FDA’s industry links revealed

The decisions of the United State’s Food and Drug Adminstration’s (FDA) advisory panel, which has a large bearing on the success of pharmaceutical companies all over the world, could be in conflict with its members’ industry links, according to a new study.

The Public Citizen, a public interest organisation supported by perennial presidential candidate Ralph Nader, found that between 2001 and 2004, 28 per cent of the panel and voting consultants had a conflict of interests and in 73 per cent of all meetings, at least one member of the panel had a conflict of interest.

Public Citizen’s deputy director of health research, Peter Lurie MD, said: “Conflicts of these magnitudes should result in automatic recusal from advisory committee meetings.”

He added: “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.”

Susan Bro, a spokesman for the FDA, said the agency was committed to “a strict code of ethics” and a “transparent process”. In 2002 the agency introduced new guidelines for its members to disclose any conflicts of interest, but Public Citizen said the rules should be expanded so that competitors are named and members give their reasons for any challenges to drug approvals.

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