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For Immediate Release

Media Contact:
Raquel Guillory, 410-576-6357
rguillory@oag.state.md.us

Attorney General Gansler Reaches Settlement with Bayer Corporation Regarding its Marketing of Yaz Oral Contraceptive
Settlement Adds Terms to 2007 Judgement Against Bayer

BALTIMORE, MD (February 9, 2009) - Attorney General Douglas F. Gansler announced today that his Consumer Protection Division, along with the Offices of Attorneys General from 26 other states, has reached a settlement with Bayer Corporation concerning misleading advertisements of its Yaz oral contraception product. The Attorney General alleged that Bayer’s televised ads for Yaz were misleading because they promoted Yaz as a treatment for common premenstrual syndrome (PMS) and for types of acne when the product has not been approved by the United States Food and Drug Administration (“FDA”) for such uses. The FDA has previously issued a warning letter to Bayer addressing the advertisements and the FDA collaborated with the Attorneys General in reaching this settlement.

The settlement adds new requirements to a 2007 Consent Judgment agreed to by Bayer concerning its product advertising. The 2007 agreement concerned problems with alleged deceptive advertising of Bayer products, including non-disclosure of safety risks associated with Bayer’s marketing of its product Baycol. The new requirements under the Yaz settlement requires Bayer to submit all future “direct to consumer” Yaz advertisements to the FDA for review and comment prior to their being broadcast to consumers. Bayer has also agreed to comply with all regulatory comments the FDA makes concerning the advertising and to clearly and conspicuously disclose the approved uses of Yaz.

“Pharmaceutical companies cannot market drugs to consumers for uses that have not been approved by the FDA,” said Attorney General Gansler. “This settlement should provide consumers better, more accurate information about how this product may be used.”

In addition to changing its advertising policies, Bayer also agreed to conduct a $20 million corrective advertising program to remedy misinformation from the misleading Yaz advertisements. The settlement agreement has been filed in the Circuit Court for Baltimore City and must now be approved by that Court.

   

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