The U.S. Food and Drug Administration has released its comprehensive FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy), marking a defining roadmap for the agency’s technological advancement and the alignment with its broader public health mission. The IT Strategy fulfills commitments under the FDA’s Prescription Drug User Fee Act (PDUFA VII) reauthorization for fiscal years (FYs) 2023-2027 and obligations under section 3627 of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023. Led by the FDA’s Office of Digital Transformation with input from FDA centers and external stakeholders, the plan is both ambitious and collaborative, designed to meet the diverse needs of its internal and external constituents.
The FDA’s existing IT modernization framework is a cornerstone for the new strategy. This robust foundation focuses on critical aspects such as technology, data, enterprise management, cybersecurity, and leadership and has already advanced the FDA’s technology maturity. The agency considers the new IT Strategy more than a roadmap: it’s a shared vision that unites the FDA’s IT portfolio and will foster innovation, enhance public health outcomes, and lead the FDA into a new era of scientific and technological advancement. The new IT Strategy also embraces the agency’s proposed plan to develop a unified Human Foods Program and new Office of Regulatory Affairs model.
The Rising Importance of Technology
In a rapidly evolving landscape, technology’s role in assuring the safety and efficacy of food, medical products, and all products that the FDA regulates, is more significant than ever. The IT Strategy will guide the agency as we transform our IT in alignment with business capabilities and needs, modernizing critical systems, enabling data sharing, and leveraging emerging technologies like Artificial Intelligence (AI).
The FDA’s IT must adapt to changes in demand, scarcity of technical talent, emerging technologies, and the need for robust governance. The increased availability and use of big data and large language models to make data-informed decisions is ushering in a new era of possibilities. By being agile and forward-thinking, the FDA aims to bridge the gap between current capabilities and rapid technological advancements, enhancing our ability to protect public health.
FDA IT Strategy for FY 2024-2027
The IT Strategy for Fiscal Years 2024 to 2027, revolves around six key goals:
- Create a Shared OneFDA Ecosystem: Enhance cross-functional collaboration and shift the FDA’s culture towards a more integrated approach.
- Strengthen IT Infrastructure: Modernize and secure the underlying IT infrastructure, ensuring adaptability and quick resolution of technology issues.
- Modernize Enterprise Services and Capabilities: Optimize the IT services portfolio to provide stable, resilient, and adaptive solutions that are aligned with mission needs.
- Share Data for Mission Outcomes: Make critical data assets widely available to drive efficiency, excellence, and promote public health innovation.
- Adopt AI and Mission-Driven Innovations: Proactively identify opportunities and risks related to emerging technologies such as AI.
- Cultivate Talent and Leadership: Develop comprehensive technology expertise, leadership, and a robust talent pipeline to keep pace with change.
The IT Strategy represents a bold paradigm shift towards a shared enterprise approach, fostering collaboration and continuous transformation in collaboration with our external cross-sector partners and stakeholders. The FDA will host the FDA Digital Transformation Symposium on December 4-6, 2023, to inform and engage the public on this exciting new agenda.
With a shared vision, modernized infrastructure, a focus on innovation and dedication to talent cultivation, the FDA’s IT portfolio will help strengthen the next phase of the agency’s evolution. The collaborative spirit that shaped this plan is a testament to our shared commitment to the health and safety of the American people.
This article was originally published on FDA Voices and is reprinted here with permission.