FDA Risk Committee To Consider Whether Earlier Information Is Really Better
This article was originally published in The Tan Sheet
Executive Summary
FDA is scrutinizing how it can make timely releases of safety information without sacrificing completeness and accuracy
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FDA is scrutinizing how it can make timely releases of safety information without sacrificing completeness and accuracy. "The historical strategy of waiting to communicate until the end of a lengthy evaluation and negotiation process doesn't work," said Nancy Ostrove, senior advisor for risk communication in FDA's Office of Planning. "We don't want it so late that too many people experience preventable adverse events that could have been avoided. But we don't want it so early that people stop using or decide not to use a beneficial product, especially when the initial signal turns out not to have been associated with the product," Ostrove said at a Dec. 6 meeting of the Food and Drug Law Institute. At the meeting in Washington, Randall Lutter, FDA's deputy commissioner for policy and planning, said the agency has yet to systematically analyze how the public receives and interprets safety information. That task will be the primary mission of the Risk Communication Advisory Committee, which is expected to convene for the first time early this year. The 15-member advisory committee is charged with improving both risk and benefit communication at the agency (1 (Also see "FDA Risk Communication Panel’s Charter Is Tweaked As Members Are Named" - Pink Sheet, 19 Nov, 2007.), p. 14). Responding to criticism that it sits too long on safety data received from firms, FDA has begun distributing early communications about ongoing safety reviews with ample caveats and no specific recommendations. The early updates are "something we feel is incumbent on us to share with the public because it helps preserve confidence and trust in our management," Lutter said. "The trust is endangered if there is any suggestion that we are not acting quickly." "We've never ever looked in a systematic way at the effectiveness of these efforts. Confidence is the core of the effectiveness of communication, and we must preserve it," he added. Whether firms should similarly disclose risk information as soon as they uncover it is a tougher question, Lutter said. "The short answer is, 'We'd sure like that they'd share it with us.'" - Jessica Bylander ([email protected]) |