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Bayer Must Submit Proposed Television Ads For "Yaz" to FDA For Approval And Must Spend $20 Million To Correct Misinformation From Prior Television Advertisements
MADISON - Attorney General J.B. Van Hollen today filed a stipulated supplemental judgment in Dane County Circuit Court against Bayer Corporation that adds new requirements to a 2007 judgment concerning its product advertising. The 2007 agreement concerned problems with alleged deceptive advertising of products including nondisclosure of safety risks associated with its marketing of Baycol. Today's judgment resolves allegations that Bayer's 2008 marketing of the oral contraceptive Yaz violated the earlier agreement.
Oregon joined by the Attorneys General of California and Illinois worked closely with the U.S. Food and Drug Administration's Division of Drug marketing and Advertising to craft the supplemental settlement which requires Bayer to submit all future television "direct to consumers" Yaz advertisements to the FDA for pre-approval prior to dissemination in the marketplace; to comply with all suggestions the FDA makes regarding the advertising; and in all Yaz print advertisements, to clearly and conspicuously disclose exactly what is FDA approved when referring to symptoms.
In an earlier warning letter to Bayer, the FDA addressed two misleading direct-to-consumer advertisements for Yaz including one where Bayer "broadened" the promotion to include the symptoms of relatively common premenstrual syndrome (PMS) when in fact, Yaz was not approved to treat this condition. The letter also warned Bayer about exaggerating the effects Yaz had on acne.
"Wisconsin law makes false and deceptive marketing unlawful," said Wisconsin Attorney General J.B. Van Hollen. "This case is an example of federal/state collaboration against unlawful marketing of prescription drugs."
In addition to changes in its advertising policies, Bayer also must conduct a $20 million corrective advertising program to remedy misinformation from the misleading YAZ advertisements.
A total of 27 states participated in the multi-state action against Bayer. The State was represented by Assistant Attorney General Lara Sutherlin.
A copy of the Order Modifying Consent Decree is available at