Should FDA prioritize more tropical disease drugs?
Executive Summary
FDA will hold a public hearing Dec. 12 soliciting input on adding additional diseases to the list of tropical diseases for which sponsors developing corresponding treatments could receive priority review vouchers. FDA is authorized under FDAAA to award the vouchers to sponsors of certain tropical disease product applications, but states in a recent draft guidance that those applications could not be reviewed until it receives congressional authorization to collect a special user fee to support the program (1"The Pink Sheet," Oct. 27, 2008, p. 28). Requests to deliver oral presentations and comments at the public hearing must be submitted by Nov. 17