DDMAC warns Bayer on YAZ TV ads

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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 YAZ and minimize serious risks associated with the use of the drug.”

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 the treatment of premenstrual dysphoric disorder (PMDD), a more severe mood disorder related to the menstrual cycle, and birth control.
Both ads show women kicking, punching or puncturing PMS and PMDD symptoms.

Moreover, the agency said distracting visuals, background music and other “competing modalities” threaten to distract viewers from serious risk disclosures. DDMAC is 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.

DDMAC has been on a tear of late, issuing five warning and untitled letters on promotions for ADHD drugs last month.
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