Public Disclosure of Advisory Committee Members' Financial Interests and Waivers
This guidance outlines FDA's procedures for public disclosure of financial interests and waivers for FDA advisory committee members. It applies to special Government employees (SGEs) and regular Government employees participating in FDA advisory committee meetings subject to the Federal Advisory Committee Act (FACA).
Recommended Actions
- Implement process to collect and review financial interest information from advisory committee members
- Develop templates for documenting financial interest disclosures and waivers
- Establish procedure for timely posting of disclosure documents on FDA website
- Create process for member acknowledgment of public disclosure of financial interests
- Set up system to track timing requirements for disclosure postings
- Implement confidentiality review process to protect sensitive commercial information
- Develop procedure for posting committee member rosters with briefing materials
- Create process to handle late-discovered conflicts of interest
- Establish documentation system for waiver determinations and justifications
Key Considerations
Other considerations
- Financial interests must be disclosed for advisory committee members and their immediate family
- The type, nature, and magnitude of financial interests requiring waivers must be publicly disclosed
- Disclosure documents must be posted on FDA’s website at least 15 days before meetings
- For conflicts discovered less than 30 days before meetings, disclosure must be made no later than the meeting day
- Waivers must be based on determination that need for service outweighs potential conflicts
- Protected/confidential commercial information will not be disclosed except when necessary to describe waived conflicts
- A roster of committee members must be posted when briefing materials are made available
Relevant Guidances
- Public Participation in Open Public Hearing Sessions of Advisory Committee Meetings
- Procedures for Medical Devices Advisory Committee Panel Meetings
- Evaluating Appearance Issues and Granting Participation Authorizations for Advisory Committee Members (Draft)
Related references and norms
- 5 CFR Part 2640: Interpretation, Exemptions and Waiver Guidance Concerning 18 U.S.C. 208 (Acts Affecting a Personal Financial Interest)
- 5 CFR Part 2634: Executive Branch Financial Disclosure, Qualified Trusts, and Certificates of Divestiture
Original guidance
- Public Disclosure of Advisory Committee Members’ Financial Interests and Waivers
- HTML / PDF
- Issue date: 2014-02-28
- Last changed date: 2019-04-20
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Dietary Supplements, Drugs, Animal & Veterinary, Food & Color Additives, Biologics, Cosmetics, Advisory Committees
- ReguVirta summary file ID: 48908fd3e1c6733491393cc3dd83b99f
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