Elan has come to terms with the U.S. Justice Department. In the latest whistleblower settlement, the Irish drugmaker agreed to pay $203 million and plead guilty to a misdemeanor violation of the Food, Drug & Cosmetic Act. The issue: Its marketing program for the epilepsy drug Zonegran.
According to the DoJ, Elan promoted Zonegran for a variety of off-label uses. The drug was FDA-approved as an adjunct treatment for epilepsy in people over 16 years of age, but it was a late entry into the market, facing competition from several other similar meds. Facing financial pressures, Elan scouted around for potential off-label sales of Zonegran, using misleading promotional information.
Among the off-label sales: mood stabilization, bipolar disorder, weight loss and pediatric use. The company paid "illegal kickbacks" to boost prescriptions as well, the DoJ states. The settlement deal includes a criminal fine of $97 million, $3.6 million in forfeited assets, and a $102 million civil settlement, the DoJ says in a statement.
"Elan deliberately chose to prioritize profit over its obligation to the FDA and consumers," U.S. Attorney Carmen Ortiz said in a statement. "Today's plea and sentencing should serve as a reminder to any company engaging in off-label marketing schemes, that the government is continuing to aggressively investigate and prosecute companies who intentionally put patient safety at risk in order to turn a profit."
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