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Transparency and the Food and Drug Administration--a quantitative study
Ragnar Lofstedt1, Frederic Bouder, Sweta Chakraborty
1King's Centre for Risk Management, Department of Geography, King's College London, London, United Kingdom. ragnar.lofstedt@kcl.ac.uk
Journal of Health Communication
|November 8, 2012
Summary
Physicians and the public disagree on when to release medical safety information. Early drug safety signal postings may cause patients to stop necessary medication, highlighting a need for better communication strategies.
Area of Science:
- Health communication
- Regulatory science
- Risk management
Background:
- Increasing political pressure on health regulatory agencies for transparency in Europe and North America.
- Limited academic evaluation of transparency initiatives from a risk communication perspective.
Purpose of the Study:
- To evaluate the U.S. Food and Drug Administration's Adverse Event Reporting System (AERS) quarterly signal postings.
- To determine if AERS signal postings assist patients and physicians in decision-making.
- To analyze differing views between the public and physicians on medical safety communication.
Main Methods:
- Quantitative internet survey of 433 physicians and 1,000 American adults.
- Analysis of transparency initiatives from a risk communication viewpoint.
Main Results:
- Significant disagreement exists between physicians and the public regarding the timing of medical safety issue communication.
- Physicians generally oppose early signal postings, while the public favors them.
- Over a quarter of the public would stop taking their medication if it appeared on AERS signal postings.
Conclusions:
- The U.S. Food and Drug Administration (FDA) needs to collaborate more with social scientists for evidence-based communication strategies.
- Transparency initiatives should be developed based on scientific communication principles, not solely stakeholder consultations.
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