The Center for Drug Evaluation and Research (CDER) at the FDA approves 25 to 30 new chemical entities each year, according to background information in the article. CDER often relies on the advice of the advisory committees composed of outside scientific experts. In 2001, 21 percent of these approvals were preceded by an advisory committee meeting. The authors note that recent high-profile cases have called attention to the possible vulnerability of committee decisions to financial conflicts of interest. A new FDA policy to disclose potential conflicts of interest for advisory committee meetings discussing specific products went into effect in January 2002. “Prior to any advisory committee meeting, both voting advisory committee members and voting consultants invited by the FDA are required to fill out form FDA 3410 detailing any financial interests they have, have had, or are currently negotiating,” the authors write. “Financial conflict types on the form include current investments, employment, patents, and contracts/grants/cooperative research and development agreements (CRADAs), as well as consulting arrangements and speaking/writing arrangements within the last 12 months. Any relevant conflicts of interest are reported at the beginning of the advisory committee meeting in a statement read aloud by the committee executive secretary.”
In this study, Peter Lurie, M.D., M.P.H., from Public Citizen’s Health Research Group, Washington, D.C., and colleagues, collected data from January 1, 2001, to December 31, 2004 by analyzing agendas and transcripts from all FDA Drug Advisory Committee meetings listed on the FDA website.
“A total of 221 meetings held by 16 advisory committees were included in the study. In 73 percent of the meetings, at least one advisory committee member or voting consultant disclosed a conflict; only one percent of advisory committee members were recused,” the authors found. “For advisory committee members (n = 1,957) and voting consultants combined (n = 990), 28 percent (n = 825) disclosed a conflict. The most commonly specified conflicts were consulting arrangements, contracts/grants, and investments. Nineteen percent of consulting arrangements involved over $10,000, 23 percent of contracts/grants exceeded $100,000, and 30 percent of investments were over $25,000.” Additionally, the authors state: “In all three conflict categories, the exclusion of advisory committee members and voting consultants with conflicts would have produced margins less favorable to the index drug in the majority of the meetings, but this would not have changed whether the majority favored or opposed the drug.”
“Ideally, all panels of scientific experts advising a federal decision making body would be free of financial conflicts of interest with the affected companies,” the authors write. “Certainly, advisory committee members who have conflicts of interest with higher dollar values should not be allowed to participate. For advisory committee members with smaller conflicts of interest, full transparency, including disclosure several days before the meeting, is necessary to allow the objective evaluation of committee decisions,” the authors conclude.