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Reading Through the Blacked-Out Lines

Public advocacy group Public Citizen is suing the US Food and Drug Administration over its redactions of information about people who serve on its advisory committees, Pharmalot's Ed Silverman reports at Stat News.

Advisory committee members review marketing applications from companies and, as Silverman notes, while FDA doesn't have to follow their recommendations, it often does. This means committee members wield a lot of influence.

Public Citizen charges that FDA too heavily redacts information about these individuals, which makes it difficult to assess whether advisory committee members might have conflicts of interest or hold biases. When it requested committee members' CVs under the Freedom of Information Act, the advocacy group said that 92 percent of the150 résumés of members of Center for Drug Evaluation and Research advisory committees included redactions, while 86 percent of the résumés from Center for Devices and Radiological advisory committee members had redactions and more than 98 percent of the Center for Devices and Radiological Health advisory committee members' résumés had redactions.

"Confidential information does not appear on documents crafted for the express purpose of sharing with other people," Rachel Clattenburg, an attorney for Public Citizen, tells Silverman. "The redactions are unjustified and show that the FDA has wasted considerable time going through (resumes) to black out information. We worry that the FDA's treatment of advisory committee member (resumes) is an indication that the agency favors secrecy over disclosure."

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