Lou Portero

Urban Health Today

<p class="whitespace-normal break-words">The Food and Drug Administration has accelerated deployment of its artificial intelligence tool &ldquo;Elsa,&rdquo; with Commissioner Martin Makary announcing an aggressive timeline to implement the system agency-wide by June 30, 2025. The announcement comes after completing a pilot program of AI-assisted scientific reviews, marking a significant shift in how the nation&rsquo;s primary drug regulator approaches pharmaceutical oversight.<p class="whitespace-normal break-words">According to Makary, Elsa has demonstrated remarkable efficiency gains, with one scientific reviewer reporting that tasks previously requiring two to three days now take just six minutes. The AI tool focuses on administrative functions, including expediting clinical protocol reviews, summarizing adverse events for safety assessments, conducting label comparisons, and generating code for database development in nonclinical applications. These efficiency improvements could potentially accelerate the availability of new treatments, particularly benefiting underserved communities who often experience delayed access to innovative therapies.</p><p class="whitespace-normal break-words">The rapid deployment has drawn both praise and criticism from industry observers. Panna Sharma, CEO of AI-focused biopharmaceutical company Lantern Pharma, views the administrative focus as appropriate, noting that current generative AI excels in document summarization and data extraction tasks. However, he emphasizes the importance of maintaining performance as the system scales across different review types and medical conditions.</p><p class="whitespace-normal break-words">Industry experts have raised several concerns about transparency and validation. Chase Feiger, CEO of AI company Ostro, questions how regularly the FDA will audit AI outputs to identify error patterns or problematic responses. Legal experts from Hogan Lovells warn that pharmaceutical companies may face limited visibility into how AI influences regulatory decisions, particularly if AI-generated analyses lead to application rejections or delays.</p><p class="whitespace-normal break-words">The security framework includes housing data within a secure &ldquo;GovCloud environment,&rdquo; and Makary assured that the language model wasn&rsquo;t trained on industry-submitted data. However, regulatory experts are calling for more detailed information about Elsa&rsquo;s development and validation processes, similar to standards the FDA expects from industry AI applications.</p><p class="whitespace-normal break-words">This initiative reflects the FDA&rsquo;s broader effort to modernize operations while managing reduced staffing levels. As the pharmaceutical industry increasingly adopts AI technologies, the FDA&rsquo;s internal use of these tools may provide valuable insights into regulatory expectations for AI-driven drug development processes. Ultimately, faster and more efficient regulatory reviews could help bridge the gap in healthcare access by bringing essential medications to market more quickly for communities that need them most.</p></p>
<div class="post-references"><h3>References</h3><p>https://www.pharmavoice.com/news/fda-elsa-ai-makary-pharma-drug/749840/</p>
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More efficient regulatory reviews could help bridge the gap in healthcare access by bringing essential medications to market more quickly.

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