The Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) has issued a Notice of Violation (NOV) to a pharmaceutical company for running a misleading television advertisement for a prescription migraine medication. The ad, which featured tennis star Serena Williams, overstated the drug's ability to quickly eliminate migraine pain, according to the FDA.
Overstated Efficacy Claims
The OPDP found that the advertisement made false and misleading claims regarding the speed at which the medication works. The ad claimed the product "works fast to eliminate migraine pain" and "QUICKLY ELIMINATES MIGRAINE PAIN." However, the FDA noted that clinical trials showed only up to 22% of patients experienced pain freedom within two hours of taking a single dose.
The agency also took issue with the claim that "One dose works fast to eliminate migraine pain," arguing that it "misleadingly suggests that all patients who take [the product] can expect their migraine pain to be eliminated after a single dose of [the product], when this has not been demonstrated." Clinical trial data indicated that 78% to 81% of patients did not achieve pain freedom after a single dose.
Misleading Visual Presentation
The OPDP also scrutinized the visual elements of the ad, which depicted Williams experiencing migraine pain and then suddenly appearing upbeat after holding the product. The FDA argued that this "compelling before-and-after presentation," combined with the efficacy claims, "misleadingly suggests that [the drug] eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials."
Impact of Celebrity Endorsement
The FDA further noted that using a celebrity athlete like Serena Williams in the ad "amplifies the misleading representations and suggestions" and increases the likelihood that viewers will find the message more believable due to the athlete's perceived credibility.
Prior Communication and Due Diligence
Notably, the OPDP had previously communicated similar concerns about product claims to the previous owner of the drug. The agency acknowledged the change in ownership but emphasized that the claims in the current TV ad mirrored those from earlier communications, underscoring the importance of due diligence regarding past regulatory feedback when acquiring pharmaceutical products.
Broader Implications for Pharmaceutical Advertising
This NOV underscores the FDA's close monitoring of pharmaceutical advertising, particularly claims related to efficacy and speed of action. The agency's scrutiny extends beyond explicit statements to encompass the overall impression conveyed by an advertisement, including visual elements and the use of celebrity endorsements. Pharmaceutical companies must ensure that their promotional materials accurately reflect clinical trial data and avoid creating misleading expectations about the benefits of their products.
