The Office of Prescription Drug Promotion (“OPDP”) of the U.S. Food and Drug Administration (“FDA”) issued a Warning Letter to Duchesnay, Inc. on August 7, 2015, regarding a social media post by Kim Kardashian for DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, for oral use. The social media post was submitted as a complaint to the OPDP Bad Ad Program.
OPDP has now issued an Untitled Letter to Biohaven Pharmaceuticals for a violative direct-to-consumer video. The video features Khloé Kardashian, identified as a paid Biohaven Pharmaceuticals spokesperson (Spokesperson), talking about Nurtec™ ODT (rimegepant) which is indicated for the acute treatment of migraine with or without aura in adults. The video originally appeared on ABC’s The View on July 15, 2020 and was also accessible on YouTube. The video was also submitted as a complaint to the OPDP Bad Ad Program.
The video includes claims by the Spokesperson, such as, “. . . something that works in about 15-30 minutes . . .” and “It literally works within, for me, 15 minutes…". According to the Untitled Letter, these claims misleadingly suggest that patients treated with Nurtec ODT will experience “relief” within 15 to 30 minutes of taking the drug. The CLINICAL STUDIES section of the PI, states that the coprimary endpoints (freedom from pain and most bothersome symptoms) were measured beginning at 2 hours after dosing with Nurtec ODT and placebo. Therefore, OPDP explains, claims that the drug provides relief in 15-30 minutes are not supported by the clinical trial data, as there were no pre-specified endpoints that evaluated the efficacy of the drug at 15 or 30 minutes after dosing. Notably, the letter also includes reference to a super "AS EVERYONE EXPERIENCES MIGRAINE DIFFERENTLY. TREATMENT RESULTS MAY VARY" however, OPDP also states how this does not mitigate the misleading impression.
The video also includes comparative claims that are misleading, according to OPDP, "because they suggest that Nurtec ODT is clinically superior to or more effective than other prescription and over-the-counter (OTC) products, when this has not been demonstrated." OPDP also notes, among other things, that the word “gamechanger” is used in the video, which misleadingly suggests that Nurtec ODT is a significant advance over other currently available products, a claim that has not been demonstrated.
Additionally, OPDP cites that the video failed to adequately communicate the full FDA approved indication and limitations of use and failed to present other risk information in a manner that included "prominence and readability reasonably comparable with the presentation of information relating to the benefits of Nurtec ODT."
OPDP requests in the letter, that Biohaven Pharmaceuticals cease any violations of the FD&C Act.