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Analysis of Draft Guidance on FDA Conflict of Interest Policy

The Food and Drug Administration (FDA) administers several laws and regulations that govern conflict of interest determinations; these laws are not entirely consistent and set out different standards. As a result, FDA’s conflict of interest screening process is complex and has been poorly understood, i.e., different types of financial interests can be weighted differently when determining if a conflict exists.

The 2000 guidance on waiver criteria was an attempt to address comprehensively the multiple variables that can be applied in reaching a determination about an individual advisory committee member. However, because of its complexity and discretionary elements, centers and offices found it difficult to achieve consistent results that the public could readily understand.

As part of FDA’s recent internal assessment of its advisory committee process, the agency has targeted its assessment of potential conflicts of interest and granting of waivers as an area that needs improvement. The goal of the new guidance is to simplify and streamline the process by which participation in advisory meetings is determined. The draft guidance describes the factors and analyses that should be considered in determining whether an advisory committee member — government employee or special government employee — has a potential conflict of interest and whether participation is appropriate.

The algorithm provided in the draft guidance consolidates the various standards and tests found in the applicable statutes into a series of straightforward steps that generally apply to all meetings, regardless of the subject matter or type of meeting and irrespective of the type of financial interest(s) held by the members.

Advisory committee members will be considered under a more stringent policy regarding the level of financial interests in organizations that potentially could be affected by the meeting deliberations. First, if an individual has disqualifying financial interests whose combined value exceeds $50,000 the member generally would not participate in the meeting, regardless of the need for particular expertise. Second, if the disqualifying financial interests are $50,000 or less, the individual would be eligible to participate only if the member met the applicable statutory standard for participation; e.g., the need for services outweighs potential conflict. Third, even where the standard for participation is met, the individual’s participation would be limited to non-voting. Fourth, FDA intends to generally limit participation in certain cases where there may be a perception of a conflict of interest, even though full participation would be permitted under the applicable statutes.

FDA believes that the public may perceive some financial interests in organizations potentially affected by advisory committee recommendations as problematic, even though those interests are not currently held. For example, FDA may wish to limit the participation of a member who has had a previous consulting arrangement within the last few months with an organization who is a party in the “particular matter” that is the subject of the advisory committee meeting. Accordingly, FDA intends to implement a policy of generally limiting participation when a member has a financial interest within the preceding 12 months that would be a disqualifying financial interest if it were currently held, even though full participation would be permitted under [the statutes].

It appears that FDA is going to greater lengths to avoid requesting waivers for affected individuals and may determine that, even when a waiver could be granted, waivers will not be requested — rather the member will participate as a non-voting member.

The algorithm uses the term “particular matter,” which refers only to matters that involve deliberation, decision or action that is focused upon the interests of specific persons or a discrete and identifiable class of persons. It does not cover consideration of adoption of broad policy options directed to the interest of a large and diverse group of persons such as actions that will affect all companies or the economy in general.

If the answer to this first question is no, then the FDA does not have to proceed further in determining whether conflicts of interest exist. It is likely that most Blood Products Advisory Committee meetings would not involve a “particular matter.” An evaluation of topics on the agenda for the March 29-30 Cellular, Tissue and Gene Therapies Advisory Committee meeting would most likely result in a determination that the topic on March 29 pertained to a “particular matter,” and the topic on March 30 did not.