Washington Post, April 16, 2005

FDA Orders Levitra Ad Off the Air

TV Spot Doesn't Explain Drug's Side Effects

The Food and Drug Administration has ordered drug giants Bayer Pharmaceuticals Corp. and GlaxoSmithKline PLC to immediately pull a television ad for impotence drug Levitra, saying that the commercial does not adequately state the drug's potential side effects and that it cannot substantiate claims that it is superior to competitors such as Viagra or that it improves female satisfaction during sexual activity.
The 15-second ad, called "My Man," which includes the tag line, "Levitra: When it counts," features an actress asking, "In the mood for something different?" She goes on to say Levitra is "the best way to experience that difference."
The FDA ruled the claim suggests that Levitra is better than its rivals in treating erectile dysfunction. "FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Levitra is superior to other (erectile dysfunction) treatments," the FDA said in a letter to the companies that was posted yesterday.
Levitra is the second impotence drug to have one of its television ads pulled. In November, the FDA told Pfizer Inc. to discontinue a Viagra ad that referred to the actor as "wild thing," saying the company did not state that the drug is for men and failed to mention potential side effects. During the commercial, a browbeaten actor grows blue horns the same color as the pill and appears to become more sexually interested in his female partner.
The drugmakers responsible for Levitra will comply with the FDA's order, said Michael Fleming, Glaxo spokesman. Bayer developed Levitra and joined with Glaxo to market the drug in 2001. In recent months, Bayer turned its half of the Levitra-promotion business over to Schering-Plough Corp. Sales of Levitra in 2004 totaled $248 million, according to the companies' annual reports.
Fleming said the commercial in question is called a "reminder ad" and does not include the listing of potential side effects that the longer, 45-second version does. The ad was produced by the Quantum Group.
Fleming would not say whether Glaxo agrees with the FDA's ruling that the commercial claims Levitra is better than its rivals. Pfizer's Viagra owns the majority of the erectile-dysfunction market share, with Levitra and Eli Lilly and Co.'s Cialis controlling around 15 percent each.
The FDA said reminder ads can only call attention to a drug, not say how to use the drug or how well it might work. "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. (By Frank Ahrens)