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FDA Advisory Committees: A Unique Element of our Decision-Making Process

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. ADVISORY COMMITTEES. “Advisory” to the Commissioner Not a “court of appeal”

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FDA Advisory Committees: A Unique Element of our Decision-Making Process

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  1. 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

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