amgen

Kentucky will join other states and the federal government in a $614 million settlement with Amgen, Inc. to resolve the drug manufacturer’s illegal marketing of some of its products. Under the settlement, Kentucky will receive more than $1.1 million. After reimbursing the federal government, Kentucky’s Medicaid program will retain $313,830.

This marks Attorney General Jack Conway’s second recovery from Amgen. In 2009, Amgen paid $2.4 million to settle claims that it published false and inflated average wholesale prices used by Kentucky Medicaid to calculate Medicaid drug reimbursement rates.

“This settlement sends a strong message to Amgen and other big drug companies that this type of illegal activity is not tolerated,” General Conway said. “I am pleased that we are able to recover this money on behalf of Kentucky taxpayers and a vital state program.”

The states and federal government accused Amgen of illegally marketing the drugs Aranesp and Epogen (used to treat anemia), Enbrel (used to treat rheumatoid arthritis), Neulasta and Neupogen (used stimulate the production of infection-fighting white blood cells), and Sensipar (used to treat kidney disease for patients on dialysis). Specifically, Amgen’s sales staff promoted Aranesp, Epogen and Enbrel for so-called “off-label” uses that were not medically accepted and had not been approved by the United States Food and Drug Administration.

Amgen also paid illegal kickbacks to physicians and other medical providers in the form of cash payments, free drugs, free equipment, free software, dinners, travel, hotels, consulting fees, bogus education and research grants, and other illegal payments to induce physicians and other Medicaid providers to prescribe Amgen drugs. Finally, Amgen reported false prices to the federal Centers for Medicare & Medicaid Services by failing to include in its calculations the value of the illegal kickbacks and other price concessions to its customers in violation of the Medicaid Rebate Statute. This latter conduct resulted in the underpayment by Amgen of its Medicaid rebates to Kentucky Medicaid.

As a condition of the settlement, Amgen will enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, to prevent future illegal marketing activities by closely monitoring the Amgen’s future marketing and sales practices. As an additional condition of the settlement, Amgen will plead guilty to the criminal offense of the introduction into interstate commerce of a drug that was misbranded in violation of the Food, Drug and Cosmetic Act.

Since January 2008, the Attorney General’s Office of Medicaid Fraud and Abuse Control has recovered or been awarded more than $270 million dollars for the state and federal Medicaid programs. These cases range from lawsuits and settlements against pharmaceutical companies to cases against individual providers.

The Attorney General’s Tip Line for reporting allegations of Medicaid fraud is 1-877-228-7384.

SOURCE: press release