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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 email@example.com.