FDA’s new ‘plausible mechanism pathway’ for personalized gene editing raises concerns

FDA’s new ‘plausible mechanism pathway’ for personalized gene editing raises concerns

When Baby KJ was introduced to the world last year as the first recipient of a personalized gene-editing treatment, the logical next question was: How can we get to more Baby KJs?  In November, six months after KJ’s debut, top Food and Drug Administration officials Marty Makary and Vinay Prasad published a paper in the New England Journal of Medicine laying out  a “Plausible Mechanism Pathway,” for approval of personalized gene editing treatment…