Hostname: page-component-7bb8b95d7b-495rp Total loading time: 0 Render date: 2024-09-22T20:11:59.308Z Has data issue: false hasContentIssue false
  • English
  • Français

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
Get access Rights & Permissions [Opens in a new window]

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

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

2 For example see Ashby, Eric and Anderson, Mary, The Politics of Clean Air (Oxford: Oxford University Press, 1981)Google ScholarPubMed; Brickman, Ronald, Jasanoff, Sheila and Ilgen, Thomas, Controlling Chemicals: The politics of regulation in Europe and United States (Ithaca, NY: Cornell University Press, 1985)Google Scholar; Kelman, Steven, Regulating America, Regulating Sweden: A comparative study of occupational safety and health policy (Cambridge, MA: MIT Press, 1981)Google Scholar; Lundqvist, Lennart J., The Hare and the Tortoise: Clean air policies in the United States and Sweden (Ann Arbor: University of Michigan Press 1980)Google Scholar; Vogel, David, National Styles of Regulation: Environmental policy in Great Britain and the United States (Ithaca, NY: Cornell University Press, 1986)Google Scholar.

3 Hayward, Jack and Berki, Robert, State and Society in Contemporary Europe (Oxford: Robertson, 1979)Google Scholar.

4 Nye, Joseph, Zelikow, Philip and King, David (eds.), Why People Don't Trust Government (Cambridge, MA: Harvard University Press, 1997)Google Scholar.

5 Kasperson, Roger, Renn, Ortwin, Slovic, Paul et al., “The social amplification of risk: A conceptual framework”, 8 Risk Analysis (1988), pp. 177–187 CrossRefGoogle Scholar.

6 Lofstedt, Ragnar E. and Vogel, David, “The changing character of regulation: A comparison of Europe and the United States”, 21 Risk Analysis (2001), pp. 399–406 CrossRefGoogle ScholarPubMed.

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

8 Majone, Giandomenico and Everson, Michelle, “Institutional reform: Independent agencies, oversight, coordination and procedural control”, in DeSchutter, Olivier, Lebessis, Notis and Paterson, John (eds.), Governance in the European Union (Luxembourg: Office for the Official Publications of the European Communities, 2001)Google Scholar.

9 European Commission, European Governance: A white paper, COM 2001 428 Final (Brussels: European Commission, 2001)Google Scholar.

10 UK Strategy Unit, Risk: Improving Government's Capability to Handle Risk and Uncertainty-summary report (London: Strategy Unit, Cabinet Office, 2002)Google Scholar.

11 European Commission, European Governance: A white paper, COM 2001 428 Final (Brussels: European Commission 2001)Google Scholar.

12 UK Strategy Unit, Risk: Improving Government's Capability to Handle Risk and Uncertainty-summary report (London: Strategy Unit, Cabinet Office, 2002).

13 Fung, Archon, Graham, Mary and Weil, David, Full Disclosure: The perils and promise of transparency (Cambridge: Cambridge University Press, 2007)CrossRefGoogle Scholar and Graham, Mary, Democracy by Disclosure: The rise of technopopulism (Washington DC: Brookings Press, 2002)Google Scholar.

14 For examples see footnote 9.

15 UK Food Standards Agency, Consumer Attitudes Survey 2002 (London:UK FSA, 2003)Google Scholar.

16 Hilts, Philip J., Protecting America's Health: the FDA, business and one hundred years of regulation (New York: Knopf, 2003)Google Scholar.

17 Vagelos, Roy and Galambos, Louis, Medicine, Science and Merck (Cambridge: Cambridge University Press, 2004)CrossRefGoogle Scholar.

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

19 Brody, Howard, Hooked: Ethics, the medical profession and the pharmaceutical industry (Lanham, MD: Rowman and Littlefield, 2007)Google Scholar.

20 Ibid.

21 Nesi, Tom, Poison Pills: The untold story of the Vioxx drug scandal (New York, NY: St Martin's Press, 2008)Google Scholar.

22 Angell, Marcia, The Truth About the Drug Companies (New York, NY: Random House Trade Paperbacks, 2005)Google Scholar.

23 Alexander S.D. Spiers, „Save the FDA”, 330 BMJ (2005), at p. 308.

24 Avorn, Jerry, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs (New York, NY: Alfred A. Knopf, 2004 Google Scholar).

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

26 Chuck Grassley, Floor statement of U.S. Senator Chuck Grassley of Iowa, FDA Legislation, 26th July (2007).

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

28 US Food and Drug Administration, FDA Acts to strengthen the safety program for marketed drugs – FDA Statement (Rockville: FDA, 5th November 2004)Google Scholar.

29 Chuck Grassley, Opening Statement of U.S.Senator Chick Grassley of Iowa at the Hearing-FDA, Merck and Vioxx: Putting patient safety first? 18th November (2004).

30 Leavitt, Michael, Leavitt: reforms will improve oversight and openness at FDA (Washington DC: HHS, 15th February 2005)Google Scholar.

31 US Food and Drug Administration, FDA improvements in drug safety monitoring.-press release (Rockville, MD: FDA 2005)Google ScholarPubMed.

32 Bruce M. Psaty, Sworn testimony before House Committee on Oversight and Government Reform (6th June 2007).

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

34 US Food and Drug Administration, The Future of Drug Safetypromoting and protecting the health of the public-FDA's response to the Institute for Medicine's 2006 Report (Rockville, MD: US FDA, 2006)Google Scholar.

35 Psaty, Bruce M. and Charo, Alta, “FDA responds to Institute of Medicine Drug Safety Recommendations-In part”, 297(17) Journal of the American Medical Association (2007), at p. 1919 Google Scholar.

36 Psaty, Bruce M. and Korn, David, “Congress responds to the IOM drug safety report-in full”, 298(18) Journal of the American Medical Association (2007), p. 2185–2187 CrossRefGoogle ScholarPubMed.

37 Food and Drug Administration's Amendments Act Title IX: Section 921, Adverse drug reaction reports and postmarket safety (Washington DC: US Congress FDAAA 2007).

38 Ricardo Alonso-Zaldivar, “Senate Oks drug-safety bill”, Los Angeles Times, 21 September 2007, at p. A19.

39 Janet Woodcock, “FDA to post quarterly report of potential safety issues”, US FDA Press Release, 5 September 2008.

40 Burgess, Adam, Cellular Phones, Public Fears, and a Culture of Precaution (Cambridge: Cambridge University Press, 2003)Google Scholar.

41 Lofstedt, Ragnar E., “Risk communication: The Avandia case, a pilot study”, 3 Expert Review Pharmacology (2010), pp. 31–41 CrossRefGoogle ScholarPubMed.

42 Barry Meier, “For drug makers, a downside to full disclosure”, New York Times, 23 May 2007.

43 It must be stated that despite interviewer experience, interviewer bias may prove a limitation in the quality of the interviews conducted. For more information see Morgan, Millett Granger, Fischhoff, Baruch, Bostrom, Ann et al., Risk Communication: A Mental Models Approach (New York, NY: Cambridge University Press, 2002)Google Scholar.

44 It is important to note that while the interview locations chosen may not necessary mimic the natural environments where some people absorb health related information, the authors did not believe the different locations chosen to make a significant impact on survey responses.

45 Lofstedt, Ragnar E., “Public perceptions of the Mars sample return programme”, 19 Space Policy (2003), pp. 283–292 CrossRefGoogle Scholar.

46 Morgan, Millett Granger, Fischhoff, Baruch, Bostrom, Ann et al. Risk Communication: A Mental Models Approach (New York, NY: Cambridge University Press, 2002)Google Scholar.

47 Babbie, Earl, The Practice of Social Research (Florence, KY: Wadsworth Publishing, 1992)Google Scholar.

48 Harris Interactive, “Confidence in FDA hits new low, according to WSJ.com/Harris interactive study”, available on the Internet at <http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=1301> (last accessed 17 January 2012).

49 House of Lords, Select Committee on Science and Technology: Science and Society. 3rd Report (London: Stationary Office, 2000).

50 Harris Interactive, “2007a. Large numbers of people do not trust the institutions they identify as most responsible for drug safety”, available on the Internet at <http://www.harrisinteractive.com/news/allnewsbydate.asp?newsid=1216> (last accessed 17 January 2012).

51 Kasperson, Roger E., Renn, Ortwin, Slovic, Paul et al., “The social amplification of risk: A conceptual framework”, 8 Risk Analysis (1988), p. 177–187 CrossRefGoogle Scholar.

52 Pidgeon, Nick, Kasperson, Rorger E. and Slovic, Paul (eds.), The Social Amplification of Risk (Cambridge: Cambridge University Press, 2003)CrossRefGoogle Scholar.

53 Jared A. Favole, “FDA unveils list of 20 drugs in side-effect probes”, Wall Street Journal, 6th September 2008, at p.A4.

54 Kahneman, Daniel and Tversky, Amos, “Prospect Theory: An Analysis of Decision Under Risk”, 47 Econometrica (1979), p. 263–291 CrossRefGoogle Scholar.

55 FDA Risk Communication Advisory Committee, “Minutes of Public Advisory Committee Meeting. August 14-15 2008”, available on the Internet at <http://www.fda.gov/ohrms/dockets/ac/oc08.html#RCAC> (last accessed 17 January 2012).

56 Seligman, Paul, “In Food and Drug Administration”, FDA Communication of Drug Safety Information. (Rockville, MD: FDA, 7th December 2005)Google Scholar.

57 Galson, Steven, “Remarks made at the US Food and Drug Administration Centre for Drug Evaluation and Research”, FDA’S Communication of Drug Safety Information, (Rockville, MD: FDA, 2008), at p. 8.Google Scholar

58 US Food and Drug Administration, Guidance: Drug safety information-FDA's communication to the public (Rockville, MD: FDA, 2007)Google Scholar.

59 US Food and Drug Administration, FDA Announces new advisory committee to address risk communication (Rockville, MD: US FDA, 2007)Google Scholar.

60 Harris Interactive. “Confidence in FDA hits new low, according to WSJ.com/Harris interactive study”, available on the Internet at <http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=1301> (last accessed on 17 January 2012).

61 Chuck Grassley, “Floor statement of U.S. Senator Chuck Grassley of Iowa”, FDA Legislation (26th July 2007).

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

63 UK Food Standards Agency, Consumer Attitudes Survey 2002 (London: UK FSA, 2003)Google Scholar.

64 Hood, Christopher, “Transparency in historical perspective”, in Hood, Christopher and Heald, David (eds.), Transparency: The key to better governance?, Proceedings of the British Academy, vol. 135, p. 3–23 Google Scholar.

65 O’Neill, Onora, A Question of Trust: The BBC Reith lectures 2002 (Cambridge: Cambridge University Press, 2002)Google Scholar.

66 O’Neill, Onora, “Transparency and the ethics of communication”, in Hood, Christopher and Heald, David (eds.), Transparency: The key to better governance?, Proceedings of the British Academy Vol. 135, p. 75–90 Google Scholar.

67 Horton, Richard, MMR Science and Fiction: Exploring the vaccine crisis (London: Granta, 2004)Google Scholar.

68 Fisher, Robert J., “Social Desirability Bias and the Validity of Indirect Questioning”, 20(2) The Journal of Consumer Research (1993), at p. 303 CrossRefGoogle Scholar.

69 Lofstedt, Ragnar E., “The Avandia case, a pilot study”, 3 Expert Review Pharmacology (2010), pp. 31–41 CrossRefGoogle ScholarPubMed.

70 Ibid.

71 Fisher, Robert J., “Social Desirability Bias and the Validity of Indirect Questioning”, 20(2) The Journal of Consumer Research (1993), at p. 303.2CrossRefGoogle Scholar

72 Dawes, Robyn, “Judgment and choice”, in Gilbert, Daniel, Fiske, Susan and Lindzey, Gardner (eds.), Handbook of Social Psychology (New York: McGraw and Hill, 1998)Google Scholar.

73 Osterberg, Lars and Blaschke, Terrence, „Adherence to Medication”, 353 New England Journal of Medicine (2005), pp. 487–497 CrossRefGoogle ScholarPubMed.

74 Paul Slovic, The Perception of Risk (London: Earthscan 2000). Aliya Sternstein, “FDA's web overhaul won't inform public, critics say”, National Journal's Technology Daily, 16 April 2007.

75 Tversky, Amos and Kahneman, Daniel, “Availability: A heuristic for judging frequency and probability”, 5 Cognitive Psychology (1973), pp. 207–232 CrossRefGoogle Scholar.

76 Tversky, Amos and Kahneman, Daniel, “Judgment under uncertainty: Heuristics and biases”, 185 Science (1974), pp. 1124–1131 CrossRefGoogle ScholarPubMed.

77 FDA Risk Communication Advisory Committee, “Minutes of Public Advisory Committee Meeting. August 14–15 2008”, available on the Internet at <http://www.fda.gov/ohrms/dockets/ac/oc08.html#RCAC> (last accessed 17 January 2012).

78 Slovic, Paul, “Perceived risk, trust and democracy”, 13 Risk Analysis (1993), pp. 675–682 CrossRefGoogle Scholar.

79 Fischhoff, Baruch, “Risk perception and communication unplugged: Twenty years of process”, 15 Risk Analysis (1995), pp. 137–145 CrossRefGoogle ScholarPubMed.