Prescription Drug User Fee Act and Foreign Manufacturers: What PDUFA Fees Mean for Market Entry

The Prescription Drug User Fee Act (PDUFA) is one of several user fee programs that fund the FDA's drug review activities, and its fee structure directly affects every foreign manufacturer that registers a drug establishment or submits a drug application to the FDA. First enacted in 1992 and reauthorized multiple times (most recently as PDUFA VII in 2022), PDUFA requires pharmaceutical manufacturers to pay application fees when submitting NDAs and BLAs, establishment fees for each registered manufacturing facility, and product fees for each approved prescription drug product. For foreign drug manufacturers, these fees represent a significant and recurring cost of US market participation that must be factored into the business case for entering the American pharmaceutical market.

Types of PDUFA fees

PDUFA imposes three categories of fees. Application fees are one-time fees paid when submitting a New Drug Application (NDA) or Biologics License Application (BLA) — for fiscal year 2026, the application fee for an NDA requiring clinical data is over $4 million, although the fee is reduced for applications that do not require clinical data and for small businesses. Establishment fees are annual fees assessed on every establishment named in an approved NDA or BLA — these fees apply to each physical facility, so a company with three manufacturing plants pays three establishment fees. Product fees are annual fees assessed on each prescription drug product identified in an approved NDA or BLA. The FDA publishes the exact fee amounts for each fiscal year in the Federal Register.

GDUFA fees for generic drug manufacturers

Generic drug manufacturers are subject to a separate fee structure under the Generic Drug User Fee Amendments (GDUFA) rather than PDUFA. GDUFA fees include ANDA application fees (paid when submitting an Abbreviated New Drug Application for a generic drug), finished dosage form facility fees (for facilities that manufacture finished generic drug products), and API facility fees (for facilities that manufacture active pharmaceutical ingredients referenced in ANDAs). GDUFA fees are generally lower than PDUFA fees but still represent a significant cost — the FY 2026 ANDA application fee, the finished dosage form facility fee, and the API facility fee are each published annually by the FDA. Foreign manufacturers who produce both brand-name and generic drugs may be subject to both PDUFA and GDUFA fees depending on their product portfolio.

Fee payment and consequences of non-payment

PDUFA and GDUFA fees are assessed annually by the FDA, and invoices are sent to each registered establishment and each holder of an approved application. Payment is typically due within 30 days of the invoice date. The consequences of non-payment are severe: the FDA will not accept any drug application from a company that has not paid its required fees, and the FDA may place a hold on the establishment registration of a facility that has not paid its establishment fees. For foreign manufacturers, a registration hold means that the facility's products will be refused entry at US ports until the fees are paid and the hold is lifted. The FDA does not grant extensions or payment plans — fees must be paid in full and on time.

Small business fee waivers and reductions

PDUFA provides limited fee waivers and reductions for small businesses. A small business is defined as a company with fewer than 500 employees, including employees of affiliates. Small businesses that have never had an approved NDA or BLA may be eligible for a first-time application fee waiver. Small businesses that do have approved products may be eligible for reduced fees. The waiver and reduction provisions are detailed in the PDUFA statute and implementing guidance, and companies must apply for these provisions — they are not automatic. For foreign manufacturers, the small business determination includes the employees of the parent company and all affiliates worldwide, not just the employees at the US-facing operation.

How PDUFA and GDUFA fees affect market entry decisions

The annual user fee burden is a significant factor in the decision to enter the US pharmaceutical market. A foreign manufacturer with a single manufacturing facility and a single approved product faces annual establishment and product fees that can total tens of thousands of dollars, plus any applicable application fees for new submissions. For small companies or companies with low-volume products, these fees may represent a disproportionate cost relative to US revenue. Foreign manufacturers should include a detailed fee analysis in their US market entry planning, accounting for application fees, annual establishment fees, annual product fees, and the ongoing registration and renewal costs of maintaining FDA compliance.

How FDABridge helps manage drug fee obligations

FDABridge provides drug establishment registration and US Agent services for foreign drug manufacturers, including guidance on the fee obligations associated with FDA registration. We help our clients understand the applicable fee structure, ensure timely registration to avoid holds, and maintain current establishment information with the FDA. Visit fdabridge.com/drug to see our drug registration services or fdabridge.com/contact to discuss your drug market entry.