FDA’s Elsa AI tool gets mixed response from some staff
The US Food and Drug Administration’s (FDA) new artificial intelligence (AI) assistant, Elsa, has received mixed reviews from agency staff who spoke to Focus. While some staff say the tool has been accurate and helpful in assisting them with their daily tasks, others say it can output erroneous answers.On 2 June, FDA Commissioner Martin Makary announced the agency had launched Elsa almost a month ahead of schedule, claiming the tool had been proven to help staff streamline their work significantly. (RELATED: FDA launches agency-wide AI tool ‘Elsa’ ahead of schedule, Regulatory Focus 2 June 2025)
“The agency is using Elsa to expedite clinical protocol reviews and reduce the overall time to complete scientific reviews,” said Makary in a video announcement. “One scientific reviewer told me, what took him two to three days, now takes six minutes.”
Focus spoke to several FDA officials, who were granted anonymity to due to concerns about professional reprisal. Those that spoke with Focus each had different impressions of the new AI assistant.
One high-level FDA official noted that Elsa has significant limitations since it has not been updated with the latest information.
“It was trained on Anthropic’s Claude so it only has public data through April 2024,” said the official.
They, and another high-level FDA official, said the tool gave outdated responses when asked who the current FDA commissioner and chief counsel are. The tool, they said, answered that Robert Califf is the FDA commissioner and Stacy Amin, who left the agency in 2021, is the agency’s chief counsel. The agency does not currently have a chief counsel.
When asked who Robert F. Kennedy Jr. is, instead of stating that he was the secretary of the Department of Health and Human Services (HHS), it said that it does not give personal opinions or engage in political discussions.
“However, I can provide some factual, FDA-relevant information related to Robert F. Kennedy Jr.,” Elsa answered. “RFK Jr. has made public statements about vaccines that conflict with established scientific consensus and FDA positions.”
“Funny enough, it thinks seed oils are okay as well as that vaccines are safe and effective,” the second source added. “I’m not sure this administration will like those answers from Elsa.”
Kennedy has a history of making claims that seed oils are unhealthy compared to other oils and fats and has raised questions about the safety of vaccines.
Another FDA source, who is a reviewer, said their experience with Elsa has been positive so far. They said they uploaded test reports to the AI, which then drew the information from the report when answering queries.
“I used it to query test reports and confirmed the accuracy,” said the reviewer. “I also compared the test reports to ISO standards to see if there were any deviations.”
“I then investigated and confirmed the responses,” they added. “It only had two minor mistakes.”
The source said that Elsa has been accurate and helpful in quickly getting them the information they need. They noted that they have probably not faced as many inaccuracies because the AI is using the documents they are uploading.
“I’m kind of using it like the Google NotebookLM and not like the ChatGPT tool,” said the source. “I think all of [the errors] are because the AI is only updated to April 2024.”
Elsa includes disclaimers stating that it is an assistive tool and not a “decision maker.” It states that human experts must make all regulatory outcomes, decisions, and enforcement actions, and it should only be used under appropriate human oversight. Users are also asked to verify outputs and ensure the information is secure, private, and only used for FDA business purposes.
“Elsa can make mistakes. Please verify responses,” the AI states. “Elsa’s knowledge is current through April 2024.”
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