Amgen has agreed to pay a settlement of $762 million to resolve federal litigation accusing the company of inappropriately marketing the anemia treatment, Aranesp, for unapproved uses. The company has pleaded guilty to illegally introducing a misbranded drug into interstate commerce by promoting it in a way that was different from the dosages stated on the label. The plea was made on Dec. 18, 2012 in the US District Court for the Eastern District of New York and was accepted on Dec. 19, 2012 by the same Court.
According to the press release, Amgen will pay approximately $612 million to resolve its civil liability for certain promotional practices of Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Neupogen (filgrastim), Neulasta (pegfilgrastim), Enbrel (etanercept) and Sensipar (cinacalcet), as alleged in the unsealed qui tam complaints. Amgen will also pay $150 million to resolve its criminal liability relating to the misbranding of Aranesp.
Cynthia M. Patton, senior vice president and chief compliance officer at Amgen said, "The government raised important concerns in the criminal prosecution. Amgen acknowledges that mistakes were made, and we did not live up to our standards."
"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, the company's chief executive officer. "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."