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

Sheryl Lawrence  
 

Abstract:
This year, 2006, marks the centennial anniversary of the Pure Food and Drug Act, the precursor to the current Federal Food, Drug, and Cosmetics Act, and the twentieth anniversary of the Coordinated Framework for the Regulation of Biotechnology.  These are two of 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 existing life form.  The innovative nature of these transgenic products challenges fundamental assumptions of the FDCA and of 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 by entirely different pathways.  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 products.  However, basing the 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 product that present potential risk.  In addition, many of transgenic organisms will present both food and drug usage possibilities, creating a strong potential for duplicative regulatory efforts, and for widespread unapproved uses of a product once it becomes commercially available.  The FDCA and the Coordinated Framework also assume that genetically modified products do not inherently pose risks of environmental harm requiring regulatory oversight.  Thus, by focusing on classification as either a food or drug as a prerequisite for regulatory review by the FDA, the door is left open for products intended for other uses, such as for industrial use or family pet use, to enter the marketplace unregulated.  Experience with transgenic crops and fish demonstrates the inadequacy of containment measures for both transgenic plants and animals, highlighting real risks to ecology, to native species, and to other life forms posed by the introduction of the novel creatures into the wild.  While the Coordinated Framework embraces the idea that existing statutory authority is adequate for biotechnology regulation, twenty years of experience shows that this concept is too inflexible, and existing laws too weak, to adequately address the challenges of biotech regulation today.  This paper will consider the available options for addressing these flaws in the FDCA and the Coordinated Framework.  The FDA’s experience in creating an Office of Combination Products in 2002, for the regulation of conventional medical products, is considered as a model for change in the regulatory landscape implicated by advances in technology.  With tactical change, the FDCA and the Coordinated Framework can ensure that all products of genetic modification receive appropriate regulatory oversight, regardless of the intended use or the novelty of the product itself.