Biotechnology giant\u00a0Amgen\u00a0today pleaded guilty in federal court to a misdemeanor charge of misbranding\u00a0Aranesp (darbepoetin alfa), its highly successful anemia drug. The government accused\u00a0Amgen\u00a0of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices.<\/p>\n
The judge deferred a decision on the plea until Wednesday. When the final settlement is announced further details about pending civil suits against\u00a0Amgen\u00a0will be unveiled. The acting U.S. Attorney said that the terms of the agreements will include multiple measures to insure that\u00a0Amgen\u00a0complies with regulations. The measures will mean that\u00a0Amgen\u00a0“won’t view this as the cost of doing business,” he said in a press conference.<\/p>\n
The agreement includes $150 million for criminal fines and penalties and an additional $612 million civil settlement. In 2011\u00a0Amgen\u00a0reported $2.3 billion in sales for Aranesp.<\/p>\n
Aranesp is\u00a0approved<\/a>\u00a0to treat anemia in chemotherapy patients and in anemia patients with chronic kidney disease (CKD). The label now includes a black box warning that it can increase the risk of death, MI, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.<\/p>\n Although it had been the subject of earlier questions, serious\u00a0criticism emerged with\u00a0the publication in 2009 of the TREAT trial<\/a>, which found no clinical benefit for the drug in patients with CKD. Results of TREAT prompted\u00a0a dramatic FDA advisory committee meeting in 2010<\/a>\u00a0followed by\u00a0a major label revision in 2011<\/a>.<\/p>\n