This article explains how genetic surgery, exemplified by Baby KJ's case, differs from traditional gene therapy by offering personalized interventions for rare genetic diseases. It discusses the need for a new regulatory framework that allows for customized treatments without the lengthy approval processes currently required by the FDA. The author proposes a certification model for genetic surgery centers to streamline patient care and enhance treatment options.

The article discusses how advancements in AI are set to accelerate drug development, potentially leading to a significant increase in the number of drugs discovered. However, the FDA's current approval backlog may hinder the American public's access to these innovations. The piece also highlights the potential for repurposing existing drugs and emphasizes the need for the FDA to adapt to these changes in medicine.