Transcript for the May 3, 2016 Joint Meeting of the Drug Safety and Risk Management Advisory

410 Pages·2016·0.82 MB·English

1
1 FOOD AND DRUG ADMINISTRATION
2 CENTER FOR DRUG EVALUATION AND RESEARCH
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5 DRUG SAFETY AND RISK MANAGEMENT AND ANESTHETIC AND
6 ANALGESIC DRUG PRODUCTS ADVISORY COMMITTEES
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11 Tuesday, May 3, 2016
12 8:01 a.m. to 5:06 p.m.
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16 FDA White Oak Campus
17 White Oak Conference Center
18 Building 31, The Great Room
19 Silver Spring, Maryland
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A Matter of Record
[phone]
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
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8 DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
9 MEMBERS (Voting)
10 Niteesh K. Choudhry, MD, PhD
11 Associate Professor
12 Harvard Medical School
13 Associate Physician
14 Brigham and Women's Hospital
15 Boston, Massachusetts
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17 Tobias Gerhard, PhD, RPh
18 Associate Professor
19 Rutgers University
20 Department of Pharmacy Practice and Administration,
21 Ernest Mario School of Pharmacy
22 New Brunswick, New Jersey
A Matter of Record
[phone]
3
1 Jeanmarie Perrone, MD, FACMT
2 Professor, Emergency Medicine
3 Director, Division of Medical Toxicology
4 Department of Emergency Medicine
5 Perelman School of Medicine
6 University of Pennsylvania
7 Philadelphia, Pennsylvania
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9 Marjorie Shaw Phillips, MS, RPh, FASHP
10 Pharmacy Coordinator
11 Clinical Research and Education
12 AU Medical Center at Augusta University
13 Clinical Professor of Pharmacy Practice
14 University of Georgia College of Pharmacy
15 Augusta, Georgia
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A Matter of Record
[phone]
4
1 Linda Tyler, PharmD, FASHP
2 Chief Pharmacy Officer
3 University of Utah Hospitals & Clinics
4 Professor (Clinical) and Associate Dean for
5 Pharmacy Practice
6 University of Utah College of Pharmacy
7 Salt Lake City, Utah
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9 Almut Winterstein, RPh, PhD, FISPE
10 (Chairperson)
11 Professor and Interim Chair
12 Pharmaceutical Outcomes and Policy
13 College of Pharmacy, University of Florida
14 Gainesville, Florida
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16 DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
17 MEMBER (Non-Voting)
18 Linda Scarazzini, MD, RPh
19 (Industry Representative)
20 Vice President
21 Pharmacovigilance and Patient Safety
22 AbbVie
A Matter of Record
[phone]
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1 ANESTHETIC AND ANALGESIC DRUG PRODUCTS ADVISORY
2 COMMITTEE MEMBERS (Voting)
3 Brian T. Bateman, MD, MSc
4 Associate Professor of Anesthesia
5 Division of Pharmacoepidemiology and
6 Pharmacoeconomics
7 Department of Medicine
8 Brigham and Women’s Hospital
9 Department of Anesthesia, Critical Care, and Pain
10 Medicine, Massachusetts General Hospital
11 Harvard Medical School
12 Boston, Massachusetts
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14 Raeford E. Brown, Jr., MD, FAAP
15 Professor of Anesthesiology and Pediatrics
16 College of Medicine
17 University of Kentucky
18 Lexington, Kentucky
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A Matter of Record
[phone]
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1 David S. Craig, PharmD
2 Clinical Pharmacy Specialist
3 Department of Pharmacy
4 H. Lee Moffitt Cancer Center & Research Institute
5 Tampa, Florida
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7 Charles W. Emala, Sr., MS, MD
8 Professor and Vice-Chair for Research
9 Department of Anesthesiology
10 Columbia University College of Physicians &
11 Surgeons
12 New York, New York
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14 Jeffrey L. Galinkin, MD, FAAP
15 Professor of Anesthesiology and Pediatrics
16 University of Colorado, AMC
17 Director of Pain Research
18 CPC Clinical Research
19 University of Colorado
20 Aurora, Colorado
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A Matter of Record
[phone]
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1 Anita Gupta, DO, PharmD
2 Vice Chair, Pain Medicine
3 Associate Professor
4 Medical Director/Fellowship Director
5 Department of Pain Medicine and Regional
6 Anesthesiology
7 Drexel University College of Medicine
8 Hahnemann University Hospital
9 Philadelphia, Pennsylvania
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11 Jennifer G. Higgins, PhD
12 (Consumer Representative)
13 Director of Strategic Planning and Business
14 Development
15 Center for Human Development
16 Springfield, Massachusetts
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18 Abigail B. Shoben, PhD
19 Assistant Professor, Division of Biostatistics
20 College of Public Health
21 The Ohio State University
22 Columbus, Ohio
A Matter of Record
[phone]
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1 ANESTHETIC AND ANALGESIC DRUG PRODUCTS ADVISORY
2 COMMITTEE MEMBER (Non-Voting)
3 William Joseph Herring, MD, PhD
4 (Industry Representative)
5 Executive Director and Section Head Neurology,
6 Clinical Neurosciences
7 Merck Research Laboratories, Merck & Co.
8 North Wales, Pennsylvania
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10 TEMPORARY MEMBERS (Voting)
11 Warren B. Bilker, PhD
12 Professor, Biostatistics
13 Department of Biostatistics and Epidemiology
14 Perelman School of Medicine
15 University of Pennsylvania
16 Philadelphia, Pennsylvania
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A Matter of Record
[phone]
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1 Amy Bohnert, PhD, MHS
2 Assistant Professor
3 Department of Psychiatry
4 University of Michigan Medical School
5 National Serious Mental Illness Treatment and
6 Resource Evaluation
7 HSR&D Center of Excellence
8 Department of Veterans Affairs
9 Ann Arbor, Michigan
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11 Chester ‘Trip’ Buckenmaier III, MD
12 COL (ret.), MC, USA
13 Program Director
14 Defense and Veterans Center for Integrative Pain
15 Management
16 Professor of Anesthesiology
17 Uniformed Services University
18 Bethesda, Maryland
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A Matter of Record
[phone]
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1 James Floyd, MD, MS
2 Assistant Professor of Medicine
3 Adjunct Assistant Professor of Epidemiology
4 Department of Medicine
5 University of Washington
6 Seattle, Washington
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8 Michael Fry, PharmD
9 Pharmacist in Charge
10 Medical Office Building Pharmacy
11 Providence Health and Services Oregon
12 Portland, Oregon
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14 Martin Garcia-Bunuel, MD
15 Acting Deputy Chief of Staff
16 Associate Chief of Staff
17 Ambulatory and Emergency Care Clinical Center
18 Veterans Affairs Maryland Health Care System
19 Baltimore, Maryland
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A Matter of Record
[phone]