The U.S. Food and Drug Administration (FDA) has taken the first steps toward reauthorizing the Prescription Drug User Fee Act (PDUFA) by announcing a hybrid public meeting scheduled for July 14, 2025, and releasing an independent assessment report on product quality communications.
The current authorization, PDUFA VII, is set to expire in September 2027. Without reauthorization, FDA would lose a critical funding source that supports the human drug review process across multiple agency components, including the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Public Meeting to Gather Stakeholder Input
As required by Section 736B(f)(2) of the Federal Food, Drug, and Cosmetic Act, FDA must hold a public meeting before beginning negotiations with industry on PDUFA reauthorization. The upcoming meeting will allow stakeholders to present their views on the program's performance and suggest potential changes.
"We're particularly interested in stakeholder assessment of PDUFA VII's performance thus far, which features should be reduced or discontinued, and what new elements might enhance the efficiency and effectiveness of the human drug review process," said an FDA spokesperson.
Registration for the meeting is free for both in-person and virtual attendance, though in-person space is limited. Those wishing to provide public comments during the meeting must register by June 16, 2025, and submit their request to speak by June 30, 2025.
Independent Assessment of Communication Practices
Concurrent with the reauthorization announcement, FDA has released the "Product Quality Information Request Communications Assessment: Final Report," which evaluates current practices in communicating through product quality information requests (IRs) during application review.
The assessment, conducted by an independent third party as part of FDA's PDUFA VII commitments, examined the effectiveness of the "Four-Part Harmony" framework used in product quality IRs. This framework requires communications to include: (1) what was provided, (2) what is the issue or deficiency, (3) what is needed, and (4) why it is needed.
FDA is now seeking public comment on the assessment findings and recommendations, asking stakeholders to indicate which recommendations they find most desirable and suggest additional actions the agency and applicants should consider.
Evolution of PDUFA Through Seven Cycles
Since its initial enactment in 1992, PDUFA has undergone significant evolution through seven reauthorization cycles, each adding new features to improve the drug review process.
PDUFA VII, authorized in 2022 under the FDA User Fee Reauthorization Act, introduced several enhancements to address changes in the drug development landscape:
- Strengthened staff capacity for cell and gene therapy product review
- Incorporated allergenic extract products into the program
- Established timelines for pre-approval review of postmarketing requirements
- Created new meeting types (Type D and INTERACT) for focused discussions
- Launched four pilot programs targeting rare diseases, real-world evidence, manufacturing, and drugs for unmet therapeutic areas
- Enhanced product quality reviews and innovative manufacturing technologies
"PDUFA has transformed FDA's human drug review process since its inception," noted a senior FDA official. "Each reauthorization has built upon previous successes while addressing emerging challenges in drug development and regulation."
Financial Structure and Resource Management
PDUFA VII continued the modernized fee structure introduced in PDUFA VI, which eliminated supplement fees, replaced establishment and product fees with a program fee, and shifted more revenue to the annual program fee for greater stability.
The current authorization also includes commitments to enhance management of user fee resources through resource capacity planning and financial transparency activities.
Looking Toward PDUFA VIII
As FDA begins the reauthorization process, the agency is seeking input on four key questions:
- Assessment of PDUFA VII's performance
- Which current features should be reduced or discontinued
- What new features should be added
- What changes to fee structures and amounts might better advance program goals
Stakeholders can provide comments at the public meeting or submit written comments during the 30-day period following the meeting. FDA will publish all comments on its website as required by law.
The reauthorization process typically involves negotiations with industry representatives and consultations with various stakeholders, including patient advocates, consumer advocates, and healthcare professionals, before a proposal is submitted to Congress for legislative action.
"The reauthorization of PDUFA is critical to ensuring FDA can continue its vital work in bringing safe and effective therapies to patients in a timely manner," the FDA spokesperson emphasized. "Stakeholder input is essential to shaping a program that meets the evolving needs of patients, industry, and the public health community."
