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12.02.20 | Amgen Corporate Integrity Agreement 2019

For the civil agreement, Amgen agreed to pay US$612 million (US$587.2 million in the United States and $24.8 million in the United States) to resolve allegations that it made false claims against Medicare, Medicaid and other state insurance programs. The federal civil settlement agreement includes allegations that Amgen: (1) Aranesp and two other drugs it manufactured, Enbrel and Neulasta, encouraged off-label applications and doses that were not authorized by the FDA and could not be properly reimbursed by federal insurance programs; (2) offered illegal bribes to a large number of institutions to influence health care providers in the choice of their products, whether repayable or medically necessary by federal health programs; and (3) false pricing practices on several of its drugs. The DOJ announced on April 25, 2019, it was announced that two other pharmaceutical manufacturers, Astellas Pharma US, Inc. (Astellas) and Amgen Inc. (Amgen) (Amgen), have reached an agreement with the government to clarify allegations that the companies violated the FCA when they used independent co-payment organizations to subsidize Medicare patient supplements for their own drugs. , while receiving large price increases for their products. Astellas and Amgen have also entered into a five-year Enterprise Integrity Agreement (CIA) with the Health and Human Services (HHS) Office of Inspector General (OIG) and must take specific compliance measures regarding interactions with independent co-payment charities. “Kickback systems can undermine our health care system, compromise medical decisions and waste taxpayers` money,” said Phillip Coyne, Special Agent in charge, Office of the Inspector General of the Department of Health and Human Service`s Boston Regional Office. “We will continue to accuse pharmaceutical companies of inseminating the donation process to circumvent safeguards to protect the integrity of the Medicare program.” The April 2019 guidelines ask three “fundamental questions” that prosecutors should ask about business compliance programs, and then present more detailed sub-themes and sub-questions to assess each fundamental issue.

With respect to the fundamental question “Is the company`s compliance program well designed?”, the April 2019 guide contains six distinct sub-themes (risk assessment, policies and procedures); Training and communication Confidential reporting structure and investigative process; Third-party management and mergers and acquisitions) with other discussions and targeted investigations. The government based its investigation on testimony and evidence, in particular, Milwaukee Representative Jill Osiecki, who, at the request of HHS investigators, had a sales line, noted MMM. Osiecki told The New York Times that when she joined the company in 1990, she had “good science, good products, a strong ethic,” but that corporate culture changed around 2000. , “when the new management arrived and Aranesp was approved, which triggered a violent marketing battle with Johnson and Johnson and its rival anti-anemia Procrit,” reports the Times. This was the year Kevin Sharer took over as Chairman of the Board of Directors.