the effort. And there is a value to the intellectual exercise even if a formal decision making grid or set of decisional guidelines remains incomplete. It will force those involved to articulate and explain their judgments about the appropriateness of granting waivers in specific cases. It may also yield—and this would be no small achievement—a common vocabulary for describing and analyzing individual cases. And, if engaged in jointly by officials from both the FDA and the OSCE, it may help to reveal common ground and to clarify differences.

The discussion thus far has focused on only the first element of the statutory formula for granting (b)(3) waivers—the potential of different types and magnitudes of financial interests to undermine a committee member's impartiality. Section 208(b)(3) also requires consideration of a member's importance to committee deliberations. The suggestion made here is that some interests can be classified as so unlikely to threaten impartiality that selection for committee membership can be taken as sufficient evidence of importance to offset the remote risk. But there may be few such interests, and they are likely to be an employer's rather than personal or family interests. Thus, in evaluating many waivers attention must be given to a member's importance to committee deliberations. I believe that this second element should also be susceptible to categorical analysis, i.e., it should be possible to formulate guidelines for evaluating individual cases. And the committee's recommends that this should be done.

There is one additional point to be made. Many readers may ask how the exercise sketched in the foregoing paragraphs fits with the statutory regime for regulating financial conflict of interest. The answer has already been suggested but warrants reiteration. Section 208(a) of the conflict-of-interest statute sweeps very broadly and, I acknowledge, as construed makes the sorts of distinctions discussed above irrelevant to a determination of whether an interest presumptively disqualifies a committee member from participating in advice on a particular matter. But section 208(b)(3) calls for an assessment, by the Commissioner of Food and Drugs, of the likelihood that a disqualifying interest will in fact affect the member's objectivity, as when as of his/her importance to the committee's deliberations. Such an assessment logically invites, and surely permits, consideration of the sorts of distinctions I have suggested.