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Lamisil's Fungus Ads Stepped On FDA's Toes

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NEW YORK -- The Food and Drug Administration is looking to write a new prescription for pharmaceutical advertising.

The explosion in ads that pitch prescription drugs directly to consumers has been an elixir for the ailing ad industry. In 2002 the ad industry grew just 4.2% overall to $117 billion, but direct-to-consumer drug ad spending grew 32% to $5 billion, according to ad tracker TNS Media Intelligence/CMR.

But monitoring the content and claims of these ads has become a headache for the FDA. With the spending have come more violations, and the agency has responded by pumping up enforcement.

''The FDA has become more vigilant in its enforcement responsibility,'' says Peter Pitt, the agency's associate commissioner for external affairs.

So vigilant, in fact, that in December the agency will issue guidance on how to improve the way marketers convey side effects and risks associated with a particular drug. The FDA requires TV ads to disclose major risks and requires print ads that accompany the TV ads to spell out in detail the effectiveness, risks associated with other health problems, drug interactions and side effects. But that fine print is lengthy and cumbersome.

''The risk information is not designed to be user-friendly,'' Pitt says. New guidelines, he says, will help marketers be in compliance and make the summaries a ''better tool for public health.''

''Patients have a generally good idea of benefits but a minimal understanding of risks. That's not good,'' he says.

Stepped-up enforcement has brought FDA warning letters to drugmakers GlaxoSmithKline, AstraZeneca and Novartis for ad violations. Novartis, in fact, was ordered to pull an ad for toenail fungus remedy Lamisil, which features a cartoon character, Digger.

A letter from the Division of Drug Marketing, Advertising and Communications cited the ad for being ''false or misleading because they overstate Lamisil's efficacy, minimize risk information and make an unsubstantiated superiority claim (over other drugs).''

Novartis, which submitted the ad idea to the FDA before it began airing this year, is trying to fix it.

''We're currently working on modifying it and working closely with the FDA to make sure the changes address their concern,'' says Charles Savino, Novartis group brand leader for respiratory and dermatological products.

The ad, by Deutsch, N.Y., features the cartoon Digger, a nail fungus otherwise known as an onychomycosis. He settles under a toenail and invites friends to join him as a voice-over explains: ''thick, discolored or flaky nails'' may be caused by an ''active, live infection.''

The character helps establish Lamisil a bit more like a consumer product rather than a prescription drug. Digger, however, was not intended to be a likable character, such as the Pillsbury Doughboy.

''We didn't want people to think he was a cute, cuddly character,'' Savino says. ''We stayed away from happy people doing happy things because we wanted a more compelling message to reach consumers. We found it was sort of a fun, friendly way to communicate our message.''

Consumers surveyed by Ad Track, USA TODAY's weekly poll, seem to agree Digger is neither cute nor cuddly. Of those familiar with the campaign, just 7% like the ad ''a lot'' vs. the Ad Track average of 21%. And 27% ''dislike'' the ad vs. Ad Track's 13% average.

But consumers do consider the ads effective, with 19% of respondents rating the ad ''very effective,'' about the average of 21%.

''We wanted to come up with a campaign that was educational,'' Savino says. ''The goal of that was to motivate consumers to talk about it with physicians. People suffer physically, physiologically and emotionally and suffer for many years without saying anything to a doctor.''

Rather than seeking medical remedies, sufferers tend to try home treatments for fungus nails, Savino says. In researching the ad, he learned people had tried such techniques as Vicks VapoRub or drilling holes into nails and pouring bleach into them.

Little wonder, then, that Novartis tried to make Digger and Lamisil more consumer-friendly. A little too friendly, says the FDA, so Novartis is working on a solution.

''It's a challenge to develop really compelling creative (ads) for consumers to take action,'' Savino says. ''But the rules are the rules, and you have to play within those rules.''

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© Copyright 2003 USA TODAY, a division of Gannett Co. Inc.

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