This is the text of my personal (NOT official) submission to the Food and Drug Administration on its proposal to reclassify ECT for some, but not all, uses as a Class II device. I argue that it should also reclassify ECT as Class II for the other uses. Note that anyone can submit comments on the FDA proposal by the March 28, 2016 (just before midnight, EDT) deadline. Here’s the link for commenting.
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I am a law professor at Stanford, as well as a professor, by courtesy, of genetics. I direct Stanford’s Program in Neuroscience and Society, am a founder and director of the International Neuroethics Society, a member of the National Academy of Medicine’s Neuroforum, a member of the NIH Multi-Council Working Group on the NIH BRAIN Initiative, and the co-chair of the Neuroethics Work Group of that Multi-Council Working Group. I regularly teach a course at Stanford on FDA Law with respect of health.
I also have a close older relative whose sanity, and, given the effects of delusions on the person’s eating, whose very life, was saved from depressive psychosis in 2015 by electroconvulsive therapy (“ECT”). Drug treatment did nothing to slow a terrifying downward spiral; in twelve days, after the fifth ECT treatment, my relative was almost back to normal. I am not submitting this comment in any of the above capacities – except as a grateful but still worried family member – and speak only for myself.
I applaud the Draft Guidance from Administration for its decision to reclassify ECT as a Class II device for adults in the acute phase of a major depressive disorder.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.