FDA To Use AI In Drug Approvals To 'Radically Increase Efficiency'

The FDA plans to use AI to 'radically increase efficiency' in deciding whether to approve new drugs and devices, drawing on lessons from Operation Warp Speed to reduce review times to weeks. The plan was laid out in an article published Tuesday in JAMA. The New York Times reports: Another initiative involves a review of chemicals and other 'concerning ingredients' that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

Last week, the agency introduced Elsa, an artificial intelligence 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 A.I. held the promise to 'radically increase efficiency' in examining as many as 500,000 pages submitted for approval decisions.

Current and former health officials said the A.I. 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 that 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.

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