US FDA User Fees

FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.

EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.

US FDA’s drug center reported a net increase of more than 300 employees in FY 2023, while the biologics center saw an overall increase of more than 30.

The minor cut would be masked by user fee revenue increases, but still would be the first time in at least a decade that agency's budget authority has dropped.

EFPIA has welcomed the adoption of the new regulation, which will take effect from January 2025. However, it cautioned that the EMA and the national agencies needed to have the necessary resources to do their job and that the new fee structure should be supported by revisions to the EU pharmaceutical legislation.

Pink Sheet reporters and editors discuss the nearly wide open 2024 FDA advisory committee calendar, CMS’s impact on Florida’s drug importation plan, and the FDA’s many missed user fee goals in 2023.

Pink Sheet reporter and editors discuss key US and EU legislation that impacted 2023 and how it also could affect 2024, including EU legislative reform, US Medicare drug price negotiation, and the US Food and Drug Administration user fee reauthorization.

Under changes in the 2022 appropriations bill, generic drug applications can be approved even if a last-minute labeling update is needed, but sponsors risk product misbranding if the CBE is late.

At least one sponsor has been recording meetings for several years, suggesting others could receive permission, but the decision comes with risks as well as benefits. As the agency again expands options for in-person meetings, sponsors may want to reflect on what works best for them.

Given confusion sometimes emerges about the content of formal meeting minutes, recording the meetings would seem like an easy solution, but also could muddy the administrative record.

While a decline in complete response letters in FY 2023 is good, the continued drop in ANDA submissions could be a bad sign for the industry’s long-term health, a former FDA official worries.

FDA launches what it hopes will the final push to reform the regulatory oversight system for lab-developed tests by proposing a relatively rapid transition period to require essentially all LDTs to comply with the existing regulations for in vitro diagnostics. Legislation, litigation, and industry negotiation will likely shape the final product.

After years where many more applications received priority assessments than standard assessments, in FY 2022 the difference narrowed.

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.