Building a Drug or Device Sampling Program that is Compliant, Accountable, and Prepared for Federal and State Law


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.
[Read more...]

Expanded Access to Investigational Drugs – Not Just About Being “Compassionate”


Expanded access use of drugs in development (also commonly known as “compassionate use”) is an issue that has come to the forefront recently with some high-profile cases involving the news media and social media. Many may recall the news of a 7-year old boy who was suffering from a severe adenovirus infection and whose family fought hard for access to a drug still being studied in clinical trials, but which presented one of the only hopes for successful treatment. After the manufacturer of the experimental drug denied the request for access to the drug by the boy’s family, a major social media campaign ensued which mounted significant public pressure on the drug company and resulted in a reversal of the decision. The drug company worked with the US Food and Drug Administration (FDA) to grant access to the drug for the boy and other patients like him.
[Read more...]

Fraud Readiness: Is Your Company Fraud Fit or Ready to Flat Line?


Two of the most often asked questions by businesses looking to gage their fraud risk management efforts are “how do we know if we’re adequately prepared for investigations and audits,” and “are we doing the right things?” The reality is that your company shouldn’t be waiting for investigations or audits to occur to determine how fit you are to deal with major fraud, compliance or regulatory related events.
[Read more...]