CQL | The Council on Quality and Leadership has joined 100 organizations in signing a new letter, urging the U.S. Food and Drug Administration (FDA) to finalize the rule banning electrical stimulation devices, prior to the change of administration. This letter was submitted on December 21, 2016, by Nancy Weiss of the National Leadership Consortium on Developmental Disabilities, Julia Bascom, of the Autistic Self Advocacy Network and Alison Barkoff, of the Center for Public Representation.
You can read the letter in its entirety:
December 21, 2016
Dr. Robert M. Califf, MD, MACC
Commissioner, U.S. Food and Drug Administration
10902 New Hampshire Avenue
Silver Spring, MD 20993
Re: Docket No. FDA-2014-N-0238
Dear Commissioner Califf,
We are writing again to urge the FDA to take action now to finalize the rule banning electrical stimulation devices. We urge you to take this action now before the change of administration.
On July 14, 2016 we met with leadership from the U. S. Department of Health and Human Services, including representatives from the Secretary’s Office, Office of Civil Rights and Administration on Community Living. This meeting was in follow up to a June 4, 2016 letter signed by seventy national and state disability organizations, urging the FDA to act expeditiously on the recommendations of the FDA’s Medical Devices Advisory Committee’s Neurological Devices Panel to ban aversive conditioning devices used for contingent electric shock and urging the FDA to finalize the rules banning these devices before the end of this Administration (copy attached).
We are writing to once again urge you to finalize these rules before the Administration ends. The FDA has now spent literally years gathering evidence, holding hearings and allowing the public to comment. The FDA rules were proposed on April 22, 2016 nearly eight months ago and a full two years after the Panel’s recommendations to ban the devices on April 14, 2014. Despite having already had multiple public comment periods related to the device, FDA allowed an extension of the comment period on the rule from a deadline of May 25 to July 25, 2016. It has now been more than twenty weeks since the extended comment period ended and time is running short.
At our July 14 meeting, representatives from the Secretary’s Office assured us that these rules were on the Department’s priority list to get completed by the end of this Administration. We hope you will hold to this commitment. As you are well aware, it is not only the disability community that is urging you to finalize these rules. On September 22, 2016, six U.S. Senators wrote to you expressing their strong support for the proposed rule to ban electrical stimulation devices to be finalized (copy attached).
We again urge you to stand by your commitment to us and take all necessary steps to finalize these rules before the end of this Administration. This Administration must swiftly take action to finally put an end to this unacceptable abuse and torture of people with disabilities. Please do not hesitate to contact us if you have any further questions.
Nancy R. Weiss, MSW
Director, National Leadership Consortium on Developmental Disabilities
University of Delaware
Julia Bascom, Incoming Executive Director,
Autistic Self Advocacy Network
Alison Barkoff, J.D., Director of Advocacy
Center for Public Representation
And the organizations below:
- A Better Life, LLC
- A Better Way of Living Inc
- Alliance for Person-Centered Accessible Technologies
- American Association on Intellectual and Developmental Disabilities (AAIDD)
- The American Association of People with Disabilities
- American Network of Community Options and Resources (ANCOR)
- ao Strategies
- The Arc of Massachusetts
- The Arc of the United States
- Arc of New River Valley
- ARC Rutland Area
- Asperger/Autism Network
- Association for Autistic Community
- Autism Delaware
- Autism Women’s Network
- Autistic Self Advocacy Network of Greater Boston
- Bazelon Center for Mental Health Law
- Branches of Life
- Capital Recovery Center
- Center on Disability and Community Inclusion
- Children’s Freedom Initiative
- Colorado Bluesky Enterprises, Inc.
- Colorado Developmental Disabilities Council
- Community Haven for Adults and Children with Disabilities
- Community Link
- Community Living Victoria
- Council of Parent Attorneys and Advocates, Inc.
- CQL | The Council on Quality and Leadership
- Creative Supports Institute
- Disability Law Center
- Disability Rights Center
- Disability Rights Vermont
- Douglas J Cartan & Associates Consultants
- Exceptional Parent Magazine
- F I R S T
- Georgia Advocacy Office
- Governor’s Advisory Council for Exceptional Citizens (GACEC)
- Hope House Foundation
- Human Services Research Institute
- Inclusion Alberta
- Inclusion Press
- Institute for Community Inclusion, UMass Boston
- Institute on Disabilities
- International Social Role Valorization Association
- InVision Human Services
- Jewish Family Service & Children’s Center of Clifton/Passaic
- Kendrick Consulting International
- Key Human Services, Inc.
- Keystone Institute
- Keystone Institute India
- The Learning Community for Person Centered Practices
- Libraries and Autism: We’re Connected
- Linda H. Rammler, Consultants
- Loveland Center, Inc.
- Lutheran Services in America Disability Network
- Massachusetts Association for Mental Health
- Massachusetts Developmental Disabilities Council
- Mental Health Legal Advisors Committee
- Metro Boston Recovery Learning Community
- National Alliance for Direct Support Professionals, Inc.
- Nat. Alliance on Mental Illness – Greater Boston Consumer Adv. Net.
- National Alliance on Mental Illness of Massachusetts (NAMI Mass)
- National Association of Councils on Developmental Disabilities
- National Council on Independent Living
- Neighbours International
- Northeastern University School of Law Disability Justice Caucus
- Not Dead Yet
- Occupy the Judge Rotenberg Center
- Ohio TASH
- Parent to Parent USA
- Partnership for People with Disabilities at VCU
- Paul V. Sherlock Center on Disabilities
- People First of Georgia
- Port Alberni Association for Community Living
- Respect ABILITY Law Center
- RISE Services, Inc
- Self-Advocacy Association of NY State, Inc.
- Self-Advocates Becoming Empowered
- Shared Support Maryland, Inc.
- TASH New England
- United Cerebral Palsy
- Values Into Action
- Vermont Center For Independent Living
- Vermont Clinical Training Consortium
- Vermont Coalition for Disability Rights
- Vermont Psychiatric Survivors, Inc.
- Virginia TASH
- Washington Metro Disabled Students Collective
- Wings to Fly Therapy and Play Center
- Wisconsin Board for People with Developmental Disabilities
- Yaldei Shluchei HaRebbe
Since 1969, CQL | The Council on Quality and Leadership has been a leader in working with human service organizations and systems to continuously define, measure, and improve quality of life and quality of services for youth, adults, and older adults with intellectual and developmental disabilities, and psychiatric disabilities. CQL offers accreditation, training, certification, research, and consultation services to agencies that share our vision of dignity, opportunity, and community for all people.