The trick for regulators is to massage existing regulations to fit gene therapy, he said. Research and practice of gene therapy is regulated by the Food and Drug Administration. The NIH is technically not a regulatory agency, although it performs certain regulatory functions. And since the RAC was not created by Congress, it has no statutory authority. The advantage of this system, Wivel said, is that the NIH can change its guidelines quickly to meet the demands of rapidly changing science.
Years can go by and nothing can happen.
So the challenge is to apply current statutory authority to somatic cell gene therapy and apply it just as you would with antibiotics. The Federal Drug Administration reviews are conducted in a closed forum because information regarding drug development is considered proprietary. The FDA regulates the construction of containment facilities for research, standard operating procedures and calibration of equipment. At the urging of AIDS activists, the NIH and FDA review new protocols simultaneously to expedite the process. Fallout of the Gelsinger case After the death of Jesse Gelsinger, the Senate conducted hearings in which both the NIH and the FDA were stringently criticized.