Healthy Skepticism Library item: 14210

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Demortain D.
From drug crises to regulatory change: The mediation of expertise
Health, Risk & Society 2008 Feb; 10:(1):37-51
http://www.tandf.co.uk/journals/journal.asp?issn=1369-8575&linktype=9

Abstract:

This paper deals with the relation between regulatory crises and regulatory change. It considers the
question of whether factors that explain how accidents or disasters escalate into a regulatory crisis also explain subsequent reforms. Looking at the evolution of post-marketing drug safety and at the crisis caused by the discovery of the fatal effects and market withdrawal of the drug cerivastatin in 2001, it investigates the conditions in which shared solutions to a regulatory crisis emerge. It argues that regulatory change is a process by which existing or emerging technologies come to be framed as a solution to the crisis. Framing means aligning the actors of the regulatory space around common schemes of interpretations of what is needed to improve the regulatory framework. The case study points at the power of scientific and medical experts to foster such cognitive alignment.

Keywords:
Regulatory crisis, regulatory failure, regulatory change, medicines safety, post-marketing surveillance, cerivastatin, expertise, framing