The American Society of Gene & Cell Therapy (ASGCT) has sent a letter to the Director of the NIH Office of Biotechnology Activities (OBA) recommending that clinical trials involving the use of human gene therapy no longer need to inform the Recombinant DNA Advisory Committee (RAC) of the research. Reasons for this recommendation stem from a recent symposium where NIH Gene Therapy Symposium attendees called for “more effective and timely regulatory review of gene therapy protocols to ensure vital therapeutics are able to move efficiently from bench to bedside.”
Established in 1974 to oversee all gene splicing / gene therapy experimental protocols, the RAC’s mission changed in the 1990s to offering advice on trials instead of being a prerequisite for approval. Oversight is currently maintained by the FDA, and insitutional ethics and biosafety boards. ASGCT states that the two main fears of gene therapy, altering germline DNA or creating a novel pathogenic vector, have not been seen on over 1000 trials.
