Looking Ahead to the President’s Budget, Part II
(Link to Part 1)
Q: When will the President’s FY 24 Budget Request be released?
A: The release is scheduled for Thursday, March 9. 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: Will we see budget news stories before the budget is released?
A: In all likelihood, yes. One or more of the major news outlets will probably receive embargoed copies, probably late on Wednesday. With that head start, they will have stories early on Thursday which may lack agency-specific details that become available later in the day. In the case of FDA, with its complex funding structure (See the How FDA is Funded slide set), it is quite possible the early stories may lack certain critical nuances. Our task at the Alliance is to quickly identify, analyze and amplify those nuances so that policymakers and thought leaders have complete and sound information.
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 is budget authority appropriations, which would grow by [x dollars or percent] from FY 23. The remainder is $2.xx billion from medical products user fees, which would grow by [x dollars or percent] from FY23. 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. The Commissioner talks about this often. 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 24 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 Thursday afternoon; earlier if possible. If you want to receive that analysis and other information about the FDA budget, we recommend that you sign up to receive our Friday Update every week.
Q: I would like to do my own analysis. How do I get started?
A: For those inclined to DIY, you can use the key items we use for our analysis. Once text of the President’s Request and the lengthy supporting justification become available, we immediately search for the All-Purpose Table and the Summary of Changes. We then compare them to the Budget Authority Crosswalk and Budget Authority by Activity.