trials). NIH, for example, funds clinical trials, and investigators associated with those would bring necessary practical expertise to a drug products advisory committee. The committee also recognizes that financial conflicts are not the only conflicts that could influence votes. It is hard to screen out or to waive positions of intellectual bias (Stossel and Shaywitz, 2006). The committee supports narrowing the policies in place today but acknowledges the difficulties of convening sufficient experts for the numerous advisory committees that review drug products. The committee supports a position of nonwaivable limits, but not a zero-tolerance policy, for financial conflicts of interest on FDA drug-product advisory committees.

4.10: The committee recommends FDA establish a requirement that a substantial majority of the members of each advisory committee be free of significant financial involvement with companies whose interests may be affected by the committee’s deliberations. The committee supports 60 percent as a reasonable definition of substantial majority and believes that a reasonable definition of free of significant financial involvement are those involvements that currently require only disclosure and do not require a waiver (see Table 4.2 for a summary). The committee urges that FDA issue waivers for the participation of the other 40 percent of advisory committee members very sparingly. The committee also urges that FDA routinely analyze the effect of their conflict-of-interest policies in protecting the objectivity and quality of committee activities. The committee further urges that each posting of an advisory committee transcript be accompanied by a list of waivers granted and that FDA publish a yearly summary of the number of waivers granted per advisory committee.


Most members of advisory committees work in academic institutions, particularly medical schools and teaching hospitals, and policies of those institutions can help to protect the integrity of those who serve. That is particularly important because the pool of experts in pharmaceutical policy who are free of financial conflicts appears to be shrinking. Pharmaceutical support of research and other academic and medical activities is widespread—a fact that the committee views with some concern. In that vein, it would be helpful if all universities and nonprofit academic healthcare institutions promulgate and enforce rigorous conflict-of-interest policies governing academe-industry relationships on the part of their faculty and their institutional leaders. At a minimum, such policies should require disclosure in all publications, speaking engagements, and consultations with government of any relationships with the pharmaceutical and device industries. Policies should also conform with recommendations concerning



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