THOUSAND OAKS, Calif.—Amgen announced it has finalized a settlement agreement with the U.S. government, 49 states and the District of Columbia related to previously disclosed investigations.
Amgen will pay approximately $612 million to resolve its civil liability related to certain promotional practices related to the drugs Aranesp (darbepoetin alfa), EPOGEN (epoetin alfa), NEUPOGEN (Filgrastim), Neulasta (pegfilgrastim), Enbrel (etanercept) and Sensipar (cinacalcet) as alleged in the unsealed qui tam complaints and $150 million to resolve its criminal liability relating to the marketing of Aranesp. The Company also entered into a Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.
"I am pleased a settlement was reached to conclude this matter. With the emphasis and investment we have made in compliance, I am confident about Amgen's continued adherence to the provisions in this agreement," said Robert A. Bradway, chief executive officer at Amgen. "Amgen remains dedicated to advancing science to dramatically improve people's lives. We are committed to meeting the expectations of the government and the healthcare community as we fulfill our mission in serving the needs of patients."
As part of the agreement, Amgen has pleaded guilty to a single misdemeanor count of misbranding Aranesp by promoting it in a way that was different from the dosages in the label. The plea was entered yesterday in the U.S. District Court for the Eastern District of New York and was accepted today by the same Court.
"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. "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."