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Tuesday, December 04, 2007

Study Proves No Need for Conflicted FDA Panel Members

In March, FDA issued draft guidelines that would revise its criteria for determining whether scientific advisory committee members have financial conflicts of interest. FDA advisory committees are standing panels comprised of individuals considered experts in a particular field. They provide advice to FDA on matters such as drug and medical device safety.

While the guidelines would be a good step toward ensuring scientific integrity on FDA panels, they would also make it too easy for FDA to grant waivers to conflicted scientists. For example, if FDA determines an individual has a financial conflict, the guidance instructs agency personnel to ask: "Does the need for the individual's services outweigh the potential for a conflict of interest?" If the answer is "yes," the member could serve on the panel but could not vote.

FDA argues that certain individuals have unique experience and qualification and, regardless of financial conflicts, are necessary for the panel. In fact, FDA recently issued a report which concluded it would be too difficult to create conflict-free advisory panels.

But a new investigation by the Center for Science in the Public Interest (CSPI) debunks that myth. CSPI analyzed the same data FDA used for its study, but came to a different conclusion:

For each of the four advisory committees analyzed in the study, it would have taken a single FDA official just one week to replace all the advisers who had conflicts of interest with experts who do not have conflicts of interest, according to CSPI's analysis of the ERG data. Moreover, the FDA would be able to choose from nearly two potential unconflicted experts for every open slot. And, based on the same criteria for the expertise of potential committee members used in the study, these easily identifiable unconflicted experts would be more qualified than the ones eventually chosen, whether they had conflicts of interest or not.