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Will The FDA Ban Shock Devices Used On Those With Special Needs?



Just one place in the country is known to use electric shock devices to modify the behavior of people with developmental disabilities. Advocates want to put an end to the practice.

With a series of call-in days, a petition, a sign-on letter and other efforts, disability advocacy groups are looking to turn up the heat on the Food and Drug Administration, calling on the agency to follow through on a proposed ban of so-called electrical stimulation devices.

The devices — which use electrodes attached to the skin to deliver electric shocks in order to condition individuals not to engage in self-injurious or aggressive behaviors — are only known to be in use at the Judge Rotenberg Educational Center, which serves children and adults with developmental disabilities as well as those with behavioral and emotional problems, in Canton, Mass.

The FDA proposed a ban on the devices two years ago saying that they “present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.” But the agency never finalized the plan.

Now, advocates are pressuring the Trump administration to act. On Friday, the Autistic Self Advocacy Network in conjunction with The Arc and the disability rights group ADAPT held the first of two planned call-in days, urging constituents to phone the FDA and ask Commissioner Scott Gottlieb to finalize the regulation.

Meanwhile, a petition calling for Gottlieb to act has over 4,000 signatures and disability advocacy groups have a sign-on letter in the works to send to the FDA. A similar letter in 2015 netted support from more than 60 organizations.

“Despite the arguments made by proponents, we know that it is possible to support everyone, including people with the most significant disabilities and the most challenges with self-injury or aggression in the community without aversives,” said Julia Bascom, executive director of the Autistic Self Advocacy Network. “The U.N. has rightly identified what is happening at the JRC (as) torture. The FDA agrees, which is why the 2014 panel recommended banning the device, and the proposed rule from 2016 would do exactly that. Given the urgency of the situation, it’s unfathomable why the FDA hasn’t put out the final rule.”

The latest push comes on the heels of a 12-day demonstration ADAPT held last month outside Gottlieb’s Washington, D.C. condominium urging the commissioner to implement the proposed ban. While ADAPT didn’t hear from Gottlieb, the group said at the time that U.S. Rep. Chris Smith, R-N.J., told them he would introduce federal legislation to ban electric shock devices used for therapeutic purposes.

For their part, the FDA remains noncommittal.

“The FDA continues its work on this important issue, including reviewing the comments submitted to the docket on our proposed ban,” agency spokeswoman Stephanie Caccomo told Disability Scoop. “We appreciate feedback from the public and patient groups and take their concerns seriously. We will communicate with the public any updates to the status of the proposed ban.”
 

Source: https://www.disabilityscoop.com/2018/04/16/will-fda-ban-shock-devices/24980/

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