Society: FDA Decision to Expand List of Tropical Diseases in Voucher Program a 'Game-Changer'

Posted 23 August 2018

Lassa fever, chikungunya, rabies, cryptococcal meningitis added to FDA tropical disease priority review voucher program 

The American Society of Tropical Medicine and Hygiene (ASTMH), the largest international scientific organization of tropical infectious disease experts, welcomes the United States Food and Drug Administration’s (FDA) addition today of four tropical diseases to its priority review voucher program. 

“The FDA priority review voucher program has been a critical driver of industry engagement in creating new products for solutions for diseases that are rare in the U.S. but can be devastating globally when they occur. The addition of Lassa fever, chikungunya, rabies and cryptococcal meningitis to the list of eligible diseases is a game-changer, as it provides an incentive to develop solutions that without this type of program face a significant innovation and development gap,” said ASTMH President Regina Rabinovich, MD, MPH, of the Harvard T.H. Chan School of Public Health.

The FDA’s tropical disease priority review program was created in 2007 to stimulate the development of new drugs and treatments to prevent and treat infectious diseases for which there are no significant markets in developed nations and that disproportionately affect the poorest populations, living in remote, rural areas, urban slums or conflict zones. According to the World Health Organization, neglected tropical diseases affect more than 1 billion people, primarily poor populations living in tropical and subtropical climates.

“We live in an interconnected world and disease doesn’t need a passport. Today’s news, combined with last month’s FDA approval of a new drug to prevent relapse of Plasmodium vivax malaria with a single dose, is welcome acknowledgement from the U.S. government that global health and America’s health are one and the same,” said Executive Director Karen A. Goraleski.