The FDA slapped Bayer HealthCare Pharmaceuticals with a warning letter on two 60-second TV ads for its YAZ contraceptive.
The agency’s Division of Drug Marketing, Advertising and Communications (DDMAC) said the spots, “Not Gonna Take It” and “Balloons,” “are misleading because they broaden the drug’s indication, overstate the efficacy of YAZand minimize serious risks associated with the use of the drug.”
In particular, the agency said the ads exploit overlapping symptoms to “misleadingly suggest that YAZ is appropriate for treating women with PMS,” for which it is not indicated. YAZ is indicated for treatment of premenstrual dysphoric disorder (PMDD), a more severe mood disorder related to the menstrual cycle, as well as birth control. Both ads show women kicking, punching or puncturing symptoms common to PMS and PMDD.
Moreover, the agency said distracting visuals, scene changes, background music and other “competing modalities” threaten to distract viewers from serious risk disclosures during the major statement.
DDMAC is currently evaluating the impact of distracting visuals on comprehension and retention of risk information in TV ads.
Bayer told MM&M the “Balloon” ads ran in 2007 and are not currently airing. The company will pull “Not Gonna Take It” and vowed to work with the agency on other promotions for the brand.
DDMAC has been on a tear of late, issuing five warning and untitled letters on promotions for ADHD drugs last month, along with an untitled letter on consumer-directed materials promoting Boehringer-Ingelheim’s Mirapex’s restless leg syndrome drug. In August, the agency issued a warning letter on a journal ad for Forest’s Bystolic and an untitled letter on banner ads for Novartis’ Diovan.