Amgen has pleaded guilty to a single misdemeanor count for illegally introducing a misbranded drug into interstate commerce and has agreed to pay $762 million to resolve criminal and civil liability arising from its sale and promotion of certain drugs.
According to a Justice Department press release, the government alleged that Amgen promoted their erythropoiesis-stimulating drug, Aranasep, for off-label use. Aranasep was approved by FDA at calibrated doses for particular patient populations suffering from anemia. In order to increase sales of Aranesp, the government said that Amgen illegally sold the drug with the intention that it be used at off-label doses that FDA had specifically considered and rejected, and for an off-label treatment that FDA had never approved. Under the terms of the criminal plea agreement, Amgen will pay a criminal fine of $136 million and criminal forfeiture in the amount of $14 million.
As part of the civil settlement, Amgen has agreed to pay $612 million to resolve allegations that it caused false claims to be submitted to Medicare, Medicaid, and other government insurance programs. The federal civil settlement agreement encompasses allegations that Amgen:
- Promoted Aranesp and two other drugs, Enbrel and Neulasta, for off-label uses and doses that were not approved by FDA and not properly reimbursable by federal insurance programs
- Offered illegal kickbacks to a wide range of entities in an effort to influence health care providers to select its products for use
- Engaged in false price reporting practices involving several of its drugs.
As part of the global settlement, Amgen has also agreed to enter into a corporate integrity agreement with the Department of Health and Human Services that will govern its conduct, and ensure careful oversight of its branding and marketing practices.
"The government raised important concerns in the criminal prosecution. Amgen acknowledges that mistakes were made, and we did not live up to our standards," said Cynthia M. Patton, senior vice president and chief compliance officer at Amgen in a company news release. "This Corporate Integrity Agreement is aligned with the significant changes and enhancements we have made to our compliance program and demonstrates our commitment to fostering a culture of compliance at Amgen."