FDA scrutiny threatens DTC media bonanza

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The Food and Drug Administration is pelting drugmakers with letters warning that they have run afoul of promotional regulations-nine in four months, already approaching 2004's total-threatening to tip the $4 billion direct-to-consumer drug industry into a full-blown crisis.

The FDA's newfound aggressiveness is causing a rush to revise campaigns, delay or pull advertising and products just weeks before the upfront, causing angst at the TV and cable networks that received 66% of total DTC dollars last year. Particularly in jeopardy is network TV news programming, since DTC ads account for nearly a third of the advertising on the major broadcast network's nightly news programs.

"People are projecting the category will spend less in the upfront because of the potential worries about drugs in regulatory purgatory," said one agency media buyer.

Worse, the ripple effect has reached marketers who have not received warnings: TAP Pharmaceuticals is voluntarily pulling the TV portion of its $100 million advertising campaign for acid-reflux remedy Prevacid because 30- or 60-second time constraints do not allow it to sufficiently communicate the product's risks as well as benefits.

Although a TAP spokeswoman said the company will put some of its TV outlay into print, publishers, hit by 4.1% falloff in pharmaceutical pages in the first quarter, aren't celebrating. A bigger schedule from Prevacid, already a major client, "would be our hope," said Kate Kelly Smith, VP-publisher of Rodale's Prevention. But thus far "we have not seen a change at all." Said Chris Allen, publisher of Time Inc.'s Cooking Light: "I haven't heard anything about" increasing print schedules.

In fact, some are going away entirely. Amylin Pharmaceuticals and Purdue Pharmaceuticals have agreed to "risk-management" programs with the FDA in which their products will get little or no consumer marketing for set periods of time.

The FDA defended its position. "This is not a crackdown, it is an enforcement," said Thomas Abrams, director of the FDA's Division of Drug Marketing, Advertising and Communication. "We're continuing our close monitoring. ... we're prepared to take whatever action necessary to stop misleading promotion."

contributing: claire atkinson, jon fine

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