The FDA’s Office of Prescription Drug Promotion sent a letter to AbbVie late last month, calling out the company for what it said was a misleading migraine drug television advertisement, and for using tennis superstar Serena Williams in the ad.
The agency took issue with not only how the ad “misleadingly suggests that Ubrelvy eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials,” but also for using Williams, a celebrity athlete who “amplifies the misleading representations and suggestions” and potentially makes the ad more believable.
“We acknowledge that the claim, ‘Some people had pain freedom within 2 hours’ appears in a small SUPER [superimposed text] on frame six. However, the SUPER is not sufficient to mitigate this misleading suggestion that Ubrelvy can eliminate migraine pain and symptoms more quickly than has been demonstrated,” the agency wrote in a letter dated Aug. 29.
An AbbVie spokesperson said via email, “We are actively addressing the FDA enforcement action regarding the TV commercial referenced in the letter, which stopped airing in the first half of this year. We will continue to further correspond with the FDA on this matter.”
This is the fourth untitled letter sent by the FDA’s OPDP in 2024.