The FDA issues untitled letters to Sanofi and Celgene over distracting ads



The FDA's Office of Prescription Drug Promotion issued two separate untitled letters for direct-to-consumer ads featuring Sanofi's insulin Toujeo and Celgene's psoriasis treatment Otezla.

The agency has issued six untitled letters in 2016, and only seven enforcement letters overall — a significant drop off from the past five years.

See also: Warning letters most often stem from missing risk information

The regulators said both ads distract viewers from understanding risk information by using frequent, distracting scene changes — and, in Otezla's case, abrupt changes in music — to distract viewers from presented risk information.  

A Sanofi spokesperson said the company is in the process of removing the Toujeo ad from all channels and they “are committed to working with the FDA to ensure all promotional materials comply” with the agency's regulations. Toujeo received FDA approval in 2015.

See also: The FDA settles with Pacira, rescinds warning letter

The OPDP said the Toujeo ad, called Daily Groove, uses frequent scene changes — from a man dancing while cooking, mowing his lawn, and then walking his dog — to minimize the superimposed risk information at the bottom of the screen. The agency said that the cumulative effect of those fast-paced visuals can distract viewers from the drug's potential risks and “undermines the communication of important risk information.” 


As for Otezla's ad, Fearless, the FDA said it abruptly switches music from “Walking on Sunshine” to a “loud brass interjection” when risk information is played. It also features numerous “attention-grabbing visuals,” including a woman jumping into a lake and a man accidentally letting go of his dog's leash and chasing after it. “The presentation of these compelling and attention-grabbing visuals...all of which are unrelated to the risk message...in addition to the frequent scene changes and the...musical interjections compete for the consumer's attention,” OPDP said.

A Celgene spokesperson said the company plans to work the FDA to address its concerns. The FDA approved Otezla in 2014.