Elan to pay $203M for off-label Zonegran marketing

It's official: Elan ($ELN) will pay $203 million to settle a Justice Department marketing probe. Almost half of that is criminal fines and forfeitures, the U.S. government said, and a subsidiary will plead guilty to a misdemeanor charge. The deal closes the book on a previously revealed investigation into the Irish drugmaker's marketing of the epilepsy drug Zonegran.

Elan Pharmaceuticals will plead guilty to misbranding Zonegran, after the Justice Department found evidence that the company pushed the epilepsy med for a wide variety of unapproved uses, including bipolar disorder, migraine and weight loss. Besides mispromoting the drug, the company "paid illegal kickbacks to physicians in an effort to persuade them to prescribe Zonegran for these off-label uses," a Justice Department statement says. Eisai, which now markets the drug, will pay $11 million.

It's yet another whistleblower-spawned off-label settlement in a year that has been full of them, including a $600 million settlement for Allergan's mismarketing of the wrinkle-fighter Botox and Forest Laboratories' September deal to settle Celexa and Lexapro-related claims for $313 million. The feds vow to continue cracking down on off-label marketing violations--even to step it up several notches by prosecuting individual executives as well as their misbehaving companies.

- see the release from Elan
- read the Bloomberg story
- get more from the New York Times
- check out the Irish Independent's coverage