Sending Office: Honorable Christopher H. Smith
Sent By:
Marisa.Kovacs@mail.house.gov
Good Morning,
As you may know, in 2016, the FDA issued a proposed ban on electrical stimulation devices (ESDs) intended to treat self-injurious or aggressive behavior, often in individuals with autism and/or other developmental disabilities. There are a number of proven
treatments, such as positive behavioral support, and medications, which are widely used to curb self-injurious behavior. In fact, only one center in the United States is known to still use ESDs on individuals with disabilities, who are self-injurious. However,
despite the initial proposed ban’s introduction over 2 years ago, the FDA has not finalized the rule. ESD is only used to treat self-injurious behavior at one facility in the U.S., the Judge Rotenberg Center in Massachusetts, and its use has twice been cited
by the United Nations Special Rapporteur on Torture, the most recent report attached (citation on page 83).
The Massachusetts governor’s office sued to stop the practice in 2013, but last week the Bristol County Probate and Family Court ruled that the state failed to demonstrate that the procedure “does not conform to the accepted standard of care for treating
individuals with intellectual and developmental disabilities”.
Working with the ARC, Autism Speaks, ADAPT, and the Autistic Self Advocacy Network, Rep. Smith has drafted the below letter, asking FDA to expeditiously finalize the rule. Please join us in in sending the below letter to Commissioner Gottlieb.
Please let me know if you have any questions or if your boss would like to sign on by COB Friday.
Marisa Kovacs (marisa.kovacs@mail.house.gov or 202-225-3765)
July 10, 2018
Secretary Alex M. Azar II Scott Gottlieb, M.D., Commissioner
U.S. Department of Health and Human Services U.S. Food and Drug Administration
200 Independence Ave, S.W. White Oak Office Building 1
Washington, DC 20201 1093 New Hampshire Avenue
Silver Spring, Maryland 20993
Dear Secretary Azar and Commissioner Gottlieb:
We write today to express our strong support for the FDA’s April 22, 2016 proposed ban on electrical stimulation devices (ESDs) intended to treat self-injurious or aggressive behavior and to ask you to expeditiously finalize the ban.
As you’re aware, there are a number of proven treatments, such as positive behavioral support, and medications, which are widely used to curb self-injurious behavior. In fact, only one center in the United States is known to still use ESDs on individuals
with disabilities, who are self-injurious.
The use of these painful, dangerous, and thoroughly unnecessary devices in the United States has been cited by the United Nations Special Rapporteur on Torture in its Report on torture and other cruel, inhuman, or degrading treatment or punishment.
In its proposal, FDA acknowledged that side effects of ESDs include: “depression, anxiety, worsening of self-injury behaviors and symptoms of posttraumatic stress disorder, pain, burns, tissue damage and errant shocks from a device malfunction.” Additionally,
the FDA found that the evidence “does not establish that ESDs improve the underlying disability” or successfully reduce the incidence of self-injurious behaviors over the long term.
As you know, when the FDA announced the proposed ban, the Administration stated that ESDs “present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling.” Dr. William Maisel, the current
Chief Medical Officer and Director of the Office of Device Evaluation at the Center for Devices and Radiological Health said at the time “These devices are dangerous and a risk to public health–and we believe they should not be used.”
We agree with Dr. Maisel and with FDA and ask that the FDA immediately finalize the 2016 rule. We further request your assistance in securing a meeting, including Secretary Azar, with the disability rights community with respect to the importance of finalizing
the proposed ban of ESDs and the existence of effective, evidence-based treatments for self-injurious behavior.
Sincerely,
CHRISTOPHER H. SMITH
Member of Congress
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