Now, here is a head scratcher. According to the Pink Sheet article written by Sue Sutter (here), “The White House requested $6.76bn, a decrease of 3.9%, or $271.5m, from the FY 2025 funding level. The proposal includes $3.17bn in budget authority, a decrease of 11.4%, and $3.59bn in user fees, a 4% increase.”
What a dandy, especially with so many FDA employees subject to a reduction in force (RIF) over the last few months. So, what is proposed in the budget request is a decrease in FDA funding of appropriated funds from the previous fiscal year, which includes a budget authority decrease of 11.4% and an increase in the amount of User Fees by 4%. Seems like this request is in direct contrast to what Secretary Kennedy has said about his dislike of User Fees and how he believes that the fees actually make for too cozy a relationship between the FDA and industry. In addition, as reported by Rachel Turow and Maya P. Florence, attorneys at Skadden, Arps, Slate, Meagher & Flom (here), Grace Graham, deputy commissioner for policy, legislation, and international affairs at the Food and Drug Administration “made clear that FDA intends to pursue user fee reauthorization, saying the ‘user fee programs have grown to provide key funding for the FDA, without which it could not achieve its mission for American patients. But as we look toward the next reauthorization, it is time to take a step back and think about if the fee structures and amounts have any unintended consequences.’”
The budget request and Secretary Kennedy’s worry about the influence of the User Fee program on the FDA, as well Ms. Graham’s comments, don’t seem to align with the current budget request. Certainly, the initial budget request and the final budget may look quite different and we will watch closely to see where it lands. However, increasing User Fees and reducing staff (which will undoubtedly have an impact on productivity) would certainly mean that the FDA would have to do more with less or shift the FDA funding burden even further to industry.
