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FOR IMMEDIATE RELEASE
February 09, 2009
Claims that Yaz could cure PMS were bloated, say attorneys general

Bayer will pay for corrective advertising campaign

SEATTLE – A TV commercial for the Yaz birth control pill showed women singing “We’re not gonna take it,” while kicking and punching balloons printed with words such as “irritability,” “moodiness” and “bloating.” Alas, suggestions that the Yaz birth control pill could treat premenstrual syndrome and all severities of acne were exaggerated, say a group of 27 attorneys general. They announced today that Bayer Corporation will pay $20 million on an advertising campaign to correct misperceptions caused by its earlier marketing.

“Women deserve to know the truth about Yaz and the pill’s approved uses and risks,” Attorney General Rob McKenna said.

State attorneys general alleged that Bayer’s 2008 marketing of the oral contraceptive violated a 2007 settlement that concerned the marketing of Baycol, a drug used to lower cholesterol that was withdrawn from the market. That agreement prohibits Bayer from making false and misleading claims about any of its products.

In conjunction with other states, the Washington Attorney General’s Office filed documents today in King County Superior Court that adds new requirements to the 2007 judgment with Bayer. The supplement requires Bayer to submit all future television commercials targeted toward consumers to the U.S. Food and Drug Administration for approval, to comply with all suggestions the FDA makes regarding the advertising and include disclosures in print advertisements that explain a drug’s approved uses.

Assistant Attorney General Bob Lipson, of the Consumer Protection Division, explained that drug companies can’t imply that products are appropriate for uses not approved by the FDA.
 
Yaz has not been approved for treating common PMS symptoms, but a more severe condition called premenstrual dysphoric disorder that causes disruptive emotional and physical symptoms, including depression, anxiety, persistent anger, headaches and joint pain. The pill has also been approved for treating moderate acne.

In an October 2008 warning letter to Bayer, the FDA said that two commercials exaggerated the effects Yaz had on an acne and failed to distinguish between PMS and the more serious PMDD, leading viewers to believe that Yaz is effective at treating PMS. The letter also alleged that warnings about the risks of Yaz were minimized by distracting visuals and background music.

Tom Abrams, director of the FDA’s Division of Drug Marketing, Advertising, and Communications, called today’s court order a great example of collaboration between the FDA and attorneys general.

“By working together, we can achieve excellent results and double our efforts to clean up misleading advertising in the marketplace,” Abrams said.

Yaz Order

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Media Contact: Kristin Alexander, Media Relations Manager – Seattle, (206) 464-6432, kalexander@atg.wa.gov

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