The FDA recently provided its opinion on a pharmaceutical television ad that should help other pharmaceutical companies in their own advertisements.  The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) informed pharmaceutical company AbbVie that their television ad for migraine medication, Ubrelvy, featuring Serena Williams “…makes false or misleading representations and suggestions about the efficacy of Ubrelvy.” The letter focused on efficacy claims made in the advertisement.  The 30-second ad shows Serena Williams experiencing symptoms of a migraine while getting ready to go on stage. The ad then goes on to show how one dose of Ubrelvy helped Serena feel better, and she is later shown smiling and laughing as she walks onto a talk show stage. The FDA’s letter explains that in the original storyboard for the ad, Serena experiences migraine pain in the afternoon and feels better before her talk show appearance in the evening. The FDA contends that the televised ad does not accurately portray the time lapse that was in the storyboard version. The FDA stated that, “This compelling before-and-after presentation in conjunction with claims such as, “One dose works fast to eliminate migraine pain” and “UBRELVY QUICKLY ELIMINATES MIGRAINE PAIN” (emphasis added) misleadingly suggests that Ubrelvy eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials.” The letter also claims that the ad “…misleadingly suggests that Ubrelvy will provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated.” 

The drug’s label states that the drug can begin taking effect on migraine pain and other symptoms in two hours and the ad also included small text that read “some people had pain freedom within 2 hours”. The FDA found that these claims were misleading and supported their concern by stating that the clinical studies portion of the Ubrelvy PI revealed that only approximately 19% to 22% of patients achieved pain freedom at two hours after receiving one dose of Ubrelvy which means 78% to 81% of patients did not achieve pain freedom after receiving one dose. The FDA also expressed that using a celebrity athlete in the 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 letter is a reminder that the FDA continues to scrutinize pharmaceutical advertisements and that claims such as the amount of time it takes for a drug to provide relief must reflect the actual clinical trial findings. Moreover, the FDA will view advertisements that use celebrities more critically given the increased amount of credibility they create by being in the advertisement.

Crowell Health Solutions can assist with questions around pharmaceutical advertisements and reviewing storyboards and scripts for alignment with clinical data. Please reach out with any questions.