FDA To Finalize Ban On Shock Devices Used On Those With Special Needs
Two years after proposing a ban on devices used to administer electric shocks on people with developmental disabilities, federal regulators say they intend to move forward with the plan.
The Food and Drug Administration will finalize a 2016 proposal to bar 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.
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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, 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 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 with 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 shocks are a needed option for individuals with severe behavior issues who have not responded to other approaches. In a statement, the center said that it will fight any efforts to ban the electric shock devices, noting a recent court decision in their favor.
“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 statement said. “As you are aware, JRC prevailed in the recent Massachusetts court trial where the court found that the treatment is humane, safe and highly effective for a population of clients who have exhausted all other options available to them and is only used as a treatment of last resort.”
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 — everyday — disabled people are being tortured in the name of ‘treatment,'” the group said in a statement.