You can download this letter as a PDF here.
Alex M. Azar II
Secretary
U.S. Department of Health and Human Services
Scott Gottlieb
Commissioner
Food and Drug Administration
John Michael Mulvaney
Director
Office of Management and Budget
Sent via electronic mail
Re: FDA proposed rule banning electrical stimulation devices
Dear Secretary Azar, Commissioner Gottlieb and Director Mulvaney,
We the undersigned write to once again urge the Federal Drug Administration (FDA) to finalize its proposed ban of electrical stimulation devices (ESDs) used to treat self-injurious or aggressive behavior. For two years since the FDA initially released its Proposed Rule to ban these devices, and for four years since a panel of experts recommended that they be banned, children and adults with disabilities have continued to suffer from painful and dangerous electric shocks. We urge you to take action now to end this abuse.
Concerned citizens and advocacy organizations first wrote to the FDA in March 2010 and again in January 2013, urging that the FDA ban these dangerous and unnecessary devices. In addition, in December 2012, the Centers for Medicare and Medicaid Services issued a letter making clear that use of the graduated electronic decelerator device, and other Level III aversive techniques, is prohibited for individuals receiving Medicaid- funded services. Advocates met with FDA representatives in April 2013. A year later, on April 24, 2014, the FDA held a day-long hearing and convened an advisory panel to seek scientific and clinical expert opinion on the risks and benefits associated with other treatment options, the risks and benefits of ESDs for aversive conditioning, and on whether these devices present a substantial and unreasonable risk of illness or injury. For a month before and a month after that meeting – from March 27 to June 24, 2014 – the FDA gave the public the opportunity to comment, and the FDA received almost 300 comments at that time (posted on Docket FDA- 2014-N-0238, available at https://www.regulations.gov/document?D=FDA-2014-N-0238-0001).
The FDA took a full two years before announcing on April 22, 2016 that it had determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. We were pleased that the FDA finally recognized what the United Nations, disability advocates, researchers, psychiatrists and psychologists, families and people with disabilities have long known – these are devices of torture and abuse – and that their use would finally be ended. However, despite having already had multiple public comment periods related to the device, FDA allowed an extension of the comment period on the rule from a deadline of May 25 to July 25, 2016. It has now been nearly twenty-one months since that comment period ended. This delay raises significant concerns.
The FDA is mandated to protect the health and safety of these individuals and must not delay further. In the eight years since this issue was raised to the FDA and in the two years it took for the FDA to release a proposed rule in response to the April 2014 hearing, many vulnerable people with disabilities were subjected to unbearably painful electric shock for such harmless behaviors as getting out of one’s seat, interrupting, whispering, slouching, swearing, or failing to maintain a neat appearance. As the proposed rule recognizes, innocent and vulnerable children and adults are experiencing dramatic short and long term effects from this abusive treatment every day.
We the undersigned urge HHS and the White House to prioritize and take all actions necessary to ensure these critical rules are finalized. Secretary Azar and Commissioner Gottlieb, we ask that you devote any and all resources necessary to swiftly review comments and finalize the rule with an immediate effective date and no further delays. Additionally, we call on the White House to take all steps necessary to ensure that the final rule is shepherded through the Office of Information and Regulatory Affairs.
If you have any questions about this letter, please contact Sam Crane of the Autistic Self Advocacy Network at scrane@autisticadvocacy.org, (202) 509-0135.
Sincerely,
| A Better Life, LLC | Denver | CO | |
| ACHIEVA | Pittsburgh | PA | |
| ACCSES | Washington | DC | |
| Access Living | Chicago | IL | |
| ADAPT | Rochester | NY | |
| ADAPT Chicago | Chicago | IL | |
| ADAPT DC Metro | Washington | DC | |
| ADAPT Georgia | Decatur | GA | |
| ADAPT Kansas | Topeka | KS | |
| ADAPT Montana | Missoula | MT | |
| ADAPT Utah/ Disabled Rights Action Committee | Salt Lake City | UT | |
| The Advocacy Institute | Marshall | VA | |
| Advocates | Framingham | MA | |
| Alliance | Denver | CO | |
| The Alliance for the Betterment of Citizens with Disabilities (ABCD) | Hamilton | NJ | |
| Alliance for Citizen Directed Supports | Philadelphia | PA | |
| Alliance for Person-Centered Accessible Technologies | Tempe | AZ | |
| Allies for Independence | Washington | DC | |
| American Academy of Developmental Medicine and Dentistry | Louisville | KY | |
| American Association of People with Disabilities | Washington | DC | |
| American Association on Health and Disability | Rockville | MD | |
| American Association on Intellectual and Developmental Disabilities | Washington | DC | |
| American Civil Liberties Union | Washington | DC | |
| American Foundation for the Blind | New York | NY | |
| American Network of Community Options and Resources | Alexandria | VA | |
| American Occupational Therapy Association | Bethesda | MD | |
| ao Strategies | Palatine | IL | |
| The Arc Arapahoe & Douglas | Centennial | CO | |
| The Arc Michigan | Lansing | MI | |
| The Arc of Adams County | Northglenn | CO | |
| The Arc of Colorado | Denver | CO | |
| The Arc of Hunterdon County | Annandale | NJ | |
| The Arc – Jefferson, Clear Creek & Gilpin Counties | Lakewood | CO | |
| The Arc of Massachusetts | Waltham | MA | |
| The Arc Mesa County | Grand Junction | CO | |
| The Arc of Tucson | Tucson | AZ | |
| The Arc of the United States | Washington | DC | |
| The Arc of Virginia | Richmond | VA | |
| The Arc of Weld County | Greeley | CO | |
| The Arc of West Central Colorado | Delta | CO | |
| The Arc of Wisconsin | Stoughton | WI | |
| Architects of Diversity | Cody | WY | |
| Association of Developmental Disabilities Providers of Massachusetts | Framingham | MA | |
| Association of Programs for Rural Independent Living | Little Rock | AR | |
| Association of University Centers on Disabilities | Silver Spring | MD | |
| AutCom | Arlington | MA | |
| Autism Society of America | Bethesda | MD | |
| Autism Society of Los Angeles | Los Angeles | CA | |
| Autism Women’s Network | Lincoln | NE | |
| Autistic Self Advocacy Network | Washington | DC | |
| Bazelon Center for Mental Health Law | Washington | DC | |
| Blue Peaks Developmental Services | Alamosa | CO | |
| Boston Center for Independent Living | Boston | MA | |
| Brain Injury Association of America | Vienna | VA | |
| Broadreach Training and Resources, Ltd. | New Westminster | BC | Canada |
| California Down Syndrome Advocacy Coalition | Danville | CA | |
| Camphill Soltane | Glenmoore | PA | |
| Center for Behavioral Education and Research, University of Connecticut | Storrs | CT | |
| Center for Disability Rights | Rochester | NY | |
| Center for Public Representation | Northampton | MA | |
| Center on Human Policy, Syracuse University | Syracuse | NY | |
| Cerebral Palsy of North Jersey | Livingston | NJ | |
| Children’s Freedom Initiative | Atlanta | GA | |
| Coalition for Juvenile Justice | Washington | DC | |
| Collaboration to Promote Self-Determination | Washington | DC | |
| Colorado Bluesky Enterprises, Inc. | Pueblo | CO | |
| Colorado Developmental Disabilities Council | Denver | CO | |
| Community Connections, Inc. | Durango | CO | |
| Community Link | Boulder | CO | |
| Community Options, Inc. | Montrose | CO | |
| Community Outreach | Colorado Springs | CO | |
| Community Systems, Inc. | McLean | VA | |
| The Coordinating Center | Millersville | MD | |
| The Council of Parent Attorneys and Advocates, Inc. | Towson | MD | |
| The Council on Quality and Leadership | Towson | MD | |
| Delaware Developmental Disabilities Council | Dover | DE | |
| Dept. of Counseling and Special Education, Virginia Commonwealth Univ. | Richmond | VA | |
| Different Dream Living | Boone | IA | |
| Disability Health Access | Los Altos | CA | |
| Disability Inclusion Guild, Inc. | Rockville | MD | |
| Disability Law Center of Alaska | Anchorage | AK | |
| Disability Law Center of Virginia | Richmond | VA | |
| Disability Law Center- MA | Boston | MA | |
| Disability Policy Consortium | Malden | MA | |
| Disability Power & Pride | Washington | DC | |
| DQIA Disabled Queers in ACTION! | Washington | DC | |
| Disability Rights Center | Rhododendron | OR | |
| Disability Rights Center of Kansas | Topeka | KS | |
| Disability Rights Center- NH | Concord | NH | |
| Disability Rights DC at University Legal Services | Washington | DC | |
| Disability Rights Education & Defense Fund | Berkeley | CA | |
| Disability Rights California | Sacramento | CA | |
| Disability Rights Connecticut | Hartford | CT | |
| Disability Rights Florida | Tallahassee | FL | |
| Disability Rights Maine | Portland | ME | |
| Disability Rights Maryland | Baltimore | MD | |
| Disability Rights Mississippi | Jackson | MS | |
| Disability Rights North Carolina | Raleigh | NC | |
| Disability Rights North Dakota | Bismarck | ND | |
| Disability Rights New Jersey | Trenton | NJ | |
| Disability Rights New York | Albany | NY | |
| Disability Rights Oregon | Portland | OR | |
| Disability Rights Pennsylvania | Harrisburg | PA | |
| Disability Rights Wisconsin | Madison | WI | |
| Down Syndrome Alliance of the Midlands | Omaha | NE | |
| Down Syndrome Association of Central Florida | Winter Park | FL | |
| Down Syndrome Association of Delaware | Middletown | DE | |
| Down Syndrome Association of Middle Tennessee | Nashville | TN | |
| Down Syndrome Association of West Michigan | Grand Rapids | MI | |
| Down Syndrome Awareness Group of East Tennessee | Knoxville | TN | |
| Down Syndrome Connection of the Bay Area | Danville | CA | |
| Easterseals | Washington | DC | |
| Education Advocacy Coalition | Baltimore | MD | |
| Endless Possibilities In The Community | Newark | DE | |
| Epilepsy Foundation | Landover | MD | |
| Equip for Equality | Chicago | IL | |
| Exceptional Parent Magazine | Chattanooga | TN | |
| Families of Children on the Autism Spectrum (FOCAS) | Westminster | MD | |
| Family Residences and Essential Enterprises, Inc. | Bethpage | NY | |
| Family Voices | Washington | DC | |
| Frontier Community Services | Soldotna | AK | |
| Gail Jacob and Associates | Madison | WI | |
| Georgia Advocacy Office | Decatur | GA | |
| Governor’s Advisory Council for Exceptional Citizens (GACEC) | Dover | DE | |
| HIGH IMPACT Mission-based Consulting & Training | Northbrook | IL | |
| Hills & Dales Child Development Center | Dubuque | IA | |
| Hope House Foundation | Norfolk | VA | |
| Human Services Research Institute | Cambridge | MA | |
| Imagine | Blacksburg | VA | |
| Inclusion Innovations | Robbinsdale | MN | |
| Independent Environments, Inc. | Eugene | OR | |
| Institute for Community Inclusion, University of Massachusetts Boston | Boston | MA | |
| Institute on Disabilities, Temple University | Philadelphia | PA | |
| Integrated Quality Management Approach (IQMA) Team | Boston | MA | |
| InVision Human Services | Wexford | PA | |
| Jannirose JOY LLC | Yellow Springs | OH | |
| Japanese Speaking Parents Association of Children with Challenges | Los Angeles | CA | |
| Job Path, Inc. | New York | NY | |
| Kentucky Association of Private Providers (KAPP) | Monticello | KY | |
| Kentucky Protection and Advocacy Division | Frankfort | KY | |
| Keystone Human Services | Harrisburg | PA | |
| Kern Down Syndrome Network | Bakersfield | CA | |
| Koinonia Homes, Inc. | Independence | OH | |
| L’Arche Syracuse | Syracuse | NY | |
| Lakeshore Foundation | Birmingham | AL | |
| The Learning Community for Person Centered Practices, Inc. | Annapolis | MD | |
| Liberty Resources Inc. | Syracuse | NY | |
| LifeShare | Manchester | NH | |
| Linda H. Rammler, Consultants | Middlefield | CT | |
| Living Well Disability Service | Eagan | MN | |
| Lutheran Services in America Disability Network | Washington | DC | |
| Maryland Association of Community Services | Columbia | MD | |
| Maryland Coalition of Families | Columbia | MD | |
| Mental Health America | Alexandria | VA | |
| Mental Health Legal Advisors Committee, Supreme Judicial Court of Massachusetts | Boston | MA | |
| Metro Boston Recovery Learning Community | Boston | MA | |
| Michigan Protection and Advocacy Service, Inc. | Lansing | MA | |
| Mosaic | Omaha | NE | |
| M-POWER | Roxbury | MA | |
| National Leadership Consortium on Development Disabilities | Newark | DE | |
| National Alliance for Direct Support Professionals | Albany | NY | |
| National Alliance on Mental Illness | Arlington | VA | |
| National Alliance for Mental Illness – Greater Boston Consumer Advocacy Network | Boston | MA | |
| National Association of Councils on Developmental Disabilities | Washington | DC | |
| National Association of State Directors for Developmental Disabilities Services | Alexandria | VA | |
| NAACP | Baltimore | MD | |
| National Association of State Directors of Special Education (NADSE) | Alexandria | VA | |
| National Association of State Head Injury Administrators | Alabaster | AL | |
| National Association of the Deaf (NAD) | Silver Spring | MD | |
| National Coalition for Mental Health Recovery | Potomac | MD | |
| National Consumer Voice for Quality Long-Term Care | Washington | DC | |
| National Council on Independent Living | Washington | DC | |
| National Disability Rights Network | Washington | DC | |
| National Down Syndrome Congress | Atlanta | GA | |
| National Down Syndrome Society | New York | NY | |
| National Empowerment Center | Lawrence | MA | |
| National LGBTQ Task Force | Washington | DC | |
| National Organization of Nurses with Disabilities | Chicago | IL | |
| Native American Disability Law Center, Inc. | Farmington | NM | |
| Neighbours, Inc | Highland Park | NJ | |
| NorthStar Supported Living Services, Inc. | Placerville | CA | |
| Not Dead Yet | Rochester | NY | |
| Occupy the Judge Rotenberg Center | Worcester | MA | |
| Oklahoma Community-based Providers, Inc. | Oklahoma City | OK | |
| Ollibean | Tampa | FL | |
| Oregon Rehabilitation Association (ORA) | Salem | OR | |
| Oregon Supported Living Program | Eugene | OR | |
| Parents of Adults with Disabilities in Colorado | Parker | CO | |
| Parent 2 Parent USA | Washington | DC | |
| Pastoral Ministry with Persons with Disabilities | Newark | NJ | |
| Play to Learn…Learn to Play, Inc. | Acton | MA | |
| Protection and Advocacy for People with Disabilities- SC | Columbia | SC | |
| Quality Trust for Individuals with Disabilities | Washington | DC | |
| Queerability | Rockville | MD | |
| Research and Training Center on Community Living, University of Minnesota | Minneapolis | MN | |
| The Resource Exchange, Inc. | Denver | CO | |
| Respect ABILITY Law Center | Royal Oak | MI | |
| RISE Services, Inc | Orem | UT | |
| Riverside Training Centers, Inc. | St Helens | OR | |
| Rocky Mountain Down Syndrome Association | Denver | CO | |
| Second Thoughts MA: Disability Rights Advocates against Assisted Suicide | Boston | MA | |
| SEEC | Silver Spring | MD | |
| Shared Support Maryland, Inc. | Baltimore | MD | |
| Southeastern Developmental Services | Lamar | CO | |
| Southern Arizona Network for Down Syndrome | Tucson | AZ | |
| Spaulding Support Services | East Syracuse | NY | |
| Starpoint | Canon City | CO | |
| Statewide Independent Living Council of Alaska | Anchorage | AK | |
| Sunshine Social Club | Whitestown | IN | |
| Support, Inc. | Aurora | CO | |
| Syntiro | Readfield | ME | |
| TASH | Washington | DC | |
| TASH New England | Boston | MA | |
| Teaching Learners with Multiple Needs/Ahern TEC | Billerica | MA | |
| The THRIVE Network | Brooklyn | NY | |
| Topeka Independent Living Resource Center | Topeka | KS | |
| Transition Consults, LLC | Bala Cynwyd | PA | |
| UMKC Institute for Human Development | Kansas City | MO | |
| Unbound Books Autism Acceptance Library | Modesto | CA | |
| United Cerebral Palsy | Washington | DC | |
| United Spinal Association | Washington | DC | |
| Unlimited Possibilities of Colorado LLC | Greeley | CO | |
| Uplift, Inc | Gardiner | ME | |
| Values Into Action- New Jersey | Burlington | NJ | |
| Values Into Action- Pennsylvania | Media | PA | |
| Velocardiofacial Syndrome Texas, Inc. | Austin | TX | |
| Vita Community Living Services | Toronto | ON | Canada |
| Washington Metro Disabled Students Collective | Washington | DC | |
| Western Massachusetts Recovery Learning Community | Holyoke | MA | |
| Wings to Fly Therapy and Play Center | Chantilly | VA | |
| Wisconsin Board for People with Developmental Disabilities | Madison | WI | |
| Wisconsin Upside Down | Hartland | WI |
Cc:
Roger Severino
Director
HHS Office of Civil Rights
Lance Robertson
Administrator
Administration on Community Living
Joseph L. Grogan
Director of Health Programs
White House Office of Management and Budget
Neomi Rao
Administrator
Office of Information and Regulatory Affairs