US FDA User Fees

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.

Capacity planning adjustment that will help calculate generic drug user fees will not include inspections at first to allow more time for time reporting system implementation.

Soon-to-be enacted limitation on user fees means building maintenance and other expenses must be paid with non-user fee dollars. The issue was thought to be a significant operational impediment, but the most recent appropriations bill provided some relief.

Proposals for a new cost-based fee structure at the European Medicines Agency are to be discussed by EU member state health ministers next week, with calls for more targeted fee rises for specific services on the agenda.

COVID-19 and Brexit have put a great strain on the resources of the EU medicines regulatory system, but the planned review of the EU fee system could produce a system that is more flexible, efficient and better able to respond rapidly to emerging technologies and the needs of health care systems, says EFPIA.

The Medicines and Healthcare products Regulatory Agency says that the fee increases to be introduced on 1 April, along with 18 new fees, are necessary for its long-term financial sustainability and its ability to provide a “responsive, innovative and efficient regulatory service.”

The usually lower-profile user fee reauthorizations could gain more attention for broader US FDA issues, said Andi Lipstein Fristedt, FDA deputy commissioner for policy, legislation and international affairs.

In past years, sponsors have pulled ANDAs at the beginning of a fiscal year in part to control their GDUFA program fee payments, but no approved ANDAs were withdrawn during the first two months of FY 2023.

Health care and medicines are among the priorities outlined by the new presidency of the Council of the EU for the first half of 2023.

US FDA gains a nearly 7% increase in non-user fee funding, some of which will go for neurology drug guidance.

The publication of a draft EU Regulation governing the fees paid by the pharmaceutical industry to the European Medicines Agency is the latest step in a long process aimed at ensuring that the payment system better reflects the actual costs of the regulatory work carried out or coordinated by the EU regulator.

More than 80% of FDA employees would continue working during a government shutdown, which appears unlikely as congressional negotiators announce a ‘framework’ agreement.