Letter to Hon. Janet Woodcock, Acting Commissioner of the FDA - Ban Electric Shock Devices on Children and Adults with Disabilities

Letter

Dear Acting Commissioner Woodcock,

We are writing to thank the U.S. Food and Drug Administration (FDA) for acting to protect
some of our most vulnerable citizens. We are disappointed with the recent decision by the U.S.
Court of Appeals for the D.C. Circuit to overturn the FDA's ban on the use of electrical
stimulation devices (ESDs), also known as electric shock devices, on people with intellectual or
developmental disabilities. We understand the agency, along with the U.S. Department of Justice
(DOJ), has filed an appeal seeking a rehearing en banc. We appreciate your defense of the rule
and ask that you continue to prioritize the protection of people with disabilities by ending this
dangerous practice.

As you know, FDA has the authority to ban devices if it finds that the device presents substantial
deception or an unreasonable and substantial risk of illness or injury. It is clear after hearing
from individuals with intellectual and developmental disabilities, their families, and their
advocates that ESDs meet those criteria. The FDA's final rule last year also acknowledged that
the medical literature shows there are psychological and physical risks associated with the use of
these devices, including worsening of underlying symptoms, depression, anxiety, posttraumatic
stress disorder, pain, burns and tissue damage.

In addition, when issuing the final rule, FDA noted that of the 1,500 comments received, the
overwhelming majority of comments supported this ban. For these reasons, we encourage the
FDA, along with the DOJ, to continue to take every step necessary to protect children and adults
with disabilities.

Thank you for your consideration.