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Immunology Devices Panel Nov. 13, 2019 Transcript

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Immunology Devices Panel Nov. 13, 2019 Transcript 1 UNITED STATES OF AMERICA DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION + + + CENTER FOR DEVICES AND RADIOLOGICAL HEALTH MEDICAL DEVICES ADVISORY COMMITTEE + + + IMMUNOLOGY DEVICES PANEL + + + November 13, 2019 8:00 a.m. DoubleTree by Hilton Washington DC North/Gaithersburg 620 Perry Parkway Gaithersburg, MD 20877 PANEL MEMBERS: RAJKUMAR RAO, M.D. Chair MICHAEL POLLARD, Ph.D. Temporary Non-Voting Member STEPHEN BADYLAK, D.V.M., Ph.D., M.D. Temporary Non-Voting Member SCOTT BURCHIEL, Ph.D. Temporary Non-Voting Member YIMING LI, D.D.S., Ph.D. Temporary Non-Voting Member JOHN SUZUKI, Ph.D., D.D.S. Temporary Non-Voting Member JOHN ZUNIGA, D.M.D., M.S., Ph.D. Temporary Non-Voting Member RICHARD BURTON, D.D.S. Temporary Non-Voting Member MICHAEL WEISMAN, M.D. Temporary Non-Voting Member PAUL JANNETTO, M.D. Temporary Non-Voting Member MARK DYKEWICZ, M.D. Temporary Non-Voting Member CHRISTINE PARKS, M.D. Temporary Non-Voting Member DORI GERMOLEC, Ph.D. Temporary Non-Voting Member JAMES TAYLOR, M.D. Temporary Non-Voting Member JACK LEMONS, Ph.D. Temporary Non-Voting Member JOSHUA JACOBS, M.D. Temporary Non-Voting Member MELISSA McDIARMID, M.D. Temporary Non-Voting Member JASON CONNOR, Ph.D. Temporary Non-Voting Member JULIA BABENSEE, Ph.D. Temporary Non-Voting Member NICHOLAS GIORI, M.D., Ph.D. Temporary Non-Voting Member Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 2 WHITNEY CHRISTIAN, Ph.D. Industry Representative WYATT A. LISON, Esq. Consumer Representative JOSEPH O'BRIEN, M.B.A. Patient Representative ADEN ASEFA, M.P.H. Designated Federal Officer This transcript has not been edited or corrected, but appears as received from the commercial transcribing service. Accordingly, the Food and Drug Administration makes no representation as to its accuracy. Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 3 FDA REPRESENTATIVES: BENJAMIN R. FISHER, Ph.D. Director, Office of Health Technology 3 Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office of Product Evaluation and Quality ARON YUSTEIN, M.D. Assistant Director, Clinical and Scientific Policy Staff Office of Product Evaluation and Quality Director, CDRH Signal Management Program MICHAEL E. ADJODHA, M.Ch.E. Acting Assistant Director, Restorative and Surgical Dental Devices Team Division of Dental Devices Office of Health Technology 1 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality MICHAEL FELBERBAUM ANGELA STARK Press Contacts Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 4 PRESENTERS: DORI R. GERMOLEC, Ph.D. Immunology Discipline Leader Toxicology Branch, National Toxicology Program National Institute for Environmental Health Sciences National Institutes of Health JENNIFER GOODE, B.S. Biocompatibility Program Advisor Office of Product Evaluation and Quality FDA/CDRH DAVID SAYLOR, Ph.D. Office of Science and Engineering Labs FDA/CDRH NADIM JAMES HALLAB, Ph.D. Rush University Medical Center LAURA SANTAMBROGIO, M.D., Ph.D. Associate Director, Precision Immunology Englander Institute for Precision Medicine Weill Cornell Medicine STEPHEN WEBER, M.D. Medical Officer Office of Health Technology 6 FDA/CDRH BENJAMIN R. FISHER, Ph.D. Director, Office of Health Technology 3 Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office of Product Evaluation and Quality FDA/CDRH YOUNG-MIN KWON, M.D., Ph.D. Associate Professor Harvard Medical School Department of Orthopaedic Surgery Massachusetts General Hospital ELIZABETH STAFFORD, Ph.D. Division of Immunology and Hematology Office of In Vitro Diagnostics FDA/CDRH YELIZAVETA (LISA) TOROSYAN, M.D., Ph.D. FDA/CDRH Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 5 MICHAEL E. ADJODHA, M.Ch.E. Acting Assistant Director, Restorative and Surgical Dental Devices Team Division of Dental Devices Office of Health Technology 1 Office of Product Evaluation and Quality FDA/CDRH ALFRED FRANZBLAU, M.D. University of Michigan School of Public Health OPEN PUBLIC HEARING SPEAKERS: KARIN A. PACHECO, M.D., M.S.P.H. Associate Professor Division of Environmental & Occupational Health Sciences National Jewish Health University of Colorado School of Medicine DIANA ZUCKERMAN, Ph.D. President National Center for Health Research RENU VIRMANI, M.D. President CVPath Institute SCOTT A. SCHROEDER, D.P.M., FACFAS Foot & Ankle Center of Wenatchee STEPHEN S. TOWER, M.D. Affiliated Professor UAA/WWAMI LINDA RADACH Patient MADRIS TOMES, M.B.A. Founder/CEO Device Events AMY BARNETT Patient FRANCES SCOTT Patient SUSAN FRANCIS Patient Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 6 TESS SCHULMAN, Ph.D. Patient Advocate Medical Device Problems ASHES Nonprofit CAREN BEILIN, Ph.D. Patient KATHRYN SHASHA Private Citizen NATALIE HECKENDORN Wife of Patient DAWN YUSTER Patient URSZULA TANOUYE Citizens 4 Clean Air LINDA NELSON Managing Director MELISA Diagnostics, Ltd. CURT HAMANN, M.D. CEO SmartPractice SUSAN ALPERT, M.D., Ph.D. AdvaMed ANTHONY RAGHEB, Ph.D., M.B.A. Vice President, Research and Engineering Testing Cook Medical Adjunct Assistant Professor, Biomedical Engineering Purdue University WILLIAM G. VAN ALSTINE, D.V.M., Ph.D. Diplomate, American College of Veterinary Pathologists Director, Veterinary Pathology Cook Medical Professor Emeritus, Comparative Pathology Purdue University JOHANN WEHRLE Consumers for Dental Choice Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 7 INDEX PAGE CALL TO ORDER - Rajkumar Rao, M.D. 10 PANEL INTRODUCTIONS 11 CONFLICT OF INTEREST STATEMENT - Aden Asefa, M.P.H. 15 DEPUTIZATION TO NON-VOTING MEMBER - Aden Asefa, M.P.H. 17 WELCOME & INTRODUCTION - Aron Yustein, M.D. 19 INTRODUCTION TO IMMUNOLOGY BASICS - Dori R. Germolec, Ph.D. 25 CLARIFYING QUESTIONS FROM THE PANEL 31 METAL IMPLANTS FDA Guidance/Biocompatibility - Jennifer Goode, B.S. 32 Corrosion - David Saylor, Ph.D. 35 Preclinical Issues Nadim James Hallab, Ph.D. 40 Laura Santambrogio, M.D., Ph.D. 48 Clinical Non-Orthopedics Stephen Weber, M.D. 54 Benjamin R. Fisher, Ph.D. 56 Clinical Orthopedics - Young-Min Kwon, M.D. 59 Diagnostics - Elizabeth Stafford, Ph.D. 70 Summary/Gap Analysis - Yelizaveta (Lisa) Torosyan, M.D., Ph.D. 76 PANEL CLARIFICATIONS/DELIBERATION 81 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 8 INDEX PAGE DENTAL AMALGAM Background - Michael E. Adjodha, M.Ch.E. 103 Clarifying Questions from the Panel 110 Summary of FDA Scientific Review - Yelizaveta (Lisa) Torosyan, M.D., Ph.D. 112 Clarifying Questions from the Panel 121 Biomarkers of Exposure - Alfred Franzblau, M.D. 122 Summary/Gap Analysis - Yelizaveta (Lisa) Torosyan, M.D., Ph.D. 129 PANEL CLARIFICATIONS/DELIBERATION 131 OPEN PUBLIC HEARING Karin A. Pacheco, M.D., M.S.P.H. 150 Diana Zuckerman, Ph.D. 152 Renu Virmani, M.D. 155 Scott A. Schroeder, D.P.M., FACFAS 159 Stephen S. Tower, M.D. 164 Linda Radach 168 Madris Tomes, M.B.A. 170 Amy Barnett 174 Frances Scott 176 Susan Francis 179 Tess Schulman, Ph.D. 181 Caren Beilin, Ph.D. 185 Kathryn Shasha 188 Natalie Heckendorn 190 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 9 INDEX PAGE OPEN PUBLIC HEARING (cont.) Dawn Yuster 193 Urszula Tanouye 197 Linda Nelson 201 Curt Hamann, M.D. 205 Susan Alpert, M.D., Ph.D. 209 Anthony Ragheb, Ph.D., M.B.A. and William G. Van Alstine, D.V.M, Ph.D. 213 Johann Wehrle 217 ADJOURNMENT 220 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 10 M E E T I N G (8:00 a.m.) DR. RAO: Good morning, everyone. I'd like to call this meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee to order. My name is Raj Rao. I'm Chair of this Panel. I am an orthopedic surgeon, professor and chair of the Department of Orthopaedic Surgery at George Washington University. I note for the record the members present constitute a quorum as required by 21 C.F.R. Part 14. I would also like to add that the Panel members participating in today's meeting have received training in FDA device law and regulations. Over the next 2 days, the Panel will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal- containing implants as well as dental amalgam. Implants are medical devices that are placed into a surgically or naturally formed opening of the human body and are intended to remain there after the procedure for an extended period of time. Recent postmarket issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological responses to the implant. These may include local peri-implant adverse events and potentially systemic manifestations which may impact a patient's quality of life and necessitate medical or surgical intervention. While not considered an implant, dental amalgam is included in this discussion because of its potential for patient and user exposure to mercury compounds and some purported similarities in the adverse biological responses and clinical manifestations elicited by some dental amalgams to that of traditional metal implants. FDA is convening this Committee to promote an open public discussion of, and seek expert opinion on, currently available scientific and clinical data pertaining to the biological Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 11 responses to metal implants and dental amalgam and the potential associated clinical sequelae. Before we begin, I would like to ask our distinguished Panel members and FDA staff seated at this table to introduce themselves.
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