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Letter to FDA re: Electric Skin Shock Ban

Letter to FDA re: Electric Skin Shock Ban

January 23, 2024

Xavier Becerra
Secretary
U.S. Department of Health and Human Services

Robert Califf
Commissioner
U.S. Food and Drug Administration

Samuel Bagenstos
General Counsel
U.S. Department of Health and Human Services

Sent via electronic mail

Re: Proposed Rulemaking to Ban Use of Electric Skin Shock Devices

Dear Secretary Becerra, Commissioner Califf, and General Counsel Bagenstos,

We, the undersigned, write once again to urge the U.S. Food and Drug Administration (FDA) to release a proposed ban on the use of electric skin shock devices to treat a person’s self-injurious or aggressive behavior. Many of us have previously written to you in May 2023 urging you to begin the rulemaking process on this critical matter. It has now been eight years since the FDA released its first proposal to ban these devices and ten years since a panel of experts recommended that they be banned. Over the decade that has passed since, people with disabilities have continued to suffer from painful and dangerous electric shocks. We urge you to take action now to end this abuse.

Concerned individuals and 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 the use of the graduated electronic decelerator device and other Level III aversive techniques is prohibited for individuals receiving Medicaid-funded services. Following several years of consultation with advocates and clinical experts, –including a day-long public hearing in April 2014 that yielded almost 300 public comments– the FDA finally announced in April 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 placing labels on the devices. We were pleased that the FDA had finally recognized what the United Nations, disability advocates, researchers, psychiatrists and psychologists, families, and people with disabilities have long known – that these are devices of torture and abuse – and that their use would finally be ended.

However, nearly eight years later – and almost four years since the original rule to ban these devices was finalized – this abuse has been allowed to continue. In 2021, a federal court overturned this rule – not based on the facts and evidence of the harms caused by these devices, but on questions about the FDA’s authority to issue the ban. Since then, Congress has answered that question decisively. In the 2022 Consolidated Appropriations Act, Congress expressly affirmed the FDA’s legal authority to ban electric skin shock devices used to treat self-injurious or aggressive behavior. With this Congressional clarification of the FDA’s authority, the time has come for the FDA to act. Now is the time to issue a ban. There is no justification for further delay of release of a proposed rule, and tremendous harm for those subjected to these devices with each additional passing day.

The FDA is mandated to protect human health and safety and must not delay further.  In the years since this issue was first brought to the FDA, many people with disabilities have been subjected – without their consent –to unbearably painful 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  FDA has already recognized, innocent and vulnerable people are experiencing dramatic short- and long-term effects from this abusive treatment every day.

We the undersigned urge the FDA and HHS to take any necessary action to ensure a swift release of the proposed rule. Secretary Becerra and Commissioner Califf, we ask that you devote all necessary resources to swiftly issuing the proposed rule without further delays. Additionally, we urge you to ensure a swift review of comments and finalization of this rule following the comment period.

If you have any questions about this letter, please contact Greg Robinson of the Autistic Self Advocacy Network at grobinson@autisticadvocacy.org

Sincerely,

Access Ready Inc

American Association on Intellectual and Developmental Disabilities (AAIDD)

American Association of People with Disabilities

American Association on Health and Disability

American Civil Liberties Union (ACLU)

American Network of Community Options and Resources (ANCOR)

Autistic Self Advocacy Network

Autism Society of America

Autism Speaks

Autistic Women & Nonbinary Network

Bazelon Center for Mental Health Law

Center for Public Representation

Communication 4 ALL

CommunicationFIRST

Council of Parent Attorneys and Advocates (COPAA)

Council of State Administrators of Vocational Rehabilitation (CSAVR)

Epilepsy Foundation

Family Voices NJ

Lakeshore Foundation

Living Resources Inc

National Association of Councils on Developmental Disabilities

National Center for Parent Leadership, Advocacy, and Community Empowerment (National PLACE)

National Disability Rights Network (NDRN)

National Down Syndrome Congress

National Health Law Program

RespectAbility

SPAN Parent Advocacy Network

The Arc of the United States

The National Leadership Consortium on Developmental Disabilities

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