FDA Ban On Shock Devices For Those With Developmental Disabilities Faces New Hurdle

Now that the Food and Drug Administration is poised to again ban the use of electric shock devices on people with developmental disabilities, advocates warn that some in Congress are quietly trying to circumvent its plans.

A bill moving through the U.S. House of Representatives would limit the FDA’s ability to eliminate so-called electrical stimulation devices. The devices deliver electrical shocks through electrodes attached to the skin to condition people not to engage in self-harming or aggressive behavior.

Currently, the devices are believed to be used in only one facility in the country: the Judge Rotenberg Center in Canton, Massachusetts, which serves children and adults with developmental disabilities, as well as those with emotional and behavioral problems.

The effort comes as the FDA just wrapped up its comment period in May on a proposed regulation that would ban the use of electric shock devices. The agency is currently considering more than 8,700 comments it received and deciding whether to finalize the rule.

The FDA already approved such a ban in 2020, citing a “substantial and unreasonable risk of illness or injury” from the devices. At the time, the agency said evidence pointed to both psychological and physical risks, including burns, tissue damage, worsening underlying symptoms, depression, anxiety and post-traumatic stress disorder. However, the regulation was overturned when the U.S. Court of Appeals for the D.C. Circuit determined in 2021 that FDA officials had overstepped their authority.

Congress has since clarified that the FDA has the right to ban the devices, prompting the agency’s latest regulatory proposal.

Now, some members of the House are trying to tie the FDA’s hands once again. Earlier this month, a subcommittee approved a rider to a federal appropriations bill that would prevent the FDA from banning a device used by court order. Since everyone who participates in shock treatment at the Judge Rotenberg Center does so under court order, the provision would effectively nullify any FDA effort to ban the devices, the Autistic Self Advocacy Network said.

The measure will go before the House Appropriations Committee on July 10, according to the advocacy group, which is lobbying against the bill’s rider known as the Food and Drug Administration Related Agencies Appropriations Act. and Agriculture, Rural Development.

“We are grateful to see so many people in the disability community spring into action to contact their representatives who oppose the rider,” said Zoe Gross, advocacy director for the Autistic Self Advocacy Network. “We will continue to fight to remove the rider from the bill and preserve the FDA’s power to end electric shock torture at the Judge Rotenberg Center.”

The Rotenberg Center said in a statement that it supports the cyclist.

“Electrical stimulation devices (ESDs), used as part of JRC’s Applied Behavior Analysis treatment plan, are a matter of life and death for the small number of our clients who rely on them,” the statement reads. . “The parents and guardians of these JRC clients are committed to ensuring that this treatment continues to be available to those for whom all other treatment options have been tried and failed.”

In March, the FDA said it estimated that about 50 people at the Rotenberg Center had treatment plans that allowed the use of electrical stimulation devices.

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