The U.S. Food and Drug Administration (FDA) is recommending statutory changes to increase the foreign fee differential from $15,000 to $25,000 starting in fiscal year 2028 for all foreign active pharmaceutical ingredient (API), finished dosage form (FDF), and contract manufacturing organization facilities.

After months of negotiations with industry, the agency made the proposal as part of its commitment letter for the Generic Drug User Fee Amendments (GDUFA IV) program for fiscal years 2028 to 2032. The current legislative authority for GDUFA III is set to expire at the end of September 2027 and must be reauthorized by Congress.

GDUFA authorizes the FDA to assess and collect user fees supporting generic drug activities, including those activities necessary for the review of generic drug applications and Type II API drug master files (DMFs), as well as conducting inspections related to generic drugs.

“The proposed enhancements for GDUFA IV address many of the top priorities identified by FDA, the regulated industry, and other stakeholders,” the agency said in a Federal Register notice published on Tuesday. “These include proposed program enhancements to stabilize fee revenue, advance approvals in fewer review cycles, improve program efficiency, enhance processes around complex data issues, and provide mechanisms to facilitate onshoring of generic drug manufacturing.”

The FDA’s notice says it is committed to encouraging domestic generic drug manufacturing to reduce supply chain risk as part of the Trump administration’s onshoring objectives, which include a May 2025 executive order meant to boost U.S. manufacturing of essential medicines.

The FDA’s commitment letter also proposes statutory amendments for a one-time application fee waiver for an original Abbreviated New Drug Application (ANDA) submission fee if a domestic applicant satisfies the proposed requirements of having the application identify only facilities located in the U.S. as both the FDF manufacturer and the API supplier.

In addition, the agency is proposing that existing U.S. generic API and FDF facilities without recent inspection history can request an inspection 24 months in advance of a planned DMF or ANDA submission.

The FDA will hold a public meeting on September 17 to discuss these proposed recommendations — and others — for the reauthorization of the GDUFA program. After the public meeting, the agency said it will revise the recommendations as necessary and present the final proposed recommendations to Congress. The new iteration of GDUFA IV would then take effect on October 1, 2028.

All of this comes as President Trump last month said in a social media post that all generic drugs imported to the U.S. will be tariff-free for another two years — after which a 100% tariff would be imposed, and a 200% tariff will kick in one year later. It’s a policy reversal that could have dire effects for America’s drug supply chain, which relies on low-cost generics manufactured in other countries.