Novo Nordisk has received a second warning letter from the FDA in less than a month, this time over an advertisement promoting its blockbuster diabetes drug Ozempic.
In a Feb. 26 letter, the FDA said a direct-to-consumer television advertisement titled “There’s Only One Ozempic” contains “false or misleading” claims about the drug’s benefits. Regulators said the ad misrepresents efficacy and creates the impression that the medication is superior to other GLP-1 treatments for Type 2 diabetes without evidence to support the claim.
Specifically, the agency said the ad misleadingly suggests all adults with Type 2 diabetes are eligible for Ozempic’s FDA-approved uses, when certain indications apply only to patients with conditions such as established cardiovascular disease or chronic kidney disease.
Regulators also said the tagline “There’s Only One Ozempic” and dialogue portraying competing GLP-1 drugs as having fewer benefits creates an unsupported impression that the drug is superior to other treatments. The agency also said the video minimizes risk disclosures and misbrands the drug in violation of the Federal Food, Drug and Cosmetic Act.
The FDA asked Novo Nordisk to take immediate action to address the violations and respond within 15 working days.
“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,” a Novo Nordisk spokesperson said in a statement to Bloomberg.
The letter follows a Feb. 5 warning from the FDA over a TV advertisement for Novo Nordisk’s newly approved Wegovy pill. In that case, regulators said the company made misleading claims suggesting the drug produced superior weight-loss results compared with other GLP-1 therapies and improperly framed the treatment as offering broader emotional benefits.
The warning letters come amid a broader FDA crackdown on misleading pharmaceutical advertising tied to the booming GLP-1 market. On March 3, the agency said it had issued 30 warning letters to telehealth companies over what it said were false or misleading claims about compounded GLP-1 products on their websites.
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