DDMAC LETTER TELLS BARR TO PULL TV AD FOR SEASONALE

The FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) has sent an untitled letter to Barr Pharmaceuticals informing the company it has conducted false and misleading advertising for Seasonale tablets, a daily birth control pill the company claims will help limit women's periods to just four a year.

DDMAC said that a TV ad promoting Seasonale (levonorgestrel and ethinyl estradiol tablets) 0.15 mg/0.03 mg is misleading because it fails to disclose warnings in Seasonale's approved labeling, specifically that patients taking the drug may experience breakthrough bleeding or spotting for up to a year.

The agency also criticized the ad for using frenetic camerawork and distracting visual elements simultaneously during the presentation of risk information.

Furthermore, DDMAC said the only statements about breakthrough bleeding in the ad suggest women may only initially experience the problem. This is problematic, the letter said, because product labeling indicates bleeding or spotting could occur even after taking the drug for 10 to 12 months.

DDMAC ordered Barr to immediately cease the dissemination of the TV ad, as well as promotions that contain similarly misleading advertising. The division also asked Barr to submit a written response to the letter by Jan. 12.

Barr plans to communicate with DDMAC "relatively soon," and will reply to the division by its requested Jan. 12 deadline, the spokeswoman added. To view the untitled letter, go to http://www.fda.gov/cder/warn/2004/12748.pdf.