Instead of relying solely on pre-approval clinical trials and the federal drug approval process, pharmaceutical companies in the USA are concentrating more on pharmacovigilance, that is “continued, systematic monitoring of drug safety under real-world conditions,” according to new report from PricewaterhouseCoopers.
The study, called Unlocking the Power of Pharmacovigilance, claims that the pharmaceutical industry is looking at this matter in response to “heightened public awareness of drug safety, greater regulatory scrutiny and a number of recent drug withdrawals and black box warnings” and this had made them “rethink how they ensure the post-market safety of their products. “
Tony Farino, leader at PwC’s US Pharmaceutical and Life Sciences Advisory Services, says that the idea that controlled clinical trials and the US Food and Drug Administration's approval procedures can establish the safety and effectiveness of drugs “has been a foundation of the industry” but “pre-approval testing alone cannot provide a perfect guarantee of safety for all potential consumers under all circumstances." He adds that “pharmaceutical companies are doing the right thing by stepping up post-market scrutiny of their products [as] these activities can reduce or even prevent costly, safety-related withdrawals while enhancing patient safety."
The report, which is based on research that includes interviews with industry experts on patient safety and pharmacovigilance, as well as consultations “with thought leaders who have successfully addressed similar challenges in other disciplines,” notes that although post-market pharmacovigilance programs are on the increase, a recent study by Duke University and the University of North Carolina pegged spending on patient safety monitoring following FDA approval at just 0.3% of revenues among the top 20 pharmaceutical manufacturers, even though R&D spending, “largely in advance of product approval,” consumes 15.6 % of their spending.
PwC also found that pharmacovigilance programmes 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,” the report argues, and programmes need to be “more integrated, flexible and proactive”. It recommends that companies develop clearly-defined safety roles and responsibilities, implement enhanced communications with patients and physicians, standardise pharmacovigilance processes and data management and adopt “risk-management strategies already employed elsewhere by leading corporate compliance operations.”
PwC’s Michael Mentesana says that “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." He concludes by noting that "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."
