Settlement resolves allegations related to their promotion of anti-epileptic drug Zonegran for unapproved uses
Attorney General John Kroger today announced that Oregon will receive nearly $400,000 under a national agreement with the Elan Corporation and Eisai, Inc. for allegedly marketing the anti-epileptic drug Zonegran for off-label purposes.
“Pharmaceutical companies need to play by the rules,” said Attorney General Kroger. “Marketing drugs for unapproved uses puts patients at risk and results in greater costs to government health care programs.”
Oregon joined the federal government and other states to reach an agreement in principle with Elan, a publicly-traded company headquartered in Ireland, to resolve claims that the company and its North American subsidiary,
Elan Pharmaceuticals, Inc. (EPI) improperly marketed its anti-epileptic drug, Zonegran, for unapproved purposes.
Elan introduced Zonegran in 2000 after obtaining approval from the U.S. Food and Drug Administration (FDA) to sell the drug to treat seizures. The state/federal investigation revealed that EPI may have improperly marketed Zonegran for uses not approved by the FDA, including promotional activities designed to increase the prescription of Zonegran by pediatric neurologists even though the drug was not approved for patients under the age of 16. The company also allegedly promoted Zonegran for the treatment of neuropathic pain, obesity, headaches and a variety of psychiatric conditions.
The settlement with Elan resolves additional allegations that the company offered and paid illegal kickbacks to health care professionals to promote and prescribe Zonegran.
Under the agreement with Elan, the company will pay a total of $203 million. Of that, $101 million in civil damages and penalties will compensate state and federal healthcare programs. The civil settlement also requires Elan to enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.
EPI also pleaded guilty to a federal misdemeanor charge under the United States Food, Drug, and Cosmetic Act (FDCA) and will pay a criminal fine of $102 million to the federal government for misbranding Zonegran through improper promotional activities.
In a related action, the states and federal government recovered $11 million from Eisai, Inc., for allegedly continuing to promote Zonegran for unapproved uses after it acquired the interests in Zonegran in 2004.
Oregon will receive $356,119 under the settlement with Elan and $39,863 under the settlement with Eisai to compensate the Oregon Health Plan for harm suffered from their improper marketing of Zonegran.
Attorney General John Kroger leads the Oregon Department of Justice. The Department’s mission is to fight crime and fraud, protect the environment, improve child welfare, promote a positive business climate, and defend the rights of all Oregonians.
Contact:
Tony Green, (503) 378-6002 tony.green@doj.state.or.us