UCB Pleads Guilty to Illegal Off-Label Marketing of Epilepsy Drug Keppra

A unit of drugmaker UCB SA (UCB) pleaded guilty in the U.S. to a misdemeanor and will pay more than $34 million in fines and penalties for the improper marketing of the epilepsy medicine Keppra.

UCB Inc. admitted today in federal court in Washington that it promoted Keppra for uses unapproved by the U.S. Food and Drug Administration. The plea was accepted by U.S. District Judge Ricardo Urbina.

UCB Inc. is a Smyrna, Georgia, unit of Brussels-based UCB SA. Keppra, with 942 million euros ($1.37 billion) in sales last year, is the company’s top-selling drug, according to data compiled by Bloomberg.

The criminal plea was part of a global settlement that the Justice Department reached with UCB, which includes resolution of a related civil false-claims case, according to a sentencing memorandum.

“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 an e-mailed statement. “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.”

UCB admitted that it unlawfully promoted Keppra for use in treating migraine, a use that was not approved by the FDA, according to the criminal charge.

Business Plans

UCB prepared business plans that recognized the market for off-label uses of Kempra “offered a much higher sales potential than the epilepsy market,” the document states. At the time, UCB was being outspent by competitors who were aggressively pursuing off-label business, according to prosecutors.

UCB’s marketing included sponsorship of doctor-paid “studies,” posters, publications and oral presentations about the supposed benefits of using Keppra to treat migraines. Prosecutors said UCB failed to disclose that a 2000 study showed that Keppra was not effective in preventing migraine.

Christie Madara, a UCB spokeswoman, said the company has been cooperating with the investigation since 2008 and is pleased to have the matter resolved. She said the probe focused on issues that occurred more than six years ago.

The case is U.S. v. UCB Inc., U.S. District Court, District of Columbia (Washington).

To contact the reporter on this story: Tom Schoenberg in Washington at tschoenberg@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.

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