Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face of operational disruption. Confronted with sweeping staff cuts and growing review backlogs, the agency is leaning on AI to transform its internal review processes — and perhaps redefine the pace of innovation oversight in the process.
This Bulletin will focus on the implications of FDA’s AI integration amid significant staffing reductions, examining the potential benefits and challenges of this strategic pivot.
Highlights
- In response to widespread layoffs, approximately 20% of its workforce, FDA is implementing AI tools across all centers by June 30, 2025, with the goal of improving internal review efficiency.
- The agency piloted a generative AI model to handle administrative tasks and reduce the burden on remaining reviewers and named Jeremy Walsh as its first head of AI and IT. This is the extent of the information shared from FDA regarding how it intends to leverage AI within the agency.
- Industry stakeholders have expressed concern that job cuts and process automation could delay product approvals and weaken oversight, such as review and approval of applications or enforcement of inspections, particularly for complex medical devices and AI-driven diagnostics.
- Some biotechnology firms are considering shifting early-phase trials outside the U.S. due to concerns about slower regulatory timelines.
AGG Observations
- Efficiency vs. Oversight: AI may help FDA maintain output during a period of reduced staffing, but the reliability and transparency of AI-driven processes will be under scrutiny — particularly in areas involving clinical data interpretation or high-risk products.
- Legal and Regulatory Strategy: Sponsors and developers should continue to anticipate delays and build contingencies into development timelines, especially for novel technologies requiring more FDA engagement.
- Data Governance: Stakeholders should monitor forthcoming FDA guidance on how it will validate and audit AI systems used internally, as these tools may influence review standards and expectations over time.
- Globalization of Trials: If regulatory application delays persist, sponsors may increasingly consider conducting early-phase trials abroad — a trend that could raise policy questions about the U.S.’s leadership role in bioproduct innovation.
As FDA leans further into automation, it enters a computer age that even Neil Young never could have imagined — where generative AI may become not only a support tool, but an embedded force shaping how the agency evaluates risk, defines evidence, and allocates its limited human capital. While the promise of speed is real, so too is the risk of creating a regulatory environment where human expertise is minimized or downplayed. FDA must walk a regulatory tightrope. The agency has acknowledged that AI introduces new uncertainties, necessitating a careful balance between efficiency gains and the risks of reduced transparency, uneven decision-making, and diminished public confidence in regulatory outcomes. Stakeholders navigating this new terrain must be prepared to encounter a new computer age with FDA.
