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UNITED STATES OF AMERICAFOOD AND DRUG ADMINISTRATIONCENTER FOR DRUG EVALUATION AND RESEARCH* * *ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEEMEETING* * *THURSDAYJANUARY 31, 2002* * *The Advisory Committee met at 8:00 a.m. inthe Grand Ballroom of the Holiday Inn, Two MontgomeryVillage Avenue, Gaithersburg, Maryland, Dr. NathanielP. Katz, Acting Chair, presiding.PRESENT:NATHANIEL P. KATZ, M.D. M Acting ChairJIM ANTHONY, PhD GuestMICHAEL A. ASHBURN, M.D., MPH ConsultantJANICE BITETTI, M.D. MemberJEFF BLOOM Patient Rep.AMANDA S. CARLISLE, PhD, M.D. ConsultantHOWARD D. CHILCOAT, M.D. GuestMARIA K. CONNOLLY, D.N.Sc Consumer Rep.KATHLEEN M. FOLEY, M.D. GuestERIC S. HOLMBOE, M.D. ConsultantTERESE T. HORLOCKER, M.D. ConsultantBRUCE ALLEN LEVY, M.D., J.D. GuestLYNN A. LLOYD, R.Ph ConsultantMITCHELL B. MAX, N.D. ConsultantCHARLES H. McLESKEY, M.D. Industry Rep.LAURA F. McNICHOLAS, M.D. ConsultantWINSTON C.V. PARRIS, M.D., FAcPM MemberSTEVEN PASSIK, M.D. GuestRUSSELL PORTENOY, M.D. GuestMARCUS M. REIDENBURG, M.D. ConsultantRICHARD G. ROBERTS, M.D. Guest
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PRESENT: (continued)MARK SCHREINER, M.D. GuestCHARLES SCHUSTER, M.D. GuestRICHARD M. SMILEY, M.D., PhD MemberJOSEPH R. TOBIN, M.D. MemberKIMBERLY TOPPER Executive Secretary
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I-N-D-E-XPAGECall to Order and Introductions4Conflict of Interest Statement8Welcome to Second Day and Comments13Open Public Hearing17Industry Presentation80J. David Haddox, M.D., DDSIntroduction to Session III:123Prescription Drug AbuseBob Rappaport, M.D.Current Data on Abuse and Diversion132Judy Ball, Ph.D.FDA Assessment of Abuse Liability157Deborah Leiderman, M.D.Criminal Drug Diversion176Howard Davis, DEAEpidemiology of Prescription Drug Abuse:192Implications for the Clinical SettingHoward Chilcoat, M.D.Prescription Drug Abuse in Pain Patients210Steven Passik, M.D.Regulatory Approaches to Risk Management240of Prescription Opioid Drug AbuseSharon HertzQuestions and Discussion257Adjourn366
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