Posted 01 July 2008

Recognizing Corporate Compliance Governance as a Critical Business Issue

In today's pharmaceutical and medical device industry, the term "compliance" means different things to different parts of each organization. To some, it means "GxP" (Good Manufacturing, Laboratory or Clinical Practice). To others, it means other areas of FDA compliance such as advertising and labeling, the Prescription Drug Marketing Act (PDMA),¹ or pharmacovigilance, device safety monitoring and postmarketing reports of adverse events. To still others, it means any of a wide array of other healthcare compliance concerns, including Medicare/Medicaid reimbursement, the seven-point compliance program of the Health and Human Services Office of Inspector General (HHS OIG), the Health Insurance Portability and Accountability Act (HIPAA),² the Federal Anti-Kickback Statute,³ or any of a variety of state and even local statutes and regulations.