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Transparency Initiative by the FDA’s Center for Drug Evaluation and Research (CDER): Two qualitative studies of Public Perceptions

Published online by Cambridge University Press:  20 January 2017

Sweta Chakraborty  and
Ragnar Lofstedt
Sweta Chakraborty
Affiliation:
Centre for Socio-Legal Studies (CSLS), University of Oxford
Ragnar Lofstedt
Affiliation:
King's Centre for Risk Management, King's College London
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Abstract

Recent calls for transparency targeted towards regulatory bodies such as the US Food and Drug Administration has prompted investigation into the indubitable adoption of such measures. Specifically, the FDA's quarterly postings of AERS (Adverse Event Reporting System) signals on its CDER (Center for Drug Evaluation and Research) website, stemming from FDAAA legislation introduced in September 2007, is analysed from a risk perception and communication perspective. This paper consists of two qualitative studies examining public perceptions and subsequent reported behaviour related to increased transparency. Interviews were conducted on two separate samples of seventy respondents in both Pittsburgh and New York City. The results found that signals postings may prove counter productive in terms of increased public alarm and early or inappropriate termination of a drug appearing on the list. We also found communication from the FDA perceived as inaccessible or confusing, particularly that the AERS signals are posted strictly on the web, while the majority of our respondents cited their primary and secondary media sources as broadcast television. We recommend that the FDA reconsider its communication strategy of AERS to the public as it may prove to be a ‘transparency step too far.’

Type
Articles
Information
European Journal of Risk Regulation , Volume 3 , Issue 1 , March 2012 , pp. 57 - 71
Copyright
Copyright © Cambridge University Press 2012

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