|Among other things, the FDA said the Levitra ads is misleading in its unsubstantiated superiority claims.
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Levitra is co-marketed by Bayer, Schering-Plough and GlaxoSmithKline.
White shirt euphemism
The Levitra account was awarded Publicis Groupe's Saatchi & Saatchi Consumer Healthcare in December. But the ad in question, entitled "My Man," was originally produced by WPP Group's Quantum Group. The sultry spot features a woman wearing an man's oversized dress shirt -- which some have said is an ad industry euphemism that she has just had sexual relations -- and happily describing Levitra's affect on her partner, whom she refers to as "my man."
In a letter to Mary Ellen Evanich, assistant director of regulatory affairs for Bayer, and copied to similar executives at Schering-Plough and GSK, the FDA states that the "TV ad fails to disclose the drug's indication, fails to include information relating to the major side effects and contraindications, and fails to make adequate provision for dissemination of the FDA-approved labeling. ... Moreover, the TV ad is misleading because it contains representations or suggestions that Levitra is superior to other erectile dysfunction treatments when this has not been demonstrated by substantial evidence or substantial clinical experience."
April 27 deadline
The FDA's Division of Drug Marketing, Advertising and Communications asked that the ad be pulled immediately and for Bayer to respond by April 27. A Schering spokesman said the company will address the issues raised by the FDA.
Pfizer also has until April 27 to respond to a warning letter, sent directly to CEO Hank McKinnell, about Zyrtec. The FDA's drug-marketing division reviewed three print ads for the allergy medication and said each makes unsubstantiated claims about the drug's superiority.
Two of the three print ads were entitled, "Tired of your allergy medicine not working?" and the third was: "Maybe it's time to switch allergy medicines." WPP's Berlin Cameron/Red Cell has the Zyrtec ad account.
"The print ads make superiority claims about Zyrtec by suggesting it is clinically superior to some other allergy medicines. To our knowledge, these claims have not been demonstrated by substantial evidence or substantial clinical experience," the letter states.
Like it did with Levitra, the division asked that Pfizer cease advertising for Zyrtec and to respond to the warning letter by April 27.
A Pfizer spokesman said, "The FDA communication addresses three print DTC advertisements from the prior year that are not currently in use. We will give careful consideration to FDA's comments and will respond in the requested time frame."