Drugmaker AbbVie scolded by the FDA over ‘misleading’ advert featuring Serena Williams

Serena Williams crying
An emotional Serena Williams

US government watchdog, the Food and Drug Administration have issued official correspondence to drugmakers AbbVie, informing the company that advertisements for their migraine medicine featuring tennis legend Serena Williams are misleading.

The agency claimed the advertisements overstate the benefits of the medicine marketed under the name Ubrelvy.

In their letter, the FDA adds that the treatment appears to show Williams’ migraine instantly going away when in reality, it would likely take multiple doses and several hours to experience any relief.

The agency took a dim view of the company using the celebrity of the tennis star to make their claims appear to be more credible.

“Health 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 FDA wrote.

The advert features a testimonial from Williams during which she says: “With Ubrelvy, there’s another option. One dose works fast to eliminate migraine pain.”

However, studies suggest that most users do not see a reduction in moderate to severe headache pain to no pain after two hours of taking a single dosage.

According to the study, between 19% and 22% of participants were pain-free after two hours.

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The collaboration between AbbVie and Williams began in 2020. Williams stated that she had long suffered from migraine episodes.

“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, a vice president at AbbVie, said in 2020.

“As a respected athlete, entrepreneur and mother, Serena continues to push boundaries time and again. She is a shining example of how to successfully navigate life’s challenges while fighting migraine. We are pleased she has been able to find relief from her migraine pain with UBRELVY.”

The FDA recently issued an enforcement letter in which the agency appeared to signal that they will apply a stricter standard for prescription drug advertisements that use a celebrity endorser.

The legal bases for the FDA’s position are as yet untested and unexplained in the agency’s letter, but it is hard not to wonder whether FDA is signaling an emerging policy campaign to discourage (if not seek to outright ban) the use of celebrities in prescription drug ads.

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