Drug Information Association (DIA) 45th Annual Meeting: Better Medicines: Improving Safety with Every Step

San Diego, CA

Topic:  Office of Inspector General (OIG) Settlements: New Integrity Obligations for Pharmaceutical Companies

This session will describe the recent Department of Health and Human Services' Office of the Inspector General (OIG) settlements involving the pharmaceutical industry. As part of those settlements, the pharmaceutical companies usually execute a corporate integrity agreement (CIAs) with the OIG. These CIAs include a wide range of contractual integrity obligations for the company to comply with over what is usually a five-year period. Pharmaceutical professionals are then trained on the terms of the CIAs likely to affect their positions. Pharmaceutical companies are also required to retain an independent review organization (IRO) to review certain systems and transactions related to these high-risk areas. One particular high-risk area of integrity focus has been government price reporting. Other particular high-risk areas include monitoring for off-label promotional activities or financial relationships with health-care prescribers. This session will highlight some of the newest integrity obligations in the CIAs with pharmaceutical companies. These integrity obligations often serve as guidance for what is recommended so that a company's voluntary corporate compliance program is effective even in the absence of a CIA.