The ability to alter the genes of future generations no longer belongs in the realm of science fiction. The genetic modification capabilities of modern science are advancing rapidly. Mitochondrial replacement therapy (MRT) represents the first crossing of the germline barrier in humans, and as of February 2015, it is the first procedure of its kind to be legalized in the Western world. How Congress decides to regulate MRT will influence future regulation of all genetic manipulation technologies. This brief argues that the current patchwork regulatory framework established in the United States is insufficient to deal with the complex issues MRT presents. As such, the creation of a new regulatory agency specifically focused on the oversight of reproductive and genetic biotechnologies may be necessary to balance the goals of ensuring the safety of research participants, promoting public debate, and stimulating continued scientific progress.
Bob Zhao, Mitochondrial Replacement Therapy and the Regulation of Reproductive Genetic Technologies in the United States, 15 Duke Law & Technology Review 121-138 (2017)