FDA is committed to ensuring user fee resources are administered, allocated, and reported in an efficient and transparent manner. Under PDUFA VI, BsUFA II, and GDUFA II, FDA committed to evaluating the financial administration of these user fee programs to help identify areas to enhance efficiency. This included a commitment to contract with an independent third party to conduct an evaluation of PDUFA, BsUFA, and GDUFA program resource management during FY 2018. Details of these commitments can be found in the respective program commitment letters.
FDA contracted through The Centers for Medicare & Medicaid Services (CMS) Alliance to Modernize Healthcare federally funded research and development center (the Health FFRDC), operated by The MITRE Corporation (MITRE) and teamed with Grant Thornton LLP (an Alliance Partner) to prepare and deliver this fiscal year (FY) 2018 financial management evaluation for human drug user fees.
Below please find the Health FFRDC’s evaluation report as well as FDA’s management response.