Tide is turning!$
By Jocelyn Kaiser Thursday, May 22, 2014 - 4:45pm
In a milestone for the field of gene therapy, the National Institutes of Health (NIH) will no longer subject all proposed gene therapy clinical trials to review by a special federal advisory committee.
“Given the progress in the field, I am confident that the existing regulatory authorities can effectively review most gene transfer protocols and that a streamlined process will reduce duplication and delays in getting gene transfer trials initiated,” said NIH Director Francis Collins in a statement today. Instead, the 40-year-old Recombinant DNA Advisory Committee (RAC) will review only a few trials that pose special risks.
Originally created to review all gene transfer experiments, the RAC in the late 1980s shifted its focus mainly to gene therapy trials. The committee selects about 20% of submitted protocols for discussion at public meetings.
As the field has matured and gene therapy has been used to treat disorders such as inherited blindness and immune deficiencies, researchers have argued that the risks are no different than those of other experimental treatments. They point out that they must already go through reviews by institutional ethics and biosafety boards and the U.S. Food and Drug Administration. RAC review is redundant and slows progress, argued the American Society of Gene & Cell Therapy.
Sentiment: Strong Buy