Evaluating Appearance Issues and Granting Participation Authorizations for Advisory Committee Members (DRAFT)
This guidance outlines FDA's process for evaluating appearance issues and granting authorizations for participation in FDA advisory committees. It applies to special government employees (SGEs) and regular government employees (RGEs) serving on FDA advisory committees subject to the Federal Advisory Committee Act (FACA). The guidance focuses on circumstances that may create the appearance of lacking impartiality, even when there are no direct financial conflicts of interest.
This is a draft guidance. Not for implementation.
Recommended Actions
- Implement screening process to identify potential appearance issues before committee meetings
- Require members to complete Form FDA 3410 disclosing relevant interests and relationships
- Evaluate reported interests against criteria for appearance issues:
- Direct financial effects on household members
- Covered relationships with parties
- Other impartiality concerns
- For identified appearance issues, assess whether to grant authorization based on:
- Nature and timing of relationship
- Financial impact
- Member’s expertise and role
- Matter sensitivity
- Alternative experts
- Possible duty adjustments
- Document authorization decisions with clear rationale based on evaluated factors
- Consider implementing partial participation restrictions when appropriate to manage appearance concerns
- Maintain records of all appearance issue evaluations and authorization decisions
- Provide training to members on appearance issue reporting requirements and evaluation process
Key Considerations
Other considerations
- Members must report any interests related to the subject matter of the meeting on Form FDA 3410
- Appearance issues arise when:
- The matter has direct and predictable effect on financial interests of member’s household
- Person/entity with whom member has “covered relationship” is party to the matter
- Other circumstances raising questions about member’s impartiality
- FDA evaluates factors like:
- Public Disclosure of Advisory Committee Members’ Financial Interests and Waivers
- Public Participation in Open Public Hearing Sessions of Advisory Committee Meetings
Related references and norms
- 5 CFR § 2635.502: Standards of ethical conduct for employees of the executive branch
Original guidance
- Evaluating Appearance Issues and Granting Participation Authorizations for Advisory Committee Members
- HTML / PDF
- Issue date: 2016-06-29
- Last changed date: 2024-10-01
- Status: DRAFT
- Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Drugs, Biologics, Advisory Committees
- ReguVirta summary file ID: 1ef5f6279d0fc04bfae2ffb7cb8132a7
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