assessment of the scientific evidence presented to them. At the same time, the criteria by which candidates for committee appointment are screened and the participation of appointed members is regulated must be both realistic and fair. These criteria must protect the agency's processes from real risks of inappropriate influence and yet not disqualify or embarrass all scientists and clinicians who have had any connection to the drug, biologics, or device industries.

The chapter deals first with financial conflict of interest, indicating the origins of the IOM committee's concern for this issue, reviewing the statutory framework that governs the area, examining the system by which the FDA administers the conflict-of-interest laws, analyzing the rapid changes in that system, including a number of controversial cases and some encouraging prospects for improvement, and concluding with a number of recommendations. The chapter addresses the issue of intellectual bias in a concluding section.

FINANCIAL CONFLICT OF INTEREST

The reality facing the FDA is that over the past decade, perhaps longer, sponsors of drugs, biologics, and devices have turned increasingly to academic researchers to help develop and test new products. This pattern is particularly obvious in the biotechnology industry. Consequently, many of the same experts whose advice the FDA wishes to obtain have affiliations with regulated firms, some with many such firms. The recognized expertise of such individuals makes them attractive to both government and industry.

In addition, the agency has sought advisory committee advice on a growing range of scientific and regulatory issues, and it is under pressure to increase the agenda items considered by its committees. One result of these coincident developments has been to generate potential financial conflicts of interest for one or more committee members in connection with every committee meeting.

The tensions that result from this set of relationships cannot be eliminated but must not be ignored. The goals of any system for mediating these tensions must be to protect the integrity of the FDA's decisions and at the same time to allow the agency access to essential expertise. The IOM Committee is concerned that the current system for managing potential financial conflicts of interest, as now administered, may be jeopardizing the latter goal without significantly advancing the first.

When Commissioner Kessler met with the IOM Committee on December 6, 1991, he emphasized his desire for guidance in "solving" the FDA's current problems with conflict of interest and its advisory committees.



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