UCB Pays $34M To Resolve Off-Label Charges

UCB Pays $34M To Resolve Off-Label Charges

June 10th, 2011 // 11:32 am @

Yet another drugmaker has been tagged for illegal marketing. This time, the US subsidiary of Belgium’s UCB has agreed to pay more than $34 million to resolve civil and criminal charges surrounding off-label promotion of its Keppra epilepsy drug, the US Department of Justice disclosed.

Under the terms of the plea agreement in the US Court for the District of Columbia, UCB pleaded guilty to a misdemeanor in connection with misbranding of Keppra, which was approved for treating seizures in adults and children. But Keppra is not approved for the treatment of migraine, headache, psychiatric conditions or pain conditions. And guess what UCB promoted Keppra for treating? That’s right.

The feds alleged that UCB promoted off label by creating and distributing posters indicating the drug was safe and effective for treating migraines based on purportedly independent investigator-initiated studies. But the posters did not disclose UCB’s sponsorship of these studies or that UCB’s own clinical trial had failed to demonstrate that Keppra was effective in treating migraines, the feds say.

And so, UCB will pay a $7.55 million criminal fine for misbranding and an asset forfeiture of $1.1 million. The drugmaker will also pay $25.7 million to resolve civil allegations under the False Claims Act, since claims were submitted to federal healthcare programs to cover headaches, mood disorders and anxiety, among other ailments. The federal share of the civil settlement is $15.9 million and the state Medicaid share of the civil settlement is $9.9 million

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