During discussions with the regulated industry in preparation for the sixth PDUFA reauthorization (PDUFA VI) and the second BsUFA reauthorization (BsUFA II), the efficiency and effectiveness of FDA human resource operations was identified as a potential impediment to regulatory effectiveness. To speed and improve development of safe and effective new therapies for patients, enhancements to the human drug review process require that FDA hire and retain sufficient numbers and types of technical and scientific experts to efficiently conduct reviews of human drug applications.
FDA committed to a comprehensive and continuous assessment of Human Resources operations supporting the human drug review program by a qualified, independent contractor with expertise in assessing HR operations and transformation.
FDA contracted Booz Allen Hamilton (BAH) as a qualified, independent contractor to conduct a comprehensive interim review of FDA hiring and retention processes.
Below please find the BAH’s evaluation report as well as FDA’s management response. FDA also plans to hold a virtual public meeting on July 30, 2020 to share high-level findings in the report.