Drug Development for Neglected Diseases — The Trouble with FDA Review Vouchers

Abstract

September 2008 marked the beginning of a new federal program intended to promote the development of pharmaceutical products for so-called neglected diseases — infectious diseases that disproportionately affect poor populations in developing countries. Implemented by the Food and Drug Administration (FDA) Amendments Act of 2007, this program will give the sponsor of a drug for a tropical disease a “voucher” entitling the company to expedited FDA review of a new drug application for any other product it makes.¹