Court Determined FDA Regulating the Practice of Medicine
The U.S. Court of Appeals for the D.C. Circuit ruled earlier this month, in a close 2-1 opinion, that the Food and Drug Administration (FDA) overstepped its authority when it issued a regulation last year banning a device that administers electrical shocks to people with developmental disabilities. The device, called the graduated electronic decelerator (GED), is known to be used at only one place — the Judge Rotenberg Educational Center in Canton, Mass. The facility has faced criticism for years for using the GED. Many disability advocates view the use of the device as a form of torture. The Judge Rotenberg Educational Center maintains that the GED is a treatment of last resort and used only when its recipients are at risk of grievous bodily harm or even death without it. When the FDA finalized its decision to ban the device last year, it was on the grounds of an “unreasonable and substantial risk of illness or injury.” The organization deemed these injuries to include burns, tissue damage, worsening of underlying symptoms, depression, anxiety, and post-traumatic stress disorder. The federal appeals court decided that the FDA does indeed have the authority to ban a device. However, in this case, they felt the agency overstepped its bounds since the regulation only sought to cease electrical stimulation devices for the purpose of treating aggressive or self-injurious behavior while still permitting these devices to be used for other purposes. The court determined this limited ban to be equivalent to regulating the practice of medicine, which is outside the authority of the FDA. Interestingly, the Rotenberg Center, parents, and advocates had differing opinions on the ruling. The center and parents praised the court’s decision. While advocates from the Autistic Self Advocacy Network called for the FDA to immediately pursue a new and complete ban of GED and similar devices.
