Chairmen Upton and Pitts, and Ranking Members Waxman and Pallone, it is my privilege to provide testimony before this Subcommittee today. My name is Richard Pops and I am Chairman and CEO of Alkermes. I am here testifying on behalf of the Biotechnology Industry Organization where I serve on BIO’s Health Section Governing Board and coordinated BIO’s strategic engagement in the Prescription Drug User Fee Act (PDUFA V) technical discussions with FDA. BIO represents over 1,100 members involved in the research and development of innovative healthcare, agricultural, industrial, and environmental technologies. As an entrepreneur with more than twenty years experience managing biotechnology companies and successfully developing novel therapies for patients, I would like to speak to the positive impact that the PDUFA program has had on patients and medical innovation, and highlight the challenges we seek to address under PDUFA V.
In short, 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.