The Prescription Drug User Fee Act of 1992 (PDUFA), Biosimilar User Fee Act of 2012 (BsUFA), and Generic Drug User Fee Amendments of 2012 (GDUFA) authorize FDA to collect user fees from industry to support activities related to the review of certain human medical product submissions. These user fee programs have expanded in scope since their origination, and the growing volume and scientific complexity of product submissions has led to increased resource demands on the agency.
To address this need, FDA committed under PDUFA VI, BsUFA II, and GDUFA II to establish a resource capacity planning (RCP) capability and to modernize its time reporting to better anticipate and address resource demands in the user fee programs. RCP is a systematic approach to quantifying the number and type of resources needed to optimally address forecasted workload. Modernized time reporting was implemented in the Center for Biologics Evaluation and Research (CBER) in 2018, the Center for Drug Evaluation and Research (CDER) in 2019, and the Office of Regulatory Affairs (ORA) in 2021. The initial RCP capability was established in CDER and CBER in 2020.
Together, the RCP and modernized time reporting capabilities enabled FDA to implement its Capacity Planning Adjustment (CPA) methodology, which adjusts user fee revenues to account for changes in resource needs. The CPA methodology uses forecasting to help FDA anticipate staffing needs in order to have resources in place to complete timely review of incoming submissions. The CPA was first implemented for adjusting FY 2021 fees for PDUFA and BsUFA. The authorization of GDUFA III includes a provision providing for a CPA for the GDUFA program beginning with the setting of FY 2024 fees. With this expansion of the CPA to GDUFA, these capabilities are being extended or established, as warranted, across CDER and ORA.
The Resource Capacity Planning and Modernized Time Reporting Implementation Plan (March 2023) outlines FDA’s approach to maturing its RCP capability during PDUFA VII, BsUFA III, and GDUFA III (i.e., FY 2023–2027) per the commitments in each respective commitment letter. The plan describes FDA’s progress to date and the current state of its RCP capability, then describes FDA’s areas of focus for further development of this capability over the next five years. By implementing the approach to RCP maturation outlined in this plan, FDA expects to help ensure optimal use of user fee resources and to enhance its ability to deliver on its commitments to the public.