FDA Takes Several Steps to Strengthen the Advisory Committee Process, Including Adopting Simultaneous VotingNovember 16, 2007
Late last week, FDA announced several steps intended to strengthen the advisory committee process. The announced improvements are part of a broader FDA effort to address recommendations made by the Institute of Medicine in its September 2006 report, titled "The Future of Drug Safety: Promoting and Protecting the Health of the Public," and to meet requirements added by the recently-enacted FDA Amendments Act ("FDAAA").
In October, FDA issued a draft guidance document concerning advisory committee member conflicts of interest. The draft guidance implements FDAAA Title VII, which, among other things, continues the requirement that all individuals under consideration for appointment to serve on an FDA advisory committee disclose to the Agency all financial interests that would be affected by the committee’s actions. (In March 2007, FDA issued a draft guidance document that discusses the procedures for determining conflicts of interest and advisory committee member eligibility.) According to FDA, the October 2007 draft guidance “makes the [advisory committee] process more transparent and consistent by having all advisory committee members publicly disclose interests for which a waiver is granted.”
In yet another draft guidance document issued last week, FDA provides guidance on advisory committee voting procedures. In particular, the guidance recommends that votes during advisory committee meetings occur simultaneously instead of sequentially to avoid potential bias. FDA’s draft guidance states:
There has been much discussion inside and outside FDA regarding sequential versus simultaneous voting. Some have expressed concern that sequential voting, in which members cast public votes in turn, has the potential to compromise the integrity of the result.
For example, scholars and social scientists have studied the risk of “momentum” in sequential voting, exploring whether some sequential voters may be influenced, perhaps even subconsciously, by the votes that precede theirs, especially if those votes are nearly identical or signal a clear trend. This potential risk may be aggravated in the advisory committee setting, where votes are often conducted in full view of a passionate public and participatory audience. In the case of sequential voting, there is also a potential risk that comments made by a committee member or a designated federal officer (DFO) during the vote could inappropriately affect the deliberations of those who have not yet voted. Another potential risk is that comments could alter the meaning (or interpretation) of the question at issue in such a way as to cast doubt on whether all the members voted on the identical question.
As such, FDA makes several recommendations “to help maximize the integrity, consistency, and utility of advisory committee voting results,” including that the Advisory Committee Chair, DFO, or other senior agency official “solicit and answer questions about its meaning before the vote begins,” and use a simultaneous voting procedure such as “a simultaneous show of hands, a simultaneous show of ‘yes’ or ‘no’ cards, or a balloting method in which members simultaneously cast written votes.”
FDA also announced improvements to the Agency’s advisory committee webpage, re-announced the Agency’s selection of members for the newly-established Risk Communication Advisory Committee, and released a report conducted under a contract with the Eastern Research Group (“ERG”) that assessed the relationship between expertise and financial conflicts of interest of FDA advisory committee members. The ERG report concludes that:
standing advisory committee members with higher overall measures of expertise were more likely than other standing advisory committee members to have been granted waivers for financial conflicts of interest[, and] that potential alternative experts can be initially identified, but that some of these individuals may not otherwise be appropriate or available to serve as advisory committee members. In particular, many alternative experts would also require waivers. Overall we judge the ability to create alternative conflict-free advisory panels to be speculative. If possible, it would represent an uncertain and potentially substantial additional burden on the cost and the timeliness of advisory committee operations. Further, FDA might not always be able to match the specialized expertise of some existing advisory committees.