Corporate Integrity Agreement Shire

The U.S. Attorney`s Office for the District of Columbia also played an active role in this investigation and sought compensation for the losses suffered by the VA in the civil agreement announced today. “Giving bribes and tips to health care providers corrupts medical treatment by introducing personal financial incentives into decisions that should focus on what`s best for a particular patient,” said U.S. Attorney Channing D. Phillips for the District of Columbia. “These kinds of illegal incitements are particularly worrisome when they try to corrupt the medical treatment of our nation`s veterans. We will aggressively pursue any company that participates in such reprehensible and illegal behavior that attempts to pass on a company`s financial profits ahead of providing the best medical treatment to those who have bravely served in our armed forces. With respect to Shire`s disclosure obligations under the CIA, the agreement states: “In general, the government claimed that Endo illegally promoted its Lidoderm product for purposes not authorized by the Food & Drug Administration (FDA), and that these activities were contrary to the Federal Food, Drug and Cosmetic Act and the False Claims Act. To address these issues, an endo subsidiary, Endo Pharmaceuticals, Inc. (EPI), entered into a deferred lawsuit agreement and agreed to pay approximately $20.8 million in fines and forfeiture. In addition, Endo entered into a civil settlement and agreed to pay $172.9 million to the federal government and the state`s Medicaid programs to clarify the false claims act`s allegations. Specific information about Shire`s commitments under the settlement agreement can be found in the full CIA document here. The Shire Agreement entered into force on 15 September; See it here.

In the agreements with GSK, J&J and Endo, HHS-OIG required these companies to establish lists of medical payments that can be consulted on their websites on a quarterly basis. Now this requirement is no longer applicable for the payment of general practitioners – Shire can only publish annually. However, as indicated in the next point, the OIG wishes to continue to make quarterly payments from “Independent Medical Education Activity Grants and Health Care Contributions”. “This transaction represents the largest U.S. recovery of the False Claims Act in a kickback case involving a medical device,” said Benjamin C. Mizer, deputy attorney general, head of the Justice Department`s civil department. “Bribes from providers of health goods and services undermine the integrity of our health care system. Patients deserve the full and independent judgment of their healthcare professionals. We also wrote a five-page overview of Shire`s 78-page corporate investment agreement. .

. .