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What the FDA plans to do with an additional $495M it has requested

The $7.2 billion budget request — a $495 million increase over last year — is part of President Biden's budget proposal for his potential second term.
What the FDA plans to do with an additional $495M it has requested
Posted at 12:33 PM, Mar 12, 2024

The Food and Drug Administration is requesting a budget increase of 7.4% for fiscal year 2025 to enhance food safety and nutrition, advance medical product safety, and help support supply chain resiliency, the agency said Monday. 

The $7.2 billion request — a $495 million increase over last year — is part of President Joe Biden’s larger budget proposal for his potential second term.  

The FDA said $15 million of its requested allocation would be used toward human foods initiatives that will “modernize its capacity to prevent or mitigate foodborne illness outbreaks by investing in necessary tools and processes to strengthen root-cause investigations.” 

It would also support the agency in addressing the “enormous public health burden” of diet-related chronic diseases, the agency said.

Another $12.3 million will focus on the FDA’s abilities to address supply chain disruptions and shortages. The agency said improved analytics and regulatory approaches will help build resilience to supply issues. 

The FDA also plans to hire additional investigators to fulfill inspection needs associated with increased supply-chain disruptions and consequent human food and medical product shortages in recent years — like the widespread shortage of infant formula that happened in 2022 that many have been critical of the FDA’s response to. 

SEE MORE: Ex-FDA official: Feds waited 4 months to recall infant formula

The largest chunk of the budget request — $114.8 million — would be used by the FDA to cover “estimated inflationary pay costs and cost-of-living adjustments” to help maintain the FDA’s staff and hiring capabilities. 

Additional funds would be used toward ensuring the safety of cosmetic products as part of the Modernization of Cosmetics Regulation Act of 2022. 

A $1 million portion of FDA’s request would expand foreign offices and strengthen imported product oversight. It said the funding would bolster agency resources to facilitate timely inspections of foreign facilities in specific countries.

SEE MORE: Lead contamination in applesauce pouches may have been intentional

Problems with foreign inspections related to imported food came to light last year when it was discovered that cinnamon applesauce pouches marketed for children in the United States and imported from Ecuador were contaminated with lead and were likely responsible for the sickening of dozens of kids. 

It was discovered that the cinnamon used in the products had more than 2,000 times the levels of lead considered safe.

A third-party supplier in another country sold the contaminated cinnamon to the Ecuadoran applesauce manufacturer. Questions were raised about the FDA’s authority to inspect foreign food supplier operations and the agency’s ability to test foods at the border. 

The FDA has said its hands are tied when it comes to manufacturers that don’t supply directly to the U.S., therefore limiting its investigation.

In addition to the specific spending areas mentioned, 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.” 

Some of the proposals noted were: 

- enhancing supply-chain resiliency for drugs, medical devices and foods 

- introducing new authorities to help ensure the safety of foods, including infant formula, medical foods and foods marketed for infants and young children, as well as 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

- implementing 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

- supporting innovation and competition, such as creating a new regulatory category of animal food additives to facilitate the marketing of innovative animal food products

- encouraging meaningful innovation and timely competition for new drugs

- providing the FDA with additional authority to increase oversight of dietary supplements

- modernizing the tobacco user fee framework 

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