E&C Draft User Fee Bill Limits Orphan Exclusivity To Indication

The House Energy & Commerce’s bipartisan draft user fee bill would limit orphan drug exclusivity to approved indications, instead of applying exclusivity to entire diseases or conditions. The measure would codify FDA’s interpretation of orphan exclusivity, which is the subject of a lawsuit that the U.S. Supreme Court has been asked to take up . The lawsuit is between Catalyst Pharmaceuticals and Jacobus Pharmaceuticals Company, both of which make drugs for the rare condition Lambert-Eaton Myasthenic Syndrome. FDA in 2018...