FDA ruling threatens DTC dollars

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The Food and Drug Administration's latest drug approval comes with a caveat that could slice more than 20% in yearly spending from the $4 billion direct-to-consumer pharmaceutical advertising industry.

In an ominous sign for already-softening category spending, the FDA last month approved the diabetes medication Symlin, with the condition that its maker, San Diego-based Amylin Pharmaceuticals, not advertise the drug directly to consumers or in medical journals for one year. That marks the second time in seven months the FDA has approved a drug under such circumstances. In September, the agency approved the analgesic Palladone from Purdue Pharmaceuticals with the stipulation that the company could not market to consumers for the first six months.

The move comes amid a relentless drumbeat of bad news for the industry, which has been under fire since September when Vioxx was pulled from the market. And there appears to be no let-up in sight. The FDA asked Pfizer to pull the arthritis medication Bextra from the market, just four months after the agency told Pfizer to cease all marketing for Celebrex, a sibling medication to Bextra. Then last week came a frightening warning from the FDA that certain well-known-and well-advertised-painkillers can cause heart damage. The news made headlines including the front page of the New York Times.

With the FDA under fire from several sectors that have linked drug safety and DTC advertising since the Vioxx/Celebrex fallout last year, many are wary that the agency will adopt-formally or informally-what many critics have long been asking for: a minimum one-year moratorium on DTC advertising following a drug's approval.

"One of the more commonly mentioned [proposals] has been the one- or two-year hiatus on DTC," said Dick O'Brien, exec VP of the American Association of Advertising Agencies. "The thinking is to have a moratorium on the advertising until the product is in the marketplace long enough for the FDA to have confidence that it is safe as when they first approved it. It's a concern for us, sure."

"A concern?" echoed one chief marketing officer from one of the major drug makers. "I'd say so, and I'd love to see how much money that would take out of the marketplace every year."

What would a one-year, new-drug ban on DTC advertising do to the industry? Here's an example: In 2003, the FDA approved 72 new-drug applications. Of those, three blockbusters were approved late in the year and began vigorous DTC campaigns in 2004. Just those three-cholesterol drug Crestor and erectile-dysfunction medications Cialis and Levitra-accounted for a combined $507 million in measured media, according to TNS Media Intelligence.

So if the one-year moratorium were in place last year, the $3.2 billion spent in 2004 on DTC would have lost 15.8% just from the ad outlays of Crestor, Cialis and Levitra, and probably more than 20% factoring in some of the other 69 drugs approved in 2003 that were marketed and promoted in 2004.

In the case of Symlin, both the marketer and the FDA said the promotional restriction was a mutual agreement since the drug has a serious side effect in that it can cause insulin-induced hypoglycemia if taken incorrectly. Amylin would not comment further. But several pharmaceutical executives contacted by Advertising Age said they believe Purdue and Amylin would only agree to the marketing ban if it was evident that the FDA would not have approved their medications without it.

OFFERED AND ACCEPTED

An FDA spokeswoman said the drug "was not approved on the basis that there be a delay in DTC advertising. In other words, the agency did not issue these `restrictions' as a basis for approval. It was not a condition of approval, it was something the company offered as a part of their Risk Management Plan and we accepted."

Sidney Wolfe, director of health research at the Washington, D.C.-based advocacy group Public Citizen and a long-time critic of DTC, has been a proponent of a moratorium on marketing. "Things change over time from when a drug is approved," Mr. Wolfe said. "There's such a rush by the pharmaceutical companies to make a buck that they're out there with a campaign five days after getting FDA approval."

But Dan Jaffe, exec VP-government relations for the Association of National Advertisers, said restraint needs to be exercised before implementing any type of moratorium. "The concern is that there may be new problems that develop once you approve a drug and roll it out," Mr. Jaffe said. "However, there's another side. What about a drug that could help some people right away who maybe aren't getting it because they didn't see an ad or their doctor hasn't seen it in a medical journal? There has to be a balance. There has to be extreme care in this area."

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