The U.S. Food and Drug Administration (FDA) said Novo Nordisk's television ads for its new weight-loss drug Wegovy made "false or misleading" claims about the drug's efficacy and benefits to patients. In a Feb. 5 letter to Novo Nordisk, the FDA noted that the ad was misleading about the oral drug.error identification, whose circulation violates federal law. The FDA requires pharmaceutical companies to take immediate action to correct the problem, including halting all advertising containing misleading content.
In a statement on Monday, Novo Nordisk confirmed it had received the letter and clarified that the ad had been airing since the tablets were launched, butNot its Super Bowl ad.
Liz Skebkova, head of media and stakeholder relations for Novo Nordisk U.S., said in a statement:
"We take all regulatory feedback seriously and are responding to the FDA's concerns about the advertising's representation."
In the hot GLP-1 market, the Danish pharmaceutical company is trying its best to regain market share from its main competitor Eli Lilly and cheap compound generic drugs. This advertising controversy will undoubtedly make the difficulties it faces even worse.
The company's Wegovy tablets are its core strength product. In January this year, it became the world’s first GLP-1 oral weight loss drug approved for marketing. Novo Nordisk said last week that more than 170,000 U.S. patients are taking the drug.
In its letter, the FDA noted that Novo Nordisk’s advertisingmisleading suggestionIts tablets work better than other approved GLP-1 weight-loss drugs. Phrases such as "living easier" and "a new way out" used in the advertisements imply that its weight loss effect is better than other treatments and that it has additional benefits, but there is no evidence to support these claims.
The FDA wrote in the letter: "The advertising content misleadingly implies that the drug can bring benefits such as mood relief, psychological burden reduction, hope, and life direction in addition to weight loss, and packages the drug as a solution to a broader life problem rather than a treatment for a specific condition, none of which has been proven."
The FDA also noted that the ad did not comply with television drug advertising requirements.Complete and standardized disclosure of risk information in audio and subtitles.
Also on Monday, Novo Nordisk filed a lawsuit against telemedicine company Hims & Hers, asking a court to ban the company from mass sales of combined versions of Wegovy tablets and injections.