Personal Injury Law

FDA Must Approve Bayer Ads For Yaz Contraceptive

By Jane Akre

The Food and Drug Administration (FDA) is venturing into the advertising industry.

The FDA has demanded that it screen any ads that German drugmaker, Bayer AG, produce for its oral contraceptive, Yaz.  Bayer must also produce $20 million in "corrective" advertisement, after the FDA says it misled consumers into believing the product should be used for conditions it is not approved to treat.

The agreement was reached between Bayer and 26 states. The agreement was announced by Massachusetts Attorney General Martha Coakley. It follows a 2007 agreement by the drugmaker to make corrective actions.

Also included in the 2007 agreement was a failure to truthfully advertise Bayer cholesterol drug Baycol, which was withdrawn from the market in 2001.

The FDA warned Bayer that two direct-to-customer ads improperly promoted Yaz to the general public. The ads said Yaz could treat premenstrual syndrome (PMS) when the drug is not approved for that condition.  Nor is it approved to treat acne, which the ads mention.

It is approved to treat premenstrual dysphoric disorder (PMDD). The symptoms include anxiety, persistent anger and tension.  

The future print ads must "clearly and conspicuously" disclose what the FDA has approved the drug to treat.  #

Full post as published by InjuryBoard on February 10, 2009 (boomark / email).