An FDA rule that sought to prohibit the use of electrical stimulation devices to address self-injurious or aggressive behaviors has been tossed out by a federal appeals court. (FDA/Flickr)
A group of senators is urging the Food and Drug Administration to keep up the fight after a federal court overturned the agency’s ban on devices used to administer electric shocks on people with developmental disabilities.
Seven Democrats sent a letter last week to the FDA asking the agency to continue its efforts to bar what are known as electrical stimulation devices.
“We are disappointed with the recent decision by the U.S. Court of Appeals for the D.C. Circuit to overturn the FDA’s ban on the use of electrical stimulation devices (ESDs), also known as electric shock devices, on people with intellectual or developmental disabilities,” reads the senators’ correspondence. “We appreciate your defense of the rule and ask that you continue to prioritize the protection of people with disabilities by ending this dangerous practice.”
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The letter is signed by Sens. Chris Murphy, D-Conn., Dianne Feinstein, D-Calif., Tina Smith, D-Minn., Tim Kaine, D-Va., Bob Casey, D-Pa., Richard Blumenthal, D-Conn., and Maggie Hassan, D-N.H.
Last year the FDA moved to bar electrical stimulation devices, which send electrical shocks through electrodes attached to the skin in order to condition people not to engage in self-injurious or aggressive behaviors. The decision came after the agency found that the devices posed an “unreasonable and substantial risk of illness or injury.” Regulators cited evidence of psychological and physical risks including burns, tissue damage, worsening underlying symptoms, depression, anxiety and post-traumatic stress disorder.
But in July, the D.C. Circuit Court of Appeals overturned the ban, ruling in favor of the Judge Rotenberg Educational Center, a Canton, Mass. facility that serves children and adults with developmental disabilities as well as those with behavioral and emotional problems. The Rotenberg Center is the only place in the country known to use the electrical stimulation devices, which the center says is a “treatment of last resort.”
That D.C. Circuit Court of Appeals decision came from three judges on the panel. In September, the FDA asked the court to reconsider the case before all of its 11 judges.
In writing the letter, the senators said they wanted to thank the FDA and show their support for the agency’s continued efforts to implement a ban.
“We encourage the FDA, along with the DOJ, to continue to take every step necessary to protect children and adults with disabilities,” the lawmakers wrote.
The FDA has said that it does not comment on ongoing litigation.
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Senators Back FDA On Electric Shock Device Ban - Disability Scoop
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