A recent ruling by the D.C. Circuit Court of Appeals in a seemingly obscure case has important implications for limits on the Food and Drug Administration’s regulatory reach and for the freedom of physician–patient relationships.
The case had an unusual background. The Judge Rotenberg Educational Center in Massachusetts treats people with severe mental disabilities including severe self-injurious or aggressive behaviors such as head-banging and self-biting. Some self-injurious patients do not respond to conventional therapies. The center, with oversight from state authorities, uses an electrical-stimulation device to briefly shock these patients to reduce or cease their behaviors. While electrical stimulators are used to treat a wide variety of conditions, the center is the only facility in the country that utilizes them for self-injurious behaviors.
In 2016 the FDA proposed banning electrical-stimulation devices to treat self-injurious behaviors, based on its determination that the device’s long-term effectiveness was uncertain for that indication and that it posed a risk of substantial and unreasonable harm to patients. The agency issued a final rule based on those findings in 2020.
Families and guardians of self-injurious patients disagreed with the FDA’s benefit–risk determination, stating that the devices had been the only effective means of deterring serious patient self-injury. Along with the center, they sued to reverse the FDA’s ban. The baseline legal question was: Does the FDA have authority to ban an otherwise legal device from a particular use while allowing it for other uses? The court answered, 2–1, in the negative.
All the parties agreed that the FDA has the power to ban a medical device altogether. One section of the Food, Drug & Cosmetics Act (21 U.S.C. §360f) gives the agency authority to ban a device that poses “an unreasonable and substantial risk of illness or injury.” But another section of the statute, entitled “Practice of medicine” (21 U.S.C. §396), prohibits the FDA from “limit[ing] or interfer[ing] with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner–patient relationship.”
The FDA did not extend its ban to other uses of the electrical-stimulation devices. The devices were, for example, still approved to treat tobacco, alcohol, and drug addictions. The two-judge majority reasoned that if a device could be legally marketed for those conditions, then section 396 constrains the agency’s authority to ban a practitioner from prescribing it for another condition — self-abusive behavior.
Read the full article at National Review.