Bayer recently launched commercials for the contraceptive drug Yaz that feature a female spokesperson and begin with a statement that the FDA thought Bayer’s previous ads were inadequate and asked Bayer to clear up a few things. “The F.D.A. wants us to correct a few points in those ads.”
I’m pretty sure that’s the first time I’ve noticed an explicit “the FDA made us do this” message in a drug ad.
The FDA really did make them do it, though, issuing a warning letter [PDF] last October stating that “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.”
Don’t remember the ads in question? If you sing “we’re not gonna take it” or “goodbye to you” [the songs used in the ads] to yourself and you picture women kicking away or popping balloons with words like “irritability” and “fatigue,” the ads will likely come to mind. Sarah Haskins featured one of the ads in her hilarious Target Women: Birth Control bit, and you can likely find them on YouTube.
You see, YAZ is approved for “PMDD” – premenstrual dysphoric disorder, a diagnosis essentially of severe PMS with depression-like symptoms that entered the general consciousness when the patent on Prozac was running out and so its maker repackaged the drug as Sarafem. [See this related discussion on direct-to-consumer advertising from OBOS]
The ads, though, didn’t make that clear, that YAZ is not intended for regular PMS symptoms. The FDA warned that the:
“TV ads misleadingly suggest that YAZ is appropriate for treating women with PMS, who may not be appropriate candidates for this drug. We note that despite listing certain symptoms of PMDD, nowhere do the TV Ads use the full phrase ‘premenstrual dysphoric disorder,’ to more completely distinguish PMDD from PMS, thereby increasing the likelihood that a viewer, in light of the claims and presentations described below, will understand it to be the same as, or substantially similar to, PMS.”
Today’s New York Times has an article on the required new ads, including commentary from our own Judy Norsigian, who notes that this was an unusual move by the FDA:
“They rarely require these corrective campaigns,” said Judy Norsigian, the executive director of Our Bodies Ourselves, a health education and women’s advocacy group in Cambridge, Mass. But she said the popularity of the Yaz brand and the misleading ads had demanded a rare punishment. “These ads should never have been out there,” Ms. Norsigian said.
Unfortunately, this action by the FDA may not adequately discourage future misleading ads – one pharmacy administrator interviewed for the piece called the corrective $20 million ad campaign “chump change” and “just the cost of doing business,” adding that, “I don’t think it is likely to stop, unless there are more significant consequences.”