I am pleased to present to the President and Congress the Food and Drug Administration’s (FDA or the Agency) Fiscal Year (FY) 2015 Prescription Drug User Fee Act (PDUFA) Performance Report. This report marks the 23rd year of PDUFA and the third year of PDUFA V (FY 2013 through FY 2017).
This report presents updated data on FDA’s progress in meeting FY 2014 performance goals, preliminary data on meeting FY 2015 review performance goals, and other commitments under PDUFA V as of September 30, 2015.
One of the key programs under PDUFA V has been the new molecular entity (NME) review program. As of September 30, 2015, FDA has received more than 160 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 2014 program cohort is nearly closed, with 96 percent of applications acted on within the goal date. The FY 2015 program cohort has received 59 applications and, as of the end of FY 2015, 100 percent of actions taken on applications within this cohort met 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. FDA continued improving performance for procedural goals in FY 2015, and the Agency will continue to strengthen efforts to improve performance in these areas 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.
Robert M. Califf, M.D.
Acting Commissioner of Food and Drugs