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Advisory Committee Member Training

Louis R. Cantilena, Jr., M.D., Ph.D.

Former Chair, Nonprescription Drug Advisory Committee

Professor of Medicine and PharmacologyUniformed Services University

Perspective of a Committee Chair

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Job Description:Advisory Committee Chair

• Facilitator

• Moderator

• Focus discussion on relevant issues

• Conduct vote

• Manage meeting time

• Ensure questions are answered for FDA

• Referee

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Job Description:Advisory Committee Chair

• Review all meeting materials as soon as available

• Teleconference with FDA Division to review/clarify/?modify questions for the advisory committee

• Ensure appropriate expertise will be at meeting

• Be responsive to FDA and committee members during the committee meeting

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The Chair Should Not:

•Limit important discussion

•Limit appropriate committee member input

•Railroad an issue

•Deviate from FDA requirements for Advisory Committee Meetings

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Suggestions for Committee Members

• Avoid pre-meeting contact from non-FDA personnel

• Know the meeting material (packet)• Keep the FDA questions in mind before and

during the meeting • Talk to the Chair on break if you think more

discussion is needed on a topic before the vote or if you would like to ask the sponsor or FDA additional factual questions before the vote is called.

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Suggestions for Committee Members

• Speak only when recognized by the chair (avoid a free for all)

• Keep comments brief and directed to the issue/topic

• Follow committee discussion closely, avoid redundant comments

• Be prepared to provide reasons for your vote (very important to FDA)

• Whenever possible, incorporate data driven explanations into your vote

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Characteristics of a “Good” Meeting

•On time and orderly meeting•On topic, questions answered and a

quality, focused discussion took place•All parties given adequate time to

speak/present•When possible, clear “advice” provided

to FDA

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Characteristics of a Not So Good Meeting

• Meeting runs late, votes lost• Discussion not focused, votes taken without

explanations provided• Committee members and/or presenters not

given adequate opportunity to provide opinions or respond to data questions