FDA to Study Ways to Be More Open With Public

Agency hopes to better explain its decisions to regain lost trust

By Steven Reinberg
HealthDay Reporter

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TUESDAY, June 2 (HealthDay News) -- The U.S. Food and Drug Administration, an agency long criticized for not informing the public about its inner workings, announced Tuesday that it has created a task force to study how to be more transparent.

"This is an agency-wide effort to try and figure out how to make FDA and its processes more transparent to the public," FDA Commissioner Dr. Margaret A. Hamburg said during a morning news conference.

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The move is part of a larger effort by the Obama administration to make all federal government agencies more open to the public, Hamburg said. In addition, the FDA is reacting to criticisms that have shaken the agency's credibility. In the past, an area of particular concern has been the release of unpublished clinical data on new drugs.

"Over the years, there have been complaints made about FDA's lack of transparency," Hamburg said. "The agency has been referred to as a 'black box' that makes important decisions without explaining them. The agency can and should communicate with the public in a way that provides more clarity about agency activity and processes, not less."

The task force will be headed by FDA Principal Deputy Commissioner Dr. Joshua Sharfstein. "Task force members will include center directors, the associate commissioner for regulatory affairs, the chief counsel and the chief scientist at FDA," he said during the news conference.

There will be two public meetings, the first on June 24, where anyone can comment on what needs to be done to make the agency more open. The FDA is also taking comments online, Sharfstein said. The deadline for public comment is Aug. 7, an agency news release stated.

The task force expects to present its report in November, but there is no set timetable for enacting any of the recommendations, Hamburg said.

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