Revisiting Financial Conflicts of Interest in FDA Advisory Committees
Revisiting Financial Conflicts of Interest in FDA Advisory Committees
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DOI：
10.1111/1468-0009.12073
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发表时间：
2014-09-01
影响因子：
6.6
通讯作者：
Pham-Kanter, Genevieve
中科院分区：
文献类型：
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作者：
Pham-Kanter, Genevieve
FDA药物评估和研究中心咨询委员会的成员如果只与药物的赞助公司有经济关系，则更有可能投票支持赞助商。在赞助公司顾问委员会任职的委员会成员表现出特别强烈的支持赞助的偏见。与传统观点相反，与许多不同公司有财务关系的委员会成员在投票行为中平均不会表现出支持行业的偏见。美国食品和药物管理局（FDA）安全与创新法案最近放宽了FDA咨询委员会成员的利益冲突规则，但人们仍然担心成员的财务关系对FDA药物批准过程的影响。本研究使用大量最新可用的数据集，仔细检查了FDA药物评估和研究中心（CDER）咨询委员会成员的经济利益与成员是否以有利于这些利益的方式投票之间的关系。该研究使用了1997-2011年15年间召开的CDER委员会会议中投票的1379名FDA咨询委员会成员的投票行为和报告的经济利益数据集。分析中使用了来自379次会议的1168个问题和15739个问题投票的数据。使用多变量logit模型来估计委员会成员的经济利益与其投票行为之间的关系。与没有财务关系的成员相比，仅与赞助公司有经济利益关系的个人更有可能投票支持赞助商（OR = 1.49, p = 0.03）。与那些与任何潜在受影响的公司没有财务关系的成员相比，与赞助公司及其竞争对手都有利益关系的成员投票支持赞助商的可能性并不大（OR = 1.16, p = 0.48）。仅为发起人担任顾问的成员更有可能投票支持发起人（OR = 4.97, p = 0.005）。在与赞助公司有独家财务关系的咨询委员会成员中，似乎存在支持赞助商的投票偏见，而在与赞助公司有非独家财务关系的成员中（即与赞助商及其竞争对手都有联系的成员）则没有。这些发现指出了财务关系的重要异质性，并建议决策者在管理FDA咨询委员会成员的财务关系时需要细致入微。
FDA Center for Drug Evaluation and Research advisory committee members who have financial ties solely to the firm sponsoring the drug under review are more likely to vote in ways favorable to the sponsor. Committee members who serve on advisory boards for sponsoring firms show particularly strong pro-sponsor bias. Contrary to conventional wisdom, committee members who have financial ties to many different firms do not, on average, show pro-industry bias in their voting behavior.ContextThe Food and Drug Administration (FDA) Safety and Innovation Act has recently relaxed conflict-of-interest rules for FDA advisory committee members, but concerns remain about the influence of members' financial relationships on the FDA's drug approval process. Using a large newly available data set, this study carefully examined the relationship between the financial interests of FDA Center for Drug Evaluation and Research (CDER) advisory committee members and whether members voted in a way favorable to these interests.MethodsThe study used a data set of voting behavior and reported financial interests of 1,379 FDA advisory committee members who voted in CDER committee meetings that were convened during the 15-year period of 1997-2011. Data on 1,168 questions and 15,739 question-votes from 379 meetings were used in the analyses. Multivariable logit models were used to estimate the relationship between committee members' financial interests and their voting behavior.FindingsIndividuals with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor than members with no financial ties (OR = 1.49, p = 0.03). Members with interests in both the sponsoring firm and its competitors were no more likely to vote in favor of the sponsor than those with no financial ties to any potentially affected firm (OR = 1.16, p = 0.48). Members who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor (OR = 4.97, p = 0.005).ConclusionsThere appears to be a pro-sponsor voting bias among advisory committee members who have exclusive financial relationships with the sponsoring firm but not among members who have nonexclusive financial relationships (ie, those with ties to both the sponsor and its competitors). These findings point to important heterogeneities in financial ties and suggest that policymakers will need to be nuanced in their management of financial relationships of FDA advisory committee members.