FDA to use AI in drug approvals to ‘radically increase efficiency’

The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

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.

“The FDA will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

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.

“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.

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-19 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.

This article originally appeared in The New York Times.

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