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FDA Advisory Committees: 

Financial Conflicts of 

Interest Overview

Advisory Committee Oversight and Management Staff (ACOMS)

Office of Special Medical Programs, Office of the Commissioner, FDA

10903 New Hampshire Ave., WO32-5129

Silver Spring, MD 20993-0002

301-796-8220

www.fda.gov/advisorycommittees/default.htm
What is a “conflict of interest”?

• A conflict of interest, for the purposes of FDA Advisory 

Committees, occurs when an individual selected to serve 

on an advisory committee has financial interests that 

may be impacted by the individual’s work on the advisory 

committee.

• 18 U.S.C. 208(a) prohibits all employees, including 

Special Government Employees (SGEs) serving on 

advisory committees, from participating in any particular 

Government matter that will have a “direct and 

predictable effect” on their financial interests.

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What is a “conflict of interest”? (cont.)

• Financial interests include anything currently held that 

can financially impact the SGE or the interests of others 

with whom the SGE has a certain relationship, including 

the SGE’s spouse, minor children, business partners, 

employer, and organizations in which the individual 

serves as officer, director, or trustee.

– Examples include:

• Stocks;

• Bonds;

• Interests through ownership, partnership, LLC;

• Consulting arrangements;

• Grants or contracts; and

• Employment.

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How does the FDA determine if there is 

a conflict of interest?

• Prior to an advisory committee meeting, SGEs selected 

to serve on the advisory committee complete the FDA 

Form 3410, which identifies potential conflicting financial 

interests with the meeting topic(s). In the FDA Form 

3410, SGEs list their financial interests that may create a 

conflict, and submit it to FDA for review.

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How does the FDA determine if there is 

a conflict of interest? (cont.)

• Based on information obtained during this screening 

process, the FDA follows the procedures outlined in 

“Guidance for the Public, FDA Advisory Committee 

Members, and FDA Staff on Procedures for Determining 

Conflict of Interest and Eligibility for Participation in FDA 

Advisory Committees” to determine whether an advisory 

committee member has a potential conflict of interest 

and whether participation in an advisory committee 

meeting is appropriate.

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What types of financial interests create 

a potential conflict?

• Prior to an advisory committee meeting, FDA identifies 

entities (including companies or other organizations) that 

could be affected by the outcome of the advisory 

committee proceedings and any FDA decision based on 

the committee’s recommendations and screens SGEs 

for interests with these entities.

– Example: The sponsor of a new drug application that is being presented 

to an advisory committee and sponsors of drugs that closely compete 

with the subject drug would all be "potentially affected organizations" for 

which the financial interest of the SGE in the organization would need to 

be considered for potential conflicts of interest.

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What types of financial interests create 

a potential conflict?

• For each financial interest held by the SGE, FDA 

examines if there is a close (“direct”) causal link between 

any decision or action to be taken in the matter and any 

expected effect of the matter on the financial interest, 

and if there is a real (“predictable”), as opposed to a 

speculative, possibility that the matter will affect the 

financial interest.

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What if a potential 

conflict of interest exists?

• If a particular matter will not have a “direct and 

predictable effect” on a SGE’s financial interests, the 

SGE, absent any “appearance” concerns*, can serve on 

the FDA Advisory Committee for that particular matter.

• If a particular matter will have a “direct and predictable 

effect” on a SGE’s financial interests, the SGE, absent 

the provisions outlined in 18 U.S.C. 208(b), cannot

serve on the FDA Advisory Committee for that particular 

matter.

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*Circumstances related to relationships that a SGE has outside the SGE’s service on an advisory committee might lead to 

questions of whether the SGE has an “appearance of a lack of impartiality.” Under 5 CFR 2635.502, the key question is whether 

a reasonable person who is familiar with the facts would question the SGE’s impartiality to serve on an advisory committee for a 

particular matter.
What if a potential 

conflict of interest exists?

• 18 U.S.C. 208(b) Applicable Provisions:

– 18 U.S.C. 208(b)(2): The SGE can serve on a FDA 

Advisory Committee if the FDA determines that the SGE’s 

financial interest falls within an applicable regulatory 

exemption, listed at 5 C.F.R. 2640, for certain financial 

interests which are too remote or too inconsequential to 

affect the integrity of the services of the SGE.

– 18 U.S.C. 208(b)(3): The FDA can grant an SGE a waiver

to serve on a FDA Advisory Committee if the FDA certifies 

in writing that the need for the SGE’s services outweighs 

the potential for a conflict of interest posed by the financial 

interest involved.

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What can be done to prevent 

conflicts of interest?

• Because of the variety of topics that come before a 

particular FDA Advisory Committee, many different 

interests can create conflicts. An interest may create a 

potential conflict for one meeting, but not for another.

• The best thing SGEs, or potential SGEs, can do is to 

keep track of their interests. SGEs must be mindful of 

not only their personal interests, but those of their 

employer and any organizations in which they have a 

leadership role. Keeping updated, easily accessible 

records will help ensure accurate disclosure and allow 

for a full evaluation of any potential conflicts of interest 

prior to service on an FDA Advisory Committee.

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