FDA Proposes Ban on Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior

The Food and Drug Administration (FDA) has announced a proposed rule to ban electrical stimulation medical devices used for the controversial treatment of “self-injurious or aggressive behavior.” This move comes as the agency’s second attempt to prohibit the practice, following a D.C. Circuit court ruling in July 2021 that challenged the FDA’s authority to ban specific uses of approved medical devices. Congress subsequently granted the FDA authority to ban specific intended uses of medical devices through the Food and Drug Omnibus Reform Act of 2022, clearing the way for the proposed rule.

The FDA initially proposed a ban in 2016 on the use of these devices for such purposes which was finalized in 2020, citing significant psychological and physical risks associated with the practice.

However, the Judge Rotenberg Educational Center in Massachusetts, which according to the decision was the sole facility utilizing these devices for this purpose, challenged the FDA’s authority to ban specific uses of approved medical devices. The U.S. Court of Appeals for the District of Columbia later ruled that while the FDA could ban medical devices, it couldn’t prohibit specific indications once a device is approved.

In response to the court ruling, seven senators, including Bob Casey (D-PA) and Christopher Murphy (D-CT), expressed disappointment to then-acting FDA Commissioner Janet Woodcock, highlighting the psychological and physical risks associated with the use of these devices.

The proposed rule comes with the FDA’s finding that these devices present an unreasonable and substantial risk of illness or injury that cannot be adequately addressed through labeling and does not apply to aversive conditioning devices intended to be used for other purposes outside of the scope of the rule. According to the FDA, approximately 50 patients currently have a treatment plan involving the use of electrical stimulation devices for such behaviors. The proposed rule is open for comment until May 28, 2024.