Source: United States Senator for California – Dianne Feinstein
Washington–Senator Dianne Feinstein (D-Calif.) joined Senator Chris Murphy (D-Conn.) and a group of their colleagues to urge the Food and Drug Administration (FDA) to continue fighting for a ban on the use of dangerous electrical stimulation devices (ESDs), also known as electric shock devices, on children and adults with intellectual or developmental disabilities. This summer, the U.S. Court of Appeals for the D.C. Circuit overturned the FDA’s ban on ESDs. The agency with the U.S. Department of Justice (DOJ) has since filed an appeal. In a letter to Acting Commissioner Janet Woodcock, the senators expressed support for the appeal and urged the agency to continue prioritizing the protection of those with disabilities.
“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,” the senators wrote. “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.”
The senators continued: “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.”
“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,” the senators concluded.
Senators Tina Smith (D-Minn.), Tim Kaine (D-Va.), Bob Casey (D-Pa.), Richard Blumenthal (D-Conn.) and Maggie Hassan (D-N.H.) also signed the letter.
Full text of the letter can be found here and below:
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.[1] 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.
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