Washington, D.C. (June 21, 2012) – BIO commends the House of Representatives for its unanimous approval of S. 3187, the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA).
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) in reconciling the differences between the user fee packages adopted by the two Chambers and for securing unanimous approval in the House.
FDASIA reflects the enhancements to PDUFA agreed upon by industry and the U.S. Food and Drug Administration (FDA). It 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 FDA’s 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 drugs available to the American public in a timely manner.
The enhanced Accelerated Approval and breakthrough therapy 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.
We are pleased that Congress is on track to send the legislation to the President for his signature into law well in advance of the expiration of PDUFA IV in September. This is critical in order to avoid a reduction in force at the FDA which would be devastating to the Agency’s public health mission and its ability to review new drugs and biologics.
Finally, BIO 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.