US FDA Alleges Novo Nordisk’s Video On Weight-loss Drugs Featuring Oprah Winfrey Is ‘False Or Misleading’

The U.S. Food and Drug Administration has sent a letter to Novo Nordisk (NVO) CEO Maziar Mike Doustdar regarding the company’s promotional communication featuring Oprah Winfrey, alleging that the video is false or misleading.

The video originally appeared on ABC as a Primetime Oprah Special on March 18, 2024. It also subsequently appeared on Hulu. The video is a 42-minute special program hosted by Oprah Winfrey, featuring patient testimonials from individuals who struggle with obesity and excessive weight, including those who have used Novo’s Wegovy, Ozempic, or Victoza.

The FDA alleged in a letter dated September 9 that the video misbranded Novo’s Wegovy, Ozempic, and Victoza, making its distribution violative. The video was also not submitted at the time of initial dissemination or publication as required by law, the agency said.

“These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety of Wegovy, Ozempic, and Victoza, which are drugs with multiple serious, potentially life-threatening risks,” the agency said.

The FDA also noted that obesity and type 2 diabetes are significant public health concerns in the U.S., and consumers who seek medical treatment for these conditions should receive truthful and nonmisleading information regarding the serious risks associated with the use of the drugs. While Novo’s Wegovy is used for weight management, its Ozempic and Victoza are used to treat type 2 diabetes.

The FDA said that several advisory comments dated as long back as 2010 addressed draft promotional communications for Victoza with certain similarities to the aforementioned video. The agency expressed concerns that Novo is promoting the three drugs in a manner that fails to present the serious risks of these drug products in a truthful and nonmisleading manner, despite the FDA’s prior comments.

While the video includes numerous representations of the benefits of Wegovy, Ozempic, and Victoza made by representatives of Novo Nordisk, it omits important risk information or minimizes the risks associated with these drug products, the FDA said. Only four minutes in total were devoted to the important risks associated with GLP-1 drugs, such as Wegovy, the FDA said.

The video also omits reference to how the drugs are contraindicated in patients with a personal or family history of Medullary Thyroid Cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2, it added. The omissions are exacerbated by statements from Amanda Velazquez, a paid consultant of Novo, made on the video, the FDA said.

NVO stock is down by 33% this year and by 58% over the past 12 months. 

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