WASHINGTON (Legal Newsline) - The federal government and states have reached a $101 million settlement with an Irish pharmaceutical company that allegedly improperly marketed an epilepsy drug.
Pharmaceutical manufacturer Elan Corporation PLC and Elan Pharmaceuticals Inc, its U.S. subsidiary, allegedly made false claims in marketing the epilepsy drug Zonegran for off-label uses.
The company allegedly promoted the sale and use of the drug as an anti-seizure medication for uses not approved by the federal government.
Although it's not normally illegal for doctors to prescribe drugs for off-label uses, drug manufacturers may not market drugs for non-FDA-approved uses under federal law.
The suit alleged that Elan marketed Zonegran to pediatric neurologists for children, but that Zonegran was not approved by the FDA for this purpose.
The government further alleged that Elan promoted the drug for a variety of other non-approved uses, including neuropathic pain, obesity, headaches and several psychiatric conditions.
It was also alleged in the suit that the company violated anti-kickback statutes by offering remuneration to health care providers who would promote and prescribe Zonegran.
Under terms of the settlement, Elan has entered into a corporate integrity agreement with the federal government, allowing the U.S. Department of Health and Human Services to watch the company's future marketing and sales practices closely.
Elan has also agreed to plead guilty in federal court to a misdemeanor criminal charge of misbranding.
In a separate civil settlement, Japanese drug marketer Eisai Inc., which purchased the drug from Elan in April 2004, will pay $11 million to resolve civil liability for its own off-label marketing of Zonegran.