FDA TO DELAY NEW GUIDELINES FOR DTC PRINT ADS

At Issue Is Tiny-Type Side Effects Data

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WASHINGTON (AdAge.com) -- The Food and Drug Administration today said the release of new direct-to-consumer drug advertising guidelines, originally slated for later this month, has now been pushed back to January.

The new guidance is expected to revise rules

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Wants Detailed Side Effects Data Dropped From Print A
for listing the side effects of prescription medications in print advertising, and may also increase what is required to be disclosed in Internet ads, but other changes remain uncertain amid pressure from consumer groups to tighten advertising requirements and media organizations to ease them.

Two-page print buy
Currently, pharmaceutical companies that elect to place a full-page DTC print ad must, in effect, place two pages, because the side effects data most often fills an entire page with very small print.

While the change appears to benefit print publishers, the FTC said it does the opposite. The suggestion is that pharmaceutical companies end up with the choice of making broadcast buys, in which all their ad spending is on message, or print buys, in which half the cost goes for the second page of tiny text.

Since the FDA first loosened rules for DTC advertising in 1997, the segment has grown to represent $2.4 billion in advertising.

Past public hearing
In addition to conducting its own survey, the FDA in September held two days of public hearings in Washington to solicit opinion on DTC advertising.

Proponents argue that DTC promotion is of educational value, will improve the physician-patient relationship and will make consumers aware of conditions they have that could benefit from treatment.

Opponents of DTC advertising contend that consumers do not have the expertise to accurately evaluate and comprehend prescription drug advertising, and that DTC promotion is typically misleading because it fails to adequately communicate risk vs. reward information.

No rollback
Some detractors called for the elimination of DTC ads, but that notion was quickly shot down on the first day of the September hearings by Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, who said: "The genie is already out of the bottle."

"Given that [DTC advertising] is likely to remain, the ongoing question is can they be made better or more useful," Ms. Woodcock said.

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