The FDA has announced the costs for applications in fiscal year 2025. Image credit: Shutterstock / grandbrothers.

The US Food and Drug Administration (FDA) has announced the cost to file a drug using clinical data will jump by around $300,000 in 2025 to more than $4.3m.

On 30 July, the agency released its federal docket, Prescription Drug User Fee Rates for Fiscal Year 2025, which outlined the new fees that pharmaceutical companies will face following clinical trials if they hope to get market access.

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Filing for approval with clinical data will cost a sponsor $4.3m while an application that does not require clinical data will cost half of that, just under $2.2m.

These costs have increased by around $300,000, from $4m for a clinical data application in 2024 and by approximately $150,000 for a drug, which does not require clinical data and cost $2m in 2024.

The costs have nearly doubled from figures a decade ago. In 2015, an application requiring clinical data cost $2.3m and an application not requiring clinical data was $1.2m.

Despite the costs increasing for clinical data and non-clinical data applications, the prescription drug program fee cost has lowered from $416,734 in 2024 to $403,889.

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The new fees are effective on October 1, 2024, and will remain in effect until 30 September 2025.

These rates have increased dramatically from those set by the agency last year, with a drug that requires a clinical data fee set at $3.2m and one not requiring data costing around $1.6m. The prescription drug program fee cost in 2023 was $393,933.

The agency predicts it will process 133 new drug applications (NDA) or biologic licence agreements (BLA) in the 2025 fiscal year through the Center for Drug Evaluation and Research (CDER) workforce. The docket also predicts the Center for Biologics Evaluation and Research (CBER) will process 15 NDAs and BLAs in 2025.

The FDA estimates that 3,049 programme fees will be invoiced in 2025 before factoring in waivers, refunds, exceptions, and exemptions. The agency approximates that there will be 81 waivers and refunds granted, with approximately 39 programme fees set to be exempted next year, based on the orphan drug exemption.

Application fees will provide 20% of the total revenue for 2025 while prescription drug programme fees provide 80% of the total annual revenue.

Earlier this year, the FDA released final guidance on how sponsors can charge for new drugs under an investigational new drug application during clinical trials or in expanded access programs.