The two separate comparisons are part of a long-standing Justice Department investigation into financial assistance provided by pharmaceutical companies to charities that help patients pay for prescription drugs. According to the terms of the comparison, Amgen will contribute $17.8 million to the federal government and nearly $7.1 million to public Medicaid programs. In a previously released statement, Amgen rejected the government`s accusations and said they were related to events “from the early to mid-2000s.” Despite the date of the offences, Amgen is no stranger to such charges. The most recent regulation of the False Claims Act is actually the second of its kind between Amgen and the DOJ in the last six months. In December 2012, Amgen pleaded guilty to embezzling aranesp advertisements for Aranesp and had to pay $762 million to settle civil charges against the company. “With this agreement, we are taking important steps to hold drug manufacturers accountable for fraudulent and abusive practices, not only in South Carolina, but across the country,” said William Nettles, U.S. Attorney for the District of South Carolina. “I am proud of the tireless work of this office in investigating this matter across the country.” As part of the overall agreement, Amgen has also agreed to enter into a 98-page Corporate Integrity Agreement (CIA) with HHS-OIG that will regulate its behavior and closely monitor its branding and marketing practices. The five-year CIA contains provisions to increase accountability for individuals and board members, increase transparency and strengthen Amgen`s compliance program. Reuters noted that corporate officers will be “on the hook” for compliance errors within that five-year period, prosecutors said. This regulation reflects Amgen`s desire to turn the page on this legal issue and focus on the needs of patients.
The company believes that all people deserve access to medications prescribed by their doctors. Donations to independent charities can help patients with their prescription supplements, and Amgen continues to believe that these programs help patients lead healthier lives. As part of Amgen`s efforts to ensure patients` access to critical drugs, Amgen continues to provide funding to independent charitable programs to help patients. 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.