The Food and Drug Administration sent a letter to AbbVie, claiming that advertisements for a migraine medicine pill in TV ads featuring tennis legend Serena Williams are misleading, 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 oversee advertising, it does not frequently issue warnings like the one for AbbVie's Ubrelvy, which was posted on the agency's website on Wednesday.
The FDA notes that the treatment in the ad appears to make Williams' migraine disappear instantly, whereas, in reality, it may require multiple doses and several hours to achieve relief.
What they're saying:
Healt care providers, patients, and caregivers should not be misled regarding the benefits that can be expected from acute migraine headache treatments. Moreover, 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.The Food and Drug Administration (FDA)
AbbVie told Bloomberg News that it is addressing the FDA's concerns and has ceased airing the ad in the first half of this year. The company added that it will continue to engage with the FDA regarding the issue.
The ads depicted Williams initially experiencing migraine pain in a talk show dressing room. She then walks down a blue corridor, holding up a 100-milligram dose packet of Ubrelvy. The scene transitions to her confidently stepping onto a brightly lit stage, smiling and waving to the studio audience.
In a voiceover, the 23-time Grand Slam winner discusses the trade-offs between treatment options and managing pain and symptoms.
The ad ends with her walking along a blue path onto a brightly lit stage, smiling and waving to the studio audience.
The FDA stated that migraines affect one in six Americans within any three months, making them one of the most common debilitating neurological conditions in the U.S.
Studies show that most users do not experience a reduction from moderate to severe headache pain to no pain within two hours of a single dose.
The research indicates that only 19% to 22% of users achieved pain relief within this timeframe.
The partnership between AbbVie and Williams began in 2020. Williams said that she has long suffered from migraine attacks.
Serena’s endless accomplishments on and off the court make her the right spokesperson and role model to raise awareness about this debilitating disease.Aimee Lenar, Vice President, AbbVie (2020)
He further stated, “As a respected athlete, entrepreneur, and mother, Serena continues to push boundaries. She exemplifies how to navigate life’s challenges while managing migraine. We are pleased she has found relief from her migraine pain with UBRELVY.”
Reference:
1. “Bloomberg - Are you a robot?,” September 11, 2024. https://www.bloomberg.com/news/articles/2024-09-11/serena-williams-migraine-ad-from-abbvie-abbv-is-misleading-fda-warns.
(Input From Various Sources)
(Rehash/Simran Sethi/MSM)