FDA issues warning to Rotenberg Center over non-approved shock devices
December 13, 2012
The U.S. Food and Drug Administration has sent a warning letter to the Judge Rotenberg Educational Center in Canton, Mass., saying the Graduated Electronic Decelerators it uses to shock patients with autism and severe behavioral disabilities are in violation of FDA regulations.
The FDA says it has twice before notified the Center, on May 23, 2011, and June 29, 2012, that because changes were made to the device since it was approved, the center must file a new application for approval with the FDA. The Judge Rotenberg Center is the sole manufacturer of the GED device, and it is the only facility in the U.S. that uses it. The latest letter from the FDA was dated Dec. 6.
The device has been the subject of years of heated controversy. Supporters of the therapy, including scores of parents of patients at the Center, say it works after many other therapies have failed, and protects patients from harming others or themselves. But a broad range of critics, from Massachusetts lawmakers to national and international social justice organizations, say the shock device is tantamount to torture and should be abolished.
The device was approved in 1994. Later the Center made changes to the device, increasing the voltage used, according to a 2008 article in Boston Magazine. This amended device was called GED4, and a previous version of the device was called GED3A. The FDA’s letter says both of those versions of the device are out of compliance with FDA regulations.
The Judge Rotenberg Center previously told the FDA it would file a new amended application for approval by this month. But according to the Dec. 6 warning letter, the Center has so far failed to do that.
The regulatory agency has set a date of Jan. 9 for a meeting at the FDA headquarters in Silver Spring, Md., to discuss an “appropriate transition period” to discontinue use of the out of compliance devices.
The Judge Rotenberg Center emailed a statement to the Boston Business Journal that reads as follows:
"JRC will attend this meeting and will respond to the Warning Letter in writing, as requested. The FDA’s position is important to JRC. JRC continues to work closely with the FDA to address the issues identified in the Warning Letter; and JRC will continue to address any and all of the agency’s concerns. The use of the GED device is approved by the Massachusetts courts as part of behavioral treatment plans for people afflicted with the most dangerous forms of behavior disorders. The GED treatment has been in use at JRC for over twenty years and has proven to be extremely beneficial and lifesaving for students with whom all other treatments have failed."
The FDA said if the devices are used beyond the agreed-upon transition period, the products could be seized and responsible persons at the facility could face enforcement actions, including fines.
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