Human genome editing has become a reality and is here to stay. A logical question that follows, therefore, is whether the government should regulate the technology and, if so, what precise measures should be adopted to promote or hinder technological development. This chapter focuses on those questions at the intersection of human genome editing—specifically, germline genome editing (GGE) —and administrative law. The chapter highlights the FDA’s role as the agency in charge of protecting the public health by ensuring the safety and efficacy of human drugs and biological products, as well as shepherding scientific discoveries into the clinical realm. By examining precedents in gene therapy and stem-cell interventions, which are likely relevant to GGE, the chapter identifies regulatory gaps and proposes a novel regulatory framework for future GGE interventions. The chapter further frames the regulatory discussion in the context of an existing de facto legislative GGE ban, which prohibits the FDA from reviewing investigational uses of GGE technology in human embryos. Lastly, the chapter argues that the current legislative ban creates more societal costs than benefits, and it increases the likelihood that GGE technologies will be forced to develop in jurisdictions where regulatory systems may be inadequate from social and ethical standpoints.

The United States does not yet have a comprehensive legal regime to manage germline editing. However, the US Congress, which appropriates funds annually to support the Food and Drug Administration (FDA), has enacted a rider that prevents the agency from using those funds to receive applications for clinical trials. In this manner, Congress has imposed a de facto moratorium that prevents scientists from creating children with modified genomes. In most of the fifty states, scientists remain free to edit human gametes and embryos in the lab as long as they mind federal regulations governing research.In the future, Congress and state legislatures may ban germline editing, in whole or in part. Such bans may face legal challenges. To be sure, the United States has not ratified the International Covenant on Economic, Social and Cultural Rights, and is not bound by its requirement that parties respect scientific freedom. Nor does the US Constitution expressly state a right to engage in scientific research. However, some academics argue that such a right can be derived from the First Amendment. Further, those who cannot conceive a healthy child without germline editing may claim that a ban violates their constitutional right to privacy.