FDA Ban On Shock Devices For Those With Developmental Disabilities Faces New Hurdle
With the Food and Drug Administration poised to again ban the use of electric shock devices on people with developmental disabilities, advocates are warning that some in Congress are quietly trying to circumvent their plans.
A bill making its way through the U.S. House of Representatives would limit the FDA’s ability to do away with so-called 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.
Currently, the devices are only believed to be used at one facility in the country — the Judge Rotenberg Center in Canton, Mass., which serves children and adults with developmental disabilities as well as those with behavioral and emotional problems.
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The effort comes as the FDA just ended its comment period in May on a proposed regulation that would prohibit use of the electric shock devices. The agency is currently considering more than 8,700 comments it received and deciding whether to finalize the rule.
The FDA already approved such a ban in 2020, citing an “unreasonable and substantial risk of illness or injury” from the devices. At the time, the agency said evidence pointed to both psychological and physical risks including burns, tissue damage, worsening underlying symptoms, depression, anxiety and post-traumatic stress disorder. But, the regulation was overturned when the U.S. Court of Appeals for the D.C. Circuit determined in 2021 that FDA officials had overstepped their authority.
Since that time, Congress clarified that the FDA does have the right to ban the devices, which prompted the agency’s latest regulatory proposal.
Now, some House members are trying to tie the FDA’s hands yet again. Earlier this month, a subcommittee approved a rider to a federal appropriations bill that would prevent the FDA from banning a device that’s used by court order. Since all of the individuals participating in shock treatment at the Judge Rotenberg Center are doing so by court order, the provision would effectively nullify any FDA effort to bar the devices, the Autistic Self Advocacy Network said.
The measure is set to go before the House Appropriations Committee on July 10, according to the advocacy group, which is lobbying against the rider to the bill known as the Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act.
“We were grateful to see so many people in the disability community spring into action to contact their representatives opposing the rider,” said Zoe Gross, director of advocacy at the Autistic Self Advocacy Network. “We will continue to fight to remove the rider from the bill and preserve the FDA’s power to end electric shock torture at the Judge Rotenberg Center.”
The Rotenberg Center said in a statement that it supports the rider.
“Electrical stimulation devices (ESDs), used as part of JRC’s Applied Behavior Analysis treatment plan, are a matter of life or death for the small number of our clients who depend on them,” reads the statement. “The parents and guardians for these clients at JRC are committed to ensuring that this treatment remains available to those for whom all other treatment options have been tried and failed.”
As of March, the FDA said it estimated that about 50 people at the Rotenberg Center had treatment plans allowing for the use of electrical stimulation devices.
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