Regulating (for the Benefit of) Future Persons: A Different Perspective on the FDA's Jurisdiction to Regulate Human Reproductive Cloning

The goal of this Article is modest-to articulate the best argument for the FDA's legal jurisdiction over cloning. The Article argues that the FDA has jurisdiction to regulate cloning as a form of gene therapy. It demonstrates the scientific and regulatory similarities between gene therapy and cloning, and concludes that cloning is the ultimate form of gene therapy, in that it replaces not only one or a few genes but rather the entire genome. Further, the Article provides evidence demonstrating that the FDA has historically viewed its responsibility to assure safety and effectiveness to encompass the evaluation of harms to future persons who are potentially at risk from exposure to FDA regulated products prior to gestation or birth.