FDA Introduces Agentic AI Tools for Staff

The Food and Drug Administration (FDA) recently announced its plan to provide employees with a broader range of artificial intelligence tools to assist in premarket reviews and various administrative tasks. This decision comes amidst ongoing concerns regarding the unpredictable behavior of AI technology.

According to the agency’s release, staff will soon utilize “agentic AI capabilities” for tasks such as meeting management, pre-market reviews, review validation, post-market surveillance, inspections and compliance, as well as other administrative functions. Agentic AI refers to systems capable of autonomously executing multistep tasks, potentially enhancing efficiency within the agency.

The FDA stated that it will implement guidelines, including human oversight, to ensure reliable outcomes when using these tools. However, there remains a degree of apprehension surrounding this technology. In an email, Ben Nichols, an FDA spokesperson, clarified that these AI tools are still in an exploratory stage and emphasized that they will not make regulatory decisions or replace human judgment. He assured that all outputs generated by the AI will undergo thorough review and validation by FDA staff before being used in any official regulatory actions. This approach aims to maintain the AI as a supportive tool rather than a replacement for human decision-making.

Interestingly, this initiative arrives at a time when the FDA’s drug center has reportedly seen a considerable reduction in staff, with over 1,000 employees leaving through layoffs and voluntary departures this year. The introduction of agentic AI tools could be perceived as a potential solution to counter the staffing shortfall by enhancing the operational efficiency of existing personnel, yet it underscores the delicate balance of integrating advanced technology while ensuring regulatory integrity.