Guidance for FDA Advisory Committee Members and Other Special Government Employees on Conflict of Interest 2000
FDA and DHHS staff developed the Waiver Criteria Document (WCD) in 1994. A commitment was made in the original document that the content would be reviewed and revised on a regular basis. The 2000 version of the document has been updated and replaces the original. Although the format of the current version differs significantly from the original model, the concepts and underlying principles remain unchanged.1 Also, new sections have been added to clarify existing waiver criteria practices not covered in the original document.
New sections include:
- Expert Witness
- Department Heads - Contracts/Grants/CRADAs
- Exceptions for Institutional Directors
The FDA Modernization Act (FDAMA) of 1997 impacts issues related to conflict of interest for members of CDER and CBER Advisory Committees. See the related appendix.
NOTE TO READER:
The following table describes the most common course of action based on FDA's experience to date. The new version of the criteria document provides clear, easy to use guidance for the Commissioner, the Senior Associate Commissioner, the Centers and other interested parties.
The table has built-in flexibility, because all reported interests are examined in context. The proposed "expected actions" in the table are the outcomes that are anticipated in the majority of cases. However, under certain circumstances alternative actions are warranted.
I. General Principles
- If special Government employees (SGEs) have a financial conflict of interest in a particular matter within the meaning of 18 U.S.C. 208, they must be excluded from participating in advisory committee meetings or other assignments pertaining to that matter unless a waiver from exclusion is granted. There are four types of waivers that may be granted to an SGE at FDA.
- An 18 U.S.C. 208 (b)(1) waiver applies to any regular Federal employee, e.g., NIH or CDC employee, serving on an FDA advisory committee. The 208 (b)(1) waiver also applies to consultants and experts, when they are performing duties other than serving on an advisory committee (e.g., when they are performing "homework" assignments). A waiver of this type may be granted when the appointing official determines that the financial interest "is not so substantial as to be deemed likely to affect the integrity of the services that the Government may expect." The size of the financial interest is a key factor under this standard, although other factors concerning the nature of the employee's services and the nature of the matters may be relevant. See 5 C.F.R. 2640.301(b).
- An 18 U.S.C. 208 (b)(3) waiver applies to members of an advisory committee and to consultants and experts who are participating in an advisory committee meeting. Its standard is more flexible than the standard for granting an 18 U.S.C. 208 (b)(1) waiver. An 18 U.S.C. 208 (b)(3) waiver may be granted when the appointing official determines that "the need for the individual's services outweighs the potential for a conflict of interest." Because of the differences in the standards for granting these two types of waivers, the agency's criteria for each will vary in some respects. For example, if the need for an Advisory Committee member or meeting participant is great, then a substantial interest could be waived under the standard of 18 U.S.C. 208 (b)(3).
- An 18 U.S.C. 208 (b)(2) waiver applies to financial interests that are determined, by a regulation issued by the Office of Government Ethics, to be too remote or inconsequential to warrant disqualification pursuant to section 208(a). These regulatory exemptions are referenced in 5 CFR 2640 Interpretation, Exemptions and Waiver Guidance Concerning 18 U.S.C. 208 (Acts Affecting a Personal Financial Interest).
- A section 505(n)(4) waiver required by Section 120 of the Food and Drug Administration Modernization Act (FDAMA) of 1997 applies only to CBER and CDER advisory committee members. Section 505(n)(4) introduces new conflict of interest considerations. Specifically, absent a waiver, a committee member may not vote on any matter if the member or the immediate family of the member could gain financially from the committee's recommendations. Waivers under section 505(n)(4) may be granted if the member's participation is necessary to afford the committee essential expertise. However, no waiver may be given if the member's own scientific work is involved. Note: a Section 505 (n)(4) waiver does not itself resolve a potential conflict of interest under 18 U.S.C. 208, and a separate waiver under section 208 may be necessary.
- A financial interest in a "competing product" is relevant to the conflict of interest analysis. The General Counsel/Ethics Division has agreed to rely on each Center's advisory committee staff, the Executive Secretaries of the committees, and other FDA officials to make such determinations, based on medical, scientific, and economic considerations. Appropriate economic considerations would consist of factors contributing to a cross-elasticity of demand, including the characteristics and demographics of the likely consumer, pricing and other comparative features of the two products, the aspects of the system of delivery of a product that might appeal to one consumer segment but not to another. As long as FDA can articulate a reasoned basis for determining that certain products are, or are not, alternative therapies for a given medical condition or a given patient population, the judgment of FDA will be final. In some circumstances, different product types (e.g., drugs and devices) may compete with each other.
- In general, a personal financial interest (e.g., a stock interest in a manufacturer or personal remuneration from a study grant) is more likely to require disqualification than a purely imputed financial interest of an institutional employer (e.g., a grant to a university employer for a study in which the employee is not involved and for which there is no effect on the employee's salary).
- Certain matters before an advisory committee (e.g., guidance documents) may involve an entire class of products, rather than the product of one particular manufacturer. Where the matter before the committee affects an entire class of products, waiver or disqualification is necessary if an SGE has a financial interest in any one of the affected manufacturers or products. However, there is a greater likelihood that a waiver will be appropriate than where the matter before the committee affects a specific product or a competing product in which the SGE has a financial interest.
- The Office of Government Ethics (OGE) Standards of Ethical Conduct provides criteria by which to judge appearance of lack of impartiality where actual conflicts of interest, as defined by 18 U.S.C. 208, do not exist. See 5 CFR Part 2635, Subpart E. The regulation 5 CFR 2635.502 provides a procedure for "waiving" certain appearance problems. Similarly, even where 5 CFR 2635.502 is not technically applicable, FDA may decide to reassign a matter where there is a concern about appearances. Appearance problems and recommended courses of action to take are addressed in this document.2 (Refer to the table.)
- When FDA chooses to disclose any financial interest or other confidential information relevant to a decision to allow an SGE to participate in a particular matter, FDA must take care that such disclosure is consistent with the Privacy Act, the Trade Secrets Act, the Ethics in Government Act, the Freedom of Information Act, and any FDA confidentiality regulations.
- In all cases, the financial interest of a spouse, minor child, general partner, organization in which the SGE is serving as officer, director, trustee, general partner or employee, and entity with whom the SGE is negotiating or has any arrangement concerning prospective employment, is an interest imputed to the SGE.
- For 18 U.S.C. 208 (b)(3) waivers, the agency must weigh the need for the services of the SGE against the extent of his or her conflict. See 5 C.F.R. 2640.302(b). In some cases, it may be possible to meet the needs of the Agency by requesting the services of another SGE, either a member of another committee or a consultant, rather than seeking a waiver. A waiver may be indicated if, for example:
- The SGE will provide expertise that is necessary to the issues on the agenda and that would otherwise be unavailable. Expertise may ordinarily be considered unavailable if the agency has failed to find similar expertise on other standing committees or among existing consultants, and has made reasonable efforts to survey the field.
- The product in question is studied widely and it would be difficult to find a qualified SGE who was not at least as involved, either personally or indirectly through his or her institution, with the product or a competing product.
- A limited waiver is one that allows an SGE with a conflict of interest less than full participation in a particular matter. The following are examples of less than full participation:
- A member of an advisory committee might be prohibited from voting on an issue before the committee but would be allowed to participate in any discussions and deliberations.
- A committee chair might step down as chair for a given meeting but is allowed to participate as a voting or non-voting member of the committee.
- A member might be restricted to answering factual questions about a study/issue or be allowed to make a presentation and answer questions related to the presentation.
II. Guidance in Particular Cases
- In the following situations no conflict of interest or appearance of conflict exists. No waiver is therefore required.
- Cases where the agenda topic is devoted to committee member training.
- Cases where the agenda topic is devoted to general scientific presentations and discussions EXCLUSIVE OF particular products or draft guidelines for a class of products. For example, a presentation solely on methodology for analyzing statistical data may be a general scientific presentation.3
- Cases where the agenda topic of the meeting is devoted to a review of intramural research, where the research would have no direct and predicable effect on an outside financial interest.
- In the following situations it is not necessary to obtain a waiver, but there may be some concern about lack of impartiality or other appearances.
These situations may be handled, in part by making a disclosure in the public record of the concern consistent with General Principle F. Disclosure is intended to permit the participants to evaluate the opinions expressed by the SGE. If the appearance concern is great, however, the agency may require the SGE to recuse him/herself.
To evaluate whether there is an appearance concern and whether participation should nevertheless be allowed, the OGE Standards of Ethical Conduct provide criteria that should be applied. See 5 Part 2635, Subpart E. Under those standards, an appearance problem arises in those instances in which a reasonable person with knowledge of the relevant facts would question the SGE's impartiality. The OGE standards also provide factors that may be considered in deciding whether the SGE's participation should nevertheless be allowed. Even in cases not technically covered by 5 CFR 2635.502, the agency may have other appearance concerns and may decide to reassign matters; in such cases, the agency may be guided by the factors listed in section 2635.502. Examples of common situations that may raise appearance concerns include the following:
- The SGE's university employer has a grant or contract with the sponsoring company or a competing company to study a product that is unrelated to the product at issue in the FDA matter or any competing product. In contrast if it is known that the financial stability of the sponsor or a competing firm is likely to be undermined, or greatly enhanced, by the approval or disapproval of any one product, then there may be an actual financial interest under section 208, and a waiver may be required.
- The SGE or his/her employer IN THE PAST had a grant or contract to study the product at issue or a competing product, but has no continuing financial or other interest in the product at issue or research.4
- There are appearance concerns because the SGE has a "conflict" because he or she is employed by a federal government agency (e.g., NIH, DOD) that has an interest (financial or otherwise) in the product before the committee or in a competing product.
1This guidance document represents the agency's current thinking on the criteria for waiving conflicts of interest. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
2The following "covered relationships" must be considered for potential impartiality concerns under section 2635.502.
- a person, other than a prospective employer, with whom the SGE has or seeks a business, contractual, or other financial relationship;
- a person who is a member of the SGE's household, or who is a relative with whom the SGE has a close personal relationship;
- a person for whom the SGE's spouse, parent, or dependent child is, to the SGE's knowledge, serving or seeking to serve as an officer, director, trustee, general partner, agent, attorney, consultant, contractor, or employee;
- a person for whom the SGE has served within the last year as officer, director, trustee, general partner, agent, attorney, consultant, contractor, or employee; or
- an organization in which the SGE is an active participant.
3 The determination of whether a matter before the committee is a general scientific discussion is one that may be made by each Center's advisory committee staff, the Executive Secretaries of the committee and other FDA officials. If, however, there is any doubt about whether something is a general scientific discussion within the meaning of this part, Ethics Staff, FDA will consult with the HHS General Counsel/Ethics Division.
4 If the SGE was the principal investigator on the study, or could become involved in reviewing his or her own data; the reader is advised to review the section on FDAMA and the Exclusion Criteria for Investigators in the table section of this document.