FDA Needs Written Statements Re: Electric Shock for Behavior Modification

April 9th, 2014

PLEASE FORWARD!
 
The Food and Drug Administration (FDA) is considering an important action that would ban the use of devices that use electric shock for behavior modification.
 
We need to assure the FDA receives as much written testimony as possible regarding this issue. The deadline for submitting statements is this Monday, April 14th.
 
Your written statement can be any length and can contain any information you want – your opinion about the use of electric shock for behavior modification, other ways of supporting people who have dangerous or difficult behaviors, issues of ethics and rights, research, etc. All comments are important and welcome.
 
Written submissions can be sent by mail to the address below if they can be received on or before April 14th. Or they can be submitted electronically by April 14th here:
http://www.regulations.gov/#!submitComment;D=FDA-2014-N-0238-0001
 
Click on the link above (or paste it into your browser) and you will receive a form. You can type (or copy and paste) your statement there or upload a document. You can choose to give contact information or to submit anonymously.
 
If you mail your statement it must be received by April 14th . Mail here:
Avena Russell
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, Rm. 1535
Silver Spring MD 20993-0002

 
and if you would, send me a copy as well:
nancy-weiss@comcast.net
 
The FDA’s decision will apply to the devices used at the Judge Rotenberg Center. These are not brief, uncomfortable shocks, but two-second long shocks that people describe as torture. Here is a link to a video of these devices in use:
http://www.youtube.com/watch?v=aAj9W0ntUMI
 
There will be a public meeting on the FDA’s decision about banning these devices on Thursday, April 24th from 8 am – 6 pm.  This is a public meeting and anyone who wants to come to the meeting to observe the proceedings is welcome:
Location: Holiday Inn, Main Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD 20879
The hotel's telephone number: 301-948-8900
 
There is more information about the FDA’s efforts here:
https://www.federalregister.gov/articles/2014/03/27/2014-06766/neurological-devices-panel-of-the-medical-devices-advisory-committee-notice-of-meeting-request-for ;
 
More Information:
The committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical 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. The Agency is considering whether to ban aversive conditioning devices that are intended to administer a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. 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 a noxious electrical stimulus automatically are not considered to be self-administered devices (therefore, will be considered). 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 "presents substantial deception or an unreasonable and substantial risk of illness or injury" based on all available 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 business days 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 the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting.
 
FOOD AND DRUG ADMINISTRATION NOTICES
Meetings:
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]
 
Nancy R. Weiss
Director, National Leadership Consortium on Developmental Disabilities
University of Delaware, Department of Human Development and Family Studies
111 Alison Hall West
Newark, DE 19716
Home Office: 443-318-4879 / www.nlcdd.org

Categories: IHDD


In this category: IHDD