Pharma Blog Watch

Orphan Drug User Fees (FDA Law Blog)
In this post, the blogger writes about the National Organization for Rare Disorders' (NORD) recent testimony before Congress about orphan drug product user fees. Current Prescription Drug User Fee Act proposals don't "include any user fee relief for orphan drug sponsors specifically."

"NORD is requesting that Congress resolve the issue 'in a way that assures the continued success of the Orphan Drug Act without undercutting the user fee program.' Specifically, NORD believes that FDA should waive product and establishment user fees for drug products with annual United States revenues less than $25 million." The current revenue cutoff is $10 million.