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# Public Citizen, Others Hit FDA on Intellectual Bias Exclusions
- URL: https://www.fdaweb.com/public-citizen-others-hit-fda-on-intellectual-bias-exclusions/
- Published: 2016-11-28T12:00:00.000Z
- Updated: 2026-09-14T21:50:48.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137435

Public Citizen and seven other consumer and government watchdog groups have told FDA that its [draft guidance](http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM508852.pdf?ref=fdaweb.com) on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees” would allow the agency to continue inappropriately excluding advisory committee members from participating in committee meetings. The groups submitted [comments ](http://qz.salsalabs.com/dia/track.jsp?v=2&c=vwm8Ad4dCeJe5Vz5lyJMn4rCZn9qH61%2F&ref=fdaweb.com)expressing concerns that the draft guidance reflects the agency’s “overly broad interpretation of the relevant regulations regarding appearance issues. This interpretation would encourage the agency to continue inappropriately excluding advisory committee members from participating in committee meetings based on an ‘intellectual bias’ – a phrase that does not appear in the draft guidance but that the FDA routinely uses in forms to screen individual advisory committee members for conflicts of interest prior to committee meetings. By not acknowledging the FDA’s current intellectual bias policy in the draft guidance, the agency limited responses to the minority of people who are aware of the current policy because they participated in recent advisory committee meetings.”

“So-called intellectual bias and situations in which an advisory committee member is an employee or member of an organization, like Public Citizen, that has taken a position in writing on a matter or issue before the committee are not circumstances involving interests or relationships that fall within the scope of appearance issues under applicable regulations,” the groups said. In the comments, the groups urged FDA to immediately cease applying such considerations when screening advisory committee members for financial conflicts of interest and other relationships or interests that may create the appearance of a lack of impartiality. In addition, the FDA should revise the proposed guidance to explicitly state the agency does not consider such circumstances when evaluating advisory committee members for appearance issues.

The groups commenting with Public Citizen are: Center for Digital Democracy, Government Accountability Project, National Coalition Against Censorship, National Women’s Health Network, Project on Government Oversight, Union of Concerned Scientists and Woody Matters.