Please login to the form below

Not currently logged in
Email:
Password:

Novartis pays $422m to settle probe

Novartis has agreed to pay $422m to settle charges that it engaged in off-label marketing and financial kickbacks to doctors for a number of its drugs

Novartis has agreed to pay $422m in criminal and civil claims to settle charges that it engaged in off-label marketing and financial kickbacks to doctors for a number of its drugs, including the epilepsy treatment Trileptal (oxcarbazepine).

According to charges made by the US Attorney's Office for the Eastern District of Pennsylvania, Novartis created marketing materials promoting Trileptal for off-label uses, including bipolar disease and neuropathic pain, and targeted psychiatrists and pain specialists who would not normally prescribe the drug. Novartis also allegedly funded continuing medical education programmes regarding the off-label uses and offered kickbacks to doctors who wrote prescriptions. The company profited by "hundreds of millions of dollars" from these illegal activities, the US Attorney's Office claims.

The settlement deal brings to a close the US Attorney's criminal charges regarding Novartis' marketing practices for Trileptal, as well as civil charges for alleged off-label marketing of the blood-pressure medications Diovan, Exforge and Tekturna; the acromegaly treatment Sandostatin; and the irritable bowel syndrome drug Zelnorm. The investigation began with a 2005 subpoena regarding the Trileptal promotions.

Novartis will plead guilty to one misdemeanor violation of misbranding under the US Food, Drug and Cosmetic Act and pay a $185m criminal fine to resolve the Trileptal allegations and $237.5m in civil claims regarding its marketing of the five other drugs.

The settlement also includes a Corporate Integrity Agreement between Novartis and the Office of the Inspector General of the US Department of Health and Human Services. The agreement calls for five years of extra compliance-related measures, including additional monitoring, auditing, training, education, reporting and disclosures.

"Prior to receiving the subpoena, NPC had already taken steps to correct the challenged practices and comply with new government guidance," Novartis said. "NPC cooperated fully with the government throughout the course of this investigation, as well as the investigations of the five other products covered under the settlement."

1st October 2010

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
COUCH Health

We are a patient engagement agency committed to making clinical study experiences human. By guiding organisations in making everything they...

Latest intelligence

JulAug cover image
The Chronicles of Pharma: a creative review of pharma’s journey to omnichannel
Chris Ross conducts a literary-inspired review of pharma’s pursuit of communications excellence...
The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor
Powerful therapies that can improve skin clarity dominate the psoriasis landscape, so why are most patients stuck in a cycle of ineffective topicals? Fishawack Health explores the market and reveals...
Virtual Speaker Program: A Customer Story
Learn how we helped our client develop a virtual speaker program and roll out a series of regional peer-to-peer education sessions....