Judge OKs $762 million Amgen settlement

A federal judge accepted biotechnology giant Amgen's guilty plea that it illegally marketed its anemia drug Aranesp, clearing the way for a $762 million settlement agreement.

The Thousand Oaks, Calif.-based company has agreed to pay $762 million in criminal fines and a civil settlement, according to the U.S. Attorney's Office in the Eastern District of New York.

“We will continue to pursue those who improperly market pharmaceuticals and biologics at the expense of individual patients' well-being and the federal healthcare system as a whole,” Stuart Delery, principal deputy assistant attorney general for the Justice Department's civil division, said in a news release. U.S. District Judge Sterling Johnson Jr. accepted the guilty plea and approved the settlement.

In a separate civil settlement, Integrated Nephrology Network, a nephrology-focused group purchasing organization and subsidiary of AmerisourceBergen, has agreed to pay $15 million to resolve claims that it offered illegal kickbacks to providers who selected Aranesp, which led to false price reporting for the drug. The company is based in Frisco, Texas.

Neither Amgen nor Integrated Nephrology Network admitted liability in the civil cases.

The attorney's office has said Amgen marketed Aranesp, an erythropoiesis-stimulating agent, for off-label uses and at unapproved dosage levels in order to increase sales of the drug. The company has agreed to pay $136 million in criminal fines and $14 million in forfeiture, as well as $612 million to settle claims that it violated the False Claims Act.

The civil settlement alleges that Amgen promoted Aranesp and two other drugs—Enbrel and Neulasta—for off-label uses, offered illegal kickbacks to influence providers to use its products and engaged in false price reporting practices.

As part of Amgen's corporate integrity agreement, it will be required to post information on its website about payments it makes to physicians.

The company had said last year that it would set aside $780 million to settle civil and criminal investigations relating to its sales and marketing practices.