1 1 FOOD AND DRUG ADMINISTRATION 2 CENTER FOR DRUG EVALUATION AND RESEARCH 3 4 5 JOINT MEETING OF THE ANESTHETIC AND ANALGESIC 6 DRUG PRODUCTS ADVISORY COMMITTEE (AADPAC) 7 AND THE DRUG SAFETY AND RISK MANAGEMENT 8 ADVISORY COMMITTEE (DSaRM) AND THE 9 PEDIATRIC ADVISORY COMMITTEE (PAC) 10 11 Friday, September 16, 2016 12 8:07 a.m. to 2:39 p.m. 13 14 15 FDA White Oak Campus 16 10903 New Hampshire Avenue 17 Building 31 Conference Center 18 The Great Room (Rm. 1503) 19 Silver Spring, Maryland 20 21 22 A Matter of Record (301) 890-4188 2 1 Meeting Roster 2 DESIGNATED FEDERAL OFFICER (Non-Voting) 3 Stephanie L. Begansky, PharmD 4 Division of Advisory Committee and Consultant 5 Management 6 Office of Executive Programs, CDER, FDA 7 8 ANESTHETIC AND ANALGESIC DRUG PRODUCTS ADVISORY 9 COMMITTEE MEMBERS (Voting) 10 Brian T. Bateman, MD, MSc 11 Associate Professor of Anesthesia 12 Division of Pharmacoepidemiology and 13 Pharmacoeconomics 14 Department of Medicine 15 Brigham and Women’s Hospital 16 Department of Anesthesia, Critical Care, and Pain 17 Medicine 18 Massachusetts General Hospital 19 Harvard Medical School 20 Boston, Massachusetts 21 22 A Matter of Record (301) 890-4188 3 1 Raeford E. Brown, Jr., MD, FAAP 2 (Chairperson) 3 Professor of Anesthesiology and Pediatrics 4 College of Medicine 5 University of Kentucky 6 Lexington, Kentucky 7 8 David S. Craig, PharmD 9 Clinical Pharmacy Specialist 10 Department of Pharmacy 11 H. Lee Moffitt Cancer Center & Research Institute 12 Tampa, Florida 13 14 Charles W. Emala, Sr., MS, MD 15 Professor and Vice-Chair for Research 16 Department of Anesthesiology 17 Columbia University College of Physicians & 18 Surgeons 19 New York, New York 20 21 22 A Matter of Record (301) 890-4188 4 1 Anita Gupta, DO, PharmD 2 (via telephone on day 1) 3 Vice Chair and Associate Professor 4 Division of Pain Medicine & Regional 5 Anesthesiology 6 Department of Anesthesiology 7 Drexel University College of Medicine 8 Philadelphia, Pennsylvania 9 10 Jennifer G. Higgins, PhD 11 (Consumer Representative) 12 Director of Strategic Planning and Business 13 Development 14 Center for Human Development 15 Springfield, Massachusetts 16 17 Alan D. Kaye, MD, PhD 18 Professor and Chairman 19 Department of Anesthesia 20 Louisiana State University School of Medicine 21 New Orleans, Louisiana 22 A Matter of Record (301) 890-4188 5 1 Mary Ellen McCann, MD, MPH 2 Associate Professor of Anesthesia 3 Harvard Medical School 4 Senior Associate in Anesthesia 5 Boston Children’s Hospital 6 300 Longwood Avenue 7 Boston, Massachusetts 8 9 Abigail B. Shoben, PhD 10 Assistant Professor, Division of Biostatistics 11 College of Public Health 12 The Ohio State University 13 Columbus, Ohio 14 15 16 17 18 19 20 21 22 A Matter of Record (301) 890-4188 6 1 ANESTHETIC AND ANALGESIC DRUG PRODUCTS ADVISORY 2 COMMITTEE MEMBER (Non -Voting) 3 W. Joseph Herring, MD, PhD 4 (Industry Representative) 5 Neurologist 6 Executive Director and Section Head 7 Neurology, Clinical Neurosciences 8 Merck Research Laboratories, Merck & Co. 9 North Wales, Pennsylvania 10 11 DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE 12 MEMBERS (Voting) 13 Tobias Gerhard, PhD, RPh 14 Associate Professor 15 Rutgers University 16 Department of Pharmacy Practice and 17 Administration 18 Ernest Mario School of Pharmacy 19 New Brunswick, New Jersey 20 21 22 A Matter of Record (301) 890-4188 7 1 Linda Tyler, PharmD, FASHP (via telephone) 2 Chief Pharmacy Officer 3 Administrative Director, Pharmacy Services 4 University of Utah Health Care 5 Professor (Clinical) and Associate Dean for 6 Pharmacy Practice 7 University of Utah College of Pharmacy 8 Salt Lake City, Utah 9 10 PEDIATRIC ADVISORY COMMITTEE MEMBERS (Voting) 11 Mary Cataletto, MD, FAAP 12 Attending Physician 13 Winthrop University Hospital 14 Professor of Clinical Pediatrics 15 SUNY Stony Brook 16 Stony Brook, New York 17 18 Avital Cnaan, PhD 19 Children's National Medical Center 20 Washington, District of Columbia 21 22 A Matter of Record (301) 890-4188 8 1 Melody Cunningham, MD 2 Medical Director 3 Palliative Medicine Service 4 Le Bonheur Children's Hospital 5 Associate Professor of Pediatrics 6 University of Tennessee, Medical School 7 Memphis, Tennessee 8 9 Robert Dracker, MD, MBA, MHA 10 Director, Summerwood Pediatrics 11 Infusacare Medical Services 12 Liverpool, New York 13 14 Peter Havens, MD, MS 15 Director, Pediatric HIV Care Program 16 Children’s Hospital of Wisconsin 17 Professor, Pediatrics 18 Medical College of Wisconsin 19 Milwaukee, Wisconsin 20 21 22 A Matter of Record (301) 890-4188 9 1 Sarah Hoehn, MD, MBe, FAAP 2 Associate Professor, Pediatrics 3 University of Kansas School of Medicine 4 Attending, Pediatric Intensive Care Unit 5 University of Kansas Medical Center 6 Kansas City, Kansas 7 8 Mark Hudak, MD 9 Chief, Division of Neonatology 10 University of Florida, College of Medicine 11 Jacksonville, Florida 32209 12 Associate Medical Director Neonatal Intensive Care 13 Unit Wolfson Children’s Hospital 14 Jacksonville, Florida 15 16 Christy Turer, MD, MHS, FAAP, FTOS 17 Assistant Professor, Pediatrics, 18 Clinical Sciences and Medicine 19 Director, General Academic Pediatrics Fellowship 20 UT Southwestern and Children’s Medical Center 21 Dallas, Texas 22 A Matter of Record (301) 890-4188 10 1 Kelly Wade, MD, PhD 2 Attending Neonatologist 3 Department of Pediatrics 4 Children’s Hospital of Philadelphia 5 Philadelphia, Pennsylvania 6 7 Michael White, MD, PhD 8 Ochsner Clinic Foundation 9 New Orleans, Louisiana 10 11 PEDIATRIC ADVISORY COMMITTEE MEMBERS (Non-Voting) 12 Bridgette Jones, MD 13 (Healthcare Representative) 14 Pediatric Health Organization Representative 15 Associate Professor of Pediatrics and Medicine 16 Children's Mercy Hospital 17 Kansas City, Missouri 18 19 20 21 22 A Matter of Record (301) 890-4188 11 1 Samuel D. Maldonado, MD, MPH, FAAP 2 (Industry Representative) 3 Vice-President and Head 4 Pediatric Drug Development 5 Center of Excellence 6 Johnson & Johnson PRD 7 Raritan, New Jersey 8 9 TEMPORARY MEMBERS (Voting) 10 Sean P. Alexander, MD 11 Director of Inpatient Medicine 12 Medical Director, Pain Medicine Care Complex 13 Sheikh Zayed Institute 14 Children’s National Health System 15 Washington, District of Columbia 16 17 Stephanie Crawford, PhD, MPH 18 Professor, Department of Pharmacy Systems, 19 Outcomes and Policy 20 Professor, Department of Medical Education 21 University of Illinois at Chicago 22 Chicago, Illinois A Matter of Record (301) 890-4188 12 1 Angela S. Czaja, MD MSc 2 Associate Professor 3 Department of Pediatrics, Critical Care 4 University of Colorado School of Medicine 5 Children’s Hospital Colorado 6 Aurora, Colorado 7 8 Randall P. Flick, MD, MPH 9 Medical Director 10 Mayo Clinic Children's Center 11 Associate Professor of Anesthesiology and 12 Pediatrics 13 Mayo Clinic College of Medicine 14 Rochester, Minnesota 15 16 17 18 19 20 21 22 A Matter of Record (301) 890-4188 13 1 Arthur F. Harralson, PharmD, BCPS 2 Professor of Pharmacogenomics and 3 Associate Dean for Research 4 Shenandoah University and 5 School of Medicine and Health Sciences 6 The George Washington University 7 Virginia Science and Technology Campus 8 Ashburn, Virginia 9 10 Arthur H. Kibbe Ph.D. 11 Emeritus Professor of Pharmaceutical Sciences 12 Nesbit School of Pharmacy 13 Wilkes University 14 Wilkes Barre, Pennsylvania 15 16 Tamar Lasky, PhD, FISPE 17 Owner/Consultant 18 MIE Resources 19 Baltimore, Maryland 20 21 22 A Matter of Record (301) 890-4188 14 1 Lynne G. Maxwell, MD 2 Associate Director 3 Division of General Anesthesiology 4 The Children’s Hospital Philadelphia 5 Associate Professor of Anesthesiology and 6 Critical Care 7 Perelman School of Medicine 8 University of Pennsylvania 9 Philadelphia, Pennsylvania 10 11 Melanie Dawn Nelson, PhD 12 (Patient Representative) 13 Mount Pleasant, Michigan 14 15 Kathleen A. Neville, M.D., M.S., M.B.A 16 Professor of Pediatrics, University of Arkansas for 17 Medical Sciences 18 Chief, Section of Clinical Pharmacology and 19 Toxicology 20 Arkansas Children's Hospital 21 Little Rock, Arkansas 22 A Matter of Record (301) 890-4188 15 1 Stephen W. Patrick, MD, MPH, MS 2 Assistant Professor, Pediatrics and Health Policy 3 Division of Neonatology 4 Vanderbilt University School of Medicine 5 Nashville, Tennessee 6 7 Anne-Michelle Ruha, MD 8 Medical Toxicology Fellowship Director 9 Clinical Associate Professor, Department of 10 Emergency Medicine 11 University of Arizona College of Medicine 12 Phoenix 13 Phoenix, Arizona 14 15 Gary A. Walco, PhD 16 Professor of Anesthesiology & Pain Medicine 17 Adjunct Professor of Pediatrics and Psychiatry 18 University of Washington School of Medicine 19 Director of Pain Medicine 20 Seattle Children's Hospital 21 Seattle, Washington 22 A Matter of Record (301) 890-4188 16 1 FDA PARTICIPANTS (Non-Voting) 2 Sharon Hertz, MD 3 Director 4 Division of Anesthesia, Analgesia and Addiction 5 Products (DAAAP) 6 Office of Drug Evaluation II (ODE-II) 7 Office of New Drugs (OND), CDER, FDA 8 9 Judy Staffa, PhD, RPh 10 Acting Associate Director for Public 11 Health Initiatives 12 Office of Surveillance and Epidemiology (OSE) 13 CDER, FDA 14 15 Ellen Fields, MD, MPH 16 Deputy Director 17 DAAAP, ODE-II, OND, CDER, FDA 18 19 Robert "Skip" Nelson, MD PhD 20 Deputy Director and Senior Pediatric Ethicist 21 Office of Pediatric Therapeutics 22 Office of the Commissioner, FDA A Matter of Record (301) 890-4188 17 1 Lynne Yao, MD 2 Director 3 Division of Pediatric and Maternal Health 4 Office of Drug Evaluation IV (ODE-IV) 5 OND, CDER, FDA 6 7 LCDR