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A missed opportunity for U.S. biotechnology regulation

Policy options for change were not on the table A rare policy window (1)—an opportunity for change that happens when problem, political, and policy streams come together—recently opened for biotechnology regulation in the United States: an explosion of genetic engineering (GE) techniques and products challenging federal oversight; intensifying public, media, and political attention; and a growing number of policy ideas for change. When the White House in summer 2015 called for a process to revisit the 1986 Coordinated Framework for the Regulation of Biotechnology (CFRB) (2–4), it was seen as an opportune moment to match biotechnology innovation with innovation in the design of a U.S. regulatory system. However, the White House's Office of Science and Technology Policy (OSTP) interagency process for reviewing the framework fell short in multiple ways. The process has prevented clarification and restructuring of the regulatory system, as well as opportunities to increase the legitimacy of that system in the eyes of the public and stakeholders.