Re: Farmas USA
ZIOP
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FDA and NIH to loosen oversight of gene therapy development
Aug. 16, 2018 9:47 AM ET|By: Douglas W. House, SA News Editor
Citing the need to safely expedite the development of gene therapies and the rapid scientific advances related to the gene editing, the FDA and NIH are backing trimmed down oversight of relevant clinical trials, specifically eliminating the duplication of oversight related to initial study protocols, annual reports, amendments and serious adverse event reporting. Senior leaders in both organizations believe that there is no longer sufficient evidence to assert that the risks of gene therapy are entirely unique and unpredictable or that the field requires special oversight over and above the existing framework.
The changes, to be published in the Federal Register tomorrow, will further limit the role of NIH and the Recombinant DNA Advisory Committee (RAC), formed in 1974 to advise the NIH director on research related to the manipulation of nucleic acids, in assessing gene therapy protocols and the review of safety information. RAC review and reporting requirements to the NIH for human gene therapy protocols will be eliminated. The responsibilities of institutional BioSafety Committees (local research oversight) will also be revised making their human gene therapy protocols consistent with other research, subject to NIH Guidelines.
RAC will continue to advise the NIH on emerging biotechnologies.
