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Sunday, December 30, 2012

Amgen Agrees to Pay $762 Million for Marketing Anemia Drug for Off-Label Use


By ANDREW POLLACK and MOSI SECRET
The New York Times
Published: December 18, 2012

The biotechnology giant Amgen marketed its anemia drug Aranesp for unapproved uses even after the Food and Drug Administration explicitly ruled them out, federal prosecutors said on Tuesday.

The federal charges were made public as Amgen pleaded guilty to illegally marketing the drug and agreed to pay $762 million in criminal penalties and settlements of whistle-blower lawsuits.

Amgen was “pursuing profits at the risk of patient safety,” Marshall L. Miller, acting United States attorneyin Brooklyn, said in a telephone news briefing on Tuesday.

David J. Scott, Amgen’s general counsel, entered the guilty plea at the United States District Court in Brooklyn to a single misdemeanor count of misbranding the drug, Aranesp, meaning selling it for uses not approved by the F.D.A.

Amgen agreed to pay $136 million in criminal fines and forfeit $14 million, with about $612 million going to settle civil litigation.

The entire article is here.