Synthetic Biology in the FDA Realm: Toward Productive Oversight Assessment.

Abstract

Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and diagnostics subject to regulatory oversight by the United States Food and Drug Administration. At the same time, there is substantial basis for concern about the uncertainties of accurately assessing the human health and environmental risks of such SB products. As such, SB is the latest in a string of emerging technologies that is the subject of calls for new approaches to regulation and oversight that involve "thinking ahead" to anticipate governance challenges upstream of technological development and adopting oversight mechanisms that are both adaptive to new information about risks and reflexive to performance data and feedback on policy outcomes over time. These new approaches constitute a marked departure from the status quo, and their development and implementation will require considerable time, resources, and reallocation of responsibilities. Furthermore, in order to develop an appropriate oversight response, adaptive or otherwise, there is first a need to identify the specific types and natures of applications, uncertainties, and regulatory issues that are likely to pose oversight challenges. This article presents our vision for a Productive Oversight Assessment (POA) approach in which the abilities and deficits of an oversight system are evaluated with the aim of enabling productive decisions (i.e., timely, feasible, effective for achieving desired policy outcomes) about oversight while also building capacity to facilitate broader governance efforts. The value ofPOA is two-fold. First, it will advance the development of a generalizable approach for making productive planning and decision-making about the oversight of any given new technology that presents challenges and uncertainties for any given oversight system whose policy goals are implicated by that technology. Second, this effort can enhance the very processes advocated under anticipatory and adaptive approaches by laying the groundwork for and providing valuable data to support future normative deliberations about the governance of emerging technologies.