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Yaz FDA Warning

FDA ISSUES WARNING LETTER TO BAYER, THE MAKER OF YAZ, FOR MISLEADING ADVERTISING

On October 3, 2008 the Food and Drug Administration, the FDA, issued a WARNING LETTER to Bayer HealthCare Pharmaceuticals, Inc. informing them that two of its television advertisements were misleading because the ads claimed that Yaz did more than the research established it did.

At the time the ads were being run, Bayer had FDA approval to market Yaz for three conditions: (1) as an oral contraceptive, (2) for the treatment of premenstrual dysphoric disorder (PMDD), and (3) for the treatment of moderate acne.

However, the FDA noted that two of Bayer's television advertisements, "Not Gonna Take It" and "Balloons" misleadingly inferred that Yaz could cure the symptoms of premenstrual syndrome (PMS), a more common condition than PMDD.

By advertising its product to women suffering from PMS, Bayer was able to secure Yaz's place in the marketplace as the best-selling birth control pill. For example, Yaz's written disclosure materials states that "Yaz has not been evaluated for the treatment of premenstrual syndrome (PMS)," but the company omitted this statement from its television advertisements, while claiming that it's product could cure symptoms of PMS.

Bayer also used the advertisements to appeal to those suffering from acne by showing images of women with completely clear skin, and claiming that Yaz helps keep skin clear. However the advertisement failed to disclose that Yaz does not help the treatment of all forms of acne, only moderate acne.

Based on Bayer's misleading advertisements, the FDA recommended that Bayer immediately cease their misleading television advertisements. The advertisements were so serious and misleading that the FDA requested that Bayer submit a comprehensive plan of action to disseminate truthful, non-misleading advertisements in order to stop misleading consumers.

Five months later, on March 26, 2009, Bayer was again cited by the FDA for its misleading Yaz advertisements on its website. In particular, the company was penalized for overstating Yaz's ability to cure acne and PMDD without mentioning any risk information about Yaz's serious and potentially life threatening side effects. The FDA requested that Bayer immediately stop the ads on Yaz's website and take measures to make them less misleading. Unfortunately, this misleading and untruthful information was given to doctors and women by means of TV, newspaper, and magazine ads long before the FDA was able to take action.

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