As part of its coalition work, ANCOR has signed onto a letter requesting that the Food and Drug Administration (FDA) finalize a proposed rule to ban electronic shock devices. While the FDA’s fall regulatory agenda does note that a ban will be proposed, as of yet it has not been published for public notice and comment. This letter is particularly timely given the announced resignation of FDA Commissioner Scott Gottlieb, which will take effect in early April.
As written in the letter:
“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.”