PDUFA, GDUFA, BSUFA, and MDUFA - FDA's User Fee Programs

For professionals who are working in drug development areas, the term PDUFA should be a very familiar term. As a matter of fact, FDA's action date or decision date to approve a new drug application (NDA) or biological license application (BLA) is called 'PDUFA date'. There are several trackers to track FDA's calendar for NDA/BLA approvals based on the PSUFA dates. 

PDUFA stands for 'Prescription Drug User Fee Amendments' and it is a program allowing FDA to collect the application fees from the sponsor. The PDUFA was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process. In "Regulatory Education for Industry (REdI) Annual Conference 2022", Dr. Kevin Bugin from FDA presented "PDUFA Overview and Reauthorization".

"Timely review of the safety and effectiveness of the new drug applications and biologics license applications is essential to FDA mission to protect and promote public health. PDUFA is essential to these efforts. In fact, before PSDUFA is enacted in 1992, American's access to innovative new medicines lacked behind other countries. FDA’s premarket review process was unstaffed and unpredictable, and frankly slow. Agency lacks sufficient staff to perform a timely review and lacks in procedures and standards to ensure a rigorous, consistent, and predictable process.

So to tackle these challenges Congress passed PDUFA and this authorized FDA to collect industry user fees to hire additional staff and upgrade its information technology systems, processes, and so on, in return, it committed the agency to timelines for the application review process for new drugs without compromising its high standards for new drug safety efficacy and quality and, over the years as the PDUFA program has been reauthorized now six times going into its seventh time here hopefully there have been additional enhancements."

PDUFA must be reauthorized or renewed by congress every five years. Since its inception in 1992, it has been amended six times and we are now waiting for congress to authorize the 7th amendment (PDUFA VII). Notice that each PDUFA amendment may have its own name associated with it. 

PDUFA I - Original 

PDUFA II - FDAMA (Food and Drug Administration Modernization Act) 

PDUFA III - Public Health Security and Bioterrorism Preparedness and Response Act of 2002

PDUFA IV - FDAAA (Food and Drug Administration Amendments Act of 2007)

PDUFA V - FDASIA (Food and Drug Administration Safety and Innovation Act)

PDUFA VI - FDARA (FDA Reauthorization Act of 2017)

There are several sister programs designed with the same purpose as PDUFA, but for different approval pathways: GDUFA (Generic Drug User Fee Amendment), BSUFA (Biosimilar User Fee Amendment), and MDUFA (Medical Device User Fee Amendment). Recently, PDUFA VII was authorized by congress, and so were these sister programs. 

Along with the approval of PDUFA, GDUFA, BSUFA, and MDUFA, the user fee rates for various types of applications are updated and released by the FDA:

PDUFA: Prescription Drug User Fee Amendments

Prescription Drug User Fee Rates for Fiscal Year 2023

GDUFA: Generic Drug User Fee Amendment

Generic Drug User Fee Rates for Fiscal Year 2023

BSUFA: Biosimilar User Fee Amendment

Biosimilar User Fee Rates for Fiscal Year 2023

MDUFA: Medical Device User Fee Amendment

Medical Device User Fee Rates for Fiscal Year 2023

For companies that are well-funded and have steady revenues, these user fees are affordable. However, these user fees could be a burden for small companies. 

For drug development in diseases with orphan drug designation, the application fees for NDAs or BLAs are waived - this is an approach to encourage the companies to develop the drugs in orphan diseases. 

FDA's guidance "User Fee Waivers, Reductions,and Refunds for Drug andBiological Products" listed the situations where the user fees can be waived.