Not long after Novo Nordisk received an untitled letter from the FDA disputing certain elements of the first TV spot for its Wegovy pill, another of the Danish drugmaker’s GLP-1 ads is in the regulator’s crosshairs.
The latest letter comes exactly three weeks after the previous one, which primarily took issue with what the FDA perceived as the “Live Lighter” ad’s implication that the Wegovy pill offered “an advancement or improvement” over other GLP-1s, though that hasn’t been clinically proven.
The new missive (PDF) is dated Feb. 26 and was uploaded to the FDA’s public database Tuesday afternoon. It homes in on one of the digital ads released as part of Novo’s “There’s Only One Ozempic” campaign, which launched in January and reunited actor Justin Long and comedian John Hodgman to riff on the “Get a Mac” Apple ads they starred in throughout the late 2000s.
According to the FDA, the ad in question “includes claims and presentations that misrepresent the efficacy of Ozempic.”
The spot shows Long and Hodgman—portraying Ozempic and “other GLP-1s for Type 2 diabetes,” respectively—joined by another character named Stan to list out Ozempic’s approved indications, including lowering A1C and reducing the risk of major cardiovascular events and worsening kidney disease.
The FDA claimed in its letter that the way the information is presented may inaccurately suggest to viewers that “all patients with type 2 diabetes are candidates for all the FDA-approved indications for Ozempic,” even though the latter two indications are approved only in Type 2 diabetes patients who also have, respectively, established cardiovascular disease or chronic kidney disease.
The regulator acknowledged that the full indication information is included in onscreen text alongside Stan’s lines, but said “the inclusion of this information is not sufficient to correct the overall misleading impression created by the claims in the voiceover at the beginning of the video.”
Elsewhere in the letter, the FDA took aim at the clip’s final joke, in which Hodgman’s character is told by Stan that he doesn’t have as many FDA-approved uses as Ozempic and retorts by showing off a bird call.
There, the FDA took umbrage at the standard marketing practice of framing an advertised product as superior to its competitors, which the agency noted was further compounded by the choice to have Long’s character in a bright orange shirt and Hodgman’s in dull gray.
The FDA pointed out that Ozempic’s approval is not based on clinical data showing superior efficacy to other GLP-1s for Type 2 diabetes—though, again, the ad centers its superiority claim on the number of FDA-approved indications for Ozempic, where its med does indeed have the upper hand over competitors.
Finally, the regulator scolded Novo for failing to “present any signal to alert the viewer that important risk information follows the close of the interaction between the two actors,” as the required presentation of Ozempic’s risk info is saved until after the ad’s storyline is complete and the jingle has played.
“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 spokesperson said in a statement to Fierce Pharma Marketing.
“Novo Nordisk is committed to responsible advertising that is accurate, balanced and meets all FDA regulatory and compliance standards,” the spokesperson added. “We believe in Ozempic and it is our hope that patients who can benefit from it are aware of it and encouraged to have an informed discussion with their healthcare professional.”