Who's next? FDA action on Viagra spooks DTC industry

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The Food and Drug Administration's bedeviling letter to Pfizer, asking the drug company to pull its current TV advertising for the erectile-dysfunction medication Viagra, has many in the industry scratching their heads.

And wondering who's next.

"I'm a little surprised, a little disappointed, but mostly I'm concerned," said one health-care-agency president. "Viagra is so high-profile that this could be a precedent-setting decision by the FDA."

The FDA asked that commercials created by Interpublic Group of Cos.' McCann Erickson, which won the $110 million account in August, be pulled. The ads in question feature a man and a woman stopping in front of 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.

But the devil was not in the details as far as the FDA was concerned, which told Pfizer the spots do not say what the medication is for or warn of the potential side effects.

The FDA did not return a call for comment. Pfizer declined to comment other than to say it would comply with the FDA's request.

Some say the FDA is nitpicking and singling out Pfizer for ads that promote sexuality, when its competitors have done the same thing. Advertising for Eli Lilly and Icos Corp.'s Cialis feature a man and a woman in bathtubs and speaks of when "the time is right." The star of Levitra's current campaign is a 40-ish woman wearing a man's dress shirt-which some say is a covert ad symbol that the woman just engaged in sexual relations-and speaking of how the Bayer AG product works for "my man." Both spots, however, do specify that the drug is for ED.

"Who's kidding who?" said the chief marketing officer for a rival pharmaceutical company. "Everybody knows what Viagra is and what it's for. You can't use its success against the manufacturer."

Dr. Sidney Wolfe, director of the Public Citizen's Health Research Group, noted that FDA enforcement letters against DTC advertising went from more than 150 actions in 1998 to 23 in 2003. "If you are the industry, you cannot help but notice the FDA has largely stopped enforcing the laws and regulations on drug advertising," he said. "Therefore, you're almost encouraged to run misleading ads like this. By the time the FDA catches up with this kind of ad, it's likely millions of people, or more, have seen the ad."

increased regulation

Acting FDA Commissioner Lester Crawford told the Chicago Sun-Times he plans to increase regulation of DTC prescription advertising, saying "We've had enough of some of these things."

Others found irony in the FDA's timing. Its warning letter to Pfizer was dated Nov. 10, just six days after the agency warned consumers not to buy or use the supplements Actra-Rx or Yilishen because they contain an ingredient that could lower blood pressure to unsafe levels. Both supplements are promoted on Web sites as ED treatments and male-enhancement drugs.

Because they are supplements, they do not face the regulatory issues from the FDA that prescription medications do. Earlier this year, Center for Science in the Public Interest filed a complaint with the Federal Trade Commission, asking that TV ads for Enzyte featuring "Smiling Bob" for Berkeley Premium Nutraceuticals, Cincinnati, be banned.

"Enzyte is more successful subtracting from the male wallet than it is adding to the male organ," said David Schardt of the Center for Science in the Public Interest. The marketer did not return a phone call for comment.

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