Mailboxes are full of seasonal greetings this time of year, but two pharma companies just received some decidedly less joyful mail from the FDA. Sanofi and Celgene were both slapped with untitled letters for television ads promoting Toujeo (PDF) and Otezla (PDF), respectively.
The FDA's Office of Prescription Drug Promotion, which has sent only five other letters this year, claimed the ads made “false or misleading representations about the risks associated with” the featured drug, a violation of the Food, Drug and Cosmetics Act.
Sanofi said it's working to pull the ad the agency considers problematic. Celgene said it plans to work with the FDA to address its concerns.
The agency's letters pointed out images and music that accompany the individual ads' risk disclosures. The rolling video and audio are distracting, the OPDP said. “As a result, it is difficult for consumers to adequately process and comprehend the risk information," both letters stated.
In the untitled letter to Sanofi, the OPDP noted that, as Toujeo's risks are detailed in audio and through text superimposed onscreen, a man is dancing to music from the song “Let’s Groove”—the FDA letter didn’t mention the band, but it’s Earth Wind and Fire—through multiple scene changes, resulting in “compelling and attention-grabbing visuals” that compete for consumers’ attention, resulting in the risk information being difficult to process.
In Celgene’s letter, the OPDP outlined problems with three scenes where risks are disclosed via audio. Distracting visuals and superimposed text slogans compete for the viewer's attention, the agency said.
Music is an issue in the Otezla ad as well. The FDA noted that, throughout the ad, "including the major statement, an instrumental version of the song, 'Walking on Sunshine' is played in the background. However, during the major statement, a loud brass interjection is played over several audio risk disclosures.”
The Otezla commercial began airing in July, and Celgene has spent more than $35 million airing the spot so far, according to data from real-time TV tracker iSpot.tv. The Toujeo TV ad has been running since August, and Sanofi has spent more than $13.5 million since then, according to iSpot data.
Responding to emailed questions, a Celgene spokeswoman said, “We have received the Untitled Letter from the U.S. Food and Drug Administration in regards to the Otezla TV advertisement, and we plan to work with the FDA to address their concerns.”
Sanofi is reviewing its letter and plans to respond to the FDA by its deadline, but it's taking the pre-emptive step of pulling the TV spot as soon as it can, the spokeswoman said.
"In the meantime, we are in the process of removing the ad from all channels," the spokeswoman said in the email. "We take regulatory requirements regarding DTC broadcast marketing very seriously, and are committed to working with the FDA to ensure all promotional materials comply with these regulations so that patients receive accurate and balanced information about our products."
The FDA has given both companies until Dec. 27 to respond. When asked how distracting music and frequent scene changes are evaluated, an FDA spokeswoman responded via email that the agency reviews all elements present when the benefit and risk information is given.
"Elements that interfere with the communication of either the benefits or risks by drawing the viewer’s attention away from that information may render an ad misleading, particularly if this happens differentially to the risks and/or the benefits," she said.
The FDA spokeswoman also pointed to some other examples of pharma brands that received letters from OPDP for similar offenses, include Bayer's Yaz (2008), Eli Lilly's Strattera (2005), GlaxoSmithKline's Paxil (2004), and Amgen's Enbrel (2005).
This is not the first time the FDA has weighed whether actors—or this case, a character—moving during a risk disclosure monopolized viewers' attention. After an expert highlighted the Nasonex bee's buzzing as the required "major statement" made its appearance, the agency commissioned a study to see whether sunny images or quick movements distracted viewers.
In 2011, the FDA completed that study, "Effect of Distraction on Information Processing in DTC Television Ads," concluding there was strong evidence that "risk-informing superimposed text during the major statement increases comprehension of that risk information." The findings on visual and sound distractions were less clear, according to the study.
Editor's Note: This story has been updated with information and comments from the FDA.