Bayer, last week, launched a $20 million “make-good” campaign for its birth-control pill Yaz. Rather than talk up the benefits of the drug, the commercial states bluntly, “You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads.”
The ads are part of a settlement with FDA that involved more than two dozen state attorneys general and two television ads deemed misleading and off-label. Last October, Bayer received a warning letter from the Feds stating that Bayer was marketing the drug inappropriately. At one point, the Yaz TV ads listed a number of symptoms related to menstruation that the drug could allegedly help—bloating, irritability, and the like. These are indeed symptoms for premenstrual dysphoric disorder (PMDD), for which Yaz is approved.
The ads even state that the drug is approved for PMDD. But the full name of the indication was used nowhere in the commercials, and FDA judged that the use of the symptoms without a fuller explanation would lead viewers to conclude that the drug was suitable for the treatment of PMS—a less severe and more common condition, for which it has not been evaluated.
Similarly, the ads refer to Yaz’s role in treating acne. The product is indeed approved for treatment of moderate acne, and the ad includes language to that effect. But FDA judged it to be not prominent enough, and declared that the ad would mislead viewers into thinking that it was approved for all severities of acne.
The 2008 warning letters stated that Bayer minimized the risk information by running the information against “fast-paced” visuals and distracting music. “These complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed,” stated FDA Drug Marketing Director Thomas Abrams. “This is particularly troubling, as some of the risks being conveyed are serious, even life-threatening.”
Bayer pulled both ads off the air soon after receiving the letters, but FDA didn’t settle for an apology. As part of the settlement, Bayer must clear all upcoming Yaz ads with FDA before they go public, and list the FDA-approved uses for the drug in the print ads.
“Pharmaceutical companies cannot market drugs to consumers for uses that have not been approved by the FDA,” stated Maryland Attorney General Douglas Gansler. “This settlement should provide consumers better, more accurate information about how this product may be used.”
Too Much of a Bad Thing
It’s clear that the Yaz ads at least walked the line between accurate and misleading. But why did they get such tough treatment from FDA—and why did 27 attorneys general need to get involved?
“Women deserve to know the truth about Yaz and the pill’s approved uses and risks,” stated Washington Attorney General Rob McKenna in a release.
McKenna also noted that this wasn’t the first time Bayer was cited for false advertising. In 2007, the drug firm settled another charge for making misleading claims in ads for the cholesterol drug Baycol (cerivastatin). As part of that deal, Bayer was given strict orders never to include false or deceptive information in any ad. Baycol was pulled off the market in 2001 because of safety issues.
“This case is a strong example of federal-state collaboration to stop the unlawful marketing of prescription drugs,” Cordray said. “By leveraging state enforcement authority with the FDA’s technical expertise, we achieved an excellent result that ensures future Yaz advertisements will be lawful.”
“Bayer blatantly broke its promise made two years ago in court—to responsibly market its drugs and disclose dangers to doctors and the public,” said Connecticut Attorney General Richard Blumenthal. “Bayer egregiously exaggerated the efficacy of Yaz, an oral contraceptive, as an acne treatment. The company's deliberate deceit endangered patient health and public trust.” (Again, Yaz’s label does include its use for the treatment of moderate acne.)
Calls to Bayer were not returned by deadline. According to The New York Times, the new print ads for Yaz do not state that they are corrective ads.