The Food and Drug Administration (FDA) is leveraging AI to tackle the challenges of prolonged approval timeframes, as the Trump administration enhances automation efforts amid numerous federal employee layoffs.
The administration seeks to “significantly boost efficiency” through this innovative technology, as highlighted in a recent article released in the Journal of the American Medical Association (JAMA) that outlines the agency’s key focus areas. The initiative encompasses the use of artificial intelligence to examine device and drug submissions, potentially shortening the approval duration by years, and utilizing AI computational modeling to decrease reliance on animal testing. It additionally proposes mandating a single major patient study to expedite approvals, as part of a reform of “legacy” systems.
The article notes the achievements of COVID-19’s Operation Warp Speed as a reference for expedited release schedules, although many professionals voice skepticism. “Reevaluating our strategy with AI, striking a balance between safety and precision while promoting innovation, is a top priority for the FDA… The FDA and our esteemed medical community must collaborate to explore new strategies addressing the evolving healthcare challenges in the US today,” the report indicates. “The FDA will address conflict of interest with seriousness.”
The article was penned by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), alongside Commissioner of Food and Drugs Martin A. Makary. Prasad and Makary endorse the departmental reform advocated by U.S. Secretary of Health and Human Services Robert F. Kennedy, Jr. Kennedy has criticized the nation’s scientists and doctors, labeling the FDA as “a puppet of industry,” approving the vaccine advisory committee of the Centers for Disease Control and Prevention (CDC), and calling for a generative AI transformation.
In May, the FDA initiated its first AI-assisted scientific review pilot project, aimed at “reducing the amount of unproductive busywork” for FDA scientists and subject matter experts, according to Makary. That same month, experts condemned a report from Kennedy’s Make America Healthy Again initiative, which was reportedly filled with fraudulent studies and erroneous citations potentially generated by artificial intelligence.