Novartis to Pay $425 mil in off-label marketing settlement


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In recent news, Novartis Pharmaceuticals Corp. was slapped with a combination of $422.5 million in fines for off-label-marketing. The Department of Justice (DOJ) announced this settlement (pdf) on September 30. The settlement resolved four cases which all were filed under the qui tam provisions of the False Claims Act.

Novartis was charged with illegally marketing an anti-epileptic drug, Trileptal. While the FDA had approved Trileptal for the treatment of seizures, they had not approved the drug for treatment of psychiatric conditions and neuropathic pain as Novartis had marketed.  Federal law prohibits the practice of marketing drugs for unapproved purposes, which is known as off-label marketing.

Attorney General Richard Blumenthal announced the agreement. “This off-label marketing, which my office has vigorously pursued in coordination with other law enforcement agencies, endangers patients for the sake of money,” Blumenthal said.  “My office will continue to aggressively pursue drug companies that illegally market drugs for unapproved uses.”

The state of Rhode Island is to receive nearly $250 million for the off-label marketing of Trileptal as part of this settlement agreement. The Connecticut Medicaid program is also set to recover $1.8 million from the settlement.

The settlement agreement also stipulated that Novartis must 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 monitor their future practices.



“Attorney General Announces $422.5 Million Settlement With Novartis For Alleged Off-Label Drug Marketing And Kickbacks”

“Novartis Pharmaceuticals pays $422M in settlement”

“RI to receive $244,391 in drug settlement”



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