James M. Jeffords: “This legislation to modernize the Food and Drug Administration and reauthorize the Prescription Drug User Fee Act will…”

“This legislation to modernize the Food and Drug Administration and reauthorize the Prescription Drug User Fee Act will, upon enactment, streamline the FDA's regulatory procedures. This modernizing 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 still attempting to block this bill. I am especially chagrined given the months of bipartisan negotiating that have led to this bill. Each major provision--every drug issue and all but one medical device provision of this measure, represents long-sought agreements with the minority and with the FDA itself. We have made significant concessions on the uniformity provision objected to by the Senator from Massachusetts to ensure that a State may act on cosmetic safety issues in the absence of FDA action. I do not understand this continued objection and delay.”