Amgen Agrees to Pay $762 Million in Drug Marketing Case

David Scott, Amgen’s general counsel, entered the guilty plea at the United States District Court in Brooklyn to a single count of misbranding Aranesp, meaning selling it for uses not approved by the Food and Drug Administration.

The company agreed to pay $136 million in criminal fines and $14 million in a criminal forfeiture, as well as $612 million to settle various civil lawsuits from whistle-blowers.

The United States attorney’s office for the Eastern District of New York said in court that Amgen had promoted uses of Aranesp at different frequencies and different doses than stated on the drug’s label. This was apparently to try to increase use of the drug and to compete with a rival anemia drug from Johnson & Johnson.

Prosecutors also said that Amgen promoted Aranesp as a treatment for anemia in cancer patients who were not undergoing chemotherapy, even though the drug’s approval was only for patients getting chemotherapy. The use of the drug in cancer patients not getting chemotherapy was later found to be dangerous.

The presiding judge, Sterling Johnson Jr., scheduled a hearing for Wednesday at which he said he would announce whether he had accepted the settlement. Until then, the whistle-blower lawsuits remain under seal.

Amgen announced 14 months ago that it had set aside $780 million for a settlement of federal and state investigations and 10 separate whistle-blower lawsuits. In more recent regulatory filings, Amgen said the settlement was likely to include an 11th whistle-blower suit, one regarding the marketing of Enbrel, its blockbuster drug for rheumatoid arthritis and psoriasis.

The company has also said that as part of the settlement it would sign a corporate integrity agreement with the inspector general of the Health and Human Services Department. That would put some restrictions on the company’s future practices.

The corporate integrity agreement requires the executives and board members to personally certify compliance. They can be held personally and criminally liable if the company does not comply.

Marshall L. Miller, a federal prosecutor, called the agreement “a sweeping victory for the American public.”

“If you introduce misbranded drugs into interstate commerce, we will find you, prosecute you and hold you accountable,” Mr. Miller said.

The United States attorney’s office in Brooklyn has been investigating Amgen since 2007, according to Amgen’s regulatory disclosures. Aranesp, which is used to treat anemia caused by kidney disease or by cancer chemotherapy, was once Amgen’s biggest seller. But sales have been declining because of concerns that the drug can cause heart attacks and make cancer worse.

One whistle-blower lawsuit that was not under seal was filed by Kassie Westmoreland, a former Amgen sales representative.

Her suit charged that Amgen overfilled vials of Aranesp as a way of providing doctors with free medicine. The doctors could bill Medicare and private insurers for this extra amount, providing the doctors with extra profits. The suit said that this was intended to induce doctors to buy Aranesp for use in their practices rather than Procrit, a competing anemia drug from Johnson & Johnson.

During depositions in that case, five former Amgen executives invoked the Fifth Amendment against self-incrimination, according to court documents.