FDA Misses Deadline To Ban Devices Used To Shock Those With Special Needs
The Food and Drug Administration missed its own deadline to finalize a ban on devices used to administer electric shocks on people with developmental disabilities.
The agency said in late 2018 that it intended to finalize a 2016 proposal to disallow so-called electrical stimulation devices. At the time, the FDA said regulations would be issued by the end of 2019, but to date, no action has been taken.
At issue are devices that use electrodes attached to the skin to deliver electric shocks in order to condition individuals not to engage in self-injurious or aggressive behaviors.
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There is only one facility in the country — the Judge Rotenberg Educational Center in Canton, Mass. — where the electrical stimulation devices are known to be used.
The proposed ban on the devices came after a 2014 FDA report detailed how former students at the center — which serves children and adults with developmental disabilities as well as those with behavioral and emotional problems — reported burns, scars, muscle spasms, seizures and other issues from the skin shocks. The report said the experience left former students “fearful” and “anxious.”
Disability advocates who have been pressing for an end to the shock devices for years are dismayed by the continued delays.
“We are deeply disturbed that the FDA has missed its deadline to finalize the ban,” said Julia Bascom, executive director of the Autistic Self Advocacy Network. “It has been almost six years since the hearing at which the FDA concluded that these devices were harming disabled children and adults. How much longer do they have to wait?”
The FDA now says that it is still working to move forward.
“Before issuing a final rule, the agency must carefully review comments submitted to the public docket in connection with the proposed ban on electrical stimulation devices, including lengthy comments on scientific and legal issues,” Jim McKinney, a spokesman for the FDA, told Disability Scoop. “FDA has been working to issue the final rule as closely as possible to the plan announced in the Fall 2019 Unified Agenda. Issuing this final rule remains a priority for FDA.”
For its part, the Judge Rotenberg Educational Center said that it would take action, if needed, to ensure that electrical stimulation devices can continue to be used.
“The Judge Rotenberg Educational Center (JRC) and the families whose children receive, or have received, this life saving treatment will continue to advocate and will move to litigate if that becomes necessary to preserve this court approved treatment,” the center said in a statement.