$500 Million Boost to FDA in President’s Budget Proposal

President Biden is seeking a $500 million boost in FDA’s spending in fiscal year 2025, which is 7.4% more than the current $6.7 billion spending level in FY 2024, according to just-released budget documents from the White House. The FY 2025 budget proposal says the president is requesting $7.2 billion for 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.”

The proposal comes on the heels of a budget compromise last week that averted an FDA partial shutdown (see earlier story). President Biden signed that measure into law on 3/9.

Under the FY 2025 proposal, $114.8 million would go to support FDA’s public health employee workforce. This would cover estimated inflationary pay costs and cost-of-living adjustments to minimize reductions to hiring capabilities and maintain the agency’s specialized staff needed to meet its public health mission. FDA would also be given $12.3 million to address supply-chain disruptions and support supply-chain resiliency. “The agency will also continue promoting manufacturing quality across the pharmaceutical industry and developing and implementing modernized systems to respond to shortages more quickly,” the budget documents say.

The president’s proposal would also give FDA a $2 million increase to support agency modernization activities. “The targeted investments will be used by the FDA to improve the efficiency of its operations by centralizing planning, implementation, and governance of high-priority business process improvement efforts,” the budget documents say. “These include the continuation of the critical inspections platform implementation and expansion effort to implement common business processes and data optimization across the agency.” It would provide $8.3 million to modernize the agency’s data infrastructure, and $1 million to expand foreign offices and strengthen imported products oversight. “Funding will support the expansion of the agency’s foreign-office footprint, expanding agency resources to facilitate timely inspections of foreign facilities in specific countries.”

Additionally, the proposal includes legislative proposals “to better support agency efforts to protect American consumers and patients.” Notable proposals include efforts to:

• Facilitate the uptake of biosimilars by updating the U.S. biosimilar program and ensuring it is more consistent with current scientific understanding.
• Encourage meaningful innovation and timely competition for new drugs by amending certain exclusivity provisions.
• Provide additional oversight tools, such as expanding authorities for information-sharing with states, broadening authority to request records or other information in advance of or in lieu of inspections to all FDA-regulated commodities, and requiring importers to destroy products that present a significant public health concern. 
• Propose new authorities that would require animal drug sponsors to make post-approval safety changes and expand FDA’s mandatory recall authority to cover all human and animal drugs. 
• Provide FDA with additional authorities to increase oversight of dietary supplements to better protect consumers from dangerous and otherwise illegal products on the market.