The Food and Drug Administration (FDA) is embracing artificial intelligence (AI) in a big way it seems. In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H. announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, following the completion of a new generative AI pilot for scientific reviewers.
“I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” said Dr. Makary.
The generative AI tools are meant to remove the tedium and repetition of tasks for the FDA scientists and subject-matter experts, thereby hopefully speeding up the review process.
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Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER), said that this was a game-changer technology that had enabled him to perform scientific review tasks in minutes that used to take three days.
Dr. Makary added that there have been years of talk about AI capabilities in frameworks, conferences and panels but that they could not afford to keep talking. That it was time to take action and that the opportunity to reduce tasks that once took days to just minutes was too important to delay.
The FDA is a U.S. government agency under the Department of Health and Human Services. It is responsible for protecting public health by ensuring the safety, effectiveness, and proper labeling of food, drugs, medical devices, vaccines, cosmetics, and tobacco products. The FDA regulates both human and veterinary products, and it plays a crucial role in approving new medicines and overseeing clinical trials. It also monitors food safety and addresses public health emergencies. Through science-based regulation and oversight, the FDA helps ensure that products used by millions of Americans are safe and beneficial to health.
The FDA is very enthusiastic to begin expanding its use of generative AI in its daily processes. Though some may wonder how efficient and credible generative AI could be if were to be used expansively within an organization like the FDA. AI still has its kinks, to overly rely on an evolving technology could cost the FDA its credibility down the line. Only time will tell how useful AI is to agencies like the FDA.