For Immediate Release
www.bio.org Stephanie Fischer
202-312-9263 or email@example.com
BIO Lauds Senate Passage of User Fee Package
Washington, D.C. (May 24, 2012) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement in support of the U.S. Senate’s approval of the Food and Drug Administration Safety and Innovation Act (FDASIA):
“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 the 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.”
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIO produces BIOtechNOW, an online portal and monthly newsletter chronicling “innovations transforming our world.”
Upcoming BIO Events
2012 BIO International Convention June 18-21, 2012 Boston, MA
BIO Business Forum June 18 – 21, 2012 Boston, MA
BIO India International Conference September 12 – 13, 2012 Mumbai, India
Livestock Biotech Summit September 19 – 21, 2012 Kansas City, MO
BIO Investor Forum October 9-10, 2012 San Francisco, CA
Pacific Rim Summit on Industrial Biotechnology and Bioenergy October 10 – 12, 2012 Vancouver, Canada
The BIO Convention in China October 24 – 25, 2012 Shanghai, China