FDA says Novo Nordisk’s obesity pill TV ad includes misleading claims
Still life of new Wegovy semaglutide tablets on white background. It is a prescription medication used in conjunction with a reduced-calorie diet and physical activity.
Michael Siluk | Universal Images Group | Getty Images
The Food and Drug Administration said: Novo NordiskA TV ad for the newly launched Wegovy pill against obesity contained “false or misleading” claims about the drug’s capabilities and benefits to patients.
One letter to Novo The FDA on Feb. 5 said the ad misbranded the oral drug and made its distribution a violation of federal law. The agency demanded that the drugmaker take immediate action to address the violations, which could include stopping all ads containing misleading claims.
Novo Nordisk confirmed in a statement Monday that it had received the letter and clarified that the ad had been running since the pill’s launch but was not the company’s Super Bowl ad.
“We take all feedback from regulators seriously and are in the process of responding to the FDA to address their concerns about the presentation of the ad,” Liz Skrbkova, Novo’s head of U.S. media and stakeholder relations, said in a statement. he said.
This adds to the growing hurdles the Danish drugmaker faces as it struggles to regain market share from its chief rival Eli Lilly and cheaper compound copies in the emerging GLP-1 market.
The company’s Wegovy pill is key to these efforts. It was the first GLP-1 obesity pill to hit the market in January, and Novo said last week that more than 170,000 American patients have already received the drug.
Bloomberg The FDA letter was first reported Monday.
In the letter, the FDA said Novo’s advertising misleadingly suggested that its pill offered superior benefits over other approved GLP-1 weight loss drugs. The agency said phrases like “live lighter” and “a path forward” used at this point imply greater weight loss and additional benefits beyond that over other treatments, although there is no evidence to support these claims.
In the letter, the FDA said the statements in the ad “misleadingly imply benefits beyond physical weight loss, such as emotional relief, reduced psychological burden, hope, or direction to patients’ lives, positioning the drug as a solution to broader life challenges rather than a treatment for a specific condition.”
The FDA also flagged the ad for failing to properly present risk information in both audio and text, a requirement for drug advertising on television.
Also on Monday, Novo Nordisk filed a lawsuit His and Hersasked the court to stop the telehealth company from mass marketing compounded versions of the Wegovy pill and injections.
