The Priority Review Voucher Program at the FDA: From Neglected Tropical Diseases to the 21st Century Cures Act

Abstract

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. While shrouded in controversy and criticism, the program has recently been bolstered by the passage of the 21st Century Cures Act, which prevented the vouchers from sunsetting and furthered the overall scope of the program. As the voucher program reaches the end of its first decade, this Article discusses its impact, with a focus on recent developments. The Article builds on literature suggesting that the voucher program has been ineffective in incentivizing research on 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 discuss the likely impact of the 21st Century Cares Act on the program.

Keywords: Priority review voucher, Food and Drug Administration (FDA), 21st Century Cures Act, neglected diseases, Ebola, Zika, incentives