Bayer HealthCare Pharmaceuticals has just introduced a new $20 million advertising campaign for Yaz, the most popular birth control pill in the United States.
But the television ads, are not typical spots promoting the benefits of a prescription drug. Instead, they warn that nobody should take Yaz hoping that it will also cure pimples or premenstrual syndrome.
As part of an unusual crackdown on deceptive consumer drug advertising, the Food and Drug Administration and the attorneys general of 27 states have required Bayer to run these new ads to correct previous Yaz marketing.
Regulators say the ads overstated the drug’s ability to improve women’s moods and clear up acne, while playing down its potential health risks. Under a settlement with the states, 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.
“You may have seen some Yaz commercials recently that were not clear,” an actress says in the new corrective television spot, as she looks into the camera. “The F.D.A. wants us to correct a few points in those ads.”
Yaz is the best-selling oral contraception pill in the United States, with sales last year of about $616 million or about 18 percent market share, according to IMS Health, a health care information company.
Critics of consumer drug advertising say that while the F.D.A. sends a few dozen letters each year asking drug companies to suspend, amend or correct informational pamphlets and videos, it is unusual for the government to require commercials to set the record straight.
“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.
Representatives of the F.D.A., and the Florida attorney general, who led the states’ effort, declined requests for phone interviews. They released a joint statement on Monday in which they said, in part, they wanted to “clean up misleading advertising in the marketplace.”
California, Texas, Massachusetts and Michigan were among other states in the settlement, in which Bayer did not admit that it had engaged in deceptive advertising or committed any wrongdoing.
The corrective television commercials, which began appearing two weeks ago, are scheduled to run until July 26. New print ads, in national magazines like Lucky and Elle, give detailed information about Yaz, but do not indicate they are meant to correct earlier television ads.
The F.D.A. first moved against the Yaz campaign last October, with a warning letter to Bayer saying that two television ads overstated the drug’s benefits while understating its risks. By giving consumers the impression that Yaz was generally a drug for acne and general mood problems, the company’s ads ran afoul of federal laws against promoting the unapproved uses of a drug, the F.D.A. said. The agency approved Yaz in 2006 as a birth control pill that has a side benefit in treating mood-related psychological problems called premenstrual dysphoric disorder.
In 2007, the agency approved another side benefit of Yaz, that of improving moderate acne. But Yaz contains drospirenone, a progestin that can cause excess potassium production in some patients, its side effects include an increased risk of serious heart and other health problems.
After the F.D.A. complained, Bayer halted the Yaz ads. The agency told Bayer to submit a media plan for a corrective message that would reach the same size and kind of television audiences as the misleading ads did.
The Bayer affair comes at a delicate moment for the pharmaceutical industry. Some of the most popular branded drugs are nearing patent expirations that will open the doors to generic competition, so many big-name drug makers now rely heavily on direct-to-consumer advertising.
Critics charge that the F.D.A. division that oversees drug promotion, with a staff of 52 people, cannot keep up with the tens of thousands of marketing and advertising items produced annually by drug manufacturers. The Yaz controversy may raise new questions about whether that oversight is sufficient.
Aimed primarily at women in their 20s, Yaz has been known for its slogan — “Beyond Birth Control” — which promotes it not only for pregnancy prevention but as a lifestyle drug.
In one of the commercials cited by the F.D.A., with the song “We’re Not Gonna Take It” by Twisted Sister playing in the background, a series of young fashionably dressed women kicked away or punctured floating signs with labels like “irritability” and “feeling anxious.” Meanwhile, a voiceover promoted Yaz as a “pill that goes beyond the rest,” with benefits like the ability to maintain clear skin.
The other commercial, set to the tune “Goodbye to You” by the Veronicas, shows a variety of women next to balloons — marked “headaches,” “acne” and “feeling anxious” — which float away, presumably after treatment with Yaz.
“The ad is basically speaking to a majority of menstruating women,” and not to the minority of women with the psychological problem for which Yaz is approved, said Dr. Nada L. Stotland, a professor of psychiatry at Rush Medical Center in Chicago and the president of the American Psychiatric Association.
For 2008 during which the ads in question were broadcast on television, sales of Yaz in the United States increased to about $616 million, from about $262 million the year before, according to IMS Health.
This is not the first time that health groups and government officials have faulted birth control commercials as being misleading. In 2003, the F.D.A. sent a warning letter to Berlex Laboratories faulting its ads for Yasmin, the precursor to Yaz, for implying the pills were superior to other oral contraceptives and for minimizing risks specific to the drug.
Bayer, which acquired Berlex as part of a deal in 2006, now markets Yasmin. Last year, Yasmin had sales of about $382 million, or about 11 percent of the United States market, according to IMS Health.
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