Novartis Pharmaceuticals, based in East Hanover, N.J., has agreed to pay $422.5 million to settle allegations that it had illegally marketed its pharmaceutical drug Trileptal, filed false claims and paid illegal kickbacks, according to a Department of Justice news release.
Novartis is settling claims that it had allegedly illegally promoted the drug Trileptal for "off-label" treatment of psychiatric, pain and other conditions, even though the Food and Drug Administration has only approved it as an anti-epileptic drug for the treatment of partial seizures. Under the Food, Drug and Cosmetic Act, a company is required to 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.
Novartis is also settling accusations that its alleged illegal marketing of Trileptal and five other drugs led to the submission of false claims to federal health programs. In addition, the agreement resolves allegations that the company paid kickbacks to healthcare professionals, inducing them to prescribe Trileptal and the five other drugs. Further details about the alleged kickbacks were not disclosed in the news release.
Under the qui tam, or whistleblower, provisions of the False Claims Act, more than $25 million of Novartis' settlement will be paid back to whistleblowers who filed four lawsuits.
Read the DOJ news release about the Novartis settlement.
Read other coverage about pharmaceutical company settlements:
- Schwarz Pharma to Settle Allegations of False Claims, Will Pay $22M
- Pharmaceutical Company AstraZeneca Settles Allegations of Off-Label Marketing and Paying Kickbacks, Pays $520M
- New Jersey-Based Pharmaceutical Company to Pay More Than $41M to Settle Allegations of Kickback Violations, Off-Label Marketing
Novartis is settling claims that it had allegedly illegally promoted the drug Trileptal for "off-label" treatment of psychiatric, pain and other conditions, even though the Food and Drug Administration has only approved it as an anti-epileptic drug for the treatment of partial seizures. Under the Food, Drug and Cosmetic Act, a company is required to 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.
Novartis is also settling accusations that its alleged illegal marketing of Trileptal and five other drugs led to the submission of false claims to federal health programs. In addition, the agreement resolves allegations that the company paid kickbacks to healthcare professionals, inducing them to prescribe Trileptal and the five other drugs. Further details about the alleged kickbacks were not disclosed in the news release.
Under the qui tam, or whistleblower, provisions of the False Claims Act, more than $25 million of Novartis' settlement will be paid back to whistleblowers who filed four lawsuits.
Read the DOJ news release about the Novartis settlement.
Read other coverage about pharmaceutical company settlements:
- Schwarz Pharma to Settle Allegations of False Claims, Will Pay $22M
- Pharmaceutical Company AstraZeneca Settles Allegations of Off-Label Marketing and Paying Kickbacks, Pays $520M
- New Jersey-Based Pharmaceutical Company to Pay More Than $41M to Settle Allegations of Kickback Violations, Off-Label Marketing