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Amgen Inc. Pleads Guilty for Misbranding Drug

American biotechnology giant Amgen Inc. pled guilty today in federal court in New York for illegally introducing a misbranded drug, Aranesp, into interstate commerce. It’s illegal for drug companies to introduce into the marketplace drugs that the company intends will be used “off-label,” i.e., for uses or at doses not approved by the FDA.

Dec 19, 2012 12:00 PM

Biotech Giant Pleads Guilty for Misbranding Drug, Pays $762 Million

American biotechnology giant Amgen Inc. pled guilty today in federal court in New York for illegally introducing a misbranded drug into interstate commerce. The plea is 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. The settlement represents the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history.

The company illegally introducing a misbranded drug, Aranesp, into the marketplace. 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,” i.e., for uses or at doses not approved by the FDA.

“Promoting drugs for unapproved purposes is beyond wrong; it jeopardizes the health and safety of the public,” said FBI Assistant Director Venizelos. “Preserving the integrity of the pharmaceutical industry is important work, and the FBI will continue working with our colleagues in law enforcement to investigate and charge those who inappropriately market drugs for scurrilous profits.”

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