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Risk/Benefit “Fair Balance” In DTC Ads Leads To Confusion – Petition

Executive Summary

FDA should redefine its policy of requiring "fair balance" of risk and benefit information in prescription drug advertising, the Coalition for Healthcare Communication says in a March 31 citizen petition

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Celebrity DTC ads

The House Energy and Commerce Committee is investigating the practice of having celebrities endorse drugs in direct-to-consumer ads. Their initial target is the appearance of Robert Jarvik, inventor of the artificial heart, in ads for Pfizer's Lipitor. "Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine," Committee Chairman John Dingell, D-Mich., says. The divide between legislators and industry on the DTC issue is exemplified by the endorsement given to a Jarvik Lipitor print ad by Coalition for Healthcare Communication Executive Director John Kamp following a CHC petition asking FDA to revise how it applies the fair balance test to DTC ads (1"The Pink Sheet" April 10, 2006, p. 26)...

Celebrity DTC ads

The House Energy and Commerce Committee is investigating the practice of having celebrities endorse drugs in direct-to-consumer ads. Their initial target is the appearance of Robert Jarvik, inventor of the artificial heart, in ads for Pfizer's Lipitor. "Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine," Committee Chairman John Dingell, D-Mich., says. The divide between legislators and industry on the DTC issue is exemplified by the endorsement given to a Jarvik Lipitor print ad by Coalition for Healthcare Communication Executive Director John Kamp following a CHC petition asking FDA to revise how it applies the fair balance test to DTC ads (1"The Pink Sheet" April 10, 2006, p. 26)...

Win, Lose Or Yawn: Is Industry’s DTC Policy Working?

Despite a strategic shift by industry curtailing playful ads and promotions in favor of a more serious clinical approach, the omission of risk information in advertising remains a pressing problem, FDA Division of Drug Marketing, Advertising & Communications Director Tom Abrams said

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