Astellas Settlement Agreement
Comparisons between Amgen and Astellas, as well as corporate integrity agreements, will be thoroughly reviewed in a future issue of the Compliance Policy and Medicine Update. Astellas pays $100 million, while Amgen pays $24.75 million. Neither company admitted these rights and signed a five-year Corporate Investment Agreement (CIA) as part of the transaction. “As a result of the allegations made in today`s comparisons, Astellas and Amgen conspired with two Copay foundations to create funds that benefit almost exclusively patients taking drugs from astellas and Amgen,” said U.S. Attorney Andrew E. Lelling. As a result, corporate payments to foundations were not “donations,” but bribes that undermined the structure of the Medicare program and illegally subsidized the high cost of corporate drugs at the expense of American taxpayers. We will continue to monitor these cases until pharmaceutical companies stop participating in this type of behaviour. “As today`s comparisons show, the FBI will act aggressively against pharmaceutical companies that try to boost their drug prices by paying illegal bribes — direct or indirect — to undermine tax-funded health programs, including Medicare,” said Joseph R. Bonavolonta, special agent in the LOT of the FBI Boston Division. These two separate comparisons are part of a lengthy Justice Department investigation into the financial support pharmaceutical companies provide to charities that help patients pay for prescription drugs.
“Amgen disagrees with the government`s view of the relevant facts or inappropriate behaviour; As a result, the comparison does not contain or constitute an admission of responsibility,” a spokeswoman said. The agreement “reflects Amgen`s desire to turn the page on this legal case and focus on the needs of patients,” she added. Amgen and Astellas entered into five-year corporate investment agreements (CIAs) with OIG as part of their respective comparisons. ASAs require companies to implement measures, controls and controls to promote independence from the patient support programs for which they donate. In addition, the companies have agreed to set up risk assessment programs and obtain compliance certifications from the company`s management and board members.