UCB Fined $34 Million for Marketing Off Label Use of Keppra for Migraines

UCB Inc., headquartered in Smyrna, Georgiapleaded guilty on June 9, 2011 to charges that it promoted the epilepsy drug Keppra for off-label use in the treatment of migraine headache and other conditions for which it was not approved by the FDA.  UCB Inc. is the U.S. subsidiary of Belgian drug manufacturer UCB SA. UCB Inc. will pay more than$34 million to settle its criminal and civil liabilities, according to the Justice Department. 

 

Keppra has been approved by the Food and Drug Administration (FDA) for the treatment of epileptic seizures in adults and children suffering from epilepsy, but not for the treatment of migraine headache, psychiatric or pain conditions.  A manufacturer may not market an FDA-approved drug for any use not specified in its FDA approval product label.  These uses are called “off-label” uses. 

 

The government alleged that UCB promoted the sale of Keppra for off-label use in treating migraine by creating and distributing posters claiming that Keppra was safe and effective for treating migraine based on purportedly independent studies.  The posters did not disclose UCB’s sponsorship of these studies or that UCB’s own clinical trial had failed to show Keppra’s supposed effectiveness in treating migraine. 

 

UCB will pay $7.55 million in criminal fines for misbranding Keppra and $25.7 million to settle civil allegations under the False Claims Act, and will forfeit assets of $1.078 million. Of the $25.7 million civil settlement, the federal will get $15,871,208.  The state Medicaid share of the civil settlement is $9,893,322. Whistleblowers will receive payments totaling more than $2.8 million from the federal share of the civil recovery. 

 

As part of the resolution accepted by the court, UCB was required to enter into a corporate integrity agreement (CIA) with the Office of Inspector General of the Department of Health and Human Services. Under the agreement, the company must implement procedures and reviews to prevent or promptly detect similar violations.

 

The resolution is part of the government’s emphasis on combating health care fraud under the Health Care Fraud Prevention and Enforcement Action Team (HEAT), a joint initiative of Health and Human Services and the Department of Justice.  The False Claims Act has been used by the Justice Department to recover more than $5.7 billion since January 2009 in cases involving fraud against federal health care programs.  The Justice Department’s total recoveries in False Claims Act cases since January 2009 are more than $7.3 billion.

 

 “Patients have a right to know that the drugs they are prescribed have been approved by the FDA as safe and effective for a particular use,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice.  “Off-label promotion of pharmaceuticals undermines the FDA’s important role in protecting the public and is a drain on taxpayer dollars.”