Yesterday, Amgen received approval of a global settlement from the federal judge in New York presiding over the criminal case filed against Amgen by the Department of Justice regarding the off-label promotion of the anemia drug Aranesp.
The settlement resolves criminal charges and civil kickback claims filed by the federal government, claims of Medicaid fraud filed by 49 states and the District of Columbia, and 10 whistleblower actions arising from marketing of various drugs including not only Aranesp, but also Enbrel, Neulasta, Epogen, Meupogen, and Sensipar.
As detailed in the DOJ’s press release and the criminal information, the settlement requires:
- Amgen will pay approximately $762 million — $150 million as a criminal penalty, $587.2 million to Medicaid, Medicare, and other government health payors, and $24.8 million directly to states;
- Amgen plead guilty to a misdemeanor count of introducing a mis-branded drug into interstate commerce. The criminal charge focused on the promotion of Aranesp for conditions for which it was not approved and at doses that had been specifically rejected by the FDA; and
- Amgen will be operating under a Corporate Integrity Agreement with HHS for the next 5 years.
Amgen states in its press release, “This Corporate Integrity Agreement is aligned with the significant changes and enhancements we have made to our compliance program and demonstrates our commitment to fostering a culture of compliance at Amgen.”