Bayer is shelling out $20 million to air a rare remedial TV ad campaign for its Yaz birth control pill as part of a settlement with FDA and 27 states over charges of deceptive advertising. Bayer also agreed to submit all ads to FDA for preclearance for the next six years.

At issue are two spots from 2007 and 2008 that drew a warning letter from the Division of Drug Marketing, Advertising and Communications late last year. The ads, dubbed “Not gonna take it” and “Balloons,” were deemed misleading because they broadened the drug’s indication—essentially promoting it for treatment of PMS, for which the drug is not indicated, and acne, for which it has a limited indication, as well as premenstrual dysphoric disorder (also known as PMDD), for which it is indicated. The agency also said risk information was minimized and compromised by distracting visuals, background music and other “competing modalities.”

In response to the warning letter, Bayer pulled “Not gonna take it” and said “Balloons” had not run since 2007.

The campaign brought a huge boost to sales, which rocketed up to $616 million in 2008 from $262 million in 2007, according to IMS Health data.

In the new spot, The New York Times reported, a woman looks directly into the camera and says “You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads.”

A statement from the office of Illinois Attorney General Lisa Madigan suggested that the ads violated a 2007 agreement stemming from allegations of deceptive marketing of statin Baycol, which was pulled from the market in 2001 over safety issues.

In the Illinois Attorney General’s statement, DDMAC director Tom Abrams called the settlement “a great example of collaboration between the FDA and state Attorneys General,” adding: “By working together, we can achieve excellent results and double our efforts to clean up misleading advertising in the marketplace. This significantly benefits the public by ensuring that consumers are not misled about information relating to their health.”

From the March 01, 2009 Issue of MM+M - Medical Marketing and Media