Please login to the form below

Not currently logged in
Email:
Password:

Elan and Eisai settle marketing charges

Elan Corporation will pay over $203m to settle charges that it engaged in illegal off-label promotions for its epilepsy drug Zonegran

Ireland's Elan Corporation and its US subsidiary Elan Pharmaceuticals have entered into a settlement agreement with the US Justice Department under which the company will pay more than $203m to settle charges that it engaged in illegal off-label promotions for its epilepsy drug Zonegran (zonisamide). Eisai, which bought the drug and its sales force from Elan in 2004, will pay $11m to resolve similar charges.

The Justice Department claims that Elan promoted the epilepsy drug for a number of unapproved uses, including mood stabilization for mania and bipolar disorder, migraine headaches, chronic daily headaches, eating disorders, obesity/weight loss and seizures in children under the age of 16. The government alleges that the company targeted non-epilepsy prescribers with the improper marketing efforts and paid illegal kickbacks to encourage the doctors to prescribe the drug for the off-label uses.

The Justice Department acknowledged that Eisai retrained the sales force and "took some steps to stop illegal marketing" after it acquired the drug. However, "some off-label marketing continued and Eisai benefited from the previous off-label marketing by Elan," the government maintains.

Elan will plead guilty to misdemeanor misbranding of Zonegran and pay a criminal fine of about $97m, as well as about $102m to resolve civil allegations that the illegal promotions caused government health programs like Medicaid to pay for the drug for indications that were not medically accepted. In addition, US-based Elan Pharmaceuticals will forfeit $3.6m in assets.

Elan has also entered into a corporate integrity agreement that was negotiated with the company by the US Department of Health and Human Services.

The whistleblower behind the allegations, a Massachusetts doctor named Dr Lee Chartock, will receive payments of more than $10m from the civil settlement.

16th December 2010

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
HAVAS LYNX

Welcome to HAVAS LYNX, a leading global healthcare communications group....

Latest intelligence

Solaris Health looks at the gene therapy revolution
Gene therapies are bringing new hope for many people with diseases caused by genetic disorders...
PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduction_feature_image_thumb.jpg
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...

Infographics