Amgen Settles Aranesp Misbranding Cases With Guilty Plea And Payment Of $762 Million

Posted On Thursday, December 20, 2012
By: Leslie A. Mariotti

A federal judge has approved a $762 million settlement agreement with Biotechnology giant Amgen to resolve a number of criminal and civil cases stemming from the sale of its anemia drug Aranesp and two other drugs. It is the largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history. 

On Tuesday, December 18, 2012, Amgen entered a guilty plea before U.S. District Court Judge Sterling Johnson of the Eastern District of New York to a criminal information charging the company with illegally introducing a misbranded drug, Aranesp, into interstate commerce.  Aranesp was approved by the U.S. Food and Drug Administration (“FDA”) for particular patients suffering from anemia.  According to federal prosecutors, in order to increase sales, Amagen illegally sold the drug with the intention that it be used at off-label doses that the FDA had explicitly considered and rejected and for an off-label treatment that the FDA had never approved. 

Under the terms of the criminal plea agreement, the company will pay $136 million in criminal fines and a $14 million criminal forfeiture payment.

As part of the civil settlement, which involved ten whistleblower lawsuits, Amgen agreed to pay $612 million – $587.2 million to the federal government and $24.8 million to individual states – to resolve claims of Medicare, Medicaid and other government insurance fraud. The civil settlement agreement encompasses allegations that Amgen promoted Aranesp and two other drugs, Enbrel and Neulasta, for uses and doses that had not been approved; offered illegal kickbacks in an effort to persuade health care providers to select its product for use; and engaged in false price reporting practices.