Gene therapy: US clinical trials imminent.

Abstract

Recent and anticipated policy announcements by the National Institutes of Health, the Office of Technology Assessment (OTA), and the Food and Drug Administration (FDA) are expected to permit research to proceed on human gene therapy experiments. A working group within NIH's Recombinant DNA Advisory Committee (RAC) has issued a draft of its guidelines, and OTA will shortly release its gene therapy study. An expected FDA announcement will classify recombinant DNA products for gene therapy as "biologicals," thereby necessitating FDA approval. No ethical objections to somatic cell therapy, as distinguished from germ cell therapy, were expressed by ethicists and religious leaders consulted by OTA or RAC.