The priority review voucher program at the Food and Drug Administration (FDA) was established in 2007 to incentivize research and development (R&D) in traditionally underfunded diseases.1 While shrouded in controversy and criticism, the program has recently been bolstered by the passage of the 21st Century Cures Act,2 which prevented the vouchers from sunsetting in late 2016 and furthered the overall scope of the program.3 As it reaches the end of its first decade, this Article discusses the impact of the program, with a focus on recent developments. The Article builds on literature suggesting that the voucher program has been ineffective in incentivizing research in neglected diseases. It is the first to consider the expansion of the vouchers to cover R&D on Ebola and Zika, arguing that the expansion was attributable to misguided bipartisan political support and is likely to result in further cross-subsidization benefiting R&D on mainstream diseases. Finally, this is also the first scholarly piece to describe and assess the likely impact the 21st Century Cares Act has on the program.
Rutschman, Ana Santos, "The Priority Review Voucher Program at the FDA: From Neglected Tropical Diseases to the 21st Century Cures Act" (2017). All Faculty Scholarship. 125.