FDA Expected to Reissue Ban on Shock Devices for those with Disabilities

Feb 02, 2024

Disability advocates want the FDA to issue a new ban on the use of electrical stimulation devices to address self-injurious or aggressive behaviors.

by Michelle Diament | February 1, 2024

Source: Disability Scoop


Federal regulators are planning to issue a new ban on devices used to administer electric shocks on people with developmental disabilities more than two years after a previous effort was blocked in court.


The Food and Drug Administration indicated that it will put forth a proposed rule to prohibit so-called electrical stimulation devices though it’s unclear when. The devices send electrical shocks through electrodes attached to the skin in order to condition people not to engage in self-injurious or aggressive behaviors.


The agency already sought to disallow the devices, finalizing a ban in 2020 citing evidence of psychological and physical risks including burns, tissue damage, worsening underlying symptoms, depression, anxiety and post-traumatic stress disorder. But, the rule was overturned in 2021 when the U.S. Court of Appeals for the D.C. Circuit found that the FDA had overstepped its authority.


Since then, Congress passed legislation specifying that the FDA has the right to ban the devices and now the agency is poised to act anew.

“The FDA intends to issue a proposed rule on this topic,” Carly Pflaum, a spokesperson for the FDA, told Disability Scoop. However, Pflaum declined to provide any timetable or further details, instead pointing to a notice in the FDA’s Unified Agenda from last spring indicating that a proposed rule was expected last December.


Disability advocates say there is no time to waste and are amping up pressure on the agency.


In a letter sent last week to U.S. Secretary of Health and Human Services Xavier Becerra and FDA Commissioner Robert Califf, more than two dozen disability advocacy groups including the Autistic Self Advocacy Network, the Autism Society of America, The Arc and the National Disability Rights Network called on the agency to move forward on a ban without delay.


“It has now been eight years since the FDA released its first proposal to ban these devices and 10 years since a panel of experts recommended that they be banned. Over the decade that has passed since, people with disabilities have continued to suffer from painful and dangerous electric shocks,” the advocates wrote in their letter. “We urge you to take action now to end this abuse.”


The Judge Rotenberg Educational Center in Canton, Mass., which serves children and adults with developmental disabilities as well as those with behavioral and emotional problems, is the only facility in the country that is believed to be using the electrical stimulation devices. The center was behind the lawsuit that led to the previous FDA ban being overturned.



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