New York Times Examines 'Unusual' FDA Order Requiring Corrections To Yaz Ad Campaign

The New York Times on Wednesday examined Bayer's new $20 million advertising campaign for its oral contraceptive Yaz, the most popular birth control pill in the U.S. The company launched the ad campaign last week under an agreement with FDA and 27 state attorneys general that requires Bayer to correct previous misleading marketing of the drug. Regulators said the original ads overstated Yaz's ability to treat acne and improve women's moods, while downplaying health risks, the Times reports. Bayer also has agreed to submit future Yaz ads for federal screening for the next six years. Although FDA sends a few dozen letters to drug companies each year regarding informational pamphlets and videos, it is "unusual for the government to require commercials to set the record straight," the Times reports. Judy Norsigian, executive director of the health education and women's advocacy group Our Bodies Ourselves, said that FDA "rarely require[s] these corrective campaigns" but that the popularity of Yaz and the misleading ads required the rare sanctions. She added that the inaccurate ads "should never have been out there." In the new ads, an actress says, "You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads."

Yaz is the best-selling oral contraceptive in the U.S., with sales of about $616 million in 2008, according to health care information company IMS Health. FDA approved the drug in 2006 as an oral contraceptive that also treats premenstrual dysphoric disorder, a mood-related psychological problem, and in 2007 expanded the indications to include moderate acne. However, the drug also carries an increased risk of serious heart or other health problems related to the ingredient drospirenone, a progestin that can cause excess potassium production in some patients. FDA in October 2008 sent a warning letter to Bayer stating that two Yaz commercials overstated the drug's benefits and downplayed its risks. The agency said the ads gave consumers the impression that the drug could be used to treat acne and general mood problems, which were not included in its approval. Nada Stotland, a professor of psychiatry at Rush University Medical Center, said the 2008 ads were "basically speaking to a majority of menstruating women," rather than the minority of women with the psychological disorder the drug is approved to treat.


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