The FDA said Tuesday that companies filing new drug and biologics applications next year with clinical data will each have to pay a fee of $4.3 million, which is about $300,000 more than they’re paying in 2024.
For applications not requiring clinical data, the filing fee has risen consistently from $1.6 million in 2023 to $2 million in 2024. It will be $2.2 million in 2025. But the program fee, which is an annual fee for marketed drugs, will decline to $403,889 in 2025 from $416,734 in 2024.
All fees are set via extended negotiations between the industry and the FDA every five years. Industry fees make up about half of the FDA’s annual budget.
As a result of the additional funds outlined in Tuesday’s Federal Register, the agency also released forecasted workload volume increases for the FDA’s Center for Drug Evaluation and Research (CDER) in 2025, predicting that it would review about 133 new drug or biologic applications, which would be 12 fewer than in 2023.
CDER also predicts an increase of more than 200 industry meetings between 2023 and 2025. The FDA’s biologics center, CBER, expects about 20 more meetings across the same timeline.
As far as employees, an area in which the FDA has struggled to keep talent, CDER is hoping to bring on 23 new full-time employees in 2025 directly focused on reviewing applications.
Since 2008, the filing fees for each application with clinical data have exceeded $1 million.
The agency also released additional user fee calculations for medical devices, biosimilars, generic drugs and more.