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# Califf Discusses Needed Changes With Advisory Committees
- URL: https://www.fdaweb.com/califf-discusses-needed-changes-with-advisory-committees/
- Published: 2017-01-18T12:00:00.000Z
- Updated: 2026-09-14T22:01:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137754

In his final days as FDA commissioner, **Robert Califf** [announced 1/18](http://blogs.fda.gov/fdavoice/index.php/2017/01/fda-advisory-committees-independent-informed-essential-and-evolving/?ref=fdaweb.com) that the agency is evaluating changes to the advisory committee (AC) process. He acknowledged that advisory committees have “been the subject of ongoing discussions concerning their impartiality, their transparency, and how they affect decisions made about FDA-regulated products.” Of particular concern, according to Califf, are waivers granted to a prospective panel member to allow participation despite a potential conflict of interest. “This aspect of the AC process has evolved over time, becoming increasingly complex and burdensome,” he added.

“Across academia, the AC system is seen as overburdened with unnecessary paperwork,” Califf continued. “Additionally, FDA has faced criticism that the concept of an ‘imputed interest’ is interpreted so that academic leaders with significant experience and insight are considered to have conflicts relating to grants and contracts held by faculty members at the same institution — even if they themselves have no involvement with the project. The proliferation of roadblocks to serving as an SGE \[special government employee\] has led some within FDA and key leaders in various scientific fields to question the value of ACs in their current form.”

  
Recently, FDA initiated a process improvement evaluation using Lean concepts, which comprise an industrial engineering toolset used for process improvement. “These tools were applied to the AC process to fully understand the administrative requirements for planning meetings and screening potential SGEs,” Califf said. “We are confident that administrative processes, both inside FDA and for SGEs, will be streamlined as a result. The next step will be to evaluate current policies and identify areas where the evaluation of conflicts of interest for SGEs can be modernized. We must consider questions such as the criteria for disqualifying AC members from specific activities, the appropriate scope of ‘imputed interests,’ and the interrelationship between the advisory role of AC members and the decisional role of agency employees.”