The Food and Drug Administration (FDA) and attorney generals from 27 states are forcing Bayer Healthcare Pharmaceuticals to correct misleading advertisements that overstated the potential medical benefits of the birth control pill Yaz. A settlement with the FDA and the states requires Bayer to run a $20 million ad campaign with corrected information about Yaz, reported The New York Times.
In 2008, the FDA sent Bayer a warning letter that described in detail the misleading nature of two of the company’s television commercials. The FDA had approved the pill to treat symptoms of premenstrual dysphoric disorder, but the ads presented the drug as a cure for the more common and mild symptoms of pre-menstrual syndrome, thus expanding its potential market. Similarly, Bayer presented Yaz as a treatment for all types of acne, but it is approved only to treat moderate acne.
Bayer’s advertisements called Yaz the “pill that goes beyond the rest” and contributed to making Yaz the highest selling birth control pill in the US, with about $616 million in sales last year, according to the New York Times. Yet, as reported in the summer 2008 issue of Ms., even the existence of PMDD remains questionable, with no conclusive evidence after 500 studies.