Categorized | Civil Justice Update

Amgen agrees to pay $762 million in off-label marketing case.



The New York Times (12/19, B3, Pollack, Secret, Subscription Publication, 1.68M) reports, “The biotechnology giant Amgen marketed its anemia drug Aranesp [darbepoetin alfa] for unapproved uses even after the Food and Drug Administration explicitly ruled them out, federal prosecutors said on Tuesday.” According to the Times, “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.”

        The Los Angeles Times (12/18, Terhune, 692K) reports, “The Thousand Oaks company said it had reached a preliminary settlement of federal criminal and civil investigations last year and had already set aside about $780 million to resolve several related cases.”

        The AP (12/19, Murphy) reports, “The Food and Drug Administration approved the drug to be administered once a week or once every two or three weeks, depending on the patient. But prosecutors accused Amgen, among other things, of promoting a once-a-month dose to help Aranesp compete with Johnson & Johnson’s Procrit [epoetin alfa], which was well-established in the market, according to federal court documents.”

        Bloomberg News (12/19, Smythe, 1M) reports, “The anemia treatments, which are administered intravenously or by injection, can cause patients pain, making less frequent dosing desirable, prosecutors said.”

        Modern Healthcare (12/18, Lee, Subscription Publication, 71K) reports, “The judge deferred final acceptance of the plea and the entry of conviction until the sentencing proceeding, which is scheduled take place Wednesday. The entire settlement, including the whistle-blower lawsuits, is expected to be released Wednesday.” Reuters (12/19, Dye) and MedPage Today (12/19, Pittman) also cover the story. 

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