Office of the Attorney General
Attorney General Conway Settles Kickback Claims Against Cholesterol Drug Manufacturer KOS Pharmaceuticals, Inc.
Attorney General Jack Conway today announced that Kentucky will participate in a settlement with KOS Pharmaceuticals, Inc., over charges the cholesterol drug manufacturer paid illegal kickbacks to doctors and marketed its products for off-label uses. Under the terms of the settlement, KOS has agreed to pay a total of $41,519,742 in civil and criminal damages, fines and penalties to resolve claims brought by the federal government, Kentucky and other participating states that KOS caused false claims to be submitted to the Medicaid program.
KOS manufactures and sells Advicor and Niaspan, which are used to raise good cholesterol (HDL) levels and lower bad cholesterol (LDL) levels. First-line therapies are those recommended for the initial treatment of a disease, sign or symptom. Advicor was approved by the Food and Drug Administration only for use as a second line therapy, after diet and life style change and other medications failed to lower overall cholesterol levels. Nevertheless, KOS marketed Advicor as a first line therapy, an off-label use not approved by the FDA.
Advicor and Niaspan have the side effect of causing "flushing" or over-heating, and it was sometimes difficult to convince people to continue with the products. KOS also paid more than $800,000 in kickbacks to doctors (through the use of quality initiatives, coupon programs, preceptorships, and local Advisory Boards) to induce them to initially prescribe Advicor and Niaspan and convince their patients to continue with the Advicor and Niaspan treatment regimen.
"The off-label marketing of drugs by pharmaceutical companies is not only illegal, it undermines the doctor –patient relationship," General Conway said. "I am pleased we were able to reach this settlement and recover money for a vital state program."
As a result of the settlement, the Kentucky Medicaid program will receive $269,135. After reimbursing the federal government for its contribution, the Kentucky Medicaid program will retain $80,198 of the settlement proceeds.
Since Attorney General Conway took office in January 2008, his Office of Medicaid Fraud and Abuse Control has recovered or been awarded more than $141 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.