New York Attorney General Eric T. Schneiderman said Wednesday, pharmaceutical maker Amgen has agreed to a $612 million national settlement of allegations it illegally marketed some drugs for use to treat kidney disease and cancer for a decade.
The company also pleaded guilty to a misdemeanor in federal court that will require ti to pay a $150 million fine.
The agreement, reached with the 50 states and the District of Columbia, also settles allegations that Amgen fixed drug prices and paid kickbacks to health care professionals, which included the filing of false claims for Medicare reimbursement by doctors.
“There are no excuses for illegally marketing off label drugs, offering kickbacks to health care professionals and ripping off the taxpayers by defrauding Medicaid and other programs,” Schneiderman said in an announcement. “With this settlement the message we are sending is clear: biotechnology giants are not above the law and my office will continue to ensure that prescriptions be written based on medical judgment—not profit motive.”
Amgen will pay the states and the federal government a total of $612 million in civil damages and penalties to compensate Medicaid, Medicare and various federal healthcare programs for harm suffered as a result of its conduct. New York led the National Association of Medicaid Fraud Control Unit Team representing the states. The other states represented on the team were from California, Illinois, Indiana, North Carolina and Massachusetts. New York State will receive $12.5 million of these monies under the agreement.
A multi-national corporation headquartered in Thousand Oaks, Calif., Amgen will pay an additional $150 million in fines and forfeitures to federal authorities for criminal conduct. In addition, Amgen pleaded guilty today to a misdemeanor charge in the United States District Court for the Eastern District of New York, in Brooklyn, for introducing a misbranded drug into interstate commerce.
According to settlement papers, Aranesp, which was approved by the Food and Drug Administration for stimulating red blood cell production in anemia patients, was illegally marketed and prescribed to patients suffering from anemia, cancer and kidney diseases and at doses larger and less frequent than approved by the FDA.
While the bulk of the settlement proceeds deals with Amgen’s conduct related to the drug Aranesp, the government also investigated Amgen’s practices involving other pharmaceuticals concerning both Amgen’s pricing and marketing activities.
The settlement resolves claims that the following drugs were also marketed off label:
Enbrel is approved by the FDA only for the treatment of severe psoriasis. It is alleged that Amgen also promoted it as a drug for mild psoriasis and at a dosing regimen not approved by the FDA. In addition, the company allegedly made unsupported or insufficiently supported claims regarding Enbrel’s safety and superiority for the treatment of the more severe plaque psoriasis.
Neulasta, which is approved to promote the production of white blood cells, was marketed at dosing regimens not approved by the FDA for treating cancer patients suffering from infection.
In addition to the off label marketing, this settlement resolves allegations that Amgen in violation of the federal anti-kickback statute and other state laws, improperly influenced medical professionals by offering price concessions, improper rebates, improper bundling of products and other inducements for the following drugs (in addition to Aranesp, Enbrel and Neulasta): Epogen, which is approved for patients with chronic kidney disease who have lower-than-normal red blood cell counts; Neupogen, which is used for treating a common side effect of chemotherapy, neutropenia; and Sensipar, which is approved as a drug to lower calcium in the blood. The failure to report these improper rebates, improper bundling and other inducements, violated the Medicaid Rebate Statue.
It is unclear if any doctors will be charged related to this case or previous ones settled by other pharmas charged with similar tactics.
Source: NY AG.