TY - JOUR
T1 - Evolution Along the Government-Governance Continuum
T2 - FDA's Orphan Products and Fast Track Programs as Exemplars of "What Works" for Innovation and Regulation
AU - Milne, C.P.
AU - Tait, Joyce
PY - 2009/11
Y1 - 2009/11
N2 - 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.”
AB - 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.”
UR - http://www.scopus.com/inward/record.url?scp=73949116749&partnerID=8YFLogxK
M3 - Article
VL - 64
SP - 733
EP - 753
JO - Food and Drug Law Journal
JF - Food and Drug Law Journal
IS - 4
ER -