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

Of the 14 priority review vouchers awarded by the FDA for neglected tropical disease (NTD) products since 2007, most went to existing therapies already widely used outside the US, with FDA approval often occurring years after use in regions in which the NTDs were prevalent. These findings suggest that the NTD voucher program largely rewards regulatory submissions rather than innovation. Policymakers should abandon the voucher or implement reforms that tie voucher eligibility to equitable pricing and demonstrable gains in patient access.