FDA seeks billons in funding for medical product safety and supply chain resiliency.
The U.S. Food and Drug Administration (FDA) announced in early March that it is requesting $7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. Approximately $12.3 million of the funding will go directly toward addressing supply-chain disruptions, supporting supply chain resiliency, and advancing medical product safety, according to the FDA.
Supply chain disruptions are currently a far-reaching issue experienced throughout the medical distribution industry. According to ECRI, delays in patient care resulting from supply and equipment shortages are included in the Top 10 Patient Safety Concerns for 2024.
To address supply chain disruptions, the FDA will allot funding to advance its capabilities to better prepare for, build resilience to, and respond to supply delays and shortages. This will be done through improved analytics and regulatory approaches, the FDA said.
With the funding, the FDA also plans to hire additional investigators to carry out inspectional needs associated with supply chain disruptions and medical product shortages. The agency also plans to respond by continuing to promote manufacturing quality across the medical product and pharmaceutical industry.
New systems
Supply chain disruptions are caused by a variety of factors. Manufacturing and quality problems, geopolitical issues, natural disasters, public health emergencies, and discontinuations are some of the many reasons supply chain disruptions can occur, according to the FDA.
According to a Healthcare Ready supply chain threat assessment, supply chain disruptions are occurring due to drought, causing the Panama Canal to restrict the number of ships passing through daily, the ongoing impacts of the pandemic, and civil unrest in the Panama and Suez Canals.
Additionally, medical product safety includes analyses and recommendations for patients and health care providers about ongoing medical device safety issues, according to the FDA. When needed, the FDA alerts patients, healthcare providers, and the industry of adverse events related to medical products.
Ultimately, the FDA’s goal with the proposed funding will be to develop and implement new and updated systems to respond to supply chain shortages and medical product safety alerts more quickly.
The rest of the funding outlined in the 2025 FY proposed budget is aimed at other ongoing national health initiatives, including enhancing food safety and nutrition, strengthening the agency’s public-health and mission-support capacity, and modernizing the FDA’s infrastructure and facilities.
According to the FDA, other notable legislative proposals, in addition to funding requests, include enhancing supply-chain resiliency with respect to addressing supply chain disruptions at the legislative level.