This letter is available as a PDF here.
March 6th, 2019
Alex M. Azar II
U.S. Department of Health and Human Services
Food and Drug Administration
John Michael Mulvaney
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 express our deep appreciation to see that the final rule for the proposed ban of electrical stimulation devices (ESDs) used to treat self-injurious or aggressive behavior has been placed on the Federal Drug Administration (FDA)’s Fall regulatory agenda. For nearly three years since the FDA initially released its Proposed Rule to ban these devices, and for almost five 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 are relieved that the FDA finally plans to formally recognize what people with disabilities, disability advocates, researchers, psychiatrists and psychologists, families, and the United Nations have long known: these are devices of torture and abuse, and their use must end. We are pleased to see that the agency intends to take action in the coming year to end this abuse.
We further wish to reiterate what we expect from the final rule: a complete, immediate ban of the use of ESDs for behavior modification. In recognition of the severe harm these devices inflict, and in light of the abundant evidence the FDA has reviewed, we do not believe any sort of “phase-down” period or any form of “grandfathering” is warranted. Given the extensive time the FDA has taken to develop the final rule, as detailed below, we urge that it be released in its final form by the 5th anniversary of the panel–April 24th, 2019. Following the issuance of the rule, 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 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 rule is expeditiously finalized and released.
As you know, 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 home and community-based 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. The FDA additionally solicited public comment, and deliberated for 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. Despite having had multiple public comment periods related to the device, FDA allowed an extension of the comment period on the proposed rule from a deadline of May 25 to July 25, 2016. It has now been over thirty months since that comment period ended.
The FDA is mandated to protect the health and safety of these individuals and must not delay further. We appreciate the swift action the FDA has taken under Commissioner Gottlieb’s leadership on many products which threaten the health and well being of Americans, particularly young people. Just this past month, the FDA warned against the potential dangers of teething necklaces and jewelry products sometimes used by autistic people for sensory regulation. We urge you to treat this matter with the same urgency. In the nine years since this issue was raised to the FDA, some of our nation’s most vulnerable people have been 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, disabled children and adults are experiencing dramatic short and long term effects 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 Julia Bascom of the Autistic Self Advocacy Network at email@example.com, or 205-558-4894.
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Cc: Jeffrey Shuren
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