Washington, DC (January 13, 2012)- Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on the transmission of the Prescription Drug User Fee Act (PDUFA) V recommendations by the Secretary of Health and Human Services to Congress today:
“Since PDUFA was enacted in 1992, it has contributed to the approval of more than 1,200 new medicines and initially reduced review times for the newest, most innovative drugs by more than a year. BIO strongly supports the PDUFA V recommendations as they will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. Most importantly, PDUFA V will provide patients and doctors with earlier access to innovative new therapies.
“In light of the scientific and regulatory complexities of modern drug development, the PDUFA V recommendations include a set of enhancements that seek to reinforce FDA’s review performance and get back-to-basics for patients with the goal of minimizing development and review issues that can delay patient access to needed treatments.
“PDUFA V also makes new resources available to modernize regulatory science in the areas of personalized medicine and rare disease drug research. Importantly, it will enable the FDA to conduct outreach to patients to better understand their perspectives on disease severity and unmet medical need.
“In the agreement, industry reinforced our commitment to a well-funded drug and biologics program that supports sound, science-based regulation consistent with FDA’s public health mission. However, user fees currently account for nearly two-thirds of the cost of human drug review. These user fees are intended to support limited FDA activities around the drug review process and were never intended to supplant a sound base of appropriations. We urge Congress to support FDA’s mission and fully fund the Agency through the appropriations process.
“BIO looks forward to working with Congress and FDA to fully implement the enhancements contained in PDUFA V in a timely manner. We share the goals of providing new medical therapies to patients more quickly and retaining the nation’s global leadership in innovation in health care.”