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Drug Settlement
Written by Josh Zach   
Tuesday, 18 August 2015 12:57

RALEIGH, NC -- Drug manufacturer Amgen will pay North Carolina and 48 other states $71 million to resolve allegations that the company illegally used a practice called off-label marketing to promote its medications, Arenesp and Enbrel, for purposes that had not been approved by the FDA.

North Carolina Attorney General Roy Cooper said Wednesday, “Drug companies have a duty to put safety before profits, and that means marketing medicines for approved uses only,” Cooper said.

The FDA has approved Arenesp to treat certain types of anemia by stimulating bone marrow to produce red blood cells. In the complaint and consent judgment filed [Tuesday] North Carolina and the other states allege that Amgen illegally promoted Aranesp for dosing frequencies longer than the FDA approved label without competent and reliable scientific evidence to substantiate the extended dosing frequencies. The states also contend that Amgen unlawfully marketed Aranesp for anemia caused by cancer without credible scientific evidence or the required FDA approval.

Enbrel is approved by the FDA to treat a number of conditions, including certain types of arthritis and plaque psoriasis. The states allege that Amgen promoted Enbrel for mild plaque psoriasis even though Enbrel is only approved by the FDA to treat chronic moderate to severe plaque psoriasis.

In addition to paying $71 million, Amgen is required to change its marketing practices to avoid false, misleading, or deceptive promotion of Enbrel or any medication in the same class as Aranesp.

North Carolina will receive more than $2.1 million as its share of the judgment.

 
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