Evolution along the Government--Governance Continuum:FDA's Orphan Products and Fast Track Programs as Exemplars of 'What Works' for Innovation and Regulation

摘要

In recent decades a body of work in the social sciences has studied the way regulations work in the field of science, technology and innovation (STI). It has detected changes in the interaction of regulators with the regulated in terms of a movement away from top-down, command-and control "government" towards a new bottom-up "governance" approach that focuses on problem-solving rather than policy bargaining. Governance is the co-ordination of multiple actors to achieve policy goals such that the state no longer dominates the policy-making process and decisions are made by problem solving rather than bargaining. The nature of governance is enabling rather than constraining (i.e., carrots are preferred to sticks), and discriminating versus indiscriminate (i.e., eligibility requirements support socially desirable goals). The tools of governance range from "steering" (e.g., public information campaigns) to "rowing" (e.g., capacity-building programs).1