{"id":9631,"date":"2025-07-08T09:41:17","date_gmt":"2025-07-08T14:41:17","guid":{"rendered":"https:\/\/www.appliedpolicy.com\/staging\/7403\/?p=9631"},"modified":"2026-02-25T22:56:48","modified_gmt":"2026-02-26T03:56:48","slug":"one-month-in-elsa-highlights-fdas-ai-ambitions-and-program-limitations","status":"publish","type":"post","link":"https:\/\/www.appliedpolicy.com\/staging\/7403\/one-month-in-elsa-highlights-fdas-ai-ambitions-and-program-limitations\/","title":{"rendered":"One Month In, Elsa Highlights FDA\u2019s AI Ambitions and Program Limitations"},"content":{"rendered":"<p style=\"font-weight: 400;\">It has been just over a month since the Food and Drug Administration <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-launches-agency-wide-ai-tool-optimize-performance-american-people\">announced<\/a> the agency-wide rollout of Elsa a generative AI tool \u201cdesigned to help employees\u2014from scientific reviewers to investigators\u2014work more efficiently.\u201d The launch, which was completed ahead of schedule, came after FDA Commissioner Marty Makary <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai\">said<\/a> he had been \u201cblown away by the success of [the agency\u2019s] first AI-assisted scientific review pilot.\u201d<\/p>\n<p style=\"font-weight: 400;\">According to several sources, including <a href=\"https:\/\/www.statnews.com\/2025\/06\/02\/fda-artificial-intelligence-implementation-plans-makary\/\">STAT News<\/a>, Elsa, a large language model (LLM), was built with Deloitte on <a href=\"https:\/\/www.anthropic.com\/\">Anthropic&#8217;s<\/a> Claude platform within Amazon Web Services\u2019 secure <a href=\"https:\/\/aws.amazon.com\/govcloud-us\/?ams%23interactive-card-vertical%23pattern-data.filter=%257B%2522filters%2522%253A%255B%255D%257D\">GovCloud<\/a> environment. It evolved through the <a href=\"https:\/\/www.fda.gov\/about-fda\/fda-organization\/center-drug-evaluation-and-research-cder\">Center for Drug Evaluation and Research<\/a> under an AI development program that has been ongoing across divisions in the FDA since 2020.<\/p>\n<p style=\"font-weight: 400;\">In sharing news of the program\u2019s agency-wide launch on June 2, Makary <a href=\"https:\/\/youtu.be\/jp6TvncQYMU\">said<\/a>, \u201cThe agency is using Elsa to expedite clinical protocol reviews and reduce the overall time to complete scientific reviews.\u201d FDA Chief AI Officer Jeremy Walsh characterized Elsa as the \u201cdawn of the AI era at the FDA.\u201d<\/p>\n<p style=\"font-weight: 400;\">Makary\u2019s and Walsh\u2019s enthusiasm for Elsa reflects the broader, high-profile embrace of AI by the Trump administration. As Applied Policy has previously <a href=\"https:\/\/www.appliedpolicy.com\/staging\/7403\/president-trump-signals-shift-in-ai-policy\/\">noted<\/a>, the January 23 executive order, <a href=\"https:\/\/www.whitehouse.gov\/presidential-actions\/2025\/01\/removing-barriers-to-american-leadership-in-artificial-intelligence\/\"><em>Removing Barriers to American Leadership in Artificial Intelligence<\/em><\/a><em>,<\/em> both revoked Biden-era AI regulations and promoted federal preemption of state-level oversight. The administration is also pursuing legislative changes to accelerate the adoption of AI across both public and private sectors.<\/p>\n<p style=\"font-weight: 400;\">This AI-forward approach\u2014most notably <a href=\"https:\/\/www.forbes.com\/sites\/jasonwingard\/2025\/03\/10\/musk-replacing-workers-with-ai-should-you-be-worried\/\">championed<\/a> by former special government employee <a href=\"https:\/\/www.wired.com\/story\/elon-musk-lieutenant-gsa-ai-agency\/\">Elon Musk<\/a> and <a href=\"https:\/\/www.brookings.edu\/articles\/how-doge-is-using-ai-in-government-the-techtank-podcast\/\">DOGE<\/a>\u2014has not been without public stumbles. The most notable may have been the \u201c<a href=\"https:\/\/www.whitehouse.gov\/wp-content\/uploads\/2025\/05\/WH-The-MAHA-Report-Assessment.pdf\"><em>Make Our Children Healthy Again Assessment<\/em><\/a><em>,\u201d<\/em> released by the Make America Healthy Again Commission in May. While the report presented ambitious goals, investigative reporting quickly <a href=\"https:\/\/www.notus.org\/health-science\/make-america-healthy-again-report-citation-errors\">revealed<\/a> certain flaws: multiple citations referenced studies that do not exist, at least seven fabricated sources, and telltale signs of AI-generated \u201challucination\u201d \u2014 including footnotes marked \u201coaicite,\u201d suggesting that parts may have been generated by OpenAI\u2019s ChatGPT.<\/p>\n<p style=\"font-weight: 400;\">The errors in the MAHA report have added to <a href=\"https:\/\/www.washingtonpost.com\/health\/2025\/05\/29\/maha-rfk-jr-ai-garble\/\">concerns<\/a> about the use of AI in policymaking. Walsh addressed some of these directly in remarks he delivered at the DIA Global Conference in June. Emphasizing that the FDA has put safeguards in place for the use of Elsa, Walsh said, \u201cIt can\u2019t hallucinate; it\u2019s not allowed to come up with figments of its imagination.\u201d He later <a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2025\/6\/fda-says-elsa-can-t-hallucinate,-unlikely-to-ever\">clarified<\/a> to Regulatory Focus that the system does not hallucinate when used as intended. It remains unclear whether Walsh was dismissing the New York Times <a href=\"https:\/\/www.nytimes.com\/2025\/06\/10\/health\/fda-drug-approvals-artificial-intelligence.html\">reporting<\/a> that some FDA employees had stated Elsa did hallucinate, or whether he was suggesting that any such instances would have resulted from improper use. As STAT <a href=\"https:\/\/www.statnews.com\/2025\/06\/04\/fda-artificial-intelligence-tool-elsa-stupidest-big-fuss-they-ever-made-ai-prognosis\/\">reported<\/a>, FDA staff are required to click through an agreement acknowledging that \u201cWhile Elsa is a powerful tool, it can make errors\u201d to access the program.<\/p>\n<p style=\"font-weight: 400;\">Concerns over the use of AI are not limited to its potential to make up \u201cfacts.\u201d There is a growing body of evidence to <a href=\"https:\/\/futurism.com\/ai-chatbots-summarizing-research\">suggest<\/a> that LLMs fall short in accurately analyzing and interpreting scientific data. This limitation may be increasing even as the models themselves progress. In a <a href=\"https:\/\/royalsocietypublishing.org\/doi\/10.1098\/rsos.241776\">study<\/a> released last month, the Royal Society found that summaries prepared by LLMs \u201cmay oversimplify or exaggerate scientific findings, which can lead to large-scale misunderstandings of science.\u201d Interestingly, research suggests that \u201cexplicitly requesting\u201d that LLMs provide accurate responses can increase generalizations. In addition, including evidence in a prompt <a href=\"https:\/\/aclanthology.org\/2023.emnlp-main.928.pdf\">may<\/a> negatively impact the accuracy of a program\u2019s responses.<\/p>\n<p style=\"font-weight: 400;\">With cybersecurity a growing concern, and healthcare a <a href=\"https:\/\/www.appliedpolicy.com\/staging\/7403\/ransomware-in-healthcare\/\">favored target<\/a> of hackers and state-sponsored cybercriminals, questions arise about maintaining system security and protecting the information shared with it. Acknowledging security questions, Makary said, \u201cAll information stays within the agency, and the AI models are not being trained on data submitted by the industry.&#8221;<\/p>\n<p style=\"font-weight: 400;\">While several pharmaceutical and medical device manufacturers have expressed enthusiasm for the FDA\u2019s use of AI, the industry has several <a href=\"https:\/\/www.statnews.com\/2025\/06\/04\/fda-artificial-intelligence-tool-elsa-stupidest-big-fuss-they-ever-made-ai-prognosis\/\">concerns<\/a> which remain unanswered. The agency has not yet specified how Elsa has been or will be, verified and validated. Nor has it detailed what safeguards will be in place to ensure the system\u2019s use does not expose trade secrets or sensitive device data. It also remains unclear whether and how applicants will be informed about the extent to which AI tools are used in reviewing their submissions.<\/p>\n<p>The FDA\u2019s agency-wide rollout of Elsa marked a shift from controlled testing to real-time implementation. It also made the program subject to sharper scrutiny from a broader range of stakeholders. The coming months will test not only the tool\u2019s utility, but also the agency\u2019s ability to navigate the challenges that come with deploying AI in a regulatory setting.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>It has been just over a month since the Food and Drug Administration announced the agency-wide rollout of Elsa a generative AI tool \u201cdesigned to help employees\u2014from scientific reviewers to investigators\u2014work more efficiently.\u201d The launch, which was completed ahead of schedule, came after FDA Commissioner Marty Makary said he had been \u201cblown away by the [&hellip;]<\/p>\n","protected":false},"author":100,"featured_media":7489,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","ap4_related_services":"","footnotes":""},"categories":[631,632],"tags":[],"class_list":["post-9631","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-artificial-intelligence","category-fda"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - 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