Hello,

 

As a reminder, please consider taking time to submit comments to the FDA on the proposal to ban electrical stimulation devices. The deadline for submission is July 25, 2016 at 11:59 PM ET. Comments can be submitted at https://www.regulations.gov/comment?D=FDA-2016-N-1111-0382.

 

Attached, are draft comments from the DD Partners, they include on example from a Senate hearing a few years ago. In the notice, the FDA, also asks for examples of schools and facilities that are able to address the needs of students with the most challenging behaviors without the use of aversive interventions. Please do not share the comments from the partners as they are still being refined and have not yet been submitted, but feel free to use them as a model for your own comments. Given the extension of the time for input, it is incredibly important that the FDA is flooded with comments in support of the proposal to ban the device.

 

Below, is an email from Dan Shannon in MA, providing more information on this topic. We are both more than happy to answer any questions.

 

Regards,

Cindy Smith, MS, CAS, JD
Director of Public Policy

National Association of Councils on Developmental Disabilities

1825 K Street, NW Suite 600

Washington, DC 20006                                             

202-506-5813 ext 104

xxxxxx@nacdd.org

www.nacdd.org

 

From Dan Shannon:

Dear Council Colleagues: 

 

As you may know, the FDA is proposing to ban electrical stimulation devices used to treat aggressive or self-injurious behavior.  The FDA has issued a finding that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.  It’s important to note that this is only a ‘proposed rule’, subject to public comment. 

 

The FDA proposal may seem logical and straightforward, but history has shown that it is not.  As you may know the ban essentially addresses the practices of a specific organization based in Massachusetts.  This organization has been utilizing electrical stimulation devices for over three decades.  Their ability to do so has been supported through multiple court rulings, and efforts to ban the practice through the state legislature have always failed.  You may ask why such a ‘progressive’ state would allow such practices to continue.  The answer is found in simple politics.  The organization spends millions on lobbyists and has a well-organized group of supporters, including a few ’insiders’.  They have no qualms about parading family members of clients into hearings to provide gut-wrenching testimony about how their family members’ life was saved by this practice.  Simply put, they are a well-oiled and powerful machine.  The other issue we have always faced is if the practice were banned in Massachusetts the organization would simply pick up and move to another state, as they did when moving here after Rhode Island banned the practice.  It is also important to note that they use these techniques not only with people from MA, but also NY, CT, DE, FL, ME, NH, NJ, RI and VA (as of December 2015).  This is a national issue, and the FDA proposal provides a national solution.

  

Given the importance of this issue and the resources that opponents of the proposal can bring to bear, it is vitally important to overwhelm the FDA with comments supporting the proposed ruling.  I know that every individual connected with the MA organization will send comments to oppose the rule.  My hope is we can send 10 times more in support.  I am pleading that if you have not yet done so please send in comments to the FDA by July 25th.  Also, please urge everyone you know who supports the ruling to do the same.

 

To comment on the proposed rule: 

https://www.regulations.gov/docket?D=FDA-2016-N-1111

 

Talking points: https://silencebreakingsound.wordpress.com/category/uncategorized/#talkingpoints

 

Sample comments:

https://silencebreakingsound.wordpress.com/category/uncategorized/#samplecomment

 

Thank you.
Dan Shannon, MA DD Council

 

 

Hello,

 

Following up on Dan’s message, attached are draft comments from NACDD, AUCD and NDRN. As they are still in draft form, please do not share outside the Council. NACDD is also still working on possible comments from a few coalitions including the Consortium for Citizens with Disabilities and Alliance to Prevent Restraint, Aversive Interventions and Seclusion.

 

Please feel free to use as a template to develop your own comments. I encourage everyone to take the time to comment as this is a proposed ban on the use of the device that applies nationwide that we have been waiting for two years to be released. If you know of other schools or programs to highlight from your state (such as the Centennial School included in these comments), the FDA is looking for additional examples of schools/programs and would suggest including them in your comments.

 

The official federal register notice, and comments can be filed at https://federalregister.gov/a/2016-09433. Comments are due by Thursday May 25, 2016.  

 

Regards,

Cindy Smith

 

 

As a follow-up to my previous message, the Federal Register notice to be published on April 25^th is attached, as is an explanation of the FDA process for banning medical devices.

 

The Federal Register posting is only a ‘proposed rule’, subject to public comment.  It is important that people and organizations submit comments to the FDA during the 30 day comment period.  Instructions for comments are included in the notice.

 

Time to get to work!

 

 

 

From: FDA Office of Health and Constituent Affairs [mailto:xxxxxx@fda.hhs.gov]
Sent: Friday, April 22, 2016 9:03 AM
To: FDA Office of Health and Constituent Affairs
Subject: Proposal to Ban Electrical Stimulation Devices used to treat Self-Injurious or Aggressive Behavior

 

Good morning,

 

Today FDA announced that it is proposing to ban electrical stimulation devices used to treat aggressive or self-injurious behavior.  FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.  FDA is proposing to include in this ban both new devices and devices already in distribution and use.

 

For more information, please view the Federal Register display notice and the FDA Medical Device Bans webpage.

 

Sincerely,

 

Shannon Thor, PharmD, MS

Lieutenant, US Public Health Service

Health Programs Coordinator

Office of Health & Constituent Affairs
Office of External Affairs
U.S. Food and Drug Administration

           

 

 

 

 

Daniel M. Shannon, Executive Director

MA Developmental Disabilities Council

100 Hancock St., Suite 201

Quincy, MA 02171

Phone - 617-770-7676 X108

Fax - 617-770-1987

www.mass.gov/mddc

“Only those who dare to fail greatly can ever achieve greatly.”

Robert F. Kennedy

 

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