It's Time to End RAC Review of Gene Therapy Protocols

Abstract

The recent recommendation of the Board of Directors of the American Society of Gene and Cell Therapy that the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC) end its review of clinical protocols in human gene therapy and human gene marking is a welcome and necessary step in the continuing evolution of the oversight of clinical gene therapy.1 In the late 1980s and early 1990s, the RAC and the Division of Cell and Gene Therapy of the Center for Biologics Evaluation and Research at the US Food and Drug Administration (FDA) met often in informal sessions following RAC meetings to discuss and review various aspects of clinical trials in gene marking and therapy. Indeed, RAC review was a productive part of the process when these early gene transfer protocols were being considered. This pooling of expertise was a completely new approach to therapeutics that greatly aided both groups. However, owing in large part to the emergence of a strong and capable full-time group devoted to cell and gene therapy within the FDA, RAC review is no longer necessary.