FDA Moves Forward with Ban on Devices Used to Administer Electric Shock on People with DD

Topics: Announcements,

According to a recent article is Disability Scoop,” 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.

 “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.”

“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.”

NASDDDS signed on to a letter to the secretary of HHS and leadership at the FDA in support of banning these devices.

FMI https://www.disabilityscoop.com/2018/12/17/fda-finalize-ban-shock-devices/25822/.

The letter can be found here: https://www.nasddds.org/uploads/documents/Letter_Requesting_FDA_finalize_ban_on_Electrical_StimulationDevices_%286.1.16%29.pdf.