What Would You Do with a Fluorescent Green Pig?: How Novel Transgenic Products Reveal Flaws in the Foundational Assumptions for the Regulation of Biotechnology

摘要

The Federal Food, Drug, and Cosmetics Act (FDCA) and the Coordinated Framework for the Regulation of Biotechnology are the primary federal tools for oversight of the products of genetic modification. Since their enactment, tremendous advancements in biotechnology have resulted in the creation of novel transgenic organisms, significantly unlike any pre-existing life form. The innovative nature of these transgenic products challenges fundamental assumptions of the FDCA and the Coordinated Framework. The first of these key assumptions is that the categories of "foods" and "drugs" are cleanly separable, and thus can be regulated through entirely different pathways. The FDCA and the Coordinated Framework also assume that genetically modified products do not pose inherent risks of environmental harm requiring regulatory oversight. On this basis, the United States has established a bifurcated system for the regulation of foods and drugs, in which drugs are subjected to much more rigorous scrutiny than food or industrial products. However, basing risk assessment for a novel transgenic organism on this classification places far too much weight on a distinction that is oblivious to the innate features of the transgenic product that present potential risk. Many transgenic organisms will present multiple usage possibilities, whether food, drug, or industrial, creating a strong potential for duplicative regulatory efforts, and for widespread unapproved uses of a product once it becomes commercially available. This focus on classification as a prerequisite for regulatory review by the Food and Drug Administration (FDA) also leaves the door open for creatures and products intended for industrial use, or as pets, to enter the marketplace without regulatory scrutiny. In addition, experience with transgenic organisms demonstrates the inadequacy of containment measures for both genetically modified plants and animals, highlighting real risks to ecology, to native species, and to other life forms posed by the unintended introduction of novel creatures into the wild. Twenty years of regulation has shown that the Coordinated Framework's regulatory structure is too inflexible, and the existing laws are too weak, to adequately address the challenges of biotechnology regulation today. To address faults in the existing regulatory structure, this Comment considers the FDA's creation of the Office of Combination Products to coordinate the regulation of interrelated classes of conventional medical products as a model for the development of a similar office overseeing the growth and marketing of genetically modified organisms and their derivative products. In addition, this Comment proposes amendments to the FDCA and the Coordinated Framework that identify and address the previously unforeseen risks presented by evolving advances in genetic engineering. Only by casting off the blinders of the Coordinated Framework and allowing federal regulators to seek out and consider the entirety of the risk potential of each novel transgenic organism can there be real confidence in the FDA's ability to broadly protect public health and safety in this amazing technological arena.