Califf Expected To Ace Senate Panel Vote, As He Ups Emphasis On Safety Surveillance
This article was originally published in The Gray Sheet
The Senate Health, Education, Labor and Pensions Committee plans a confirmation vote on Robert Califf Jan. 12 to become the next FDA commissioner. Public health researchers and Sens. Sanders and Warren have argued that the long-time academic research leader's ties to industry are too close. Meanwhile, Califf recently has emphasized his focus on strengthening postmarket safety oversight.
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As FDA Commissioner Robert Califf prepares to step down from his post to make way for a Trump administration replacement, former Acting Commissioner Stephen Ostroff may step into the breach.
In a draft guidance, FDA explains how it plans to communicate signs of postmarket device risks before it has performed a full analysis or developed specific recommendations. Public health advocates say it is a positive move to get ahead of potential safety problems early. The agency is seeking comment from companies on whether it needs to consult with firms prior to releasing information on emerging signals about their devices.
Robert Califf responded to questions about improving postmarket device surveillance during his Nov. 17 confirmation hearing, including from HELP Committee Ranking Member Patty Murray, D-Wash., who raised the issue in relation to tainted duodenscopes that led to the deaths of several people in her state. Califf also addressed questions on lab-developed test oversight and charges that FDA overuses guidance documents.