FDA to Bayer: Quit Overstating the Efficacy of Yaz and Misleading Consumers

Below is the beginning of a letter, written in late-2008, to the President & Chief Executive Officer of Bayer, Reinhard Franzen, from the FDA. It warns Bayer that its TV ads for Yaz are misleading and misbrand the drug, which is in direct violation of the Federal Food, Drug, and Cosmetic Act, and that the ads undermine the FDA's ability to implement regulations. However, Bayer has chosen to ignore the FDA's warning, and, since this letter was written, many users of the drug maker's Yaz and similar birth control products have experienced serious-to-life threatening side effects.

"Warning Letter" to Bayer:

Dear Mr. Franzen,

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed two 60-second direct-to-consumer (DTC) broadcast television advertisements (TV Ads) entitled "Not Gonna Take It" and "Balloons" for Yaz (drospirenone and ethinyl estradiol) Tablets. The TV Ads are misleading because they broaden the drug's indication, overstate the efficacy of Yaz, and minimize serious risks associated with the use of the drug. Thus, the TV Ads misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), 352(f)(1) & 321(n), and FDA's implementing regulations. These violations are concerning from a public health prospective because they encourage use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with Yaz [. . .]

Click here for the rest of the letter.