accusing the drugmaker of making misleading claims that imply the pill delivers superior results relative to other approved GLP-1 treatments for weight loss.
“These claims and presentations misleadingly imply that Wegovy in pill form uniquely enables patients to achieve outcomes that were not previously possible with other GLP-1 treatments for weight loss,” the agency wrote in the letter. “For example, the claims ‘live lighter’ and ‘a way forward’ misleadingly imply additional weight loss compared to other currently approved GLP-1 treatments, when this has not been demonstrated.”
The FDA also said the advertisement misleadingly positions the drug as a solution to broader challenges beyond physical weight loss, such as emotional relief and reduced psychological burden. Parts of the ad are also in violation of rules requiring drugmakers to present risk information in both audio and text form, the FDA said.
“For the reasons described above, the TV ad misbrands Wegovy and makes distribution of the drug in violation of the [Federal Food, Drug, and Cosmetic Act],” the letter states.
Federal regulators requested Novo Nordisk respond to the letter within 15 business days, detailing how the violations will be addressed.
The FDA approved Novo Nordisk’s pill version of Wegovy in December. It is the first oral GLP-1 therapy cleared for weight loss. Healthcare analysts have said the pill may mark the fastest drug launch in the nation’s history, with more than 26,000 prescriptions reported in the third week after its approval.
A spokesperson for Novo Nordisk confirmed receipt of the letter in a statement to Becker’s.
“We take all regulatory feedback seriously and are in the process of responding to the FDA to address their concerns regarding the advertisement’s presentation,” the statement said.
“Novo Nordisk is committed to responsible advertising that is accurate, balanced and meets all FDA regulatory and compliance standards.”
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