According to a June 9, 2011 US Department of Justice (DOJ) press release, UCB, Inc., Smyrna Georgia, pleaded guilty to off-label promotion of its drug Keppra. The company will pay more than $34 million to settle the case.
UCB is the U.S. subsidiary of giant Belgian pharmaceutical manufacturer, UCB SA.
The company pleaded guilty to a misdemeanor for its misbranding of its anti-epileptic drug Keppra, a violation of the Food, Drug and Cosmetic Act.
The drug received Food and Drug Administration (FDA) approval as an anti-epileptic agent to treat seizures in adult and children epileptics.
The government claimed UCB promoted Keppra for off-label use to treat migraine headaches. It generated and disseminated posters representing Keppra as safe and effective for treating migraine based on purportedly independent investigator-initiated studies.
UCB failed to reveal that they sponsored the studies or that their own clinical trial failed to show Keppra was effective in treating migraines.
A manufacturer may not market or promote a drug for any use not approved in its initial trials. These uses are also known as unapproved or “off-label” uses.
Doctors may prescribe for different uses but manufacturers are prohibited from marketing for such.
UCB will pay a criminal fine of $7.55 million for the misbranding of Keppra and forfeit assets of $1.078 million.
And that’s not all. UCB must pay $25.7 million to resolve civil allegations under the False Claims Act (FCA). Those claims say the company illegally promoted Keppra and, as a result, caused false claims to be submitted to government healthcare programs for a variety of off-label uses.
The federal share of the civil settlement is $15,871,208, and the state Medicaid share of the civil settlement is $9,893,322.
In addition, the court ordered UCB to enter into a corporate integrity agreement (CIA) with the Office of Inspector General of the Department of Health and Human Services.
The agreement calls for procedures and reviews to be put in place to prevent and promptly detect conduct similar to that which was revealed in this case.
Today’s resolution arose out of the filing of two whistleblower lawsuits, under stipulations of the False Claims Act. The suits will be settled as part of today’s agreement. The two whistleblower filers will receive payments in excess of $2.8 million from the federal portion of the settlement.
One of the most powerful tools in the government’s efforts to fight Medicare fraud is the False Claims Act. Using it, the Justice Department has recovered more than $5.7 billion since January 2009 in cases involving fraud against federal health care programs.
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