Bayer runs "corrective" Yaz ad, agrees to preclearance

Share this article:
Bayer runs "corrective" Yaz ad, agrees to preclearance
Bayer runs "corrective" Yaz ad, agrees to preclearance
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.”
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...