by Ben Vernia | June 9th, 2011
On June 9, the Department of Justice announced that a subsidiary of the pharmaceutical firm UCB will pay more than $34 million in fines and damages, will plead guilty to a misdemeanor violation of the Food, Drug & Cosmetic Act, and will enter into a five-year corporate integrity agreement. According to DOJ’s press release:
The U.S. subsidiary of Belgian pharmaceutical manufacturer UCB SA. pleaded guilty today to the off-label promotion of its epilepsy drug Keppra and will pay more than $34 million to resolve criminal and civil liability arising out of its illegal conduct, the Justice Department announced today.
Under the terms of the plea agreement before the U.S. Court for the District of Columbia, UCB Inc., which has its headquarters in Smyrna, Ga., pleaded guilty to a misdemeanor in connection with the company’s misbranding of Keppra, in violation of the Food, Drug and Cosmetic Act. Keppra was approved by the Food and Drug Administration (FDA) as an anti-epileptic drug, for the treatment of seizures in adults and children suffering from epilepsy. Keppra is not approved for the treatment of migraine, headache, psychiatric conditions or pain conditions. 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.
The government alleged that UCB promoted the sale of Keppra for off-label use in the treatment of migraine by generating and disseminating posters representing that Keppra was safe and effective for treating migraine based on purportedly independent investigator-initiated studies. 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 that the company illegally promoted Keppra and caused false claims to be submitted to government healthcare programs for a variety of off-label uses that were not medically accepted indications and therefore not covered by those programs, including headache, migraine, pain, bipolar, mood disorders and anxiety. The federal share of the civil settlement is $15,871,208, and the state Medicaid share of the civil settlement is $9,893,322.
The case arose from two qui tam, or whistleblower suits, filed in the District of Columbia and Oregon. According to DOJ, the relators will receive $2.8 million of the federal civil damages (a 17.6% relator’s share).