Amgen has reached a settlement with a stream of states in the US under which it will pay a total of $71 million to lay to rest allegations of marketing its Aranesp and Enbrel biologics for off-label uses.
Aranesp (darbepoetin alfa) is approved to treat certain types of anaemia, while Enbrel (etanercept) can be used to treat severe plaque psoriasis.
But according to the multistate complaint, Amgen breached state consumer protection laws by promoting Aranesp for dosing frequencies longer than approved by the FDA and for anaemia caused by cancer without regulatory permission.
Also, the firm promoted Enbrel for the unapproved indication of mild plaque psoriasis and overstating the length of its efficacy, it is claimed.
“Pharmaceutical companies are prohibited from making unapproved and unsubstantiated claims about prescription drugs,” said New York Attorney General Eric Schneiderman. “Consumers need to have confidence in the accuracy of claims made by pharmaceutical companies.”
In this case, Amgen reportedly hasn’t admitted any wrongdoing, but said in a statement it is “pleased to have this matter resolved”. Most of allegations pre-date 2007.
However, back in December 2012 the biotechnology giant admitted conducting illegal marketing practices for Aranesp, agreeing to pay more than $760 million in fines and the resolution of various whistleblower lawsuits.