Amgen announced Wednesday that it has finalized an agreement with the U.S. government, 49 states, and the District of Columbia resolving investigations into promotional practices for six drugs: Aranesp, Epogen, Neuopogen, Neulasta, Enbrel, and Sensipar.
The company pleaded guilty to a single misdemeanor count of misbranding Aranesp by promoting its use in a different way than was described on the label approved by the Food and Drug Administration. Doctors are free to use FDA-approved drugs in any way they see fit, but drug companies aren't allowed to promote the so-called off-label use.
Amgen will pay a criminal fine of $150 million as part of the plea agreement. The company also resolved civil liabilities for which it will pay the state and federal governments $612 million to cover allegedly fraudulent Medicare and Medicaid claims.
"Amgen acknowledges that mistakes were made, and we did not live up to our standards," Cynthia M. Patton, senior vice president and chief compliance officer at Amgen, is quoted as saying in the company press release.
Amgen took a charge in the third quarter of 2011 that will cover the $762 million payments, so the settlement won't have a negative effect on future earnings announcements.
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