The Impact of the Priority Review Voucher on Research and Development for Tropical Diseases.

ABSTRACT:

Background

In 2007, the priority review voucher (PRV) was implemented in the US to incentivize research and development (R&D) for tropical diseases. The PRV is issued by the US FDA and grants a quicker review to manufacturers upon successful development of a product for a disease eligible for the program.

Objective

The objective of this analysis was to assess whether the PRV has incentivized R&D (measured as clinical trial activity) for the intended tropical diseases.

Method

We used a difference-in-difference-in-differences (DDD) strategy by exploiting variation in its implementation across diseases and registries around the world. Clinical trials were retrieved from the World Health Organization International Clinical Trials Registry Platform for the years 2005-2019.

SUBMITTER: Aerts C 

PROVIDER: S-EPMC9217899 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature