The FDA sent a letter to AbbVie saying that an ad for its migraine medication Ubrelvy was overhyping the drug
By
Bruce Gil
Published8 hours ago
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Serena Williams attends the 2024 ESPY Awards at Dolby Theatre on July 11, 2024 in Hollywood, California.
Serena Williams attends the 2024 ESPY Awards at Dolby Theatre on July 11, 2024 in Hollywood, California.Image: Tommaso Boddi / Stringer (Getty Images)
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The U.S. Food and Drug Administration (FDA) reprimanded AbbVie (ABBV) over an ad for its migraine medication, Ubrelvy, that featured tennis star Serena Williams.
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“The TV ad makes false or misleading representations and suggestions about the efficacy of Ubrelvy,” the agency said in letter sent to the pharma giant on Aug. 29 — and published this Wednesday on the FDA website.
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The FDA took issue with the ad’s suggestion that the drug worked faster than scientifically proven.
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In the ad, Williams is seen suffering from the symptoms of a migraine, but moments later, her symptoms are relieved, and she is shown holding a bottle of Ubrelvy. Williams states, “One dose works fast to eliminate migraine pain,” while the on-screen text claims the drug “quickly eliminates migraine pain.”
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The agency said that the “compelling before-and-after presentation” suggested Ubrelvy eliminated migraine pain faster than proven in clinical trials.
Studies showed the pill relieved migraine pain in about two hours. Although the ad included small print noting that some users experienced “pain freedom” within that time, the FDA argued this did not adequately address the misleading implications.
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Additionally, the FDA said, “the use of a celebrity athlete in this TV ad amplifies the misleading representations and suggestions made and increases the potential for audiences to find the misleading promotional communication more believable due to the perceived credibility of the source.”
AbbVie did not immediately respond to a request for comment from Quartz, however, it told STAT News that it is “actively addressing the FDA enforcement action regarding the TV commercial referenced in the letter, which stopped airing in the first half of this year.”
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This is the FDA’s fourth letter this year calling out pharma companies for misleading communications, STAT reported.
The FDA issued warning letters to Bristol Myers Squibb (BMY) for false claims about a lung cancer treatment, Kaléo for a deceptive social media post about an epinephrine injector, and Novartis (NVS) for misleading statements about a breast cancer treatment in a TV ad.
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