Brooklyn, NY – The federal court judge in this lawsuit has accepted a guilty plea by Amgen Inc. as part of a plea deal on federal misdemeanor charges. The biotech firm admitted to illegally introducing the misbranded drugs Aranesp, Enbrel, and Neulasta into the market for uses not approved by the FDA, according to the L.A. Times.
Aranesp is an erythropoiesis-stimulating agent that had been approved at regulated doses for patients suffering from anemia. Anemia is a blood condition where there is a low density of healthy red blood cells. The cells of the body receive inadequate oxygen, making the sufferer feel fatigued. Anemia can be caused from a chronic iron deficiency.
Enbrel had been marketed with the intention as a treatment of moderate to severe psoriatic diseases.
Neulasta was prescribed to treat neutropenia. This is condition of having an abnormally low or a complete lack of neutrophils (certain white blood cells) often decimated by cancer chemotherapy.
Forbes reports that Amgen has agreed to pay $762 million to resolve criminal and civil liability associated with the distribution of improperly marketed, unapproved drugs. $612 million is intended to resolve False Claims Act suits, and $150 million applied towards criminal penalties. The False Claims Act was enacted in 1863. The FCA provides that any person who knowingly submits false claims to the government is liable for double the government’s damages plus a penalty for each false claim. Under the Food, Drug, and Cosmetic Act, it is illegal for companies to dispense drugs that will be for uses or at doses not approved by the FDA. This is considered the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history.
Primary concerns surrounding the lawsuit emphasized the distrust in pharmaceutical manufacturers putting patients at risk in order to fatten corporate profits. Having done so, they had undermined the federal health care laws put in place to protect people from this very abuse.
The United States Department of Justice quoted Acting US Attorney of the Eastern District of New York, Mr. Miller in response to the victory:
“Instead of working to extend and enhance human lives, Amgen illegally pursued corporate profits while jeopardizing the safety of vulnerable consumers suffering from disease. Americans expect—and the law requires—much more. Today’s settlement demonstrates our vigilance in protecting America’s health care consumers and pursuing any corporation that seeks to profit by violating U.S. law. To all who might consider introducing misbranded drugs into the marketplace, you are on notice: we remain steadfastly committed to prosecuting such violations of law.”