Hostname: page-component-745bb68f8f-l4dxg Total loading time: 0 Render date: 2025-01-09T21:05:45.995Z Has data issue: false hasContentIssue false
  • English
  • Français

Regulatory Transparency: Forthcoming Lessons from the FDA

Published online by Cambridge University Press:  20 January 2017

Sweta Chakraborty  and
Ragnar E. Lofstedt
Ragnar E. Lofstedt
Affiliation:
King's College London
Get access Rights & Permissions [Opens in a new window]

Abstract

This section discusses issues related to risk communication across a range of publicly perceived high-risk industries (such as pharmaceuticals, nuclear, oil, etc.). It reports critically and provides analysis on risk communication as an outcome of risk research within these industries. Contributions are intended to include methods working towards the advancement of risk perception research and describe any lessons learned for successfully communicating to the public about risk.

Type
Reports
Information
European Journal of Risk Regulation , Volume 1 , Issue 2 , June 2010 , pp. 159 - 162
Copyright
Copyright © Cambridge University Press 2010

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1 Lofstedt, R. E., “Risk communication and management in the twenty-first century”, International Public Management Journal (2004), Vol. 7, pp. 335–346 Google Scholar.

2 Nye, J. S. Jr., Zelikow, P. D. and King, D. C. (eds), Why People Don’t Trust Government (Cambridge, MA: Harvard University Press, 1997)Google Scholar.

3 Lofstedt, R. E. and Vogel, D., “The changing character of regulation: A comparison of Europe and the United States”, Risk Analysis (2001), Vol. 21, pp. 399–406 CrossRefGoogle ScholarPubMed; Lofstedt, R. E., “The impact of the Cox-2 inhibitor issue on perceptions of the pharmaceutical industry: Content analysis and communication implications”, Journal of Health Communication (2007), Vol. 12, pp. 471–491 CrossRefGoogle Scholar.

4 Kasperson, R. E., Renn, O., Slovic, P. et al., “The social amplification of risk: A conceptual framework”, Risk Analysis (1988), Vol. 8, pp. 177–187 CrossRefGoogle Scholar.

5 European Commission (2001), “European Governance: A white paper”, COM 2001, 428 Final (Brussels: European Commission); Lofstedt, R. E., “Risk communication and management in the twenty-first century”, International Public Management Journal (2004), Vol. 7, pp. 335–346 Google Scholar; UK Strategy Unit (2002), “Risk: Improving Government's Capability to Handle Risk and Uncertainty –summary report” (London: Strategy Unit, Cabinet Office).

6 European Commission (2001), “European Governance: A white paper”, COM 2001, 428 Final (Brussels: European Commission); UK Strategy Unit (2002), “Risk: Improving Government's Capability to Handle Risk and Uncertainty –summary report” (London: Strategy Unit, Cabinet Office).

7 Fung, A., Graham, M. and Weil, D., Full Disclosure: The perils and promise of transparency (Cambridge: Cambridge University Press, 2007)CrossRefGoogle Scholar; Graham, M., Democracy by Disclosure: The rise of technopopulism (Washington DC: Brookings Press, 2002)Google Scholar.

8 C. Bombardier, L. Laine et al. (2000), Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis, 343: 1520–1528.

9 J. Graham, “FDA, Merck and Vioxx: Putting Patient Safety First?”, Senate Finance Committee Hearing, 20 November 2004.

10 Lofstedt, R. E., “The impact of the Cox-2 inhibitor issue on perceptions of the pharmaceutical industry: Content analysis and communication implications” (2007), Journal of Health Communication, Vol. 12, pp. 471–491 CrossRefGoogle Scholar.

11 Abbasi, K., “Is drug regulation failing?” (2004), BMJ, 329: 865 CrossRefGoogle Scholar; Lenzer, J., “FDA is incapable of protecting US ‘against another Vioxx’” (2004), BMJ, 329: 1253 CrossRefGoogle Scholar; M. Herper, “Face Of The Year: David Graham” (2006), Forbes.com, 2007, available on the Internet at <http://www.forbes.com/2004/12/13/cx_mh_1213faceoftheyear.html>.

12 Horton, R., “Vioxx, the implosion of Merck, and aftershocks at the FDA” (2005), The Lancet, 364(9450): 1995–1996 CrossRefGoogle Scholar.

13 Avorn, J., Powerful Medicines: The benefits, risks and costs of prescription drugs (New York, NY: Knopf, 2004)Google Scholar.

14 Abbasi, K., “Is drug regulation failing?” (2004), BMJ, 329: 865 CrossRefGoogle Scholar; Spiers, A.S.D., “Save the FDA” (2005), BMJ, 330: 308 CrossRefGoogle Scholar; Lofstedt, R. E., “The impact of the Cox-2 inhibitor issue on perceptions of the pharmaceutical industry: Content analysis and communication implications”, Journal of Health Communication (2007), Vol. 12, pp. 471–491 CrossRefGoogle Scholar.

15 Abbasi, K., “Is drug regulation failing?” (2004), BMJ, 329: 865 CrossRefGoogle Scholar.

16 Institute of Medicine, “The Future of Drug Safety: Promoting and protecting the health of the public” (Washington DC: National Academy of Sciences, 2006).

17 A. Breckenridge, Evidence given to the House of Commons Health Committee hearing. The Influence of the Pharmaceutical Industry, 20 January. In House of Commons, Health Committee. The Influence of the Pharmaceutical Industry. Evidence (London: Stationary Office, 2005), pp. Ev347–348.

18 Lexchin, J. and Mintzes, B., “Transparency in drug regulation: Mirage or oasis?”, Canadian Medical Association Journal (2004), Vol. 171, pp. 1363–1365 CrossRefGoogle ScholarPubMed.

19 Institute of Medicine, “The Future of Drug Safety: Promoting and protecting the health of the public” (Washington DC: National Academy of Sciences, 2006).

20 Lofstedt, R. E., “The impact of the Cox-2 inhibitor issue on perceptions of the pharmaceutical industry: Content analysis and communication implications”, Journal of Health Communication (2007), Vol. 12, pp. 471–491 CrossRefGoogle Scholar.

21 Psaty, B. M. and Korn, D., “Congress responds to the IOM drug safety report-in full”, Journal of the American Medical Association (2007), Vol. 298, n. 18, pp. 2185–2187 CrossRefGoogle ScholarPubMed.

22 S. Chakraborty and R. Lofstedt, “Transparency and the FDA: Two Pilot Studies”, Working Paper.

23 MSRI (2010), “FDA Risk Communication Program Research”, Final Report, King's College London.

24 Chakraborty, S., “Ex-Post Pharmacovigilance and Trust: A Perspective”, 1(1) European Journal of Risk Regulation (2010), pp. 83–85 CrossRefGoogle Scholar.

25 S. Chakraborty and R. Lofstedt, “Transparency and the FDA: Two Pilot Studies”, Working Paper.

26 Abbasi, K., “Is drug regulation failing?” (2004), BMJ, 329: 865 CrossRefGoogle Scholar; Spiers, A.S.D., “Save the FDA” (2005), BMJ, 330: 308 CrossRefGoogle Scholar.

27 Vincenzo Salvatore, “Towards a new role for the European Medicines Agency in Pharmacovigilance?”, presented at the 1st Conference on European Risk Regulation “Latest Developments in EU Risk Regulation: REACH, Nanotech, and Pharmaceuticals”, 22 March 2010, Brussels, Belgium.