FDA Tells Sanofi and Celgene to Stop Airing Misleading TV Advertisements

Posted 14 December 2016 | By Zachary Brennan 

FDA Tells Sanofi and Celgene to Stop Airing Misleading TV Advertisements

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) on Wednesday called on Sanofi-aventis and Celgene to stop broadcasting two of their direct-to-consumer television advertisements due to their misleading nature.

The similar letters, which were the sixth and seventh untitled and warning letters issued by OPDP in 2016, both say: ““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 overall effect undermines the communication of the important risk information and thereby misleadingly minimizes the risks associated with the use” of both treatments, the letters say.

The FDA letter to Sanofi says the advertisement (YouTube video here) “makes false or misleading representations about the risks” associated with its diabetes treatment Toujeo (insulin glargine) while the Celgene letter is for the company’s advertisement (YouTube video here) for its psoriasis and psoriatic arthritis treatment Otezla (apremilast).

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 (with the submission date) for both treatments that contain violations and explanations for plans to discontinue using such violative materials.

Celgene Letter

Otzela Promotional Materials

Sanofi-aventis US letter

Toujeo Promotional Materials

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.