- When Government Employees Can Participate in Advisory Committees: New FDA Guidance
- May 9, 2007 | Author: Kimberly Egan
- Law Firm: DLA Piper - Washington Office
FDA advisory committees "provide independent expert advice to the agency on scientific, technical, and policy matters related to the development and evaluation of FDA-approved products." For each advisory committee, FDA must comply with several existing statutes and regulations laws governing conflicts of interests, not all of which are entirely consistent. See, e.g., 21 U.S.C. § 355(n) (containing the general rules for advisory committees on clinical investigations or marketing approval); 18 U.S.C. § 208 (containing conflicts rules for government employees); 5 C.F.R. § 2640 (containing regulatory exemptions for conflicts of interest rules).
Recently, the FDA issued draft guidance outlining a new 6-step process for determining whether a government employee possesses a conflict of interest that disqualifies her from serving on an advisory committee:
Step 1: The Meeting Must Involve a Particular Matter
First, FDA will determine whether the advisory committee meeting at issue involves a particular matter. The draft guidance defines particular matter as one that focuses on the interests of a specific person or an identifiable class of persons. "It does not cover consideration or adoption of broad policy options directed to the interests of a large and diverse group of persons such as actions that will affect all companies or the economy in general." Draft Guidance at 8-9.
If there is no particular matter at issue in the advisory committee meeting, then all committee members may participate and no further conflict of interest analysis is required. If the meeting does address a particular matter, FDA must continue to step 2.
Step 2: The Meeting Must Have a Direct, Predicable Effect on Financial Interests
If a particular matter is at issue, FDA will determine whether the meeting will have a direct and predictable effect on the financial interests of any organization with a stake in the outcome of the advisory committee.
The draft guidance defines direct effect as a close, but not necessarily immediate, causal connection between any decision or action to be taken in the matter and an effect on a financial interest. A predictable effect is one that is real and not contingent or speculative.
Examples of affected organizations include new drug application sponsors or companies that compete closely with such a sponsor. If the meeting will not have a direct and predictable effect on the financial interests of anyone with a stake in the outcome, then all committee members may participate and no further conflict of interest analysis is required. But if FDA concludes there will be a direct and predictable effect, it will proceed to step 3.
Step 3: A Potential Member Must Not Have Disqualifying Financial Interests
If there will be a direct and predictable financial effect, FDA will determine whether the meeting will also affect the financial interests of the individual member or the organization whose interests are imputed to the member. FDA will consider the potential for gain or loss for:
- The member;
- The member’s spouse and minor children;
- The member’s general partner(s);
- Prospective employers of the member; and
- Any organization in which the member is an officer, director, trustee, or employee.
If there are no disqualifying financial interests, then FDA will proceed to step 4a. If there are disqualifying financial interests, FDA must proceed to part 4b.
Step 4A: No Disqualifying Financial Interests within the Preceding 12 Months
Even if a member has no current, disqualifying financial interests, he or she may still be disqualified if the member had any disqualifying financial interests in the preceding year. If a member had no disqualifying interests in the preceding year, then he or she may participate fully in the meeting and no further conflict of interest analysis is required.
If a member did have disqualifying financial interests in the preceding year, the member should not participate in the meeting if the sum of the previous year’s disqualifying interests is more than $50,000. If the sum is less than $50,000, the member may participate but not vote.
Step 4B: Some Financial Interests Are Exempt
A member with disqualifying financial interests may still participate in a meeting if he or she qualifies for certain exemptions. The following financial interests are exempt from the calculation:
- Certain mutual funds;
- Securities in any entity with an interest in the meeting, provided the securities have an aggregate market value of less than $15,000;
- Certain financial interests that may arise for individuals on a leave of absence from an institution of higher education;
- Certain financial interests that may arise from employment at state institution of higher education; and
- Certain financial interests that may arise from federal government employment or from Social Security or veterans benefits.
If the remaining value of a member’s financial interests exceeds $50,000, the member generally should not participate in the meeting. If the remaining value is $50,000 or less, the FDA staff will proceed to part 5 of the algorithm.
Step 5: Obtaining a Conflict of Interest Waiver
A member with financial interests in the proceeding of $50,000 or less may obtain a waiver to participate in the meeting without voting. In general, FDA will consider:
- The uniqueness of the member’s qualifications;
- The difficulty locating similarly qualified individuals without a disqualifying financial interest;
- The value of the member’s expertise to the matter being addressed by the committee; and
- The nature and extent of the disqualifying financial interest.
In addition, FDA will consider whether a reasonably thorough search been conducted for a candidate who is similarly qualified, or better qualified, but has fewer conflicts. The results of such a search may be the most persuasive sign that a waiver is needed.
A member who does not qualify for a waiver should not participate in the meeting.
Step 6: Other Reasons to Disqualify a Member
If a member with financial interests does not qualify for a waiver, FDA will determine whether any regulatory exemptions make the waiver unnecessary. For example, if the disqualifying interest is $25,000 or less of publicly traded stock in an organization affected by the matter, FDA may apply a regulatory exemption. 5 C.F.R. § 2640.202(c)). If a member no longer has a financial conflict of interest after the amount that qualifies for a regulatory exemption is excluded, no waiver is necessary. The member will, however, be restricted to a non-voting capacity.
FDA also proposes to limit the participation of members whose previously held financial interests would be disqualifying if currently held. A member whose financial interests during the previous year were greater than $50,000 will not be able to participate in a meeting at all. If the financial interest were less than $50,000, the member may participate but cannot vote.
Guidance Period Closes May 21
The public comment period on the draft guidance closes on
May 21, 2007.
The draft guidance is available at http://www.fda.gov/oc/guidance/advisorycommittee.html.