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Not a Unique Challenge Anymore

Officials from the US National Institutes of Health and the Food and Drug Administration have proposed changing regulations put in place to oversee gene therapy trials, the Associated Press reports.

When gene therapy was first proposed in the 1990s, NIH set up a special panel called the Recombinant DNA Advisory Committee (RAC) to evaluate studies and their potential risks, as the field was viewed as having its own special concerns, the AP adds. But in the New England Journal of Medicine, NIH Director Francis Collins and FDA Commissioner Scott Gottlieb say that gene therapy doesn't seem to warrant such special oversight anymore and that the existing clinical trial framework can oversee such studies.

"Although scientific and safety challenges do remain — improving gene-transfer and gene-editing efficiencies, addressing immune responses and cytokine release syndrome, and in the case of gene editing, delivery and off-target effects — the robust clinical research oversight system already accommodates for the fact that each field of research has associated unique challenges," the pair writes.

A notice appearing in the Federal Register Friday proposes making changes to eliminate some duplicative oversight as well as modify the role of the RAC.

Johns Hopkins University's Jeffrey Kahn tells the AP the change is in line with recommendations the Institute of Medicine made a few years ago. "We have mechanisms in place to protect patients," he adds. "It doesn't need to be treated as a special case of clinical research any longer."