CQL | The Council on Quality and Leadership has joined nearly 200 organizations in urging the FDA, HHS and the White House to finalize the proposed ban of electrical stimulation devices. A formal letter officially requesting action and signed by 193 organizations, was submitted on June 1, 2016, by Nancy Weiss of the National Leadership Consortium on Developmental Disabilities, Ari Ne’eman of the Autistic Self Advocacy Network and Alison Barkoff of the Bazelon Center.
First in March 2010 and again in January 2013, advocates wrote the FDA urging that such dangerous and unnecessary devices be banned from use. In December 2012, CMS issued a letter stating that the use of electronic devices and other aversive techniques, is prohibited for those receiving Medicaid-funded services. In April 2013, the FDA and advocates met to discuss the use of electrical stimulation devices, and on April 24, 2014, there was a day-long hearing conducted, bringing together an advisory panel of scientific and clinical experts. Two years later, on April 22, 2016, the FDA announced that it had determined that these devices present an “unreasonable and substantial risk of illness or injury” that cannot be corrected or eliminated by labeling.
A comment period was also established for soliciting public feedback, and nearly 300 comments were submitted during that period, involving a proposed deadline of May 25, 2016. On May 20, 2016, the FDA announced that it would be extending the comment period for an additional 60 days, marking an extension following 6 years of prior advocacy efforts.
The letter requests that the Administration:
- Prioritize and take all actions necessary to ensure rules are finalized
- Devote any and all resources necessary to swiftly review comments
- Finalize the rules with an immediate effective date and no further delays
- Ensure that the final rule is published no later than October 31, 2016
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.