Notice to Healthcare Providers and Entities
As you may be aware, Avanir Pharmaceuticals, Inc. (Avanir) recently entered into a criminal, civil, and administrative settlement with the United States and individual states in connection with Avanir’s marketing and promotion of Nuedexta. This letter provides you with additional information about the global settlement, explains Avanir’s commitments going forward, and provides you with access to information about those commitments.
In general terms, the government alleged that Avanir violated the Federal Anti-Kickback Statute and caused the submission of false claims for Nuedexta to Federal health care programs. To address criminal liability, Avanir entered into a Deferred Prosecution Agreement with the United States relating to violations of the federal Anti-Kickback Statute and agreed to pay more than $12.8 million in criminal fines and forfeiture. In addition Avanir entered into settlement agreements with the Federal government and certain states to resolve allegations that it engaged in improper marketing and promotion of Nuedexta. To resolve those allegations, Avanir agreed to pay $103 million to federal and state health care programs. More information about this settlement may be found at the following: https://www.justice.gov/usao-ndga/pr/pharmaceutical-company-targeting-elderly-victims-admits-paying-kickbacks-resolves, https://www.justice.gov/opa/pr/pharmaceutical-company-targeting-elderly-victims-admits-paying-kickbacks-resolves-related and www.avanir.com.
As part of the global settlement, Avanir 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 https://oig.hhs.gov/compliance/corporate-integrity-agreements/cia-documents.asp. Under this agreement, Avanir 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 Avanir’s representatives to Avanir’s Compliance organization or the FDA using the information set out below.
Please call Avanir at 855-363-6473 or visit us at firstname.lastname@example.org if you have questions about the settlement referenced above. Please call Avanir at 855-809-3045 or visit us at http://www.avanir.alertline.com to report any instances in which you believe that a Avanir 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 a Avanir Representative to the FDA’s Office of Prescription Drug Promotion at 301-796-1200. You should direct medical questions or concerns about Avanir products to 855-572-2722.
President & CEO