FILE - In this Monday, Nov. 13, 2017 file photo, a nurse practitioner prepares to start the first human gene editing treatment for Hunter syndrome, an inherited metabolic disease, at a hospital in Oakland, Calif. On Wednesday, Aug. 15, 2018, federal officials said that gene therapy is becoming an established form of medical care and carries no special risks that warrant special regulation, as they revised rules for vetting such experiments and products. (AP Photo/Eric Risberg)

No special rules needed for now-common gene therapy studies

August 15, 2018 - 6:05 pm

U.S. health officials are eliminating special regulations for gene therapy experiments. They say that what was once exotic science is quickly becoming an established form of medical care with no extraordinary risks.

Gene therapy aims to get at the root cause of a disease by altering DNA rather than just treating symptoms of a genetic illness.

When it began decades ago, an oversight panel at the National Institutes of Health reviewed every proposal to evaluate risks to patients. Now federal officials say more is known about gene therapy's safety and the panel can take on a broader role and let the Food and Drug Administration review studies and products.

They announced the change Wednesday in an article in the New England Journal of Medicine.

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