FDA Requests $7.2 Billion To Strengthen Medical Product Safety
This year’s funding request builds on the FDA’s accomplishments and lessons learned over the past year and adds new funding to modernize the FDA and its capabilities for the future.
The U.S. Food and Drug Administration is requesting $7.2 billion in FY 2024 budget to leverage new and emerging technologies, recruit and support a highly skilled workforce, and adapt oversight to new production and business models. This funding will have an immediate impact on food, tobacco and medical product safety while also preparing the agency to address rapid innovation.
This year’s funding request builds on the FDA‘s accomplishments and lessons learned over the past year and adds new funding to modernize the FDA and its capabilities for the future. It includes investments to strengthen medical product safety and availability, along with funding for vital oversight of tobacco products.
The budget provides a historic investment to strengthen the FDA’s food safety, medical product safety and nutrition capacity, demonstrating the administration’s commitment to these responsibilities. The administration’s foremost focus is on the well-being of patients and consumers, and they look forward to continuing their work with Congress to help meet the critical public health challenges ahead.
The FY 2024 request includes $128.2 million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight. The budget seeks to strengthen consumer protection and implement lasting solutions for more efficient operations through continued investments in the New Era of Smarter Food Safety.
The budget includes funding to modernize infant formula oversight and strengthen efforts to respond to shortages of critical foods, empower consumers to make healthier food choices, and reduce exposure to toxic chemicals in the food supply.
The budget request includes $23 million in additional funds to advance the goal of ending the opioid crisis. This funding will support the development of opioid overdose reversal treatments and treatments for substance use disorders, enhance regulatory oversight, expand compliance, enforcement, and laboratory support, and advance the development, evaluation, and market authorizations of related digital health medical devices.
Additionally, $11.6 million will be allocated to improve the medical device supply chain and shortage programmes, allowing the FDA to work proactively with medical device companies, health care providers, device distributors, and patients to enhance resiliency in the supply chain of critical medical devices and prevent shortages of critical devices that most often impact vulnerable populations. $2.5 million to implement ACT for ALS and $50 million to advance the President’s Cancer Moonshot goals.
Furthermore funding will strengthen the FDA’s ability to issue new grants and contracts, hire dedicated expert staff, and facilitate access to investigational therapies and medical devices for neurodegenerative diseases such as ALS. This budget will also enhance efforts to improve evidence generation for underrepresented subgroups in oncology clinical trials and support pragmatic and decentralized trials.
The budget will expand the FDA’s efforts to facilitate the approvals of innovative and new cancer treatments by international regulatory authorities and foster collaboration of cancer treatments in other countries with standards comparable to the U.S. standard of care.
It will also invest in enterprise data and IT modernization to better meet the challenges of the FDA’s programmes and mission-critical responsibilities. Specific focuses include emerging threats, supporting needs for real-time evaluation, and continuously accessing, analyzing, and aggregating multiple sources of information.
The budget includes $16 million for regulatory and mission support functions within the Office of the Commissioner, $9.4 million for FDA buildings, facilities and infrastructure improvements, and additional funding to ensure secure, modern, reliable and cost-effective spaces for the FDA’s workforce to protect and promote the safety and health of American families.
Additionally, the budget includes funding for the new enterprise transformation effort to improve business processes, data and technology management. The FDA’s budget proposal includes a package of legislative proposals to bolster its authorities to protect and promote public health.
Animal drug sponsors must make post-approval safety-related labelling changes, develop programmes for safe use of certain products, provide the FDA the ability to exclude certain products or classes of products that the FDA and EPA agree are more appropriately regulated by the EPA, and facilitate an orderly transfer of regulatory responsibility from the EPA to the FDA of specified products that are currently registered as pesticides.
The proposed changes would remove regulatory uncertainty and provide clarity to sponsors about which agency intends to regulate a given product or type of products. Expand the drug shortage notification requirements to include situations when a drug manufacturer is unlikely to meet an increased demand.
Broaden the FDA’s authority to request records or other information in advance of or in lieu of inspections to include all FDA-regulated product areas. Remote regulatory inspections are currently limited to drug, device and biomedical research. This proposal will promote regulatory compliance and facilitate certain oversight activities prior to arriving for or instead of an inspection.
Remove limitations that require manufacturers to notify the FDA about interruptions or discontinuances in the manufacture of certain medical devices only during or in advance of a Public Health Emergency (PHE).
Medical device shortages occur in many situations that fall outside of or are unrelated to PHEs, including natural or human-made disasters, recalls, geopolitical conflicts, production shutdowns, and cybersecurity incidents. These events can lead to device shortages that significantly impact patient care and jeopardize healthcare workers’ safety.
The FDA is seeking the requirement for manufacture notifications at all times and the authority to require and review risk management plans to ensure manufacturers are prepared for situations where their ability to manufacture product may be disrupted or insufficient to meet demand.
The FDA is seeking to expand its mandatory recall authority to cover all human and animal drugs, establish binding contamination limits in food, and require industry to test final food products marketed for consumption by infants and children for toxic elements.
This new authority would help the FDA better understand levels of toxic elements in these products, monitor industry progress in reducing levels of these toxic elements over time, and assess user fees on and collect fees from manufacturers and importers of all tobacco products.