1 Advisory Committee Member Training Louis R. Cantilena, Jr., M.D., Ph.D. Former Chair, Nonprescription Drug Advisory Committee Professor of Medicine and Pharmacology Uniformed Services University Perspective of a Committee Chair

2 Job Description: Advisory Committee Chair Facilitator Moderator Focus discussion on relevant issues Conduct vote Manage meeting time Ensure questions are answered for FDA Referee

3 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

4 The Chair Should Not: Limit important discussion Limit appropriate committee member input Railroad an issue Deviate from FDA requirements for Advisory Committee Meetings

5 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.

6 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

7 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

8 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