The US Food and Drug Administration has announced plans to deploy AI tools all across the agency in order to assist in conducting scientific reviews. Following the very successful completion of a pilot program that incorporated generative AI into the reviews.
Martin Makary, in his very first actions as commissioner, has gone on to direct all the FDA centers to start rolling out an AI-assisted system ASAP with the objective of decreasing the time it takes in order to conduct tasks across scientific reviews. FDA has gone on to say that it will push an aggressive timeline in order to deploy AI tools throughout its centers with the idea of complete integration by 30th June 2025.
However, the FDA has gone on to provide very scant details when it comes to the pilot and has not specified what kind of products or tasks have been involved, nor has it elaborated on the types of tasks that AI could assist in once it is completely integrated in June.
It is well to be noted that in recent years, the FDA has gone on to investigate the usage of AI when it comes to internal processes, and in August 2024, it formed an internal AI Council within the Center for Drug Evaluation and Research in order to oversee AI-concerning activities. And former FDA Commissioner Robert Califf discussed discovering the usage of AI technologies when it comes to internal operations as well as regulatory processes earlier that year.
The agency has also gone on to observe a prominent rise in drug submissions, which include AI elements in recent years.
According to Makary, he was indeed blown away by the success of the first AI-assisted scientific review pilot. He added that they indeed need to value their scientists’ time and decrease the amount of non-productive, so-called busywork that has historically consumed much of the review procedures. The agency-wide rollout of these capabilities goes on to hold massive promise when it comes to speeding up the review time for new therapies.
Jinzhong Liu, who happens to be the deputy director at the Office of Drug Evaluation Sciences, said that this is indeed a game-changing technology that has helped him to perform scientific review tasks in minutes rather than days.
The FDA went on to announce that during the rollout, work will continue to broaden the usage, enhance operations, and also adapt to the growing needs of each center. By June 30, all the centers will be operating on a common and secure generative AI system that’s integrated with FDA’s internal data platforms.
There would be future enhancements that will aim to elevate usability, spike document integration, and also personalize output in order to meet specific requirements of each center, all while at the same time ensuring stringent information security along with compliance with FDA policies.
It is well to be noted that the agency’s vice deployment happens to be led by Jeremy Walsh, who is the newly appointed chief AI officer of the FDA, and also Sridhar Mantha. Prior to joining the FDA, Walsh was the chief technologist at Booz Allen Hamilton for a period of 14 years, while Mantha has recently led the office of business informatics at CDER. Commissioner Makary went on to address the requirement when it comes to shortening the drug approval process by way of using ai at the American hospital association’s yearly membership meeting in Washington, DC. He went on to state that at the FDA, they now have to ask questions that were never asked prior to this. Why does it take more than 10 years for a new drug to come out in the market, or why are things not modernized with AI as well as certain other questions.
