More Advertising Woes Wrack the Industry

By: Grete Dudek, CIS Associate
gretedudek@cis-partners.com

While watching Grey’s Anatomy a few weeks ago, an interesting advertisement came on. It was for Yaz, the most popular birth control pill in America, and it began with, “You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads.” After pointing out the difference between PMS and PMDD, the ad mentioned a wide variety of side effects, including “Yaz contains DRSP, a different kind of hormone that for some may increase potassium too much, so you shouldn’t take Yaz if you have kidney, liver or adrenal disease…” At the end, I thought to myself, “Wow. That was weird.”

My curiosity was answered when I came across an article while reading the New York Times on February 10 about the ad. (1) I discovered that Bayer’s advertising troubles started in 2007, when the FDA sent them a warning letter regarding non-disclosure of the risks involved in taking Baycol. Something similar happened again in 2008, this time with Yaz. According to the warning letter issued in October of 2008 by the FDA, “[t]he 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.” (2) The two direct-to-consumer ads “misled consumers into thinking that Yaz treats premenstrual syndrome and promoted the contraceptive as a treatment for types of acne that the drug is not approved to treat.” (3)

“Bayer’s 2008 marketing of the oral contraceptive Yaz violated the terms of the 2007 agreement by not disclosing the uses the Food and Drug Administration (FDA) has approved for Yaz.” (4) Because of the popularity of Yaz, the FDA required Bayer not just to discontinue or correct the advertisements, but to embark on an unusual campaign to set the record straight.

“Bayer agreed last Friday to spend at least $20 million on the campaign and for the next six years to submit all Yaz ads for federal screening before they appear” (1). The ad campaign began on February 9 with the ad I saw, which was put out to set the record straight. This ad is much clearer about what Yaz is and is not approved for, and listed more side effects than I’ve ever seen televised. In addition to submitting ads to the FDA prior to their appearance, Bayer must also comply with all changes suggested by the FDA.”(4) The “director of the FDA’s Division of Drug Marketing, Advertising, and Communications, added, ‘This is a great example of collaboration between the FDA and state Attorneys General…. This significantly benefits the public by ensuring that consumers are not misled about information relating to their health.’” (4) In their print ads as well, Bayer must clearly disclose what symptoms can be treated with Yaz.

Sources:
1. http://www.nytimes.com/2009/02/11/business/11pill.html?_r=1&ref=health
2. http://www.fda.gov/cder/warn/2008/YAZ_wl.pdf
3. http://news.moneycentral.msn.com/provider/providerarticle.aspx?feed=ACBJ&date=20090209&id=9593063
4. http://www.mass.gov/?pageID=cagopressrelease&L=1&L0=Home&sid=Cago&b=pressrelease&f=2009_02_09_bayer_settlement&csid=Cago