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

C.P. Milne, Joyce Tait

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

In governing the life sciences, there is a need to foster innovation, but also to control risk. While the scientific complexity and public unease with new healthcare technologies typically proscribe industry self-regulation, overly burdensome regulatory regimes can thwart the speed of innovation and the diversity of innovators necessary for a high-tech field to sustain itself. The premise of this article is that FDA has two programs, the orphan product and fast track programs for biopharmaceuticals, which serve as useful models of a regulatory system evolving towards a so-called ‘governance’ approach, which is characterized by push-pull incentives and a problem-solving philosophy. However, in this case, it also demonstrates features of old-style command-and-control ‘government,’ but with more control, and less command. The authors’ analysis presents evidence that these programs are exemplars of “what works.”
Original languageEnglish
Pages (from-to)733-753
JournalFood and Drug Law Journal
Volume64
Issue number4
Publication statusPublished - Nov 2009

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