The FDA is swallowing AI to speed up the drug approval process

The FDA is rapidly deploying artificial intelligence across its operations in an ambitious effort to transform drug review processes. This government-wide push toward AI integration showcases both the potential efficiency gains and inherent risks of implementing generative AI in highly regulated environments where scientific accuracy is paramount and errors could have significant public health implications.

The big picture: The FDA has announced immediate implementation of AI tools across all centers following a generative AI pilot program for scientific reviewers, with full agency-wide integration mandated by June 30.

• The agency is promoting the technology as a way to accelerate drug reviews by automating repetitive scientific tasks that previously required days of manual work.
• This aggressive timeline for deploying AI across the entire agency raises questions about appropriate testing, validation, and safeguards against AI hallucinations in critical scientific review processes.

What they’re saying: FDA officials are touting dramatic efficiency improvements from their initial AI implementation experience.

• “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, a deputy director in the FDA’s Center for Drug Evaluation and Research.
• FDA commissioner Martin Makary has directed all FDA centers to achieve “full AI integration” with a “common, secure generative AI system integrated with FDA’s internal data platforms” by the end of June.

Behind the scenes: The FDA’s AI initiative appears to have connections to private sector AI developers and government efficiency advocates.

• According to Wired reporting, representatives from OpenAI met multiple times with FDA officials and associates from Elon Musk‘s “Department of Government Efficiency” regarding a project called “cderGPT.”
• The FDA’s official announcement notably omits any mention of OpenAI’s involvement, despite these reported meetings.

Why this matters: The FDA’s rapid AI adoption represents one of the most significant deployments of generative AI in federal regulatory science, potentially establishing precedents for how AI tools are implemented in high-stakes government decision-making processes.