FDA will now assess gene therapy experiments and products as it does with other treatments, drugs
THURSDAY, Aug. 16, 2018 (HealthDay News) — A U.S. National Institutes of Health oversight panel will no longer review all applications for gene therapy experiments, according to a perspective piece published online Aug. 15 in the New England Journal of Medicine.
Instead, the panel will assume an advisory role, while the U.S. Food and Drug Administration will assess gene therapy experiments and products as it does with other treatments and drugs.
When the NIH panel of independent experts was created, there were numerous safety concerns and scientific unknowns about gene therapy. But it is now an established field of medical care with no extraordinary risks, according to health officials. It’s time for the FDA to review gene therapy proposals on its own without duplication of regulatory oversight, according to NIH Director Francis Collins, M.D., Ph.D., and FDA Commissioner Scott Gottlieb, M.D., the authors of the perspective piece.
There are more than 700 proposals for gene therapy in the pipeline, and “it seems reasonable to envision a day when gene therapy will be a mainstay of treatment for many diseases,” Collins and Gottlieb write. “The tools we use to address other areas of science are now well suited to gene therapy.”
NIH Statement
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