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By Katherine A. McComas, Dept. of Communication,
Cornell University and
Linda Ann Sherman, Chair of the FDA Advisory Committee Council
This document summarizes the findings of a study of attitudes and opinions of a sampling of people who attended FDA advisory committee meetings in the spring of 2003 and advisory committee members who participated in those meetings. The study's intent was to examine the perceived fairness and credibility of FDA advisory committee meetings related to FDA's management of real or potential conflicts of interest among advisory committee members. We also wanted to gain insight into knowledge about the FDA's conflict of interest procedures among audience members, as well as what audience members considered most important about advisory committee meetings. Finally, we measured audience and advisory committee member satisfaction with the FDA, its advisory committee meetings, and its conflict of interest procedures.
We took great efforts to ensure that the study was conducted in an unbiased manner and have tried to present the summary report as objectively as possible. The funding was provided by the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a University of Maryland/FDA collaborative research institute; however, the results should not be construed as representing the viewpoints of JIFSAN, FDA, or Cornell University. Questions about this report or the research should be directed to Katherine McComas, Dept. of Communication, 313 Kennedy Hall, Cornell University, Ithaca, New York, 14853; phone 607-255-06508; email firstname.lastname@example.org.
From March to July 2003, we distributed questionnaires on audience members' chairs at 11 FDA advisory committee meetings held in the Washington D.C. metropolitan area. Meetings were selected to represent the four largest FDA centers: the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Food Safety and Applied Nutrition (CFSAN). Each questionnaire contained a letter describing the research and soliciting participation and a business reply envelope. We encouraged participants to complete the questionnaire before leaving the meeting and drop it in the box marked "FDA Survey" at the meeting registration table; however, we also told them they could return the questionnaire at a later time in the business reply envelope. Responses were anonymous.
Of the questionnaires distributed, 273 were returned and included in the data analysis. To estimate response rates, we counted the number of non-FDA individuals sitting in the audience at several points during each meeting. (FDA employees typically wore official name tags and sat in a separate section.) We used the highest estimate of attendance to provide a conservative estimate of response rates. Table 1 lists the meetings used in this study, as well as the estimated response rates for audience members per meeting. Our intent was not to draw comparisons among meetings but to examine relationships among variables; therefore, having a statistically representative sample of responses from any particular meeting was unnecessary. Still, given the non-random sampling procedures and the likelihood of self-selection bias in responding to the questionnaire, it is important to underscore that our data should not be generalized to all individuals who attend FDA advisory committee meetings.
Table 1. Meetings and Estimated Response Rates for Audience Members
|Oncologic Drugs (CDER)||March 12-13||170||61||36%|
|Blood Products (CBER)||March 13-14||200||36||18%|
|Dietary Supplements (CFSAN)||March 25||27||14||52%|
|Circulatory System Devices (CDRH)||April 10||100||21||21%|
|National Mammography Quality Assurance (CDRH)||April 28||26||15||58%|
|Antiviral Drugs (CDER)||May 13-14||180||35||19%|
|Dental Products (CDRH)||May 22||17||4||24%|
|Cardio-Renal Drugs (CDER)||May 29-30||250||30||12%|
|Nonprescription Drugs (CDER)||June 12||25||8||32%|
|Endocrinologic and Metabolic Drugs (CDER)||July 9||175||22||13%|
|Transmissible Spongiform Encephalopathy (CBER)||July 17-18||150||27||18%|
|Overall Response Rate for Data Collection||1,320||273||21%|
|Average Response Rate for 11 Meetings||28%|
The first set of questions focused on audience members' knowledge of the FDA's conflict of interest procedures, attitudes about the fairness of FDA advisory committee meetings, tolerance toward real or potential conflicts of interest among advisory committee members, satisfaction with the FDA and its advisory committee process, and attitudes about disclosing committee members' real or potential conflicts of interest. Data were collected using 1 to 7 scales, from "strongly disagree" to "strongly agree." Tables 2 through 6 provide a percentage breakdown of responses to the questions.
Table 2. Audience Knowledge
Table 3. Audience Opinions Regarding the Fairness of FDA Advisory Committee Meetings
Table 4. Audience tolerance for Conflicts of
Among FDA Advisory Committee Members
Table 5. Audience Satisfaction
Table 6. Audience Opinions Regarding the Fairness of Disclosing Conflicts of Interest among Advisory Committee Members
We also asked audience members to rate the credibility of scientific information coming from four different sources: the FDA, industry scientists, academic scientists, and advisory committees. Figure 1 displays a chart showing the average credibility score each source received. The scale ranged from 5 to 25, with higher scores indicating higher credibility.
Figure 1. Audience Opinions Regarding the Credibility of Different Information Sources
We also invited audience members to tell us, on a scale of 1 to 7, what was important to them at advisory committee meetings. Figure 2 displays a chart illustrating their mean responses, with higher scores indicating greater importance. It is important to note that these aspects may not represent all of the aspects of advisory committee meetings that audience members consider important; however, below are the relative rankings of the list we provided to respondents.
Figure 2. Audience Opinions Regarding the Importance of Different Aspects of Advisory Committee Meetings
Note: "COI" is "conflict(s) of interest"
Finally, we asked some questions to let us know something about the audience members who responded to our survey. The results showed:
At each of the 11 meetings, the advisory committee executive secretaries permitted us to distribute questionnaires at the advisory committee member's seat. Each questionnaire included a letter describing the research and soliciting participation, as well as a business reply envelope. As with audience members, advisory committee members were encouraged to complete questionnaires before leaving the meeting and drop them in the "FDA Survey" box; however, they were also told they could return the questionnaire at a later time in the business reply envelope. Responses were anonymous.
Of questionnaires distributed, 92 were completed and returned. Table 7 lists the estimated response rates for advisory committee members per meeting. As with the audience data, given the non-random sampling procedures and the likelihood of self-selection bias in responding to the questionnaire, our data should not be generalized to all FDA advisory committee members.
Table 7. Meetings and Estimated Response Rates for AC Members
|Oncologic Drugs (CDER)||March 12 to13||16||11||69%|
|Blood Products (CBER)||March 13 to 14||12||11||92%|
|Dietary Supplements (CFSAN)||March 25||8||4||50%|
|Circulatory System Devices (CDRH)||April 10||12||7||58%|
|National Mammography Quality Assurance (CDRH)||April 28||13||8||62%|
|Antiviral Drugs (CDER)||May 13to 14||17||9||53%|
|Dental Products (CDRH)||May 22||8||8||100%|
|Cardio-Renal Drugs (CDER)||May 29to 30||14||8||57%|
|Nonprescription Drugs (CDER)||June 12||10||8||80%|
|Endocrinologic and Metabolic Drugs (CDER)||July 9||14||6||43%|
|Transmissible Spongiform Encephalopathy (CBER)||July 17 to 18||15||12||80%|
|Overall Response Rate for Data Collection||139||92||66%|
|Average Response Rate for 11 Meetings||68%|
The questionnaire for advisory committee members was shorter in length than the one distributed to audience members; however, the questions also related to the perceived impartiality of the advisory committee process and the fairness of FDA's conflict of interest procedures. Figure 3 provides the mean scores of responses to the seven primary questions. These questions were coded on a "strongly disagree" to "strongly agree" scale of 1 to 7, with higher scores indicating greater agreement.
Figure 3. Advisory Committee Member Opinions Regarding Advisory Committee Meetings and Conflict of Interest Procedures
Finally, we asked some questions to let us know something about the advisory committee members who responded to our survey. The results showed:
This report has provided a general overview of the survey results. For those interested in additional theoretical and methodological detail, the following publications and conference papers are available from Katherine McComas upon request:
The generosity of many individuals and organizations supported this project. This included JIFSAN, which provided the funding, Leah Simone Tuite, who was this project's graduate student research assistant, and Norman Porticella, who assisted with the compilation of this report. We also wish to express our sincere gratitude to individuals who completed a questionnaire or otherwise assisted with data collection. We are especially grateful to the members of the FDA Advisory Committee Council and the executive secretaries of the advisory committee meetings we attended.