--- title: "The FDA Is Using an AI to “Speed Up” Drug Approvals and Insiders Say It’s Making Horrible Mistakes" description: "Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug approvals." date: "2025-07-24" modified: "2025-07-24" authors: - name: "Victor Tangermann" job_title: "Senior Editor" link: "https://futurism.com/authors/victor" url: "https://futurism.com/neoscope/fda-ai-drugs-hallucinations" categories: - "Developments" - "Health & Medicine" tags: - "artificial intelligence" - "fda" - "generative ai" - "rfk jr" --- # 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.]() *\Image: Getty / Futurism\* 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 the FDA. It's part of a [high-stakes and greatly accelerated effort]() by the US government to embrace deeply flawed AI tech. Elsa, much like other currently available AI chatbots, often makes stuff up. "Anything that you don’t have time to double-check is unreliable," one FDA employee told *CNN*. "It hallucinates confidently." Health and Human Services secretary Robert Kennedy Jr, a noted figure of the anti-vaccine movement, who has no relevant credentials for the job and frequently furthers discredited conspiracy theories, lauded the administration's embrace of AI as a sign that the "[AI revolution has arrived]()." "We are using this technology already at HHS to manage health care data, perfectly securely, and to increase the speed of drug approvals," he told Congress last month. But reality is rapidly catching up — which shouldn't be a surprise to anybody who's used a large language model-based tool before. Given the [tech's track record so far](), the medical community's embrace of AI has already been mired in controversy, with critics [pointing out]() the risks of overrelying on the tech. Instead of saving scientists time, Elsa is doing the exact opposite, [highlighting a common refrain]() among companies' already backfiring attempts to shoehorn the tech into every aspect of their operations. "AI is supposed to save our time, but I guarantee you that I waste a lot of extra time just due to the heightened vigilance that I have to have," a second FDA employee told *CNN*. The insiders claim that Elsa can't really help them review drugs for approvals since it doesn't have access to relevant documentation. It can't even "answer basic questions," such as how many times a company filed for FDA approval, according to *CNN*. Worse yet, it often cites studies that don't exist, and when challenged, it ends up being "apologetic" and tells employees that its output needs to be verified. The damning claims fly in the face of the FDA's attempts to paint Elsa as a revolutionary tool that can significantly speed up drug evaluations. In response to this story, a spokesperson for the Department of Health & Human Services provided a very Trump-inflected statement. "The information provided by FDA to *CNN* was mischaracterized and taken out of context," it read. "FDA was excited to share the success story of the growth and evolution of its AI tool, Elsa. Unfortunately, *CNN* decided to lead the story with disgruntled former employees and sources who have never even used the current version of Elsa. The only thing 'hallucinating' in this story is *CNN*’s failed reporting.'" In a [June statement](), the FDA boasted that it was "already using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets." Meanwhile, FDA's head of AI, Jeremy Walsh, told *CNN* that it's possible Esla "could potentially hallucinate," saying employees "don't have to use" the tool "if they don't find it to have value." In an attempt to reassure, Walsh said that Elsa's hallucinations could be mitigated by using more detailed questions. In many ways, Elsa couldn't have come at a worse time as Congress is racing to figure out how to approach AI regulation. Instead of implementing new rules to avoid a disaster, the Trump administration has remained far more focused on clearing a regulatory path as tens of billions of dollars continue to be poured into the industry. In other words, there doesn't appear to be much interest in reining in the FDA's use of unproven AI tech — a concerning bet that could one day come home to roost. **More on the FDA:** *[The FDA Is Already Outsourcing Drug and Food Analysis to Error-Plagued AI Chatbot]()* ## Author I've been at Futurism since 2017, where my role has evolved to encompass design, writing, and increasingly editing. I've always been fascinated by space exploration and advanced transportation, which I've leaned into by interviewing luminaries in those fields while closely following the dimensions of policy and regulation that allow next-generation projects to succeed -- or, sometimes, to fail. I'm also keenly interested in the effects of generative AI on society, policies, and democratic institutions, as well as clean energy, physics and biology, and the vagaries of tech leadership. My work for Futurism has been cited by publications including Ars Technica, Gizmodo, PC Magazine, Jalopnik, Fox News, and the New York Post. I spent my childhood living in locations including Manila, the Philippines, and Geneva, Switzerland, attended McGill University, and now live in Toronto, Canada. Before Futurism I worked at AskMen and a small photography studio. In my free time, I'm an avid gardener, foodie, and craft beer lover, as well as a maker of artisanal hot pepper sauces. I have a magnificent dog named Freida. ### Author social links [Bluesky]()