Cranbury, N.J.-based Kos Pharmaceuticals has agreed to pay more than $41 million to settle allegations that the pharmaceutical company violated anti-kickback laws and promoted off-label use of its cholesterol treatment drugs Advicor and Niaspan, according to a news release by the Office of the Inspector General.
Kos manufactured prescription drugs Advicor and Niaspan, which were marketed to treat low levels of HDL or "good cholesterol." Kos has been accused of paying illegal kickbacks to physicians through the use of quality initiatives, coupon programs, preceptorships and local advisory boards to induce them to prescribe or recommend the drugs.
Under the Food, Drug and Cosmetic Act, a company must specify each intended use of a product in its application to the FDA. After the FDA approves the product for its specified uses, any promotion by the manufacturer for other uses, or "off-label" uses, renders the product misbranded. In addition to allegedly paying illegal kickbacks, the company also allegedly falsely marketed the off-label use of Advicor as a first line therapy, even though it was only approved by the FDA as a second line therapy after diet and lifestyle changes and if other medications failed to lower overall cholesterol levels.
Of the $41 million settlement, more than $9 million will be paid back to state Medicaid programs, including Wisconsin and Missouri.
Read the OIG news release about the Kos Pharmaceutical settlement (pdf).
Read other coverage about pharmaceutical company settlements.
- Omnicare Pays $21M to Settle Allegations of Medicaid Fraud
- Pharmaceutical Company Allergan Agrees to Pay $600M for Paying Kickbacks to Physicians, Promoting Unapproved Use of Botox, Other Violations of False Claims Act
- States' Medicaid Programs Get Piece of Johnson & Johnson Subsidiaries' More Than $80M Settlement
Kos manufactured prescription drugs Advicor and Niaspan, which were marketed to treat low levels of HDL or "good cholesterol." Kos has been accused of paying illegal kickbacks to physicians through the use of quality initiatives, coupon programs, preceptorships and local advisory boards to induce them to prescribe or recommend the drugs.
Under the Food, Drug and Cosmetic Act, a company must specify each intended use of a product in its application to the FDA. After the FDA approves the product for its specified uses, any promotion by the manufacturer for other uses, or "off-label" uses, renders the product misbranded. In addition to allegedly paying illegal kickbacks, the company also allegedly falsely marketed the off-label use of Advicor as a first line therapy, even though it was only approved by the FDA as a second line therapy after diet and lifestyle changes and if other medications failed to lower overall cholesterol levels.
Of the $41 million settlement, more than $9 million will be paid back to state Medicaid programs, including Wisconsin and Missouri.
Read the OIG news release about the Kos Pharmaceutical settlement (pdf).
Read other coverage about pharmaceutical company settlements.
- Omnicare Pays $21M to Settle Allegations of Medicaid Fraud
- Pharmaceutical Company Allergan Agrees to Pay $600M for Paying Kickbacks to Physicians, Promoting Unapproved Use of Botox, Other Violations of False Claims Act
- States' Medicaid Programs Get Piece of Johnson & Johnson Subsidiaries' More Than $80M Settlement