Vermont will receive over $717,000 of a settlement reached between 49 Attorneys General and Amgen Inc. Amgen will pay a total of $71 million to resolve allegations that itunlawfully promoted its Aranesp® and Enbrel® drugs, and must adhere to specific restrictionswith respect to future drug promotions.
“Promoting drugs without the required scientific evidence or FDA approval exposesconsumers to enormous health risks, particularly those consumers whose health is alreadycompromised. This settlement directly addresses that dangerous practice,” said Attorney GeneralBill Sorrell.
Aranesp® is used to treat certain types of anemia by stimulating bone marrow to producered blood cells. Enbrel® is used to treat a number of conditions, including “plaque psoriasis,”the most common type of psoriasis. The State’s Complaint alleges that Amgen violatedVermont’s consumer protection laws by: (1) promoting Aranesp® for dosing frequencies longerthan the FDA approved label without the required scientific evidence; (2) promoting Aranesp®or anemia caused by cancer without having FDA approval or the required supporting scientificevidence; and (3) promotingEnbrel® for mild plaque psoriasis even though Enbrel® is onlyapproved by the FDA to treat chronic moderate to severe plaque psoriasis.
In addition to the monetary payment, the settlement requires that Amgen reform itsmarketing and promotional practices in specific ways, including the means by which Amgenpromotes drugs to health care professionals for “off-label” use (meaning a use or dose other thatapproved by the FDA); and that only certain Amgen personnel who are highly trained expertswith specialized scientific or medical knowledge (as opposed to Amgen sales personnel) arepermitted to respond to healthcare professionals’ requests for medical information about Amgen