WASHINGTON (AP) -- Irish pharmaceutical manufacturer Elan Corporation PLC and its U.S. subsidiary have agreed to pay more than $203 million for alleged illegal promotion of the epilepsy drug Zonegran, the Justice Department said Wednesday.
The department said Japanese drug marketer Eisai Inc., which bought the drug from Elan, will pay $11 million for so-called off-label marketing of Zonegran.
Elan has agreed to plead guilty to a misdemeanor for allegedly promoting Zonegran for a wide variety of improper uses, including mood stabilization, migraine headaches, eating disorders and weight loss.
The Food and Drug administration approved Zonegran as an anti-epileptic drug, but not for other uses.
Elan will pay a criminal fine of $97 million, will pay $102.3 million to resolve civil allegations and will forfeit $3.6 million in assets.
This settlement is part of the government's emphasis on combating health care fraud. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover more than $5 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department's total recoveries in False Claims Act cases since January 2009 have topped $6 billion.
The settlement resolves a whistle-blower lawsuit filed by a Massachusetts physician. The law allows citizens with knowledge of fraud to file civil actions on behalf of the United States and share in any recovery.
The Justice Department says it has recovered more than $5 billion since January 2009 in cases involving fraud against federal health care programs.
The department said Japanese drug marketer Eisai Inc., which bought the drug from Elan, will pay $11 million for so-called off-label marketing of Zonegran.
Elan has agreed to plead guilty to a misdemeanor for allegedly promoting Zonegran for a wide variety of improper uses, including mood stabilization, migraine headaches, eating disorders and weight loss.
The Food and Drug administration approved Zonegran as an anti-epileptic drug, but not for other uses.
Elan will pay a criminal fine of $97 million, will pay $102.3 million to resolve civil allegations and will forfeit $3.6 million in assets.
This settlement is part of the government's emphasis on combating health care fraud. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover more than $5 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department's total recoveries in False Claims Act cases since January 2009 have topped $6 billion.
The settlement resolves a whistle-blower lawsuit filed by a Massachusetts physician. The law allows citizens with knowledge of fraud to file civil actions on behalf of the United States and share in any recovery.
The Justice Department says it has recovered more than $5 billion since January 2009 in cases involving fraud against federal health care programs.
