The Food and Drug Administration is requesting 7.4 percent more for certain aspects of its budget for fiscal year 2025 than it received for the current year, which began on Oct. 1, 2023, and runs through Sept. 30 this year.
The FDA’s request is less than 1 percent of President Biden’s proposed $7.3 trillion budget announced Monday. The FDA requests an increase of $495 million above its current funding level. The requested amount is generally less than the allocated amount.
“The FDA’s request reflects the agency’s top priorities in key areas of importance for human and animal health,” according to a Monday statement from the agency.
“This funding will allow the agency to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public health and mission-support capacity, and modernize the FDA’s infrastructure and facilities.”
A small part of the FDA’s $702 billion request would go toward food safety. The vast majority of the FDA’s budget goes to the operations on the drug side of the agency.
In a $15 million slice of the FDA’s request pie, specific food safety efforts include modernizing the ability to prevent or manage foodborne illness outbreaks by investing in tools and processes to strengthen root-cause investigations. That aligns with some of the goals set by Jim Jones, the first-ever Deputy Commissioner for Human Food Programs. Also earmarked out of the same $15 million slice of the agency’s wish pie would be working on the public health burden of diet-related chronic diseases.
For a $12.3 million portion of its request, the FDA says it will improve supply chain disruptions and support supply chain resiliency.
“Through an agency-wide crosscutting initiative, the FDA will advance its capabilities to help prepare for, build resilience to, and respond to shortages through improved analytics and regulatory approaches. Amongst other initiatives, the agency will hire additional investigators to fulfill inspectional needs associated with increased supply-chain disruptions and consequent human food and medical product shortages in recent years.”
On the food side of the agency, supply chain issues were brought to the forefront in 2022 when an infant formula production plant had to be closed because of an outbreak of cronobacter infections linked to it. Multiple products and locations in the plant were found to be contaminated, though none of the positive tests precisely matched the outbreak strain.
The plant’s closure resulted in parents having to drive for hours to find infant formula because shelves were left bare of products.
A former employee of the implicated plant reported that some products had tested positive for contaminants. Still, the FDA mailroom misdirected that report, and it did not come to light until months after it was received.
The FDA’s budget proposal says it wants to provide new authority to help ensure the safety of foods, including infant formula, medical foods, and foods marketed for infants and young children. Part of that authority would include setting binding contaminant limits by administrative order, requirements for contaminant testing of final products, more frequent environmental monitoring for pathogens in certain facilities, and mandatory reporting when certain products test positive for pathogens.
A $1 million portion of FDA’s request would expand foreign offices and strengthen imported product oversight. The funding would expand agency resources to facilitate timely inspections of foreign facilities in specific countries. Additional deployed personnel would also improve oversight of imported products, according to the agency’s budget request.
Problems with inspections related to imported food came to light in the fall of 2023 when it was discovered that cinnamon applesauce marketed for children in the United States and imported from Ecuador was contaminated with lead. It was found that the cinnamon had more than 2,000 times the levels of lead considered safe.
Traceback’s efforts discovered that a third-party supplier in another country sold the contaminated cinnamon to the Ecuadoran applesauce manufacturer. Questions have been raised about the FDA’s authority to inspect foreign food supplier operations and also the agency’s ability to test foods at the border. Some FDA records have shown that testing samples of all food imports is impossible because of limited staffing and laboratory capacity.
A $43.6 million portion of the FDA’s request would go toward ensuring the optimal functioning of the FDA’s offices and labs. The money would allow the FDA personnel at facilities across the country to carry out its mission, including evaluating food safety and medical products, continuing to expand laboratory operations, and supporting inspections at points of entry to reduce the flow of adulterated and illicit imported products and respond to emergencies.
Part of a $2 million slice of the FDA request pie would increase support of agency modernization activities. Although the agency did not specify how much, if any, of the $2 million would go toward the food side of its operations, modernization has been a priority of food administrators in recent years.
The agency did say that the targeted investments would be used to improve the efficiency of its operations by centralizing planning, implementation, and governance of high-priority business process improvement efforts. In creating the Deputy Commissioner for Human Food Programs post, FDA Commissioner Robert Califf said streaming operations and simplifying the chain of command was a goal.
The agency’s budget request states that modernization efforts would include the continuation of the critical inspections platform implementation and expansion efforts to implement common business processes and data optimization across the agency. The budget also proposes a new two-year spending authority to support such investments.
$114.8 million of the proposed budget would support the FDA’s “public health employee workforce,” though the agency did not specify how much money would go toward food operations. The funding would help the FDA cover estimated inflationary pay costs and cost-of-living adjustments to “minimize reductions to hiring capabilities and maintain the agency’s highly qualified, specialized staff crucial to carrying out its public health mission.”
$8.3 million is requested to modernize data infrastructure to support agency operations. The money would allow the agency to continue building the FDA’s centralized data-modernization capabilities and strengthen its common data infrastructure. Still, again, the agency statement did not indicate how much of this portion of its budget request would go to food programs. The budget request proposes a new two-year spending authority to support these investments.
In addition to the specific spending areas mentioned above, the FDA’s proposed budget includes money to fund a “package of legislative proposals designed to support better agency efforts to protect American consumers and patients.” Those proposals deal with:
- additional oversight tools, such as expanding authorities for information-sharing with states, broadening authority to request records or other information in advance of or instead of inspections of all FDA-regulated commodities, and requiring importers to destroy products that present a significant public health concern,
- various medical devices and food;
- regulations for animal food;
- timely competition for new drugs;
- meeting tobacco program public health mandates;
- additional authorities to increase oversight of dietary supplements and
- modernizing the tobacco user fee framework.
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