Online Exclusive: DTC Advertising

FDA PANEL SAYS NO TO P&G's FEMALE SEX DRUG PATCH

Recommends Rejection of Intrinsa Bid for Marketing Approval

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CINCINNATI (AdAge.com) -- An advisory panel of the U.S. Food and Drug Administration dealt Procter & Gamble Co. and Publicis Groupe a blow Thursday, recommending the agency reject P&G's female sex-drive patch Intrinsa.
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In a unanimous vote, the panel said P&G should continue monitoring women who use the patch to watch for negative long-term health effects, such as heart disease or cancer.

'Female Viagra'
P&G executives previously had expressed optimism the testosterone patch would be approved for use in 2005. Various agencies affiliated with ad agency holding company Publicis Groupe had been picked to handle what would have been a high-profile launch campaign of a drug dubbed the "female Viagra," including Publicis Worldwide, New York, and Publicis-backed Amazon, San Francisco.

The FDA isn't bound by the advisory panel's recommendations, but has generally followed them.

The panel's recommendation is among the first on a major drug destined for direct-to-consumer advertising following the withdrawal of Merck & Co.'s Vioxx after it was linked to contributing to increased risk of heart attack.

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