The following text was disseminated by Nancy Weiss at the National Leadership Consortium on Developmental Disabilities (NLCDD) via email. She has been working very closely with the team at the Autistic Self Advocacy Network (ASAN) for years on this issue.
There is very exciting news to share. We have been working with the FDA for several years urging them to require the Judge Rotenberg Center to have the GED, the electric shock device that is manufactured and used by JRC, receive FDA approval. Attached is a letter I wrote to the FDA in March of 2010 to this effect.
We have been in touch with the FDA fairly regularly over the last week or so. We received a call from the FDA this morning announcing much bigger news than we anticipated. They are convening an advisory panel on April 24th to help them decide if they should ban all electric devices used for aversive behavior modification. This announcement will be published in the Federal Register tomorrow and available here: http://federalregister.gov/a/2014-06766
In April, a group of us met with about 25 FDA representatives urging an analysis of whether the GED 4 (the most recent and powerful of the electric shock devices used at the Judge Rotenberg Center) was substantially similar to the original GED 1 (the original GED had been ‘grandfathered in’ on the basis of it being substantially similar to the SIBIS Helmet). The consideration of a decision to ban all electric shock devices used for aversive behavior modification was beyond what any of us thought possible.
There are only a few spots for oral testimony on April 24th. We will identify a select group of people to speak to the issues of efficacy and short and long term risks of contingent electric shock. The opportunity to testify at the hearing will be limited but if you are able to be in Washington DC on April 24th and want to testify or want to recommend someone with specific experience or expertise, please let me know. A small group is meeting on Friday to discuss our recommendations for people to speak.
Although opportunities to speak are limited, there is unlimited opportunity to submit written testimony. Again, they are more interested in issues of efficacy and risk than on what we view as right or humane; still, in written testimony, there is far more leeway regarding content.
Written submissions can be sent on or before April 14th to:
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, Rm. 1535
Silver Spring MD 20993-0002
There is more information here:
Remember that the deadline for written comments is April 14. I [Nancy Weiss at email@example.com] would appreciate a copy of course.
Here is more information:
On April 24, 2014, the committee will discuss the current knowledge about thesafety and effectiveness of aversive conditioning devices that are intended to deliver a noxiouselectrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. TheAgency is considering whether to ban aversive conditioning devices that are intended toadminister a noxious electrical stimulus to a patient to modify undesirable behavioralcharacteristics. The meeting will concern only devices classified under 21 CFR 882.5235(aversive conditioning device, class II) that are not self-administered. Devices which deliver anoxious electrical stimulus automatically are not considered to be self-administered devices.Section 516 of the FD&C Act (21 U.S.C. 360f) sets forth the standard for banning devices.Under that provision, in order to ban a device, FDA must make a finding that a device “presentssubstantial deception or an unreasonable and substantial risk of illness or injury” based on allavailable data and information. FDA regulations provide additional details about the procedures and standards for banning a device (21 CFR part 895).FDA intends to make background material available to the public no later than 2 businessdays before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of theadvisory committee meeting, and the background material will be posted on FDA’s Web siteafter the meeting. Background material is available at
http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.
FOOD AND DRUG ADMINISTRATION NOTICES
Neurological Devices Panel of the Medical Devices Advisory Committee
2014-06766 [Docket No. FDA-2014-N-0238; Filed: 03/26/14 at 8:45 am; Publication Date: 3/27/2014]