Chairman Upton and Pitts, Ranking Member Waxman and Pallone, 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 led BIO’s engagement in the Prescription Drug User Fee Act (PDUFA) technical discussions with the Food and Drug Administration (FDA) and managed BIO’s involvement in the biosimilars user fee (BsUFA) technical discussions.
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.
PDUFA V: GETTING BACK TO BASICS FOR PATIENTS
BIO supports quick enactment of the PDUFA V recommendations as we believe they can enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. Most importantly, from the standpoint of young, innovative companies, our hope is that PDUFA V will provide patients and doctors with earlier access to breakthrough therapies.
When we began the process of organizing for our discussions of PDUFA V, we in the industry started with a simple set of principles that could provide the foundation for our discussions with FDA and other stakeholders. These were that a science-based, transparent, and well-managed review process that appropriately balances benefits and risks can enhance public trust and increase patient access to new medicines.