During the mass layoffs that occurred in the DOGE days and the involuntary and voluntary separation and payouts to FDA employees to reduce the head count, I often questioned how much money the FDA was spending. Interestingly, during discussions with my spouse when all of this transpired, she asked me the same question. To which I responded, good question!
Well, now Senator Frank Pallone is also asking that question of the FDA. In a letter dated July 14, 2026 (here), he is asking the FDA for some clarity and answers to his questions.
The money had to come from somewhere and we know that user fee funds are (as is stated in Pallone’s letter), “[A]s FDA itself explains itself, the agency is required by law to spend user fee funds only on specified activities….The activities that FDA can use these dollars to fund are specified in statute and are intended to support the goal of timely review to bring safe and effective medical products to Americans. For example, under the most recent reauthorization of the Prescription Drug User Fee Act (PDUFA), this includes support for regulatory review activities, such as reviewing applications, conducting inspections, monitoring of research, conducting post-market safety activities, and resources needed in connection with those activities”. He goes on to state, “[A]s such, FDA has used these [user fee] resources for staffing and resource capacity building to engage in those activities.”
He also notes that the various UFA programs have negotiated terms between the government and regulated industry and commitment letters that “clarifies the intended purposes for the funds”. He stresses the point that “[N]owhere in the statute or commitment letters is there a stated or implied allowance for fees to pay for loss of staff that were spurred by actions of the federal government”.
Senator Pallone also wants to know how and what money was spent and he asks numerous questions regarding the spending of concern. Check out his letter at the link above for additional information and his specific questions. The replies to the questions of whether appropriated funds were used or if it was user fee funds that paid for these payouts to voluntarily separated FDA employees should be very interesting to review!
The Senator also notes that “Despite the RIF actions, there are unexplained increases in payroll expenses between FY 2024 and FY 2025 for several of the medical product programs”. As an industry representative and a taxpayer, I would like to finally know the answer to who and how those expenses were paid and would certainly hope that none of the user fee money was expended in the DOGE cuts, layoffs and government payouts. October 1, the start of the new FY, will be here before we know it and user fees for FY 2027 will soon be announced. Somehow, I don’t think that we will see a lowering of the UFA fees and would be surprised if they did not increase! Don’t you want to know too?
