The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal worker layoffs.
The administration wants to “radically increase efficiency” using the burgeoning technology, according to a new article published in the Journal of the American Medical Association (JAMA) outlining the agency’s priorities. The department’s plan includes using artificial intelligence to examine device and drug applications, which would reportedly shave years off of the approval process, as well as AI computational modeling to reduce animal testing. The plan also proposes requiring just one major patient study to facilitate approvals, part of an overhaul of “legacy” processes.
The article cites the success of COVID-19’s Operation Warp Speed as precedent for diminished release timelines, but many professionals remain skeptical. “Rethinking our approach to AI, balancing safety and accuracy while fueling innovation, is a leading FDA priority… The FDA and our great medical profession should unite to consider fresh new approaches to the evolving health topics facing the US today.” the report reads. “The FDA will take conflict of interest seriously.”
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The article was authored by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), and Commissioner of Food and Drugs Martin A. Makary. Prasad and Makary have backed the department overhaul touted by U.S. Secretary of Health and Human Services Robert F. Kennedy, Jr. Kennedy has been on the offensive against the nation’s scientists and physicians, labelling the FDA “a sock puppet of industry,” clearing the Centers for Disease Control and Prevention (CDC)’s vaccine advisory committee, and pushing for a generative AI overhaul.
In May, the FDA launched its first AI-assisted scientific review pilot, intended to “reduce the amount of non-productive busywork” for FDA scientists and subject matter experts, according to Makary. That same month, experts admonished a report by Kennedy’s Make America Healthy Again initiative that was allegedly riddled with fake studies and incorrect citations possibly produced by artificial intelligence.
