$700m fines for Amgen
pharmafile | December 20, 2012 | News story | Manufacturing and Production, Sales and Marketing | Amgen, FDA, off label, off-label
Amgen has pleaded guilty to misbranding its anaemia drug Aranesp following a string of US lawsuits against the biotech company.
The Financial Times reports that Amgen has agreed to a $612m civil settlement, a $14m forfeiture and $136m in criminal fines.
Lawyers for the US government had accused the company of the off-label use of Aranesp (darbepoetin alfa) as well as other illegal marketing tactics.
Representatives of Amgen in the UK said they were not yet able to comment in response to the guilty plea.
The FDA has approved Aranesp at specific doses to treat anaemia caused by chronic renal failure or by chemotherapy in people with non-myeloid malignancies – but not anaemia caused by cancer.
Yet the US attorney alleged that Amgen had trained sales reps to convince doctors to switch patients to the drug for this indication.
One part of the case against Amgen was that the product’s label “lacked adequate directions for intended uses and dosages that were not approved by the FDA”.
The US attorney alleged that Amgen benefited from the mislabelling of Aranesp from perhaps as early as 2001 until “at least the first quarter of 2009”.
While $700 million in fines is a significant sum, Amgen is a very large company: turnover for 2011 was up 4% year on year to $15.6 billion, with net profit down 3% to $4.8 billion.
Global sales of Aranesp fell 7% to $2.3 billion in 2011, largely due to what Amgen calls “a high-teens percentage point unit decline” in the US.
The Financial Times quotes a lawyer representing one of the Aranesp whistleblowers as being happy with the outcome.
“[We] believe it will go a long way in preventing Amgen from continuing to violate federal regulations by promoting the off-label use of its powerful drugs and providing medical providers with kickbacks for inappropriately prescribing them,” said David Sanford, chairman of Sanford Heisler.
The settlement may also encourage more pharma employees to blow the whistle on companies’ alleged misdeeds, he added.
Adam Hill
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