The FDA is proposing a new ban on the use of electrical stimulation devices to address self-injurious or aggressive behavior. (FDA/Flickr)
More than two years after a ban was blocked in court, federal regulators are seeking to stop the use of devices that deliver electric shocks to address behavioral problems in people with developmental disabilities.
The Food and Drug Administration said this week that it is proposing a ban about those known as electrical stimulation devices intended to reduce or stop self-harming or aggressive behaviors. The agency said it has determined that the devices “present a substantial and unreasonable risk of illness or injury.”
The FDA already finalized a similar rule in 2020, but the regulation was overturned in 2021 when the U.S. Court of Appeals for the D.C. Circuit found that the FDA had exceeded its authority. Congress later clarified that the FDA has the right to ban the devices powering the new effort.
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“These devices present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage,” said Owen Faris, acting director of the Office. of Product Evaluation and Quality at the FDA’s Center for Devices and Radiological Health, in a statement this week.
Faris said the new proposal takes into account additional information from clinical and scientific data, experts in the field, people who have undergone treatment with the devices, disability advocates and others that have been available since the previous ban was formulated. .
“Importantly, the new information supported and did not alter the FDA’s previous determinations regarding the risks and benefits associated with these devices when used for self-injurious or aggressive behaviors, or the agency’s conclusion that these devices present a unreasonable and substantial risk of illness or injury to the public,” Faris said.
In the proposal, the FDA notes that some people who exhibit these types of behaviors have intellectual and developmental disabilities that limit their ability to communicate or make independent decisions about treatment.
The Judge Rotenberg Educational Center, which serves children and adults with developmental disabilities as well as those with emotional and behavioral problems, is the only facility in the country believed to use electrical stimulation devices. The Canton, Massachusetts, center was behind the lawsuit that ended the FDA’s initial ban.
The FDA said it estimates that about 50 people at the Rotenberg Center currently have treatment plans that allow the use of electrical stimulation devices and indicated that those people may need time to wean off that approach.
“The FDA intends to consider the needs of these patients should we finalize the proposed ban,” Faris said.
Rotenberg Center officials said they plan to oppose the new proposal.
“Responsible use of ESD as part of our applied behavior analysis treatment plan is a matter of life and death for a small number of our clients,” the center said in a statement. “Parents and guardians of Judge Rotenberg Education Center clients will remain vigilant to ensure that this treatment continues to be available to those for whom all other treatment options have been tried and failed.”
The proposed rule will be open to public comment until May 28, at which time the FDA will review it and decide whether or not to proceed with finalizing the rulemaking.
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