[The following public comment was excerpted from a national sign on letter which Not Dead Yet joined and which was developed in May 2016 by Nancy Weiss of the National Leadership Consortium on Developmental Disabilities, Ari Ne’eman of the Autistic Self Advocacy Network and Alison Barkoff of the Bazelon Center.]
This comment is submitted by Not Dead Yet, a national disability rights organization (www.notdeadyet.org). The FDA took 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. We were pleased that the FDA finally recognized what the United Nations, disability advocates, researchers, psychiatrists and psychologists, families and people with disabilities have long claimed – these are devices of torture and abuse – and that their use would finally be ended. But FDA’s delay in finalizing these rules, by providing an additional two months of public comment understandably raised concerns about whether these rules will be finalized during this Administration.
The FDA is mandated to protect the health and safety of these individuals and must not delay further. In the six years since this issue was raised to the FDA and in the two years it took for the FDA to release proposed rules in response to the April 2014 hearing, many vulnerable people with disabilities 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, innocent and vulnerable children and adults are experiencing dramatic short and long term effects from this abusive treatment every day.
We urge HHS and the White House to prioritize and take all actions necessary to ensure these critical rules are finalized in this Administration. Secretary Burwell and Commissioner Califf, we ask that you devote any and all resources necessary to swiftly review comments and finalize the rules 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 final rule is shepherded through the Office of Information and Regulatory Affairs and published no later than October 31, 2016.
We appreciate – and are relying on – this Administration’s commitment to finally putting an end to the use of this dangerous and abusive device. It is an important legacy, consistent with President Obama’s efforts the past eight years to improve the health and well-being of all Americans, and we are hopeful that you will ensure this final regulation goes into effect before the President leaves office.