The Food and Drug Administration (FDA) in the United States has announced an ambitious timeline to implement artificial intelligence (AI) across all its centres by 30 June, following the successful completion of its first AI-assisted scientific review.

FDA commissioner Marty Makary highlighted the urgency of modernising drug approval processes: "Why does it take over 10 years for a new drug to come to market? Why are we not modernised with AI and other things? We've just completed our first AI-assisted scientific review for a product and that's just the beginning."

The agency has directed all its centres to begin deployment immediately, with the goal of full integration within two months. According to the FDA, the generative AI tools will allow scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.

"This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days," said Jinzhong Liu, deputy director of the Office of Drug Evaluation Sciences in FDA's Center for Drug Evaluation and Research.

Robert Califf, former FDA commissioner, noted that the agency's review teams have been using 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," he said.

The agency-wide rollout is being coordinated by Jeremy Walsh, the FDA's newly appointed chief artificial intelligence officer, and Sridhar Mantha, who previously led the Office of Business Informatics in the Center for Drug Evaluation and Research.

"There have been years of talk about AI capabilities in frameworks, conferences and panels but we cannot afford to keep talking. It is time to take action. The opportunity to reduce tasks that once took days to just minutes is too important to delay," Makary stated.

Separately, Wired magazine has reported that the FDA has been in discussions with OpenAI about potentially using AI in drug evaluations. According to their sources, a small team from OpenAI has met with the FDA and associates of Elon Musk's non-governmental Department of Government Efficiency to discuss a project called cderGPT, though no contract has been signed.

The FDA plans to share additional details and updates on its AI initiative publicly in June.

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