ASAN Letter Urging FDA to Release Final Rule

This letter is available as a PDF here.

November 25, 2024

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

Robert Califf
Commissioner
Food and Drug Administration

Shalanda Young
Director
Office of Management and Budget

Sent via electronic mail

Re: FDA proposed rule banning electrical stimulation devices

Dear Secretary Becerra, Commissioner Califf, and Director Young,

We the undersigned write to express our deep appreciation for the Food and Drug Administration’s (FDA’s) continued efforts to ban the use of electrical stimulation devices (ESDs) used to treat self-injurious or aggressive behavior, and to urge the FDA to take all necessary steps to release the final rule banning these devices as soon as possible. For nearly eight years since the FDA initially released its Proposed Rule to ban these devices, and for almost ten years since a panel of experts recommended that they be banned, people with disabilities have continued to suffer from painful and dangerous electric shocks. We appreciate that the FDA has, across three presidential administrations, recognized what people with disabilities, families, disability advocates, researchers, medical professionals psychiatrists and psychologists, and the United Nations have long known: these are devices of torture and abuse, and their use must end. While we have seen support across multiple Administrations, the further delay that will be caused by a change in Administration and bringing them up to speed necessitates a release of the final rule as quickly as possible to ensure that members of our community are protected.

Given the extensive time the FDA has taken to develop the final rule and the fact that there have been no material changes to the science underlying the FDA’s original 2020 decision to ban these devices, there is no need to delay this final rule further. Following the rule’s issuance, we expect the FDA to take prompt action to enforce the ban and ensure the safety and well-being of individuals known to have been subject to ESDs. Secretary Becerra and Commissioner Califf, we ask that you devote all necessary resources to finalize the rule without further delays. Additionally, we call on the White House to take all steps necessary to ensure that the rule is expeditiously finalized and released.

The FDA is mandated to protect the health and safety of these individuals and must not delay further. We appreciate the actions the FDA has taken under Commissioner Califf’s leadership to continue to protect the health and safety of individuals with disabilities and urge you to complete this work. In the fourteen years since this issue was first raised to the FDA, some of our nation’s most vulnerable people have been subjected to unbearably painful electric shocks for such harmless behaviors as getting out of their seats, interrupting, whispering, slouching, swearing, or failing to maintain a neat appearance. As the previous rule recognized and the proposed ban continues to note, disabled people are experiencing dramatic short and long-term harm from this abusive treatment every day. They cannot afford to wait any longer. We the undersigned urge HHS and the White House to prioritize and take all actions necessary to ensure this critical rule is immediately finalized and implemented.

If you have any questions about this letter, please contact Gregory Robinson of the Autistic Self Advocacy Network at grobinson@autisticadvocacy.org, or (202) 891-6500.

Signed,

10 Minutes A Day
A Better Life LLC
Access Ready Inc
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