Biotechnology giant Amgen has admitted conducting illegal marketing practices for its anaemia drug Aranesp, agreeing to pay more than $760 million in fines and the resolution of various whistleblower lawsuits.
The company has reportedly entered a guilty plea in the US District Court in Brooklyn to one misdemeanour charge regarding misbranding for Aranesp (darbepoetin alfa), which was being promoted for uses not approved by regulators.
In the US, Aranesp has regulatory clearance for treating anaemia caused by either kidney failure or the use of chemotherapy.
But sales representatives at the firm stand accused of pushing for its unlicensed use in patients with anaemia caused by cancer, as well as in different, unapproved dosing regimens.
It is alleged that these illegal marketing activities aimed to help Aranesp, which brings in annual sales of more than $2 billion a year, gain ground against Johnson & Johnson’s rival drug Procrit.
Marshall Miller, head of the criminal division of the US Attorney’s Office in Brooklyn, said Amgen was “pursuing profits at the expense of patient safety,” according to media reports.
Criminal charges have not been filed against any individuals involved at this time, and the group’s participation in government programs, such as Medicaid/Medicare, will not be affected, he noted.
Integrity pact
Amgen will, however, be tied into a five-year corporate integrity agreement with the government, under which its senior staff could be liable in the event that such offences are repeated during the term.
The plea agreement – which reportedly includes $612 million in a civil settlement and a criminal fine of $136 million – must still be approved by a Judge.
If accepted, the company, which booked a $780 million charge to resolving the matter in the third quarter of last year – said it expects to immediately “complete the comprehensive resolution of related civil and criminal matters”.
