Level-Funding in FY 24: A Substantial Risk to FDA Priorities
As discussed in last week’s Analysis and Commentary (Concrete Progress; Still A Long Way from Settling FDA’s FY 24 Funding), FDA’s FY 24 funding has a best case and worst case that are $900 million apart. The broad range of possible outcomes creates a situation where budget, personnel, and program planning are near-impossible, especially when we are already a month into the fiscal year.
Some clarity emerged this week with the Senate passage of HR 4366, which will fund Agriculture/FDA, along with Transportation/HUD and Military Construction/VA.
In the Senate bill, FDA would receive an additional $20 million above the FY 23 level of $3.5 billion. We won’t know where the House will come out until at least the week of November 13, when the Ag/FDA appropriations bill is due to be considered. Based on recent efforts on that bill, it is possible that it might contain a large, across-the-board cut that might be as great as 14%.
The likely final outcome is funding at–or close to–the FY 23 level. That will hurt the agency by requiring that existing program dollars be stretched to cover:
FDA’s expanding mission and growing responsibilities.
Increased complexity of science, growth in regulated industries, and the need for major initiatives in food safety, gene and cell therapy, etc.
Improved IT and infrastructures that are critical to modernizing the agency.
FDA does not have the spare capacity or budget to do all these things.
Further, the President’s Request included $105 million for mandated pay raises in FY24. At level-funding, FDA will have to absorb that amount, which effectively reduces funds available to sustain existing programs at current funding levels.
The President’s Request for FY 24 envisioned adding $372 million to the FDA budget, to meet the following growing needs at the agency:
Food Safety and Nutrition
$128.2 million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight.
$5 million toward modernizing oversight of cosmetics (implementing new law)
Medical Products
$23 million in additional funds to advance the goal of ending the opioid crisis.
$11.6 million increase toward improving the medical device supply chain/addressing shortages.
$2.5 million to foster the development of treatments for ALS and other rare neurodegenerative diseases (implementing new law).
$50 million to advance the President’s Cancer Moonshot goals.
Cross-Cutting Initiatives
$10 million in further investments in enterprise data and IT modernization.
$16 million for regulatory and mission support functions within the Office of the Commissioner.
$9.4 million for FDA buildings, facilities, and infrastructure improvements.
$105.3 million for cost-of-living salary increases for FY 24.
There are many additional priorities and initiatives that will require resources that are not attached to an explicit request for additional funding:
Combating misinformation
Reimagining clinical trials (address diversity, expedited approvals, real-world evidence, etc.
Reviving the promise of cell and gene therapy
Pandemic preparedness
Re-organization of CFSAN/ORA/FDA inspections
Level funding–or slightly more–may be all that FDA receives for FY 24. No one should be under any illusion: it will not be enough to cover all the demands placed on the agency this year.
Editorial Note:
The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.