These comments are available as a PDF here.
Dear Secretary Becerra, Commissioner Califf, and General Counsel Bagenstos
We the undersigned write to urge the Federal Drug Administration (FDA) to reissue its ban of electrical stimulation devices (ESDs) used to treat self-injurious or aggressive behavior. In 2020 the Food and Drug Administration (FDA) banned the use of these devices as aversive therapy, a well-reasoned position that is consistent with the overwhelming weight of the scientific literature and treatment practices across the country. Unfortunately, FDA’s proposed ban was reversed1 on a technicality related to the FDA’s regulatory authority. However, Congress has recently clarified the FDA’s authority to issue such a ban.2
For two years since the FDA’s original ban on these devices was overturned by the courts, -eight years after a panel of experts recommended that they be banned- children and adults with disabilities have continued to suffer from Congress affirmed that the FDA has the authority to do so. The medical evidence that this is an ineffective and harmful intervention is clear. When the FDA’s judgment was questioned, the American Academy of Pediatrics, the American Academy of Developmental Medicine and Dentistry, the American Association on Intellectual and Developmental Disabilities, the International Association for the Scientific Study of Intellectual and Developmental Disabilities, the National Association for the Dually Diagnosed, the National Association of State Directors of Developmental Disabilities Services, and the National Association of State Directors of Special Education all agreed that the evidence supported an ESD ban. As Manfred Nowak, the UN’s Special Rapporteur on Torture, has bluntly3 stated: “This is torture.”4
On April 22, 2016, the FDA announced 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. This followed outcry from concerned members of the public and advocacy organizations dating back more than 13 years to our first outreach in March 2010. As the FDA found, use of these devices
Present[s] a number of psychological and physical risks: Depression, fear, escape and avoidance behaviors, panic, aggression, substitution of other behaviors (e.g., freezing and catatonic sit-down), worsening of underlying symptoms (e.g., increased frequency or bursts of self-injury), pain, burns, tissue damage, and errant shocks from device misapplication or failure. Based on literature for implantable cardioverter defibrillators, FDA has determined that ESDs present the risks of posttraumatic stress or acute stress disorders, shock stress reaction, and learned helplessness.That literature provides additional support for the risks of depression, anxiety, fear, and pain. Experts in the field of behavioral science, State agencies that regulate the use of ESDs, the sole current manufacturer and user of ESDs, and individuals who were subject to ESDs corroborate most of these findings, and they attest to additional risks. 5
We were pleased that the FDA agreed with 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.
The FDA is mandated to protect the health and safety of these individuals and must not delay further. In the years since this issue was first raised with the FDA, many vulnerable people with disabilities were subjected to electric shocks for behaviors such as getting out of one’s seat, interrupting, whispering, slouching, swearing, or failing to maintain a neat appearance. As the previously-issued rule recognized, vulnerable children and adults are experiencing dramatic short and long-term effects from this abusive treatment every day.
We, the undersigned, urge HHS to prioritize and take all actions necessary to ensure this critical rule is reissued. Secretary Becerra and Commissioner Califf, we ask that you devote any and all resources necessary to swiftly reissue the rule with an immediate effective date and no further delays. If you have any questions about this letter, please contact Larkin Taylor-Parker of the Autistic Self Advocacy Network at ltaylorparker@autisticadvocacy.org.
Signed,
Access Ready
22Q Texas, Inc.
ADAPT Montana
ADAPT National
Advocacy Institute
Alabama Disabilities Advocacy Program (ADAP)
Alliance Against Seclusion and Restraint
Alliance Colorado
Allies for Independence
American Academy of Developmental Medicine & Dentistry (AADMD)
American Academy of Pediatrics
American Association on Health and Disability
American Association on Intellectual and Developmental Disabilities
American Civil Liberties Union (ACLU)
American Foundation for the Blind
ANCOR (The American Network of Community Options & Resources)
Arc of Alabama
Arizona Center for Disability Law
Atlantis ADAPT
Autism Society of America
Autism Speaks
Autistic People of Color Fund (APOC)
Autistic Self Advocacy Network
Autistic Women & Nonbinary Network
Barbara L’Italien
Bazelon Center for Mental Health Law
Blue Peaks Developmental Services
Boston Center for Independent Living
Broadreach Training and Resources ltd
Broadreach training ltd
Caldwell Family Services Inc.
California Down Syndrome Advocacy Coalition
Callisto Services LLC
Caring Across Generations
Central Wisconsin ADAPT
Chattanooga Autism Center
Children and Adults with Attention-Deficit/Hyperactivity Disorder
CommunicationFIRST
Council of Parent Attorneys and Advocates
CQL | The Council on Quality and Leadership
Developmental Disabilities Coalition, Inc.
DisAbiity Rights Idaho
Disabilities Law Program, CLASI
Disability Law Center
Disability Law Center of Alaska
disAbility Law Center of Virginia
Disability Law Colorado
Disability Policy Consortium
Disability Right Idaho
Disability Rights Arkansas
Disability Rights California
Disability Rights Center -NH
Disability Rights Center of Kansas
Disability Rights Education & Defense Fund
Disability Rights Florida
Disability Rights Iowa
Disability Rights Maine
Disability Rights Maryland
Disability Rights Michigan
DISABILITY RIGHTS MISSISSIPPI
Disability Rights New Jersey
Disability Rights New York
Disability Rights North Carolina
Disability Rights of West Virginia
Disability Rights Ohio
Disability Rights Oregon
Disability Rights Pennsylvania
Disability Rights South Carolina
Disability Rights Tennessee
Disability Rights Wisconsin
Disabled Queers in Action
Down Syndrome Association of Central Florida
Dreamweavers, Inc. Supported Living
End The TTI
Epilepsy Foundation
Equip for Equality
Family Voices
Georgia ADAPT
Georgia Advocacy Office
Georgia Council on Developmental Disabilities
Gulf Coast Adapt
Hawaii Disability Rights Center
HELEN, The Journal of Human Exceptionality
Human Services Research Institute
ICAPA Network
IGNITE Collective, Inc.
Imagine
Institute on Disability at the University of New Hampshire
International Coalition Against Restraint and Seclusion (ICARS)
InVision Human Services
Japanese Speaking Parents Association of Children with Challenges (JSPACC)
Juvenile Law Center
Kentucky Protection and Advocacy
Lakeshore Foundation
MARC, Inc.
Maryland Coalition for Inclusive Education
Maryland Coalition of Families
Massachusetts Advocates Standing Strong (MASS)
Michigan Developmental Disabilities Council
Michigan Developmental Disabilities Institute
Michigan Disability Rights Coalition
National ADAPT
National Alliance on Mental Illness (NAMI)
National Alliance on Mental Illness, Massachusetts
National Association of Councils on Developmental Disabilities
National Association of State Directors of Developmental Disabilities Services
National Association of the Deaf
National Council on Severe Autism
National Disability Rights Network (NDRN)
National Down Syndrome Congress
National Health Law Program
National Organization of Nurses with Disabilities
Native American Disability Law Center
Neighborhood Access
Neighbours, Inc
Nevada Disability Advocacy & Law Center
New Haven Voices
North Dakota Protection & Advocacy Project
Not Dead Yet
Oklahoma Disability Law Center, Inc
Ollibean
Options in Community Living, Inc.
Place of Mind
Quality Trust for Individuals with Disabilities
RespectAbility
RespectABILITY Law Center
RISE Services, Inc
RISE UP, Inc.
Second Thoughts MA: Disability Rights Advocates Against Assisted Suicide
Shared Support Maryland
Syntiro
TASH
TASH New England
The Alliance for Citizen Directed Supports
The Arc – Jefferson, Clear Creek & Gilpin Counties
The Arc Michigan
The Arc of Alabama
The Arc of Hunterdon County
The Arc of Massachusetts
The Arc of the United States
The Arc of Virginia
The Collaborative For Citizen Directed Supports New Jersey
The National Leadership Consortium on Developmental Disabilities
The Partnership for Inclusive Disaster Strategies
Thinking Person’s Guide to Autism
Unsilenced Project Inc.
Uplift, Inc.
Values Into Action -New Jersey
Values Into Action -Pennsylvania
West Virginia Center of Excellence in Disabilities
Wildflower Alliance
Wings to Fly Therapy
WV Developmental Disabilities Council
References
| ↑1 | Food and Drug Administration. 21 CFR Parts 882 and 895. Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Proposed Rule https://www.govinfo.gov/content/pkg/FR-2016-04-25/pdf/2016-09433.pdf |
|---|---|
| ↑2 | Consolidated Appropriations Act of 2023, H.R. 2617 (Dec. 2022) SEC. 3306. https://www.congress.gov/bill/117th-congress/house-bill/2617 |
| ↑3 | No. 20-1087 JRC v FDA, Brief of Amici Curiae (Jan. 22, 2021), https://www.iassidd.org/wp-content/uploads/2021/02/As-filed-Amicus-Brief.pdf |
| ↑4 | https://abcnews.go.com/Nightline/shock-therapy-massachussetts-school/story?id=11047334 |
| ↑5 | U.S. Food andDrug Administration, Final Rule: Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior, 85 Fed. Reg. (Mar. 6, 2020), 13,312https://www.govinfo.gov/content/pkg/FR-2020-03-06/pdf/2020-04328.pdf. |