April _, 2019
Norman Sharpless, M.D., Acting Commissioner
U.S. Food and Drug Administration
White Oak Office Building 1
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Jeffrey Shuren, M.D., J.D., Director
U.S. Food and Drug Administration
Center for Devices and Radiological Health
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Alex M. Azar II
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Secretary Azar, Acting Commissioner Sharpless and Director Shuren,
[We/I] write to express [our/my] support for the Federal Food and Drug Administration (FDA)’s proposed ban on electrical stimulation devices (ESDs) for use in treating self-injurious or aggressive behavior, as well as our support of the FDA’s recent decision to place finalization of the proposed rule on its regulatory agenda. The FDA found in its 2016 proposed rule that these ESDs are dangerous and provide no long-term benefit to children and adults with disabilities.The ESDs deliver an electric shock that the FDA found had side effects such as anxiety, post-traumatic stress disorder, depression, and tissue damage. There are plentiful and more effective alternatives to the use of ESDs, such as positive behavioral interventions and supports (PBIS), which better support the needs of individuals with aggressive and self-injurious behavior. In short, they “present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling,” as Commissioner Gottlieb stated in his blog on the agenda.
The FDA recommended that the devices be banned in 2016 and solicited additional public comments at that time. It has been nearly three years since the proposed rule’s last comment period ended, during which time these devices have still been in use on some of our most vulnerable citizens.
As [a Member of Congress/Members of Congress] with constituents who have significant disabilities, [I/We] feel that the FDA must take action and prohibit the use of dangerous devices that pose a risk to any segment of the public. Additionally, [any pertinent details with respect to the citizens with disabilities in the Member/Member of Congress’ states, or relating to whether that state has any citizens who are residents of the Judge Rotenberg Center].
[We/I] therefore strongly urge the Department of Health and Human Services, the FDA, and the White House to take any and all actions necessary to finalize the Rule without further delay.Sincerely,
[signature of Member/Members of Congress]