The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently sent an Untitled Letter to Merz Pharmaceuticals over a social media promotion for its injectable XEOMIN. In the Untitled Letter, OPDP notes that the post was made by Merz Pharmaceuticals GmbH (Merz) on the Xeomin Aesthetics Instagram account and Nate Berkus on his personal Instagram account and was labeled as a “paid partnership.”
OPDP states that the post on Instagram made “false or misleading representations and suggestions about the risks and efficacy of Xeomin,” thereby misbranding Xeomin “within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” OPDP found the violations concerning “from a public health perspective because the promotional communication creates a misleading impression regarding the safety and effectiveness of Xeomin, a drug with a number of serious and potentially life-threatening risks, including a boxed warning regarding the risk of distant spread of toxin effects.”
OPDP noted that the social media post was misleading “because it fails to present information relating to side effects and contraindications associated with the drug with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug.” One example is Berkus dancing around the room, preparing for a night out, during which he voices over the video saying Xeomin is a “smart tox” and it “smoothes the look of frown lines” and keeps him “looking fresh.”
The social media post also displays the indication and use of Xeomin as static text on the screen during the first forty seconds or so of the reel while risk information is presented only at the end of the reel, after Berkus says “see you guys at the next big event,” turning around and walking out the door. After Berkus walked out the door, and before the risk information started scrolling on the screen, the screen blacked out with no audio, perhaps causing viewers to think the reel was over, leading them to miss the presentation of the risk information entirely. OPDP further notes that “the reel does not present any signal to alert the viewer that important risk information is presented after the close of Nate Berkus’s presentation.”
OPDP stated that “the overall effect of this presentation undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Xeomin.
In addition to the presentation, OPDP took issue with some of Berkus’ voiceover, particularly when he said Xeomin is a “double-filtered smart tox that smoothes the looks of frown lines with only the ingredients that you need for treatment,” misleadingly suggesting that Xeomin offers benefits over other botulinum toxin products because of its manufacturing process and formulation, when no such benefits have been demonstrated to the FDA.
In the letter, OPDP notes that it previously submitted advisory comments to Merz that addressed certain topics and that the agency is concerned that “Merz is not presenting the benefits and serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP.”