James M. Jeffords: “The legislation is to modernize the Food and Drug Administration, and we authorize the Prescription Drug User Fee Act…”

“The legislation is to modernize the Food and Drug Administration, and we authorize the Prescription Drug User Fee Act, which will, upon enactment, streamline the FDA's regulatory procedures. This modernization will help the agency review medical devices and drugs more expeditiously and will let the American public have access sooner to newer, safer and more effective therapeutic products. I am disappointed that some of my Democratic colleagues are not desirous of proceeding at this time, but I will do my best to accommodate them and also to move forward on this bill. I am especially chagrined, given the months of bipartisan negotiating that has led to this bill. Each major provision--all of the drugs and medical device provisions of this measure--represents long-sought agreements with the minority and with the FDA itself. I do not understand this continued delay. In particular, Senator Kennedy has played a key role in reaching this agreement, and I wish to applaud his willingness and tenacity in working through several difficult issues to reach a consensus on this legislation.”