Looking Ahead to the President’s FY25 Budget Request
The President's FY25 budget request is expected to be released this coming Monday, March 11, 2024. As in years past, there are likely to be a number of misunderstandings of what is being proposed.
In last week’s Analysis and Commentary (here), we explored two such “budget angles.” First, medical product and tobacco user fees—which are in no way alike— are often lumped together, creating a mis-impression about the role of user fees in funding FDA programs.
Second, descriptions of increased/decreased amounts will be compared to obsolete numbers. The only base that matters is what is in the just-passed FY 24 appropriations bills, which were not available when the budget request was put together.
What we can predict with some certainty is that the OMB “headline number” for FDA will be widely circulated in the media, yet not provide an accurate and meaningful picture of the proposal being made by the President. The important numbers will be in the budget tables, not in the OMB summaries. (We discuss this further below).
Q: When will the President’s FY 25 Budget Request be released and what will be in it?
A: The release is scheduled for Monday, March 11. Usually, the high-level budget summaries will be released mid-to-late morning and appear first on the White House website. Over the following hours, successively more granular documents are released until the HHS website finally has the entire request for FDA. It is likely to be 300 to 400 pages, so it is not a “quick read.”
Q: What is the “headline number” and why does it concern the Alliance?
A: The “headline number” is what appears in the first news stories based on the most general summaries. Predictably for FDA, it will read something like this: “Under the President’s proposal, FDA would receive $6.xx billion, an increase of $ xxx dollars over the prior year. This is a x% increase.” Unfortunately, those numbers do not mean much because they combine funding from budget authority appropriations (taxpayer monies), medical product user fees, and tobacco user fees.
If it were up to us (and we know it is not), the media would say: “FDA would receive $6.xx billion, of which $3.xx billion in budget authority appropriations, which would grow by [x dollars or percent] from FY 24 levels. The remainder is $2.xx billion from medical products user fees, which would grow by [x dollars or percent] from FY24. Separately, the agency receives more than $700 million in user fees that pay for the cost of FDA regulation of the tobacco industry.”
Q: In addition to increased BA funding, what else would you hope to see in the budget request?
A: In order to maintain its standing as the world’s premier regulatory agency, the FDA needs a substantial budget to support data and technology modernization. This is reflected in the 2019 Technology Modernization Action Plan (here); the 2021 Data Modernization Action Plan (here); and the 2022 Enterprise Modernization Action Plan (here). It demonstrates that the agency has been diligent in analyzing what is needed and the benefit that will result. While some increase is likely to be included in the budget, we would welcome a proposal for Congress to allocate substantial no-year money to that effort.
Q: How can FDA stakeholders get accurate information on how FDA fares under the FY 25 President’s Budget Request?
A: We will distribute our analysis of the President’s Budget Request as soon as we have enough information to provide accurate numbers and useful insights. That should be mid-to-late Monday afternoon. It will be sent to the list of individuals who receive our Friday Update. If you don’t receive that every week, contact Ben Dash to be added to the list.
Editorial Note:
The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.