FDA Requires Pharmaceutical Company to Clarify Birth Control Ads

NY Times: A Birth Control Pill that Promised too Much:

As part of an unusual crackdown on deceptive consumer drug advertising, the Food and Drug Administration and the attorneys general of 27 states have required Bayer to run these new ads to correct previous Yaz marketing.

Regulators say the ads overstated the drug’s ability to improve women’s moods and clear up acne, while playing down its potential health risks. Under a settlement with the states, Bayer agreed last Friday to spend at least $20 million on the campaign and for the next six years to submit all Yaz ads for federal screening before they appear...

The F.D.A. first moved against the Yaz campaign last October, with  a warning letter to Bayer saying that two television ads overstated the drug’s benefits while understating its risks. By giving consumers the impression that Yaz was generally a drug for acne and general mood problems, the company’s ads ran afoul of federal laws against promoting the unapproved uses of a drug, the F.D.A. said. The agency approved Yaz in 2006 as a birth control pill that has a side benefit in treating mood-related psychological problems called premenstrual dysphoric disorder.