Pharmaceutical giant Bayer Corp. has agreed to conduct a $20 million corrective advertisement program for its oral contraceptive Yaz, as part of a settlement reached Monday with 27 US states.

 

In addition, the drug company must also submit all its future Yaz television ads to the US Food and Drug Administration for approval and comply with all changes suggested by the regulatory agency.

 

In 2007, the Food and Drug Administration sent Bayer a warning over two of its television ads for Yaz in which it said the ads misled consumers into thinking that the contraceptive treated premenstrual syndrome and several types of acne that the drug is not approved to treat. Yaz is approved to treat premenstrual dysphoric disorder, or PMDD, a more serious condition, which causes anxiety, tension, persistent anger and other symptoms.

 

Twenty-seven states accused Bayer of violating the terms of a 2007 agreement, in which the company agreed not to make false marketing claims about any of its products. The 2007 agreement settled claims that Bayer failed to disclose safety risks in advertisements for cholesterol-control drug Baycol.

 

Tom Abrams, director of the FDA’s Division of Drug Marketing, Advertising, and Communications said the case is a great example of collaboration between the FDA and state Attorneys General. “By working together, we can achieve excellent results and double our efforts to clean up misleading advertising in the marketplace. This significantly benefits the public by ensuring that consumers are not misled about information relating to their health.”