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Elan Pharmaeuticals Settles Off-Label Charges

Pharmaceutical company Elan Corporation recently announced an agreement with the DOJ to pay $203.5 million to settle Medicaid fraud claims involving its previously divested antiepileptic drug, Zonegran. As a result of the agreement, Elan pled guilty to a misdemeanor violation of the Food Drug and Cosmetics Act (FDCA) and plans to enter into a Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.

Elan had disclosed in early 2007 that the federal government was investigating its marketing practices for Zonegran, approved for the treatment of partial epileptic seizures in adults. Allegedly, Elan had engaged in the off-label promotion of Zonegran for such uses as treating tremors for Parkinson’s disease patients, combating obesity and preventing migraines.

Similarly, two other antiepileptic drugs have also been found to have been also promoted for off-label uses. Earlier this year, Novartis was fined $185 million for off-label promotion of Trileptal and Johnson & Johnson paid $81.5 million to settle a case concerning its drug Topamax.