Attorney General announces Colorado will receive $210,000 from Irish drug company to settle off-label marketing allegations

DENVER — Colorado Attorney General John Suthers today announced that Colorado will receive more than $210,000 as part of a settlement with Elan Corporation to resolve allegations that Elan, through its subsidiary Elan Pharmaceuticals, Inc. improperly marketed its anti-epileptic drug Zonegran for off-label uses. Colorado’s recovery comes as part of a $101 million settlement that resolves allegations that Ireland-based Elan Corporation and its subsidiary promoted the sale and use of Zonegran, an anti-seizure medication, for uses not approved by the federal government.

It generally is not illegal for doctors to prescribe drugs for off-label uses, but it is illegal for drug manufacturers to market drugs for non-FDA-approved uses. State Medicaid programs generally do not pay for drugs prescribed for off-label purposes. Colorado’s share of the settlement reimburses the state for losses its Medicaid program incurred as a result of the company’s off-label marketing.

The claims alleged 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. The government also alleged that Elan promoted the drug for a variety of other non-approved uses including neuropathic pain, obesity, headaches, and a variety of psychiatric conditions. The claims also alleged that Elan gave illegal remuneration to health care providers to induce them to promote and prescribe Zonegran, in violation of anti-kickback statutes.

In a related settlement, the federal government and states have separately agreed in principle to recover $11 million from Eisai, Inc., for allegedly continuing to improperly promote Zonegran after it acquired the interests in Zonegran from Elan in April of 2004.

The Colorado Attorney General’s Medicaid Fraud Control Unit facilitated Colorado’s share of the settlements. In addition to the monetary recoveries, Elan has entered into a corporate integrity agreement with the federal government, which allows the U.S. Department of Health and Human Services to closely monitor the company’s future marketing and sales practices. The company also has agreed to plead guilty in federal court to a misdemeanor criminal charge of misbranding.

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