FDA proposes ban on electrical stimulation devices at Canton center for people with disabilities

CANTON, Mass. — In a step rarely taken by the agency, the Federal Drug Administration is proposing a ban on electrical stimulation devices used for self-injurious or aggressive behavior, which are used at a Canton center for people with disabilities.

The devices, known as EDSs, are “intended to reduce or stop self-injurious or aggressive behavior,” the FDA said in a statement on Monday. They are only used at the Judge Rotenberg Education Center in Canton, a day and residential school for people with severe autism and other developmental disabilities.

The FDA estimates around 50 people at the Canton home currently have a treatment plan that includes the use, or potential use, of an ESD.

“The agency has determined that these devices present an unreasonable and substantial risk of illness or injury,” the FDA said in its statement, noting that this is the second time the FDA has proposed a ban of these particular devices.

ESDs deliver electrical shocks through electrodes attached to an individual’s skin to attempt to reduce or stop harmful behaviors.

“This proposed rule proposes to ban ESDs intended for self-injurious and aggressive behaviors,” the FDA said. “Notably, some people who exhibit self-injurious or aggressive behavior have intellectual or developmental disabilities that make it difficult for them to communicate or make their own treatment decisions.”

The devices have a number of psychological risks, including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage, the FDA said.

In a statement, the Judge Rotenberg Education Center called ESD treatments “life-saving.”

“The Judge Rotenberg Educational Center (JRC) will continue to advocate for and, if necessary, litigate to preserve the court-approved, life-saving ESD treatment,” the center said in its statement. “FDA has once again made a decision to move forward with a ban of this treatment based on politics, not facts The D.C. Circuit Court of Appeals vacated a similar 2020 FDA rule banning the use of our treatment and we are confident that we will once again prevail on behalf of our clients and their families.”

“JRC has provided countless hours of testimony, volumes of information and made clinicians, other staff and family members of our clients, or clients themselves, available to the FDA over the past 13 years,” the center said in its statement. “The FDA previously attempted to ban ESDs without giving a fair hearing to JRC or the parents. Fortunately, JRC successfully appealed the ban to the United States Court of Appeals for the D.C. Circuit, where the Court found that the FDA was illegally engaging in the practice of medicine. Judge Rotenberg Educ. Ctr., Inc. v. United States Food & Drug Admin., 3 F.4th 390, 393 (D.C. Cir. 2021).”

“In moving toward a ban, the FDA is citing risk of injury and PTSD, however, after 44 days of testimony, a 2018 Massachusetts court decision found that: there was no evidence as to any psychological side effects experienced by JRC students receiving electric skin shock aversive treatment,” the center said in its statement. “The Court also found that the GED devices effectively treat the severe problem behaviors of JRC clients, and that there is no evidence of physical or psychological side effects from ESD treatment when used according to JRC’s policies and protocols.”

“In 2023, The Massachusetts Supreme Judicial Court affirmed the trial court’s findings that the ESD treatment is safe and for some patients the only effective treatment for their life-threatening self-abuse and aggression,” the center said. “JRC has exceeded all reporting requirements, and the school opted many years ago to install a 24 hour per day video monitoring system - offering unprecedented oversight of the students and staff.”

Meanwhile, in a statement, the Autism Self Advocacy Network praised the FDA’s proposed ban of the devices.

“We’re excited to see the FDA release their proposed ban on the use of electric shock devices for behavior modification,” the statement said. “Tomorrow begins a 60-day public comment period when Americans can weigh in on the rule, and we hope that people who care about disability rights will submit public comments in support of the proposed ban. ASAN will have lots of information about how to do that available on our website and social media in the coming days and weeks.”

The proposed FDA ban, if finalized, will remove ESDs from the market, and the devices will no longer be considered legally marketed.

“Those exposed to these devices may need time to gradually transition away from this device and adjust treatment plans,” the FDA said. “The FDA intends to consider the needs of these patients should we finalize the proposed ban.”

The FDA’s first ban of these devices in 2020 was challenged in court and vacated based on the court’s interpretation of the FDA’s authorities under the Federal Food, Drug, and Cosmetic Act. Since that decision, changes to the FD&C Act make clear that the FDA has authority to issue a ban such as the previous ban on ESDs for self-injurious or aggressive behavior, which applies to specific intended uses.

The proposed rule does not apply to aversive conditioning devices intended to be used for other purposes, such as those used to stop smoking, which are outside the scope of this rule, or other FDA-cleared or approved devices or technologies.

Evidence considered by the FDA in proposing the ban included clinical and scientific data, input from experts in the field and state agencies, comments received from the previous proposed rule to ban ESDs, input from patients and parents of individuals who have been treated with ESDs, and disability rights groups, as well as insights from FDA advisory panels, officials said.

“Importantly, the new information supported and did not alter the FDA’s previous determinations regarding the risks and benefits associated with these devices when used for self-injurious or aggressive behavior, or the agency’s conclusion that these devices present unreasonable and substantial risk of illness or injury to the public,” the FDA said.

The Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior will be open for comment until May 28. The FDA will then review and consider comments before determining whether to issue a final rule.

This is a developing story. Check back for updates as more information becomes available.

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