Independent Review Organizations ( “IRO”) and Conflicts of Interest - Much Ado About Nothing or a Serious Problem

This article examines the various view points and what it means for the life science compliance professional. Although the concept of the Independent Review Organization or IRO has been around for many years, with the advent of Sarbanes-Oxley in 2002, the IRO came to the forefront in life sciences. During the settlement of compliance and regulatory claims with life-science companies, the government typically now requires companies to retain IROs to assist in the investigation, review, negotiations, and settlement process. Requiring an IRO has become so ingrained in the settlement process that the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) explicitly states that, in terms of facilitating Corporate Integrity Agreements (“CIAs”), IROs play an integral role in including assisting both the Government and the company involved with compliance and regulatory issues. To Read the Full Story, Subscribe, Download a Sample Issue, or Sign In       Related StoriesA New Application of Escobar: Gilead or When Half-Truths Can Become Actionable Under the FCAA Murky Future for Off-label Promotion: States vs. FDA - Arizona to Allow Pharma Companies to Legally Communicate Off- Label Treatment OptionsA Murky Future for Off-label Promotion: Off-Label Bills Garner Minimal Traction in Congress 
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs