On April 25, the FDA published a Proposed Rule in the Federal Register banning the use of electrical stimulation devices (ESD) to treat aggressive or self-injurious behavior. In considering the ban, the FDA determined that the risks of ESDs outweighed any potential benefits. The FDA “determined, on the basis of all available data and information, that state-of-the art treatments for SIB [self-injurious behavior] and AB [aggressive behavior] are positive-based behavioral approaches, sometimes alongside pharmacotherapy, as appropriate, and do not include ESDs. We focused on data in the scientific literature, current clinical practices, and information about the evolution of treatments for SIB and AB.”
These devices are believed to be currently in use by only one provider in the country, the Judge Rotenberg Educational Center (JRC) in Canton, MA. The FDA’s proposed rule provides an extensive review of the use of ESDs by JRC and the opposition to it by state agencies in Massachusetts and New York, as well as the United Nations and the U.S. Department of Justice. An Advisory Panel recommended the ban in 2014. The FDA is proposing that the ban apply to devices already in use, as well as devices sold or commercially distributed in the future, although it is willing to allow for some period of transition for some individuals. The agency notes that for “certain individuals currently subject to ESDs, immediate cessation could possibly result in a significant increase of SIB or AB before appropriate alternative therapies are in effect, and a more gradual reduction toward complete removal may be necessary for some patients, especially those who have been subject to ESDs for a considerable amount of time.” The FDA welcomes comment on how long those transitions may take.
Comments on the proposed regulation are due May 25, 2016. The Arc has been involved in advocating against the use of these devices for decades and applauds this proposed rule.