BIO Commends Senate for Approval of User Fee Package

FDASIA headed to President for signature into law

WASHINGTON--()--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.”

About BIO

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.” Subscribe to BIOtechNOW.

Upcoming BIO Events

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


Biotechnology Industry Organization
Stephanie Fischer, 202-312-9263


Biotechnology Industry Organization
Stephanie Fischer, 202-312-9263