Priority Without Progress: the FDA’s Neglected Tropical Disease Voucher Program After 18 Years

Introduction To incentivize drug and vaccine development for neglected tropical diseases (NTDs), Congress created the Priority Review Voucher program in 2007. Sponsors that obtain Food and Drug Administration (FDA) approval for an eligible product receive a voucher redeemable to accelerate review of another product. Methods We reviewed the program’s public health impact by examining all 14 vouchers awarded for NTD products between 2007 and 2024, including the timing of FDA approval relative to World Health Organization (WHO) Prequalification, Essential Medicines List inclusion, first use in endemic countries, and voucher disposition. Results Eight (57%) achieved WHO prequalification, and 8 (57%) were listed in the Essential Medicines list. FDA approval occurred a median of 8.7 years after first regulatory approval or use in an endemic country, and a median of 5.2 years after WHO Essential Medicines list inclusion. Conclusion Our findings suggest the PRV program has primarily rewarded regulatory filings for long-established therapies rather than stimulating innovation or improving access. We propose reforms linking voucher eligibility to equitable pricing and endemic country registration.