OBJECTIVES: To understand how the FDA Priority Review Voucher (PRV) program has incented the development of new treatments for neglected, tropical diseases, and its effect on patient need. METHODS:  The study employed a pragmatic literature review to determine which diseases experienced an increase in development research, as well as an analysis of the effect on treatment options and algorithms, as well as epidaemiology RESULTS: Between 1975 and 1999, less than 1% of newly approved drugs were for tropical diseases. Between 2007-2016, 12 PRVs were awarded; four have contributed to development programmes for tropical diseases, while the remaining eight were awarded for developments in rare pediatric diseases. The rare pediatric diseases that now have a treatment option are Morquio A syndrome, high-risk neuroblastoma, rare bile acid synthesis disorder, hereditary orotic aciduria, hypophosphatasia, lysosomal acid lipase deficiency, Duchenne muscular dystrophy, and spinal muscular atrophy. The neglected tropical diseases with newly developed treatment options are malaria, tuberculosis, leishmaniasis, and cholera. Rare diseases affect about 12.5 million pediatric patients in the US, and the use of these new treatments allows for a significant increase in overall survival and quality of life. However, some critics believe this program addresses goals for neither tropical diseases, nor rare pediatric diseases. This is due to the lack of accountability with regard to development and regulatory follow-through. In support of this, manufacturers do not cite an expedited review process as a main consideration for initiating a development in neglected tropical or rare diseases. CONCLUSIONS:  The PRV program has rewarded the development of 12 new drugs for neglected disease areas. While there are still many rare diseases that lack even one treatment option, and can thus benefit from the priority review voucher program, it is uncertain if the incentive is strong enough for manufacturers to initiate developments in these areas