FDA Gives Thumbs Down To Amgen’s Film Noir Aranesp Promo
This article was originally published in The Pink Sheet Daily
Amgen’s direct mailer featuring the image of a man in free fall misleading suggests Aranesp is useful in a broader patient population than it is indicated for, agency says.
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OPDP Director Tom Abrams cautions against reading into the “snapshot.”
Amgen pled guilty to marketing Aranesp off-label as part of a global settlement with the government; the final agreement, expected to be approved on Dec. 19, could involve marketing practices of Enbrel and six other drugs.
From the rise of DTC to the shadow of Caronia, Abrams, the long-time head of the Office of Prescription Drug Promotion, monitored dramatic changes in the pharmaceutical marketplace and regulatory environment. He retired from FDA on 23 October after a tenure marked as much by careful research projects and copious guidances as it was by promotional and legal upheavals.