The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently sent an Untitled Letter to AbbVie, Inc., regarding a television ad starring Serena Williams for its migraine medicine Ubrelvy. According to the letter, the television ad misbrands the drug and therefore, its distribution is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
OPDP took issue with the ad as it “misleadingly suggests that Ubrelvy will provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated.” Additionally, the letter notes that “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.”
OPDP stated that it previously sent advisory comments to Ubrelvy’s former application holder, Allergan, Inc., regarding certain misleading claims and presentations for the drug. While Allergan is no longer the application holder, “OPDP is concerned that AbbVie, Inc. appears to be promoting Ubrelvy using similar claims and presentations in a misleading manner.”
Specifically, OPDP notes that claims and presentations made in the commercial “misleadingly suggest that Ubrelvy provides greater benefits to patients with acute migraine headache than has been demonstrated,” seeming to take issue with the speed with which Ubrelvy appears to eliminate migraine headaches.
According to the clinical studies section of the Ubrelvy prescribing information, the efficacy of Ubrelvy for the acute treatment of migraine was established in two clinical trials based on two endpoints: (1) effect on pain freedom at two hours post-dose and (2) effect on most bothersome symptom (i.e., photophobia, phonophobia, nausea) freedom at two hours post-dose, when compared to a placebo. Roughly 19% to 22% of patients achieved pain freedom at two hours after receiving one dose of Ubrelvy, according to the studies. OPDP notes that while the claim “Some people had pain freedom within 2 hours” appears in a small SUPER in the commercial, it is “not sufficient to mitigate this misleading suggestion that Ubrelvy can eliminate migraine pain and symptoms more quickly than has been demonstrated.”
Additionally, OPDP notes that the claim that just one dose works fast to eliminate migraine pain is misleading as it suggests that all patients who take the prescription medication can expect their migraine pain to be gone after just one single dose of Ubrelvy, a claim that has not been supported.
OPDP requested AbbVie provide a written response to the letter within 15 working days and stop any violations of the FD&C Act.
This is not the first letter OPDP has sent in 2024 regarding a promotional material that involves a celebrity or influencer. A promotional post made by an NFL wife was also the cause of an Untitled Letter regarding a post promoting Auvi-Q. This may be an indication that the FDA and OPDP plans to continue to crack down on influencer and celebrity promotions of prescription drugs.
For a copy of the Untitled Letter, click here. For a copy of the promotional material at issue, click here.