Washington, D.C. (July 9, 2012) The signing of Food and Drug Administration Safety and Innovation Act (FDASIA) into law today represents the culmination of a year of true collaboration for the best interests of patients.
The open, inclusive and constructive dialogue during the formative stages of the fifth Prescription Drug User Fee Act (PDUFA) reauthorization that was led by the Food and Drug Administration (FDA) and the Pharmaceutical and Biotech industries should be a model for future efforts. Through a thoughtful and engaging process, the FDA and industry developed an innovative, scientifically rigorous and patient-centered foundation for Congress to build their legislation upon.
The pace and bipartisan fashion which the House and Senate moved this legislation shows their keen understanding of the need for enhanced scientific capacity at the FDA and the urgency that patients across the United States have for new life-saving treatments for diseases like cancer.
We deeply appreciate the members and the staff of Senate Health, Education, Labor and Pensions Committee and House Energy and Commerce Committee for their tireless work on this reauthorization.
We especially applaud HELP Committee Chairman Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) Chairman Fred Upton (R-MI) and Ranking Member Henry Waxman (D-CA) and their staff for the their incredible leadership throughout this process.
We would also like to congratulate Senators Bennet (D-CO) Hatch (R-UT) and Burr (R-NC) and Representatives Bilbray (R-CA) and DeGette (D-CO) for their “Breakthrough Therapy” legislation, which was included in FDASIA. This section of the law establishes a Breakthrough Therapy Designation, will allow the FDA to more actively keep pace with scientific progress, and more quickly engage with developers, ensuring that the most promising new therapies are reaching patients as safely and efficiently as possible.