Novartis Corp. pleaded guilty to this offense and misdemeanor and agreed to pay a criminal penalty and forfeiture amounting to $185 million. U.S. Attorney Zane Memeger said mentioned that every patient in the country looked for sound and safe advice from doctors and that this off-label marketing can destruct this harmonious doctor-patient relationship.
Novartis will pay an additional $237.5 million to compromise for the civil liabilities for off-label marketing and kickbacks of Trileptal, according to the agreement of settlement. The drug making company illegally advertised and marketed Trileptal as a medicine for nerve pain and bipolar disorder by sending its sales persons to the offices of pain specialists, psychiatrists and neurologists.
Memeger said that doctors are permitted to prescribe off-label drugs based on their medical experience but drug making companies aren’t allowed to advertise or market their products for any use which is not authorized by the Food and Drug Administration.
The Federal prosecutors have not alleged that any patient was harmed because of these drugs. Novartis released a statement saying that, “NPC is pleased to have this matter behind us, and will continue to work with the government and other organizations to improve health care for all Americans. We are committed to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products.”
The criminal information filed on Thursday in Philadelphia states that Novartis sought the approval of FDA in 1995 to sell Trileptal as a medicine for mania but it says that it wasn’t as effective in the clinical trials.
The East Hanover based company has entered into an agreement with the government under which it will be subjected to strict scrutiny.