Despite Proposed FDA Ban, Shock Devices Remain
A day and residential school for those with special needs in Canton, Mass. is the only school in the country using an electrical shocking device that the Food and Drug Administration has proposed banning.
The Judge Rotenberg Educational Center, uses electrical stimulation devices, which send electrical shocks through electrodes attached to the skin.
In April 2016, the FDA proposed a rule banning the devices due to their “unreasonable and substantial risk to public health.” Since then, nothing has changed.
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The school has been under fire for its use of aversive therapies, or therapies that use painful or unpleasant stimuli to change an unwanted behavior, for decades.
A viral video in 2012 showed a student getting shocked more than 30 times over a seven-hour period. And last summer, Terri Du Bois told MassLive about her experiences at the school, saying she is still haunted by her time there and is too afraid to return to Massachusetts.
Last April — it seemed — that after decades of similar complaints of students and complaints by those in the industry, the FDA was on the side of disability advocates.
On April 22, 2016 the FDA proposed the rule banning the devices. There was then a comment period until May 25, which got extended until July 25.
Nine months later, the proposed rule remains untouched.
So why is the FDA taking so long to decide what course to take?
One reason may be that this would only be the third time the FDA has passed a ban on a medical device. The first time was in 1983 for prosthetic hair fibers, which were scalp implantation devices to simulate natural hair. The FDA, however, found the devices did not work and could cause serious injury or illness.
They have also recently placed a ban on powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. This rule was proposed April 1, 2016 and was banned Jan. 18.
A standard drug approval process takes the FDA about 10 months. But according to Stephanie Caccomo, FDA press officer, this doesn’t follow the same guidelines and the agency is unable to give a timeline on when it will be decided.
Another reason might be the topic’s complex nature.
On one hand, parents with children at the Rotenberg Center are often challenged greatly by keeping their children safe, be it from accidentally hurting themselves or others, balancing medication or finding a place in the public school system. The Rotenberg Center’s method, some contend, is the last hope for their children.
On the other hand, there are advocates, former students and staff members and the families of students who say the Rotenberg Center’s methods are harmful.
All of these opinions were offered during the comment period. Depending on the number of comments and information brought in during that time, it could take the FDA some time to sort through all of it.
No matter the reason, the ball is now in the court of the Trump administration.
Advocates had pushed the Obama administration to finalize the ban but were unsuccessful, which means it is transferred to the next administration.
“There are a couple of possibilities for this rule going forward,” said Samantha Crane, legal director at Autistic Self Advocacy Network. “One is the FDA could theoretically just finalize the rule.”
The other is much more complicated.
Typically, Crane said, when there’s an administration change, the head of the FDA looks over the pending rules and decides what moves forward. At this time, it’s not uncommon to rewrite the rule, issue a new notice and allow for another comment period.
“It could easily take another year,” Crane said.
Crane points out that the panel the FDA used to make this decision was academic, not political and is urging the administration to finalize the proposed rule, rather than go through these additional steps.
If the ban doesn’t pass, however, advocates say they aren’t giving up.
© 2017 MassLive.com
Distributed by Tribune Content Agency, LLC
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