Under pressure from disability advocates, the Food and Drug Administration says it will finalize regulations sometime next year banning electrical stimulation devices used in administering electric shocks on people with disabilities.
The Food and Drug Administration will finalize a 2016 proposal to bar the so-called electrical stimulation devices, according to Scott Gottlieb, the agency’s commissioner.
“We believe these products present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling,” Gottlieb wrote.
The devices use electrodes attached to the skin to deliver electric shocks in order to condition individuals not to engage in self-injurious or aggressive behaviors.
The Judge Rotenberg Educational Center in Canton, Massachusetts, which serves children and adults with physical and developmental disabilities as well as those with behavioral and emotional problems, is the only facility in the country where the electrical stimulation devices are known to be used.
In a 2014 FDA report, investigators said that former students reported burns, scars, muscle spasms, seizures, and other issues from the skin shocks and said the experience left them “fearful” and “anxious.” The agency subsequently proposed a ban but has failed to act further.
Now, with a notice in its fall agenda, the FDA is formally signaling its intention to issue final regulations by the end of 2019.
The move comes after activists within the disability rights group ADAPT camped out in front of Gottlieb’s condominium in Washington, D.C. for 12 days earlier this year in an effort to pressure his agency to finalize the regulations.
The Rotenberg Center’s supporters say that electric shock is a needed option for individuals with a disability, especially those with severe behavior issues.
FDA spokeswoman Sandy Walsh said the rule is still being finalized and the agency “cannot speculate on specific timing.”
For their part, ADAPT said it is pleased to see that federal regulators plan to move forward, but will keep up the pressure until a ban is in place.
“We must continue to press the FDA to move forward as quickly as possible with this ban because — every day — people with disabilities are being tortured in the name of ‘treatment,'” the group said in a statement.
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