ISSN Print: 1050-6934
Volumes:Volume 27, 2017 Volume 26, 2016 Volume 25, 2015 Volume 24, 2014 Volume 23, 2013 Volume 22, 2012 Volume 21, 2011 Volume 20, 2010 Volume 19, 2009 Volume 18, 2008 Volume 17, 2007 Volume 16, 2006 Volume 15, 2005 Volume 14, 2004 Volume 13, 2003 Volume 12, 2002 Volume 11, 2001 Volume 10, 2000
Journal of Long-Term Effects of Medical Implants
Abstract of "Translating Evidence from the Technical to the Social for Regulatory Approval"
Janice E. Graham
Technoscience and Regulation Research Unit, Department of Pediatrics (Infectious Diseases), Faculty of Medicine, Dalhousie University, Halifax, NS, Canada B3H 4R2
Social, technical, and moral issues surround the construction and interpretation of research data and how scientific evidence is used to arrive at regulatory and policy decisions. When a new pharmaceutical or biological agent receives its federal market approval in Canada, i.e., a Notice of Compliance, the public assumes that the product is safe, effective, and of consistent quality. When provincial committees refuse to fund these same products, citizens are understandably confused. Our newspapers regularly feature stories about patients seeking treatments outside of their own jurisdictions, and of inequities and access issues associated with different formulary decisions. Using longitudinal ethnographic data and techniques and analytical tools from anthropology, science and technology studies, and epidemiological critical appraisal, this paper compares scientific evidence to policy decisions at various sites of the pharmaceuticals life cycle and regulatory process. Structural constraints at each level of the therapeutic product life cycle, many of which are neither transparent nor subject to accountability, lead to different weights given to evidence. Conclusion: This succeeds in altering the essential balance of risks and harms used in working out the details of a decision. Variability in negotiation, in assessing the science, and in public pressure result in differences of opinion regarding what new therapies will be accessible. Issues of public involvement, corporate drivers, clinical judgment, political will, and scientific evidence are involved. The scientific and policy nuances of premarket product approval along with the wider implications to understanding the current shift toward emphasizing postmarket regulatory follow-up are addressed.
|Begell Digital Portal||Begell Digital Library||eBooks||Journals||References & Proceedings||Research Collections|