Legal Issues Related to Human Germline Genome Editing in the United States

Zusammenfassung

Genome editing is a tool, not a specific drug, device or biological therapy. The United States regulates most technologies by regulating their development and use in the context of a particular application, rather than by regulating the technology itself. By way of example, the emerging field of nanotechnology is the subject of national-level policy with regard to strategic planning for basic science research. But if it were used for foods, the food would be subject to existing food regulations, and the nanotechnology would be incorporated into the analysis of risks and benefits. The same would be true if it were used for drugs. Therefore, one cannot really speak of the “law of genome editing” but rather one must look at it in each of its areas of use and identify the relevant existing law. In some cases, the use of an emerging technology may make existing law difficult to apply, for example where the technology blurs the line between definitional categories such as drug or device. In these cases, new interpretation of older law will be needed. But overall, one examines the field in the context of the applications.

The substance of much of this material may also be found in the 2017 report of the National Academies of Sciences, Engineering and Medicine, entitled “Human Genome Editing: Science, Ethics and Governance.”.

Acronyms: HHS: Department of Health and Human Services; FDA: Food and Drug Administration (a unit of HHS); IND: Investigational New Drug exemption (granted by FDA); NIH: National Institutes of Health (a unit of HHS); RAC: Recombinant DNA Advisory Committee (an NIH activity); IBC: Institutional Biosafety Committee; IRB: Institutional Review Board; IACUC: Institutional Animal Care and Use Committee; IVF: in vitro fertilization; PGD: preimplantation genetic diagnosis