What Bayer Campaign Means for Pharma Ads

FDA Orders Company to Correct Earlier Claims About Yaz Birth Control

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NEW YORK (AdAge.com) -- A sea change is coming to the $5 billion direct-to-consumer pharmaceutical-advertising category in the wake of the Food and Drug Administration's decision to force Bayer to run corrective advertising for one of its brands.

"This will cause drug companies to get way more conservative," said Dorothy Wetzel, exec VP-managing director of New York-based health-care agency Glow Worm and former VP-consumer marketing at Pfizer. "They're going to test and test and test their spots, and ultimately the advertising won't be as effective."

Yaz: FDA said ads were unclear.
Yaz: FDA said ads were unclear.
The FDA and 27 state attorneys general ordered Bayer to produce a six-month, $20 million corrective-advertising campaign for Yaz, the German pharma company's birth-control pill. It began in late January and is scheduled to end July 26.

Yaz brought more than $600 million in sales to Bayer last year, and is the leading non-generic in the birth-control market, with a share of almost 20%. The amount Bayer must spend on corrective ads is almost a third of the $66.7 million it spent in measured media in January through November 2008, according to TNS Media Intelligence.

The FDA ruled that Bayer's marketing and advertising for Yaz was deceptive and made false claims regarding its efficacy for acne and premenstrual syndrome. In a statement, Illinois Attorney General Lisa Madigan, who crafted the terms of the agreement with two other attorneys general and the FDA, said, "This settlement reflects the continual monitoring my office performs to ensure the pharmaceutical industry is not using deceptive marketing and advertising practices."

Bayer also has to submit all its advertising for Yaz to the FDA for preapproval for the next six years.

Expected crackdown
It wasn't the first time a company has been ordered to run corrective advertising. In 1999, the Federal Trade Commission forced Novartis to run ads to correct misleading marketing about its Doan's Pills for back pain. The FTC said the original advertising made claims that Doan's was superior to other over-the-counter back-pain medications.

But this is a surprising development by the FDA, which rarely asks for corrective advertising -- and even more rarely asks that it be produced for broadcast TV.

But with a Democratic president and Congress, the crackdown was expected.

Michael Guarini, president of New York-based Flaum Communications, said he agreed with Ms. Wetzel that the corrective advertising punishment could force a philosophical change in DTC advertising.

"Companies are ... going to be even more careful of how to bring DTC to market. You're going to see an acceleration of DTC to below the line, CRM and digital, and probably a little less in broadcast and maybe a little less in print. There's going to be an overall conservatism about going to market with DTC."

John Kamp, executive director of the Coalition for Healthcare Communication, took it further.

"Corrective advertising is the WMD [weapon of mass destruction] of marketing," Mr. Kamp says. "Although the FDA always claimed they had it, FDA had never opened fire like this against broadcast DTC. This could open a new chapter in the history of government attempts to censor pharmaceutical marketing."

The FDA could not be reached for comment. Bayer AG did not respond to an interview request.

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