Transparency and the Food and Drug Administration—A Quantitative Study

Abstract

In Europe and North America, there is increasing political pressure being put on health regulatory agencies to become more transparent. To date, however, there has been little academic evaluation—let alone analysis—of these transparency initiatives from a risk communication perspective. This review examines whether the U.S. Food and Drug Administration's Adverse Event Reporting System quarterly signal postings, put in place after the passage of the Food and Drug Administration Amendments Act 2007, will assist patients and doctors in their decision-making processes, on the basis of results of a quantitative Internet survey of 433 physicians and 1,000 American adults. The results indicate that there is significant disagreement between physicians and the public about when medical safety issues should be communicated in the first place, with physicians opposed to early signal postings while the public in general is in favor. In addition the findings show that if the public were to find their drugs listed on the Adverse Event Reporting System signals web postings, more than a quarter would stop taking their medicine. Going forward, the Food and Drug Administration needs to work to a greater degree with social scientists in developing scientific-based communication strategies, rather than developing transparency initiatives on the basis of stakeholder consultations.

Acknowledgments

In conducting this research, the authors received materials, assistance, and advice from the Dutch Medicines Evaluation Board, Eli Lilly, the European Medicines Agency, the Irish Medicines Board, Roche, the Swedish Medical Products Agency, the U.K. Medicines and Healthcare Products Agency, and the U.S. Food and Drug Administration. The funding of this paper was provided in part by grants from Dutch Royal Academy of Sciences, Eli Lilly, and Roche. The authors received additional travel grants from the Dutch Medicines Evaluation Board and from the Swedish Medical Products Agency. The authors are grateful to the following individuals who provided materials for this study or who commented on earlier drafts of this article: Jane Alqvist, Alasdair Breckenridge, Baruch Fischhoff, Hans Georg Eichler, Andrew Jack, Deborah Szafir, as well as officials from the Dutch Medicines Evaluation Board, the European Medicines Agency, Marketing Research Services Inc., the Swedish Medical Products Agency, the U.K. Medicines and Healthcare Products Agency, and the U.S. Food and Drug Administration.

Notes

¹The survey produced some 37 pages of results which were shared with the U.S. Food and Drug Administration on two occasions, with the Swedish Medical Products Agency, and the Dutch Medicines Evaluation Board. Of all the results made available, individuals at the three agencies focused most of their attention on the policy relevance associated with the two tables discussed in this review.