Amgen pays $71 mln to settle Enbrel, Aranesp marketing case

Amgen will pay a total of $71 million to resolve allegations that it unlawfully promoted its Aranesp® and Enbrel® drugs, and must adhere to specific restrictions with respect to future drug promotions.

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.

Each of the other five New England states are also part of the settlement.

Arenesp is approved to treat certain types of anemia.

“Yet again, a major pharmaceutical company has engaged in deceptive marketing practices, potentially jeopardizing patient health in order to boost their bottom line”, said Attorney General Kilmartin said in a news release.

The settlement was announced by several state attorneys general on Tuesday.

Additionally, though Amgen’s drug Enbrel has only been approved to treat chronic moderate to severe plaque psoriasis, the company had promoted it for mild plaque psoriasis.

The FDA sent a Warning Letter to Amgen in February 2005 advising that Amgen’s direct-to-consumer television advertisement “Freedom” overstated the effectiveness of Enbrel and minimized the risks associated with the drug.

Amgen was accused of using a practice called off-label marketing to promote Arenesp and Enbrel, two biologic medications, for purposes that had not been approved by the Food and Drug Administration. Amgen pleaded guilty to a misdemeanor count of misbranding relating to Aransep and paid a criminal fine of $136 million, as well as a criminal forfeiture in the amount of $14 million.

In its statement, Amgen said it is pleased to have the matter resolved and added that it has a strong compliance program. Amgen shares fell $2.17 to $167.62 in afternoon trading.