Legal Eagle Review, 09 February 2009

Bayer to Launch Ad Campaign to Correct Misleading Information About Oral Contraceptive Yaz

Sacramento, California - Attorney General Edmund G. Brown Jr. today announced an agreement requiring Bayer Corporation to stop a "deceptive ad campaign" regarding an oral contraceptive, "Yaz," and obligating the company to spend $20 million publicly correcting misleading assertions about the product.

"Bayer's deceptive ad campaign led young women to believe that its oral contraceptive would cure symptoms for which it was not approved for use," Attorney General Brown said. "This judgment modification forces the company to stop making those claims and spend $20 million correcting misleading assertions about the product."

Bayer claimed the drug could treat symptoms related to premenstrual syndrome (PMS), and acne, in addition to anxiety, tension, irritability, moodiness, fatigue, headaches, and muscle aches. None of these claims have been approved by the Food and Drug Administration (FDA).

In a television ad, for instance, Bayer claimed that Yaz "can help keep your skin clear," despite the fact that clinical studies have not concluded that taking Yaz results in acne-free skin.

The Attorney General's Office contends that the advertisements for Yaz violated a 2007 agreement with Bayer after the company failed to adequately disclose safety risks associated with the use of Baycol, a drug used to lower cholesterol, which was pulled from the market in August 2001. The agreement required future marketing, sale, and promotion of pharmaceutical and biological products to comply with all legal requirements, and prohibited Bayer from making false or misleading claims relating to any products sold in the United States.

In addition to adhering to the 2007 judgment, the company agreed to:
• Conduct a $20 million corrective advertising campaign consisting of a television advertisement and a print advertisement that have been approved by the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) and reviewed by the Attorneys General involved in the suit.
• The television ad must be broadcast on national cable and network television.
• The print ad must be published in magazines with national distribution.
• Submit all new Direct to Consumer television ad campaigns for Yaz to FDA for pre-review.
• Cease any and all claims about the drug that are not FDA-approved.
• Submit an annual report to each participating attorney general's office.

The States joining California's agreement are; Arizona, Arkansas, Connecticut, Delaware, Florida, Idaho, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Montana, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Washington, and Wisconsin.

see also FDA cites Bayer for misleading birth control ads

New York Times, February 11, 2009

A Birth Control Pill That Promised Too Much

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, now running during prime-time shows like “Grey’s Anatomy” and on cable networks, 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.
A Bayer spokeswoman responded to a query with an e-mail message. “The ad for Yaz was revised to more clearly state the indications for Yaz,” she wrote, adding that no one from Bayer was available for a phone interview to answer other questions on Tuesday.
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.
Bruce L. Lambert, a professor of pharmacy administration at the University of Illinois at Chicago, lauded the F.D.A. for insisting this time that Bayer run a corrective advertising campaign. But he referred to the corrective $20 million ad campaign for Yaz as “chump change” and “just the cost of doing business.”
“I don’t think it is likely to stop,” he said, “unless there are more significant consequences.” By NATASHA SINGER