Feds Will End Extra Regulations For Gene Therapy Experiments Due To 2017 Successes, 700 Pending Proposals
Federal health officials said Wednesday they will be ending extra regulations that govern gene therapy experiments, as the technique has become a proven way to treat health problems by editing patients’ DNA.
The Food and Drug Administration (FDA) and National Institutes of Health (NIH) will reduce NIH’s role in the gene therapy application process to an “advisory” position, according to a notice filed Thursday as a public inspection document, set to be officially published Friday. The move will streamline the current process in which both agencies examine and approve applications for clinical trials separately, reported the Associated Press.
The FDA will follow the same approval process for gene therapy experiments it uses for other treatments, reported the AP.
The proposal comes after three gene therapies to treat cancer and blindness exited the trial phase and were approved in 2017. More than 700 gene therapy trial proposals are pending review, reported the AP.
NIH director Dr. Francis Collins and FDA head Dr. Scott Gottlieb detailed the proposal, which will be implemented after a 60-day public comment period, in an article in the New England Journal of Medicine Wednesday.
“In the view of the senior leaders of the FDA and the NIH, there is no longer sufficient evidence to claim that the risks of gene therapy are entirely unique and unpredictable—or that the field still requires special oversight that falls outside our existing framework for ensuring safety,” Collins and Gottlieb wrote.
Gottlieb said in June that he hopes 40 gene therapies will be FDA-approved by 2022, according to BioSpace.
Some experts in the science community are warning that gene therapy can still be risky. A teenage patient died in a gene therapy trial in 1999, prompting the NIH to create a special committee on the treatment’s potential risks. A recent 12-patient trial for a hemophilia gene therapy treatment had mostly good results, but sent one patient to the hospital. (RELATED: Scientists Are Hopeful About Gene Therapy To Cure People Who Thought They’d Have Hemophilia Forever)
“This is not the right time to be making any moves based on the idea that we know what the risks are,” Stanford bioethicist Mildred Cho said, according to the AP.
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