• Ad Age , Thursday, October 9, 2008 11:15 AM

The U.S. Food and Drug Administration says that two television ads for the birth-control pill Yaz go too far in suggesting the drug can help overcome PMS and acne. While the FDA previously approved the use of Yaz for premenstrual dysphoric disorder (PMDD) and some cases of acne , a warning letter says the TV ads could be viewed as suggesting the drug also remedied premenstrual Syndrome (PMS) and broader conditions of acne.

The FDA cites the failure of an ad called "Not Going to Take It," which has already been taken off the air, to sufficiently distinguish between PMDD and PMS. The FDA has a similar criticism of an ad still in rotation and claims the acne relief mentioned in the ad overstates the drug's effect.

Bayer, the manufacturer, will respond to the FDA's letter and work with the agency with regard to the other promotional materials in the campaign, Ira Teinowitz reports.

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