April 26, 2006

Financial conflicts of interest are common in FDA drug advisory committee meetings, a report by a frequent critic of the FDA argues, necessitating a more aggressive effort to change this process.

Public Citizen is calling on the agency to make several fundamental changes to its advisory committee policies regarding conflict of interest based on the findings of a study the group published in the Journal of the American Medical Association. These recommendations include their call for the FDA to lower the threshold for mandatory recusal. The agency also should make more of an effort to find committee members without any conflicts, the group said.

These and other changes are necessary to ensure the integrity of these drug reviews, said Peter Lurie, the deputy director of Public Citizen's Health Research Group. While the group did not find any instances where conflicts of interest resulted in a change in the outcome of a review, it likely altered the vote count, he said.

The margin of victory affects whether the FDA will support the committee's findings, Lurie said. "My belief is that at the FDA they count votes" and the wider the margin, the more likely the agency will adopt the advisory committee's findings. The group also found that for every voting member with a conflict of interest of any type, there was a 10 percent greater likelihood that the meeting would favor the drug being considered.

Public Citizen's study found that 28 percent of advisory committee members and voting consultants had some sort of conflict of interest, and at least one member or consultant had a conflict in 73 percent of the meetings. The group reached this conclusion by studying the agency's advisory committee reviews from 2001 to 2004, assessing the number of conflicts of interest that were reported under the FDA's disclosure policies.

To lessen the amount of conflict of interest the agency must reduce its threshold of more than $100,000 in industry investments before a mandatory recusal is required, the group said. "That line is drawn too high," allowing members with substantial financial investments to influence FDA policy, Lurie said.

The agency's current policy allows the FDA to grant a conflict of interest waiver based on review by various parties, including the FDA division or office responsible for deciding on the safety and efficacy of the therapy, the center component that oversees the relevant advisory committee, and agency's ethics staff. One factor the FDA considers is the amount of financial investments a committee member has.

The agency must also make more of an effort to find members with no conflicts. The agency and industry advocates have argued that it is too difficult to find experts without some sort of relationship with industry, but Public Citizen rejects this argument. "They just aren't trying hard enough," Lurie said. "We should have zero tolerance for accepting levels of conflict that would have even a small impact upon voting outcome, but in our study we found such impacts. What we need is not simply disclosure of conflicts, but also greater efforts to identify members without conflicts."