User Fee Reauthorization Act will spur FDA pilot programs
Congress passed the Food and Drug Administration (FDA) User Fee Reauthorization Act of 2022. This legislation applies to fees associated with the following acts: Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDFUA), and Biosimilar User Fee Act (BSUFA).
With this user fee reauthorization medical product review programs will have continuity in regards to staffing, performance, and accountability. Industry stakeholders believe that with this continuity, financial transparency, program improvements, hiring, and retention will be supported.
Created in 1992, PDUFA provides the FDA with consistent funding and the reauthorization in 2022 means that the funding will continue during fiscal years 2023-2027.
With the reauthorization of PDUFA the administration ensures that it will have the capacity to review new and innovative products to advance its drug review program.
The FDA made a statement that with this reauthorization there will be a program to support drug development for rare diseases. As well as a program to generate real-world evidence (RWE) to meet regulatory requirements.
Additionally, the FDA will pilot the Split Real Time Application Review (STAR) program to provide earlier patient access to therapies. STAR reduces time from the date of complete submission to action date.
Funding from this legislation can support investments in program infrastructure like that of information technology modernization and bioinformatics.
GDFUA, enacted in 2012, will provide funding to expand and modernize the generic drug regulatory review process by providing resources for regular inspections of entities involved in generic drug manufacturing.
GDUFA III, the reauthorization in 2022, is intended to reduce the number of assessment cycles for abbreviated new drug applications. It will additionally facilitate access to generic medicines which the FDA has taken actions to bolster.
This legislation also holds enhancements designed to foster the development, assessment, and approval of complex generic products. These products are often more difficult to develop and have an available generic option.
Additional opportunities to facilitate reviews of complex generics applications, and regulatory feedback through expanded use of controlled correspondence are included in GDUFA III.
Reauthorization of BsUFA, BsUFA III, includes a pilot new regulatory science program to further advance the development of interchangeable biosimilar products.
This legislation does not include the policy reforms that industry stakeholders view as key public health reforms needed to modernize the FDA’s regulatory process.
The FDA stated that it will continue efforts to bring these reforms through congress by the year of 2022.