The FDA reprimanded Bayer for “attention-grabbing visuals” and “frequent scene changes” in ads for its prostate cancer drug Nubeca.
FDA officials expressed their concerns in an untitled letter (PDF) after reviewing a direct-to-consumer (DTC) YouTube video and Nubeka’s Spanish-language television ads. The FDA ruled that Bayer’s promotional materials were false or misleading because they claimed the benefits of Nubeka but omitted risk information about the drug.
Bayer included a statement saying, “Nubeka can cause serious side effects, including heart disease and seizures.” However, the FDA flagged additional details that were included in the patient information but not included in the advertisement.
Patient information states that Nubeka patients may have a potentially fatal heart condition, are at risk for a stroke, and should avoid activities where sudden loss of consciousness could cause serious harm to themselves or others. The FDA said Bayer gave a misleading impression about the drug’s safety by omitting information.
The FDA also took issue with how Bayer presented its risk information. Bright colors, constant movement within the scene, frame transitions, camera movements, and frequent scene changes during the adverse event section of the advertisement impede understanding of the information, the FDA said.
In that section, the prostate cancer patient featured at the beginning of the ad visits his family at a carnival and eats hot dogs. The ad depicts a patient and her partner driving to a relative’s house, arriving and sitting down.
The 21-second section contains five scenes, one of which includes cuts. The camera moves in four of the five scenes, and all involve either the patient, family, or car. Some scenes, particularly the carnival scene, maintain the bright color palette established in the first section of the ad.
Bayer is the latest in a string of companies to receive untitled letters since the FDA began cracking down on DTC advertising last year. The agency has repeatedly criticized companies for “attention-grabbing visuals” and “frequent scene changes.”
Another FDA criticism of Bayer’s advertising focused on its “dual modality” of presenting key side effects and contraindications using both audio and text simultaneously. Bayer’s YouTube ad narrates a text list of important safety terms. However, the FDA said the ad failed to “use both audio and text to simultaneously present key statements.”
Bayer will respond to the agent within 15 business days.
