FDA wants court to reconsider ban on shock devices for people with DID

0

An FDA rule to ban the use of electrical stimulation devices to combat self-injurious or aggressive behavior was rejected by a federal appeals court. (FDA / Flickr)

The Food and Drug Administration is fighting back after a federal court overturned its ban on devices used to administer electric shocks to people with developmental disabilities.

The federal agency filed a petition with the court this month seeking to reinstate a regulation released last year banning so-called electrical stimulation devices. The devices send electric shocks through electrodes attached to the skin to condition people not to engage in self-injurious or aggressive behaviors.

Only one location 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.

Advertising – Continue Reading Below

Disability advocates have pushed for years to end the use of skin shock devices arguing that the practice amounts to torture, but those who support the Rotenberg Center say the approach is needed for some people with severe behavior 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,” highlighting evidence of psychological and physical risks associated with the devices, including burns, tissue damage, worsening of underlying symptoms, depression, anxiety and post-traumatic stress. disorder.

The Rotenberg Center sued the regulation banning the devices, and in July, the United States Court of Appeals for the DC Circuit overturned the ban.

The 2-1 advisory revealed that the FDA exceeded its authority when it issued the regulations. While the FDA can ban a device, the court overturned the rule because it only banned electrical stimulation devices for the purpose of treating aggressive behavior or self-harm while still allowing the devices for other uses. . Such a limited ban qualifies as the regulation of the practice of medicine, which is outside the scope of the FDA, the court said.

Now, the FDA argues that the court ruling “wrongly and unnecessarily compels” the FDA in its efforts to protect public health.

“A divided panel of this court held that if a medical device has multiple uses, the FDA does not have the legal authority to ban a device for a particular use, as this would impermissibly regulate the practice of medicine. This position wrongly limits the power of the FDA to prevent the sale and distribution of medical devices for uses that present unjustifiable risks of pain, injury and psychological trauma, ”the FDA said in its filing.

The July decision came after the case was heard by three judges from the DC Court of Appeals. Now the FDA is asking that she appear before the eleven judges on the court.

Defenders of the Autistic Self Advocacy Network, which has long called for the ban, applauded the FDA’s decision.

“It is essential that the entire court react quickly to reinstate the ban – not only to prevent further torture, but also to ensure that the FDA can take action against other dangerous medical devices,” said the group in a press release.

An FDA spokeswoman declined to answer any questions about the case, saying the agency did not comment on “possible litigation, pending or pending.”

The Judge Rotenberg Educational Center did not respond to a request for comment on the case.


Source link

Leave A Reply

Your email address will not be published.