Levitra ads pulled by FDA

Saturday, April 16, 2005

The Food and Drug Administration (FDA) has penned a stiff reminder to drug giants Bayer Pharmaceuticals Corp. and GlaxoSmithKline PLC: pull your 15-second “reminder” ad for the erectile dysfunction drug, Levitra, off TV.

FDA said there is no evidence Levitra is better than rival drugs Viagra from Pfizer, or Cialis, owned by Eli Lilly and Co., in producing results that make female partners happy.

Levitra and Cialis together control about 30 per cent of the market for such drugs, but Pfizer takes the majority share.

Reminder ads can only call attention to a drug, not claim it works better, or at all.

"In one of [the ad's] scenes, the man strokes the woman's hair and face as she affectionately puts her hand on his wrist," the FDA wrote. "In the other, she puts her arms around his neck and they embrace."

"The totality of the TV ad also represents or suggests that Levitra will provide a satisfying sexual experience from the female partner's perspective," the agency wrote.

Glaxo spokesman Michael Fleming said the drug makers would comply. Bayer developed Levitra and partnered with Glaxo to market the pills in 2001. Bayer recently turned its part of the promotion over to Schering-Plough Corp.

Shares of Bayer fell 75 cents to $32.96 on Friday. Shares of GlaxoSmithKline rose 32 cents to close at $47.82. Schering-Plough shares rose 8 cents to end at $20.65.

Sources

Frank Ahrens. "FDA Orders Levitra Ad Off the Air" — Washingtonpost.com, April 16, 2005
Carla Mozee. "FDA orders Bayer, Glaxo to pull Levitra TV ad" — MarketWatch (Pharmaceuticals), April 16, 2005

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