Pharmacovigilance Seen as Complementing Pre-Approval Testing
NEW YORK, 30 JAN 2007 – Heightened public awareness of drug safety, greater regulatory scrutiny and a number of recent drug withdrawals and black box warnings are causing pharmaceutical companies to rethink how they ensure the post-market safety of their products. Instead of relying solely on pre-approval clinical trials and the federal drug approval process, pharmaceutical companies are shifting to “pharmacovigilance” – continued, systematic monitoring of drug safety under real-world conditions, according to “Unlocking the Power of Pharmacovigilance,” a new PricewaterhouseCoopers report.
Although pre-approval testing of new drugs is rigorous, medications are sometimes prescribed and taken in ways for which they were neither intended nor clinically tested, increasing the possibility of unexpected adverse reactions. Concerned about such post-market problems, drug companies are expanding pharmacovigilance activities to detect, assess and prevent adverse reactions
after products have been approved and marketed. The PwC report details this shift and identifies leading practices.
“The idea that controlled clinical trials and the FDA’s approval procedures can establish the safety and effectiveness of pharmaceutical products has been a foundation of the industry. However, pre-approval testing alone cannot provide a perfect guarantee of safety for all potential consumers under all circumstances,” said Tony Farino, PricewaterhouseCoopers partner and U.S. Pharmaceutical and Life Sciences Advisory Services leader. “Pharmaceutical companies are doing the right thing by stepping up post-market scrutiny of their products. These activities can reduce or even prevent costly, safety-related withdrawals while enhancing patient safety.”
Although post-market pharmacovigilance programs are on the increase, a recent study by Duke University and the University of North Carolina at Chapel Hill pegged spending on patient safety monitoring following FDA approval at just 0.3 percent of sales revenue among the top 20 pharmaceutical manufacturers, even though research and development spending – largely in advance of product approval – consumes 15.6 percent of revenue. While few suggest that pharmacovigilance spending be brought in line with R&D spending, the report suggests that pharmaceutical companies should spend more in both time and dollars on post-market monitoring and analysis of their products.
“Unlocking the Power of Pharmacovigilance” is based on PricewaterhouseCoopers research, including interviews with industry experts on patient safety and pharmacovigilance and consultations with thought leaders who have successfully addressed similar challenges in other disciplines.
The report found that pharmacovigilance programs are at various stages of maturity, but nearly all of the companies whose activities were reviewed have struggled with their efforts. The problem is that pharmacovigilance has evolved in reaction to – rather than in anticipation of – safety events. Instead, pharmacovigilance programs need to be more integrated, flexible and proactive, the report finds/suggests.
The report reviews recommended leading practices in pharmacovigilance. Companies should develop clearly-defined safety roles and responsibilities, implement enhanced communications with patients and physicians, standardize pharmacovigilance processes and data management and adopt risk management strategies already employed elsewhere by leading corporate compliance operations.
“The pharmaceutical industry offers the promise of a better life for millions around the world. Yet very real concerns about the safety of medication threaten to further erode the public confidence that is essential for the industry to grow,” said Michael Mentesana, PricewaterhouseCoopers U.S. Pharmaceutical and Life Sciences R&D Advisory Services leader. “The time for companies to develop and implement effective, best-in-class pharmacovigilance solutions is now. Neither the industry nor those who depend on its lifesaving possibilities can afford anything less than the fulfillment of its promise.”
An executive summary of the report “Unlocking the Power of Pharmacovigilance: An Adaptive Approach to an Evolving Drug Safety Environment,” may be downloaded from
www.pwc.com/pharma.
About PricewaterhouseCoopers Pharmaceutical and Life Sciences Industry Group
PricewaterhouseCoopers Pharmaceutical and Life Sciences Industry Group (www.pwc.com/pharma) provides clients with audit, tax and advisory services. The firm has extensive experience in delivering solutions to a wide range of strategic, financial and operational issues. The firm has also developed industry-specific services in the areas of regulatory compliance, IT and financial effectiveness, and performance improvement. The Pharmaceutical and Life Sciences Industry Group is part of PricewaterhouseCoopers’ larger initiative for the health-related industries that brings together expertise and allows collaboration across all sectors in the health continuum.
About PricewaterhouseCoopers
PricewaterhouseCoopers provides industry-focused assurance, tax and advisory services to build public trust and enhance value for its clients and their stakeholders. More than 140,000 people in 149 countries across our network share their thinking, experience and solutions to develop fresh perspectives and practical advice.
“PricewaterhouseCoopers” refers to the network of member firms of PricewaterhouseCoopers International Limited, each of which is a separate and independent legal entity.
# # #
Additional media contact:
Lisa Stearns, The Hubbell Group, Inc.
Tel: (781) 878-8882
