Improving the Incentives of the FDA Voucher Program for Neglected Tropical Diseases

Abstract

"The largest Ebola outbreak to date—first detected in December 2013 and still ongoing as of April 2015—has cast new light on the shortfalls of international public health systems.1 As in previous health crises, scrutiny has reemerged over the pharmaceutical industry’s ability and willingness to innovate new medicines for underserved disease areas. The public debate has intensified following revelations that promising drug candidates to treat Ebola had gone undeveloped despite compelling preclinical results.2 This lack of development is especially troubling because it occurred after a recently implemented U.S. incentive scheme—the Food and Drug Administration’s (FDA) tropical disease priority review voucher program—designed to counteract exactly this problem. Taking Ebola as a case in point, it is useful to examine the short history and ongoing refinement of this voucher program, since it represents one of the most significant legislative efforts to systematically address the relative absence of com- mercial rewards for drugs targeting tropical diseases. This analysis evaluates the voucher program’s effectiveness for both stimulating private sector innovation and achieving positive health impacts among populations most severely burdened by tropical diseases. It then proposes specific recommendations for how law- makers can improve the program’s legislation to better achieve these objectives. "