FDA Aims To Explain Itself Better With New Transparency Task Force

Full article reprinted from "The Gray Sheet" - June 8, 2009 

FDA's newly formed transparency task force will try to identify more effective ways to explain controversial agency decisions to the public. Find out more...

FDA Aims To Explain Itself Better With New Transparency Task Force

Full article reprinted from "The Gray Sheet" - June 8, 2009 

FDA's newly formed transparency task force will try to identify more effective ways to explain controversial agency decisions to the public.

While the effort could lead to increased regulatory transparency for industry, it also may pose challenges, in that it could result in the release of product information previously shielded to protect trade secrets, officials suggested June 2 in announcing the formation of the task force.

Principal Deputy Commissioner Joshua Sharfstein will lead the task force of senior FDA officials, which will solicit recommendations from inside and outside the agency on how it can make "useful and understandable information on its activities and decisions" more readily available.

FDA has been repeatedly criticized by safety advocates and lawmakers, among others, for failing to warn the public in time about safety issues and in some cases for approving products without sufficient consideration of safety and effectiveness.

"In many cases, the agency has a very good explanation, or has an explanation," according to Sharfstein, who joined with FDA Commissioner Margaret Hamburg in announcing the effort. "[But] in many cases you don't hear that explanation very clearly."

FDA officials are often hesitant to speak publicly about specific product decisions because the law requires the agency to protect proprietary manufacturer information.

"I am interested in the task force exploring with the people at FDA ... the things that they would like to be able to say about different issues," Sharfstein said. "And really start from a new point. What is the right balance to be drawn on transparency? What things have run the agency into trouble from their perspective and what information could be made available that could avoid trouble?"

He stressed the task force will also be cognizant of the fact that some information does need to be kept secret.

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