In eBulletin Issue No. 67, we examined the limits of ethics amongst the pharmaceutical industry. After the not-so-infrequent cases of fines and sanctions, another settlement case with hefty payment was reported.

 

This time, the axe fell on Belgian drugmaker - UCB’s US subsidiary. The company has agreed to pay some US$34 million to resolve civil and criminal charges against its epilepsy drug (Keppra) found to be implicated in off-label promotion. Under the plea agreement, UCB admitted to a misdemeanor of misbranding Keppra for non-approved indications (treatment of migraine, headache, psychiatric conditions or pain conditions) whilst the official licensed indication is for treating seizures in adults and children.

The US Department of Justice prosecutor alleged that UCB promoted off label by creating and distributing posters indicating the drug was safe and effective for treating migraines based on purportedly independent investigator-initiated studies (IIS). But 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 migraines. And as a consequence, UCB will pay a US$7.55 million criminal fine for misbranding and an asset forfeiture of US$1.1 million. The drugmaker will also pay US$25.7 million to resolve civil allegations under the False Claims Act, since claims were submitted to federal healthcare programmes to cover headaches, mood disorders and anxiety, among other ailments. The Department of Justice’s statement can be read here.

 

 

 

 

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