BIO's Testimony to the Senate Health, Education, Labor, and Pensions Full Committee Hearing on the FY2012 FDA User Fee Agreements

 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name is Sara Radcliffe and I am Executive Vice President for Health for the Biotechnology Industry Organization (BIO). In that role, I have had the opportunity to manage BIO’s involvement in the biosimilars user fee (BsUFA) technical discussions, as well as lead BIO’s engagement in the Prescription Drug User Fee Act (PDUFA) technical discussions with the Food and Drug Administration (FDA).

BIO represents over 1,100 members involved in the research and development of innovative healthcare, agricultural, industrial, and environmental technologies. The U.S. biotechnology industry is poised to be a major driver in an innovation-driven economy. Biotechnology offers real solutions to our most pressing health care needs: curing disease, reducing costs, increasing quality, and ensuring that people enjoy not only longer lives, but better and more productive lives.

I am here today to express BIO’s support for the establishment of the biosimilars user fee program as part of FDA’s ongoing implementation of a well-constructed, science-based pathway for the approval of biosimilar products that protects patient safety and preserves incentives to innovate. BsUFA will provide FDA with the resources and capacity to facilitate the development and evaluation of biosimilars products, while also continuing to prioritize the review of innovative drugs and biologics under PDUFA so that safe and effective new treatments – many for currently untreatable and serious diseases – can be made readily available to patients.