2 yrs After Ban Was Blocked in Court, FDA Continues Pushing To Eradicate Electrical Stimulation Devices Used To Control Self-Injurious or Aggressive Behavior

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The U.S. Food and Drug Administration (FDA) is taking a bold step by proposing a ban on electrical stimulation devices (ESDs) designed to address self-injurious or aggressive behavior. This is a significant move for the agency, as it rarely takes such actions. The FDA has thoroughly assessed these devices and concluded that they pose an unreasonable and substantial risk of illness or injury. It's worth noting that this is the second time the FDA has proposed a ban on these specific devices.

ESDs work by delivering electrical shocks through electrodes attached to a person's skin, with the aim of reducing or stopping harmful behaviors. However, this proposed rule seeks to prohibit the use of ESDs for self-injurious and aggressive behaviors. It's important to recognize that individuals who exhibit such behaviors may have intellectual or developmental disabilities that hinder their ability to communicate or make decisions about their own treatment.

These devices come with a range of psychological risks, including depression, anxiety, exacerbation of underlying symptoms, the potential development of post-traumatic stress disorder, as well as physical risks like pain, burns, and tissue damage. The FDA's proposal to ban these devices underscores their commitment to ensuring the safety and well-being of individuals who may be subjected to them.

Once the proposed rule is finalized, ESDs will be eradicated from the market, thereby losing their legal recognition. The Judge Rotenberg Education Center in Canton, Massachusetts is currently the only facility in the United States employing these devices. Approximately 50 individuals presently have treatment plans that involve or may involve the use of an ESD. It is important to allow these individuals sufficient time to gradually transition away from these devices and adapt their treatment plans accordingly. The FDA is committed to considering the needs of these patients if the proposed ban is ultimately approved.

The proposed rule carefully examines updated information gathered since the FDA's previous rulemaking on the risks and effects of ESDs in treating self-injurious and aggressive behavior. The agency considered a range of evidence, including clinical and scientific data, expert opinions, feedback from state agencies, comments on the previous proposed ban, input from patients and parents, and insights from disability rights groups and FDA advisory panels. It is worth noting that the new information reaffirmed the FDA's initial findings on the risks and benefits of ESDs for such behaviors, as well as the agency's stance that these devices pose significant risks to public health.

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In 2020, the FDA implemented a final rule prohibiting the devices from being sold in the market. However, this rule was invalidated by a federal appeals court, which stated that the FDA lacked the power to ban the devices under the Federal Food, Drug, and Cosmetic Act.

Following this court ruling, amendments to the act have been made to explicitly grant the FDA the authority to impose such a ban. This information was conveyed in a statement released on Monday.

The FDA said the devices “present 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.”

“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 agency said.

According to CNN, the Judge Rotenberg Educational Center made it clear in their statement on Tuesday that a court ruling in Massachusetts back in 2018 found no traces of psychological side effects on students who underwent their treatment. Going above and beyond, the school not only met reporting standards but also took the initiative to enhance supervision by implementing round-the-clock video monitoring, as stated in their official announcement.

“The responsible use of electrical stimulation devices as part of our Applied Behavior Analysis treatment plan is a matter of life or death for a small number of our clients,” the statement says. “The parents and guardians of clients at the Judge Rotenberg Educational Center will remain vigilant to ensure that this treatment remains available to those for whom all other treatment options have been tried and failed.”

The ban being considered would specifically target electrical stimulation devices designed for self-harm or aggression, excluding those used for different purposes like quitting smoking, as per the agency's announcement. The public can provide feedback on the proposal until May 28, and the FDA will take these comments into account when deciding on a final ruling.

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