The FDA has reprimanded Bayer for the “attention-grabbing visuals” and “frequent scene changes” in ads for the company’s prostate cancer drug Nubeqa.
FDA officials communicated (PDF) the concerns in an untitled letter after reviewing a direct-to-consumer (DTC) YouTube video and a Spanish-language TV ad for Nubeqa. The FDA ruled that Bayer’s promotional materials are false or misleading because they make claims about the benefits of Nubeqa but omit risk information about the medicine.
Bayer included the statement that “Nubeqa may cause serious side effects including heart disease and seizure.” However, the FDA flagged additional details that are in the patient information but missing from the ads.
The patient information states that Nubeqa patients can have heart disease that leads to death, and that the seizure risk means people should avoid activities where sudden loss of consciousness could seriously harm themselves or others. By omitting the information, Bayer created a misleading impression about the drug’s safety, according to the FDA.
The FDA also took issue with how Bayer presented the risk information. Vibrant colors, constant motion within the scenes, frame transitions, camera movements and frequent scene changes during the adverse event section of the ad interfere with comprehension of the information, the FDA said.
In that section, the prostate cancer patient introduced at the start of the ad visits his family at a carnival and eats a hot dog. The ad then shows the patient and his partner driving to, arriving at and sitting in their relatives’ house.
The 21-second section features five scenes, one of which includes a cut. The camera moves in four of the five scenes, and either the patient, a family member or a car moves in all the scenes. Some scenes, especially those at the carnival, maintain the bright color palette established in the first section of the ad.
Bayer is the latest in a series of companies to receive untitled letters since the FDA began clamping down on DTC ads last year. The agency has repeatedly lambasted companies for “attention-grabbing visuals” and “frequent scene changes.”
The FDA’s other criticism of Bayer’s ads centered on “dual modality,” the requirement that the major side effects and contraindications are presented concurrently using both audio and text. Bayer’s YouTube ad features text lists of key safety terms as they are communicated in the voiceover. However, the FDA said the ad fails “to present the major statement concurrently using both audio and text.”
Bayer has 15 working days to respond to the agency.
