Pharma Manufacturer Fined $34 Million for Off-Label Promotion

UCB Inc. pleads guilty of promoting anti-epileptic drug Keppra for migraine use.

In violation of the Food, Drug and Cosmetic Act, UCB Inc., the U.S. subsidiary of Belgian pharmaceutical manufacturer UCB SA,. misbranded the drug Keppra. The drug is used for the treatment of seizures in adults and children suffering from epilepsy.

However the company was promoting the sale of Keppra for the treatment of migraine by disseminating posters representing that Keppra was safe and effective for treating migraine based on purportedly independent investigator-initiated studies. Once approved by the FDA, a manufacturer may not market or promote a drug for any use not specified in the FDA-approved product label. These uses are also known as unapproved or "off-label" uses.

Furthermore 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 migraine.

UCB will pay a $7.55 million criminal fine for the misbranding of Keppra and an asset forfeiture of $1.078 million. In addition, UCB will pay $25.7 million to resolve civil allegations under the False Claims Act

"UCB put its pursuit of profits ahead of its obligations to patients," said Ronald C. Machen Jr., U.S. Attorney for the District of Columbia. "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."

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