US FDA User Fees

However, user fee carryover balances will not last forever and service cuts are inevitable if a shutdown lingers for several weeks.

EU ministers say that implementing an appropriate fee structure that is more in line with actual costs will promote innovation in the pharmaceutical sector while ensuring “fair access” to safe and effective medicines for patients.

The cost of filing a New Drug Application with the US FDA has pushed above the $4 million mark. That is a remarkable rate of increase from the original $100,000 fee set in 1992 – but it does buy a lot more.

Generic drug sponsors are on pace to submit the second-fewest number of ANDAs in a fiscal year in the history of GDUFA.

Postmarketing activities, such as REMS document and annual report reviews, are now part of the formula used to account for workload changes in user fee calculations, which likely helped push fees higher in fiscal year 2024.

Increases in the consumer price index helped drive some of the user fee increases that will take effect on 1 October, even though personnel costs declined in some FDA programs.

Fiscal year 2024 prescription drug user fees skyrocket in part because of a low application volume in FY 2022, while biosimilar user fees continue to drop due to the program’s healthy operating reserve.

Through three-quarters of fiscal year 2023, CBER had hired nearly 70% of the mandated new PDUFA VII employees, while CDER had only hired 40%. The drug center also hired only 36% of the required new BsUFA III employees.

Agreement on a new, more streamlined fee structure for the European regulator could be reached by the end of this year. 

Oncology division officials summarize the agreements and discussions reached during formal meetings so there are no misunderstandings later. Sponsors want the practice used more widely by the FDA.

CBER Director Peter Marks said the FDA’s remote and in-person work system is functioning well and continues to help recruitment.

As the FDA flies the Progressive Pride Flag in honor of Pride Month, an appropriations bill provision would limit the flags that could be flown at it and other federal agency buildings. Plus news on Medicare's amyloid PET NCD, reimbursement for new end-stage renal disease drugs, opioid disposal and what FDA can't use its user fees for in 2024. 

The ENVI committee says the regulatory work done by national regulators on behalf of the European Medicines Agency must be properly remunerated to ensure “world-class pharmaceutical supervision."

The Council of the EU has broadly accepted the European Commission’s proposal for a new, cost-based fee and remuneration system, but has suggested giving the European Medicines Agency’s management board – and hence the member states – a bigger role in future fee changes.

With regulatory science research already funded for generic drugs and biosimilars, CDER Director Patrizia Cavazzoni wants a program for prescription drugs considered for the next user fee renewal.

An agency official said the GDUFA III provision hopefully will be used for only a small number of ANDAs. Pink Sheet charts the approval times and first-cycle clearances over the course of the generic user fee program.