Orrin Hatch: “I rise in support of S. 1082, the Food and Drug Administration Revitalization Act. This legislation addresses many…”

“I rise in support of S. 1082, the Food and Drug Administration Revitalization Act. This legislation addresses many critical issues, including the need for provide proper incentives and support for the development and review of pharmaceuticals and medical devices, including products for children, and the need for heightened efforts to assure the safety of medications. As we debate this legislation, let us remember we all have the same goals in mind. We want Americans to benefit from life-saving, life-enhancing drug and device products. We want Americans to have access to drugs that are safe and effective. We want Americans to have all the relevant safety information available on their drugs. And, indeed, we want Americans to know that the Food and Drug Administration, the agency responsible for ensuring drug and device safety, has the resources to do its job. That is what this bill is all about protecting Americans and giving the FDA the tools to do its job. The legislation before us reauthorizes both the Prescription Drug User Fee Act, better known as PDUFA, and the Medical Device User Modernization Fee Act, better known as MDUFMA.”