American Biotechnology giant Amgen Inc. (Amgen) pleaded guilty to improperly introducing drug Aranesp, an erythropoiesis-stimulant for patients suffering from anemia, for "off-label," usage. Within the Food, Drug, and Cosmetic Act, it becomes illegal for drug companies to provide medicine used for "off-label," a term translatable to usage and dosage of a particular drug that is not approved by the FDA. "Instead of working to extend and enhance human lives, Amgen illegally pursued corporate profits while jeopardizing the safety of vulnerable consumers suffering from disease." said Acting U.S. Attorney of the Eastern District of New York Miller.
At the Federal Courthouse in Brooklyn, New York, U.S District Judge Sterling Johnson Jr. witnessed Amgen agreeing to pay $762 million in response to the civil and criminal liabilities-this settlement has become the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history. "Promoting drugs for unapproved purposes is beyond wrong; it jeopardizes the health and safety of the public," said FBI Assistant Director Venizelos. In lieu of what these drugs are intended for, Amgen had fixed their eyes on profits by illegally selling the drug at "off-label doses" in which the FDA had rejected. According to the Department of Justice-under the criminal plea agreement- Amgen will pay a criminal fine of $136 million and criminal forfeiture in the amount of $14 million. "This sends a powerful message to pharma companies: you must not put profits ahead of patients' health and doctors' trust. Drugs should be prescribed because they make people better, not because they make companies money," said Western District of Washington U.S. Attorney Durkan.
Under the False Claims Act, certain provisions has allowed private citizens on behalf of the United States to bring civil actions and has been a powerful tool for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services in May 2009. Civil settlements claiming that Amgen illegally marketed Aranesp has amassed over $600 million dollars contained in ten lawsuits brought under the "qui tam" or whistle blower provisions of the False Claims Act.
Spite of the alarming allegations against Amgen, Amgen has ironically been awarded a beneficial drug deal within the Stimulus Package under President Obama- only to be uncovered moments before the Bill's signature. Spearheaded by Senators from Montana, Utah, as well as Senate Minority Leader Mitch McConnell, Amgen's political influences in the nation's capital seems to provide for the financial dues the Pharmaceutical company is expected to make.