The Alliance’s FY 25 Ask: Urgent Initiatives That Need More Funding
Over the past month, we have been preparing readers for the release of the Alliance’s FY 25 “ask” for FDA funding. Columns explaining the context are:
Preparing for the Alliance’s FY 25 Ask March 22, 2024
President’s FY 25 Budget Request: FDA Needs More April 5, 2024
The Alliance’s Appropriations Ask: Realistic for Meeting FDA’s Needs April 12, 2024
For those needing more background on the President’s Request and the Alliance response, our summary is here.
The “ask” is now released and can be found here. To give you a feel, here are five of the requests contained within the Alliance ask:
Food Chemical Safety. A robust food chemical safety/post-market review program is a pressing need that is supported by a broad range of consumer and industry stakeholders, many of whom view it as their highest food safety funding priority. Additional funding--well beyond the President’s budget request—is needed to ensure a rigorous and timely review of chemical and toxicological issues now pending before the agency, including twenty-one chemicals currently prioritized for reassessment. Such reviews can take many months to complete, so there is an urgency to get started and a need for substantial funding in FY 25.
Enhancements in Risk-Based Targeting of Foods and Animal Health Program Oversight Activities. As the agency restructures to establish a new Human Foods Program, additional resources (advanced data systems, external data sets, and data scientists) are needed to create a data-driven foundation to improve risk-based oversight and surveillance activities in both human foods and animal food and drugs. More substantial investments in FY 25 could also help to accelerate work planning and data sharing with state regulatory partners.
Expand regulatory sciences investments. Science, by its nature, involves a constantly changing body of information, data, and evidence. FDA must keep pace with scientific advancement by embracing, developing, and applying innovative regulatory science and technology that can be used to improve processes and help to regulate innovative approaches developed and employed by regulated industry. The regulatory science enhancements can make clinical and post-market evaluation more efficient; expand the use of medical product drug and device development tools and manufacturing innovations; leverage electronic health records; address substance use, misuse, and addiction and more effectively empower patients and consumers.
Expand medical product inspection capabilities. FDA is improving risk prioritization and modernizing medical product inspections through the restructuring of the Office of Regulatory Affairs (ORA). This effort will streamline the work across product centers and help to achieve FDA’s public health and prevention-oriented goals. The Agency needs additional resources to effectively update their processes and accelerate the transformation of the program. When fully operational, a restructured ORA will help to ensure more timely access to new and innovative medical products by improving the capabilities to meet review goals and facilitating more first-cycle approvals.
Shortages and Supply Chain. This agency-wide crosscutting initiative supports FDA’s efforts to prepare for, build resilience to, and respond to shortages through improved analytics and regulatory approaches. Among other uses, FDA should be using monies to hire additional investigators, domestically and abroad, to fulfill inspectional needs associated with increased supply chain disruptions and consequent human food and medical product shortages in recent years. For much of the stakeholder community, it is a priority to upgrade the FDA’s efforts to a level that will require additional funding--well beyond the President’s budget request.
Editorial Note:
The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.