FDA's Orphan Drug Exclusivity Policy May Face Second Court Challenge
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA denies seven years of orphan drug exclusivity for Eagle Pharmaceuticals' Bendeka (bendamustine) despite district court ruling in Depomed case rejecting agency's "clinical superiority" requirement.
You may also be interested in...
Judge Jackson’s Patent, FDA Rulings Show She Is ‘Super Smart’ And Would Be Beneficial For Pharma
Supreme Court nominee issued three decisions on Hatch-Waxman regime as district court judge, including case in which she ruled against the FDA’s denial of orphan drug designation and another in which she deferred to the agency’s view on exclusivity. Her analysis of facts may play a role if the court takes up a case on administrative agency deference.
Eagle Will Be Last Firm To Bypass FDA's Orphan Drug Exclusivity Requirement
Court orders US FDA to award Bendeka seven years of exclusivity without requiring clinical superiority test; law codifying FDA policy passed prior to suit and is not retroactive.
Pediatric Cancer Study Requirements Added To FDA User Fee Bill
User fee legislation headed for a US House vote this week would require pediatric studies of certain molecularly targeted cancer drugs; the requirement, which could apply to some orphan drugs, would not take effect for three years.