The US Food and Drug Administration’s of Prescription Drug Promotion (OPDP) has called for integrated healthcare company Sanofi-aventis and global biopharmaceutical company Celgene, to stop broadcasting two of their direct-to-consumer television advertisements due to their misleading nature.
False advertising
Similar letters, which were the sixth and seventh untitled and warning letters issued by OPDP in 2016 stated: “The presentation of these compelling and attention-grabbing visuals, all of which are unrelated to the risk message presented in the audio and on-screen SUPERS [superimpositions], in addition to the frequent scene changes and the other competing modalities such as the background music, compete for the consumers’ attention. As a result, it is difficult for consumers to adequately process and comprehend the risk information.”
The adverts for Sanofi’s diabetes treatment toujeo (insulin glargine) and Celgene’s psoriasis and psoriac arthritis treatment Otezla (apremilast) are both stated to make misleading representations about the risks associated with the products.
Both companies have until 27 December to respond to FDA and offer more information on whether they intend to comply with FDA’s requests, in addition to providing a listing of all promotional materials for both treatments that contain violations and explanations for plans to discontinue using such abusive materials.