Amgen To Pay $762 Million To Settle Off-Label Marketing Allegations

Amgen, one of the world’s largest biotechnology companies, agreed to pay $762 million to resolve criminal and civil allegations that it marketed its drug Aranesp for off-label uses.  Of the $762 million, $612 million will be used to settle a number of whistleblower suits brought under the qui tam provisions of the False Claims Act, with $136 million to be paid in criminal fines, and $14 million forfeited. Amgen’s general counsel, David Scott, entered a guilty plea to a misdemeanor count of misbranding Aranesp, in order to resolve allegations that Amgen promoted the drug to treat anemia in cancer patients who were not receiving chemotherapy.  The FDA only approved Aranesp for patients who were receiving chemotherapy, and a later study sponsored by Amgen showed that the use of Amgen in non-chemotherapy cancer patients increased the patients’ risk of death.  According the federal charges, Amgen sales employees were instructed to engage in “reactive” marketing where they would elicit questions from doctor’s on the off-label use of the drug and then provide studies, which the FDA deemed inadequate, on the efficacy of the off-label use.  Judge Sterling Johnson Jr. has not yet decided if he will accept Amgen’s agreement, but has indicated that he will make this decision soon.

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