North Carolina among States to Receive Settlement Payout from Amgen

North Carolina among States to Receive Settlement Payout from Amgen
August 19, 2015

A prominent drug manufacturer has reached a settlement in response to accusations of illegal behavior.

Amgen, of Thousand Oaks, CA, has agreed to pay $71 million to North Carolina and 48 other states to resolve allegations that the company unlawfully promoted two medications. The complaint claimed that Amgen marketed Arenesp and Enbrel for purposes that had not been approved by the U.S. Food and Drug Administration (FDA). Once the FDA has approved a particular use of a drug as safe and effective, drug companies are prohibited from marketing it for any unapproved use.

North Carolina will receive a $2.1 million portion of the settlement, according to North Carolina Attorney General Roy Coopers. "Drug companies have a duty to put safety before profits, and that means marketing medicines for approved uses only," Cooper said in a press release.

The FDA approved Arenesp to treat certain types of anemia by stimulating bone marrow to produce red blood cells. The states allege that Amgen illegally promoted Aranesp for dosing frequencies longer than the FDA approved label. 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 the cash penalty, the consent judgement requires Amgen to change its marketing practices to avoid false, misleading, or deceptive promotion.