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FDA ORDERS PFIZER VIAGRA ADS PULLED

Cites Unsubstantiated Erectile Claims in 'Mischief' Spot

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DETROIT (AdAge.com) -- The Food and Drug Administration has asked Pfizer to pull its current TV advertising for Viagra, telling the pharmaceutical company in a three-page warning letter that the spots do
Viagra must pull its latest TV commercial.
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not say what the erectile dysfunction medication is for or warn of the potential side effects.

The letter, sent to Pfizer's Robert B. Clark, vice president of U.S. regulatory, was dated Nov. 10. It states that the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) reviewed two TV advertisements that "fail to disclose the drug's indication, fail to include information relating to the major side effects and contraindications, and fail to make adequate provision for dissemination of the FDA-approved or permitted package labeling."

Ads 'misbrand Viagra'
The letter goes on to state the "TV ads contain representations or suggestions that Viagra is better, more effective, or useful in a broader range of patients than has been demonstrated by substantial evidence or substantial clinical," and that the ads "thus misbrand Viagra."

A Pfizer spokesman said, "Of course we'll comply with the FDA's directive and we'll respond within the time frame requested." He had no other comment.

The spots in question are the first produced by Interpublic Group of Cos.' McCann Erickson Worldwide, which won the $110 million account earlier this year. The FDA references a 30-second commercial and a 15-second spot that appears to be a shortened version of the longer ad.

Wild thing
The ads show a man and a woman walking down a street when the man notices a lingerie store. A voice-over says, "Remember that guy who used to be called 'Wild Thing?' The guy who wanted to spend the entire honeymoon indoors? Remember the one who couldn't resist a little mischief? Yeah, that guy. He's back."

Blue horns then sprout from the back of the man's head, forming the "V" in Viagra. The tagline of the spot is "Get Back to Mischief."

'Not aware of this benefit/
The FDA writes that the "TV ads claim that Viagra will provide a return to a previous level of sexual desire and activity. They refer to the sexually active past of the man (e.g., 'Remember that guy who used to be called "Wild Thing"?') and then declare 'He's back,' implying that, by taking Viagra, he has returned to that previous level of sexual desire and activity. FDA is not aware of substantial evidence or substantial clinical experience demonstrating this benefit for patients who take Viagra. If you have data substantiating this claim, please submit them to FDA for review."

DDMAC requested Pfizer immediately cease the dissemination of promotional materials for Viagra, and submit a written response by Nov. 24.

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