FDA looks to AI to enhance efficiency

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The agency plays a central role in pursuing the agenda of the US health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration's efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.
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Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that AI is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.
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'I don't want to be dismissive of speeding reviews at the FDA,' said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. 'I think that there is great potential here, but I'm not seeing the beef yet.'
A major AI rollout closely follows the release of a report by Kennedy's MAHA Commission, which uses an acronym for Make America Healthy Again, that was found to be rife with references to scientific research apparently fabricated by an AI program.
For some cases, the FDA officials proposed speeding major drug approvals by requiring only one major study in patients rather than two, a practice the agency has used in recent years. The pandemic provided a precedent, they said, for accelerating the process.
'We believe this is clear demonstration that rapid or instant reviews are possible,' Makary and Prasad wrote.
But Holland pointed out that during the pandemic, many staff members were transferred from routine duties, including overseas inspections of food or drug facilities, and reassigned to hasten critical COVID product reviews.
The agency was also better staffed. In recent months, the FDA shed about 1,940 employees, reducing the workforce to 8,000 from roughly 10,000.
Last week, the agency introduced Elsa, an AI large-language model similar to ChatGPT. The FDA said it could be used to prioritize which food or drug facilities to inspect, to describe side effects in drug safety summaries and to perform other basic product-review tasks. The FDA officials wrote that AI held the promise to 'radically increase efficiency' in examining as many as 500,000 pages submitted for approval decisions.
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Current and former health officials said the AI tool was helpful but far from transformative. For one, the model limits the number of characters that can be reviewed, meaning it is unable to do some rote data analysis tasks. Its results must be checked carefully, so far saving little time.
Staff members said the model was hallucinating, or producing false information. Employees can ask the Elsa model to summarize text or act as an expert in a particular field of medicine.
Makary said the AI models were not being trained by data submitted by the drug or medical device industry.
When it comes to food oversight, Makary and Prasad said there would be a renewed focus on 'our increasingly chemically manipulated diet,' a goal embraced by Republicans and Democrats. 'For all additives,' the article said, 'the benefit-to-harm balance must be reevaluated.'
Although the Trump administration is seeking steep cuts in the FDA's budget for the next fiscal year, the food division is expected to receive additional funds.
Others noted the fine line agency officials were walking, given Kennedy's complaints that the FDA is too close to the drug industry and the Trump administration's business-friendly approach.
Makary and Prasad wrote that the FDA must be 'partners with industry' while avoiding 'a cozy relationship that has characterized the agency in the past.'
Dr. Reshma Ramachandran, a director of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency, pointed out that Makary and Prasad were going on a six-city, closed-door listening tour to meet with chief executives of the drug industry.
'How is this guarding the agency 'against a cozy relationship' with industry?' she asked. The FDA priorities 'read as though they're straight out of PhRMA's playbook,' she said, referring to the trade group.
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