Attorney General Richard Blumenthal announced today that Connecticut has joined with other states and the federal government in a preliminary agreement with Novartis Pharmaceuticals Corporation to settle allegations involving illegal off-label drug marketing and kickback schemes designed to induce physicians to prescribe several drugs.
The Connecticut Medicaid program will recover $1.8 million under the agreement in principle.
Novartis will pay the states and the federal government a total of $237.5 million in damages and penalties for losses to the Medicaid and other federal health care programs, and another $185 million to resolve criminal allegations.
Blumenthal announced the agreement in coordination with Chief State’s Attorney Kevin T. Kane and Department of Social Services Commissioner Michael P. Starkowski.
“This agreement reimburses Connecticut taxpayers for schemes that put self-gain before safety — the illegal promotion of Trileptal for unapproved uses,” Blumenthal said. “Novartis promoted its drug and paid off doctors — through trips and other compensation — in an effort to boost prescriptions for Trileptal beyond its limited FDA-approved use.
“This off-label marketing, which my office has vigorously pursued in coordination with other law enforcement agencies, endangers patients for the sake of money. My office will continue to aggressively pursue drug companies that illegally market drugs for unapproved uses.”
Starkowski said, “This action underscores the need for constant vigilance over public dollars in the Medicaid program. The state’s pharmaceutical assistance expenditures are about $450 million each year, and the recovery expected from this settlement will help relieve pressure on the overall budget.”
Chief State’s Attorney Kane commended the Medicaid Fraud Control Unit in the Office of the Chief State’s Attorney, the Office of the Attorney General and the Department of Social Services for their cooperative efforts in this matter, which have benefitted the state and its taxpayers.
The civil settlement resolves claims that from Jan. 1, 2001 through June 30, 2005, Novartis promoted Trileptal for certain uses unapproved by the FDA (Food and Drug Administration).
Trileptal is an anti-epileptic drug approved by the FDA to treat partial seizures in patients who have epilepsy. Novartis allegedly promoted the drug to health care professionals to induce physicians to prescribe Trileptal for unapproved uses such as the treatment of bipolar disorder and neuropathic pain. Novartis also offered and paid illegal reimbursements to health care professionals to promote and prescribe Trileptal.
The settlement also resolves allegations that from Jan. 1, 2002 to Dec. 31, 2009, Novartis provided illegal compensation — payments for speaker programs, advisory boards and the giving of gifts, (including entertainment, travel and meals) — to health care professionals to induce them to promote and prescribe the drugs Diovan, Zelnorm, Sandostatin, Exforge, and Tekturna.
The settlement also requires that Novartis enter into a Corporate Integrity Agreement with the Office of the Inspector General of the U.S. Department of Health and Human Services (HHS-OIG), which will closely monitor Novartis’ practices going forward.
Novartis is a pharmaceutical manufacturer incorporated in Delaware and headquartered in New Jersey.
