Advocates Call On FDA To Reissue Ban On Shock Devices For Those With Disabilities
The Food and Drug Administration is under pressure to ban devices used to administer electric shocks on people with developmental disabilities years after a previous attempt was blocked in court.
More than 100 disability advocacy groups have written to the federal agency to ask that a new regulation be issued to bar what are known as electrical stimulation devices. 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 FDA finalized a regulation in 2020 to disallow use of the devices after finding that they posed an “unreasonable and substantial risk of illness or injury.” At the time, federal regulators cited evidence of psychological and physical risks including burns, tissue damage, worsening underlying symptoms, depression, anxiety and post-traumatic stress disorder.
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But the rule was overturned in 2021 by the U.S. Court of Appeals for the D.C. Circuit, which found that the FDA had overstepped its authority. Congress then passed legislation late last year clarifying that the agency does have the right to impose a ban.
Now, advocates are calling on the FDA to act again.
“For two years since the FDA’s original ban on these devices was overturned by the courts, — eight years after 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 urge you to end this abuse,” reads the letter signed by the Autistic Self Advocacy Network, the National Disability Rights Network, the American Academy of Pediatrics, the American Civil Liberties Union and dozens of other organizations.
Currently, the devices are believed to be used at only one facility in the U.S. — 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. The center was responsible for the lawsuit that got the previous FDA ban overturned.
“The parents and guardians of clients of the Judge Rotenberg Educational Center (JRC) will continue to work to ensure that that the life-saving electrical stimulation device (ESD) treatment remains available to those for whom all other treatment options have been tried and failed,” the Rotenberg Center said in a statement. “JRC is prepared to defend this life-saving treatment again at FDA and, if necessary, in court.”
An FDA spokesperson said the agency has received the advocates’ letter and is considering its options in light of the legislation approved last year.
“The agency is continuing to evaluate the provisions in the omnibus legislation and their impact with regards to the oversight of these devices,” the spokesperson said.
Zoe Gross, director of advocacy at the Autistic Self Advocacy Network, said representatives from her group and others recently met with the FDA and “we felt that they are taking our concerns seriously.”
“We have not heard from them about when we can expect another rule, but I am hopeful that it will be soon,” she said. “It is vital that the FDA acts as quickly as possible, since every day of delay is another day that our community members at the Judge Rotenberg Center are being tortured with electric shocks.”
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