The Federal Budget Process and Its Impact on Your Research Program

The federal budgeting process is a complex undertaking that involves both the Legislative and Executive branches of government. Lawmakers are now in the early stages of crafting the budget for Fiscal Year 2024 (FY24), which begins October 1, 2023 and goes through September 30, 2024. 

The federal budgeting process begins with the President's budget request, which President Biden submitted to Congress on March 9. The President's budget request outlines the administration's spending priorities for the upcoming fiscal year and includes funding recommendations for federal agencies and programs. The President’s proposal is more commonly utilized as an agenda-setting statement for the administration rather than as a basis for dollars-and-cents negotiation with Congress. Even so, the priorities highlighted in the request are a useful guide for the conversations that will take place over subsequent months.  

Requests in President’s budget that are of interest to ASGCT include:  

• $48.265 billion to the National Institutes of Health (NIH), a 1.7% increase over FY23. Appropriated funds for NIH are the primary source of research grants and funding, which many of our members rely on to support their basic and translational research. 

• $3.96 billion to the Food and Drug Administration (FDA), an 11.86% increase over FY23. For gene and cell therapies, FDA’s appropriated funds are utilized alongside statutory user fees to regulate clinical-stage drugs all the way from the Investigational New Drug (IND) application to Biologics Licensing Application (BLA) and into post-marketing. FDA plays a crucial role to ensure the therapeutic pipeline puts patient safety and product efficacy first. 

• $2.5 billion to the Advanced Research Projects Agency for Health (ARPA-H), a new agency that Congress authorized in 2022 and which recently launched its first Open Broad Agency Announcement. Inaugural ARPA-H Director Dr. Renee Wegrzyn (who in a prior role spoke at ASGCT’s 2020 Policy Summit) has highlighted gene and cell therapies as one of the transformative avenues for her agency to explore. 

Once the President's budget request is submitted, Congress begins its work. Traditionally House and Senate Appropriations Committees would develop a non-binding budget resolution that sets overall spending levels for the upcoming fiscal year. In recent years though, House and Senate Appropriations Committee Chairs have sometimes utilized a process known as “deeming” to set their topline budget number in lieu of a formal budget resolution.  

After the budget resolution is passed (or the deemed limit is set), Congress must craft individual appropriations bills that allocate funding to specific federal agencies and programs. There are 12 separate appropriations bills that must be passed each year. For the gene and cell therapy field, the most critical pieces are the Agriculture bill, which includes FDA funding, and the Labor, HHS, & Education bill, which includes NIH and ARPA-H. The 12 appropriations bills may be passed individually or combined into an overarching omnibus appropriations bill. The text of all appropriations bills must be passed by both the House and the Senate and signed into law by the President.  

The official deadline to complete the budgeting process is June 30, but that deadline is routinely pushed back until the fall. If the process stretches beyond October 1, when the fiscal year begins, Congress may choose to pass a continuing resolution (CR) which allows federal agencies to keep operating at levels from the expired fiscal year. 

Throughout the budgeting process, there are numerous opportunities for stakeholders to weigh in on funding priorities and advocate for specific programs or initiatives. Each year, ASGCT is a strong supporter of robust funding to the regulatory and research agencies. We are also actively engaged in efforts to educate bipartisan members of the Senate and House about the unique nature of cell and gene therapies and how a robust research pipeline benefits patients. As this year’s budget process plays out, we will continue to be a voice for our members on Capitol Hill. 

Christina Mayer, MPA, is ASGCT's Senior Manager of Government Affairs. 

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