FDA Wants Court To Reconsider Ban On Shock Devices For Those With IDD
The Food and Drug Administration is fighting back after a federal court overturned its ban on devices used to administer electric shocks on people with developmental disabilities.
The federal agency filed a petition with the court this month in an effort to reinstate a regulation issued last year barring what are known as 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.
Only one place in the country is known to use the devices — 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.
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Disability advocates have pushed for years to end use of the skin shock devices arguing that that the practice is akin to torture, but those who support the Rotenberg Center say that the approach is needed for some people with severe behaviors who have tried other treatment options without success.
The FDA ban was the culmination of years of deliberation on the issue. Ultimately, the agency determined that the devices posed an “unreasonable and substantial risk of illness or injury,” pointing to evidence of psychological and physical risks from the devices including burns, tissue damage, worsening underlying symptoms, depression, anxiety and post-traumatic stress disorder.
The Rotenberg Center sued over the regulation disallowing the devices, and in July the U.S. Court of Appeals for the D.C. Circuit overturned the ban.
The 2-1 opinion found that the FDA overstepped its authority when it issued the regulation. While the FDA can ban a device, the court struck down the rule because it only barred electrical stimulation devices for the purpose of treating aggressive or self-injurious behavior while continuing to permit the devices for other uses. Such a limited ban qualified as regulating the practice of medicine, which is outside the scope of the FDA, the court said.
Now, the FDA is arguing that the court decision “mistakenly and unnecessarily constrains” the FDA in its efforts to protect public health.
“A divided panel of this court held that if a medical device has multiple uses, FDA lacks statutory authority to ban a device for a particular intended use because that would impermissibly regulate the practice of medicine. That holding erroneously limits FDA’s authority to prevent the sale and distribution of medical devices intended for uses that pose unjustifiable risks of pain, injury, and psychological trauma,” the FDA said in its filing.
The decision in July came after the case was heard by three judges on the D.C. Circuit Court of Appeals. Now, the FDA is asking that it go before all eleven of the court’s judges.
Advocates with the Autistic Self Advocacy Network, which has long pressed for the ban, applauded the FDA’s move.
“It is critical that the full court move swiftly to reinstate the ban — not only to prevent further torture, but also to ensure that the FDA can take action on other dangerous medical devices,” the group said in a statement.
A spokeswoman for the FDA declined to answer any questions about the case saying that the agency doesn’t comment on “possible, pending or ongoing litigation.”
The Judge Rotenberg Educational Center did not respond to a request for comment on the matter.