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Amgen to pay $71 million for off-label drug promotion
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Amgen Inc. has agreed to pay $71 million to settle a lawsuit with 48 states and the District of Columbia that alleged the biotech company unlawfully promoted Aranesp and Enbrel for off-label uses.
The complaint alleged that Amgen violated state consumer protection laws by promoting its anemia drug Aranesp for dosing frequencies longer than the FDA approved label, and promoting its use to treat anemia caused by cancer without having FDA approval. The drug is approved to treat anemia caused by chemotherapy and anemia caused by kidney disease.
The suit also accused Amgen of promoting Enbrel for mild plaque psoriasis even though Enbrel is only approved by the FDA to treat chronic moderate to severe plaque psoriasis, and overstating the length of Enbrel’s efficacy in treating plaque psoriasis.
In a statement, Amgen said the settlement resolves some of the same matters addressed in a 2012 settlement with the federal government. "Separate state and federal resolutions of the same underlying issues is the normal practice in such legal matters."
In December 2012 Amgen pleaded guilty in a federal court in New York to misbranding Aranesp and agreed to pay $762 million in a civil settlement and criminal fines. The case focused on Amgen’s off-label marketing campaign and use of illegal kickbacks to promote the sale of Aranesp. -by Rebecca Zumoff