Statement by Research!America President and CEO Mary Woolley on 21st Century Cures Initiative Discussion Draft
The release of the 21st Century Cures discussion draft is a sign that innovative ideas to speed the delivery of lifesaving treatments to patients are being actively considered by Congress. We applaud the extraordinary commitment of Congressman Fred Upton (R-MI), Congresswoman Diana DeGette (D-CO) and their respective staff members, and the many policymakers from both sides of the aisle who have weighed in. We urge them to work together to translate their common goals into responsible action. The draft bill, now officially in the public domain for additional input and modification, could be a game-changer for the medical innovation ecosystem. We expect that its final provisions will be consistent with the frame of the initiative - "Discovery, Development and Delivery" - and touch on all phases of the research and development pipeline - from basic and applied research, to FDA review, to coverage and access.
Among the provisions Research!America is promulgating is a measure to reduce the administrative burden on researchers. Several other provisions we are glad to see included are those to streamline the institutional review board process for clinical trials conducted at multiple sites, foster data sharing, incorporate patients' perspectives in the regulatory process, and explore strategies to accelerate the pace in which new medical devices reach patients. Another of our priorities is to ensure relevant agencies, including the National Institutes of Health and the Food and Drug Administration, receive the additional resources necessary to carry out the tasks and responsibilities noted in the discussion draft. We look forward to working with the 21st Century Cures team, along with patient groups, academia and industry, to boost our nation's commitment to groundbreaking research and innovation.