FDA Begins Preparation for GDUFA IV Reauthorization: Generic Drug User Fee Program 2028-2032

Key Takeaways

• FDA has begun preliminary work on GDUFA IV reauthorization for fiscal years 2028-2032
• The reauthorization will determine generic drug user fee structure and FDA performance commitments for the next five years
• Stakeholder engagement and public input will be critical components of the reauthorization process over the coming years

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FDA Launches GDUFA IV Preparation Phase

The U.S. Food and Drug Administration has initiated preliminary preparations for the fourth reauthorization of the Generic Drug User Fee Amendments (GDUFA IV), which will govern the agency’s generic drug review program from fiscal years 2028 through 2032.

Background on GDUFA Program

The Generic Drug User Fee Amendments program, first enacted in 2012, allows FDA to collect fees from generic drug manufacturers to fund the review of abbreviated new drug applications (ANDAs). These user fees have significantly enhanced FDA’s capacity to review generic drug applications and reduce approval timelines.

The current GDUFA III program, covering fiscal years 2023-2027, established performance goals for ANDA review times and set user fee rates that generate approximately $493 million annually for FDA’s generic drug program.

What’s at Stake for GDUFA IV

The upcoming reauthorization will determine several critical elements:

• User fee structure and rates for generic drug manufacturers
• Performance commitments for ANDA review timelines
• Resource allocation for FDA’s Office of Generic Drugs
• Program enhancements to address emerging challenges in generic drug development

Industry Impact and Timeline

The reauthorization process typically involves extensive stakeholder consultation, including public meetings with industry representatives, patient advocacy groups, and healthcare professionals. These discussions help shape the program’s priorities and performance metrics.

Generic drugs represent approximately 90% of prescriptions filled in the United States, making the GDUFA program essential for maintaining access to affordable medications. The program’s success has contributed to consistent growth in generic drug approvals, with FDA approving over 1,000 ANDAs annually in recent years.

Next Steps

FDA will release additional information about the GDUFA IV reauthorization process as it becomes available, including timelines for stakeholder meetings and opportunities for public input. The agency must submit its reauthorization proposal to Congress well in advance of the September 2027 expiration of GDUFA III.

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Frequently Asked Questions

What is GDUFA and why does it need reauthorization?

GDUFA is the Generic Drug User Fee Amendments program that allows FDA to collect fees from generic drug companies to fund application reviews. It requires congressional reauthorization every five years to continue operating.

How will GDUFA IV affect generic drug availability?

GDUFA IV will determine FDA’s resources and performance goals for reviewing generic drug applications from 2028-2032, directly impacting how quickly new generic medications reach patients.

When will stakeholders be able to provide input on GDUFA IV?

FDA will announce opportunities for stakeholder engagement and public meetings as the reauthorization process develops over the coming years, with formal proceedings expected to begin in the next 1-2 years.