The Discussion on PDUFA VI Begins


This week kicks off the first of a series of public forums on the Prescription Drug User Fee Act (PDUFA), the legislation that provides the Food and Drug Administration (FDA) with funding and resources. By design, Congress must review and approve PDUFA every five years--and since PDUFA will be up for renewal in 2017, it's time to start discussing what the next version will include.

These meetings will provide an opportunity for industry, patients, and advocacy groups--including you!--to voice opinions, share concerns, and tell the FDA what should be reflected in the new legislation. Public input will help the FDA assess how effective PDUFA has been, determine which parts of the bill work and learn what might need to be added.

An effective PDUFA helps the FDA evaluate new medicines in a way that's as streamlined, transparent and efficient as possible. Congress initially passed PDUFA in 1992 and its effect was immediate. Within the first 10 years, median review time for standard-application medicines dropped from almost two years to just 13 months. That means that Americans in need of innovative new medicines have had speedier access to the treatments that could help--or even save--their lives.

PDUFA V, the fifth and current version of the act, passed with overwhelming support from the House and Senate in 2012. The revised legislation amplified the voices of patients through a revamped benefit/risk analysis and the Patient Focused Drug Development Initiative. Previous bills have focused on areas such as transparency and safety monitoring initiatives-- issues that were raised through public dialogue with the FDA. It's my hope that the next version of PDUFA will be just as patient-focused--and I'm excited to see what attendees at this week's meeting have to say.

Registration for the first meeting has closed, but you can still participate via the live webcast. Every five years, you get an opportunity to improve how you access the treatments you need. Your next chance begins today.