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The Pulse of the Pharmaceutical Industry

Amgen Reaches $71 Million Settlement With States

Written by: | | Dated: Tuesday, August 18th, 2015

Amgen Inc. reached a $71 million settlement with 48 states related to allegations that the biotechnology company made unsubstantiated marketing claims about blockbuster drugs Aranesp and Enbrel, according to several state attorneys general.

In a statement on Tuesday, Amgen said the settlement with the states resolves some of the same issues addressed in Amgen’s December 2012 settlement with the federal government related to the company’s marketing practices.

The 2012 settlement resolved criminal and civil liability claims related to marketing for Aranesp and Enbrel. Under the roughly $150 million settlement Amgen pleaded guilty to a misdemeanor count of misbranding relating to Aransep.

The $71 million settlement announced Tuesday covers a total of 48 states and the District of Columbia.

The allegations included accusations that Amgen promoted Aranesp for dosing frequencies beyond the levels approved by the Food and Drug Administration, promoted Aranesp for anemia caused by cancer without FDA approval and promoted Enbrel for mild plaque psoriasis though it had FDA approval to treat only moderate to severe cases of the disease.

The states also had alleged that Amgen had lobbied for Aranesp to be included in a drug compendium recognized by the Centers for Medicare and Medicaid to receive reimbursements from insurers and the federal government.

As part of the settlement with the states, Amgen didn’t admit any wrongdoing or liability.

In its statement, Amgen said it is pleased to have the matter resolved and added that it has a strong compliance program.


Aug. 18, 2015 1:55 p.m. ETWrite to Tess Stynes at

Source: Wall Street Journal Health

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