By Gina Shaw
The FDA’s proposed $7.2 billion budget for the 2025 fiscal year includes approximately $12.3 million in funds aimed at addressing supply chain disruptions and supporting supply chain resiliency, according to a summary released by the agency.
“Through an agency-wide, cross-cutting initiative, the FDA will advance its capabilities to help prepare for, build resilience to, and respond to shortages through improved analytics and regulatory approaches,” stated the 2025 Budget Summary Fact Sheet, which was released on March 11. One initiative is to hire additional investigators to meet the increased inspection needs related to supply chain disruptions and drug shortages. Additionally, the agency said, it will “continue promoting manufacturing quality across the pharmaceutical industry and developing and implementing modernized systems to respond to shortages more quickly.”
The FDA is also targeting funds toward improving its data infrastructure and other “modernization activities.” Some $8.3 million will be dedicated to enhancing the FDA’s centralized enterprise data-modernization capabilities and strengthening its common data infrastructure, while an additional $2 million is slated for improving operational efficiency.
A representative from ASHP expressed the hope that this funding will only be the beginning. “We strongly support additional funding for FDA, particularly for efforts to shore up supply chains and address shortages,” said Jillanne Schulte Wall, ASHP’s senior director of healthcare regulatory policy.
Although $12.3 million is “a good start,” she added, to build and sustain long-term supply chain monitoring and resiliency efforts will require more substantial funding. “Considering the obvious detrimental effects of shortages of critical medications, including medications for cancer and mental health,” Ms. Schulte Wall concluded, “we would like to see appropriations well in excess of FDA's ask.”
Ms. Schulte Wall reported no relevant financial disclosures.
