FDA panel to mull DTC changes

Brace yourselves: An FDA advisory committee meets today to hash over the possibility of putting a side-effects hotline number in every DTC television commercial. The meeting comes at a time when drug ads are under increased scrutiny; just last week, Congress heard testimony about the ads, including expert assessment that commercials are engineered to play down warnings and emphasize benefits. One researcher said she'd found that 80 percent of TV viewers could recall drug benefits mentioned in commercials, but only 20 percent remembered side effects.

Print ads, you'll recall, already include FDA contact info so patients can report side effects. Some lawmakers and consumer groups say adding that info to TV ads as well would help regulators catch drug safety problems sooner.

- see the item [1] at Pharmalot
- check out the Associated Press story [2]

ALSO: A stent skeptic assails DTC advertising for Johnson & Johnson's Cypher product in the New England Journal of Medicine, saying the TV commercials cross an ethical line; J&J says the ad is balanced and points viewers to sources of more detailed information. Report [3]

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