A Birth Control Pill That Promised Too Much

Interesting... especially considering some of our presentations last semester...

from:
http://www.nytimes.com/2009/02/11/business/11pill.html?_r=2&partner=rss

A Birth Control Pill That Promised Too Much
By NATASHA SINGER
Published: February 10, 2009

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.....

LOTS MORE ARTICLE TO READ AT THE SITE - GO TO: http://www.nytimes.com/2009/02/11/business/11pill.html?_r=2&partner=rss


....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.”