Drugs

Clarifications Sought in Advisors Conflict Guidance

David McFarland

— 2 min read
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The Association of American Medical Colleges (AAMC) says that an FDA draft guidance on procedures for evaluating appearance issues and granting authorization for participation in FDA advisory committees would benefit from additional clarification. The association also says it is pleased that the agency drafted the document, which seeks to explain a process and application of law and regulation that is not well understood, especially by those members of the academic medicine community who seek or are asked to participate in FDA advisory committees as special government employees.

Clarifications recommended in the AAMC comment letter include: 

  •          provide a decision-tree or other step-by-step depiction of the decision-making process that identifies what information should be provided to FDA; what would trigger recusal and when required recusal can be waived; when and how an appearance issue would be identified; and under what circumstances an individual with an appearance issue but not financial conflict of interest would be given authorization to participate in the advisory committee or prohibited from participating;
  •          include an indication of what, if any, of the decision-making process will be documented by FDA and communicated to the member, who may not understand why authorizations were granted in some cases and not in others;
  •          voluntary disclosure of authorizations should not be recommended through the draft guidance or in FDA policy now without a clear and consistent process for its adoption.

Eight nonprofit organizations say they commend the agency for proposing guidance that would identify a wide range of circumstances involving interests and relationships that could create, at a minimum, the appearance of a conflict of interest and, therefore, could reasonably justify recusal of the member of an advisory committee.

But the groups—Center for Digital Democracy, Government Accountability Project, National Coalition Against Censorship, National Women’s Health Network, Project on Government Oversight, Public Citizen, Union of Concerned Scientists, and Woody Matters—also say that based on prior FDA actions and current agency policies in screening advisory committee members for appearances of a lack of impartiality, they have serious concerns about the agency’s actual practice implementing the catch-all category described as “other circumstances that may raise a question about the member’s impartiality.” The groups say they are concerned that the agency’s overly broad interpretation of the regulation would encourage it to continue “inappropriately excluding advisory committee members from participating in committee meetings based on an ‘intellectual bias,’ a phrase that does not appear in the draft guidance but that FDA now routinely uses … when screening individual advisory committee members for conflicts of interest prior to committee meeting.”

The advocacy groups say that “so-called intellectual bias and situations in which an advisory committee member is an employee of an organization, like Public Citizen, that has taken a position in writing on a matter or issue before the committee are not circumstances involving interests or relationships that fall within the scope of appearance issue…. We therefore urge FDA to immediately cease applying such considerations when screening advisory committee members for financial conflicts of interest and other relationships or interests that may create the appearance of a lack of impartiality. In addition, we urge FDA to revise the proposed guidance to explicitly state the agency does not consider such circumstances when evaluating advisory committee members for appearance issues”

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