As of FY2023, the FDA has five user fee programs that apply to its life sciences portfolio: PDUFA, MDUFA, GDUFA, BsUFA, and OMUFA. These programs require the FDA to develop new guidance documents, launch pilot programs, deploy technology systems, and hire new staff. The FDA has more than 300 tasks to complete during the authorization periods for these programs.
However, it is difficult to determine whether the FDA has met its user fee obligations. The FDA does not maintain an active list of its obligations, and when information is released, it is often outdated or fragmented.
Despite the challenges in tracking the FDA’s progress, it appears that the agency has mostly met its obligations so far. There are only four commitments that have not been met, all of which are related to the OMUFA program. These commitments involve meeting hiring targets and publishing guidance documents.
To provide an overview of the FDA’s commitments and deliverables, AgencyIQ has compiled a program-by-program analysis. The analysis includes the commitment start date, due date, and a link to AgencyIQ’s analysis of each commitment and deliverable.
For the PDUFA program, some of the commitments include establishing a multi-year modernization roadmap, launching the STAR program, publishing guidance on the use of Digital Health Technologies in clinical trials, and establishing a pilot Advancing RWE Program.
For the MDUFA program, commitments include updating guidance on developing and responding to deficiencies, publishing a 5-year financial plan, finalizing guidance on premarket submissions for device software functions, and enrolling products in a TPLC pilot program.
The GDUFA program also has commitments, including finalizing guidance on controlled correspondence, implementing electronic submission of certain post-approval changes, and implementing changes to the GDUFA fee structure.
The BsUFA program commitments include publishing guidance on the contents and format of biologics license applications, issuing communications to applicants regarding the status of biosimilar applications, and facilitating the development of standards for interchangeability of biosimilars.
Lastly, the OMUFA program commitments involve publishing guidance on product categories and establishing an advisory committee to provide advice on monograph development.
Overall, while the FDA has faced challenges in meeting all of its obligations, it has made progress in most areas. By providing a comprehensive analysis of the FDA’s commitments and deliverables, AgencyIQ aims to shed light on how the FDA is fulfilling its user fee obligations.
