FDA Finds Sanofi and Celgene DTC Ads are Misleading

The US Food and Drug Administration (FDA) has identified two direct-to-consumer (DTC) ads for prescription drugs, which it believes misleads consumers in regards to the safety of the medications. The FDA’s Office of Prescription Drug Promotion (OPDP) ordered Sanofi and Celgene to discontinue the ads, in two separate letters to the drugmakers.

Sanofi’s ad was in promotion of its diabetes drug, Toujeo (insulin glargine), and showed a man dancing to an upbeat song while a narrator disclosed the contra-indications and potential side effects of the drug. The FDA’s OPDP took issue with the ad’s rapid camera cuts and “attention-grabbing” visuals which could distract the viewer from the important risk information.

“The overall effect undermines the communication of the important risk information and thereby misleadingly minimizes the risks associated with the use of Toujeo,” said the FDA’s letter to Sanofi. “The presentation in the video is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug.”

Celgene’s ad for its severe plaque psoriasis drug, Otzela (apremilast), was similarly fast-paced, featuring four successive scenes while the narrator reads the risk information. In this case, the visuals were deemed to be too distracting, thereby minimizing the risks of taking the medication.

“The presentation of these compelling and attention-grabbing visuals and SUPERs, all of which are unrelated to the risk message, in addition to the frequent scene changes and the other competing modalities such as the musical interjections, compete for the consumers’ attention,” said the FDA’s letter to Celgene. “As a result, it is difficult for consumers to adequately process and comprehend the risk information.”

Since January, the OPDP has only issued five other letters like these to drugmakers. Still, they serve as a timely reminder that DTC ads must follow strict guidelines to ensure that benefit/risk information is presented equally.