A joint conflict-of-interest study by FDA and the University of Maryland will survey attendees at the agency's April Circulatory System Devices Advisory Panel and National Mammography Quality Assurance Advisory Committee meetings, according to the project's primary investigator.

University of Maryland Department of Communication Assistant Professor Katherine McComas, PhD, whose research focuses on communication between scientific and lay audiences within the context of risk communication and public participation in policy-making, was approached about the topic in 2001 by FDA's Linda Suydam - then the agency's senior associate commissioner for communications & constituent relations.

After becoming familiar with McComas' research, concerns about how conflict-of-interest considerations influence the perceived credibility of FDA advisory committee meetings and subsequent satisfaction with the agency's policy decisions led Suydam to suggest the CoI topic.

McComas agreed to undertake the project, and initial funding was granted in July 2001 for a pilot study and interviews with panel members.

Sponsored by the University of Maryland and FDA's Joint Institute for Food Safety & Applied Nutrition (JIFSAN), the project is now being administered at the agency by Advisory Committee Council Chair Linda Sherman, following Suydam's departure in June 2002 (¹ Also see "FDA Management Hierarchy Under Crawford Takes Shape; Alderson Elevated" - Medtech Insight, 13 May, 2002., p. 24).

In an effort to "understand what people know and think about the procedures that the FDA uses to monitor and manage real or potential conflicts of interest [in] its advisory committee process," the study will survey attendees at panels from the agency's major centers over the next three months, according to McComas.

Surveys were first distributed March 12 to CDER's Oncologic Drugs Advisory Committee and at CBER's Blood Products Advisory Committee meeting March 13. In the device arena, the circulatory and mammography panel participants will be the first to be surveyed - on April 10 and 28, respectively.

With a high number of panelists having CoIs, the circulatory committee could provide an interesting proving ground for the survey.

Entitled "Investigating the Perceived Credibility of FDA's Advisory Committee Meetings as Techniques for Communicating about Food, Drug, Biologics, and Medical Device Issues," the project is based on the hypothesis that potentially negative perceptions regarding FDA's advisory panel CoI waiver process could be mitigated if it were better understood by participants.

The project will determine the degree to which knowledge of the waiver process influences perceptions of impartiality, FDA says.

Although the committees have been a principal component of the FDA regulatory decision-making process for years, the panels have "recently received criticism regarding the impartiality of its pool of experts," the abstract for the project states.

In February 2002, the agency released a draft guidance announcing it would be disclosing the extent and magnitude of panel members' conflicts of interest (² Also see "Cancer Imaging Tech Forum May Lead To Further FDA/CMS Collaboration" - Medtech Insight, 4 February, 2002., p. 3).

Upon completion, the agency hopes study findings will "comprise a scientific foundation on which to build future communication efforts aimed at improving credibility and satisfaction." McComas expects FDA will use her data internally to "help identify ways to improve participant satisfaction with the FDA advisory committee process."

The project's research design includes the use of questionnaires, focus groups and participant-observation at advisory committee meetings. The 15-minute, voluntary survey is confidential and seeks to gauge respondents' familiarity with CoI procedures and concerns about their fairness.

The survey will further examine participants' feelings about panel members from different areas, drawing comparisons between opinions on panelists from academia, industry, particular FDA committees and the agency in general.

Moreover, the project will include interviews with FDA officials and experts who have served on advisory committees, as well as a content analysis of media coverage of the agency's panels.

McComas will publish her results in a professional journal in the next 12 months and will make her findings available to interested survey respondents.

The results should prove useful for groups like the Center for Science in the Public Interest, which in a March 10 letter called for regulations governing federal advisory panels to require full disclosure of financial interests and industry associations.

Addressed to Office of Government Ethics Director Amy Comstock, the letter urges establishment of "uniform guidelines across all federal agencies to strengthen the independence, transparency and public trust in the federal advisory committee process."

The letter's recommendations, aimed at improving guidelines for keeping committees free from CoIs, are motivated in part by recent perceptions of the Bush administration's politicization of scientific advisory committees (³ Also see "HHS Genetics Panel Replaces SACGT; Thompson Defends Membership Rules" - Medtech Insight, 28 October, 2002., p. 9). "Weak ethics rules can lead to excessive corporate representation on key committees...and skewed public policies," CSPI writes.

The letter draws attention to the shortcomings of the Federal Advisory Committee Act (FACA), suggesting existing CoI loopholes. One involves the distinction between panel members who are special government employees (SGEs) and "representatives" - members expected to present the "particular bias" of an NGO or trade association, and therefore are not required to disclose financial interests.

The document also recommends broadening the scope of financial information to be reported on OGE Form 450, the standardized method used by executive branch employees to disclose financial interests. The form needs to "request information on certain direct and indirect ties that create potentially biasing conflicts of interest," CSPI asserts.

Direct ties, such as a research grant to a scientist, and indirect ties, such as grant support to a committee nominee's university center, are examples.

Recommending the promotion of public participation in the committee selection process, the CSPI letter applauds the National Academy of Sciences for routinely providing "the public the opportunity to comment on appointments to its study committees in accordance with requirements under the 1997 amendments to FACA." Sen. Edward Kennedy (D-Mass.) questioned incoming FDA Commissioner Mark McClellan about applying the NAS medium to the agency during his confirmation hearing (⁴ Also see "McClellan Outlines Vision For Device User Fees, Third-Party Inspections" - Medtech Insight, 14 October, 2002., p. 3).

FDA Tags Academic Researcher To Probe Advisory Panel Conflicts Of Interest

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