February 4th, 2008

Ad Groups Unfazed by DTC-Drug Debacles

By Rich Thomaselli and Ira Teinowitz
Advertising Age

First came headlines that a study showing that cholesterol drug Vytorin doesn’t reduce plaque buildup in arteries was delayed by drug makers that spent millions advertising the claim. Then came news that Eli Lilly & Co. might pay an astounding $1 billion to settle a federal investigation into the marketing of its antipsychotic drug Zyprexa, potentially the largest sum ever paid by a drug company for breaking federal laws regarding marketing of prescription medication.

But the ad industry is standing by its opposition to a two-year moratorium on advertising new drugs directly to consumers.

Mark Senak, senior VP at the Washington office of public-relations powerhouse Fleishman-Hillard, who specializes in public health and health policy, said this latest crisis gives drug-industry opponents license to go after the Food and Drug Administration to institute a “two- or three-year moratorium” on advertising new drugs and put “greater teeth” into monitoring DTC.

Reforming the FDA
Mr. Senak, who was previously national director of health policy at Manning Selvage & Lee and writes the blog Eye on FDA, said the First Amendment makes it difficult to abolish the $5 billion DTC ad business—but it can be reined in by the FDA. “We’re not seeing the beginning of the end of DTC; we’re seeing the beginning of an incredible effort to reform the FDA,” he said.

Ad groups argue that the FDA last year was given increased powers—it can now fine marketers $250,000 a day for a misleading ad and double the fine’s size for subsequent ads—and that a moratorium is a draconian, if not dangerous, solution.

“Not running any advertising is not a medical solution, it is a political compromise,” said Wally Snyder, president-CEO of the American Advertising Federation. “If the product has been approved after an elaborate scientific presentation, it makes no sense not to run ads. Who are you penalizing? Consumers?” He added: “If the FDA has decided that a drug is effective, why shouldn’t consumers have that information?”

Dan Jaffe, exec VP of the Association of National Advertisers, said: “We believe the FDA was given substantially increased power over drug advertising and that the FDA can act against false and deceptive advertising. A moratorium could block all sorts of truthful and non-deceptive advertising from consumers that could literally be a matter of life and death.”

No new 4A’s guidelines
The American Association of Advertising Agencies isn’t planning any directives for its members following the latest flaps. Noting that the pharmaceutical manufacturers association is looking at revising its marketing guidelines, 4A’s Exec VP Dick O’Brien said: “Pharma is the principal here. They are the ones who set the code of conduct. Agencies don’t need to duplicate it.”

Now that the Democrats control Congress and, therefore, its key committees, they are “exercising that oversight right to an astonishing degree—and there’s no sign of that letting up,” Mr. Senak said.

In the first month of the year, Congress has explored the use of medical doctors in commercials, specifically Pfizer’s use of artificial-heart inventor Dr. Robert Jarvik in a Lipitor spot. The House Committee on Energy and Commerce is also investigating the continued advertising of Vytorin, and, according to reports, Merck is the subject of a probe by the U.S. Attorney’s office in Massachusetts regarding sales and marketing for Vioxx, the painkiller it pulled from the market in 2004 after it was discovered the drug increased the risk of heart attacks and strokes.

In Lilly’s case, the investigation centers on whether the drug maker marketed “off-label” uses for antipsychotic Zyprexa. In addition to a potential $1 billion fine, Lilly is facing a lawsuit filed last week by two of its shareholders, who accused company executives of “recklessly disregarding risks posed by illegal drug marketing tactics, which have been alleged in lawsuits and newspaper articles.”

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