Isakson Hopes To Attach OTC Fees, Exclusivity To Final User Fee Package

During Thursday's Senate health committee user fee markup, Sen. Johnny Isakson (R-GA) plugged his bipartisan over-the-counter (OTC) monograph reform discussion draft, which would authorize a new FDA user fee program for OTC drugs and provide two years of exclusivity for a drug developer that submits original human data on its drug. While the senator stopped short of introducing the bill as an amendment to the must-pass user fee package, staffers tell Inside Health Policy that the senator is eying...