Neglected tropical diseases (NTDs) remain important sources of morbidity, mortality and disadvantage in low and middle-income countries, and yet the development and registration of new treatments for these diseases is rare. Funding to support the research and development of new medicines for these diseases is directly correlated with their low potential for return on investment, and remains insufficient to consistently meet regulatory standards. To drive this drug development, in 2007 the United States Congress created the priority review voucher (PRV) to reward sponsors who successfully register medicines to treat specified NTDs. The PRV is saleable to any company wishing to gain priority review of their new treatment, regardless of indication, creating a market that has yielded up to US$350 million per PRV. Although three new NTD treatments have been approved under the scheme, concerns have been expressed that sponsors benefitting from PRV sale are not bound to ensure treatment access and that the program does little to drive new NTD drug development.
Mark Sullivan presenting at American Society of Tropical Medicine and Hygiene (14 November 2016, Atlanta, GA)
November 10, 2016