FDA's GDUFA IV Plan Would Raise Foreign Drug Fees

FDA's opening bid for the next five years of generic-drug review economics leans hard into onshoring. The draft GDUFA IV commitment letter, published 11 August 2026, proposes the first increase to the foreign facility fee differential since the program began in 2013 — and a three-year fee holiday for sponsors who build manufacturing capacity in the United States. FDA has set a hybrid public meeting for 17 September.

One of four fee programs racing the same deadline

GDUFA is one of four human medical product user-fee programs — alongside the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Amendments (MDUFA), and the Biosimilar User Fee Act (BsUFA) — that Congress reauthorizes together roughly every five years. All four expire on 30 September 2027, and FDA has run their public-meeting processes back to back this summer: MDUFA VI's draft commitment letter on 8 July, GDUFA IV's on 11 August, and PDUFA VIII's on 14 August. GDUFA funds the bulk of FDA's generic-drug review staff; miss the deadline and the Office of Generic Drugs loses that funding on 1 October 2027 regardless of what happens to the other three programs.

The foreign fee goes up for the first time

GDUFA charges facilities a base fee plus a differential for foreign sites — API manufacturers, finished-dosage-form makers, and contract manufacturing organizations located outside the US pay more than domestic ones doing the same work. That differential has sat at $15,000 since GDUFA's first authorization in FY 2013. The draft GDUFA IV letter proposes raising it to $25,000 starting FY 2028, a 67 percent increase FDA and industry negotiators frame as correcting more than a decade of inflation-adjusted erosion, and as one lever among several 2026 user-fee negotiations aimed at shifting manufacturing economics toward the US — a priority that also shows up in PDUFA VIII's proposed discount for US-run Phase 1 trials.

A three-year fee holiday for new US plants

The more direct incentive sits on the other side of the ledger: a proposed statutory amendment waiving ANDA submission fees and facility fees for the first three years for sponsors that establish new manufacturing of finished generic drugs or active pharmaceutical ingredients on US soil. Paired with the foreign differential increase, the package pushes on both ends of a sponsor's siting decision at once — a bigger penalty for staying offshore, a multi-year subsidy for building here. Neither change takes effect on its own; both require Congress to amend the FD&C Act as part of the final reauthorization.

The rest of the package

• Program efficiency: the commitment letter proposes four new meeting types between applicants and FDA, aimed at resolving deficiencies earlier in the ANDA review cycle rather than through additional review cycles.
• Advance approvals: changes to how FDA handles facility-related advance approvals ahead of a full ANDA submission, intended to reduce duplicate facility assessments across related applications.
• Fee waivers for API-only US sourcing: a separate proposed waiver for ANDA submission fees when a sponsor uses exclusively US-based finished-dosage-form manufacturers and API suppliers, distinct from the three-year new-facility holiday.
• Data processing: commitments to modernize how FDA processes facility and product data submitted under GDUFA, an infrastructure line item that mirrors similar commitments in the MDUFA VI and PDUFA VIII letters.

What is not settled

Everything here is a draft twice over. FDA can revise the recommendations after the 17 September meeting and the comment period that follows, and Congress still has to legislate both the foreign differential increase and the new-facility fee waiver — neither changes the fee schedule until the FD&C Act is amended. The notice does not set the base GDUFA fee amounts for FY 2028 onward; those arrive with the final commitment letter. What is fixed is the calendar: GDUFA III authority expires 30 September 2027, and FDA is running all four fee-program reauthorizations toward that same line.