Colorado will receive more than $210,000 as part of a settlement with Ireland-based Elan Corp.
This settlement is to resolve allegations that Elan – through subsidiary Elan Pharmaceuticals – improperly marketed its anti-epileptic, anti-seizure drug Zonegran for off-label uses. The state’s portion is part of a $101 million settlement against Elan and its subsidiary for promoting the sale and use of Zonegran, for uses not approved by the federal government.
Although, generally, it’s not illegal for doctors to prescribe drugs for off-label uses, it is illegal for drug manufacturers to market drugs for non-FDA-approved uses. Colorado’s settlement share reimburses the state for Medicaid-program losses as a result of the company’s off-label marketing.
The government stated that Elan promoted the sale and use of Zonegran to pediatric neurologists, even though the drug had not been FDA-approved for use in children, and that the company also promoted the drug for a variety of other non-approved uses including obesity, headaches, neuropathic pain, and a variety of psychiatric conditions.
In a related settlement, the federal government and states will recover $11 million from Eisai Inc., which allegedly continued to improperly promote Zonegran after it acquired the interests in Zonegran from Elan in April of 2004.
As part of the settlement, U.S. Department of Health and Human Services will closely monitor Elan’s future marketing and sales practices.