Healthcare Business News

Amgen to pay $762 million in misbranding case

By Jaimy Lee
Posted: December 18, 2012 - 4:15 pm ET

Amgen, the world's largest biotechnology firm, pleaded guilty in federal court in New York to criminal charges that it illegally misbranded its anemia drug Aranesp and agreed to pay $762 million in criminal fines and a civil settlement.

The Thousand Oaks, Calif.-based company entered its guilty plea earlier today and has agreed to pay $136 million in criminal fines and $14 million in forfeiture, according to the U.S. Attorney's Office for the Eastern District of New York.

The total settlement, which was not disclosed by the U.S. attorney's office, will include a $612 million civil settlement, according to a law firm representing a whistle-blower who was involved in the investigation.

The judge deferred final acceptance of the plea and the entry of conviction until the sentencing proceeding, which is scheduled take place Wednesday. The entire settlement, including the whistle-blower lawsuits, is expected to be released Wednesdsay.

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“Pursuing profits at the risk of patient safety, Amgen illegally introduced Aranesp into the marketplace for use at higher, less frequent dosage quantities, even though the FDA had specifically considered those doses and refused to approve them,” acting U.S. Attorney Marshall Miller said during a call with reporters.

In a statement, Amgen said it had pleaded guilty to one misdemeanor count of misbranding Aranesp.

“If the court accepts the plea and enters an agreed sentence, Amgen expects immediately thereafter to complete the comprehensive resolution of related civil and criminal matters,” the company said in the e-mailed statement.

According to court documents (PDF), Amgen promoted Aranesp for off-label uses as it sought to take over more of the market for erythropoietin-stimulating agents, which help prevent anemia in patients undergoing dialysis. The company also promoted off-label uses for oncology patients. The company is required to enter into a “corporate integrity agreement that will make personally accountable Amgen board members and executives, increase corporate transparency and strengthen its legal compliance structures,” Marshall said.

Amgen reported $2.3 billion in sales of Aranesp sales in 2011, including $1 billion of which was sold in the U.S. that year.

Amgen said in October 2011 that it would set aside $780 million to settle civil and criminal investigations in New York and Washington relating to its sales and marketing practices.

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