Inside the FDA's plans to embrace AI agencywide

OpenAI has been connecting with various companies in an effort to incorporate its generative artificial intelligence technology, and federal agencies are rumored to be part of that effort. While a contract with Open AI has yet to be confirmed, the Food and Drug Administration is suggesting that AI will be a part of its operations sooner rather than later.

FDA seeking 'aggressive' adoption of AI

The FDA announced an "aggressive timeline" to deploy artificial intelligence internally immediately, with full integration across all FDA centers by June 30, following the completion of a new generative AI pilot for scientific reviewers. FDA Commissioner Martin Makary was "blown away by the success of our first AI-assisted scientific review pilot," he said in the announcement. The agency needs to "reduce the amount of non-productive busywork that has historically consumed much of the review process." This aggressive agency-wide deployment of AI "holds tremendous promise in accelerating the review time for new therapies," said Makary.

The announcement came a day after Wired reported that the drug regulator, along with two associates of the Department of Government Efficiency, met with OpenAI several times to discuss the agency's use of AI. The meetings appeared to be "part of a broader effort at the FDA to use this technology to speed up the drug approval process," Wired said.

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"Why does it take over 10 years for a new drug to come to market?" Makary said on X. The comment came after an annual meeting of the American Hospital Association, where he pointed to AI's potential to facilitate the approval of new treatments for diabetes and some types of cancer. "Why are we not modernized with AI and other things?"

While OpenAI was not mentioned in the announcement of AI integration, sources close to the project said meetings with the company included discussions for a project named cderGPT. The project's name "likely stands for Center for Drug Evaluation," which "regulates over-the-counter and prescription drugs" and "Research GPT" Wired said. Jeremy Walsh, who was recently named as the FDA's first-ever AI officer, has reportedly led the discussions with OpenAI, but so far, "no contract has been signed."

'Broader trend of AI adoption in federal agencies'

There could be an upside to incorporating AI for the FDA. Using AI to assist in final drug reviews would "represent a chance to compress just a small part of the notoriously long drug-development timeline," said Wired. The majority of drugs "fail before ever coming up for FDA review."

Rafael Rosengarten, a cofounder of the Alliance for AI in Healthcare, is in favor of automating some tasks in the drug-review process but thinks there is a need for policy guidance around what kind of data is used to train AI models and what kind of model performance is considered acceptable. The machines are "incredibly adept at learning information," but they have to be "trained in a way so they're learning what we want them to learn," he said to Wired. AI could be used more immediately to address "low-hanging fruit," such as checking for application completeness. A step as "trivial as that could expedite the return of feedback to the submitters based on things that need to be addressed to make the application complete."

The FDA's announcement about embracing AI "parallels a broader trend of AI adoption in federal agencies during the Trump administration," said Futurism. In March, OpenAI introduced a version of its chatbot called ChatGPT Gov "designed to be secure enough to process sensitive government information." Elon Musk has "pushed to fast-track the development of another AI chatbot for the US General Services Administration," called GSAi. Still, said Futurism, the risks of "using the technology in a medical context are concerning, to say the least."