Life Science Compliance Update

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July 26, 2016

FDA: Draft Guidance - Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees

FDA released draft guidance to deal with what it describes as "appearance issues" that make advisory committee members appear to lack impartiality. This applies even to those who do not have financial interests and relationships that are conflicts of interests. If an appearance issue exists, FDA will weigh the member's participation against the concern that a reasonable person may question the integrity of the FDA's decision. This is a troubling development for the constitutional freedom of association, especially if professionals are going to be forced to recuse themselves for merely the appearance of a conflict.

The guidance comes after Public Citizen filed a Freedom of Information Act lawsuit against FDA in a bid to get unredacted copies of advisory committee members' curriculum vitae -- which describe their education, qualifications and previous experience -- posted on the agency's website.

Michael Ortwerth, FDA's director of the Advisory Committee Oversight and Management Staff, said in an FDA Voice blog post that a lack of understanding about the agency's selection and evaluation process has resulted in public confusion and misunderstanding. He explains the guidance contains: "the circumstances that FDA considers when determining whether an appearance issue may exist. We evaluate the circumstances and assess whether the interests, relationships, or circumstances would cause a reasonable person with knowledge of the relevant facts to question the advisory committee member's impartiality in the matter before the committee."

As an example: "if an advisory committee member serves on the board of directors of a nonprofit organization and that organization receives donations from the sponsor that is presenting before the committee, we review the details of the donation to determine whether the member should be cleared for service on the advisory committee."

He notes this is not finalized, however: "The draft guidance is being issued for public comment before we issue a final guidance. Under Federal law, FDA is not permitted to disclose confidential information provided by advisory committee members related to appearance issues. But we are specifically requesting comments on whether the agency should request that advisory committee members voluntarily disclose if they have been granted an appearance authorization."

Background

Members of FDA's advisory committees are subject to Government-wide standards of ethical conduct regulations in addition to Federal conflict of interest laws. Even where a member has no financial interests that would require her to refrain from participating in an advisory committee meeting ("recuse" herself) under Federal conflict of interest laws, the member may be disqualified from participation under the Government-wide Federal regulation at 5 CFR § 2635.502 ("section 502") if she has interests or relationships that may create the appearance that she lacks impartiality on the issue before the advisory committee.

Section 502 gives FDA and other agencies significant flexibility and discretion in deciding whether a member with an appearance issue should participate in a particular matter. Under section 502, when a member has an appearance issue, FDA may authorize the member to participate in the advisory committee meeting based on a determination, made in light of all relevant circumstances, that the interest of the Government in the member's participation outweighs the concern that a reasonable person may question the integrity of the agency's programs and operations. If FDA does not issue an authorization, the individual may not participate in the meeting or the portion of the meeting involving the particular matter relevant to the appearance issue.

In determining whether to grant an authorization under section 502 to a member with an appearance issue, FDA balances the agency's interest in access to the advice of qualified experts to make important public health decisions with the need to avoid serious questions about the member's impartiality. Section 502 places the initial burden of identifying potential appearance issues on the member. It also gives the member the initial responsibility to recuse herself where she determines that the circumstances would cause a reasonable person with knowledge of the relevant facts to question her impartiality in the matter, unless she informs FDA of the issue and receives authorization from FDA to participate. FDA has the discretion to make independent determinations about whether a member has an appearance issue and to decide whether to grant her an authorization to participate once an appearance issue is identified.

Screening to Identify Possible Appearance Issue

In preparation for an advisory committee meeting involving a particular matter, members report to FDA any interests related to the subject matter of the meeting. These interests are reported on the Confidential Financial Disclosure Report. Although the Confidential Financial Disclosure Report Form primarily focuses on current financial interests, it also asks for information about past financial interests that directly relate to the products or issues to be considered at the meeting, and any other interests or relationships that might give rise to an appearance issue.

A member may seek assistance from FDA in completing this form. In completing this form, a member is required to report anything that would create an appearance issue not otherwise disclosed on the Form. The member may make a threshold judgment as to whether the information would cause a reasonable person to question her participation, and so inform the agency. FDA reviews the completed Confidential Financial Disclosure Report for each member in advance of every committee meeting to determine whether an appearance issue exists. As part of this review, FDA may ask for clarification about reported interests or about interests not reported but of which FDA may otherwise be aware.

What Circumstances May Create Appearance Issue?

Section 502 specifically lists certain interests and relationships that could create an appearance issue. It also includes a "catch-all" provision, which covers any other circumstances that may cause a reasonable person to question the member's impartiality. Once these circumstances raise a concern regarding the impartiality of the member, FDA considers the totality of the circumstances when determining to grant an authorization.

  • "Direct and Predictable Effect" on the Current Financial Interest of a Member of the Advisory Committee Member's Household

Under section 502, the following scenario would raise a potential appearance issue: where the particular matter coming before the advisory committee is likely to have a "direct and predictable effect" on the current financial interest of a member of the advisory committee member's household.

  • A Person or Entity with Whom the Member has a "Covered Relationship" is or Represents a "Party to the Matter"

Under section 502, the following scenario would also raise a potential appearance issue: where a person (or entity) with whom the advisory committee member has a "covered relationship" is or represents a "party to the matter" coming before the advisory committee. Both "covered relationship" and "party to the matter" are described in the guidance document.

  • Other Circumstances that May Raise a Question about the Member's Impartiality

Examples include broadly stated, "matters of general applicability". "Particular matters of general applicability" involve potential changes to regulations or agency guidance, or other broad topics such as policy-making and decisions that affect an entire class of products, such as reviewing labeling changes for an entire class of products. Particular matters of general applicability tend to raise fewer appearance issues than particular matters involving specific parties. However, the agency may require members to recuse from particular matters that do not involve specific parties, based on the concern that the member's impartiality reasonably may be questioned under the circumstances.

Other listed examples include relationships that are not technically "covered relationships" such as social relationships. Past financial interests ending more than one year before the meeting that suggest a close relationship with the sponsor or involvement with the product(s) before the committee was also a part of the "catch-all" provision.

Example from FDA Guidance

Scenario: The advisory committee is reviewing the safety and efficacy of a product. The meeting is a particular matter involving specific parties with one party to the matter ("the sponsor").

Example: The member's primary employment is as a dean of the medical school at a large university. The member reported that her employer has a multi-year grant from the product sponsor (i.e., the sponsor of the product that will be reviewed and evaluated at the advisory committee meeting) and the grant is not related to the product before the committee. This is an interest or relationship that could cause a reasonable person to question the member's impartiality.

Factors FDA Would Consider in Determining Whether or Not to Grant a Section 502 Authorization For the Member to Participate in the Meeting:

  • Whether the member receives any personal funding or remuneration from the grant (if not, this would weigh in favor of a section 502 authorization);
  • Size and diversity of the range of products made or under development by the sponsor providing the grant funding to the employer (the larger and more diverse the range of products the more this would weigh in favor of a section 502 authorization);
  • Whether the member's employer relies solely, or principally, on this grant from the sponsor (if not, this would weigh in favor of a section 502 authorization);
  • Whether the matter before the committee is considered sensitive or controversial (matters that are typical and routine without controversy would weigh in favor of a section 502 authorization);
  • Whether the member has expertise that is important to the committee's work and others with comparable expertise have conflicts or appearance issues more extensive than the member's (if so, this would weigh in favor of a section 502 authorization);
  • If there is a need for multiple experts in a field (if so, this would weigh in favor of a section 502 authorization).

Commentary

It comes to a point, that this is becoming ridiculous. The examples FDA uses would disqualify any physician whose institution is working on a research grant for the sponsor for a different product. Good luck in finding medical school faculty. The scenarios of "appearance" could go on forever, if the FDA wants to spend their time on fruitless exercises, then this is the guidance for you. Would not their time be better evaluating products then hunting through CV's for hidden conflicts.

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