The US Food and Drug Administration (FDA) plans to rely more heavily on artificial intelligence to streamline the review of new drugs and medical devices, part of a sweeping set of priorities aimed at increasing the agency’s efficiency, according to an article published Tuesday in JAMA, the New York Times reported.
The agenda also includes a renewed effort to review chemicals and additives in U.S. food, many of which are banned in other developed countries. In addition, officials want to accelerate the final stages of approval decisions for drugs and devices to just a matter of weeks—drawing inspiration from the rapid reviews seen during Operation Warp Speed at the height of the Covid pandemic.
“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,” wrote Dr. Marty Makary, the agency’s commissioner, and Dr. Vinay Prasad, head of the division that oversees vaccines and gene therapy, in JAMA.
Ambitious goals, but AI’s role sparks skepticism
FDA leaders say artificial intelligence has the potential to “radically increase efficiency” when analysing the vast volumes of data—often more than 500,000 pages—that companies submit with their approval applications. Last week, the agency introduced Elsa, an AI language model similar to ChatGPT, that could help prioritize facility inspections, summarize drug safety data, and perform other review-related tasks.
But some experts are skeptical of claims that AI can meaningfully speed the review of complex new drugs and high-risk medical devices. “I think that there is great potential here, but I’m not seeing the beef yet,” said Stephen Holland, a former health adviser to the House Energy and Commerce Committee.
FDA staffers have also reported that Elsa is prone to hallucination—producing inaccurate information—and has significant limitations in its ability to process large amounts of data. Officials say the AI model is not being trained on data submitted by industry applicants.
Lessons from the pandemic—and warnings about staffing
FDA officials believe their Covid-era experience demonstrated that fast-track approvals are possible. The agency proposes that in some cases, it could approve drugs based on a single major clinical trial rather than two, as has been done for certain treatments in recent years.
Yet critics note that the pandemic’s accelerated reviews were made possible in part by shifting staff away from other duties, such as inspections of overseas manufacturing facilities. The FDA was also better staffed then; in recent months, it has lost about 1,940 employees, shrinking its workforce to roughly 8,000.
Renewed focus on food chemicals and additives
The FDA’s new priorities include re-evaluating chemicals in the U.S. food supply—a goal that has bipartisan support. “For all additives, the benefit-to-harm balance must be re-evaluated,” the agency leaders wrote.
The Trump administration has proposed deep cuts to the FDA’s overall budget, but the agency’s food division is expected to receive additional funding. The FDA has already begun urging manufacturers to phase out artificial food dyes.
Navigating industry relationships under political pressure
Balancing public trust with industry engagement remains a challenge. Dr Makary and Dr Prasad emphasized that the FDA must be “partners with industry” without falling into the “cozy relationship” that has drawn criticism in the past. But some observers are wary.
Dr Reshma Ramachandran of Yale’s Collaboration for Regulatory Rigor, Integrity and Transparency noted that the FDA leadership is embarking on a closed-door, six-city listening tour with pharmaceutical industry CEOs.
“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 industry trade group.
As the FDA pushes forward with its ambitious new road map, the balance between faster approvals, public trust, and regulatory rigor will remain under close scrutiny.
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