FDA Advisory Committees: A Unique Element of our Decision-Making Process Murray M. Lumpkin, M.D. Acting Deputy Commissioner International and Special Programs US Food and Drug Administration

2 ADVISORY COMMITTEES “Advisory” to the Commissioner Not a “court of appeal” Advisors and Consultants Staff Executive Secretaries Federal Advisory Committee Act (FACA) Open public microphone (time) Conflict of Interest - waivers Part of much of what FDA does Not just at the approval decision time IND phase and post-approval Non-committee work (individual consultants)

3 ADVISORY COMMITTEES Consultants to FDA Independent Advice and Perspective Represent many scientific disciplines and various stakeholder perspectives Temporary Voting Members Active participants (pro-active!) Chair Agendas / Questions Meeting Management Don’t always take advice Slice of the NDA – often other issues

4 PRODUCT ISSUES Major New Uses or first in class NME Significant new pre-authorization safety or effectiveness issues Post-authorization safety issues Different interpretations of data Needed outside expertise Rx to OTC switch - first in class Closed: Specific early development issues and general development update

5 POLICY ISSUES General scientific policy issues Specific guidelines that have significant impact Special new role under pediatric legislation - labeling disputes

6 PUBLIC INTEREST Products/ issues that have attracted significant public interest or controversy

7 CONCLUSION THANK YOU! YOUR PERSPECTIVES, THOUGHTS, and TIME ARE SO VERY IMPORTANT TO US AND THE JOB WE ARE TRYING TO DO FOR ALL OF OUR CITIZENS