Booz Allen Hamilton provides results of independent study on FDA’s PDUFA and BsUFA capacity planning adjustment methodology

Booz Allen Hamilton provides results of independent study on FDA’s PDUFA and BsUFA capacity planning adjustment methodology

Today, the U.S. Food and Drug Administration (FDA) posted the results of Booz Allen Hamilton’s study of the Agency’s Capacity Planning Adjustment (CPA) methodology for the Prescription Drug User Fee Act (PDUFA) VI and Biosimilar User Fee Act (BsUFA) II programs. The study was commissioned as part of the FDA Reauthorization Act of 2017, which required FDA to obtain an evaluation and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the human drug review and biosimilar programs before the end of FY 2020.

Booz Allen’s evaluation found that FDA’s proposed CPA methodology aligns with the objective to develop a methodology accounting for sustained increases in PDUFA and BsUFA resource needs to perform reviews. FDA’s proposed CPA methodology also addresses key issues stemming from the Agency’s current workload and resource adjustment methodology. Booz Allen additionally developed recommendations that FDA may consider when the proposed CPA methodology matures.

Following review of the study’s results and public comments, FDA will implement new methods for assessing resource needs of the PDUFA VI & BsUFA II programs to include adopting a new CPA methodology.

The full study is available on FDA’s website. Public comments and suggestions on the study’s results will be accepted for 30 days under Federal Register Docket No.: FDA-2020-N-0989.