Four Disclosure Compliance Risks that Clinical Trial Sponsors Should Identify and How to Avoid Them

Trial disclosure regulations around the world continue to evolve, are not well harmonized across jurisdictions and can be fairly complex.  There are over 40 countries or regions with mandatory trial disclosure regulations and over 30 trial registries for posting clinical data.  While trial sponsors have developed policies, processes and systems to address key trial disclosure requirements, few have evolved systems for continuous monitoring of trial disclosure and registry requirements, or have the systems to monitor and harmonized disclosure of trial information globally. Four practices in particular rise to the surface as major risks for trial sponsors regarding current and ongoing compliance. [Read more…]

Four Risks Pharma Companies Face

The pharmaceutical industry, like many others, has faced increased legal challenges and regulatory oversight as it has expanded into emerging markets and it has confronted additional risks associated with technological advances. In recent years, pharmaceutical companies have paid hundreds of millions of dollars to resolve Department of Justice (“DOJ”) investigations, seen employees charged in criminal cases around the world and have been besieged by faceless aggressors seeking proprietary information.  Here, we detail four of the biggest risks facing pharmaceutical companies today: cybersecurity, global corruption, fraudulent marketing, and government scrutiny of potentially anticompetitive conduct that could violate antitrust laws.
[Read more…]

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…]