The Food and Drug Administration cited AbbVie for making misleading claims about a migraine pill in TV ads featuring tennis legend Serena Williams and ordered the company to come up with a plan for discontinuing the ads or halting distribution of the drug.
Why it matters: While the FDA has the authority to police advertising, it doesn’t regularly issue warnings like the one for AbbVie’s Ubrelvy, which was posted on the agency’s website on Wednesday.
What they’re saying: The FDA said representations that “one dose works fast to eliminate migraine pain” are misleading and weren’t demonstrated in clinical trials.
AbbVie’s use of a celebrity athlete in the ad furthermore “amplifies the misleading representations” and increases the potential for consumers to find the misleading ad more believable, the agency said.
The FDA noted that it raised similar concerns in 2020 when the drug was promoted by Allergen, which was subsequently acquired by AbbVie. Regulators are “concerned that AbbVie Inc. appears to be promoting Ubrelvy using similar claims and presentations in a misleading manner.”
AbbVie told Bloomberg News it’s addressing the FDA’s concerns and that it stopped airing the ad in the first half of this year. The company said it will continue to further correspond with the FDA on the matter.
Go deeper: The ads featured Williams appearing to experience migraine pain in a talk show dressing room, then walking down a blue corridor and holding up a 100-milligram dose packet of Ubrelvy.
In a voiceover, the 23-time Grand Slam winner discusses the tradeoffs of treatment versus coping with pain and symptoms.
The ad concludes with her walking on the blue path onto a brightly lit stage, smiling and waving to the studio audience.
Migraines affect one in six Americans within any three-month period, making them one of the most common debilitating neurologic conditions in the U.S., the FDA said.
