The pharmaceutical industry is experiencing a period of heightened regulatory scrutiny both in the US and globally. This scrutiny is occurring in a number of areas, including: sales and marketing practices, government drug price reporting, privacy of patient and/or customer health information, clinical operations, post-marketing drug safety reporting, and in quality control activities around manufacturing operations. Recent highly visible investigations and aggressive prosecutions have resulted in significant financial judgments and criminal convictions. This trend is driving a powerful reaction among companies to put in place robust enterprise-wide compliance management programs designed to reduce risk, enhance management controls, and ensure compliance. The industry’s regulators (both in the US and globally) have also provided guidance that enables innovation and potential cost savings in manufacturing operations. A thorough understanding of the new guidance (e.g., the FDA’s Process Analytical Technology initiative or “PAT”) and a commitment to embed it in the way companies work can bring competitive advantage and prepare the industry for the future as today’s guidance is translated into tomorrow’s regulations.
In addition to the industry regulatory establishment (i.e., FDA, DHHS, EMEA, VA and others), most major pharmaceutical and healthcare products companies are subject to the Security and Exchange Commission’s rules promulgated by the Sarbanes-Oxley (SOX) legislation. The intersection of SOX requirements and industry regulatory concerns is best understood within the context of the reporting and control mandates set forth under the SOX legislation’s Section 404. Industry-based regulatory compliance is highly relevant to the financial and operational control requirements described in Section 404 and thus creates additional impetus to align corporate compliance activities with multiple regulatory regimes.
Regulatory scrutiny and enforcement actions will certainly continue given the ever increasing volume of drug sales to both state and federal government entities—especially with the full implementation of the Medicare drug benefit. The industry will be challenged to move beyond the current crisis management approach to regulatory compliance and implement a comprehensive strategic approach that builds compliance into the way companies do business.
PricewaterhouseCoopers has a wide array of industry-focused compliance management and performance improvement services in the area of regulatory compliance for pharmaceutical and healthcare products companies. Our portfolio of services includes capabilities around developing compliance programs in sales and marketing— including samples management, government price reporting, and in clinical development around the implementation of good clinical practices, to name just a few examples.