FDA cites Novo Nordisk for airing misleading Wegovy ad
In a letter sent last week, the US Food and Drug Administration (FDA) said that a TV ad for Novo Nordisk's Wegovy (semaglutide) tablets misleads consumers into thinking the pill is better than other glucagon-like peptide-1 (GLP-1) receptor agonists that are currently only available as injectables.On 5 February, FDA’s Office of Prescription Drug Promotion (OPDP) sent Novo Nordisk an untitled letter stating that a TV ad the company produced to air in January made false or misleading claims. The ad states that the Wegovy pill is the first and only FDA-approved GLP-1 weight loss drug that can help people lose weight and keep it off.
FDA said the totality of the claims in the ad misleads consumers and suggests that, since the drug is in pill form, rather than an injectable like other GLP-1 drugs, it is superior to the other drugs.
"Specifically, 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," said FDA. "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.
"Additionally, they misleadingly imply benefits beyond physical weight loss such as emotional relief, reduced psychological burden, hope, or direction for patients’ lives, positioning the drug as a solution to broader life challenges rather than a treatment for a specific condition, when this has also not been demonstrated," the agency added.
(Source: YouTube - Commercial Archivist)
FDA said that it is not aware of any data to support claims that the pill version of Wegovy is superior to other similar injectables and asked the company to provide any information that would prove otherwise. Furthermore, that company said that some of the major statements in the ad were not in the voice-over but in text, which is also considered misleading because the major statements need to use dual modality to concurrently present information in audio and text.
"Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all promotional communications (with the 2253 submission date) for Novo Nordisk that contain representations like those described above, and explaining your plan for the discontinuation of such communications, or for ceasing distribution of Wegovy," said FDA. "If you believe that your products are not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 working days from the date of receipt of this letter."
After FDA sent the untitled letter to Novo Nordisk, the company aired a different ad during Super Bowl LX that included several celebrities, including Kenan Thompson, DJ Khaled, and Danny Trejo.
Untitled letter
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