FDA Under Pressure To Finalize Ban On Shock Devices For People With Developmental Disabilities
With the White House set to change hands, nearly 200 advocacy groups are calling on the Food and Drug Administration to finalize a ban on the use of devices that administer electric shocks to address behavior issues in those with disabilities.
In a letter to top federal health officials, the organizations say that the FDA should act “as soon as possible” on a proposed regulation banning so-called electrical stimulation devices. The devices send electrical shocks through electrodes attached to the skin in order to condition people not to engage in self-injurious or aggressive behaviors.
“For nearly eight years since the FDA initially released its proposed rule to ban these devices, and for almost 10 years since a panel of experts recommended that they be banned, people with disabilities have continued to suffer from painful and dangerous electric shocks,” reads the letter from the Autistic Self Advocacy Network, the American Academy of Pediatrics, Autism Speaks, the National Disability Rights Network and dozens of others. “While we have seen support across multiple administrations, the further delay that will be caused by a change in administration and bringing them up to speed necessitates a release of the final rule as quickly as possible to ensure that members of our community are protected.”
Advertisement - Continue Reading Below
The FDA issued a proposed rule in March that would bar use of the electric shock devices and the comment period on the proposal concluded in May. Since that time, the agency has been reviewing the more than 8,700 comments submitted and weighing how to proceed.
The devices are only believed to be used at one facility in the country — the Judge Rotenberg Educational Center in Canton, Mass., which serves children and adults with developmental disabilities as well as those with behavioral and emotional problems. Officials at the center have said that the shock devices are used with clients who have exhausted other treatment options.
The FDA previously approved a ban on the electric shock devices in 2020 after determining that they posed an “unreasonable and substantial risk of illness or injury.” At the time, the agency cited evidence of psychological and physical risks including burns, tissue damage, worsening underlying symptoms, depression, anxiety and post-traumatic stress disorder.
However, the rule was overturned in 2021 by the U.S. Court of Appeals for the D.C. Circuit, which found that the FDA had overstepped its authority. Subsequently, Congress clarified that the FDA does have the right to ban the devices.
“Given the extensive time the FDA has taken to develop the final rule and the fact that there have been no material changes to the science underlying the FDA’s original 2020 decision to ban these devices, there is no need to delay this final rule further,” reads the advocacy groups’ letter, which urges top federal health officials to “devote all necessary resources to finalize the rule without further delays.”
Currently, the FDA’s unified agenda shows that a final rule is not expected until September 2025.
“This estimate is subject to change as the FDA continues to thoroughly review and assess all timely comments received on the proposed rule in accordance with our rulemaking procedures,” said Carly Pflaum, a spokesperson for the agency.
Read more stories like this one. Sign up for Disability Scoop's free email newsletter to get the latest developmental disability news sent straight to your inbox.