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BTG is committed to ethical business practices and complying with healthcare laws and regulations, including those relating to improper product promotion, bribery and corruption such as providing kickbacks to generate business, and making or causing the submission of false reimbursement claims to government or commercial payers.
As you may be aware, in January 2011, Biocompatibles was acquired by BTG. As a result of that acquisition, Biocompatibles became an affiliate of BTG plc (“BTG”). Based on Biocompatibles’ conduct before the acquisition, Biocompatibles agreed to enter into a criminal and civil settlement with the United States of America in connection with the marketing of LC Bead®. This letter provides you with additional information about the settlements, explains our commitments going forward, and tells you how to obtain more information about those commitments.
To resolve these matters, Biocompatibles pled guilty to violating the Federal Food, Drug, & Cosmetic Act and agreed to pay a criminal penalty of $11 million. In addition, the federal government and several individual states alleged that Biocompatibles’ conduct violated the federal False Claims Act and equivalent state statutes. To resolve those allegations, BTG (as Biocompatibles’ parent) entered into a separate civil settlement whereby BTG agreed to reimburse federal and state healthcare programs an additional $25 million. Copies of and more information about these settlements may be found at the following website:
As part of the agreement, we pledged to maintain our existing comprehensive compliance and ethics program, to undertake certain actions designed to advance compliance with federal healthcare program and FDA requirements, and to make periodic compliance certifications to the Department of Justice. We also agreed to provide this notice to LC Bead® users to inform them of the criminal and civil settlements and to remind them that they are encouraged to report any questionable practices by our employees to BTG’s North America Compliance Department (1-877-440-7227, or LCBeadConcerns@btgplc.com) or the FDA (1-888-INFO-FDA).
You should direct any medical questions or concerns about our prescription products to our Medical Information Team (1-877-377-3784 or email@example.com).
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