Viagra: A Drug Ad Too Far?


By Amy Tsao Pharmaceutical companies love to tout their drug ads as examples of consumer education. But that argument hardly stands up in Pfizer's (PFE) latest Viagra pitches. The Food & Drug Administration recently sent the outfit a warning letter saying its racy consumer ads for the male impotence drug don't contain enough information about risks and side effects. Pfizer agreed on Nov. 15 to pull the ads after the letter was made public.

In the campaign, which began in August, the V part of the Viagra logo turns into a pair of glowing devil's horns atop a 40-something man's head. The horns and the impish look on his face hint that Viagra is fueling his mischief. The punch line: He's back. No mention of impotence, and nothing on the drug's side effects, which include, most commonly, headaches and blurred vision. Men with a history of cardiovascular problems are cautioned against using the drug. Pfizer says it plans to respond in writing to the FDA's warning letter by the agency's deadline of Nov. 24.

NOT THE FIRST TIME. The trouble with such ads is that they suggest what the drug treats through visuals without explicitly explaining risks and side effects. The FDA allows drugmakers to advertise their drugs without the side-effects summary if they don't mention the medical condition at all. These are known as "reminder" ads.

However, Pfizer's pitch is another matter. It strongly implied the medical problem with images, thereby getting around the requirement of mentioning possible side effects. "It's the most blatantly out-of-control ad I've seen," charges Janell Mayo Duncan, legislative and regulatory counsel at Consumers Union, the nonprofit publisher of Consumer Reports. "It has been tremendously disappointing that the FDA has allowed companies to continue to use ads that don't adequately disclose risks," she says. Efforts to reach Pfizer for comment were unsuccessful.

Pfizer isn't alone in getting warned, and it's not the first time for the outfit, either. In recent years, the FDA has warned the makers of Vioxx and Celebrex, Merck (MRK) and Pfizer, respectively, about advertising their drugs in a too-positive light without explaining possible side effects.

MORE DELAY. This latest warning, however, highlights broader problems in the way direct-to-consumer pitches are governed. The FDA's division of drug-marketing advertising and communication sets criteria on what ads can and cannot say. Companies are expected to submit ad materials to FDA "at the time of dissemination" -- that is, when they start broadcasting them. They don't even have to show the agency the ads beforehand.

After broadcast, oversight remains scant -- until problems arise. "The agency simply doesn't have enough staff ," says Michael Montagne, professor of social pharmacy at the Massachusetts College of Pharmacy and Health Sciences. "It's not a case of an ad not making it through to the media. It's always someone catching it after the fact."

The process of warning drugmakers is also ineffective. Pfizer's horned-devil ads ran for several months before the FDA warned it. That's in part a result of a change in how warning letters are issued. Local FDA offices used to send warning letters as they saw fit. That altered in the last few years. Now, warnings to businesses for inappropriate ads need to first be cleared through the FDA's office of the general counsel to get sent.

WELCOME PUBLICITY. The slowness "benefits companies tremendously," says Mayo Duncan. By the time a warning gets to a pharmaceutical concern, "they've achieved [their] goal of ginning up interest and sales without informing people of potential side effects."

An FDA warning to the world's largest drugmaker for misrepresenting a blockbuster medication (Viagra sales topped $1 billion in 2003) isn't likely to teach the industry any lessons. Pharmaceutical outfits will likely continue to push the boundaries on how they market to the public. "They will go up to the line and over," warns Mayo Duncan.

In Pfizer's case, it has agreed to stop running the ads, but Winton Gibbons, analyst at Chicago-based investment bank William Blair, figures Pfizer might simply be able to amend its ads with the information the FDA wants. And in a perverse way, the fresh attention on Viagra may even boost sales amid hyper-competition from recently launched brands Cialis, made by Eli Lilly (LLY) and Icos (ICOS), and Bayer's Levitra (BAY). "No publicity is bad publicity in this context," says Gibbons. "This is stimulating discussion around the brand."

Direct-to-consumer pitches for prescription drugs are here to stay. Many analysts predict the guidelines will be loosened even further, so businesses will continue to push the envelope. "The FDA has to have the resources and the will" to police better, says CU's Mayo Duncan. But the reality is that direct-to-consumer advertising is relatively low on the agency's list of priorities. Now, more than ever, it's buyer beware. Tsao is a writer for BusinessWeek Online in New York


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