Washington, D.C. (May 24, 2012) – BIO commends the bipartisan Senate approval of FDASIA, which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA).
In particular, we appreciate the leadership shown by Chairman Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) to craft a bipartisan measure which will continue to ensure patient safety, access to the newest cures and therapies, and job growth in America. 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.
The inclusion of an enhanced Accelerated Approval pathway, crafted by Senator Kay Hagan (D-NC), 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. Senator Hagan is to be congratulated for her hard work and leadership on this very important provision.
FDASIA also enables a transparent, predictable and balanced regulatory framework for the review and approval of biosimilars by establishing reasonable performance goals and dedicated, independent funding for biosimilar review activities. This will allow the FDA to continue to prioritize the review of innovative drugs and biologics so that safe and effective new therapies – many for currently serious, untreatable diseases – can be available to the patients who need them.
BIO strongly supports the inclusion of the permanent reauthorization of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act. The provisions included 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 greatly appreciate the Senate defeat of amendments which would have threatened final approval of FDASIA, including an amendment which would have slowed the FDA’s consideration of genetically-modified salmon. We thank Senators Pat Roberts (R-KS), John Kerry (D-MA) and Scott Brown (R-MA) for working to defeat this amendment. BIO also appreciates the Senate defeat of amendments pertaining to patent settlements, importation, and the elimination of innovator data protections.
We look forward to working with Senate and House leaders as they continue their work on PDUFA reauthorization, in order to address differences between the two bills and to ensure final passage of a package which meets with overwhelming bipartisan approval. Timely reauthorization, well in advance of the expiration of PDUFA IV in September, is critical in order to avoid a reduction in force at the FDA. Even the threat of a downsizing would be devastating to the Agency’s public health mission and its ability to review new drugs and biologics.