Amgen has agreed to pay $762 million to settle allegations that it misbranded its anemia drug Aranesp. According to an article in Bloomberg, a plea agreement reached between Amgen and federal prosecutors was accepted by a U.S. District Judge Sterling Johnson in New York on December 19, 2012. Pursuant to the agreement, Amgen will pay $150 million in criminal penalties and $612 million to settle civil claims by various states and whistleblowers who allege that the company also illegally marketed certain drugs.
The specific allegations presented in the lawsuit include assertions that Amgen marketed Aranesp for uses that were not approved by the U.S. Food and Drug Administration (FDA) from 2001 through March 2007 in an effort to compete with Johnson & Johnson anemia treatment, Procrit. State and federal laws prohibit pharmaceutical companies from marketing drugs for uses that have not approved by the FDA, even though doctors may write prescriptions for off-label purposes as they deem necessary.
With approval of the plea agreement, several whistleblower lawsuits were also unsealed, revealing allegations that the company engaged in the illegal promotion of other drugs, including Enbrel (a psoriasis medication) and Neulasta (a drug used to increase white blood cells in chemotherapy patients). For instance, two former Amgen sales representatives alleged that they were directed by management to promote Enbrel for mild psoriasis even though it had only been approved for more severe forms of the skin condition. Some of the whistleblower lawsuits also included allegations Amgen paid kickbacks to doctors who prescribed the drugs for off-label uses.
As part of the settlement, Amgen has agreed to sign a corporate integrity agreement obligating it to regularly report to the government on its compliance with drug marketing regulations.
Bloomberg reports that U.S. revenue from Aranesp totaled more than $11 billion from 2001 through 2008, with about $6 billion coming from health-care programs Medicaid and Medicare.
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