- A Food and Drug Administration office in charge of overseeing prescription drug promotion has flagged two direct-to-consumer TV ads from major drugmakers Sanofi and Celgene for creating misleading impressions about the safety of the drugs advertised in the commercials.
- In two separate untitled letters, the FDA's Office of Prescription Drug Promotion (OPDP) ordered the companies to discontinue use of the ads, which promote Sanofi's diabetes drug Toujeo (insulin glargine) and Celgene's Otzela (apremilast), respectively.
- Letters from the OPDP have been few and far between this year, with only five others issued to drugmakers since January.
In Sanofi's ad, a man dances to Earth, Wind & Fire's song "Let's Groove" while a narrator describes the potential side effects and contra-indications of the injectable Toujeo. While the upbeat tone and styling of the ad are a familiar marketing tactic, the FDA objected to the pairing of "attention-grabbing" visuals and quick camera cuts with Toujeo's risk message.
"The overall effect undermines the communication of the important risk information and thereby misleadingly minimizes the risks associated with the use of Toujeo," the FDA's letter said.
Celgene ran into a similar problem. The 60-second ad features four scenes showing people using a rope swing, walking a dog, trying on new clothes and setting up for a party. Like Sanofi's ad, Celgene's risk information is conveyed through narration over the fast-paced action.
In both cases, the OPDP argues the visuals distract the viewer from hearing the risk message, in effect minimizing the risks of each drug. The OPDP's warnings also illustrate the fine line drugmakers need to walk in advertising drugs direct to consumers — an important marketing channel.
The letters to Sanofi and Celgene, both issued December 12, were only the sixth and seventh such letters sent to drugmakers this year. This just about matches last year, which saw nine drugmakers cited for misbranding.
Both this year's and last year's numbers are only a fraction of the dozens of citations issued annually in the late 1990s and early 2000s, according to the Eye on FDA blog.