The U.S. Food and Drug Administration (FDA) is planning to incorporate artificial intelligence (AI) into its decision-making processes for various health-related fields, according to a recent article published in the Journal of the American Medical Association [1][2][3]. This move, while aimed at improving efficiency, has sparked concerns among experts in the scientific community.

Dr. Marty Makary, FDA Commissioner, and Dr. Vinay Prasad, Director of the Center for Biologics Evaluation and Research, co-authored the article outlining the potential applications of AI at the FDA. These include accelerating drug and device approvals, reducing animal testing, and addressing concerning ingredients in food [1][2][3].

However, the exact implementation of AI in FDA processes remains to be determined. This uncertainty has led to apprehension among health and science professionals [1][2][3].

Elisabeth Marnik, a scientist and science communicator based in Maine, expressed particular concern about this shift. Her worries stem from a recent incident where fake citations, likely due to unsystematic AI use, appeared in a Make America Healthy Again report [1][2][3].

The FDA's initiative comes at a time when AI's role in healthcare is under intense scrutiny. The potential benefits of faster decision-making and reduced animal testing are weighed against risks such as data reliability and the need for human oversight in critical health-related decisions.

As the FDA moves forward with its plans, the scientific community continues to debate the implications of AI integration in healthcare regulation. The coming months will likely see further discussions on how to balance technological advancement with the need for accuracy and safety in health-related decision-making.