What do new FDA letters dinging 'misleading' pharma TV ads mean for the industry?

Now that the FDA has handed down disciplinary letters to Celgene and Sanofi, pharma insiders are debating what the moves might signal.

Last week's FDA admonishment of Celgene and Sanofi for DTC TV ads has industry insiders checking the tea leaves for what the letters might signal. The upshot? Possibly an end to overly happy and energetic lifestyle pharma ads.

The main complaint in both untitled letters from FDA drug marketing enforcer OPDP—to Celgene for oral psoriasis treatment Otezla and Sanofi for diabetes drug Toujeo—is distracting music and visuals that interfere with consumers fully understanding the risk information. Both ads have been running since this summer.

An FDA spokeswoman explained via email that the agency always reviews those kind of elements both individually and for overall effect in ads to determine if they draw viewers' attention away from risk information. However, the new letters left one industry consultant wondering where the line is now.

“These commercials are not much different from many other upbeat DTC ads with music,” Bob Ehrlich, chairman and CEO of DTC Perspectives, told FiercePharma in an email interview. “If they are cracking down on these two, then they have decided to look at all of these type of ads. FDA is very subjective about these kind of violations.”

Another industry watcher noted that DTC issues in general have been on the FDA’s research radar lately, and the letters may be making a policy point about distracting music and images.

“Back in 2009, when FDA wanted to make a policy point about the use of links to risk information, they issued 14 letters on the same subject on the same day about the practice. Here, similarly, I think the  agency is using these two ads as a policy point to say that risk information conveyed in a DTC vehicle should be imparted in a way that maximizes the ability of the audience to pick up the information and therefore, should not be presented accompanied by distraction such as imagery and music,” Mark Senak, a public relations professional and blogger at Eye on FDA, told FiercePharma in an email interview. Senak also wrote a column about the issue.

So, do the letters spell the end of overly cheerful people in pharma ads?

“I think FDA has just decided that the quality of life ads with happy people dancing have gone beyond where they want drug ads to be," Ehrlich said. "They might argue that all the music and happy scenes have tipped the scale on fair balance.”

Both Senak and Ehrlich said they doubted, however, that the letters would have a chilling effect on TV advertising overall by pharma brands, especially many that depend on TV as a major media promotional channel.

Meanwhile, Sanofi and Celgene have until Dec. 27 to submit written responses to the FDA. Sanofi told FiercePharma in an interview last week that it is working to pull the Toujeo TV ads, while Celgene said more broadly that it will work with the FDA to address its concern.