PDUFA Extension Adds More than Funding

The expiring Prescription Drug User Fee Act (PDUFA) has been reauthorized and expanded. For the first time, the bill provides a mechanism for risk management planning. The new PDUFA also requires FDA to turn to independent consultants to help resolve disputes over Phase III trial design. At a time when managerial issues at the FDA seem to have raised the level of uncertainty, the new PDUFA rules could prove a welcome measure of predictability.