Smyrna, Ga.-based UCB has pleaded guilty to the off-label promotion of its epilepsy drug Keppra and will pay more than $34 million to resolve criminal and civil liability, according to a news release from the Federal Bureau of Investigation.
The government alleged that UCB promoted the sale of Keppra for the treatment of migraine, when the FDA had approved it for the treatment of seizures in adults and children suffering from epilepsy. Of the $34 million in fines, UCB will pay $25.7 million to resolve civil allegations under the False Claims Act that the company illegally promoted Keppra and caused false claims to be submitted to government healthcare programs.
"UCB put its pursuit of profits ahead of its obligations to patients," Ronald C. Machen Jr., U.S. Attorney for the District of Columbia, said in the release. "Today's guilty plea and UCB's $34 million payout should remind drug companies that try to cleverly design off-label marketing schemes that we will not allow them to compromise patient safety."
Read the FBI release on Keppra, UCB and off-label marketing.
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The government alleged that UCB promoted the sale of Keppra for the treatment of migraine, when the FDA had approved it for the treatment of seizures in adults and children suffering from epilepsy. Of the $34 million in fines, UCB will pay $25.7 million to resolve civil allegations under the False Claims Act that the company illegally promoted Keppra and caused false claims to be submitted to government healthcare programs.
"UCB put its pursuit of profits ahead of its obligations to patients," Ronald C. Machen Jr., U.S. Attorney for the District of Columbia, said in the release. "Today's guilty plea and UCB's $34 million payout should remind drug companies that try to cleverly design off-label marketing schemes that we will not allow them to compromise patient safety."
Read the FBI release on Keppra, UCB and off-label marketing.
Related Articles on Pharmaceutical Fraud:
Johnson & Johnson Reserves Money in Federal Probe Over Risperdal
Johnson & Johnson to Pay South Carolina $327M for Deceptive Drug Marketing
Michigan Accuses McKesson of Inflating Drug Prices, Overbilling Medicaid