Schneiderman today announced a $71 million multistate settlement with Amgen Inc.to resolve allegations that the pharmaceutical company unlawfully promoted biologic medications Aranesp and Enbrel for off-label uses.
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Attorney General Schneiderman’s Office served on the Executive Committee of this multi-state investigation. Specifically, Koster alleges Amgen violated Missouri’s consumer laws by promoting Aranesp for dosing frequencies longer than the FDA approved for use, without reliable scientific evidence to substantiate the extended dosing frequencies.
The FDA has approved Arenesp to treat certain types of anemia by stimulating bone marrow to produce red blood cells.
“Yet again, a major pharmaceutical company has engaged in deceptive marketing practices, potentially jeopardizing patient health in order to boost their bottom line”, said Attorney General Kilmartin said in a news release. Under the roughly $150 million settlement Amgen pleaded guilty to a misdemeanor count of misbranding relating to Aransep.
The AGs claimed that Amgen advertised Enbrel for mild plaque psoriasis even though the FDA only approved the drug to treat chronic moderate to severe plaque psoriasis.
Enbrel was Amgen’s top-selling drug in 2014, with $4.69 billion of sales.
In a statement, Amgen noted that it previously reached a settlement with the federal government over numerous same issues raised by the states.
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Tuesday’s settlement came after Amgen agreed in December 2012 to pay $762 million to settle criminal and civil litigation over its marketing of Aranesp, Enbrel and other drugs. It also said company management was “dedicated to fostering a culture of doing the right thing at Amgen in full compliance with the law”.
