In a historic settlement agreement, Amgen, drug manufacturer of Aranesp (anemia drug) and Enbrel (arthritis and psoriasis drug) agreed to pay a $71 million settlement after attorneys general from 48 states alleged that the company was marketing the two drugs for off-label purposes.
After the $71 million settlement offer was announced on Aug. 18, Amgen representatives said the company was happy to have the matter resolved, but it admitted no wrongdoing.
The US Food and Drug Administration approved Aranesp to treat anemia and Enbrel for moderate-to-severe plaque psoriasis. States’ top lawyers brought to light the fact that Amgen was actively promoting the drugs for anemia caused by cancer and Enbrel for mild plaque psoriasis. Neither application is approved by the FDA.
The Feds now maintain that Amgen violated consumer protection laws by using “deceptive and misleading marketing of biological medications.” According to the settlement, Pennsylvania can expect $2.4 million of the settlement while NJ will get about $1.57 million.
This settlement was announced three years after Amgen, located in Thousand Oaks, Calif., plead guilty to similar federal criminal charges. In that case, the drug giant agreed to pay $762 million in penalties and settlements. In 2012, when that case was settled, thanks to 11 whistleblower complaints, prosecutors said it was the “single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history.”
It’s important to note that physicians are permitted, at their discretion, to prescribe medications for off-label purposes. However, drug makers are prohibited from marketing off-label uses.
Amgen was “pursuing profits at the risk of patient safety,” federal prosecutors said.
Thanks to whistleblowers who come forward with information about fraud being committed against the federal government, companies like Amgen are being forced to take responsibility for their wrongdoing. If you have information about fraudulent activity, contact Begelman & Orlow for a free consultation about your whistleblower lawsuit.