Post

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).

Posted
By ReguVirta
3 min read

What You Need to Know? 👇

What are the disclosure requirements for FDA advisory committee members with financial interests?

FDA requires public disclosure of the type, nature, and magnitude of financial interests for advisory committee members who receive waivers under 18 U.S.C. § 208. This includes personal, family, and imputed interests related to the meeting’s subject matter.

When must FDA post financial disclosure information and waivers on their website?

FDA must post disclosure statements and waivers at least 15 days before advisory committee meetings. For conflicts discovered less than 30 days prior, documents must be posted as soon as practicable but no later than the meeting day.

What types of financial interests must be disclosed by advisory committee members?

Disclosed interests include stocks/investments, employment, consulting work, contracts/grants, patents/royalties, expert witness work, and teaching/speaking engagements. Both personal/family interests and imputed interests through employers or board positions must be reported.

Under what circumstances can FDA grant waivers for conflicted advisory committee members?

FDA can grant waivers under 18 U.S.C. § 208(b)(1) if financial interests aren’t substantial enough to affect integrity, or under § 208(b)(3) if the individual’s expertise outweighs potential conflicts. The public health benefit must justify participation.

What information is protected from public disclosure in FDA advisory committee processes?

Information exempt under the Freedom of Information Act, confidential commercial information, and other statutorily protected data remain confidential. However, FDA may disclose protected information if necessary to describe the waived financial conflict’s nature.

How does FDA categorize the magnitude of financial interests in disclosure documents?

Personal/family interests are categorized as: $0-5,000, $5,001-10,000, $10,001-25,000, or $25,001-50,000. Other imputed interests use ranges of: $0-50,000, $50,001-100,000, $100,001-300,000, or over $300,000.

What You Need to Do 👇

  1. Implement process to collect and review financial interest information from advisory committee members
  2. Develop templates for documenting financial interest disclosures and waivers
  3. Establish procedure for timely posting of disclosure documents on FDA website
  4. Create process for member acknowledgment of public disclosure of financial interests
  5. Set up system to track timing requirements for disclosure postings
  6. Implement confidentiality review process to protect sensitive commercial information
  7. Develop procedure for posting committee member rosters with briefing materials
  8. Create process to handle late-discovered conflicts of interest
  9. 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 🔗

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 ID: 48908fd3e1c6733491393cc3dd83b99f
FDA guidance, Final
Radiation-Emitting Products Tobacco Medical Devices Food & Beverages Dietary Supplements Drugs Animal & Veterinary Food & Color Additives Biologics Cosmetics Advisory Committees
This post is licensed under CC BY 4.0 by the author.