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1 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 + + + NEUROLOGICAL DEVICES PANEL + + + April 24, 2014 8:00 a.m. Holiday Inn 2 Montgomery Village Avenue Gaithersburg, Maryland PANEL MEMBERS: LYNDA J. YANG, M.D., Ph.D. Panel Chair E. RAY DORSEY, M.D., M.B.A. Voting Member JASON CONNOR, Ph.D. Voting Member SCOTT Y. KIM, M.D., Ph.D. Non-Voting Member GLENN T. STEBBINS, Ph.D. Non-Voting Member GUERRY M. PEAVY, Ph.D. Non-Voting Member ERIKA F. AUGUSTINE, M.D. Non-Voting Member STEVEN MILES, M.D. Non-Voting Member DONALD E. RICHARDSON, M.D. Non-Voting Member KAREN L. WEIGLE, Ph.D. Non-Voting Member MARK W. GREEN, M.D. Non-Voting Member BRIAN IWATA, Ph.D. Non-Voting Member WAYNE K. GOODMAN, M.D. Temporary Non-Voting Member DANIEL ARMSTRONG, Ph.D. Temporary Non-Voting Member WARREN BICKEL, Ph.D. Temporary Non-Voting Member NORMAN FOST, M.D., M.P.H. Temporary Non-Voting Member J. STEPHEN MIKITA, J.D. Patient Representative KRISTINE R. MATTIVI, M.S. Consumer Representative JOHN B. REPPAS, M.D., Ph.D. Industry Representative LCDR AVENA RUSSELL, M.S. Designated Federal Officer Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 2 2 FDA REPRESENTATIVES: CARLOS PEÑA, Ph.D. Director, Division of Neurological and Physical Medicine Devices Office of Device Evaluation JENNIFER RODRIGUEZ Press Contact FDA PRESENTERS: KRISTEN A. BOWSHER, Ph.D. Division of Neurological and Physical Medicine Devices Office of Device Evaluation VINCENT AMATRUDO, J.D. Office of the Chief Counsel PETER G. COMO, Ph.D. Division of Neurological and Physical Medicine Devices Office of Device Evaluation LAWRENCE PARK, M.D. Division of Neurological and Physical Medicine Devices Office of Device Evaluation MICHELLE ROTH-CLINE, M.D., Ph.D. Office of Pediatric Therapeutics AFFECTED FIRMS PRESENTERS: GLENDA P. CROOKES Executive Director Judge Rotenberg Educational Center, Inc. NATHAN BLENKUSH, Ph.D., BCBA-D Director of Research Judge Rotenberg Educational Center, Inc. ANTHONY B. JOSEPH, M.D. Judge Rotenberg Educational Center, Inc. EDWARD A. SASSAMAN, M.D. Judge Rotenberg Educational Center, Inc. Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 3 3 OPEN PUBLIC HEARING SPEAKERS - PROFESSIONAL SOCIETIES: MARGARET NYGREN, Ed.D. Executive Director/CEO American Association on Intellectual and Developmental Disabilities BARBARA TRADER Executive Director TASH: Equity, Opportunity, and Inclusion for People with Disabilities KIM MUSHENO Director, Public Policy Association of University Centers on Disabilities ARI NE'EMAN President Autistic Self Advocacy Network ERIC MATTHEWS Disability Rights International RICK GLASSMAN Director of Advocacy Disability Law Center NANCY THALER Executive Director National Association of State Directors of Developmental Disability Services NANCY WEISS, M.S.W. National Leadership Consortium on Developmental Disabilities at the University of Delaware FREDDA BROWN, Ph.D. Queens College Regional Center for Autism Spectrum Disorders MAUREEN FITZGERALD Director, Disability Rights The Arc of the United States ESME GRANT Director, Public Policy National Association of Councils on Developmental Disabilities Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 4 4 LOUISA GOLDBERG BRI Parents & Friends Association CHRISTOPHER OLIVA, Ph.D. Gateways: Educational and Behavioral Consultation Services JENNIFER BELLAMY Legislative Counsel American Civil Liberties Union LYDIA BROWN Board of Directors TASH: New England CURTIS DECKER, J.D. Executive Director National Disability Rights Network EMILY MINTON Occupy JRC OPEN PUBLIC HEARING SPEAKERS - GENERAL SESSION: ARACELIS SANCHEZ Former JRC Student/Pro device use BRIAN AVERY Former JRC Student/Pro device use JAMES BUTLER Concerned Citizen/Against device use CHERYL McCOLLINS Parent of Former JRC Student/Against device use DIANE ENGSTER, J.D. Concerned Citizen/Against device use IAN COOK Former JRC Student/Against device use LAUREN EMMICK Parent of JRC Student/Pro device use MARCOS PUCHA Former JRC Student/Pro device use ILANA SLAFF-GALATAN, M.D. Sister of JRC Student/Pro device use Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 5 5 ROGER AND SHARON WOOD Parents of JRC Student/Pro device use MICHAEL J. CAMERON, PH.D. Pro device use ARTHUR AND MICHELE PERAZZO Parents of JRC Student/Pro device use GREGORY MILLER Former JRC Employee/Against device use JENNIFER MSUMBA Video Testimony Former JRC Student/Against device use SHAIN NEUMEIER Concerned Citizen/Against device use VITO ALVENESE Concerned Citizen/Against device use Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 6 6 INDEX PAGE CALL TO ORDER - Lynda J. Yang, M.D., Ph.D. 10 PANEL INTRODUCTIONS 10 CONFLICT OF INTEREST STATEMENT AND TEMPORARY VOTING MEMBER STATEMENTS - LCDR Avena Russell, M.S. 13 AVERSIVE CONDITIONING DEVICES REGULATORY HISTORY Introduction - Kristen A. Bowsher, Ph.D. 18 FDA Standard for Banning - Vincent Amatrudo, J.D. 20 Regulatory History and Device Description - Kristen A. Bowsher, Ph.D. 22 FDA CLINICAL AND SCIENTIFIC PRESENTATION Clinical Background - Regarding Self-Injurious Behavior (SIB) and Aggressive Behavior in Intellectual and Developmental Disorders - Peter G. Como, Ph.D. 29 Benefit/Risk Assessment of ESDs for Aversive Conditioning - Lawrence Park, M.D. 43 Ethical Considerations in the Use of Aversive Conditioning - Michelle Roth-Cline, M.D., Ph.D. 68 Summary - Kristen A. Bowsher, Ph.D. 73 Q&A FDA 74 AFFECTED FIRMS PRESENTATION Judge Rotenberg Educational Center, Inc. Introduction - Glenda P. Crookes 92 Clinical Data Demonstrating Safety and Efficacy of Aversive Conditioning Devices - Nathan Blenkush, Ph.D., BCBA-D 98 Anthony B. Joseph, M.D. 108 Edward A. Sassaman, M.D. 111 Q&A JRC 113 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 7 7 INDEX PAGE OPEN PUBLIC HEARING - PROFESSIONAL SOCIETIES American Association on Intellectual and Developmental Disabilities - Margaret Nygren, Ed.D. 153 TASH: Equity, Opportunity, and Inclusion for People with Disabilities - Barbara Trader 156 Association of University Centers on Disabilities - Kim Musheno 159 Autistic Self Advocacy Network - Ari Ne'eman 162 Disability Rights International - Eric Matthews 165 Disability Law Center - Rick Glassman 168 National Association of State Directors of Developmental Disability Services - Nancy Thaler 170 National Leadership Consortium on Developmental Disabilities at the University of Delaware - Nancy Weiss, M.S.W. 173 Queens College Regional Center for Autism Spectrum Disorders - Fredda Brown, Ph.D. 176 The Arc of the United States - Maureen Fitzgerald 179 National Association of Councils on Developmental Disabilities - Esme Grant 181 BRI Parents & Friends Association - Louisa Goldberg 184 Gateways: Educational and Behavioral Consultation Services - Christopher Oliva, Ph.D. 186 American Civil Liberties Union - Jennifer Bellamy 189 TASH: New England - Lydia Brown 192 National Disability Rights Network - Curtis Decker, J.D. 195 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 8 8 INDEX PAGE OPEN PUBLIC HEARING - GENERAL SESSION Aracelis Sanchez 198 Brian Avery 200 James Butler 201 Cheryl McCollins 203 Diane Engster, J.D. 205 Ian Cook 207 Lauren Emmick 208 Marcos Pucha 210 Ilana Slaff-Galatan, M.D. 212 Roger and Sharon Wood 214 Michael J. Cameron, Ph.D. 217 Arthur and Michele Perazzo 219 Gregory Miller 221 Jennifer Msumba 224 Shain Neumeier 226 Vito Alvenese 227 OPEN PUBLIC HEARING - PROFESSIONAL SOCIETIES (cont.) Occupy JRC - Emily Minton 228 Q&A OPEN PUBLIC HEARING 230 PANEL DELIBERATIONS 237 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 9 9 INDEX PAGE FDA QUESTIONS Question 1a 272 Question 1b 281 Question 2a 286 Question 2b 298 Question 3 313 Question 4 330 Question 5 336 Question 6 345 FDA SUMMARY Carlos Peña, Ph.D. 356 ADJOURNMENT Error! Bookmark not defined. Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 1010 M E E T I N G (8:02 a.m.) DR. YANG: Good morning. It is approximately 8:00 a.m., and I would like to call this meeting of the Orthopaedic and Rehabilitation Devices Panel [sic] to order. I am Lynda Yang, the Chairperson of this Panel. I am a neurosurgeon at the University of Michigan, with expertise in spine, peripheral nerve, and brachial plexus surgery. For today's agenda, the Panel will discuss current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. Before we begin, I would like to ask our distinguished Panel members and FDA staff seated at the table to introduce themselves. Please state your name, your area of expertise, your position, and your affiliation. So, Dr. Reppas, why don't we start with you. DR. REPPAS: Sure. John Reppas, M.D., Ph.D. I am the Director of Public Policy for the Neurotechnology Industry Organization. MS. MATTIVI: Kris Mattivi. I am the Consumer Representative for the Panel. I am a physical therapist and a business consultant for Wellpoint. DR. RICHARDSON: Donald Richardson. I am a neurosurgeon Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 1111 specializing in functional neurosurgery at Tulane University Health Sciences Center. DR. IWATA: Brian Iwata, Professor of Psychology, University of Florida. DR. GREEN: Mark Green, Professor of Neurology, Anesthesiology, and Rehabilitation Medicine, and director of headache and pain medicine at Icahn School of Medicine in New York. DR. WEIGLE: I'm Karen Weigle, and I am a clinical psychologist. I am affiliated with the University of New Hampshire's Institute on Disability, and I am a founder and clinician at the Chattanooga Autism Center. DR. FOST: Norm Fost, Professor of Pediatrics and Bioethics at the University of Wisconsin, Madison.