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The Food and Drug Administration’s top officials say the public health agency will prioritize “harnessing big data” and “unleashing AI” to streamline operations as mass layoffs unfold.
FDA Commissioner Martin A. Makary and vaccine czar Vinay Prasad said Tuesday that a technological reboot is needed to correct the U.S. medical system’s “50-year failure” to stop the spread of chronic childhood illnesses.
“Rethinking our approach to AI, balancing safety and accuracy while fueling innovation, is a leading FDA priority,” Drs. Makary and Prasad wrote in a column for the Journal of the American Medical Association.
The two physicians blamed “our increasingly chemically-manipulated diet” — including talc in candy and petroleum-based food coloring that’s “meant to attract attention from children” — as the top cause of a chronic disease epidemic.
They pledged to use cloud-based computer systems to monitor real-time food safety issues related to chronic diseases.
Their column also touted a first-of-its-kind, generative AI scientific review pilot program introduced in May. They said expanding the pilot program would reduce the need for animal testing, cut the time needed to approve medicines from years to weeks and encourage innovation in products like baby formula.
The Trump administration has embarked on a whole-of-government effort to “make America healthy again” by rolling back access to years of FDA-approved food products.
At the same time, it has announced plans to lay off 3,500 scientists across all FDA divisions as part of a broader effort to downsize the federal government. Roughly 18,000 people work at the federal agency.
Critics have accused the White House of undermining its public health goals by removing many of the people responsible for reviewing the safety of drugs, vaccines, tobacco products and food ingredients.
In a statement to The Washington Times, an FDA spokesperson said that Drs. Makary and Prasad wrote their column “to clearly articulate … how we will use gold-standard science and common sense” to “rethink our processes.”
“The American public deserves a stronger, more efficient FDA that advances both modern medicine and the MAHA agenda,” the statement reads. “AI unleashes the potential for new efficiencies, enabling FDA experts to invest their time and resources into previously untapped, overlooked, or neglected areas that are important to ushering in a new era of public health protection and innovation.”
The spokesperson said the administration is “bringing in top scientific minds to re-evaluate what is broken at the FDA and how to fix it.”
“Our goals are simple: deliver more cures and meaningful treatments to the American public, healthier food for children, and approaches to rebuild the public trust,” the statement adds.
Drs. Makary and Prasad noted in their column that 40% of U.S. children now have a chronic medical condition, 1 in 6 has a neurodevelopmental disorder and the nation’s life expectancy has plateaued despite years of massive public health expenditures.
They also noted that early onset Alzheimer’s disease has grown by 300% as obesity, diabetes, colon cancer, depression and autoimmune diseases have surged in young people in recent decades.
“Historical and comparative global data do not support a genetic etiology for this rise, nor a deficit in will power,” they wrote. “Fresh new ideas are needed to address root causes and develop innovative approaches.”
Their column touted recent FDA efforts to remove chemical dyes, ultraprocessed ingredients, cheap additives and environmental toxins from food products that they said “paralleled the epidemic of chronic disease” as corporations introduced them in recent decades.
“We will transition from a purely reactionary health care system to one that is proactive, intellectually curious about underlying causes, and financially aligned to promote health — not just treat sickness,” Drs. Makary and Prasad wrote. “At the same time, the FDA must have the courage to create new pathways for therapeutic and device developers to respond to the current forest fire that is the worsening health of the US population. We will rapidly usher to market new products with transformational potential.”