Corporate Integrity Agreement
On July 24, 2020, Indivior Inc. reached a global resolution with the United States Attorney’s Office for the Western District of Virginia regarding the previously disclosed investigation into civil and criminal allegations in connection with Indivior’s sales and promotion of SUBOXONE® Film. Under the agreement, Indivior will pay a total of USD 600 million in criminal and civil claims.
As part of the settlement, Indivior entered into a Corporate Integrity Agreement (CIA) with the Office of the Inspector General of the US Department of Health and Human Services. Under the terms of this agreement, Indivior was required to implement additional compliance-related measures, which include additional monitoring, auditing, training, education, reporting and disclosures for a period of five years.
Indivior is committed to high standards of ethical business conduct and has a comprehensive compliance program in place to help ensure we consistently act in a responsible manner.
Notice to Healthcare Providers of Indivior’s CIA
Dear US Healthcare Providers,
As you may be aware, Indivior recently entered into a civil, criminal, and administrative settlement with the United States and individual states in connection with Indivior’s sales and promotion of Suboxone Film. This letter provides you with additional information about the global settlement, explains Indivior’s commitments going forward, and provides you with access to information about those commitments.
In general terms, the Government alleges that Indivior engaged in certain unlawful and improper conduct relating to the promotion of Suboxone Film. To address criminal liability, a subsidiary of Indivior agreed to plead guilty to criminal charges of making materially false statements relating to health care matters and agreed to pay almost $300 million in criminal fines and forfeiture. In addition, to resolve liability under the Federal False Claims Act, Indivior agreed to enter into a civil settlement agreement and pay $300 million. Further, Indivior has agreed to a stipulated injunction with the Federal Trade Commission. More information about this settlement may be found at the following: https://www.justice.gov/civil/consumer-protection-branch, https://www.justice.gov/usao-wdva, and http://indivior.com/.
As part of the global settlement, Indivior also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.
The corporate integrity agreement is available at the US Officer of the Inspector General (OIG) website and can be downloaded here. Under this agreement, Indivior agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by Indivior’s representatives to Indivior’s Compliance organization or the FDA using the information set out below.
Please call Indivior at 1-855-881-7196 or visit us at www.indivior.ethicspoint.com to report any instances in which you believe that an Indivior representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Indivior Representative to the FDA’s Office of Prescription Drug Promotion at 1-301-796-1200. You should direct medical questions or concerns about Indivior products to 1-877-782-6966.
Mark Crossley, CEO