Posts Tagged ‘misbranded drug’

AMIGEN PEADS GUILTY 172 MILLION SETTLEMENT

Friday, December 21, 2012 | By arlene | No Comments

Bill Ruehle Fights Back – Corporate Crime Reporter

For nine years, William Ruehle was the chief financial officer of Broadcom.

Then, in 2006, Ruehle and Broadcom got caught up in the options backdating scandal.

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The American biotech giant Amgen pled guilty illegally introducing a misbranded drug into interstate commerce.

The plea was part of a global settlement with the United States in which Amgen agreed to pay $762 million to resolve criminal and civil liability arising from its sale and promotion of certain drugs.

Amgen pled guilty to illegally introducing a misbranded drug, Aranesp, into interstate commerce.

Amgen was represented in the criminal case by David Rosenbloom of McDermott Will & Emery in Chicago.

Under the Food, Drug and Cosmetic Act, it is illegal for drug companies to introduce into the marketplace drugs that the company intends will be used “off-label” – for uses or at doses not approved by the FDA.

Aranesp is an erythropoiesis-stimulating agent (ESA) that was approved by the FDA at calibrated doses for particular patient populations suffering from anemia.

In order to increase sales of Aranesp and reap the resulting profits, Amgen illegally sold the drug with the intention that it be used at off-label doses that the FDA had specifically considered and rejected, and for an off-label treatment that the FDA had never approved. Continue reading “AMIGEN PEADS GUILTY 172 MILLION SETTLEMENT” »