SACRAMENTO- Attorney General Edmund G. Brown Jr. today announced an agreement requiring Bayer Corporation to stop a “deceptive ad campaign” regarding an oral contraceptive, “Yaz,” and obligating the company to spend $20 million publicly correcting misleading assertions about the product.
“Bayer’s deceptive ad campaign led young women to believe that its oral contraceptive would cure symptoms for which it was not approved for use,” Attorney General Brown said. “This judgment modification forces the company to stop making those claims and spend $20 million correcting misleading assertions about the product.”
Bayer claimed the drug could treat symptoms related to premenstrual syndrome (PMS), and acne, in addition to anxiety, tension, irritability, moodiness, fatigue, headaches, and muscle aches. None of these claims have been approved by the Food and Drug Administration (FDA).
In a television ad, for instance, Bayer claimed that Yaz “can help keep your skin clear,” despite the fact that clinical studies have not concluded that taking Yaz results in acne-free skin.
The Attorney General’s Office contends that the advertisements for Yaz violated a 2007 agreement with Bayer after the company failed to adequately disclose safety risks associated with the use of Baycol, a drug used to lower cholesterol, which was pulled from the market in August 2001. The agreement required future marketing, sale, and promotion of pharmaceutical and biological products to comply with all legal requirements, and prohibited Bayer from making false or misleading claims relating to any products sold in the United States.
In addition to adhering to the 2007 judgment, the company agreed to:
• Conduct a $20 million corrective advertising campaign consisting of a television advertisement and a print advertisement that have been approved by the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) and reviewed by the Attorneys General involved in the suit.
• The television ad must be broadcast on national cable and network television.
• The print ad must be published in magazines with national distribution.
• Submit all new Direct to Consumer television ad campaigns for Yaz to FDA for pre-review.
• Cease any and all claims about the drug that are not FDA-approved.
• Submit an annual report to each participating attorney general’s office.
The States joining California’s agreement are; Arizona, Arkansas, Connecticut, Delaware, Florida, Idaho, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Montana, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Washington, and Wisconsin.
The Modification of Judgment and the October 2008 Warning Letter are attached.