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12:00 AM
May 14, 2007
 |  BioCentury  |  Regulation

ODAC, Pazdur agree on DTC


ODAC, Pazdur agree on DTC

FDA advisory committee meetings usually revolve around interpretations of data presented in briefing documents or articles from peer reviewed journals, but the discussion at last week's Oncologic Drugs Advisory Committee meeting on erythropoiesis-stimulating agents was heavily colored by TV advertisements and newspaper reports of impropriety in the marketing of ESAs.

Otis Brawley diverted the meeting onto the topic of media criticism by chastising Johnson & Johnson's television advertisements that purported to show cancer patients leading vigorous lives and attributing their energy levels to the company's Procrit epoetin alfa.

"Most doctors and most patients think this drug has been approved because it improves quality of life - it improves fatigue," said Brawley, who served as a temporary voting member of ODAC. "I don't see that on the FDA indication. I see it on late night television. There is a lot of sleight of hand here on what the drug is used for and what it is approved for."

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