Acting Commissioner’s Report
I am pleased to present to Congress the Food and Drug Administration’s (FDA or the Agency) Fiscal Year (FY) 2016 Prescription Drug User Fee Act (PDUFA) Performance Report. This report marks the 24th year of PDUFA and the 4th year of PDUFA V (FY 2013 through FY 2017).
This report presents updated data on FDA’s progress in meeting FY 2015 performance goals, preliminary data on meeting FY 2016 review performance goals, and other commitments under PDUFA V as of September 30, 2016.
One of the key programs under PDUFA V has been the Enhanced Review Transparency and Communication for NME NDAs and Original BLAs (the Program). As of September 30, 2016, FDA has received 218 applications through this Program since its inception, which involves more communication and transparency between the applicant and FDA review team during review of the marketing application. The FY 2015 Program cohort is nearly closed, with 95 percent of applications acted on within the goal date, and one additional application pending within goal. The FY 2016 Program cohort has received 43 applications to date. While most of these applications are still under review and within their PDUFA goal date, those applications that received a first cycle action by September 30, 2016, all were acted on within the goal date. FDA will continue to focus on these highly innovative products that represent important new medicines for the American people.
We are committed to meeting all PDUFA performance goals related to human drug review. In FY 2016, the Agency engaged in sustained efforts to recruit and hire new talent for the human drug review program to better enable FDA to meet increasing demands on the program, particularly in the area of meeting management goals. Moving forward into FY 2017, FDA will continue to enhance the program’s staffing in addition to strengthening our efforts to improve program performance while maintaining a focus on ensuring that safe, effective, and high-quality new drugs and biologics are reviewed in an efficient and predictable time frame.
Stephen M. Ostroff, M.D.
Acting Commissioner of Food and Drugs