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The Law and the Public's Health column by Wood and Perosino, which appears in this issue (p. 527),1 illustrates some of the complexities the U.S. Food and Drug Administration (FDA) encounters in ensuring the integrity of its processes, while making every effort to base them on the best available science. Achieving this dual task is particularly challenging when selecting outside members of FDA's advisory committees (ACs), who provide our agency with invaluable expertise on the safety and effectiveness of medical and other regulated products. This is because their understanding of these products' benefits and risks is often in part the result of research conducted on the product at issue or on competing products, and the associated financial arrangements frequently raise the question of potential conflicts of interest (COIs).
Moreover, statutes and regulations administered by the FDA require evaluation of financial relationships not uniformly recognized as COIs. For example, AC members are assumed to share their employers' financial interests. Accordingly, the law imputes to a university professor a grant that the university has received even if that grant does not support or relate to the professor's work. To a lesser extent, financial ties to manufacturers of regulated products may also complicate the selection of the committee's patient and consumer representatives.
The FDA has confronted this problem on numerous occasions and has repeatedly strengthened its policies to ensure that COI concerns do not undermine public confidence in the ACs' recommendations and discussions, which are valuable sources of information for the agency. In 2006, the success of these efforts was confirmed in a study by Lurie et al., which concluded that, “excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied.”2 A careful read of Lurie's article also suggests that, for the meetings he studied, committee members tended to vote in a manner inconsistent with their disclosed financial interests.3 Nevertheless, we continue to strengthen measures to protect the AC system against inappropriate influences. For example, in recent months our agency issued two draft guidances4,5 and took several other steps to address its procedures on AC voting and disclosure of COI information.
One of the draft guidances, published last November, calls for simultaneous rather than sequential voting and immediate announcement of voting results. This measure is aimed at protecting the integrity of the vote by eliminating the risk that members could be influenced by votes that precede their own. The second draft guidance, which in part was issued to implement FDA Amendments Act (FDAAA) requirements, sets out procedures for the public disclosure of information regarding committee members' financial interests for which the agency has granted a waiver. This guidance also included redesigned disclosure and waiver templates to make them more easily understood by the public. In addition, the FDA has improved access to waiver information on the FDA AC website and formalized procedures to protect the right to free speech at AC meetings, while ensuring their security and decorum.
As Wood and Perosino point out, the FDAAA calls on our agency to take additional actions to ensure the AC system's integrity. We have implemented many of the FDAAA's requirements and are in the process of implementing the rest. We are limiting the number of waivers in accordance with the FDAAA requirement and are issuing waivers only if they meet the standards set forth in the FDAAA. We are developing new strategies for recruiting potential AC members and, as noted previously, we have published a draft guidance and we are implementing an FDAAA requirement regarding public disclosure of information on financial interests (including their type, nature, and size) for which COI waivers are granted within specified time frames before AC meetings.
The task of creating highly qualified advisory panels completely free from COIs is not as easy as it may appear from the number of academicians and other scientists who are potentially available for AC membership. A recent study by Eastern Research Group, Inc., involving 124 members participating in 16 FDA AC meetings, found that in general, those members who have received COI waivers had longer experience and greater scientific credentials as reflected in their contributions to peer-reviewed literature than members who were conflict-free.6
The study, which was contracted by the FDA, concluded that the prospect for creating completely conflict-free ACs in all situations is uncertain and, even if possible, the involved recruiting and screening costs would be much higher than current expenditures. While we recognize these difficulties, the FDA is determined to fully implement the FDAAA and take any additional measures that may be needed to uphold the highest scientific and ethical standards for our agency's critically important AC system.