Judy Fox | CIS
Within the Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers (OIG Guidance), three key risk areas are identified. One of the key risk areas is compliance with laws regulating drug sampling. With the enforcement of drug sample transparency spawned from implementation of §6004 of the Patient Projection and Affordable Care Act (PPACA), manufacturers are giving renewed attention to the Prescription Drug Marketing Act of 1987 (PDMA). This law, passed by Congress in 1988, is designed to discourage the sale of counterfeit, adulterated, misbranded, sub-potent, and expired drugs as a means to help ensure the safety and effectiveness of those drugs. The PDMA mandates that pharmaceutical companies implement specific accounting policies and procedures, auditing and monitoring protocols, and thresholds. Civil and criminal penalties are also established for individuals and corporations found guilty of noncompliance with the law.