ABSTRACT
Structured frameworks for benefit-risk analysis in drug licensing decisions are being implemented across a number of regulatory agencies worldwide. The aim of these frameworks is to aid the analysis and communication of the benefit-risk assessment throughout the development, evaluation, and supervision of medicines. In this review, authors from regulatory agencies, pharmaceutical companies, and academia share their views on the different frameworks and discuss future directions.
Subject(s)
Communication , Government Agencies/trends , Risk Assessment/trends , United States Food and Drug Administration/trends , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/epidemiology , Europe , Forecasting , Government Agencies/standards , Humans , Risk Assessment/methods , United States , United States Food and Drug Administration/standardsABSTRACT
European and U.S. regulatory policies have changed considerably over the past 30 years. In Europe, since the mid-1980s, consumer and environmental regulation has become more politically salient and regulations have by and large become stricter. On the other hand, in the United States consumer and environmental issues have become less salient and contentious, and regulations have not become (comparatively) stricter. This apparent "flip-flop" of regulatory systems has not been analyzed in much detail to date. This perspective is an attempt to analyze some examples in which it has occurred and identifies one possible cause--namely, credibility.
ABSTRACT
In light of the present day risk controversies such as global warming and hormones in beef, partially caused by a more globalized world, national differences and similarities in how to manage risks become increasingly important. In this brief "perspective" we focus on how risks are managed in three nations, namely Japan, Sweden, and the United States, specifically focusing on the roles of deliberation, risk analysis, and the importance of cultural factors.
