Are Priority Review Vouchers The Answer To Incentivize Drug Development? Not So Fast.

In the May issue of Health Affairs, two papers examine the potential for voucher systems to incentivize drug development in areas of unmet medical need. Co-authors Kevin Outterson and Anthony McDonnell take a look at potential exclusivity voucher programs designed to encourage development of new antibiotics, while David Ridley and Stephane Régnier analyze the effects that expansion of existing priority review voucher (PRV) programs may have on the value of PRVs as a development incentive. Ridley and Régnier’s work is of particular importance as both houses of Congress pursue a spate of legislative proposals that do make extensions to the PRV system for the Zika virus, pediatric diseases, and generics among other areas of unmet need (Table 1). While these proposals are based on the potential promise of PRVs to spur innovation, it is unclear whether or not the program as currently established has actually delivered on that potential to date. As noted in both articles, there are a number of challenges that could result from over-expanding the application of voucher incentive programs, and without careful consideration of the impact increased PRVs could have on regulatory review and broader drug development incentives, policymakers’ well-intentioned efforts may not ultimately achieve their desired aims and could actually create unintended negative consequences. Recent Experience with PRV Programs The PRV program was first proposed by David Ridley, Henry Grabowski, and Jeffr...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Costs and Spending Drugs and Medical Technology Featured Global Health Health Professionals Quality FDA FDAAA priority review rare diseases Source Type: blogs