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August 19, 2015

Amgen to Pay State $972,000 in Nationwide Agreement to Stop Off-Label Drug Marketing

Settlement part of $72 million agreement with 48 states & D.C. over marketing of Aranesp and Enbrel

(DES MOINES, Iowa) Pharmaceutical company Amgen Inc. will pay the State of Iowa more than $972,000 to settle allegations that it improperly marketed two of its leading medications.

The settlement is part of a nationwide $72 million agreement with 48 states and the District of Columbia over allegations that the California-based drugmaker unlawfully promoted anemia drug Aranesp and psoriasis drug Enbrel.

The petition filed Tuesday in Polk County District Court alleges that Amgen violated Iowa’s consumer protection laws. The allegations include:

  • Promoting Aranesp for dosing frequencies longer than the FDA approved label without competent and reliable scientific evidence to substantiate the extended dosing frequencies.
  • Promoting Aranesp for anemia caused by cancer without having FDA approval or competent and reliable scientific evidence to support it.
  • Promoting Enbrel for mild plaque psoriasis even though Enbrel is only approved by the FDA to treat chronic moderate to severe plaque psoriasis.

The agreement requires Amgen to reform its marketing practices and prevents it from promoting off-label uses of Enbrel and Aranesp. The company is barred from a variety of marketing strategies related to the two medications, including promoting off-label uses to medical professionals through non-profit drug reference books called compendia.

In 2012 in New York, Amgen pleaded guilty to a federal charge that it illegally introduced misbranded drug Aranesp into the marketplace. Amgen agreed to pay $762 million to resolve criminal and civil liability arising from its sale and promotion of three drugs, including Aranesp.

Iowa’s share of Tuesday’s settlement will go the state’s consumer education and litigation fund.

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