US EditionFDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
UNITED STATES, JUL 23 – The FDA's Elsa AI tool has produced fabricated studies and misrepresented research, raising concerns about drug approval reliability amid efforts to speed up the process, according to multiple FDA employees.
- On June 2, 2025, FDA Commissioner Marty Makary deployed Elsa, an AI tool, across the agency to speed drug and device approvals.
- Following a strong endorsement from the head of the Department of Health and Human Services to implement generative AI, this deployment proceeded despite ongoing doubts about the technology's accuracy and regulatory oversight.
- Several current and former FDA officials have expressed concerns that Elsa commonly fabricates false studies and inaccurately represents research, limiting its reliability for important regulatory responsibilities.
- Makary acknowledged Elsa's potential to hallucinate but said such errors may be reduced with more detailed queries, while Kennedy testified AI already speeds drug approvals.
- These flaws raise risks of unsafe drug approvals, prompting calls for stricter AI regulation and systematic postmarket evaluations to protect public health.
11 Articles
11 Articles
The FDA Is Using an AI to "Speed Up" Drug Approvals and Insiders Say It's Making Horrible Mistakes
Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug approvals. As CNN reports, six current and former FDA officials are warning that the AI, dubbed Elsa, which was unveiled weeks earlier, is "hallucinating" completely made-up studies. It's a terrifying reality that could, in a worst-case scenario, lead to potentially dangerous drugs mistakenly getting the stamp of approval from t…
FDA’s Artificial Intelligence is Supposed to Revolutionize Drug Approvals. It’s Making up Studies
From CNN. “To hear health officials in the Trump administration talk, artificial intelligence has arrived in Washington to fast-track new life-saving drugs to market, streamline work at the vast, multibillion-dollar health agencies, and be a key assistant in the quest to slash wasteful government spending without jeopardizing their work. “The AI revolution has arrived,” Health and Human Services Secretary Robert F. Kennedy Jr. has declared at co…
An investigation by CNN reveals the slipping of Elsa, a new AI tool that was supposed to boost the effectiveness of the Food and Drug Administration.
FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up nonexistent studies.
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.
FDA’s Elsa AI Tool Hallucinates Studies, Sparks Concern Over Lack Of Oversight In High-Stakes Healthcare Decisions Where Accuracy Directly Impacts Public Safety And Trust
With artificial intelligence being adopted rapidly, varied domains are increasingly looking for ways to implement the technology in order to improve efficiency and save time. We see a vast use of AI assistants for smoother processes. It has not been long since the FDA rolled out Elsa, its generative AI tool that was meant to be a forward-thinking move, to help improve drug and medical device approval workflows, but it seems like the platform is …
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