An Irish pharmaceutical company and its U.S. subsidiary have agreed to pay the federal government more than $203 million after pleading guilty to illegal promotion of its epilepsy drug Zonegran, according to a Washington Post news report.
Although the Food and Drug Administration only approved Zonegran for treatment of epilepsy, Elan admitted to illegally promoting the drug for off-label uses not approved by the FDA, including mood stabilization, migraine headaches, eating disorders and weight loss.
As part of the settlement, Elan will pay $97 million in criminal fines and $102.3 million to resolve civil allegations. The company will also give up $3.6 million in assets. Japanese drug marketer Eisai, which bought Zongran from Elan, will also pay $11 million to the federal government for the off-label marketing.
Read the Washington Post news report about Elan's settlement.
Read other coverage about pharmaceutical fraud:
- 20 Largest False Claims Cases of 2010
- Kos Pharmaceuticals Will Pay $41M to Settle Kickback, Off-Label Promotion Allegations
- Three Pharmaceutical Companies Will Pay Combined $421M to Settle Drug-Pricing Lawsuit
Although the Food and Drug Administration only approved Zonegran for treatment of epilepsy, Elan admitted to illegally promoting the drug for off-label uses not approved by the FDA, including mood stabilization, migraine headaches, eating disorders and weight loss.
As part of the settlement, Elan will pay $97 million in criminal fines and $102.3 million to resolve civil allegations. The company will also give up $3.6 million in assets. Japanese drug marketer Eisai, which bought Zongran from Elan, will also pay $11 million to the federal government for the off-label marketing.
Read the Washington Post news report about Elan's settlement.
Read other coverage about pharmaceutical fraud:
- 20 Largest False Claims Cases of 2010
- Kos Pharmaceuticals Will Pay $41M to Settle Kickback, Off-Label Promotion Allegations
- Three Pharmaceutical Companies Will Pay Combined $421M to Settle Drug-Pricing Lawsuit