More than two years after a ban was blocked in court, federal regulators are seeking to stop the use of devices that administer electric shocks to address behavior issues in people with developmental disabilities.

The Food and Drug Administration said this week that it is proposing a ban on what are known as electrical stimulation devices intended to reduce or stop self-injurious or aggressive behavior. The agency said it has determined that the devices “present an unreasonable and substantial 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 overstepped its authority. Subsequently, Congress clarified that the FDA has the right to ban the devices prompting 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 in the FDA’s Center for Devices and Radiological Health, in a statement this week.

Faris said that the new proposal takes into account additional information from clinical and scientific data, experts in the field, individuals who have undergone treatment with the devices, disability advocates and others that’s been made 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 behavior, or the agency’s conclusion that these devices present unreasonable and substantial risk of illness or injury to the public,” Faris said.

In the proposal, the FDA highlights that some people who exhibit these types of behaviors have intellectual and developmental disabilities which 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 behavioral and emotional problems — is the only facility in the country believed to be using the electrical stimulation devices. The Canton, Mass. center was behind the lawsuit that brought an end to the FDA’s initial ban.

The FDA said it estimates that around 50 people at the Rotenberg Center currently have treatment plans that allow for the use of electrical stimulation devices and indicated that those individuals may need time to transition away from the approach.

“The FDA intends to consider the needs of these patients should we finalize the proposed ban,” Faris said.

Officials with the Rotenberg Center said they plan to fight the new proposal.

“The responsible use of ESDs as part of our applied behavior analysis treatment plan is a matter of life or death for a small number of our clients,” the center said in a statement. “The parents and guardians of clients at the Judge Rotenberg Educational Center will remain vigilant to ensure that this treatment remains available to those for whom all other treatment options have been tried and failed.”

The proposed rule will be up for public comment until May 28 at which point the FDA will review and decide whether to proceed with finalizing the regulation.

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