FDASIA headed to President for signature into law
Washington, D.C. (June 26, 2012) –Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on passage of S. 3187, the Food and Drug Administration Safety and Innovation Act (FDASIA), by the U.S. Senate:
“We are pleased that Congress was able to move quickly to consider, pass, and send this legislation to the President for his signature well in advance of the expiration of the Prescription Drug User Fee Act (PDUFA IV) at the end of September.
“We appreciate the leadership of Senate Health, Education, Labor and Pensions Committee Chair Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) as well as of House Energy and Commerce Committee Chair Fred Upton (R-MI) and Ranking Member Henry Waxman (D-CA) for securing approval in both Chambers.
“FDASIA reflects enhancements to PDUFA that were widely and strongly supported by stakeholders. The legislation will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review. It will also increase the Food and Drug Administration’s (FDA) access to external expertise to improve the drug review process.
"FDASIA will foster timely interactive communication with sponsors during the drug development phase as a core Agency activity to facilitate the conduct of efficient and effective drug development programs and help make safe and effective medicines available to Americans in a timely manner.
“Further, the enhanced Accelerated Approval pathway will help expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases while preserving the FDA’s robust standards for safety and effectiveness.
“The inclusion of the permanent reauthorization of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act in FDASIA will encourage continued investment in pediatric research and help ensure that new drugs and biologics can be used safely and appropriately in pediatric patients.
“BIO looks forward to working with the FDA on the implementation of FDASIA, and we will continue to work with Congress on the creation of a uniform national standard for pharmaceutical product traceability to preserve patient access to safe medicines.”