12. May 2025
Fda Unveils Revolutionary Ai System To Speed Up Medical Review Process
The Food and Drug Administration (FDA) has announced that it will be utilizing artificial intelligence (AI) across all of its centers, marking a significant milestone in the agency’s efforts to modernize its operations. The decision follows the completion of a new generative AI pilot for scientific reviewers, which promises to accelerate the review process by reducing the time spent on tedious and repetitive tasks.
According to Jinzhong Liu, a deputy director in the FDA’s Center for Drug Evaluation and Research (CDER), the AI tool has enabled him to perform scientific review tasks in minutes that used to take three days. This assertion highlights the potential of AI to streamline the review process, thereby increasing efficiency and reducing costs.
The FDA commissioner, Martin Makary, has directed that all FDA centers achieve full AI integration by June 30, a timeline that raises questions about the agency’s ability to meet this objective. By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms. This ambitious goal underscores the significance of AI in the FDA’s operations and its potential impact on the review process.
The announcement comes just a day after Wired reported that the FDA and OpenAI were holding talks to discuss the agency’s use of AI. Notably, the FDA’s new statement makes no mention of OpenAI or its potential involvement. Behind the scenes, however, sources suggest that a team from the ChatGPT maker met with the FDA and associates from Elon Musk’s Department of Government Efficiency multiple times in recent weeks to discuss a project called “cderGPT.” The name is likely a reference to the FDA’s CDER, which regulates drugs sold in the US.
This may have been a long time coming. In 2023, the FDA sponsored a fellowship to develop large language models for internal use. Additionally, according to Robert Califf, who served as FDA commissioner between 2016 and 2017, review teams have already been experimenting with AI for several years. It will be interesting to hear the details of which parts of the review were “AI assisted” and what that means.
Califf’s comments highlight the agency’s interest in leveraging AI across various aspects of its operations. Final reviews for approval are only one part of a much larger opportunity, emphasizing the potential benefits of AI beyond just speeding up the review process.
Makary has frequently expressed his enthusiasm for the technology, citing concerns about the lengthy timeframe for bringing new drugs to market. “Why does it take over ten years for a new drug to come to market?” he tweeted on Wednesday. “Why are we not modernized with AI and other things?”
The FDA news parallels a broader trend of AI adoption in federal agencies during the Trump administration. In March, OpenAI announced a version of its chatbot called ChatGPT Gov designed to be secure enough to process sensitive government information. Musk has pushed to fast-track the development of another AI chatbot for the US General Services Administration, while using the technology to try to rewrite the Social Security computer system.
However, concerns about the risks of using AI in a medical context are valid and warrant scrutiny. Speaking to Wired, an ex-FDA staffer who tested ChatGPT as a clinical tool pointed out the chatbot’s propensity for making up convincing-sounding lies – a problem that won’t go away anytime soon. The potential risks of relying on AI for medical review tasks must be carefully considered.
Despite these concerns, the potential benefits of AI in the FDA’s operations are undeniable. By streamlining the review process and increasing efficiency, the agency can potentially bring new drugs to market faster while reducing costs. Moreover, AI has the potential to improve patient outcomes by enabling healthcare professionals to access timely and accurate information.
As the FDA continues to explore the use of AI across its centers, it is essential to prioritize transparency and accountability. By providing clear details about which parts of the review process were “AI assisted” and what that means, the agency can ensure that stakeholders have a comprehensive understanding of the technology’s role in its operations.
The future of AI in the FDA will likely be shaped by ongoing debates about its risks and benefits. As the agency continues to navigate this complex landscape, it is essential to strike a balance between embracing innovation and protecting public health.
In recent years, the FDA has taken steps to modernize its operations, including the implementation of electronic submissions and the development of new clinical trials infrastructure. However, AI represents a significant step forward in terms of process efficiency and patient safety. The integration of AI in the FDA’s operations also underscores the broader trend of technological innovation in federal agencies during the Trump administration.
The parallels between AI adoption in government and the development of new technologies in industry are striking, highlighting the need for cooperation and collaboration between sectors. Ultimately, the success of AI in the FDA will depend on its ability to enhance patient outcomes while ensuring public trust and confidence in the agency’s operations. By embracing this technology with caution and responsibility, the FDA can position itself at the forefront of a new era in medical innovation and regulatory oversight.
The integration of AI in the FDA also raises important questions about the role of humans in the review process. As AI takes on more tasks, there will be a need to reevaluate the skills and expertise required for scientific reviewers. Moreover, the agency must ensure that its use of AI does not compromise the integrity of its decision-making processes.
In conclusion, the FDA’s decision to utilize AI across all its centers is a significant development in the agency’s efforts to modernize its operations. While concerns about the technology’s risks are valid, the potential benefits of AI in streamlining the review process and improving patient outcomes must be carefully considered. By prioritizing transparency, accountability, and public health, the FDA can ensure that its use of AI is effective and responsible.