Botox Manufacturer, Allergan, Will Pay $600 Million to Settle Civil and Criminal Charges

Botox Manufacturere Allergan to pay $600 Million for civil settement

Allergan, Inc., the maker of cosmetic product Botox, will pay $600 million to settle a federal investigation about its marketing practices of the top-selling drug.

In a joint statement issued on Wednesday, Allergan and the Justice Department said that Allergan will plead guilty to a single charge of “misbranding”, a misdemeanor, for allegedly misleading doctors to use their product for unapproved purposes, including treating pain, headache, spasticity, and cerebral palsy.

The company said it will pay $375 million as part of the plea agreement, which also includes the forfeiture of assets worth $25 million. Allergan will also pay civil fines totaling $225 million, $210 million of which will go to the federal government and $15 million to several states.

According to Assistant Attorney General Tony West, Irvine, California-based Allergan “paid kickbacks to induce physicals to inject Botox for off-label uses and Allergan also taught doctors how to bill for off-label uses, including coaching doctors how to miscode Botox claims leading to millions of dollars of false claims being submitted to federal and state programs.”

“The FDA had approved therapeutic uses of Botox for only four rare conditions, yet Allergan made it a top corporate priority to maximize sales of far more lucrative off-label uses that were not approved by the FDA,” said Sally Yates, U.S. Attorney for the Northern District of Georgia.

“Allergan further demanded tremendous growth in these off-label sales year after year, even when there was little clinical evidence that these uses were effective,” Yates added.

The settlement will not be official until a federal judge approves it.

Posted by George Daniels on Sunday September 05 2010, 8:38 AM EST. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0