FDA Pushes for Onshoring and Improved Data Fidelity in Generic Drug User Fee (GDUFA IV) Negotiations

The FDA is in the midst of negotiating the fourth cycle of the Generic Drug User Fee Amendments (GDUFA IV), covering fiscal years 2028-2032, with a public kickoff meeting held in July 2025 and ongoing monthly stakeholder meetings1 5 9.

A major focus of these talks is on incentives for onshoring:
the FDA has introduced a new pilot program giving priority review to generic drug applications that use U.S.-based manufacturing and testing, aiming to reduce the nation's reliance on foreign suppliers and speed up domestic drug approval processes4.

To qualify for this pilot, applicants must show pivotal bioequivalence testing and finished dosage form manufacturing are performed in the U.S., and that active pharmaceutical ingredients (APIs) are sourced domestically4.

The FDA is also proposing the 'PreCheck' program, which would enable companies to submit comprehensive facility data up front. This aims to improve inspection readiness, address quality issues earlier, and facilitate faster, more reliable approval decisions—directly improving data 'fidelity' and transparency in drug manufacturing processes4.

Discussions around user fee structures and updates aim to ensure the financial stability and operational predictability of the generic drug review program, with proposals to further standardize fee collection and enhance program performance measures1 7.

Public and advocacy groups have called for more input into GDUFA performance metrics, urging the FDA to prioritize safety, efficacy, and meaningful quality measures—topics closely tied to concerns about data reliability and the real-world performance of generic drugs3.